4/09/2001 – Ghostwriting Articles for Medical Journals

Dennis Silver, who serves as webmaster for the Prozac: Panacea or Pandora?
website (members.aol.com/atracyphd), has just brought to our attention an
amazing article from CBS Health Watch. In the ten years I have been fighting
this battle to get the truth out to the public about what goes on behind the
scenes in medcine this strikes at the heart of the issue like no other!

As I did the research for my book I was appalled at the difference in the
studies on serotonin BEFORE the development of the SSRIs and the studies
being published on serotonin AFTER and during the development of the SSRI
antidepressants. It was clear to me that the drug companies were manipulating
the science to build a market for their drugs. It was as if the new studies
were contradicting the old studies. Truth is consistent not variable. It was
clear something had changed. I say BRAVO!!! to CBS and to Dr. Marcia Angell,
former editor of the New England Journal of Medicine, who has worked hard to
expose this situation over the last year or so! Thank you for demonstrating
that integrity still exists in our country by exposing those with no
knowledge of what integrity is.

Note how the spokesperson for Wythe Ayers justifies their criminal behavior
with the same old line: “well everyone else does it too.”

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

http://cbshealthwatch.medscape.com/medscape/p/G_Library/article.asp?RecId=2381

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Ghostwriting Articles for Medical Journals

April 5 (CBS) Amidst the billion-dollar competition to create the newest
blockbuster drug, there’s one thing worth more than all the ads money can
buy: a single positive mention in a respected medical journal. Doctors rely
so heavily on what’s printed in journals that a drug’s success or failure may
be directly affected.

Now, many drug companies are actually writing those articles and then paying
doctors to sign their names to them. It’s called ghostwriting, reports CBS
News Correspondent Sharyl Attkisson.

“The articles are written by drug company researchers, given to an outside
doctor to review and sign his or her name to, and then submitted to a
journal. In effect, it’s like washing dirty money,” explains Douglas Peters,
a medical malpractice attorney.

It’s not illegal, but it can be misleading.

Critics say that’s just what happened when Wyeth-Ayerst wanted to create a
market demand for its “fen-phen” diet drug, Redux.

Wyeth hired a middleman, a company called Excerpta Medica, to write and get
published nine medical journal articles on Redux. Excerpta paid doctors to
review and sign the articles, then submitted them to journals with no mention
of Wyeth. Excerpta claims it told the doctors that Wyeth was behind all of
it.

But Dr. Richard Atkinson, a professor of medicine and nutritional sciences
and the director of the Beers-Murphy Clinical Nutrition Center at the
University of Wisconsin Madison Medical School, says he wasn’t told. He
reviewed and signed one of those Redux papers thinking Excerpta was an
independent researcher, he says.

“If I knew that a drug company had some role, whatever role, in sponsoring a
talk, an article, a symposium, whatever, I think I would be more on my guard
to make sure that there was not any bias introduced,” says Atkinson.

Biased literature can make a drug sound better or safer than it really is.
And unbeknownst to most doctors, it’s even finding its way into the most
respected medical journals.

Dr. Marcia Angell, former editor of the New England Journal of Medicine, says
that as time passed she was getting more and more ghostwritten papers.

“A drug company that controls the data and has a ghostwriter writing the
paper may neglect to write about the side effects of a drug,” says Angell.

In a deposition on January 15, 1999, former Wyeth executive Jo Alene Dolan
said all drug companies ghostwrite, but it doesn’t mean the articles aren’t
accurate.

When questioned about Atkinson’s article, she said, “Apparently we wrote this
article for him.” She was then asked if it was bought and paid for by
Wyeth-Ayerst and replied, “I’m not sure that’s the way I would characterize
it. It was funded by Wyeth-Ayerst.”

Yet Wyeth’s middleman, Excerpta Medica, claims it doesn’t ghostwrite. It says
it “facilitates,” that doctors always know about drug industry involvement,
and that “the author has final editing authority.”

Atkinson did tell Excerpta that article may make Redux “sound better than it
really is” and suggested some changes. But before the article could be
published, Redux was linked to heart and lung problems and pulled from the
market.

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4/9/2001 – FDA Doc Claims Fen-Phen Cover Up

Once again the CBS Health Watch has given us another great article – this
time on the subject of corruption in the FDA.

With this revelation about the cover up with Fen-Phen let us hope that the
truth will begin to come out about the rest of these dangerous serotonergic
drugs. The real shame about Fen-Phen and Redux is that the drug company is
still getting away with all the psychiatric side effects their drugs
produced. The serotonergic effect with these drugs produced as many psychotic
breaks as the SSRIs have and in the end we will see that the SSRIs are
producing similar heart and lung problems as Fen-Phen and Redux did.

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

http://cbshealthwatch.medscape.com/SRS/c/ShowDoc.asp?ContentID=214123&ContentType=5

FDA Doc Claims Fen-Phen Cover Up

April 7 (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.

But 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.

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