Re: Vioxx and the BUSH campaign

outrider_at_despammed.com
Date: 11/20/04 

Date: 19 Nov 2004 18:24:24 -0800

Jim Chinnis wrote:
> outrider@despammed.com wrote in part:
>
> >Tsk tsk. Jim. And yes Jim. This is science bowed low.
>
> I'd say it is business bowed low. The science is unchanged.

Well yes. Science has willingly allowed itself to be co-opted by
business.

>
> Yes, the journalists did a good thing. I only warned that they will
stumble if
> they begin to write incoherent or just plain wrong material such as
the bit
> you quoted by Pizzo.

It was not the point. I gave you two: one 'straight', one sarky. They
each made pithy and factual points. They were different styles, from
different publications, but neither was 'wrong'.

It was the issue that was 'wrong'.

Zee

> --
> Jim Chinnis Warrenton, Virginia, USA jchinnis@alum.mit.edu

Sorry no url:

FDA Official Assails Agency
On Monitoring of Risks

At Hearing on Vioxx Recall,
Safety Expert Cites Lapses,
And Points to Other Drugs

By ANNA WILDE MATHEWS and HEATHER WON TESORIERO
Staff Reporters of THE WALL STREET JOURNAL
November 19, 2004; Page A1

WASHINGTON - A debate over how the Food and Drug Administration
responds to newly discovered risks in drugs escalated yesterday, as an
FDA official criticized his agency's approach and raised concerns about
a handful of medications already on the market.

David Graham, associate director for science and medicine in the
agency's drug-safety office, told the Senate Finance Committee that his
agency discounts recommendations from its own safety researchers and
doesn't give sufficient weight to safety concerns once drugs are
approved.

Some other witnesses echoed his critique at the hearing, which focused
largely on the history of Vioxx, a painkiller with $2.5 billion in
annual sales that was withdrawn by Merck& Co. on Sept. 30 because it
was tied to an increased risk of heart attack and stroke with long-term
use.

Dr. Graham, who said he clashed with FDA officials about his
conclusions on Vioxx's safety, cited five other drugs that he believes
require stronger regulatory action: Pfizer Inc.'s Bextra, a painkiller
in the same class of medications as Vioxx; Crestor, a cholesterol drug
made by AstraZeneca PLC; Meridia, Abbott Laboratories' obesity drug;
Accutane, an acne drug made by Roche Holding AG and available
generically; and Serevent, an asthma medicine from GlaxoSmithKline PLC.

Those drugs already have drawn heightened scrutiny of the FDA as well
as the attention of consumer advocates and some regulatory agencies
abroad. The companies that make those five drugs defended their
products, most of which already have warnings on their labels about the
safety issues he raised.

Although Dr. Graham's sharp criticism of his agency and his public
warning about specific drugs was unusual, his concerns about the FDA's
drug-safety policies reflect a longstanding tension within the agency.
It has been accused of both dragging its feet in getting some drugs to
market - a complaint heard regarding approvals of some AIDS
medicines, for instance - and of moving too quickly to accommodate
new drugs backed by big pharmaceutical companies.

Sandra Kweder, deputy director of the FDA's office of new drugs, who
testified on behalf of the agency, said the drug-review divisions of
the FDA "work extremely closely with our colleagues in drug safety" and
scientific disagreements are dealt with properly. But, she added,
"There is clearly concern that somehow the system is not working as
well as it could. ... We need to address that."

In an interview, Steven Galson, acting director of the FDA's drug
center -- of which the drug-safety office is a part -- said that each
of the five drugs "does have safety issues that need to be addressed
and discussed," and added that he feels the agency is "on top of them."

The Vioxx withdrawal -- which has driven Merck stock down to about $27
a share from the prior $45 -- is adding new weight to the idea that the
FDA should develop an independent process for overseeing drugs once
they are on the market, to help it strike a balance between the
benefits offered by important new treatments and the sometime-serious
side effects.

Finance Committee Chairman Charles Grassley, an Iowa Republican, said
he supports greater independent authority for the office that oversees
drugs' safety after they go on the market. "I intend to keep pressing
for reforms inside the FDA," he said during yesterday's hearing. "An
independent office of drug safety would be a positive change."

The FDA's Dr. Kweder said the agency has commissioned an outside review
of how it handles drug safety and "we look forward to change if that is
deemed needed."

The broader theme of the FDA's handling of drug safety provided a
backdrop for testimony that centered mostly on Vioxx. Two academic
researchers offered a detailed timeline of the growing evidence of
concerns about the drug, drawing largely on Merck and FDA documents
that have been previously reported. Questions about the drug's
cardiovascular safety arose before it went on the market in May 1999.
"The failure to conduct large long-term safety studies subjected
millions of patients over four years to a drug whose safety had been
questioned by the FDA even before its approval," said Gurkirpal Singh,
an adjunct clinical professor of medicine at Stanford, who was
testifying by a live video hookup.

Raymond Gilmartin, chief executive of Merck, said at the hearing that
his company acted responsibly by studying Vioxx extensively, disclosing
data about the drug and pulling it from the market when the latest
results appeared to demonstrate increased risk. "Merck puts patients
first," he said.

Dr. Graham has in the past clashed with other FDA scientists who have
disagreed with his interpretations of data, and he has raised early
alarms internally on drugs that were eventually pulled from the market
because of their risks. In his testimony yesterday, he argued that FDA
is "incapable of protecting America against another Vioxx," and the
FDA's drug center "overvalues the benefits of the drugs it approves and
seriously undervalues, disregards, and disrespects drug safety." The
FDA divisions that review drugs for approval become too attached to
them, he said.

Dr. Kweder yesterday defended the agency's handling of Vioxx and other
safety matters. The agency "pursued ... vigorously" a label change that
added cardiovascular concerns to Vioxx's label in 2002, she said: "We
did not sit back."

The agency's Dr. Galson said that the office of drug safety is already
separate from the review divisions -- though it doesn't have
independent authority over drugs -- and "we think it would be really
dangerous to separate the assessment of benefits of drugs too much from
the assessment of risks."

Separating the FDA's drug-review divisions from its post-approval
safety oversight wouldn't be simple to implement. Currently, the
drug-review divisions generally oversee labeling and other decisions
even after the medicines go on the market, with the drug-safety office
in an advisory role. Doctors in the review divisions, which are made up
of medical specialists, are often the most familiar with how a drug
works and where it fits in clinical practice. They are used to relying
on placebo-controlled trials, the "gold standard" of scientific
evidence, to make their approval decisions.

However, once a drug is approved, the FDA typically has to rely largely
on reports of incidents that come in through its "adverse event"
reporting system. By some estimates, that system captures just 10% of
the problems. Sometimes, the agency does studies such as one Dr. Graham
worked on, which troll through large databases for trends. The FDA
can't order a drug maker to do another safety trial after the product
is approved, though it has strong indirect influence.

There has long been concern -- sometimes expressed by FDA officials --
that the agency has limited resources to detect safety problems once a
drug is approved. The other question, raised by Dr. Graham, is whether
the FDA acts aggressively enough to obtain data and respond to the
safety information it does get.

In defending the other drugs mentioned in Dr. Graham's testimony,
GlaxoSmithKline said Serevent "is safe and effective when used
appropriately" according to labeling guidelines, and has a "black box"
warning on its label. A spokeswoman for Abbott said that Meridia is one
of the few effective drugs available for treating obesity and has been
"extensively studied" in more than 12,000 patients. A Pfizer
spokeswoman said that a recent analysis had found no increased
cardiovascular risk in Bextra.

A spokeswoman for AstraZeneca said Dr. Graham's comments were
"inconsistent with past statements of the FDA" and the drug's safety
profile is "comparable" to competing drugs. A Roche spokeswoman said
that the company and other manufacturers are working on a new registry
to monitor Accutane prescriptions: "It's a high priority for all of
us," she said.

Write to Anna Wilde Mathews at anna.mathews@wsj.com6 and Heather Won
Tesoriero at heather.tesoriero@wsj.com7

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