7/25/2000 – Ewing’s Letter to the New York Times

Mr. Rick Ewing, a trial attorney for the firm of Vickery and Waldner,
responds to the purported balance of opinions expressed in the
New York Times article on Prozac and violence (Article #108 on
our eGroups list).

It is a wonderful analysis, and I hope you’ll read it. Mark
——-

Ms. Goode’s article is a balanced account of an ongoing debate
about suicide and violence temporally associated with the SSRI
drugs. If “opinion leaders” differ sharply then we are in
intellectual equilibrium.

Right? Wrong. The leaders are as data-starved as the public.
The FDA is charged with accumulating and interpreting
post-marketing data on drug adverse events, and there is data
on well over a million events in the records of that agency. There
is no funding for meaningful analysis, and no initiatives for
funding. The data simply sit there. Neither is there any
requirement that drug companies investigate and report in detail
to the agency on adverse events. They are simply reported. If
the death and injury toll from a particular formulation, such as
“Oraflex” or “Fen-Phen” is overwhelming, the drug may be
withdrawn, not because of a systematic analysis, but because
the death toll speaks for itself.

What about less blatant data? By the fall of 1997, the FDA had
collected more than 44,000 adverse event in connection with
Prozac, more than the sum total of all reports on all psychoactive
drugs in history. The FDA receives reports on less than 10% of
the actual events by its own estimates. www.fda.gov. Those
reports now include more than 2500 deaths reasonably related
to suicide and violence. In fact, the pre 1998 reports are
scattered among some fifteen different “CO-START” terms
depending on the subjectivity’s or thoroughness of the reporting
physician. (There were 15 single-spaced pages of such terms,
a monument to ambiguity when applied to psychoactive drugs.)
Interestingly there was no term for either “suicide” or “murder.”
The majority of deaths (OUTCOME: DIE) are coded to the terms
“suicide attempt”, somewhat euphemistic applied to completed
suicides. By October of 1997, there were more than 1500 Prozac
deaths clearly coded to suicide or murder and another 300 for
which suicide or murder was the most plausible conclusion.

The United States Army developed an accepted technique for
investigating an alarming suicide rate among recruits – the
psychological autopsy, based on in-depth study of the subject’s
psychological history, and immediate life circumstances. It is
accepted as a generally useful technique. What kinds of
questions could have been answered if drug companies were
required to utilize psychological autopsies through independent
investigators?

Were there suicidal thoughts before the administration of the
drug? Did the suicide appear impulsive? Was the suicide
inconsistent with life-affirming elements? Did survivors consider
the suicide shocking and inconsistent? Did the deceased use
violent or grotesque modalities for suicide?
……………………..

Would it be useful and germane to the ongoing debate which
Ms. Goode so ably describes to have answers to those
questions for some 2500 deaths under SSRI drugs?

Would it be of interest that while men in the general population
are more than 8 times as lethal in their suicidal gestures as
women, that under these drugs men and women commit
suicide at almost equal rates? The suicide rates in the United
States hover around 30,000 per year, varying a few hundred.
Men commit suicide at a rate 4.3 to 1 over women. But
depression is thought to be twice as prevalent in women. It
would follow that men are more than 8 times as lethal in
depression suicides as women. Yet the demographic figures
connected with the adverse reports on Prozac (and other SSRI
drugs) show that women commit suicide at almost equal rates
with men, over 40%. Are these drugs obliterating what is
otherwise an immutable behavioral difference between men and
women?

If anyone has struggled through this letter, I have to admit that I
am a plaintiff’s lawyer who has been involved in SSRI litigation
for the past 10 years. You can now turn me into a cartoon
symbol of unalloyed greed, but before you do, isn’t it a frightening
thought that the only people on the trail of SSRI tragedy are
people like me? Shouldn’t there be others?

Congratulations on a very professional article. How I would love
to see you take on an in-depth study of the sources of
information and misinformation relating to licensed drugs!

Sincerely,
Richard W. Ewing
rick@…

7/24/2000 – Prozac [Sarafem] and PMS – What’s in a name?

Once again we thank Vera Hassner Sharav, President, CIRCARE: Citizens for
Responsible Care & Research, a Human Rights organization, for passing on this
interesting commentary on Prozac’s name being changed to Sarafem for PMS. The
dangers of interaction leading to serotonin syndrome – a life threatening
complication of serotonergic medications – is most obvious in all of these
name changes.

Ann Blake-Tracy

~~~~~~~~~~~~~~

http://mentalhealth.about.com/health/mentalhealth/library/weekly/aa071700a.htm

Prozac and PMS – What’s in a name?
Leonard Holmes, Ph.D.

Drug companies are doing some interesting things to the names of their
products. The FDA recently approved the chemical fluoxetine for the treatment
of symptoms related to PMS – Premenstrual Syndrome (officially known as PMDD
– pre-menstrual dysphoric disorder). Fluoxetine is sold by Eli Lilly and
Company under the name Prozac. Will women with PMS be taking prescriptions
for Prozac to their pharmacist? Not likely. Lilly has decided to rename the
drug Sarafem when it is prescribed for this problem. Why the new name?
Lilly’s official position follows:

The additional trademark will help with educational efforts for this largely
underrecognized disorder while reducing confusion about the differences
between depression and PMDD. (Lilly Newsroom 7/00)

What about the confusion that is added by two different names for the same
chemical? What happens when a patient gets Prozac from one doctor and
Sarafem from another?

Prozac has a mixed reputation. While some have hailed it as the first in a
class of wonder drugs others have implicated it it in some cases of suicidal
behavior. There have never been any substantiated cases of suicidal behavior
traced to Prozac or any other antidepressant. Lilly has a response to these
rumors too:

Concerning media allegations of Prozac and suicide there is no credible
evidence that establishes a causal link between Prozac and violent or
suicidal behavior. In fact, in September 1991, a panel of experts appointed
by the FDA found no credible evidence of a causal link between the use of
antidepressant drugs, including Prozac, and suicidal or violent behavior.
(Lilly Newsroom quoted 7/00)

This is not the first time that a drug company has given a new name to the
same medication. In 1997 bupropion was approved for smoking cessation. This
medication, better known by the trade name Wellbutrin was re-christened Zyban
when used for smoking cessation. That’s why the Zyban ads warn you not to
take it if you are taking Wellbutrin. Not much fuss was made about this at
the time, but it seems to have started a trend.

Steve Cartun, M.D. did write to protest the renaming back in 1997. His logic
still rings true, and there is a great deal of irony in the example that he
used at the time. An excerpt:

New indications for old medications have become a staple of
psychopharmocology. Prozac, for example, originally introduced as an
antidepressant, has since garnered FDA approval for the treatment of
obsessive-compulsive disorder. Eli-Lilly, the company that manufactures and
holds the patent for Prozac, did not rename it’s product simply because it
had earned a new indication. Even though Prozac had been subjected to false
and damaging statements, Eli-Lilly chose not to fashion it in newer clothes.
The renaming of Wellbutrin by the same company that manufactures it, simply
because research studies show that it has a new and valuable use, gravely
concerns me….

The renaming of medications is a dangerous semantic. While a pharmaceutical
company can argue that a new name that gains wider use will ultimately help
the patient, I believe that such a measure treats physicians like naive
consumers who care more about a logo than the gritty science that logo
represents. Perhaps this is an alarming symptom of how trivialized the
importance of reality, at the expense of marketing, is becoming. Physicians
have already been renamed health care providers. Wellbutrin is now being
named Zyban for a new use. An industry insider once told me that the letter
“Z” is particularly useful for gaining audience attention. I hope that Zyban
gains all the attention it can to prevent this naming process from becoming a
trend. Enough misrepresentation. Convolution must be resisted. If it
continues, the meaning of health care will become even more lost than it is
now. (Cartun, 1997)

I’m afraid that Dr. Cartun’s hopes have not been realized. Lilly has renamed
Prozac to appeal to women with PMS who might otherwise shy away from the
medication. It’s hard enough to keep track of all of the different
medications out there. We shouldn’t have to keep track of multiple trade
names for the same medication from the same company.

Excerpt from a 1997 letter by Dr. Steve Cartun:

New indications for old medications have become a staple of
psychopharmocology. Prozac, for example, originally introduced as an
antidepressant, has since garnered FDA approval for the treatment of
obsessive-compulsive disorder. Eli-Lilly, the company that manufactures and
holds the patent for Prozac, did not rename it’s product simply because it
had earned a new indication. Even though Prozac had been subjected to false
and damaging statements, Eli-Lilly chose not to fashion it in newer clothes.
The renaming of Wellbutrin by the same company that manufactures it, simply
because research studies show that it has a new and valuable use, gravely
concerns me….

The renaming of medications is a dangerous semantic. While a pharmaceutical
company can argue that a new name that gains wider use will ultimately help
the patient, I believe that such a measure treats physicians like naive
consumers who care more about a logo than the gritty science that logo
represents. Perhaps this is an alarming symptom of how trivialized the
importance of reality, at the expense of marketing, is becoming. Physicians
have already been renamed health care providers. Wellbutrin is now being
named Zyban for a new use. An industry insider once told me that the letter
“Z” is particularly useful for gaining audience attention. I hope that Zyban
gains all the attention it can to prevent this naming process from becoming a
trend. Enough misrepresentation. Convolution must be resisted. If it
continues, the meaning of health care will become even more lost than it is
now. (Cartun, 1997)

7/23/2000 – FDA officer advised diet-drug clinic about Fen-Phen

In case any of you missed this last fall when it broke in the Philadelphia
Inquirer and the Wall Street Journal, here it is again so you have it for
reference.

Notice that this FDA official is also the doctor who is credited with
starting the Fen-Phen craze with a medical study he published suggesting the
use of this deadly combination of drugs.

Ann Blake-Tracy

http://www.FreeRepublic.com/forum/a37f02e3073c5.htm

FreeRepublic.com “A Conservative News Forum”

Crime/Corruption

News Source: AP
Published: 9/27/99 Author: AP
Posted on 09/27/1999 19:55:44 PDT by Joe Montana

CROOKED FDA WORKS HAND IN HAND WITH DRUG COMPANIES THEY ARE SUPPOSED TO
“REGULATE”–

Ex-FDA officer advised diet-drug clinic about fen-phen

9/27/99

PHILADELPHIA (AP) – A high-ranking U.S. Food and Drug Administration official
helped a small businessman in Florida promote the popular diet drug fen-phen
in 1995, during the height of the pill combination’s popularity, newspapers
reported.

Though the FDA never approved or endorsed fen-phen, which has since been
linked with heart-valve problems, Dr. Michael Weintraub provided advice and
patient referrals to a fledgling chain of weight-loss clinics dispensing
fen-phen, The Philadelphia Inquirer reported Sunday and The Wall Street
Journal reported Monday.

Weintraub suggested a list of doctors who might endorse the diet drug
combination, talked to at least three potential clients and allowed his name
to be used in advertising, said Tampa, Fla., attorney John Trevena, who
founded Advantage Weight Control in 1994. Weintraub denies allowing his name
used in advertising.

Weintraub, who left the FDA in 1998 after five years and is now a
pharmaceutical consultant, has not been investigated by the FDA for
wrongdoing. Weintraub said his activities were similar to assistance he
offered to other people who sought advice about fen-phen.

“I couldn’t reject talking to people who called me up,” Weintraub told the
Inquirer. “I believed that the drugs could help people.”

Weintraub is largely credited for launching the fen-phen fad with a 1992
medical study that suggested combining fenfluramine, sold under the brand
names Pondimin and Redux, and phentermine in an “off-label” combination
use. Each drug was FDA approved, but the cocktail was not.

American Home Products Corp. marketed Pondimin and Redux until September
1997, when the FDA pushed for their withdrawal after a study linked the drugs
to potentially fatal heart valve damage. [And after an August 1997 National
Institute of Health study linked the drugs to brain damage.] American Home
Products now faces thousands of lawsuits from patients who claim to be hurt
by them and is negotiating a settlement estimated at $4 billion.

Weintraub joined the FDA in 1993, and eventually became director of
over-the-counter-drug evaluation. Weintraub agreed to advise Trevena
beginning in 1995, though he refused to be paid, citing government ethics
policies.

In the months that followed, Trevena recommended names of prominent obesity
experts who might serve as the center’s medical director. He testified before
the state medical board urging it not to ban fen-phen – though he explained
his remarks were not on behalf of the FDA – and praised Trevena’s centers to
the Florida news media.

Weintraub also personally advised at least three prospective Trevena clients
who were considering joining the program, Trevena said. After speaking with
Weintraub, all three signed up.

In one case, a client asked Weintraub for a referral to a weight-loss
physician in her area. Weintraub’s reply, written on FDA letterhead dated
February 1995, gave her the name of Trevena’s marketing consultant – not a
physician.

“He enthusiastically assisted us,” Trevena told the Journal.

He said his business, which has since filed for bankruptcy, relied heavily
on Weintraub’s advice on such matters as how to monitor patients. Its
publicity materials said the center used the “Weintraub Protocol.”

Weintraub said he did suggest a name or two as possible medical directors and
referred at least one patient to Trevena. He said that to anyone who asked
about fen-phen he explained the possible side effects, “potential and
real,” and stressed the need for a full physical exam and medical
monitoring.

In one of their three conversations, Trevena said he asked Weintraub whether
his advice and help with the weight-loss clinic were ethical.

“Dr. Weintraub indicated that because of his high-level position and
contacts within the FDA, he wasn’t concerned about it,” Trevena said. “He
said it wasn’t a problem.”

9/22/2000 – Exercise better than Zoloft.

Seems like exercise works better than SSRI’s!

What a surprise. After 16 weeks, patients who exercised
showed statistically significant and comparable improvement
relative to those who took Zoloft, or those who took the Zoloft and
exercised.

Be sure to look at the wide disparity in the percentage on drugs
who relapse into depression after eight weeks vs. those not on
drugs!

Here’s the complete story out of Duke University.

Mark
—————–
Effect of exercise on reducing major depression appears to be
long-lasting

DURHAM, N.C. After demonstrating that 30 minutes of brisk
exercise three times a week is just as effective as drug therapy
in relieving the symptoms of major depression in the short term,
Duke University Medical Center researchers have now shown
that continued exercise greatly reduces the chances of the
depression returning.

Last year, the Duke researchers reported on their study of 156
older patients diagnosed with major depression which, to their
surprise, found that after 16 weeks, patients who exercised
showed statistically significant and comparable improvement
relative to those who took anti-depression medication, or those
who took the medication and exercised.

The new study, which followed the same participants for an
additional six months, found that patients who continued to
exercise after completing the initial trial were much less likely to
see their depression return than the other patients. Only 8
percent of patients in the exercise group had their depression
return, while 38 percent of the drug-only group and 31 percent of
the exercise-plus-drug group relapsed.

“The important conclusion is that the effectiveness of exercise
seems to persist over time, and that patients who respond well
to exercise and maintain their exercise have a much smaller risk
of relapsing,” said lead researcher, Duke psychologist James
Blumenthal, who published the results of his team’s study in the
October issue of the journal Psychosomatic Medicine.

The research was supported by grants from the National
Institutes of Health (NIH). The Duke researchers are now using
a new $3 million NIH grant to better understand the subtle
factors that may explain the positive effects of exercise in a new
trial that begins enrolling patients this month.

“We found that there was an inverse relationship between
exercise and the risk of relapsing the more one exercised, the
less likely one would see their depressive symptoms return,”
Blumenthal explained. “For each 50-minute increment of
exercise, there was an accompanying 50 percent reduction in
relapse risk. “Findings from these studies indicate that a modest
exercise program is an effective and robust treatment for
patients with major depression,” he continued. “And if these
motivated patients continue with their exercise, they have a much
better chance of not seeing their depression return.”

Researchers were surprised that the group of patients who took
the medication and exercised did not respond as well as those
who only exercised.

“We had assumed that exercise and medication together would
have had an additive effect, but this turned out not to be the
case,” Blumenthal said. “While we don’t know the reasons for
this, some of the participants were disappointed when they
found out they were randomized to the exercise and medication
group. To some extent, this `anti-medication’ sentiment may
have played a role by making patients less excited or enthused
about their combined exercise and medication program.”

He suggested that exercise may be beneficial because patients
are actually taking an active role in trying to get better. “Simply
taking a pill is very passive,” he said. “Patients who exercised
may have felt a greater sense of mastery over their condition and
gained a greater sense of accomplishment. They may have felt
more self-confident and competent because they were able to
do it themselves, and attributed their improvement to their ability
to exercise.”

Once patients start feeling better, they tend to exercise more,
which makes them feel even better, Blumenthal said. The
greatest risk for these patients, since they are older, would be to
suffer an injury or illness that would interrupt their exercise
routine, he added.

While the researchers enrolled middle-aged and elderly people
in their study, Blumenthal said it is logical to assume that the
results would hold true for the general population, since older
people tend to have additional medical problems or infirmities
that might make regular exercise more difficult than for younger
patients.

Researchers used the anti-depressant sertraline (trade name
Zoloft), which is a member of a class of commonly used
anti-depressants known as selective serotonin reuptake
inhibitors (SSRI).

Blumenthal cautioned that the study did not include patients who
were acutely suicidal or had what is termed psychotic
depression. Also, since patients were recruited by
advertisements, these patients were motivated to get better and
interested in exercise.

###

The research team included, from Duke, Michael Babyak, Steve
Herman, Parinda Khatri, Dr. Murali Doraiswamy, Kathleen
Moore, Teri Baldewicz and Dr. Ranga Krishnan. Edward
Craighead, from the University of Colorado at Boulder also
participated.

7/18/2000 – NY Times – Once Again, Prozac Takes Center Stage, in Furor

July 18, 2000

Once Again, Prozac Takes Center Stage, in Furor

By ERICA GOODE

——————————————————————————

Naum Kazhdan/ The New York Times

At least two recently published books say that Prozac and related
antidepressants are often indiscriminately prescribed and pose the risk of
serious side effects, but critics of those views call them alarmist and
overblown.

Prozac has never been just any drug.

Soon after arriving on drugstore shelves 12 years ago, Eli Lilly’s
antidepressant transcended simple pilldom, becoming instead a cultural icon.

Hailed as a wonder drug one minute, cast as evil incarnate the next, the
green and white capsule has generated multitudes of lawsuits, and garnered
more attention than some presidential candidates.

Perhaps because Prozac treats the ills of the mind, not the complaints of the
body, it has also served as a kind of public Rorschach test, a screen upon
which Americans project deeply rooted attitudes about illness, character,
biology and free will.

So, perhaps predictably, as the drug edges into adolescence and Lilly’s
exclusive patent on the medication nears expiration, Prozac is once more
causing a stir.

More or less at the center of the newest squall are two psychiatrists, Dr.
Joseph Glenmullen, the author of a recently published book, “Prozac Backlash”
(Simon & Schuster), and Dr. David Healy, author of “The Antidepressant Era”
(Harvard University Press, 1998). They claim that Prozac and its chemical
cousins are often indiscriminately prescribed and have more serious and more
frequent side effects than the public is aware of or than the package
labeling indicates.

Many of their assertions are old ones, in particular the notion that the
drugs cause some people to become suicidal or violent, an accusation that
Lilly and other antidepressant manufacturers deny and that has so far failed
to persuade juries in product liability lawsuits.

But Dr. Glenmullen, who is on the staff of the Harvard University Health
Services, and Dr. Healy, a lecturer in psychological medicine at the
University of Wales College of Medicine, raise new fears. They suggest that
Prozac and similar drugs, like the antipsychotic medications of the 1950’s
and 1960’s, might pose a significant risk of neurological side effects, that
long-term use of the drugs might cause brain damage and that future
generations might look back on the antidepressants and other psychiatric
drugs, in Dr. Glenmullen’s words, “as a frightening human experiment.”

“Too many people have been lulled into thinking that they have no side
effects and no risk,” he said.

The contentions of Dr. Glenmullen, Dr. Healy and other critics, however, have
themselves drawn harsh criticism from scientists, psychiatric clinicians and
mental health groups, who view them as alarmist and overblown.

Some scientists whose studies are cited in “Prozac Backlash” to support its
thesis said that the author never contacted them about their work and they
strongly disagreed with his conclusions.

And many psychiatrists said they worried that the new dispute would
discourage people with depression from seeking needed treatment.

“Some of the statements that Glenmullen makes are simply outrageous,” said
Dr. Frederick Jacobsen, a psychopharmacologist in Washington. “He trashes any
benefit of the drugs and selectively quotes studies in a very biased way.”

The idea that Prozac and its later-arriving relatives are dangerous drugs
runs counter to the experience of most psychiatrists and researchers. They
see the medications — which enhance the availability in the brain of
serotonin, a neurotransmitter believed to be involved in depression — as
useful, and sometimes lifesaving, tools for treating a variety of psychiatric
disorders.

In their view, the antidepressants have both advantages and limitations. The
drugs, called selective serotonin reuptake inhibitors or S.S.R.I.’s, are far
less lethal in overdose than the older generation of so-called tricyclic
antidepressants, making them more difficult for depressed patients to use in
suicide attempts. And they lack some annoying side effects of the earlier
drugs, like dry mouth, constipation and weight gain.

Yet 30 percent to 40 percent of patients given the newer antidepressants
receive no benefit from them, a weakness they share with earlier medications.
Studies indicate the drugs may be less effective than tricyclics for severe
depression. And the medications, like all drugs, have side effects of their
own, including loss of libido and other sexual difficulties, which occur in
anywhere from 36 percent to 75 percent of patients, and a host of other,
mostly mild, adverse reactions.

Their long-term side effects, if any, are less clear. No scientist can offer
an ironclad guarantee that Prozac and its counterparts — or for that matter,
any other potent drugs — are absolutely safe when taken continuously for
long periods.

Yet what is known, scientists say, suggests that the medications are more
benign in their long-term effect on the brain than many other psychoactive
drugs. And 12 years of widespread use have convinced most researchers and
clinicians of the antidepressants’ basic safety.

“The S.S.R.I.’s are not innocuous,” said Dr. Matthew Rudorfer, associate
director for treatment research at the National Institute of Mental Health’s
Division of Services and Intervention Research, “and they should not be used
casually. But it’s a vast overinterpretation to say that they are dangerous
and should be avoided.”

The Arguments
A Calm Critique Amid Strong Claims

r. Glenmullen and Dr. Healy said they were not opposed to the use of Prozac
or similar drugs, and that they prescribed them regularly in their own
practices. But they deplore their use for people whose complaints are very
mild and they criticize physicians who place patients on the drugs for long
periods with little or no supervision, a trend that has increased under
managed care.

Lilly estimates that 38 million people worldwide have taken Prozac since it
was introduced in 1988. And 10.3 million new prescriptions for the drug were
written in 1999, says IMS Health, a market research firm.

“For people with only mild to moderate symptoms whose functioning is not
compromised,” Dr. Glenmullen said, alternative approaches, like psychotherapy
and exercise, “are preferable forms of treatment.”

Dr. Glenmullen also educates readers of his book about the withdrawal effects
— including nausea, vertigo, flu-like symptoms, mood swings and irritability
— that can result if newer antidepressants are stopped too abruptly.
(Prozac, which leaves the body more slowly than other S.S.R.I.’s, is an
exception). And both he and Dr. Healy criticize the pharmaceutical companies,
which they say influence medical research and often minimize adverse side
effects in an effort to make their products look good.

Yet it is difficult to find scientists or clinicians who support the more
extreme suppositions of Prozac’s critics.

Dr. Glenmullen and Dr. Healy, for example, argue that neurological side
effects — including muscle spasms, facial tics, Parkinson’s diseaselike
symptoms, extreme agitation and even tardive dyskinesia, a disabling movement
disorder — are more common in patients taking newer antidepressants than the
labeling on the drug packaging indicates, and that their occurrence augurs
serious problems to come.

Such side effects are frequently produced by older medications used to treat
psychosis. But Dr. Glenmullen said it took decades for doctors to recognize
the extent or severity of the reactions.

“Do we this time want to ignore the early warning signs of these effects with
serotonin boosters?” he asks in “Prozac Backlash.” “Even if disfiguring tic
disorders turn out to be infrequent, with tens of millions of people having
been on serotonin boosters, hundreds of thousands could be affected.”

But other scientists say it is misleading to compare antipsychotic drugs,
which directly act on the neurotransmitter dopamine, with the
antidepressants, which affect dopamine only indirectly.

“If S.S.R.I.’s do in fact cause tardive dyskinesialike syndromes, and that’s
far from proven,” said Dr. William Wirshing, a professor of psychiatry at the
University of California at Los Angeles and an expert on neurological
problems caused by antipsychotic drugs, “they do at a rate so low that it’s
indistinguishable from background noise in the untreated general population.”

Although some neurological side effects are reported in patients taking
Prozac and similar antidepressants, researchers and clinicians say that in
their experience the reactions are infrequent; some are so rare that many
psychiatrists never see them in years of practice. In many reported cases
patients have used other medications, making cause and effect difficult to
determine.

The Prognosis
Cause for Concern or Reassurance?

any scientists said that in their views “Prozac Backlash” also blurred
distinctions between newer antidepressants and many other types of drugs. In
a discussion of possible long-term effects of Prozac and similar drugs, for
example, Dr. Glenmullen drew analogies to cocaine and MDMA (the recreational
drug known as ecstasy), which are known to cause brain damage, and diet drugs
like Redux, which was pulled off the market in 1997.

Dr. Glenmullen said research was scant on how Prozac and other S.S.R.I.’s
affected nerve cells in the brain with long-term use, but he argued that
findings on the effects of ecstasy and other drugs offered reason for concern
about the antidepressants.

“Surely we already know enough to indicate these drugs should be prescribed
far more cautiously than they typically are today,” he wrote.

But Dr. George Ricaurte, an associate professor of psychiatry at Johns
Hopkins University and a leading expert on ecstasy’s effects on the brain,
said that MDMA and newer antidepressants “are two entirely different classes
of drugs.”

“The toxicity produced by MDMA is not produced by Prozac and related drugs,”
Dr. Ricaurte said. “Quite the contrary, they prevent the toxicity of MDMA and
related drugs.”

Dr. Efrain Azmitia, a professor of biology and psychiatry at New York
University and an authority on serotonin, said he regarded the newer
antidepressants as “remarkably effective and in a way, remarkably safe,”
because unlike many drugs their mechanism of action had “a more physiological
flavor, more in harmony with the body’s natural rhythms,” offering the
possibility that “you’re not going to all of a sudden see something appear
that you didn’t see at two years.”

Dr. Glenmullen, asked about other scientists’ disparate views, said that in
his book, “I’m very careful to be really clear about when I’m talking about
S.S.R.I.’s versus other classes of drugs” and his point was that “we badly
need more research.”

The Suicide Question
‘A Needle in a Haystack’

f all the issues raised by Prozac skeptics, the most difficult for many
people to sort out is the accusation that the drug is linked to suicide, an
association that began in 1990 when a Harvard University researcher, Dr.
Martin Teicher, reported on six patients who “developed intense, violent
suicidal preoccupation” shortly after starting Prozac.

Dr. Teicher’s report was followed by a few other case descriptions from other
researchers. Some scientists offered hypotheses about how such an effect, if
it existed, might occur.

One theory centered on an infrequent reaction to Prozac and other
medications, a state of agitation and restlessness known as akathisia. In
some cases, researchers suggested, akathisia may be so uncomfortable that it
sets off suicidal thoughts, or intensifies existing suicidal impulses.

Other investigators proposed that in rare cases the drugs might paradoxically
produce a drop in serotonin levels. Lowered serotonin levels have been
associated in some studies with suicide and other forms of violence.

In the public arena, the suicide question also created a commotion. Of the
more than 100 lawsuits filed against Lilly, many have been dismissed, and
some — the drug company will not say how many — have been settled out of
court. Two have come to trial, with both resulting in jury verdicts in favor
of the pharmaceutical company. In one case Lilly paid the plaintiffs an
undisclosed amount.

By the mid-1990’s, however, most scientists had lost interest in the issue.
Several larger studies — which compared Prozac to other antidepressants or
to dummy pills, including a reanalysis of Lilly’s clinical trial data —
concluded that subjects on Prozac showed no increase in suicidal acts or
feelings; some reported that the drug reduced suicide risk. In 1991, a Food
and Drug Administration advisory committee concluded that there was no
persuasive evidence for a suicide link, allaying many people’s fears.

The consensus of most researchers was that, in any case, disentangling the
effects of the antidepressants from the effects of depression itself, a
disease that has a high rate of suicide, was difficult or impossible.

“It would always be a needle in a haystack,” said Dr. Rudorfer, of the
National Institute of Mental Health.

For its part, Lilly said there was no data supporting the idea that Prozac
increased suicidal risk. “On the contrary,” said Dr. Steven Paul, a
psychiatrist who is a vice president at Lilly Research Laboratories, “all the
available data supports the fact that Prozac reduces suicidal risk in
depressed patients.”

In reviving the issue, Dr. Glenmullen and Dr. Healy, like earlier critics,
focus on Lilly’s role in lawsuits and research. They reprise, for instance,
accusations that the F.D.A.’s inquiry was tainted by some scientists’ drug
company ties. And they criticize the larger studies of Prozac and suicide,
citing problems in methodology, and pointing out that they were carried out
by scientists financed by Lilly or working for the company.

They also recycle excerpts from internal Lilly memos, retrieved by lawyers
for plaintiffs in earlier lawsuits.

Dr. Healy recently published a study in which 20 normal volunteers, who told
researchers they had no history of depression or other psychiatric problems,
were alternately given Zoloft, an S.S.R.I., and reboxetene, another
antidepressant that has not been approved for use in the United States. Two
of the volunteers, Dr. Healy reported, became acutely suicidal while taking
Zoloft.

Dr. Healy said that compared with the normal suicide rate in Great Britain,
the healthy volunteers on Zoloft showed a 2,000-fold increase in suicide
risk. He believes the same is true for other S.S.R.I.’s. “My estimates are
that Prozac alone has led to 25,000 people committing suicide” who would not
have otherwise, Dr. Healy said.

But the Zoloft study, published in a British journal, Primary Care
Psychiatry, is controversial. Critics said its methodology was flawed — for
example, they said, the study included no placebo control, the subjects were
employees of the hospital where Dr. Healy practiced, and no medical records
or other independent sources were evaluated to confirm the subjects’ reports
about their psychiatric histories.

To conclude that Zoloft made the subjects suicidal, , said Dr. Wirshing of
U.C.L.A., “is ludicrous.”

Celeste Torello, a spokeswoman for Pfizer Inc., which manufactures Zoloft,
Prozac’s closest competitor, said the drug’s “safety and efficacy has been
proven time and again, in more than 180 clinical trials involving more than
10,000 patients worldwide.”

Meanwhile, some researchers whose early reports on the suicide issue were
cited in “Prozac Backlash” said they did not agree with the way the issue was
characterized in the book.

One is Dr. Anthony Rothschild, a professor of psychiatry at the University of
Massachusetts in Worcester and the author of a 1991 report of three patients
who developed akathisia and became more suicidal on Prozac.

“Akathisia can occur,” Dr. Rothschild said, “and in some people, who have a
previous propensity to feel suicidal and are still suffering from depression,
this can sometimes push them over the edge. But is it common? No. Can it be
easily recognized and treated? Yes.”

Even Dr. Teicher, author of the original suicide report, said he viewed the
risk for suicide as something “that clinicians need to be aware of but it’s
generally not a huge problem.”

Dr. Teicher, who along with others holds the patent on R-fluoxetene, a
refined version of Prozac that Lilly has licensed and is testing in clinical
trials as a potential successor to the drug, speculated that patients who
became suicidal on Prozac and other drugs in the early 1990’s might have done
so as a result of the higher doses prescribed by physicians. Lilly’s
exclusive patent on Prozac expires in December 2003.

Dr. Glenmullen has written to the F.D.A. requesting that stronger warnings
about akathisia and suicides be added to labels for antidepressants.

But the federal agency, a spokesman said, is satisfied that current warning
labels, which mention both akathisia and suicidal thoughts as having been
reported since the drugs reached the market, are sufficient. The agency said
it had no plans to begin another official investigation into the issue,
although it would review any new data that emerged, as it does routinely on
topics of public concern.

In the end, the message for anyone contemplating taking Prozac, Zoloft,
Paxil, Luvox or other antidepressants, scientists said, may be simply that
drugs have side effects, and the decision to take medication always involves
the weighing of benefit against risk.

“No one should really be on any type of medication for long periods of time
unless they have to,” said Dr. Azmitia, of N.Y.U. “But some people really
can’t function unless they are on these drugs.”

7/18/2000 – Tonight San Francisco News

Fox news on KTVU, Chan. 2 out of San Francisco
will air a special tonight at 10:00 PM Pacific Time
and again tomorrow night at the same time on the
adverse reactions and long-term reactions to SSRI
antidepressants.

The reporters flew to Salt Lake City two weeks ago
to interview me (Ann Blake-Tracy), along with several victims
of the SSRI antidepressants I have worked with over
the last several years. I am grateful to those
individuals and all the others who offered to be
interviewed for having the courage to share their
experiences in order to prevent these tragedies in
the lives of others.

KTVU also interviewed Andy Vickery for this news
piece. Mr. Vickery’s Houston, TX law firm has been
the leading firm in more SSRI wrongful death suits
than any other law firm that I am aware of in the world.
In case you have missed their link on our site, their
website is located at (www.justiceseekers.com) and
is packed with very informative SSRI material.

Ann Blake-Tracy

7/17/2000 – Call for Stories and Photos.

Dear ICFDA eGroups subscribers….

This is a rather different message, and a difficult one at that.

As many of you may know, my wife and I lost our 13-year son to
an SSRI-induced suicide three years ago next week.
(drugawareness.org/matthewmiller.html)

In a few weeks we will be going to trial here in Kansas City in
attempt to prove that Pfizer has long known about the
relationship between their drug Zoloft, and violent or suicidal
actions. (information posted at justiceseekers.com)

It most likely will be a long, difficult and personally taxing ordeal.

My wife and I have chosen to pursue this litigation because we
believe there need to be changes in the ways these drugs are
marketed and labeled, especially by doctors who prescribe
off-label to children.

We know we are not going into this alone. We have outstanding
legal representation. We have the prayers of many who have
also suffered. We know that all those who have died on these
medications, and they are far too numerous to mention, stand
with us. (It is no understatement to say that we feel their
presence every day. Perhaps even your own loved ones.) And
we ultimately know that the good Lord blesses our efforts—this
“rising up in righteous anger.”

In the coming weeks, we will have an opportunity to share our
story with many people, especially within the news media. In
fact, we have an important interview with a national news
organization in August.

And that’s why I’m writing.

One of the things that most convinced us that Matt’s medicine
was responsible for his actions were the countless letters we
have received from our website. They still come in every day.
For the most part, they represent a tragic realization that the
“cure” was “cause.”

If you have suffered on SSRI medications, specifically Prozac,
Paxil, Zoloft, Luvox, Effexor, Serzone, Celexa (or any other
serotonergic medicine), please send me a photo and a short
paragraph on a separate piece of 8 1/2″ X 11″ paper stating what
happened. It could be as simple as “My brother took his life on
Zoloft after three weeks of use,” or “I almost lost my life trying to
withdraw from Paxil.” Please use names and addresses and
phone numbers. I want to build a scrapbook to share with the
press.

Perhaps with your help, we can make a difference. And your
help in building this scrapbook will go a long ways to show the
human dimension to this national tragedy.

If you can, please send a photo and short paragraph to me by
August 15, 2000 to:

13920 Garnett
Overland Park, KS 66221

Or if you prefer, email me your photo (preferably as JPEG file)
and paragraph to me at mmiller1@…. I will not be able
to return originals, but I will let you know I’ve received them.

Thank you for your cooperation. Obviously some of you reached
by this email will not have had a personally devastating
experience with these drugs, and for that I am grateful. But, if you
have, please take a moment to help out in this way.

I know this book will make a powerful statement with whomever
we talk to.

Thank you again…Mark and Cheryl Miller

7/15/2000 – FDA Warning Comes 40 Years Too Late on Mellaril

We are grateful to our e-group member, Martin Hirschfeld,
and also to Vera Hassner Sharav, President, CIRCARE:
Citizens for Responsible Care & Research, for forwarding
this information to us.
AFTER 40 YEARS OF USE – the FDA has put new
restrictions on the use of the antipsychotic, Mellaril.
Obviously for many patients this strong warning about
life threatening side effects has come 40 years too late!
How many patients would still be alive had the warning
come when it should have – 40 years ago? This should
cause us to ask just how many more drugs are as
damaging or even more dangerous, that we have yet
to be warned by the FDA of their dangers?

For those using SSRIs, note that an additional warning
of contraintication is issued to those using Luvox or another
drug often given in conjunction with SSRIs, propranolol.
Considering the accumulation rate of SSRIs, including
Luvox, the contraindication for Mellaril should include
anyone who has been on Luvox in the recent past
as well. And because psychosis is listed as a “frequent”
side effect of Luvox, the prescribing of an antipsychotic
such as Mellaril could be a fairly common practice
threatening the lives of many.

Dr. Ann BlakeTracy
________________________

New Labeling For Novartis’ Mellaril Reflects Restricted Use

http://www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
NEW YORK, Jul 13 (Reuters Health) – The US Food and
Drug Administration (FDA) has asked Novartis to update
the labeling for its antipsychotic drug Mellaril (thioridazine)
to warn of potentially life-threatening side effects, the
company said on Wednesday.

Thioridazine has been shown to prolong patients’ QTc
interval, an electrocardiogram measurement reflecting
the refractory period of the heart, which can lead to the
potentially fatal ventricular tachycardia known as torsades
de pointes and sudden death, according to the FDA.

As a result, Mellaril is now indicated only for patients
with schizophrenia who either cannot tolerate other
antipsychotic drugs or who fail to respond to them,
the company said.

In addition to changing Mellaril’s label, Novartis will
send letters to about 360,000 US doctors and 60,000
pharmacies apprising them of the FDA’s new position
on the drug, and asking them to share the information
with their patients.

The letters advise that “switching to a different antipsychotic
agent should be considered.”

Mellaril, which was approved in 1959, has already been
eclipsed by newer therapies for many patients, a Novartis
spokesperson told Reuters Health. While the new warnings
threaten to slash sales of the drug even further, “in the short
term, we won’t be discontinuing it,” he said.

The product is also sold by a handful of generic manufacturers,
including Geneva and Mylan.

Novartis’ letter to physicians stresses that, in light of the new
information about Mellaril, the drug is “now contraindicated
with certain other drugs,” including the antidepressant
fluvoxamine [Luvox] and the beta-blocker propranolol, and
is considered inappropriate for patients with a history of
cardiac arrhythmias and certain other conditions.

Before being treated with Mellaril, patients should be
evaluated with a baseline ECG and should have their
serum potassium levels measured, the letter adds,
noting that monitoring should be continued throughout
the treatment.

The letter points out that Boehringer Ingelheim’s Serentil
(mesoridazine), which is chemically related to thioridazine,
“also appears to have the capacity to prolong the QTc interval.”

Boehringer Ingelheim and the FDA did not respond to telephone
calls seeking comment.

Copyright © 2000 Reuters Ltd. All rights reserved.
=================================================================
New Labeling For Novartis’ Mellaril Reflects Restricted Use

www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
NEW YORK, Jul 13 (Reuters Health) – The US Food and Drug Administration
(FDA) has asked Novartis to update the labeling for its antipsychotic drug
Mellaril (thioridazine) to warn of potentially life-threatening side

effects, the company said on Wednesday.
Thioridazine has been shown to prolong patients’ QTc interval, an
electrocardiogram measurement reflecting the refractory period of the heart,
which can lead to the potentially fatal ventricular tachycardia known as
torsades de pointes and sudden death, according to the FDA.
As a result, Mellaril is now indicated only for patients with schizophrenia
who either cannot tolerate other antipsychotic drugs or who fail to respond
to them, the company said.
In addition to changing Mellaril’s label, Novartis will send letters to
about 360,000 US doctors and 60,000 pharmacies apprising them of the FDA’s
new position on the drug, and asking them to share the information with
their patients.
The letters advise that “switching to a different antipsychotic agent should
be considered.”
Mellaril, which was approved in 1959, has already been eclipsed by newer
therapies for many patients, a Novartis spokesperson told Reuters Health.
While the new warnings threaten to slash sales of the drug even further, “in
the short term, we won’t be discontinuing it,” he said.
The product is also sold by a handful of generic manufacturers, including
Geneva and Mylan.
Novartis’ letter to physicians stresses that, in light of the new
information about Mellaril, the drug is “now contraindicated with certain
other drugs,” including the antidepressant fluvoxamine and the beta-blocker
propranolol, and is considered inappropriate for patients with a history of
cardiac arrhythmias and certain other conditions.
Before being treated with Mellaril, patients should be evaluated with a
baseline ECG and should have their serum potassium levels measured, the
letter adds, noting that monitoring should be continued throughout the
treatment.
The letter points out that Boehringer Ingelheim’s Serentil (mesoridazine),
which is chemically related to thioridazine, “also appears to have the
capacity to prolong the QTc interval.”
Boehringer Ingelheim and the FDA did not respond to telephone calls seeking
comment.

Copyright © 2000 Reuters Ltd. All rights reserved.

7/7/2000 – FDA Boosts PMS Insanity

Sarafem, what a nice sounding name for such a deadly drug. How many patients
will know that they are really getting Prozac with a different name? Why is a
name change necessary? If it said Prozac on the label, would the patient take
it? We will not know with the FDA allowing Lilly to change Prozac’s name when
being prescribed for this disorder. Giving these SSRIs different brand names
does nothing to change the dangers of these drugs, but much to confuse the
patient about the dangers and just what drug they are really getting. Talk
about “failure to warn”!

For some time now doctors have given SSRI antidepressants for PMS. They have
encouraged patients to take the drugs in the most dangerous manner I am aware
of – taking them for a week or so and dropping “cold turkey,” then doing the
same the following month! Well, if we thought we saw rage before with PMS,
just wait! Now we can see SSRI withdrawal rage every month rather than the
PMS. At least we will see a change in the time it occurs and the intensity,
right? And now we can, with the FDA’s approval, cure PMDD with drug-induced
psychosis, suicide or murder/suicide. What a novel idea!

Sorry about the sarcasm. I guess I have seen too many people die or have
their lives destroyed as a result of using serotonergic drugs. Just how much
longer can these terrible heart rending tragedies be the “acceptable” risk in
anothers’ feeling better due to a drug-induced hase for things like PMS or
shyness? Please someone tell me where the “acceptable” risk is in using these
powerful and very dangerous drugs for such minor health problems when there
are so many simple and harmless natural solutions like Omega 3 oils? It
couldn’t be because those harmless solutions don’t make anywhere near the $30
– $40 million per day that these drugs bring in, could it? It is clear whose
interest the FDA has in mind with this approval.

Ann Blake-Tracy
_________________

FDA APPROVES FLUOXETINE TO TREAT PREMENSTRUAL DYSPHORIC DISORDER

FDA has approved fluoxetine (Sarafem) as the first drug treatment for
Premenstrual Dysphoric Disorder(PMDD), a disorder that causes mood changes
and physical symptoms such as bloating and breast tenderness in women.
Fluoxetine was approved as Prozac in December l987 for treating depression,
and has also been approved for treating obsessive compulsive disorder and
bulimia. The following may be used to respond to questions.

On November 3, 1999, FDA’s Psychopharmacologic Advisory Committee unanimously
recommended approval for fluoxetine to treat women with PMDD. The committee
concluded that fluoxetine was effective for the condition and that PMDD has
well defined, accepted diagnostic criteria. The committee also advised that
the drug should be used only to treat women whose symptoms are severe enough
to interfere with functioning at work or school, or with social activities
and relationships.

According to the American Psychiatric Association Diagnostic and Statistical
Manual (DSM-IV), a diagnosis of PMDD requires that patients experience at
least five of the symptoms that characterize PMDD. PMDD has both affective
(mood) and physical symptoms, and is characterized by depressed mood,
anxiety, tension, affective lability (a tendency to alternate between
cheerful and somber moods), and persistent anger or irritability. Other
features include decreased interest in activities, difficulty concentrating,
lack of energy, change in appetite, headache, joint and muscle pain. The mood
symptoms often cause disturbances in social relationships. Physical symptoms
include weight gain, bloating, and breast tenderness. To support a diagnosis
of PMDD, the symptoms must occur regularly in the luteal phase of a woman’s
cycle, and disappear after onset of menstruation. (The luteal phase
corresponds to the period between ovulation and onset of menstruation.)

Fluoxetine’s effectiveness for the treatment of PMDD was established in two
double-blind placebo-controlled trials. In the first study, 320 patients were
given fluoxetine continuously throughout the menstrual cycle. This study
showed that the drug was significantly more effective than placebo by
measurements of changes in mood and physical symptoms of PMDD. In a second
study, 19 patients were treated with fluoxetine and placebo continuously
throughout the menstrual cycle for a period of three months each. In this
study, fluoxetine was significantly more effective than placebo on a scale
measuring changes in mood, physical and social impairment symptoms.

Sarafem will be marketed by Eli Lilly, of Indianapolis, Ind., with a patient
information brochure and physician labeling specific for the drug’s use. The
drug was not studied in women who were taking oral contraceptives. Common
side effects were similar to those experienced by other fluoxetine users and
included nausea, tiredness, nervousness, dizziness and difficulty
concentrating.

Is there a steroid effect with Prozac

“Wouldn’t it be wonderful if I regain my desire to write and paint when I finally get off Prozac?”

 

I was placed on Prozac a few years ago and tried to stop using it several times. Each time I did, I begin feeling dizzy at times and nauseous. Not long after I begin using Prozac, I started to ‘itch’. My ears itched especially, and the palms of my hand began to appear dry. Are there some ‘corticosteroids’ in Prozac?

[Note: You will find in Prozac: Panacea or Pandora? that there is a DOUBLING of Cortisol levels with only one 30mg dose of Prozac. This would give a VERY powerful corticosteroid effect.]

Now there’s a claim that antidepressants help women in menopause. What’s next?

Prozac is supposed to be now OKed for OCD. Well, it didn’t work for me. I did realize a particular habit it produced for me that was OCD. Every day at noon, I would drive to the same thrift shop stay for about 45 minutes then return to work. If I didn’t go I felt as though something was wrong. I really felt I had to go.

I must say, I believe MOST individuals have some form of OCD. Of course if a company can market a drug, initially meant for one disease, for another disease (problem) whatever euphemistic title applied, then the more $$$ for their corporation. I wonder if someday there will be a “Antidepressant,” rebellion because of the medicines/drugs/chemicals prescribed to persons.

Children are being doped up to keep them quiet so their parents can go to work and not worry about their ‘normal’ activities. I suppose certain mental problems are a continuing trend. “My kid is more of a problem than yours?” “I’m on more med that you?”

I realize I am ranting by writing, but I am so frustrated and disappointed. And, when one complains about such things, what’s one of the first, if NOT the first question one is asked, “How old is the person.” Then, too often, it’s the VICTIM on whom the FAULT is placed.

I know there was a time while taking alprazolam that showed bizarre conduct on my workplace in NJ. I told my supervisor I would apologizes to the person, but I was told NOT to because apparently my conduct was to be kept quiet. I was placed on leave of absence because of my condition. While that conduct occurred, I was under treatment and had been for some time. My conduct was definitely out of character, impulsive, and destructive to my reputation.

The snowball began when I commenced having panic attacks and was ultimately depressed I needed to see a doctor/psychiatrist/counselor. I saw all three. The first med. I was given was Xanax, then Imipramine, I have a list written somewhere, although the list may be got from my former physician, in NJ. Although, with the patient/physician confidentiality law, I suppose one has not access to the files.

I truly hope I can stop using Prozac. Presently I am not under a Dr care and auspices. When we left NJ nearly a year ago, I was given a Prozac prescription 3 month supply, I have been opening the capsules and dividing the contents by thirds. Every other day I would use a third. I suppose when the company I worked for 12 years downsized me in March 1999, I was also egotistically downsized.

That’s another thing, in the past I wrote poetry well, and in an instant. While using Prozac, I lost so much of my artistic desire that I actually became more depressed. Wouldn’t it be wonderful if I regain my desire to write and paint when I finally get off Prozac?

Sincerely

Lorraine B. Jacobs

 

7/2/2000

This is Survivor Story number 17.
Total number of stories in current database is 96