The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Ablechild – Unsung Hero in Battle Against Psychopharmaceutical Industry

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.

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Filed under: 'ADHD', 2010, Ablechild, CHADD, drugging children, front groups, MEDICAID, Ritalin, TeenScreen

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.

Filed under: 2010, antipsychotics, Natural News, off-label

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.

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Filed under: 2010, autism, Preemption, Supreme Court, thimerosal, vaccines

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.”

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Filed under: 'ADHD', 2010, addiction, off-label, Provigil

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)

Filed under: 'ADHD', 2010, addiction, Biederman, Provigil

Paxil Birth Defect Litigation – First Trial A Bust For Glaxo

Evelyn Pringle February 18, 2010

GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in 1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.

On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

Glaxo’s lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.

Over 600 Trials To Go

A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.

“Although one might worry that this would cause a jury to blame the prescribing doctor,” says Vickery, “in this case, we can show that GSK encouraged this use, by sending out over 1500 “medical information” letters touting the benefits of Paxil for migraine headaches, and by leaving “approved WLF reprint” articles with the prescribing doctors.”

Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow.

In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the “FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations,” and advised:

“Despite this categorization,” says Vickery, “in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects.”

“Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia,” he notes.

Case of the Dead Rats

During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were “going to see documents in this case that have never seen the light of day before.”

“You will see internal GlaxoSmith documents that the FDA hasn’t seen, that the United States Congress hasn’t seen, and that no jury has ever laid their eyes on before,” he said. “They have been under seal for over three years.”

Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.

Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.

Healy explained that a teratogen is an agent that will cause birth defects and “it could be a drug or maybe a virus or maybe an illness.”

In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.

The jury heard about studies 295, 296 and 297, with the most damning being study 295, in which three groups of pregnant rats were given Paxil at doses of 5, 15, and 50 milligrams. The pregnancy outcomes at birth, and 4 days beyond, were then compared to rats born to mothers who received no Paxil.

The rat pups born to mothers who did not receive Paxil were all born alive. Of the 415 pups born to mothers who were given Paxil, 47 were born dead.

In the group of rats exposed to 5 milligrams of Paxil, 65 percent were dead by day four. In the 15 milligram group, 92 percent had died by the fourth day. Of the pups exposed to 50 milligrams, 100 percent were dead by day 4.

Eighty-eight percent of the pups born to mothers who received no Paxil were still alive at day four.

Autopsies were not performed on all the rats to figure out why they died or whether they had birth defects, and specifically heart defects.

After Tracey described the study in his opening statement, in regard to the product information that Glaxo was providing in April 2005, during her opening statement, Glaxo attorney, Varner, told the jury, “GSK in its label reported on the animal studies, including the death of the rat pups that you have heard so much about this morning.”

“I would like you to note three things about the discussion in the product information about the animal studies,” she said.

“First, there were no birth defects in the study,” she told he jury. “That is, there were no malformations or difficulties, structural difficulties, with the animals.”

“Second,” she said, “the rat pups who died shortly after birth were dosed at something like ten times the normal dose.”

“And, third, the dosing occurred not in the first trimester, the dosing occurred in the third trimester and continued throughout lactation,” Varner told the jury.

“You will hear expert testimony that the death of the rat pups is believed to have been due to a lactation problem,” she said, “it was during the lactation period that these pups died.”

While Healy was testifying, Tracey read part of a summary on the study that directly contradicted Varner’s claims in stating: “Females were dosed for 14 days prior to pairing, throughout the pairing period, during gestation and for those females allowed to litter during lactation.”

He then asked Healy whether the female rats were exposed to Paxil for more than just the third trimester. “Yes, they were,” Healy said. “They were actually exposed throughout the pregnancy and for a period of time before the pregnancy and after.”

He also told the jury that there were three major malformations in the Paxil exposed group, and “there may well have been more.”

“The figures from the studies do give grounds for concern that there were, in fact more,” he said, “far more.”

The fact that the more Paxil they got the more they died, “indicates that the drug has played a part … in whatever the cause of death is,” Healy told the jury.

“It’s clearly the drug that has caused the death,” he said. “What we aren’t clear from here is just what actually happened. Why they died.”

In 1980, Glaxo had a doctor by the name of John Baldwin review the Ferrosan rat and rabbit studies. In a March 20, 1980 memo to the company, Baldwin discussed the studies and further dispelled Varner’s claim that the rats received 10 times the normal dose.

“At first the examination of individual litter data, et cetera, supports the possibility of embryo lethality then this observation at nonmaternally toxic dose levels which are only three to six times the proposed human dose could contraindicate the use of Paroxetine in pregnancy,” Baldwin wrote.

“That means that this appears to be grounds for concern from the work that Dr. Baldwin has reviewed,” Healy told the jury.

“That Paxil is a drug that if it comes on the market, may cause birth defects,” he said. “So that it would be classified with the drug like Accutane where the drug would have to come on the market contraindicated.”

Which “would mean in this case,” Healy said, “do not use the drug in women of childbearing years unless, for instance, they’re using some form of birth control.”

Another portion of Baldwin’s memo stated: “On the other hand, if the embryonic death is unrelated to treatment, we would have to repeat the study at higher dose levels to produce some maternal or embryonic/fetal effect. There remains the possibility of this compound could be teratogenic at higher dose levels.”

“This means that Dr. Baldwin is saying there is a real risk here from the data that we have that this drug may cause birth defects,” Healy told the jury. “We need to do more work to actually before it’s out, does the drug come with this risk or not.”

“He says we need to check and see if the company that has made this drug has conducted this extra research or are in the process of doing the extra research or not,” Healy said. “The implication being that if they haven’t done it, we should.”

In reviewing the documents for the case, Healy found nothing to show that Glaxo ever did the studies that Baldwin was talking about. “I know they did further studies, but I don’t think they did anything to address the issues that were raised by 295, 296, 297,” he said. “Or if they did, they kept it well hidden it would seem.”

Yet nine years after he wrote the memo, Baldwin published a 1989 paper on the reproductive toxicology of Paxil in a journal called, “Active Psychiatric Scandinavia,” and stated: “There appeared to be no selective effect on the embryo or any signs of teratogenicity.”

Baldwin “appears to be saying here that there is no evidence that the drug causes birth defects,” Healy told the jury. “That appears to me to be incompatible with the data that we reviewed earlier.”

Baldwin’s paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989.

Incriminating Data Destroyed

During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: “It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993.”

Healy told the jury that he had done studies for Glaxo and other major pharmaceutical companies and he still had the raw data 15 or 20 years later. “From my work on the serotonin system back in the early ’80s, almost 30 years ago,” he said, “I still have the raw data.”

“The idea that I would destroy the data is almost inconceivable,” Healy stated.

People may be concerned about a particular study and want to go back and look at the books, he said. “It’s a bit like auditing a major company like Enron.”

But it’s “even more important actually in science,” Healy told the jury. “People with a different point of view need to be able to say, look, show me the data.”

They may “even suspect that I didn’t do the study,” he said, “so a defense for me is to be able to say here are the notebooks, here are the clinical records.”

So you have to “be prepared to have all sorts of challenges,” he told the jury. “But for that to happen, the notebooks, the clinical records, the lab notebooks must be there.”

Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. “I believe there were efforts to try and find the microfilms, but they have not been found,” he said.

Healy explained that when studies are done, there are a set of procedures called “good laboratory practice,” or GLP.

“And it is hoped these days when a company brings a drug to the market,” he said, “that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice.”

“And part of the requirements here of good laboratory practice is that the raw data is maintained,” he told the jury.

Later in Healy’s testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under “maintenance of records,” stated “this material will be stored,” and the “material will not be discarded or released from these laboratories without the sponsor’s prior consent.”

Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus.

During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil.

A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs. Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony.

Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C.

When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company “do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born,” she said.

“Cross-fostering is … taking rats from treated mothers and putting them with a control rat that didn’t receive the drug,” she explained to the jury. “So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born.”

The FDA asked Glaxo to submit a protocol for the study, “for our concurrence,” before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study.

She testified that such a study “would have helped to address where the negative effects were coming from.”

While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam’s mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester.

The label stated: “in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester.”

Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label “implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester,” she testified.

The label is saying “there is no evidence of teratogenic effects,” she said, “that means that it’s safe for the first trimester. “

“If a physician were to read this, they would be more likely to prescribe it early in pregnancy,” she told the jury.

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com)

Filed under: 2010, Birth Defects, ghostwritten, Glaxo, Kilker, KOL, Paxil, Paxil birth defect litigation, SSRIs, Vickery

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