Re: [MOL] Evidence Sheds Light on Dark Side of Prozac......./comment [00503] Medicine On Line


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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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