The FDA and Prozac

When I ask patients or audiences, "How lengthy do you think the studies or trials were before Prozac was approved by the FDA?" most people guess several years or more. Aware of how long it sometimes takes to get FDA approval, some people assume that the drugs are tested for ten years. No one guesses the truth - that the Prozac scientifically controlled testing trials lasted a mere five or six weeks. Following that, the FDA is largely dependent on unscientific follow-up studies and anecdotal reports spanning a year or two. Once approval of the drug is then given, there is no reliable mechanism at the FDA for keeping track of dangerous effects that turn up with long-term use. Instead the FDA relies on information from the drug company itself. The FDA must keep track of so many reports that it scans them with a computer looking for unusual clusters of adverse effects. In my interviews with several past and present FDA administrators, it became apparent that long-term follow-up at the FDA is a low priority, largely because it is not demanded by the public and the Congress, which is more concerned with the initial approval process.

People assume that FDA approval and the widespread distribution of a drug - with many patients taking it for months or years- means that long-term studies have found it safe in regard to side effects, drug interactions, dependency, addiction, and withdrawal. Thus FDA approval grossly misleads the public, lulling it into an unfounded security.

The PDR also admits that Prozac's effectiveness has not been tested in controlled trials of "more than 5 or 6 weeks" and that "long-term" usefulness has therefore not been demonstrated. Yet by now many patients have been on the drug for more than a year, never imagining that it has not been tested or approved for long-term or continuous use.
http://www.sntp.net/prozac/breggin_prozac_1.htm

27 DEATHS DURING CLINICAL TRIALS

Additional documents obtained under the Freedom of Information Act reveal that both Eli Lilly and Co., manufacturer of Prozac, and officials of the FDA were aware that at least 27 deaths had been linked to Prozac's use before the drug was released.

One of the documents shows that as of October 15, 1987, two months before Prozac was allowed on the market, there had already been 15 suicides linked to it - six by overdose, four by gunshot, three by hanging and two by drowning.

A total of 12 other deaths are also described in the document, provided by Lilly to the FDA.

Despite the startling information about these 27 fatalities - a substance has been recalled from the market (1) with as few as two deaths - FDA officials failed to prevent Prozac from being released. Instead, it was given final FDA approval on December 29, 1987.

1986 SAFETY REVIEW WARNED OF PROZAC'S DANGERS

Another document obtained under the Freedom of Information Act, dated March 23, 1986, is a safety review of Prozac by the FDA's Richard Kapit, who observed that "fluoxetine [Prozac] may exacerbate certain depressive symptoms and signs."

Kapit, a medical doctor, noted, "Certain clinical risks of mild to moderate severity did appear to be associated with the use of fluoxetine, as determined by a review of the safety data in this NDA (2) submission. These potential risks include intensification of the vegetative (3) signs and symptoms of depression."

The 1986 FDA safety review also discovered that Lilly had failed to report information about the onset of psychotic episodes in people during Prozac's testing. No action was taken against the drug maker, however.

Kapit concluded his safety review with this warning: "It is suggested that labeling be developed which advises physicians about possible exacerbation of the vegetative manifestations of depressive illness.... If the drug is marketed, post-marketing studies should be required to assess more precisely the severity of these potential risks."

As early as 1986, in other words, long before Prozac was approved for public consumption, evidence existed which linked Prozac to worsened symptoms of depression and the onset of psychotic episodes - a fact underscored by the 1,089 suicides as of September 16, 1993, along with many episodes of senseless violence, homicide and even multiple murder.

Despite these deaths and Kapit's warning, today's Prozac bottle fails to carry an adequate warning of the drug's dangers.

The FDA had another opportunity to act in the public interest in September 1991, when its Psychopharmacologic Drugs Advisory Committee held a hearing to review evidence showing links between Prozac and similar psychiatric drugs and psychotic, violent acts.

For over three hours, more than two dozen Prozac victims or their surviving family members recounted horror stories linking the drug to multiple murders, suicide, attempted suicide, self-mutilation, psychosis and other nightmarish effects.

The committee, however, ignored this information and voted against this information and voted against relabeling Prozac to carry a proper warning of its dangers.

CORRUPT RELATIONSHIP WITH DRUG COMPANIES

A lengthy investigation by FREEDOM and the Citizens Commission on Human Rights has linked the FDA committee's failure to protect the public from the dangers of Prozac to improper relationships between its members and the drug companies which they are mandated to oversee.

At least five out of 10 of the members on the FDA's Psychopharmacologic Drugs Advisory Committee had conflicts of interest based on business dealings with manufacturers of antidepressant drugs - including Lilly - totaling a minimum of $1,108,587.

In a memorandum for the public record, committee member David Dunner of the University of Washington, prior to participating in the hearing, had agreed to report any possible conflicts of interest to the committee. He made the startling acknowledgment in his disclosure statement that he had two $100,000 studies pending with Lilly. Also, though Dunner reported having received approximately $100,000 to conduct an ongoing study of a drug called Paroxetine, he made no mention of the fact that this study also included Prozac.

Dunner also failed to report that he had been paid in the past to conduct clinical trials of Prozac. In one instance, he conducted a clinical trial for Prozac involving 100 people. The results of these tests were submitted by Lilly with its New Drug Application, seeking FDA approval of Prozac.

One day after the hearing, panelist Dunner was scheduled to speak at a Lilly-sponsored seminar in Pittsburgh on "depressive disorders," with two similar events following shortly thereafter.

Dunner had already appeared at five such seminars and, at the time of the hearing, knew he was scheduled to attend three more. Despite this, and despite his financial connection to Lilly, he easily convinced the FDA he had "no pending commitments at the present time" which would represent a conflict of interest.

Five days after the committee rendered its pro-Prozac opinion, Dunner received yet another Lilly grant; this one for a NEW study on the effects of Prozac on sleep patterns. Research has brought to light that Lilly has showered some $1.4 million on Dunner since 1982.
http://www.pnc.com.au/~cafmr/newsl/prozac.html


Anti-depressants taken by thousands of Brits 'do NOT work', major new study reveals
http://www.dailymail.co.uk/pages/live ... id=518669&in_page_id=1797

Legal Drugs Kill Far More Than Illegal
http://www.nytimes.com/2008/06/14/us/ ... JcdJMiB+o5tag&oref=slogin

Schoolboy found hanged in his bedroom after Ritalin prescription was increased:
http://www.dailymail.co.uk/pages/live ... id=533313&in_page_id=1770

Tranquillisers putting children's lives at risk: "Anti-psychotics may cause long-term harm, say critics. Youngsters under 6 being given unlicensed drugs"
http://www.guardian.co.uk/society/2008/apr/07/mentalhealth.drugs

ADHD drug linked to suicide attempts: Health Canada
http://www.cbc.ca/health/story/2008/07/03/adhd-drug-warning.html

Dangers Of Antidepressants Suppressed http://www.youtube.com/watch?v=1Bzwx5HcurM

Prozac Testimonials - Suicide, Violence http://www.youtube.com/watch?v=VdkFasjSJ_g

Withdrawing from Antidepressants Can be Dangerous http://www.youtube.com/watch?v=xSUAsdBgh70&feature=related