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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness and Full Disclosure

www.ahrp.org



FYI



Much to their professional embarassment, doctors are finding that they have
been fed a pack of lies by smooth talking pharmaceutical company sales reps,
who persuaded them that the new, and (always) more expensive drugs provided
a greater benefit and improved safety over the older ones, doctors
unwittingly prescribed drugs that killed their patients.



The New York Times reports:

"A growing number of health care organizations have in recent years taken
rigorous steps to close one of medicine's biggest information gaps. They are
scrutinizing findings about all drugs, new and old, available to treat a
particular health condition to determine which work best at the lowest cost.

Such evidence-based reviews, as they are known, are an effort to separate
scientific wheat from chaff by examining not just the quantity, but also the
quality of clinical trials and studies on a given drug. They also seek to
determine how a drug's risks and benefits stack up against competing
treatments. These reviews have been applied to every major category of
medication, from blood pressure treatment to antidepressants."

"The drive to base medical practice on such reviews is not new, but it is
taking on more urgency as health care costs rise and many newer drugs prove
to be only marginally better, if that, than older ones."

AHRP supports scientific evaluations to determine whether the safety and
clinical efficacy of prescribed medical treatments is based on evidence or
say so (a.k.a. proclaimed "consensus"). Whether those who claim a drug is
safe and effective are company employees or academics affiliated with
prestigious institutions makes absolutely no difference.

We believe that FDA's data review and drug approval process fails to meet
scientific standards of objectivity--relying as it does on manufacturers'
summaries of selectively coded data which all too often obscure the drug's
adverse effects. As recent revelations in the press have demonstrated FDA's
seal of approval on widely marketed, aggressively advertised drugs is
untrustworthy.



Contact: Vera Hassner Sharav

212-595-8974

veracare@ahrp.org



http://www.nytimes.com/2004/12/30/b...rs.html?ei=5094
<http://www.nytimes.com/2004/12/30/b...4&en=6cf9cd
a5a5c6f176&hp=&ex=1104469200&partner=homepage&pagewanted=print&position>
&en=6cf9cda5a5c6f176&hp=&ex=1104469200&partner=homepage&pagewanted=print&pos
ition=

December 30, 2004

MEDICINE'S DATA GAP

Doctors, Too, Ask: Is This Drug Right?

By BARRY MEIER



AAcross the country, doctors are struggling to decide which pain relievers
to prescribe now that they know that popular drugs like Vioxx and Celebrex
pose potentially serious heart risks. "We are desperately in need of
information," said Dr. Stephen Brenner, an internist in New Haven. Yet for
at least two years, doctors at the Mayo Clinic, the federal Veterans Affairs
Department and the Kaiser Permanente health plan have been sharply limiting
their use of Vioxx and Celebrex.

That is because those three institutions, after undertaking separate reviews
of test data available on various painkillers, reached the same conclusion:
For most patients, Vioxx, Celebrex and a related drug, Bextra, did not work
any better than older pain relievers or provide any safety benefits beyond
them.

A growing number of health care organizations have in recent years taken
rigorous steps to close one of medicine's biggest information gaps. They are
scrutinizing findings about all drugs, new and old, available to treat a
particular health condition to determine which work best at the lowest cost.

Such evidence-based reviews, as they are known, are an effort to separate
scientific wheat from chaff by examining not just the quantity, but also the
quality of clinical trials and studies on a given drug. They also seek to
determine how a drug's risks and benefits stack up against competing
treatments. These reviews have been applied to every major category of
medication, from blood pressure treatment to antidepressants.

Practitioners like Dr. Brenner do not typically consult such reviews when
deciding which drugs to prescribe, but instead rely on their own experience.
But that may change as government agencies and academic centers disseminate
drug review research more broadly.

The drive to base medical practice on such reviews is not new, but it is
taking on more urgency as health care costs rise and many newer drugs prove
to be only marginally better, if that, than older ones.

Dr. Eric L. Matteson, a rheumatologist with the Mayo Clinic, said such
reviews also help to counterbalance the forces that influence doctors in
writing prescriptions, like drug company pitches, medical specialists
championing certain medicines and patients eager to get the latest drug
advertised on television.

"The pressures to prescribe are enormous," Dr. Matteson said. "You
constantly have people at your door."

One of the leading institutions doing drug class reviews is the
Evidence-based Practice Center at Oregon Health and Science University in
Portland. In recent years, some states have started to use reviews produced
by the center to draw up lists for preferred drugs that their Medicaid
programs will cover.

Today, about 12 states, including Washington, Oregon and Missouri, use the
center's reports to differing degrees.

Earlier this month, the federal government announced that it was planning to
spend $15 million in coming years to pay for evidence-based reviews that
will compare the effectiveness of various procedures and drugs used to treat
10 of the most common health conditions, including stroke, arthritis,
pneumonia, diabetes and ulcers. The studies will be made available to
doctors and the public as well as to government and private health plans.

Physicians like Dr. Brenner may welcome the help in deciding which
painkillers are appropriate for certain patients. In recent weeks, studies
have linked Vioxx, Bextra and Celebrex - all of which are in the class of
drugs known as COX-2 inhibitors - to increased heart risks under certain
conditions. In late September, Vioxx was withdrawn from the market by its
manufacturer, Merck
<http://www.nytimes.com/redirect/mar...http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=MRK> . Pfizer
<http://www.nytimes.com/redirect/mar...http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=PFE> , the maker
of Bextra and Celebrex, continues to sell both drugs but has limited
marketing.

Another recent study has suggested that an older pain reliever, naproxen,
which is sold as Aleve, might also increase heart attacks, though several
experts said the Aleve data was less troubling because the numbers appeared
too small to be statistically significant. Drug companies say they support
the idea of evidence-based medicine. But they also contend that the Oregon
center's approach is more about cutting costs than about science.

"What Oregon is doing is hiding a cost-cutting agenda that they are
marketing widely under the rubric of evidence-based medicine," said Dr. Mark
Horn, the medical director for the government relations group at Pfizer. Dr.
Mark Helfand, the director of the Oregon center, dismissed that suggestion.

And Dr. Matteson said he had heard similar complaints about the Mayo
Clinic's work from drug company representatives. "We've had plenty of
criticism from the representatives of different companies that market these
drugs to us that we are just looking at the bottom line and not to the
patient's best interest," he said.

Advocates of evidence-based reviews say they can help make sense of the
incomplete and conflicting state of knowledge about different drugs used for
the same problem. Newer drugs, for example, are typically tested more
extensively than older ones, and not all drugs in the same class are tested
against each other. Moreover, the quality of clinical drug trials run on
each drug and their relevance to medical practice can also vary sharply.

Those advocates have also long called upon pharmaceutical companies to
disclose all clinical trials run on a drug so that all evidence about the
drug is available to the public. Legislation to require companies to
register their drug trials was recently introduced in Congress.

To do an analysis, researchers try to pull together published and
unpublished clinical trials and studies about all drugs in a treatment class
by doing extensive literature reviews and asking pharmaceutical companies
for data. They analyze the studies to determine their scientific rigor,
eliminating those that they believe do not make the cut. Even clinical
trials, which are considered the most thorough because they test medications
under controlled conditions, can be flawed or misleading because of their
design.

"The biggest contribution that we make is in laying out the evidence," Dr.
Helfand said.

Because responses to pain relievers varies among individuals, a drug that
works for one patient might not work for another. But after reviewing all
relevant data, the Oregon group and others doing similar studies decided
that Vioxx, Celebrex and Bextra did not relieve arthritis-related pain any
better than other drugs they had been tested against, like ibuprofen, which
is also a nonsteroidal anti-inflammatory drug, or Nsaid.

In terms of safety, Vioxx showed the strongest evidence of reducing the
incidence of stomach bleeding associated with older Nsaids. Stomach bleeding
is a problem that is generally limited to older patients or those with a
history of gastrointestinal problems.

So even as the prescribing of COX-2 drugs by doctors in general was
increasing, the use of these drugs by doctors working for organizations
doing evidence-based studies was falling.

Doctors working for the Veterans Affairs Department have been curtailing
their use of COX-2 drugs since late 2001. The Mayo Clinic decided two years
ago to cut down its use of the medications by 50 percent.

Those groups and Kaiser Permanente, which also sharply limited its COX-2
prescriptions, saved money. Their actions may have also saved lives. A study
conducted by an F.D.A. researcher that was released in September found that
Kaiser patients relied on high doses of Vioxx, which can increase the risk
of heart attacks, less than half as often as the general population.

In undertaking its drug review, Veterans Affairs also re-examined the value
of a lesser-known pain reliever, etodolac, and began using it more. The drug
was first sold in 1991 as Lodine by a company that is now part of
GlaxoSmithKline
<http://www.nytimes.com/redirect/mar...http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=GSK> . Like many
older medications, however, it was not extensively tested.

A study based on a review of V.A. patient records that was published last
month in a medical journal, Gastroenterology, found that the rate of stomach
bleeding caused by etodolac was substantially lower than that caused by
naproxen and comparable to that of Vioxx.

Dr. Byron Cryer, a researcher at the University of Texas Southwestern
Medical School in Dallas who led the study, said his group was reviewing
those same patient records in effort to determine whether etodolac increased
heart risks. Dr. Cryer said that analysis should be completed in about a
month.

Dr. David Campen, a medical director at Kaiser, said that his organization
had not yet changed its prescribing guidelines for Celebrex, which was
reported to pose heart risks during a trial of the drug as a cancer
treatment.

The Mayo system, which operates hospitals and clinics in several states,
meanwhile, has decided to reduce its use of the COX-2 drug even further.

Previously, any patient over 60 qualified for Celebrex, Dr. Matteson said.
But earlier this month, a group of Mayo Clinic doctors, epidemiologists and
pharmacists, after reviewing old and new test data, decided to limit the
drug's use to patients at risk of stomach bleeding or to others with highly
specific conditions.



<http://www.nytimes.com/ref/memberce.../copyright.html> Copyright
2004 The New York Times Company <http://www.nytco.com/>



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