---

Banned Report on Vioxx Published


Banned Report on Vioxx Published -- Posted by Roman Bystrianyk on 01-25-05 02:52


http://www.healthsentinel.com/news.php?event=news_print_list_item&id=563

Thomas H. Maugh II, "Banned Report on Vioxx Published", Los Angeles
Times, January 25, 2005,
Link:
http://www.latimes.com/features/health/medicine/la-sci-vioxx25jan25,1,4291183.story?coll=la-health-medicine

A report on Vioxx risks previously blocked by the Food and Drug
Administration was published online Monday after the agency withdrew
its opposition.

The study found that as many as 140,000 cases of heart disease in the
United States and as many as 56,000 deaths were caused by the
painkiller during the five years that it was on the market.

The study's findings were announced in August at a medical meeting in
France and in a Nov. 18 Senate hearing by its lead author, Dr. David J.
Graham of the FDA's Office of Drug Safety. Graham has been an outspoken
critic of the FDA's regulatory policies for new drugs.

Similar to other research released last year, the study of 1.4 million
patients found that low doses of Vioxx increased the risk of heart
disease by about 50%, and higher doses increased it by 358%.

The study, published by the journal Lancet, was sponsored by the FDA
and used data collected from patients of Kaiser Permanente California
over a three-year period.

The report was accepted by the Lancet last year and scheduled for
publication in November, about the same time that Graham was to testify
to a Senate committee about the study's findings.

"On Nov. 16, I was ordered to withdraw the paper or 'face severe
consequences' - which I interpreted to mean that I would be fired,"
Graham said. "With a gun to my head, I called Lancet and withdrew the
article."

Merck & Co. withdrew Vioxx from the market Sept. 30 after other studies
linked the drug to increased heart attack risk.

The FDA cleared Graham's paper for publication this month.

The study identified about 40,000 people who used Vioxx, a million who
used ibuprofen, 435,000 who used naproxen and 27,000 who used Celebrex,
a drug from the same family as Vioxx known as Cox-2 inhibitors.

Graham's study found 8,143 cases of serious coronary heart disease and
1,508 deaths among all the painkiller users. The risk of heart disease
and death was substantially higher for those taking Vioxx. No increased
risk was associated with use of Celebrex.

Extrapolating the results on a nationwide scale, Graham and his
colleagues estimated that Vioxx was responsible for 88,000 to 140,000
cases of heart disease.

In other developments Monday, Dr. William B. White at the University of
Connecticut School of Medicine and his colleagues studied Vioxx,
Celebrex and naproxen in patients with type 2 diabetes, hypertension
and osteoarthritis. They reported in the Archives of Internal Medicine
that Vioxx increased blood pressure significantly, but that the other
two drugs did not. All gave similar pain relief, the report said.


Re: Banned Report on Vioxx Published -- Posted by Ilena Rose on 01-25-05 06:10



Thank you so much for this post Roman ...

No wonder the pharma front groups go into a frenzy and attack any
possible death related to non Con Med medical care ...

Quackwatch's Ragtag Posse members screech 'MURDERER' 'MURDERER'
'MURDERER' ...

They have an enormous death toll to attempt to cover up ...

I recall one from this Posse taking bows when this story originally
broke congratulating Merck for voluntarily removing the product from
the market.
www.humanticsfoundation.com/andysposse.htm


On 25 Jan 2005 02:52:47 -0800, "Roman Bystrianyk"
wrote:

>
>http://www.healthsentinel.com/news.php?event=news_print_list_item&id=563

>
>Thomas H. Maugh II, "Banned Report on Vioxx Published", Los Angeles

>Times, January 25, 2005,
>Link:
>http://www.latimes.com/features/health/medicine/la-sci-vioxx25jan25,1,4291183.story?coll=la-health-medicine
>
>A report on Vioxx risks previously blocked by the Food and Drug

>Administration was published online Monday after the agency withdrew
>its opposition.
>
>The study found that as many as 140,000 cases of heart disease in the

>United States and as many as 56,000 deaths were caused by the
>painkiller during the five years that it was on the market.
>
>The study's findings were announced in August at a medical meeting in

>France and in a Nov. 18 Senate hearing by its lead author, Dr. David J.
>Graham of the FDA's Office of Drug Safety. Graham has been an outspoken
>critic of the FDA's regulatory policies for new drugs.
>
>Similar to other research released last year, the study of 1.4 million

>patients found that low doses of Vioxx increased the risk of heart
>disease by about 50%, and higher doses increased it by 358%.
>
>The study, published by the journal Lancet, was sponsored by the FDA

>and used data collected from patients of Kaiser Permanente California
>over a three-year period.
>
>The report was accepted by the Lancet last year and scheduled for

>publication in November, about the same time that Graham was to testify
>to a Senate committee about the study's findings.
>
>"On Nov. 16, I was ordered to withdraw the paper or 'face severe

>consequences' - which I interpreted to mean that I would be fired,"
>Graham said. "With a gun to my head, I called Lancet and withdrew the
>article."
>
>Merck & Co. withdrew Vioxx from the market Sept. 30 after other studies

>linked the drug to increased heart attack risk.
>
>The FDA cleared Graham's paper for publication this month.

>
>The study identified about 40,000 people who used Vioxx, a million who

>used ibuprofen, 435,000 who used naproxen and 27,000 who used Celebrex,
>a drug from the same family as Vioxx known as Cox-2 inhibitors.
>
>Graham's study found 8,143 cases of serious coronary heart disease and

>1,508 deaths among all the painkiller users. The risk of heart disease
>and death was substantially higher for those taking Vioxx. No increased
>risk was associated with use of Celebrex.
>
>Extrapolating the results on a nationwide scale, Graham and his

>colleagues estimated that Vioxx was responsible for 88,000 to 140,000
>cases of heart disease.
>
>In other developments Monday, Dr. William B. White at the University of

>Connecticut School of Medicine and his colleagues studied Vioxx,
>Celebrex and naproxen in patients with type 2 diabetes, hypertension
>and osteoarthritis. They reported in the Archives of Internal Medicine
>that Vioxx increased blood pressure significantly, but that the other
>two drugs did not. All gave similar pain relief, the report said.



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