Evelyn Pringle November 7, 2007
Since August 2006, as part of an on-going, multistate investigative effort by approximately 30 states, Eli Lilly has received civil investigative demands or subpoenas seeking a broad range of documents relating to the company's marketing and promotion of the antipsychotic drug
Zyprexa, and more states are expected to join the effort.
In addition, a total of ten states are now suing Lilly for Medicaid fraud to recover the cost of Zyprexa purchases for persons covered by the program, along with the past and future costs of treating Zyprexa-related illnesses. Alaska, Arkansas, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, Utah and West Virginia have filed cases thus far.
Zyprexa belongs to a new generation of antipsychotic drugs known as "atypicals" which arrived on the US market in 1994, beginning with Risperdal, marketed by Johnson and Johnson subsidiary Janssen. Other drugs in this class include Seroquel, sold by AstraZeneca; Geodon, by Pfizer; Abilify, from Bristol-Myers Squibb and Clozaril, marketed by Novartis.
For the first four years that Zyprexa was on the market in the US, it was only approved to treat adults with schizophrenia, and it was not until 2000 that the FDA approved the drug for adults in the manic phase of bipolar disorder.
However, in a matter of a few short years, Lilly turned Zyprexa into its best-selling product, despite the drug's extremely limited approved uses, by influencing doctors to prescribe the drug off-label.
In addition to prescribing a drug for unapproved uses, off-label can mean treating an approved condition for a longer duration of time, or prescribing a drug in combination with other drugs, or at a different dosage, or to a different patient population such children or the elderly, other than those specified on the FDA-approved label.
According to Lilly's SEC filings, the Office of the US Attorney for the Eastern District of Pennsylvania has also advised Lilly that it has commenced a civil investigation related to the company's marketing and promotion of Zyprexa, and a "number of State Medicaid Fraud Control Units are coordinating with the EDPA in its investigation of any Medicaid-related claims relating to Lilly's marketing and promotion of Zyprexa."
Lilly has also received subpoenas from the Office of the Attorney General of the State of Illinois, and the Florida Office of the Attorney General, Medicaid Fraud Control Unit, asking for documents relating to sales, marketing and promotion of Zyprexa.
Lilly's SEC filings also report that the company has received requests for information related to the company's marketing and promotion of Zyprexa from the offices of Representative Henry Waxman, Chairman of the House Committee on Oversight and Government Reform, and Senator Charles Grassley, the ranking Republican on the Senate Finance Committee.
Collectively, the Medicaid fraud lawsuits allege that Lilly illegally influenced doctors to prescribe Zyprexa off-label to patients, including children, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, Alzheimer's, Tourette's syndrome, dementia and other unapproved indications.
The lawsuits also allege that Lilly concealed the adverse effects associated with Zyprexa, including drastic weight gain, high blood sugar levels, diabetes and pancreatitis.
Other serious adverse effects known to be associated with Zyprexa include Parkinson-like symptoms, akathisia, tardive dyskinesia, dystonia, hypotension, constipation, tachycardia, seizures, liver abnormalities, white blood cell disorders and death.
The Mississippi lawsuit alleges that about 10% of Zyprexa patients have developed diabetes, some of whom are children, even though Zyprexa "has never been approved for, nor found to be effective, in the treatment of children."
An estimated 1,500 Utah Medicaid patients who took Zyprexa have developed diabetes, according to the lawsuit filed on May 29, 2007, by state attorney general David Stallard.
Utah is seeking damages including $5,000-$10,000 for each prescription that was "not medically necessary."
Lilly recently attempted to get the Utah case dismissed, in part by arguing that the allegations of off-label promotion and failure to warn were preempted by FDA regulations under a new rule put in place by the Bush Administration, largely viewed as a gift to the pharmaceutical industry.
In 2006, the FDA published a preamble to new prescription drug labeling rules in which it asserted that its approval of the labeling would prevent the filing of lawsuits in state courts premised on a theory that a drug company should have provided additional warnings on a drug's label.
However, the Utah court ruled against Lilly on this issue and stated, in part: "In fields traditionally occupied by the states, such as health and safety regulation, there is a strong presumption against federal preemption," and Lilly "has not overcome this strong presumption."
Pennsylvania alleges that the state spent millions of dollars "for non-medically accepted indications and non-medically necessary uses of Zyprexa," as well as "significant sums of money for the care and treatment" of patients injured by the drug.
Montana's complaint charges that, "Lilly management participated, encouraged and authorized the unlawful payment of illegal kickbacks to physicians in order to continue generating sales of Zyprexa."
The Montana lawsuit is asking for reimbursement on behalf of all citizens who purchased Zyprexa, and not only patients covered by public health care programs, because under the law in that state, the attorney general can request treble damages and attorneys' fees on behalf of all consumers.
There are also several RICO class actions filed against Lilly on behalf of union insurance plans, pension funds, and other private health insurers, which accuse Lilly of violating racketeering laws and allege the drug maker engaged in illegal marketing schemes to promote the sale of Zyprexa for off-label uses and seek to recover the cost of purchasing the drug, as well as treble damages, punitive damages and attorneys' fees.
On June 28, 2007, Lilly lost a motion for a summary judgment dismissal of the RICO claims, based on the preemption argument, when District Court Judge Jack Weinstein for the Eastern District of New York ruled against the company, In re Zyprexa Products Liability Litigation, 2007 WL 1851161.
In a written ruling rejecting Lilly's argument that state law failure-to-warn claims are preempted, Judge Weinstein wrote that "the regulation of public health is an area traditionally occupied by the states, supporting a presumption against preemption."
"Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs' bar," he stated, "the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs."
The Judge also noted that Congress had not stated an intent to preempt these claims. "The FDA cannot be allowed to usher in such a sweeping change in substantive law through the back door," he wrote.
The Medicaid fraud lawsuits allege that many children have been turned into customers for the off-label prescribing of Zyprexa. A recent October 7, 2007, report from the Florida Agency for Health Care Administration entitled, "The Use of Antipsychotic Medications with Children," found that pediatric use of antipsychotics increased in the late 1990's and early 2000's, largely due to the arrival of the atypicals on the market.
The report noted that one study documented a 75% increase with commercially insured children aged 0 to 17 from 1997 to 2001, and another study of the managed care population from 1996 to 2001 found a 127% increase among children aged 0 to 18.
The study also reported that antipsychotic use in the Medicaid populations was three to four times higher than commercial populations in the late 1990's, and in one program in the Midwest, the rate of prescriptions grew 304% between 1996 and 2001.
The authors said the analysis showed that the drugs are being used to treat a broad spectrum of disorders, and some of the disorders, such as attention deficit hyperactivity disorder and major depression, "clearly do not call for antipsychotic treatment."
In the 0 to 5 age group, the study found that more than 53% of the drugs were prescribed for ADHD, even though antipsychotic use with children under 6 "should be considered only in very rare circumstances."
A report in the May 10, 2007, New York Times revealed some of the known adverse events that occurred in children who were prescribed antipychotics in 2006 alone. The FDA received reports of 29 children dying, and at least 165 other serious side effects in children, where an antipsychotic was listed as the primary suspect, according to the Times.
The FDA acknowledges that its reporting system only picks up between one and ten percent of the adverse events that take place, which means the number of deaths and injuries above must be multiplied many times over to obtain an accurate estimation of how many children have been harmed by the drugs.
Showing posts with label Eli Lilly. Show all posts
Showing posts with label Eli Lilly. Show all posts
Sunday, August 8, 2010
Lilly Faces Mounting Legal Battles Over Zyprexa - Part II
Evelyn Pringle November 10, 2007
Several Zyprexa-related class actions have been filed against Eli Lilly on behalf of the company's shareholders charging Lilly, and certain of its officers and directors, with violations of the Securities Exchange Act.
On April 2, 2007, the Schiffrin Barroway Topaz & Kessler law firm issued a press release to announce a class action filed on behalf of all purchasers of Lilly stock between March 28, 2002, and December 22, 2006, alleging that Lilly disseminated false and misleading statements regarding Zyprexa.
More specifically, it alleges that Lilly was aware of a "clear link" between Zyprexa and diabetes, failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur when reports of side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for Zyprexa based on "off-label" uses, in direct violation of Lilly's own code of conduct.
The complaint further alleges that concealing the side effects and engaging in an illegal marketing campaign subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company's overall financial condition and prospects.
According to the complaint, between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and between July 18, 2002, and May 7, 2004, Lilly's stock value increased from $43.75 per share to $76.95.
But when public warnings were issued about the safety of Zyprexa, the lawsuit alleges, sales slowed and share prices dropped from $76.95 to $50.34 between May 7, 2004, and October 25, 2004, representing a loss of market capitalization of over $30 billion.
Another shareholder's complaint claims that Lilly had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, "the Company adamantly refused to acknowledge any wrongdoing."
Still another lawsuit alleges that Zyprexa does cause such side effects, and to a greater extent than its competitors, and the "revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements."
A number of Zyprexa cases have been filed against Lilly in other countries as well.
In private litigation, almost all of the federal lawsuits are part of a Multi-District Litigation proceeding before Judge Jack Weinstein in the Federal District Court for the Eastern District of New York.
Since June 2005, Lilly has entered into out-of-court settlements with approximately 30,200 claimants in the US for about $1.2 billion, and there were still about 350 lawsuits covering about 540 claims pending at the time of the company's August 7, 2007, SEC filing.
However, on June 29, 2007, Rob Waters and Margaret Cronin Fisk reported in Bloomberg News that Lilly "may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from US regulators."
They report that Lilly was told in March that the FDA would delay the approval of Symbyax, which contains both Zyprexa and Prozac, for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the prescribing label. Symbyax was already approved for bipolar disorder.
In a letter obtained by Bloomberg, the FDA stated: "We are concerned that the proposed labeling is deficient with regard to information about weight gain and high levels of sugar and fat in the blood of patients who took the drug."
"We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks," the agency wrote.
According to Bloomberg, the FDA said Lilly's proposed prescribing information for Symbyax failed to disclose that almost half of the patients who had high or borderline blood sugar levels when they started taking the drug ended up with levels high enough to be considered diabetic and that was over nine times the number of patients on placebos.
"We were troubled that this important information was not included in your proposed label," the agency said.
"The FDA's request," Bloomberg points out, "may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa," attorneys told the reporters.
"When the FDA says something damning about the warnings of a drug, it's admissible as evidence on the reasonableness of the manufacturer's decisions," said David Logan, dean of the Roger Williams University School of Law, in an interview with Bloomberg.
"It would likely carry some weight with juries," he stated.
Experts say, in light of all the studies which have shown that the older cheaper antipsychotics work as well or better than atypicals for schizophrenia patients, it's difficult to understand why Zyprexa is still being prescribed for those patients.
An October 2006 study in the Archives of General Psychiatry, funded by the British government and lead by Dr Peter Jones, a psychiatrist at the University of Cambridge, compared treatment outcomes for schizophrenia patients with the older antipsychotics with treatment results from the new atypicals and found the quality of life of patients was slightly better with the older drugs.
The study was conducted on behalf of Britain's National Health Service to determine whether the increased cost of the new atypicals was justified and involved 227 patients who were assigned to two groups and evaluated by researchers who did not know which medication the patients were taking for over a year.
In the October 3, 2006, Washington Post, Dr Jones said a conservative interpretation of the data suggests that there is no difference, "so the notion you would pay 10 times as much would be difficult to justify."
"Why were we so convinced?" he asked, referring to the widespread belief that the new drugs were worth the cost. "I think pharmaceutical companies did a great job in selling their products," he said.
Experts are quick to point out that earlier studies in the US had produced the same results. In 2003, the Department of Veterans Affairs found there was no difference in compliance, symptoms or overall quality of life in patients treated with the older drug Haldol compared with Zyprexa, and a September 2005 government-funded study in the New England Journal reported that patients taking the older drug perphenazine did as well as patients on the new drugs and patients on atypicals experienced more side effects.
"The story of these newer antipsychotic drugs is a story that reveals an institutional gap," according to Dr Robert Rosenheck, who was involved in both US studies, in the Post on October 3, 2006.
"It should not have needed 10 years to get three government studies," he noted.
The fact is, Lilly promoted Zyprexa as being more effective than the older drugs with less side effects right from the start. On November 14, 1996, the FDA's Division of Drug Marketing, Advertising and Communications sent a letter to Lilly addressing the company's misrepresentations of the risks and benefits of Zyprexa in an October 2, 1996, promotional teleconference conducted by Dr Gary Tollefson, Vice President of Lilly Research Laboratories.
During the conference, the FDA said, Dr Tollefson made the false claim that Zyprexa did not cause the Parkinsons-like side effects observed in patients who received Haldol, and even though the FDA labeling for Zyprexa included weight gain as an adverse effect, during the conference Dr Tollefson claimed that it usually occurred in patients who were underweight to begin with, making it sound like weight gain was actually a benefit of the drug, according to the FDA letter.
In addition to the many serious health problems found to be associated with Zyprexa in recent years, experts say the suicide rate amongst Zyprexa patients is also high. According to an analysis of the FDA's adverse event reports by Dr Gregory Warren, an independent researcher and statistician, since Zyprexa came on the market in 1996, there have been 532 suicide reports on the drug filed by health care professionals.
UK psychiatrist and professor Dr David Healy, one of the world's leading authorities on pharmacology, says there has been a ten- to twenty-fold increase in the rate of suicide among patients diagnosed with schizophrenia since antipsychotics were first introduced.
All that said, apparently no amount of litigation will slow the off-label prescribing of Zyprexa. In 2006, sales were $4.3 billion, and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to the SEC filings.
Critics say going after the drug makers is not enough, that it's time to sue the doctors who prescribe drugs off-label. Alaska human rights attorney Jim Gottstein says psychiatrists are seldom held legally responsible for their failure to adequately inform patients about the true efficacy and harms of the drugs they prescribe.
"This has likely lulled them into a false sense of security," he notes, "because there are various factors at work which could loosen a tidal wave of legal cases against doctors who do not adequately inform their patients about the benefits and harms, including the efficacy of other approaches and of nontreatment."
Several Zyprexa-related class actions have been filed against Eli Lilly on behalf of the company's shareholders charging Lilly, and certain of its officers and directors, with violations of the Securities Exchange Act.
On April 2, 2007, the Schiffrin Barroway Topaz & Kessler law firm issued a press release to announce a class action filed on behalf of all purchasers of Lilly stock between March 28, 2002, and December 22, 2006, alleging that Lilly disseminated false and misleading statements regarding Zyprexa.
More specifically, it alleges that Lilly was aware of a "clear link" between Zyprexa and diabetes, failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur when reports of side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for Zyprexa based on "off-label" uses, in direct violation of Lilly's own code of conduct.
The complaint further alleges that concealing the side effects and engaging in an illegal marketing campaign subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company's overall financial condition and prospects.
According to the complaint, between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and between July 18, 2002, and May 7, 2004, Lilly's stock value increased from $43.75 per share to $76.95.
But when public warnings were issued about the safety of Zyprexa, the lawsuit alleges, sales slowed and share prices dropped from $76.95 to $50.34 between May 7, 2004, and October 25, 2004, representing a loss of market capitalization of over $30 billion.
Another shareholder's complaint claims that Lilly had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, "the Company adamantly refused to acknowledge any wrongdoing."
Still another lawsuit alleges that Zyprexa does cause such side effects, and to a greater extent than its competitors, and the "revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements."
A number of Zyprexa cases have been filed against Lilly in other countries as well.
In private litigation, almost all of the federal lawsuits are part of a Multi-District Litigation proceeding before Judge Jack Weinstein in the Federal District Court for the Eastern District of New York.
Since June 2005, Lilly has entered into out-of-court settlements with approximately 30,200 claimants in the US for about $1.2 billion, and there were still about 350 lawsuits covering about 540 claims pending at the time of the company's August 7, 2007, SEC filing.
However, on June 29, 2007, Rob Waters and Margaret Cronin Fisk reported in Bloomberg News that Lilly "may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from US regulators."
They report that Lilly was told in March that the FDA would delay the approval of Symbyax, which contains both Zyprexa and Prozac, for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the prescribing label. Symbyax was already approved for bipolar disorder.
In a letter obtained by Bloomberg, the FDA stated: "We are concerned that the proposed labeling is deficient with regard to information about weight gain and high levels of sugar and fat in the blood of patients who took the drug."
"We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks," the agency wrote.
According to Bloomberg, the FDA said Lilly's proposed prescribing information for Symbyax failed to disclose that almost half of the patients who had high or borderline blood sugar levels when they started taking the drug ended up with levels high enough to be considered diabetic and that was over nine times the number of patients on placebos.
"We were troubled that this important information was not included in your proposed label," the agency said.
"The FDA's request," Bloomberg points out, "may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa," attorneys told the reporters.
"When the FDA says something damning about the warnings of a drug, it's admissible as evidence on the reasonableness of the manufacturer's decisions," said David Logan, dean of the Roger Williams University School of Law, in an interview with Bloomberg.
"It would likely carry some weight with juries," he stated.
Experts say, in light of all the studies which have shown that the older cheaper antipsychotics work as well or better than atypicals for schizophrenia patients, it's difficult to understand why Zyprexa is still being prescribed for those patients.
An October 2006 study in the Archives of General Psychiatry, funded by the British government and lead by Dr Peter Jones, a psychiatrist at the University of Cambridge, compared treatment outcomes for schizophrenia patients with the older antipsychotics with treatment results from the new atypicals and found the quality of life of patients was slightly better with the older drugs.
The study was conducted on behalf of Britain's National Health Service to determine whether the increased cost of the new atypicals was justified and involved 227 patients who were assigned to two groups and evaluated by researchers who did not know which medication the patients were taking for over a year.
In the October 3, 2006, Washington Post, Dr Jones said a conservative interpretation of the data suggests that there is no difference, "so the notion you would pay 10 times as much would be difficult to justify."
"Why were we so convinced?" he asked, referring to the widespread belief that the new drugs were worth the cost. "I think pharmaceutical companies did a great job in selling their products," he said.
Experts are quick to point out that earlier studies in the US had produced the same results. In 2003, the Department of Veterans Affairs found there was no difference in compliance, symptoms or overall quality of life in patients treated with the older drug Haldol compared with Zyprexa, and a September 2005 government-funded study in the New England Journal reported that patients taking the older drug perphenazine did as well as patients on the new drugs and patients on atypicals experienced more side effects.
"The story of these newer antipsychotic drugs is a story that reveals an institutional gap," according to Dr Robert Rosenheck, who was involved in both US studies, in the Post on October 3, 2006.
"It should not have needed 10 years to get three government studies," he noted.
The fact is, Lilly promoted Zyprexa as being more effective than the older drugs with less side effects right from the start. On November 14, 1996, the FDA's Division of Drug Marketing, Advertising and Communications sent a letter to Lilly addressing the company's misrepresentations of the risks and benefits of Zyprexa in an October 2, 1996, promotional teleconference conducted by Dr Gary Tollefson, Vice President of Lilly Research Laboratories.
During the conference, the FDA said, Dr Tollefson made the false claim that Zyprexa did not cause the Parkinsons-like side effects observed in patients who received Haldol, and even though the FDA labeling for Zyprexa included weight gain as an adverse effect, during the conference Dr Tollefson claimed that it usually occurred in patients who were underweight to begin with, making it sound like weight gain was actually a benefit of the drug, according to the FDA letter.
In addition to the many serious health problems found to be associated with Zyprexa in recent years, experts say the suicide rate amongst Zyprexa patients is also high. According to an analysis of the FDA's adverse event reports by Dr Gregory Warren, an independent researcher and statistician, since Zyprexa came on the market in 1996, there have been 532 suicide reports on the drug filed by health care professionals.
UK psychiatrist and professor Dr David Healy, one of the world's leading authorities on pharmacology, says there has been a ten- to twenty-fold increase in the rate of suicide among patients diagnosed with schizophrenia since antipsychotics were first introduced.
All that said, apparently no amount of litigation will slow the off-label prescribing of Zyprexa. In 2006, sales were $4.3 billion, and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to the SEC filings.
Critics say going after the drug makers is not enough, that it's time to sue the doctors who prescribe drugs off-label. Alaska human rights attorney Jim Gottstein says psychiatrists are seldom held legally responsible for their failure to adequately inform patients about the true efficacy and harms of the drugs they prescribe.
"This has likely lulled them into a false sense of security," he notes, "because there are various factors at work which could loosen a tidal wave of legal cases against doctors who do not adequately inform their patients about the benefits and harms, including the efficacy of other approaches and of nontreatment."
Lilly's Worst Zyprexa Nightmare Comes True
Evelyn Pringle May 7, 2007
Eli Lilly is not all that worried about personal injury lawsuits related to Zyprexa because the company has enough money to pay the relatively small pay-outs that arise from such actions, according to Attorney Barry Turner, a professor of law and ethics in the UK and a leading authority on consumer fraud litigation involving the pharmaceutical industry.
But he says the Medicaid fraud lawsuits filed by 9 states thus far, under the Federal and State False Claims Act are another matter. "The biggest penalties so far in Federal and State False Claims Act violations," Mr Turner reports, "were awarded against drug companies and there are very many more cases under seal."
But an even larger nightmare for top Lilly officials, he says, arises when a product like Zyprexa causes deaths and injuries to consumers and shareholders face huge losses including the millions of people who have their pensions invested in the company.
When a blockbuster drug is announced, Mr Turner says, it attracts huge investment and if that investment has been attracted to a product that Lilly knew was faulty, the company has risked shareholder funds beyond the pale.
This kind of behavior, he notes, is a Sarbox violation. The Sarbanes-Oxley Act was enacted to restore investor confidence in publicly traded companies in the wake of Enron and similar debacles by improving corporate accountability. Its official title is the "Public Company Accounting Reform and Investor Protection Act of 2002," named after its sponsors Senator Paul Sarbanes (D-MD) and Representative Michael G Oxley (R-OH), and is commonly referred to as SOX.
One of the features of SOX is the ability to bring an action against those who recklessly and fraudulently deal with stockholder's money and, "promoting the off label use of a drug with undeclared dangerous side effects, or being negligent as to such promotion, is the kind of behavior justifying an action under Sarbanes Oxley," according to Mr Turner.
"Those at the top of Eli Lilly," he states, "gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed."
"The lifeblood of a business," he says, "is the investment that goes into it and in the case of Eli Lilly it means the investment of millions of shareholders."
"Anyone who defrauds them," he explains, "is defrauding people not business."
Mr Tuner says it is easy to think of shareholders as "rich lazy fat cats" living off the efforts of others but it is fundamentally wrong by ethical standards to think that if they are defrauded that perhaps they deserve it. "What needs to be understood," he says, "is that many millions of people who own no stock at all get defrauded in scams all the time."
"Those who pay into pension funds," he explains, "are vulnerable to the financial shenanigans not only of fund managers but of boards of companies and CEO's that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices."
The worst of all legal nightmares resulting from the Zyprexa "shenanigans," occurred over a period of 9 days between April 2, 2007 and April 11, 2007, when not one, but 4 shareholder class action lawsuits were announced against Lilly and "certain of its officers and directors" filed in the US District Court for the Eastern District of New York, for violations of the Securities and Exchange Act alleging that the defendants hid the side effects of Zyprexa and engaged in illegal off-label marketing campaigns.
On April 2, 2007, the Law Firm of Schiffrin Barroway Topaz & Kessler, issued a press release to announce that a class action was filed on behalf of all securities purchasers of Lilly from March 28, 2002 and December 22, 2006, charging the defendants with disseminating false and misleading statements regarding Zyprexa.
More specifically, it alleges that they were aware of a "clear link" between Zyprexa and diabetes; and yet failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur, and did occur, when reports of Zyprexa's side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for the drug based on "off-label" uses and that the off-label marketing program was a direct violation of Lilly's own code of conduct.
The complaint further alleges that concealing the side effects and engaging in a massive illegal marketing campaign potentially subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company's overall financial condition and prospects.
The complaint reports that between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and that between July 18, 2002 and May 7, 2004, Lilly's stock value increased from $43.75 per share to $76.95.
Throughout the class period, the lawsuit says, Lilly had information about the link between Zyprexa and extreme weight gain and diabetes and in the face of mounting research linking the drug to diabetes and weight gain, and the lawsuits filed by persons who developed these conditions, "Lilly emphatically denied any such link."
The complaint alleges that when public warnings were issued about the safety of Zyprexa, sales slowed and between May 7, 2004 and October 25, 2004, stock prices dropped from $76.95 per share to $50.34, representing a loss of market capitalization of over $30 billion.
The press release cites reports in the New York Times between December 17 and 21, 2006, as disclosing for the "first time" that Lilly had engaged in a decade-long effort to play down the risks of Zyprexa; and actively marketed the drug for illegal off-label uses such as treating elderly patients with symptoms of dementia.
Therefore, the lawsuits alleges, the over $30 billion decline in stock value between May 7, 2004 and October 25, 2004 was the direct result of defendants' fraudulent conduct.
In addition it says, the publication of the Times articles caused another $3.49, or 6.4%, decline in stock value and represented a further market loss of approximately $3.5 billion.
Two days after the first class action was announced, on April 5th, the Lerach Coughlin Stoia Geller Rudman & Robbins Law Firm announced that another had been filed.
The second complaint also charges Lilly and certain of its officers and directors with violations of the Securities Exchange Act, and alleges that at the beginning of the class period, defendants contended that Zyprexa did not cause diabetes-related side effects and that once the clinical data rendered that position untenable, defendants argued instead that Zyprexa did not cause any more side effects than its competitors.
Eventually, the press release notes, more and more clinical data showed that, in fact, Zyprexa does cause such side effects and to a greater extent than its competitors and the "revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements."
It also alleges that defendants intentionally suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes, citing the series of articles in the Times, with excerpted "documents detailing defendants' deception."
The release says the documents revealed that defendants intentionally misled patients, doctors, and investors and as a result, "the price of Lilly's stock declined almost 6% in the five trading days during which the series of articles was published."
The members of the class, it notes, invested in Lilly securities unaware that defendants' fraud had artificially inflated the prices of those securities and when "the truth was finally revealed those investors lost many millions of dollars as a result of defendants' fraud."
Four days after the second lawsuit was announced, on April 9th, the Schatz Nobel Izard Law Firm announced the third case seeking class action status on behalf of all persons who purchased or otherwise acquired securities of Lilly between March 28, 2002 and December 22, 2006.
This lawsuit also alleges that the same defendants violated securities laws by making misleading statements and specifically that they "contended that Zyprexa did not cause diabetes-related side effects," and later that, "Zyprexa did not cause more side effects than its competitors."
This press release also quotes the Times articles as showing "that defendants intentionally misrepresented the side effects of Zyprexa," and "suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes "
"In the five trading days during which the series of articles was published," the press release advises, "the price of Lilly's stock declined almost 6%."
Two days later, on April 11th, the Harwood Feffer Law Firm announced a fourth class action accusing the same defendants of making misleading statements and specifically that they failed to disclose: (i) dangerous side-effects resulting from the use of Zyprexa; (ii) the decade-long illegal campaign to increase sales by marketing Zyprexa for off-label uses not approved by the FDA, in violation of FDA regulations that proscribe such marketing.
As a result of these fraudulent business practices, the press release states, sales of Zyprexa rose from $3.69 billion to $4.42 billion between 2002 and 2004, and the value of stock increased from $43.75 per share to $76.95, between July 18, 2002 and May 7, 2004.
The release says defendants had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, "the Company adamantly refused to acknowledge any wrongdoing."
The Law Firm goes on to note that as public agencies raised warnings about Zyprexa, sales plummeted and stock price dropped from $76.95 per share to $50.34, between May 7, 2004 and October 25, 2004, amounting to a loss of market value of over $30 billion.
Subsequently, the press release alleges, after the Times published a series of articles the price of Lilly stock "collapsed" an additional $3.49 per share, or 6.4%, and amounted to a further loss of market value of approximately $3.5 billion.
Zyprexa was FDA approved for the limited use of treating adults with the most severe mental illnesses, schizophrenia and manic episodes of bipolar disorder, but it quickly became Lilly's best selling product.
In order to find that Lilly did not make the drug its top seller by illegally promoting it for off-label uses, a jury would have to believe the highly unlikely scenario that doctors in every field of medicine came up with the idea of prescribing a schizophrenia drug to patients as young as 2 and as old as 100, for every kind of condition imaginable from anxiety and attention deficit disorder to autism and dementia.
On April 25, 2007, the New York Times reported that the FDA was examining whether Lilly provided the agency with accurate data about the side effects of Zyprexa. However, that may be a dead issue in light of the fact that on May 4, 2007, Lilly issued a press release of its own to announce that Alex Azar II will be joining the company as a senior vice president, who until February 3, 2007, just happened to be the Deputy Secretary of the US Health and Human Services Department.
According to Lilly, "Azar supervised all operations of the HHS, including the regulation of food and drugs," and among others, agencies under his direction included the FDA.
Eli Lilly is not all that worried about personal injury lawsuits related to Zyprexa because the company has enough money to pay the relatively small pay-outs that arise from such actions, according to Attorney Barry Turner, a professor of law and ethics in the UK and a leading authority on consumer fraud litigation involving the pharmaceutical industry.
But he says the Medicaid fraud lawsuits filed by 9 states thus far, under the Federal and State False Claims Act are another matter. "The biggest penalties so far in Federal and State False Claims Act violations," Mr Turner reports, "were awarded against drug companies and there are very many more cases under seal."
But an even larger nightmare for top Lilly officials, he says, arises when a product like Zyprexa causes deaths and injuries to consumers and shareholders face huge losses including the millions of people who have their pensions invested in the company.
When a blockbuster drug is announced, Mr Turner says, it attracts huge investment and if that investment has been attracted to a product that Lilly knew was faulty, the company has risked shareholder funds beyond the pale.
This kind of behavior, he notes, is a Sarbox violation. The Sarbanes-Oxley Act was enacted to restore investor confidence in publicly traded companies in the wake of Enron and similar debacles by improving corporate accountability. Its official title is the "Public Company Accounting Reform and Investor Protection Act of 2002," named after its sponsors Senator Paul Sarbanes (D-MD) and Representative Michael G Oxley (R-OH), and is commonly referred to as SOX.
One of the features of SOX is the ability to bring an action against those who recklessly and fraudulently deal with stockholder's money and, "promoting the off label use of a drug with undeclared dangerous side effects, or being negligent as to such promotion, is the kind of behavior justifying an action under Sarbanes Oxley," according to Mr Turner.
"Those at the top of Eli Lilly," he states, "gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed."
"The lifeblood of a business," he says, "is the investment that goes into it and in the case of Eli Lilly it means the investment of millions of shareholders."
"Anyone who defrauds them," he explains, "is defrauding people not business."
Mr Tuner says it is easy to think of shareholders as "rich lazy fat cats" living off the efforts of others but it is fundamentally wrong by ethical standards to think that if they are defrauded that perhaps they deserve it. "What needs to be understood," he says, "is that many millions of people who own no stock at all get defrauded in scams all the time."
"Those who pay into pension funds," he explains, "are vulnerable to the financial shenanigans not only of fund managers but of boards of companies and CEO's that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices."
The worst of all legal nightmares resulting from the Zyprexa "shenanigans," occurred over a period of 9 days between April 2, 2007 and April 11, 2007, when not one, but 4 shareholder class action lawsuits were announced against Lilly and "certain of its officers and directors" filed in the US District Court for the Eastern District of New York, for violations of the Securities and Exchange Act alleging that the defendants hid the side effects of Zyprexa and engaged in illegal off-label marketing campaigns.
On April 2, 2007, the Law Firm of Schiffrin Barroway Topaz & Kessler, issued a press release to announce that a class action was filed on behalf of all securities purchasers of Lilly from March 28, 2002 and December 22, 2006, charging the defendants with disseminating false and misleading statements regarding Zyprexa.
More specifically, it alleges that they were aware of a "clear link" between Zyprexa and diabetes; and yet failed to warn the public and engaged in an illicit scheme to offset a drop in sales that was certain to occur, and did occur, when reports of Zyprexa's side effects emerged, by creating a marketing plan which included the evaluation and pursuit of sales for the drug based on "off-label" uses and that the off-label marketing program was a direct violation of Lilly's own code of conduct.
The complaint further alleges that concealing the side effects and engaging in a massive illegal marketing campaign potentially subjected Lilly to substantial regulatory fines, penalties and other legal action, compromising the company's overall financial condition and prospects.
The complaint reports that between 2002 and 2004, sales of Zyprexa grew from $3.69 billion to $4.42 billion, and that between July 18, 2002 and May 7, 2004, Lilly's stock value increased from $43.75 per share to $76.95.
Throughout the class period, the lawsuit says, Lilly had information about the link between Zyprexa and extreme weight gain and diabetes and in the face of mounting research linking the drug to diabetes and weight gain, and the lawsuits filed by persons who developed these conditions, "Lilly emphatically denied any such link."
The complaint alleges that when public warnings were issued about the safety of Zyprexa, sales slowed and between May 7, 2004 and October 25, 2004, stock prices dropped from $76.95 per share to $50.34, representing a loss of market capitalization of over $30 billion.
The press release cites reports in the New York Times between December 17 and 21, 2006, as disclosing for the "first time" that Lilly had engaged in a decade-long effort to play down the risks of Zyprexa; and actively marketed the drug for illegal off-label uses such as treating elderly patients with symptoms of dementia.
Therefore, the lawsuits alleges, the over $30 billion decline in stock value between May 7, 2004 and October 25, 2004 was the direct result of defendants' fraudulent conduct.
In addition it says, the publication of the Times articles caused another $3.49, or 6.4%, decline in stock value and represented a further market loss of approximately $3.5 billion.
Two days after the first class action was announced, on April 5th, the Lerach Coughlin Stoia Geller Rudman & Robbins Law Firm announced that another had been filed.
The second complaint also charges Lilly and certain of its officers and directors with violations of the Securities Exchange Act, and alleges that at the beginning of the class period, defendants contended that Zyprexa did not cause diabetes-related side effects and that once the clinical data rendered that position untenable, defendants argued instead that Zyprexa did not cause any more side effects than its competitors.
Eventually, the press release notes, more and more clinical data showed that, in fact, Zyprexa does cause such side effects and to a greater extent than its competitors and the "revelations sharply curtailed the sales growth of Zyprexa and resulted in thousands of product liability lawsuits against Lilly and hundreds of millions of dollars in settlements."
It also alleges that defendants intentionally suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes, citing the series of articles in the Times, with excerpted "documents detailing defendants' deception."
The release says the documents revealed that defendants intentionally misled patients, doctors, and investors and as a result, "the price of Lilly's stock declined almost 6% in the five trading days during which the series of articles was published."
The members of the class, it notes, invested in Lilly securities unaware that defendants' fraud had artificially inflated the prices of those securities and when "the truth was finally revealed those investors lost many millions of dollars as a result of defendants' fraud."
Four days after the second lawsuit was announced, on April 9th, the Schatz Nobel Izard Law Firm announced the third case seeking class action status on behalf of all persons who purchased or otherwise acquired securities of Lilly between March 28, 2002 and December 22, 2006.
This lawsuit also alleges that the same defendants violated securities laws by making misleading statements and specifically that they "contended that Zyprexa did not cause diabetes-related side effects," and later that, "Zyprexa did not cause more side effects than its competitors."
This press release also quotes the Times articles as showing "that defendants intentionally misrepresented the side effects of Zyprexa," and "suppressed and misrepresented data showing that Zyprexa causes weight gain, high blood sugar, and diabetes "
"In the five trading days during which the series of articles was published," the press release advises, "the price of Lilly's stock declined almost 6%."
Two days later, on April 11th, the Harwood Feffer Law Firm announced a fourth class action accusing the same defendants of making misleading statements and specifically that they failed to disclose: (i) dangerous side-effects resulting from the use of Zyprexa; (ii) the decade-long illegal campaign to increase sales by marketing Zyprexa for off-label uses not approved by the FDA, in violation of FDA regulations that proscribe such marketing.
As a result of these fraudulent business practices, the press release states, sales of Zyprexa rose from $3.69 billion to $4.42 billion between 2002 and 2004, and the value of stock increased from $43.75 per share to $76.95, between July 18, 2002 and May 7, 2004.
The release says defendants had knowledge of a link between Zyprexa and extreme weight gain and diabetes and when sued by private individuals who developed these adverse effects, "the Company adamantly refused to acknowledge any wrongdoing."
The Law Firm goes on to note that as public agencies raised warnings about Zyprexa, sales plummeted and stock price dropped from $76.95 per share to $50.34, between May 7, 2004 and October 25, 2004, amounting to a loss of market value of over $30 billion.
Subsequently, the press release alleges, after the Times published a series of articles the price of Lilly stock "collapsed" an additional $3.49 per share, or 6.4%, and amounted to a further loss of market value of approximately $3.5 billion.
Zyprexa was FDA approved for the limited use of treating adults with the most severe mental illnesses, schizophrenia and manic episodes of bipolar disorder, but it quickly became Lilly's best selling product.
In order to find that Lilly did not make the drug its top seller by illegally promoting it for off-label uses, a jury would have to believe the highly unlikely scenario that doctors in every field of medicine came up with the idea of prescribing a schizophrenia drug to patients as young as 2 and as old as 100, for every kind of condition imaginable from anxiety and attention deficit disorder to autism and dementia.
On April 25, 2007, the New York Times reported that the FDA was examining whether Lilly provided the agency with accurate data about the side effects of Zyprexa. However, that may be a dead issue in light of the fact that on May 4, 2007, Lilly issued a press release of its own to announce that Alex Azar II will be joining the company as a senior vice president, who until February 3, 2007, just happened to be the Deputy Secretary of the US Health and Human Services Department.
According to Lilly, "Azar supervised all operations of the HHS, including the regulation of food and drugs," and among others, agencies under his direction included the FDA.
Saturday, August 7, 2010
April 2007 Big Pharma Litigation Update - Drugs - Part I
Evelyn Pringle April 5, 2007
For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.
Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.
Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.
It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.
On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.
There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth's 2005 Annual Report. The case was later settled for an undisclosed amount.
PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH "results in death in about 40% of affected individuals within 4 years."
The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.
And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff's attorney, Paul Rheingold, in "Fen-Phen and Redux: A Tale of Two Drugs," says, "there is blame enough to go around."
The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.
On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.
Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff's heart attack and awarded $20 million in damages.
According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff's heart attack.
A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff's allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.
Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a "signature disease," meaning a condition easily tied to the drug because it is rare.
The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. "We've uncovered about 1,000 patients in the past six to nine months alone," he said, "so the magnitude of the problem is just starting to be recognized."
FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA's Office of Drug Safety.
Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, "Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people."
The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs' attorneys that the company is willing to cut a deal.
Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.
The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.
There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.
On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.
Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon's painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.
Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.
In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.
In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.
Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.
He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.
According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.
The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.
More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa's link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.
To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.
On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.
All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.
Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.
For the last two decades, illegal drug marketing schemes have paid off well for Big Pharma. However, as the old saying goes, all good things must come to an end, and every major drug company is currently involved in massive litigation.
Some companies are facing thousands of lawsuits with a common complaint that the drug maker deliberately concealed the side effects of their products while illegally promoting the drugs for off-label use.
Off-label refers to prescribing drugs to treat conditions other than those approved by the FDA and listed on the label. It can include prescribing drugs to unapproved populations, such as children or the elderly, or in higher doses than specified on the label.
It is illegal for drug companies to promote a drug for off-label uses, but doctors are allowed to prescribe a drug for any use they choose. Almost without exception, the lawsuits currently pending accuse the pharmaceutical companies of influencing doctors to prescribe the product for unapproved uses.
On August 18, 2006, Bloomberg News reported that Wyeth has accumulated more than 175,000 lawsuits since the Fen-Phen diet combination was removed from the market after studies revealed that the drugs caused heart valve damage, and primary pulmonary hypertension, or PPH, a life-threatening lung disorder. All total, Wyeth has set aside more than $21 billion to cover legal costs and settlements since the drugs were withdrawn, according to Reuters on May 24, 2006.
There was a national class-action settlement involving claims for heart valve damage, but it did not include claims for PPH which are proving to be costly. In one 2004 case alone, a Texas jury awarded over $1 billion to the family of a woman who died of PPH after taking Fen-Phen for about two years, including $113.4 million in compensatory damages and $900 million in punitive damages, according to Wyeth's 2005 Annual Report. The case was later settled for an undisclosed amount.
PPH is a life-threatening condition that can require a heart-lung transplant. According to the FDA, PPH "results in death in about 40% of affected individuals within 4 years."
The Fen-Phen combination was never FDA approved for any use, which means every prescription was off-label. Patients were able to get Fen-Phen on the internet, and Jenny Craig and Nutri-System set up weight-loss programs where doctors would prescribe the drugs to customers.
And there appears to be no end in sight for Fen-Phen lawsuits. On December 5, 2006, five more women who took the drugs in 1996 and 1997, filed lawsuits against Wyeth after being diagnosed with PPH. When it comes to liability, a plaintiff's attorney, Paul Rheingold, in "Fen-Phen and Redux: A Tale of Two Drugs," says, "there is blame enough to go around."
The doctors who set up store-front Fen-Phen clinics and prescribed the drugs are obvious culprits, he says, and so are drug companies that profited financially from the fad and may have neglected to pass on information about deadly side effects.
On August 18, 2006, Bloomberg reported that Wyeth was facing 5,000 lawsuits over the menopause drug, Prempro, alleging that Wyeth misled the plaintiffs through deceptive marketing about the cancer risks associated with estrogen and progestin. As many as 6 million women took Prempro before it was linked to cancer in a 2002 study.
Financial analysts are predicting that, Merck in the end, will pay out as much as $50 billion for Vioxx litigation. On March 12, 2007, Reuters reported that a New Jersey jury found the drug was responsible for a plaintiff's heart attack and awarded $20 million in damages.
According to Reuters, the jury also found that Merck committed consumer fraud by making misrepresentations concerning the heart risks, and intentionally concealing safety information from doctors prior to the plaintiff's heart attack.
A large number of lawsuits have also been filed against Merck, over the osteoporosis drug Fosamax, and against Johnson and Johnson, over the Ortho-Evra birth control patch. The plaintiff's allege that Fosamax causes jaw-bone death (OJN) and that the patch causes blood clots, which in turn lead to strokes.
Legal experts predict causation in cases involving Fosamax and the Ortho patch will be easy to prove because the plaintiffs have what is referred to as a "signature disease," meaning a condition easily tied to the drug because it is rare.
The jaw-bone death occurring in people taking Fosamax is extremely uncommon. Kenneth Hargreaves of the University of Texas, noted the increasing cases in the April 3, 2006 LA Times. "We've uncovered about 1,000 patients in the past six to nine months alone," he said, "so the magnitude of the problem is just starting to be recognized."
FDA approved in 1995, Fosamax is a relatively new drug, and unreported cases may be higher than expected because doctors may attribute the pain caused by ONJ to osteoporosis, according to Diane Wysowski of the FDA's Office of Drug Safety.
Dr Salvatore Ruggiero, an oral surgeon and one of the first doctors to notice the rise in ONJ in 2001, told the Times, "Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people."
The same goes for the Ortho patch. Blood clots seldom develop in young women of childbearing age. And legal experts say, for that reason, many Ortho patch lawsuits have already ended in confidential settlements with hardly a peep in the mainstream press, and J&J has made it clear to other plaintiffs' attorneys that the company is willing to cut a deal.
Experts predict that many more lawsuits will be filed because there are thousands of young patch victims who are still unaware that the patch caused the health problems. In 2005 alone, more than 9.4 million prescriptions were written for the Ortho patch, according to IMS Health, an industry-tracking firm.
The FDA says it has received about 9,000 reports of adverse events related to the patch, but the agency also acknowledges that only between 1% and 10% of adverse events are ever get reported.
There are over a hundred more lawsuits filed against J&J involving the Duragesic pain patch. The device is supposed to deliver controlled doses of fentanyl, a drug so powerful that high doses can turn off the respiratory center in the brain.
On July 8, 2006, the Associated Press reported that a Houston jury had awarded $772,500 to the daughter of a woman who died after a leak on the patch increased the dose of the painkiller, and the jury found J&J negligent in the way the patch was made.
Another fentanyl product that legal experts say will bring a wave of lawsuits in the next couple of years, is Cephalon's painkilling lollipop, Actiq. The product was only approved to treat cancer patients in chronic pain who are already on an opioid drug, because life-threatening conditions can occur at any dose in patients without a built-up tolerance for opioids. But a recent study by Prime Therapeutics found Actiq is being prescribed off-label nearly 90% of the time.
Fentanyl is reportedly 80 times stronger than morphine, and is a Schedule II narcotic drug, in the same category as cocaine, opium, methamphetamine and methadone, a class known to have the highest potential for abuse and overdose.
In 2004, there were an estimated 8,000 emergency-room visits for fentanyl overdoses, according the US Substance Abuse and Mental Health Services Administration. Overdose can result in sudden death through respiratory arrest, cardiac arrest, severe respiratory depression, cardiovascular collapse or severe anaphylactic reaction, according to the agency. As of November 16, 2006, there were 653 deaths confirmed in the US since 2005.
In November 2006, the Wall Street Journal, said evidence obtained in litigation showed Cephalon had set high sales quotas for its sales representatives that could not be reached without promoting Actiq off-label.
Internal company documents show sales reps were regularly sent to doctors who treated no cancer patients, with free coupons for doctors to pass out to patients. According to the Journal, Dr Stephen Leighton, a general practitioner with only 3 cancer patients at any given time, said a Cephalon saleswoman stop by once a month and gave him about 60 to 70 coupons to pass out to patients for 6 Actiq lollipops.
He told the Journal that the coupons led him to try the drug for migraines and back pain and said he prescribes Actiq 15 to 20 times a month to patients who do not have cancer.
According to the November 3, 2006, report in the Journal, Actiq sales increased from $15 million in 2000, to more than $400 million today.
The consequences of the off-label prescribing of this product are far reaching. On January 22, 2006, the Free Press reported that the wife of a minister, a former schoolteacher and mother of three, was charged with involuntary manslaughter because she gave Actiq to a friend for a migraine, and the friend died of a drug overdose.
More lawsuits are sure to be filed against Eli Lilly since secret internal documents obtained in litigation by attorney, Jim Gottstein, from Dr David Egilman, an expert in previous Zyprexa litigation, prove that the company concealed Zyprexa's link to severe weight gain, high blood sugar, and diabetes for a decade, while Lilly promoted the drug for so many off-label uses that more than 20 million people have taken Zyprexa.
To date, Eli Lilly has spent well over $1 billion to settle about 26,000 Zyprexa lawsuits, with still more litigants waiting in line. Zyprexa has been linked to serious side effects, including diabetes, hyperglycemia and pancreatitis.
On January 14, 2005, a class-action lawsuit was filed in Canada with claims that Lilly also withheld information on the safety of Prozac. The plaintiffs allege that the reason Lilly failed to disclose the documents was because they showed a drastic increase in suicide attempts and other violent acts in patients taking Prozac, when compared to patients taking 4 other drugs.
All through the 1990s, Lilly swore that Prozac did not increase the risk of suicide or violence, while the company was quietly settling lawsuits out of court which made it possible to keep the incriminating evidence hidden with court orders, just as it has been doing with Zyprexa until the secret documents showed up in the press in December 2006.
Similar lawsuits are being filed against AstraZeneca over its antipsychotic drug, Seroquel, which reportedly has been used by more than 16 million people since it came on the market in 1997. The plaintiffs in those cases also claim that Astra downplayed the diabetes risks and concealed safety information.
Makers of Zyprexa Risperdal and Seroquel Under Fire
Evelyn Pringle March 9, 2007
Eli Lilly, Johnson & Johnson, and AstraZeneca, are all named defendants in a new lawsuit filed by the state of Pennsylvania on February 26, 2007, to recover money paid through public health care programs to purchase Zyprexa, Risperdal, and Seroquel, and the costs of medical care for the people injured by these drugs.
Pennsylvania is the 5th state to sue Lilly over its illegal marketing of Zyprexa. And according to SEC filings, Lilly was served with four Canadian lawsuits in 2005, with claims "similar to those in the litigation pending in the United States."
So far, two states have sued Johnson & Johnson over Risperdal, but Pennsylvania is the first state to file a lawsuit against Seroquel-maker AstraZeneca.
The drugs belong to a class known as "atypical" antipsychotics, FDA approved only to treat adults with schizophrenia or bipolar disorder, and yet they are some of the most widely prescribed drugs in the world. In 2006, Zyprexa sales were $4.3 billion, Seroquel's earned $3.4 billion, and Risperdal had sales of $4.1 billion, according to SEC filings.
A July 2006, report by Decision Resources, a leading advisory firm on healthcare issues, listed antipsychotics in 2005, as the fourth-highest-ranking class of drugs, and said two of the top ten drugs in worldwide sales were atypicals.
According to the lawsuit, the defendant drug makers concealed the risks of atypicals and exaggerated their benefits while persuading doctors to prescribe the drugs off-label for dementia, attention deficit disorders, and mood and behavior disorders.
When the FDA approves a drug it also approves the label, which lists the indications for which the drug can be prescribed, along with instructions for use and warnings about the risks associated with the drug. Once a drug is approved to treat one condition, doctors may prescribe it for others if they think it will be effective, but by law drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.
On March 1, 2007, four days after the Pennsylvania lawsuit was filed, two of the three drug companies became the target of another investigation, when Representative, Henry Waxman (D-Cal), the chairman of the House Oversight and Government Reform Committee, sent letters to Eli Lilly and AstraZeneca, requesting information related to the exact same charges alleged in lawsuits filed by individual states.
The letter sent to Lilly states in part, "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa," and requests information relevant to these allegations.
The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to physician prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.
In addition, Rep Waxman wants Lilly to turn over all internal company documents that were kept under seal for years with a court order, but were provided to him by Attorney, James Gottstein, in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.
According to the New York Times, some of these documents reveal that Lilly knew about Zyprexa's link to high blood sugar and extreme weight gain that often leads to diabetes, and others show the details of off-label marketing scheme called "Viva Zyprexa."
Rep Waxman's letter to AstraZeneca basically asks for the same documents requested from Lilly except that he requests more information related to the physicians and authors involved in company sponsored studies and writing the reports.
Late last year, the atypical makers also received subpoenas from the attorney general of California seeking much of the same information.
In pursuing the Pennsylvania lawsuit, Governor Edward Rendell, has hired private attorneys. According to the complaint, the defendants cost Pennsylvania millions of dollars "for non-medically accepted indications and non-medically necessary uses of Zyprexa, Seroquel and Risperdal," as well as "significant sums of money for the care and treatment" of patients injured by the drugs.
The Pennsylvania case comes on the heels of lawsuits by two Pennsylvania whistleblowers, Allen Jones and Stefan Kruszewski, who say, drug companies are making a fortune from the off-label sale of drugs to patients whose care is funded by Medicaid and Medicare.
At the heart of the off-label scheme, they say, are the preferred drug lists, or medication formularies, maintained in many states. Once drugs are added to the list, they must be prescribed as a first line of treatment for all patients in state run institutions and patients in the general population who are covered by public health care programs.
In the summer of 2002, psychiatrist, Dr Kruszewski, was employed with the Pennsylvania Department of Public Welfare, and charged with reviewing psychiatric care provided by state-funded agencies to identify waste, fraud, and abuse. He was also responsible for reviewing the deaths of individuals in state care who died under suspicious circumstances in facilities inside and outside of Pennsylvania.
Early in his investigation, Dr Kruszewski noticed that almost all of the patients under state care were on drug cocktails consisting of antipsychotics, antidepressants, and anticonvulsants. The populations he found drugged most often, he said, were children in state care, the disabled, people in state prisons, and children in the juvenile justice system.
For instance, he says, Neurontin was only approved for controlling seizures, but "was being prescribed for anxiety, social phobia, PTSD, oppositional defiant behavior, and attention deficit disorder with no evidence to support these uses."
When he informed his superiors about the high rate of off-label prescribing and warned about the risk of liability to the state of Pennsylvania if it continued, he was told, "it is none of your business."
In June 2003, Dr Kruszewski inspected a facility in Oklahoma that housed children from Pennsylvania after an unexpected death of a child, and found children were being overmedicated and housed in deplorable living conditions, in addition to being sexually and physically abused by staff and kept in unnecessary restraints and seclusion.
In a report, Dr Kruszewski recommended removing the children from the facility, "in order to protect other innocent individuals from morbid and mortal consequences of severe over-medication, including chemical restraints; emotional, physical and sexual abuse; seclusion; and dirty and inadequate living conditions."
A day later, Dr Kruszewski was accused of "trying to dig up dirt," and was subsequently fired in July 2004, because he refused to keep quiet and accept that it was none of his business, he says.
A year later, Dr Kruszewski filed a whistleblower lawsuit alleging that patients under state care were being drugged for profit and prescribed as many as 5 psychiatric drugs at the same time, and that four children and one adult had died.
In his action, Dr Kruszewski alleged that his superiors violated his right to free speech by firing him because he made statements about the abuses in the state system, which were a matter of public concern.
Dr Kruszewski is represented by attorneys from Government Accountability Project, Thad Guyer, Stephania Ayers, Tom Devine, and Mark Cohen, in Federal Court in the Middle District of Pennsylvania with Chief Judge Yvette Kane presiding.
Defendant, Christopher Gorton, is the Chief Medical Officer for DPW, who fired Dr Kruszewski. He filed a motion for summary judgment to dismiss the First Amendment claim on the basis that the law does not protect whistleblowers if they are fired for making comments they would be expected to make in the context of their employment.
In reading the Court's March 2, 2007, Decision denying Mr Gorton's motion, it appears that Mr Gorton tried to have it both ways. When Dr Kruszewski was employed and tried to report the harm to people under state care, he was told it was none of his business and to quit digging up dirt. Under oath in a deposition, Dr Kruszewski stated that he was told that the subjects of his statements were not part of his job duties.
However, in his motion, Mr Gorton now claims that Dr Kruszewski's comments were made pursuant to his official employment duties. In her written opinion, Judge Kane, quoted relevant case law to describe comments that are protected:
"A public employee's statement is protected activity when (1) in making it, the employee spoke as a citizen, (2) the statement involved a matter of public concern, and (3) the government employer did not have an adequate justification for treating the employee different from any other member of the general public as a result of the statement he made."
"The statements in question can be categorized," Judge Kane wrote, "as: (1) reports regarding poor quality of care, including abuse of patients by staff at treatment facilities; (2) complaints about the lack of qualifications of another private contract doctor; and (3) statements about use and costs of medications."
In order to grant a motion for summary judgment, a judge has to find that there are no genuine disputes of material fact that would require a jury to resolve. In this case, Judge Kane found there were disputes regarding Dr Kruszewski's job duties and whether his statements were substantial and motivating factors in his termination.
In his motion, Mr Gorton claims the statements were not protected speech, but then says, even if they were, they were not a factor in his decision to terminate Dr Kruszewski, because he was unaware of the statements when he decided to fire Dr Kruszewski.
However, Judge Kane found evidence in the record that, "if credited by a fact-finder," she wrote, "would support Plaintiff's claim that Gorton knew of at least some of Plaintiff's protected statements."
"Because there remain genuine disputes of material fact," she states, "regarding Plaintiff's job duties and whether Plaintiff's statements were substantial and motivating factors in his termination, the Court cannot grant summary judgment for Defendant Gorton."
According to Dr Kruszewski, apart from all the legal wrangling, his focus remains on trying to protect Pennsylvania citizens against unwarranted drugging, sexual and physical abuse, and unnecessary restraint and seclusion.
His original lawsuit alleges that drug companies used "political friendships, money, and other emoluments" to achieve "a level of influence with Pennsylvania's state government" to promote "the use of their products."
These charges echo those previously made by the other Pennsylvania whistleblower, Allen Jones, who was also a fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, and was fired after he informed his superiors that drug companies were funneling money to state officials and policy makers in positions of influence over the state's preferred drug formulary known as PennMap.
Last year, Mr Jones settled a whistleblower lawsuit in Pennsylvania, also with the assistance of the Government Accountability Project. While he did not agree to a gag order regarding his concerns, he did agree not to discuss the terms of the settlement.
During his investigation, Mr Jones found collusion between drug companies and several state officials and specifically, Steven Fiorello, Pennsylvania's chief pharmacist, a valuable player because he monitored pharmacy operations at 9 state hospitals and served on the committee that determined which drugs would be prescribed to patients in state hospitals.
On November 21, 2006, Mr Fiorello was arraigned on two felony counts of conflict of interest and misdemeanor counts of accepting money and failing to disclose the income on his yearly financial interest statements.
A year and a half earlier, the Pennsylvania State Ethics Commission had determined that Mr Fiorello had repeatedly violated state ethic laws by using his position to earn money from drug companies. To settle the charges with the Ethics Commission, Mr Fiorello paid fines totaling $27,269, before the case was referred for criminal prosecution.
Down in Texas, another state official, Dr Steven Shon was fired from his job in October 2006, after the state's attorney general, Greg Abbot, found J&J had improperly influenced Dr Shon to list Risperdal in a state formulary called the "Texas Medication Algorithm Project," or TMAP, while receiving money from J&J.
In December 2006, Mr Abbott joined another whistleblower lawsuit filed by Mr Jones, against J&J, alleging in part, that the company misrepresented the safety and effectiveness of Risperdal and unduly influenced Dr Shon and others, to make it a drug of choice for persons covered by public health care programs in Texas.
TMAP required doctors to prescribe atypicals rather than the older, less expensive antipsychotics. "The plan," Mr Jones explains, "was part of a larger scheme designed to infiltrate public institutions to influence prescribing practices in which drug companies bought the opinions of a few key doctors and state policymakers, and opened the door for spending billions of tax dollars on dangerous drugs."
The Texas lawsuit describes exactly how the TMAP preferred drug list was developed in Texas in 1997, and according to the complaint, Dr Shon traveled around the country at J&J's expense to convince officials in other states to adopt the TMAP model, which is now used in 17 states.
The lawsuit says, J&J promoted Risperdal by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments and that Risperdal was recommended as the drug of choice for children, even though it was not approved for use with children.
TMAP was highly successful in getting doctors to prescribe atypicals to kids. According to an investigation of psychiatric drug use by Texas children on Medicaid, ACS-Heritage, a medical consulting firm, found 19,404 teens were prescribed an antipsychotic in July or August of 2004, with nearly 98% being atypicals.
ACS also found that more than half of the doses were inappropriately high, almost half of the prescriptions did not appear to have diagnoses warranting their use, and one-third of the children were on two or more drugs.
The Texas lawsuit alleges that J&J concealed Risperdal's link to hyperglycemia, stroke, and renal failure, to qualify for reimbursement under Medicaid, and that Texas seeks to recover money paid to purchase the drug for off-label uses and the cost of medical care for the people injured by Risperdal.
In 2005 alone, according to the Texas Health and Human Services Commission, Texas paid for approximately 308,000 Risperdal prescriptions at a cost of $73.5 million.
Critics say, the Governor of Pennsylvania is suing atypicals makers now to portray a hard stance against the pharmaceutical industry because he wants to run for higher office, when in reality, he has known about the PennMap off-label scheme for years.
The consensus is that Mr Rendell believes he missed a chance for national prominence by allowing the two whistleblowers to be fired and sweeping the results of their investigations under the rug. Critics point out that PennMap is still in place even though TMAP has been discredited in Texas and other states.
In November 2005, USA Today quoted FDA Drug Safety Officer, Dr David Graham's estimate that 62,000 Americans die each year from the off-label prescribing of atypicals. According to Mr Jones, this translates into nearly 10,000 deaths occurring in Pennsylvania during Governor Rendell's first term.
During a congressional hearing last month, Dr Graham testified that the off-label use of atypicals to sedate people in nursing home kills roughly 15,000 people a year. Based on this estimate, Mr Jones says, about 2,400 Pennsylvania senior citizens died in the Governor's first term.
"During this time," Mr Jones reports, "Pennsylvania citizens, insurers and taxpayers paid in the neighborhood of one billion dollars for drugs proven to be no more effective, and far more deadly, than the older antipsychotic medications."
Eli Lilly, Johnson & Johnson, and AstraZeneca, are all named defendants in a new lawsuit filed by the state of Pennsylvania on February 26, 2007, to recover money paid through public health care programs to purchase Zyprexa, Risperdal, and Seroquel, and the costs of medical care for the people injured by these drugs.
Pennsylvania is the 5th state to sue Lilly over its illegal marketing of Zyprexa. And according to SEC filings, Lilly was served with four Canadian lawsuits in 2005, with claims "similar to those in the litigation pending in the United States."
So far, two states have sued Johnson & Johnson over Risperdal, but Pennsylvania is the first state to file a lawsuit against Seroquel-maker AstraZeneca.
The drugs belong to a class known as "atypical" antipsychotics, FDA approved only to treat adults with schizophrenia or bipolar disorder, and yet they are some of the most widely prescribed drugs in the world. In 2006, Zyprexa sales were $4.3 billion, Seroquel's earned $3.4 billion, and Risperdal had sales of $4.1 billion, according to SEC filings.
A July 2006, report by Decision Resources, a leading advisory firm on healthcare issues, listed antipsychotics in 2005, as the fourth-highest-ranking class of drugs, and said two of the top ten drugs in worldwide sales were atypicals.
According to the lawsuit, the defendant drug makers concealed the risks of atypicals and exaggerated their benefits while persuading doctors to prescribe the drugs off-label for dementia, attention deficit disorders, and mood and behavior disorders.
When the FDA approves a drug it also approves the label, which lists the indications for which the drug can be prescribed, along with instructions for use and warnings about the risks associated with the drug. Once a drug is approved to treat one condition, doctors may prescribe it for others if they think it will be effective, but by law drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.
On March 1, 2007, four days after the Pennsylvania lawsuit was filed, two of the three drug companies became the target of another investigation, when Representative, Henry Waxman (D-Cal), the chairman of the House Oversight and Government Reform Committee, sent letters to Eli Lilly and AstraZeneca, requesting information related to the exact same charges alleged in lawsuits filed by individual states.
The letter sent to Lilly states in part, "Allegations have been raised that Eli Lilly misled physicians and inappropriately promoted off-label uses of Zyprexa," and requests information relevant to these allegations.
The letter asks for a list of all Zyprexa trials, studies, or reports; all presentations given to employees who promoted Zyprexa; information shown to physicians; presentations related to physician prescribing patterns, continuing medical education, and off-label use; and all documents and correspondence related to funding for nonprofit professional organizations or consumer patient groups.
In addition, Rep Waxman wants Lilly to turn over all internal company documents that were kept under seal for years with a court order, but were provided to him by Attorney, James Gottstein, in December 2006, which Rep Waxman subsequently returned to Lilly on December 21, 2006, to honor the court order.
According to the New York Times, some of these documents reveal that Lilly knew about Zyprexa's link to high blood sugar and extreme weight gain that often leads to diabetes, and others show the details of off-label marketing scheme called "Viva Zyprexa."
Rep Waxman's letter to AstraZeneca basically asks for the same documents requested from Lilly except that he requests more information related to the physicians and authors involved in company sponsored studies and writing the reports.
Late last year, the atypical makers also received subpoenas from the attorney general of California seeking much of the same information.
In pursuing the Pennsylvania lawsuit, Governor Edward Rendell, has hired private attorneys. According to the complaint, the defendants cost Pennsylvania millions of dollars "for non-medically accepted indications and non-medically necessary uses of Zyprexa, Seroquel and Risperdal," as well as "significant sums of money for the care and treatment" of patients injured by the drugs.
The Pennsylvania case comes on the heels of lawsuits by two Pennsylvania whistleblowers, Allen Jones and Stefan Kruszewski, who say, drug companies are making a fortune from the off-label sale of drugs to patients whose care is funded by Medicaid and Medicare.
At the heart of the off-label scheme, they say, are the preferred drug lists, or medication formularies, maintained in many states. Once drugs are added to the list, they must be prescribed as a first line of treatment for all patients in state run institutions and patients in the general population who are covered by public health care programs.
In the summer of 2002, psychiatrist, Dr Kruszewski, was employed with the Pennsylvania Department of Public Welfare, and charged with reviewing psychiatric care provided by state-funded agencies to identify waste, fraud, and abuse. He was also responsible for reviewing the deaths of individuals in state care who died under suspicious circumstances in facilities inside and outside of Pennsylvania.
Early in his investigation, Dr Kruszewski noticed that almost all of the patients under state care were on drug cocktails consisting of antipsychotics, antidepressants, and anticonvulsants. The populations he found drugged most often, he said, were children in state care, the disabled, people in state prisons, and children in the juvenile justice system.
For instance, he says, Neurontin was only approved for controlling seizures, but "was being prescribed for anxiety, social phobia, PTSD, oppositional defiant behavior, and attention deficit disorder with no evidence to support these uses."
When he informed his superiors about the high rate of off-label prescribing and warned about the risk of liability to the state of Pennsylvania if it continued, he was told, "it is none of your business."
In June 2003, Dr Kruszewski inspected a facility in Oklahoma that housed children from Pennsylvania after an unexpected death of a child, and found children were being overmedicated and housed in deplorable living conditions, in addition to being sexually and physically abused by staff and kept in unnecessary restraints and seclusion.
In a report, Dr Kruszewski recommended removing the children from the facility, "in order to protect other innocent individuals from morbid and mortal consequences of severe over-medication, including chemical restraints; emotional, physical and sexual abuse; seclusion; and dirty and inadequate living conditions."
A day later, Dr Kruszewski was accused of "trying to dig up dirt," and was subsequently fired in July 2004, because he refused to keep quiet and accept that it was none of his business, he says.
A year later, Dr Kruszewski filed a whistleblower lawsuit alleging that patients under state care were being drugged for profit and prescribed as many as 5 psychiatric drugs at the same time, and that four children and one adult had died.
In his action, Dr Kruszewski alleged that his superiors violated his right to free speech by firing him because he made statements about the abuses in the state system, which were a matter of public concern.
Dr Kruszewski is represented by attorneys from Government Accountability Project, Thad Guyer, Stephania Ayers, Tom Devine, and Mark Cohen, in Federal Court in the Middle District of Pennsylvania with Chief Judge Yvette Kane presiding.
Defendant, Christopher Gorton, is the Chief Medical Officer for DPW, who fired Dr Kruszewski. He filed a motion for summary judgment to dismiss the First Amendment claim on the basis that the law does not protect whistleblowers if they are fired for making comments they would be expected to make in the context of their employment.
In reading the Court's March 2, 2007, Decision denying Mr Gorton's motion, it appears that Mr Gorton tried to have it both ways. When Dr Kruszewski was employed and tried to report the harm to people under state care, he was told it was none of his business and to quit digging up dirt. Under oath in a deposition, Dr Kruszewski stated that he was told that the subjects of his statements were not part of his job duties.
However, in his motion, Mr Gorton now claims that Dr Kruszewski's comments were made pursuant to his official employment duties. In her written opinion, Judge Kane, quoted relevant case law to describe comments that are protected:
"A public employee's statement is protected activity when (1) in making it, the employee spoke as a citizen, (2) the statement involved a matter of public concern, and (3) the government employer did not have an adequate justification for treating the employee different from any other member of the general public as a result of the statement he made."
"The statements in question can be categorized," Judge Kane wrote, "as: (1) reports regarding poor quality of care, including abuse of patients by staff at treatment facilities; (2) complaints about the lack of qualifications of another private contract doctor; and (3) statements about use and costs of medications."
In order to grant a motion for summary judgment, a judge has to find that there are no genuine disputes of material fact that would require a jury to resolve. In this case, Judge Kane found there were disputes regarding Dr Kruszewski's job duties and whether his statements were substantial and motivating factors in his termination.
In his motion, Mr Gorton claims the statements were not protected speech, but then says, even if they were, they were not a factor in his decision to terminate Dr Kruszewski, because he was unaware of the statements when he decided to fire Dr Kruszewski.
However, Judge Kane found evidence in the record that, "if credited by a fact-finder," she wrote, "would support Plaintiff's claim that Gorton knew of at least some of Plaintiff's protected statements."
"Because there remain genuine disputes of material fact," she states, "regarding Plaintiff's job duties and whether Plaintiff's statements were substantial and motivating factors in his termination, the Court cannot grant summary judgment for Defendant Gorton."
According to Dr Kruszewski, apart from all the legal wrangling, his focus remains on trying to protect Pennsylvania citizens against unwarranted drugging, sexual and physical abuse, and unnecessary restraint and seclusion.
His original lawsuit alleges that drug companies used "political friendships, money, and other emoluments" to achieve "a level of influence with Pennsylvania's state government" to promote "the use of their products."
These charges echo those previously made by the other Pennsylvania whistleblower, Allen Jones, who was also a fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, and was fired after he informed his superiors that drug companies were funneling money to state officials and policy makers in positions of influence over the state's preferred drug formulary known as PennMap.
Last year, Mr Jones settled a whistleblower lawsuit in Pennsylvania, also with the assistance of the Government Accountability Project. While he did not agree to a gag order regarding his concerns, he did agree not to discuss the terms of the settlement.
During his investigation, Mr Jones found collusion between drug companies and several state officials and specifically, Steven Fiorello, Pennsylvania's chief pharmacist, a valuable player because he monitored pharmacy operations at 9 state hospitals and served on the committee that determined which drugs would be prescribed to patients in state hospitals.
On November 21, 2006, Mr Fiorello was arraigned on two felony counts of conflict of interest and misdemeanor counts of accepting money and failing to disclose the income on his yearly financial interest statements.
A year and a half earlier, the Pennsylvania State Ethics Commission had determined that Mr Fiorello had repeatedly violated state ethic laws by using his position to earn money from drug companies. To settle the charges with the Ethics Commission, Mr Fiorello paid fines totaling $27,269, before the case was referred for criminal prosecution.
Down in Texas, another state official, Dr Steven Shon was fired from his job in October 2006, after the state's attorney general, Greg Abbot, found J&J had improperly influenced Dr Shon to list Risperdal in a state formulary called the "Texas Medication Algorithm Project," or TMAP, while receiving money from J&J.
In December 2006, Mr Abbott joined another whistleblower lawsuit filed by Mr Jones, against J&J, alleging in part, that the company misrepresented the safety and effectiveness of Risperdal and unduly influenced Dr Shon and others, to make it a drug of choice for persons covered by public health care programs in Texas.
TMAP required doctors to prescribe atypicals rather than the older, less expensive antipsychotics. "The plan," Mr Jones explains, "was part of a larger scheme designed to infiltrate public institutions to influence prescribing practices in which drug companies bought the opinions of a few key doctors and state policymakers, and opened the door for spending billions of tax dollars on dangerous drugs."
The Texas lawsuit describes exactly how the TMAP preferred drug list was developed in Texas in 1997, and according to the complaint, Dr Shon traveled around the country at J&J's expense to convince officials in other states to adopt the TMAP model, which is now used in 17 states.
The lawsuit says, J&J promoted Risperdal by influencing policymakers with trips, perks, travel expenses, speaking fees and other payments and that Risperdal was recommended as the drug of choice for children, even though it was not approved for use with children.
TMAP was highly successful in getting doctors to prescribe atypicals to kids. According to an investigation of psychiatric drug use by Texas children on Medicaid, ACS-Heritage, a medical consulting firm, found 19,404 teens were prescribed an antipsychotic in July or August of 2004, with nearly 98% being atypicals.
ACS also found that more than half of the doses were inappropriately high, almost half of the prescriptions did not appear to have diagnoses warranting their use, and one-third of the children were on two or more drugs.
The Texas lawsuit alleges that J&J concealed Risperdal's link to hyperglycemia, stroke, and renal failure, to qualify for reimbursement under Medicaid, and that Texas seeks to recover money paid to purchase the drug for off-label uses and the cost of medical care for the people injured by Risperdal.
In 2005 alone, according to the Texas Health and Human Services Commission, Texas paid for approximately 308,000 Risperdal prescriptions at a cost of $73.5 million.
Critics say, the Governor of Pennsylvania is suing atypicals makers now to portray a hard stance against the pharmaceutical industry because he wants to run for higher office, when in reality, he has known about the PennMap off-label scheme for years.
The consensus is that Mr Rendell believes he missed a chance for national prominence by allowing the two whistleblowers to be fired and sweeping the results of their investigations under the rug. Critics point out that PennMap is still in place even though TMAP has been discredited in Texas and other states.
In November 2005, USA Today quoted FDA Drug Safety Officer, Dr David Graham's estimate that 62,000 Americans die each year from the off-label prescribing of atypicals. According to Mr Jones, this translates into nearly 10,000 deaths occurring in Pennsylvania during Governor Rendell's first term.
During a congressional hearing last month, Dr Graham testified that the off-label use of atypicals to sedate people in nursing home kills roughly 15,000 people a year. Based on this estimate, Mr Jones says, about 2,400 Pennsylvania senior citizens died in the Governor's first term.
"During this time," Mr Jones reports, "Pennsylvania citizens, insurers and taxpayers paid in the neighborhood of one billion dollars for drugs proven to be no more effective, and far more deadly, than the older antipsychotic medications."
Zyprexa Injury Clock Keeps Ticking Away
Evelyn Pringle February 2, 2007
The on-going legal battle over the disclosure of secret Eli Lilly documents that reveal the serious health risks associated with Zyprexa and the company's off-label promotion of the drug involves a matter of grave public concern.
But observers on the sidelines of this courtroom circus say the conduct of the judge in helping Lilly keep documents secret that give the specific details of an illegal marketing scheme that is literally killing people is almost as disturbing as the underlying acts.
The off-label prescribing of Zyprexa has created a public health crisis. According to the New York Times, the secret documents show a pattern of unlawful activities that may have left the 20 million individuals who have taken Zyprexa with incomplete information regarding the side effects of the drug.
Harvard trained psychiatrist, Dr Stefan Kruszewski, reports that Zyprexa increases the risk of obesity, diabetes, hypertension, cardiovascular complications, heart attacks and stroke.
Keeping in mind that the FDA says that only between 1% and 10% of adverse events are reported to the agency, a study conducted 5 years ago, in the July 2002, issue of Pharmacotherapy, reviewed the adverse event reports submitted on Zyprexa and found that of the 289 cases of diabetes reported, 225 of the patients were newly diagnosed.
The review also identified 100 Zyprexa patients who had developed ketosis, a serious complication of diabetes, 22 cases of pancreatitis, a life-threatening inflammation of the pancreas, and 23 deaths associated with the drug.
Zyprexa is an antipsychotic approved by the FDA to treat adults with schizophrenia and bipolar disorder only. But doctors are prescribing the drug for conditions, treatment durations, and patient populations for which it was never intended and worst of all it is being widely prescribed for children.
For instance, in February 2006, public health officials in Florida ordered an investigation into why the number of children who are prescribed antipsychotics billed to Medicaid in Florida had nearly doubled in five years, from 9,500 children to almost 18,000.
The lawsuits filed against Lilly to recover the money paid for Zyprexa by state Medicaid programs due to the company's off-label promotion say the drug is being sold for unapproved uses such as anxiety and other mood disorders, sleep disruption, autism, attention deficit disorders, hyperactivity, and dementia.
According to the attorney general of Mississippi, about 10% of Zyprexa patients on Medicaid in that state, have developed diabetes. In fact, the health problems associated with Zyprexa have become so prevalent, that one class action lawsuit is demanding money to cover the medical monitoring of all patients who took Zyprexa but have not yet been diagnosed with high blood sugar, diabetes, or pancreatitis.
Children on Zyprexa are developing life-long injuries. At the annual meeting of the American Academy of Child and Adolescent Psychiatry in Washington, DC, on October 20, 2004, researchers from the Johns Hopkins Children's Center reported that atypical antipsychotics were found to trigger insulin resistance in children. The researchers evaluated 11 children who gained significant amounts of weight while taking the drugs.
Weight gain is a known risk factor that contributes to insulin resistance. Insulin is produced by the pancreas to help cells absorb glucose and provide energy. When resistance occurs, the pancreas tries to keep up with the demand by producing more insulin until it eventually cannot keep up, and excess glucose builds up in the bloodstream which can increase the risk of type-2 diabetes, heart disease, and stroke.
All six children in the John Hopkins study who were on moderate or high doses of an antipsychotic developed symptoms of insulin resistance, and three of the 5 children on low doses did as well.
The study's lead author, Dr Mark Riddle, director of the division of child and adolescent psychiatry at the Center, said, "The insulin resistance seen in these children was greater than what would be expected from weight gain alone, suggesting there is a factor distinct from excess weight that directly induces insulin resistance."
Experts say Zyprexa is poison for some people. According to Dr Louis Caplan, Professor of Neurology at Harvard Medical School, there is overuse of antipsychotics in patients admitted to hospitals. "These drugs," he said, "are often given in high doses to very sick patients in intensive care units or on medical and surgical units," in the February 21, 2006, journal Neurology.
"They cause symptoms and neurological dysfunctions that are a common reason for neurological consultations in the hospital," Dr Caplan warns.
"Old sick people with abnormal brains do not tolerate these drugs well," he says. "In patients with Lewy-body disease and some Parkinsonian syndromes, their use is a disaster, setting patients back for weeks," he warns.
When the FDA approves a drug, it also approves the labeling which explains the manner in which the drug is to be prescribed. While doctors may prescribe drugs as they see fit, its illegal for drug companies to promote drugs for uses outside the labeling.
However, as vividly evidenced here, drug makers do it and get away with it all the time and the leaked Lilly documents prove that the US court system is aiding and abetting drug companies in hiding their illegal marketing schemes.
For instance, in one article, the Times quotes a sealed document that served as a script for a company meeting in 2001, where a Mr Bandick praised sales representatives for the number of new Zyprexa prescriptions they got doctors to write. According to the script, more than 100 representatives convinced doctors to write at least 16 extra prescriptions.
The legal battle over the documents began in December 2006, when Dr David Egilman, provided the documents to Alaskan attorney, Jim Gottstein, and Mr Gottstein turned them over to Alex Berenson, a reporter for the New York Times.
Dr Egilman first learned about Lilly's illegal conduct when he reviewed the documents a few years back as an expert witness in the Zyprexa litigation. However, when Lilly was successful in the settling the cases out of court, Dr Egilman was forcibly silenced because the court allowed Lilly to continue to keep the documents hidden with a protective order.
As soon as the articles began to appear in the New York Times, describing an off-label marketing scheme called, "Viva Zyprexa," Lilly got a judge to issue a mandatory temporary injunction on December 18, 2006, ordering Mr Gottstein to return the documents and list the names of everyone he disclosed them to or discussed them with.
After he supplied the list, Lilly got the court to issue a second temporary injunction on December 29, 2006, to prohibit the dissemination of the documents by Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski, Laura Ziegler, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Will Hall.
The above list reads like a Big Pharma hit list. It includes about every well-known expert on the side effects of psychiatric drugs in the US, as well as the journalists and authors who have investigated and written most extensively about the misconduct of drug companies when it comes to the off-label promotion of drugs, and specifically Zyprexa.
Conspicuously absent from the injunction is the New York Times and the reporter who actually used the documents when writing five articles on the matter. Most curious is the fact that Lilly has never even asked the court to issue an injunction for the Times.
On January 3, 2007, a hearing was held on a request by Lilly to extend the temporary injunction, and to force Mr Gottstein to appear in New York City for a deposition within 5 days, as a prelude to charging him with civil and criminal contempt of court for publicizing the documents.
As a result of that hearing, several more entities were added to the injunction list including Eric Whalen and his web site at www.joysoup.net; the MindFreedom web site at www.mindfreedom.org, and the Alliance for Human Research Protection (AHRP) web sites at www.ahrp.org and www.ahrp.blogspot.com.
Once again, the Times and Alex Berenson were not added, and in fact, during the hearing, Judge Jack Weinstein said he was not about to issue an injunction against the Times.
By its own estimate in the media, Lilly produced approximately 11 million documents in discovery for Zyprexa litigation thus far, and has designated them all confidential pursuant to Case Management Order 3, a protective order entered on August 9, 2004.
When issuing CMO-3, the court gave Lilly the right to designate documents confidential, as long as Lilly "in good faith" believed that they were. However legal experts say the secret documents at issue here never should have been covered by a protective order.
According to attorneys in the case, in entering CMO-3, the court did not articulate the reasons why a protective order was necessary or set forth any criteria to use when determining whether a document was actually confidential and deserving of protection.
Yet instead of keeping the focus on why the 11 million documents were ever permitted to remain hidden in the first place, Judge Weinstein is allowing Lilly to hammer away at the messengers who gave the documents to the press, after deciding that the information needed to be circulated before more people were injured and killed.
In a January 17, 2007, hearing, Mr Gottstein was asked: "In this particular case involving Zyprexa, at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?"
He answered: "Absolutely."
Mr Gottstein was then asked whether it was his impression that there were thousands of cases of harm to people from Zyprexa, while Lilly was in the process of settling cases out of court, and he said yes and that was why he wanted the documents out there "to protect people from this drug."
He had nothing to gain personally by providing the documents the Times. Mr Gottstein testified that he does not represent clients who were injured by Zyprexa for money damages and that his sole interest was protecting patients.
On January 25, 2007, in response to a request for Dr Egilman to appear at a deposition in preparation for Lilly to file civil and criminal contempt of court charges against him, though his attorney, Dr Egilman informed Lilly's legal team that he will refuse to testify under the protection of the Fifth Amendment.
A number of persons restrained by the injunction have obtained attorneys to file briefs with First Amendment arguments including the public's right to know what is in the documents and some people appeared at the last court hearing.
Ms Sharav and Dr Cohen point out in their brief, that they are not ex-employees of Lilly who have stolen trade secrets. They are merely a public health advocate and a professor who seek to share Lilly's own words with the public and they view exposing the information that "Lilly wants so desperately to keep hidden" as their primary public role.
Ms Sharav testified at the January 17, 2007, hearing, and when asked why she was interested in the documents by a Lilly attorney, said because they document the fact that Lilly knew in 2000, that Zyprexa caused diabetes, "from a group of doctors that they hired who told them you have to come clean."
"And instead of warning doctors who are widely prescribing the drug," she testified, "Eli Lilly set about in an aggressive marketing campaign to primary doctors."
"Little children are being given this drug," she said, "Little children are being exposed to horrific diseases that end their lives shorter."
"Now, I consider that a major crime," she stated, "to continue to conceal these facts from the public is I think really not in the public interest. This is a safety issue."
Lilly's attorney asked the court to strike her comments from the record but the request was denied.
Attorney, Alan Milstein, appeared on behalf of Ms Sharav, the AHRP, and Dr Cohen, and toward the end of the hearing noted that in handling the underlying Zypexa litigation, the judge had had occasion to look at the documents in question or at least to read the Times articles and stated: "What is abundantly clear is that they are not trade secrets."
"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," Mr Milstein told Judge Weinstein.
"What Lilly wants to prevent," he said, "is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it."
"Documents like that are not confidential and should not be marked confidential," he stated.
At the end of the hearing, the judge instructed the parties to file more briefs and another hearing is scheduled for February 7, 2007, for oral arguments.
In the latest turn of events, right out of the blue, Judge Weinstein issued an order this week with an "invitation" for Mr Berenson to appear in court to give testimony and be cross-examined on whether he participated in a conspiracy with Mr Gottstein and Dr Egilman to violate the original court order that sealed the documents.
In the meantime, while this circus plays out in the courts, every day thousands of doctors and patients are making uninformed decisions on whether to use Zyprexa. And the injury clock is ticking.
Allen Jones, a former fraud investigator in the Pennsylvania Office of Inspector General, states: "My best effort at correlating dollars spent with deaths suggests that people may be dying from side effects at the rate of at least one death for each one million dollars spent on the drug."
The on-going legal battle over the disclosure of secret Eli Lilly documents that reveal the serious health risks associated with Zyprexa and the company's off-label promotion of the drug involves a matter of grave public concern.
But observers on the sidelines of this courtroom circus say the conduct of the judge in helping Lilly keep documents secret that give the specific details of an illegal marketing scheme that is literally killing people is almost as disturbing as the underlying acts.
The off-label prescribing of Zyprexa has created a public health crisis. According to the New York Times, the secret documents show a pattern of unlawful activities that may have left the 20 million individuals who have taken Zyprexa with incomplete information regarding the side effects of the drug.
Harvard trained psychiatrist, Dr Stefan Kruszewski, reports that Zyprexa increases the risk of obesity, diabetes, hypertension, cardiovascular complications, heart attacks and stroke.
Keeping in mind that the FDA says that only between 1% and 10% of adverse events are reported to the agency, a study conducted 5 years ago, in the July 2002, issue of Pharmacotherapy, reviewed the adverse event reports submitted on Zyprexa and found that of the 289 cases of diabetes reported, 225 of the patients were newly diagnosed.
The review also identified 100 Zyprexa patients who had developed ketosis, a serious complication of diabetes, 22 cases of pancreatitis, a life-threatening inflammation of the pancreas, and 23 deaths associated with the drug.
Zyprexa is an antipsychotic approved by the FDA to treat adults with schizophrenia and bipolar disorder only. But doctors are prescribing the drug for conditions, treatment durations, and patient populations for which it was never intended and worst of all it is being widely prescribed for children.
For instance, in February 2006, public health officials in Florida ordered an investigation into why the number of children who are prescribed antipsychotics billed to Medicaid in Florida had nearly doubled in five years, from 9,500 children to almost 18,000.
The lawsuits filed against Lilly to recover the money paid for Zyprexa by state Medicaid programs due to the company's off-label promotion say the drug is being sold for unapproved uses such as anxiety and other mood disorders, sleep disruption, autism, attention deficit disorders, hyperactivity, and dementia.
According to the attorney general of Mississippi, about 10% of Zyprexa patients on Medicaid in that state, have developed diabetes. In fact, the health problems associated with Zyprexa have become so prevalent, that one class action lawsuit is demanding money to cover the medical monitoring of all patients who took Zyprexa but have not yet been diagnosed with high blood sugar, diabetes, or pancreatitis.
Children on Zyprexa are developing life-long injuries. At the annual meeting of the American Academy of Child and Adolescent Psychiatry in Washington, DC, on October 20, 2004, researchers from the Johns Hopkins Children's Center reported that atypical antipsychotics were found to trigger insulin resistance in children. The researchers evaluated 11 children who gained significant amounts of weight while taking the drugs.
Weight gain is a known risk factor that contributes to insulin resistance. Insulin is produced by the pancreas to help cells absorb glucose and provide energy. When resistance occurs, the pancreas tries to keep up with the demand by producing more insulin until it eventually cannot keep up, and excess glucose builds up in the bloodstream which can increase the risk of type-2 diabetes, heart disease, and stroke.
All six children in the John Hopkins study who were on moderate or high doses of an antipsychotic developed symptoms of insulin resistance, and three of the 5 children on low doses did as well.
The study's lead author, Dr Mark Riddle, director of the division of child and adolescent psychiatry at the Center, said, "The insulin resistance seen in these children was greater than what would be expected from weight gain alone, suggesting there is a factor distinct from excess weight that directly induces insulin resistance."
Experts say Zyprexa is poison for some people. According to Dr Louis Caplan, Professor of Neurology at Harvard Medical School, there is overuse of antipsychotics in patients admitted to hospitals. "These drugs," he said, "are often given in high doses to very sick patients in intensive care units or on medical and surgical units," in the February 21, 2006, journal Neurology.
"They cause symptoms and neurological dysfunctions that are a common reason for neurological consultations in the hospital," Dr Caplan warns.
"Old sick people with abnormal brains do not tolerate these drugs well," he says. "In patients with Lewy-body disease and some Parkinsonian syndromes, their use is a disaster, setting patients back for weeks," he warns.
When the FDA approves a drug, it also approves the labeling which explains the manner in which the drug is to be prescribed. While doctors may prescribe drugs as they see fit, its illegal for drug companies to promote drugs for uses outside the labeling.
However, as vividly evidenced here, drug makers do it and get away with it all the time and the leaked Lilly documents prove that the US court system is aiding and abetting drug companies in hiding their illegal marketing schemes.
For instance, in one article, the Times quotes a sealed document that served as a script for a company meeting in 2001, where a Mr Bandick praised sales representatives for the number of new Zyprexa prescriptions they got doctors to write. According to the script, more than 100 representatives convinced doctors to write at least 16 extra prescriptions.
The legal battle over the documents began in December 2006, when Dr David Egilman, provided the documents to Alaskan attorney, Jim Gottstein, and Mr Gottstein turned them over to Alex Berenson, a reporter for the New York Times.
Dr Egilman first learned about Lilly's illegal conduct when he reviewed the documents a few years back as an expert witness in the Zyprexa litigation. However, when Lilly was successful in the settling the cases out of court, Dr Egilman was forcibly silenced because the court allowed Lilly to continue to keep the documents hidden with a protective order.
As soon as the articles began to appear in the New York Times, describing an off-label marketing scheme called, "Viva Zyprexa," Lilly got a judge to issue a mandatory temporary injunction on December 18, 2006, ordering Mr Gottstein to return the documents and list the names of everyone he disclosed them to or discussed them with.
After he supplied the list, Lilly got the court to issue a second temporary injunction on December 29, 2006, to prohibit the dissemination of the documents by Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski, Laura Ziegler, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Will Hall.
The above list reads like a Big Pharma hit list. It includes about every well-known expert on the side effects of psychiatric drugs in the US, as well as the journalists and authors who have investigated and written most extensively about the misconduct of drug companies when it comes to the off-label promotion of drugs, and specifically Zyprexa.
Conspicuously absent from the injunction is the New York Times and the reporter who actually used the documents when writing five articles on the matter. Most curious is the fact that Lilly has never even asked the court to issue an injunction for the Times.
On January 3, 2007, a hearing was held on a request by Lilly to extend the temporary injunction, and to force Mr Gottstein to appear in New York City for a deposition within 5 days, as a prelude to charging him with civil and criminal contempt of court for publicizing the documents.
As a result of that hearing, several more entities were added to the injunction list including Eric Whalen and his web site at www.joysoup.net; the MindFreedom web site at www.mindfreedom.org, and the Alliance for Human Research Protection (AHRP) web sites at www.ahrp.org and www.ahrp.blogspot.com.
Once again, the Times and Alex Berenson were not added, and in fact, during the hearing, Judge Jack Weinstein said he was not about to issue an injunction against the Times.
By its own estimate in the media, Lilly produced approximately 11 million documents in discovery for Zyprexa litigation thus far, and has designated them all confidential pursuant to Case Management Order 3, a protective order entered on August 9, 2004.
When issuing CMO-3, the court gave Lilly the right to designate documents confidential, as long as Lilly "in good faith" believed that they were. However legal experts say the secret documents at issue here never should have been covered by a protective order.
According to attorneys in the case, in entering CMO-3, the court did not articulate the reasons why a protective order was necessary or set forth any criteria to use when determining whether a document was actually confidential and deserving of protection.
Yet instead of keeping the focus on why the 11 million documents were ever permitted to remain hidden in the first place, Judge Weinstein is allowing Lilly to hammer away at the messengers who gave the documents to the press, after deciding that the information needed to be circulated before more people were injured and killed.
In a January 17, 2007, hearing, Mr Gottstein was asked: "In this particular case involving Zyprexa, at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?"
He answered: "Absolutely."
Mr Gottstein was then asked whether it was his impression that there were thousands of cases of harm to people from Zyprexa, while Lilly was in the process of settling cases out of court, and he said yes and that was why he wanted the documents out there "to protect people from this drug."
He had nothing to gain personally by providing the documents the Times. Mr Gottstein testified that he does not represent clients who were injured by Zyprexa for money damages and that his sole interest was protecting patients.
On January 25, 2007, in response to a request for Dr Egilman to appear at a deposition in preparation for Lilly to file civil and criminal contempt of court charges against him, though his attorney, Dr Egilman informed Lilly's legal team that he will refuse to testify under the protection of the Fifth Amendment.
A number of persons restrained by the injunction have obtained attorneys to file briefs with First Amendment arguments including the public's right to know what is in the documents and some people appeared at the last court hearing.
Ms Sharav and Dr Cohen point out in their brief, that they are not ex-employees of Lilly who have stolen trade secrets. They are merely a public health advocate and a professor who seek to share Lilly's own words with the public and they view exposing the information that "Lilly wants so desperately to keep hidden" as their primary public role.
Ms Sharav testified at the January 17, 2007, hearing, and when asked why she was interested in the documents by a Lilly attorney, said because they document the fact that Lilly knew in 2000, that Zyprexa caused diabetes, "from a group of doctors that they hired who told them you have to come clean."
"And instead of warning doctors who are widely prescribing the drug," she testified, "Eli Lilly set about in an aggressive marketing campaign to primary doctors."
"Little children are being given this drug," she said, "Little children are being exposed to horrific diseases that end their lives shorter."
"Now, I consider that a major crime," she stated, "to continue to conceal these facts from the public is I think really not in the public interest. This is a safety issue."
Lilly's attorney asked the court to strike her comments from the record but the request was denied.
Attorney, Alan Milstein, appeared on behalf of Ms Sharav, the AHRP, and Dr Cohen, and toward the end of the hearing noted that in handling the underlying Zypexa litigation, the judge had had occasion to look at the documents in question or at least to read the Times articles and stated: "What is abundantly clear is that they are not trade secrets."
"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," Mr Milstein told Judge Weinstein.
"What Lilly wants to prevent," he said, "is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it."
"Documents like that are not confidential and should not be marked confidential," he stated.
At the end of the hearing, the judge instructed the parties to file more briefs and another hearing is scheduled for February 7, 2007, for oral arguments.
In the latest turn of events, right out of the blue, Judge Weinstein issued an order this week with an "invitation" for Mr Berenson to appear in court to give testimony and be cross-examined on whether he participated in a conspiracy with Mr Gottstein and Dr Egilman to violate the original court order that sealed the documents.
In the meantime, while this circus plays out in the courts, every day thousands of doctors and patients are making uninformed decisions on whether to use Zyprexa. And the injury clock is ticking.
Allen Jones, a former fraud investigator in the Pennsylvania Office of Inspector General, states: "My best effort at correlating dollars spent with deaths suggests that people may be dying from side effects at the rate of at least one death for each one million dollars spent on the drug."
Experts Predict Many Cases of Permax Heart Valve Damage
Evelyn Pringle January 21, 2007
Nearly three years ago, HealthDay News reported that a study had confirmed previous findings that the drug, Permax, used to treat Parkinson's disease, could damage heart valves and surgery would be needed to correct the problem.
The April 28, 2004, report quoted the lead researcher, Dr Richard Dewey Jr, an associate professor from the University of Texas Southwestern Medical Center, as saying he believed the drug should be taken off the market.
Permax (pergolide) belongs to a class of drugs known as dopamine agonists. Dopamine helps regulate movement and balance. People with Parkinson's suffer from a shortage of dopamine and Permax stimulates nerves in the brain that would normally be stimulated by dopamine. The drug has also been prescribed to treat restless leg syndrome.
Two years earlier, in December 2002, doctors at the Mayo Clinic reported heart valve disease in three patients who had been taking Permax for several years, similar to the damage found in patients who took the Fen-Phen diet drugs.
The 3 cases involved women aged 61, 72, and 74, with no history of heart disease, who had been taking Permax for between three and seven years to treat Parkinson's symptoms. They were all diagnosed with serious valve disease and two required replacement surgery.
As a follow-up to the earlier reports of valve damage in Permax patients, Dr Dewey, and his fellow researchers sent out 200 letters to people who were known to be taking Permax for Parkinson's to determine whether the reports were isolated cases or a common side effect of the drug, and to suggest that patients should switch to anther drug. Patients who wanted to continue taking Permax were urged to have an echocardiogram, to check for heart valve damage.
For the Dewey study, echocardiograms were performed on 46 patients, and then compared the test results from a similarly-aged healthy comparison group. The study found that 89% of the patients receiving Permax had evidence of leaky heart valves, called valvular insufficiency, and Permax patients were up to 18 times more likely to have significant leakage in at least one valve, than patients in the comparison group.
Blood is pumped through the heart in only one direction, according to the Texas Heart Institute. Heart valves play a key role in this one-way blood flow, opening and closing with each heartbeat. Pressure changes on either side of the valves cause them to open their flap-like "doors" at just the right time, then close tightly to prevent a backflow of blood. There are 4 valves in the heart:
* Tricuspid valve
* Pulmonary valve
* Mitral valve
* Aortic valve
Valvular insufficiency occurs when the heart valves do not close properly. It forces the heart to work harder to circulate the blood and can lead to serious problems such as heart attack or heart failure, according to WebMD. Symptoms of heart valve disease include:
* Shortness of breath and/or difficulty breathing
* Weakness or dizziness
* Chest pain or pressure
* Heart palpitations
* Swelling of ankles, feet, or abdomen
* Rapid weight gain
Two new studies published in the January 4, 2007, New England Journal of Medicine, report that the number of Parkinson patients on Permax who have developed heart valve damage is higher than expected.
In one study titled, "Dopamine Agonists and the Risk of Cardiac-Valve Regurgitation," researchers led by Dr Renzo Zanettini, in Milan, Italy obtained echocardiograms from 155 patients taking various Parkinson's drugs, and 90 healthy patients for a comparison group.
The study found moderate to severe valve problems in more than 23% of the patients receiving Permax compared to less than 6% of the patients in the comparison group.
The second study found that Permax users were five to seven times more likely to have leaky heart valves than patients taking other types of Parkinson's drugs, and patients taking the highest doses of Permax had a 37 times greater risk of valve damage. In this study, Dr Rene Schade and colleagues in Berlin and Montreal reviewed records from over 11,400 patients with Parkinson's disease in the UK.
"This is not a rare side effect," says Dr Bryan Roth, a pharmacology professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM. "That's an extraordinarily high incidence," he warns. "That makes this a serious problem."
Experts note that there are no medications that can be used to reverse valve damage and replacement surgery is the only solution.
Dr Roth published a paper several years ago warning that Permax appeared to trigger the same heart valve problems as the Fen-Phen combination of the drugs, Pondimin and Redux, which were pulled off the market in 1997, after they were linked to valve disease.
The findings of the new Permax studies could potentially represent a public health crisis. The drugs, available in generic form from a variety of producers, "have been around a long time, and a large number of people have potentially been exposed to them," said Dr Michael Okun, medical director of the National Parkinson Foundation, in the January 4, 2007 LA Times.
Permax came on the market in the US about 14 years ago, and an estimated half million people had already taken the drug by the time its maker, Eli Lilly, added valve damage to the side effects listed on the labeling in late 2003. The warning included the statement: "Some patients have required valve replacement, and deaths have been reported," but at the same time, Lilly claimed that the problem only occurred in five out of every 100,000 Permax users.
The drug is now marketed in the US by Valeant Pharmaceuticals.
Heart valve damage is an extremely serious medical condition that is both life-threatening and costly to treat. During valve replacement surgery, the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine. Because the heart or aorta must be opened, it requires open heart surgery, according to the Texas Heart Institute.
The two kinds of valves used for replacement surgery are mechanical valves made from materials such as plastic or metal, and biological valves made from animal tissue or human tissue from a donated heart.
Mechanical valves are stronger and last longer but because blood tends to stick to them and create blood clots, patients need to take blood-thinning drugs for the rest of their lives. And because these medicines increase the risk of bleeding within the body, patients must always wear a medical alert bracelet so medical professionals will know they are taking a blood-thinning medication.
Patients with biological valves usually do not have to take blood-thinning drugs but because the valves are not as strong as mechanical valves patients may need have the valve replaced every 10 years.
Following surgery, a patient can expect to stay in the hospital for about a week, including at least 1 to 3 days in the Intensive Care Unit, the Texas Institute says. Patients with an office job, can usually go back to work in 4 to 6 weeks but those with more physically demanding jobs may need to be off work longer.
In addition to switching to another drug to treat Parkinson's disease, medical experts are advising all Permax patients to undergo testing to check for heart valve damage.
Nearly three years ago, HealthDay News reported that a study had confirmed previous findings that the drug, Permax, used to treat Parkinson's disease, could damage heart valves and surgery would be needed to correct the problem.
The April 28, 2004, report quoted the lead researcher, Dr Richard Dewey Jr, an associate professor from the University of Texas Southwestern Medical Center, as saying he believed the drug should be taken off the market.
Permax (pergolide) belongs to a class of drugs known as dopamine agonists. Dopamine helps regulate movement and balance. People with Parkinson's suffer from a shortage of dopamine and Permax stimulates nerves in the brain that would normally be stimulated by dopamine. The drug has also been prescribed to treat restless leg syndrome.
Two years earlier, in December 2002, doctors at the Mayo Clinic reported heart valve disease in three patients who had been taking Permax for several years, similar to the damage found in patients who took the Fen-Phen diet drugs.
The 3 cases involved women aged 61, 72, and 74, with no history of heart disease, who had been taking Permax for between three and seven years to treat Parkinson's symptoms. They were all diagnosed with serious valve disease and two required replacement surgery.
As a follow-up to the earlier reports of valve damage in Permax patients, Dr Dewey, and his fellow researchers sent out 200 letters to people who were known to be taking Permax for Parkinson's to determine whether the reports were isolated cases or a common side effect of the drug, and to suggest that patients should switch to anther drug. Patients who wanted to continue taking Permax were urged to have an echocardiogram, to check for heart valve damage.
For the Dewey study, echocardiograms were performed on 46 patients, and then compared the test results from a similarly-aged healthy comparison group. The study found that 89% of the patients receiving Permax had evidence of leaky heart valves, called valvular insufficiency, and Permax patients were up to 18 times more likely to have significant leakage in at least one valve, than patients in the comparison group.
Blood is pumped through the heart in only one direction, according to the Texas Heart Institute. Heart valves play a key role in this one-way blood flow, opening and closing with each heartbeat. Pressure changes on either side of the valves cause them to open their flap-like "doors" at just the right time, then close tightly to prevent a backflow of blood. There are 4 valves in the heart:
* Tricuspid valve
* Pulmonary valve
* Mitral valve
* Aortic valve
Valvular insufficiency occurs when the heart valves do not close properly. It forces the heart to work harder to circulate the blood and can lead to serious problems such as heart attack or heart failure, according to WebMD. Symptoms of heart valve disease include:
* Shortness of breath and/or difficulty breathing
* Weakness or dizziness
* Chest pain or pressure
* Heart palpitations
* Swelling of ankles, feet, or abdomen
* Rapid weight gain
Two new studies published in the January 4, 2007, New England Journal of Medicine, report that the number of Parkinson patients on Permax who have developed heart valve damage is higher than expected.
In one study titled, "Dopamine Agonists and the Risk of Cardiac-Valve Regurgitation," researchers led by Dr Renzo Zanettini, in Milan, Italy obtained echocardiograms from 155 patients taking various Parkinson's drugs, and 90 healthy patients for a comparison group.
The study found moderate to severe valve problems in more than 23% of the patients receiving Permax compared to less than 6% of the patients in the comparison group.
The second study found that Permax users were five to seven times more likely to have leaky heart valves than patients taking other types of Parkinson's drugs, and patients taking the highest doses of Permax had a 37 times greater risk of valve damage. In this study, Dr Rene Schade and colleagues in Berlin and Montreal reviewed records from over 11,400 patients with Parkinson's disease in the UK.
"This is not a rare side effect," says Dr Bryan Roth, a pharmacology professor at the University of North Carolina, who wrote an editorial accompanying the reports in the NEJM. "That's an extraordinarily high incidence," he warns. "That makes this a serious problem."
Experts note that there are no medications that can be used to reverse valve damage and replacement surgery is the only solution.
Dr Roth published a paper several years ago warning that Permax appeared to trigger the same heart valve problems as the Fen-Phen combination of the drugs, Pondimin and Redux, which were pulled off the market in 1997, after they were linked to valve disease.
The findings of the new Permax studies could potentially represent a public health crisis. The drugs, available in generic form from a variety of producers, "have been around a long time, and a large number of people have potentially been exposed to them," said Dr Michael Okun, medical director of the National Parkinson Foundation, in the January 4, 2007 LA Times.
Permax came on the market in the US about 14 years ago, and an estimated half million people had already taken the drug by the time its maker, Eli Lilly, added valve damage to the side effects listed on the labeling in late 2003. The warning included the statement: "Some patients have required valve replacement, and deaths have been reported," but at the same time, Lilly claimed that the problem only occurred in five out of every 100,000 Permax users.
The drug is now marketed in the US by Valeant Pharmaceuticals.
Heart valve damage is an extremely serious medical condition that is both life-threatening and costly to treat. During valve replacement surgery, the breastbone is divided, the heart is stopped, and blood is sent through a heart-lung machine. Because the heart or aorta must be opened, it requires open heart surgery, according to the Texas Heart Institute.
The two kinds of valves used for replacement surgery are mechanical valves made from materials such as plastic or metal, and biological valves made from animal tissue or human tissue from a donated heart.
Mechanical valves are stronger and last longer but because blood tends to stick to them and create blood clots, patients need to take blood-thinning drugs for the rest of their lives. And because these medicines increase the risk of bleeding within the body, patients must always wear a medical alert bracelet so medical professionals will know they are taking a blood-thinning medication.
Patients with biological valves usually do not have to take blood-thinning drugs but because the valves are not as strong as mechanical valves patients may need have the valve replaced every 10 years.
Following surgery, a patient can expect to stay in the hospital for about a week, including at least 1 to 3 days in the Intensive Care Unit, the Texas Institute says. Patients with an office job, can usually go back to work in 4 to 6 weeks but those with more physically demanding jobs may need to be off work longer.
In addition to switching to another drug to treat Parkinson's disease, medical experts are advising all Permax patients to undergo testing to check for heart valve damage.
Court Allows Eli Lilly to Bury Zyprexa Documents
Evelyn Pringle November 21, 2006
Alaskan attorney, Jim Gottstein, says that after being served with a mandatory injunction, he has returned the internal Eli Lilly documents that he obtained in litigation and provided to the New York Times to the court.
Information from the documents related to Lilly's antipsychotic drug, Zyprexa, was highlighted two days in a row in front-page articles in the Times
The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.
For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8,000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.
It's really comical the way Lilly keeps acting all indignant over the disclosure of these documents as if they contain brand new charges, when the company has been under federal and state investigations related to its off-label marketing of Zyprexa for several years already. The company is also facing Medicaid fraud charges in lawsuits all over the county.
In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite these extremely limited approved uses, Zyprexa went on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly's best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.
The documents provided to Times, span a decade and clearly show that the company promoted off-label the sale of Zyprexa for uses not approved by the FDA as being safe and effective. They also reveal that Lilly knew about Zyprexa's link to drastic weight gain and diabetes for years but failed to inform prescribing doctors and consumers.
In fact according to the Times, Lilly knowingly distributed false information to doctors about the risks as late as 2001. On December 21, 2006, the Times reported that the information provided to doctors about the blood-sugar risks of Zyprexa did not match data circulated inside the company after a review of Lilly's clinical trials.
The Times quotes a Lilly report from November, 1999, that shows that after examining 70 clinical trials, Lilly found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, the company used data from a smaller group of trials that showed roughly 30% of Zypexa patients gained 22 pounds.
Mr Gottstein is not involved in the case in which the judge issued a protective order In re: Zyprexa Products Liability litigation, MDL No. 1596, United States District Court, Eastern District of New York (MDL 1596), "in any manner whatsoever," he says.
He is the leader of, "The Law Project for Psychiatric Rights" (PsychRights), a public interest law firm devoted to the defense of people facing forced psychiatric drugging against their will.
Currently, Mr Gottstein represents an Alaskan patient and says the injunction will prevent him from using the Lilly documents to show that the side effects of Zyprexa are well-established by the company's own clinical trials and therefore, his client should not be forced to take such drugs against his will.
In Myers v Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein last summer, the Alaska Supreme Court ruled that Alaska's forced drugging procedures were unconstitutional because they did not require the court to find such drugging to be in the person's best interests, and that there were no less restrictive
alternatives.
In order to present the evidence in the case he is handling now, Mr Gottstein is looking to the Alaskan courts to issue a ruling that says his client's right to avoid forced drugging outweighs Lilly's right to keep the information about risks hidden.
He says the documents are highly relevant to a court inquiry, now required in Alaska, before a court can make an informed decision about whether to order forced drugging for his client.
In a December 17, 2006, letter to the court in the New York case, Mr Gottstein stated: "In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs."
"My impression is," he wrote, "that Eli Lilly's lies about Zyprexa form the basis of the plaintiffs' claims in MDL 1596, but that is not PsychRights' focus."
"PsychRights' focus," he explained, "is helping people avoid being forcibly drugged pursuant to court orders, where the courts have been, in my view, duped by Eli Lilly and other pharmaceutical company prevarications."
"In my view," Mr Gottstein concluded, "the proper disposition of the question would be in favor of my client's right to inform the court of the extreme harm caused by Zyprexa, which Eli Lilly has successfully hidden for so long, while making its billions off the pill."
A court hearing was held in Brooklyn, New York, on a December 18, 2006, on a motion by Lilly, asking the court to order Mr Gottstein to return the documents to the court, and to bar him from disseminating them any further.
According to the transcript, Lilly also asked the court to require Mr Gottstein to "preserve all emails and all correspondence of any kind, whether it's voice mail, written letters, emails, so that we can pursue a contempt proceeding against both he and Dr Egilman."
Even though the Lilly documents prove that the company knew that Zyprexa was causing diabetes, and kept pushing the drug anyways, potentially harming millions more patients, the judges gave Mr Gottstein hell and threatened to find him in contempt for doing nothing more than warning the public about the side effects of Zyprexa after Lilly concealed the information for a decade.
There is not one single word in the transcripts about Lilly knowingly injuring and killing people with Zyprexa or illegally pushing the drug to unwitting victims for off-label use.
Instead, Judge Brian Cogan, granted Lilly's motion, and told Mr Gottstein's attorney that his client, "deliberately aided and abetted Dr Egilman in getting these documents released from the restriction that they were under, under the protective order. He knew what he was doing, and he did it deliberately."
Judge Cogan went on to tell the attorney, "your client should be on notice that of this moment, he is under a mandatory injunction to return those documents ... to take them down from any websites that he may have posted them on, and to take any reasonable effort to recover them from any sites or persons to which he has delivered them."
On December 18, 2006, at an earlier telephone conference in Brooklyn, Judge Roane Mann also did not utter one word about Lilly's illegal conduct, but instead admonished Mr Gottstein for not playing fair with poor Eli Lilly in making the information about Zyprexa public, stating:
"I personally am not in a position to order you to return the documents. I can't make you return them but I can make you wish you had because I think this is highly improper not only to have obtained the documents on short notice without Lilly being advised of the amendment but then to disseminate them publicly before it could be litigated. It certainly smacks as bad faith."
These judges apparently believe that an expert, such as Dr David Egilman, who is hired to review documents in a case and subsequently learns that people are being seriously injured and killed, should be forced to keep that knowledge a secret if a judge issues a protective order.
There is something very wrong with this picture. It begs the question of how can an ethical doctor not speak if he knows that patients are being harmed.
The reason always cited for the need to keep documents under seal is the claim that the information contains trade secrets. However, just as Lilly has done here, drug companies have for too long been abusing the process by using protective orders to hide illegal conduct by concealing documents that show the company is illegally promoting the off-label use of a drug or that a drug can cause serious injuries or that a drug does not work.
In a case like this, if a court truly does not have a choice and is required to seal documents even when they show blatant illegal conduct on the part of a drug company, then Congress had better get busy and pass a law to stop the use the US court system to protect what could very easily be described as corporate murder.
In response to an earlier article on this issue, reader Larry Bone wrote and asked this author, "Is the corruption on this so widespread that no one would dare prosecute?"
"It is criminal behavior," he points out, "on a huge scale that is being virtually totally ignored by the authorities responsible for the public safety."
"I just feel," Mr Bone wrote, "that there has to be an attorney or someone in a judicial or ethical capacity who would have the guts, and persistence to prosecute Lilly."
"It seems incredibly ridiculous," he states, "let alone obscene, that such blatant wrongdoing seemingly continues to be ignored by the legal authorities with jurisdiction over these sorts of cases."
"If these companies believe they have done nothing wrong," he says, "then let them prove their innocence in court."
Ellen Liversridge also wants a criminal investigation of Lilly. She lost her 30-year-old son, Rob, to the adverse effects of the drug. "He gained almost 100 pounds while taking Zyprexa," Ellen says.
"Rob lapsed into a coma," she recalls, "and died of profound hyperglycemia four days later on October 5, 2002."
"I believe that the people who did this should have a criminal trial," Ellen says. "Enron executives went to prison for wiping out people's life savings," she points out.
"Lilly executives should go to prison," she says, "for knowingly being responsible for people's deaths, shattered families; ruined and grieving families."
Ellen has nothing but praise for the New York Times and its source. "I am grateful to Jim Gottstein for making available this awful truth and hope it results in justice being done."
"If there can ever be justice for a crime as heinous as this," she adds.
Daniel Haszard, of Bangor Maine, feels the same way. In 1996, he was prescribed Zyprexa off-label to supposedly treat Post Traumatic Stress Disorder, and he remained on the drug for 4 years.
Although he paid $250 a month for the drug, Mr Haszard says the drug did not relieve his symptoms of PTSD at all and in early 2000, he was diagnosed with diabetes.
He was shocked to hear the diagnosis, he said, because there was no history of diabetes in his family. Just as thousands of other Zyprexa victims, Mr Haszard did not make the connection between his diabetes and the drug until he saw a commercial for a law firm in December 2005.
Zyprexa causes diabetes, he says, and public health programs are left to pick up the tab for the medial expenses. According to Mr Haszard, "there are now 7 states going after Lilly for fraud and restitution," related to the promotion of Zyprexa for off-label use and the concealment of its risks.
Dr Stefan Kruszewski, MD, a Harvard trained, certified psychiatrist in adult, adolescent, and geriatric psychiatry, from Harrisburg, Pennsylvania, also finds Lilly's conduct appalling.
"Neither health professionals nor consumers," he states, "can accurately provide information about the risk and benefits of a drug like Zyprexa - or any drug for any condition - without a comprehensive awareness of the risks and benefits."
"If the clinical research data regarding effectiveness, efficacy or safety is sequestered or misrepresented from observation studies, randomized drug trials or meta-analyses," he says, "then it is not possible for any provider to give any patient what he or she needs to make an informed consent."
"At that point," Dr Kruszewski says, "individuals receive drugs that may or may not help them, but always at their own peril."
"Zyprexa causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," Dr Kruszewski advises, "at the same time that it continues to cause neurological side-effects like the older antipsychotics."
"Zyprexa and its antipsychotics cousins," he explains, "were marketed to be safer and easier to tolerate because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or 'akathesia,' and tardive dyskinesia."
Those assertions are false he says, and "what we have now is a drug whose massive revenues and promotion are based upon faulty disclosures by Eli Lilly."
Alaskan attorney, Jim Gottstein, says that after being served with a mandatory injunction, he has returned the internal Eli Lilly documents that he obtained in litigation and provided to the New York Times to the court.
Information from the documents related to Lilly's antipsychotic drug, Zyprexa, was highlighted two days in a row in front-page articles in the Times
The documents reveal the illegal marketing schemes used by Lilly to make Zyprexa its best-seller, which the company has managed to keep hidden for years by entering into out of court settlements in civil lawsuits which included confidentiality clauses and by getting judges to place the documents under protective orders to shield them from public view.
For instance, the documents under seal here are from a case where Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8,000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on.
It's really comical the way Lilly keeps acting all indignant over the disclosure of these documents as if they contain brand new charges, when the company has been under federal and state investigations related to its off-label marketing of Zyprexa for several years already. The company is also facing Medicaid fraud charges in lawsuits all over the county.
In 1996, Zyprexa was approved for the treatment of adults with schizophrenia, and a few years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite these extremely limited approved uses, Zyprexa went on to become the top selling antipsychotic worldwide with an estimated 20 million people having used the drug and Lilly's best-selling product, with $4.2 billion in sales in 2005, which translates into 30% of its total revenues.
The documents provided to Times, span a decade and clearly show that the company promoted off-label the sale of Zyprexa for uses not approved by the FDA as being safe and effective. They also reveal that Lilly knew about Zyprexa's link to drastic weight gain and diabetes for years but failed to inform prescribing doctors and consumers.
In fact according to the Times, Lilly knowingly distributed false information to doctors about the risks as late as 2001. On December 21, 2006, the Times reported that the information provided to doctors about the blood-sugar risks of Zyprexa did not match data circulated inside the company after a review of Lilly's clinical trials.
The Times quotes a Lilly report from November, 1999, that shows that after examining 70 clinical trials, Lilly found that 16% of patients taking Zyprexa for a year had gained over 66 pounds. But instead of making these findings public, the company used data from a smaller group of trials that showed roughly 30% of Zypexa patients gained 22 pounds.
Mr Gottstein is not involved in the case in which the judge issued a protective order In re: Zyprexa Products Liability litigation, MDL No. 1596, United States District Court, Eastern District of New York (MDL 1596), "in any manner whatsoever," he says.
He is the leader of, "The Law Project for Psychiatric Rights" (PsychRights), a public interest law firm devoted to the defense of people facing forced psychiatric drugging against their will.
Currently, Mr Gottstein represents an Alaskan patient and says the injunction will prevent him from using the Lilly documents to show that the side effects of Zyprexa are well-established by the company's own clinical trials and therefore, his client should not be forced to take such drugs against his will.
In Myers v Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein last summer, the Alaska Supreme Court ruled that Alaska's forced drugging procedures were unconstitutional because they did not require the court to find such drugging to be in the person's best interests, and that there were no less restrictive
alternatives.
In order to present the evidence in the case he is handling now, Mr Gottstein is looking to the Alaskan courts to issue a ruling that says his client's right to avoid forced drugging outweighs Lilly's right to keep the information about risks hidden.
He says the documents are highly relevant to a court inquiry, now required in Alaska, before a court can make an informed decision about whether to order forced drugging for his client.
In a December 17, 2006, letter to the court in the New York case, Mr Gottstein stated: "In large part, this state of affairs has been created by the lies told by the manufacturers of psychiatric drugs."
"My impression is," he wrote, "that Eli Lilly's lies about Zyprexa form the basis of the plaintiffs' claims in MDL 1596, but that is not PsychRights' focus."
"PsychRights' focus," he explained, "is helping people avoid being forcibly drugged pursuant to court orders, where the courts have been, in my view, duped by Eli Lilly and other pharmaceutical company prevarications."
"In my view," Mr Gottstein concluded, "the proper disposition of the question would be in favor of my client's right to inform the court of the extreme harm caused by Zyprexa, which Eli Lilly has successfully hidden for so long, while making its billions off the pill."
A court hearing was held in Brooklyn, New York, on a December 18, 2006, on a motion by Lilly, asking the court to order Mr Gottstein to return the documents to the court, and to bar him from disseminating them any further.
According to the transcript, Lilly also asked the court to require Mr Gottstein to "preserve all emails and all correspondence of any kind, whether it's voice mail, written letters, emails, so that we can pursue a contempt proceeding against both he and Dr Egilman."
Even though the Lilly documents prove that the company knew that Zyprexa was causing diabetes, and kept pushing the drug anyways, potentially harming millions more patients, the judges gave Mr Gottstein hell and threatened to find him in contempt for doing nothing more than warning the public about the side effects of Zyprexa after Lilly concealed the information for a decade.
There is not one single word in the transcripts about Lilly knowingly injuring and killing people with Zyprexa or illegally pushing the drug to unwitting victims for off-label use.
Instead, Judge Brian Cogan, granted Lilly's motion, and told Mr Gottstein's attorney that his client, "deliberately aided and abetted Dr Egilman in getting these documents released from the restriction that they were under, under the protective order. He knew what he was doing, and he did it deliberately."
Judge Cogan went on to tell the attorney, "your client should be on notice that of this moment, he is under a mandatory injunction to return those documents ... to take them down from any websites that he may have posted them on, and to take any reasonable effort to recover them from any sites or persons to which he has delivered them."
On December 18, 2006, at an earlier telephone conference in Brooklyn, Judge Roane Mann also did not utter one word about Lilly's illegal conduct, but instead admonished Mr Gottstein for not playing fair with poor Eli Lilly in making the information about Zyprexa public, stating:
"I personally am not in a position to order you to return the documents. I can't make you return them but I can make you wish you had because I think this is highly improper not only to have obtained the documents on short notice without Lilly being advised of the amendment but then to disseminate them publicly before it could be litigated. It certainly smacks as bad faith."
These judges apparently believe that an expert, such as Dr David Egilman, who is hired to review documents in a case and subsequently learns that people are being seriously injured and killed, should be forced to keep that knowledge a secret if a judge issues a protective order.
There is something very wrong with this picture. It begs the question of how can an ethical doctor not speak if he knows that patients are being harmed.
The reason always cited for the need to keep documents under seal is the claim that the information contains trade secrets. However, just as Lilly has done here, drug companies have for too long been abusing the process by using protective orders to hide illegal conduct by concealing documents that show the company is illegally promoting the off-label use of a drug or that a drug can cause serious injuries or that a drug does not work.
In a case like this, if a court truly does not have a choice and is required to seal documents even when they show blatant illegal conduct on the part of a drug company, then Congress had better get busy and pass a law to stop the use the US court system to protect what could very easily be described as corporate murder.
In response to an earlier article on this issue, reader Larry Bone wrote and asked this author, "Is the corruption on this so widespread that no one would dare prosecute?"
"It is criminal behavior," he points out, "on a huge scale that is being virtually totally ignored by the authorities responsible for the public safety."
"I just feel," Mr Bone wrote, "that there has to be an attorney or someone in a judicial or ethical capacity who would have the guts, and persistence to prosecute Lilly."
"It seems incredibly ridiculous," he states, "let alone obscene, that such blatant wrongdoing seemingly continues to be ignored by the legal authorities with jurisdiction over these sorts of cases."
"If these companies believe they have done nothing wrong," he says, "then let them prove their innocence in court."
Ellen Liversridge also wants a criminal investigation of Lilly. She lost her 30-year-old son, Rob, to the adverse effects of the drug. "He gained almost 100 pounds while taking Zyprexa," Ellen says.
"Rob lapsed into a coma," she recalls, "and died of profound hyperglycemia four days later on October 5, 2002."
"I believe that the people who did this should have a criminal trial," Ellen says. "Enron executives went to prison for wiping out people's life savings," she points out.
"Lilly executives should go to prison," she says, "for knowingly being responsible for people's deaths, shattered families; ruined and grieving families."
Ellen has nothing but praise for the New York Times and its source. "I am grateful to Jim Gottstein for making available this awful truth and hope it results in justice being done."
"If there can ever be justice for a crime as heinous as this," she adds.
Daniel Haszard, of Bangor Maine, feels the same way. In 1996, he was prescribed Zyprexa off-label to supposedly treat Post Traumatic Stress Disorder, and he remained on the drug for 4 years.
Although he paid $250 a month for the drug, Mr Haszard says the drug did not relieve his symptoms of PTSD at all and in early 2000, he was diagnosed with diabetes.
He was shocked to hear the diagnosis, he said, because there was no history of diabetes in his family. Just as thousands of other Zyprexa victims, Mr Haszard did not make the connection between his diabetes and the drug until he saw a commercial for a law firm in December 2005.
Zyprexa causes diabetes, he says, and public health programs are left to pick up the tab for the medial expenses. According to Mr Haszard, "there are now 7 states going after Lilly for fraud and restitution," related to the promotion of Zyprexa for off-label use and the concealment of its risks.
Dr Stefan Kruszewski, MD, a Harvard trained, certified psychiatrist in adult, adolescent, and geriatric psychiatry, from Harrisburg, Pennsylvania, also finds Lilly's conduct appalling.
"Neither health professionals nor consumers," he states, "can accurately provide information about the risk and benefits of a drug like Zyprexa - or any drug for any condition - without a comprehensive awareness of the risks and benefits."
"If the clinical research data regarding effectiveness, efficacy or safety is sequestered or misrepresented from observation studies, randomized drug trials or meta-analyses," he says, "then it is not possible for any provider to give any patient what he or she needs to make an informed consent."
"At that point," Dr Kruszewski says, "individuals receive drugs that may or may not help them, but always at their own peril."
"Zyprexa causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems," Dr Kruszewski advises, "at the same time that it continues to cause neurological side-effects like the older antipsychotics."
"Zyprexa and its antipsychotics cousins," he explains, "were marketed to be safer and easier to tolerate because the pharmaceutical companies said that the newer drugs caused fewer neurological injuries, like restlessness or 'akathesia,' and tardive dyskinesia."
Those assertions are false he says, and "what we have now is a drug whose massive revenues and promotion are based upon faulty disclosures by Eli Lilly."
FDA Advisory Committee Schedules Hearing on SSRIs and Suicide
Evelyn Pringle December 5, 2006
The FDA's Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants.
The panel is expected to vote on whether the risk of suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
The fact is, the FDA has known about the increased suicide risk associated with SSRIs for over 15 years as evidenced at a September 20, 1991, hearing, at which FDA official Dr Robert Temple stated:
"The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category.
"But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.
"The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it - that is not too surprising - it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it."
Yet here it is nearing the end of 2006, and the FDA is still refusing to provide a logical answer to explain why people who were not depressed before taking SSRIs would all of a sudden commit suicide after taking the drugs.
Top experts from all over the US and abroad will be testifying at the hearing and for many it will be a repeat performance. For instance, Baum Hedlund attorney, Karen Barth-Menzies, will be testifying again. She has been battling SSRI makers for over a decade and as a result, she has obtained internal company documents that show the SSRI makers were fully aware of the increased suicide risks associated with SSRIs but instead of warning the public, they continued to promote SSRIs as safe and effective with children and adults.
"Through our Paxil litigation," Ms Menzies says, "we obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," Ms Menzies says.
"The manufacturers of the SSRIs," she states, "have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the 'disease.'"
"This is notwithstanding clear evidence," Ms Menzies says, "very early on in the clinical trials of these drugs that they can cause these problems."
"We have documents," she notes, "obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI, Prozac, was approved for marketing in this country."
Over the past 10 years, in addition to representing thousands of clients in SSRI lawsuits, Ms Menzies has been a tireless advocate working to increase public awareness about the host of health risks now known to be associated with SSRIs.
After listening to her testimony before the FDA Advisory Committee in 2004, a California state Senator invited Ms Menzies to work on legislation designed to inform California healthcare providers and parents about the increased risk of suicidality in children and adolescents taking SSRIs.
She also testified at a hearing in August 2004, before the California State Senate and called for better patient informed consent on the risks associated with SSRIs.
Ms Menzies has given presentations at medical conferences in the US and other countries to warn healthcare professionals about the dangers of SSRIs.
In fact, she gave one presentation that directly addressed the FDA's mishandling of the SSRI matter titled, "Federal Preemption - How the U.S. Food & Drug Administration Has Become an Advocate for the Drug Industry Against the Consumers It Has a Duty to Protect" - SSRIs and Collisions Between Medical, Legal and Regulatory Worlds, at the 29th International Congress On Law and Mental Health, in Paris, France, on July 2-8, 2005.
Another one of the world's most highly respected experts on SSRIs, Dr David Healy, a professor at the Department of Psychological Medicine, at Cardiff University in North Wales, will be traveling from the UK to testify. His appearance will also be a repeat performance.
Dr Healy states that he will testify about the manipulation of the scientific data on SSRIs. "We have here," he says, "the greatest divide in medicine between the raw data on an issue on the one side and the published accounts purporting to represent those data on the other."
"The divide," he says, "it is important to note, only came to light as a result of the efforts of journalists and lawyers."
"No clinician or scientist had a hand in questioning the validity of the 'science'," he points out.
The most famous fraudulent study involving SSRIs is GlaxoSmithKline's study 329, involving Paxil. The study stated that Paxil was safe, well-tolerated and effective in children, but noted that some children became emotionally "labile" while taking the drug.
"In the published version of 329," Dr Healy points out, "suicidality vanishes under a carpet of emotional lability."
Few readers of this paper, academic or lay, he says, would have realized what lay behind this term as it appeared in the paper. "The question of what was happening to children," Dr Healy says, "deemed to have become emotionally labile, was picked up by journalists and lawyers rather than scientists or regulators."
As a result of Glaxo's application for a license for the use of Paxil to treat children with nervous disorders, he explains, the raw data from clinical trials were lodged with a number of national regulators.
"Within a fortnight of seeing the raw data in May 2003," Dr Healy says, "after the events lying behind the term emotional lability had been clarified, the regulators in the UK issued a warning against the use of Paxil for minors."
A few weeks later, he notes, Glaxo wrote to all doctors warning that Paxil was linked to suicidality and that withdrawal from the drug was also linked to an apparent doubling of the rate of suicidality.
"This reassessment of the data does not however represent a triumph of scientific method," Dr Healy says, "it indicates rather a crisis triggered by media concerns."
The final nail in the coffin as far as selling SSRIs to kids in the UK, came in December 2003, when British regulators issued a position statement that said none of the SSRIs had demonstrated efficacy in treating depression in children.
By far the most damning revelations about what SSRI makers knew about the link between SSRIs and suicide came when the British Medical Journal received internal company documents from an anonymous source that left no doubt that Eli Lilly knew about the suicide risks with Prozac years before the drug was FDA approved.
After receiving the documents, the BMJ sent them to officials at the FDA, and to US Congressman, Maurice Hinchey, who in turn sent them to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of, "Talking Back to Prozac," and "The Anti-Depressant Fact Book."
After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert witness in Prozac litigation and discussed when testifying during a trial in 1994.
Evidence of the hidden studies showing the suicide risk can be found in a May 1984 document presented at trial which states regarding Prozac: "During the treatment with the preparation 16 suicide attempts were made, 2 of these with success."
"As patients with a risk of suicide were excluded from the studies," the document says, "it is probable that this high proportion can be attributed to an action of the preparation."
In fact, a March 29, 1985 document says that the rate of suicide with Prozac was 5.6 times higher than with the other medication imipramine and went on to state:
"The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine than to imipramine, so that the higher incidence of suicide attempts may be tolerable."
On November 13, 1990, a memo from a Lilly employee in Germany, Claude Bouchy, to another Lilly employee, Leigh Thompson, regarding the adverse drug event reporting of suicide and Prozac written in response to Lilly's request that he change the event "suicidal ideation" to "depression," Mr Bouchy writes:
"Hans (Lilly employee) has medical problems with these directions and I have great concerns about it.
"I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation."
A second memo dated November 14, 1990, from Mr Bouchy to Leigh Thompson about adverse drug event reporting states: "I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation."
The documents also reveal how worried Lilly was about the commercial impact to the company if the truth about the Prozac-induced suicides got out. A February 7, 1990 Leigh Thompson Memo, says, "Anything that happens in the UK can threaten this drug in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation."
On February 7, 1990, a Leigh Thompson memo also says, "I hope Patrick (a Lilly employee) realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that."
Dr Breggin says that after he testified in the trial in 1994, these documents seemed to just disappear, until they were handed over to the BMJ.
The FDA's Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants.
The panel is expected to vote on whether the risk of suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.
The fact is, the FDA has known about the increased suicide risk associated with SSRIs for over 15 years as evidenced at a September 20, 1991, hearing, at which FDA official Dr Robert Temple stated:
"The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category.
"But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.
"The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it - that is not too surprising - it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it."
Yet here it is nearing the end of 2006, and the FDA is still refusing to provide a logical answer to explain why people who were not depressed before taking SSRIs would all of a sudden commit suicide after taking the drugs.
Top experts from all over the US and abroad will be testifying at the hearing and for many it will be a repeat performance. For instance, Baum Hedlund attorney, Karen Barth-Menzies, will be testifying again. She has been battling SSRI makers for over a decade and as a result, she has obtained internal company documents that show the SSRI makers were fully aware of the increased suicide risks associated with SSRIs but instead of warning the public, they continued to promote SSRIs as safe and effective with children and adults.
"Through our Paxil litigation," Ms Menzies says, "we obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," Ms Menzies says.
"The manufacturers of the SSRIs," she states, "have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the 'disease.'"
"This is notwithstanding clear evidence," Ms Menzies says, "very early on in the clinical trials of these drugs that they can cause these problems."
"We have documents," she notes, "obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI, Prozac, was approved for marketing in this country."
Over the past 10 years, in addition to representing thousands of clients in SSRI lawsuits, Ms Menzies has been a tireless advocate working to increase public awareness about the host of health risks now known to be associated with SSRIs.
After listening to her testimony before the FDA Advisory Committee in 2004, a California state Senator invited Ms Menzies to work on legislation designed to inform California healthcare providers and parents about the increased risk of suicidality in children and adolescents taking SSRIs.
She also testified at a hearing in August 2004, before the California State Senate and called for better patient informed consent on the risks associated with SSRIs.
Ms Menzies has given presentations at medical conferences in the US and other countries to warn healthcare professionals about the dangers of SSRIs.
In fact, she gave one presentation that directly addressed the FDA's mishandling of the SSRI matter titled, "Federal Preemption - How the U.S. Food & Drug Administration Has Become an Advocate for the Drug Industry Against the Consumers It Has a Duty to Protect" - SSRIs and Collisions Between Medical, Legal and Regulatory Worlds, at the 29th International Congress On Law and Mental Health, in Paris, France, on July 2-8, 2005.
Another one of the world's most highly respected experts on SSRIs, Dr David Healy, a professor at the Department of Psychological Medicine, at Cardiff University in North Wales, will be traveling from the UK to testify. His appearance will also be a repeat performance.
Dr Healy states that he will testify about the manipulation of the scientific data on SSRIs. "We have here," he says, "the greatest divide in medicine between the raw data on an issue on the one side and the published accounts purporting to represent those data on the other."
"The divide," he says, "it is important to note, only came to light as a result of the efforts of journalists and lawyers."
"No clinician or scientist had a hand in questioning the validity of the 'science'," he points out.
The most famous fraudulent study involving SSRIs is GlaxoSmithKline's study 329, involving Paxil. The study stated that Paxil was safe, well-tolerated and effective in children, but noted that some children became emotionally "labile" while taking the drug.
"In the published version of 329," Dr Healy points out, "suicidality vanishes under a carpet of emotional lability."
Few readers of this paper, academic or lay, he says, would have realized what lay behind this term as it appeared in the paper. "The question of what was happening to children," Dr Healy says, "deemed to have become emotionally labile, was picked up by journalists and lawyers rather than scientists or regulators."
As a result of Glaxo's application for a license for the use of Paxil to treat children with nervous disorders, he explains, the raw data from clinical trials were lodged with a number of national regulators.
"Within a fortnight of seeing the raw data in May 2003," Dr Healy says, "after the events lying behind the term emotional lability had been clarified, the regulators in the UK issued a warning against the use of Paxil for minors."
A few weeks later, he notes, Glaxo wrote to all doctors warning that Paxil was linked to suicidality and that withdrawal from the drug was also linked to an apparent doubling of the rate of suicidality.
"This reassessment of the data does not however represent a triumph of scientific method," Dr Healy says, "it indicates rather a crisis triggered by media concerns."
The final nail in the coffin as far as selling SSRIs to kids in the UK, came in December 2003, when British regulators issued a position statement that said none of the SSRIs had demonstrated efficacy in treating depression in children.
By far the most damning revelations about what SSRI makers knew about the link between SSRIs and suicide came when the British Medical Journal received internal company documents from an anonymous source that left no doubt that Eli Lilly knew about the suicide risks with Prozac years before the drug was FDA approved.
After receiving the documents, the BMJ sent them to officials at the FDA, and to US Congressman, Maurice Hinchey, who in turn sent them to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of, "Talking Back to Prozac," and "The Anti-Depressant Fact Book."
After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert witness in Prozac litigation and discussed when testifying during a trial in 1994.
Evidence of the hidden studies showing the suicide risk can be found in a May 1984 document presented at trial which states regarding Prozac: "During the treatment with the preparation 16 suicide attempts were made, 2 of these with success."
"As patients with a risk of suicide were excluded from the studies," the document says, "it is probable that this high proportion can be attributed to an action of the preparation."
In fact, a March 29, 1985 document says that the rate of suicide with Prozac was 5.6 times higher than with the other medication imipramine and went on to state:
"The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine than to imipramine, so that the higher incidence of suicide attempts may be tolerable."
On November 13, 1990, a memo from a Lilly employee in Germany, Claude Bouchy, to another Lilly employee, Leigh Thompson, regarding the adverse drug event reporting of suicide and Prozac written in response to Lilly's request that he change the event "suicidal ideation" to "depression," Mr Bouchy writes:
"Hans (Lilly employee) has medical problems with these directions and I have great concerns about it.
"I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation."
A second memo dated November 14, 1990, from Mr Bouchy to Leigh Thompson about adverse drug event reporting states: "I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation."
The documents also reveal how worried Lilly was about the commercial impact to the company if the truth about the Prozac-induced suicides got out. A February 7, 1990 Leigh Thompson Memo, says, "Anything that happens in the UK can threaten this drug in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation."
On February 7, 1990, a Leigh Thompson memo also says, "I hope Patrick (a Lilly employee) realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that."
Dr Breggin says that after he testified in the trial in 1994, these documents seemed to just disappear, until they were handed over to the BMJ.
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