The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Weighing Benefits of SSRIs Against Suicide Risk

Evelyn Pringle December 8, 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mental Illness Epidemic Hits US

Evelyn Pringle December 6, 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lexapro Legal Problems Mount Against Forest Laboratories

Evelyn Pringle November 15, 2006

According to Forest Laboratories’ Annual Report, for the year ending March 31, 2006, Celexa and Lexapro, accounted for 68% of the company’s sales.

The drugs belong to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Sales of Lexapro, the filing notes, increased 16% in the 4th quarter to $464,100,000, compared to $399,381,000 in the same quarter a year ago.

However, the Report filed with the SEC on June 14, 2006, also says that Forest Labs is currently a named defendant in approximately 25 active SSRI related lawsuits, with most of the cases claiming that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.

On November 7, 2005, Forest moved to consolidate all of the cases pending in Federal courts into a multidistrict proceeding, and on February 6, 2006, its motion was granted and multidistrict litigation was established with the cases then pending transferred to Judge Rodney Sippel in the US District Court for the Eastern District of Missouri.

But the company’s legal troubles by far are not limited to a few civil lawsuits. The US Attorney’s Office for the District of Massachusetts is investigating whether Forest has committed not only civil violations but also criminal violations of the Federal Anti-Kickback laws with “off-label” promotional activities in the marketing of Lexapro and other products.

As part of the investigation, Forest first received a subpoena from the Office of Inspector General of the Federal Office of Personnel Management requesting documents relating to Celexa, but the company has since received another subpoena from the US Attorney’s Office related to Lexapro and other products.

The subpoenas request documents relating to a broad range of the company’s marketing and promotional activities dating back to January 1, 1997, all the way up to the present.

The truth is, right along with all the other SSRI makers, Forest has been marketing Lexapro for the off-label treatment of a wide variety of ailments in part, by promoting the notion that every uncomfortable feeling is caused by a “chemical imbalance.” However, according to Dr David Healy, “none of the SSRI manufacturers can tell us what constitutes a proper chemical balance of serotonin in the brain.”

“Thus,” he says, “the truth is that Lexapro and its serotonergic cousins lie somewhere on the continuum between “magic bullets and snake oil.”

Dr Healy is one of the world’s leading authorities on SSRIs and the author of, “The Antidepressant Era,” and “The Creation of Psychopharmacology.”

To expand the market for SSRIs, the drug companies have transformed everyday sadness, stress, and worry into mental disorders that demand one cure: drugs. Strong emotions felt after the death of a loved one, or a divorce, or job loss are now irrational and symptoms of mental illness.

In fact, over the past 15 years Big Pharma has managed to cultivate the development of a whole new batch of mental illnesses, with names like generalized anxiety disorder, social anxiety disorder, panic disorder, and premenstrual dysphoric disorder, by simply greasing the palms of the so-called psychiatric “experts” who determine the criteria for the inclusion of a disorder in the Diagnostic and Statistical Manual for Mental Disorders (DSM).

Other more recent additions to the DSM, intended to further widen the customer recruitment net to specifically target children, have names like reading disorder, mathematics disorder, disorder of written expression, and oppositional defiant disorder.

And with the inclusion in the DSM, comes the guaranteed payment for the drugs to treat the disorder from public and private health insurance programs. The first edition of the DSM had a little over 100 disorders; the latest edition lists close to 375.

The mass marketing of mental illness has led many people experiencing minimal symptoms of distress to believe they need drugs to exist. And because most doctors are not trained on the side effects of SSRIs, patients can exhibit a wide range of actions or behaviors that appear to be symptoms of another “disorder,” and are then prescribed more drugs to counter the unrecognized adverse reactions to the first.

Even the medical education courses that doctors must take each year to maintain their professional license are most of the time sponsored by drug companies which means the courses are intended to increase the sale of specific drugs, and to educate doctors on their adverse effects would defeat the whole purpose of the seminar.

In fact, experts say the drug makers continue to ignore and discount all of the adverse effects associated with SSRIs. For instance, sexual dysfunction, such as lack of libido or interest, orgasmic dysfunction in women, and delayed ejaculation in men, are extremely common but seldom mentioned. Studies have shown that as high as 70% of patients on SSRIs experience sexual side effects.

According to WebMD, on July 2005, these side effects cause significant problems of their own. “For both men and women, this means being unable to initiate, participate fully in, or enjoy sex,” the article states, “and that can lead to a crippling loss of self-confidence that can, in turn, undermine depression recovery.”

But then not to worry, because a study in the January 1, 2003, Journal of the American Medical Association says that people experiencing SSRI related sexual dysfunction may be helped by simply taking another pill, Viagra.

And, although the FDA has not approved Viagra for women, some “experts” recommend that women experiencing SSRI related sexual problems should give it a shot anyways.

Whenever possible, patients are convinced that they need to take SSRIs for life. It would be interesting to see the results of a survey that asked patients if they would be willing to begin a life-long drug treatment if it meant waving good-by to a normal healthy sex life.

As a follow-up, a survey should also be conducted on the partners of SSRI patients to find out how long they will be willing to remain in what often becomes a sexless relationship.

The drug companies have also tried for years to discount the many studies showing an increased risk of suicide in patients taking SSRIs, when compared to patients taking a placebo, by claiming that suicide is a side effect of depression.

This claim is an insult to the intelligence of consumers. If that assertion were true, there would be more suicides by people taking placebos, not the other way around.

An FDA patient information sheet for Lexapro now says: “Persons taking Lexapro may be more likely to think about killing themselves or actually try to do so, especially when Lexapro is first started or the dose is changed.”

“People close to persons taking Lexapro can help by paying attention to changes in user’s moods or actions,” the paper says. “Contact your health-care professional right away,” it warns, “if someone using Lexapro talks about or shows signs of killing him or herself.”

“If you are taking Lexapro yourself and you start thinking about killing yourself,” it instructs patients, “tell your health-care professional about this side effect right away.”

That simple warning, critics say, added to the doctor and patent information sheet for SSRIs when the problem was first discovered could have saved tens of thousand of lives.

One of the Lexapro-induced suicide lawsuits mentioned in Forest’s Annual Report, was filed by Raymond Badyna, as the administer of his deceased son, Ray Badyna’s estate.

The action was filed in the US District Court for the District of New Jersey on September 25, 2005, by attorneys, Derek Braslow and Harris Pobust, of the Pogust & Braslow, LLC law firm in Conshohocken, Pennsylvania.

On September 30, 2003, Ray was prescribed Lexapro by his primary care physician who noted that Ray was experiencing anxiety, depression and was having problems relaxing and sleeping at night.

Ray’s doctor said that he prescribed Lexapro because he believed the drug was effective in treating depression and anxiety based on research that was distributed by Forest Labs.

However, the drug did not help and Ray’s condition immediately began to deteriorate. Friends and co-workers spoke with Ray concerning his use of Lexapro and they recall that Ray said that he was not feeling himself and feeling very strange.

At his sister’s birthday party on October 4, 2003, the family observed Ray as appearing extremely withdrawn, tired and isolated. His sister noticed that he was pacing back and forth throughout the house, looked uneasy, and that his hands were shaking.

His sister became convinced that something was seriously wrong with Ray and she was right. Unbeknownst to his family, Ray was suffering from suicidal ideation and had expressed thoughts about harming himself to others.

In a conversation with his friend, Ray complained that Lexapro was making him “feel weird” and said that he “had very strange thoughts running through his mind.”

On October 7, 2003, while at work, Ray got what should have been great news when he was notified that his year to date performance had qualified him to receive the, “Countrywide Circle of Excellence Award,” for the second consecutive year in a row.

Two days later, on October 9, 2003, Ray, age 32, committed suicide by overdosing and cutting his wrists. An autopsy showed the presence of Lexapro in his bloodstream.

Ray’s death was senseless. He life was a model for the all-American success story. He was popular, outgoing and sociable and had a loving close relationship with his family.

Ray had a college education, and a good career in real estate and owned his own home, as well as four other investment properties, and even a boat.

Family members, friends and co-workers alike, all say Ray was outgoing, had a great sense of humor, enjoyed life and seemed to everything to live for, prior to being prescribed Lexapro. If Ray’s family members had been told to watch for the warning signs that Ray was exhibiting, they would have intervened, and he would be alive today.

The family’s lawsuit alleges that in “the last decade there has been a host of peer-reviewed scientific literature linking the SSRI drugs, of which Lexapro is one, to violence – both self-directed and directed towards others.”

Among others, the complaint specifically cites a peer reviewed article published in 2000, on an epidemiological study, funded in part by Eli Lilly and SmithKlineBeecham, that reports that the incident of deliberate self-harm of people on SSRI medications is 5.5 times higher than that of people on the more traditional tricyclic antidepressants.

“Had Ray or his physician known of the increased risk of suicide and suicidal ideation from Lexapro,” the family’s lawsuit states, “Ray would have never taken the drug.”

Next year’s annual report will have new additions to the list of lawsuits against Forest. For instance, in July 2006, Mark Bibbee, filed a lawsuit after losing his only 2 sons to Lexapro-induced suicides. The family’s attorney, Charles E Grisi, filed the action in Summit County Ohio Common Pleas Court.

David Bibbee was only 27 when he killed himself on February 23, 2003 at his fathers home, and Brian Bibbee was only 24, when he committed suicide 17 months later at his mother’s home on July 24, 2004.

The lawsuit charges that Forest Labs knew of the increased risk of suicide, yet failed to conduct tests to see how often the problem occurred and failed to properly warn doctors, pharmacists and patients of the risk, or provide ways to reduce the risk.

The lawsuit points out that a link between SSRIs and suicide was first noted in 1990, even though the FDA did not issue a public health advisory until March 2004, more than a year after David’s death and about four months prior to Brian’s death.

“Strong warnings and instructions, coupled with reasonable effort to ‘get the word out’ could still have saved Brian Bibbee’s life,” the lawsuit states.

“Unfortunately,” the complaint charges, “Forest took the path of least resistance and greatest profits by doing only the minimum amount that the FDA urged it to do.”

“Therefore,” the lawsuits states, “this warning was ‘too little, too late’ for David and Brian Bibbee.”

These three cases of unexpected suicides by young people taking Lexapro are not isolated incidents. Jo Ann Kelly has been trying to raise awareness about the increased risk of suicide associated with SSRIs since her son, David died of a self inflicted gun shot wound after he was prescribed Lexapro for an anxiety disorder.

A few days before his death, Jo Ann noticed a dryness of skin and an increased agitation in David, and her son-in-law noticed a yellowish appearance in David’s eyes.

Jo Ann became frantic and feared that her son might not be metabolizing the Lexapro correctly so she called to schedule a doctor’s appointment but could not get in for 2 days.

The day of the appointment came too late; David had already shot himself.

Over the past several years, studies have shown that SSRIs are associated with serious birth defects in babies born to women who use the drugs during pregnancy. Within the last year, the FDA has added warnings to the labels on SSRIs about the risks of heart birth defects and a life-threatening lung disorder.

As a result of the new revelations about birth defects, lawsuits are now being filed against the SSRI makers on behalf of injured infants.

Medical professionals say the value of any drug must be determined by weighing its benefits against its risks. In the case of SSRIs, the benefits, if any, are a topic of great controversy. An analysis of studies submitted to the FDA between 1987 and 1999, on the six most popular SSRIs, found that approximately 80% of the positive responses to the drugs were the same in patients participating in the placebo groups.

Simply put, with all the known harms identified over the past 20 years associated with SSRIs, they do not even work.

Filed under: 2006, Birth Defects, Celexa, Forest, Lexapro, settlement, SSRIs, suicide

SSRIs – Wonder Drugs From Hell

Evelyn Pringle February 7, 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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