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).
Friday, November 19, 2010
Sunday, November 14, 2010
Incarcerated kids drugged with antipsychotics
Evelyn Pringle
On October 1, 2010, John Kelly reported on an investigation by Youth Today that found atypical antipsychotics were prescribed to many incarcerated youths in juvenile facilities in the US without a diagnosis of schizophrenia or bipolar disorder, the only FDA-approved indications for use with juveniles.
A wide variety of diagnoses were listed for the prescribing of the drugs including general mood disorders, intermittent explosive disorder, oppositional defiant disorder, PSTD and ADHD.
However, Kelly reports that critics believe most of these diagnoses are simply a cover for the fact that prisons now use drugs as a substitute for the banned physical restraints that were once used on juveniles who aggressively acted out.
"Fifty years ago, we were tying kids up with leather straps, but now that offends people, so instead we drug them," Robert Jacobs, a former Florida psychologist and lawyer who now practices psychology in Australia, told Kelly.
"We cover it up with some justification that there is some medical reason, which there is not," he said.
The atypical drugs include Bristol-Myer Squibb's Abilify, Pfizer's Geodon, Seroquel from AstraZeneca, Eli Lilly's Zyprexa, and Risperdal and Invega from Johnson & Johnson.
Youth Today has been working for over a year to find out how much money individual states have been spending on the drugs for incarcerated youth, and for what reason. Medicaid records would not contain the relevant information because federal Medicaid money cannot be used to fund medical care for anyone incarcerated for a crime, whether adult or juvenile, Kelly reports.
Because funds for medications prescribed to juvenile inmates must come from state sources, each state's juvenile justice agency was asked how much was spent, in the most recent year available, on five drugs - Abilify, Geodon, Risperdal, Seroquel, and Zyprexa - and to provide the diagnosis listed for the prescriptions.
Only 14 states provided some information on the amount spent in either 2008 or 2009, with wide variations. For instance, New Jersey and Minnesota reported spending less than $100,000 a year, while Texas, Florida and Virginia each spent over $1 million.
Only five states were able to provide a comprehensive list of diagnoses along with the amounts. The total number of prescriptions for those five states combined was 5,299, with an off-label condition listed as the diagnosis for 3,709, or 70 percent.
In Texas, nearly 4,000 atypical prescriptions were written in 2008, for a total juvenile population in state facilities of between 1,600 and 1,900, with only 29 percent diagnosed with schizophrenia or bipolar disorder and no diagnosis listed for nearly 25 percent of the prescriptions.
Because Seroquel accounted for so many prescriptions with no diagnosis, Texas officials feared that it had become the "sleeping pill of choice" for agency clinicians, Kelly reports. Seroquel was prescribed 2,553 times in 2008, almost twice as often as the other four atypicals combined.
On October 1, 2010, John Kelly reported on an investigation by Youth Today that found atypical antipsychotics were prescribed to many incarcerated youths in juvenile facilities in the US without a diagnosis of schizophrenia or bipolar disorder, the only FDA-approved indications for use with juveniles.
A wide variety of diagnoses were listed for the prescribing of the drugs including general mood disorders, intermittent explosive disorder, oppositional defiant disorder, PSTD and ADHD.
However, Kelly reports that critics believe most of these diagnoses are simply a cover for the fact that prisons now use drugs as a substitute for the banned physical restraints that were once used on juveniles who aggressively acted out.
"Fifty years ago, we were tying kids up with leather straps, but now that offends people, so instead we drug them," Robert Jacobs, a former Florida psychologist and lawyer who now practices psychology in Australia, told Kelly.
"We cover it up with some justification that there is some medical reason, which there is not," he said.
The atypical drugs include Bristol-Myer Squibb's Abilify, Pfizer's Geodon, Seroquel from AstraZeneca, Eli Lilly's Zyprexa, and Risperdal and Invega from Johnson & Johnson.
Youth Today has been working for over a year to find out how much money individual states have been spending on the drugs for incarcerated youth, and for what reason. Medicaid records would not contain the relevant information because federal Medicaid money cannot be used to fund medical care for anyone incarcerated for a crime, whether adult or juvenile, Kelly reports.
Because funds for medications prescribed to juvenile inmates must come from state sources, each state's juvenile justice agency was asked how much was spent, in the most recent year available, on five drugs - Abilify, Geodon, Risperdal, Seroquel, and Zyprexa - and to provide the diagnosis listed for the prescriptions.
Only 14 states provided some information on the amount spent in either 2008 or 2009, with wide variations. For instance, New Jersey and Minnesota reported spending less than $100,000 a year, while Texas, Florida and Virginia each spent over $1 million.
Only five states were able to provide a comprehensive list of diagnoses along with the amounts. The total number of prescriptions for those five states combined was 5,299, with an off-label condition listed as the diagnosis for 3,709, or 70 percent.
In Texas, nearly 4,000 atypical prescriptions were written in 2008, for a total juvenile population in state facilities of between 1,600 and 1,900, with only 29 percent diagnosed with schizophrenia or bipolar disorder and no diagnosis listed for nearly 25 percent of the prescriptions.
Because Seroquel accounted for so many prescriptions with no diagnosis, Texas officials feared that it had become the "sleeping pill of choice" for agency clinicians, Kelly reports. Seroquel was prescribed 2,553 times in 2008, almost twice as often as the other four atypicals combined.
Saturday, November 6, 2010
Vaccination Profiteers Gang Up on Hannah Bruesewitz in Supreme Court
Evelyn Pringle
The American Academy of Pediatrics announced the submission of an amicus brief to the US Supreme Court on July 30, 2010, “joined by 21 partnering health organizations,” in the vaccine injury case of Bruesewitz v Wyeth, to support the powerful vaccine maker against a lone family.
Oral arguments in the case took place on October 12, 2010, but a final decision won’t be known for months. The most recent drug injury preemption case decided by the Court was also against Wyeth and the ruling came down in favor of plaintiff, Diane Levine.
The Court took the Bruesewitz case to determine whether 18-year-old Hannah, disabled by injuries she received from Wyeth’s diphtheria, tetanus and pertussis (DPT) vaccine at 6-months-old in 1992, has the right to bring a lawsuit against Wyeth after the Vaccine Court, set up by the 1986 National Childhood Vaccine Injury Act, refused compensation even though she will require life-long care and her vaccine was traced to a lot that had 65 adverse reactions including two deaths, 39 emergency room visits, and 6 hospitalizations.
After compensation was denied, the family filed suit against Wyeth in Pennsylvania and argued that the vaccine Hannah received was defectively designed and had a known safer vaccine been used her injuries could have been avoided.
Wyeth filed for summary judgment and the lower court dismissed the case holding that the 1986 vaccine law preempted all design defect claims. In March 2009, the Third Circuit Court of Appeals affirmed the ruling and the family filed a petition for review in the Supreme Court.
“Amici—all of whom support the routine vaccination of children against a host of vaccine-preventable infectious diseases—urge this Court to affirm the judgment of the Third Circuit below,” the brief filed by the 22 groups states.
The term “host” inadequately describes the number of “routine” shots kids get today, along with the increased risk of injury. Before 1986, children’s vaccines included diphtheria, tetanus, pertussis, measles, mumps, rubella and inactivated poliovirus. Since the Vaccine Injury Act was passed, nine new vaccines have been added, including hepatitis B, rotavirus, haemophilus influenzae type b, pneumococcal, influenza, varicella, hepatitis A, meningococcal, human papillomavirus (for girls), or an additional 46 doses for girls and 43 for boys, the CDC’s 2009 Recommended Immunization Schedule shows.
Amici Anything But Impartial
JB Handley, co-founder of Generation Rescue, as well as co-founder and contributor to Age of Autism, says whenever he meets pediatricians he asks what percentage of their revenue comes from vaccine administration. “The number always astounds me,” he said on Age of Autism. “The answers I get are that anywhere from 50-80% of their revenue comes from giving vaccines.”
In addition to their individual income from giving shots, Wyeth is now owned by Pfizer and over the past few years, the grant reports of the two companies show millions of dollars pouring into the American Academy of Pediatrics and many of the “partnering health organizations” that signed off on the brief.
For instance, Pfizer 2009 report lists two grants to the Academy totaling $56,000 and Wyeth donated $630,000 to benefit the group in 2009. Wyeth also gave the Academy $345,919 in 2008. The group received $524,080 from Pfizer in the first two quarters of 2010 alone.
In 2009, the Academy presented the “President’s Certificate for Outstanding Service” award to Dr Paul Offit, whose least offensive nickname, of many, is “Dr Proffit.”
Offit was also called the “poster child” for the term “biostitute,” by Robert Kennedy Jr at a green vaccine rally in Washington in 2008, for making himself the spokesperson for the vaccine industry and pretending to be an independent scientist without disclosing his ties to and the millions of dollars he’s made off the vaccine industry.
“The AAP is honoring Dr. Offit in recognition of his ongoing commitment to promote immunization,” the Academy’s October 16, 2009 announcement stated, without mentioning the financial windfalls he received due to his “commitment to promote immunization.”
On December 9, 2009, a report on Offit was published on Age of Autism with the headline, “Counting Offit’s Millions: More on How Merck’s Rotateq Vaccine Made Paul Offit Wealthy,” by Dan Olmsted and Mark Blaxill, authors of the new book, “Age of Autism: Mercury Medicine and A Manmade Epidemic.”
The report points out that Paul Offit, “vaccine entrepreneur and public health spokesperson, has earned approximately $10 million in income from Rotateq® royalties through 2009 and stands to earn a total of between $13-35 million over the life of his rotavirus vaccine patents.”
The analysis by Blaxill and Olmsted found that Offit’s future royalty income is tied to the vaccine’s future sales in the US and international markets, which gives him a strong financial stake in both the specific success of the rotavirus vaccine category and the global reputation of vaccines in general.
The American Academy of Family Physicians also signed off on the amicus brief. This group, along with its state chapters and Foundation, received a combined total of more than $5 million from Pfizer in 2009, and another $856,772 from Wyeth. In the first half of 2010, Pfizer gave the Family Physician groups $1,334,165.
Another signer, the American Medical Association, received grants worth $751,500 from Pfizer and a $5,000 grant from Wyeth in 2009. The Association received $447,400 from Pfizer in the first two quarters of 2010.
Several other members of the group that ganged up on Hannah in the brief also received plenty from the vaccine makers. Pfizer gave $55,000 to the National Foundation for Infectious Diseases in 2009, and Wyeth gave $45,000. In 2008, the Foundation received $2,153,500 Wyeth, and Pfizer gave it $58,500 in the first half of 2010.
In 2009, the Infectious Diseases Society of America received $15,000 from Wyeth and $65,000 in 2008.
The American Public Health Association received three grants totaling $200,000 from Pfizer in 2009.
The March of Dimes and its Foundation combined got $4,500 from Wyeth in both 2008 and 2009. Pfizer gave the groups $14,500 in the first half of 2010.
In 2009, Wyeth gave the National Association of Pediatric Nurse Practitioners Foundation four grants totaling $175,150 and three worth $70,000 in 2008.
Parents of Kids with Infectious Diseases received $75,000 from Wyeth in 2009.
The Immunization Action Coalition was paid $95,000 by Wyeth in 2009 and $136,743 in 2008.
Every Child By Two received nearly a million dollars, or $950,000, from Wyeth in 2009, and $350,000 in 2008.
In the August 4, 2008 report, “Every Child By Two: A Front Group for Wyeth,” JB Handley points out that Craig Engesser, an employee of Wyeth with a title of Senior Director, Professional Affairs, was on the Board of Every Child By Two for as far back as he could track. In fact, Engesser had even served as the group’s treasurer.
Handley also noted that Paul Offit had recently joined the group’s Board.
For the year 2006, Handley found IRS filings showed Wyeth gave Every Child By Two $350,769 and page 23 of the filing read: “Wyeth Vaccine: Ensure all children from birth to Age 2 are fully immunized.”
The National Healthy Mothers, Healthy Babies Coalition received $200,000 from Pfizer in 2009, and Wyeth gave the Georgia chapter $500 in 2008. Other corporate sponsors listed on the group’s website in 2009 included Merck, GlaxoSmithKline, Johnson & Johnson and Sanofi-Pasteur.
Amici for Hannah
Amicus briefs were also submitted in support of the Bruesewitz family in September 2009 and June 2010, by attorneys from the state of New York, Mary Holland and Robert Krakow, on behalf of the National Vaccine Information Center and its cofounders, parent advocates who helped draft the 1986 legislation, the New Jersey Coalition for Vaccine Choice, No Mercury, Truth About Gardasil, Age of Autism, National Autism Association, Autism One, SafeMinds, Autism United, US Autism and Asperger Association, Talk About Curing Autism, Generation Rescue, and the Elizabeth Birt Center for Autism Law and Advocacy.
It would require too much space to list every organization, but all together more than 25 signed off on the briefs - none of which receive money from vaccine makers. Basically the question to be answered by the Supreme Court is: Does § 22(b)(1) preclude all vaccine design-defect claims even if the vaccine’s side effects were avoidable?
“The legislative history suggests that all the stakeholders – Congress, parents, manufacturers and physicians – understood that victims preserved the right to take design defect claims to court,” the June brief says. “Respondent and its amici appear to be trying to achieve through the judiciary what they failed to obtain through Congress.”
In fact, the brief includes several statements made at the time the Act was passed that suggest that Congress recognized that victims, who duly filed for compensation in the Vaccine Program, could take design defect claims to court under Section 22(b).
For instance, when presenting the Act to the full House of Representatives for a vote, Rep Henry Waxman, the chief sponsor of the Act, stated that civil claims for “inadequately researched” vaccines would be preserved under Section 22. Waxman’s description of this claim, that a vaccine’s design did not take adequate account of avoidable safety risks, would likely be a design defect, the brief notes.
“Furthermore, the Committee explicitly rejected the opportunity to create a broad exemption for all design defect claims when it considered the Act,” it says. “Proposals were considered by the Committee that would have explicitly preempted all design defect claims, but the final version did not contain those provisions.”
“By rejecting language that would have barred all design defect claims,” the attorneys wrote, “Congress showed its intent to permit courts to decide on a case-by-case which side effects were genuinely ‘unavoidable.’”
“The Act and its legislative history simply do not make sense without the understanding that the tort system remains an available alternative for such cases,” the brief says. “And Congress’ intent to keep the courthouse doors open is even more important today than it was in 1986.”
“The significance of the Bruesewitz case relates to all vaccine injury – it goes to the heart of whether Vaccine Court is fulfilling the role Congress set for it, and whether it is possible to challenge the design safety of a vaccine in any court in the United States,” Holland explained in a March 10, 2010 commentary on Age of Autism.
“For the autism community, the case could not be more central,” she says, “it will determine whether the 5,000 petitioners in the Omnibus Autism Proceeding can continue their claims in state and federal courts if Vaccine Court ultimately dismisses their claims.”
Right about now, paranoia in the vaccine industry is no doubt running at an all time high since the announcement of the first award in a vaccine-autism case in September 2010 for another girl named Hannah, with $1.5 million to start and $500,000 a year for life to pay for her care. “Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime,” CBS News reported on September 10, 2010.
Hannah was “described as normal, happy and precocious in her first 18 months,” until “she was vaccinated against nine diseases in one doctor's visit,” in July 2000, CBS said.
A government study titled, “The Prevalence of Parent-Reported Diagnosis of Autism Spectrum Disorder among Children in the United States, 2007,” evaluated the number of children in the US who currently had an Autism Spectrum Disorder diagnosis in 2007, based on data from a national Survey of Children's Health, and found that 1 in 91 children between the ages of 3 and 17 carried an ASD diagnosis.
”Even more alarming, for the subset of children between ages 6 and 14 immunized during the 1990's the prevalence is actually 1 in 71 children with an autism diagnosis,” Age of Autism reported.
”This age group represents children in the U.S. with the highest exposure to thimerosal, the mercury preservative routinely used until CDC, AAP and industry recommended its removal “as soon as possible” from all childhood vaccines,” AoA explained.
It’s obvious that parents no longer trust claims by the government and drug companies about harmless vaccines. On October 17, 2010, in the Huffington Post, Kim Stagliano, managing editor of AoA and author of the new book, “All I Can Handle I’m No Mother Teresa,” reported that a new study from CS Mott Children’s Hospital found 89% of parents think vaccine safety is the most important topic in medical research today.
“That makes sense, since the American pediatric vaccine schedule now includes 48 vaccinations before the age of six,” Stagliano says. “Parents are facing vaccination choice issues at every pediatric visit.”
Fictional Fear Factors
In the brief filed by the groups with all the money from Wyeth and Pfizer, when warning that vaccine makers might flee the market if they have to face the threat of lawsuits and unpredictable litigation costs, they argue that the number of vaccine makers has not greatly increased since 1986 and refer to the “precarious state of the vaccine industry.”
“The preemption of all design defect claims is critical to Congress’s objective of stabilizing the vaccine market and safeguarding the Nation’s vaccine supply,” they claim.
First of all, the vaccine industry is not in dire financial straights, in fact far from it. On June 11, 2009, Kalorama Information issued a press release for the vaccine sales forecast in a market analysis report with the headline, “New Report Forecasts More Than Doubling of Vaccine Sales by 2013.”
“Few areas of pharmaceuticals have seen the fast-moving developments in the marketplace that the vaccine market has,” Kalorama noted. The press release described 2008 as another “stellar year for the world vaccine market,” in which sales “grew 21.5% since 2007 to reach $19.2 billion.”
A year earlier, Kalorama reported that stronger than anticipated revenues for flu vaccines and the “surprising commercial success” of Merck's Gardasil had led to $16.3 billion in vaccine sales in 2007, “an increase of 38% over 2006 sales of $11.7 billion.”
However: “Vaccine manufacturers face many challenges in bringing new vaccines to market,” the amicus brief points out, with a note to: “See Paul A. Offit, Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?, 24 Health Affairs 622, 623-629 (2005).”
The brief goes on to complain about how much the cost of developing vaccines has increased. “Between 1991 and 2003, for instance, costs for research and development, post licensure clinical studies, and production process improvements grew from $231 million to $802 million,” it said, citing Stanley A Plotkin, et al, Vaccines 38 (5th ed 2008). Plotkin was a co-inventor with Offit on the Rotateq vaccine.
But in any event, the high prices charged for vaccines today wipe out those costs in record time. For instance, Rotateq runs close to $200 for a 3 dose series and when you multiply that by the CDC’s calculation of more than 4 million babies born each year in the US, annual sales come to over $800 million in this country alone. Wyeth’s pneumococcal vaccine “makes $2 billion a year in sales,” according to a July 25, 2008 report by CBS News.
About a year ago, Dr Proffit was shilling for vaccine makers in the October 18, 2009 “Wall Street Journal,” by claiming infants should get 2 regular flu and 2 swine flu vaccines, without mentioning that all 4 contained the mercury-based preservative, thimerosal. “Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart,” Offit said.
With the headline, “Most flu shots contain mercury, but few know it,” on November 13, 2007, the Milwaukee Journal Sentinel reported that when using the standards set for methyl mercury consumption, a 22-pound baby getting the flu shot “would get more than 25 times the amount of mercury considered safe.”
In the WSJ article, Offit was identified only as “chief of infectious disease” at the Children's Hospital of Philadelphia, when in fact he holds a “$1.5 million dollar research chair at Children's Hospital, funded by Merck,” according to CBS News.
That bit of advice from Offit in the WSJ could potentially drum up over 4,000,000 new customers every year for shot givers and vaccine makers in the US for flu vaccines alone. Last year, the September 14, 2009 Los Angeles Times reported that physician offices usually “charge about $25 to $75 for the seasonal shot, including administration fees.”
“If you are immunizing a child for the first time, the child may need two shots,” the Times said. “Ask the healthcare professional giving the shot if you will have to pay two fees.”
For the sake of simplicity, let’s say doctors threw in both seasonal flu shots for one fee of $75. The total amount made from vaccinating 4,000,000 babies would be $300 million.
The Times said the H1N1 shot would be free, although doctor's offices and clinics may charge an administrative fee. But the swine flu shots were in no way free. Tax payers paid vaccine makers a fortune as a result of the pig flu hoax. However, for the sake of non-argument, let’s say the shot givers only charged $10 per infant to give each of the two swine flu vaccines. They would still make $80 million.
Will Health Care Workers Revolt?
The fact that health care workers have an aversion to flu vaccines is likely the best testament to the lack of benefits and potential harms associated with vaccines including the inability to sue for compensation if injured. It only stands to reason that if vaccines worked so great this group would be the first in line to get them.
But a new policy statement by the American Academy of Pediatrics, in a paper in the October, 2010 issue of their official journal, “Pediatrics,” gives notice of plan to force health care workers to get flu vaccines with the heading, “Recommendation for Mandatory Influenza Immunization of All Health Care Personnel.”
The Academy claims that “despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low.”
Mandatory influenza immunization for all health care personnel is “ethically justified, necessary and long overdue to ensure patient safety,” the group said in a statement.
“The influenza vaccine is safe, effective, and cost-effective, so health care organizations must work to assuage common fears and misconceptions about the influenza virus and the vaccine,” the Academy claims.
Their paper reports that in January 2010, the CDC estimated the percentage of health care personnel who received vaccines was only 61.9% for seasonal flu, 37.1% for swine flu, and only 37.1% received both the seasonal and swine flu vaccines.
However, it’s not like the industry is suffering from a lack of flu shot customers even when health care workers refuse to get them. In 2009 alone, multi-national corporations took home profits of $2.8 billion in influenza vaccine sales, according to an October 2010 report by Barbara Loe Fisher, co-founder of the National Vaccine Information Center.
By comparison, since the Vaccine Injury Act was passed roughly 25 years ago, the vaccine court has paid out less than $2 billion. Of the more than 13,550 petitions filed covering all vaccines, compensation for injuries was only awarded in about 2,500 cases.
Of course the estimates in the paper, if true at all, would have come from the same CDC that was run for years by Julie Gerberding and has put out the trumped up claim year after year that 36,000 people in the US die of the flu annually, with the death number never changing even when vaccination rates greatly increase.
In a December 21, 2009 Pharmalot Blog, Ed Silverman reported that Gerberding, “who until this year was the director of the US Center for Disease Control and Prevention, was named president of Merck’s vaccine division.”
As the former “top dog” at the CDC, she “has plenty of experience overseeing the selection of recommended immunizations,” FiercePharma noted on December 22, 2009.
“Autism activists, particularly those who believe vaccines are a primary cause of regressive autism, are often derided for conspiratorial comments about the CDC and Big Pharma,” JB Handley pointed out on the Pharmalot blog.
“This one is making us look more sane every day,” he said.
On October 7, 2010, Barbara Loe Fisher reported that doctors at Children’s Hospital of Philadelphia (Dr Proffit’s Kingdom), are ordering all employees to get a flu shot every year or be sent home for two weeks without pay to “think about it.”
“Anyone, who still refuses to get a flu shot after that, is fired,” she wrote. And that goes for not just doctors and nurses, she says, but every person who has anything to do with the health care facility, including students, volunteers, and contract workers.
“An exception could be made if the doctors in charge approve a “medical exemption” to vaccination, which, today,” Fisher warns, “is about as hard to get as a job.”
(Evelyn Pringle is a columnist for Scoop International and an investigative journalist and researcher focused on exposing corruption in government and corporate America)
The American Academy of Pediatrics announced the submission of an amicus brief to the US Supreme Court on July 30, 2010, “joined by 21 partnering health organizations,” in the vaccine injury case of Bruesewitz v Wyeth, to support the powerful vaccine maker against a lone family.
Oral arguments in the case took place on October 12, 2010, but a final decision won’t be known for months. The most recent drug injury preemption case decided by the Court was also against Wyeth and the ruling came down in favor of plaintiff, Diane Levine.
The Court took the Bruesewitz case to determine whether 18-year-old Hannah, disabled by injuries she received from Wyeth’s diphtheria, tetanus and pertussis (DPT) vaccine at 6-months-old in 1992, has the right to bring a lawsuit against Wyeth after the Vaccine Court, set up by the 1986 National Childhood Vaccine Injury Act, refused compensation even though she will require life-long care and her vaccine was traced to a lot that had 65 adverse reactions including two deaths, 39 emergency room visits, and 6 hospitalizations.
After compensation was denied, the family filed suit against Wyeth in Pennsylvania and argued that the vaccine Hannah received was defectively designed and had a known safer vaccine been used her injuries could have been avoided.
Wyeth filed for summary judgment and the lower court dismissed the case holding that the 1986 vaccine law preempted all design defect claims. In March 2009, the Third Circuit Court of Appeals affirmed the ruling and the family filed a petition for review in the Supreme Court.
“Amici—all of whom support the routine vaccination of children against a host of vaccine-preventable infectious diseases—urge this Court to affirm the judgment of the Third Circuit below,” the brief filed by the 22 groups states.
The term “host” inadequately describes the number of “routine” shots kids get today, along with the increased risk of injury. Before 1986, children’s vaccines included diphtheria, tetanus, pertussis, measles, mumps, rubella and inactivated poliovirus. Since the Vaccine Injury Act was passed, nine new vaccines have been added, including hepatitis B, rotavirus, haemophilus influenzae type b, pneumococcal, influenza, varicella, hepatitis A, meningococcal, human papillomavirus (for girls), or an additional 46 doses for girls and 43 for boys, the CDC’s 2009 Recommended Immunization Schedule shows.
Amici Anything But Impartial
JB Handley, co-founder of Generation Rescue, as well as co-founder and contributor to Age of Autism, says whenever he meets pediatricians he asks what percentage of their revenue comes from vaccine administration. “The number always astounds me,” he said on Age of Autism. “The answers I get are that anywhere from 50-80% of their revenue comes from giving vaccines.”
In addition to their individual income from giving shots, Wyeth is now owned by Pfizer and over the past few years, the grant reports of the two companies show millions of dollars pouring into the American Academy of Pediatrics and many of the “partnering health organizations” that signed off on the brief.
For instance, Pfizer 2009 report lists two grants to the Academy totaling $56,000 and Wyeth donated $630,000 to benefit the group in 2009. Wyeth also gave the Academy $345,919 in 2008. The group received $524,080 from Pfizer in the first two quarters of 2010 alone.
In 2009, the Academy presented the “President’s Certificate for Outstanding Service” award to Dr Paul Offit, whose least offensive nickname, of many, is “Dr Proffit.”
Offit was also called the “poster child” for the term “biostitute,” by Robert Kennedy Jr at a green vaccine rally in Washington in 2008, for making himself the spokesperson for the vaccine industry and pretending to be an independent scientist without disclosing his ties to and the millions of dollars he’s made off the vaccine industry.
“The AAP is honoring Dr. Offit in recognition of his ongoing commitment to promote immunization,” the Academy’s October 16, 2009 announcement stated, without mentioning the financial windfalls he received due to his “commitment to promote immunization.”
On December 9, 2009, a report on Offit was published on Age of Autism with the headline, “Counting Offit’s Millions: More on How Merck’s Rotateq Vaccine Made Paul Offit Wealthy,” by Dan Olmsted and Mark Blaxill, authors of the new book, “Age of Autism: Mercury Medicine and A Manmade Epidemic.”
The report points out that Paul Offit, “vaccine entrepreneur and public health spokesperson, has earned approximately $10 million in income from Rotateq® royalties through 2009 and stands to earn a total of between $13-35 million over the life of his rotavirus vaccine patents.”
The analysis by Blaxill and Olmsted found that Offit’s future royalty income is tied to the vaccine’s future sales in the US and international markets, which gives him a strong financial stake in both the specific success of the rotavirus vaccine category and the global reputation of vaccines in general.
The American Academy of Family Physicians also signed off on the amicus brief. This group, along with its state chapters and Foundation, received a combined total of more than $5 million from Pfizer in 2009, and another $856,772 from Wyeth. In the first half of 2010, Pfizer gave the Family Physician groups $1,334,165.
Another signer, the American Medical Association, received grants worth $751,500 from Pfizer and a $5,000 grant from Wyeth in 2009. The Association received $447,400 from Pfizer in the first two quarters of 2010.
Several other members of the group that ganged up on Hannah in the brief also received plenty from the vaccine makers. Pfizer gave $55,000 to the National Foundation for Infectious Diseases in 2009, and Wyeth gave $45,000. In 2008, the Foundation received $2,153,500 Wyeth, and Pfizer gave it $58,500 in the first half of 2010.
In 2009, the Infectious Diseases Society of America received $15,000 from Wyeth and $65,000 in 2008.
The American Public Health Association received three grants totaling $200,000 from Pfizer in 2009.
The March of Dimes and its Foundation combined got $4,500 from Wyeth in both 2008 and 2009. Pfizer gave the groups $14,500 in the first half of 2010.
In 2009, Wyeth gave the National Association of Pediatric Nurse Practitioners Foundation four grants totaling $175,150 and three worth $70,000 in 2008.
Parents of Kids with Infectious Diseases received $75,000 from Wyeth in 2009.
The Immunization Action Coalition was paid $95,000 by Wyeth in 2009 and $136,743 in 2008.
Every Child By Two received nearly a million dollars, or $950,000, from Wyeth in 2009, and $350,000 in 2008.
In the August 4, 2008 report, “Every Child By Two: A Front Group for Wyeth,” JB Handley points out that Craig Engesser, an employee of Wyeth with a title of Senior Director, Professional Affairs, was on the Board of Every Child By Two for as far back as he could track. In fact, Engesser had even served as the group’s treasurer.
Handley also noted that Paul Offit had recently joined the group’s Board.
For the year 2006, Handley found IRS filings showed Wyeth gave Every Child By Two $350,769 and page 23 of the filing read: “Wyeth Vaccine: Ensure all children from birth to Age 2 are fully immunized.”
The National Healthy Mothers, Healthy Babies Coalition received $200,000 from Pfizer in 2009, and Wyeth gave the Georgia chapter $500 in 2008. Other corporate sponsors listed on the group’s website in 2009 included Merck, GlaxoSmithKline, Johnson & Johnson and Sanofi-Pasteur.
Amici for Hannah
Amicus briefs were also submitted in support of the Bruesewitz family in September 2009 and June 2010, by attorneys from the state of New York, Mary Holland and Robert Krakow, on behalf of the National Vaccine Information Center and its cofounders, parent advocates who helped draft the 1986 legislation, the New Jersey Coalition for Vaccine Choice, No Mercury, Truth About Gardasil, Age of Autism, National Autism Association, Autism One, SafeMinds, Autism United, US Autism and Asperger Association, Talk About Curing Autism, Generation Rescue, and the Elizabeth Birt Center for Autism Law and Advocacy.
It would require too much space to list every organization, but all together more than 25 signed off on the briefs - none of which receive money from vaccine makers. Basically the question to be answered by the Supreme Court is: Does § 22(b)(1) preclude all vaccine design-defect claims even if the vaccine’s side effects were avoidable?
“The legislative history suggests that all the stakeholders – Congress, parents, manufacturers and physicians – understood that victims preserved the right to take design defect claims to court,” the June brief says. “Respondent and its amici appear to be trying to achieve through the judiciary what they failed to obtain through Congress.”
In fact, the brief includes several statements made at the time the Act was passed that suggest that Congress recognized that victims, who duly filed for compensation in the Vaccine Program, could take design defect claims to court under Section 22(b).
For instance, when presenting the Act to the full House of Representatives for a vote, Rep Henry Waxman, the chief sponsor of the Act, stated that civil claims for “inadequately researched” vaccines would be preserved under Section 22. Waxman’s description of this claim, that a vaccine’s design did not take adequate account of avoidable safety risks, would likely be a design defect, the brief notes.
“Furthermore, the Committee explicitly rejected the opportunity to create a broad exemption for all design defect claims when it considered the Act,” it says. “Proposals were considered by the Committee that would have explicitly preempted all design defect claims, but the final version did not contain those provisions.”
“By rejecting language that would have barred all design defect claims,” the attorneys wrote, “Congress showed its intent to permit courts to decide on a case-by-case which side effects were genuinely ‘unavoidable.’”
“The Act and its legislative history simply do not make sense without the understanding that the tort system remains an available alternative for such cases,” the brief says. “And Congress’ intent to keep the courthouse doors open is even more important today than it was in 1986.”
“The significance of the Bruesewitz case relates to all vaccine injury – it goes to the heart of whether Vaccine Court is fulfilling the role Congress set for it, and whether it is possible to challenge the design safety of a vaccine in any court in the United States,” Holland explained in a March 10, 2010 commentary on Age of Autism.
“For the autism community, the case could not be more central,” she says, “it will determine whether the 5,000 petitioners in the Omnibus Autism Proceeding can continue their claims in state and federal courts if Vaccine Court ultimately dismisses their claims.”
Right about now, paranoia in the vaccine industry is no doubt running at an all time high since the announcement of the first award in a vaccine-autism case in September 2010 for another girl named Hannah, with $1.5 million to start and $500,000 a year for life to pay for her care. “Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime,” CBS News reported on September 10, 2010.
Hannah was “described as normal, happy and precocious in her first 18 months,” until “she was vaccinated against nine diseases in one doctor's visit,” in July 2000, CBS said.
A government study titled, “The Prevalence of Parent-Reported Diagnosis of Autism Spectrum Disorder among Children in the United States, 2007,” evaluated the number of children in the US who currently had an Autism Spectrum Disorder diagnosis in 2007, based on data from a national Survey of Children's Health, and found that 1 in 91 children between the ages of 3 and 17 carried an ASD diagnosis.
”Even more alarming, for the subset of children between ages 6 and 14 immunized during the 1990's the prevalence is actually 1 in 71 children with an autism diagnosis,” Age of Autism reported.
”This age group represents children in the U.S. with the highest exposure to thimerosal, the mercury preservative routinely used until CDC, AAP and industry recommended its removal “as soon as possible” from all childhood vaccines,” AoA explained.
It’s obvious that parents no longer trust claims by the government and drug companies about harmless vaccines. On October 17, 2010, in the Huffington Post, Kim Stagliano, managing editor of AoA and author of the new book, “All I Can Handle I’m No Mother Teresa,” reported that a new study from CS Mott Children’s Hospital found 89% of parents think vaccine safety is the most important topic in medical research today.
“That makes sense, since the American pediatric vaccine schedule now includes 48 vaccinations before the age of six,” Stagliano says. “Parents are facing vaccination choice issues at every pediatric visit.”
Fictional Fear Factors
In the brief filed by the groups with all the money from Wyeth and Pfizer, when warning that vaccine makers might flee the market if they have to face the threat of lawsuits and unpredictable litigation costs, they argue that the number of vaccine makers has not greatly increased since 1986 and refer to the “precarious state of the vaccine industry.”
“The preemption of all design defect claims is critical to Congress’s objective of stabilizing the vaccine market and safeguarding the Nation’s vaccine supply,” they claim.
First of all, the vaccine industry is not in dire financial straights, in fact far from it. On June 11, 2009, Kalorama Information issued a press release for the vaccine sales forecast in a market analysis report with the headline, “New Report Forecasts More Than Doubling of Vaccine Sales by 2013.”
“Few areas of pharmaceuticals have seen the fast-moving developments in the marketplace that the vaccine market has,” Kalorama noted. The press release described 2008 as another “stellar year for the world vaccine market,” in which sales “grew 21.5% since 2007 to reach $19.2 billion.”
A year earlier, Kalorama reported that stronger than anticipated revenues for flu vaccines and the “surprising commercial success” of Merck's Gardasil had led to $16.3 billion in vaccine sales in 2007, “an increase of 38% over 2006 sales of $11.7 billion.”
However: “Vaccine manufacturers face many challenges in bringing new vaccines to market,” the amicus brief points out, with a note to: “See Paul A. Offit, Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?, 24 Health Affairs 622, 623-629 (2005).”
The brief goes on to complain about how much the cost of developing vaccines has increased. “Between 1991 and 2003, for instance, costs for research and development, post licensure clinical studies, and production process improvements grew from $231 million to $802 million,” it said, citing Stanley A Plotkin, et al, Vaccines 38 (5th ed 2008). Plotkin was a co-inventor with Offit on the Rotateq vaccine.
But in any event, the high prices charged for vaccines today wipe out those costs in record time. For instance, Rotateq runs close to $200 for a 3 dose series and when you multiply that by the CDC’s calculation of more than 4 million babies born each year in the US, annual sales come to over $800 million in this country alone. Wyeth’s pneumococcal vaccine “makes $2 billion a year in sales,” according to a July 25, 2008 report by CBS News.
About a year ago, Dr Proffit was shilling for vaccine makers in the October 18, 2009 “Wall Street Journal,” by claiming infants should get 2 regular flu and 2 swine flu vaccines, without mentioning that all 4 contained the mercury-based preservative, thimerosal. “Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart,” Offit said.
With the headline, “Most flu shots contain mercury, but few know it,” on November 13, 2007, the Milwaukee Journal Sentinel reported that when using the standards set for methyl mercury consumption, a 22-pound baby getting the flu shot “would get more than 25 times the amount of mercury considered safe.”
In the WSJ article, Offit was identified only as “chief of infectious disease” at the Children's Hospital of Philadelphia, when in fact he holds a “$1.5 million dollar research chair at Children's Hospital, funded by Merck,” according to CBS News.
That bit of advice from Offit in the WSJ could potentially drum up over 4,000,000 new customers every year for shot givers and vaccine makers in the US for flu vaccines alone. Last year, the September 14, 2009 Los Angeles Times reported that physician offices usually “charge about $25 to $75 for the seasonal shot, including administration fees.”
“If you are immunizing a child for the first time, the child may need two shots,” the Times said. “Ask the healthcare professional giving the shot if you will have to pay two fees.”
For the sake of simplicity, let’s say doctors threw in both seasonal flu shots for one fee of $75. The total amount made from vaccinating 4,000,000 babies would be $300 million.
The Times said the H1N1 shot would be free, although doctor's offices and clinics may charge an administrative fee. But the swine flu shots were in no way free. Tax payers paid vaccine makers a fortune as a result of the pig flu hoax. However, for the sake of non-argument, let’s say the shot givers only charged $10 per infant to give each of the two swine flu vaccines. They would still make $80 million.
Will Health Care Workers Revolt?
The fact that health care workers have an aversion to flu vaccines is likely the best testament to the lack of benefits and potential harms associated with vaccines including the inability to sue for compensation if injured. It only stands to reason that if vaccines worked so great this group would be the first in line to get them.
But a new policy statement by the American Academy of Pediatrics, in a paper in the October, 2010 issue of their official journal, “Pediatrics,” gives notice of plan to force health care workers to get flu vaccines with the heading, “Recommendation for Mandatory Influenza Immunization of All Health Care Personnel.”
The Academy claims that “despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low.”
Mandatory influenza immunization for all health care personnel is “ethically justified, necessary and long overdue to ensure patient safety,” the group said in a statement.
“The influenza vaccine is safe, effective, and cost-effective, so health care organizations must work to assuage common fears and misconceptions about the influenza virus and the vaccine,” the Academy claims.
Their paper reports that in January 2010, the CDC estimated the percentage of health care personnel who received vaccines was only 61.9% for seasonal flu, 37.1% for swine flu, and only 37.1% received both the seasonal and swine flu vaccines.
However, it’s not like the industry is suffering from a lack of flu shot customers even when health care workers refuse to get them. In 2009 alone, multi-national corporations took home profits of $2.8 billion in influenza vaccine sales, according to an October 2010 report by Barbara Loe Fisher, co-founder of the National Vaccine Information Center.
By comparison, since the Vaccine Injury Act was passed roughly 25 years ago, the vaccine court has paid out less than $2 billion. Of the more than 13,550 petitions filed covering all vaccines, compensation for injuries was only awarded in about 2,500 cases.
Of course the estimates in the paper, if true at all, would have come from the same CDC that was run for years by Julie Gerberding and has put out the trumped up claim year after year that 36,000 people in the US die of the flu annually, with the death number never changing even when vaccination rates greatly increase.
In a December 21, 2009 Pharmalot Blog, Ed Silverman reported that Gerberding, “who until this year was the director of the US Center for Disease Control and Prevention, was named president of Merck’s vaccine division.”
As the former “top dog” at the CDC, she “has plenty of experience overseeing the selection of recommended immunizations,” FiercePharma noted on December 22, 2009.
“Autism activists, particularly those who believe vaccines are a primary cause of regressive autism, are often derided for conspiratorial comments about the CDC and Big Pharma,” JB Handley pointed out on the Pharmalot blog.
“This one is making us look more sane every day,” he said.
On October 7, 2010, Barbara Loe Fisher reported that doctors at Children’s Hospital of Philadelphia (Dr Proffit’s Kingdom), are ordering all employees to get a flu shot every year or be sent home for two weeks without pay to “think about it.”
“Anyone, who still refuses to get a flu shot after that, is fired,” she wrote. And that goes for not just doctors and nurses, she says, but every person who has anything to do with the health care facility, including students, volunteers, and contract workers.
“An exception could be made if the doctors in charge approve a “medical exemption” to vaccination, which, today,” Fisher warns, “is about as hard to get as a job.”
(Evelyn Pringle is a columnist for Scoop International and an investigative journalist and researcher focused on exposing corruption in government and corporate America)
Tuesday, September 21, 2010
The Rise and Fall of Provigil - Part II
Evelyn Pringle
A little over a year after the Volkow study reported that Provigil (modafinil), affects the same brain chemicals as stimulants and may be addictive, on July 20, 2010, in the Atlanta Science News Examiner, Kevin Murnane reported that research showed modafinil "produces some effects that are similar to abused stimulants, such as cocaine."
In what may turn out to be the final nail in the modafinil coffin, rhesus monkeys were given modafinil prior to undergoing behavioral, neurochemical, and brain imaging studies for a study led by Monica Andersen, conducted at the Yerkes National Primate Research Center at Emory University, in the June 2010, "Psychopharmacology" journal.
"Similar to other stimulants, these researchers found that modafinil increased movement or locomotion in their subjects," Murnane wrote. "Furthermore, an acute bolus of modafinil elicited a return or reinstatement of cocaine self-administration that had been previously diminished through extinction training."
"These behavioral effects are very consistent with those of other stimulant-type drugs," he reported.
Mechanistically, the researchers found "using Positron Emission Tomography (PET) imaging that modafinil bound to and occupied a protein in the brain called the dopamine transporter," he explained. "This protein is the same one that cocaine binds to."
"Furthermore, they found that modafinil increased dopamine neurotransmission," Murnane said. "This is the same mechanism thought to mediate the euphoric and addictive properties of cocaine."
He pointed out that the findings "closely paralleled those of a study by Volkow and colleagues in human subjects that was published in the March 2009 issue of the Journal of the American Medical Association."
"Collectively, these studies show that modafinil has similar behavioral and pharmacological effects to stimulant-type drugs of abuse, such as cocaine," he wrote.
"These data indicate that modafinil has the potential to be abused or produce dependence," Murnane said. "Accordingly, closer monitoring of the modafinil supply and abuse patterns may be warranted."
In June 2010, when the European Medicines Agency recommended restricting the use of modafinil for the treatment of narcolepsy only, on Pharmalot, Ed Silverman said the issue to watch was what this meant for Cephalon’s Nuvigil. For the moment, EMA may have given Cephalon a boost, "especially since the FDA keeps delaying approval to use Nuvigil for jet-lag disorder and studies for other indications have either flopped or will take quite awhile to complete," he wrote.
"A similar step to restrict Nuvigil, of course, would make it harder to broaden the Nuvigil market," he pointed out, and noted that the drug's label states: "Psychiatric adverse experiences have been reported in patients treated with modafinil. Modafinil and armodafinil (NUVIGIL) are very closely related. Therefore, the incidence and type of psychiatric symptoms associated with armodafinil are expected to be similar to the incidence and type of these events with modafinil."
However, the Frazer, Pennsylvania-based firm's Annual Report for 2009, does not show Nuvigil as approved for use in any other country besides the US.
Unprecedented Price Gouging
On November 18, 2008, Pharmalot reported that Cephalon had raised the price on Provigil by 28% since March 2008. The drug was then 74% more expensive than four years earlier, with an average wholesale price of $8.71 per pill.
The price hikes were in preparation for the expected launch of Nuvigil in 2009. By sharply raising prices, Cephalon hoped to convert patients to Nuvigil before cheap generic versions of Provigil came on the market.
A year later, Dow Jones reported that in November 2009, Cephalon had raised the price on Provigil by 29%, to $13.62 a pill, and that the cost of Nuvigil, launched in June 2009, with patent protection until 2023, was $8.98 per tablet. Five years earlier, "Provigil's cost was $5.53 per pill," Dow Jones noted on December 22, 2009.
Nuvigil Launch
In launching Nuvigil, in addition to promotional efforts in the field, Cephalon "initiated patient sampling programs, discount programs for patients, a significant number of key opinion leader/speaker presentations, and a contracting plan with certain health care payers," Bob Roche, of Cephalon's Worldwide Pharmaceutical Operations, said in an August 4, 2009 Earnings Call, posted by "Seeking Alpha."
Sampling programs included regular distribution of samples to doctors and a free 7-day coupon for patients to print out from an online website.
Cephalon also implemented a "Co-Pay Assistance Program," which provides up to $50 of co-pay assistance per prescription. "To make things easier for patients, this program is administered automatically in many pharmacies, making co-pay assistance coupons or cards unnecessary," Roche said.
However, patients covered by government plans like Medicare and Medicaid do not qualify for the co-pay assistance, CEO, Frank Baldino, pointed out in the call.
Cephalon also developed a data base of approximately 50,000 individuals who requested information on Nuvigil and mailed "these people a launch kit, with a free seven-day coupon and information on our Co-Pay Assistance Program," he said.
The company also planned to implement an online, "Wake Information Support and Education Program," as part of a professional education and support campaign designed for doctors in the sleep/wake field, Roche reported. "In addition to information on sleep and wakefulness issues, physicians can, with just a click of a mouse get information on NUVIGIL, order samples, request coupons, ask questions, or request to see a sales representative," he explained.
In the first quarter of 2010, Cephalon also launched a Nuvigil shift work disorder campaign. There are "15 million shift workers in the United States and approximately 1/3 of them suffer from excessive sleepiness associated with shift work disorder," Baldino reported in a May 4, 2010 Earnings Call.
A non-branded radio campaign was launched "in select markets where shift work is a significant part of the working population," said Robert Repella in the call. We "expect to see the benefits coming out of that as we move through the year.”
Cephalon also started a program with WebMD in the first quarter, he said. We've had "over 7 million visits to their website related to either NUVIGIL or disease area content.”
Today it's doubtful that shift workers in the US make enough money to pay for Provigil or Nuvigil. In August 2010, one hundred 250mg tablets of Nuvigil cost $1,080, or $10.80 per tablet, and the price for 100 tablets of 200mg of Provigil was $1,855, or $18.55 per pill, at DrugStore.com.
If generic Provigil was to hit the market, patients who converted to Nuvigil would likely be pressured by payers to switch back to a cheaper Provigil generic. In the meantime, the same drug, sold as Modalert, can currently be purchased online from other countries for as low as $120 per hundred, at EuroDrugstore.
Off-Label Marketing Schemes
Back on November 8, 2007, Ed Silverman’s Pharmalot reported that Cephalon had struck a deal with the US Attorney in Philadelphia to pay $425 million to settle off-label marketing charges. He noted that the settlement was no surprise because the firm had been under a microscope for off-label marketing for some time and had received an FDA warning letter in February 2007, ordering an end to promotional materials claiming Provigil could be used to treat fatigue.
The underlying lawsuits were filed in 2003, by three former employees, Bruce Boise, Michael Makalusky, and Lucia Paccione, and another whistleblower, Joseph Piacentile, in federal court in the Eastern District of Pennsylvania, under the False Claims Act, arising from false claims submitted to Medicaid, Medicare and other federal insurance programs that do not provide coverage for such off-label uses.
About six months after the settlement became known, on April 30, 2008, Cephalon announced the hiring of Gerald Pappert, former Attorney General of Pennsylvania, as Executive Vice President and General Counsel. Pappert was First Deputy Attorney General from 1997 to 2003 and Attorney General from 2003 to 2005.
When he took over as attorney general, Pappert "launched a vigorous fight to lower the cost of prescription drugs for Pennsylvanians," the AG’s website states.
"I will ensure that prescription drugs are priced fairly, and I will take action against those who defraud our Commonwealth programs or cheat us through illegal pricing and other schemes," he promised, after being sworn into office in February 2004.
The same month, Pappert was appointed to the Pharmaceutical Pricing and Prescription Drug Abuse task forces, of the National Association of Attorneys General, "which were formed to ensure that pharmaceuticals are priced fairly and to prevent the illegal use and sale of prescription drugs, respectively," according to February 4, 2004 press release.
In May 2004, Pappert reported that Cephalon's Actiq, a narcotic lollipop, was showing up in illegal sales in Philadelphia under the street nickname "perc-o-pops," according to the September 30, 2008 Philadelphia Inquirer.
In September 2004, the US attorney in Philadelphia subpoenaed documents about Cephalon's sales and marketing of Actiq, Provigil, and Gabitril, an epilepsy drug, the Inquirer reported
During his tenure in Harrisburg, Pappert filed a lawsuit accusing 13 drug companies of price-fixing in March 2004. "As Attorney General, I am committed to doing everything I can to reduce the price of prescription drugs for the Commonwealth and its citizens," he said, in a March 10, press release on the suit.
He explained that many consumers purchase drugs, either by themselves or through a health plan or insurer, and "are financially harmed when drug companies intentionally raise the prices of their drugs to manipulate the market.”
In part, the lawsuit accused the companies of "the widespread practice of offering trips, consulting opportunities, seminars, gifts, meals and cash payments to medical providers in return for prescribing their products," the press release noted.
"Several of the companies named in my lawsuit," Pappert wrote in a March 19, 2004, Oped, "have already pled guilty to and/or agreed to settle federal charges of having engaged in unlawful marketing and sales practices with respect to certain of their prescription drugs."
"These companies have already paid more than $1 billion in fines and civil penalties to the federal government," he pointed out.
"My pharmaceutical industry lawsuit focuses on the pricing practices, which I believe are clearly illegal," he told Insider. "If we ultimately succeed, it is going to change the way the industry prices pharmaceuticals, and stop the prices from continuing to skyrocket, and reduce prices."
About five months after Pappert went to work for Cephalon, on September 29, 2008, the US Department of Justice announced that the firm would enter a criminal plea to one count of "Distribution of Misbranded Drugs," and pay $425 million to settle federal and state charges and resolve allegations that it marketed three drugs, Provigil, Actiq and Gabitril, for unapproved uses.
Pappert signed off on the agreement as Executive VP and General Counsel of Cephalon.
The government's investigation began in January 2003, when Bruce Boise, a sales representative in Ohio, contacted the FDA about Cephalon's sales practices. Boise agreed to wear a wire to a company sales conference to help the government gather evidence, according to his attorney, Peter Chatfield, in a September 29, 2008 press release by his firm, Phillips & Cohen. In November 2003, another sales rep, Lucia Paccione of Philadelphia, filed the first lawsuit. The complaints remained sealed until the settlement was announced.
"What makes this case unique is that it's the first time, in the absence of substantial kickbacks, that the federal government has used the False Claims Act to go after a pharmaceutical company for marketing drugs for off-label indications for which there were no credible published scientific research supporting these drugs' safety or effectiveness," Chatfield said. "Not only were these uses marketed by Cephalon not approved by the FDA, there was absolutely no literature published in any medical compendia that supported them."
While federally funded healthcare programs "often will pay for off-label use of drugs supported by credible medical research and prescribed based on the medical judgment of physicians, Cephalon's marketing efforts pushed well beyond those constraints," according to the press release.
From 2001 through 2006, "Cephalon improperly promoted Provigil to treat sleepiness, tiredness, decreased activity, lack of energy and fatigue," the DOJ sentencing memorandum reports.
"Cephalon continued its illegal promotional activities after January 2002, when the FDA specifically directed the company to stop promoting Provigil for off-label uses," it states. For instance, in November 2002, a Cephalon manager accompanying a sales representative on calls to physicians, told the sales person: "Your best call of the day was with Dr. [a psychiatrist] ... Informing the physician of the transition that we have made with Provigil from narcolepsy to the variety of areas in which it is currently being used was also effective."
"Cephalon had its sales representatives call on doctors who would not normally
prescribe the defendant’s drugs in the course of the doctors’ practice," DOJ states. In fact, during a February 15, 2007 program, ABC's "20/20," revealed a copy of a sales report that showed allergists, internists, pediatricians and even dentists were prescribing Provigil off-label to people with depression, MS, hyperactivity and cancer.
Celaphon marketed directly to psychiatrists after concluding that they respond to a "lower threshold of scientific proof" than other doctors. "In other words, Cephalon targeted physicians that would least object to their promoting Provigil for uses with little clinical support," says a September 29, 2008 press release by Connecticut's attorney general.
In December 2002, Cephalon sought to expand Provigil’s label to cover excessive sleepiness, without regard to the patient’s underlying medical condition. However, in January 2004, the FDA approved only a narrow expansion for excessive sleepiness associated with obstructive sleep apnea and shift work sleep disorder.
Harvard professor, Dr Charles Czeisler, chief of sleep medicine at Brigham and Women's Hospital, was lead investigator in the shift-worker study, which showed Provigil kept participants awake 1.7 minutes longer than a placebo. In September 2003, Czeisler went before the FDA to lobby for approval to treat shift-workers on behalf of Cephalon.
The FDA formally approved it for shift work disorder on January 23, 2004. Less than four months later, on May 21, 2004, Science Magazine reported that Cephalon was providing $2.75 million to fund an endowed chair at Harvard Medical School to be named after Cephalon's founder and CEO, Frank Baldino, and that Czeisler would hold the chair. Baldino was also on the advisory board of Harvard, Science noted.
Czeisler published a paper in the August 2005, "New England Journal of Medicine," and claimed night-shift workers remained more alert with Provigil. "I would characterize [Provigil] as the treatment of choice with patients with shift-work disorder," he said.
However, in an editorial in the same issue, Dr Robert Basner, director of Columbia University's Cardiopulmonary Sleep and Ventilatory Disorders Center, said the researchers' data showed only slight improvements in workers wakefulness and productivity with Provigil, and the drug seemed to exacerbate insomnia for some patients.
"That's not a very robust endorsement of the drug coming from the investigators themselves," Basner wrote. "This drug is little better than nothing in terms of making them less sleepy during shift work at night.”
For the February 2007 program, "20/20" wanted to find out how well Provigil worked in studies not funded by Cephalon, which led them to the sleep labs of the US Army and research psychologist, Nancy Wesensten, who studies drugs to help soldiers stay awake.
In studying Provigil for the army, Wesensten compared it to caffeine in terms of how well soldiers performed on tests, how alert they were, and side effects. "In our hands, at the dosages we tested, modafinil did not work any better than caffeine," she told 20/20.
Cephalon arranged for "case studies to drive growth for off-label uses such as multiple sclerosis, adult ADD and depression," the DOJ press release charges. And in fact, a literature review, by Dr Jacob Ballon and Dr David Feifel, for an April 2006 paper in the "Journal of Clinical Psychiatry," was conducted on PubMed, with the search term modafinil OR Provigil, and shows a total of 397 articles for on and off-label uses.
"Cephalon employed sales representatives and retained medical professionals to speak to doctors about off-label uses," the press release said. "The company funded continuing medical education programs, through millions of dollars in grants, to promote off-label uses of its drugs."
"Cephalon sent doctors to “consultant” meetings at lavish resorts to hear the company’s off-label message," the DOJ reports. According to a Cephalon document, these meetings "proved incredibly effective in driving prescription growth among the attendees," the memo notes.
"Cephalon trained its sales representatives on techniques to prompt the doctors into
off-label conversations," and "had its sales representatives tell doctors how to document their off-label uses of drugs to get these uses paid by insurers, who often will not pay for off-label uses," the DOJ reports.
The drug maker "also structured its sales quota and bonuses in such a way that sales representatives could only reach their sales goals if they promoted and sold the drugs for off-label uses," the press release notes.
According to the sentencing memo, for over six years, the very top levels of the company knew and approved of these efforts.
Cephalon’s sales reports show the success of the off-label campaigns, with Provigil sales rising from $146 million in 2001, to $691 million in 2006, to more than $850 million in 2007. Sales increased more than a 1,000% from 2000 to 2007, according to Connecticut's attorney general and the government found more than 80% were for off-label use.
It's difficult to see where the off-label marketing has ended because Provigil profits have never fallen. SEC filings show sales of the drug exceeded $988 million in 2008, the year the settlement agreement was signed, roughly $138 million more than 2007.
In 2009, Provigil sales topped the billion dollar mark, and Nuvigil earned $73,391 million. Combined, these two products had an 11% increase in sales over 2008, and made up 51% of Cephalon's total net sales for 2009.
With a doubling of Provigil sales in the first 6 months of 2010, totaling $547,281 million, sales could potentially beat the record set in 2009. In comparison, sales in first 6 months of 2009 were only $515,430 million. Nuvigil had sales of, $75,890 million in the first 6 months of 2010, compared to $16,786 million in the first 6 months of 2009.
Since the launch of Nuvigil on June 1, 2009, Cephalon has been aiming at approvals for additional indications, including people with jet lag and traumatic brain injury, as well as adjunctive therapy for schizophrenia and bipolar disorder, and fatigue associated with cancer treatment. "We expect NUVIGIL to be a much bigger drug than PROVIGIL ever was in a long run," CEO, Baldino, said in a February 11, 2010 Earnings Call.
However, in March 2010, the FDA nixed approval for jet lag, which Cephalon was counting on because it would have allowed sales reps to hit virtually every kind of physician that might treat jet lag, instead of only doctors who treat sleep disorders, according to market analysts.
In the last week of June, Cephalon filed a formal response to the FDA's non-approval. The FDA “classified the response as a class two resubmission requiring a six-month review with a PDUFA date of December 30,” Baldino said in a July 27, Earnings Call.
Also, in June 2010, the results for a study of Nuvigil, in conjunction with antipsychotics, for schizophrenia showed the drug failed to meet its primary endpoint, and in the July 27, Earnings Call, Dr Lesley Russell, Cephalon's Chief Medical Officer, said the company had “decided not to move forward with cancer related to fatigue for NUVIGIL.”
Hammered Again in Court
On the same day that the FDA refused approval of Nuvigil for jet lag, a federal judge refused to dismiss the antitrust lawsuits filed against Cephalon by the Federal Trade Commission and others.
In 2005 and 2006, Cephalon entered into settlements with the generic drug makers, Barr, Mylan, Teva, and Ranbaxy, and agreed to pay the four companies a combined total of more than $200 million, in return for agreements that would keep generic versions of Provigil from coming on the market until April 2012, instead of 2008.
In March 2006, when announcing the settlements, CEO Baldino told the Philadelphia Business Journal: "We were able to get six more years of patent protection. That's $4 billion in sales that no one expected."
Later in 2006, a class of direct purchasers (such as health plans and pharmacies) filed a lawsuit against Cephalon and the generic companies, followed soon after by a class of end-payers of Provigil, and Apotex, another generic firm. They all alleged that Cephalon, and the generic makers were engaged in anticompetitive conduct in violation of the Sherman Antitrust Act.
Pay-For-Delay Deals
The so-called "pay-for-delay" agreements (also known as "reverse payments") are settlements of patent litigation in which a brand-name company pays a potential generic competitor to abandon a patent challenge and delay entering the market with a generic.
Brand-name companies "can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time," the FTC explained in a January 2010 report titled, "Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions," which summarized the savings lost to US consumers through such deals during the previous six years.
The FTC found the number of pay-for-delay agreements had increased from none in 2004, to a record 19 in the fiscal year of 2009. On average, these agreements precluded generic entry for 48 months, the agency reports.
Most of the deals reached since 2005 were still in effect, and were protecting at least $20 billion in brand-name sales from generic competition. "These sweetheart deals are being done on the backs of consumers," FTC chairman, Jon Leibowitz, told the New York Times in January 2010. "From the perspective of the Federal Trade Commission, these deals are one of the worst abuses across the board in health care and should be stopped.”
The FTC estimates the agreements currently cost American consumers $3.5 billion a year in higher prescription costs when they miss out on generic prices that can be as much as "90 percent less than brand prices," according to the study.
"Based on a preliminary analysis, already, in the first nine months of FY 2010, there have been more brand-generic settlements involving some sort of compensation - 21 - than in any prior full fiscal year," Leibowitz reported in July 27, 2010 testimony before the House Judiciary Subcommittee on Courts and Competition Policy.
Those settlements protect $9 billion in drug sales from generic competition. "That’s almost an epidemic," he told lawmakers, "and left untreated, these types of settlements will continue to insulate more and more drugs from competition."
The FTC joined the Cephalon antitrust litigation on February 13, 2008, by filing a lawsuit against Cephalon, but not the generics makers, alleging violations of the Federal Trade Commission Act. Cephalon’s anticompetitive scheme "denies patients access to lower-cost, generic versions of Provigil and forces consumers and other purchasers to pay hundreds of millions of dollars a year more for Provigil," the agency stated in a press release the same day.
On March 29, 2010, a federal judge in Philadelphia denied a defense motion to dismiss the FTC’s case (and related cases) against Cephalon. The case is now in the discovery phase, according to the FTC. However, nobody better look for a resolution and cheap generic Provigil anytime soon because Cephalon has every intention of dragging out this litigation as long as possible and is geared up for round two of delay and motion filing.
In a May 4, 2010 Earnings Call, George Pappert, the former champion of lower drug prices for citizens of Pennsylvania, informed listeners that the discovery process "will take us to roughly the middle of 2011."
"And then we will be filing our dispositive motions, our motions for summary judgment," he said. "I believe the court has a schedule set for July of 2011, and then the court will consider those motions at that time."
Being the first batch of motions took years to resolve, generic Provigil will likely enter the market in 2012, exactly as specified in the pay-for-delay deals, and long before the litigation ends. Providing the drug is still allowed to be sold at all that is.
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)
A little over a year after the Volkow study reported that Provigil (modafinil), affects the same brain chemicals as stimulants and may be addictive, on July 20, 2010, in the Atlanta Science News Examiner, Kevin Murnane reported that research showed modafinil "produces some effects that are similar to abused stimulants, such as cocaine."
In what may turn out to be the final nail in the modafinil coffin, rhesus monkeys were given modafinil prior to undergoing behavioral, neurochemical, and brain imaging studies for a study led by Monica Andersen, conducted at the Yerkes National Primate Research Center at Emory University, in the June 2010, "Psychopharmacology" journal.
"Similar to other stimulants, these researchers found that modafinil increased movement or locomotion in their subjects," Murnane wrote. "Furthermore, an acute bolus of modafinil elicited a return or reinstatement of cocaine self-administration that had been previously diminished through extinction training."
"These behavioral effects are very consistent with those of other stimulant-type drugs," he reported.
Mechanistically, the researchers found "using Positron Emission Tomography (PET) imaging that modafinil bound to and occupied a protein in the brain called the dopamine transporter," he explained. "This protein is the same one that cocaine binds to."
"Furthermore, they found that modafinil increased dopamine neurotransmission," Murnane said. "This is the same mechanism thought to mediate the euphoric and addictive properties of cocaine."
He pointed out that the findings "closely paralleled those of a study by Volkow and colleagues in human subjects that was published in the March 2009 issue of the Journal of the American Medical Association."
"Collectively, these studies show that modafinil has similar behavioral and pharmacological effects to stimulant-type drugs of abuse, such as cocaine," he wrote.
"These data indicate that modafinil has the potential to be abused or produce dependence," Murnane said. "Accordingly, closer monitoring of the modafinil supply and abuse patterns may be warranted."
In June 2010, when the European Medicines Agency recommended restricting the use of modafinil for the treatment of narcolepsy only, on Pharmalot, Ed Silverman said the issue to watch was what this meant for Cephalon’s Nuvigil. For the moment, EMA may have given Cephalon a boost, "especially since the FDA keeps delaying approval to use Nuvigil for jet-lag disorder and studies for other indications have either flopped or will take quite awhile to complete," he wrote.
"A similar step to restrict Nuvigil, of course, would make it harder to broaden the Nuvigil market," he pointed out, and noted that the drug's label states: "Psychiatric adverse experiences have been reported in patients treated with modafinil. Modafinil and armodafinil (NUVIGIL) are very closely related. Therefore, the incidence and type of psychiatric symptoms associated with armodafinil are expected to be similar to the incidence and type of these events with modafinil."
However, the Frazer, Pennsylvania-based firm's Annual Report for 2009, does not show Nuvigil as approved for use in any other country besides the US.
Unprecedented Price Gouging
On November 18, 2008, Pharmalot reported that Cephalon had raised the price on Provigil by 28% since March 2008. The drug was then 74% more expensive than four years earlier, with an average wholesale price of $8.71 per pill.
The price hikes were in preparation for the expected launch of Nuvigil in 2009. By sharply raising prices, Cephalon hoped to convert patients to Nuvigil before cheap generic versions of Provigil came on the market.
A year later, Dow Jones reported that in November 2009, Cephalon had raised the price on Provigil by 29%, to $13.62 a pill, and that the cost of Nuvigil, launched in June 2009, with patent protection until 2023, was $8.98 per tablet. Five years earlier, "Provigil's cost was $5.53 per pill," Dow Jones noted on December 22, 2009.
Nuvigil Launch
In launching Nuvigil, in addition to promotional efforts in the field, Cephalon "initiated patient sampling programs, discount programs for patients, a significant number of key opinion leader/speaker presentations, and a contracting plan with certain health care payers," Bob Roche, of Cephalon's Worldwide Pharmaceutical Operations, said in an August 4, 2009 Earnings Call, posted by "Seeking Alpha."
Sampling programs included regular distribution of samples to doctors and a free 7-day coupon for patients to print out from an online website.
Cephalon also implemented a "Co-Pay Assistance Program," which provides up to $50 of co-pay assistance per prescription. "To make things easier for patients, this program is administered automatically in many pharmacies, making co-pay assistance coupons or cards unnecessary," Roche said.
However, patients covered by government plans like Medicare and Medicaid do not qualify for the co-pay assistance, CEO, Frank Baldino, pointed out in the call.
Cephalon also developed a data base of approximately 50,000 individuals who requested information on Nuvigil and mailed "these people a launch kit, with a free seven-day coupon and information on our Co-Pay Assistance Program," he said.
The company also planned to implement an online, "Wake Information Support and Education Program," as part of a professional education and support campaign designed for doctors in the sleep/wake field, Roche reported. "In addition to information on sleep and wakefulness issues, physicians can, with just a click of a mouse get information on NUVIGIL, order samples, request coupons, ask questions, or request to see a sales representative," he explained.
In the first quarter of 2010, Cephalon also launched a Nuvigil shift work disorder campaign. There are "15 million shift workers in the United States and approximately 1/3 of them suffer from excessive sleepiness associated with shift work disorder," Baldino reported in a May 4, 2010 Earnings Call.
A non-branded radio campaign was launched "in select markets where shift work is a significant part of the working population," said Robert Repella in the call. We "expect to see the benefits coming out of that as we move through the year.”
Cephalon also started a program with WebMD in the first quarter, he said. We've had "over 7 million visits to their website related to either NUVIGIL or disease area content.”
Today it's doubtful that shift workers in the US make enough money to pay for Provigil or Nuvigil. In August 2010, one hundred 250mg tablets of Nuvigil cost $1,080, or $10.80 per tablet, and the price for 100 tablets of 200mg of Provigil was $1,855, or $18.55 per pill, at DrugStore.com.
If generic Provigil was to hit the market, patients who converted to Nuvigil would likely be pressured by payers to switch back to a cheaper Provigil generic. In the meantime, the same drug, sold as Modalert, can currently be purchased online from other countries for as low as $120 per hundred, at EuroDrugstore.
Off-Label Marketing Schemes
Back on November 8, 2007, Ed Silverman’s Pharmalot reported that Cephalon had struck a deal with the US Attorney in Philadelphia to pay $425 million to settle off-label marketing charges. He noted that the settlement was no surprise because the firm had been under a microscope for off-label marketing for some time and had received an FDA warning letter in February 2007, ordering an end to promotional materials claiming Provigil could be used to treat fatigue.
The underlying lawsuits were filed in 2003, by three former employees, Bruce Boise, Michael Makalusky, and Lucia Paccione, and another whistleblower, Joseph Piacentile, in federal court in the Eastern District of Pennsylvania, under the False Claims Act, arising from false claims submitted to Medicaid, Medicare and other federal insurance programs that do not provide coverage for such off-label uses.
About six months after the settlement became known, on April 30, 2008, Cephalon announced the hiring of Gerald Pappert, former Attorney General of Pennsylvania, as Executive Vice President and General Counsel. Pappert was First Deputy Attorney General from 1997 to 2003 and Attorney General from 2003 to 2005.
When he took over as attorney general, Pappert "launched a vigorous fight to lower the cost of prescription drugs for Pennsylvanians," the AG’s website states.
"I will ensure that prescription drugs are priced fairly, and I will take action against those who defraud our Commonwealth programs or cheat us through illegal pricing and other schemes," he promised, after being sworn into office in February 2004.
The same month, Pappert was appointed to the Pharmaceutical Pricing and Prescription Drug Abuse task forces, of the National Association of Attorneys General, "which were formed to ensure that pharmaceuticals are priced fairly and to prevent the illegal use and sale of prescription drugs, respectively," according to February 4, 2004 press release.
In May 2004, Pappert reported that Cephalon's Actiq, a narcotic lollipop, was showing up in illegal sales in Philadelphia under the street nickname "perc-o-pops," according to the September 30, 2008 Philadelphia Inquirer.
In September 2004, the US attorney in Philadelphia subpoenaed documents about Cephalon's sales and marketing of Actiq, Provigil, and Gabitril, an epilepsy drug, the Inquirer reported
During his tenure in Harrisburg, Pappert filed a lawsuit accusing 13 drug companies of price-fixing in March 2004. "As Attorney General, I am committed to doing everything I can to reduce the price of prescription drugs for the Commonwealth and its citizens," he said, in a March 10, press release on the suit.
He explained that many consumers purchase drugs, either by themselves or through a health plan or insurer, and "are financially harmed when drug companies intentionally raise the prices of their drugs to manipulate the market.”
In part, the lawsuit accused the companies of "the widespread practice of offering trips, consulting opportunities, seminars, gifts, meals and cash payments to medical providers in return for prescribing their products," the press release noted.
"Several of the companies named in my lawsuit," Pappert wrote in a March 19, 2004, Oped, "have already pled guilty to and/or agreed to settle federal charges of having engaged in unlawful marketing and sales practices with respect to certain of their prescription drugs."
"These companies have already paid more than $1 billion in fines and civil penalties to the federal government," he pointed out.
"My pharmaceutical industry lawsuit focuses on the pricing practices, which I believe are clearly illegal," he told Insider. "If we ultimately succeed, it is going to change the way the industry prices pharmaceuticals, and stop the prices from continuing to skyrocket, and reduce prices."
About five months after Pappert went to work for Cephalon, on September 29, 2008, the US Department of Justice announced that the firm would enter a criminal plea to one count of "Distribution of Misbranded Drugs," and pay $425 million to settle federal and state charges and resolve allegations that it marketed three drugs, Provigil, Actiq and Gabitril, for unapproved uses.
Pappert signed off on the agreement as Executive VP and General Counsel of Cephalon.
The government's investigation began in January 2003, when Bruce Boise, a sales representative in Ohio, contacted the FDA about Cephalon's sales practices. Boise agreed to wear a wire to a company sales conference to help the government gather evidence, according to his attorney, Peter Chatfield, in a September 29, 2008 press release by his firm, Phillips & Cohen. In November 2003, another sales rep, Lucia Paccione of Philadelphia, filed the first lawsuit. The complaints remained sealed until the settlement was announced.
"What makes this case unique is that it's the first time, in the absence of substantial kickbacks, that the federal government has used the False Claims Act to go after a pharmaceutical company for marketing drugs for off-label indications for which there were no credible published scientific research supporting these drugs' safety or effectiveness," Chatfield said. "Not only were these uses marketed by Cephalon not approved by the FDA, there was absolutely no literature published in any medical compendia that supported them."
While federally funded healthcare programs "often will pay for off-label use of drugs supported by credible medical research and prescribed based on the medical judgment of physicians, Cephalon's marketing efforts pushed well beyond those constraints," according to the press release.
From 2001 through 2006, "Cephalon improperly promoted Provigil to treat sleepiness, tiredness, decreased activity, lack of energy and fatigue," the DOJ sentencing memorandum reports.
"Cephalon continued its illegal promotional activities after January 2002, when the FDA specifically directed the company to stop promoting Provigil for off-label uses," it states. For instance, in November 2002, a Cephalon manager accompanying a sales representative on calls to physicians, told the sales person: "Your best call of the day was with Dr. [a psychiatrist] ... Informing the physician of the transition that we have made with Provigil from narcolepsy to the variety of areas in which it is currently being used was also effective."
"Cephalon had its sales representatives call on doctors who would not normally
prescribe the defendant’s drugs in the course of the doctors’ practice," DOJ states. In fact, during a February 15, 2007 program, ABC's "20/20," revealed a copy of a sales report that showed allergists, internists, pediatricians and even dentists were prescribing Provigil off-label to people with depression, MS, hyperactivity and cancer.
Celaphon marketed directly to psychiatrists after concluding that they respond to a "lower threshold of scientific proof" than other doctors. "In other words, Cephalon targeted physicians that would least object to their promoting Provigil for uses with little clinical support," says a September 29, 2008 press release by Connecticut's attorney general.
In December 2002, Cephalon sought to expand Provigil’s label to cover excessive sleepiness, without regard to the patient’s underlying medical condition. However, in January 2004, the FDA approved only a narrow expansion for excessive sleepiness associated with obstructive sleep apnea and shift work sleep disorder.
Harvard professor, Dr Charles Czeisler, chief of sleep medicine at Brigham and Women's Hospital, was lead investigator in the shift-worker study, which showed Provigil kept participants awake 1.7 minutes longer than a placebo. In September 2003, Czeisler went before the FDA to lobby for approval to treat shift-workers on behalf of Cephalon.
The FDA formally approved it for shift work disorder on January 23, 2004. Less than four months later, on May 21, 2004, Science Magazine reported that Cephalon was providing $2.75 million to fund an endowed chair at Harvard Medical School to be named after Cephalon's founder and CEO, Frank Baldino, and that Czeisler would hold the chair. Baldino was also on the advisory board of Harvard, Science noted.
Czeisler published a paper in the August 2005, "New England Journal of Medicine," and claimed night-shift workers remained more alert with Provigil. "I would characterize [Provigil] as the treatment of choice with patients with shift-work disorder," he said.
However, in an editorial in the same issue, Dr Robert Basner, director of Columbia University's Cardiopulmonary Sleep and Ventilatory Disorders Center, said the researchers' data showed only slight improvements in workers wakefulness and productivity with Provigil, and the drug seemed to exacerbate insomnia for some patients.
"That's not a very robust endorsement of the drug coming from the investigators themselves," Basner wrote. "This drug is little better than nothing in terms of making them less sleepy during shift work at night.”
For the February 2007 program, "20/20" wanted to find out how well Provigil worked in studies not funded by Cephalon, which led them to the sleep labs of the US Army and research psychologist, Nancy Wesensten, who studies drugs to help soldiers stay awake.
In studying Provigil for the army, Wesensten compared it to caffeine in terms of how well soldiers performed on tests, how alert they were, and side effects. "In our hands, at the dosages we tested, modafinil did not work any better than caffeine," she told 20/20.
Cephalon arranged for "case studies to drive growth for off-label uses such as multiple sclerosis, adult ADD and depression," the DOJ press release charges. And in fact, a literature review, by Dr Jacob Ballon and Dr David Feifel, for an April 2006 paper in the "Journal of Clinical Psychiatry," was conducted on PubMed, with the search term modafinil OR Provigil, and shows a total of 397 articles for on and off-label uses.
"Cephalon employed sales representatives and retained medical professionals to speak to doctors about off-label uses," the press release said. "The company funded continuing medical education programs, through millions of dollars in grants, to promote off-label uses of its drugs."
"Cephalon sent doctors to “consultant” meetings at lavish resorts to hear the company’s off-label message," the DOJ reports. According to a Cephalon document, these meetings "proved incredibly effective in driving prescription growth among the attendees," the memo notes.
"Cephalon trained its sales representatives on techniques to prompt the doctors into
off-label conversations," and "had its sales representatives tell doctors how to document their off-label uses of drugs to get these uses paid by insurers, who often will not pay for off-label uses," the DOJ reports.
The drug maker "also structured its sales quota and bonuses in such a way that sales representatives could only reach their sales goals if they promoted and sold the drugs for off-label uses," the press release notes.
According to the sentencing memo, for over six years, the very top levels of the company knew and approved of these efforts.
Cephalon’s sales reports show the success of the off-label campaigns, with Provigil sales rising from $146 million in 2001, to $691 million in 2006, to more than $850 million in 2007. Sales increased more than a 1,000% from 2000 to 2007, according to Connecticut's attorney general and the government found more than 80% were for off-label use.
It's difficult to see where the off-label marketing has ended because Provigil profits have never fallen. SEC filings show sales of the drug exceeded $988 million in 2008, the year the settlement agreement was signed, roughly $138 million more than 2007.
In 2009, Provigil sales topped the billion dollar mark, and Nuvigil earned $73,391 million. Combined, these two products had an 11% increase in sales over 2008, and made up 51% of Cephalon's total net sales for 2009.
With a doubling of Provigil sales in the first 6 months of 2010, totaling $547,281 million, sales could potentially beat the record set in 2009. In comparison, sales in first 6 months of 2009 were only $515,430 million. Nuvigil had sales of, $75,890 million in the first 6 months of 2010, compared to $16,786 million in the first 6 months of 2009.
Since the launch of Nuvigil on June 1, 2009, Cephalon has been aiming at approvals for additional indications, including people with jet lag and traumatic brain injury, as well as adjunctive therapy for schizophrenia and bipolar disorder, and fatigue associated with cancer treatment. "We expect NUVIGIL to be a much bigger drug than PROVIGIL ever was in a long run," CEO, Baldino, said in a February 11, 2010 Earnings Call.
However, in March 2010, the FDA nixed approval for jet lag, which Cephalon was counting on because it would have allowed sales reps to hit virtually every kind of physician that might treat jet lag, instead of only doctors who treat sleep disorders, according to market analysts.
In the last week of June, Cephalon filed a formal response to the FDA's non-approval. The FDA “classified the response as a class two resubmission requiring a six-month review with a PDUFA date of December 30,” Baldino said in a July 27, Earnings Call.
Also, in June 2010, the results for a study of Nuvigil, in conjunction with antipsychotics, for schizophrenia showed the drug failed to meet its primary endpoint, and in the July 27, Earnings Call, Dr Lesley Russell, Cephalon's Chief Medical Officer, said the company had “decided not to move forward with cancer related to fatigue for NUVIGIL.”
Hammered Again in Court
On the same day that the FDA refused approval of Nuvigil for jet lag, a federal judge refused to dismiss the antitrust lawsuits filed against Cephalon by the Federal Trade Commission and others.
In 2005 and 2006, Cephalon entered into settlements with the generic drug makers, Barr, Mylan, Teva, and Ranbaxy, and agreed to pay the four companies a combined total of more than $200 million, in return for agreements that would keep generic versions of Provigil from coming on the market until April 2012, instead of 2008.
In March 2006, when announcing the settlements, CEO Baldino told the Philadelphia Business Journal: "We were able to get six more years of patent protection. That's $4 billion in sales that no one expected."
Later in 2006, a class of direct purchasers (such as health plans and pharmacies) filed a lawsuit against Cephalon and the generic companies, followed soon after by a class of end-payers of Provigil, and Apotex, another generic firm. They all alleged that Cephalon, and the generic makers were engaged in anticompetitive conduct in violation of the Sherman Antitrust Act.
Pay-For-Delay Deals
The so-called "pay-for-delay" agreements (also known as "reverse payments") are settlements of patent litigation in which a brand-name company pays a potential generic competitor to abandon a patent challenge and delay entering the market with a generic.
Brand-name companies "can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time," the FTC explained in a January 2010 report titled, "Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions," which summarized the savings lost to US consumers through such deals during the previous six years.
The FTC found the number of pay-for-delay agreements had increased from none in 2004, to a record 19 in the fiscal year of 2009. On average, these agreements precluded generic entry for 48 months, the agency reports.
Most of the deals reached since 2005 were still in effect, and were protecting at least $20 billion in brand-name sales from generic competition. "These sweetheart deals are being done on the backs of consumers," FTC chairman, Jon Leibowitz, told the New York Times in January 2010. "From the perspective of the Federal Trade Commission, these deals are one of the worst abuses across the board in health care and should be stopped.”
The FTC estimates the agreements currently cost American consumers $3.5 billion a year in higher prescription costs when they miss out on generic prices that can be as much as "90 percent less than brand prices," according to the study.
"Based on a preliminary analysis, already, in the first nine months of FY 2010, there have been more brand-generic settlements involving some sort of compensation - 21 - than in any prior full fiscal year," Leibowitz reported in July 27, 2010 testimony before the House Judiciary Subcommittee on Courts and Competition Policy.
Those settlements protect $9 billion in drug sales from generic competition. "That’s almost an epidemic," he told lawmakers, "and left untreated, these types of settlements will continue to insulate more and more drugs from competition."
The FTC joined the Cephalon antitrust litigation on February 13, 2008, by filing a lawsuit against Cephalon, but not the generics makers, alleging violations of the Federal Trade Commission Act. Cephalon’s anticompetitive scheme "denies patients access to lower-cost, generic versions of Provigil and forces consumers and other purchasers to pay hundreds of millions of dollars a year more for Provigil," the agency stated in a press release the same day.
On March 29, 2010, a federal judge in Philadelphia denied a defense motion to dismiss the FTC’s case (and related cases) against Cephalon. The case is now in the discovery phase, according to the FTC. However, nobody better look for a resolution and cheap generic Provigil anytime soon because Cephalon has every intention of dragging out this litigation as long as possible and is geared up for round two of delay and motion filing.
In a May 4, 2010 Earnings Call, George Pappert, the former champion of lower drug prices for citizens of Pennsylvania, informed listeners that the discovery process "will take us to roughly the middle of 2011."
"And then we will be filing our dispositive motions, our motions for summary judgment," he said. "I believe the court has a schedule set for July of 2011, and then the court will consider those motions at that time."
Being the first batch of motions took years to resolve, generic Provigil will likely enter the market in 2012, exactly as specified in the pay-for-delay deals, and long before the litigation ends. Providing the drug is still allowed to be sold at all that is.
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)
The Rise and Fall of Provigil – Part I
Evelyn Pringle
On July 22, 2010, the European Medicines Agency recommended restricting the use of modafinil. Doctors and patients should be advised to use the drug only for the treatment of narcolepsy and all other indications should be withdrawn from market authorization, the press release said.
In addition to the brand-name, Provigil, marketed by Cephalon in the US, modafinil is also sold as Alertec, Modalert, Modavigil, Modiodal, Provake, and Vigil.
A review by the Agency’s Committee for Medicinal Products for Human Use (CHMP), began in May 2009, because of safety concerns relating to psychiatric disorders, such as suicidal thoughts, depression, and psychotic episodes, and life threatening skin reactions, as well as significant off-label use and potential for abuse.
CHMP looked at all the clinical trial data on modafinil for narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and articles from the published literature. CHMP also reviewed all the side effects reported on modafinil-containing medicines, and convened a group of experts on clinical neurosciences to provide advice, according to a Q&A document on EMA's website.
On the basis of the available data, CHMP concluded that the benefits of modafinil only outweighed the risks in treating narcolepsy and the clinical trials for other disorders did not provide strong evidence to support use of the drug. For other indications, CHMP found the data on effectiveness insufficient to outweigh the risks of skin reactions, psychiatric adverse reactions, and cardiovascular adverse reactions, such as hypertension and irregular heart beat.
CHMP concluded that the product information should carry a recommendation saying modafinil should not be prescribed to children and use of the drug be contraindicated in patients with uncontrolled moderate-to-severe hypertension and cardiac arrhythmias. The recommendations were forwarded to the European Commission for the adoption of a binding decision, the press release said.
Because CHMP noted in its review that modafinil has often been used for conditions not indicated, the drug makers were asked to carry out further studies, including a "drug utilisation study," to look at why family doctors prescribe the drug, according to the Q&A. In addition, data on misuse by university students is currently being collected and will be analyzed once available, the EMA reports.
The Medicines and Healthcare product Regulatory Agency issued a "stop press" notice in the August 2010 edition of "Drug Safety Update," reminding healthcare professionals of the EMA’s recommendations.
US Market
Provigil was approved for narcolepsy in late 1998, which only affects around 200,000 people in the US, according to a July 2010 report by Global Industry Analysts.
US sales began in February 1999. Ten months later, "25% of narcolepsy patients in the country, more than 31,000 people, were taking the drug. It generated $25 million in 1999 sales, and Cephalon's revenue nearly tripled to $45 million," according to an August 1, 2000 report, by Matthew Herper, on Forbes.com.
A November 20, 2002, New York Times article reported that Cephalon CEO, Frank Baldino, himself, was taking Provigil, but would not say what condition he used it for. Provigil is short for "promotes vigilance," according to the Times.
Use of the drug is "expanding rapidly, with more than 80 percent of the prescriptions written to treat the fatigue and sleepiness associated with many other diseases, like depression and multiple sclerosis, or even just sleepiness caused by no disease at all," the article reported in 2002.
At that time, Baldino denied that the drug was or would be abused. "I don't think it's going to happen, because we're careful about how we sell it and doctors are careful how they write prescriptions," he told the Times.
"He added that the growing use of the drug for conditions other than narcolepsy is being driven by physicians, not by Cephalon's marketing," the article said.
Less than eleven months earlier, the FDA had sent a letter warning Cephalon to quit promoting Provigil for off-label uses. The FDA objected to language indicating the drug could be used for symptoms such as sleepiness, tiredness, decreased activity, lack of energy and fatigue. "Provigil is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Provigil is not approved for use as a daytime stimulant," the FDA wrote in January 2002.
The letter requested an immediate end to the dissemination of “all sales aids, journal advertisements, websites and all other promotional materials and activities for Provigil that contain the same or similar violations.”
In 2002, Provigil sold for $5 a pill and some insurers were reluctant to pay that price for narcolepsy because amphetamines were much cheaper, according to the Times.
The treatment of excessive sleepiness associated with sleep apnea and shift work sleep disorder with Provigil were not approved until January 2004. Right before the Summer Olympics in August 2004, the World Anti-Doping Agency added modafinil to the list of banned drugs after a runner in the 2003 World Track and Field Championships tested positive for it.
Provigil Addiction
On March 17, 2009, Harrisburg, Pennsylvania psychiatrist and addiction specialist, Dr Stefan Kruszewski, told USA Today that he was currently treating his third case of Provigil addiction. "I had two doctors back-to-back who were addicted to modafinil," he said, "so I became alarmed." Both were also alcoholics.
The same day, Bloomberg ran the headline, "Narcolepsy Pill Used as Smart Drug May Be Addictive," in reporting a study, by researchers at the National Institute on Drug Abuse, that found Provigil "effects the same brain chemicals as stimulants like Ritalin and amphetamines."
"PET or positron emission tomography scans of the brain activity in 10 healthy volunteers who took the drug showed it boosted the level of dopamine circulating in the part of the brain involved in pleasure, reward and addiction," Bloomberg wrote, in summarizing the study published in the "Journal of the American Medical Association."
The increase of dopamine seen with the medicine is "the signature for drugs that have the potential for producing addiction," Nora Volkow, the lead author and director of the National Institute on Drug Abuse, told Bloomberg.
Physicians prescribing Provigil should "be alert to the possibility that it could produce addiction," she said. Consumers also should be aware the drug "may have more abuse potential than originally believed."
Volkow wanted to add questions about the Provigil to the Institute's annual survey of high school drug use, she told Bloomberg.
The study noted that Provigil was being used off-label by people who want to boost their mental ability. "Modafinil is increasingly being diverted for nonmedical use by healthy individuals with the expectation that it will improve cognitive performance," the authors wrote in the March 18, 2009 Journal.
"The growing use of modafinil in clinical medicine and as a cognitive enhancing agent and the uncertainties surrounding the mechanisms underlying its pharmacological effects highlight the need to better understand its mechanisms of action," they advised.
"Modafinil was developed with an expectation that a medication could have a nondopaminergic target for its wake-promoting effects," they said. "However, the current findings in humans, along with preclinical studies documenting the indispensable role of dopamine in the wake-promoting effects of modafinil, support modafinil’s dopamine-enhancing effects as a mechanism for its therapeutic actions.”
"In addition," they reported, "a recent imaging study in anesthetized monkeys documented significant occupancy of dopamine transporters by intravenously administered modafinil."
They also pointed out that "modafinil was shown to be self-administered in monkeys previously trained to self-administer cocaine."
But the potential for abuse is not the only reason why healthy people should not take modafinil or other so-called "smart drugs," Volkow told USA Today. They can have serious adverse effects, such as brief psychotic episodes, she said, and there is little evidence they improve cognition. Modafinil also significantly increased heart rate and systolic blood pressure, the study found.
In the paper, the authors pointed out that there had been previous "debate surrounding its potential for abuse," and cited two examples. The first, was a March 2006 Letter to the Editor, of the American Journal of Psychiatry, from Dr Kruszewski, in response to an August 2005 paper in the Journal, by Dr Charles O’Brien, that claimed modafinil may decrease cocaine use in some cocaine users and specifically stated: "The medication has not been reported to produce euphoria, and there has been no indication of excessive use or abuse in clinical trials."
As the scientific basis for his comments, O'Brien referenced two studies by his own research group. In his letter, Kruszewski wrote that, "the author's statement does not appear to be supported by his referenced work, nor is it supported by information widely available in the 2004 edition of the Physicians' Desk Reference."
The referenced article may demonstrate that modafinil can, in some cases, blunt cocaine euphoria, he said. "However, it does not say anything about modafinil's intrinsic ability to produce euphoria (or not)."
In fact, the 2004 PDR raises specific concerns about modafinil, saying that it can produce "psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants," he wrote.
The PDR also states that "modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine," Kruszewski noted.
He pointed out that the comment on the lack of euphorigenic effects was also contradicted by the FDA in a January 14, 2002, warning letter sent to Paul Kirsch, the senior director of regulatory affairs at Cephalon, which specifically reiterates the drug's package insert addressing the modafinil's euphorigenic effects and its potential for abuse.
That the euphorigenic side effects or abuse potential may be minimized has current treatment implications because modafinil is increasingly promoted for fatigue and excessive sleepiness unrelated to narcolepsy as well as for cocaine abuse, he warned.
The implications loomed even larger, he said, because Cephalon had submitted a “reformulated” modafinil to the FDA under a new name for the treatment of children and adolescents with attention deficit hyperactivity disorder.
The second example of the debate, was a June 2007 Letter to the Editor, of the Journal of Clinical Psychiatry, from Dr Kruszewski and Dr Steven Klotz, in response to an article published in an August 2006 supplement to the Journal titled, “New Developments in the Treatment of Attention-Deficit/ Hyperactivity Disorder,” by Dr Joseph Biederman, Chief of Pediatric Psychopharmacology at Massachusetts General Hospital and Professor of Psychiatry at Harvard Medical School.
The supplement was underwritten by an educational grant from Cephalon.
In his article, Biederman stated: “The pharmacologic profile and structure of modafinil are notably different from those of stimulants and other agents used to treat ADHD, and modafinil may reduce the core symptoms of ADHD via the same mechanism by which it improves wakefulness—selective activation of the cortex without generalized effects on the central nervous system.”
“This mechanism results in reduced abuse potential and less likelihood of jitteriness, anxiety, or excess locomotor activity than traditional stimulants,” he claimed.
Their concern with Biederman's commentary was that “it appears to seriously misrepresent modafinil’s neuropharmacologic characteristics, contradicting the science-based evaluation of the data by the U.S. FDA and DEA,” Kruszewski and Klotz wrote.
“Dr. Biederman may have misrepresented modafinil’s pharmacologic (stimulant) properties and minimized modafinil’s abuse potential—as described in the authoritative FDA-approved product label,” they told the Editor.
“Dr. Biederman’s misrepresentation of the serious risks posed by this drug, whose target population is children with ADHD, requires reexamination and correction,”they wrote.
In conclusion, they correctly pointed out that if Cephalon “ere to directly mischaracterize modafinil’s pharmacocharacteristics—as Dr. Biederman has—they could be prosecuted under federal law.”
In a June 2007 reply letter, Biederman wrote, the “background research to support the claims of Drs. Kruszewski and Klotz begins and ends with the manufacturer’s package insert.”
“However, the manufacturer’s package insert is neither a standard of care nor the most comprehensive and up-to-date review of the preclinical or clinical science about a molecule,” he said. “Were that so, new knowledge or findings would never be able to be conveyed to the field until the company or the U.S. Food and Drug Administration (FDA) determined to alter the manufacturer’s package insert.”
“Further, the labeling reflects information provided to the FDA at the time of submission of the compound and not necessarily the universe of scientific information available,” he wrote.
"The letter by Drs. Kruszewski and Klotz seriously misrepresents the facts, shows ignorance about the neuropharmacologic characteristics of modafinil, and demonstrates a failure to understand the clinical significance of alternative treatments for ADHD," the hubristic Biederman told the Editor.
"As an independent clinician-researcher and not the agent of the manufacturer, I am compelled to base my teaching on all the information and knowledge available to me," he said.
However, an investigation, the very next year, by the US Senate Finance Committee, led by Iowa Republican Senator, Charles Grassley, found Biederman to be far from independent from Cephalon. For instance, when disclosing plans for a study sponsored by Cephalon in 2001, Biederman claimed he had no financial relationship with the sponsor. But seven years later, in March 2008, Grassley found Cephalon had paid him $13,000 in 2001.
Again in 2005, when Biederman began another trial, sponsored by Cephalon, to run from September 2005 to September 2006, he disclosed no financial relationship with the firm. But in March 2008, Grassley learned that Cephalon had paid him $11,000 for honoraria in 2005, and an additional $24,750 in 2006.
In fact, all total, Biederman had earned about $1.6 million from drug companies between 2000 and 2007, but failed to report about $1.4 million on forms filed with Harvard.
In disclosures at the end of his reply letter, Biederman listed fourteen drug companies, including Cephalon. In December 2008, Mass General announced that Biederman would no longer be participating in several drug company funded trials and would limit his speaking and consulting activities, pending the outcome of an inquiry of his potential conflict of interests and disclosure obligations.
As mentioned by Kruszewski in his letters to the editor, Cephalon had applied for approval of modafinil (in a larger dose formulation called Sparlon), to treat children and adolescents with ADHD, in December 2004.
However, Biederman was out giving talks promoting off-label use with kids long before it came up for approval. On May 26, 2005, in Doctors Guide Dispatch, Bruce Sylvester reported on a May 24th presentation titled, "Modafinil Pediatric Formulation Has Early and Sustained Effect in ADHD," given by Biederman at the annual meeting of the "American Psychiatric Association," on a study funded by Cephalon and led by Biederman, which claimed Sparlon was effective for children aged 6 to 17 with ADHD.
"This study not only shows that this medication is effective and rapid in onset for the treatment of pediatric ADHD," Biederman said in the presentation. "It also gives the clear signal that here we have a medication that can be used by physicians to treat ADHD in children who cannot tolerate amphetamine salts or for whom the clinician simply prefers not to use amphetamine salts."
Another study, in the December 2005, “Pediatrics” journal, with lead investigator Biederman, said Sparlon's effectiveness and safety profile, along with its low potential for abuse, may offer doctors and parents a new option for children with ADHD. At that time, Biederman’s disclosures showed he received research funding from ten drug companies, served on the speaker's bureau of four, and sat on advisory boards of six.
In applying for FDA approval, Cephalon submitted three trials of Sparlon on less than 700 children. According to a report by FDA reviewer Andrew Mosholder, "two kids experienced psychotic or manic episodes; four kids considered suicide; and nine kids engaged in serious "aggression events" in the modafinil trials," Merrill Goozner reported in GoozNews on March 20, 2006.
"That was the equivalent of 20 negative reactions for every 100 patients who take the drug for a year," Goozner said. "Only Adderall and a skin patch had a worse record."
In the end, an FDA Advisory Committee determined that Sparlon was not safe enough to be marketed to kids, by a vote of 12 to 1, in March 2006, and in August 2006, Cephalon reported that the FDA had rejected the drug for children and the company decided to end development of Sparlon.
(Part II will be published tomorrow)
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)
On July 22, 2010, the European Medicines Agency recommended restricting the use of modafinil. Doctors and patients should be advised to use the drug only for the treatment of narcolepsy and all other indications should be withdrawn from market authorization, the press release said.
In addition to the brand-name, Provigil, marketed by Cephalon in the US, modafinil is also sold as Alertec, Modalert, Modavigil, Modiodal, Provake, and Vigil.
A review by the Agency’s Committee for Medicinal Products for Human Use (CHMP), began in May 2009, because of safety concerns relating to psychiatric disorders, such as suicidal thoughts, depression, and psychotic episodes, and life threatening skin reactions, as well as significant off-label use and potential for abuse.
CHMP looked at all the clinical trial data on modafinil for narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and articles from the published literature. CHMP also reviewed all the side effects reported on modafinil-containing medicines, and convened a group of experts on clinical neurosciences to provide advice, according to a Q&A document on EMA's website.
On the basis of the available data, CHMP concluded that the benefits of modafinil only outweighed the risks in treating narcolepsy and the clinical trials for other disorders did not provide strong evidence to support use of the drug. For other indications, CHMP found the data on effectiveness insufficient to outweigh the risks of skin reactions, psychiatric adverse reactions, and cardiovascular adverse reactions, such as hypertension and irregular heart beat.
CHMP concluded that the product information should carry a recommendation saying modafinil should not be prescribed to children and use of the drug be contraindicated in patients with uncontrolled moderate-to-severe hypertension and cardiac arrhythmias. The recommendations were forwarded to the European Commission for the adoption of a binding decision, the press release said.
Because CHMP noted in its review that modafinil has often been used for conditions not indicated, the drug makers were asked to carry out further studies, including a "drug utilisation study," to look at why family doctors prescribe the drug, according to the Q&A. In addition, data on misuse by university students is currently being collected and will be analyzed once available, the EMA reports.
The Medicines and Healthcare product Regulatory Agency issued a "stop press" notice in the August 2010 edition of "Drug Safety Update," reminding healthcare professionals of the EMA’s recommendations.
US Market
Provigil was approved for narcolepsy in late 1998, which only affects around 200,000 people in the US, according to a July 2010 report by Global Industry Analysts.
US sales began in February 1999. Ten months later, "25% of narcolepsy patients in the country, more than 31,000 people, were taking the drug. It generated $25 million in 1999 sales, and Cephalon's revenue nearly tripled to $45 million," according to an August 1, 2000 report, by Matthew Herper, on Forbes.com.
A November 20, 2002, New York Times article reported that Cephalon CEO, Frank Baldino, himself, was taking Provigil, but would not say what condition he used it for. Provigil is short for "promotes vigilance," according to the Times.
Use of the drug is "expanding rapidly, with more than 80 percent of the prescriptions written to treat the fatigue and sleepiness associated with many other diseases, like depression and multiple sclerosis, or even just sleepiness caused by no disease at all," the article reported in 2002.
At that time, Baldino denied that the drug was or would be abused. "I don't think it's going to happen, because we're careful about how we sell it and doctors are careful how they write prescriptions," he told the Times.
"He added that the growing use of the drug for conditions other than narcolepsy is being driven by physicians, not by Cephalon's marketing," the article said.
Less than eleven months earlier, the FDA had sent a letter warning Cephalon to quit promoting Provigil for off-label uses. The FDA objected to language indicating the drug could be used for symptoms such as sleepiness, tiredness, decreased activity, lack of energy and fatigue. "Provigil is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Provigil is not approved for use as a daytime stimulant," the FDA wrote in January 2002.
The letter requested an immediate end to the dissemination of “all sales aids, journal advertisements, websites and all other promotional materials and activities for Provigil that contain the same or similar violations.”
In 2002, Provigil sold for $5 a pill and some insurers were reluctant to pay that price for narcolepsy because amphetamines were much cheaper, according to the Times.
The treatment of excessive sleepiness associated with sleep apnea and shift work sleep disorder with Provigil were not approved until January 2004. Right before the Summer Olympics in August 2004, the World Anti-Doping Agency added modafinil to the list of banned drugs after a runner in the 2003 World Track and Field Championships tested positive for it.
Provigil Addiction
On March 17, 2009, Harrisburg, Pennsylvania psychiatrist and addiction specialist, Dr Stefan Kruszewski, told USA Today that he was currently treating his third case of Provigil addiction. "I had two doctors back-to-back who were addicted to modafinil," he said, "so I became alarmed." Both were also alcoholics.
The same day, Bloomberg ran the headline, "Narcolepsy Pill Used as Smart Drug May Be Addictive," in reporting a study, by researchers at the National Institute on Drug Abuse, that found Provigil "effects the same brain chemicals as stimulants like Ritalin and amphetamines."
"PET or positron emission tomography scans of the brain activity in 10 healthy volunteers who took the drug showed it boosted the level of dopamine circulating in the part of the brain involved in pleasure, reward and addiction," Bloomberg wrote, in summarizing the study published in the "Journal of the American Medical Association."
The increase of dopamine seen with the medicine is "the signature for drugs that have the potential for producing addiction," Nora Volkow, the lead author and director of the National Institute on Drug Abuse, told Bloomberg.
Physicians prescribing Provigil should "be alert to the possibility that it could produce addiction," she said. Consumers also should be aware the drug "may have more abuse potential than originally believed."
Volkow wanted to add questions about the Provigil to the Institute's annual survey of high school drug use, she told Bloomberg.
The study noted that Provigil was being used off-label by people who want to boost their mental ability. "Modafinil is increasingly being diverted for nonmedical use by healthy individuals with the expectation that it will improve cognitive performance," the authors wrote in the March 18, 2009 Journal.
"The growing use of modafinil in clinical medicine and as a cognitive enhancing agent and the uncertainties surrounding the mechanisms underlying its pharmacological effects highlight the need to better understand its mechanisms of action," they advised.
"Modafinil was developed with an expectation that a medication could have a nondopaminergic target for its wake-promoting effects," they said. "However, the current findings in humans, along with preclinical studies documenting the indispensable role of dopamine in the wake-promoting effects of modafinil, support modafinil’s dopamine-enhancing effects as a mechanism for its therapeutic actions.”
"In addition," they reported, "a recent imaging study in anesthetized monkeys documented significant occupancy of dopamine transporters by intravenously administered modafinil."
They also pointed out that "modafinil was shown to be self-administered in monkeys previously trained to self-administer cocaine."
But the potential for abuse is not the only reason why healthy people should not take modafinil or other so-called "smart drugs," Volkow told USA Today. They can have serious adverse effects, such as brief psychotic episodes, she said, and there is little evidence they improve cognition. Modafinil also significantly increased heart rate and systolic blood pressure, the study found.
In the paper, the authors pointed out that there had been previous "debate surrounding its potential for abuse," and cited two examples. The first, was a March 2006 Letter to the Editor, of the American Journal of Psychiatry, from Dr Kruszewski, in response to an August 2005 paper in the Journal, by Dr Charles O’Brien, that claimed modafinil may decrease cocaine use in some cocaine users and specifically stated: "The medication has not been reported to produce euphoria, and there has been no indication of excessive use or abuse in clinical trials."
As the scientific basis for his comments, O'Brien referenced two studies by his own research group. In his letter, Kruszewski wrote that, "the author's statement does not appear to be supported by his referenced work, nor is it supported by information widely available in the 2004 edition of the Physicians' Desk Reference."
The referenced article may demonstrate that modafinil can, in some cases, blunt cocaine euphoria, he said. "However, it does not say anything about modafinil's intrinsic ability to produce euphoria (or not)."
In fact, the 2004 PDR raises specific concerns about modafinil, saying that it can produce "psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants," he wrote.
The PDR also states that "modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine," Kruszewski noted.
He pointed out that the comment on the lack of euphorigenic effects was also contradicted by the FDA in a January 14, 2002, warning letter sent to Paul Kirsch, the senior director of regulatory affairs at Cephalon, which specifically reiterates the drug's package insert addressing the modafinil's euphorigenic effects and its potential for abuse.
That the euphorigenic side effects or abuse potential may be minimized has current treatment implications because modafinil is increasingly promoted for fatigue and excessive sleepiness unrelated to narcolepsy as well as for cocaine abuse, he warned.
The implications loomed even larger, he said, because Cephalon had submitted a “reformulated” modafinil to the FDA under a new name for the treatment of children and adolescents with attention deficit hyperactivity disorder.
The second example of the debate, was a June 2007 Letter to the Editor, of the Journal of Clinical Psychiatry, from Dr Kruszewski and Dr Steven Klotz, in response to an article published in an August 2006 supplement to the Journal titled, “New Developments in the Treatment of Attention-Deficit/ Hyperactivity Disorder,” by Dr Joseph Biederman, Chief of Pediatric Psychopharmacology at Massachusetts General Hospital and Professor of Psychiatry at Harvard Medical School.
The supplement was underwritten by an educational grant from Cephalon.
In his article, Biederman stated: “The pharmacologic profile and structure of modafinil are notably different from those of stimulants and other agents used to treat ADHD, and modafinil may reduce the core symptoms of ADHD via the same mechanism by which it improves wakefulness—selective activation of the cortex without generalized effects on the central nervous system.”
“This mechanism results in reduced abuse potential and less likelihood of jitteriness, anxiety, or excess locomotor activity than traditional stimulants,” he claimed.
Their concern with Biederman's commentary was that “it appears to seriously misrepresent modafinil’s neuropharmacologic characteristics, contradicting the science-based evaluation of the data by the U.S. FDA and DEA,” Kruszewski and Klotz wrote.
“Dr. Biederman may have misrepresented modafinil’s pharmacologic (stimulant) properties and minimized modafinil’s abuse potential—as described in the authoritative FDA-approved product label,” they told the Editor.
“Dr. Biederman’s misrepresentation of the serious risks posed by this drug, whose target population is children with ADHD, requires reexamination and correction,”they wrote.
In conclusion, they correctly pointed out that if Cephalon “ere to directly mischaracterize modafinil’s pharmacocharacteristics—as Dr. Biederman has—they could be prosecuted under federal law.”
In a June 2007 reply letter, Biederman wrote, the “background research to support the claims of Drs. Kruszewski and Klotz begins and ends with the manufacturer’s package insert.”
“However, the manufacturer’s package insert is neither a standard of care nor the most comprehensive and up-to-date review of the preclinical or clinical science about a molecule,” he said. “Were that so, new knowledge or findings would never be able to be conveyed to the field until the company or the U.S. Food and Drug Administration (FDA) determined to alter the manufacturer’s package insert.”
“Further, the labeling reflects information provided to the FDA at the time of submission of the compound and not necessarily the universe of scientific information available,” he wrote.
"The letter by Drs. Kruszewski and Klotz seriously misrepresents the facts, shows ignorance about the neuropharmacologic characteristics of modafinil, and demonstrates a failure to understand the clinical significance of alternative treatments for ADHD," the hubristic Biederman told the Editor.
"As an independent clinician-researcher and not the agent of the manufacturer, I am compelled to base my teaching on all the information and knowledge available to me," he said.
However, an investigation, the very next year, by the US Senate Finance Committee, led by Iowa Republican Senator, Charles Grassley, found Biederman to be far from independent from Cephalon. For instance, when disclosing plans for a study sponsored by Cephalon in 2001, Biederman claimed he had no financial relationship with the sponsor. But seven years later, in March 2008, Grassley found Cephalon had paid him $13,000 in 2001.
Again in 2005, when Biederman began another trial, sponsored by Cephalon, to run from September 2005 to September 2006, he disclosed no financial relationship with the firm. But in March 2008, Grassley learned that Cephalon had paid him $11,000 for honoraria in 2005, and an additional $24,750 in 2006.
In fact, all total, Biederman had earned about $1.6 million from drug companies between 2000 and 2007, but failed to report about $1.4 million on forms filed with Harvard.
In disclosures at the end of his reply letter, Biederman listed fourteen drug companies, including Cephalon. In December 2008, Mass General announced that Biederman would no longer be participating in several drug company funded trials and would limit his speaking and consulting activities, pending the outcome of an inquiry of his potential conflict of interests and disclosure obligations.
As mentioned by Kruszewski in his letters to the editor, Cephalon had applied for approval of modafinil (in a larger dose formulation called Sparlon), to treat children and adolescents with ADHD, in December 2004.
However, Biederman was out giving talks promoting off-label use with kids long before it came up for approval. On May 26, 2005, in Doctors Guide Dispatch, Bruce Sylvester reported on a May 24th presentation titled, "Modafinil Pediatric Formulation Has Early and Sustained Effect in ADHD," given by Biederman at the annual meeting of the "American Psychiatric Association," on a study funded by Cephalon and led by Biederman, which claimed Sparlon was effective for children aged 6 to 17 with ADHD.
"This study not only shows that this medication is effective and rapid in onset for the treatment of pediatric ADHD," Biederman said in the presentation. "It also gives the clear signal that here we have a medication that can be used by physicians to treat ADHD in children who cannot tolerate amphetamine salts or for whom the clinician simply prefers not to use amphetamine salts."
Another study, in the December 2005, “Pediatrics” journal, with lead investigator Biederman, said Sparlon's effectiveness and safety profile, along with its low potential for abuse, may offer doctors and parents a new option for children with ADHD. At that time, Biederman’s disclosures showed he received research funding from ten drug companies, served on the speaker's bureau of four, and sat on advisory boards of six.
In applying for FDA approval, Cephalon submitted three trials of Sparlon on less than 700 children. According to a report by FDA reviewer Andrew Mosholder, "two kids experienced psychotic or manic episodes; four kids considered suicide; and nine kids engaged in serious "aggression events" in the modafinil trials," Merrill Goozner reported in GoozNews on March 20, 2006.
"That was the equivalent of 20 negative reactions for every 100 patients who take the drug for a year," Goozner said. "Only Adderall and a skin patch had a worse record."
In the end, an FDA Advisory Committee determined that Sparlon was not safe enough to be marketed to kids, by a vote of 12 to 1, in March 2006, and in August 2006, Cephalon reported that the FDA had rejected the drug for children and the company decided to end development of Sparlon.
(Part II will be published tomorrow)
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)
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