6/2/2000 – Use of Sertraline Linked to Suicidality

Use of Sertraline Linked to Suicidality

LONDON, May 30 (Reuters Health) – The use of sertraline might
prompt some patients to commit suicide, a UK researcher
warns based on a study of healthy volunteers.

In a double-blind, randomized crossover study, Dr. David Healy
of the University of Wales College of Medicine compared the
effects of two selective serotonin reuptake inhibitors (SSRIs) in
20 individuals, ages 28 to 52, who had no history of psychiatric
illness.

The study aimed to monitor the effects of the drugs on the state
of well being and “in particular the serenic effect that appears
associated with the use of SSRIs,” Dr. Healy writes in the June
issue of Primary Care Psychiatry.

Subjects received either reboxetine (marketed as Edronax in the
UK and as Vestra in the US), 4 mg q.d. for 5 days and increased
to 4 mg b.i.d. if tolerated, or sertraline (Zoloft), 50 mg q.d. for 5
days, increased to 100 mg b.i.d. if tolerated. Treatment lasted for
a total of 2 weeks, followed by a 2-week washout period and
then crossover to the opposite arm.

None of the subjects had suicidal ideation on reboxetine
although two reported depression, Dr. Healy found. “In contrast,
two developed suicidal thoughts on sertraline,” he writes. Within
a few days of treatment both of these patients reported feeling
restless and “fidgety.”

There is “no easy means of explaining what happened other
than by invoking an SSRI-induced suicidality,” Dr. Nealy writes.
“The mechanism…appears to have been a combination of
akathisia and emotional blunting, as well as other features
suggestive of an automatism.”

He points out that the risk of drug-induced problems in
nondepressed volunteers is of concern because
“antidepressants are commonly prescribed for stress reactions.”

Prim Care Psychiatry 2000;6:25-28.

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6/1/2000 – Direct to consumer advertising

It is my opinion that one of the most frightening and dangerous practices in
American medicine today is this direct to consumer advertising. Advertising
of tobacco products has been banned, yet they are allowed to advertise
prescription drugs? Where is the logic?

Clearly many who have had their lives destroyed by the SSRIs would not have
ever taken the first pill had it not been for direct to consumer ads leading
them to believe that someone coming back to Prozac would be young, slender,
and athletic, rather than old and worn out, overweight and bloated, and
barely able to move or function. Or the Paxil ad leading them to believe the
drug would help them “come into life” rather than being honest about the drug
helping them come into the “afterlife” thanks to the very deadly effects of
Paxil.

It is my opinion that these drug company ads are the most perfect example of
the biblical prophesy about our day when they would call evil “good” and good
“evil.”

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

http://www.washingtonpost.com/wp-dyn/articles/A56322-2000May12.html

With TV Spots, Drug Firms Aim At Patients’ Role

By Susan Okie
Washington Post Staff Writer
Monday, May 22, 2000 ; A01

In an animated television commercial for the anti-anxiety drug Buspar, a
woman sweeps her list of woes–worry, sleeplessness, muscle aches,
irritability–into the trash.

In one for Prilosec, a long-acting heartburn remedy, smiling people play or
recline on the faces of giant clocks.

And in a commercial for the antihistamine Zyrtec, a man with “indoor and
outdoor allergies” is sniffle-free as he flies a toy plane around his yard.

A pill can fix whatever ails you: That’s the message that makers of these
and other heavily advertised prescription drugs seem to be sending American
consumers. For years, pharmaceutical companies promoted
such medicines exclusively to doctors, since they wrote the prescriptions and
thus determined sales. But in the last decade, as managed care has limited
the drugs that doctors can choose from health plans’ formularies and as
consumers have demanded more say in their treatment, some companies have
dramatically shifted their marketing strategy.

Now, for a growing number of drugs, the patient is the target.
Direct-to-consumer advertising for prescription medicines increased nearly
20-fold during the 1990s. Last year, U.S. drug companies spent almost
$1.9 billion urging consumers to try prescription remedies for conditions
ranging from allergies and baldness to diabetes and high cholesterol. Of that
total, $1.1 billion was spent on television commercials, the fastest-growing
medium for advertising prescription medicines. The goal is to send patients
to the doctor demanding a brand-name drug, even if they have to pay for it
themselves.

“There are a lot of forces now that are basically pushing the decision-making
back to the consumer,” said Jim Daly, general manager for respiratory and
anti-infective marketing at Glaxo Wellcome, the top-spending company for
consumer advertising of prescription drugs.

Sabrina Smith of Arlington is the kind of consumer these companies are
trying to reach. Smith, 32, suffers from hay fever and is allergic to her two
cats. She has tried five different prescription medicines in the last two
years in response to TV commercials, with little success.

Drug ads “really grab my attention,” she said. “Why is it that I trust them
so much more than any other ad? . . . My allergies are so bad that I just get
desperate.” When a commercial mentioned a drug’s side effects, she added, “I
used to not even hear them, because I’d think, ‘Oh my God, here’s something
else that might help me.’ ”

Sales figures for heavily promoted drugs suggest that the strategy works.
U.S. sales for the antihistamine Claritin, No. 1 in direct consumer
advertising, were $2.3 billion last year; Prilosec, one of the top five, had
$3.8 billion in sales. But whether such advertising is good for patients–and
for the U.S. health care system–are hotly debated questions.

Advocates say the ads alert people to new treatments and open up discussion
of once-forbidden topics such as impotence or depression. Critics charge that
the ads play down medicines’ risks, contribute to steeply rising prescription
drug costs and encourage Americans to believe that pills–rather than
lifestyle changes or other nondrug interventions–are invariably the
treatment of choice.

“The aim is to sell a product,” said Barbara Mintzes, a public health
researcher at the University of British Columbia’s Centre for Health Services
and Policy Research. She noted that the United States and
New Zealand are the only countries that allow direct-to-consumer advertising
of prescription drugs, although Canada is considering such a policy. “It
doesn’t give [consumers] an overview of what’s available and whether it’s the
most appropriate treatment or the best value for money,” Mintzes said.

Although most prescription drug advertising still focuses on doctors, the
number of medicines being promoted to patients is growing. Many drugs
marketed in this way are for problems that are more bothersome than
dangerous: allergy symptoms, baldness, acne, migraine headaches. But
medicines for serious, chronic illnesses such as diabetes and asthma are
promoted, as well.

“Even on TV, we’re talking about over 40 drugs” advertised to consumers, said
Nancy M. Ostrove, chief of the division of drug
marketing, advertising and communications at the Food and Drug
Administration’s Center for Drug Evaluation and Research. “It’s
easily over 100 if you count print [advertising] too.”

The boom in television ads began in August 1997, after the FDA issued a
“guidance” that made it easier for companies to craft commercials that
complied with agency regulations. Previously, every broadcast advertisement
linking a drug with a condition had to state the medicine’s potential side
effects and tell consumers how to get a copy of the product labeling. The new
guidance allowed TV and radio ads to mention only major risks and to list
four sources–“your doctor,” a toll-free number, a Web site and a concurrent
print ad–for people who wanted additional information.

In the three years since the guidance, television ads for drugs have
proliferated–and quite a few have run afoul of the FDA for lack of balance,
incomplete information or misleading claims.

Drug commercials need not be preapproved by the agency. Companies must send a
copy to the FDA whenever a new TV ad (or any other prescription drug ad)
debuts. Ostrove said her staff of 15 reviewers was responsible for screening
about 30,000 pieces of promotional material last year, including more than
100 television commercials. Even though TV ads for drugs are a top priority,
misleading ads have sometimes reached millions of viewers before FDA staffers
saw them and picked up violations.

According to an FDA official, 50 prescription drugs have been promoted on TV
or radio since August 1997. In the same period, the agency has sent 23
regulatory letters to drug companies for advertisements that violated FDA
rules. That total doesn’t include violations found in so-called reminder ads,
which the agency counts separately. (Reminder ads mention a drug’s name but
must not specify what it’s for, and they are not required to list its side
effects.)

So far this year, two companies have received letters about TV commercials
that violated FDA regulations. The offending ads
were for the heartburn remedy Prevacid and the anti-allergy nasal spray
Flonase.

“Sometimes [companies] will argue with us, but generally they pull the ads,”
Ostrove said. “In some cases we have asked for
remedial advertisements.”

Daly of Glaxo Wellcome, which makes Flonase, said the FDA’s position on
direct-to-consumer advertising is still evolving and often difficult for
companies to predict. “It is far from black and white, in terms of what
claims and what fair balance the agency feels comfortable with,” he said.

Every prescription drug ad contains some variation of the phrase “ask your
doctor”–and physicians say that’s just what patients are doing. As a result,
direct-to-consumer advertising is shifting the agenda of many doctor-patient
encounters and influencing treatment decisions.

“One-fifth or one-sixth of the patients that I see either come in with an
advertisement that they’re holding or mention something that they’ve seen,”
said Michael S. Wilkes, a professor of medicine at the
University of California at Los Angeles who has published studies on the
impact of consumer advertising.

About 75 percent to 80 percent of the time, a patient who asks for a
specific drug receives it, according to several surveys. “The physician
doesn’t want to disappoint patients,” Wilkes said. “It takes time to answer,
to argue or to reeducate somebody. [Doctors] don’t want to be perceived as
cheap or cutting corners.”

A selection of Washington area doctors said drug advertisements sometimes
prompt patients to seek treatment for serious problems that they might
otherwise have ignored.

“If they come in and say, ‘I’m anxious or depressed and I’d like to consider
medication,’ it just makes talking about it so much easier,” said Bryan J.
Arling, who practices internal medicine in the District.

But doctors also complained that responding to requests for specific drugs
takes up time that might be better used discussing lifestyle changes or other
issues. “[Patients] all say, ‘Well, it [the drug] is paid for by my insurance
plan,’ ” said Ronald E. Greger, a family physician in Gaithersburg. “It’s
going to take the doctor time to explain why an alternative might be better.
. . . If I’m going to get paid $38 or $48 for the visit, I can just give you
the [drug] that you really wanted in two minutes and you’re going to leave
happy.”

The explosion in consumer advertising is contributing to rising health care
costs. Americans spent more than $100 billion on prescription medicines last
year, about 10 cents in every health care dollar. The average cost of a
prescription rose 11.6 percent last year–partly because of increasing
research and development costs, but also because of hefty promotion budgets.
Drugs advertised to consumers tend to be among the newest and most expensive
on the market, and ads may woo patients away from cheaper generic drugs.

There’s indirect evidence that consumer advertising also increases visits to
the doctor and medical testing. For example, in the year after an advertising
campaign for Fosamax, an osteoporosis treatment, patient visits for
osteoporosis evaluations almost doubled, according to the market research
firm IMS Health Inc. In the first nine months of 1998, according to a survey
by Scott-Levin, a drug-marketing research firm, total patient visits rose by
only 2 percent compared with the same period in 1997, but visits for hair
loss doubled and visits for smoking cessation more than tripled. Drugs for
baldness and to help smokers quit were being heavily promoted at the time.

Daly of Glaxo Wellcome said consumer advertising motivates people to seek
help for problems–such as migraine, allergies or irritable bowel
syndrome–that many doctors tend to minimize and treat in a limited way. “I
think it’s an empowering message . . . that the condition you have is real,
it’s not psychosomatic, it’s not in your head, there’s a biological basis and
there are effective treatments available,” he said.

Smith, the Arlington woman, recalled one occasion when a drug ad provoked a
valuable exchange with her doctor. She saw a commercial for Zyban, an
antidepressant marketed for people who want to quit
smoking.

Smith, who was a longtime smoker, asked her doctor at Kaiser Permanente, an
HMO, about the drug. “He said, ‘Well, that’s a lot
of money, and it usually doesn’t work,’ ” she recalled. Instead, the doctor
suggested she try a nicotine patch and a smoking-cessation program at a local
hospital. She did–and she hasn’t smoked since.

Cathy Alphin of Springfield, another Kaiser Permanente member, believes drug
advertisements have made her a more knowledgeable patient. Alphin said seeing
such ads prompted her to ask her doctor about alternative treatments for her
chronic sinusitis.

Drug ads directed her to pharmaceutical company Web sites, which she learned
to check regularly for new treatments and rebate offers. From there, she
began to surf other health sites to address her medical questions. “Now I go
out and look on the Web,” she said. “I’m responsible to be an informed
consumer.”

© 2000 The Washington Post Company

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6/1/2000 – Misleading Drug Coverage

You’ll find this story on the wire today, or at
http://www.abcnews.go.com/sections/living/DailyNews/drugs_m
edia0601.html

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
medications.

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
cost.

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
there’s
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
redistributed.

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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
business.

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

http://www.drkoop.com/news/stories/may/r/trials_money.html

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
data.”

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
freedom.”

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.

 1,918 total views

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

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

http://chat.abcnews.go.com/cgi/chat/chat.dll?room=glenmullen

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
medications.

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.

F E A T U R E D B O O K

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
moderator.

 1,952 total views

5/24/2000 – Antidepressants-Suicide Link

This appears at

http://abcnews.go.com/sections/living/DailyNews/antidepressant
s0515.html
——

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
redistributed.

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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
serotonin
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
brain’s
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
disorder.

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
dangers.

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
“depression.”

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
behavior.

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
murderer.

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.

THIS POSTING CAN BE FOUND AT
http://www.drkoop.com/news/stories/may/prozac.html

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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
www.drugawareness.org
________________________________

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
database.

Steve Whiting
http://www.effexorfx.freeuk.com
__________________________

Please refer to
http://www.fda.gov/medwatch/safety/2000/mar00.htm#effexo

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

DRUG ABUSE AND DEPENDENCE:

Physical and Psychological Dependence: New third paragraph –
“Discontinuation effects have been reported in patients receiving venlafaxine
(see DOSAGE AND ADMINISTRATION).”

DOSAGE AND ADMINISTRATION:
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
period.”

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
http://abcnews.go.com/sections/living/DailyNews/ssri000524.html

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
ninth.

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
Backlash.

“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
dosage.

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.

http://www.salon.com/health/feature/2000/05/17/backlash/index.html?CP=SAL&DN=1
10

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
www.drugawareness.org

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