Saturday, August 7, 2010

Business Booming for SSRI Makers

Evelyn Pringle January 8, 2007

The market for antidepressants is the largest segment of the Central Nervous System drug sector with global sales of $16.2 billion in 2005. Depression costs the US economy an estimated $44 billion a year and the World Health Organization predicts depression will be the leading cause of disability by 2020, according to a report by Research and Markets.

Currently, depression seems to have reached epidemic proportions in the US only. In 2005, the US market for antidepressants accounted for 66% of the global market, compared to 23% in Europe, and 11% for the rest of world, largely Japan, according to R&M's December 18, 2006, press release.

Since the new class of selective serotonin reuptake inhibitor antidepressants, or SSRIs, arrived in the late-1980s, the market has exploded. In 1985, sales of antidepressants in the US totaled roughly $240 million, but from September 1, 2003 to August 30, 2004, sales rose to $11.2 billion, according to IMS, a health care tracking firm.

The most commonly prescribed SSRIs in the US include Prozac, by Eli Lilly, Paxil by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro by Forest Laboratories.

Award winning journalist and author, Robert Whitaker, reports that no coincidently, during the same time-frame, the "number of Americans disabled by mental illness has nearly doubled since 1987, when Prozac-the first in a second generation of wonder drugs for mental illness-was introduced."

There are now nearly 6 million Americans disabled by mental illness, and this number increases by more than 400 people each day, according to Mr Whitaker's report in the Spring 2005, issue of Ethical Human Psychology and Psychiatry, Volume 7, Number I.

In 1955, the number of people disabled by mental illness in the US was 3.38 per 1,000, but during the past 50 years, when psychiatric drugs have become the cornerstone of care, Mr Whitaker reports, "the disability rate has climbed steadily, and has now reached around 20 people per 1,000."

"A review of the scientific literature," he notes, "reveals that it is our drug-based paradigm of care that is fueling this epidemic."

"The drugs," he states, "induce new and more severe psychiatric symptoms in a significant percentage of patients."

"In Prozac's first 2 years on the market," Mr Whitaker says, "the FDA's Medwatch program received more adverse-event reports about this new "wonder drug" than it had received for the leading tricyclic in the previous 20 years."

In terms of adding to the number of people disabled by mentally ill, Mr Whitaker says, "the propensity of Prozac and other SSRIs to trigger mania or psychosis is undoubtedly the biggest problem with these drugs."

According to Harvard trained psychiatrist, Dr Stefan Kruszewski, "due to predictable neurochemical changes in the human central nervous system, SSRIs can also increase the risk of violence and aggressive acting out."

And experts say, when that happens, instead of recognizing the side effects of SSRIs, doctors change the diagnosis to schizophrenia or bipolor disorder and prescribe more drugs which pretty much guarantees that disability due to mental illness is right around the corner.

It is at this junction that the tax payers become completely responsible for the injuries caused by the drug makers, and must pay not only for the patient's medical care and drugs, but for the person's very existence.

Dr Kruszewski says that because SSRI makers have concealed the research that identified the adverse effects, doctors who prescribe SSRIs have not been adequately warned about the risks. "Neither patients nor physicians," he explains, "can accurately assess the risks and benefits of any medicine unless the manufacturers and the FDA work together to ensure that all information is transparent and readily available."

Regulatory agencies have focused most of their attention on the link between suicidality and SSRIs. In October 2004, the FDA directed SSRI makers to change their labeling to include a black box warning about an increased risk of suicide and suicidal thoughts in children and adolescents. The FDA strengthened the warnings after assessments showed that at least 13 of the 15 studies on SSRI use with children failed to show efficacy and there appeared to be an activation syndrome associated with the drugs.

In July 2005, the FDA issued a public health advisory saying the possibility of a risk of suicidality should also be applied to adults taking SSRIs. And last month, the FDA's Psychopharmacologic Drugs Advisory Committee held a public hearing to review the suicidality data on adults and SSRIs, and recommended a widening of the black box warning to include adults.

The data presented to the Committee by the FDA showed that SSRIs double the risk of suicidal behavior in young adults, from around three cases per thousand to 7, and for the first time, the FDA publicly acknowledged that SSRIs are linked to suicidality among persons over the age of 18.

Many of the world's leading experts on SSRIs traveled to Washington to testify at the hearing, as did many family members who lost love ones to suicide. In many cases family members testified that the deceased patients were not depressed to begin with and that the SSRIs were prescribed for conditions other than depression.

The day before the hearing, the Alliance for Human Research Protection, together with, arranged two press conferences, one at the National Press Club and the other at the Silver Springs Hilton in Maryland, to provide a forum for the experts to brief the public and media on the issues.

At the press conferences, presentations were made by Kim Witczak and Eric Swann, Vera Hassner Sharav, Dr Joseph Glenmullen, Dr David Healy, Dr John Abramson, Dr David Cohen, and Attorney, Karen Barth Menzies.

Kim Witczac and Eric Swann described their personal experience of living through the tragic suicide of Kim's husband, Woody, a happy, healthy 37-year-old man who committed suicide after being prescribed Zoloft off-label for insomnia.

Vera Sharav, president of the Alliance for Human Research Protection, discussed how SSRIs have been marketed as "magic bullets," but compared them to "snake oil." She went over a long list of conditions for which the drugs are approved, followed by an even longer list of conditions for which doctors are prescribing SSRIs off-label.

Ms Sharav also pointed out the disparity between reports by the FDA and UK regulators when analyzing the same data. She noted that the UK found 16 suicides and 177 attempts in 40,000 patients, compared to the FDA's report of 8 suicides and 133 attempts in 100,000 patients.

UK psychiatrist, Dr David Healy, a professor at North Wales Department of Psychological Medicine, at Cardiff University, and author of, The Antidepressant Era, and The Creation of Psychopharmacology, also discussed how data obtained from British regulators contradicts the data released by the FDA. He questioned the overall validity of the information used by the FDA to draw conclusions about SSRI induced suicidality.

Dr Healy explained how the effectiveness of SSRIs has been misconstrued, when in fact, the data reveals that only one in 10 patients on the drugs can be shown to respond specifically to the SSRI rather than a nonspecific factor or a placebo.

He discussed the manipulation of trial data and showed how suicide related events in previous trials were arbitrarily switched from drug treated groups to placebo treated groups and gave several examples of ghostwritten reports professing to validate safety and efficacy of SSRIs in clinical trials.

In his presentation, Dr David Cohen, co-author with Dr Peter Breggin of, "Your Drug May Be Your Problem," explained why clinical trials used by the FDA to determine whether there is a link between SSRIs and suicidality are completely unsuited for that purpose.

He pointed out that these trials were conducted by drug companies as a means of testing a drug's superiority over a placebo or its equivalency to an existing drug, and not to determine how a drug might be psychologically influencing patients who take the drug for a long period of time.

Dr John Abramson, a clinical faculty member at Harvard Medical School, and author of, Overdosed America, gave an overview of the overwhelming industry influence inside what experts say should be the most scientific and evidence-based forums of general and primary care physicians.

He presented slides illustrating the presence of the industry in every location at an annual convention for a professional organization, including drug ads at each registration desk, ads on the cards given to doctors to record attendance of specific courses for continuing education credits, and how ads were even placed in the bathrooms.

Dr Joe Glenmullen, an instructor at Harvard Medical School, and the author of, Prozac Backlash, and The Antidepressant Solution, gave a brief review of the literature related to antidepressant induced suicidality.

He explained that the difference between SSRI suicidality and ordinary suicidality can be easily distinguished due to an activation syndrome that usually accompanies SSRI suicidality which includes akathisia and mania.

According to Dr Glenmullen, the FDA has systematically swept the suicide issue under the carpet even though the agency has possessed ample research linking SSRIs to suicidality for many years.

Attorney, Karen Barth Menzies, a partner at the Baum Hedlund law firm, who has battled the SSRI makers in the legal arena for a decade, summarized the numerous instances where data on suicidality was suppressed by the drug companies for years and finally made public only after it surfaced in litigation.

Its not as if more studies are necessary to link SSRIs to suicide, but a recent study in the December 2006, issue of Archives of General Psychiatry, analyzed the data on 15,390 people, from age 10 to 100-years-old, who had been hospitalized after attempting suicide, and determined that 602 of these people went on to commit suicide, and 7,136 attempted suicide again, over the following 3 years.

In making their comparisons, the researchers found that although people who took antidepressants were slightly, or 9%, less likely to successfully commit suicide than people who took no drugs, antidepressant users were 36% more likely to attempt suicide than people who were not taking the drugs, and the risk was slightly higher for persons between 10 and 19-years-old.

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