Prozac, called fluoxetine by generic name, is a psychiatric drug prescribed to over 50 million people including millions of children. The drug was linked to increased suicides and violence as early as 1988, in a recently emerged document. Apparently the evaluation was known to Prozac's maker Eli Lilly as early as the 'eighties, but was never even given to the FDA.

This is the preoccupying picture that emerged just days ago, as the British Medical Journal passed on documents to the FDA which it had received by an anonymous whistleblower.

Can such a "head in the sand" policy be characterized as merely overzealous business practice, or is it an indication of something much more devastating? Eli Lilly is one of the multinational drug companies that have developed the "Texas Medication Algorithm Project", which is part of George Bush II's sweeping program to test kids at school as well as pregnant mothers for "psychiatric disorders" and Prozac is one of the drugs that are to be given to kids that don't meet the evaluating personnel's standards of "normal" behaviour.

When other similar drugs received FDA mandated warning labels, Prozac wasn't on the list and indeed, in Europe the drug has been called "safe for children" for years.

The whole FDA approval procedure has been called into question, and apparently with good reason. It appears that the policy of the agency has been one of sustaining a profitable industry, in sharp contrast with the publicly maintained image of protecting patients from dangerous pharmaceutical drugs, after recent revelations of heart attack risk for the users of several "new generation" painkillers - Vioxx, Bextra, Celebrex and others.

Not only the drug approval process seems to be slanted in favor of industry. Even the food supply has been compromised with products such as artificial sweeteners and genetically modified plants, animals and bacteria that are by no means innocuous. While aspartame for instance has brought great profits to the industry, the FDA plain refuses to look at the numerous adverse reaction reports. FDA field agents are reported to block people from even reporting events, because "aspartame could not cause such a reaction".

The same is true for cholesterol lowering statin drugs, where apparently widespread reports of muscle pains, memory loss and other side effects just don't seem to make it into the FDA's system, despite being fairly widespread. The pains associated with statin drug use may even have led to the overuse of painkillers those recently found to cause an increase of heart attacks.

Meanwhile, the FDA is complaining that it does not have sufficient means to control dangerous food supplements and is promoting stringent legislation on those nutrient rich products.

What has this world come to?


Journal hands over Prozac papers
(original on BBC news)

Confidential papers on anti-depressant drug Prozac that went missing during a murder case have been handed to the US drug regulator by a UK medical journal.

The documents, belonging to Eli Lilly, the makers of Prozac, included details of clinical trials of the drug, the British Medical Journal said.

The documents reportedly went missing after the relatives of the victims of Joseph Wesbecker started legal action.

Mr Wesbecker, who was on Prozac, shot eight people dead in 1989 in the US.

Another 12 people were injured during the shooting spree at a printing plant in Louisville, Kentucky.

Data

The 47-year-old then shot himself.

In 1994, the relatives brought a civil case against Eli Lilly.

The company subsequently won the case but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the BMJ reported.

Dr Richard Kalpit, the clinical reviewer at the US Food and Drug Administration, the US drugs regulator, who approved the drug, told the BMJ he was not given the data included in the documents.

"These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it."

Recent research has suggested children who use Prozac are at greater risk of suicide.

And earlier this month the Medicines and Healthcare Products Regulatory Authority said analysis of both published and unpublished data by experts on the Committee on Safety of Medicines showed "a modest increase in the risk of suicide from SSRIs [such as Prozac and Seroxat] compared to placebos [dummy pills]" in adults.

The FDA is now reviewing the papers, which were given to the BMJ by an anonymous source.

Confidential

BMJ deputy editor Dr Tony Delamothe said the journal had handed the confidential drug company documents to the FDA as it believed healthcare decisions need to be made using all the information available.

"The BMJ is committed to ensuring that results good, bad, or indifferent are reported."

A spokesman for Eli Lilly said it would not be appropriate to comment on the content of the papers as officials from the company have not seen them.

But he added: "Lilly is committed to the public disclosure of all clinical trial data to ensure that healthcare professionals and families have the information they need to make informed treatment decisions about Lilly medicines.

"Prozac has been prescribed for more than 50m people worldwide and is one of the most studied drugs in the history of medicine."