Evelyn Pringle
The founders of Ablechild, Patricia Weathers and Sheila Matthews, have earned the title of “Unsung Heroes,” as both pioneers and warriors for over a decade, in the battle to protect children from the Psychopharmaceutical Industry.
Ablechild (Parents for A Label and Drug-Free Education), is a national non-profit founded in 2001, by these two mothers who each had personal experiences with being coerced by the public school system to label and drug their children for ADHD. Patty and Sheila went from being victims to become national advocates for the fundamental rights of all parents and children in the US.
Now with thousands of members, Ablechild acts as an independent advocate on behalf of parents whose children have been subjected to mental health screening and psychiatric labeling and drugging, and as a proponent for children in foster care who are improperly treated with psychotropic drugs, many times off-label, without informed consent.
Long Battle Against Coerced Drugging
Roughly eight years ago, on September 26, 2002, then Chairman the US House Government Reform Committee, Congressman Dan Burton (R-IN), held a hearing on the “Overmedication of Hyperactive Children,” prompted by a series in the New York Post.
“It's estimated that 4 to 6 million children in the United States take Ritalin every single day,” Burton said in his opening statement. He pointed out that Ritalin was a Schedule II stimulant under the Federal Controlled Substances Act, that research showed it was a more potent transport inhibitor than cocaine, and use in the US had increased over a 500% since 1990. The Schedule II category also includes drugs such as cocaine, morphine, and Oxycontin.
On one side of the issue, Burton said, they would hear from the associations of psychiatrists and an organization known as Children and Adults with Attention Deficit Hyperactivity Disorder (CHADD), and they believed 13% of the US population suffered from an attention disorder and it should be treated with medication.
At the other end of the discussion, he said, was the Citizens Commission for Human Rights (CCHR), and concerned parents, who challenged the legitimacy of calling ADHD a neurobiological disorder and raised questions about giving psychiatric drugs to children. Two of these “concerned parents” were Patty Weathers and Neil Bush, the brother of then President Bush, who was pressured by a private school in Houston to drug his son with Ritalin after he was misdiagnosed with ADHD by the school.
Unsung Hero - Patty Weathers
At the hearing, Patty testified about the ordeal she and her son, Michael, went through in a public school in New York State that began in 1997. When Michael entered first grade, the teacher told Patty his learning development was not normal and he would not be able to learn without medication.
“Near the end of first grade, the school principal took me into her office and said that unless I agreed to put Michael on medication, she would find a way to transfer him to a special education center,” Patty told the committee.
At this point, his teacher filled out an actor's profile for boys, an ADHD checklist, and sent it to his pediatrician, she said. “This checklist, along with a 15-minute evaluation by the pediatrician, led to my son being diagnosed with ADHD and put on Ritalin.”
Michael was not given a physical exam prior to the prescribing of Ritalin and no exams were conducted during appointments when refills for prescriptions were written.
“I would never have subjected my son to being labeled with a mental disorder if I had known that it was a subjective diagnosis,” Patty told the panel. “I would not have allowed my son to be administered drugs if I had been given full information about the documented side effects and the risks.”
“At no time was I offered any alternatives to my son's needs, such as tutoring or standard medical testing.” she said. “The school's one and only solution was to have my child drugged.”
Early on, Michael experienced the common side effects of Ritalin, such as sleep problems and loss of appetite, and by the third grade, Michael became withdrawn, stopped socializing with other children, and began chewing on pencils and other objects. He was then put on Dextrostat, an amphetamine, which only worsened the problems.
But instead of recognizing the drug side effects, the school psychologist then claimed Michael had either bipolar or social anxiety disorder and needed to see a psychiatrist. The psychologist gave Patty the number for a psychiatrist to call and the psychiatrist talked to her and Michael for a short time, and “again, with the aid of school reports, diagnosed him with social anxiety disorder,” she recalled.
Without telling her it was not approved for children, the psychiatrist prescribed the antidepressant, Paxil, saying it was a “wonder drug for kids.” “Those were her exact words,” Patty told the committee.
The drug cocktail caused even more horrendous side effects, until Michael’s behavior became so out of character that Patty could not even recognize her own son. “Through this whole ordeal, the school psychologist's favorite saying was that it was trial and error,” she said. “If one drug didn't work, try another.”
After watching Michael become violent, psychotic, hear voices and hallucinate, Patty stopped giving him the drugs. Not recognizing that he was going through withdrawal, the psychiatrist wanted to hospitalize Michael and try different sedatives and antipsychotics until they found “the right one,” but Patty refused to allow it.
After she became unwilling to give Michael the drugs, “the school threw him out,” she told the panel. “As a final blow, they proceeded to call Child Protective Services on my husband and I, charging us with medical neglect for refusing to drug our child,” she said.
The complaint filed by the school stated in part: “[Michael's] behavior at school is bizarre: He hears voices and appears delusional, he chews on his clothes and paper, he talks to himself and rambles when he talks.”
A month-long investigation cleared the charges and independent psychiatrists determined the bizarre behaviors were caused by the drugs and Michael did not need hospitalization. Medical testing by Dr Mary Ann Block, a Texas osteopathic physician, later showed that Michael suffered from anemia, hypoglycemia and allergies. When those conditions were treated, any attention problems disappeared.
On August 7, 2002, the “New York Post” ran a front-page article featuring Patty’s story. Within a few days, over 65 parents came forward to describe similar stories of coercion and intimidation used by school districts to strong arm them into drugging their kids.
Unsung Hero – Sheila Matthews
Connecticut mom, Sheila Matthews, turned on the TV one day and saw Patty testifying on C-Span at a hearing titled, “Behavioral Drugs in Schools,” on September 29, 2000, before the US House Subcommittee on Oversight and Investigations, Committee on Education and the Workforce.
Sheila immediately related with Patty because she was then going through what she would later call the “ADHD nightmare,” of being pressured to put her 7-year-old son on Ritalin, after he was screened and diagnosed with ADHD by a school psychologist, with claims he would “self-medicate” and end up a drug addict if she did not medicate him.
While testifying at this hearing, Patty explained that being labeled made Michael feel worse about himself and “like a freak” because he “had to be drugged to go to school.”
She also voiced her concerns for other families over the intimidation tactics used by schools to coerce parents into drugging their children. “If I didn't have family members who were willing to financially back my son and I in my son's cause, it is entirely possible that my son would have ended up in a psychiatric ward,” she told the panel.
That very day, Sheila made up her mind to expose the misleading information being given to parents about so-called mental disorders in public schools and expose the coercive tactics being used on parents who refused to label and drug their children.
She wanted to meet Patty so she contacted the Congressional office and they put her in touch with Marla Filidei, Vice President of CCHR International. Marla hooked her up with Patty, and together, they founded Ablechild.
National Spokespersons
Over the past ten years, Patty and Sheila have become national spokespersons. The normally shy, quiet Patty has made appearances on more than two dozen media programs including ABC’s Good Morning America, the Today Show on NBC, Hannity & Colmes on Fox, CNN’s Lou Dobbs, A&E’s Investigative Reports, and Montel Williams.
She has also been interviewed for stories in major newspapers including the New York Times, New York Post, USA Today, and Christian Science Monitor, as well as Time, People and Redbook magazines, and has been interviewed by Gary Null, Sean Hannity, Michael Regan, and other popular radio talk show hosts.
In February 2001, Patty received a “Human Rights Award,” from CCHR, and was recognized for standing up against the injustice of psychiatric labeling and drugging of children in public schools at the group’s annual banquet. Sheila received an award from CCHR in 2002, and was recognized for her hard work and role as national spokesperson.
Sheila has also appeared on TV numerous times including shows on CNN, NBC and Fox, and has been interviewed on many talk radio programs. Her story has also been featured in major newspapers and magazines including the Boston Globe, USA Today, Insight News, and the Hartford Courant, as well as Time Magazine and the Ladies Home Journal.
In her home state of Connecticut, Sheila worked with State Representative, Lenny Winkler (a nurse by trade), to secure passage of the first state law in the country that restricts schools from suggesting psychiatric diagnosing and drugging of any child as a condition of attending school. She testified before the Connecticut State Assembly about her own personal experience with the school trying to pressure her to put her son on Ritalin and the lack of validity of the disorders children are being labeled with.
Sheila was with the Connecticut Governor when he signed the bill into law in 2001 and told USA Today that she was thrilled “because it gives parents an awareness that there should be a clear difference between education and medication.”
“No other industry has total access to our children the way the psychiatric community does, and I think this new law is just the beginning of changes to come,” she told Kelly Patricia O’Meara, in an interview for Insight News.
“Kids should be off-limits as targets of convenience for the drug industry,” Sheila said. “I want the mental-health industry out of our schools.”
However, any victory celebration was short lived because in September 2001, a number of family orientated magazines began running the first ever ads for ADHD drugs. “It seems like every time we take a step forward, they come back and hit us harder,” Patty told Time Magazine.
After the Connecticut law was passed, Sheila continued to work with other parents on state and federal levels to pass similar bills. By 2003, seven states had passed laws against schools coercing parents to drug their children or expelling students whose parents refused to medicate them.
On a national level, both Sheila and Patty made many trips to Washington to educate lawmakers. In September 2001, Patty and CCHR’s Bruce Wiseman and Marla Filidei, briefed legislators at a national congress of the “National Foundation of Women Legislators,” and gained their unanimous approval of a model law in the “Child Medication Safety Act (CMSA),” which mandates that: “State educational agencies develop and implement policies and procedures that will prohibit school personnel from requiring a child to obtain a prescription for a controlled substance such as Ritalin as a condition of attending school or receiving services.”
In both October and November of 2001, Sheila traveled to Washington with Marla and Lawrence Smith, whose 11-year-old son died of a heart attack caused by Ritalin, to meet with key lawmakers and discuss the crisis of children being diagnosed and drugged in schools and the need for federal legislation to end it. They also worked with Congressional staff to get co-sponsors for the CMSA
In July 2002, the nationally syndicated columnist and radio show host, Armstrong Williams, featured Sheila, Patty and Lawrence Smith in a radio show on safeguarding children from being labeled and drugged in public schools.
The next month, Patty appeared on NBC’s “Today Show,” on August 8, 2002, and the same day, the “New York Post,” ran an article reporting that Patty was calling for a state wide tracking system to determine how widespread forced drugging was in schools.
On September 24, 2002, Patty was a guest on Hannity & Colmes on Fox, and was interviewed on CNN’s “Talk Back Live,” two days later. The next month, Patty and Michael were both guests on the “John Walsh Show,” on NBC. Patty was also featured in a Discovery Channel program that month with pediatrician, Dr Lawrence Diller, and psychiatrist, Dr Peter Breggin, which focused on the over-drugging of kids for ADHD.
Strongest Foe Funded by ADHD Drug Makers
In March 2003, Patty, Michael, and Sheila appeared on a Montel Williams show on promoting “A Parents Right to Choose,” along with Connecticut Rep, Lenny Winkler, Bruce Wiseman, Patricia Marks, Dr Mary Ann Block, and Vicky and Steve Dunkle, whose 10-year-old daughter died from Desipramine toxicity, after the antidepressant was prescribed for ADHD as a result of pressure from school officials to medicate the child.
The guests covered everything from the subjective diagnosis of mental disorders, with no confirming medical testing, to the many side effects of psychiatric drugs, to the fact that most children involved in school shootings were on psychiatric drugs. They warned that due to coercion in schools, parents all over the country were losing the right to choose whether their kids would take powerful drugs, including stimulants, referred to as “kiddie cocaine.” At the end of the program, Montel asked the audience to write to Congress asking for federal legislation against the coerced drugging of school children.
After the show aired, CHADD, the main front group for the stimulant makers, organized a letter writing campaign to Montel, who they said “mocked” ADHD, as part of responding to “offensive media depictions” of ADHD, they claimed in CHADD’s 2002-2003 Annual Report.
The group also published an open letter to Montel, saying no one would “dispute that unnecessarily placing a child on medication is deplorable.”
“But the greater travesty is delaying proper diagnosis and effective treatment for those who truly need it,” CHADD said. “The sad truth is that many more children with mental disorders slip unrecognized past the gatekeepers of mental health services than those who are improperly diagnosed.”
In April 2003, Ablechild issued a press release blasting CHADD for lobbying against the CMSA with claims that only a “handful” of incidents had occurred involving parents being coerced by schools to drug their children.
In lobbying to CHADD’s membership, the group’s CEO, E Clarke Ross, used the electronic newsletter, “News from CHADD,” to raise questions about whether the problem was common enough to require federal legislation and called such cases “isolated and highly publicized.” Because a number of states and school boards had passed laws or resolutions, Ross claimed the federal bill was “legislative overkill.”
However, for a May 13, 2003 investigative report on the CMSA published in “Insight Magazine,” in which Ross again referred to “a few highly publicized cases,” Kelly Patricia O’Meara interviewed Mike Stokke, deputy chief of staff to the Speaker of the House at the time, and found cases of school personnel demanding that parents drug children as a condition of staying in school were far from isolated in numbers or areas.
In case after case, Stokke told Insight, “when we started meeting some of these families who have been through this problem, such as in New York, New Jersey and Connecticut, we saw the coercive action of the state come in and say that the teacher says you have to take these drugs.”
“And if you don't it's child neglect and the child is taken away from the parents,” he said.
“Many of the parents that we talk to are people who have the means to fight back but what is troubling,” he said, “is that there are many families out there in similar situations who don't have the means to fight the system.”
In the press release, Ablechild noted that CHADD was only opposing the CMSA because its livelihood was at stake being the group was funded by stimulant makers. Complaints about the funneling of money through CHADD, to increase drug sales and the diagnosis of ADHD, were discussed at length during the September 29, 2002, hearing on the use of behavioral drugs in schools. Portions of a 1995 report on the matter, by the US Drug Enforcement Administration, were even read into the record.
“It has recently come to the attention of the DEA that Ciba-Geigy, the manufacturer of Ritalin, marketing under the brand name Ritalin, contributed $748,000 to CHADD from 1991 to '94,” the agency reported. “The DEA has concerns that the depth of the financial relationship with the manufacturer was not well known to the public, including CHADD members, that have relied upon CHADD for guidance as it pertains to the diagnosis and treatment of their children,” it wrote.
The agency was particularly concerned that most of the ADHD material prepared for public consumption by CHADD, and made available to parents, did not address the potential or actual abuse of Ritalin. Instead, it was portrayed as a benign, mild substance that's not associated with abuse or any serious side effects.
CHADD received $848,000 from Novartis in 2001, according to testimony at the hearing.
Kids Disabled for Cash
On its website, CHADD provides a link to a webpage on “Disability Benefits,” and tells parents that some kids with ADHD can be declared disabled and receive benefits including “cash payments,” under the federal Supplemental Security Income program.
“Children under age 18 who have disabilities, including some children with AD/HD, can receive SSI if they meet eligibility criteria,” CHADD says. “The SSI program can provide monthly cash payments based on family income, qualify the child for Medicaid health care services in many states, and ensure referral of a child into the system of care available under State Title V programs for Children with Special Health Care Needs.”
At the congressional hearing ten years ago, Colorado Representative, Bob Schaffer, reported concerns about Federal cash incentives to label children with ADHD, and specifically the two that resulted in cash payments to parents and schools.
In 1990, the SSI program made low-income parents eligible for a cash benefit of more than $450 a month for each ADHD child, and in 1991, the Department of Education made it so schools could receive more than $400 a year for students with ADHD, under the Individuals With Disabilities Education Act (IDEA).
Both cash incentives coincided with a dramatic rise in the number of children labeled with ADHD. In 1989, children citing mental impairments, including ADHD but not retardation, made up only 5% of disabled kids on SSI. But that figure rose to nearly 25% by 1995. Between 1990 and 1992, the number of ADHD diagnoses jumped from about one million to over three million, Schaffer informed the committee.
The IDEA also had a “child find” provision which required states to actively seek out kids who may qualify for special education in order to receive Federal special education funds, Patti Johnson, a member of the Colorado State Board of Education, told the panel. In many states, schools had also become authorized Medicaid providers and collected funds for children labeled with one of the learning or behavior disorders, she reported.
“Between SSI, Medicaid and IDEA, we have turned schools into aggressive identifiers of disabled children,” Schaffer told the panel. “Without a doubt we are subsidizing the aggressive pursuit of children with disabilities.”
“It is not resulting in accurate diagnosis,” he said. “It is resulting in an over diagnosis.”
Roughly a decade after the hearing, the new book, “Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America,” by Robert Whitaker, reports that the number of kids receiving SSI checks due to mental illness increased 35-fold between 1987 and 2007, from 16,200 to 561,569.
Drug Money Pours In
Despite non-stop criticism over being in the pocket of the pharmaceutical industry, money from ADHD drug makers continues to pour into CHADD year after year.
The group’s Income & Expense Reports, show CHADD received $507,000 in 2002, $674,000 in 2003, and five years later, the amounts nearly tripled. For the fiscal year of July 1, 2007 to June 30, 2008, CHADD received a total of $1,205,000, from Eli Lilly, J&J's McNeil division, Novartis, Shire US, and UCB. In addition, 64% of sales and advertising, or $466,104, came from drug companies.
The next year’s report shows CHADD received a total of $1,174,626, from Lilly, J&J's McNeil division, Novartis, and Shire, and 57.2 % of sales and advertising, or $412,500, was from drug companies.
For the year 2008, Lilly's full year grant report lists a $200,000 donation to CHADD. The 2008 IRS filing for the Eli Lilly Foundation also shows a $50,000 gift, a drop from the $100,000 given to CHADD in 2007. Lilly's 2009 grant report lists a $130,000 donation and the first quarter report for 2010 shows a $50,000 grant for CHADD. Lilly is the only ADHD drug maker required to post grant reports online, so there is no way to break down how much money is pouring into CHADD from the other companies.
The group’s 2008 IRS filing lists CHADD’s most significant activity as, “provides support for individuals with Attention Deficit/Hyperactivity Disorders.” Yet the non-profit blew $330,000 on its annual conference and another $114,950 on a 20th Anniversary Gala that same year, according to the 2008 I&E report.
Also, in sharp contrast to the yearly SSI income of about $8,000 for persons disabled by ADHD, the group’s 2008-2009 tax forms lists compensation for CEO Ross as $187,747, and the next two highest paid officials of this “non-profit” earn $130,217 and $121,095.
Landslide Vote
On May 21, 2003, the CMSA passed by a landslide vote of 425-1 in the House. On May 27, 2003, Sheila and Patty appeared on the national radio show “Scams and Scandals,” for a program about the need for the Act to end the abuse of parents by schools. During the show, they asked all parents who had experienced abuse similar to theirs to go online and sign Ablechild’s petition.
The next month, Sheila was featured in her hometown newspaper, “The New Canaan Advertiser,” in a front-page article on June 5, 2003 with the headline: “Mother pushing Congress to prevent schools from ADD testing,” with details of her campaign to enact federal legislation. The article profiled AbleChild, and criticized CHADD for its industry funding and opposition to the CMSA.
When public health officials in the UK and US announced that Paxil increased the risk of suicide in children in June 2003, Sheila pushed her Governor’s office to issue a press release warning against the use of Paxil with kids. In July 2003, the Associated Press reported that the Department of Children and Family Services in Connecticut planned to stop using Paxil to treat young people with depression.
The “New American,” published an article titled, “Drugging Our Kids,” by William Norman Gregg in August 2003, and covered Patty and Michael’s story in depth, along with similar cases reported by other parents including Neil Bush and two families in which children died as a result of coerced drugging.
On February 20, 2004, Patty spoke on the nationally syndicated Joyce Riley radio show, and discussed the need for the CMSA in the wake of recent FDA hearings on the link between antidepressants and suicide, including Paxil, the drug Michael was prescribed.
Patty and Michael were both on CNN’s Lou Dobbs on April 15, 2004. Patty noted the need for the CMSA, evidenced by nearly 1,000 signatures on Ablechild’s website from parents with similar stories. Michael described how bad it felt to be on medications and Patty warned about the lack of informed consent given to parents regarding both the diagnoses of mental disorders and the drugs used as treatment.
The next month, Patty led a protest of hundreds of parents, children and human rights activists at the opening of the American Psychiatric Association's annual conference in New York City, saying parents were fed up with psychiatrists telling them their children's behavior was a “mental disorder” requiring dangerous drugs.
Sheila was again featured in her hometown newspaper on May 10, 2004, in an article about the need for an investigation by the Connecticut Attorney General into the drugging of children in foster care. Sheila was quoted throughout and promoted passage of CMSA.
Another federal bill that was introduced as a “Prohibition on Mandatory Medication,” amendment to the IDEA in April 2003, was passed by the House and Senate on May 13, 2004, and banned state and local educational agency personnel from requiring a child to take a drug covered by the Controlled Substance Act as a condition of attending school, receiving an evaluation, or receiving services. Key wording from the CMSA was included in the amendment.
On September 13, 2004, Patty testified at an FDA advisory panel hearing on the need for black box warnings on antidepressants about the risk of suicide and violence. “The FDA had enough evidence 14 years ago to issue these warning labels,” she told the committee.
She also testified about the lack of science behind psychiatric labels given to children. “Parents are told that their child has a chemical imbalance or a neurobiological illness,” she testified. “We risked our child's life based on this fundamental lie.”
“The FDA is well aware that there are no x-rays, biopsies, blood tests or brain scans that verify these mental disorders as a disease or illness,” she said. “The FDA should not be condoning or approving these drugs without evidence of disease, illness or physical abnormality that would justify risking our children's lives with a harmful and potentially lethal drug.”
The hearing ended with a vote by the panel in favor of black box warnings.
In November 2004, Patty was interviewed by a French TV producer for a news program in France, similar to 60 Minutes, focused on the pressuring of parents by schools in American to put children on psychiatric drugs. Other guests included Vicky Dunkel and Tom Woodward, whose daughter committed suicide after being prescribed an SSRI.
On February 17, 2005, Patty testified at a hearing titled, “ADHD Diagnosis, Treatment & Consequences,” in New York City, and told the story of what happened when Michael was labeled mentally ill in a public school and she refused to keep drugging him.
“The irony of the whole ordeal was that I was charged with medically neglecting my son, when there was no proof that anything was medically wrong with him,” she testified.
The next month, the “Ladies Home Journal,” ran an article titled, “A Generation out of Control,” with a sub-heading that read: “A record four million children -- some as young as 2 -- are being diagnosed with ADHD and many are being put on powerful medications, perhaps for life.”
The article featured Sheila, and Patricia Marks, another Connecticut mom whose son was misdiagnosed with ADHD. The article discussed the dangers of teachers diagnosing kids in schools to solve classroom problems and warned parents to make sure and rule out undiagnosed medical conditions that might manifest as ADHD.
Also in March, in letters to the US Attorney for the District of Minnesota and the FDA, Ablechild called for an investigation into the role of antidepressants in a school shooting by Jeff Weise in Red Lake, Minnesota, who was on Prozac when he went on a rampage, killing his grandfather first, and then fellow students and teachers at his school, before committing suicide with the same gun.
In a press release, Ablechild expressed outrage and frustration with the FDA for “continuing to turn a blind eye to the all so obvious link to violence and mania that these drugs are having on our youth, and even more, their deadly link to uncontrolled school terror that has occurred from coast to coast.”
In October 2005, Sheila issued a statement from Ablechild strongly opposing TeenScreen, a program aimed at screening kids for mental illness in schools. “TeenScreen is nothing more than the bio-behavioral health industry's attempt to garnish big government funding for useless programs that profitably promote a course of recommended psychotropic drug “treatment” which has been clearly liked to suicide and violent behavior,” she warned.
In October 2006, Sheila appeared on “The Big Story,” with John Gibson on Fox, in a segment titled “Investigating the Link: Antidepressants & Violence,” based on recent school shootings in Pennsylvania and Colorado, and spoke of the need to investigate the correlation between psychiatric drugs and school shooters, and toxicology tests to determine whether shooters were on drugs. As the founders of Ablechild, parents came to them all the time, Sheila said. “Their children are committing suicide on these drugs and we’re very concerned.”
At the end of the show, the reporter noted particular concern about the fact that 30 million Americans were taking antidepressants, and being that 5% would develop mania, there could be “a million and a half potential maniacs waiting to explode.”
Focus On Drug Side Effects
Over the years, Ablechild has also focused on educating the pubic on drug side effects and MedWatch, the FDA’s adverse drug reaction reporting system. On December 13, 2006, Sheila testified at the FDA advisory hearing on the risk of suicide with adults on SSRIs and presented the results of two surveys showing a lack of public knowledge about Medwatch, and asked the FDA to initiate campaigns to let consumers know where and how to report ADRs, as consumers detect adverse effects sooner than providers.
In June 2007, Shelia, along with two CCHR representatives, met with Washington lawmakers regarding the renewal of the “Prescription Drug User Fee Act.” The new Act was signed into law in September 2007, with key measures to help increase public knowledge about prescription drug risks, as well as better safety monitoring by the FDA.
On November 6, 2007, Ablechild issued a news alert to warn that despite the black box warnings, the mental health industry was continuing to downplay the suicide risk of antidepressants. Based on information posted within the MedWatch system, “an estimated 63,000 suicides have been committed by people under the influence of antidepressants,” the alert reported.
It also noted that most parents were not aware that at least eight school shooters “were under the influence of antidepressants documented to cause not only suicidal ideation but also mania, psychosis, hostility, hallucinations and even ‘homicidal behavior.’”
With 1.5 million children on antidepressants in the US alone, “Ablechild is deeply concerned about the number of children being prescribed the powerful and potentially lethal drugs,” the alert stated.
In December 2007, Sheila called into a National Public Radio program, when the topic was the recently passed FDA reform bill, and discussed a new requirement that all print ads include an 800 number and information on reporting side effects to MedWatch. She also noted the importance of the new clinical drug trial registry that would be available on the internet, and the elimination of conflicts of interest on FDA advisory committees.
Protect Youngest Victims
In 2008, Ablechild teamed up with Amy Philo’s “Unite for Life” coalition of advocacy groups in efforts to protect unborn children and nursing infants from forced drugging through their mothers’ ingestion of drugs, by lobbying against a bill called the “Mothers Act,” for short, aimed at screening pregnant women and new mothers for mental illness.
The Act “quite simply is a feeder line for the psycho-pharmaceutical industry and will result in more mothers and infants being put at risk for being prescribed antidepressants and other dangerous psychiatric drugs,” AbleChild warned in a letter made available on its website for persons to sign and send to members of Congress.
In April 2008, Patty, Amy Philo, Marla Fidili from CCHR, Mathy Downing, whose 12-year-old daughter committed suicide after being given Zoloft off-label for test anxiety, and about 40 more advocacy allies, went to Washington to lobby against the Mother's Act.
The latest evidence of infants being harmed by psychiatric drugs ingested by their mothers was reported on July 2, 2010, with a Medscape Today headline, “Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children,” for a study by Danish researchers of 4,500 adverse drug reactions (ADRs), in children younger than 17, listed in the national Danish ADR database between 1998 and 2007.
The results showed 429 reports were from psychotropic drugs, with the largest share from stimulants at 42%, followed by antidepressants with 31%, and antipsychotics at 24.5%.
Almost 19%, or 80 of the ADRs, were for children between the age of birth and 2. All but one was serious, with two deaths associated with the SSRIs Celexa and Prozac. These findings were “probably due to the mothers' intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy,” the study authors wrote.
Sheila and Patty, along with Amy Philo, Mathy Downing, and Vicky Dunkle, received an “Outstanding Achievement Award for Children’s Rights,” in February 2009, at CCHR’s annual banquet, highlighted by a video tribute featuring much of their work.
In April 2009, Sheila drafted a petition in support of the “Parental Consent Act,” and made it available on Ablechild’s website for persons to sign and send to members of Congress. Introduced by Texas Congressman and physician, Ron Paul, the bill prohibits federal funds from being used to establish or implement any universal or mandatory mental health screening program for public school students and establishes a parent's right to refuse screening of a child without fear of being charged with child abuse or neglect. In an April 30, 2009 speech, Paul pointed out that “parents are already being threatened with child abuse charges if they resist efforts to drug their children.”
“Imagine how much easier it will be to drug children against their parents' wishes if a federally-funded mental-health screener makes the recommendation,” he said.
Million Kids Misdiagnosed With ADHD
After a decade of work by Sheila and Patty to expose the fraud behind labeling kids with ADHD, on August 17, 2010, USA Today reported that a new study from Michigan State University found nearly 1 million children may have been misdiagnosed with ADHD, not because of any real behavioral problems, but because they were the youngest in the class.
Children who are the youngest in their grades are 60% more likely to be diagnosed with ADHD than the oldest kids, according to the study published in the Journal of Health Economics. In fifth and eighth grade, the youngest children were more than two times as likely to be on Ritalin compared with the oldest students, the study found.
(This article is the first in an on-going series honoring the many “Unsung Heroes” in the two decade battle against the drugging of children by the Psychopharmaceutical industrial Complex).
Showing posts with label MEDICAID. Show all posts
Showing posts with label MEDICAID. Show all posts
Friday, November 19, 2010
Sunday, August 8, 2010
Lilly Faces Mounting Legal Battles Over Zyprexa - Part I
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.
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.
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."
Psychotropic Drug Makers Bankroll Prescribing Shrinks Part I
Evelyn Pringle August 30, 2007
On August 21, 2007, the Associated Press reported that drug companies spend a lot of money on the members of Minnesota advisory panels who help select the drugs which are to be used by patients covered by Medicaid.
The news agency's review of financial disclosure records in Minnesota found that a doctor and a pharmacist on the 8-member panel simultaneously received large checks from drug companies for speaking about their products.
According to the report, Minneapolis psychiatrist John Simon, appointed to the panel in 2004, earned $354,700 from drug makers that included Eli Lilly and AstraZeneca, from 2004 to 2006, in honoraria, speaker and consulting fees, as well as other payments ranging from $500 to $93,012.
The records also showed that Robert Straka, a University of Minnesota pharmacy professor, was paid $78,000 by drug companies while he served on the panel from 2000 to 2006. He told the Associated Press that he was paid for "educational talks" and that he routinely discloses his ties with drug companies and did so as a panel member, both verbally and in writing.
But according to information obtained with a public records request by the AP, there is no indication that Mr Straka made any such disclosures in meeting minutes dating back to February 2001, and other panel members and staff interviewed by the AP could not remember Mr Straka making any such disclosures either.
The Associated Press reported that roughly a third of the drugs on Minnesota's preferred drug list were sold by companies which paid Mr Simon or Mr Straka, but the news agency could not track any link between the payments and their votes because the minutes from the advisory panel meetings did not record how the 8 members voted.
The top-selling drugs prescribed to Minnesota Medicaid patients for the years 2000 through 2006 included the atypical antipsychotic drugs Zyprexa, marketed by Eli Lilly; Seroquel, sold by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
These drugs were originally FDA-approved for the limited use of treating adults with schizophrenia or the manic phase of bipolar disorder. However, the massive over-prescribing of this enormously expensive class of drugs for unapproved uses has caused many states to remove them from the Medicaid preferred drugs lists and requires doctors to obtain prior authorization before prescribing them to Medicaid patients.
In fact, roughly 10 states are now suing several atypical makers for Medicaid fraud to recoup the cost of purchasing the antipsychotics prescribed off-label to Medicaid patients and also to recover the money paid for medical care of the persons injured by the drugs.
The lawsuits allege that the drug makers illegally influenced doctors to prescribe the drugs off-label to patients of all ages, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, dementia, and many other unapproved indications, and concealed the adverse effects associated with the drugs.
The atypical makers are also facing tens of thousands of lawsuits filed by patients, private insurance carriers and company shareholders for similar allegations.
According to Lilly's August 6, 2007, SEC filing, since August 2006, Lilly has received civil investigative demands or subpoenas from a number of states. "Most of these requests are now part of a multistate investigative effort being coordinated by an executive committee of attorneys general," the filing states.
"We are aware that approximately 30 states," Lilly wrote, "are participating in this joint effort, and it is possible that additional states will join the investigation."
The filing notes that the attorneys general are seeking a broad range of Zyprexa documents, "including documents relating to sales, marketing and promotional practices, and remuneration of health care providers."
Presumably, that would also include the "remuneration" of Minnesota shrinks like Dr Simon. According to the August 27, 2007, Pioneer Press, since 2002, Dr Simon has received more than $570,000 from six drug makers, with most of the money coming from Eli Lilly, "whose antipsychotic drug Zyprexa is the most costly each year for Minnesota's fee-for-service health program for the poor and disabled," the article states.
In fact, Lilly's disclosure records for 2004 show payments to Dr Simon totaling a whopping $91,854.95 in that one year, and he also received another couple grand from Seroquel maker AstraZeneca.
Dr Simon told the Pioneer Press that companies pay him to speak about their drugs at conferences and clinics or about the conditions that are treated with the drugs. "Most of the psychiatrists who are really good," he said, "have ties to industry."
Whether Dr Simon is a "really good" psychiatrist is certainly open to debate. In 1997, the state medical board made him complete a clinical training program and issued a report which said that Dr Simon, "frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies."
The board also noted that Dr Simon prescribed addictive drugs to addicts and failed to stop giving medicines to patients when they were suffering severe drug side effects. He said in an interview with the Times that the board's action was a learning experience and that drug makers continued to hire him to speak because he was respected by his peers.
For years, Dr Simon reportedly shared an office with another "really good" psychiatrist by the name of Dr Faruk Abuzzahab. On June 3, 2007, Gardiner Harris and Janet Roberts published a story in the New York Times with the headline: "After Sanctions, Doctors Get Drug Company Pay," and stated:
A decade ago, the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a "reckless, if not willful, disregard" for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.
Over the past 20 years, this "really good" psychiatrist has repeatedly prescribed narcotics and other controlled substances to addicts and prescribed narcotics to pregnant women, one of whom delivered a baby prematurely that died, the board found.
The Times reports that separately, in 1979 and 1984, the FDA concluded that Dr Abuzzahab had violated the protocols of every study that the agency audited and that he reported inaccurate data to drug makers.
The FDA said he routinely oversaw 4 to 8 trials at the same time, moved patients from one study to another, gave experimental drugs to patients at their first consultation and once hospitalized a patient for the sole purpose of enrolling him in a study.
As recently as June 2006, the medical board criticized Dr Abuzzahab once again for writing prescriptions for narcotics and this time to patients he knew were using false names, according to the Times.
All that said, Dr Abuzzahab told the Times that he has helped study many popular psychiatric drugs, including Lilly's Zyprexa and Prozac, Janssen's Risperdal, AstraZeneca's Seroquel, Glaxo's Paxil and Pfizer's Zoloft.
A review of the Minnesota disclosure records for 2004 show that the drug makers apparently thought it was beneficial to keep paying big bucks to Dr Abuzzahab. Glaxo paid him $1,000, Pfizer gave him $750, and Wyeth forked over $18,084, in that year alone.
In 2003, psychiatrist Dr Ronald Hardrict pleaded guilty to Medicaid fraud. But a little charge like fraud apparently did not effect this Minnesota psychiatrist's earning power either. The very next year, disclosure records for 2004 show Risperdal maker Janssen paid him $10,000; Seroquel maker AstraZeneca gave $1,250; Abbott Labs paid him over $7500; Glaxo paid $1,500, and Wyeth forked over $8,846.
In reviewing the Minnesota disclosure records for 2004, the name Dr Dean Knudson kept popping up. A September 2004 Newsletter from the Ada Canyon Medical Education Consortium listed Dr Knudson as an associate professor of psychiatry at the University of Minnesota Medical School.
He must be a "really good" psychiatrist, too, because in 2004 alone, Lilly paid him close to $37,000; he earned nearly $2,750 from Pfizer; Seroquel maker AstraZeneca paid him $6,700; Janssen forked over $3750; Wyeth paid him $11,632, and he received $2,082 from Abbott. Lilly's 2003 forms also show another $8,740 paid to Dr Knudson.
The newsletter showed that Dr Knudson was paid to give educational presentations on dementia. On October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia raised their risk of death.
For the study, the researchers pooled the results of 15 studies on the atypicals Zyprexa, Risperdal, Seroquel and Abilify and among more than 5,000 dementia patients, those taking any of the four drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.
Another name that jumps out in the 2004 disclosure records is Dr David Adson. According to the August 20, 2007, Pioneer Press, Dr Adson, of the University of Minnesota, also has a state advisory role as the clinical leader of a program funded by Lilly and provided free of charge to Minnesota, which notifies doctors when their prescriptions for psychiatric drugs are out of line with clinical standards.
Although the program is funded by Lilly, it is supposedly run by an independent company called Comprehensive NeuroScience, Inc. All totaled, 20 states have contracts with CNS to identify doctors "who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness," according to the Press.
Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.
Ben Hansen, a member of the Michigan Department of Community Health Recipient Rights Advisory Committee, has been investigating the atypical makers' involvement in the Medicaid programs in Michigan and other states and says that none of the states with CNS contracts require prior authorization for the atypical drugs.
Mr Hansen published some of the results of his investigation in the Spring 2007 Newsletter of the International Center for the Study of Psychiatry and Psychology. By using the FOIA, Mr Hansen says he has obtained nearly a thousand pages of documents which show that Medicaid is being "milked like a huge cash cow."
According to Allen Jones, a former Medicaid fraud investigator, the long list of corporate sponsors for CNS includes: AstraZeneca, Janssen, Bristol-Myers, Pfizer, Lilly and Glaxo.
Back in 2002, Mr Jones found that Janssen was using CNS to funnel payments to state officials who controlled the Medicaid preferred drug lists in Pennsylvania to ensure that Risperdal would be on the list.
For his part, the leader of the Minnesota CNS program, Dr Adson, was paid $5,200 by AstraZeneca, Glaxo shows $331,947 going to him, and Pfizer gave him $1,000, in 2004 alone.
Also, in 2006, Dr Adson received $83,325 from AstraZeneca and roughly $6,100 from Bristol-Myers, according to a compilation of disclosure forms by the Pioneer Press and the watchdog group Public Citizen.
On August 21, 2007, the Associated Press reported that drug companies spend a lot of money on the members of Minnesota advisory panels who help select the drugs which are to be used by patients covered by Medicaid.
The news agency's review of financial disclosure records in Minnesota found that a doctor and a pharmacist on the 8-member panel simultaneously received large checks from drug companies for speaking about their products.
According to the report, Minneapolis psychiatrist John Simon, appointed to the panel in 2004, earned $354,700 from drug makers that included Eli Lilly and AstraZeneca, from 2004 to 2006, in honoraria, speaker and consulting fees, as well as other payments ranging from $500 to $93,012.
The records also showed that Robert Straka, a University of Minnesota pharmacy professor, was paid $78,000 by drug companies while he served on the panel from 2000 to 2006. He told the Associated Press that he was paid for "educational talks" and that he routinely discloses his ties with drug companies and did so as a panel member, both verbally and in writing.
But according to information obtained with a public records request by the AP, there is no indication that Mr Straka made any such disclosures in meeting minutes dating back to February 2001, and other panel members and staff interviewed by the AP could not remember Mr Straka making any such disclosures either.
The Associated Press reported that roughly a third of the drugs on Minnesota's preferred drug list were sold by companies which paid Mr Simon or Mr Straka, but the news agency could not track any link between the payments and their votes because the minutes from the advisory panel meetings did not record how the 8 members voted.
The top-selling drugs prescribed to Minnesota Medicaid patients for the years 2000 through 2006 included the atypical antipsychotic drugs Zyprexa, marketed by Eli Lilly; Seroquel, sold by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
These drugs were originally FDA-approved for the limited use of treating adults with schizophrenia or the manic phase of bipolar disorder. However, the massive over-prescribing of this enormously expensive class of drugs for unapproved uses has caused many states to remove them from the Medicaid preferred drugs lists and requires doctors to obtain prior authorization before prescribing them to Medicaid patients.
In fact, roughly 10 states are now suing several atypical makers for Medicaid fraud to recoup the cost of purchasing the antipsychotics prescribed off-label to Medicaid patients and also to recover the money paid for medical care of the persons injured by the drugs.
The lawsuits allege that the drug makers illegally influenced doctors to prescribe the drugs off-label to patients of all ages, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, dementia, and many other unapproved indications, and concealed the adverse effects associated with the drugs.
The atypical makers are also facing tens of thousands of lawsuits filed by patients, private insurance carriers and company shareholders for similar allegations.
According to Lilly's August 6, 2007, SEC filing, since August 2006, Lilly has received civil investigative demands or subpoenas from a number of states. "Most of these requests are now part of a multistate investigative effort being coordinated by an executive committee of attorneys general," the filing states.
"We are aware that approximately 30 states," Lilly wrote, "are participating in this joint effort, and it is possible that additional states will join the investigation."
The filing notes that the attorneys general are seeking a broad range of Zyprexa documents, "including documents relating to sales, marketing and promotional practices, and remuneration of health care providers."
Presumably, that would also include the "remuneration" of Minnesota shrinks like Dr Simon. According to the August 27, 2007, Pioneer Press, since 2002, Dr Simon has received more than $570,000 from six drug makers, with most of the money coming from Eli Lilly, "whose antipsychotic drug Zyprexa is the most costly each year for Minnesota's fee-for-service health program for the poor and disabled," the article states.
In fact, Lilly's disclosure records for 2004 show payments to Dr Simon totaling a whopping $91,854.95 in that one year, and he also received another couple grand from Seroquel maker AstraZeneca.
Dr Simon told the Pioneer Press that companies pay him to speak about their drugs at conferences and clinics or about the conditions that are treated with the drugs. "Most of the psychiatrists who are really good," he said, "have ties to industry."
Whether Dr Simon is a "really good" psychiatrist is certainly open to debate. In 1997, the state medical board made him complete a clinical training program and issued a report which said that Dr Simon, "frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies."
The board also noted that Dr Simon prescribed addictive drugs to addicts and failed to stop giving medicines to patients when they were suffering severe drug side effects. He said in an interview with the Times that the board's action was a learning experience and that drug makers continued to hire him to speak because he was respected by his peers.
For years, Dr Simon reportedly shared an office with another "really good" psychiatrist by the name of Dr Faruk Abuzzahab. On June 3, 2007, Gardiner Harris and Janet Roberts published a story in the New York Times with the headline: "After Sanctions, Doctors Get Drug Company Pay," and stated:
A decade ago, the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a "reckless, if not willful, disregard" for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.
Over the past 20 years, this "really good" psychiatrist has repeatedly prescribed narcotics and other controlled substances to addicts and prescribed narcotics to pregnant women, one of whom delivered a baby prematurely that died, the board found.
The Times reports that separately, in 1979 and 1984, the FDA concluded that Dr Abuzzahab had violated the protocols of every study that the agency audited and that he reported inaccurate data to drug makers.
The FDA said he routinely oversaw 4 to 8 trials at the same time, moved patients from one study to another, gave experimental drugs to patients at their first consultation and once hospitalized a patient for the sole purpose of enrolling him in a study.
As recently as June 2006, the medical board criticized Dr Abuzzahab once again for writing prescriptions for narcotics and this time to patients he knew were using false names, according to the Times.
All that said, Dr Abuzzahab told the Times that he has helped study many popular psychiatric drugs, including Lilly's Zyprexa and Prozac, Janssen's Risperdal, AstraZeneca's Seroquel, Glaxo's Paxil and Pfizer's Zoloft.
A review of the Minnesota disclosure records for 2004 show that the drug makers apparently thought it was beneficial to keep paying big bucks to Dr Abuzzahab. Glaxo paid him $1,000, Pfizer gave him $750, and Wyeth forked over $18,084, in that year alone.
In 2003, psychiatrist Dr Ronald Hardrict pleaded guilty to Medicaid fraud. But a little charge like fraud apparently did not effect this Minnesota psychiatrist's earning power either. The very next year, disclosure records for 2004 show Risperdal maker Janssen paid him $10,000; Seroquel maker AstraZeneca gave $1,250; Abbott Labs paid him over $7500; Glaxo paid $1,500, and Wyeth forked over $8,846.
In reviewing the Minnesota disclosure records for 2004, the name Dr Dean Knudson kept popping up. A September 2004 Newsletter from the Ada Canyon Medical Education Consortium listed Dr Knudson as an associate professor of psychiatry at the University of Minnesota Medical School.
He must be a "really good" psychiatrist, too, because in 2004 alone, Lilly paid him close to $37,000; he earned nearly $2,750 from Pfizer; Seroquel maker AstraZeneca paid him $6,700; Janssen forked over $3750; Wyeth paid him $11,632, and he received $2,082 from Abbott. Lilly's 2003 forms also show another $8,740 paid to Dr Knudson.
The newsletter showed that Dr Knudson was paid to give educational presentations on dementia. On October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia raised their risk of death.
For the study, the researchers pooled the results of 15 studies on the atypicals Zyprexa, Risperdal, Seroquel and Abilify and among more than 5,000 dementia patients, those taking any of the four drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.
Another name that jumps out in the 2004 disclosure records is Dr David Adson. According to the August 20, 2007, Pioneer Press, Dr Adson, of the University of Minnesota, also has a state advisory role as the clinical leader of a program funded by Lilly and provided free of charge to Minnesota, which notifies doctors when their prescriptions for psychiatric drugs are out of line with clinical standards.
Although the program is funded by Lilly, it is supposedly run by an independent company called Comprehensive NeuroScience, Inc. All totaled, 20 states have contracts with CNS to identify doctors "who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness," according to the Press.
Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.
Ben Hansen, a member of the Michigan Department of Community Health Recipient Rights Advisory Committee, has been investigating the atypical makers' involvement in the Medicaid programs in Michigan and other states and says that none of the states with CNS contracts require prior authorization for the atypical drugs.
Mr Hansen published some of the results of his investigation in the Spring 2007 Newsletter of the International Center for the Study of Psychiatry and Psychology. By using the FOIA, Mr Hansen says he has obtained nearly a thousand pages of documents which show that Medicaid is being "milked like a huge cash cow."
According to Allen Jones, a former Medicaid fraud investigator, the long list of corporate sponsors for CNS includes: AstraZeneca, Janssen, Bristol-Myers, Pfizer, Lilly and Glaxo.
Back in 2002, Mr Jones found that Janssen was using CNS to funnel payments to state officials who controlled the Medicaid preferred drug lists in Pennsylvania to ensure that Risperdal would be on the list.
For his part, the leader of the Minnesota CNS program, Dr Adson, was paid $5,200 by AstraZeneca, Glaxo shows $331,947 going to him, and Pfizer gave him $1,000, in 2004 alone.
Also, in 2006, Dr Adson received $83,325 from AstraZeneca and roughly $6,100 from Bristol-Myers, according to a compilation of disclosure forms by the Pioneer Press and the watchdog group Public Citizen.
Psychotropic Drug Makers Bankroll Prescribing Shrinks Part II
Evelyn Pringle September 2, 2007
Influence peddling in the field of psychiatry is out of control. An analysis of Minnesota disclosure records by the Pioneer Press and the consumer watchdog group Public Citizen shows that, between 2002 and 2006, 187 Minnesota doctors received payments from drug companies worth a grand total of $7.38 million.
No other field of medicine even comes close to that amount. The next highest specialty was neurology, with 99 doctors receiving $2.89 million, according to the analysis.
In psychiatry, drug makers underwrite decision makers at every level of care, according to a May 10, 2007, report by Gardiner Harris in the New York Times. "They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow," Mr Harris states.
He determined that, between 2000 and 2005, payments to Minnesota psychiatrists increased more than six-fold. The Times also analyzed Minnesota Medicaid records, and the report provides details on how the financial relationships between doctors and drug makers have played a major role in the growing use of atypical antipsychotics with children.
The drugs include Zyprexa, marketed by Eli Lilly; Seroquel, by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
The drugs are the most powerful psychiatric drugs on the market and were FDA-approved only to treat adults with schizophrenia or adults in the manic phase of bipolar disorder.
Over the past three years, every atypical maker has come under fire for influencing doctors to prescribe the drugs off-label to children for uses never approved by the FDA, and they are all currently involved in litigation related to the illegal promotion and sales of the drugs.
A study at Columbia University on the use of antipsychotics with children found that only a small percentage of the kids on the drugs had psychotic disorders and that, most of the time, the drugs were prescribed to treat mood disorders, depression, anxiety and ADHD.
Mr Harris reports that the Minnesota psychiatrists who received the most money from the drug's makers tended to prescribe them to kids the most often. On average, psychiatrists who received at least $5,000 between 2000 to 2005 appeared to have written 3 times as many prescriptions for kids as psychiatrists who received less or no money, the Times notes.
The rising Medicaid costs for atypicals also coincides with the rising payments to doctors. For instance, Minnesota Medicaid spent roughly $521,000 in 2000 on antipsychotics for children; but in 2005, the cost was more than $7 million, or a 14-fold increase.
In June 2007, Vermont officials revealed that disclosure records in that state showed payments to psychiatrists had more than doubled in one year, from an average of $20,835 in 2005, to an average $45,692 in 2005. There, too, antipsychotics were among the highest Medicaid drug expense.
The drug makers have shrinks in their pockets all over the country. However, only 3 states, Minnesota, Vermont and Maine, have laws that require companies to disclose their payments.
The media's recent reporting that members of a Minnesota advisory panel who decide which drugs will be covered by the state's Medicaid program are on the take, adds a new chapter to an old book. This same scam has been used in states all over the country since the late 1990's, and if not for two relentless fraud investigators from Pennsylvania, the fact that the formulary committees are bought and paid for by the pharmaceutical industry might have remained a secret for all time.
The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.
According to Mr Jones, "the pharmaceutical industry has systematically infiltrated the mental health service delivery system of this nation."
"The situation uncovered in Minnesota," he says, "will be exposed in every state that demonstrates the political will to force transparency through full disclosure of industry payments to decision makers."
"Thinly veiled bribery of public officials by the pharmaceutical industry is a pervasive and deeply rooted problem," he warns.
During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the "Texas Medication Algorithm Project (TMAP)".
Mr Jones calls the Texas panel the "most transparent example" of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered "opinion leaders" in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.
For instance, Dr John Rush, from the University of Texas Southwestern Medical Center, served as the TMAP Project Co-Director with Dr Steven Shon, the Medical Director of the Texas Department of State Health Services.
Mr Jones determined that Dr Rush had received grants, research funding and served as a consultant and speaker for atypical makers Bristol-Myers, Janssen, Eli Lilly and Pfizer.
The director for the schizophrenia module was Dr Alexander Miller, of the University of Texas Health Science Center at San Antonio, who also served as a consultant, advisory board member and speaker for AstraZeneca, Bristol-Myers, Lilly, Janssen and Pfizer.
The director of the bipolar disorder module was Dr Patricia Suppes, from the University of Texas Southwestern Medical Center in Dallas, who also received grants and research funding and served as a consultant for AstraZeneca, Bristol-Myers, Janssen, Lilly and Pfizer.
Other University of Texas professors who participated in the development of TMAP included psychiatrist Dr Graham Emslie, who has received grants and research support and served as a consultant and member of speakers' bureaus for atypical makers Bristol-Myers, Lilly and Pfizer.
Another professor, Dr Karen Dineen Wagner, was a member of the speakers' bureaus for Janssen, Lilly and Pfizer, and a member of a scientific advisory board for Lilly, Janssen and Pfizer and received research funding from the same 3 atypical makers and Bristol-Myers.
Once the formulary was in place in Texas, the drug makers paid Dr Shon to travel around the country to convince policy makers in other states to use the TMAP model for their Medicaid approved list. Pennsylvania adopted the program and called it PennMap.
Mr Jones found that Janssen paid for Dr Shon to fly to Pennsylvania two times, and a document he obtained shows that the grant covering Dr Shon's travel expenses was "to expand atypical usage."
The New York Times reported that some payments were made through patient advocacy groups instead of directly to state officials. In 2002, Janssen gave the Olympia, WA, chapter of the National Alliance for the Mentally Ill a grant of $15,000 to fly Dr Shon and other Texas officials to speak to state legislators about the formulary, the Times found.
While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.
In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.
According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.
In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.
The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker's encouragement of the rampant prescribing of atypicals or go broke.
For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, "Foster Children - Texas Health Care Claims Study." In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.
The report also pointed out that the drugs were not approved for children, and listed the health risks associated with the atypicals and stated, in part:
"These very powerful and expensive medications were prescribed despite a lack of studies demonstrating their safety and efficacy in children. There are questions regarding the long-term safety of these medications; documented serious side-effects include menstrual irregularities, gynecomastia, galactorrhea, possible pituitary tumors, hyperglycemia, type 2 diabetes and liver function abnormalities."
In a May 10, 2006 Press Release, Comptroller Carole Keeton Strayhorn said she was "particularly concerned" about the use and side effects of the atypical antipsychotic drugs.
"A clear pattern of overmedication and potential misdiagnosis of foster children is evident," she said and the "potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming."
A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to Zyprexa, choking and liver failure.
A 15-year-old boy died of an overdose, an 8-year-old boy died of cardiac arrest, a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin, and the youngest death was a 4-year-old boy whose symptoms suggested diabetes complications, who was also taking 10 other drugs.
A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.
Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should "only be considered under the most extraordinary of circumstances."
According to Mr Jones, these new "miracle" drugs have proven to be no better than generics, and, "it is a statistical certainty that many lives have been lost and many others irreparably damaged."
In September 2005, the New England Journal of Medicine, reported that although Zyprexa was the most expensive and most prescribed antipsychotic, it was the only atypical that worked slightly better than the 40-year-old generic drug, perphenazine, but the NEJM also noted that Zyprexa had more side effects. The cost for a 3 month supply of Zyprexa in September, 2005 at drugstore.com, was $1,500, while a 3 month supply of perphenazine was only $135.
And the atypical drugging for profit scheme is not limited to the Medicaid population. An analysis revealed in March 2006 by investment firm CIBC World Markets showed that in the previous 12 months, the top 20 drugs in managed care spending included Zyprexa with $2.6 billion, Seroquel at $2.5 billion, and Risperdal was $2.2 billion.
The corrupt psychiatrists in Minnesota and other states might want to think about what is happening to "professionals" who were involved in similar behavior in Pennsylvania and Texas.
In Pennsylvania, the state Ethics Commission determined that Pfizer operated its own "Advisory Boards," comprised exclusively of formulary committee chairmen from various states who received honorariums and all-expense-paid trips from Pfizer at the same time they were evaluating Pfizer drugs for use in state mental health systems.
The Commission determined that Steven Fiorello, Director of the Pharmacy Services in the Office of Mental Health and Substance Abuse Services in Pennsylvania, and Chairman of the Formulary Committee, had used his office to obtain private pecuniary benefits for his participation in Pfizer's advisory board meetings in New York when he received honoraria for his participation in the meetings, as well as for his presentations at conferences in Orlando, Florida and Dublin, Ireland.
Mr Jones found that Mr Fiorello traveled to Pfizer's world headquarters in Manhattan 3 times to participate in advisory board meetings, with all expenses paid for by Pfizer, including lodging at Manhattan's Millennium Hotel and he was paid an honorarium of $1,000 for attending each meeting.
The Commission also found a number of additional violations, including Mr Fiorello's receipt of honoraria from other companies for whom he made presentations in connection with his public employment, and ordered Mr Fiorello to make restitution of $27,268.50 and referred the case to the Pennsylvania Attorney General's Public Corruption Unit.
On November 21, 2006, Mr Fiorello was charged with two counts of conflicts of interest, one count of accepting honoraria and one count of failing to disclose income on annual Statements of Financial Interests. In a press release, Pennsylvania's Attorney General stated: "As part of his responsibilities, Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals - decisions which guided more than $9 million in annual drug purchases by the Commonwealth."
He also noted that, "while Fiorello was helping to guide the purchase of various drugs by the Department of Public Welfare, he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board."
Down in Texas, Dr Shon was fired last fall after the state's attorney general found that Janssen had improperly influenced him to list Risperdal on the state formulary. An October 9, 2006, letter to Dr Shon from Dr Charles Bell, acting commissioner of the Texas Department of State Health Services, obtained by the Austin American-Statesman states: "It is my determination that your services are no longer required by the Department."
"I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately," Dr Bell wrote.
In addition, Texas is now closely monitoring the prescribing of psychiatric drugs to Medicaid patients, and several psychiatrists have been ordered to reimburse the state for the cost of the drugs they prescribed to foster children.
Texas and Pennsylvania have also recently filed Medicaid fraud lawsuits against the makers of Zyprexa, Risperdal and Seroquel, seeking to recoup the cost of the drugs prescribed to Medicaid patients, as well as the medical care for persons injured by the drugs.
Influence peddling in the field of psychiatry is out of control. An analysis of Minnesota disclosure records by the Pioneer Press and the consumer watchdog group Public Citizen shows that, between 2002 and 2006, 187 Minnesota doctors received payments from drug companies worth a grand total of $7.38 million.
No other field of medicine even comes close to that amount. The next highest specialty was neurology, with 99 doctors receiving $2.89 million, according to the analysis.
In psychiatry, drug makers underwrite decision makers at every level of care, according to a May 10, 2007, report by Gardiner Harris in the New York Times. "They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow," Mr Harris states.
He determined that, between 2000 and 2005, payments to Minnesota psychiatrists increased more than six-fold. The Times also analyzed Minnesota Medicaid records, and the report provides details on how the financial relationships between doctors and drug makers have played a major role in the growing use of atypical antipsychotics with children.
The drugs include Zyprexa, marketed by Eli Lilly; Seroquel, by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.
The drugs are the most powerful psychiatric drugs on the market and were FDA-approved only to treat adults with schizophrenia or adults in the manic phase of bipolar disorder.
Over the past three years, every atypical maker has come under fire for influencing doctors to prescribe the drugs off-label to children for uses never approved by the FDA, and they are all currently involved in litigation related to the illegal promotion and sales of the drugs.
A study at Columbia University on the use of antipsychotics with children found that only a small percentage of the kids on the drugs had psychotic disorders and that, most of the time, the drugs were prescribed to treat mood disorders, depression, anxiety and ADHD.
Mr Harris reports that the Minnesota psychiatrists who received the most money from the drug's makers tended to prescribe them to kids the most often. On average, psychiatrists who received at least $5,000 between 2000 to 2005 appeared to have written 3 times as many prescriptions for kids as psychiatrists who received less or no money, the Times notes.
The rising Medicaid costs for atypicals also coincides with the rising payments to doctors. For instance, Minnesota Medicaid spent roughly $521,000 in 2000 on antipsychotics for children; but in 2005, the cost was more than $7 million, or a 14-fold increase.
In June 2007, Vermont officials revealed that disclosure records in that state showed payments to psychiatrists had more than doubled in one year, from an average of $20,835 in 2005, to an average $45,692 in 2005. There, too, antipsychotics were among the highest Medicaid drug expense.
The drug makers have shrinks in their pockets all over the country. However, only 3 states, Minnesota, Vermont and Maine, have laws that require companies to disclose their payments.
The media's recent reporting that members of a Minnesota advisory panel who decide which drugs will be covered by the state's Medicaid program are on the take, adds a new chapter to an old book. This same scam has been used in states all over the country since the late 1990's, and if not for two relentless fraud investigators from Pennsylvania, the fact that the formulary committees are bought and paid for by the pharmaceutical industry might have remained a secret for all time.
The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.
According to Mr Jones, "the pharmaceutical industry has systematically infiltrated the mental health service delivery system of this nation."
"The situation uncovered in Minnesota," he says, "will be exposed in every state that demonstrates the political will to force transparency through full disclosure of industry payments to decision makers."
"Thinly veiled bribery of public officials by the pharmaceutical industry is a pervasive and deeply rooted problem," he warns.
During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the "Texas Medication Algorithm Project (TMAP)".
Mr Jones calls the Texas panel the "most transparent example" of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered "opinion leaders" in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.
For instance, Dr John Rush, from the University of Texas Southwestern Medical Center, served as the TMAP Project Co-Director with Dr Steven Shon, the Medical Director of the Texas Department of State Health Services.
Mr Jones determined that Dr Rush had received grants, research funding and served as a consultant and speaker for atypical makers Bristol-Myers, Janssen, Eli Lilly and Pfizer.
The director for the schizophrenia module was Dr Alexander Miller, of the University of Texas Health Science Center at San Antonio, who also served as a consultant, advisory board member and speaker for AstraZeneca, Bristol-Myers, Lilly, Janssen and Pfizer.
The director of the bipolar disorder module was Dr Patricia Suppes, from the University of Texas Southwestern Medical Center in Dallas, who also received grants and research funding and served as a consultant for AstraZeneca, Bristol-Myers, Janssen, Lilly and Pfizer.
Other University of Texas professors who participated in the development of TMAP included psychiatrist Dr Graham Emslie, who has received grants and research support and served as a consultant and member of speakers' bureaus for atypical makers Bristol-Myers, Lilly and Pfizer.
Another professor, Dr Karen Dineen Wagner, was a member of the speakers' bureaus for Janssen, Lilly and Pfizer, and a member of a scientific advisory board for Lilly, Janssen and Pfizer and received research funding from the same 3 atypical makers and Bristol-Myers.
Once the formulary was in place in Texas, the drug makers paid Dr Shon to travel around the country to convince policy makers in other states to use the TMAP model for their Medicaid approved list. Pennsylvania adopted the program and called it PennMap.
Mr Jones found that Janssen paid for Dr Shon to fly to Pennsylvania two times, and a document he obtained shows that the grant covering Dr Shon's travel expenses was "to expand atypical usage."
The New York Times reported that some payments were made through patient advocacy groups instead of directly to state officials. In 2002, Janssen gave the Olympia, WA, chapter of the National Alliance for the Mentally Ill a grant of $15,000 to fly Dr Shon and other Texas officials to speak to state legislators about the formulary, the Times found.
While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.
In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.
According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.
In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.
The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker's encouragement of the rampant prescribing of atypicals or go broke.
For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, "Foster Children - Texas Health Care Claims Study." In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.
The report also pointed out that the drugs were not approved for children, and listed the health risks associated with the atypicals and stated, in part:
"These very powerful and expensive medications were prescribed despite a lack of studies demonstrating their safety and efficacy in children. There are questions regarding the long-term safety of these medications; documented serious side-effects include menstrual irregularities, gynecomastia, galactorrhea, possible pituitary tumors, hyperglycemia, type 2 diabetes and liver function abnormalities."
In a May 10, 2006 Press Release, Comptroller Carole Keeton Strayhorn said she was "particularly concerned" about the use and side effects of the atypical antipsychotic drugs.
"A clear pattern of overmedication and potential misdiagnosis of foster children is evident," she said and the "potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming."
A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to Zyprexa, choking and liver failure.
A 15-year-old boy died of an overdose, an 8-year-old boy died of cardiac arrest, a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin, and the youngest death was a 4-year-old boy whose symptoms suggested diabetes complications, who was also taking 10 other drugs.
A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.
Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should "only be considered under the most extraordinary of circumstances."
According to Mr Jones, these new "miracle" drugs have proven to be no better than generics, and, "it is a statistical certainty that many lives have been lost and many others irreparably damaged."
In September 2005, the New England Journal of Medicine, reported that although Zyprexa was the most expensive and most prescribed antipsychotic, it was the only atypical that worked slightly better than the 40-year-old generic drug, perphenazine, but the NEJM also noted that Zyprexa had more side effects. The cost for a 3 month supply of Zyprexa in September, 2005 at drugstore.com, was $1,500, while a 3 month supply of perphenazine was only $135.
And the atypical drugging for profit scheme is not limited to the Medicaid population. An analysis revealed in March 2006 by investment firm CIBC World Markets showed that in the previous 12 months, the top 20 drugs in managed care spending included Zyprexa with $2.6 billion, Seroquel at $2.5 billion, and Risperdal was $2.2 billion.
The corrupt psychiatrists in Minnesota and other states might want to think about what is happening to "professionals" who were involved in similar behavior in Pennsylvania and Texas.
In Pennsylvania, the state Ethics Commission determined that Pfizer operated its own "Advisory Boards," comprised exclusively of formulary committee chairmen from various states who received honorariums and all-expense-paid trips from Pfizer at the same time they were evaluating Pfizer drugs for use in state mental health systems.
The Commission determined that Steven Fiorello, Director of the Pharmacy Services in the Office of Mental Health and Substance Abuse Services in Pennsylvania, and Chairman of the Formulary Committee, had used his office to obtain private pecuniary benefits for his participation in Pfizer's advisory board meetings in New York when he received honoraria for his participation in the meetings, as well as for his presentations at conferences in Orlando, Florida and Dublin, Ireland.
Mr Jones found that Mr Fiorello traveled to Pfizer's world headquarters in Manhattan 3 times to participate in advisory board meetings, with all expenses paid for by Pfizer, including lodging at Manhattan's Millennium Hotel and he was paid an honorarium of $1,000 for attending each meeting.
The Commission also found a number of additional violations, including Mr Fiorello's receipt of honoraria from other companies for whom he made presentations in connection with his public employment, and ordered Mr Fiorello to make restitution of $27,268.50 and referred the case to the Pennsylvania Attorney General's Public Corruption Unit.
On November 21, 2006, Mr Fiorello was charged with two counts of conflicts of interest, one count of accepting honoraria and one count of failing to disclose income on annual Statements of Financial Interests. In a press release, Pennsylvania's Attorney General stated: "As part of his responsibilities, Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals - decisions which guided more than $9 million in annual drug purchases by the Commonwealth."
He also noted that, "while Fiorello was helping to guide the purchase of various drugs by the Department of Public Welfare, he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board."
Down in Texas, Dr Shon was fired last fall after the state's attorney general found that Janssen had improperly influenced him to list Risperdal on the state formulary. An October 9, 2006, letter to Dr Shon from Dr Charles Bell, acting commissioner of the Texas Department of State Health Services, obtained by the Austin American-Statesman states: "It is my determination that your services are no longer required by the Department."
"I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately," Dr Bell wrote.
In addition, Texas is now closely monitoring the prescribing of psychiatric drugs to Medicaid patients, and several psychiatrists have been ordered to reimburse the state for the cost of the drugs they prescribed to foster children.
Texas and Pennsylvania have also recently filed Medicaid fraud lawsuits against the makers of Zyprexa, Risperdal and Seroquel, seeking to recoup the cost of the drugs prescribed to Medicaid patients, as well as the medical care for persons injured by the drugs.
Investigations of Anemia Drug Profiteering Far from Over - Part II
Evelyn Pringle August 7, 2007
According to US Renal Data System and the Medicare Payment Advisory Commission, Medicare spends about $64,000 annually for each person on hemodialysis for all medical services, and the anemia drugs Procrit, Epogen and Aranesp are the single largest drug expense for Medicare.
In 2005, Medicare spent $2 billion on the drugs, and from 1991 to 2004, the cost of the medications to Medicare increased 716% from $245 million to $2 billion, according to a report by the US House Ways and Means Committee.
Amgen produced the synthetic epoetin in 1989 and sold it under the brand name Epogen as a treatment for anemic kidney patients and HIV related anemia. Shortly after Epogen came on the market, Amgen entered into an agreement to allow J&J to sell the same drug under the brand name Procrit, as long as it stayed out of the dialysis market, which basically helped the young company raise capital.
In 1993, J&J received approval to sell Procrit as a treatment for cancer patients with chemotherapy-related anemia, and a few years later, Amgen gained FDA approval for the long-lasting version of the drug, Aranesp, to treat both renal and chemotherapy related anemia.
Recent investigations have shown the drug makers are providing incentives to encourage the over-prescribing of ESA's to Medicare patients by charging less for the drugs than the Medicare reimbursement rates.
A March 2006 government report entitled "Medicare Reimbursement for New End Stage Renal Disease Drugs," found freestanding dialysis facilities on average were able to acquire Aranesp for between 14 and 27% below the Medicare reimbursement amounts in 2005.
On May 10, 2007, due to reports of rampant over-prescribing of the drugs for uses and doses not approved by the FDA and the deaths and injuries to patients as a result, the Oncology Drug Advisory Panel (ODAC) voted 15-2 in favor of adding new restrictions on the use of the drugs and voted 17-0 in favor of requiring the drug makers to conduct new clinical trials.
However, experts say the recommendations come about ten years and probably tens of thousands of deaths and injuries too late, because the FDA was made aware of the serious health risks associated with ESA's in a report on the Amgen sponsored Normal Hematocrit Study back in 1996, and the FDA did little more than revise the product labeling a wee bit.
The 1996 study was designed to evaluate whether patients with chronic renal failure undergoing dialysis had fewer cardiovascular complications if the ESA was administered to attain a higher hematocrit level as compared to a lower level. The trial was terminated early because of a finding of more deaths and non-fatal myocardial infarctions in the patients randomized to the higher hematocrit target level.
The labeling revision recommended that the ESA's not be used to achieve hematocrit in excess of 36%, or a hemoglobin level of 12 g/dL and was accompanied by the sponsor's agreement to conduct a study to further examine the risk for blood clots among patients receiving ESA's because an increased thrombotic risk was suspected to be one of the causes for the risks detected in the study, according to the FDA.
So ten years later, two clinical trials and an editorial finally appeared in the New England Journal of Medicine in November 2006, to report the risks associated with the use of ESA's in the treatment of anemia from chronic renal failure.
The Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study showed increases in serious and potentially life-threatening cardiovascular events when Procrit was administered to reach higher hemoglobin levels, and the Cardiovascular Risk Reduction by Early Treatment with Epoetin Beta (CREATE) study trended toward more cardiovascular events in a pattern similar to the CHOIR study, thus strengthening the findings of the CHOIR study, the FDA said.
On June 26, 2007, Dr John Jenkins, Director of the FDA's Office of New Drugs Center for Drug Evaluation and Research, testified at a hearing before the House Ways and Means Committee and said the study findings "underscore the importance of the warnings previously described in the labeling for Procrit, Epogen, and Aranesp regarding cardiovascular risks that include thrombotic events and increased mortality in hemodialysis patients who participated in the Normal Hematocrit Study."
He told the Committee that the new studies, combined with the findings from the Normal Hematocrit Study, showed that patients with anemia due to chronic renal failure, whether or not receiving dialysis, "were at increased risk for serious cardiovascular complications when ESA's were administered to attain hemoglobin levels in excess of the 12 g/dL level recommended in the ESA product labels."
Dr Jenkins also said the FDA became aware of safety concerns about the use of ESA's in cancer patients receiving chemotherapy between 2001 and 2003, when the agency received reports from two trials (BEST and ENHANCE) that demonstrated higher mortality and more rapid tumor growth when the ESA's were given to maintain hemoglobin levels of greater than 12 g/dL and the findings were discussed at a May 2004 meeting of the ODAC.
He said the new safety data was added to the labeling for ESA products shortly after that meeting and that the advisory panel recommended additional data be gathered to further evaluate the new safety concerns about patients with cancer.
However, according to Dr Jenkins, it was not until late 2006 and early 2007 that the FDA was informed of several new trials in cancer patients that raised additional safety concerns.
In December 2006, the ESA makers informed the FDA of the interim results of the Danish Head and Neck Cancer Study Group trial (DAHANCA 10), a trial that compared radiation therapy alone to radiation therapy plus Aranesp in the treatment of advanced head and neck cancer.
The trial assessed whether treating anemia to achieve and maintain a hemoglobin concentration of 14.0-15.5 g/dL during radiotherapy would improve local-regional disease control.
The data monitoring committee for this trial found that 3-year local-regional control in patients treated with Aranesp was worse than for those not receiving Aranesp. Overall survival time also favored those not treated with Aranesp, he said, and the monitoring committee recommended the ESA treatment be stopped in the experimental arm on December 1, 2006.
Dr Jenkins said the FDA was notified in January 2007 of the results of a 989 patient trial of Aranesp in cancer patients with anemia who were not receiving chemotherapy when the target hemoglobin in the Aranesp treatment group was 12 g/dL.
The FDA's analysis of the study data, he told the Committee, demonstrated that Aranesp did not significantly reduce the need for red blood cell transfusions and showed an increase in mortality in patients receiving Aranesp compared to those receiving placebo.
He said the FDA was also notified in February 2007 of the final results of a double-blind, placebo-controlled study that was designed to evaluate whether Epoetin alpha improved the quality of life for patients with non-small cell lung cancer who were not receiving chemotherapy with the dose titrated to maintain a hemoglobin level of 12 to 14 g/dL.
However, according to Dr Jenkins, this study was closed down in December 2003 after enrolling only 70 patients because its data monitoring committee found higher mortality rates in patients treated with Epoetin alfa.
Dr Jenkins informed the panel that the median time to death in patients treated with Epoetin alfa was 68 days and significantly shorter than the median time of 131 days in those treated with placebo. Also, he noted, treatment with Epoetin alfa did not significantly reduce the need for red blood cell transfusion or improve quality of life.
Dr Jenkins also explained that in 1996, the FDA approved the indication for use of ESA's to reduce the need for blood transfusions in patients with hemoglobin values between 10 and 13 g/dL scheduled to undergo non-vascular, non-cardiac surgery.
Here, too, the approval was accompanied by a commitment to complete a post-marketing study to evaluate the risk for thrombotic events among patients who were not receiving preventive therapy with anti-thrombotic drugs.
In this case, according to Dr Jenkins, the FDA only received the results of this post-marketing study in 2007. Specifically, he said, the FDA was notified in February 2007 of the preliminary results of a trial with Procrit compared to the standard of care in patients undergoing spinal surgery.
"In this trial," he said, "the frequency of deep venous thrombosis in patients treated with Procrit was 4.7 percent (16 patients), a rate more than twice that of patients who received usual blood conservation care (2.1 percent, seven patients)."
On June 26, 2007, Robert Vito, Regional Inspector General in Philadelphia at the US Department of Health and Human Services' Office of Inspector General, testified at a hearing before the House Ways and Means Committee subcommittee and described cases where dialysis centers have been found to be overbilling Medicare for the anemia drugs.
He discussed a 2004 audit of payments to DaVita for ESA services provided at one Philadelphia dialysis center, which found that 44 of the 143 claims reviewed did not meet Medicare payment requirements.
In some cases, he said, they identified inconsistencies between the number of units prescribed in the physician order and the number billed to Medicare and also identified instances in which the drug was still administered to the patient after the doctor had ordered its discontinuation.
As another example, he told the committee that, in 2005, Gambro Healthcare, owner and operator of over 500 dialysis centers, agreed to pay over $350 million to resolve civil and criminal fraud allegations in the Medicare, Medicaid and TRICARE programs. To resolve its civil liability, he noted, Gambro paid $310.5 million for submitting false claims to Medicare and paying doctors improper remuneration related to their medical director services.
The new CMS reimbursement rules stipulate that cancer patients receiving chemotherapy should only use ESA's if their hemoglobin levels fall below 10 and also limit the duration of therapy to a maximum of eight weeks after the completion of chemotherapy. They also limit the starting dose to match the FDA recommendations and limit the levels by which doses can be raised and Medicare will not cover treatment for anemic cancer patients who are not receiving chemotherapy or radiation.
The subpoena from New York Attorney General is just the tip of the iceberg when it comes to Amgen's legal woes. The company's failure to disclose the results of a Danish study in head and neck cancer has resulted in an inquiry by the SEC and several shareholder lawsuits.
According to the SEC filing, a class-action lawsuit was filed on May 11, 2007, in California, alleging that Amgen and its executives "made false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities."
On May 14, 2007, the company was also served with a shareholder demand on the board of directors to establish a "special litigation committee" to investigate potential breaches of fiduciary duties by current or former officers and directors of the company, according to the filing.
The shareholders allege that these individuals violated core fiduciary duties, causing Amgen to suffer damages, and seek to recover damages resulting from their breach of fiduciary duties, monies and benefits improperly granted to them, insider trading proceeds and all costs associated with the inquiry by the SEC.
According to US Renal Data System and the Medicare Payment Advisory Commission, Medicare spends about $64,000 annually for each person on hemodialysis for all medical services, and the anemia drugs Procrit, Epogen and Aranesp are the single largest drug expense for Medicare.
In 2005, Medicare spent $2 billion on the drugs, and from 1991 to 2004, the cost of the medications to Medicare increased 716% from $245 million to $2 billion, according to a report by the US House Ways and Means Committee.
Amgen produced the synthetic epoetin in 1989 and sold it under the brand name Epogen as a treatment for anemic kidney patients and HIV related anemia. Shortly after Epogen came on the market, Amgen entered into an agreement to allow J&J to sell the same drug under the brand name Procrit, as long as it stayed out of the dialysis market, which basically helped the young company raise capital.
In 1993, J&J received approval to sell Procrit as a treatment for cancer patients with chemotherapy-related anemia, and a few years later, Amgen gained FDA approval for the long-lasting version of the drug, Aranesp, to treat both renal and chemotherapy related anemia.
Recent investigations have shown the drug makers are providing incentives to encourage the over-prescribing of ESA's to Medicare patients by charging less for the drugs than the Medicare reimbursement rates.
A March 2006 government report entitled "Medicare Reimbursement for New End Stage Renal Disease Drugs," found freestanding dialysis facilities on average were able to acquire Aranesp for between 14 and 27% below the Medicare reimbursement amounts in 2005.
On May 10, 2007, due to reports of rampant over-prescribing of the drugs for uses and doses not approved by the FDA and the deaths and injuries to patients as a result, the Oncology Drug Advisory Panel (ODAC) voted 15-2 in favor of adding new restrictions on the use of the drugs and voted 17-0 in favor of requiring the drug makers to conduct new clinical trials.
However, experts say the recommendations come about ten years and probably tens of thousands of deaths and injuries too late, because the FDA was made aware of the serious health risks associated with ESA's in a report on the Amgen sponsored Normal Hematocrit Study back in 1996, and the FDA did little more than revise the product labeling a wee bit.
The 1996 study was designed to evaluate whether patients with chronic renal failure undergoing dialysis had fewer cardiovascular complications if the ESA was administered to attain a higher hematocrit level as compared to a lower level. The trial was terminated early because of a finding of more deaths and non-fatal myocardial infarctions in the patients randomized to the higher hematocrit target level.
The labeling revision recommended that the ESA's not be used to achieve hematocrit in excess of 36%, or a hemoglobin level of 12 g/dL and was accompanied by the sponsor's agreement to conduct a study to further examine the risk for blood clots among patients receiving ESA's because an increased thrombotic risk was suspected to be one of the causes for the risks detected in the study, according to the FDA.
So ten years later, two clinical trials and an editorial finally appeared in the New England Journal of Medicine in November 2006, to report the risks associated with the use of ESA's in the treatment of anemia from chronic renal failure.
The Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study showed increases in serious and potentially life-threatening cardiovascular events when Procrit was administered to reach higher hemoglobin levels, and the Cardiovascular Risk Reduction by Early Treatment with Epoetin Beta (CREATE) study trended toward more cardiovascular events in a pattern similar to the CHOIR study, thus strengthening the findings of the CHOIR study, the FDA said.
On June 26, 2007, Dr John Jenkins, Director of the FDA's Office of New Drugs Center for Drug Evaluation and Research, testified at a hearing before the House Ways and Means Committee and said the study findings "underscore the importance of the warnings previously described in the labeling for Procrit, Epogen, and Aranesp regarding cardiovascular risks that include thrombotic events and increased mortality in hemodialysis patients who participated in the Normal Hematocrit Study."
He told the Committee that the new studies, combined with the findings from the Normal Hematocrit Study, showed that patients with anemia due to chronic renal failure, whether or not receiving dialysis, "were at increased risk for serious cardiovascular complications when ESA's were administered to attain hemoglobin levels in excess of the 12 g/dL level recommended in the ESA product labels."
Dr Jenkins also said the FDA became aware of safety concerns about the use of ESA's in cancer patients receiving chemotherapy between 2001 and 2003, when the agency received reports from two trials (BEST and ENHANCE) that demonstrated higher mortality and more rapid tumor growth when the ESA's were given to maintain hemoglobin levels of greater than 12 g/dL and the findings were discussed at a May 2004 meeting of the ODAC.
He said the new safety data was added to the labeling for ESA products shortly after that meeting and that the advisory panel recommended additional data be gathered to further evaluate the new safety concerns about patients with cancer.
However, according to Dr Jenkins, it was not until late 2006 and early 2007 that the FDA was informed of several new trials in cancer patients that raised additional safety concerns.
In December 2006, the ESA makers informed the FDA of the interim results of the Danish Head and Neck Cancer Study Group trial (DAHANCA 10), a trial that compared radiation therapy alone to radiation therapy plus Aranesp in the treatment of advanced head and neck cancer.
The trial assessed whether treating anemia to achieve and maintain a hemoglobin concentration of 14.0-15.5 g/dL during radiotherapy would improve local-regional disease control.
The data monitoring committee for this trial found that 3-year local-regional control in patients treated with Aranesp was worse than for those not receiving Aranesp. Overall survival time also favored those not treated with Aranesp, he said, and the monitoring committee recommended the ESA treatment be stopped in the experimental arm on December 1, 2006.
Dr Jenkins said the FDA was notified in January 2007 of the results of a 989 patient trial of Aranesp in cancer patients with anemia who were not receiving chemotherapy when the target hemoglobin in the Aranesp treatment group was 12 g/dL.
The FDA's analysis of the study data, he told the Committee, demonstrated that Aranesp did not significantly reduce the need for red blood cell transfusions and showed an increase in mortality in patients receiving Aranesp compared to those receiving placebo.
He said the FDA was also notified in February 2007 of the final results of a double-blind, placebo-controlled study that was designed to evaluate whether Epoetin alpha improved the quality of life for patients with non-small cell lung cancer who were not receiving chemotherapy with the dose titrated to maintain a hemoglobin level of 12 to 14 g/dL.
However, according to Dr Jenkins, this study was closed down in December 2003 after enrolling only 70 patients because its data monitoring committee found higher mortality rates in patients treated with Epoetin alfa.
Dr Jenkins informed the panel that the median time to death in patients treated with Epoetin alfa was 68 days and significantly shorter than the median time of 131 days in those treated with placebo. Also, he noted, treatment with Epoetin alfa did not significantly reduce the need for red blood cell transfusion or improve quality of life.
Dr Jenkins also explained that in 1996, the FDA approved the indication for use of ESA's to reduce the need for blood transfusions in patients with hemoglobin values between 10 and 13 g/dL scheduled to undergo non-vascular, non-cardiac surgery.
Here, too, the approval was accompanied by a commitment to complete a post-marketing study to evaluate the risk for thrombotic events among patients who were not receiving preventive therapy with anti-thrombotic drugs.
In this case, according to Dr Jenkins, the FDA only received the results of this post-marketing study in 2007. Specifically, he said, the FDA was notified in February 2007 of the preliminary results of a trial with Procrit compared to the standard of care in patients undergoing spinal surgery.
"In this trial," he said, "the frequency of deep venous thrombosis in patients treated with Procrit was 4.7 percent (16 patients), a rate more than twice that of patients who received usual blood conservation care (2.1 percent, seven patients)."
On June 26, 2007, Robert Vito, Regional Inspector General in Philadelphia at the US Department of Health and Human Services' Office of Inspector General, testified at a hearing before the House Ways and Means Committee subcommittee and described cases where dialysis centers have been found to be overbilling Medicare for the anemia drugs.
He discussed a 2004 audit of payments to DaVita for ESA services provided at one Philadelphia dialysis center, which found that 44 of the 143 claims reviewed did not meet Medicare payment requirements.
In some cases, he said, they identified inconsistencies between the number of units prescribed in the physician order and the number billed to Medicare and also identified instances in which the drug was still administered to the patient after the doctor had ordered its discontinuation.
As another example, he told the committee that, in 2005, Gambro Healthcare, owner and operator of over 500 dialysis centers, agreed to pay over $350 million to resolve civil and criminal fraud allegations in the Medicare, Medicaid and TRICARE programs. To resolve its civil liability, he noted, Gambro paid $310.5 million for submitting false claims to Medicare and paying doctors improper remuneration related to their medical director services.
The new CMS reimbursement rules stipulate that cancer patients receiving chemotherapy should only use ESA's if their hemoglobin levels fall below 10 and also limit the duration of therapy to a maximum of eight weeks after the completion of chemotherapy. They also limit the starting dose to match the FDA recommendations and limit the levels by which doses can be raised and Medicare will not cover treatment for anemic cancer patients who are not receiving chemotherapy or radiation.
The subpoena from New York Attorney General is just the tip of the iceberg when it comes to Amgen's legal woes. The company's failure to disclose the results of a Danish study in head and neck cancer has resulted in an inquiry by the SEC and several shareholder lawsuits.
According to the SEC filing, a class-action lawsuit was filed on May 11, 2007, in California, alleging that Amgen and its executives "made false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities."
On May 14, 2007, the company was also served with a shareholder demand on the board of directors to establish a "special litigation committee" to investigate potential breaches of fiduciary duties by current or former officers and directors of the company, according to the filing.
The shareholders allege that these individuals violated core fiduciary duties, causing Amgen to suffer damages, and seek to recover damages resulting from their breach of fiduciary duties, monies and benefits improperly granted to them, insider trading proceeds and all costs associated with the inquiry by the SEC.
Amgen and J&J Funnel Tax Dollars Through Kidney and Cancer Patients
Evelyn Pringle April 17, 2007
Medicare has provided coverage for all patients with End Stage Renal Disease since 1972, and according to the House Ways and Means Committee, the government pays for 93% of services provided to dialysis patients, at a cost of about $2 billion a year.
In 2005, the drugs darbepoetin and epoetin, commonly used by patients who must undergo dialysis, accounted for almost 20% of the $13 billion spent on the Medicare Part B drug plan, and total sales for these drugs worldwide topped $9 billion.
Amgen manufactures and markets darbepoetin as Aranesp, and epoetin is sold under the names Procrit and Epogen. But Procrit is distributed by Ortho Biotech Products, a Johnson & Johnson subsidiary. There are no generic versions of these medications.
The drugs are among the top sellers for both companies. Amgen's Epogen and Aranesp combined sales were $6.6 billion in 2006, nearly half of the company's total revenues. Johnson and Johnson's revenues were $3.2 billion in 2006, making it the company's second-biggest-selling drug, according to Forbes.com on March 21, 2007.
The drugs are man-made versions of erythropoietin, a hormone normally produced in the kidneys, and belong to a class of drugs known as Erythropoiesis Stimulating Agents. ESA's are used to treat anemia in raising hemoglobin levels by increasing the number of red blood cells in the body. Anemia's severity is monitored by a patient's hematocrit, the proportion of red blood cells in whole blood, which should stay between 33% and 36%.
According to the FDA, ESAs are approved to treat anemia in patients with chronic kidney failure, patients with cancer whose anemia is caused by chemotherapy, patients scheduled for major surgery to reduce potential blood transfusions, and for the treatment of anemia due to zidovudine therapy in HIV patients.
But Aranesp, Epogen, and Procrit are being administered "off label" for uses and in doses not approved by the FDA. For instance, an Amgen vice president recently estimated that about 10% to 12% of Aranesp sales are for the unapproved use of treating "anemia of cancer" in patients who are not undergoing chemotherapy.
A recent company study conducted to support FDA approval for using the drug to treat "anemia of cancer" in patients with cancer in remission who were not undergoing chemotherapy, revealed that Aranesp actually increased the risk of death in these patients.
The February 2, 2007, "Cancer Letter ," a newsletter for cancer professionals, warns, "If the findings of the recently reported study hold up, more than one in 10 Americans getting Aranesp without chemotherapy has no chance of benefiting from the agent and could be harmed or killed by it, experts say."
The report estimated that up to 12% of the use of ESAs in the US was for this condition.
After reviewing the results of this study and several others, on March 9, 2007, the FDA announced that black box warnings would be added to the labels for all ESAs and recommended using the lowest possible dose to raise the hemoglobin concentration to the lowest level.
The FDA-approved labeling for the drugs says patients should have a hemoglobin level of 10-12 grams per deciliter of blood, and patients are considered to need treatment if their levels fall below 10 grams.
During a press briefing, Dr Richard Pazdur, director of the FDA's Office of Oncology Drug Products at the Center for Drug Evaluation and Research, said the black box warning was being added based on the results of several recently reported clinical trials.
Dr Karen Weiss, deputy director of the Office of Oncology Drug Products, said the FDA became concerned after receiving the results from several trials evaluating the aggressive use of ESAs to raise hemoglobin levels higher than listed on their approved labels.
In the March 10, 2007 Wall Street Journal, Dr Weiss was quoted as saying, the "bulk of the data that has raised concerns" came when patients were given higher doses, whether they were experiencing anemia from kidney disease or cancer treatment.
The evidence shows that "this type of strategy is not beneficial and, in fact, has some evidence of harm," she said.
On March 9, 2007, the FDA also issued a public health advisory based on the results of a number of studies and warned doctors treating patients with kidney disease or cancer not to push hemoglobin levels over 12 grams per deciliter of blood.
The FDA noted a higher chance of death and an increased rate of tumor growth in cancer patients with advanced head and neck cancer receiving radiation therapy and in patients with metastatic breast cancer receiving chemotherapy, when ESAs were given to maintain levels of more than 12.
There was also a higher rate of death reported, but no fewer blood transfusions, when ESAs were given to patients with cancer and anemia who were not receiving chemotherapy.
A higher chance of death and an increased number of blood clots, strokes, heart failure and heart attacks were found in patients with chronic kidney failure when ESAs were given to raise hemoglobin levels of more than 12.
The Advisory warned that a higher risk of blood clots was also reported in patients who were scheduled for major surgery and received ESAs.
The FDA pointed out that ESAs are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer, surgical patients and patients with HIV.
The drug makers have been using direct-to-consumer advertising to increase sales with cancer patients by claiming the drugs could restore energy and reduce fatigue in patients undergoing chemotherapy. But the FDA says there has never been any evidence to support claims that ESAs could increase energy or ease fatigue in patients undergoing cancer treatment.
In recent months, Congress has been investigating Medicare reimbursement policies that guarantee dialysis clinics a 6% profit for administering ESAs, since it became apparent that patients are being given higher doses than needed. Critics say any deal that allows for cost plus payments comes with a built-in incentive to provide unnecessary services.
On October 24, 2006, the Boston Globe reported that dialysis clinics are also increasing profits by administering ESAs intravenously instead of by injection, and about 95% of the patients receive the drugs intravenously.
Clinics could use 30% less, the Globe says, because when ESAs are injected they stay in the system longer and require a lower dose. A 2004 analysis found patients injected with the drugs were given 21% less, for a potential total savings of about $375 million.
The two clinic chains that dominate the dialysis industry are DaVita, with over 1,200 clinics, and Fresenius Medical Care, with about 1,500. According to the Globe, the clinics claim the intravenous method is more convenient because patients are already hooked up to IVs for dialysis.
Critics think differently. "The industry is incentivized to use intravenous because they make a profit margin on every unit they administer," said Dr Peter Crooks, who oversees dialysis for 3,000 patients for Kaiser Permanente where most patients receive injections.
In an April 11, 2007 report, Bernstein Research estimates that dose volume in renal patients could fall as much as 25% if doctors abide by the new black box warning and insurers refuse to pay for the drugs in patients with hemoglobin levels over 12.
On November 17, 2006, the British journal Lancet reported that about half of all dialysis patients have hemoglobin levels above what the FDA considers safe, and about 20% of patients experience dangerously high levels, creating a risk for heart attack and stroke.
Medicare has provided coverage for all patients with End Stage Renal Disease since 1972, and according to the House Ways and Means Committee, the government pays for 93% of services provided to dialysis patients, at a cost of about $2 billion a year.
In 2005, the drugs darbepoetin and epoetin, commonly used by patients who must undergo dialysis, accounted for almost 20% of the $13 billion spent on the Medicare Part B drug plan, and total sales for these drugs worldwide topped $9 billion.
Amgen manufactures and markets darbepoetin as Aranesp, and epoetin is sold under the names Procrit and Epogen. But Procrit is distributed by Ortho Biotech Products, a Johnson & Johnson subsidiary. There are no generic versions of these medications.
The drugs are among the top sellers for both companies. Amgen's Epogen and Aranesp combined sales were $6.6 billion in 2006, nearly half of the company's total revenues. Johnson and Johnson's revenues were $3.2 billion in 2006, making it the company's second-biggest-selling drug, according to Forbes.com on March 21, 2007.
The drugs are man-made versions of erythropoietin, a hormone normally produced in the kidneys, and belong to a class of drugs known as Erythropoiesis Stimulating Agents. ESA's are used to treat anemia in raising hemoglobin levels by increasing the number of red blood cells in the body. Anemia's severity is monitored by a patient's hematocrit, the proportion of red blood cells in whole blood, which should stay between 33% and 36%.
According to the FDA, ESAs are approved to treat anemia in patients with chronic kidney failure, patients with cancer whose anemia is caused by chemotherapy, patients scheduled for major surgery to reduce potential blood transfusions, and for the treatment of anemia due to zidovudine therapy in HIV patients.
But Aranesp, Epogen, and Procrit are being administered "off label" for uses and in doses not approved by the FDA. For instance, an Amgen vice president recently estimated that about 10% to 12% of Aranesp sales are for the unapproved use of treating "anemia of cancer" in patients who are not undergoing chemotherapy.
A recent company study conducted to support FDA approval for using the drug to treat "anemia of cancer" in patients with cancer in remission who were not undergoing chemotherapy, revealed that Aranesp actually increased the risk of death in these patients.
The February 2, 2007, "Cancer Letter ," a newsletter for cancer professionals, warns, "If the findings of the recently reported study hold up, more than one in 10 Americans getting Aranesp without chemotherapy has no chance of benefiting from the agent and could be harmed or killed by it, experts say."
The report estimated that up to 12% of the use of ESAs in the US was for this condition.
After reviewing the results of this study and several others, on March 9, 2007, the FDA announced that black box warnings would be added to the labels for all ESAs and recommended using the lowest possible dose to raise the hemoglobin concentration to the lowest level.
The FDA-approved labeling for the drugs says patients should have a hemoglobin level of 10-12 grams per deciliter of blood, and patients are considered to need treatment if their levels fall below 10 grams.
During a press briefing, Dr Richard Pazdur, director of the FDA's Office of Oncology Drug Products at the Center for Drug Evaluation and Research, said the black box warning was being added based on the results of several recently reported clinical trials.
Dr Karen Weiss, deputy director of the Office of Oncology Drug Products, said the FDA became concerned after receiving the results from several trials evaluating the aggressive use of ESAs to raise hemoglobin levels higher than listed on their approved labels.
In the March 10, 2007 Wall Street Journal, Dr Weiss was quoted as saying, the "bulk of the data that has raised concerns" came when patients were given higher doses, whether they were experiencing anemia from kidney disease or cancer treatment.
The evidence shows that "this type of strategy is not beneficial and, in fact, has some evidence of harm," she said.
On March 9, 2007, the FDA also issued a public health advisory based on the results of a number of studies and warned doctors treating patients with kidney disease or cancer not to push hemoglobin levels over 12 grams per deciliter of blood.
The FDA noted a higher chance of death and an increased rate of tumor growth in cancer patients with advanced head and neck cancer receiving radiation therapy and in patients with metastatic breast cancer receiving chemotherapy, when ESAs were given to maintain levels of more than 12.
There was also a higher rate of death reported, but no fewer blood transfusions, when ESAs were given to patients with cancer and anemia who were not receiving chemotherapy.
A higher chance of death and an increased number of blood clots, strokes, heart failure and heart attacks were found in patients with chronic kidney failure when ESAs were given to raise hemoglobin levels of more than 12.
The Advisory warned that a higher risk of blood clots was also reported in patients who were scheduled for major surgery and received ESAs.
The FDA pointed out that ESAs are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer, surgical patients and patients with HIV.
The drug makers have been using direct-to-consumer advertising to increase sales with cancer patients by claiming the drugs could restore energy and reduce fatigue in patients undergoing chemotherapy. But the FDA says there has never been any evidence to support claims that ESAs could increase energy or ease fatigue in patients undergoing cancer treatment.
In recent months, Congress has been investigating Medicare reimbursement policies that guarantee dialysis clinics a 6% profit for administering ESAs, since it became apparent that patients are being given higher doses than needed. Critics say any deal that allows for cost plus payments comes with a built-in incentive to provide unnecessary services.
On October 24, 2006, the Boston Globe reported that dialysis clinics are also increasing profits by administering ESAs intravenously instead of by injection, and about 95% of the patients receive the drugs intravenously.
Clinics could use 30% less, the Globe says, because when ESAs are injected they stay in the system longer and require a lower dose. A 2004 analysis found patients injected with the drugs were given 21% less, for a potential total savings of about $375 million.
The two clinic chains that dominate the dialysis industry are DaVita, with over 1,200 clinics, and Fresenius Medical Care, with about 1,500. According to the Globe, the clinics claim the intravenous method is more convenient because patients are already hooked up to IVs for dialysis.
Critics think differently. "The industry is incentivized to use intravenous because they make a profit margin on every unit they administer," said Dr Peter Crooks, who oversees dialysis for 3,000 patients for Kaiser Permanente where most patients receive injections.
In an April 11, 2007 report, Bernstein Research estimates that dose volume in renal patients could fall as much as 25% if doctors abide by the new black box warning and insurers refuse to pay for the drugs in patients with hemoglobin levels over 12.
On November 17, 2006, the British journal Lancet reported that about half of all dialysis patients have hemoglobin levels above what the FDA considers safe, and about 20% of patients experience dangerously high levels, creating a risk for heart attack and stroke.
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