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Posted on 12/30/2004 10:16:24 PM PST by neverdem
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BMJ 2005;330:7 (1 January), doi:10.1136/bmj.330.7481.7
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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. Joseph 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 Joseph 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 Richard 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 John 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."
David 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."
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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 Peter 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."
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© 2004 BMJ Publishing Group Ltd
Obviously this the problem. Never mind the drugs, never mind the individual, it was the gun. Ban guns. Never mind that if he didn't have an AK type rifle, he'd have used a shotgun. If he didn't have a shotgun, he might just have blown the whole place to Kingdom Come, using a propane gas cylinder and a match.
FReepmail me if you want on or off my health and science ping list.
What are you, telepathic? Happy New Year!
Years ago my doctor tried to put me on Prozac. I lost 3 pounds in three days, had a resting HR of 140, RR 40 and slept three hours a night. He halved the dose and my HR went down to 110, RR 24. Paxil was a different type of hell.
The stuff is poison. I went the alternative medicine route.
Which was what, if I may ask, St. John's wort?
At first I tried homeopathy. I found a MD is San Francisco who utilized it in his practice. It didn't solve my particular problem, but I have used an OTC product for something else which was quite effective. I do know others who had great success using homeopathy.
Ayurveda worked well for me. The Hindu system treats the body as a whole system, using certain foods, herbs, body work and prayer practice. Plus it is thousands of years old and the best organized system of natural medicine I've found. There wasn't one herb per se that helped me because programs are tailored to the individual and my situation was complicated. One person might take one herb which might be totally wrong for another person with the same problem. My practitioner didn't target a disease but focused on putting my entire body back in balance. Over the years I have become more sensitive to conventional drugs so this system is preferable to me whenever possible.
"as it is similar to cocaine in its effects on serotonin."
Wrong.
Cocaine causes the release of large amounts of dopamine, another neurotransmitter.
Some people DO have adverse reactions to these drugs, but I am certain they have saved far more lives than they have taken.
poing
There is a small percentage of the population that cannot metabolize a byproduct of the earlier SSRIs. It sounds like you are one of them.
Wrong.
Cocaine causes the release of large amounts of dopamine, another neurotransmitter.
I have read that virtually all addictive substances to include nicotine, alcohol, marijuana, cocaine and heroin involves the neuortransmitter dopamine.
Many antidepressants can be considered stimulants and have the same adverse effects as the amphetamines. Enter antidepressants AND stimulants into the previous link. You'll find 771 citations.
Neverdem, as much as I respect BMJ as a legitimate medical journal, when they quote anything by Dr. Peter Breggin, Scientologist, a member of the Board of Directors of the Church of Scientology, and a founding member of Scientology's sub-cult Citizen's Commission on Human Rights (CCHR) the entire credibility of the article is toast.
Now why would a Democratic Congressman be hot against Eli Lilly & Co., the manufacturer of Prozac?
This may be only a coincidence, but President George H.W. Bush, our President's Father, was at one point the CEO of Eli Lilly & Co.
"George H W Bush was on Eli Lilly's board of directors, as was Ken Lay."
That's the best that I can find with a google, and that's an obviously left wing website.
Regarding your previous point that Breggin is a scientologist, and thusly discredited in your eyes, that's your prerogative. That's news to me. However, I do know that Breggin has been a determined crusader against drugging children, mostly boys, for attention deficit disorder(ADD) and attention deficit hyperactivity disorder(ADHD), diagnoses that are controversial and which have become current epidemics for what was previously considered normal behavior for boys.
Dr. Peter Breggin is a Scientologist. Breggin's membership in the cult of Scientology has everything to do with his lack of credibility on all issues.
Dr. Peter Breggin belongs to a cult which believes in Xenu, a cult which believes that aliens inhabit human bodies and a cult which condones destroying/ discrediting members of the cult when they attempt to leave.
Scientologist Dr. Peter Breggin has spewed disinformation about the heritable neurological condition known as attention deficit hyperactivity disorder.
Scientologist Dr. Peter Breggin led a legal team of Scientologists in their attack against Novartis, pharmaceutical company and manufacturer of Ritalin, one medication used for over forty years in the treatment of attention deficit hyperactivity disorder.
Scientologist Dr. Peter Breggin, and his team of Scientology lawyers lost their Scientology sponsored lawsuit against Novartis, and they lost their earlier Scientology sponsored Prozac lawsuit against Eli Lilly & Co.
The article is about Prozac, but the information comes from the Scientologists. Therefore the article is skewed at the very least but more likely it is pure disinformation.
The link you provided goes to a parent directory with folders entitled "detoxification", "beingalkaline" "human parasite" "cleanse your liver", "world-health-site" which coincidentally bears the name of yet another sub group of the Church of Scientology.
However I disagree with everything which is tainted by the Church of Scientology.
There have been times in the past when I've found enjoyment discussing issues muddled up by Scientology, but it's New Year's Eve, and I'm needing to catch up on some real life things.
Happy New Year to you and yours!
The FDA has just required a black box warning on all prescriptions of SSRIs because of its tendency to cause suicidal ideation.
Columbine shooter was prescribed anti-depressant
Teen Says Antidepressants Led to Slayings
The SSRIs are potent enough that when various adverse effects become intolerable in some folks they are switched to Prozac, because of its longer half-life, as they are gradually weaned off of them in order to avoid withdrawal or discontinuation syndrome.
Happy New Year!
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