Taking Zoloft During Pregnancy Linked to Birth Defects

Evelyn Pringle June 7, 2007

Less than a year ago, in July 2006, the FDA issued a Public Health Advisory on a birth defect found to be associated with Zoloft and other selective serotonin reuptake inhibitor antidepressants by a study in the February 2006 New England Journal of Medicine that found a higher risk of a life-threatening lung disorder in infants exposed to SSRIs, stating:

"A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy."

PPHN infants have difficulty making the transition from breathing inside the womb to normal breathing after delivery, often leading to respiratory failure that requires mechanical ventilation. Even when treated, between 10% to 20% of babies born with PPHN do not survive.

Between 1998 and 2003, the research team interviewed 377 women who had recently given birth to a baby with PPHN, with questions about medical history and the drugs taken during pregnancy and found that 3.7% of the infants had been exposed SSRIs after the 20th week of pregnancy, or about 6 times the rate among healthy infants in a comparison group born at the same time.

Infants with PPHN typically show abnormal muscle cell growth in their respiratory system. Previous investigations have found that SSRIs tend to accumulate in adult users' lungs and serotonin can promote the proliferation of certain muscle cells. This may explain how the drugs could have an effect on the developing fetus, according to the study authors in the NEJM.

This birth defect is also not as rare as once thought. After the results of the PPHN study were released in February 2006, the lead author and researcher, Dr Christina Chambers, told the Wall Street Journal that women contacted her from all over the US who had given birth to babies with PPHN after using SSRIs during pregnancy.

Medical experts say its important to recognize that Pfizer promotes Zoloft for many disorders besides depression, meaning women may be taking the drug even though they have never been diagnosed with depression. According to the FDA, in addition to depression, Zoloft is approved to treat obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder.

In March 2006, Health Canada issued its own warning, "advising women who are taking antidepressants known as selective serotonin reuptake inhibitors and who are pregnant or intend to become pregnant to discuss the situation with their doctor, due to potential risks to the baby."

On April 7, 2006, the BBC reported that a Canadian study from the University of Ottawa of almost 5,000 mothers found that SSRI use during pregnancy doubled the risk of delivering a stillborn baby and that women who took the drugs were also more likely to have a premature or low-birth-weight baby.

The study found almost 20% of women who used SSRIs gave birth prematurely, compared to 12% of those who did not use the drugs and that babies born to women using SSRIs were also more likely to have seizures.

On August 25, 2006, Reuters Health reported another Canadian study that found that babies born to women who took SSRIs during pregnancy appear to be at increased risk of having a low birth weight and to develop respiratory distress.

Lead investigator Dr Tim Oberlander told Reuters that "our study was undertaken to distinguish the effects of maternal mental illness -- pregnancy-related depression -- from its treatment -- SSRIs -- on neonatal outcomes."

The research team at the University of British Columbia, Vancouver, examined data for almost 120,000 live births between 1998 and 2001, and found 14% of the mothers who were diagnosed with depression.

The study compared the outcomes of babies born to depressed mothers treated with SSRIs and of those born to depressed mothers who were not treated, and there was a significantly greater incidence of respiratory distress, 13.9% vs 7.8%, and longer hospital stays for infants born to mothers on SSRIs, the team reported in the Archives of General Psychiatry.

Birth weight and gestational age were also significantly less in SSRI infants, and a significantly greater proportion were born before 37 weeks. "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.

Preterm birth is the leading cause of infant mortality in the US, accounting for at least a third of all infant deaths in 2002, and the contribution of prematurity to infant mortality may be twice as high as originally estimated, according to Dr William Callaghan and colleagues in the October 2006 Pediatrics journal.

For the study, the researchers looked at the top 20 causes of infant deaths in 2002 and found that 34% of the deaths occurred in preterm infants, 95% of whom were born before 32 weeks gestational age and weighed less than 3.3 lbs. Two-thirds of the deaths in preterm infants occurred in the first 24 hours of life, the research team found.

The fact that SSRIs are highly addictive also adds to the health risks that a pregnant woman faces if she is already taking Zoloft. "A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor," said Dr Sandra Kweder, deputy director of the FDA's Office of New Drugs, in a March/April 2006 update on the FDA's Web site.

But on the flip-side of the coin, continuing to take Zoloft places the infant at risk for withdrawal. A February 2006 study in the Archives of Pediatrics & Adolescent Medicine reports that nearly one-third of infants born to women taking SSRIs show symptoms of withdrawal including tremors, high-pitched crying, gastrointestinal problems and sleep disturbances. The researchers found that 13% of the 60 newborns exposed to SSRIs exhibited severe symptoms of withdrawal.

An earlier study in the February 2004 Pediatrics journal found abnormal heart rhythms, sleeping patterns, and levels of alertness in babies exposed to SSRIs in the womb. Dr Philip Zeskind, a professor of pediatrics at the University of North Carolina-Chapel Hill, and lead author, referred to the results as alarming.

The researchers compared one-day-old babies of mothers who took SSRIs with babies of mothers who did not and looked at sleeping and waking patterns, movements and heart rates. According to the study, infants exposed to SSRIs tended to be locked in one "sleep state" and showed "fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants."

In July 2004, the rising number of reports prompted the FDA to alter labeling for the entire SSRIs, warning that some newborns exposed to SSRIs and Effexor in the womb had developed problems requiring prolonged hospitalizations, respiratory support and tube feeding.

Critics also say, an important point to consider when weighing the risks and benefits of taking Zoloft during pregnancy, is that most experts who have evaluated all the clinical data on SSRIs say the benefits of the drugs are minimal.

In the July 2005 British Medical Journal, Moncrieff & Kirsch state in part: (1) Recent meta-analyses show [SSRIs] have no clinically meaningful advantage over placebo; (2) Methodological artifacts may account for the small degree of superiority over placebo; and (3) Given doubt about their benefits and concern about their risks, current recommendations for prescribing antidepressants should be reconsidered.

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."

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.

FDA Used to Shield Big Pharma From Lawsuits

Evelyn Pringle May 12, 2006

In January 2006, the FDA announced the Bush administration's latest gift to Big Pharma in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts.

"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.

To soften the blow, the agency's claim of federal preemption was included as a preamble to the long sought after new drug labeling guidelines. In response to the FDA's statement, Senator Edward Kennedy (D-MA) issued a statement of his own that said: "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."

The ploy was also readily recognized by state lawmakers and trial lawyers as another attempt to reduce the public's ability to hold Big Pharma accountable. "Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.

"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," Mr Suggs told the Washington Post.

According to Attorney Mark Labaton, a partner at the firm Kreindler & Kreindler, LLP, with offices in New York and LA, "the Administration's recent efforts to misuse federal rulemaking in the pharmaceutical and other areas to eviserate consumer rights is a big step backward."

"The new FDA rules to limit consumers' rights," he says, "are part and parcel of a larger effort to deny persons injured by unsafe products - be they drugs, cigarettes or automobiles - any form of redress."

"Clearly," Mr Labaton notes, "this Administration and its supporters want to slam the courthouse doors on working men and women injured by unsafe products.

He says its ironic that "an Administrative that calls itself "compassionate" and "conservative" consistently turns its back on "limited government" and "states rights" when it comes to protecting the rights of seriously injured consumers."

Upon learning of the FDA's power grab, the National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have. The organization bases its opposition, in part on the following:

"FDA has usurped the authority of Congress, state legislatures and state courts. There is no statutory authority in the FDCA for FDA to preempt state product liability laws as they relate to prescription drugs.

"Instead of seeking valid congressional authority, unelected agency officials are seeking to preempt state product liability laws by writing this preemption into a final rule, thereby undermining state policy and judicial decision made in this area.

"State tort laws and civil justice systems serve as an important check on federal standards. Our civil justice system establishes a duty of care that protects citizens when the federal government is too slow to act or when federal standards are insufficient. States have the ability to achieve greater protections for their citizens through successful product liability lawsuits."

In an earlier gift delivered to Big Pharma in December 2005, Republican leaders, and specifically Senator Bill Frist (R-TN), attached protective provisions to a Department of Defense appropriations report that gave the industry "unprecedented immunity," according to Democratic lawmakers who described the underhanded move as follows:

"Republican leaders added provisions to the conference report after cutting a back-room deal in the middle of the night. The conference report grants sweeping immunity to drug companies for injuries caused by vaccines and drugs and for the administration of those vaccines and drugs, even if they are made with flagrant disregard for basic safety precautions.

"Moreover, the compensation program is a sham, leaving people who become injured from a drug or vaccine without recourse."

Since 2002, Senator Frist had tried numerous times to insert this rider in Homeland Security Bills after thousands of lawsuits were filed by parents who believe the mercury-based preservative thimerosal, contained in childhood vaccines until recently, caused autism and other neurological disorders in their kids.

The rider could save Big Pharma hundreds of millions, if not billions of dollars.

The latest revelation on this little stunt came on May 8, 2006 when the Tennessean reported that vaccine industry officials helped shape legislation behind the scenes that Frist secretly amended into a bill, according to e-mails obtained by Pubic Citizen, a public advocacy group.

The industry group, called the Biotechnology Industry Organization, wanted the vaccine liability language in the bill, the e-mails proves.

"At Senator Frist's staff's request, this morning, BIO (Tom and I) participated in a meeting with three other industry representatives (Sanofi and an outside counsel who works for both Pfizer and Roche, I believe), administration staff (HHS, DoJ and WH Leg Affairs), and Liz Hall to further discuss liability," BIO official Dave Boyer wrote in a November e-mail obtained by Public Citizen.

Other E-mails and documents show that BIO met privately with Frist's staff and the White House to figure out ways to give drug makers protection from people injured by vaccines.

"The lack of any restriction on jury trial is problematic," the BIO analysis said. "Where injured parties have no other avenue for relief, juries are likely to find ways to award damages."

In another e-mail, Boyer described a meeting in which Karl Rove said it was "important to the President that a bill move this year," and said "they had invited industry to discuss what they understood to be a few key remaining points" of contention.

Republicans members of Congress had tried on several occasions to enact similar legislation of its own, but with voters already so angry over soaring drug costs, they finally had to back off.

With less than 3 years left in office, and the Democrats positioned to take over Congress in the fall elections, Bush had to find a way to repay Big Pharma so he came up with the bright idea to utilize the FDA and kill 2 birds with one stone.

This route would spare Republicans the task of trying to pass pro-industry legislation in an election year and still reward Big Pharma for the more than $80 million that Republicans received from drug makers over the past decade.

Since 2000, the top drug corporations, their trade group, and their employees gave more than $10 million to 527 organizations, tax-exempt political committees which operate in the grey area between federal and state campaign finance laws, according to Drug Lobby Second to None, July 7, 2005, M. Asif Ismail.

Nearly $87 million of the contributions went to federal politicians, with almost 69% going to Republicans. Top recipients include Bush, with upwards of $1.5 million, and members who sit on committees that have jurisdiction over pharmaceutical issues, reports Drug Lobby Second to None.

During Bush's campaigns, 21 pharmaceutical industry executives and lobbyists achieved "Ranger" or "Pioneer" status, which means they raised at least $200,000 or $100,000, respectively, during the 2000 or 2004 campaigns.

According to Public Citizen, the group included 5 executives from brand-name drug companies, 6 officials from HMOs, the CEO of a pharmacy services company that runs a PBM, the head of a direct-mail pharmacy, and 8 Washington lobbyists who represent drug companies and HMOs.

Frist is never shy when it comes to calling in markers from drug companies. In November 2004, when he wanted to take a victory tour celebrating the newly elected Republican senators, "A Gulfstream corporate jet owned by drug maker Schering-Plough was ready to zip the Senate majority leader to stops in Florida, Georgia and the Carolinas," according to the April 25, 2005 USA Today

Frist's PAC reimbursed Schering $10,809, the equivalent of a commercial first-class fare, but that was only a fraction of the cost of a charter flight, which would have cost 3 times that much. Besides, the cost was almost a wash because Schering had donated $10,000 to Frist's committee in 2003-04, according to USA Today.

Its also worth pointing out that Big Pharma was the largest contributor to the National Republican Senatorial Campaign Committee while Frist chaired the Committee.

The ever-growing number of lawsuits in state courts has created a nagging fear in drug makers. Local juries and elected judges in state courts are much more likely to go against drug giants than juries and appointed judges in federal courts which is a one of the main reasons why Big Pharma wants all cases moved to federal courts.

Vioxx set off the industry's worst nightmare when users or their heirs began filing lawsuits all over the US. According to the January 24, 2006, Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts.

But Vioxx by far is not the only worry for Big Pharma. These days, every major drug company has litigation problems involving one or more FDA-approved products and a few prominent law firms have taken up the battle for plaintiff's in state courts.

For instance, since 1990, the Los Angeles based Baum Hedlund Law Firm has been handling SSRI (selective serotonin reuptake inhibitor) suicide/violence cases and served on the Plaintiffs' Steering Committee in the first SSRI-suicide litigation involving Prozac, the first SSRI approved by the FDA.

Baum Hedlund partner, Karen Barth Menziess, has been litigating claims involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft and, more recently, Lexapro/Celexa, for over a decade.

She heads a team of attorneys, who have successfully defeated Pfizer's and the FDA's preemption arguments in a number of cases, including Motus v Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms Menziess has testified about the dangers of SSRIs before the California State Assembly and the FDA's Psychopharmacologic Drugs Advisory Committees and met with members of Congress regarding the risk of antidepressant induced suicidality and preemption issues.

Ms Menziess wrote an article discussing the ill-effects of preemption in Mealey's Emerg. Drugs & Devices 27 (2006), titled, "Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug Manufacturers From Tort Liability At The Expense of Consumer Safety," and stated in part:

"Pharmaceutical industry lobbying efforts and zealot tort reformers have sired a new wave of brazen attempts to shield drug manufacturers from tort liability.

"The preemption language in the preamble to the Final Rule is but the latest attempt. Preemption has become the argument du jour and politically appointed regulatory officials the mouthpieces. The crafty messages sound of consumer protection, but are just the opposite. Limiting the liability of drug companies will not improve public safety.

"The FDA s purported position on preemption assumes that the FDA is infallible and that negligent misconduct by pharmaceutical companies should be the sole purview of FDA. Recent regulatory failures demonstrate that FDA is neither infallible nor does it have the capability of policing drug manufacturers negligent misconduct."

The Bush administration went up against a tough opponent in Baum Hedlund when it turned to the courts, and had the FDA file amicus briefs hoping the courts would rule in favor of preemption, but those attempts also failed.

Ms Menziess explains some of the history of the FDA's intervention into lawsuits she was involved in stating: "Until his resignation in late 2004, FDA Chief Counsel, Daniel Troy, was the pharmaceutical industry's 'inside man,' filing legal briefs on behalf of former clients such as Pfizer (the maker of Zoloft) and soliciting defense attorneys to submit their cases for government amicus brief consideration."

"Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks the blatant pharmaceutical industry ties that Troy had," she advises, "he clearly was not selected to his position because of a sudden change-of-heart in the political leadership or direction of the FDA."

"In fact," Ms Meziess says, "following in his predecessor's footsteps, Bradshaw submitted a legal brief in support of Pfizer's federal preemption arguments."

The FDA filed its first brief in favor of a manufacturer of SSRIs in September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in California, which was pending in the 9th Circuit Court of Appeals.

Daniel Troy, who was the FDA's Chief Counsel at the time, was contacted by Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002 requesting that the government get involved in this private lawsuit to help Pfizer with its preemption argument related to Zoloft-induced suicidality.

Despite the fact that Pfizer had been one of his clients and Troy was paid over $358,000 for work he had conducted for Pfizer in the year he took office, Troy acquiesced, arguing that there was no impropriety in doing so because he did not become involved until after the required 1-year period in which government employees may not participate in official activities involving former clients.

From public accounts, it appears that the 1-year "grace period" elapsed less then a month before Troy entered the fray.

Troy argued in the FDA brief that, even though Pfizer never sought to strengthen Zoloft's warning label concerning suicidality, any warning, no matter how worded, that suggested a link between Zoloft and suicidality would have been false and misleading, would have misbranded the drug, and the FDA would have rejected any effort by Pfizer to use such a warning.

The 9th Circuit never decided the preemption issue, instead ruling on another appellate issue, which concluded the case on unrelated grounds.

Nevertheless, Menzies said that Pfizer has continued to use the brief in its battle against Zoloft-induced suicide cases, arguing that the lawsuits are federally preempted and should be dismissed.

But Judges across the US have been rejecting Pfizer's arguments, as well as the FDA brief itself. A federal judge in Texas pointed out that the law "allows, even encourages, manufacturers to be proactive when learning of new safety information related to their drug."

"Manufacturers, not the FDA, are tasked with the responsibility of taking proactive steps once a manufacturer learns of 'reasonable evidence of an association of a serious hazard with a drug,'" the judge stated.

A state court judge in California ordered the FDA brief stricken from the record, calling it "hearsay and irrelevant."

In an Illinois case, the judge said the brief "contains nothing more than legal argument by [FDA] counsel."

In a Zoloft suicide case in Minnesota, the court rejected Pfizer's arguments, stating that it "declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law." The same judge also called Pfizer's arguments "perverse" and a "public policy argument gone awry."

Ms Menziess notes that the FDA's legal stance on preemption is "particularly egregious in the wake of congressional investigations involving FDA failures to protect the public health, in particular related to antidepressants."

Without state liability laws, she says, drug companies will be able to escape liability for injuries and deaths caused by drugs like SSRIs and Vioxx.

Baum Hedlund currently represents approximately 50 victims and their families in cases involving alleged antidepressant-induced suicide and suicide attempts, over one third of whom are children and adolescents.

As with Vioxx, the risks associated with SSRIs were also kept hidden. Ms. Menziess' litigation has evidence from as far back as the 1980's that people taking SSRIs were at a heightened risk of suicidality, and not just children, she notes.

In fact, in the early 1990s, it was the FDA safety officer Dr David Graham, of recent Vioxx fame, who raised concerns about the risk between antidepressants and suicidality, but no one listened, Ms Menziess says.

Fourteen years later, the FDA finally ordered black box warnings labels on SSRIs alerting physicians about the increased risk of suicidality. Ms Menziess describes the FDA during these years as "complacent, ignoring its own internal scientist when they raise concerns, and in the pocket of industry."

She believes that the FDA would never have confronted the issue had it not been for the public outcry from victims, consumer groups, courageous experts willing to place their careers on the line, investigative reporters and pressure from certain members of Congress; and yes, she says, "lawyers uncovering the drug industry's dirty little secrets through legal discovery and speaking out about the dangers."

Ms Menziess points out that "the antidepressant controversy and resultant congressional investigations, and later, the Vioxx public health debacle, have served to highlight deep-seeded problems within the FDA."

Over the past couple of years, a growing number of lawmakers have been turning up the heat on both the FDA and the industry in response to their combined failure to reveal the problems found in studies conducted on drugs like SSRIs and Vioxx.

At one point, Senator Charles Grassley (R-IA), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect industry profits and the careers of certain FDA officials.

"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.

The results of a trial that took place in 2000, surfaced that showed that the FDA and Merck were aware that heart attacks were 5 times more likely in patients taking Vioxx than among those taking a similar drug, Senator Grassley pointed out, but the FDA did nothing to change the labeling for nearly 2 years, he said, while Merck marketed its product on nightly TV.

On November 18, 2004, Senator Grassley drew enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr Graham, testified that he determined that Vioxx may have caused tens of thousands of heart attacks and strokes but that his superiors at the FDA pressured him to keep quiet.

"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised. "For the survivors," he added, "their lives were changed forever."

To put the number of injuries into perspective, Dr Graham told members of the committee that instead of side-effects from a drug, to think of it as if they were talking about jetliners.

"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."

"This translates to 2-4 aircraft every week," he advised, "week in and week out, for the past 5 years."

"If you were confronted by this situation," Dr Graham asked the panel, "what would be your reaction, what would you want to know and what would you do about it?"

He noted the problems with the FDA's reliance on a 95% paradigm. In other words, he said, a drug is considered safe "until you can show with 95% or greater certainty that it is not safe."

The scientist condemned the FDA's failure to acknowledge the Vioxx risks sooner. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee.

Ms Menziess often cites his testimony to demonstrate that the FDA's position on preemption is wrong and states: "Dr. Graham's testimony illustrates why FDA approval and subsequent post-marketing acquiescence should have no preemptive effect."

The Vioxx matter caught the attention of the Senate Finance Committee basically because of the drug's cost to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs.

At the November 18, 2004 hearing, Senator Max Baucus discussed the high-costs related to the drug: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug," he said.

In addition to the prescription costs, government programs are now paying for the damage caused by Vioxx. "Medicaid bears the cost of any additional medical care necessary when drugs cause injury," Senator Baucus pointed out.

By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.

On September 3, 2005, Shane Ellison, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and the problems within the FDA.

According to Mr Ellison, the FDA and Merck knew about the dangers of Vioxx for at least 4 years before it was pulled off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."

Mr Ellison says compliant politicians have "democratized" the industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports. "Science and choice no longer prevail at the FDA or at pharmaceutical companies," he added.

"To go against the 51% means losing your career," Mr Ellison explains. "Therefore, the majority of scientists choose to please drug companies, not the general public."

To substantiate this allegation, Dr Ellison points to Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg went public with findings that Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.

"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."

"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.

Another relevant, but little-mentioned fact, is that many FDA officials end up working for Big Pharma. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.

"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."

In addition, when leaving office many federal employees and members of Congress go to work for Big Pharma in one area or another. For instance, of the 1,274 people registered to lobby in Washington for drug companies in 2003, according to an April 2005 report by the Center for Public Integrity, 476 are former federal officials, including 40 former members of Congress.

Critics say the Prescription Drug User Fee Act, is in large part to blame, for the current problems within the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected complete the review process within 12 months.

User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding. This situation creates a major conflict of interest according to Dr Graham: "This culture views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.

Another problem he said is that even when the FDA does try to take measures to limit harm, the agency lacks the authority to force drug companies to comply. For example with Vioxx, he said, it took more than 2 years to get Merck to add the increased risk of heart attack and stroke on the label.

Then there is the matter of the conflicts of interests involving the FDA panels that advise the agency on which drugs should be approved, what their warning labels should say, and how studies should be conducted.

The approximately 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with very few exceptions the FDA follows their advice.

Members of the panels are supposed to be free of conflicts of interest relating to products they consider but they rarely are. For example, in February 2005, when the hearings were held to determine whether the COX-2 inhibitors should be allowed to remain on the market, a panel mired with conflicts was exposed. Out of the 32 voting members, ten had served as consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators, Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.

"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors," said their letter to the GAO in September 2005.

"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically referred to the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.

According to Ms Menziess, "The FDA's preemption argument, if successful, would take away the sole means by which American consumers may obtain compensation for drug-induced injuries caused by a drug company's failure to warn."

"Civil lawsuits uncover internal company documents to which not even the FDA has access," she explains.

"The tort system provides an important check on the regulatory process and on drug companies' compliance with law."

"Preemption," Ms Menziess warns, "would close off one of the few avenues by which we learn of safety and efficacy information that pharmaceutical companies do not publish or hide from FDA."

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.

Jury Trials In 2008 Expected To Expose SSRI Maker's Dirty Secrets

Evelyn Pringle January 2008

The blockbuster sales figures for the new generation of selective serotonin reuptake inhibitor antidepressants (SSRI's), which have resulted from their promotion for so many unapproved uses, represents the most profitable off-label marketing coup in the history of modern medicine. Sales total about $21 billion a year, according to IMS Health.

However, in the end these drugs will probably also hold the title for the most lawsuits filed against drug companies for overstating their benefits while concealing their serious side effects from as far back as 20 years ago.

The SSRI's include Prozac by Eli Lilly; Paxil marketed by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro from Forest Laboratories. Cymbalta by Eli Lilly and Effexor by Wyeth are often called SSRI's, but they are actually serotonin norepinephrine reuptake inhibitors (SNRI's). Wellbutrin sold by Glaxo is an inhibitor of the neuronal uptake of norepinephrine and dopamine. Several of these antidepressants now have generic counterparts.

In 2008, at least a dozen jury trials are scheduled all over the country for Paxil suicide-related cases, all of which allege that Glaxo failed to warn consumers and doctors about the known risk of suicide associated with the drug. Many of these cases will be tried by Baum, Hedlund, Aristei & Goldman, the national law firm with the longest track record of handling SSRI cases.

Going into the trials, Baum Hedlund will be armed with the largest collection of internal GSK documents, depositions of GSK employees and experts, as well as the fruits of the firm's investigation of antidepressants and their makers for the past decade and a half.

During litigation, virtually every Paxil-related document obtained by Baum Hedlund was stamped "confidential" by Glaxo and sealed under a court order. However, through a series of legal challenges, the firm was able to unseal many of the documents, in part, by forcing Glaxo to admit that they did not contain trade secrets and should never have been sealed to begin with.

Off-label Promotion and Prescribing Drive Profits

The FDA approves drugs for uses that have been tested for safety and efficacy and includes those uses on the drug's label. The term off-label means prescribing a drug for a use that has not been tested and proven safe and effective or for a different patient group, or at a different dose, or for a longer duration, or in combination with other drugs.

While doctors may legally prescribe a drug for an unapproved use, it is illegal for drug makers to promote off-label prescribing. Over the past 20 years, SSRI's have been prescribed off-label to children as young as infants, the elderly and pregnant women, and for off-label uses that include insomnia, anxiety, shyness, grief, menstrual discomfort, pain, bed wetting, ADHD, dementia, impotence and restless leg syndrome, to name just a few.

To gain FDA approval to legally sell SSRI's to kids, all the drug companies would have to do is provide two clinical studies showing that the drugs work better than a placebo in depressed children, and they can conduct 100 trials to achieve the necessary results. But after 20 years on the market, they still have not been able to give the FDA two positive studies to prove these drugs work with children, with the exception of Prozac.

Critics are quick to point out that this is certainly not for lack of trying because there have been dozens of pediatric trials conducted that show the drugs work no better than a placebo. How Prozac gained approval remains a mystery in light of the thousands of adverse events that were already recorded among children.

A study conducted at the University of Georgia and published in the June 2006 Journal of Clinical Psychiatry reviewed prescribing records for 107,000 Medicaid recipients on drugs that act on the central nervous system and found that 75% of SSRI patients received the drugs off-label and most of the time without their knowledge.

In April 2004, the CDC reported in the Journal of Women's Health that antidepressants were the top drugs prescribed to women in doctors' offices and outpatient departments, ahead of estrogens and progestins, antiarthritics and drugs for acid/peptic disorders.

According to another report by the CDC, during 2005, antidepressants were the most prescribed drugs overall in visits to doctors and hospitals and were even prescribed more often than drugs used to treat high blood pressure, cholesterol, diabetes and headaches.

Chemical Imbalance - Selling Sickness in the Absence of Efficacy

The standard line used to sell SSRI's is that mental illnesses are caused by a chemical imbalance in the brain and that SSRI's correct the imbalance. The Lexapro website even states: "Antidepressant medicines relieve the symptoms of depression by restoring chemical imbalances in the brain."

However, "Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature," in the November 8, 2005, PLoS Journal, by Jeffrey Lacasse, a visiting lecturer at the Florida State University, and Jonathan Leo, an Associate Professor of Neuroanatomy at Lincoln Memorial University, reports that, "there is not a single peer-reviewed article that can be accurately cited to directly support claims of serotonin deficiency in any mental disorder, while there are many articles that present counterevidence."

In their most recent paper titled, "The Media and the Chemical Imbalance Theory of Depression," appearing in the February 2008 issue of Society, Mr Lacasse and Mr Leo report that, "In spite of the enormous amount of money and time that has been spent in the quest to confirm the chemical imbalance theory, direct proof has never materialized."

In fact, they advise that the Diagnostic and Statistical Manual of Mental Disorders, which almost all psychiatrists use to diagnose and treat their patients, clearly states that the cause of depression and anxiety is unknown.

Even when prescribed for their intended purpose in treating depression, many experts say SSRI's are ineffective. One of the world's most famous psychopharmacologists, Dr David Healy, author of "The Antidepressant Era," and "Let Them Eat Prozac," says that an overall review of the published clinical trial data on the new antidepressants reveals a 10% difference in the way people respond to the drugs verses a placebo.

He reports that 50% of patients taking the antidepressants showed some improvement and 40% of people taking a placebo showed improvement. And when the data from the unpublished clinical trials are added in, 45% of patients taking a placebo showed improvement.

The author of "Surviving America's Depression Epidemic," Dr Bruce Levine also says "legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all."

However, most prescribing doctors have never heard about this 5% or 10% efficacy statistic, which researchers have referred to as the "dirty little secret," because many of the studies that revealed the "secret" remained hidden for years. In fact, much of the information is still not in the public domain.

A new study in the January 18, 2008 New England Journal of Medicine reports that the makers of the new antidepressants failed to publish many of the clinical trials that were submitted to the FDA for market approval that did not show positive outcomes in patients taking the drugs.

The researchers found that a total of 37 studies were viewed by the FDA as having positive results and all but one were published. But 22 studies that were viewed as having negative or questionable results were not published and 11 were published in a way that conveyed a positive outcome.

The study compared drug efficacy inferred from the published literature with efficacy determined in the FDA reviews and found that in the published medical literature, it appeared that 94% of the trials were positive when the FDA analysis showed that only 51% were positive.

The clinical trials analyzed included the drugs, Wellbutrin, Celexa, Cymbalta, Lexapro, Prozac, Remeron, Serzone, Paxil, Paxil CR, Zoloft, Effexor, and Effexor XR.

"For each of the 12 drugs," the researchers wrote, "the results of at least one study either were unpublished or were reported in the literature as positive despite a conflicting judgment by the FDA."

A total of 12,564 patients participated in these trials and data from 3,449 patients were not published. Data from an additional 1,843 patients were reported in journal articles that highlighted findings that conflicted with the FDA-defined primary outcome.

For each of the 12 drugs, the researchers also found that the effect size derived from the journal articles exceeded the effect size in the FDA reviews, with the increases in effect size in the published reports ranging from 11% to 69%, with an average increase of 32%.

The literature-search strategy used for the study consisted of a search of articles in PubMed, references listed in review articles, and a search of the Cochrane Central Register of Controlled Trials.

The researchers also contacted the drug maker's medical-information department by phone or email; and contact was also made by way of a certified letter to the company's medical-information department, including a deadline for responding in writing as to whether the results of a study had been published. If these steps failed to reveal any publications, the researchers concluded that the results had not been published.

The researchers who conducted the study include Erick Turner, MD, Annette Matthews, MD, Eftihia Linardatos, BS, Robert Tell, LCSW, and Robert Rosenthal, PhD, from Oregon Health and Science University, Portland Veterans Affairs Medical Center; Kent State University; the University of California–Riverside, and Harvard University.

In their paper, "The Media and the Chemical Imbalance," Mr Lacasse and Mr Leo point out the problem in the media where reporters still quote the people responsible for publishing bogus studies that have long been debunked.

"For instance," they write, "several of the researchers involved with the studies of SSRIs in children are still cited in the press even though the following information has come out about their published studies: they downplayed the suicide risk; they exaggerated the benefits; and the papers published under their names were actually written by ghostwriters paid by the pharmaceutical industry."

According to Dr Levine, depression is not a biochemical disorder and refers to it as a strategy used to shut down overwhelming pain. Dr Levine states that, if the strategy is used to excess, it can lead to immobilization and greater pain.

He explains that depressed people experience feelings of hopelessness and helplessness and that labeling them with a disease leads to more of the same feelings.

Instead of calling it an illness or weakness, Dr Levine says, depression can be lessened by helping patients understand that it is a normal human reaction and they can identify the source of the pain and heal.

More Disorders Equals More Profits

To expand the market, the SSRI makers have managed to create a whole new generation of psychiatric illnesses by simply padding the bank accounts of a few psychiatrists who determine the criteria for the inclusion of mental disorders in the DSM. With their inclusion in the billing bible comes the guaranteed payment for the cost of the SSRI's and the visits to the prescribing doctor by public and private health insurance programs.

There are also a whole new slew of SSRI treatable disorders lining up for inclusion in the next DSM edition. For instance, an August 3, 2006 article by Reuters reported that, "People with 'body dysmorphic disorder' are 45 times more likely to commit suicide than people in the general population, a new study shows."

"The findings underscore the importance of recognizing and treating this 'often secretive' psychiatric disorder," Dr Katherine Phillips, the study's co-author, told Reuters.

Individuals with body dysmorphic disorder, she said, have a distorted body image and think obsessively about their appearance, often for hours a day, but can be helped with drugs like Prozac or Zoloft and cognitive behavioral therapy.

On October 3, 2006, the New York Times ran the headline: "Can't Keep From Shopping? Help Could Be on the Way," for an article that said, compulsive buying, "in its extreme forms may be a psychiatric illness -- an impulse control disorder associated with abnormal levels of depression and anxiety."

The article discussed a study in the American Journal of Psychiatry, and the lead author, Dr Lorrin Koran, told the Times: "Many of those who come in for treatment suffer from depression, anxiety disorders and other impulse control disorders like pathological gambling and binge eating."

She also threw in a sales pitch saying, "studies suggest that psychotherapy or medications help many compulsive buyers to stop."

This news could potentially raise SSRI profits by 10%, because the Times says a statistical analysis of the study results found 5.5% of men and 6% of women could be afflicted.

The article also points out that compulsive buying is not yet a recognized psychiatric diagnosis, but that it is being considered for inclusion in the next edition of the DSM.

Good news for Pfizer came in the October 2006, Journal of Clinical Psychiatry, from a study led by Dr Susan Kornstein, at Virginia Commonwealth University, that claims low doses of Zoloft for 2 weeks before the onset of the menstrual period may be effective and well-tolerated for treating women with moderate-to-severe PMS.

The researchers also claim that other dosing strategies are effective, including taking Zoloft daily or waiting until symptoms begin to start taking it.

Zoloft is already approved for premenstrual dysphoric disorder (PMDD), but profits could skyrocket with widespread dissemination of this study because the researchers report that up to 60% of women suffer from PMS, while only about 5% suffer from PMDD.

On October 26, 2006, an Indianapolis Star headline warned that: "Midnight munchies can signal big problems." The article explained that routine and heavy nighttime snacking can be a sign of eating for reasons other than hunger and more serious symptoms can point to "a little-known eating disorder called night-eating syndrome."

But not to worry, because the researchers who did the study told the Star that Zoloft can help these poor souls as well, along with therapy to change eating and exercise patterns.

Great news for Glaxo came on October 27, 2006, when United Press International ran the headline: "Paxil helps compulsive hoarding syndrome".

According to UPI, persons with this syndrome exhibit 3 features: failure to discard objects due to severe anxiety related to discarding what most might regard as inconsequential objects; excessive acquisition, sometimes resulting in buying sprees, and excessive clutter to the point where home and work spaces can no longer be used.

Here again, however, researchers led by Dr Sanjaya Saxena at the University of California, report that Paxil is effective in treating this dastardly new disorder.

Risks Outweigh the Benefits

Experts say that if patients were adequately informed about the long list of side effects associated with SSRI's and their dubious efficacy before they took the first pill, they would be more than a little skeptical about whether their benefits outweigh the risks.

The SSRI labels now warn patients not to take them with common over-the-counter medications such as aspirin and many other pain relievers, or with cold remedies or herbal supplements like St John's Wort, or with alcohol.

SSRI side effects include suicidality, violence and homicide, birth defects, abnormal gastrointestinal and uterine bleeding, a decrease in bone density, fertility problems, sexual dysfunction, severe withdrawal and the life-threatening condition, serotonin syndrome.

According to the SSRI labels, symptoms of serotonin syndrome include mental status
changes such as agitation, hallucinations, or coma; autonomic instability like tachycardia, labile blood pressure and hyperthermia; neuromuscular aberrations such as hyperreflexia and incoordination, and gastrointestinal symptoms of nausea, vomiting and diarrhea.

All the current labels say that anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania have been reported in adult and pediatric patients treated for major depressive disorder, as well as for other indications, both psychiatric and non-psychiatric.

The labels also report that infants exposed in the womb have developed complications requiring prolonged hospitalization, respiratory support and tube feeding upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.

The labels note that these features are consistent with either a direct toxic effect or possibly a drug discontinuation syndrome and say it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.

On December 8, 2005, the FDA issued a public health advisory to report that women who take Paxil in early pregnancy are at an approximately 2-fold increased risk of having an infant born with a cardiac defect compared to the general population.

Also cited on the labels is a study finding that infants exposed to SSRI's in late pregnancy showed a 6-times greater risk of developing the lung disorder known as persistent pulmonary hypertension of the newborn (PPHN), a condition that, despite treatment, results in the death of approximately 10 to 20 percent of affected infants.

In December 2006, a Journal of Clinical Psychiatry study reported that about seven of every ten people who take antidepressants have impaired driving ability and that 16% have severe motor impairments after taking the drugs.

A short list of the adverse effects listed on the various SSRI labels as "frequent," and occurring on one or more occasions in at least 1 out of every 100 patients, includes light-headed feeling, appetite increased, increased weight, heartburn, abdominal cramp, gastroenteritis, allergy, pain in limb, fever, hot flushes, chest pain, lethargy, irritability, concentration impaired, abnormal dreams, sleep disorder, menstrual cramps, menstrual disorder, impotence, anorgasmia/orgasm abnormal, bronchitis, sinus congestion, coughing, migraine, sinus headache, vision blurred, urinary frequency and urinary tract infection.

Upcoming Jury Trials

Veteran trial lawyer, Ronald Goldman, who won one of the largest verdicts for the death of an unmarried person in Ohio state's history last year, is leading the Baum Hedlund team in the trials.

Glaxo has good reason to fear jury trials. The first Paxil-related suicide trial resulted in a verdict for the plaintiff. The case took place in Wyoming in May 2001 and involved a man, Donald Schell, who shot and killed his wife, daughter, and infant granddaughter before turning the gun on himself, after being on Paxil for only 2 days.

The instructions given to the jury required a finding that, "Paxil was a proximate cause of Donald Schell committing the homicides and suicide involved in this litigation" and that Glaxo's failure to test or to warn "was a proximate cause of the homicides and suicide in this litigation."

On June 6, 2001, the jury returned a verdict in favor of the plaintiffs and the Court entered a judgment against Glaxo for more $6 million. Glaxo filed an appeal and the parties settled out of court while the appeal was pending.

Baum Hedlund has litigated over 3,000 pharmaceutical cases in the past 18 years and the firm currently has approximately 30 SSRI suicide-related cases in litigation.

Baum Hedlund served on the Plaintiffs' Steering Committee in the first suicide-related case involving Prozac and served as lead counsel for the Plaintiffs' Steering Committee in Paxil Products Liability Litigation. The firm is also handling SSRI-related birth defect lawsuits.


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

UpHill Battle - Warning Pharma Customers About Dangers of SSRIs

Evelyn Pringle October 5, 2006

Recent concerns about the adverse effects of selective serotonin reuptake inhibitor antidepressants (SSRIs) have focused on suicide risks. However, a new study published in the September 2006 journal, Public Library of Science (PLoS), reports that in addition to self-harm, the drugs can also cause some patients to become violent and homicidal.

Professors David Healy and David Menkes from Cardiff University in Britain, and Andrew Herxheimer from the Cochrane Centre, conducted the study to determine the risk of violent behavior in people taking SSRIs.

During their investigation, the researchers reviewed all available clinical data on SSRIs and summarized a series of what they refer to as “medico-legal” cases involving patients who became violent on SSRIs in which they have given evidence.

In addition, they analyzed 1,374 emails from patients on SSRIs sent in response to a British television program on Paxil featured on Panorama.

The authors focus mostly on Paxil because they had access to more medico-legal case material for Paxil patients than other drugs and because GlaxoSmithKline recently submitted data on the rates of “hostile” events for the review of SSRIs by the British regulatory Committee on Safety of Medicines Expert Working Group.

Dr Healy is one of the world's leading authorities on SSRIs. He is the author of over 120 articles and 12 books, including, Let Them Eat Prozac, The Antidepressant Era, and The Creation of Psychopharmacology.

His expert testimony at the trial of a Wyoming lawsuit involving violence associated with Paxil in 2001, was a deciding factor in the return of a favorable verdict for the plaintiffs. The trial involved the tragic case where 60-year-old, Donald Schell, shot and killed his wife, daughter and granddaughter and then himself after taking Paxil for only two days.

Mr Schell's surviving family members sued SmithKlineBeecham and won. Another decisive factor in the Wyoming case relevant to the results of the current study, is that the company's own internal clinical trial data revealed at trial showed that Glaxo knew prior to 1998, when the deaths occurred, that Paxil had caused some patients to become violent and suicidal.

The data included an unpublished study of incidents of serious aggression in 80 patients, 25 of which involved homicide. After weighing all the evidence, the jury said that Paxil “can cause some people to become homicidal and/or suicidal,” and ordered Glaxo to pay the plaintiffs $8 million.

In the PLoS study, Dr Healy and his colleagues warn that, "The new issues highlighted by these cases need urgent examination jointly by jurists and psychiatrists in all countries where antidepressants are widely used.”

However, that might be easier said than done because according to Dr Healy, “even though PLoS is braver than most journals and less influenced by industry than most, it still took close to 18 months for this article to appear.”

“I have several articles that have taken this long,” he reports. “The hold up," he says, "is the journal - whether PLoS or BMJ being terrified of industry and a legal action against them."

“This stands in contrast" Dr Healy points out, "to the good news about drugs which industry manages to get out rapidly in the best quality, highest impact factor journals, apparently authored by the biggest name academics in the field.”

“But these articles,” he advises, “are based on selected data and no-one has access to the full dataset and no-one makes a judgment based on full access.”

Investigative reporter, Kelly Patricia O'Meara, author of, “Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills That Kill (2006),” is also painfully aware of the difficulties involved in getting the information published about SSRIs and violence that most experts have known about for years.

"It seems to me that the "new" study is an old issue," she says. "I don't believe there is anyone remotely familiar with these drugs who wouldn't admit a strong correlation between them and violence.”

“It is an issue that must be addressed,” she warns, “given the numbers of violent acts that appear to be associated with their use."

"The issues the doctors raise about the medical/legal aspects," Ms O'Meara says, "are extremely pertinent."

Specifically, she notes, in recent weeks in the Washington DC area, there have been three cases reported in the Washington Post all dealing with violence/murder associated with "mental illness."

"While all three cases reportedly were receiving psychiatric care," she says, "only one of the cases mentions the use of psychotropic drugs."

"Naturally," she points out, "any progress on this will depend largely on whether the press is informed enough to even ask the question: were they on prescription mind-altering drugs?"

Dr Healy acknowledges that, “SSRIs can be very useful and there are unquestionably people who are hugely helped, but the benefits have been over-hyped,” he says, “and the risks concealed and denied.”

It would be helpful, he notes, to have access to all the data on the violence side effect associated with SSRIs. “Based on access to all the data in this area,” he explains, “we might be able to work out if men or women are at greater risk or young or old or people being treated for anxiety rather than depression.”

“Until then,” he advises, “the key thing is that people being put on these pills need to be warned that they may not suit them and if they feel odd or more anxious they should either stop treatment or return to their doctor.”

“The worry,” Dr Healy has, “is that doctors indoctrinated by company input on this will still only see the risks from the condition being treated and faced with a patient saying they feel worse will double the dose of the treatment rather than reducing the dose or halting the treatment or switching to a different kind of treatment.”

“This would be exactly the wrong thing to do if the drug is the source of the problem,” he warns.

Other recognized experts on SSRIs share the same concerns. According to Dr John Abramson MD, author of Overdosed America, and clinical instructor at Harvard Medical School, a double standard exists in the way that information is received by physicians.

“Commercially advantageous “knowledge” travels fast and is delivered by many paths,” he says, “while commercially disadvantageous information, though available sometimes in a legalistic sense, is not communicated in the way that doctors have been formally and informally trained to receive new information.”

In the Paxil trials reviewed for the PLoS study, aggression and violence were coded under the term "hostility" which included homicide, homicidal acts, and homicidal ideation as well as aggressive events and conduct disorders, but no homicides were reported in the trials.

When combined, hostile events in both the adult and pediatric trials, during therapy and the 30-day tapering off phase, 60 out of 9,219 patients experienced hostile events.

The study found hostile events in excess in both adults and children, and across all indications. The hostility rates were highest among children with obsessive-compulsive disorder, where the rate of a events was 17 times greater.

In their submissions to the Committee on Safety of Medicines, Glaxo also reported clinical trials comparing 11,491 patients on Paxil and on other SSRIs, and there were 44 hostile events in patients on Paxil or other drugs.

In the trials comparing Paxil with another SSRI, there were 16 hostile events in a group of 2,418 patients. These SSRI comparator trials may be confounded by indication, the researchers note. They might, for instance, have included a higher proportion of OCD patients.

However, most noteworthy in this review, the researchers found that in healthy volunteer clinical trials that took place in the late 1980s or early 1990s, hostile events occurred in three of the 271 healthy volunteers taking Paxil, while none occurred in the 138 volunteers taking a placebo.

“Although not statistically significant,” the authors point out, “this finding is striking because hostile events are unusual in healthy volunteer trials, and this figure was higher than the rate reported in clinical populations above.”

Glaxo attributed these events to the fact that the volunteers were confined, although the study authors note that both the Paxil and placebo volunteers were confined.

But here again, Dr Healy acknowledged the significance of the findings in the healthy volunteer trials 6 years ago. "We can make healthy volunteers belligerent, fearful, suicidal and even pose a risk to others," he wrote in the June 2000, Primary Care Psychiatry.

“People don't care about the normal consequences as you might expect,” he stated. “They're not bothered about contemplating something they would usually be scared of.”

Four years later, on September 21, 2004, Dr Healy is sounding the alarm again and quoted by The Guardian, as saying, "I think there is very clear evidence for all of the SSRI group of drugs that in addition to making people suicidal, they can make people homicidal or seriously aggressive and the data have been sitting in the MHRA's files on this issue.”

“It is there for children across a range of different problems,” he said, “it is there for healthy volunteers and a range of adults and the MHRA has paid no heed to this.”

Another recognized expert on SSRIs, Ann Blake Tracy, PhD, Executive Director, International Coalition For Drug Awareness, and author of, “Prozac: Panacea or Pandor?” has been investigating the adverse events associated with SSRIs for the better part of two decades and says that, “This study confirms all of the previous data we have on increased levels of serotonin and violence.”

Ms Tracy has been working to make her findings public for the past 16 years. “This understanding that increased levels of serotonin - the exact so called “therapeutic” effect that antidepressants are designed to have,” she states, “has long been associated with psychosis, mania, suicide, violent crime (including rape, arson, murder), and could have saved many, many lives in the past two decades that these drugs have been in such widespread use worldwide.”

According to Ms Tracy, research has shown that impairing serotonin metabolism will produce tension and anxiety which appear from out of nowhere, depression, suicide - especially very violent suicide, hostility, violent crime, impulsive behavior with no concern for punishment, and argumentative behavior.

“How anyone ever thought it would be “therapeutic” to chemically induce these reactions is beyond me,” she states. “Yet, these reactions are exactly what we have witnessed in our society over the past decade and a half as a result of the widespread use of these drugs.“

She makes a very good point when she poses a thought provoking question. “Can you remember two decades ago,” she asks, “when depressed people used to slip away quietly to kill themselves rather than killing everyone around them and then themselves as they do while taking SSRI antidepressants?”

In the PLoS violence study, the authors provide an excellent example of the bizarre violent murders and suicides that Ms Tracy refers to, when they discuss the 1989 case of Joseph Wesbecker who shot and killed eight people, and injured 12 others, before killing himself at his place of employment in Kentucky after taking Prozac for about four weeks.

This incident also led to a lawsuit against Prozac maker Eli Lilly. The case was tried and settled in 1994, and a number of documents about drug-induced activation were made public back then.

The cases of out of character acts of violence by persons taking SSRIs are not isolated incidents or limited to certain age groups. Delnora Duprey has observed first hand the horror that can result from prescribing SSRIs to children. She is the maternal grandmother of Christopher Pittman, who at 12-years-old was placed on Paxil and Zoloft simultaneously, and subsequently murdered his paternal grandparents by shooting them as they lay sleeping and then burning the house down.

The following morning, two hunters found young Christopher hysterical in the woods yelling and waving a loaded shotgun over his head.

Ms Duprey says that she would like to stress as a family member who has gone through a terrible tragedy due to these drugs, that she knows how they can change people. "Our Christopher went from a sweet shy good kid," she recalls, "to an angry hyper aggressive person in a very short time period."

"This was not a normal change in a personality," she states, "it was the medication.”

Ms Duprey, along with every other relative, blames the SSRIs, and says that Christopher would never have murdered his grandparents because he adored them both.

"While off the medication our Chris is back," she says, "he has gotten his GED and has done very well under some rough conditions."

Christopher has remained in jail ever since the night he killed his grandparents in 2001.

He was tried as an adult, found guilty and sentenced to 30 years in prison.

At a sentencing hearing his aunt, Melinda, the daughter of the slain grandparents, begged the court to show mercy toward her nephew, stating that her parents would want the court to show mercy toward Christopher.

The South Carolina Supreme Court has opted to hear an appeal and the case is set for a hearing in October 2006.

Through their review of adverse event records in the UK, Dr Healy and his collegues found that by 2003, there were already 121 cases of aggression in patients on Paxil reported to the Medicines and Healthcare Products Regulatory Agency, and furthermore, by January 2006 that number had risen to 211.

The authors specifically point out that such reporting systems estimate that doctors only report between one and ten percent of adverse effects.

The data reviewed for the study that was submitted by Pfizer on Zoloft’s pediatric trials showed aggression to be the most common cause for discontinuation in the two Zoloft placebo-controlled trials in depressed children.

In the Pfizer trials, eight of 189 patients in the Zoloft group discontinued for aggression, agitation, or hyperkinesis (a coding term for akathisia), compared to no dropouts for these reasons in the group of 184 patients on a placebo.

When discontinuations were considered for any treatment-induced activation including suicidal ideation or attempts, aggression, agitation, hyperkinesis, or aggravated depression, there were 15 drop outs by patients on Zoloft and only two in the placebo group.

In the only other placebo-controlled Zoloft pediatric trial, of children with OCD, out of 92 patients on Zoloft, there were ten dropouts. Five for behavioral activation, two for agitation, one for aggression, one for nervousness, and one for emotional lability.

In comparison, in the group of 95 children taking placebos, there was one discontinuation for hyperkinesis out of two dropouts overall.

In addition, in one healthy volunteer trial on Zoloft run by Dr Healy, one of twenty volunteers reported aggressive behavior. This is not the only Zoloft healthy volunteer trial to show hostility after Zoloft intake, Dr Healy says, but the other data remain unpublished.

Finally, in pediatric trials of Wyeth's Effexor, 2% of the children dropped out because of hostility, more than double the rate of children on a placebo.

The researchers also analyzed the 1,374 emails that were received by the BBC television following a program on Paxil and found that many people described emotional storms and thoughts and acts of violence or self-harm.

The analysis, they said, indicated a clear link between severe mood changes when Paxil treatment began, or later when the dosage was increased, decreased, or withdrawn.

Remarkably, the analysis found reports of violence in patients with no prior history of violent behavior. The results, the authors note, were also consistent with an analysis of reports by people on Paxil submitted to the MHRA by doctors between 1991 and 2002.

The authors say the strength of the current study showing an association between violence and SSRIs is that the data are unselected, but consistent even though it comes from a variety of sources.

“A weakness of the study,” they note, “is that we have been able to include only a subset of existing data in the analysis.”

“Data on aggression on other antidepressants will necessarily have been collected as part of the development programmes for these drugs,” they state, “but these data are not in the public domain.”

“Earlier reports have linked antidepressants to violence,” they note, “but this is the first independent study to offer a quantitative analysis of the issue; no other studies exist with which our results can be compared.”

By now many experts are questioning whether it can be said that the benefits of SSRIs outweigh their risks or whether they have any benefits at all. According to Dr Peter Breggin, another well-known expert on SSRIs, and author of, The Antidepressant Factbook, “study after study has confirmed that antidepressants typically perform only a little better than sugar pills.”

“In some studies,” he notes, “antidepressants actually turn out to be less effective than the lowly sugar pill.”

He also points out that “if depression is a product of our conflicts, stressful life experiences, and stifled choices, a drug would have no direct effect on treating it.”

Another expert in the field, and author of, The ADHD Fraud, Dr Fred Baughman, says, “we have the “disease-ing” of emotional and behavioral problems—of life’s problems with never a mention that the causes can be found in every-day life difficulties—things people can and must be helped with.”

He says when people get help in solving their work problems or marital and family problems or financial problems their “mental illness” is often gone in a day.

“The drugging psychiatry-pharmaceutical cartel,” Dr Baughman warns, “is too anxious to “disease” and “disable” those with real-life problems and the emotional symptoms they beget.”

Dr Healy has said that most patients diagnosed with mild or moderate depression would be better characterized as suffering from "community nervousness." And although he views the condition as a real disorder, he says that it "could be due to a host of different factors such as overwork, stress, and constitutional deficits. But clinicians everywhere are diagnosing depression because that's what they have a treatment for.”

"The Prozac story," he writes in the book, ”Let Them Eat Prozac,” is one of a "wholesale creation of depression on so extraordinary and unwarranted a scale as to raise grave questions about whether pharmaceutical and other health care companies are more wedded to making profits from health than contributing to it."