8/25/2000 – 20/20 Show Tonight on SSRI Medications

FYI–Tonight (Friday, 8/25/00) on ABC 20/20 at 10pm eastern
time will be another show about the problems with SSRI
medication.

Please check your TV GUIDE for the time in your area. Mark

H I G H L I G H T S
Friday. Aug. 25 Dr. Nancy Snyderman examines the possible
side effects when discontinuing an antidepressant like Paxil and
Zoloft. Chris Wallace confronts a man who was convicted of
trying to get his ex-wife murdered.

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8/16/2000 – Research Hearings on Conflict of Interest

Marcia Angell, former editor in chief of the New England Journal
of Medicine, wrote in an editorial this spring titled “Is
Academic
Medicine For Sale?” This article seems to confirm these
suspicions. Hearings are scheduled next Tuesday in
Washington, D.C. on this issue. Mark
———-

Questioning Research
Hearings on Keeping Conflict of
Interest Out of Clinical Research

Subjects of clinical trials are typically required to sign informed
consent papers that explain every detail about the experiment’s
risks and benefits. But these papers often fail to say whether the
investigators will be profiting from the results. (Art Today)

By Melissa Schorr

B O S T O N, Aug. 14 — An 18-year-old young man dies in a
gene therapy trial led by an investigator at University of
Pennsylvania.Soon after, it is revealed that the investigator and
the school both had a stake in the biotech company planning to
commercialize the study’s findings.
Rezulin, a diabetes drug that was put on the fast track for
Food and Drug Adminstration approval, is yanked when it is
found to have led to the deaths of 63 patients and caused liver
damage in thousands of others. It is later revealed that
members of the review board and trial investigators had received
compensation from the drug’s manufacturer.
In response to cases like these from the past year, and a
rising concern that financial conflicts of interest could be
harming the safety of patients in clinical trials — not to
mention
the integrity of research itself — the Department of Health and
Human Services will kick off a two-day public meeting on the
issue Tuesday in Washington, D.C.

Patients, Not Pocketbooks
The conference, called “Human Subject Protection and Financial
Conflicts of Interest,” will bring together patient advocates,
university academics, clinical researchers, hospital staff,
entrepreneurs and government officials to help the agency firm
up its policy requirements.
The key issue will be ensuring that medical researchers are
always looking out for the best interests of their patients, not
their
pocketbooks.
Of concern: Might some researchers bend the results to get
the answer that will give them the million-dollar payoff? Would
they cover up any adverse effects when signing on new patients?
And should patients always be told of possible investigator
bias?
“Today, we’re living in a world where the primary
investigator
may own the company [conducting the study] or have stock in it,”
says Abbey Meyers, president of the National Organization for
Rare Diseases, a patient advocacy group. “It’s in his best
interest that if the trial isn’t successful, maybe he won’t
release
all that information to the public.”

Gelsinger Case Highlighted
The case of Jesse Gelsinger, the 18-year-old Tuscon, Ariz.,-man
who died in a gene therapy trial last September, has put this
issue in the spotlight.
After Gelsinger’s death, an FDA investigation revealed he
may
not have been properly informed of all the risks of the study and
that he may not have been a suitable candidate for the study, but
was admitted anyway.
“We’re left wondering: Was the scientist’s
financial benefit
linked to the fact that this young man was not told the whole
truth?” says Meyers, who will be voicing such concerns at the
conference. “There should never be that doubt.”
Of course, experts point out, other motivations have always
been at play in the research world: ego, reputation, social
agendas, pressure to “publish or perish.”

Money Conflicts Potentially Enormous
But financial conflicts of interest are of immense interest now
because academic researchers today are more likely to also be
stakeholders or CEOs of companies than ever before.
Marcia Angell, former editor in chief of the New England
Journal of Medicine, wrote in an editorial this spring titled “Is
Academic Medicine For Sale?” that the ties between industry and
academia have gotten out of hand.
“So much clinical work today is co-mingled with
commercialization,” agrees Sheldon Krimsky, a science policy
expert at Tufts University in Medford, Mass.
And that may affect decision-making. “Any time you’ve
invested money into something, it’s going to reinforce any
enthusiasm you have,” Krimsky says. “You wonder, `Are
they
holding on to this trial because their kid’s education is in the
balance?’ It’s a real issue.”

Lapses Exception, Not Rule
But many researchers say that these high-profile cases of
alleged ethical lapses reflect the exception and not the rule.
Adequate protections are already in place and just need to be
better enforced, they say.
“If I invent a new drug and build a start-up company and
begin
to test my invention, I must follow a dizzying set of regulations to
assure a valid and honest test of the drug,” says Dr. Patrick
Lyden, chief of clinical neurology at the University of California at
San Diego. “I believe that further legislation or administrative
rule-making is unnecessary.”
Current policy requires researchers to disclose possible
financial conflicts of interest when applying to the Public Health
Services, including the National Institutes of Health, for a grant,
and when applying for FDA approval. Researchers must then
inform their patients of financial conflicts, as well.

Money Interests Not Disclosed
But no one is ensuring that patients are being told.
At individual hospitals, institutional review boards are
given
the responsibility of evaluating proposed clinical trials and
making sure patients will be protected.
Subjects of clinical trials are typically required to sign
informed consent papers that explain every detail about the
experiment’s risks and benefits — but often omit whether the
investigator will be profiting from the results.
At schools like the University of California at Los Angeles
and
at Johns Hopkins School of Medicine in Baltimore, Md., policy
requires that researchers tell patients when they have a financial
interest in the product being tested.
“We are obligated to fully disclose any information that
a
reasonable person would want to know,” says Steven Peckman,
associate director of human subjects research at UCLA. “A
potential research subject can make a considered decision
whether they want to embark on the project.”

Public’s Right to Know
But Mark Brenner, associate vice president of research at
University of Indiana, who will speak at the conference on behalf
of the American Association of Universities, says the AAU’s
policy will be that researchers disclose possible conflicts of
interest to their review boards, who then make the call as to
whether the information gets passed along to the research
subjects.
“Whenever it’s appropriate, you should inform
patients,” he
says. “But there are times where you may well overdo it. There
are examples of where it is more benign.”
Some worry the public will stop volunteering for trials if
the
suspicion of impropriety is planted in patients’ minds. “This
could have a downside effect, it might turn people away from
entering clinical trials,” says Krimsky. “It produces a kind
of
skepticism that is not really going to be helpful to science.”
But Meyers advocates that patients have a right to know.
“Leave it up to the judgment of the patients,” she says.
“It’s
wrong to hide it.”

Link to at:
http://www.abcnews.go.com/sections/living/DailyNews/fdahearin
gs000814.html

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8/2/2000 – Learning about SSRI dangers from the Ecstasy epidemic

Thanks to George Ellis for bringing the following report on Ecstasy to
our attention and for his voice of sanity in this insane serotonin drug
situation. Be sure to note the comment “First patented under a differnet name
as an appetite suppressant, ecstasy releases a neurotransmitter called
serotonin, which heightens energy levels. The drugs short-term side effects
include muscle pain, impaired sexual performance and depression.”

Ecstasy – yet another prescription medication gone bad. With the same end
effect being an increase in serotonin and the side effects being so similiar
to the SSRI antidepressants why is the Ecstasy use considered an “epidemic”
when one eighth of the population of America is on SSRIs?

Ann Blake-Tracy
_____________________

Watching ABC World News tonight, I was watching a segment on the
interception of a million Ecstasy tablets by Customs officials when I saw
an absolute Lewis Carroll absurdity. Peter Jennings narrated that many
people don’t think Ecstasy is harmful, but that others warn of the “Suicide
Tuesday” that follows a weekend Ecstasy high. He then explained, with an
illustration, how Ecstasy works by increasing seratonin production,
flooding the synapses with seratonin. It looked so familiar.

Excuse me, but isn’t this a case of the government putting an alarm label
on Ecstasy while the SSRIs get a clean bill of health for doing exactly the
same thing? I mean, isn’t the real difference a matter of whether a company
and its army of lawyers and paid researchers have spent what it takes to get
FDA approval vs. someone who skips all that and just makes the pills and
sells them to partygoers? So who’s really being protected here, the public or
the pharmaceutical companies? If Ecstasy is so bad for flooding the brain
with seratonin, and Prozac does the same thing, Why is one the target of
federal law enforcement and the other pushed by doctors and HMOs? Does the
difference consist of continuing to pop the pills (can you spell “mandated
addiction”?), and Suicide Tuesday is perhaps moved to a Friday?

Huh? I just don’t get it.

George Ellis
Chief Copy Editor
_______________

Here is the ABC news report:

First patented under a different name as an appetite suppressant,
ecstasy releases a neurotransmitter called serotonin, which heightens energy
levels. The drugs short-term side effects include muscle pain, impaired
sexual performance and depression.

Dangers of Ecstasy

Designer Drug Holds Unknown Health Risks

U.S. Customs Commissioner Raymond W. Kelly holds up a bag full of Ecstasy
during a hearing on Capitol Hill on Tuesday before the Senate Caucus on
International Narcotics Control in Washington. (James R. Tourtellotte, U.S.
Customs/AP Photo)

By Bill Blakemore

July 26 On Saturday, federal agents intercepted 2.1 million tablets, nearly
1,100 pounds, of the drug MDMA, commonly known as Ecstasy at Los Angeles
International Airport. Valued at $40 million, officials said it is the
biggest Ecstasy bust in history and it marked the high point of a 10-month
investigation by the Southwest Border Initiative, a multi-agency task force.
That™s 2.1 million tablets of Ecstasy that won’t go to our kids this
year, Stephen Wiley, FBI special agent in charge, said during a news
conference today.
Three men were arrested Tuesday. Authorities were still searching for
Tamer Ibrahim, 26, of Los Angeles, the alleged ringleader of the operation.
They arrested Ryu Steve Jiha, 35, Mark Edward Belin, 28, and Damon Todd
Kidwell, 29, all of the Los Angeles area.
The group has been linked to several other large seizures around the
world, including 700 pounds found by U.S. Customs agents in December 1999,
authorities said.
The cache confiscated Saturday was found in 15 boxes on an Air France
flight from Paris and represented one-fourth of the 8 million tablets of
Ecstasy seized in the United States this year, officials said. By comparison,
only 400 tablets of the drug were seized in the United States three years
ago.

Unknown Risks Across the Board

Ecstasy, a synthetic drug manufactured mostly in Europe, is a hallucinogenic
stimulant that gives its users a feeling of euphoria.
The popular drug has spread beyond rave parties to college campuses and
even into middle-class, professional America.
Its growing pervasiveness is troublesome because the prevailing belief
is that it’s perfectly safe in part because some scientists think it might
have therapeutic effects. Also, it does not produce extreme behaviors as some
other illegal drugs do. It just seems to make you feel good.
My experience has been very safe with it, and everyone around me has
been safe, says one 29-year-old professional who runs her own business and
choose not to use her name. I don’t know anyone who’s addicted to it or
has
problems with it.
But a number of users do report a depression they call Suicide
Tuesdays. Dozens of people are reported to have died after Ecstasy raised
their body temperature to extreme levels. And scientists who study how
Ecstasy works in the brain say there is a great deal of evidence that should
make us worry.

Irreversible Brain Damage

Repeated Ecstasy exposure has been shown to lead to clear brain damage and
that brain damage is correlated with behavioral deficits in learning and
memory processes, says Alan Leshner, the director of the National Institute
on Drug Abuse, which is a part of the National Institutes of Health. This is
not a benign, fun drug.
Normally, your brain controls mood partly by passing the chemical
serotonin in small amounts from one brain cell to another. But Ecstasy
forces lots of serotonin across the gap. Some new research suggests it leaves
brain cells weakened and may cause irreversible brain loss.
We know from primates, non-human primates, that the damage lasts for
years, says Una McCann, a neuroscientist at Johns Hopkins University.
Some scientists, on the other hand, report Ecstasy may have benefit in
strictly limited cases.
One group were interested in studying are individuals with end-stage
cancer who have severe depression and anxiety and physical pain which have
not responded to conventional measures, says Charles Grob, a psychiatrist at
Harbor UCLA Medical Center.
If medical use is ever allowed, it is far off. For now, government
agents are battling the spread, and the myths, of a pill called Ecstasy,
which for them, at least, is anything but.

The Associated Press contributed to this report.

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7/27/2000 – TV Interview on 8/4/2000

Jurgen and Brenda Viktor will be on the Queen Latifah Show on August 4, 2000.
They will be interviewed about their son Jared’s tragic experience on Paxil,
an account of which, written by his mother and posted on the
www.drugawareness.org site, follows below. You will need to check your local
TV guide to find times and stations in your area that will cover this program.

16 Year Old Son Convicted Of Murder After 5 Days On Paxil

——————————————————————————

“I was frightened and bewildered. Nothing like that had ever happened before
with any of our children.”

I’m writing regarding the radio show you were interviewed on in June of this
year. I was very fortunate to catch this interview, normally I am not awake
at this hour of the night. I was both delighted and disappointed. Delighted
because you almost never hear the dangers of these “mind altering drugs.”
Disappointed because nobody seems to care. I call these drugs “mind altering”
because the name “anti-depressant” doesn’t fit the consequences they can
have. I feel you are a ray of hope to people like me who have experienced the
horrible effects these drugs have.

I have four children. My youngest child, Jarred was put on Paxil at 16. I
took my son to the doctor because I was concerned about his abuse of alcohol.
After a 15 minute evaluation, the doctor concluded Jarred was depressed. He
gave us sample boxes of Paxil, a month supply. He gave us no instruction
except to take one a day. There were no instructions with or on the sample
packets. After the first day on this drug, my son complained of severe
agitation, he said he felt “weird.” I called the doctor and asked if he had a
smaller dosage. I told him I thought they were too strong for Jarred. The
doctor told me there was not a smaller dosage than 20mg. He said I should cut
them in half. A couple days later my son became combative with me and his
father. The police had to be called. I was frightened and bewildered. Nothing
like that had ever happened before with any of our children. I didn’t connect
these drugs with this incident, I thought it was from alcohol use. Three days
later, a family friend was murdered. Jarred was charged and convicted of
first degree murder. He is in a California state prison serving life without
parole. We were in shock, in total disbelief this happened.

The victim was someone we spent time with. Jarred would play games with her.
He spent nights at her house with my other children. Jarred cared very much
for this special lady. This was extremely out of character for Jarred. We
couldn’t understand what happened. No one believed Jarred could do this. We
didn’t connect the drug to what had happened until Jarred’s attorney asked us
about the Paxil he was taking. He said he found cases where people have taken
these drugs and committing horrible crimes. It puzzled Jarred’s lawyer
because Jarred had never been in trouble or had never been violent.

This has been heavy on my heart for four years. We’re hearing of more and
more cases of horrible crimes committed by people who are on these drugs.
There is definitely a connection.

My question to you is what can I to help get the message across. I have been
silent too long. I want to do something to help. I want to do anything I can
to stop these tragedies from happening. I know they will continue to occur
with some doctors handing these drugs out like aspirin.

I realize you are very busy. I greatly appreciate your work. I would love
very much to hear from you.

Brenda Victor
jvikt@…

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7/25/2000 – Clinical trial revenue streams lead to more scandals

This article might explain why your doctor’s interest has shifted away from
you as a patient. He may be looking at you with $$$$ signs stamped all over
you as he envision another guenia pig for yet another clinical trial funded
by a large drug company.

Most of you are aware, or certainly should be aware, of the scandal involving
the two researchers in Georgia that are now in prison for their fraudulent
research over a ten year period on drugs such as Paxil, Celexa, Zyprexa and
others. They were out spending their millions that was coming in on the
research while their secretaries conducted the research for them.

Now breaking news out of Oklahoma reminds us once again of the dangers
involved when research is conducted in this way. Can you guess yet where the
old family doc who used to make house calls went? Thanks to the
pharmaceutical industry, medicine in America has become nothing more than
just another big business.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://neurology.medscape.com/LWW/NP/2000/v07.n06/np0706.01.html

Clinical Trials – Drug Studies Provide Benefits for Patients, Knowledge and
Revenue for Neurologists

[Neuro Practice 7(6):41,43, 2000. © 2000 Lippincott Williams & Wilkins]

——————————————————————————

Introduction

A growing number of neurologists are discovering a gold mine in their
clinical practices: Their patient population. Pharmaceutical companies and
contract research organizations (CROs) are looking for patients with a
variety of neurological conditions to participate in clinical studies,
generally for Phase III and Phase IV post-marketing drug studies.
Participating in clinical trials is a worthwhile way to keep current with
medical developments, assure patients access to the latest technology, and
not incidentally, provide a substantial revenue stream for the clinical
practice.

“There are many opportunities for neurologists,” says Matthew D. Heller, MD,
co-author with James A. Boyle, MD, of The Physicians Guide to Clinical
Research Opportunities (Los Angeles: Practice Management Information Corp.;
1996). “You’re going to learn about new drugs way before they’re out on the
market. And when physicians come under the crunch financially, it’s a
wonderful way to earn alternative income.”

Physicians in private practice play a key role in the drug development and
monitoring process. While Phase I and Phase II clinical trials involve
healthy volunteers, primarily males, post-marketing studies and many Phase
III clinical trials require large numbers of patients with the conditions
being studied. The pharmaceutical industry depends on physicians with access
to patient populations to participate in post-marketing studies. Clinical
study subjects are needed in the areas of stroke, Alzheimer and Parkinson
diseases, and movement disorders.

“Phase IV post-marketing studies are very good for the general neurologist,”
says Bill Nikolov, MD, neurologist at New York Hospital Cornell Medical
Center, who is a study coordinator for a 21-site clinical trial of topiramate
(Topamax, Ortho-McNeil Pharmaceutical) for the treatment of amyotrophic
lateral sclerosis. “Being involved in clinical research is very good for
professional development, and you learn about new drugs years before the
papers are published.”

Community Setting

In February, the National Library of Medicine launched a website
(clinicaltrials.gov) to provide physicians and patients easy access to
information about the location of clinical trials. There are presently more
than 440 clinical studies involving diseases of the nervous system,
everything from abetalipoproteinemia to Zellweger syndrome, including 115
studies of nervous system neoplasm, 16 studies of Alzheimer disease, and
eight studies of tremor.

Far greater opportunities for clinical research are found in the private
sector, particularly since accelerated drug-approval processes have placed
greater importance on post-marketing studies to identify potential untoward
effects and interactions of prescription medication.

In 1997, the pharmaceutical and biotech industry spent more than $3.5 billion
on grants to physicians who provide investigator services, and the grants
went to fewer than 10% of U.S. physicians, according to consultant Tracy
Blumenfeld, chief executive officer of Wayne, PA-based Physicians Clinical
Research Solutions.

“The demand for productive, high-quality sites [for clinical research] is
increasing rapidly,” says Blumenfeld, whose company markets the clinical
trial capabilities of physician groups to commercial research sponsors.

While demand for physician investigators is rising, so is competition for
private-sector clinical trial dollars. Heller says that the number of
private-practice physicians participating in drug studies has increased 60%
in the last five years. “It’s tougher to get a study these days than it used
to be,” he says. “There are many more investigators. Everybody wants to get
into it.”

Still, opportunities abound for physicians willing to accept the burdens of
clinical research, even for those without a university affiliation. “Often,
drug companies prefer that you don’t have a university affiliation,” says
Heller. “The patients at tertiary medical centers are quite different than
the populations found in the private practice.”

Revenue Stream

Community-based physicians have something that drug makers desperately need
patients. Post-marketing studies require a broad cross-section of patients,
representing a range of ages and illness severity. “It’s the patients they’re
looking for,” confirms Blumenfeld.

Participating in clinical studies can provide a substantial revenue stream
for medical practices. Blumenfeld says that physicians can expect
compensation ranging from $5000 to $10,000 per patient. One stroke study
presently under way pays $8500 per patient, she says.

The seemingly lucrative money in clinical trials has caused the activity to
come under fire in the popular press, suggesting that pharmaceutical
companies are bribing physicians to change prescription habits. However, the
compensation provided to participating physicians includes reimbursement for
office visits and diagnostic testing, typically leaving about 20% after
expenses.

“Nobody makes a lot of money from post-marketing studies,” says Nikolov. The
most common error made by physicians is underestimating the amount of time
and labor demanded by clinical trials. “It’s important that physicians
realize the time commitment that’s required,” says Blumenfeld. “Physicians
who look at clinical trials as selling data don’t have a clear idea of what’s
involved. It’s not like the pharmaceutical company hands the doctor $5000. He
or she has to work for it.”

U. of Okla. Scandal Leads to Exodus

.c The Associated Press

By KELLY KURT

TULSA, Okla. (AP) – A research scandal that led to the shutdown of 75 human
experiments at the University of Oklahoma medical school in Tulsa has brought
the departure of three top university officials and dismissal proceedings
against a scientist.

“I think we have no choice but to demonstrate we’re making a fresh start,”
university President David Boren said Friday. “We simply have to send a very
strong signal for the sake of all our research programs.”

The scandal broke earlier this month over a skin cancer study. An outside
audit found flaws in the manufacturing the study’s vaccine and lapses in the
monitoring of its participants, all of whom were seriously ill with melanoma.

Twenty-six of the 94 participants who received the vaccine over the three
years of the study died, though officials found no evidence the study
contributed to the deaths.

In the wake of the discovery, the university suspended 70 clinical trials at
the university and the government suspended five others.

Boren said that the university has started termination proceedings against
the study’s lead researcher, Dr. Michael McGee, and that three officials had
either resigned or retired: Harold Brooks, dean of the college of medicine in
Tulsa; Edward Wortham Jr., director of the Office of Research at the Health
Science Center; and Daniel Plunket, chairman of the school’s research
oversight board.

Boren also announced stringent new procedures, including the establishment of
a research compliance office with a hot line for anonymous callers to report
violations.

07-21-00

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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@…

706 total views, 5 views today

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)

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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.”

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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.

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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.”

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