Eli Lilly The Habitual Offender

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By Evelyn Pringle (about the author) Page 2 of 3 page(s)

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But with the massive off-label sales, so came the less newsworthy adverse events. The reporting system for prescription drugs in the US is called Medwatch. Within 10 years of Prozac's arrival on the US market, there were 39,000 adverse events submitted to Medwatch, a number said to represent only between 1% and 10% of the actual number.

"So, if we get 39,000 adverse event reports about Prozac, the number of people who have actually suffered such problems is estimated to be 100 times as many, or roughly four million people," investigative journalist Robert Whitaker explained in an interview for Street Spirit in August 2005.

"This makes Prozac," he said, "the most complained about drug in America, by far."

"There were more adverse event reports received about Prozac in its first two years on the market than had been reported on the leading tricyclic antidepressant in 20 years," he added.

On December 18, 2003, Lilly sent letters to healthcare professionals in the UK, saying that Prozac was not recommended for children for any use, but issued no warning to doctors in the US.

In a situation similar to the Zyprexa document case, a couple years ago, the British Medical Journal received a series of internal Lilly documents and studies on Prozac from an anonymous source. The BMJ sent the documents to authorities, including US Congressman Maurice Hinchey and the FDA.

Congressman Hinchey sent the materials to psychiatrist, Dr Peter Breggin, author of Talking Back to Prozac, and The Anti-Depressant Fact Book, who reviewed the documents and issued a January 12, 2005 report.

After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert for the combined Multi-District Litigation concerning Prozac. He in fact testified about the documents during a trial in 1994 after which, he says, they seemed to just disappear.

One group of documents he examined, contained a study by the FDA on the increased post marketing reports of "hostility" and "intentional injury" by patients on Prozac. For this study, the FDA compared patients using the antidepressant, trazodone, with Prozac patients, and found a 24-fold relative increase of reports of hostility and intentional injury per prescription of Prozac compared to trazodone.

The documents Dr Breggin 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.

An August 6, 1989, Lilly document says that doctors should be warned that Prozac patients were at a higher risk of suicide unless they receive a sedative, stating: "The counterindication because of acute suicidality should become a warning whereby the physicians should be advised that in the absence of sedation, the risk of higher suicidality should be taken into account."

A June 13, 1990, letter to Lilly from a concerned doctor states: "There appears to be growing concern that Prozac may somehow trigger a suicidal preoccupation in a small subset of patients and that their families should be warned of this potential risk. It is certainly possible that some of the cases reported are "coincidence" in that the depressed person may have attempted suicide independently of Prozac. However, some of these cases appear to be in patients taking Prozac for reasons other than depression."

Yet two months later, on August 31, 1990, Lilly sent out a Dear Doctor letter assuring health care professionals that there is no "causal relationship between Prozac and suicidality (ideation or acts)."

The hidden Prozac documents have come back to haunt Lilly. On January 14, 2005, a class action lawsuit was filed in Canada with claims that Lilly withheld information on the safety of Prozac. The plaintiffs contend that the reason Lilly failed to disclose the documents was because they showed a drastic increases in suicide attempts and other violent acts in patient using Prozac when compared to four other drugs.

Throughout the 1990s, while swearing publicly that Prozac did not increase the risk of suicide or violence, Lilly quietly settled lawsuits out of court and was able to keep the incriminating evidence hidden by obtaining court orders to seal the documents, just as it had been doing with Zyprexa until the latest batch of documents was leaked to the press.

Since the FDA was placed on permanent vacation when George W Bush took up residence in the White House, these days litigation appears to be about the only means available for unearthing hidden studies that show a drug's adverse effects.

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