Drug company deception & cover-up

[Guest guest]

Another drug company cover-up and this time its Prozac. With a

continuing history of deception by the drug companies, it really

makes me wonder as to the accuracy of any of the clinical research

on GH and Lupron. See the following article from the most recent

British Medical Journal.

Jean

FDA to review " missing " drug company documents

Jeanne Lenzer

New York

The US Food and Drug Administration has agreed to review

confidential drug company documents that went missing during a

controversial product liability suit more than 10 years ago. The

documents appear to suggest a link between the drug fluoxetine

(Prozac), made by Eli Lilly, and suicide attempts and violence.

The missing documents, which were sent to the BMJ by an anonymous

source last month, include reviews and memos indicating that Eli

Lilly officials were aware in the 1980s that fluoxetine had

troubling side effects and sought to minimise their likely negative

effect on prescribing.

The documents received by the BMJ reportedly went missing during the

1994 Wesbecker case that grew out of a lawsuit filed on behalf of

victims of a work-place shooting in 1989. ph Wesbecker, armed

with an AK-47, shot eight people dead and wounded another 12. He

then shot and killed himself. Mr Wesbecker, who had a long history

of depression, had been placed on fluoxetine one month before the

shootings.

One of the internal company documents, a report of 8 November 1988,

entitled " Activation and Sedation in Fluoxetine Clinical Trials, "

found that in clinical trials " 38% of fluoxetine-treated patients

reported new activation but 19% of placebo-treated patients also

reported new activation yielding a difference of 19% attributable to

fluoxetine. "

The FDA recently issued a warning that antidepressants can cause a

cluster of " activating " or stimulating symptoms such as agitation,

panic attacks, insomnia, and aggressiveness. Dr ph Glenmullen, a

Harvard psychiatrist and author of The Antidepressant Solution,

published by Free Press, said it should come as little surprise that

fluoxetine might cause serious behavioural disturbances, as it is

similar to cocaine in its effects on serotonin.

Dr Kapit, the FDA clinical reviewer who approved fluoxetine,

said he was not given the Lilly data. " 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. "

Congressman Maurice Hinchey's office is currently reviewing the

documents to determine whether Lilly withheld data from the public

and the FDA. Mr Hinchey (Democrat, New York) said: " This is an

alarming study that should have been shared with the public and the

FDA from the get-go, not 16 years later.

" This case demonstrates the need for Congress to mandate the

complete disclosure of all clinical studies for FDA-approved drugs

so that patients and their doctors, not the drug companies, decide

whether the benefits of taking a certain medicine outweigh the

risks. "

The plaintiffs in the Wesbecker product liability sought to show

that Eli Lilly withheld negative study data from the FDA and that

fluoxetine tipped Wesbecker over into a homicidal rage. Lilly won a

9 to 3 jury verdict in late 1994 and subsequently claimed that it

was " proven in a court of law... that Prozac is safe and effective. "

The trial judge, Justice Potter, suspecting that a secret deal

had been struck, pursued Lilly and the plaintiffs, eventually

forcing Lilly in 1997 to admit that it had made a secret settlement

with the plaintiffs during the trial. Infuriated by Lilly's actions,

Judge Potter ordered the finding changed from a verdict in Lilly's

favour to one of " dismissed as settled with prejudice, "

saying, " Lilly sought to buy not just the verdict but the court's

judgment as well. "

Graham, currently associate director in the FDA's Office of

Drug Safety, criticised the analysis of post-marketing surveillance

data submitted by Lilly to the FDA. After discovering that Lilly

failed to obtain systematic assessments of violence and had excluded

76 of 97 cases of reported suicidality, Dr Graham concluded in a

memo dated 11 September 1990 that " because of apparent large-scale

underreporting, [Lilly's] analysis cannot be considered as proving

that fluoxetine and violent behavior are unrelated. "

Congressman Maurice Hinchey said that the internal Lilly

data " should have been shared with the public "

Credit: CONGRESSMAN MAURICE HINCHEY

An FDA advisory panel was convened in 1991 to review the fluoxetine

data. It concluded that fluoxetine was safe despite the concerns

raised by Dr Graham and others, leading critics to point out that

several of the panellists had financial ties to Eli Lilly.

Dr Glenmullen said the missing documents obtained by the BMJ

provide " the missing link " between the recent advisory issued by the

FDA and what Lilly scientists knew 16 years ago.

Since the 1991 FDA hearings Dr Breggin, who served as the

medical expert in the Wesbecker case, has warned that the stimulant

effects of fluoxetine can cause suicide and violence. He cautions

that the 38% activation rate reported in the missing document is

probably low because " it doesn't include other symptoms of

activation such as panic attacks, hypomania, and mania. "

Dr Kapit, the original reviewer for fluoxetine, told the BMJ, " If we

have good evidence that we were misled and data were withheld then I

would change my mind [about the safety of fluoxetine]. I do agree

now that these stimulatory side effects, especially in regards to

suicidal ideation and homicidal ideation, are worse than I thought

at the time that I reviewed the drug. "

Lilly declined to be interviewed but issued a written statement

saying, " Prozac has helped to significantly improve millions of

lives. It is one of the most studied drugs in the history of

medicine, and has been prescribed for more than 50 million people

worldwide. The safety and efficacy of Prozac is well studied, well

documented, and well established. "