Doctors, Too, Ask: Is This Drug Right?

[Guest guest]

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@...

http://www.nytimes.com/2004/12/30/business/30doctors.html?ei=5094

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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. 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. 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/marketwatch/redirect.ctx?MW=http://custom.m

arketwatch.com/custom/nyt-com/html-companyprofile.asp & symb=MRK> . Pfizer

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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

GlaxoKline

<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=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. 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.

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