In article <gEF8d.2804$q%7.2465@newssvr11.news.prodigy.com>,
"Harvey R. Stone" <hrstone@swbell..net> posted:

Forwarded message from "Michael Givel" <mgivel@earthlink.net>

[ Subject: Vioxx woes raise new questions about drug agency oversight
[ From: "Michael Givel" <mgivel@earthlink.net>
[ Date: 3 Oct 2004 10:36:11 -0500

http://www.sfgate.com/cgi-bin/article.cgi?file=/news/archive/2004/10/02/national
1257EDT0506.DTL

Vioxx woes raise new questions about drug agency oversight

DIEDTRA HENDERSON, AP Science Writer

Saturday, October 2, 2004

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(10-02) 09:57 PDT WASHINGTON (AP) --

Americans should feel reasonably safe taking government-approved
prescription drugs -- with a few caveats -- even after a popular arthritis
medication was pulled from the market, medical experts say.

Vioxx was the first prescription drug since 2001 to be taken off the market
for safety reasons. Its maker, Merck & Co., cited an increased risk of heart
attack and stroke in people who used the medication.

The withdrawal on Thursday came just weeks after the company defended the
safety of the drug, which accounted for $2.5 billion in worldwide sales in
2003, and the Food and Drug Administration approved the use of Vioxx in
children as young as 2 years old.

The problems with Vioxx raise questions about the agency's safety review
process and the length of time it took Merck to pull the drug, observers
say.

"No drug is fully safe," said Crystal Rice, an FDA spokeswoman. "Our job is
to appropriately balance our decisions, based on the risk-benefit profile
for a drug and the societal need and desire for new drugs," Rice said in an
e-mail. "We believe that our actions regarding Vioxx were appropriate and
consistent with our public health mission."

The FDA has come under intense pressure from the industry and elsewhere to
approve drugs more quickly, despite clinical trials that some say enroll too
few patients and for too short a time for worrisome side effects to surface.

Research from Harvard, Vanderbilt University and Merck's own clinical trial
long ago uncovered concerns about an increased risk of heart attacks and
high blood pressure linked to Vioxx, said Dr. Jerry Avorn, who pointed to
the issue in his book, "Powerful Medicines: The Benefits, Risks and Costs of
Prescription Drugs."

"Why does it take this long for them to acknowledge the risk?" he asked. "I
fear that FDA has gotten a little bit too cowed by industry demands to
function as a good regulator," said Avorn, an associate professor of
medicine at Harvard Medical School who is affiliated with Brigham and
Women's Hospital in Boston.

An agency spokeswoman, Kathleen K. Quinn, said the FDA gets "pressure from
all sides -- allegations that we're too fast, too slow. We make decisions on
the basis of the science. We weigh the benefits against the risks, ... and
we make the tough calls."

Because of inherent limitations in clinical trials, problems can lie hidden
until drugs go into wider used.

"More than half of all drugs introduced have a new side effect ... after
approval with the current system. I find that disturbing," said Curt
Furberg, a public health sciences professor at Wake Forest University School
of Medicine. For three decades, Furberg has conducted research on how
clinical trials are designed.

Dr. Wayne A. Ray, a Vanderbilt professor of preventive medicine, said the
FDA has a reason to make judgment calls on less than perfect clinical trial
data.

"The FDA is not going to hold up a medication for a generation to make sure
it's safe. And similarly, they're not going to require you to study half a
million people," Ray said.

Still, Ray acknowledged that after drugs are approved, data gaps loom
larger.

Take a drug such as the widely used antibiotic erythromycin. When the
antibiotic is used in concert with newer drugs, the risk of cardiac death is
five times higher, according to a study that Ray conducted. The findings
were published in early September in the New England Journal of Medicine.

An FDA spokesman said erythromycin labels already note that risk. Still, the
agency is reviewing the study to see if additional label changes are
warranted.

Ray said the single study points to a larger problem.

"There is no provision for systematically assessing and reviewing the safety
of the many, many medications that are out there," Ray said. "And the
patients are the ones who are going to suffer."

The vast majority of companies do not follow through on promises to conduct
those reviews, the FDA says. The FDA received 2,400 agreements to conduct
post-marketing studies on drugs. Only 882 such studies were completed,
according to an FDA analysis from Feb. 8, 2002, the most recent data
available.

The FDA could take a simple step that would improve clinical trial quality
before it approved drugs, observers say. Drug companies with products
comparable to Vioxx could be required to conduct longer clinical trials.

"If you're the FDA, you'll say `OK, all bets are off. We're going to make
you do studies lasting 18 months,"' said Dr. Sidney Wolfe, director of
Public Citizen.

At the time of approval, the FDA had data from clinical trials on Vioxx that
lasted for 12 months. The increased risk of heart attack and stroke that
prompted Merck to pull Vioxx did not begin to appear until older patients
had taken took the drug for 18 months.

In a telephone briefing with reporters, Dr. Steven Galson, the agency's
acting director of the Center for Drug Evaluation and Research, said the FDA
will move in that direction for comparable drugs on the market and for such
drugs that might be approved in the future.

"It's too early for me to say, right now, how we're going to change our
requirements," Galson said. "But, obviously, we're going to be more
interested in long-term data."

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On the Net:

Food and Drug Administration: www.fda.gov

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End of forwarded message from "Michael Givel" <mgivel@earthlink.net>

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