Nursing - Vioxx and veracity

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Vioxx and veracity

Ilena Rose

2004-11-07, 11:09 am

http://www.thejournalnews.com/newsr.../07edvioxx.html

Vioxx and veracity
(Original publication: November 7, 2004)

It's a Hollywood movie plot, right?

Calculating corporation, well aware that its product is harmful, even
fatally so, sells it anyway. Along the way to billions of dollars in
profits, the company coaches its workers to deflect questions about
safety. And it intimidates, then threatens, anyone who dares question
it. Meanwhile, the government hides in the shadows.

Stars Travolta or Roberts or Streep, right?

No, and it's not even a script. The emerging tale of Merck & Co.'s
peddling of widely prescribed Vioxx is for real. For the thousands of
adults and children who have taken it for pain and inflammation
reduction since the Food and Drug Administration approved it in 1999,
it may be all too real.

On Sept. 30, New Jersey-based Merck voluntarily withdrew Vioxx from
the market, citing a company study and "new" concern: The company told
the FDA that it had evidence that when patients take Vioxx for 18
months or longer, it can increase health risks — actually, doubling
the risk of heart attacks and strokes, its own, and subsequent
studies, found. It was a decision, the FDA reports on its Web site,
made independent of the regulating agency.

In the last week, news reports have covered, and uncovered, an
astounding trail of information showing that Merck indeed had more
than a little indication, and notice, that Vioxx might be harmful to
patients:

• A Page One Wall Street Journal report Monday cited internal Merck
documents and marketing materials, including a 2000 e-mail from the
company's research chief at the time, that tied Vioxx to heart risks.
Interviews with outside scientists and doctors show "that the company
fought forcefully for years to keep safety concerns from destroying
the drug's commercial prospects,'' the newspaper reported. Merck also
advised its own trainees to "dodge" questions from physicians about
Vioxx's heart risks, and tried to intimidate critics.

• Swiss researchers reported in an international medical journal
Thursday that evidence was clear and overwhelming in 2000 that Vioxx
doubled the rate of heart attacks. They contended that Merck should
have withdrawn the drug from the market four years ago. The
researchers had examined results from 18 Vioxx studies — all sponsored
by Merck.

• Tuesday, the FDA released a study that said Vioxx may have
contributed to an additional 27,785 heart attacks or deaths from 1999
to 2003, deaths that might have been avoided if patients were taking
Pfizer Inc.'s Celebrex, The Associated Press reported. The study
analyzed medical records of 1.4 million adult members of Kaiser
Permanente, the nation's largest health maintenance organization.

• Also Thursday, the editor of a top medical journal criticized U.S.
drug regulators for ignoring requests to order more clinical safety
testing for Vioxx in 2001.

"Too often the FDA saw and continues to see the pharmaceutical
industry as its customer — a vital source of funding for its
activities — and not as a sector of society in need of strong
regulation," Lancet editor Richard Horton wrote.

A FDA spokeswoman quickly responded, "The industry is not our
customer." She told Bloomberg News that the agency checked for heart
risk as it reviewed Merck's application for Vioxx approval, starting
in 1998.

By Friday, with media reports of hundreds of additional lawsuits
against Merck being pulled together by plaintiffs' lawyers and Merck's
financial indicators slipping, there were calls for new leadership for
the company.

More important for American consumers and patients, the Food and Drug
Administration finally began to shore up its own credibility. The
agency has been under attack for its slow response to concerns about
anti-depressants given to children and teens, and flu vaccine
availability, and reports it discouraged public disagreement among its
scientific reviewers. Friday, the FDA announced that it would appoint
a new director of drug safety and sponsor a study by the Institute of
Medicine to look at the effectiveness of its oversight of drugs.

Congress needs to decide, and soon, whether that's enough to ensure
that the FDA really is regulating drugs and putting patients' safety
first, not manufacturers'.

Todd Gastaldo

2004-11-07, 7:10 pm

> Merck also
> advised its own trainees to "dodge" questions from physicians about
> Vioxx's heart risks, and tried to intimidate critics.
--via "Ilena Rose" <ilena@san.rr.com> wrote in message
news:5b8so0hp1e46v6trjnjjrg20pm8nduhb63@4ax.com...
> http://www.thejournalnews.com/newsr.../07edvioxx.html
>
> Vioxx and veracity
> (Original publication: November 7, 2004)
>

It's not Merck and its not FDA - these are just mental crutches to help
shift blame.

It's MDs. For the love of money, most aren't ASKING obvious questions.

MDs are running an obvious criminal enterprise - saying babies can't
"verbalize" pain - claiming they are opening birth canals even as they close
them up to 30% - among other obvious felonies...

See CAM C-sections and WMDs in S. Korea? (WMDs approached 40% c-sec rate in
2000)
http://health.groups.yahoo.com/grou...st/message/2932

I'm in favor of pardons in advance for MDs. As young med students MDs are
TRAINED to perform the felonies.

Young, impressionable med students are trained by MD "superiors" who had the
same medical "science" training in performing obvious felonies.

Todd

Dr. Gastaldo
todd@chiromotion.com

Todd Gastaldo

2004-11-10, 2:13 am