[Mr_Tracys_Corner] Fw: Review Details Drug Companies' Reach

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Sun, 20 Aug 2006 02:20:08 -0700 (Pacific Daylight Time)

[Mr_Tracys_Corner] Fw: Review Details Drug Companies'

Reach?OT for some groups

 

 

 

 

 

 

Review Details Drug Companies' Reach

 

 

 

 

Review Details Drug Companies' Reach

They subtly influence doctors' prescribing patterns, report contends

 

By Amanda Gardner

HealthDay Reporter

 

MONDAY, Aug. 14 (HealthDay News) -- Drug companies often influence

physicians' prescribing practices without the doctors even knowing it,

a new report contends.

 

" A lot of strategies are quite subtle, but because they are so

pervasive, they really add up, " said Dr. Michael Steinman, a staff

physician with the San Francisco Veterans Affairs Medical Center and

lead author of a paper that details the marketing activities of Pfizer

Inc. on behalf of its drug gabapentin (Neurontin).

 

The drug was originally approved by the U.S. Food and Drug

Administration in 1993 for the treatment of " partial complex seizures "

involved in epilepsy. By the mid-to-late 1990s, however, it was widely

used off-label for psychiatric conditions and pain.

 

Although gabapentin was eventually approved for one pain indication,

Pfizer subsidiary Warner-Lambert settled litigation in 2004, admitting

it had violated federal regulations by promoting the drug for pain,

psychiatric conditions, migraine and other unapproved uses.

 

The court case gave Steinman and his colleagues an unusual opportunity

to review about 8,000 pages of documents -- including internal

correspondence and reports, presentations, transcripts and depositions

-- that covered a period during which gabapentin was still only

approved for treating epilepsy.

 

Their review is published in the Aug. 15 issue of the Annals of

Internal Medicine.

 

" A lot of the marketing was related to off-label use, but the issue we

were trying to frame wasn't so much on-label versus off-label but the

sorts of marketing strategies used to promote drugs regardless of what

the labeling was, " Steinman explained.

 

The marketing often had the twin purposes, Steinman said --

influencing physicians to write more prescriptions for the drug

without realizing they were being influenced.

 

" A lot of the strategies that were used to promote this drug were

activities that doctors might not recognize as promotional at all, "

Steinman said. " The real danger is that doctors are being marketed to

without their even knowing it. You don't know that the material should

be taken with a grain of salt, and this might adversely impact the way

you prescribe. "

 

In 1998, the company had a $40 million advertising and promotion

budget for the drug. From 1996 through 1998, " professional education "

accounted for half to two-thirds of the budget, according to the study.

 

As part of this push, company officials identified physicians who were

already frequent prescribers of anticonvulsants and further

categorized them by the dollar value of anti-convulsant prescriptions

they had the potential to generate.

 

Another targeted group was doctors who had the potential to influence

gabapentin use among colleagues. Some doctors were recruited and

trained to serve as speakers in " peer-to-peer selling " programs.

Others were " thought leaders " or " movers and shakers, " influential

doctors affiliated with major medical centers. Some " thought leaders "

requested or were allocated $10,250 to $158,250 in honoraria, research

grants or educational grants between 1993 and 1997, according to the

study.

 

The company also sponsored continuing medical education programs for

doctors that appeared to be thinly veiled attempts to influence

prescribing patterns, the study authors said.

 

" A lot of continuing medical education in this country now is run by

medical education companies that are funded through unrestricted

educational grants from drug companies, " Steinman said. " Unrestricted

means no-strings-attached, but we found that some of the same

companies that are putting on medical education programs are also

working for drug companies in different ways. There's an intrinsic

conflict of interest. They're supposedly doing an objective program,

but, at the same time, they're telling the company how they can

increase sales. "

 

Clinical trials could also have a hidden agenda, the study authors

said. In one example they cited, 700 physicians were enlisted to

participate in an uncontrolled, open-label trial of gabapentin in

which they were instructed to increase the dose until patients were

seizure-free or until a maximum of twice the FDA-approved limit was

reached. The physicians enrolled an average of three patients each and

were paid $300 per patient.

 

The question the study authors raised is, how can doctors negotiate

this tricky terrain if they don't know how tricky it is?

 

" I don't have an easy answer, " Steinman said. " It's become very hard

to know where bias exists anymore, because the bright line between

what is promotion and what is objective has become quite blurred, but

it's not apparent that it's blurred. "

 

" Most physicians are doing what they think is right, and the drug

industry is not evil, " Steinman added.

 

" The problem is that the reach of the drug industry is so deeply

embedded into all aspects of the daily practice of medicine that it's

really become quite hard to separate out what is promotional and

what's not, " he said. " The absence of a clear demarcation really puts

us at great risk of prescribing either suboptimally for care of

patients or in an excessively expensive way, which harms the

health-care system as a whole. "

 

However, Pfizer spokesman Bryant Haskins said, " Pfizer promotes all

medications and provides medical education grants in accordance with

standard guidelines established by FDA and the American Medical

Association among others. "

 

He continued, " As with all of our medications, our FDA-approved label

dictates what physicians may say about our medications when physicians

are speaking on behalf of the company. When physicians are acting as

advisors, it is to provide clinical experience/expert opinion in the

development of clinical trial protocols or educational information. "

 

Dr. Mark Fendrick, a professor of internal medicine at the University

of Michigan School of Medicine, noted, " Ultimately, it comes back into

the hands of practitioners. It's extraordinarily important for

physicians to understand that it's ultimately up to them to be able to

weigh the risks and benefits of every intervention they do. They can

say no. "

 

The details in the paper recall a recent move by the Journal of the

American Medical Association (JAMA) to tighten its

conflict-of-interest policy in response to scientists' failure to

disclose all financial ties to pharmaceutical companies, Fendrick

added. JAMA is not the only medical journal to have had such problems

in recent months.

 

More information

 

SourceWatch has more on off-label prescribing.

 

 

 

SOURCES: Michael Steinman, M.D., staff physician, San Francisco

Veterans Affairs Medical Center, and assistant professor of medicine,

University of California, San Francisco; Mark Fendrick, M.D.,

professor of internal medicine, University of Michigan School of

Medicine, Ann Arbor; Bryant Haskins, spokesman, Pfizer Inc.; Aug. 15,

2006, Annals of Internal Medicine

 

Last Updated: Aug. 14, 2006

 

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