6/1/2000 – Misleading Drug Coverage

You’ll find this story on the wire today, or at

Misleading Drug Coverage
Study Finds Failure to Disclose Important Information in Media

By Katharine Webster
The Associated Press

June 1 — A study of how the mass media covers health found
that many news stories on drugs fail to report side effects or
researchers’ financial ties to the companies that make the

The researchers looked at 207 newspaper and TV stories from
1994 to 1998 on three drugs: aspirin, used to prevent heart
disease; pravastatin, a cholesterol-lowering drug also used to
prevent heart disease; and alendronate, a drug for preventing
and treating osteoporosis.

In the 170 stories that cited experts or scientific studies, half
included at least one expert or study with financial ties to the
drug’s manufacturer. Of those, only 40 percent reported the
potential conflict of interest.

The study also found that fewer than half the news stories
reported the drugs’ side effects and only 30 percent noted their

The study by researchers from Harvard University and Harvard
Pilgrim Health Care, a managed care insurer, was being
published in today’s New England Journal of Medicine, whose
incoming editor has been criticized for an apparent conflict of
interest involving a drug company.

Reporting the Numbers
Wire service stories were included in the study, including some
by The Associated Press.

Forty percent of the stories studied did not report the
numbersbehind the claims of medical benefits. Among the 124
stories that did quantify the benefits of a drug, 83 percent
reported only the relative benefit and 2 percent reported only the
absolute benefit. Just 15 percent reported both, the study found.

For example, many 1996 stories about an alendronate study
said the drug would cut an osteoporosis patient’s risk of a
broken hip in half — the relative benefit. But most failed to
include the absolute reduction in risk, from a 2 percent chance of
a hip fracture to 1 percent.

Reporting only the relative benefit is “an approach that has been
shown to increase the enthusiasm of doctors and patients for
long-term preventive treatments and that could be viewed as
potentially misleading,” the authors wrote.

Some studies do not report absolute benefits. Others look at
drugs in the experimental phase; manufacturers will not release
a price until the drug is approved and on the market.

Disclosing Financial Ties
In addition, while the top medical journals require researchers to
report their financial ties to drug companies, some studies do
not include the information because a researcher fails to
disclose it.

“The financial entanglements can be essential information for
these science stories, and we want to provide readers whatever
details we can,” said Mike Silverman, deputy managing editor for
national news of The Associated Press.

“We try very hard to provide an adequate context for the readers,
and sometimes the information is available in [medical] journal
articles or obtainable in interviews on deadline, and sometimes
it isn’t,” said Cornelia Dean, science editor of The New York
Times, another of the publications studied.

“I think it makes some really valuable points,” Rob Stein, science
editor for The Washington Post, said of the study. “I think
a real danger of oversimplifying these things.”

The study was led by Ray Moynihan, a fellow at the
Commonwealth Fund, a nonprofit organization dedicated to
improving health care. Funding was provided by the
Commonwealth Fund and the Harvard Pilgrim Health Care
Foundation, a nonprofit organization linked to the insurer.

The incoming editor of the journal this week responded to
reports about an apparent conflict of interest stemming from his
ties to drug companies. Dr. Jeffrey Drazen, who becomes editor
in July, said he may have made a mistake last year when he
praised a new asthma drug made by a company that had hired
him to evaluate studies about the medication. He also said he
would divest himself of any financial interests in drug companies
before taking over as editor.

Copyright 2000 The Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten or

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5/31/2000 – Profit Motive Creates Conflicts in Drug Trials

Here are another couple of articles on the close ties between the drug
industry and medicine have become even closer. From these articles we learn
what has gone wrong with the clinical trials that we thought were protecting
us from big profit motives. The overall general attitude now seems to be:
“Approve all drugs in exchange for profits and let the general population be
the true clinical trial.”

Please note that I have highlighted the statement about Dr. Angell leaving
the New England Journal of Medicine as a doctor with very close ties to the
pharmaceutical companies comes in to replace her as the journal’s editor. So
much for any honesty coming from the New England Journal of Medicine now. As
Dr. Angell leaves her prestigious post she is basically airing the industry’s
dirty laundry. The subject of her article that follows this e-mail is Dr.
Bodenheimer’s journal article mentioned below – a long needed followup to Dr.
Seymour Fisher’s classic article, “Hanky Panky in the Pharmaceutical
Industry.” (Dr. Fisher’s article has been posted at www.pssg.org if you would
like to read it.)

Free speech? Protection from conflicts of interest that could cost consumers
their lives? You will not fine either in this industry! Clearly patients need
to understand that medicine in America has become just another very big

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness


Profit Motive Creates Conflicts in Drug Trials

May 21, 2000

Reuters Health Information

NEW YORK — Pharmaceutical companies that pay researchers to design and
interpret drug trials sometimes spin or suppress unfavorable findings, The
New England Journal of Medicine reported on Wednesday.

The scathing new report discusses tactics used to mask negative results and
warns that the profit motive of commercial research outfits threatens to
further corrupt the high-stakes process of translating science into
marketable drugs.

The report, “Uneasy Alliance — Clinical Investigators and the
Pharmaceutical Industry,” was written by Dr. Thomas Bodenheimer of the
University of California at San Francisco (UCSF) School of Medicine.

Bodenheimer’s interviews with people involved in the drug trial process
highlight the conflicts that arise in the process of
testing new drugs and publishing those results.

An accompanying editorial by Dr. Marcia Angell, the journal’s editor,
picks apart the cozy relationship that has developed between clinical
researchers and industry.

“Academic institutions and their clinical faculty members must take care
not to be open to the charge that they are for sale,” she writes.

The articles come a week after the peer-reviewed journal’s publisher,
the Massachusetts Medical Society, announced that it had named Dr. Jeffrey M.
Drazen, a prominent asthma researcher with strong ties to the drug industry,
as its new editor. He replaces Angell, who will be retiring.

Jeffrey Trewhitt, a spokesperson for the drug industry’s lobbying
group, the Pharmaceutical Research and Manufacturers of America, told
Reuters that “the articles overlook many safeguards in the system, including
the fact that the FDA (US Food and Drug Administration) reviews all the study

Trewhitt said that the FDA issued financial disclosure rules 18 months
ago “and they help to avoid conflicts of interest.” But six investigators
interviewed by Bodenheimer cited cases in which a sponsor actually halted
publication or altered a report’s content.In one instance, Dr. Steven
Cummings, professor of medicine and epidemiology at University of California,
San Francisco, said that a company held up the prepublication review process
for more than 6 months, secretly penning a competing article that favored the
company’s point of view.

Another investigator who found adverse reactions while studying a drug
was told by the sponsor that it would never fund his research again. It
published a competing article that barely mentioned the adverse reactions.

Critics have long questioned the integrity of drug research funded by
the pharmaceutical industry. But Bodenheimer warns of a deepening conflict as
more and more of those studies are farmed out to commercial research outfits.

When academia conducts drug studies, there is at least the potential
that researchers’ scientific goals will offset the pharmaceutical industry’s
commercial interests, he notes. “In contrast, trials conducted in the
commercial sector are heavily tipped toward industry interests, since
for-profit CROs (contract-research organizations) and SMOs (site-management
organizations), contracting with industry in a competitive market, will fail
if they offend their funding sources,” he argues.

Bodenheimer’s article recalls the time Dr. Curt Furberg, a professor of
public health sciences at Wake Forest University School of Medicine, refused
to place his name on published results of a study because the sponsor was
“attempting to wield undue influence on the nature of the paper.” Furberg
describes the effort as “so oppressive that we felt it inhibited academic

Furberg noted, “Companies can play hardball, and many investigators
can’t play hardball back. You send the paper to the company for comments, and
that’s the danger. Can you handle the changes the company wants? Will you
give in a little, a little more, then capitulate? It’s tricky for those who
need money for more studies.”

SOURCE: The New England Journal of Medicine 2000;342:1539-1544, 1516-1518.

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5/24/2000 – Dr. Joseph Glenmullen on ABC’s Chatroom Tonight

This chat is on tonight on the following ABC news site.


Join Dr. Joseph Glenmullen, clinical instructor in psychiatry at
Harvard Medical School, and author of Prozac Backlash:
Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other
Antidepressants with Safe, Effective Alternatives, for a chat about
this withdrawal phenomenon at 6 p.m. ET.

Dr. Joseph Glenmullen, Harvard Psychiatrist and Author of
Prozac Backlash: Prozac and other serotonin boosters are
among the top 10 best-selling drugs in this country. They are
medications to treat depression, obsessive-compulsive
conditions and panic disorders.

But some doctors and psychiatrists charge that many doctors
are prescribing these drugs to patients with much less severe
versions of these psychiatric illnesses — without warning them
of the side effects that can occur when they stop the

When these individuals, who did not necessarily need to be on
the drug on a long-term basis, try to stop taking the drugs
because they are feeling better, up to 80 percent may start
experiencing some withdrawal effects, such as sadness and
dizziness. Fearing a return to the condition that put them on the
drug to begin with, they continue taking the pill.


Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft,
Paxil, and Other Antidepressants with Safe, Effective Alternatives.
by Joseph Glenmullen, M.D.

Post your questions now and join us when the chat is live.
Remember, your comments will not be seen until posted by the

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5/24/2000 – Antidepressants-Suicide Link

This appears at


Antidepressants-Suicide Link
Harvard Psychiatrist: Studies Needed

The Associated Press
B O S T O N, May 15 — Dr. Jonathan O. Cole, a Harvard
psychiatrist who has suggested a link between antidepressants
like Prozac and suicide, says drug manufacturers and the
federal government haven’t adequately investigated the problem.

In the decade since Cole and Harvard colleagues first reported
on early cases of extreme agitation among people taking Prozac
and related antidepressants, use of these drugs — called
selective serotonin reuptake inhibitors, or SSRIs — has reached
84 million prescriptions a year, according to The Boston Globe.

No one has done the large-scale studies necessary to pin down
the frequency of SSRI-related suicides, Cole said in a document
filed in U.S. District Court in Kansas City in support of a lawsuit
brought by the family of Matthew Miller, a Missouri teenager.

Miller, 13, had been taking Zoloft, a chemical cousin of Prozac,
for only a week when he hanged himself in his bedroom closet
July 28, 1997.

Adequate Evidence of a Link
Dr. David Healy, a British researcher who is the family’s chief
expert witness, said there is adequate evidence that Zoloft
caused the youth to commit suicide.
However lawyers for Pfizer Inc., maker of Zoloft, said there is no
credible scientific evidence that Zoloft and related drugs
precipitate suicide.

Dr. Anthony J. Rothschild of the University of Massachusetts
Medical School said he thinks drug manufacturers, specifically
Eli Lilly and Co., Prozac’s maker and the FDA have adequately
addressed their critics’ concerns.

“The thing that disturbs me” about current SSRI critics,
Rothschild said, “is the tone that suggests there’s almost a
conspiracy to cover up information, and not do the right studies.”

Copyright 2000 The Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten or

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5/24/2000 – Questions Persist Concerning Prozac’s Role in Suicide Risk

The former US Surgeon General, Dr. C. Everett Koop has joined
in the current concern over SSRI medications and suicide, and
posts this on his site, drkoop.com.

Questions Persist Concerning Prozac’s Role in Suicide Risk

May 11, 2000

Lee Hickling
drkoop.com Health News

The question of whether Prozac, the most-prescribed
antidepressant, can make some patients more likely to commit
suicide just won’t go away, despite repeated and categorical
rebuttals by the drug’s manufacturer, Eli Lilly and Co.

Based on his experience as a suicide counselor and
investigator, Dr. Ronald W. Maris, director of the Center for the
Study of Suicide at the University of South Carolina, is firmly
convinced that a risk exists.

Research done in Wales by Dr. David Healy, director of the
University of Wales’ North Wales Department of Psychological
Medicine, appears to show a cause-and-effect relationship
between Zoloft (sertraline) and the emergence of suicidal
thinking in a group of physically and mentally healthy adult
volunteers. Zoloft, like Prozac (fluoxetine), is a selective
uptake inhibitor (SSRI). Healy has completed a similar study with
Prozac, but its results have not yet been published.

A spokesman for Lilly said today, “There is no scientific evidence
to establish a link between Prozac and suicide.” He cited a l991
study by a Food and Drug Administration advisory panel, which
unanimously agreed that there was “no credible evidence of a
causal link between the use of antidepressants, including
Prozac, and violent behavior.”

Even the drug’s critics agree that the effect, which the company
says does not exist, occurs in only a small number of cases —
fewer than 1 percent. Maris said that although the incidence is
very low, when it happens it is such a serious matter that doctors
should be very careful in prescribing Prozac, and extremely
watchful when they do.

Maris said the danger is greatest during the first week or two of
Prozac use, when some patients who were already at risk for
suicide have a rare reaction that makes them feel energized and
more ready to act on their self-destructive impulses. There is
another dangerous time later, when a patient, who had been
virtually immobilized by deep depression, still entertains suicidal
thoughts. At this time, the drug has moderated their depression
enough to make them able to carry out these thoughts.

Healy’s study showed a similar pattern, and left him convinced
that a direct link exists between SSRIs and the emergence of
suicidal thinking in people who had never had such thoughts. He
is not the first medical researcher to suspect such a reaction. Dr.
Martin Teicher of Harvard Medical School reported in 1990 that
he and his colleagues had observed suicidal thoughts emerging
in six patients who were taking Prozac. Other researchers and
clinicians began reporting that they saw it too.

Serotonin is a relatively simple chemical that is vital to the
regulation of a great many body functions — sleep, appetite, and
even more basic activities such as muscular activity, breathing
and blood circulation. Abnormal serotonin levels have been
blamed for a large number of mental and physical problems,
including depression, obsessive-compulsive disorder and panic

Prozac and the other SSRIs have been prescribed for all those
problems and more, and have produced dramatic improvement
in a majority of cases. “Prozac is a valuable drug,” Maris said.
“For every horror story, there are thousands of persons who say
their lives were saved by it.”

But he said, doctors need to be much more careful about
prescribing it. They should investigate the patient’s history,
particularly the psychological history, to see if there have been
any indications of suicidal thought or other instability, and then
should monitor each patient very carefully. He said that is not
always done.

Because any physician can prescribe Prozac, and general
practitioners, primary care doctors and specialists in other areas
might not be as alert for danger signs as a psychiatrist might be,
Maris said Lilly should have warned doctors about Prozac’s

The company did not do that. According to a Boston Globe story
earlier this week, internal Lilly documents show that in 1990,
corporate executives pressured Lilly scientists to alter records
on physicians’ experiences with Prozac. They changed mentions
of suicide attempts to “overdose” and of suicidal thoughts to

Some of Lilly’s own studies were cited by the German equivalent
of the Food and Drug Administration, delaying Prozac’s approval
there. They showed that previously nonsuicidal patients who
took the drug had five times the rate of suicide or suicide
attempts as patients on older antidepressants. When the drug
was approved for sale in Germany, a warning was required on
the label. The label warned that the drug’s use carried a risk of
suicide, and recommended that sedatives be given along with it.

The Globe said figures in Lilly internal documents showed that
in early clinical trials, 1 in 100 previously nonsuicidal patients
who took Prozac became anxious and agitated, and either
attempted or committed suicide during the studies.

Some of the previously unknown information that Eli Lilly
possessed about the drug has come to light during civil trials in
which the company was sued for wrongful deaths following
suicides, or during criminal trials in which defense lawyers
argued that Prozac caused a defendant’s violent and homicidal

Maris has been an expert witness in a number of trials, including
one in Hawaii last year in which Healy also testified. William D.
Forsyth Sr., a retired businessman, stabbed his wife 17 times
and then stabbed himself to death. He had been taking Prozac
for 10 days. His family brought a wrongful death suit against Lilly,
claiming that the company knew Prozac could make some
people violent or suicidal, and failed to notify physicians about it.

The plaintiffs wanted $1 million in damages and the addition of a
warning statement to the Prozac label. A jury found for the
defendant, Lilly. So far, Lilly has won every Prozac-related civil
suit against it, more than 100 and possibly 200. The number is
difficult to verify because most did not go to trial. Some — Lilly
says only a few — were settled out of court to avoid the expense
of defending them.

In criminal cases up to now, prosecutors, frequently with the help
of expert witnesses suggested by the company, have been able
to obtain convictions despite defense claims that the drug had
turned a previously stable and nonviolent person into a

The most often-prescribed antidepression drug in the world,
Prozac has been Lilly’s major moneymaker ever since it was
introduced in 1988. Its sales, however, have been falling, for
which the company’s annual report blames “changes in
wholesaler purchasing patterns and intense competition.” Four
years ago, it accounted for more than one-third of Lilly’s total
sales. Last year it represented just over one-quarter.

The company’s patents on Prozac will start to expire next year. A
patent has been granted for its successor, R-fluoxetine, which
Lilly will make and market. In the patent application, which the
Boston Globe obtained, the company said the new drug will
decrease such side effects such as headaches, anxiety and
insomnia, and also “inner restlessness (akathisia), suicidal
thoughts and self-mutilation.”

Akathisia, an overwhelming physical and mental restlessness,
has been cited by physicians and researchers as a frequent
side effect in the cases in which they believe Prozac is causing
violent, impulsive and sometimes suicidal behavior. Teicher,
who pioneered research on the question, observed it in a
number of Prozac patients who attempted or committed suicide.

Teicher is one of the developers of the “new Prozac,”
R-fluoxetine, and a co-owner of the patent.


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5/24/2000 – Effexor – FDA Discontinuation Warnings

Thanks to Steve Whiting for alerting us to the following warnings from the
FDA. It is about time the gave us some warning about the terrible withdrawal
associated with the SSRI and SNRI antidepressants. I have highlighted a few
spots in this warning that I want you to take note of in particular.

Knowing HOW TO safely withdraw from serotonergic medications is one of the
most critical pieces of information patients need about these drugs –
information they are unfortunately not getting from their doctors. How one
withdraws can make the difference between life and death and can prevent the
long term debilitating effects that come from an abrupt or a much too rapid
withdrawal. Let me remind you once again that I have made an hour and a half
long audio tape to give patients and doctors withdrawal tips on safe and
successful withdrawal from these drugs as well as information on rebuilding
the body after their use. I could not longer find time to eat or sleep
because I was spending all of my time answering questions from doctors and
patients about safe withdrawal. A tape answering those questions seemed the
logical solution. The tape is inexpensive and very helpful. You can find
order information at

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness

The FDA has forced safety related drug labeling changes regarding Effexor.

The changes acknowledge the existence of severe
discontinuation problems which are both dose and time
related and that the evidence of the problems has been
obtained from a retrospective survey of the clinical trials

Steve Whiting

Please refer to

EFFEXOR & EFFEXOR XR (venlafaxine HCl) Tablets
[March 3, 2000: Wyeth-Ayerst]


Physical and Psychological Dependence: New third paragraph –
“Discontinuation effects have been reported in patients receiving venlafaxine

Discontinuing Effexor (venlafaxine HCl): First sentence revised –

“When discontinuing Effexor after more than 1 week of therapy, it is
generally recommended that the dose be tapered to minimize the risk of
discontinuation symptoms. Patients who have received Effexor for more than 6
weeks or more should have their dose tapered gradually over at least a 2-week

New second paragraph –

“Discontinuation symptoms have been systematically evaluated in patients
taking venlafaxine, to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surveys of trials in
depression. Abrupt discontinuation or dose reduction of venlafaxine at
various doses has been found to be associated with the appearance of new
symptoms, the frequency of which increased with increased dose level and with
longer duration of treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth,
dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia,
nausea, nervousness, nightmares, sensory disturbances (including shock-like
electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting. I
t is therefore recommended that the dosage of Effexor be tapered gradually
and the patient monitored. The period required for tapering may depend on the
dose, duration of therapy and the individual patient. Discontinuation effects
are well known to occur with antidepressants.”

Discontinuing Effexor XR:

“When discontinuing Effexor XR after more than 1 week of therapy, it is
generally recommended that the dose be tapered to minimize the risk of
discontinuation symptoms. In clinical trials with Effexor XR, tapering was
achieved by reducing the daily dose by 75 mg at one week intervals.
Individualization of tapering may be necessary. [The remainder of the
paragraph beginning with “While the discontinuation effects of Effexor XR
have not been systematically evaluated in controlled clinical trials,
retrospective…” has been deleted] and replaced with –

“Discontinuation symptoms have been systematically evaluated in patients
taking venlafaxine, to include prospective analyses of clinical trials in
Generalized Anxiety Disorder and retrospective surveys of trials in
depression. Abrupt discontinuation or dose reduction of venlafaxine at
various doses has been found to be associated with the appearance of new
symptoms, the frequency of which increased with increased dose level and with
longer duration of treatment. Reported symptoms include agitation, anorexia,
anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth,
dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia,
nausea, nervousness, nightmares, sensory disturbances (including shock-like
electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting.
It is therefore recommended that the dosage of Effexor XR be tapered
gradually and the patient monitored. The period required for tapering may
depend on the dose, duration of therapy and the individual patient. Discontinu
ation effects are well known to occur with antidepressants.”

Return to Quick Reference

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5/24/2000 – Falling Off Prozac

This appears today on the ABC News website at

Falling Off Prozac

Doctors and Patients Unaware of Withdrawal Side Effects

By Robin Eisner

N E W Y O R K, May 24 — Tara Calhoun wanted to kill herself.

The then-48-year-old mother of two from Norman, Okla., had
forgotten to take her small dose of Paxil, an antidepressant
prescription medication.

But her suicidal feelings were not a return to symptoms of
depression, her doctor said. Rather, they were withdrawal
symptoms from seven months on a drug that had altered her
brain chemistry.

Calhoun’s reaction to ending her treatment with a serotonin
booster — drugs that increase the neurotransmitter serotonin in
the brain to treat depression, panic disorder and compulsive
behavior — was extreme but not unique.

Up to 85 percent of patients who take these kinds of drugs may
have some type of symptom when they stop, studies say.
Symptoms include balance problems, nausea, flu-like
symptoms, tingling and electric shock sensations, vivid dreams,
nervousness and melancholy.

The problem, doctors now are saying, is that patients and even
other doctors may not be aware that stopping these drugs, which
are among the top 10 best-selling pills in the United States, may
be causing the symptoms. Patients, they say, may unnecessarily
continue taking the drugs after they try to stop because the
symptoms of withdrawal may scare them into thinking they are
still suffering from the bad feelings they had — such as
depression — when they first started taking the drug.

Many doctors and patients also may not know that to end
treatment, levels of the drug should be tapered off while under a
doctor’s care.

The Way to Stop
According to recent research in the Journal of Clinical Psychiatry,
as many as 70 percent of general practitioners and 30 percent of
psychiatrists do not know about the side effects of ending
serotonin-boosting drugs. Of those who do know, only 20
percent of psychiatrists and 17 percent of general practitioners
caution their patients about the proper way to slowly lower the
levels of these drugs to come off them.

“Getting off these drugs properly is an issue that is
underappreciated,” says Dr. Alexander Bodkin, director of the
clinical psychopharmacology research program at McLean
Hospital, a teaching affiliate of Harvard Medical School located in
Belmont, Mass. “These drugs are being prescribed without the
full knowledge of how they should be monitored.”

Pharmaceutical companies place the responsibility of proper
prescribing on the doctor. “The decision about how long a
patient should be on treatment and how treatment should be
stopped is a highly individual one between the physician and
patient,” says Brian Jones, a spokesman for SmithKline
Beecham of Philadelphia, the manufacturer of Paxil.

Lifesavers, But Also Overprescribed
While these serotonin boosters can be life-savers for people
who suffer from severe depression, panic disorder and
obsessive-compulsive illnesses, and could offer help to
thousands of others on a long-term basis, psychiatrists and
doctors acknowledge that not everyone taking them should
necessarily be on them and that stopping might be a problem.

The numbers tell the story. Prozac, manufactured by Eli Lilly &
Co., of Indianapolis, Ind., has been on the market since 1988
and is the third best-selling drug in the country, according to IMS
Healthcare, a healthcare information company in Plymouth
Meeting, Mass. Zoloft, made by Pfizer Inc., of New York City, was
introduced in 1992 and is seventh. Paxil, available since 1993, is

But the down side of these popular drugs has only recently been
addressed.”We are only beginning to see concerns about these
drugs like what inevitably happened with other so-called miracle
drugs over time,” says Dr. Joseph Glenmullen, a clinical
instructor of psychiatry at Harvard Medical School in Cambridge,
Mass., and author of the recently published book Prozac

“People during last century have wanted to take drugs that will
make them feel better, such as Valium, amphetamines and
cocaine elixirs, but it takes time to see the side effects of these
quick cures,” he says.

Glenmullen says today the serotonin boosters are being
prescribed for more and more moderate conditions, but that they
should be reserved for people who are truly debilitated by their
mental illness.

Once Taken, Forever Stuck?
And once on a drug, Glenmullen says, many people who don’t
really need it for the long haul have trouble getting off. When the
dosage is lowered, he says, it can be difficult to determine
whether it’s the symptoms of the disorder returning or the side
effects of withdrawal.

“If a doctor is unaware of these withdrawal symptoms, they
might put the patient back on the drug or another one and this
can go on for years,” Glenmullen says. Doctors also sometimes
switch patients to other serotonin drugs when these
discontinuation effects occur.

Calhoun’s story about stopping Paxil is cautionary. At the time
she forgot her medication, she had been trying to get off the drug
for six months, after being hospitalized from what she calls the
side effects of the drug — inability to sleep, constant suicidal
thoughts and chemical sensitivity.

Her general practitioner had prescribed Paxil when Calhoun had
told him she was feeling anxious upon losing a job. She worried
about supporting her two children. She says her doctor had not
told her about potential adverse effects of the drug. Nor did he
tell her the appropriate way to stop taking the medication.

Eventually, another doctor, who agreed she was suffering from
serious side and withdrawal effects, gradually lowered her

Today, Calhoun has been off the drug for a year and a half, has
two jobs and counsels people getting weaned from serotonin
boosters. “When I felt the suicidal feelings that day I forgot the
drug, I realized that it was not me that was crazy, but…the
changing level of the drug inside my brain,” Calhoun says.

Stopping Serotonin Boosters
Each person will respond differently to stopping serotonin
boosters, or selective serotonin reuptake inhibitors (SSRI),
doctors say.

While many people experience no problem stopping the drug,
some people will have side effects from lowering the dosage,
since the brain has become used to certain levels of serotonin.

Medical research indicates that it is easier to get off Prozac than
Paxil. That’s because Prozac lasts longer in the body. So when
dosages are cut back, withdrawal effects are minimized.

Doctors caution no one should stop taking their drug cold turkey
and that use should be tapered off.

“A doctor should communicate with a patient at least once a
month when they are on these drugs,” says Dr. Bruce Bagley,
president of the American Academy of Family Physicians.

“I tell patients that they may need to be on these drugs for at
least six months to see an improvement, but you must talk to
them to see if conditions in their life have changed to warrant
considering ending the drug treatment.”

SSRIs act by increasing the amount of the neurotransmitter
serotonin available to the brain. Exactly how they work to treat all
the disorders for which they are prescribed is unknown, but
serotonin is a chemical that allows neurons in the brain to
communicate with each other. Over time, the drug changes the
way the neurons respond, according to Jerrold Rosenbaum, a
psychiatrist at Harvard Medical School.

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5/24/2000 – Salon Magazine addresses the SSRIs

Salon Magazine has put several articles out this week on the SSRIs. The first
article is about Dr. Joseph Glenmullen’s new book “Prozac Backlash.” Of
course in their usual form Eli Lilly representatives and other critics have
slammed it as misleading and lacking in scientific rigor. And now the author
claims Eli Lilly reps are harassing him. After ten years of writing about
these drugs learning this is no surprise me at all. I extend a hearty welcome
to Dr. Glenmullen as he joins the group of us who are all too familiar with
that type of harrassment from Lilly. 🙂 The article is Prozac Indignation –
How a little-known Harvard clinician needled sleeping giant Eli Lilly.


A second piece looks at the sexual side effects of the drug. And the third is
an essay by a woman who has taken the pills for 13 years and calls them her
salvation. “She addresses the school of thought that says happiness shouldn’t
be come by quite so easily.”

I have really reached a saturation point on the “happiness shouldn’t be come
by quite so easily” comments. I would like to point out that no amount of
“happiness” (drug-induced high) is worth what even one of the families who
have lost a loved one to these drugs has had to suffer! The price for that
“happiness” has NOT come easily. In reality the price has been far too great
for far too many! When there are so many safe, natural alternatives to reach
a true feeling of happiness, there is absolutely no excuse to cause such pain
and suffering for so many others in order for even one to achieve this
drug-induced high. The risk vs benefit ratio is much to great to justify the
use of these drugs.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness

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5/23/2000 Accutane May Be Linked To Depression, Suicide

In case you missed this I wanted to send this out again. I feel it is very
important to know. There are too many children on this type of medication and
little knowledge of these serious side effects to this drug. How many
children are ending up on antidepressants as a result of their acne meds?

Ann Blake-Tracy


FDA Reports Accutane May Be Linked To Depression, Suicide

WASHINGTON, MD — February 26, 1998 — The United States Food and Drug
Administration is advising consumers and health care providers of new
safety information regarding the prescription anti-acne drug Accutane
(isotretinoin) and isolated reports of depression, psychosis and rarely
suicidal thoughts and actions.

Accutane was approved in 1982 to treat only a very special type of acne —
severe nodular acne that has not responded to other therapies.

Although the Accutane label already included information regarding
depression as a possible adverse reaction, the agency felt health care
providers and others needed additional information as a result of adverse
event reports the agency has received.

FDA and the drug manufacturer are strengthening this label warning, even
though it is difficult to identify the exact cause of these problems. Such
problems could already be more common among the patient populations likely
to be on the drug.

However, because some patients who reported depression also reported that
the depression subsided when they stopped taking the drug and came back
when they resumed taking it, the agency and the manufacturer felt the
strengthened labelling was warranted as a precautionary measure.

Given the complex nature of depression and suicidal conditions, the new
label information will advise health care providers that merely
discontinuing the drug may be insufficient to remedy these adverse events
and that further evaluation may be needed.

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5/23/2000 Insight Magazine – “A Hill and Tip Trip”

I hope you have all had the chance to read “The Next Generation Medical
Guinea Pigs–Our Prozac, Zoloft and Paxil Babies” (located near the bottom of
the page at https://drugawareness.org/200000.html). I wrote this article for
the two major Salt Lake newspapers and it was published the summer of 1998.
It will give you the background information you need to understand before
reading Kelly O’Meara’s excellent article from Insight Magazine which follows
below. You will see clearly that the plan put into place then to get these
drugs approved for small children is coming to fruition now.

How can we stand by and allow $5 million of OUR tax dollars to go toward the
damaging of preschool children with these drugs?! And how can we allow an
additional $70 million to go toward producing even more citizens on
disability due to the adverse effects of these drugs – citizens who we will
then have to support for the rest of their lives with even more tax dollars?
And then there are all of those who we will support while they serve time in
prison for the crimes they committed while under the influence of the drugs,
not to mention all of those lives lost – productive creative individuals who
could have contributed to make our society even greater. Our allowing this to
happen makes us all accomplices to this terrible national tragedy because it
could not happen without our money and our consent. We must all do all in our
power to educate those around us and alert our government officials that we
do not want this to continue.

And thank you Kelly and Insight Magazine for your hard work in bringing these
issues to the attention of the public!

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness

A Hill and Tip Trip
By Kelly Patricia O’Meara

Insight Magazine

This Clinton-Gore team advocates identifying schoolchildren as mentally ill
and requiring them to take psychotropic drugs to control any inattentive

I think that part of what we’ve got, though, is to reflect how we can both
identify and get help to children who need it, whether or not they want it or
are willing to accept it,” declared first lady and wanna-be junior senator
from New York, Hillary Rodham Clinton. The first lady’s comment, put in the
context of how to deal with tragedies such as the shooting at Col-umbine High
School in Littleton, Colo., was delivered to a standing-room-only crowd at
the June 7, 1999, White House Conference on Mental Health. She was directly
advocating the forced drugging of schoolchildren with psychotropic drugs such
as Ritalin.

The first lady, however, was not alone in advocating this chilling agenda for
dealing with schoolhouse behavioral problems. During the conference that
critics dubbed a cheerleading session for the pharmaceutical industry, the
president’s top mental-health adviser and candidate for first lady, Tipper
Gore, joined in leading the psychopharmacological charge. In fact, nodding to
Tipper, President Clinton told the mesmerized crowd: “She knows more and
cares more about this issue than anyone else I personally know.”

The vice president’s wife “knows more” about this issue? Beyond earning a
masters’ degree in psychology more than 20 years ago and having been treated
for depression, say critics, Gore’s knowledge of mental illness is limited at
best and misinformed at worst. For example, Gore displayed some of her
knowledge on this subject during the president’s weekly radio address to the
nation just before the White House conference when she announced that
Americans must change their attitudes and “dispel the myths about mental
illness once and for all.” She said, “One of the most widely believed, and
most damaging, myths is that mental illness is a personal failure, not a
physical disease … and we are learning that many mental disorders are
biological in nature and can be medically treated.”

Members of the opposing team, which include a growing number of
well-respected physicians who have spent their lives resisting subjective
diagnoses of mental illnesses, are astonished by such pronouncements. They
tell Insight they would jump at the opportunity to present their contrary
data from such a highly visible platform as the well-publicized Clinton-Gore
White House conference but were not invited to offer opposing research.
Instead, the spotlight was given to Steven Hyman, director of the National
Institute of Mental Health, or NIMH.

Hyman pulled a slide show out of his black bag and wowed the star-struck
crowd with his evidence that, indeed, mental illness is a “real disorder of
the brain.” To prove his point, Hyman said, “I brought a few pictures”
because “I think pictures are worth an awful lot. I just want to show you a
picture that is somewhat alarming. What we see here on the left is a healthy
person with a normal brain, and then on the right, someone who has had severe
depression for a long time. What you see outlined in red at the bottom is
that a key structure acquired from memory actually gets smaller. It
deteriorates if depression is not treated.”

Apparently caught up in the frenzy of breakthrough medical “proof” of mental
illness, the audience broke into enthusiastic applause.

Hyman’s slide show was nothing if not deeply flawed, the most basic omission
being a failure to present the case history of the subject shown in the
slides. For instance, during Hyman’s show not once did he mention whether the
patient on the right, who “had severe depression” and whose slide showed “red
at the bottom” had been given psychotropic drugs for any length of time prior
to capturing the brain on film. In fact, if this were the case, critics tell
Insight, the right-brain slides, rather than being reflective of a
scientific breakthrough supporting the premise that the depression caused the
mental illness, would support arguments made by opponents that the change in
the brain in fact was caused by prescribed psychotropic medication.

To psychiatrist Peter Breggin, founder and international director of the
Center for the Study of Psychiatry and Psychology (www.Breggin.com), or
ICSPP, a Maryland-based research and educational network, and author of a
dozen books, including Talking Back to Ritalin, Talking Back to Prozac and
Reclaiming Our Children, Hyman’s slide show was just that — a show.
“Physicians and researchers like Hyman are guilty of the PET-scan scam,” says
Breggin. “They compare the brains of people who are diagnosed with something
like Attention Deficit-Hyperactivity Disorder, or ADHD, or depression with
people who don’t have these diagnoses. They then claim to the gullible
audience that there is a discernible difference in the brains.” According to
Breggin, “There is no known difference in the brains of any patient with a
psychiatric diagnosis, nor is there any difference with the mythical
biochemical imbalance. In fact, we have no instrument for even measuring such
an imbalance. When there are differences in brain scans between two
individuals they sometimes are caused by psychiatric-drug use and other times
represent normal variation. No reputable physician would ever claim to be
able to diagnose a psychiatric problem from a brain scan.”

Harold Koplewicz, the vice-chairman of the department of psychiatry at the
New York University Medical Center, an invited guest speaker at the White
House conference, even went beyond the contention that mental illnesses are
brain disorders. Koplewicz said, “Essentially, these diseases are no-fault
brain disorders. They are familial, they run in families and they have
predictable onset and course.” The doctor presented no data to support such
interesting remarks but “essentially” waived any personal responsibility or
validation that such life experiences as mental distress or anxiousness might
be normal.

Since such problems are physical, and beyond personal control or remedy,
Koplewicz reasons, tragedies such as what occurred in Littleton are “most
probably preventable” as a matter of public health. “Normal children,” he
continued, “just don’t snap and go out on a shooting spree. Children who
commit violent crimes almost always have histories of violence, depression or
other mental-health problems. The problem is we have never really looked at
the underlying cause of all this violence — which is childhood psychiatric

So what was going on there? Apparently “looking at all the possible
underlying causes” of school-age violence — the announced reason for the
Hillary-Tipper conference — was not on the agenda. Making a statement about
the 6 million children being “treated” for ADHD with highly addictive
stimulants, including Ritalin, did not fit that bill. Nor did even one of the
distinguished speakers raise the issue first reported last year by Insight
[see “Guns & Doses,” June 28, 1999], faxed to the White House before the
conference, revealing the dramatic connection between the then five most
recent school shootings: All the accused shooters had been treated with
psychotropic drugs, including Ritalin, Luvox and Prozac.

It would not be long before the New York Times, the Washington Post and
national weekly newsmagazines were following Insight’s lead, but when the
Hillary-Tipper team had the chance to recognize the problem quickly and in
prime time they demurred.

The controversy surrounding the use of psychotropic drugs on children began
after the diagnosis for ADD/ADHD was voted into the Diagnostic and
Statistical Manual of Mental Disorders, or DSM-IIIR, in 1987. The
prescription of Ritalin (methyl-phenidate), a highly addictive stimulant
categorized as a Schedule II drug by the Drug Enforcement Agency, or DEA,
skyrocketed from less than a quarter of a million in 1986 to 6 million today.
Certainly it is unlikely that Clinton-Gore psychiatric spokesmen Hyman and
Koplewicz were unaware that Ritalin is pharmacologically similar to cocaine
in its pattern of abuse, given that red flags were raised years ago by the
World Health Organization, or WHO, the DEA and even the Archives of General

Within the year since Insight began reporting on this issue, not only are
many mental-health experts questioning the overuse of psychotropic drugs on
children but also the validity of the latest Diagnostic and Statistical
Manual of Mental Disorders, the DSM-IV, as it continues to broaden the circle
of mental illness to in-clude practically every child, with the implication
that pharmacology offers a quick solution. For example, in the January 2000
issue of Clinical Psychiatry News, respondents were asked to evaluate the
psychiatric diagnoses presented in the DSM-IV. The result was dramatic. “The
DSM-IV has gone too far. There are too many diagnoses without any objective
basis or biological support,” said Houston psychiatrist Theodore Pearlman.
“There has never been any criterion that psychiatric diagnoses require a
demonstrated biological etiology,” said Harold Pincus, vice chairman of the
DSM-IV task force.

To indicate how far from reality are the advocates of passing out pills in
the schools, it is noteworthy that Hyman apparently was not even
communicating with his colleagues at the American Academy of Pediatrics, or
AAP. All of the new AAP guidelines for diagnosing ADHD, like those listed in
the DSM-IV — for example, exhibiting behaviors such as not listening when
spoken to directly, failing to follow directions, losing things, being
forgetful and easily distracted and fidgeting with hands or feet — are
subjective observations on the part of the treating physician. However, after
listing the new guidelines, the AAP concludes that “other diagnostic tests,
sometimes considered positive indicators for ADHD, have been reviewed and
considered not effective [emphasis added]. These tests include lead
screening, tests for generalized resistance to thyroid hormone, and brain
image studies [emphasis added].”

In other words, the dog-and-pony show that Hyman put on for the first and
second ladies was not based in science, and the AAP is just another in a long
list of experts to refute such fraudulent claims. Hyman also was
contradicting his own remarks made earlier in a New York Times article when
he said, “Magnetic Resonance Imaging, or MRIs, produce scientifically
meaningless pretty pictures which are essentially reminiscent of phrenology.
Who knows where or when the much-sought answers will emerge?”

While it is insulting to many physicians who are aware of the fraud that is
being perpetrated in the name of treating mental illness for men in positions
of extreme power to continue to push the strict pharmacological line, this
has been endemic in the Clinton-Gore administration. David Satcher, the U.S.
surgeon general, is a case in point.

Fred Baughman, a pediatric neurologist dedicated to exposing fraudulent
medical diagnoses of mental illnesses, took the surgeon general to task for
what Baughman called Satcher’s “attempt to represent mental disorders as
actual diseases.” In response to a first-ever Surgeon General’s Report on
Mental Illness, made public in December 1999, just months after the Columbine
shooting tragedy, Baughman wrote to the nation’s top medicine man asking,
“Why have you chosen to be the first-ever Surgeon General to issue a report
on mental health? As I have shown, it has little or nothing to do with
medical science, bona fide diseases or epidemics. Have other factors
motivated you? You might have addressed the biggest, most heinous epidemic of
all, that of mandating Ritalin and other addictive, dangerous, even deadly
amphetamines for 5-6 million entirely normal American children, as
‘treatment’ for the wholly fraudulent psychiatric ‘disease’ ADHD.”

Baughman concluded his letter: “Your role in this deception and victimization
is clear. Whether you are a physician so unscientific that you cannot read
their contrived ‘neurobiologic’ literature and see the fraud, or whether you
see it and choose to be an accomplice — you should resign.”

Loren Mosher, a psychiatrist and 30-year member of the American Psychiatric
Association, or APA, resigned from the organization over the blatant
infiltration of pharmaceutical money now permeating the organization and
concurs with Baughman about the surgeon general’s mental health report.
Mosher tells Insight that “the report is a joke.” He says, “There are no
tests for these so-called mental diagnoses. You can’t do that with
psychiatric diagnoses.”

Regardless of the continual stream of articles from reputable physicians
contradicting the biochemical advocacy being pushed by the administration,
Satcher, Hyman and Koplewicz have been elevated in stature and now are
considered foremost authorities on psychiatric public health, greatly due to
the platform provided by the nation’s first and second ladies. Now the first
lady has announced a $5 million research grant for Hyman’s NIMH to study the
effects of psychotropic drugs on children under the age of 7.

“Hillary is promoting young children to take psychiatric drugs,” says
Breggin. “This is the most extreme Big Brother, Nineteen Eighty-Four kind of
national policy. It has empowered NIMH to do something that they never would
have done — that is to spend $5 million on clinical trials involving hundreds
of preschool children. In the past, NIMH would have been afraid of doing such
dangerous, unethical and unscientific research. The repercussions are going
to be worse because this will now encourage the Food and Drug Administration,
or FDA, to accept similar clinical trials done on very young children with
Ritalin of a sort that have shown disastrous effects leading to the
discontinuation of use in most cases.”

For David Oaks, coordinator of Support Coalition International, an
Oregon-based organization representing 80 groups working for mental-health
rights, the first lady’s research announcement was a warning shot over the
bow. Oaks is alarmed by what he considers the push to medicate. “There is no
safety anywhere,” he tells Insight. “The forced administration of drugs is
definitely going up. Nearly 40 states have laws where they have
forced-drugging in your own home. Out of the White House conference came the
endorsement of the Program of Assertive Community Treatment, or PACT. That’s
the teeth of the outpatient forced-drugging: at-home drug delivery, where
they will come to your home every day if necessary for medication compliance.
Drugging is the be-all and end-all.”

Not everyone is buying the Clinton administration line. In mid-May a
class-action lawsuit was filed in Dallas for alleged fraud and conspiracy in
overpromoting the stimulant medication Ritalin. Three national defendants are
named: Novartis Pharmaceutical Corp. (formerly Ciba Geigy), the manufacturer
of Ritalin; CHADD (Children and Adults with Attention Deficit/Hyperactivity
Disorder), a parent’s organization that is partially funded by drug
companies; and the APA. Among the allegations: The drug company
“deliberately, intentionally, and negligently promoted the diagnosis of
ADD/ADHD and sales of Ritalin through its promotional literature.” The
lawsuit also charges the drug company with “actively supporting groups such
as Defendant CHADD, both financially and with other means, so that such
organizations would promote and support the ever- increasing implementation
of the ADD/ADHD diagnosis as well as directly increasing Ritalin sales.” And
the lawsuit further claims that “Defendant American Psychiatric Association
conspired, colluded and cooperated with the other Defendants” while taking
“financial contributions from Ciba Geigy as well as other members of the
pharmaceutical industry.”

Andy Waters of the Dallas law firm of Waters and Kraus, www.RitalinFraud.com,
is lead attorney for the plaintiffs. He tells Insight that “the nature of the
lawsuit is for consumer fraud. The legal concept is the unholy alliance of
the psychiatrists, manufacturers and parents groups that have combined to
create a diagnosis that didn’t exist and create and accelerate an enormous
market for Ritalin. My sincere hope is that 60 to 90 days from now we’ll have
a judge ordering the defendants to release information. I think we will find
that Novartis was involved in the making of the diagnosis — it’s just too
close a connection to rule it out.”

Meanwhile, a growing number of members of state boards of education, state
legislatures and the U.S. Congress have been taking action to stop the tidal
wave of psychotropic drugs being prescribed for children under the guise of
public health. New York, New Jersey, Idaho, Rhode Island, Minnesota, Georgia,
Colorado, Arizona and Pennsylvania have passed or have legislation pending
that confronts the issue of widespread prescription of psychotropic drugs to
school-age children. Legislative topics include examining the impact of
psychotropic drugs, prohibiting school personnel from recommending or
discussing medications for schoolchildren, requiring pharmacists to disclose
the potentially addictive nature of psychotropic drugs and preventing any
school official from requiring that children be placed on psychotropic drugs
as a condition for remaining in school.

Back at the White House conference, however, the solution to the violence
confronting America’s youth —the Hillary-Tipper answer to the
psychotropic-drug epidemic — was more drugging. In fact, the first and second
ladies exercised all their mental-health resources to try to convince the
nation that mental illnesses are “real illnesses of the brain” and “should be
treated the same as physical illness.” This would mean, of course, that
public-health authorities should have the right to examine every American
child for mental illness as a matter of public health — and diagnose and
treat them pharmacologically in whatever way they choose.

Regardless of the fact that there simply are no data to support such claims,
the president praised his wife and mental-health guru — the person “who knows
more and cares more,” Mrs. Gore, for the “truly remarkable experience.” The
White House conference was, to the president, “stimulating, moving and
humbling,” because “it’s so real.”

Then, under the guise of exercising presidential authority, Clinton
in-structed the nation’s largest private insurer, the Federal Employee Health
Benefit Plan, to provide full parity for mental and physical health. He
directed the Health Care Finance Administration to encourage states to better
coordinate mental-health services, and he called for medication targeted at
people with the most serious mental disorders who rely on Medicaid. And, to
wind up his mental-health giveaway, the president announced that he had
requested the largest increase in history — some $70 million — “to help
provide more mental-health services.”

Tipper Gore did not respond to questions Insight faxed to her office and
Hillary Clinton’s communications director refused Insight’s request for an
interview, saying, “We’re going to pass on providing comments to your
questions.” So one only can imagine the kind of mental-health programs those
ladies will be working for should Hillary be elected to the Senate and Tipper
take over as first lady. As for the need to profile, diagnose and dope
America’s schoolchildren to assure their mental health, well, the
Clinton-Gore psychiatrists have proved how much children “need” it — “whether
or not they want it or are willing to accept it.”

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