The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Relentless and Tragic Marketing: Psychiatric Drugs from Before the Cradle to the Grave

by John Breeding, PhD and Amy Philo

Working with others, we strive to alleviate distress and to support and enhance the personal growth, transformation, individuation, self-determination, and clear and expanded awareness of individuals. Necessity dictates that we also spend a lot of time challenging aspects of the mental health profession that do the opposite—creating more distress, suppressing growth and transformation, violating self-determination, and dulling and blinding awareness. We call it psychiatric oppression, the systematic, institutionalized mistreatment of those judged as “mentally ill.” This essay focuses especially on the ever expanding encroachment of psychiatric oppression to more and more of the population, and to individuals who are less and less in need of actual help. This encroachment takes the form of mass marketing for psychiatry and the pharmaceutical industry. One key aspect of oppression theory is the claim to virtue. For psychiatric oppression that claim is the notion that mentally ill people need their treatment; its growing extension is the concept of prevention, that potentially mentally ill people need treatment as well!

The Regressive Progression: Treatment to Prevention

“An ounce of prevention is a pound of cure.” Like all great aphorisms, this one, often associated with Ben Franklin, holds wisdom and is partly true, based on assumption. In this case, one must assume the role of victim of unnecessary malady that necessitates a cure…and that there is a felt connection or empathic relatedness to the one who suffers malady. Where these assumptions are not met, the aphorism is false. To wit, for the giant corporation of Halliburton and its government and military operations group, or for the mercenary army of Blackwater, going to war is worth a great deal more than diplomacy.

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Weighing Benefits of SSRIs Against Suicide Risk

Evelyn Pringle December 8, 2006

Before the FDA’s Psychopharmacologic Drugs Advisory Committee begins the discussion at the December 13, 2006, public hearing on the suicide risks associated with selective serotonin inhibitor antidepressants, it should get honest with the audience and openly admit that the SSRIs do not even work.

Medical professionals maintain that in order to justify the use of a drug, its benefits are supposed to outweigh its risks and therefore, there should be a discussion of exactly what benefits result from the use of SSRIs, in any population, that would outweigh the suicide risks associated with this class of medications.

The most popular SSRIs sold in the US include Paxil, Prozac, Zoloft, Lexapro and Celexa.

As far as the benefits of the various SSRIs, an April 2002 study in the Journal of American Medical Association compared the effectiveness of Zoloft, St John’s Wort, and a placebo and found that the placebo treated patients had the highest rate of remission of symptoms at 31.9%, and Zoloft’s 24.8% was barely better than the rate of remission with St John’s Wort of 23.9%.

The FDA’s own records on Celexa (citalopram) show the agency knew the drug to be ineffective when it was approved, and the agency based its approval on 2 marginally positive studies out of a total of 17 conducted.

A March 26, 1998, memorandum by Thomas Laughren, of the FDA’s Psychiatric Drug Products, notes a total of 17 clinical trials on Celexa, including 2 uncontrolled trials, 6 active controlled trials showing no difference between treatments, and 2 placebo controlled trials that were too small to be considered studies.

Dr Laughren’s memo discusses 5 short-term trials (85A, 91206, 86141, 89303, and 89306) and 2 long-term studies (89304 and 89305). “In summary,” he wrote, “I consider studies 85A and 91206 positive support for the claim of short-term antidepressant efficacy for citalopram.”

“While 3 other placebo-controlled short-term trials (86141, 89303, and 89306) were negative, and not easily interpretable since there were no active control arms,” he stated, “I feel there were sufficient reasons to speculate about the negative outcomes and, therefore, not count these studies against citalopram.”

Dr Laughman also counted 2 relapse prevention trials as effective to support the drug’s approval. “Overall,” he wrote, “I consider these results sufficient to support claims of both short-term and long-term antidepressant effectiveness of citalopram.”

However, other FDA officials were not so eager to stretch the truth about the weak studies with medical professionals and consumers. For instance, a May 4, 1998 memo by Paul Leber, Director of the Division of Neuropharmacological Drug Projects, on the subject of “Approvable Action on Forrest Laboratories NDA 20-822 Celexa,” said the pubic had a right to know the truth about all the trials submitted to the FDA for the approval of Celexa.

He advised that the drug labeling should not only describe the trials that showed Celexa’s adequate effects; but should also describe the “well controlled clinical studies that failed to do so.”

Dr Leber specifically pointed out that Study 86141, Study 89303, and Study 89306, all failed to provide results confirming the positive findings of Studies 85 and 91206, the two clinical trials that Dr Laughman listed to support the approval of Celexa.

“I am aware that clinical studies often fail to document the efficacy of effective drugs,” Dr Leber wrote, “but I doubt the public, or even the majority of medical community, are aware of this fact,” he said.

“I believe that labeling,” he stated, “that selectively describes positive studies and excludes mention of negative ones can be viewed as being potentially “false and misleading.””

“I believe it is useful for the prescriber, patient, and 3rd party payer to know,” Dr Leber wrote, “without having to gain access to official FDA review documents, that citalopram’s antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects.”

“I am persuaded,” he stated, “they not only have a right to know, but should know.”

When Forest Labs got Lexapro approved in 2002, it was nothing more than a chemically altered version of Celexa, and Forest Labs spent a fortune on persuading doctors to switch patients to Lexapro before its top selling drug Celexa lost its patent protection in 2004.

At the time, Forest could point to only one lone study, that the company itself paid to have published that claimed Lexapro was any better than Celexa. The paper, by Dr Jack Gorman, of the Mount Sinai School of Medicine, pooled the results of three studies and concluded that Lexapro “may have a faster onset” than Celexa, according to a report by Melody Peterson in the November 22, 2002 New York Times.

Dr Gorman’s paper was published in CNS Spectrums, a medical journal he edits, and Forest paid Medworks Media, a small medical marketing company that publishes the journal, to print the article in a special supplement.

Other researchers disagreed with the study results. “The Medical Letter, a nonprofit newsletter respected for its independence from the pharmaceutical industry,” Ms Petersen reports, “reviewed the same clinical trials as Dr. Gorman and concluded … that Lexapro had not been shown to be better than any other antidepressant, including Celexa.”

As for Paxil, in June 2004, New York State Attorney General, Eliot Spitzer, charged GlaxoSmithKline, with fraud for hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.”

According to Mr Spitzer, Glaxo published only one of 5 studies it conducted, and even that one showed mixed results.

Prozac (fluoxetine) was also known to be ineffective before it was approved for use in the US. While serving as an expert witness in a lawsuit, psychiatrist and SSRI expert, Dr Peter Breggin, author of, “Talking Back to Prozac,” reviewed a July 1985 in-house analysis by its maker, Eli Lilly, that showed Prozac had failed to demonstrate efficacy in clinical trials with patients taking Prozac verses a placebo or a tricyclic antidepressant.

“When this potential economic disaster for Eli Lilly was discovered,” Dr Beggin reports, “the FDA allowed the company to include in its efficacy data those patients who had been illegally treated with concomitant benzodiazepine tranquilizers in order to calm their over stimulation.”

“Basically, Prozac was approved in combination with addictive benzodiazepines such as Ativan, Xanax, and Valium,” he says, “but neither the FDA nor the drug company revealed this information.”

“With these patients included,” he states, “statistical manipulations enabled the FDA to find the drug marginally approvable.”

An internal Lilly document dated March 29, 1985, says, “The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits.”

Medwatch is the reporting system by which adverse events involving prescription drugs are reported to the FDA. Within one decade of Prozac’s arrival on the market, there were 39,000 adverse event reports submitted to Medwatch and that number is said to represent only about 1% of the actual number of adverse events, according to an April 22, 2006 report by the Citizens Commission on Human Rights.

Serious questions about the possible link between suicide and SSRIs began in 1990, when Martin Teicher, of McLean Hospital in Massachusetts, reported on 6 patients who he said experienced “intense, violent suicidal thoughts” after taking Prozac.

He offered three possible theories for the increased suicidality: (1) SSRIs gave patients more energy before lifting their depression, allowing them to act on a suicidal impulse; (2) the drugs worsened depression in a small subset of patients; or (3) SSRIs caused a state of agitation and restlessness.

In a February 10, 1990, report titled, “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” Dr Teicher said, “The purpose of this report is to suggest the surprising possibility that fluoxetine may induce suicidal ideation in some patients.”

“In our experience,” he wrote, “this side effect has occurred in 3.5% of patients receiving fluoxetine.”

Throughout the 1990s, Eli Lilly publicly denied that Prozac was associated with suicide or violence, but by the year 2000, the company had quietly paid an estimated $50 million to settle over 30 lawsuits, according to an Indianapolis Star investigation.

When reviewing Lilly’s studies on Prozac, Dr Breggin found that there were 12 suicide attempts in the Prozac group verses only one in the placebo group and one in the tricyclic antidepressant group, but that many of the suicide attempts were hidden under false categories.

“Even after the company winnowed out six of the suicide attempts,” Dr Breggin says, “the remaining 6:1 ratio was alarming.”

He also reviewed a November 8, 1998, study titled, “Activation and Sedation in Fluoxetine Clinical Trials,” that showed a 38% rate of stimulation in the patients taking Prozac, even though, he says, many patients were sedated and many parameters of stimulation were not counted.

Another group of documents that he examined, contained a study conducted by the FDA on increased spontaneous post marketing reports of “hostility” and “intentional injury” by patients on Prozac. “These documents,” Dr Breggin says, “were generated shortly before the 1991 FDA PDAC meeting that evaluated antidepressant-induced suicidality.”

For this study, the FDA used the antidepressant, trazodone, as a control and found a 24-fold relative increase of reports of hostility and intentional injury per prescription of Prozac when compared to patients on trazodone.

“The spike in Prozac reports,” Dr Breggins says, “occurred even before any public controversy surrounding Prozac and violence.”

The documents he reviewed also contained graphs showing a 40-fold relative increase in reports of suicide attempts, overdose, and psychotic depression, in patients on Prozac compared to patients on trazodone.

“In one memo,” Dr Breggin reports, “a Lilly employee expresses shame and regret about hiding this data.”

In the case where Dr Breggin testified, Lilly was able to have the records sealed by the court where they remained hidden for roughly 10 years.

On April 10, 2004, the British Medical Journal, citing Jurendi et al, criticized the authors of studies on SSRIs for exaggerating benefits and downplaying their harm and noted a clinical trial of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only two in children in the placebo group.

But the Paxil suicide risk does not only apply to children. An August 22, 2005, study by Norwegian researchers found that Paxil also increases suicide risk in adults. In the study of over 1,500 adults, 7 Paxil patients attempted suicide compared to only one attempt in the group of patients on a placebo. The researchers recommended that the warning not to prescribe Paxil to children should be extended to adults.

In Insight News, on October 4, 2002, investigative reporter, Kelly Patricia O’Meara, author of, “Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills That Kill (2006),” revealed a study conducted by Dr Arif Khan, medical director of the Northwest Clinical Research Center in Bellevue, Washington, that disclosed the number of suicides committed or attempted by patients in the clinical trials on SSRIs, that were kept hidden from doctors and consumers.

For the study, Dr Khan examined the official clinical drug-trial data for all SSRIs approved by the FDA between 1985 and 2000.

According to Ms O’Meara, the rate of suicides in the general public is 11 in 100,000, but the incidence rate for people participating in the SSRI trials was 718 for every 100,000. Dr Kahn’s research also revealed that nearly 4% of study participants attempted suicide within the following year.

As for weighing the benefits against the above risks, the British Medical Journal published a study on July 16, 2005, by Joanna Moncrieff, senior lecturer in psychiatry at University College London, that found SSRIs no more effective than a placebo in reducing depression.

The study also found that trials on SSRIs with negative results were less likely to be published than those with positive results, and that even in the published trials, negative outcomes were often not presented.

Dr Moncrieff said she found “no good evidence that these drugs work.”

Filed under: 2006, Celexa, Effexor, Forest, Lexapro, Paxil, Prozac, Spitzer, SSRIs, Study 329, suicide, Teicher, Zoloft

Mental Illness Epidemic Hits US

Evelyn Pringle December 6, 2006

In the run-up to the December 13, 2006, meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, to review the suicidality data from adult SSRI studies, a host of newly identified disorders have been popping up in the media, all treatable with SSRIs.

The committee is expected to vote on whether the association between the selective serotonin reuptake inhibitor antidepressants and suicide in adults should be included in a Black Box warning label on all SSRIs, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.

In light of all these new SSRI treatable disorders in the news, advocates who have been campaigning for the Black Box warning are wondering whether the SSRI makers have received some kind of inside information from the FDA, or the advisory committee members, that is not known to the public.

In fact, its quite possible that the public will have no access to any information that will be discussed at the hearing until the last minute, because the FDA announcement says: “The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site.”

Critics say it seems odd that drug makers would be pouring money into studies to increase the use of SSRIs by finding new “disorders” to add to the DSM, at the very same time that stronger warnings to doctors and consumers on the use of the drugs are being considered.

The ever-expanding Diagnostic and Statistical Manual for Mental Disorders, was released in 1952, and had about 106 different mental disorders. It has since gone through 5 revisions and now has about 375.

The next version of what is referred to as the “Psychiatric Billing Bible,” is not due out until 2011, but there are definite sightings of new “disorders” already on the horizon.

For instance, to the “untrained eye,” a person afflicted with one of the newly identified ailments would probably be viewed as a typical and harmless everyday slob; but GlaxoSmithKline is apparently getting ready market Paxil as a cure for what a new study estimates to be 2 million everyday slobs in the US.

On November 10, 2006, HealthDay News discussed the study, published in the Journal of Psychiatric Research, that said Paxil is effective in treating people with a condition called “compulsive hoarding syndrome.”

The researchers claim it has 3 main features: (1) severe anxiety prevents patients from throwing out seemingly worthless items; (2) patients are prone to acquiring things, sometimes leading to buying sprees; and (3) there is excessive clutter in the patient’s home and work spaces.

Indecisiveness, procrastination and disorganization are also listed as other symptoms. Although the syndrome is found in patients with other diseases, such as dementia, Alzheimer’s, schizophrenia and anorexia, the researches note, it is most often seen in patients with obsessive-compulsive disorder (OCD).

According to Healthday, the research team is not yet certain whether compulsive hoarding is a subtype of OCD, or a separate disorder. The study included 79 patients with OCD, and 32 were found to have “compulsive hoarding syndrome.”

The good news is that the researchers say that both the hoarding and non-hoarding patients showed significant improvement in their symptoms when treated with Paxil.

Moving on to the next earth-shaking discovery, a study from Stanford University, in the October 2006, American Journal of Psychiatry, measured the prevalence of the dreaded, “compulsive buying disorder,” and found that more than 1 in 20 adults in the US suffers from this ailment.

On October 3, 2006, the New York Times reported that compulsive buying is not a recognized psychiatric diagnosis, “but it is now being considered for inclusion in the next edition of the Diagnostic and Statistical Manual of Mental Disorders.”

Lorrin Koran, a professor at Stanford, and senior author of the study, told the San Francisco Chronicle on October 13, 2006, that the results were a surprise. “It was thought previously that this was a disorder that primarily affects women,” he said. “It turns out that it afflicts almost as many men.”

The study found that about 6% of women and 5.5% of men show symptoms of “compulsive buying disorder,” which is characterized by “an irresistible, intrusive and often senseless impulse to buy.”

A finding that doubles the number of “compulsive buying” patients had to be good news for Forest Laboratories, the company that not only paid for the study, but believes its top money making SSRI drugs, Lexapro and Celexa, can be used to treat the disorder.

“My hope,” Dr Koran told the Times, “is that people who think they have this disorder will seek help because available studies suggest that psychotherapy or medications help many compulsive buyers to stop.”

Critics say from an economic stand point, the amount of money that could be saved by seeking treatment would depend on the shopaholic. If weekly therapy sessions cost $200 and the prescription for Lexapro runs $250 a month, a patient might end up in the hole.

Then there is the little-known disorder called “night-eating syndrome,” discussed in an article titled, “Midnight munchies can signal big problems,” in the October 26, 2006 Courier-Journal.

“Those who skip breakfast, eat more than half the day’s calories after dinner and sometimes wake up and snack likely have this condition,” the Courier reported.

“It’s characterized by hormonal imbalances,” the article says, “that lead to disturbed patterns of sleep and eating.”

But help can be found in the old reliable SSRIs here as well. “Research at the University of Pennsylvania has found the antidepressant Zoloft helped,” the Courier reports, “along with therapy to change eating and exercise patterns.”

Considering the recent estimates that more than a third of all Americans are considered obese, with a good PR firm, Zoloft sales could go through the roof if the “night-eating syndrome,” gets enough publicity because according to the Courier, “some research has found that up to 28 percent of obese people have it.”

Zoloft is on a roll. In the October 2006, Journal of Clinical Psychiatry, researchers reported that low doses of Zoloft taken for 2 weeks before the menstrual period may be an effective treatment for moderate-to-severe premenstrual syndrome, or PMS.

Pfizer already managed to get Zoloft approved for the treatment of premenstrual dysphoric disorder (PMDD), referred to as a severe form of premenstrual syndrome.

Apparently, this study is meant to snag customers among the gals whose suffering is less severe. By the way, Pfizer paid for the study that found its drug helpful for PMS.

As for recruitment efforts aimed at the other gender, according to Health Day News on September 9, 2006, “SSRIs, which are used to treat depression and other psychiatric disorders, are now also used “off-label” as a treatment for premature ejaculation.”

However, the article reports that experts say continued use of SSRIs can have negative side effects, such as psychiatric problems, skin reactions, weight gain, and loss of libido.

But not to be discouraged, researchers have gone ahead and developed a new SSRI, dapoxetine, just for premature ejaculation. “This is the first drug specifically developed for premature ejaculation,” lead researcher Dr Jon Pryor, a professor and chairman of urologic surgery at the University of Minnesota, told Health Day News.

In a study, after 12 weeks, men taking a 30-milligram dose of the drug increased their time to ejaculation to 2.78 minutes, and men receiving a 60-milligram dose went for 3.32 minutes. For men taking a placebo, the time to ejaculation averaged 1.75 minutes.

Dr Pryor thinks this study will get people talking about the problem. “I hope this paper brings premature ejaculation out of the closet,” he told Health Day News.

Moving on to the next SSRI miracle, in what is sure to be an extremely successful widening of the customer base for Paxil and Effexor, doctors at the University of Rochester Medical Center, now claim that nearly half of all Parkinson’s patients suffer from depression, but they assume that depression is something they just have to live with.

Not so, say the doctors who announced a nationwide study to test the effectiveness of Paxil and Effexor with Parkinson’s patients, in a September 19, 2006 Press Release.

The doctors say the study is funded by the “National Institute of Neurological Disorders and Stroke,” which can mean one of two things. One, that tax payers are funding the research to find new uses for these drugs, or two, the drug makes are funneling money by way of contributions to the Institute, which the government Web site says it accepts.

The benefit that results from the funneling scheme is that when the doctors find the drugs effective, which they no doubt will, instead of saying the research was paid for by the drug’s makers, it lists the government as the funding source.

Either way, no tax dollars should be spent on this type of study. If there is funding available for research on Parkinson’s disease, it should be spent on finding a cure.

If GlaxoSmithKline and Wyeth want to go on a wild-goose chase looking for new uses for Paxil and Effexor, let them do it on their own dime and time. And after that, they need to apply for approval of any new use with the FDA, instead of using a trumped up study as justification for prescribing the drugs off-label.

In a completely different field of medicine, on October 30, 2006, Reuters reported that researchers at Jerusalem’s Hebrew University discovered what surely must be described as another scientific wonder. Their study found that depression can lead to brittle bones and the Israeli scientists suggest that SSRIs can be used to treat osteoporosis.

They reached this conclusion after they found that mice that were given drugs to induce human-like depression suffered a loss of bone mass, but after receiving SSRIs, their bone density increased, along with their level of activity and social interaction.

According to Reuters, an earlier study at the Forsyth Institute in Boston also found that Prozac increased bone mass – in mice.

When mulling over all the new “disorders” being considered for the DSM, it should be recognized that according to a study in the April 2006, Psychotherapy and Psychosomatics journal, 80% of the members on the expert panels, involved in approving most of the off-the-wall disorders for the DSM in recent years, had undisclosed financial ties to the drug companies whose drugs would be used to treat the disorders approved.

In fact, the review found that 100% of the experts involved in writing diagnostic criteria for depression and schizophrenia had undisclosed financial relationships with the drug companies who market drugs to treat those conditions.

Filed under: 2006, Celexa, DSM, Effexor, Lexapro, Paxil, prices, SSRIs, Zoloft

SSRIs – Wonder Drugs From Hell

Evelyn Pringle February 7, 2006

The Glenn McIntosh family has to introduce 12-year-old Caitlin, with a photograph because that is all they has left. Caitlin committed suicide 8 weeks after being prescribed the SSRIs, Paxil and Zoloft.

“We were told that antidepressants like Paxil and Zoloft were wonder drugs, that they were safe and effective for children. We were lied to,” Caitlin’s father said.

According to Glenn, his daughter was a straight “A” student, an artist, and a talented musician who loved animals and wanted to be a veterinarian.

With the onset of puberty, Caitlin seemed to be having trouble coping, and was also having sleeping problems due to a mild seizure disorder.

“We wanted to help, of course,” her father explains, “so we took her to our family physician, who prescribed her Paxil.”

Right off the bat, Caitlin did not do well on Paxil, so the doctor took her off the drug. About a week later the family went to see a psychiatrist and Caitlin was put on Zoloft.

According to Glenn, “She then started having strong suicidal ideations, along with severe agitation known as akathisia and hallucinations, and she was put in the adolescent ward of a mental hospital to balance her meds.”

Once she entered the hospital, the situation got worse as Caitlin was put on more and more psychiatric drugs to treat symptoms and behaviors that Glenn says he now realizes were caused by the SSRIs to begin with.

When she was released from the hospital, the downward spiral continued until the day that Caitlin used her shoe laces to hang herself in a bathroom at school.

“Let me be very clear about something,” Glenn said, “the dramatic and severe symptoms that led to my daughter’s suicide manifested only after she started taking antidepressant drugs.”

“The pharmaceutical companies have known for years that these drugs could cause suicide in some patients,” Glenn said. “Why didn’t we?”

Grieving the loss of their 14-year-old daughter Dominique, Lorraine and Robert Slater also make the point that, “informed parental consent is only possible as long as full disclosure is made by the pharmaceutical companies, the FDA, and the medical community.”

“How can teenagers be allowed to be given antidepressants that were never approved for adolescent consumption, only for adults?” Lorraine wants to know. “How come the medical profession doesn’t fully disclose the possible harmful and fatal effects of medication as well as watch carefully for diverse effects on its adolescent population?”

Shortly after she was prescribed Celexa, Dominique attempted suicide. She was treated by several mental health professionals after her initial adverse reaction to the first SSRI.

And, each time they met with professionals, her parents explained that the drugs seemed to maker Dominique’s condition worse rather than better. Unfortunately, as so often happens, the adverse reactions and behaviors caused by the SSRIs, were treated as a worsening of an underlying condition and Dominique was prescribed other drugs from the same class.

“Dominique’s mind and behavior were slowly being altered to the point that she became very agitated, irrational, ultimately suicidal,” her mother recounts, “because none of the so-called medical professionals acknowledged the drug’s role in her irrational and suicidal behavior or properly withdrew her from their suicidal effects.”

On February 6, 2003, Dominique was switched to the SSRI Effexor, and during the two weeks that followed, her doctor doubled the dose.

The morning of February 21, 2003, Robert dropped his daughter off at school and they said goodbye as usual. Around 11 am, Dominique told her teacher she needed to go outside for some fresh air. She left classroom and never returned.

Next to nothing is known about Dominique’s activities from the time she left school on February 21, until her body was found 3 weeks later in the Delta Mendota canal in California on April 14, 2003.

Lorraine is still racked with guilt and blames herself for giving her daughter the prescribed medication. “How can you imagine I feel, knowing now that I was slowly poisoning my daughter every day as I was dispensing her antidepressant medication?” she said.

Tom and Kathy Woodward’s daughter, Julie, who had no history of suicide or self-harm, hung herself in a matter of days after being prescribed Zoloft. “Julie began experiencing akathisia almost immediately,” Tom recalls.

But he knew nothing about Zoloft’s side effect of “akathisia” at the time. The doctor had stressed that Zoloft was safe and had very few side effects. He never advised Tom and Kathy about the possibility of violence, self-harm, or suicidal acts and the information they received with the drug never mentioned self-harm or suicide either.

According to her parents, Julie was a young woman who had everything to live for. Just weeks before her death, she had scored high on her SATs and was excited about starting college.

However, “instead of picking out colleges with our daughter, my wife and I had to pick out a cemetery plot for her,” Tom said. “Instead of looking forward to visiting Julie at school, we now visit her grave,” he added.

Like so many other cases of suicides of young people on SSRIs, Julie’s body apparently could not handle the drug. “We now know from a blood test from the coroner’s office, that she was not metabolizing the drug,” Tom said.

Tom and Kathy are angry at government officials. “The FDA has placed the interests of the drug industry over protecting the American public,” Tom said, “if the trials don’t favor a drug, the public never hears of them.”

“It is clear that the FDA is a political entity,” he continued, “and its leadership has protected the economic interests of the drug industry.”

Tom believes that suppressing unfavorable studies should be illegal, “the drug industry must be compelled to produce all of their findings and studies,” he said.

Cheryl and Mark Miller lost their 13-year-old son, Matthew to suicide, after a psychiatrist gave him Zoloft. His parents were told that Matt had a chemical imbalance that could be helped by a new, wonder drug called Zoloft.

“It was safe, effective, only two minor side effects were cautioned with us – insomnia, indigestion,” they said.

While on the drug, Matt became agitated, could not eat, sleep, or sit still. The night before the family was set to leave for vacation, Matt hung himself in a bedroom closet from a hook, barely higher than he was tall.

“To commit this unthinkable act,” Mark said, “he was able to pull his legs up off the floor and hold himself that way until he lost consciousness.”

His parents had no warning of their son’s plan to kill himself. Mark had never spoken about suicide or threatened to commit suicide.

Mark and Cheryle have since learned that Matt’s doctor has served as “a well-paid spokesman for Pfizer,” the maker of Zoloft.

Terri Williams’ 14-year-old son, Jacob, was an exceptional athlete and participated in both the varsity and junior varsity football teams at his school.

In September 2000, Jacob seemed to lose interest in school activities except for football, and a conflict arose with regard to his grades and school attendance. As a result, his parents attended a conference in October 2000, at which the school administrator suggested that Jacob might be depressed and recommended seeking medical help.

Terri contacted Jacob’s pediatrician and made an appointment for the same afternoon. The doctor prescribed Prozac, and three weeks later increased the dose.

Shortly after he started taking the drug, Jacob complained of having strange bad dreams and shortly after the dose was increased, his mother noticed an aggressive behavior which had not been there before. “Jacob also became destructive and destroyed some of his favorite things,” Terri said.

When questioned, Jacob told his mother, “I don’t know what is making me do this.” Terri wrote it off to normal adolescent behavior and did not pursue the issue further.

On December 5, 2000, Terri found Jacob’s body hanging from the rafter in their attic. He had hung himself with his own belt. He left a letter on the ladder leading up to the attic for his parents, thanking them for giving him 14 years of a happy life.

After her son’s death, his friends told Terri that they had noticed the same changes in Jacob, that he had become short tempered and verbally aggressive.

“Had I known that this was a potential side effect, suicide,” Terri said, “I would have never allowed my son to take the drug Prozac.”

And the sad fact is, the FDA could have warned Terri, because by 1998, according to the FDA’s adverse reaction reporting system, Prozac alone had already accumulated over 40,000 adverse reaction reports, including over 2,100 deaths, far more than any other drug in the history of the reporting system.

Filed under: 2006, Celexa, Effexor, FDA, Glaxo, Lexapro, Paxil, Pfizer, Prozac, SSRIs, suicide, Wellbutrin, Zoloft

FDA’s Preemption Gift to Big Pharma

Evelyn Pringle November 18, 2006

An item sure to end up on the chopping block with the Democrats back in power, is the Bush administration’s multi-billion dollar gift to Big Pharma, that bars people who have been injured by drugs approved by the FDA from suing the drug’s maker in state courts.

Under the FDA’s federal preemption position, victims injured by dangerous drugs would go uncompensated, the regulatory powers of the states would end, and the drug companies would only be answerable to the FDA.

The claim of preemption was inserted into the preamble of new drug labeling guidelines in January 2006. At the time, Ken Suggs, president of the Association of Trial Lawyers of America, told the Washington Post: “The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process,”

But then the FDA claimed it had preemptive authority long before the new rule was announced. The agency has repeatedly supported drug companies in failure-to-warn lawsuits since former Pfizer attorney, Daniel Troy, took over the helm of the FDA’s legal division.

Bush’s appointment of a Pfizer attorney as lead council at the FDA has been criticized far and wide. An investigation by Representative, Maurice Hinchey (D-NY), found that Mr Troy had received more than $350,000 in legal fees from Pfizer in the year before he took the FDA position, according to a July 13, 2004 Press Release from Rep Hinchey’s office.

As soon as he settled into his public employment, Mr Troy registered his on-going allegiance to Pfizer by filing an amicus brief in the Motus v Pfizer lawsuit, a case involving a widow whose husband committed suicide after taking the SSRI antidepressant, Zoloft.

In fact, the Bush administration’s FDA and Justice Department joined together in arguing that Pfizer should be immune from lawsuits in state courts by plaintiffs alleging that the company failed to properly inform the public about the increased risk of suicidality with Zoloft.

The court in the Motus case denied the motion noting that other courts had found FDA requirements to be minimum standards, and that FDA approval of a new drug did not shield the drug maker from liability, and that Pfizer had not cited a single case to the contrary.

Since the FDA brief was filed in the first case, Pfizer has used it, albeit with little success, to support its summary judgment motions in other Zoloft-induced suicide cases against private citizens.

With a large part of his work on behalf of Big Pharma completed, Mr Troy did not stay at the FDA for long, before he returned to private practice, but the FDA “ultimately drafted the formal Preemption Preamble before he left,” according to the October 23, 2006 report, “FDA Plays Both Sides,” by Melissa Davis, for The Street.com.

“Troy now offers his services,” Ms Davis reports, “to companies facing state lawsuits that could be derailed by the new rule.”

Houston attorney, Andy Vickery, has been battling the giant SSRI makers on behalf of injured victims for more years than he likes to count. He has represented clients in civil and criminal cases involving SSRI-induced violence and suicides.

Along with a majority of the nation’s attorneys, Mr Vickery views the FDA preemption position as an assault on the rights of everyday citizens. “For 38 years,” he says, “through both Democratic and Republican administrations, the FDA took the stance that private tort litigation was a good thing.”

“By and large,” he notes, “it avoided becoming embroiled in civil litigation but when it did intervene, usually with amicus briefs, its position typically protected consumers.”

Attorneys note the FDA’s total reversal in position from 1996, when the agency’s argument was favorable for private citizens against federal preemption in the medical device case of, Medtronic v Lohr, in the US Supreme Court.

In 1998, the FDA’s statements were that its labeling regulations established minimum standards, and in 2000, when the FDA published the proposed new labeling rule, the FDA said that it did not preempt state law. 65 Fed Reg 81082, 81193 (December 22, 2000) specifically stated: “FDA has determined that this proposed rule does not contain policies that have federalism implications or that preempt State law.”

But the next year, after Bush took office, the FDA began what can only be viewed as the “kick-off” for its preemption campaign by filing briefs arguing in favor of drug companies.

Mr Vickery says the state tort system has worked well as a scheme of checks and balances for many years. Civil litigants and their lawyers, he reports, have on many occasions uncovered information about the hidden dangers of drugs that had escaped the attention of the FDA.

This is precisely what happened, he notes, with the issue of Paxil and suicidality. On June 6, 2001, in a Wyoming case he was handling against GlaxoSmithKline, a federal jury found that “Paxil can cause some people to commit homicide and/or suicide.”

In the wake of that verdict, Mr Vickery says, Glaxo should have issued a warning immediately and the FDA should have begun its reclassification and analysis immediately, but they did not.

“Instead,” he states, “the FDA rode to the defense of industry via its first pro-preemption brief in the Motus case.”

He currently represents Jackie Giles and Annabelle Dobbs, who he refers to as, “Effexor-widows,” against Effexor maker, Wyeth, in federal wrongful death actions.

Specifically, the lawsuits allege that Jackie Giles’ husband Jeff died from a self-inflicted gunshot wound on October 30, 2002, only two days after his general practitioner prescribed Effexor; and Terry Dobbs died on December 30, 2002, only 6 days after his doctor switched him from another SSRI to Effexor.

According to Mr Vickery, numerous federal courts have rejected preemption claims in the drug-induced suicide cases. “At the present time,” he says, “the only Article III judge to consider claims of preemption by Wyeth in Effexor-suicide cases has denied Wyeth’s motion,” in the case Jackson v Pfizer, et al.

He handled that case, in which the Jackson’s 11-year-old son was under the influence of both Zoloft and Effexor, when he killed himself, and the court refused to give deference to the FDA’s precatory preamble and advisory amicus briefs. The case has since been settled.

Mr Vickery also handled the Kallas v Pfizer lawsuit, another case in which the FDA filed a brief in support of the drug maker’s preemption position, but the action was settled before any decision was reached on Pfizer’s preemption motion.

In that case, Shyra Kallas was only 15 when she went to her doctor seeking treatment for warts and came home with a prescription for Zoloft on October 8, 2002.

A mere two days later, on October 10, 2002, the FDA formally asked Glaxo to reanalyze the pediatric data on Paxil, to help the FDA understand the “greater number of adverse events” it had observed in the data the company had submitted to the FDA.

Nonetheless, the FDA took the position in its amicus brief that it would have considered an added warning to Shyra’s physician about Zoloft “false and misleading” when her initial prescription was written two days before the agency formally asked Glaxo for an explanation about the increased number of adverse events.

Attorneys agree that this “false and misleading” argument is the most silly of all because, 21 CFR § 201.57(e) requires a manufacturer to provide warnings in a drug’s label “as soon as there is reasonable evidence of an association of a serious hazard with a drug.”

In fact, during a Vioxx trial in March 2006, a New Jersey judge told the jury, “I just want to advise you that the law under FDA regulations does allow a company to change their warnings, to warn consumers and physicians about dangers they find out about after the label is approved.”

“They’re allowed to make changes,” the judge said, “through a special procedure, without prior FDA approval.”

Mr Vickery says the hidden studies uncovered in the Wyoming litigation in 2001, as well as the jury verdict that said Paxil could cause some people to commit homicide and or suicide, at least started the ball rolling down the hill, as far as alerting the public about the suicide risks associated with SSRIs.

Since then, he points out, the Attorney General of New York sued Glaxo for fraudulently concealing the studies that showed the increased risks of Paxil-induced suicidality and the ineffectiveness of Paxil with children, and obtained a settlement that requires the company to post its clinical trial data on the internet.

The same year, there was also the revelation that the FDA itself had suppressed a study that showed SSRI-related suicidality in children by one of its own scientist, Dr Andrew Mosholder.

Attorneys point out that many more studies, some dating back to before many of the SSRIs were even approved for use, have been unearthed through private litigation that show the SSRI makers knew about the serious side effects associated with the drugs, but concealed the reports and only allowed the positive studies to become public.

The preemption rule could not have come at a worse time for consumers. Under the current Big Pharma backed administration, the FDA is not adequately policing the marketing activities of drug makers. A recent investigation by the House Committee on Government Reform, found a sharp decline in enforcement actions taken against the pharmaceutical industry since December 2001.

From 1999 to 2001, the investigators reported that the FDA had sent out 250 “Notice of Violation” or “Warning” letters to drug companies; but for the period between 2002 through 2004, the FDA only sent out 70 letters, or a reduction of more than two-thirds.

According to Robert Brava-Partain, an associate attorney with the Baum Hedlund law firm, “there has been a steady decline in the FDA’s consumer-based orientation resulting in an FDA that is a conduit for large drug and device manufacturers to gain access to the US market where they reap billions of dollars in profit.”

Mr Brava-Partain says the FDA has traditionally been known to favor the health and safety of consumers over the interests of drug makers, but says “this focus has recently shifted towards the protection of the companies whose drugs the agency is supposed to be regulating.”

Mr Brava-Partain is a member of Baum Hedlund’s pharmaceutical products liability department which handles SSRI-related suicide and suicide attempt cases. Along with other members of the firm, he has successfully defended against preemption arguments in cases, including Witczak v Pfizer, Cartwright v Pfizer, and Zikis v Pfizer.

Baum Hedlund is currently also handling SSRI-related birth defect lawsuits involving cases where infants of mothers who took SSRIs during pregnancy were born with serious heart birth defects or a life-threatening long disorder.

The antidepressants involved in litigation include the SSRIs Paxil, Zoloft, Prozac, Lexapro, and Celexa. Effexor, a slightly different antidepressant, is also known to be associated with many of the same adverse effects associated with the SSRIs.

The majority of judges in cases where FDA briefs were submitted, have been critical of the FDA’s position. In a Minnesota Zoloft-induced suicide case, the court rejected Pfizer’ attempt to use the FDA to support its arguments, stating that it “declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law,” and called the arguments “perverse” and a “public policy argument gone awry.”

The fact is, only Congress has the authority to enact preemption legislation and it has not chosen to do so. And furthermore, with the Democrats in power, it is not likely to do so anytime soon.

In response to the FDA’s initial preemption announcement, Senator Edward Kennedy (D-MA), issued a statement making his opinion clear by stating, “It’s a typical abuse by the Bush Administration — take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry.”

Senator Kennedy will take over as chairman of the powerful Senate Committee on Health, Education, Labor, and Pensions when the Democrats regain control of the Senate in 2007, and legal analysts say to look for the FDA’s preemption gift to Big Pharma to be high on the list of priorities for change.

Filed under: 2006, Baum, Effexor, FDA, Glaxo, Pfizer, Preemption, SSRIs, suicide, Troy, Vickery

Big Pharma Hits On Pregnant Women

Evelyn Pringle November 22, 2006

If Big Pharma cared one iota about the unborn fetus, at a bare minimum, it would call off its hired-guns traveling around the country peddling SSRI antidepressants to pregnant women by convincing doctors to prescribed the drugs and ignore the studies and FDA warnings that say SSRIs are associated with serious birth defects.

Less than a month ago, on October 16, 2006, the first lawsuit in the nation was filed against GlaxoSmithKline in which an infant charges that his life-threatening lung disorder was caused by exposure to the SSRI Paxil in the womb during his mother’s pregnancy.

Eric Jackson was born in Denver, Colorado on October 28, 2004, with persistent pulmonary hypertension of the newborn (PPHN), a condition in which the infant’s arteries to the lungs remain constricted after birth and limit the amount of blood flow to the lungs and oxygen in the bloodstream.

Immediately after birth Eric had to be placed on a ventilator and eventually had to be placed on an oscillating ventilator for a month.

In his 2 short years on earth, Eric has undergone two cardiac catherizations, and another procedure to combat gastral reflux caused from being on a ventilator for so long. Since birth, he has remained on oxygen and medications to help him breathe and he continues to suffer with eating and digestive problems.

With their lawsuit, Eric’s parents hope to recover the medical and other expenses incurred in treating, and attempting to cure Eric’s condition, as well as the related illnesses. Some of the related health problems may not even surface until Eric is a teenager.

A study in the October 3, 2006 Archives of Pediatrics and Adolescent Medicine by Dr Agnes Whitaker, MD, of Columbia University and the New York State Psychiatric Institute, and colleagues, reported that low birth weight infants who require mechanical ventilation, with no obvious disability early on, can have subtle and cognitive deficits discernable at age 16.

The study sample represented a cohort of babies who were born at or admitted to one of three hospitals in New Jersey between September 1, 1984 and June 30, 1987.

The research team said, two factors, male gender and days of ventilation were predictors of motor problems. For each additional week of mechanical ventilation, they said, total and oral motor problem scores were higher by 0.33 and 0.14 points, respectively.

Legal analysts predict that Glaxo will attempt to reach early settlements with the families of infants born with birth defects because the company in no way wants injured toddlers paraded in front of a jury.

Karen Barth Menzies is one of Eric’s attorneys. She is a partner at Baum Hedlund, a national pharmaceutical products liability law firm with offices in Los Angeles, Washington, DC and Philadelphia, where she heads the Pharmaceutical Antidepressant Litigation Department.

Ms Menzies has been waging legal battles against the SSRI makers on behalf of injured consumers for more than a decade and she currently represents many other families in Paxil birth defect cases

Jennifer Liakos is an associate attorney at Baum Hedlund in Los Angeles, and she is also a member of the firm’s Pharmaceutical Antidepressant Litigation Department, handling Paxil birth defect cases. She explains that between 10% to 20% of babies born with PPHN do not survive, even when they receive treatment.

Having been the leader in the Paxil litigation against Glaxo for years now, and through their intensive litigation and discovery, Baum Hedlund has evidence that reveals specifics relating to Paxil and birth defects. Eric’s attorneys do not have to newly learn the inter-workings of Glaxo because they know how the company operates regarding Paxil and how they analyze or fail to analyze data.

According to Ms Menzies, studies have shown that infants who are exposed to selective serotonin reuptake inhibitor antidepressants (SSRIs), after the 20th week of gestation are more likely to develop PPHN than infants who were not exposed to an SSRI during pregnancy.

In addition to Paxil, the other SSRIs sold in the US include Prozac by Eli Lilly; Zoloft, from Pfizer; Celexa and Lexapro, from Forest Laboratories; and Luvox, from Solvay. Wyeth markets Effexor, a serotonin-norepinephrine inhibitor.

Adding to the problem of curtailing the prescribing of SSRIs to pregnant women, is the fact that SSRI makers have doctors prescribing the drugs for many other conditions besides depression, and often for off-label uses, meaning they are not approved by the FDA.

According to Dr Jay Cohen, author of, “Over Dose: The Case Against The Drug Companies,” the “drug companies have marketed SSRI antidepressants vigorously not only to psychiatrists, who are supposed to have some expertise with these drugs, but also to family practitioners, pediatricians, gynecologists, internal medicine specialists, and anyone else who can pen a prescription.”

“But this doesn’t mean,” he says, “that they possess in-depth knowledge of SSRIs or their actions and toxicities.”

A study from the University of Georgia in the June 2006, Journal of Clinical Psychiatry, found that 75% of the people prescribed antidepressants received them for a reason not approved by the FDA.

Little Eric’s lawsuit contends that when allowing Paxil to be prescribed to pregnant women, Glaxo has an ongoing duty of pharmacovigilance. The FDA describes the term pharmacovigilance to mean “all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events.”

This includes, the agency notes, the use of pharmacoepidemiologic studies and activities “undertaken with the goal of identifying adverse events and understanding, to the extent possible, their nature, frequency, and potential risk factors.”

“During the entire time Paxil has been on the market in the US,” Ms Menzies says, “FDA regulations have required Glaxo to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Paxil.”

“FDA regulations specifically state,” she explains, “that a causal link need not have been proven before a new warning is issued and they explicitly allow Glaxo to issue a new warning without prior FDA approval.”

Ms Menzies reports that research as far back as October 3, 1996 in the New England Journal of Medicine, by Dr Christina Chambers and colleagues, of the Department of Pediatrics, Division of Dysmorphology and Teratology, at the University of California–San Diego, indicated a risk of PPHN in babies born to mothers taking SSRIs.

For this study, the researchers identified 228 pregnant women taking Prozac between 1989 through 1995, and compared the outcomes of their pregnancies with those of 254 women who were not taking Prozac.

The study found that babies exposed to the Prozac, during the third trimester of pregnancy, had significantly higher rates of premature delivery, respiratory difficulties, admissions to special care nurseries, jitteriness, and poor neonatal adaptation including cyanosis on feeding.

There have also been studies specific to the use of Paxil during pregnancy that have shown respiratory problems in exposed infants upon delivery. For instance, in 2003, researchers at the Motherisk Program at the University of Toronto, reported that exposure to Paxil in late pregnancy was associated with a significantly higher rate of neonatal complications among 55 exposed newborns, when compared to infants exposed to Paxil in early pregnancy or to newborns with no exposure, and respiratory distress was the most commonly reported adverse reaction.

In June 2004, the journal, Prescrire International, reported that newborns exposed to SSRIs toward the end of pregnancy had breathing and suction problems and showed signs of agitation, and altered muscle tone. The study estimated that 20% to 30% of infants were effected and warned that doctors should be aware of the risks when considering treatment during pregnancy with Paxil, Celexa, Prozac, Zoloft, and Lexapro.

The following month, on July 9, 2004, WebMd reported that over the past decade the FDA had received “hundreds” of reports of adverse effects with infants born to mothers taking SSRIs.

That same month, the FDA changed the labeling for all SSRIs, warning that upon delivery, some infants exposed to SSRIs required respiratory support, tube feeding and prolonged hospitalizations.

In May 2005, a University of Pittsburgh study in the Journal of American Medical Association, combined the previous research and found that women who took SSRIs late in pregnancy had a three times higher risk of giving birth to infants suffering from serious respiratory problems, jitteriness, and irritability in the first couple of weeks after birth.

The drugs involved in this study also included the serotonin norepinephrine reuptake inhibitor Effexor. The researchers estimated that in any given year in the US, at least 80,000 pregnant women are prescribed the drugs. According to psychiatrist, Dr Eydie Moses-Kolko, the lead author of the study, serious respiratory problems develop in about one out of 100 infants born to these women.

As a follow-up to her findings of breathing problems in the previous Prozac study in 1996, Dr Chambers, now an assistant professor of pediatrics at the University of California, San Diego, and colleagues, performed a case control study of women on SSRIs who gave birth between 1998 and 2003, to determine whether PPHN was associated with exposure to SSRIs in late pregnancy.

The results of the study published in the February 9, 2006, New England Journal of Medicine, reported that mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to babies with PPHN.

The study found 14 infants with PPHN in the group who had been exposed to an SSRI, compared to 6 infants with the disorder in the group who were not exposed to the drugs.

The FDA found the study so alarming that it prompted the agency to hold a press conference. “This appears to be a very well-conducted study and we find the results to be very concerning,” said Dr Sandra Kweder, deputy director of the office of new drugs at the FDA.

She also told reporters that women of reproductive age are the “biggest users of antidepressant drugs.”

Instead of immediately taking action to warn doctors and consumers of this development, the pharmaceutical industry went into all-out damage control to protect SSRI profits by encouraging pregnant women to keep taking SSRIs.

A corresponding study in the February 2006, Journal of the American Medical Association, warned that pregnant women who stopped taking the drugs could greatly increase their risk of a relapse of depression. The authors of the study predicted that their findings would prompt some women to stay on SSRIs throughout pregnancy.

The JAMA study got much more media attention than Dr Chambers, and included headlines warning about the dangers of relapse in pregnant women going off SSRIs. Many local television news broadcasts even ran an unedited video provided by JAMA, featuring a study author and one of his patients.

However, 5 months later, on July 11, 2006, the Wall Street Journal published an expose on the researchers involved in the study who were encouraging pregnant women to keep taking SSRIs. “But the study,” it reported, “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.”

Most of the authors, the WSJ noted, were leading psychiatrists at Massachusetts General Hospital, the University of California Los Angeles, and Emory University

The lead researcher, Dr Lee Cohen, a professor at Harvard Medical School, it reported, “is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers.”

Among the most significant of the missing financial disclosures, the Journal said, were those of study author, Lori Altshuler, director of the Mood Disorders Research Program at UCLA, who was a speaker or consultant for at least 5 antidepressant makers.

Vivien Burt and Victoria Hendrick were also authors who did not report financial relationships with SSRI makers, and Dr Viguera, another author, did not disclose her paid speaking relationship with Glaxo.

All total, the Journal said, “the authors failed to disclose more than 60 different financial relationships with drug companies.”

“The work of these academic researchers,” the article wrote, “highlights the role of “opinion” or “thought” leaders coveted by drug companies because of their ability to influence not only the practice of doctors, but popular opinion as well.”

In the case of SSRI use by pregnant women, the WJS said, the industry-paid opinion leaders have become dominant authorities in the field and stated:

“They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed.”

According to the WSJ, as soon as their study was published, Dr Cohen and some the other authors went out on the lecture circuit, telling doctors about their findings and pointing out flaws in the studies that found an increased risks of birth defects with infants exposed to SSRIs.

For instance, the panel of experts who criticized the Chambers study during the May 17, 2006, continuing medical education lecture, “Psychotropic Drug Use During Pregnancy,” sponsored by the Massachusetts General Hospital Psychiatry Academy, was comprised entirely of psychiatrists with financial ties to drug companies.

During the lecture, the panelists were also critical of the FDA for adding new warnings about birth defects to Paxil’s label. On December 8, 2005, the FDA issued a Public Health Advisory after US and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy to be associated with an increased risk of heart birth defects.

With the warning, the agency for the first time placed an SSRI in the D category, its second highest for the risk of birth defects. Category D means that either controlled or observational studies of pregnant women “have demonstrated a risk to the fetus.”

The agency did not ban Paxil from use with by pregnant women, but it did go so far as to say, “FDA is advising patients that this drug should usually not be taken during pregnancy.”

At the May 17 conference, panelist, Zachary Stowe, from the women’s mental health center at Emory University, described the FDA’s decision to change the label as “driven by a single set of data that is unpublished, non-peer reviewed, and somehow this trumps the very nicely done prospective investigations that have really failed to find this risk.”

However, here once again, according to the WSJ, Dr Stowe has served as an paid adviser and speaker for several SSRI makers.

In July 2006, corresponding with the WSJ’s expose about the undisclosed financial relationships of the Cohen study authors with SSRI makers, JAMA published a correction to announce that 7 of the authors of the February 2006, study had failed to reveal their financial ties with drug companies.

Critics of Big Pharma‘s influence over studies published in medical journals were quick to respond to the disclosure. On July 11, 2006, Merrill Goozner, director of the Center for Science in the Public Interest, issued a statement saying: “It’s clear that the Journal of the American Medical Association does not evaluate conflict of interest disclosures when articles are submitted.”

“As a result,” Mr Goozner said, “some authors with blatant conflicts of interest apparently feel they can ignore the journal’s policy with impunity.”

“The only solution,” he added, “is for journals to adopt strong penalties for authors who fail to disclose – a three-year ban from publishing in the pages in the journal.”

A month later in August 2006, another study in the Archives of General Psychiatry, by Canadian researchers at the University of British Columbia, found babies born to women who took SSRIs during pregnancy to be at an increased risk of having respiratory distress and low birth weight.

Lead investigator, Dr Tim Oberlander, told Reuters Health on August 25, 2006, that “our study was undertaken to distinguish the effects of maternal mental illness — pregnancy-related depression — from its treatment — SSRIs — on neonatal outcomes.”

The researcher reviewed health records for almost 120,000 live births between 1998 and 2001 and determined that 14% of the mothers were diagnosed with depression. They then compared the outcomes of infants born to women treated with SSRIs to those born to depressed women who were not treated with SSRIs and found a significantly higher incidence of respiratory distress in infants exposed to SSRIs by a ratio of 13.9% to 7.8%.

The study reported longer hospitalizations for infants born to mothers on SSRIs, and found birth weight and gestational age were also significantly less in SSRI exposed infants.

“These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression,” Dr Oberlander told Reuters.

In October, 2006, the journal, Pediatrics, reported that CDC researchers cited preterm birth as the leading cause of infant mortality in the US, accounting for at least one-third of all infant deaths in 2002.

The contribution of prematurity to infant mortality may be twice as high as originally estimated, reported Dr William Callaghan, MD, MPH, and colleagues.

The research team looked at the top 20 causes of infant deaths in 2002, and found that 34% occurred in preterm infants, 95% of whom were born before 32 weeks gestational age of 32 weeks and weighed less than 3.3 pounds.

“The extreme prematurity of most of the infants and their short survival indicate that reducing infant mortality rates requires a comprehensive agenda to identify, to test, and to implement effective strategies for the prevention of preterm birth,” the authors wrote in Pediatrics.

There are also studies showing infants born with symptoms of neurological damage associated with SSRI exposure in the womb. In February 2004 a study in the American Journal of Pediatrics reported abnormal sleeping patterns, heart rhythms and levels of alertness linked to SSRIs.

Dr Philip Zeskind, a developmental psychologist and research professor at the University of North Carolina, Chapel Hill, led the investigation and on February 22, 2006, told the Sunday Telegraph, “What we’ve found is that SSRIs disrupt the neurological systems of children, and that this is more than just a possibility, and we’re talking about hundreds of thousands of babies being exposed to these drugs during pregnancy.”

In reaching their results, the team of researchers compared 17 babies born to mothers who took the Prozac, Paxil, Zoloft or Celexa throughout their pregnancy, with 17 babies born to mothers who had never taken SSRIs.

According to Dr Zeskind, “These babies are bathed in serotonin during a key period of their development and we really don’t know what it’s doing to them or what the long-term effects might be.”

“It could be that they go `cold turkey’ when they are born,” he explained in the Telegraph, “or the serotonin could be having an effect on their brains, or it could be a bit of both.”

“We’re not saying that pregnant women should not take the drugs, because depression is itself a big problem,” he said. “But these drugs are being given away like smarties, and this is a big problem,” Dr Zeskind warned.

Legal analysts predict that this first PPHN lawsuit is just the tip of the proverbial iceberg because there are tens of thousands of infants exposed to SSRIs in the womb each year.

After the results of her PPHN study were made public, Dr. Chambers says she heard from women all across the country who took SSRIs during pregnancy and had babies born with PPHN.

The fact that Glaxo has not ordered its hired-guns to stop promoting the sale of Paxil to pregnant women, proves that the company plans to go on sacrificing the lives of babies in the name of profits and that should be a fairly easy point to get across to a jury.

(Written as part of the Paxil Litigation Monthly Round-Up series, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)

Filed under: 2006, Baum, Birth Defects, Effexor, Glaxo, KOL, Paxil, PPHN, SSRIs

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    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

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Videos: Psych Drugs, Birth Defects, Infant Death, Violence & Suicide

UNITE ARCHIVES – Add Your Group To The Coalition Against The MOTHERS Act

CADIMA: 54 Groups and Counting!

UNITE ARCHIVES – The MOTHERS Act Citizen Voting Area on Open Congress

Status: 76% AGAINST S. 324 The MOTHERS Act. Vote & Comment.

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3,271 Facebook Members and Counting!

UNITE ARCHIVES – Stop The Dangerous and Invasive MOTHERS Act!

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