RE: [MOL] Evidence Sheds Light on Dark Side of Prozac......./comment [00520] Medicine On Line


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RE: [MOL] Evidence Sheds Light on Dark Side of Prozac......./comment



Hi all,

Interesting story isn't it.  I was the Research Administrator at McLean
Hospital at that time and Marty Teicher was not only a colleague but a dear
friend as well.  No more objective unobligated scientist have I ever met.
Lilly sponsored many trials at McLean and, for the most part, they were
performed objectively and the results of those trials, good or bad, were
published by the McLean staff.  Lilly decide to distance itself from
oversight of the trials, as many companies did, and contracted the conduct
of the trials out to Clinical Trial Coordinating Companies who seem to feel
that if the data supports the interest of the company contracting them, then
it is good business to come up with good results.  The decision to place a
commercial layer between the pharmaceutical company and the researchers
doing the trial was one of the most ill advised moves ever made by the
companies.

Yes, there are abuses because there is so much money riding on these things.
For the most part, Hospitals and Medical Centers do not want to involve
themselves in ANY venture that will back-fire in terms of bad press.  It is
truly a crime that Companies feel the need for profit at the expense of
human suffering is justified.  These corporate suites need a good reality
check.

Sorry, but it gives a bad name to my profession by association that, for the
most part, is focused on helping, not hurting people.

God Bless.

John

-----Original Message-----
From: Bridget Rambeau [mailto:bsbridget@hotmail.com]
Sent: Thursday, May 11, 2000 4:44 AM
To: mol-cancer@lists.meds.com
Subject: Re: [MOL] Evidence Sheds Light on Dark Side of
Prozac......./comment


Interesting article but kind of scares the **** out of you!
Your friend,
Bridget


>From: "Lillian" <firefly@islc.net>
>Reply-To: mol-cancer@lists.meds.com
>To: "Nancy J." <mol-cancer@lists.meds.com>
>Subject: [MOL] Evidence Sheds Light on Dark Side of Prozac.......
>Date: Wed, 10 May 2000 13:13:59 -0700
>
>Evidence Sheds New Light On Dark Side Of Prozac
>Leah R. Garnett
>
>
>Just as the 14-year patent on Prozac is about to expire and the drugs 
>maker, Eli Lilly and Co., is preparing to launch a new version, a body of 
>evidence has come to light revealing the antidepressants dark side.
>
>The companys internal documents, some dating to the mid-1980s, as well as 
>government applications and patents, indicate that the pharmaceutical giant

>has known for years that its best-selling drug could cause suicidal 
>reactions in a small but significant number of patients. The reports could 
>become critical as Lilly seeks government approval for its new Prozac.
>
>Among the findings:
>
>--Internal documents show that in 1990, Lilly scientists were pressured by 
>corporate executives to alter records on physician experiences with Prozac,

>changing mentions of suicide attempt to ``overdose and suicidal thoughts to

>``depression.
>
>--Three years before Prozac received approval by the US Food and Drug 
>Administration in late 1987, the German BGA, that countrys FDA equivalent, 
>had such serious reservations about Prozacs safety that it refused to 
>approve the antidepressant based on Lillys studies showing that previously 
>nonsuicidal patients who took the drug had a fivefold higher rate of 
>suicides and suicide attempts than those on older antidepressants, and a 
>threefold higher rate than those taking placebos.
>
>--Lillys own figures, in reports made available to the Globe, indicate that

>1 in 100 previously nonsuicidal patients who took the drug in early 
>clinical trials developed a severe form of anxiety and agitation called 
>akathisia, causing them to attempt or commit suicide during the studies.
>
>--Though Lilly has steadfastly defended the drugs safety and downplayed 
>studies linking Prozac to suicide, the patent for the new Prozac, 
>R-fluoxetine, expected to be marketed by Lilly beginning in 2002, notes 
>that the new version will not produce several existing side effects 
>including ``akathisia, suicidal thoughts, and self-mutilation, which the 
>patent calls ``one of its more significant side effects.
>
>--A McLean Hospital researcher and associate professor at Harvard Medical 
>School, Dr. Martin Teicher, whose early 1990s studies linked Prozac to 
>akathisia and suicide, is a co-inventor of the new Prozac, which Lilly 
>plans to market, along with Timothy J. Barberich, the CEO of Sepracor Inc.,

>a Marlborough, Mass. drug company, and James W. Young.
>
>--A just-published book, ``Prozac Backlash, by a Cambridge psychiatrist, 
>Dr. Joseph Glenmullen, has drawn Lillys ire for discussing Prozacs link to 
>suicide, tics, withdrawal symptoms, and other side effects of Prozac and 
>similar antidepressants.
>
>Lilly officials continue to defend the drugs effectiveness, saying its 
>track record is borne out by the fact it is still the most widely 
>prescribed drug of its kind. In a written statement, Jeff Newton, a Lilly 
>spokesman, said: ``There is no credible evidence that establishes a causal 
>link between Prozac and violent or suicidal behavior. There is, to the 
>contrary, scientific evidence showing that Prozac and medicines like it 
>actually protect against such behaviors.
>
>Using figures on Prozac both from Lilly and independent research, however, 
>Dr. David Healy, an expert on the brains serotonin system and director of 
>the North Wales Department of Psychological Medicine at the University of 
>Wales, estimated that ``probably 50,000 people have committed suicide on 
>Prozac since its launch, over and above the number who would have done so 
>if left untreated.
>
>Healy, meanwhile, is conducting a new study that he says is the first of 
>its kind, giving antidepressants to healthy people to study possible links 
>to suicide. The results are expected to be published in June.
>
>Prozacs success is certainly unquestioned. The introduction of the drug to 
>the US market in the late 1980s changed the way Americans viewed their most

>intimate emotions and limitations. Billed as a wonder drug to combat 
>depression by boosting levels of the brain chemical serotonin, Prozac and 
>others like it were also said to remedy a host of human frailties from poor

>self-esteem and concentration to fear of rejection.
>
>By the end of last year, more than 35 million people worldwide were using 
>the drug, which provided Lilly with more than 25 percent of its $10 billion

>in 1999 revenue.
>
>Yet the problems with Prozac were known even before it was introduced to 
>the US market. Figures in a 1984 Lilly document indicated that akathisia, 
>the severe agitation that can lead to suicide, occurs in at least 1 percent

>of patients, a level considered a ``frequent event, and as such must be 
>disclosed in a companys product literature and package inserts. But there 
>is no such disclosure in Prozacs US literature, and it is not clear whether

>the FDA panel charged with approving Prozac simply overlooked or did not 
>have access to certain critical data of Lillys.
>
>As a result, researchers say that most US doctors do not know to warn 
>patients of the potentially dangerous effect which, according to published 
>literature on the topic, can be alleviated with sedatives or by going off 
>the drug.
>
>German regulators, who eventually approved Prozac for use in that country, 
>require a warning label about the risk of suicide and suggest the 
>concurrent use of sedatives when necessary.
>
>Akathisia is listed in Lillys US product literature, but as an infrequent 
>event in Prozac users. No mention is made of its potential relationship to 
>suicide.
>
>A relationship, however, was found in a Globe search of US patents. The 
>patent for the new Prozac or R-fluoxetine (US Patent no. 5,708,035), which 
>Lilly will market after the existing patent expires in 2001, contains a 
>wealth of information about the original Prozac. According to the patent, 
>the new Prozac will decrease side effects of the existing Prozac such as 
>headaches, nervousness, anxiety, and insomnia, as well as ``inner 
>restlessness (akathisia), suicidal thoughts and self-mutilation - the same 
>effect Lilly has contended has not occurred in any substantial way in some 
>200 lawsuits against it over the past decade. Most of the suits were 
>settled out of court and the terms kept confidential.
>
>A 1990 COMMUNIQUE
>
>In an electronic communique obtained by author Glenmullen dated Nov. 13, 
>1990, from Claude Bouchy, a Lilly employee in Germany, to three Lilly 
>corporate executives at the companys Indianapolis headquarters, Bouchy says

>he and a colleague ``have problems with the directions our safety people 
>are getting from the corporate group (Drug Epidemiology Unit) and 
>requesting that we change the identification of events as they are reported

>by the physicians. . . . Our safety staff is requested to change the event 
>term `suicide attempt (as reported by the physician) to `overdose.
>
>Bouchy continued that ``. . . it is requested that we change . . . 
>`suicidal ideation to `depression.
>
>And then Bouchy makes an appeal to his US Lilly colleagues: ``I do not 
>think I could explain to the BGA, to a judge, to a reporter or even to my 
>family why we would do this especially on the sensitive issue of suicide 
>and suicide ideation. At least not with the explanations that have been 
>given to our staff so far.
>
>Lilly has also aggressively sought to discredit researchers who published 
>data linking its product to suicide. One of its early targets was Dr. 
>Martin Teicher, an associate professor of psychiatry at Harvard Medical 
>School and a McLean Hospital researcher, who wrote a crucial paper on the 
>link between suicide and Prozac in 1990; he found that 3.5 percent of 
>patients put on Prozac either attempt or commit suicide due to severe 
>agitation from akathisia. As a result of Lillys campaign, many in the 
>psychiatric community say they believe Teicher has distanced himself from 
>his original work. But in a rare interview with the Globe, Teicher said 
>that he stood by his work, and that the ability of Prozac to induce suicide

>in a minority of patients ``is a real phenomenon.
>
>Teicher, Barberich, and Young filed their patent for the new Prozac in 
>August 1993, the same year Teicher published another report, this one in 
>the journal Drug Safety titled ``Antidepressant Drugs and the Emergence of 
>Suicidal Tendencies.
>
>The paper was a direct challenge to data reported in the March 1991 issue 
>of the Journal of Clinical Psychiatry by Drs. Maurizio Fava and Jerrold 
>Rosenbaum of Massachusetts General Hospital. Their study found no 
>significant difference in ``suicidal ideation in patients treated with 
>fluoxetine compared to those receiving other antidepressants.
>
>Teicher wrote in his 1993 paper that Fava and Rosenbaums statistics were 
>flawed. Using Fava and Rosenbaums data, Teicher came to the opposite 
>conclusion: namely, that patients on Prozac were at least three times more 
>likely to become suicidal than those on older antidepressants.
>
>The FDA came up with similar results even before Teicher published his 1993

>data. Dr. David Graham, chief of the FDAs Epidemiology Branch, wrote on 
>Sept. 11, 1990, that Lillys data on suicide and Prozac, as well as the Fava

>and Rosenbaum study, were insufficient to prove that Prozac was safe. In an

>internal FDA memo, Graham wrote: ``Because of apparent large-scale 
>underreporting, the firms analysis cannot be considered as proving that 
>fluoxetine and violent behavior are unrelated.
>
>``PROZAC BACKLASH
>
>Now a decade later, Lilly has targeted Dr. Joseph Glenmullen, whose book 
>``Prozac Backlash has apparently incensed Lilly executives.
>
>Glenmullen, a clinical instructor in psychiatry at Harvard Medical School 
>and a clinician at the Harvard University Health Services, says he wrote 
>the book because he was alarmed by the number of patients who were 
>reporting severe side effects from the serotonin-boosting antidepressants 
>including Prozac, Paxil, Zoloft, and Luvox. ``The two most upsetting side 
>effects were patients becoming suicidal on the drugs, and the development 
>of disfiguring facial tics, he said in an interview.
>
>After obtaining hundreds of pages of FDA documents through the Freedom of 
>Information Act, as well as internal Lilly memos that are part of the 
>public record in lawsuits filed against the drug company, Glenmullen wrote 
>that Lilly had tried to downplay side effects of Prozac for years.
>
>Lilly alerted newspapers and TV stations to the book and began a campaign 
>to discredit the author, saying that Harvard Medical School professors were

>unfamiliar with his work and didnt recognize his name. Glenmullen, a 
>graduate of Harvard Medical School, is one of 415 clinical instructors in 
>medicine at Harvard.
>
>BLAST FROM A CRITIC
>
>Chief among Glenmullens critics is Mass. Generals Rosenbaum, a professor of

>psychiatry at Harvard Medical School, who, in a written statement sent to 
>the Globe calls ``Prozac Backlash a ``dishonest book that is `` 
>manipulative and ``mischievous.
>
>But Rosenbaums objectivity has also been questioned. Not only was his 1991 
>study on Prozac and suicide criticized by at least two sets of researchers 
>as well as the FDA, documents obtained by the Globe show that Rosenbaums 
>relationship to Lilly is a cozy one: he has served as a Prozac researcher 
>and sat on a marketing advisory panel for Lilly before Prozac was launched.
>
>When asked in an interview why he was speaking out against Glenmullens 
>book, Rosenbaum said that the suicide controversy was ``old news and that 
>the book presents the information as new research. He noted that akathisia 
>is ``pretty rare and that ``it doesnt occur more than in people given a 
>placebo.
>
>But because there is no official reporting system for drug side effects, no

>one knows how common drug side effects are, said Larry Sasich, a research 
>analyst at Public Citizen in Washington, D.C.
>
>``There is no active surveillance system to look at adverse events, he 
>said. ``Unless something very unfortunate happens and a large number of 
>people are harmed in a unique way, no one is going to look at it; nobody 
>ever puts two and two together.
>
>SEPRACORS PATENT
>
>On April 12, the Federal Trade Commission opened the way for Lilly to 
>market Teichers, Barberichs, and Youngs new Prozac, for which Sepracor 
>holds the patent. The new Prozac, R-fluoxetine, is a modified form of an 
>ingredient found in Prozac, which, according to Sepracor, not only has 
>fewer side effects but more potential uses and benefits than the original.
>
>In making the decision, the FTC rejected arguments from its lawyers and the

>generic drug industry that the agreement unfairly limits generic Prozac 
>competition.
>
>According to a Sepracor press release dated April 13, the company will 
>receive an upfront payment and license fee of $20 million from Lilly and an

>additional $70 million based on the progression of the drug. Sepracor will 
>receive royalties, and in exchange, Lilly will get the exclusive world 
>rights to R-fluoxetine for all indications and uses. Lilly will be 
>responsible for the development of the drug, regulatory submissions, 
>product manufacturing, marketing and sales, according to the release.
>
>Glenmullen wonders whether the new Prozac will, in fact, be little more 
>than an effort to prolong the life of a product with a soon-to-expire 
>patent. Although it is touted as having fewer side effects, no one knows 
>what effects may surface once large numbers of people begin taking it for 
>months or years. In the epilogue to his book, he simply says: ``Like any 
>new drug, it too will be an ongoing experiment.
>
>
>-----
>
>
>
>We invite you to take a look at our Album.
>www.angelfire.com/sc/molangels/index.html
>
>   ( Very informational, good tips, Molers pictures, art work and much 
>more....
>

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