The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Lawmakers Catch Glaxo Hiding Paxil Suicide Risks – Again (Part I)

Evelyn Pringle February 12, 2008

GlaxoSmithKline recently received greetings from a Congressional Committee, asking the company to explain the findings in a report unsealed last month in a lawsuit which shows that Glaxo knew as early as 1989 that Paxil increased the risk of suicidal behavior in patients by more than 8-fold compared to patients who received a placebo.

In a February 6, 2008 letter, Senator Charles Grassley (R-Iowa), ranking member of the Senate Finance Committee, is asking Glaxo to explain why the American public was never adequately informed of this risk until May 2006 in a “Dear Healthcare Professional” letter which reported a “higher frequency of suicidal behavior” associated with Paxil as compared to placebo.

The report showing the 8-fold suicide risk, by Harvard instructor and psychiatrist Joseph Glenmullen, was unsealed on January 18, 2008, by a federal judge in a US District Court in Sacramento, California in the Paxil suicide case of O’Neal v SmithKline Beecham d/b/a GlaxoSmithKline, filed by the surviving family members of 13-year-old Benjamin Bratt.

Dr Glenmullen was retained as an expert in the case by the California-based Baum, Hedlund, Aristei & Goldman law firm.

On January 30, 2008, the court dismissed the lawsuit on the basis of the Bush Administration’s new preemption policy, largely unknown to most Americans, which says that once the FDA approves a drug and its label, citizens may not sue a company for failing to warn about a risk not listed on the label, even in cases like this where the plaintiff can prove that the company knew about the risk and intentionally concealed it.

SSRI’s are antidepressants known as selective serotonin reuptake inhibitors and include Paxil, Eli Lilly’s Prozac, Zoloft by Pfizer and Celexa and Lexapro marketed by Forest Labs. Wyeth’s Effexor, Lilly’s Cymbalta and Glaxo’s Wellbutrin are not considered SSRI’s, but they also carry a warning about an increased risk of suicidality in young people.

Two SSRI suicide cases are now awaiting a joint decision from the Third Circuit Court of Appeals for which oral arguments took place in December 2007.

In the case of Colacicco v Apotex, the US District Court for the Eastern District of Pennsylvania was the first to dismiss a failure-to-warn claim based on the new preemption policy, and in McNellis v Pfizer, the US District Court for the District of New Jersey found no preemption.

Also unbeknownst to most Americans, the Bush Administration is instructing judges to dismiss the lawsuits against the SSRI makers in amicus briefs filed by the government’s top attorneys, who also attend hearings when necessary to argue on behalf of the SSRI makers during oral arguments on motions to dismiss.

In fact, in regard to requiring a warning about suicide, during oral arguments in the Third Circuit, Bush Administration attorney Sharon Swingle told the court that the FDA “had again and again and again made an expert determination that the warning was not appropriate.”

She maintained that the claims were preempted because the SSRI makers were not allowed to add warnings to the label under any circumstances without prior approval from the FDA.

At one point, the court asked an attorney for an SSRI maker, “assume for the moment that you had reasonable evidence of an association between your product and a serious hazard or a serious possibility of an enhanced suicide risk.”

Under federal regulations, “what would be your obligation?”

The attorney stated, “our obligation would be to take that information to the FDA, advise the FDA of the information.”

“It then would be the FDA’s determination whether that represented a substantial relationship,” he told the court.

“So if you had evidence internally that there’s an enhanced risk of suicide, you would go to the FDA,” the court said, and asked, “And how long would that take?”

“I do not know the answer to that, your Honor,” the attorney said, and the court asked, “Could it take months?”

“I imagine it would depend on the seriousness –,” the attorney stated.

“But isn’t there a significant possibility that additional people then might have the same consequence that happened here with McNellis, or with Colacicco and McNellis’s father?” the court asked.

The attorney said, “on the basis of the information that was available we would take it per FDA directive to the FDA and they would make the determination whether the label should be changed.”

“Other people could then,” the court continued, “possibly have an enhanced risk of suicide and other people may commit suicide as a result of taking your product?”

“We would be bound by law to comply with the FDA, then to comply with its directives,” the attorney replied.

“Are they requiring that you go through them first rather than act on your own?” the court asked.

“That’s exactly correct, your Honor, because there is the bigger issue of the –” the attorney stated.

However, at the end of the hearing, Pennsylvania attorney Derek Braslow proved beyond any doubt that the claims made by the Bush Administration attorney and the attorneys for the drug makers were blatant lies, when he informed the court that Glaxo had “independently, strengthened their warning in May 2004 to warn about increased suicidality and worsening depression in everyone, not just children.”

“There was specifically in bold letters a new warning with respect to increased suicidality and worsening depression in May 2004,” he stated.

“Glaxo changed the label on their own without FDA approval,” Mr Braslow told the court.

Glaxo did it again in May 2006, he said, when they sent out a “Dear Healthcare Professional” letter and warned about the increased risk of suicidality and suicidal behaviors with Paxil in persons of all ages.

During oral arguments in the O’Neal case on January 21, 2008, Glaxo’s preemption argument was presented by King & Spalding attorney Mark Brown, who just happens to be a former Associate Chief Counsel for the FDA from the first Bush Administration.

The family intends to ask the court to reconsider the ruling in the O’Neal case, according to a statement by Baum Hedlund.

In his report, Dr Glenmullen sums up the inadequacy of the system, including the FDA, that allowed Glaxo to keep this vital information hidden from prescribing doctors and patients for nearly 2 decades and states, in part:

“One of the most sobering aspects of the story of Paxil-induced suicidality is that GlaxoSmithKline was not forthcoming with its data demonstrating the risk and regulatory agencies like the FDA did not take the initiative to get to the bottom of and expose the true risk.”

“Rather, the impetus came from attorneys and medical experts surprised by what they found in GlaxoSmithKline’s confidential documents, which only came to light through litigation.”

“The GlaxoSmithKline documents that have so-far made it into the public record have in turn been critical to educating patients, the public, and the media about the true risk. The media – particularly the BBC in England – played a crucial role in turning the tide in the history of Paxil-induced suicidality.”

According to Dr Glenmullen, “it was the diligent efforts of plaintiff’s attorneys that forced GlaxoSmithKline to divulge the inaccurate counting method to the FDA.”

Another leading expert on pharmacology, Dr Peter Breggin, warns that an 8-fold increased risk of suicidality in controlled clinical trials could mean 80-fold in actual practice. “We can’t determine exactly how much greater the risk will be in clinical practice but it will be astronomically greater,” he advises.

In actual practice, he explains, many patients are already suicidal when they start taking the drug, increasingly the likelihood that the drug can push them over the edge.

Despite the warnings to watch patients closely, Dr Breggin says, busy doctors do not monitor patients properly. He explains that they are almost never evaluated for suicidality and are often given multiple drugs at the same time, by doctors who know little about their adverse effects on the mind.

Glaxo is facing lawsuits from surviving family members of Paxil suicide victims all over the country and is attempting to use preemption to avoid public trials for good reason. The first case to go before a jury in Wyoming in 2001, involved a man who shot his wife, daughter and infant granddaughter before shooting himself after being on Paxil for just a matter of days.

The trial resulted in a verdict against Glaxo for $6.4 million after the jury weighed the expert testimony of famed pharmacologist Dr David Healy, who presented a summary of Glaxo’s hidden suicide data on Paxil, against the testimony of the industry-funded SSRI defender Dr John Mann, whose name appears on many of the studies issued over the years, some as late as 2007, that steadfastly proclaim that SSRI’s are not linked to suicide and should be prescribed to children.

In addition to Dr Healy’s revelations about hidden data showing that Glaxo was aware of the increased risk, Dr Mann’s credibility was likely weighed against the fact that he had received over $30 million in research funding from drug companies between the early 1990’s and the trial in 2001, which was brought out during his testimony by Houston attorney Andy Vickery.

Mr Vickery also established that, roughly 10 years and $30 million earlier, Dr Mann had published a paper stating that SSRI’s could increase suicidality in a small subset of patients.

In his report, Dr Glenmullen states that, since Glaxo had the original data in 1989 that showed a greater than eightfold increased risk, it should have warned doctors and patients about the risk “a decade-and-a-half ago when Paxil was first approved by the FDA.”

The report includes portions of an April 29, 1991 report, written by Glaxo psychiatrist Dr Geoffrey Dunbar, sent to the FDA in response to a specific request for information on suicidality in which Glaxo openly lies in stating: “analyses of our prospective, clinical trials for depression show that patients who were randomized to Paxil therapy were at no greater risk for suicidal ideation or behavior than were patients randomized to placebo or other active control therapies.”

Dr Glenmullen notes the importance of the date that this false data was submitted because the FDA had scheduled a hearing with a nine-member advisory panel for September 20, 1991, to discuss concerns raised a year earlier about the possibility of Prozac making patients suicidal. Paxil was not approved for use in the US until December 2002.

In his report, Dr Glenmullen points out that 5 of the 9 members on the advisory panel had conflicts of interest with drug makers and that 2 psychiatrists, Dr David Dunner of the University of Washington in Seattle and Dr Stuart Montgomery from England, had done research on Prozac for Eli Lilly, and later played crucial roles in Glaxo’s publishing of what he calls “bad” suicide numbers in the Paxil story.

Dr Glenmullen’s report includes portions of a September 19, 1991, memo distributed to over 20 senior staff the day before the hearing with a “Statement to be used to respond to inquiries re Paxil/Suicide,” which claims explicitly that during GlaxoSmithKline’s studies: “the incidence of suicide was lower among patients receiving Paxil than among those receiving placebo.”

This was the statement the company ordered employees to make, even though 5 patients on Paxil committed suicide while no patients in the placebo group did. In addition, Dr Glenmullen points out that, up to 1989, seriously suicidal patients were excluded from Glaxo’s studies, and therefore “anyone who became seriously suicidal during the studies only became so after being given Paxil or a placebo.”

Yet the actual numbers show that there were 40 suicide attempts in the clinical trials by patients taking Paxil compared to 1 suicide attempt in the placebo groups.

Despite the poor quality of the data available to the advisory committee, and despite the many conflicts of interest of its members, one third of the members still voted for a warning in 1991, Dr Glenmullen points out.

Three months later, in December 1991, Dr Dunner, together with Glaxo psychiatrist Dr Dunbar, presented Glaxo’s Paxil data with the “bad” numbers at a meeting of the American College of Neuropsychopharmacology (ACNP) in Puerto Rico.

During the presentation, the doctors told the ACNP: “Suicide and suicide attempts occurred less frequently with Paxil than with either placebo or active control,” according to the Glenmullen report.

The ACNP’s members are considered prominent academic psychiatrists who specialize in pharmacology, and the group has issued a number of position papers over the years which consistently denied a link between SSRI’s and suicidality.

Dr Mann led an ACNP task force which included Dr Fred Goodwin, Dr Charles O’Brien and Dr Robinson, which supposedly reviewed all the clinical trial data on SSRI’s and issued a consensus statement with the position that SSRI’s did not increase the risk of suicidal behavior, which was published in the journal Neuropsychopharmacology in 1993.

In March 1995, Dr Dunner, Dr Montgomery and Dr Dunbar published the paper, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo,” in the European journal Neuropsychopharmacology. This paper included a table with the “bad” numbers and claimed that other antidepressants were more likely to increase the risk of suicide than Paxil.

The paper specifically states: “Consistent reduction in suicides, attempted suicides, and suicidal thoughts, and protection against emergent suicidal thoughts suggest that Paxil has advantages in treating the potentially suicidal patients.”

On July 5, 1995, Glaxo’s marketing department issued a memo urging its sales force to use the Dunner-Dunbar paper to reassure doctors who were concerned over Paxil-related suicide that there was no need for concern.

The fact is, documents obtained in litigation prove that the FDA has known about the suicide risks of SSRI’s for roughly 23 years. Two years before Prozac was approved, in May 1985, the FDA’s chief investigator, Dr Richard Kapit, wrote: “Unlike traditional tricyclic antidepressants Fluoxetine’s profile of adverse side effects more closely resembles that of a stimulant drug than one that causes sedation.”

“It is Fluoxetine’s particular profile of adverse side-effects which may perhaps, in the future give rise to the greatest clinical liabilities in the use of this medication to treat depression,” he noted.

Dr Kapit’s review described data from 46 clinical trials with a total of 1,427 patients and under the section, “Catastrophic and Serious Events,” he listed 52 cases of “egregiously abnormal laboratory reports which were the reason for early termination,” and “additional adverse event reports not reported by the company were revealed on microfiche.”

“In most cases,” he wrote, “these adverse events involved the onset of an unreported psychotic episode.”

There were ten reports of psychotic episodes including 2 reports of completed suicides, 13 attempted suicides, 4 seizures, and 4 reports of movement disorders. In 1985, Dr Kapit recommended “labeling warning the physician that such signs and symptoms of depression may be exacerbated by this drug”.

When Prozac was approved, no such warning was issued.

Two weeks after the FDA advisory panel met in February 2004 to review the data on SSRI’s to determine whether they were linked to suicide, Dr Healy sent a report to Peter Pitts, Associate Commissioner for External Relations, at the FDA, in response to an invitation by Dr Robert Temple for a submission of the details of studies referred to in the course of a presentation at the meeting.

“A great number of the patient testimonies in the course of the Feb 2nd hearing were from individuals who became suicidal on an SSRI when their underlying disorder was Lyme Disease, migraine or a condition such as social phobia,” Dr Healy pointed out.

He also noted that this had been the case in the 1991 hearings, when it was framed by FDA’s Dr Temple as follows:

“The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category. But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.”

“The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it – that is not too surprising – it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it.”

Dr Healy’s analysis submitted to the FDA included the data from the pediatric trials on suicidality and hostility, including some that were concealed for years. To distinguish the difference between suicide caused by SSRI’s verses suicide caused by the underlying depression, he separated the data on children who were treated for depression and children who were treated for obsessive compulsive disorder or social phobia.

The analysis found that SSRI’s can cause some children who are not depressed to become suicidal when taking the drugs for other conditions. From a pool of 931 depressed patients taking SSRI’s versus 811 depressed patients taking placebo, Dr Healy determined that there were 52 suicidal acts by patients on SSRI’s versus 18 in the placebo group.

In a pool of 638 patients taking SSRI’s for other disorders versus 562 patients taking a placebo, there were 10 suicidal acts in the SSRI group versus 1 in the placebo group.

When these data sets were combined, there were 62 episodes of suicidality in the 1,569 patients on SSRI’s versus only 19 episodes in the 1,373 patients on a placebo.

In his submission to the FDA, Dr Healy also explained that he had conducted his own trial on Zoloft in 2000 with 20 “healthy volunteers,” meaning they had no mental disorder when entering the trial, and two of the Zoloft patients became suicidal. This type of study provides the strongest evidence of drug-induced suicidality because it’s impossible for drug companies to claim that a patient became suicidal as a result of the underlying depression.

Seven years ago, during the Wyoming jury trial involving the tragic Paxil-induced murder-suicide, the man’s physician testified that he may not have prescribed Paxil if a warning regarding homicide and suicide had been added to the drug’s label.

In his report released last month, Dr Glenmullen offers the following heart-wrenching conclusion to the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”

On April 24, 2004, the Lancet medical journal published an editorial entitled, “Depressing Research,” with the following comments that surely ring doubly true today for the Bratt family, as well as all the other families whose children committed suicide while on SSRI’s:

“It is hard to imagine the anguish experienced by the parents, relatives, and friends of a child who has taken his or her own life. That such an event could be precipitated by a supposedly beneficial drug is a catastrophe. The idea of that drug’s use being based on the selective reporting of favourable research should be unimaginable.”

Filed under: 2008, Baum, Braslow, Breggin, Colacicco, FDA, FDA hearing, Fraud, ghostwritten, Glaxo, KOL, Mann, Paxil, Preemption, SSRIs, Study 329, suicide, Vickery

American Kids Being Drugged To Death

Evelyn Pringle August 22, 2007

As result of the marketing power the pharmaceutical industry obtained by spending tens of billions of dollars to gain influence over politicians in power, the FDA and the medical profession, American kids are being pumped full of the most powerful and dangerous psychiatric medications on the market, in drug cocktails that are literally killing them.

Neurologist Dr Fred Baughman, author of “The ADHD Fraud,” calls the leadership of the psycho-pharm-government cartel (FDA, NIMH, White House New Freedom Commission on Mental Health) the biggest, most evil drug cartel in history. “At least the pusher of ‘crack’ on inner city streets does not come in a white coat,” he says.

According Dr Baughman, kids have become “for-profit receptacles” for psychiatric drugs which will forever alter their brains and bodies. And its happening all across America he says, not by thousands but by tens of thousands.

Experts say the drugging regime usually begins by doctors convincing parents that their children have attention deficit disorder, and the medications prescribed are the exact same drugs that street addicts call “speed.” They include the amphetamines Adderall, Dexedrine, and methylphenidates such as Ritalin and Concerta.

FDA records show that, between 1999 and 2003, seventy-eight million prescriptions were written for ADHD drugs for children ranging in age from one to 18. A review of adverse events posted on the FDA web site reveals that, between January 2000 and June 30, 2005, there were nearly 1,000 reports of psychosis or mania possibly linked to ADHD drugs, with psychosis characterized by the inability to distinguish real and imaginary events.

“The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD,” according to a March 3, 2006, memo penned by two members of the agency’s ADHD psychiatric review team.

FDA records also show reports of 25 deaths in children and adults between 1999 and 2003, and 54 cases of serious cardiovascular problems, including stokes, heart attacks, hypertension, palpitations and arrhythmia. But according to Dr Baughman, in addition to the deaths cited by the FDA, the MedWatch database also contains 186 more deaths of persons using ADHD drugs for the period between 1990 and 2000.

Dr Grace Jackson, author of “Rethinking Psychiatric Drugs: A Guide for Informed Consent,” says that “whether by ignorance or design, the FDA remains oblivious to the evidence-based limitations of ADHD drugs.”

She notes that at least 40% of children fail to respond or tolerate stimulant therapy, “and about twice as many respond at least as well to non-pharmacological interventions.”

“The link between stimulants, cardiovascular disease, and death,” Dr Jackson reports, “is well documented but doctors and government regulators have refused to acknowledge the dangers associated with the drugs.”

The long-term outcomes for kids on ADHD drugs, she says, show diminishing effects over time, including “artificial behavioral improvements” which end when the medication is withdrawn.

Because stimulant drugs cause insomnia, sleeping pills are now being fed to children to counteract the insomnia side effect. Medco Health Solutions, a managed-care firm, found an 85% increase in the use of sleeping pills among children between 2002 and 2004.

One of the world’s leading authorities on psychiatric drugs, Dr Peter Breggin, founder of the International Center for the Study of Psychiatry and Psychology and the journal Ethical Human Sciences and Services, warns that all ADHD drugs can cause “a continuum of stimulation, which includes agitation and irritability, anger, hostility, disinhibition, hypomania and mania.”

The activation syndrome, he says, was observed decades ago with the amphetamines like Adderall and Dexedrine, and methylphenidates such as Ritalin and Concerta.

As an unrecognized side effect to most doctors, the syndrome more often than not results feeding the kids more drugs. As a child’s emotional control breaks down due to the stimulant effects, Dr Breggin says, mood stabilizers such as antiseizure medications and antipsychotics may be added to the mix. “Eventually,” he states, “these kids end up on four or five psychiatric drugs all at once and toddlers are even being diagnosed with bipolar disorder.”

The new generation of “atypical” antipsychotics, originally approved only to treat adults with schizophrenia and bipolar disorder, which include Zyprexa (Eli Lilly), Risperdal (Johnson & Johnson), Seroquel (AstraZeneca), Abilify (Bristol-Myers Squibb), Clozaril (Novartis) and Geodon (Pfizer), were not approved for any condition in children, but studies of Medicaid records and HMO databases found an alarming increase in the use of these drugs by kids, particularly for behavioral disorders such as ADHD, according to the spring 2006 issue of the Journal of Ambulatory Pediatrics.

Researchers led by Dr William Cooper at Vanderbilt University analyzed data on health care services rendered in the US and found that between 1995 and 2002, there were 5,762,193 outpatient visits where children between the ages of 2 and 18 were prescribed an antipsychotic.

The researchers explained that there had been no increase in mental disorders and noted that, “schizophrenia and psychosis accounted for only 13.5% of the total antipsychotic visits during the study period, so this diagnosis alone could not explain the increase.”

A USA TODAY analysis of the FDA’s adverse event reporting system between 2000 and 2004 found at least 45 deaths of kids where the “primary suspect” was an atypical and more than 1,300 reports of other serious side effects.

Dr Breggin has served as an expert witness in several cases that resulted in favorable verdicts for the plaintiffs in which Risperdal caused a condition known as tardive dyskinesia in children, when it was prescribed in attempt to control behaviors that were in fact caused by ADHD drugs.

He explains that tardive dyskinesia is a neurological movement disorder that is often mistaken for a mental illness because the symptoms are so “strange” and “bizarre.” The abnormal movements, he says, can affect any muscle group in the body and impair the ability to speak, walk, breathe and swallow.

According to Dr Breggin, this serious disorder occurs at a cumulative rate of between 4% and 7% in otherwise healthy patients taking antipsychotics each year and after only a few years, 20% or more of patients will be afflicted.

The drug makers have apparently found ways to influence the prescribing habits of Canadian doctors, because the new antipsychotics are now being doled out in record numbers to Canadian children for behavior and mood problems, with a significant proportion for children under nine, according to new research from Canada.

On June 18, 2007, Sharon Kirkey of CanWest News reported that ninety-four per cent of 176 child psychiatrists in Canada surveyed are prescribing the antipsychotics for a variety of disorders and symptoms, including anxiety, attention-deficit hyperactivity disorder and “poor frustration tolerance,” citing a study in the Canadian Journal of Psychiatry

Risperdal was the most commonly prescribed, followed by Zyprexa and Seroquel. The report said that a “surprising” number of the prescriptions were for the very young, with 12% written for children aged eight or under, including three-year-olds, and noted that none of the drugs has been officially approved for use in children in Canada.

Lilly, J&J and AstraZeneca are currently named as defendants in Medicaid fraud lawsuits related to the illegal off-label marketing of Zyprexa, Risperdal and Seroquel, filed to recover money paid for patients’ use the drugs, as well as the costs of medical care for patients injured by them.

In addition, investigations in several states have recently started looking into the behind-the-scenes financial relationships between the drug makers and some of the doctors who have been heavily involved in promoting the prescribing of the drugs for off-label uses.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, Breggin, drugging children, SSRIs

Evelyn Pringle July 24, 2007

On July 27, 2007, Bush’s Big Pharma friendly CDC issued a press release clearly aimed at increasing the sale of SSRIs to pregnant women. “Use of certain antidepressants, selective serotonin-reuptake inhibitors most commonly known as SSRIs, during pregnancy does not significantly increase the risk for most birth defects,” the CDC wrote.

The press release cited a new CDC study released in the New England Journal of Medicine and further stated, “a second study on SSRI and birth defects, also published in the June 28 issue of NEJM, did not find such an association with birth defects overall, but did find significant associations between specific SSRIs and several birth defects.”

Since the CDC put out the press release, hundreds of headlines have flooded the internet citing the new studies as proof that there is a low risk of birth defects with SSRI use during pregnancy, and the results of the studies have been reported as breaking health care news by every major media outlet in the US.

The pharmaceutical industry as a whole has spent a fortune buying influence in the media since 1997, when the government lifted restrictions on direct-to-consumer advertising.

In an article titled, Physicians and Bribery, published by News Target on July 7, 2005, Dani Veracty says the real story about prescription drugs is not being told because the drug makers are controlling the budgets of the major media companies by pumping hundreds of millions of dollars into TV, magazine, newspaper and online advertising.

“Because of this,” he states, “the media companies out there don’t want to say anything bad about these prescription drugs.”

In the July-August Columbia Journalism Review, contributing editor Judy Lieberman, reported that at the end of 2004, drug-company ad revenue for Time Magazine totaled $67 million; for Newsweek $43 million; and for The New York Times took in $13 million.

By 2004, she reported, advertising revenues for the five networks including CNN and Fox news was $1.5 billion.

The drugs in the NEJM studies included Prozac by Eli Lilly, Zoloft from Pfizer; Paxil by GlaxoSmithKline, Celexa and Lexapro from Forest Labs; Luvox by Solvay, Effexor by Wyeth, and generic SSRI makers include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

Prior to the arrival SSRIs on the market, depression was estimated to affect only 100 people per million and patients with depression sought help from a medical professional trained in psychiatry and the treatment of disorder.

However, the rate of depression is now estimated to be in the range of 50,000 to 100,000 cases per million, or between a 500 to 1,000-fold increase, according to Jane Currie in the Marketization of Depression, in the May 2005 journal Women and Health Protection.

In April 2004, the CDC reported that antidepressants topped the list of drugs prescribed to women at visits to doctor’s offices and outpatient departments, followed by estrogens and progestins, antiarthritics, and medicines for acid/peptic disorders, in the Journal of Women’s Health.

By 2005, the CDC recently reported, antidepressants were the most prescribed drugs in the US during visits to doctors and hospitals and were prescribed far more often than even medications used to treat high blood pressure, cholesterol, diabetes, and headaches.

Yet, a recent analysis of studies on the efficacy of 12 second-generation antidepressants including SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), released on January 25, 2007, by the Agency for Healthcare Research and Quality’s (AHRQ), a division of the US Department of Health and Human Services, offers little support for the wide-spread use of these medications.

The AHRQ reviewed efficacy in treating major depressive disorder, dysthymia and subsyndromal depression (including minor depression), and also evaluated comparative efficacy for maintaining remission and for treating accompanying symptoms such as anxiety or insomnia or neurovegetative symptoms.

The review included 187 studies deemed to be of good or fair quality, including 89 head-to-head randomized controlled trials, 57 placebo-controlled randomized studies, with 126 of the studies sponsored by drug companies and 17 funded by government agencies or independent sources, and analyzed the effectiveness of Cymbalta, Wellbutrin, Effexor, Celexa, Lexapro, Prozac, Luvox, Remeron, Serzone, Paxil, Zoloft, and Desyrel, many of which are now also sold in generic form.

Overall the analysis found that in controlled studies, during 6 to 12 weeks of treatment, well over a third of the patients, or 38%, saw no improvement in their condition and 54% had only partial improvement and did not achieve remission.

In light of this clear lack of efficacy, it should be noted that as early as August 2004, the FDA label for SSRIs warned that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric”

According to one of the world’s leading experts on SSRIs, Dr Peter Breggin, author of The Antidepressant Fact Book, “few physicians realize that meta-analyses have shown that antidepressants work no better than placebo at lifting depression.”

So in the case of pregnant women he says, “The risk/benefit ration weighs a placebo effect against increased parental suicide and violence, and babies with congenital defects, babies undergoing withdrawal reactions, and babies whose brains have been forever changed by being soaked in SSRIs during their development.”

Dr Breggin also notes that the NEMJ researchers failed to consider the serious withdrawal reaction in newborns and the potentially disastrous consequences of SSRI use by pregnant women. “Withdrawal reactions confirm that the brain of the fetus has been bathed in SSRIs and that it has suffered significant functional changes,” he warns.

“It should be no surprise that it is not good to bath the growing brain in toxic drugs like SSRIs,” he says, “because serotonin is intimately involved in the development of the brain in utero and SSRIs inhibit normal brain cell development.”

Experts say, SSRI use creates an unnecessary risk for fetus. Dr David Healy, another leading authority on SSRIs, and the author of “The Creation of Psychopharmacology,” and “The Antidepressant Era,” says, “the overwhelming majority of women who are prescribed SSRIs are at little or no risk for suicide or other adverse outcomes from their nervous state.”

He points out that every pregnant woman may have symptoms of depression such as anxiety, disturbed sleep, fatigue, or a loss of interest in sex. “But having depressive symptoms and being depressed are two different things,” he states.

Dr Healy also notes the lack of efficacy shown with SSRIs, and says the risks of the neonatal withdrawal syndrome and serious birth defects to the infant far outweigh any benefits of their use by expectant mothers.

Houston Attorney, Robert S Kwok, is outraged by the new campaign to promote the use of SSRI with pregnant women. “It’s ludicrous to think a woman is at greater risk of depression during her pregnancy and should take antidepressants despite the proven risk to her developing fetus,” he states, “yet physician “opinion leaders” with industry ties are actively trying to convince doctors and patients of just that.”

Mr Kwok represents the family of Gavin Shore, a baby born with a severe cardiac defect known as Shone’s Anomaly after his mother was prescribed the SSRI Celexa during pregnancy and says Gavin’s mother was not warned that taking an SSRI could double the risk of her baby being born with a severe heart defect.

Although some of the reports citing the NEMJ studies in media mentioned that Glaxo money was involved in funding the CDC study, most neglected to mention the financial contributions of the other drug companies for the study, or the steady stream of drug money that flows to the medical facilities and researchers involved in the studies.

When combined, the named universities, hospitals and researchers involved have received money from Lilly, Pfizer, Wyeth, Glaxo, Aventis, Sanofi Pasteur, and the 3 companies that make generic versions of SSRIs.

The CDC study lists Harvard Medical School and Massachusetts General Hospital as participating and the Harvard Medical School receives nearly 25% of its funding from non-government sources, including nearly $3.5 million from Aventis Pharmaceuticals, $2.5 million from Bristol-Myers Squibb, and $2.1 million from Merck, according to an April 12, 2006 report in The Phoenix.

In addition, The Phoenix noted, SEC filings showed Harvard stock holdings of $16 million with Merck, $8 million of Bristol Myers Squibb, $34 million of Johnson & Johnson, and $33 million of Pfizer.

In one NEJM study, Dr Jan Friedman reported receiving honoraria for consulting from I3 Research, which is actually a huge conglomerate of “research” firms with names that begin with i3. The April 12, 2006 Phoenix reported that a firm called i3 Innovus, which co-authored 16 medical-journal articles in 2005, “provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle.”

The Phoenix also noted that this i3 firm had a Boston office for its vice-president of US operations, Milton Weinstein, who also happened to be a professor at Harvard Medical School and Harvard School of Public Health.

The same group of industry backed research institutions credited in the NEJM CDC study, began the disinformation campaign to boost the sale of SSRIs to pregnant women more than a year ago when “experts” at Harvard and Mass General published a study to intentionally dilute the finding of a mounting number of studies that found serious birth defects to be associated with the use of the drugs by pregnant women.

In response to a study in the February 2006, New England Journal of Medicine that showed infants exposed to SSRIs in the womb were 6 times more likely to be born with the life-threatening lung disorder, persistent pulmonary hypertension, a study appeared in the Journal of the American Medical Association the same month warning that stopping SSRIs could greatly increase the risk of pregnant women relapsing into depression.

On February 1, 2006, the Associated Press described the methods used by the Massachusetts gang when conducting the JAMA study and said researchers “followed 201 pregnant women with histories of major depression who were taking drugs such as Prozac, Zoloft, Effexor and Paxil.”

“Because of ethical concerns,” the article said, “the researchers did not randomly assign the women to either stop or continue medication.”

Instead, the AP reported, the women decided what to do and then the “researchers watched what happened.”

But the actual report on the study shows that of the 201 participants, 13 miscarried, 5 terminated their pregnancy, 12 were lost to follow-up prior to the end of pregnancy, and 8 chose to withdraw from the study.

So when reporting on the few pregnant women that remained, the study said mothers were 5 times more likely to suffer a relapse than those who continued taking the drugs.

However, a highly relevant finding rarely mentioned, in what turned out to be this wee little study, is that 26% of the women who remained on the drugs became depressed anyways.

The study authors noted that of the 82 women who continued antidepressant treatment throughout pregnancy, 21 or 26% relapsed. But there were only 65 women in the group that discontinued the drugs, so the results logically showed a higher rate of relapse when 45 became depressed.

Moreover, nearly 2 years before the study was published in JAMA, on January 13, 2004, the lead author, Dr Lee Cohen was quoted in the New York Times as saying about 75 to 80% of pregnant women who go off antidepressants will relapse during the pregnancy.

Six months after JAMA ran the study, the July 11, 2006 Wall Street Journal explained why the 13 “experts” might encourage pregnant women to keep taking SSRIs, in stating the lead author, Dr Cohen, who was a Harvard Medical School professor and director of the research program at Massachusetts General, was a longtime consultant to the 3 antidepressant makers, a paid speaker for 7, and his research work was funded by 4 drug companies.

In fact, the Journal reported, “the study and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants,” and “the authors failed to disclose more than 60 different financial relationships with drug companies.”

And just like clock-work, the Cohen’s study was widely cited in other journals promoting the sale of SSRIs to pregnant women. “In summary, it seems clear that the risks of not receiving adequate antidepressant treatment thus far outweigh the risks of adverse events, not only in infants but in mothers as well,” wrote Dr Pierre Blier of the University of Ottawa in editorial in the Journal of Psychiatry and Neuroscience, 2006;31(4):226-8.

“The population,” he warned, “should therefore learn to fear the illness more than the antidepressant.”

But as it turns out, Dr Blier conflicting interests included among others, being a consultant with Lilly, Forest Labs, Janssen, Wyeth and Sanofi-Aventis, and a contract employee with Forest Labs. He was also in the speaker’s bureau for Lilly, Forest Labs, and Wyeth, and received grant funding from Lilly, Forest Labs and Wyeth.

The JAMA study, along with a brief note from Dr Cohen himself, was also featured in the Spring 2006 issue of Massachusetts General Hospital’s Center for Women’s Health Newsletter, in a publication that downplayed the risk of just about all the birth defects discovered in recent years including heart birth defects and the infant withdrawal syndrome.

Since 1990, JAMA has required authors of studies to list all financial interests and has published the disclosures. In an online editorial in July 2006, JAMA editor, Dr Catherine DeAngelis announced her intention to enforce the policy in part by publicizing any author’s failure to follow the rules and specifically noted that 3 consecutive nondisclosures involved authors from Harvard Medical School and included Dr Cohen’s study.

On July 11, 2006, citing material promoting the events, the Wall Street Journal reported that the Massachusetts General psychiatry academy planned to conduct Continuing Medical Education seminars in a dozen cities across the US, with Dr Cohen overseeing a segment on the treatment of pregnant women with psychiatric disorders.

One of the funding sources for the seminars was revealed less than a year later on May 1, 2007, when the Journal reported the major recipients of the $11.8 million that Eli Lilly gave out during the first three months of 2007, and said the largest single grant “was $825,000 to Massachusetts General Hospital’s psychiatry department for a year-long educational program with more than 150,000 registrants.”

It should be noted that Lilly introduced the first SSRI, Prozac, in the late 1980s and its current best-selling antidepressant Cymbalta earned the company $1.3 billion in 2006.

The financial ties between the researchers and SSRI makers was brought to the attention of the JAMA editor by Dr Adam Urato and a letter from Dr Urato was also published in JAMA, stating that being the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

However, all that being said, the Cohen study is still being cited to promote the use of SSRIs with pregnant women, and as recently as April 26, 2007, in a paper by Dr Claudio Soares, director of Women’s Health Concerns Clinic, McMaster University, Ontario in Journal Watch Women’s Health, a publication put out by the NEJM.

“Results of a recent prospective study of pregnant women,” he wrote, “who were taking antidepressants at or near the time of conception demonstrated that women who opted to discontinue treatment during pregnancy were five times more likely to relapse than were those who stayed on treatment.”

“Despite the cautionary remarks commonly made by most regulatory agencies and medical societies about the use of psychotropic medications during pregnancy,” Dr Soares states, “considerable data supporting the efficacy and reproductive safety of antidepressants have accrued.”

“Conversely,” he warns, “evidence suggests that untreated depression has negative consequences for both mother and child.”

“In summary,” Dr Soares states, “clinicians should bear in mind the mounting evidence about the adverse effects of uncontrolled depression during pregnancy.”

But here too, Dr Urato, wrote a response to this obvious sales pitch objecting to the total lack of citations to studies that support the assertion that the risks of birth defects associated with SSRI are rare and that the benefits of SSRIs use to avoid relapse into depression outweigh the risks.

But most concerning, Dr Urato wrote, “is the complete lack of financial disclosure information to go along with the article.”

“As I was reading this piece,” he wrote, “I kept thinking to myself “‘Boy, this sounds like it was written by someone working for the antidepressant makers.'”

And sure enough, Dr Urato found that Dr Soares is on the Speaker’s Bureau for Forest Labs, Wyeth, Glaxo, and Pfizer and has received honoraria as a research consultant for Sepracor, Glaxo, Wyeth, and Neurocrine.

Mr Kwok is also highly critical of the increasingly common practice of using “opinion leaders” like Dr Soares to sell SSRIs to pregnant women, but states, “there will come a time when the drug manufacturers will have to face the music on SSRIs causing PPHN, and that time is coming soon.”

He says his firm has an abundance of new cases that prove it’s no coincidence that pregnant mothers on SSRIs have an increased likelihood of giving birth to babies with PPHN in families where there is no history of respiratory illness.

“Just yesterday,” Mr Kwok states, “I spoke to a mother who birthed a baby with a serious breathing disorder that requires regular use of a nebulizer, a device used to administer medication via liquid mist to the airways, commonly used in treating asthma and other respiratory diseases.”

“This young mother is now at risk of losing her job,” Mr Kwok reports, “since her infant requires full time care.”

He says doctors should be instructed to screen patients who are pregnant or planning to become pregnant and inform them of the risks of SSRIs to a developing fetus. “At least educate this “class” of women,” he says, “so they may make informed personal decisions.”

“Sure, the loss of this “class” may cost the drug manufacturers some profit,” he notes, “but it’s the right thing to do and it will save many families a lifetime of torture caring for a sick child like we see over and over again.”

The need to recapture pregnant women as customers is crucial for some SSRI makers. For instance, Forest Labs reported that Lexapro and Celexa accounted for 68% of the firm’s total sales for the year ending March 31, 2006, in its Annual Report filed with the SEC.

Back in May 2005, researchers from the University of Pittsburgh estimated that in any given year at least 80,000 pregnant women in US are prescribed SSRIs, in JAMA.

(This article is written as part of a series on Celexa related litigation and is sponsored by Robert Kwok & Associates, LLP)

Filed under: 2007, Birth Defects, Breggin, CDC, DTC, KOL, Kwok, SSRIs

CDC Leads SSRI Disinformation Media Blitz

Evelyn Pringle July 20, 2007

In a June 27, 2007 press release that made headlines all over the world the US Centers for Disease Control announced that birth defects associated with the use of antidepressants by pregnant women are rare. As proof for this claim, the CDC cited two new studies published in the New England Journal of Medicine.

Over the following 2 weeks hundreds of stories magically appeared in newspapers with headlines splashed all over the internet and “medical experts” appeared live on all the major television networks to tout the new studies as major health “news” in a well-coordinated media blitz clearly aimed at promoting the sale of selective serotonin reuptake inhibitor antidepressants (SSRIs) to pregnant women.

The well-coordinated blitz downplayed all the serious birth defects that have been reported in numerous studies over the past several years and all the warnings issued by the FDA over the past several years about the fetal harm known to be associated with the drugs.

The antidepressants included in the NEJM studies included Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

The public needs to know that the CDC study was funded in part by GlaxoSmithKline, the maker of Paxil, which carries the strongest FDA warnings about birth defects developing in infants exposed to the drug in the womb.

Experts point out that the hundreds of headlines failed to disclose the best kept secret about SSRIs – that the drugs do not work. “When tested in head-to-head competition it would take more space than a newspaper article will permit to explain how hard the researchers have to “work” to “prove” that these antidepressants work at all,” says SSRI expert, Dr Grace Jackson, author of “Rethinking Psychiatric Drugs: A Guide for Informed Consent.”

A fact also not mentioned in the headlines is that the studies were limited to women who took the drugs during the first trimester of pregnancy and the research consisted of mostly phone conversations that took place years ago with women who relied on their own memories without reviewing any medical records or actual pharmacy prescription data.

Most importantly, experts say, the researchers diluted the FDA warning about studies that found babies exposed to SSRIs after the 20th week of pregnancy, have a 6-fold increased risk of developing persistent pulmonary hypertension, a life-threatening lung disorder.

On July 19, 2006, the agency issued a Public Health Advisory and said, “the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.”

The Advisory warned that: “Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies” and “Babies with PPHN can be very sick and may die.”

On October 16, 2006, the first PPHN related lawsuit was filed against Glaxo on behalf of the family of an infant born with the disorder after exposure to Paxil in the womb, by Attorney Karen Barth Menzies, a partner in the Baum Hedlund law firm and the leader of the firm’s Antidepressant Litigation Department.

According to Ms Menzies, “FDA regulations require Glaxo to issue stronger warnings whenever there is reasonable evidence of an association between a serious risk and Paxil.”

She points out that research indicated the risk of PPHN in a study published more than 10 years ago on October 3, 1996, in the New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego.

“FDA regulations specifically state that a causal link need not be proven and allow Glaxo to issue a new warning without prior FDA approval,” Ms Menzies notes.

She reports that infants born with PPHN often require mechanical assistance to breath but 10% to 20% of infants do not survive even when they receive treatment.

The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.

The headlines about the NEJM studies in the media were also misleading because the researchers did find that Zoloft and Paxil were associated with “significant increases” in specific birth defects, and stated the “current study suggests that specific SSRIs may increase the risk of specific birth defects, and further studies will need sufficient power to pursue these important clinical questions.”

Heart birth defects in infants exposed to Paxil were found to occur 3 times more often and heart defects were 2 times higher in newborns exposed to Zoloft. The CDC researchers reported that by using an “embryologically based classification” of heart defects, “we found a doubling of the risk of septal defects” associated with Zoloft use, and “a tripling of the risk of right ventricular outflow tract obstruction defects” associated with Paxil.

The studies also found a nearly 6-fold rise in the risk of clubfoot in children of women who used Paxil and reported other birth defects including (1) anencephaly, (2) craniosynostosis; and (3) omphalocele.

Anencephaly, a neural tube defect where much of the brain does not develop, was found to be 2.4 times higher, and omphalocele, a condition in which the infant’s intestine or other abdominal organs protrude from the navel was 2.8 times more prevalent overall and 6.4 times higher with Paxil.

Craniosynostosis, an abnormality in which connections of the skull bones close prematurely, was found to be 2.5 times greater, and the neural tube defect, spina bifida, a condition where the spinal column does not completely close in the first month of pregnancy, was also noted.

Experts warn that far more infants will be born with birth defects in the coming years as a result of tens of thousands of infants being exposed to SSRIs in the womb every year.

In addition to birth defects, many other serious adverse events have been found to be associated with SSRIs over the past decade. Studies have shown the drugs to be linked to suicidality, violent and homicidal behavior, abnormal gastrointestinal and uterine bleeding, fertility problems, sexual dysfunction, a decrease in bone density, and a severe withdrawal syndrome in patients and infants born to mothers taking the drugs.

The risk associated with depression in pregnancy is suicidality. But one of the world’s leading authorities on SSRIs, Dr Peter Breggin, reports that SSRIs are known to increase the risks of suicide. “In fact,” he says, “the new FDA labels for antidepressants specifically warn about SSRI-induced suicidality in youth and in young adults, the very group most likely to become pregnant.”

“The SSRIs not only threaten to cause the death of the mother through suicide but the death of the child through lethal birth defects as well,” Dr Breggin advises.

As a direct result of the industry’s control over the mainstream media, the public is never properly warned about serious risks found to be associated with a drug because if the story gets told at all, it will only be in the news for a day or two, and then “medical experts” will suddenly show up on “news” programs for 2 or 3 days in a row to present what amounts to an infomercial to discount the risks reported in the study.

The industry’s control of the media began back in the late 1990s when the ban on direct-to-consumer advertising was lifted. Since then, the industry has invested so much money in advertising that all the media companies in the US are now dependent on drug money.

Due to this control, the industry paid shills are now dispatched on a regular basis to disseminate false information about the risks and benefits of a drug using the public airwaves even when an advertisement that contained the same bogus information would result in the sanction of a drug company for presenting false and misleading information to the public.

Drug companies basically bribe the medial journals to print their studies because the editors know the company will purchase thousands of copies for distribution to prescribing doctors, with full knowledge that most doctors will never read the whole study, but will remember the misleading headline because it was published in the “reputable” medical journal.

And Big Pharma funnels money to researchers in a variety of ways. Dr Marcia Angell, a nationally recognized authority on medical ethics and a former editor of the New England Journal of Medicine, had this to say in a the NEJM in 2000, about the financial ties between the industry and researchers:

“The ties between clinical researchers and industry include not only grant supports, but also a host of other financial arrangements.

“Researchers also serve as consultants to companies whose products they are studying, join advisory boards and speakers bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings”

After a rigged study is planted in a medical journal, the next step in the marketing scam is to provide a favorable report on the findings, also ghost-written by the drug maker or a PR firm, in a press release that is sent out to all the major news outlets which guarantees that headlines about the results will appear all over the world.

From there, the company uses the media to plant feature stories to reinforce the headline of the press release and in many cases, the news articles will quote the information verbatim from the drug maker’s press release.

In the final act, the media provides the company with a platform for the “medical experts” to reach consumers to tout the new study on all the major networks in “news” segments which in turn sends patients running to their doctors with news of the miraculous new findings and demanding a prescription for the drug.

In the book, “Trust Us We’re Experts,” by Sheldon Rampton and John Stauber, the authors document the many techniques used by PR firms hired to pump out propaganda through the press and refer to the mainstream media as the “disinfotainment industry.”

They report that the psychiatric manipulation industry is enormous and pays out about $10 billion a year to propaganda experts and that about 40% of all stories in the media are planted by PR firms.

Because most news stories on radio and TV are nothing more than a rehashing of stories published in newspapers, the book notes, the news Americans receive every day amounts to nothing but propaganda.

The success of the media backed campaign to sell SSRIs to pregnant women by discounting the years of studies showing serious harm to the fetus is clear evidence that “disinfotainment industry” is still paying high dividends to all shareholders in the US.

Filed under: 2007, Baum, Birth Defects, Breggin, CDC, KOL, Paxil, PPHN, SSRIs

FDA Advisory Committee Schedules Hearing on SSRIs and Suicide

Evelyn Pringle December 5, 2006

The FDA’s Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants.

The panel is expected to vote on whether the risk of suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.

The fact is, the FDA has known about the increased suicide risk associated with SSRIs for over 15 years as evidenced at a September 20, 1991, hearing, at which FDA official Dr Robert Temple stated:

“The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category.

“But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.

“The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it – that is not too surprising – it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it.”

Yet here it is nearing the end of 2006, and the FDA is still refusing to provide a logical answer to explain why people who were not depressed before taking SSRIs would all of a sudden commit suicide after taking the drugs.

Top experts from all over the US and abroad will be testifying at the hearing and for many it will be a repeat performance. For instance, Baum Hedlund attorney, Karen Barth-Menzies, will be testifying again. She has been battling SSRI makers for over a decade and as a result, she has obtained internal company documents that show the SSRI makers were fully aware of the increased suicide risks associated with SSRIs but instead of warning the public, they continued to promote SSRIs as safe and effective with children and adults.

“Through our Paxil litigation,” Ms Menzies says, “we obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children.”

“That’s about as reprehensible as you can get,” Ms Menzies says.

“The manufacturers of the SSRIs,” she states, “have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the ‘disease.'”

“This is notwithstanding clear evidence,” Ms Menzies says, “very early on in the clinical trials of these drugs that they can cause these problems.”

“We have documents,” she notes, “obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI, Prozac, was approved for marketing in this country.”

Over the past 10 years, in addition to representing thousands of clients in SSRI lawsuits, Ms Menzies has been a tireless advocate working to increase public awareness about the host of health risks now known to be associated with SSRIs.

After listening to her testimony before the FDA Advisory Committee in 2004, a California state Senator invited Ms Menzies to work on legislation designed to inform California healthcare providers and parents about the increased risk of suicidality in children and adolescents taking SSRIs.

She also testified at a hearing in August 2004, before the California State Senate and called for better patient informed consent on the risks associated with SSRIs.

Ms Menzies has given presentations at medical conferences in the US and other countries to warn healthcare professionals about the dangers of SSRIs.

In fact, she gave one presentation that directly addressed the FDA’s mishandling of the SSRI matter titled, “Federal Preemption – How the U.S. Food & Drug Administration Has Become an Advocate for the Drug Industry Against the Consumers It Has a Duty to Protect” – SSRIs and Collisions Between Medical, Legal and Regulatory Worlds, at the 29th International Congress On Law and Mental Health, in Paris, France, on July 2-8, 2005.

Another one of the world’s most highly respected experts on SSRIs, Dr David Healy, a professor at the Department of Psychological Medicine, at Cardiff University in North Wales, will be traveling from the UK to testify. His appearance will also be a repeat performance.

Dr Healy states that he will testify about the manipulation of the scientific data on SSRIs. “We have here,” he says, “the greatest divide in medicine between the raw data on an issue on the one side and the published accounts purporting to represent those data on the other.”

“The divide,” he says, “it is important to note, only came to light as a result of the efforts of journalists and lawyers.”

“No clinician or scientist had a hand in questioning the validity of the ‘science’,” he points out.

The most famous fraudulent study involving SSRIs is GlaxoSmithKline’s study 329, involving Paxil. The study stated that Paxil was safe, well-tolerated and effective in children, but noted that some children became emotionally “labile” while taking the drug.

“In the published version of 329,” Dr Healy points out, “suicidality vanishes under a carpet of emotional lability.”

Few readers of this paper, academic or lay, he says, would have realized what lay behind this term as it appeared in the paper. “The question of what was happening to children,” Dr Healy says, “deemed to have become emotionally labile, was picked up by journalists and lawyers rather than scientists or regulators.”

As a result of Glaxo’s application for a license for the use of Paxil to treat children with nervous disorders, he explains, the raw data from clinical trials were lodged with a number of national regulators.

“Within a fortnight of seeing the raw data in May 2003,” Dr Healy says, “after the events lying behind the term emotional lability had been clarified, the regulators in the UK issued a warning against the use of Paxil for minors.”

A few weeks later, he notes, Glaxo wrote to all doctors warning that Paxil was linked to suicidality and that withdrawal from the drug was also linked to an apparent doubling of the rate of suicidality.

“This reassessment of the data does not however represent a triumph of scientific method,” Dr Healy says, “it indicates rather a crisis triggered by media concerns.”

The final nail in the coffin as far as selling SSRIs to kids in the UK, came in December 2003, when British regulators issued a position statement that said none of the SSRIs had demonstrated efficacy in treating depression in children.

By far the most damning revelations about what SSRI makers knew about the link between SSRIs and suicide came when the British Medical Journal received internal company documents from an anonymous source that left no doubt that Eli Lilly knew about the suicide risks with Prozac years before the drug was FDA approved.

After receiving the documents, the BMJ sent them to officials at the FDA, and to US Congressman, Maurice Hinchey, who in turn sent them to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of, “Talking Back to Prozac,” and “The Anti-Depressant Fact Book.”

After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert witness in Prozac litigation and discussed when testifying during a trial in 1994.

Evidence of the hidden studies showing the suicide risk can be found in a May 1984 document presented at trial which states regarding Prozac: “During the treatment with the preparation 16 suicide attempts were made, 2 of these with success.”

“As patients with a risk of suicide were excluded from the studies,” the document says, “it is probable that this high proportion can be attributed to an action of the preparation.”

In fact, a March 29, 1985 document says that the rate of suicide with Prozac was 5.6 times higher than with the other medication imipramine and went on to state:

“The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine than to imipramine, so that the higher incidence of suicide attempts may be tolerable.”

On November 13, 1990, a memo from a Lilly employee in Germany, Claude Bouchy, to another Lilly employee, Leigh Thompson, regarding the adverse drug event reporting of suicide and Prozac written in response to Lilly’s request that he change the event “suicidal ideation” to “depression,” Mr Bouchy writes:

“Hans (Lilly employee) has medical problems with these directions and I have great concerns about it.

“I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation.”

A second memo dated November 14, 1990, from Mr Bouchy to Leigh Thompson about adverse drug event reporting states: “I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation.”

The documents also reveal how worried Lilly was about the commercial impact to the company if the truth about the Prozac-induced suicides got out. A February 7, 1990 Leigh Thompson Memo, says, “Anything that happens in the UK can threaten this drug in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation.”

On February 7, 1990, a Leigh Thompson memo also says, “I hope Patrick (a Lilly employee) realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that.”

Dr Breggin says that after he testified in the trial in 1994, these documents seemed to just disappear, until they were handed over to the BMJ.

Filed under: 2006, Baum, Breggin, Eli Lilly, FDA, FDA hearing, Glaxo, Paxil, Prozac, SSRIs, Study 329, suicide

ADHD Experts Head to Washington – Is the FDA up to the Task?

Evelyn Pringle March 14, 2006

Heavy-hitters from across the country are heading to Washington this month to debate representatives of the pharmaceutical industry during FDA hearings on the controversy surrounding the over-prescribing of attention deficit drugs to children.

The International Center for the Study of Psychiatry and Psychology (ICSPP) will be represented by five of the leading experts on attention deficit disorders at the FDA’s Pediatric Advisory Committee’s meeting on March 22, to include Dr Fred Baughman, Dr Peter Breggin, Dr S DuBose Ravenel, Dr Grace Jackson, MD, and Dr David Stein. These experts combined have authored hundreds of books, papers and reports on attention deficit disorders.*

And all five have one common goal; to put an end to the drugging for profit of the nation’s most vulnerable citizens and pharma’s most lucrative customer base – innocent children.

Dr Baughman says drugging kids is commonplace today. “Its happening all across country not by thousands but tens of thousands, picking most on the disenfranchized, powerless,” he warns.

“These children become for-profit receptacles for psychiatric drugs,” he says, “which will, undoubtedly alter their bodies and brains.”

The harm caused by these medications is well-documented. Although the FDA staff reports shows 51 deaths between 1999-2003 in persons using ADHD drugs, according to Dr Baughman, the MedWatch database contains 186 deaths between 1990 and 2000. Because only 1% to 10% of all adverse events are reported to the FDA, the actual number of deaths is known to be much higher.

Studies have determined that ADHD drugs endanger the cardiovascular system and according to Dr Jackson, “the cardiovascular risks of stimulants are hardly new.”

“As early as 1977,” she says, “Drs. Vernon Fischer and Hendrick Barner documented the cell changes associated with heart muscle enlargement in a chronic consumer of Ritalin.”

“The connection between stimulants, cardiovascular disability, and death has long been documented in the medical literature,” Dr Jackson notes, “but physicians and government regulators have refused to acknowledge the hazards associated with prescriptions.”

Dr Jackson takes exception with FDA officials who say warnings on ADHD drugs are unnecessary and that their benefits outweigh their risks.

“Whether by ignorance or design,” Dr Jackson states, “the regulators remain oblivious to the evidence-based limitations of the prescription pad: at least 40% of all children fail to tolerate or respond to stimulant therapy; about twice as many respond at least as well to non-pharmacological interventions; and, as documented in the National Institute of Mental Health’s most prestigious study to date (the MTA study), the long term outcomes for medicated children demonstrate diminishing returns over time, persistent suppression of growth (about 1 cm per year), and artificial behavioral improvements which dissipate when treatment is withdrawn.”

“Not surprisingly,” she says, “the world community observes the United States with alarm for the unjustified chemical exploitation of those who are different, but not diseased.”

Dr David Stein also rejects the pill solution, and promotes a parent training program called the caregivers’ skills program that helps children learn appropriate behavioral and cognitive skills permanently, without drugs. For over twenty-five years, he has conducted workshops providing realistic, practical and effective alternatives to stimulant medications.

Dr DuBose Ravenel agrees with Dr Stein’s overall assessment that “this behavioral syndrome likely represents basically a culturally derived phenomenon rather than a biological or neurological one.”

He stresses the importance of providing positive reinforcement for appropriate behavior while dealing with oppositional behavior and encourages fellow professionals to employ Dr Stein’s approach when dealing with children with attention deficit problems.

ADHD drugs are known to have serious adverse psychological effects on children which is one of the main reasons Dr Breggin is dead against giving stimulants to kids. “That we are doing this,” he says, “I believe, is ethically and scientifically wrong.”

“We’re the only country in the world, along with Canada, that is doing this to such massive numbers of our children,” Dr Breggin notes. “It’s a reflection not on our children, but on ourselves as parents and as teachers.”

Dr Breggin describes an all too common occurrence in recent years. “As the child’s emotional control breaks down due to medication effects, mood stabilizers may be added,” he explains. “Eventually, these children end up on four or five psychiatric drugs at once and a diagnosis of bipolar disorder by the age of eight or ten,” he says.

In addition, there is now a mountain of evidence that stimulants disrupt growth hormone production on a daily basis and that they also can reduce the child’s overall growth, including height and weight, according to Dr Breggin.

“All stimulants impair growth,” he notes, “not only by suppressing appetite but also by disrupting growth hormone production.”

“This poses a threat to every organ of the body, including the brain, during the child’s growth,” Dr Breggin warns. “The disruption of neurotransmitter systems adds to this threat.”

“It is hard to imagine a more serious warning flag than growth inhibition,” he says, “since it affects the overall growth of the body and all its organs, including the brain.”

Its a well documented fact that the pharmaceutical industry funnels money to front groups, which in turn fund marketing campaigns and come out to do battle at times like this when drug company profits are threatened and scrutinized.

On February 15, 2006, Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), the leading Pharma backed front group responsible for pushing ADHD drugs issued a press release criticizing the FDA Advisory Committee’s recommendation last month to add black box warnings to the labels of stimulant drugs.

In the press release, E Clarke Ross, identified as CEO of CHADD stated: “The committee’s recommendation to include warning language about rare and unproven cardiac health risks on medications used to treat ADHD is premature, at best, and could unnecessarily alarm patients and clinicians.”

“The committee,” the press release continued, “directed by the FDA to decide how to move ahead with additional research on the medication’s safety, endorsed future studies, trials and surveys for both pediatric and adult patients.”

Clarke said the committee “approved the unsolicited recommendation to include warning language on patient inserts and labels.”

On March 13, 2006, the Shreveport Times published an article by Terry Davis, that seems to directly address the issue raised by CHADD, which began with the question: “Do drugs used to treat attention deficit hyperactivity disorder need a black box warning because of reports that they may cause sudden death?”

Ms Davis was a member of the FDA advisory committee that decided last month that they did. In the article she explains the reasoning behind the decision.

“The panel felt the parents of the 2.5 million children taking medication such as Ritalin or Adderall – the 1.5 million adults also on these medicines, as well as their physicians – need to be alerted about the drugs’ significant risks,” she wrote.

“The advisory panel was also concerned that ADHD drugs are overused,” she said and noted that more than “30 million prescriptions – valued at $3.1 billion – are filled annually.”

“ADHD medications help,” Ms Davis acknowledged, “however, they are also known to increase blood pressure and heart rate and may increase risk of stroke and arrhythmia in adults,” she said.

She pointed out that last year, “25 people, mostly children, died suddenly after taking these prescribed drugs.”

In light of this logical explanation, CHADD’s criticism of the panel’s recommendation is obviously unwarranted but hardly surprising.

The group bills itself as the nation’s largest patient education group for persons affected by ADHD, and says it provides consumer, patient, and professional information. But those familiar with the marketing tactics of ADHD drugs know all about CHADD’s long history of concerted effort to increase drug company profits through the sales of stimulants.

According to Dr Baughman, as far back as 1995, the DEA was contacted by the United Nations International Narcotics Control Board (INCB), about the financial ties between CHADD and Ciba-Geigy, the manufacturer of Ritalin at the time.

The INCB discovered CHADD had received over $775,000 from Ciba-Geigy and charged the organization with being a vehicle for marketing a controlled substance to the public in violation of the international statute known as the Controlled Substances Act of 1971.

Ritalin is classified as a Schedule II medication. In order for a product to be classified as a Schedule II drug under the Federal Controlled Substances Act, it must meet three criteria: one, it has to have a high potential for abuse; two, it has to have a currently accepted medical use in treatment in the US; and three, it has to show that abuse may lead to severe psychological or physical dependence.

It seems CHADD was lobbying the Drug Enforcement Agency to get Ritalin removed from the Schedule II class and moved into a less controlled group to make the drug easier to buy.

“They couldn’t do anything more valuable for the drug company, and more dangerous to the public,” according to Dr Baughman.

However, it’s lobbying failed, in part because of the disclosure about CHADD receiving so much money from the drug companies, according to Dr Breggin.

After conducting its own research, the DEA not only refused to reclassify the drug, on May 16, 2000, the agency issued a report to Congress that said Ritalin use had reached epidemic proportions, and that it was being abused as a recreational drug.

DEA told Congress that police were reporting that Ritalin was being stolen, sold and traded on playgrounds, as well as snorted, injected, and cut much like any other amphetamine. Although the DEA presented a thorough report, nothing was done to slow the sale of Ritalin to children.

And nothing changed as far as CHADD’s employment status as a major pusher for Pharma either. For the fiscal year 2002-2003, the group’s financial statements showed it received more than $670,000 from various drug companies.

In the November 29, 2004 Alternet article “Drug Companies Pushing ADHD Drugs for Children,” reporter Kelly Hearn further discussed the ties between CHADD and the drug companies in an interview with Dr William Pelham, director of the Center for Children and Families at State University of New York at Buffalo, a leading ADHD researcher for 30 years, and a former advisory board member of McNeil Pharmaceuticals, which markets the ADHD drug Concerta.

Over his career, Dr Pelham has written more than 250 research papers on ADHD, and in 2002, he even received a lifetime achievement award from CHADD.

However, he has few good words to say about CHADD, regulatory officials, medical professionals, or anybody else involved in selling ADHD drugs to children.

“In recent years,” Dr Pelham told Alternet, “I have come to believe that the individuals who advocate most strongly in favor of medication – both those from the professional community, including the National Institutes of Mental Health, and those from advocacy groups, including CHADD – have major and undisclosed conflicts of interest with the pharmaceutical companies that deal with ADHD products.”

“I believe that parents of ADHD children and the public at large should be made aware of this situation,” he told Ms Hearn.

According to Dr Breggin, front groups like CHADD use pharma money in several marketing techniques that increase the sale of drugs. “They put out newsletters and other information that praise medications,” he says.

“Sometimes,” he notes, “they actively suppress viewpoints that are critical of drugs – for example, by discouraging the media from airing opposing viewpoints.”

Representatives of CHADD showed up at the FDA hearings last month and the group will no doubt be out in full force this month ready to go head to head against pharma’s number one enemy – the advocacy groups opposed to the mass drugging of children for profit.

Filed under: 'ADHD', 2006, addict, Breggin, CHADD, FDA hearing, front groups

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