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

More Adverse Effects Linked to SSRI Celexa

Evelyn Pringle November 14, 2006

According to testimony at an inquest into the deaths of Roxanne Richardson, 30, and her children, Luke, 3, and Grace, 20 months, an autopsy revealed that at the time of their murders, husband and father-turned-killer, Michael Richardson, had Celexa in his system higher than prescribed which may have caused him to become agitated and irritable.

When he arrived at the Richardson home on July 12, 2004, Detective Sergeant Fox said the four bodies lay side by side on a bed. The medical evidence was that Mrs Richardson had been stabbed in the chest and then suffocated, the children had been suffocated, and Mr Richardson had died from a gunshot wound, according to the November 1, 2006 Sidney Morning Herald.

A far cry from alleviating his depression, on the day of the tragedy, while pumped full of Celexa, Mr Richardson wrote in his diary: “I’m hurting so much, nothing matters to me any more except my family and they are getting taken away from me.”

Over the past 15 years, there have been a growing number of criminal cases where people have claimed that their aggression and violence was caused by the use of antidepressants like Celexa, a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

Psychiatrist, Dr Peter Breggin, author of 20 books including, “Toxic Psychiatry,” has been researching psychiatric drugs and serving as an expert witness and consultant in civil and criminal cases involving drug companies for more than 25 years.

In 1972, he founded The International Center for the Study of Psychiatry and Psychology (ICSPP), a non-profit research and educational network, focused on the impact of mental health theory and practices upon patient well-being, personal freedom, and family and community values. He also founded the journal, Ethical Human Sciences and Services.

According to Dr Breggin, all SSRIs can produce stimulation or activation with the potential for increased agitation, disinhibition, irritability, aggression, hostility, mania, and crashing into depression and suicide.

“They can also cause a flattening of emotional responses,” he notes, “including a loss of caring, that can unleash dangerous actions.”

“Beginning with the widespread use of Prozac in the early 1990s,” he says, “the struggle to gain public and professional recognition of antidepressant-induced suicide and violence has a long and stormy history. “

The debate peaked in 1994 when Dr Breggin testified against Eli Lilly in a case of Prozac-induced suicide and mass murder by a postal worker in Kentucky.

“My testimony, in effect,” Dr Beggin recalls, “was that the perpetrator, Joseph Wesbecker, hadn’t gone “postal,” he’d gone “Prozacal.”

After the drug company won a split jury decision at the end of the trial, the judge figured out that the trial had been fixed. “The plaintiffs,” Dr Breggin says, “had been paid off by the drug company to conduct a fake trial that was rigged to end in favor of the drug company.”

In the end, when the judge realized what happened, he was outraged and voided the verdict.

According to Dr Breggin, while the FDA and antidepressant makers continue to deny that SSRIs cause violence, many lives continue to come to tragic ends.

It wasn’t until late 2004, that the FDA finally made drug companies add a black box warning to the labels of SSRIs about the increased risk of suicide among patients taking the drugs, even though Dr John Abramson MD, author of, “Overdosed America,” and a clinical instructor at Harvard Medical School, says the FDA knew about the increased suicide risk since before the drugs were approved.

The findings from a study published in the Archives of General Psychiatry in 2000, he says, evaluating the findings from the “pivotal studies” submitted to the FDA on the 7 new antidepressants approved between 1987 and 1997, including Prozac, Zoloft, Paxil, Effexor, Serzone, Remeron, and Wellbutrin SR, went largely ignored.

In studies that included depressed but not suicidal patients, the completed suicide rate for those taking one of the new antidepressants was 842 in 100,000 per year, or 0.84%, while the rate of suicide for patients taking a placebo was less than half at 360 in 100,000, or 0.36%.

“In other words,” Dr Abramson explains, “the pre-approval studies considered by the FDA to be highest quality and most important for these 7 new and supposedly safer and more effective antidepressants showed that treating 1000 depressed non-suicidal patients for one year with the new drugs led to about 5 more successful suicides than if the same group of 1000 patients had been treated with a sugar pill.”

“This is an enormously high death rate,” he points out.

And although the incidence of violent behavior is not included in the above report on antidepressants, Dr Abramson says, “it certainly seems logical that when the risk of violent actions against self are more than doubled, that the incidence of violent actions against others might be similarly affected.”

At the very least, he notes, this possibility should have been studied.

Critics say, getting the FDA to issue warnings about the increased suicide risk with SSRIs was like pulling teeth. According to investigative journalist and author of, “Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill,” Kelly Patricia O’Meara, “based on the evidence that twice as many children in clinical trials showed a greater risk of suicidality taking the antidepressants, coupled with the evidence that the antidepressants in the majority of the clinical trials were no more effective than sugar pills, the FDA had little choice but to “request” the pharmaceutical companies add the black-box warnings.”

Also in 2004, what would become a steady stream of studies showing harm to infants born to mothers taking SSRIs began to emerge.

In February 2004, the study, “Maternal Selective Serotonin Reuptake Inhibitor,” by Philip Zeskind PhD and Laura Stephens, in the journal Pediatrics, reported that “first-trimester use of SSRIs has been associated with higher rates minor physical anomalies and miscarriages, thus suggesting possible early effects of SSRI exposure on embryonic development.”

The study also reported that third-trimester use off SSRIs had been associated with lower gestational age, low birth weight, higher rates of neonatal intensive care unit admissions.

In June 2004, a French study published in the journal Prescrire International, reported that newborns exposed to SSRI during pregnancy showed signs of agitation, altered muscle tone, and breathing and suction problems.

The following month, in July 2004, the FDA changed the labeling for all SSRIs, warning that some newborns exposed to SSRIs had developed problems requiring respiratory support, tube feeding and prolonged hospitalizations.

But as it turns out, the FDA had received hundreds of reports of adverse effects in infants born to mothers taking SSRIs over the past decade, according to WebMd. The most common adverse events reported included irritability, trouble eating, body rigidity, and respiratory problems, said Kathleen Phelan, a safety evaluator in the division of drug risk evaluation, to WebMD.

A February 2005 study in the journal, Lancet, screened the World Health Organization’s database on SSRI adverse reactions in cases of neonatal convulsions and withdrawal syndrome, and found that by November 2003, there was a total of 93 case reports of maternal SSRI use in babies born with convulsions or withdrawal syndrome.

An analysis of the reports showed 64 cases were associated with Paxil, 14 with Prozac, 9 with Zoloft, and 7 were associated with Celexa.

Research released earlier this year linked SSRI use by mothers during pregnancy to infants born with the life-threatening persistent pulmonary hypertension (PPHN) lung disorder. According to a study by researchers at the University of California, San Diego School of Medicine, in collaboration with Boston University’s Slone Epidemiology Center, in the February 9, 2006 New England Journal of Medicine, babies born to women who took SSRIs in the second half of pregnancy, had a 6 times greater risk of developing the lung disorder.

In September 2005, studies conducted by Danish and US researcher determined that SSRI use in the first trimester of pregnancy was linked to a 40% increased risk of birth defects such as cleft palate and that cardiac defects in newborns also appeared to be 60% more likely with women who used SSRIs.

In February 2006, a study conducted in Israel found that one out of 3 infants exposed to SSRIs in the womb showed signs of drug withdrawal at birth, including high-pitched crying, tremors, and a disturbed sleep pattern.

On April 7, 2006, the BBC reported a Canadian study of almost 5,000 pregnant women that found mothers on SSRIs were twice as likely to have a premature birth and also nearly twice as likely to have low birth weight infants and stillbirths.

Less than 3 months later, in July 2006, the FDA issued an advisory that warned against taking SSRIs together with triptans, drugs used to treat migraine headaches, because a life-threatening condition called serotonin syndrome may occur. The condition, the FDA said, causes serious changes in how the brain, muscles and digestive system work due to high levels of serotonin in the body.

Last month, doctors at the Cornell Medical Center, in New York, who were treating the two men for infertility, including one who was on Celexa, found that when the men stopped taking the SSRIs, their fertility problems disappeared, only to resume again when they went back on SSRIs.

The problem is believed to be caused by an adverse effect of SSRIs on both the concentration and swimming ability of sperm. The men were tested over a 2-year period

Dr Peter Schlegel, who presented the research at the American Society for Reproductive Medicine conference, in New Orleans, explained that:

“The patients had normal sperm counts and motility before medication. On the medication they have severe deterioration of both. The same patients going on and off medication had the same pattern. It shows a strong association.”

Impotence and delayed ejaculation are well-known side-effects of SSRIs, and now Dr Schlegel says he believes that the drugs may be preventing sperm from getting into semen.

“These were men with normal sperm counts that went to nearly zero when they were on these antidepressants but returned to normal when they were off them. It’s a dramatic effect and it’s never been described before,” said Professor Schelgel in the Guardian on October 24, 2006.

“We believe that while it’s had a profound effect on these two men,” he said, “it could be having a significant but more subtle effect on many more men.”

But no matter how many adverse events are found to be associated with SSRIs, there seems to be no way to curtail the over-selling of these drugs to all populations. For the year ending March 31, 2006, Forest Laboratories top selling drugs were the SSRIs, Celexa and Lexapro, which when combined, accounted for 68% of the drug maker’s sales.

However, there may be a few dents in the company’s profit margin for SSRIs in the coming years because according to Forest Lab’s Annual Report filed with the SEC on June 14, 2006, the company is a named defendant in approximately 25 active product liability lawsuits, with most alleging that Celexa or Lexapro caused or contributed to persons committing or attempting suicide.

In addition, Forest Labs may not know it yet, but the company will soon be hit with the first Celexa-related birth defect lawsuit alleging that the company engaged in “repeated and persistent fraud” by misrepresenting, concealing and otherwise failing to disclose, information concerning the safety and effectiveness of Celexa in treating pregnant women.

Named plaintiffs in the case will be Lacee Shore, who was prescribed Celexa during her first trimester of pregnancy and her baby Gavin Shore, who was born with heart birth defects. Attorney, Robert Kwok, of the Houston, Texas lawfirm Robert Kwok & Associates, LLP, is handling the case.

To cover lawsuits, according to Forest’s Annual Report, the company maintains $140 million of product liability insurance coverage per “occurrence” and in the aggregate.

However, in conclusion the Report points out that, “litigation is subject to many factors which are difficult to predict and there can be no assurance that we will not incur material costs in the resolution of these matters.”

Filed under: 2006, Birth Defects, Celexa, Forest, Kwok, sex, 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

FDA Runs Protection Racket For Big Pharma

January 7, 2007 Evelyn Pringle

Why would Americans trust the FDA to regulate the pharmaceutical industry? Since the Bush administration took office the FDA has become the industry’s partner in crime.

The most notorious protection scheme put in place by the FDA and Big Pharma is the preemption policy that bans private lawsuits against drug companies in state courts once a drug and its label have been approved by the FDA.

On January 18, 2006, the FDA issued new rules for the labeling of prescription drugs, and in the preamble to the rules on page 43, the FDA says, State law actions “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs,” requiring lay persons to second-guess its expert assessments of a drug’s risks and benefits.

So, after all of the concerns raised about the FDA’s failure to protect consumers against dangerous products over the last several year, by top experts from all over the world, the FDA has hereby declared itself the sole authority on decisions regarding prescription drugs, including whether a drug’s label contains adequate descriptions of indications for use, risks and benefits.

In an October 6, 2006, articled titled, “The Doctrine of Preemption,” Stan Kaufman aptly refers to the new policy as the “Doctrine of Preemptive Crony Capitalism.” When announcing this multi-billion dollar immunization gift to Big Pharma, the FDA told drug makers:

“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.”

A statement saying the complete opposite was made in 1996, by the FDA’s Chief Counsel in a speech that said the FDA had a “longstanding presumption against preemption” and that “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”[

The preemption claim reverses a long-standing policy of permitting State actions intended to protect consumers and undermines the States’ ability to protect their citizens, yet State and local entities were given no opportunity to object to it.

Under Executive Order 13132, issued first by President Reagan, and then reissued by President Clinton, the FDA is supposed to consult with State and local authorities about the effects of each regulation it issues that affects the States.

Nowhere in the proposed rule did the FDA provide notice or seek comment on the preemption provisions added to the preamble. In the only proposed rule known to State and local officials, the FDA said that the regulation would not preempt State law. In fact, the language published in the Federal Register on December 22, 2000, explicitly stated that “this proposed rule does not preempt state law.”

The rule requested comment on products liability issues, but only by asking whether the new “Highlights” section raised liability concerns and, if so, how the FDA might alleviate those concerns without eliminating the Highlights section. This request can hardly be called “notice” of the preemption statement that suddenly appeared in the preamble in 2006.

By relying on this false representation, State and local authorities were robbed of any opportunity to object to the preamble. In a January 2006, letter to Michael Leavitt, Secretary of Health and Human Services, the National Conference of State Legislators called the regulation a “thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute.”

The NCSL also stated the failure to allow for an appropriate comment period constitutes “an abuse of agency process and complete disregard for dual system of government.”

Ken Suggs, president of the Association of Trial Lawyers of America, was quoted in the January 19, 2006 Washington Post, as saying, 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 the political process.”

Legal experts point out that it was never the intent of Congress to preempt private lawsuits in State courts, and that in fact, when Congress was considering the Food, Drug, and Cosmetic Act of 1938, it specifically rejected a proposal to include a private right of action for damages on the ground that such a right already existed under State common law.

According to Houston attorney, Robert Kwok, who handles complex pharmaceutical litigation involving drugs such Fosamax, Norvasc and SSRI antidepressants like Celexa:

“The real losers from this attempted power grab would be the millions of Americans who depend on safe drugs. Without the protection of state laws Big Pharma can ride shipshod over Americans who are injured by their unsafe drugs. That’s unacceptable and I’m seeing even conservative judges resist it.”

Many members of Congress have also weighed in on the issue and reaffirmed that Congress never intended to preempt State claims in a February 23, 2006, letter to Michael Leavitt, Secretary of Health and Human Services, from Representatives Henry Waxman (D-Calif.), John Dingell (D-Mi.), and Sherrod Brown (D-Ohio).

Rep. Maurice Hinchey (R-NY) and Senator Edward Kennedy (D-MA), have threatened to fight preemption through legislation if necessary. Rep. Hinchey issued a press release on January 18, 2006, immediately after the policy was announced, stating that the “FDA has once again gone to bat for the drug industry by fully endorsing a policy that shelters pharmaceutical companies from Americans who want to file lawsuits because a drug has made them or a loved one seriously ill, or in some cases caused death.”

Rep. Hinchey also called it “the latest example of the FDA sticking its nose where it does not belong and treating the drug companies as clients rather than regulated entities.”

The FDA’s language on page 38 of the preamble that states “whether it be in the old or new format, the Food, Drug and Cosmetic Act preempts conflicting or contrary state law,” appears to imply that the preemption policy is retroactive.

Part of the language also says that lawsuits against doctors are preempted for failure-to-warn patients of risks associated with a drug, apparently even when a drug is prescribed “off-label,” for a use other than those approved by the FDA.

“Pre-emption would include not only claims against manufacturers,” the FDA states, “but also against health-care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling.”

The FDA has never before, in its entire history, claimed that a drug label preempts actions against health care professionals for failure-to-warn patients about risks. In fact, labels carry no information about the risks or benefits of “off-label” uses.

Critics see this language as an attempt to immunize all the doctors who the industry has convinced to over-prescribe drugs to treat conditions or patient populations for which the drugs have never been approved as safe and effective to increase profits.

“Doctors need to be held just as accountable as the drug manufacturers when things go wrong,” attorney Kwok says.

“The profession of medicine is in danger of being totally co-oped by the business of medicine,” he warns, “with more and more of the burden is being placed on the consumer.”

“And with only minimum consumer protection standards set by the FDA, that isn’t very reassuring,” Mr Kwok notes.

“I predict there could be a flood of litigation,” he says, “before FDA policy changes any more.”

In any event, restrictions that the FDA places on drug labeling do not prohibit drug companies from disseminating warnings about a danger by other means. When it originally promulgated these regulations, the FDA made clear that:

These labeling requirements do not prohibit a manufacturer, packer, re-labeler, or
distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered. The addition to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters directed to health care professionals (e.g., “Dear Doctor” letters containing such information) is not prohibited by these regulations. 44 Fed. Reg. 37434, 37447 (June 26, 1979).

One of the main authors of the new labeling rules was the FDA’s Chief Counsel at the time, Daniel Troy, who in previous employment fought the FDA in court to allow drug companies to promote drugs to doctors for “off label” use.

Its now obvious when looking back, that Mr. Troy was appointed by the Bush administration to implement tort reform under the guise of preemption, and under the cover of the Office of Chief Counsel at the FDA.

In the midst of the Vioxx and SSRI antidepressant disasters, instead of going after the drug makers for knowingly injuring hundreds of thousands of consumers with dangerous products, Mr. Troy devoted the majority of his time on the clock to filing five amicus briefs on behalf of Big Pharma to be used against the very citizens who were paying his salary.

In his briefs, Mr. Troy focused his main attention on protecting the profits of the makers of SSRIs, drugs second only to Vioxx when it comes to the concealment of studies and information about harm that if revealed, could have prevented tens of thousands of deaths and injuries over the past 20 years.

And even though there has been an infinite number of reports over the past decade regarding an increased risk of suicide with SSRIs, instead of withdrawing the approval of the drugs, requiring more studies, or demanding a warning be added to their label, Mr. Troy did nothing to protect potential SSRI victims as Chief Counsel of the FDA.

In late 2004, Mr. Troy quit the FDA to go back into private practice to once again represent pharmaceutical companies openly against private citizens, only with the added benefit of using the preemption defense he put in place.

On October 9, 2006, Mr. Troy published an article in the Legal Times, that said, “I was also at the FDA while January’s Physician Labeling Rule, which contains a statement in its preamble about the FDA’s pre-emption authority, was written.”

“And I now,” he states in an obvious ad for new clients, “advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements.”

In the Times article, Mr. Troy points out the importance of drug companies staying cozy with the FDA to ensure success in future litigation. “Savvy companies,” he wrote, “are recognizing that how they interact with the FDA today may profoundly affect their pre-emption defenses in the future.”

“They are trying to ensure their communications with the agency are as formal as they can be,” he said, “in light of commercial considerations and the need to stay on the FDA’s good side.”

“More formal communications,” he advises, “can help buttress a future case for why a particular state law claim should be pre-empted.”

In the article, Mr. Troy brags that his filing of FDA briefs on behalf of Big Pharma “has reduced the negative consequences of the current pharmaceutical-liability regime.”

But for once, he at least mentions that it cost the tax payers plenty. “FDA involvement in state-law cases is not an ideal solution,” he writes, “not least because each instance of such involvement involves the costly investment of substantial agency resources.”

It should be noted that two years before Mr. Troy filed his first brief as a kick-off for the preemption policy, the “costly investment of substantial agency resources” went for an FDA brief, in which the FDA acknowledged “the historic primacy of state regulation of matters of health and safety” and the appropriateness of a presumption against preemption where the state-law claims allege defective design, negligent manufacturing, or failure-to-warn in, Buckman v. Plaintiffs’ Legal Committee, 531 US 341 (2001).

In the Legal Times, Mr. Troy goes on to explain that the new labeling rule is intended to limit the direct involvement of the FDA in lawsuits. “The preamble to that rule,” he says, “makes an official statement of FDA’s views on preemption easily available to courts hearing state-law tort cases.”

“If courts give appropriate deference to this statement of FDA’s considered judgment,” he notes, “FDA will not be forced to file briefs in individual cases.”

Until reading this article, its likely that most people had never realized that Mr. Troy was “forced” to file briefs on behalf of Big Pharma while he worked at the FDA.

In a March 31, 2006 paper, titled, State-Level Protection for Good-Faith Pharmaceutical Manufacturers, Mr. Troy can be found advising State lawmakers to pass shield laws for Big Pharma based on a Michigan model, to “help to reduce the negative consequences of the current pharmaceutical-liability regime,” he says.

“In so doing,” he states, “they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing.”

Such a statement might be a wee bit credible if it also included a suggestion for the lowering of the multi-million dollar annual salary and benefit packages enjoyed by Big Pharma CEOs or a reduction in the billions of dollars that are spent each year on illegal off-label promotion and marketing schemes.

For all the whining he does about litigation keeping products off the market, Mr. Troy cannot cite a single case in which a failure-to-warn claim interfered with the FDA’s federal regulatory authority or kept a drug off the market. In fact, in a lecture to Big Pharma attorneys in December 2003, on how to use the preemption defense, Mr. Troy told the attorneys that the FDA had “no good evidence” showing product liability concerns “keep good products off the market,” even though he had “combed the literature” to find such evidence.

Apparently to help resolve this nagging little problem, Mr. Troy told the defense attorneys to pay for research to find some evidence to back this claim even if it was weak, stating: “you guys really shoot yourself in the foot by not funding research to this effect. … I’ll even take anecdotal evidence and stories if you have them.”

Mr. Troy filed the FDA’s first brief in support of Big Pharma in September 2002, in the California Zoloft case titled Motus v. Pfizer, after he was contacted by Pfizer attorney, Malcolm Wheeler, in the summer of 2002, requesting that he get the government involved to help Pfizer win the preemption argument.

Despite the fact that Pfizer had paid Mr. Troy’s law firm over $358,000 in the year before he became Chief Counsel, Mr. Troy argued later that he did not become involved in the case until after the 1-year grace period in which employees may not participate in activities involving former clients. From all public accounts, the time period elapsed less then a month before he entered the case.

In the brief, Mr. Troy argued that any warning that suggested a link between Zoloft and suicidality would have been false and misleading, and the FDA would have rejected any effort to add such a warning. However, that argument contradicts 21 CFR § 314.126(b), which requires warnings to be added based on reasonable evidence of an association, even absent proof of a causal relationship. The preemption issue was never decided in Motus because the case was concluded on unrelated grounds.

Legal experts say the preemption defense will not only be used in SSRI-related suicide cases, it will be applied in SSRI cases involving the failure-to-warn about other types of injuries and deaths caused by these drugs as well.

For instance, Big Pharma will no doubt attempt to preempt cases filed on behalf of infants born with birth defects to mothers who unwittingly took the drugs during pregnancy, such as with Lacee Shore, who was prescribed Celexa during her first trimester of pregnancy and as a result, her baby, Gavin Shore, was born with serious heart birth defects and diagnosed with Shone’s Complex, which can lead to the obstruction of blood flowing to the body from the left side of the heart.

Gavin has already gone through several surgeries in attempt to correct the heart defects and will have to undergo more in the future.

The successful use of the preemption argument in a case such as this, where the drug maker, Forest Laboratories, could and should have warned doctors and pregnant women about the possibility of birth defects associated with Celexa, would leave the Shore family strapped with the burden of life-long medical costs related to Gavin’s condition.

According to attorney Kwok, who is handling the Shore case, the birth defect situation is even more devastating than with patients harmed by Vioxx because the Celexa victims are so young. “Their whole lives,” he says, “if they survive, will be under the threat of illness and additional surgery, with a very poor prognosis.”

Mr. Kwok points to a 1990 study conducted at the University of Michigan that shows the outlook for infants born with heart defects like Gavin is very poor. “One quarter of patients die after their second operation,” he says.

“The second operations are very often necessary,” he explains, “because of the complexity of the heart problem.”

Forest Labs knew about the potential for birth defects caused by Celexa because more than two years before Gavin was born, on June 9, 2004, Web MD reported that the FDA was concerned about reports that SSRIs may cause adverse effects to babies born to mothers taking the drugs late in pregnancy.

According to Web MD, the FDA had been receiving reports for 10 years. In fact, it said that hundreds of reports on adverse effects in babies were received involving all the SSRIs sold in the US, which would include Prozac, Paxil, Luvox, Zoloft, and Celexa.

In July 2004, the FDA finally asked the SSRI makers to change the labels, warning that some infants had developed problems requiring tube feeding, respiratory support, and prolonged hospitalizations.

On September 1, 2005, the BBC reported that Danish and U.S. scientists found that cardiac birth defects appeared to be 60% more likely in newborns when women used SSRIs.

Studies show that women are prescribed SSRIs twice as often as men and yet the drug makers have made no effort to evaluate the use of these drugs with pregnant women. And as a result, Mr. Kwok says, “new moms are finding out too late that the Celexa they took was putting their unborn baby in grave danger.”

A successful preemption ruling would go a long way as far as protecting profits against damage awards based birth defects, because pregnant women represent a major share of the market. According to a May 2005, study in the Journal of American Medical Association, 80,000 pregnant women are prescribed SSRIs in any given year in the U.S., which means there are bound to be many cases where babies were born with birth defects.

The majority of courts that have addressed the preemption argument have ruled against it. One of the first federal courts to specifically rule against the FDA’s preamble position was a Nebraska District Court on May 31, 2006, in Jackson v. Pfizer, where the plaintiffs’ son took both Zoloft and Effexor and then committed suicide.

The parents alleged that the drugs caused their son to commit suicide and Nebraska law required additional warnings about the suicide risk. The drug maker defendants moved for summary judgment claiming that the State law claims were preempted by the FDA.

The court said that the claims were not preempted because the federal regulations did not conflict with State law and specifically held that there was no Congressional directive that the field was preempted.

The court stated the FDA preamble was not persuasive and pointed out that the Eighth Circuit had adopted the proposition that the FDA prescribes only minimum standards and the Fourth Circuit had declared that complying with federal regulations does not release a manufacturer from liability.

The court also noted that the FDA “failed . . . to allow the states an opportunity to participate in the proceedings prior to a preemption decision,” and dismissed the FDA’s brief stating that it “will not treat amicus briefs as the force of law.”

On May 25, 2006, a federal court in Pennsylvania was the first to grant the FDA’s preemption rule full deference in a wrongful death and survival action, with failure-to-warn claims against Paxil maker GlaxoSmithKline, and generic Paxil maker Apotex, in Colacicco v. Apotex, Inc, Civ No 05-cv-5500, 2006 WL 1443357 (E.D. Pa. May 26, 2006).

In this case, the plaintiff alleged that his wife’s suicide resulted from the drug makers’ failure-to-warn of the increased risk of suicide linked to Paxil and its generic equivalent.

The judge on his own initiative, invited the FDA to file a brief. The current Chief Counsel, Sheldon Bradshaw, went to bat for the drug makers and filed a brief at record speed within 20 days, urging the court to dismiss the lawsuit on the basis of preemption, stating that in October 2003, when Paxil was prescribed to the suicide victim, “there was no reasonable evidence available at the time of an association between adult use of the drug and suicide.”

The FDA argued that any such warning regarding an association between Paxil and suicide would have been false or misleading, and thus would have constituted misbranding under the FDCA.

The plaintiff responded by arguing that the court should not afford deference to the brief because 21 C.F.R. § 314.70, does permit manufacturers to strengthen labels without FDA approval and the FDA has no authority to simply declare that a drug is misbranded.

The court disagreed and determined that it was to give significant deference to the amicus brief based on the U.S. Supreme Court’s decisions in Chevron, Medtronic, and Geier which state that an amicus brief is an appropriate form to express preemptive intent and held that the principles of deference do not permit a court to question the FDA’s interpretation of its own regulations.

The plaintiff argued that the preamble which was promulgated in 2006 could not be retroactively applied to the October 2003, death of his wife. However, the Court said that preemption could be applied retroactively because the preamble simply clarified the FDA’s “longstanding views on preemption,” and characterized the preamble as an “interpretive rule,” rendering retroactivity concerns “irrelevant.”

The Court went on to say that even if the preamble did not apply retroactively, it would have found preemption anyway based on the views previously expressed in amicus briefs by the FDA.

An appeal is pending on the Colacicco decision, and the case has drawn amicus support from a dozen scientists and doctors who contend that preemption “would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA.”

The national non-profit consumer advocacy organization, Public Citizen, the Trial Lawyers for Public Justice, a national public interest law firm, and the Association of Trial Lawyers of America, an international coalition of attorneys, law professors, paralegals, and law students, have together filed an amicus brief supporting Mr Colacicco, stating:

“Products liability lawsuits help to protect patients from drugs with undisclosed risks because the potential for being held liable for harm caused by their products provides a powerful incentive for drug companies to make their products as safe and effective as possible and to revise labels as soon as new risks become apparent.

“Furthermore, because FDA lacks authority to subpoena documents from the companies it regulates, products liability lawsuits help to uncover information that can lead to safer products.”

In fact, the group points out, since at least several months before the victim’s suicide, the FDA had been reviewing data about a possible link between SSRIs and suicidality, and the agency issued a Public Health Advisory on the topic in October 2003, the same month that Mrs. Colacicco died.

The amicus brief also notes that the FDA’s preemption statement lacks the “consistency” needed to warrant any degree of deference because prior to 2002, the FDA’s consistent view was that State common law was not preempted by federal drug regulation. “For example,” the brief wrote, “in both 1979 and 1998, in preambles accompanying various drug regulations, FDA stated that state tort law did not interfere with federal regulation.”

In 1998, when addressing pharmacists’ provision of written patient information for “Medication Guides,” when issuing the final rule, the FDA rejected calls for the agency to express an intent to preempt State regulation of labeling requirements stating:

“FDA regulations establish minimal standards necessary, but were not intended to preclude states from imposing additional labeling requirements. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling.” 63 Fed. Reg. at 66384.

According to the amicus brief, “The authority to regulate drug labeling may carry with it the authority to address state drug labeling regulations, but it does not carry with it authority to determine the preemptive effect of federal regulation on state common-law compensation systems.”

It appears that the FDA’s own regulations acknowledge that preambles are not statements of law and that they should not be presented as such in legal proceedings.

The amicus group states that the preamble is not part of the regulation, will not appear in the Code of Federal Regulations, and does not have the force of law. “In fact,” the brief notes citing FDA regulations, “a longstanding FDA regulation provides that a statement in a regulatory preamble constitutes only an “advisory opinion.”

The FDA recognizes that an advisory opinion may be used to “illustrate acceptable . . . procedures or standard, but not as a legal requirement,” the brief points out.

“Having made no effort to legislate on the topic of drug-related damages remedies,” the brief concludes, “Congress can hardly be said to have authorized FDA to supersede the damages remedies traditionally provided by the states.”

There was an extremely important preemption ruling handed down on June 9, 2006, in the Vioxx case of Doherty v. Merck prior to the beginning of the actual jury trial. Merck moved to dismiss the failure-to-warn claim arguing that the preamble barred claims with respect to FDA approved drugs.

The June 9, ruling from the bench, drew massive attention to the case when New Jersey Superior Court Judge, Carol Higbee, refused to exclude the claims.

“The preamble, as I see it, is a political statement by the FDA,” she said.

“The primary purpose of it,” she stated, “is to criticize state courts and to set forth the FDA’s position, not to criticize state courts so much as to set forth the FDA’s position that they believe there should be federal preemption of all tort actions.”

“What the preamble is saying,” Judge Higbee noted, “is the FDA should be the final word.”

She refused to dismiss the claims based on the preamble she said, because it “has nothing to do with science.” In conclusion, she told Merck defense attorneys:

“It has nothing to do with what happened back in 2000, 2001, 2002, when these issues were being debated. It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption.

“And I am not going to allow you to use it.”

Merck later enjoyed a victory at trial when a jury decided that Vioxx was not the main cause of Elaine Doherty’s heart attack, but a favorable ruling on the preemption issue prior to trial could have potentially saved the company billions of dollars. According to the company’s SEC filings, as of October 9, 2006, Merck is a named defendant in about 13,850 Vioxx cases in the New Jersey State court coordinated litigation.

The next victory using the preemption argument was a major win in August, 2006, when a California court dismissed the Celebrex failure-to-warn claims against Pfizer, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (N.D. CA, August 16, 2006).

In opposing the motion, the plaintiffs argued that because the FDCA does not provide a monetary remedy, Congress must not have intended the FDA to have authority over damage claims and that the FDA’s position on preemption was not entitled to deference because it was clearly erroneous and inconsistent with the regulations.

Saying the FDA specifically considered the safety risks about Celebrex alleged in the lawsuit and determined the risks should not be included on the label, the court said the failure-to-warn claims “conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the FDCA.”

But the judge refused to dismiss the false advertising claims. The plaintiffs argued that the Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and also minimized the established risks of the drug.

Pfizer claimed that because it submitted the ads for FDA approval, and the FDA did not object, the FDA had determined that the ads were accurate and struck a fair balance of the risks and the benefits of Celebrex.

However, the court refused to preempt the claims without a record showing that the FDA had reviewed each ad and approved it. The court also pointed out the FDA’s silence about whether its regulations preempt false advertising claims, in contrast to its stated position on failure-to-warn claims.

A little over a month later, on September 29, 2006, across the country in New Jersey, the court in McNellis v. Pfizer, refused to allow the preemption defense based in part on the fact that the text of FDA regulations had remained unchanged for years, and the regulations did not conflict with New Jersey’s failure-to-warn laws.

The McNellis Zoloft-suicide case comes with a history. On December 29, 2005, the U.S. District Court for the District of New Jersey had also denied Pfizer’s original motion for summary judgment. The court reasoned that the FDA’s approval of a label creates only a minimum standard and that the drug maker may strengthen the warnings as long as the new warning is not false or misleading.

After the FDA published the new rule and preamble with the preemptive language in January 2006, Pfizer filed another motion asking the court to vacate the order denying summary judgment, or to certify the question for interlocutory appeal

In opposing the motion, Ms. McNellis said that the preamble amounted to nothing more than the FDA’s opinion on preemption; the same opinion expressed previously by the FDA in amicus briefs, and the same opinion already rejected by the court. It is irrelevant that this opinion now comes in the form of a preamble to a regulation rather than an amicus brief, she said.

In her brief filed on March 2, 2006, Ms. McNellis argued that the FDA had also exceeded its authority, stating:

“In this instance, an executive agency, the FDA, has expressed an opinion that Congress has never agreed to. Without notice or comment, the FDA found it within its jurisdiction to go against the wishes of Congress as well as the wishes of those states which have product liability failure-to-warn statutes.”

Ms. McNellis also pointed out that the last six courts to decide the issue “have found, consistent with this Court’s finding, that the FDA regulations establish minimum requirements such that they do not preempt state tort laws.”

She also noted that the preamble was not in effect at the time that her father committed suicide as a result of taking Zoloft.

The court held that regulations allow a drug company to increase warnings when new risks emerge, that the Food, Drug and Cosmetic Act does not contain a preemption clause, and that Congress gave no implicit empowerment to the FDA to preempt State law.

Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker’s preemption motion on the failure-to-warn claims in Perry v. Novartis Pharma Corp, — F Supp 2d —-, 2006 WL 2979388.

This case involved Elidel, a drug used to treat eczema, prescribed to Andreas Perry when he was 2-years-old. Six months after he began using the cream, in October, 2003, Andreas was diagnosed with a form of cancer known as lymphoblastic lymphoma.

Elidel belongs to a class of drugs known as calcineurin inhibitors, so called because they reduce immune activity by inhibiting the activity of the enzyme calcineurin. Prior to the approval of Elidel for treating skin conditions in children over 2 years of age, calcineurin inhibitors were used as systemic immunosuppressants in organ transplant patients.

Systemic use of the drugs has long been known to increase the risk of cancer and the labels on the drugs prescribed to organ transplant patients say so. But because Elidel is applied topically for eczema, it was not known at the time of approval in December 2001, whether long-term use posed a risk of cancer.

This case illustrates why drug companies must be made to alert the public of known dangers as soon as they are known. On February 15, 2005, an FDA advisory committee met to discuss calcineurin inhibitors. In particular, reports of “off label” use of the drugs in children under two caused concern for some members of the committee.

At the meeting, the committee voted to add a “Black Box” warning about the possible increased risk of cancer associated with the topical use of Elidel, and the lack of long-term safety data on the use of the drug.

On March 10, 2005, the FDA told the drug maker to add a “Black Box” warning and issued a public health advisory about the possible cancer risk. However, it was nearly a year later when Novartis finally got around to adding a “Black Box” warning to Elidel’s label on January 19, 2006.

In their brief in opposition to the preemption motion to dismiss, the plaintiffs said that the FDA’s broad claim of preemption is not entitled to deference, “whether it is expressed in the January 2006 Preamble to the Final Rule,” or “in amicus curiae briefs filed by the agency in support of drug manufacturers.”

“The FDA’s claims,” the brief wrote, “which are tantamount to an advisory opinion, lack the force of law and contradict the FDA’s governing statute, its regulations, and its regulatory purpose.”

It also noted that the FDA’s current opinion directly opposes the FDA’s longstanding views on preemption. “For these reasons,” the brief pointed out, “a majority of courts that have considered this issue, both before and after the FDA issued the Preamble, have held that FDA approval of labeling does not preempt state failure-to-warn claims.”

In denying Novartis’ preemption motion, U.S. District Court Judge, Stewart Dalzell, of the Eastern District of Pennsylvania, wrote in the decision that the FDA’s new “Preamble is not entitled to any special consideration in our analysis.”

Where the agency attempts to “supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,” no deference is warranted, he noted.

In reaching its decision, the court said preemption would only apply if a specific warning about Elidel and pediatric cancer had been considered by the FDA and found to be unnecessary and that had not happened in this case.

In discussing the FDA’s assertions in its amicus brief, the court stated, “To be sure, because of its expertise in the area, the FDA’s construction of its own regulations is likely to carry great weight.”

“But where an interpretation has changed frequently in significant respects,” it wrote, “the persuasive force of the argument diminishes.”

The court also said that even if the Preamble represents a change of policy with the force of law, it would not apply to this case. “The FDA cannot retroactively absolve Novartis of a duty it may have owed the Perrys in 2003,” it wrote.

The court also noted that the FDCA provides no remedy for an injured consumer and said, “a finding of preemption here will foreclose a remedy that was traditionally available and for which federal law provides no substitute.”

In its decision, the court made an interesting observation about the viability of the preemption defense on failure-to-warn claims based on other available methods of warning the public about the dangers of a drug, stating:

“It is worth noting that, even where FDA regulations or other federal law prevent a manufacturer from modifying the approved labeling, a modification of the label is not the only form that a warning could take.

“If, for example, a plaintiff claimed that a manufacturer was negligent in not sending a letter to prescribing physicians or other health care professionals, that might present a different case, even if modification of the approved labeling were prohibited.”

In conclusion, citing a September 23, 2006, New York Times report by Gardiner Harris, the court said, “given the recent concerns about the effectiveness of the FDA’s safety monitoring of recently approved drugs, . . . the availability of state law tort suits provides an important backstop to the federal regulatory scheme,” and further stated:

“If, at some future date, Congress determines that FDA monitoring is sufficiently effective on its own to warrant the elimination of state law incentives for manufacturers to provide adequate warnings, it also has the authority to declare that failure-to-warn suits, like the Perrys’ action, are preempted.”

“Until it does so, however,” the court said, “in the absence of a specific FDA safety determination, such suits can go forward.”

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

Filed under: 2007, Bextra, Birth Defects, Bush, Celexa, Colacicco, Elidel, FDA, Glaxo, Kwok, McNellis, Novartis, Paxil, Perry, Preemption, SSRIs, Troy, Vioxx

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