Re: [MOL] Evidence Sheds Light on Dark Side of Prozac......./comment/Joh [00540] Medicine On Line


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Re: [MOL] Evidence Sheds Light on Dark Side of Prozac......./comment/John!



This is a serious one; but there are many more stories such as this.  Thanks
for your comments, I know this hit you hard.....love you nephew!  lillian


We invite you to take a look at our Album.
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----- Original Message -----
From: <jlehner@nyee.edu>
To: <mol-cancer@lists.meds.com>
Sent: Thursday, May 11, 2000 10:09 AM
Subject: 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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