4/30/2000 – Gumble’s Interview with MI Medical Examiner re: Ritalin

From Ann Blake-Tracy….

We sent you the news last week that Oakland County Medical
Examiner Dr. Ljubisa Dragovic in Pontiac, MI attributed a ten year
span of Ritalin use to the heart failure death of 14 year old
Matthew Smith.

Apparently for years the school had threatened to turn the family
in for neglect if the boy was not kept on Ritalin – a problem facing
far too many families today in a country that has been given
warnings by the United Nations because the United States uses
90% of the world’s Ritalin supply. This is going on in schools
that deceive us all by posting signs that read “Drug Free Zone.”
It would be far more appropriate to post signs that read “Drug
Zone.” I have always said it is so ironic that the police could
probably confiscate more “meth” raiding a school for
methylphenidate (Ritalin) than they would in shutting down a
meth lab.

Matthew’s chest pains and racing heart had been ignored as
warning signs that the small blood vessels that supply the heart
were being shut off by the Ritalin because, “You just don’t see
this in the younger population.”

On April 17, 2000 Bryant Gumbel interviewed Dr. Dragovic and a
psychiatrist who was attempting to defend psychiatry’s use of
Ritalin. Some very interesting points were made by Dr. Dragovic
in the interview that we would like to share with you. Some of the
most important points I have highlighted.

Ann Blake-Tracy
___________________________

GUMBEL: Matthew’s cause of death was officially listed as heart
attack. Why do you blame Ritalin?

Dr. DRAGOVIC: Well, because we found, at autopsy, changes
that were of significance, and these changes were particularly in
small blood vessels that supply the heart muscle. These
chronic changes, these are the changes that result from
long-term type of exposure to a stimulant like this.

GUMBEL: Could–could there possibly be no other cause for a
heart attack in a 14-year-old? No family history of heart trouble,
no–no possibility of drug use?

Dr. DRAGOVIC: Well, we did all the toxicological workup. The
only medication he was on was actually Ritalin, which is
methylphenidate. We certainly excluded all other disease
processes in his body. There was nothing wrong with the
14-year-old, other than the fact that he had some significant
changes, long-term changes in the small vessels that supply
his heart muscle. And I’m not talking about large coronary
arteries. I’m talking about arterioles. These are the smaller
vessels that, over a period of time, get really primed up by-by the
effect of this type of medication.

GUMBEL: I want to bring in our guest here. Psychiatrist Bill Koch
has prescribed Ritalin to thousands of patients. You’ve
characterized Dr. Dragovic’s views on Matthew Smith’s death as
a wild claim. How come?

Dr. KOCH: Unfortunately, with all due respect to the doctor, there
is absolutely no evidence that Ritalin causes vascular disease.
This medication has been around for almost 50 years. It’s been
used in millions of children, and there’s no evidence that it
causes heart disease. In fact, it has been cleared by the
American Heart Association as being very safe. They don’t
require even any monitoring, unless there is somebody who
already has heart disease. Among the patients that I see, I even
give it to people who have heart disease. I mean, obviously, if
they have heart disease pre-existing, they’re very carefully
monitored. But there is no evidence. In fact, one of the nice
things about Ritalin is that it has very little effect on the heart,
as
do some of the other stimulant medications.

GUMBEL: …Dr. Dragovic is there something you’re not looking
at?

Dr. DRAGOVIC: Well, I would like to remind my esteemed
colleague over there that in pathology, and particularly in forensic
pathology, we don’t come to a conclusion through a democratic
process of arguing the points. It’s the findings that dictate the
diagnosis, and they are there. We didn’t put them there. If there
is a better explanation I will certainly take it. To exclude the
possibility of effect on the heart of a known adrenergic agonist is
really a far-fetched type of expression. Unfortunately, we learn
through our mistakes, and the analogy can be found in Seldane,
or the cases of which I have deaths related to Seldane I have
investigated, cases of deaths of Parlodel, Bromocriptine and
things like that–we are just learning through the unfortunate
experiences, and…

GUMBEL: Let me ask you something. Where Ritalin is
concerned, will you have any pause about prescribing it from
here on?

Dr. KOCH: Absolutely not.

GUMBEL: And Dr. Dragovic?

Dr. DRAGOVIC: I’m not a psychiatrist. I’m a forensic pathologist
and a unipathologist. I’m a basic scientist. I have seven children.
I would never suggest or allow my kids to take it or anyone who I
know would I advise to take it.

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4/30/2000 – FDA Warns of Fatal Risks Linked to TriCitrasol

WASHINGTON, Apr 19 (Reuters Health) – The US Food and
Drug Administration (FDA) is warning US hospital pharmacies
and dialysis centers of at least one case of fatal cardiac arrest
linked to the unapproved injectable drug triCitrasol.

The agency issued its warning after learning of the fatality, in
which a patient went into cardiac arrest after receiving a 46.7%
concentration of the sodium citrate anticoagulant, which was
introduced into a hemodialysis permanent blood access
catheter. The catheter was implanted into the patient
immediately prior to the incident.

Rapid or excessive infusion of triCitrasol has been blamed for a
host of serious reactions, including fatal heart rhythm disorders,
seizures or bleeding due to loss of blood calcium.

The FDA is warning against the use of the drug with blood
access catheters. The agency said that it is currently reviewing a
number of additional cases that might be associated with
triCitrasol infusion when performing hemodialysis. The drug’s
manufacturer and its distributor are collaborating on the recall
effort.

Cytosol Laboratories, of Braintree, Massachusetts, markets the
drug in individual sterile, 30 mL glass vials and in catheter “kits.”
Medcomp, of Harleysville, Pennsylvania, distributes the kits
under the trade name Ash Split Catheter II, as well as the
individual vials. Medcomp is handling the recall of only those kits
and separate vials marketed before November 1, 1999.

“We have every single [catheter] kit tracked,” a Medcomp
spokeswoman told Reuters Health, noting that recall of the kits
began on April 9, followed by recall of the separate vials on April
14. The FDA claims that about 3,000 Cytosol catheter kits are
sold nationwide, although Todd Polk, Medcomp’s head of
regulatory affairs, would not confirm those numbers to Reuters
Health. Polk declined to speculate when the recall might be
brought to a close.

As to the question of whether Medcomp knew of the Cytosol
product’s status as an unapproved drug, Polk responded,
“obviously not.” The FDA said that alternative 4% citrate solutions
remain available for use in hospital pharmacies, hemodialysis
and other medical settings. The agency said that it is working
with Cytosol on a limited access plan, as the drug is still needed
in some cases to prepare white cells for transfusion.

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4/21/2000 – More Prozac Backlash

Here is a commentary that defends Dr. Joseph Glenmullen’s
book, Prozac Backlash, by Nicholas Regush, a medical features
writer for ABCNEWS. Mark

It appears today on the ABC News site:

More Prozac Backlash
Drug Firm Attacks Prozac Book, But Lacks Long-Term Data

Commentary
By Nicholas Regush

Prozac Nightmare. This is what I would have called Dr. Joseph
Glenmullen’s book on the vastly over-prescribed, so-called
miracle happiness pill and its cousins such as Zoloft and Paxil.
He was actually much too kind in dubbing it Prozac Backlash.

Glenmullen, who has a private practice in Cambridge, Mass.,
claims far too many people, including 28 million Americans,
have taken the new antidepressants that boost serotonin in the
brain. He claims that their numerous side effects, including loss
of sex drive and self-destructive and violent feelings, are poorly
tracked and long-term safety data sorely lacking.

He is also concerned these drugs can cause some brain
damage and cites effects such as loss of motor control and
grotesque facial and whole body tics.

Glenmullen emphasizes, however, that individuals who have
moderate to severe illness might benefit from these drugs.
Those with mild depression or the “worried well” should avoid
the potentially harmful effects of these drugs and seek
alternatives such as talk therapy, he says.

Company Denounces Book
But Eli Lilly and Company, makers of Prozac, have denounced
Glenmullen’s book as loaded with “omissions,” “half-truths,” and
“anecdotes.”

A call to Lilly provided me with an official company statement
about the book that pointed out Prozac “is one of the most
studied medicines in the world and often the first choice of
doctors.” Lilly, however, omitted the nagging fact that very little
is
known about their product’s long-term side effects.

Lilly’s statement goes on to say that Glenmullen discredits the
work of the Food and Drug Administration. But what does it
mean to discredit a government agency that does a pathetic job
of tracking drug side effects once a new drug gets on the
market? By the FDA’s own estimates, only some 1 percent to 10
percent of all drug side effects are reported to its surveillance
system.

The “anecdotes” or case reports that Lilly denounces in
Glenmullen’s book can be a tip-off of what might be happening
to many more patients. It seems to me that it is better to have
case reports that point to potential problems than rely on the FDA
to process a tiny fraction of harmful events caused by the new
antidepressant drugs.
The company also writes that Glenmullen attacks the work of
research scientists, academic medical institutions and doctors.
In his indictment of the health care system, he apparently finds
collusion, conspiracy and ineptitude around every corner.

Valid Criticisms
Having read Glenmullen’s book, I can’t recall any conspiracy
theories. He does, however, do a very fine job of pointing out how
inept the drug approval and drug tracking systems are in this
country and that medical researchers financed by the drug
industry are on FDA advisory boards and sometimes even vote
on drugs that they helped to research.

Which brings me to Lilly’s suggestion that I contact several
doctors “who are available for comment on the book.” The first
one I reached was Dr. Jerrold Rosenbaum, director of outpatient
psychiatry at Massachusetts General Hospital, in Boston.
But wait, did he read Glenmullen’s book? Oh, only about 60 to 70
of the 386 pages, he said. (He “thumbed through” some other
parts of it). “There’s nothing new in this book,” he said. “There
are gross exaggerations.”

Rosenbaum also objected to Glenmullen’s suggestion that St.
John’s Wort might serve as an alternative for some patients who
are mildly depressed. True, this herbal approach to depression
needs more science behind it — but then so does Prozac. Did
Rosenbaum see anything of value in the small parts of the book
he read and thumbed through? Yes, Glenmullen offers some
ideas in the book “that are reasonable for fair debate.” For
example, maybe Glenmullen is correct in writing that the
managed care system gets too many people on
antidepressants because that’s often the cheaper approach.
Talk therapy, for example, can cost a bundle.

No Long-term Data
Dr. Anthony Rothschild, a psychiatrist affiliated with University of
Massachusetts Memorial Health Care, in Worcester, Mass.,
didn’t much care for the book either. He says he read most of it.

“The book ignores years of experience of the safety and efficacy”
of the serotonin boosters, he says. Really? I thought the book
included the strong argument that it would be really neat to have
long-term safety and efficacy data so that we can have some real
experience with these antidepressants.

Whose years of experience is Rothschild referencing here,
anyway? Considering that large numbers of users of these
drugs take them for more than a year, let’s not get too huffy and
puffy about people questioning their safety, particularly over the
longer term.

Yes, Glenmullen’s book may at times seem too insistent on the
value of case reports (often from his own patients), and, yes, his
interpretations of some of the scientific literature might differ
from those who strongly support the use of these
antidepressants.

But in the end, he raises important questions that will become
increasingly difficult for Lilly and its doctor pals to duck.

Perhaps the federal government needs to do long-term studies
on the impacts of these drugs as the pharmaceutical companies
have little incentive at this point to do it because the drugs have
been on the market for several years.

Someone has to care about the long-term effects.

http://www.abcnews.go.com/sections/living/SecondOpinion/seco
ndopinion.html

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Nurse Tells of Horrors after Gaining Weight on Prozac

“Prozac is a dangerous drug!!!!! It has changed my body, my health, my financial status, influenced my marital status and almost destroyed me.”

 

Hi Ann Blake-Tracy,

Tomorrow will be 77 days off Prozac.

I feel relieved and elated that I have made it this far…and feel good. I hope my story can help some of the readers, as I have been on a real rollercoaster ride with this drug.

Let me start at the beginning. I have been prescribed and have taken sporadically antidepressant drugs for about 29 years. I have been diagnosed as bipolar but have neither manic episodes or deep depression. I do have time to time mild depression which causes some anxiety in my day to day living.

Three years ago a psychiatrist, seeing me for 10 minutes as a requirement as an adjunct to my one on one therapy with my therapist, prescribed Prozac. I was started on 20mg per day and within 1 day could feel it “kicking in” and making the world tolerable again. I immediately felt that I had really needed this drug..and why did I wait so long to feel better….as the weeks wore on however, the initial good feelings for my fellow man were replaced by transient feelings of anxiety…feeling that I couldn’t cope with things, situations… and an ongoing feeling that I didn’t want to deal with anything anymore.

I also started to gain weight…..mostly craving fast food and sweets…..at the end of 3 years I have gained 65 pounds and have the appearance of a cushinoid patient with upper body weight, buffalo hump, facial weight. I look different..I don’t look healthy. I also quit a job that I had for 7 years and started job hopping…had 4 jobs in one year. Financially..somehow I went from good credit…to bad credit with my 2nd mortgage becoming a reality to get my life back. I also divorced a husband of 26 years and remarried…but I believe that was a good choice. Would I have made different choices without the Prozac….I don’t know…….I weaned myself off the drug after reading your book and feel so much better mentally…..I have started another job and have stuck to it…I feel I have myself back again.

The only problem is the weight…..I can’t seem to get it off………Do you have any suggestions on diet types for this problem? I know the Cortisol is directly at fault…does it continue??? How do we stop it? I am a nurse and have been trying to research it on my own…what I have found is disheartening…..effects may last 2 years…….any suggestions….

I have also sent your book to my daughter who was also on Prozac..and my other daughter on Paxil….. Both are off the drugs after weaning…and doing better…..Prozac is a dangerous drug!!!!! It has changed my body, my health, my financial status, influenced my marital status…..and almost destroyed me……Please write back on any suggestions you may have on diet to crack this weight..I am 52 years old.
———–

Note from Ann Blake-Tracy:

Whatever you do as an ex-SSRI user, DO NOT try the high protein diet craze that is making a come back in spite of destroying the health of so many in the 1970’s! Ex-SSRI users are becoming EXTREMELY ill trying to follow this diet. I personally believe the reason for that is that the serotonergic drugs, while impairing one’s ability to break down serotonin, also impair one’s ability to metabolize proteins. This would make high protein diets very dangerous for them. Good nutrition, walking, sufficient water intake, proper sleep, and good fats Vs bad fats have always been the keys to weight loss. Check out Udo Erasmus’ book, “Fats the Heal, Fats that Kill” at www.edoerasmus.com.

Susan in Michigan

4/17/2000

This is Survivor Story number 24.
Total number of stories in current database is 96

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4/17/2000 – Heat deaths related to medication raised

The inability to handle heat has been a common report from
patients for years with the serotonergic medications. Many
patients also find that it continues after coming off the
medication. Now the Dallas Morning News brings us some
insight into the dangers of that reaction.

Ann Blake-Tracy
————————

Heat deaths related to medication raised
Dallas Morning News (April 17, 2000).

DAYTON, Ohio – Findings from health authorities have doubled
the number of deaths related to psychiatric medications taken by
the mentally ill during last summer’s fierce Midwestern heat
wave.

New figures from the U.S. Centers for Disease Control and
Prevention in Atlanta and the Cook County medical examiner’s
office in Chicago show that at least 23 of the estimated 300 dead
were mentally ill people who took medicines that made them
especially vulnerable to death from intense summer heat.

The total could be higher because not all coroners where heat
deaths occurred performed toxicology tests. The medications
interfere with the body’s thermo-regulatory system, hazards
known to physicians but seldom publicized.

Common drugs included Mellaril, Elavil, Prozac and Zoloft.

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4/17/2000 – Ritalin May Have Led to Boy’s Death

Medical Examiner: Ritalin May Have Led to Boy’s Death
Monday, April 17, 2000

THE ASSOCIATED PRESS

PONTIAC, Mich. — A medical examiner says long-term use of
Ritalin, a drug used to treat hyperactive children, may have led to
a 14-year-old boy’s death.

Matthew Smith collapsed at his home on March 21 while playing
with a skateboard and was pronounced dead at a hospital a
short time later. Oakland County Medical Examiner Ljubisa
Dragovic concluded that the boy died of a heart attack the likely
cause of which was 10 years of taking Ritalin for attention deficit
hyperactivity disorder.

“This was a gradual development,” Dragovic said Sunday in The
Oakland Press. “There were changes that occurred in the small
blood vessels that supply the heart muscle.

Smith’s family told Dragovic the teen-ager occasionally
complained of chest discomfort and racing heart, signs that
something was wrong, the medical examiner said. “This is not a
heart condition, which could have been diagnosed just like that,”
Dragovic said. “You just don’t see this in the younger population.”

But Dragovic’s naming of Ritalin as a suspect in the boy’s death
is being questioned by some experts who say the drug has been
shown to be extremely safe. Ritalin is a popular brand name for
the stimulant methylphenidate, believed to increase a child’s
alertness by stimulating the central nervous system.

Joseph Biederman, professor of psychology at Harvard
University and a longtime researcher of stimulants, said
Dragovic’s conclusion was unfounded.

“It is a free country and people can have whatever opinion they
want,” Biederman said. “But Ritalin has a long history of safety
unparalleled by any other drug.”

Cardiac side effects to Ritalin are rare and don’t include death,
said David Rosenberg, a child psychiatrist with Children’s
Hospital of Michigan in Detroit.

“There have been reported increases in blood pressure and
pulse that aren’t clinically significant,” Rosenberg said. “But I
would want to avoid it in someone with an underlying heart
condition.”

Biederman, who also is chief of pediatric pharmacology at
Massachusetts General Hospital in Boston said it is not unusual
for people to take Ritalin their entire lives.

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4/14/2000 – FDA Doc Claims Fen-Phen Cover-Up

More “hanky-panky” in the pharmaceutical industry. Did you see
this article posted this week on the CBS news site? There is a
link on our site to the class-action lawsuit suit if you or someone
you know has been effected by fen-phen. Mark

http://cbsnews.cbs.com/now/story/0,1597,181616-412,00.shtml

FDA Doc Claims Fen-Phen Cover-Up

* Says Drug Maker Altered His Findings
* Diet Drug Linked To Heart, Lung Maladies
* Company Agreed To $4.8 Billion Settlement Last Year

WASHINGTON
CBS
Fen-phen

(CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with
the drug that emerged during Food and Drug Administration
testing, a former FDA scientist tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of
people who took the drug have sued American Home Products
of Madison, N.J., for health problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent
Sharyl Attkisson reports the FDA’s key reviewer of fen-phen, Dr.
Leo Lutwak, claims the company knew about the problems long
before the drug was pulled.

“I felt from the very beginning the drug companies were covering
up. I felt from the very beginning that these drugs were
dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his
research to make it seem as if there was no way to predict
fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of
predicting some of these side effects,” he said.

One of those who sued American Home Products was Patricia
Buol, who developed severe heart problems after taking
fen-phen. She’s now in line for a life saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is
a struggle,” said Buol. “But I just take one day at a time and do
the best I can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s.
But the FDA won’t let him testify. Now Lutwak says he’s planning
to retire, making him free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to
work within the system, it didn’t work. People died as a result of a
dangerous deadly drug being released,” he said.

Defendant American Home Products would not be interviewed,
but has said in the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request
to answer the allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the
agency’s current approach to drug regulation.

“I have some concerns that we may be losing sight of what the
FDA is all about,” said Kessler. “The question is, who’s the
agency’s customers? Who’s the agency partner?”

Consumer advocates say the FDA is constantly keeping
damaging information from the public.

“They view the drug industry in many ways as their customers, at
least the bosses do, as opposed to viewing the public as the
customers they need to protect from some of the excesses of the
drug industry,” said Sidney Wolfe of Public Citizen.

Concerns about the FDA also emerged during the controversy
over the diabetes drug Rezulin.

Kessler said the agency needs to realize the American
consumer is its customer.

American Home Products also makes such drugs as
Caordarone, Sectral, Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine
and phentermine, which work by suppressing the appetite of a
person who is trying to lose weight.

It was estimated that in 1996, 18 million Americans took the
drugs.

FDA: Under The Micriscope
Click here to read CBS News Correspondent Sharyl Attkisson’s
reports on the FDA and the diabetes drug RezulinBut a report in
the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary
hypertension, a rare, almost always fatal, disease. It was also
linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new
evidence about significant side-effects,” asked the
manufacturers to voluntarily withdraw both medications,
marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home
Products, complied.

However, the company continued to deny the drugs caused the
alleged problems. In November, 1998, Wyeth-Ayerst published a
study that compared heart function in people who had taken
fen-phen and a group who hadn’t, and concluded there was “no
significant differences in cardiovascular clinical outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News &
World Report revealed that Wyeth-Ayerst knew more than it told
about the pulmonary hypertension risks, a charge the company
denied.

In September 1999, the Wall Street Journal reported that the FBI
was investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to
$4.83 billion to settle the more than 11,000 fen-phen lawsuits,
one of the biggest product liability settlements ever.

As part of the settlement agreement, the company admitted no
wrongdoing.

Copyright 2000, CBS Worldwide Inc., All Rights Reserved.

558 total views, 2 views today

4/14/2000 – Safety Study Skimping?

This article appeared yesterday on the ABC News site. We know
that drugs are given only cursory tests before being introduced
into the marketplace. Pharmaceuticals counter that they do
extensive follow-up testing (post-marketing) to assure that the
drugs are in fact safe. Now, it appears that this is something to
which they only give lip service. Mark

http://abcnews.go.com/onair/WorldNewsTonight/wnt_000413_fd
a_feature.html

Report Says Drug Companies Fail to Complete Required Tests
When the Food and Drug Administration approves a drug it may
still have lingering questions about its safety or effectiveness
which it expects will be answered by the drug company.
(ABCNEWS.com)

By John McKenzie

N E W Y O R K, April 13 Evidence gathered by an
independent advocacy group suggests that many drug
companies in the United States are not keeping all of their
promises.

When a drug is approved by the Food and Drug Administration,
pharmaceutical firms are required to fulfill “post-marketing”
commitments to continue studying the safety and effectiveness
of the new product. Such research is necessary because the
FDA often approves drugs that have been tested on only a few
thousand people and lingering questions may remain about
how the drugs interact with other medicines or foods and what
kinds of side effects they may create in various patients.

The new study indicates, however, that many companies
routinely fail to follow through with these studies after the new
drugs reach the market. And the FDA is virtually powerless to do
anything about their lack of compliance.

The group that issued the report, Public Citizen, presented the
evidence to the FDA today, based on information obtained
through the Freedom of Information Act.

“Reliance on post-marketing studies as a way of safely
approving drugs is a dumb idea,” says Dr. Sidney Wolfe of Public
Citizen. “And a very dangerous idea because the studies mainly
are not getting done.”

Non-Compliance, No Consequences

According to Wolfe and the other authors of the report, FDA files
reveal that five drugs that were approved in the past decade and
later withdrawn from the market for safety reasons never had all
of their required follow-up studies completed.

And as of last December, only 11 out of the 88 new drugs that
were approved with post-marketing commitments between 1990
and 1994, had been subjected to the necessary studies or
properly filed the results. That€ ‘²s a compliance rate of just 13
percent.

“Five to ten years is certainly more than enough for the
overwhelming majority of these studies to be completed,” says
Dr. Brian Strom of the University of Pennsylvania. “The longer it
takes to answer these questions the longer patients are
exposed to potentially unnecessary risks.”

FDA Lacks Power

Representatives for the drug industry, however, say such studies
require greater patience.

“Specific studies that have to be designed, executed’. and if
they’re done in a comprehensive way they take a long time
to
do,” says Wayne Pines, a pharmaceutical industry spokesman.

But while the FDA can tell the drug companies to conduct
additional post-marketing studies, the fact is that once a drug is
on the market there’s little it can do to enforce the order.

Consumer advocates say Congress needs to give the FDA the
authority to impose fines on drug companies that break their
promises.

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Spaced Out on Zyban

“I was a very frightening experience.”

I took Zyban (Wellbutrin) to help me stop smoking. Was on it for 2 weeks and never have I felt so awful! I felt “spaced out”, nervous, crying spells, jittery feeling, and just didn’t feel myself…felt almost out of control. I went off it and almost immediately felt myself again. It was a very frightening experience and I certainly have no wish to repeat it.

glayres@bmts.com

4/13/2000

This is Survivor Story number 25.

Total number of stories in current database is 96

335 total views, 1 views today