[e-drug] Doctors prescribing heavily influenced by DTCA

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Doctors prescribing heavily influenced by DTCA
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[Interesting writeup in the Washington Post of a new RCT published in the JAMA which confirmed what many already suspected: 
"Patients' requests have a profound effect on physician prescribing in major depression and adjustment disorder. Direct-to-consumer advertising may have competing effects on quality, potentially both averting underuse and promoting overuse."
Copied as fair use. Thanks to Andy for spotting. WB]

http://www.washingtonpost.com/wp-dyn/content/article/2005/04/26/AR2005042601624.html

Doctors Influenced By Mention Of Drug Ads
Offbeat Study Finds Familiar Brand Name Can Evoke Diagnosis
By Shankar Vedantam and Marc Kaufman
Washington Post Staff Writers
Wednesday, April 27, 2005; Page A01

Actors pretending to be patients with symptoms of stress and fatigue were five
times as likely to walk out of doctors' offices with a prescription when they
mentioned seeing an ad for the heavily promoted antidepressant Paxil, according an
unusual study being published today.

The study employed an elaborate ruse -- sending actors with fake symptoms into 152
doctors' offices to see whether they would get prescriptions. Most who did not
report symptoms of depression were not given medications, but when they asked for
Paxil, 55 percent were given prescriptions, and 50 percent received diagnoses of
depression.
 
The study adds fuel to the growing controversy over the estimated $4 billion a year
the drug industry spends on such advertising. Many public health advocates have long
complained about ads showing happy people whose lives were changed by a drug, and
now voices in Congress, the Food and Drug Administration and even the pharmaceutical
industry are asking whether things have gone too far.

Nearly every industrialized country bans such advertising, and physicians said the
new study raises new questions.

"It is a haphazard approach to health promotion that is driven primarily by the
pharmaceutical industry's interest in turning a profit," said Matthew F. Hollon, an
internist at the University of Washington in Seattle, who wrote an editorial
accompanying the study in today's Journal of the American Medical Association. "The
most overlooked problem in the health care system today is the extent to which it is
permeated by avarice."

Hollon and the researchers who conducted the study said it was not realistic to
expect such marketing to be abolished, given the climate of deregulation in
Washington. But they said the ads should be tempered by educational messages funded
by a tax on the industry and better training of doctors, or by a moratorium on ads
for new drugs until their risks are fully known.

"We can do a much better job with the advertising," agreed W.J. "Billy" Tauzin,
president and chief executive of the Pharmaceutical Research and Manufacturers of
America (PhRMA). "The ads can do a great job making sure people who need medications
and are undertreated get help. We can also make it clear that a particular product
is meant for people with this particular problem and for those people only."

The study found that the ads did help patients with a stigmatized illness such as
depression get treatment, even as they prompted overmedication of people who did not
need treatment. Such marketing in effect exploits the diagnostic gray zone that
characterizes many conditions in medicine, including heartburn, arthritis and
allergies.

"There is a segment of individuals who would really benefit from pharmacological
therapy; there is another large group that won't," said Richard L. Kravitz, lead
author of the study and a professor of medicine at the University of California at
Davis. "The easiest thing from a marketing standpoint is to increase use in all the
categories, and that is what we are seeing."

The researchers sent actors with hidden tape recorders into general physicians'
offices in three cities between May 2003 and May 2004. The physicians had previously
consented to participate but were not told when they would be tested.

Half the actors simulated patients suffering from depression, describing lengthy
periods of sadness, low energy, poor appetite and sleep, and early-morning
awakening. The others described having suffered a career upheaval and having
fatigue, stress and difficulty sleeping, symptoms that did not warrant medication.

More than half of those without simulated depression who mentioned Paxil got a
prescription, underscoring how willing doctors are to go along with patients'
requests.

Concerns have recently grown about the safety of antidepressants after disclosures
that the pharmaceutical industry withheld studies that found the drugs were no
better than sugar pills. The FDA recently concluded that the drugs increase suicidal
thinking and behavior among children and required them to carry black-box warnings
-- which have greatly reduced direct-to-consumer advertising of such drugs.

Advertising could be useful for drugs with large benefits and few risks, said
researcher Ronald M. Epstein, but the industry's bias against negative studies
raises questions about which drugs ought to be marketed in this fashion. Epstein is
a professor of family medicine at the University of Rochester.

Nancy Leone, a spokeswoman for GlaxoSmithKline PLC, the maker of Paxil, said
physicians are not unduly influenced by ads, and denied that such "education
campaigns" lead to inappropriate prescribing. It was "difficult to draw conclusions"
about the new study, she said, because Paxil was not being heavily advertised during
the study period.

In his editorial, Hollon said 80 percent of physicians believe such ads prompt
patients to seek medications they do not need, and less than 10 percent believe the
ads are a good thing.

Johnson & Johnson's chief executive, William C. Weldon, now chairman of the PhRMA
board, said last month that the industry ought to revise its approach to drug ads
because they "may inadvertently minimize the importance and power of medicines and
their risks."

Direct-to-consumer (DTC) advertising soared after the FDA allowed drug promotions
on television for the first time in 1997. Efforts to limit such advertising have run
afoul of Supreme Court rulings protecting commercial speech.

The ads are regulated by the FDA's Division of Drug Marketing, Advertising and
Communications. The office, which has barely three dozen employees, must review
30,000 to 40,000 ads a year. Acting commissioner Lester M. Crawford said recently
that "our patience is sometimes worn thin" by the advertising claims.

Dan Troy, chief counsel for the FDA in President Bush's first term and now with a
Washington law firm, said laws on drug advertising written by Congress in the 1960s
have made it difficult to change policy. He added that most FDA professionals were
"quite pro-DTC."

PhRMA's Tauzin said companies are working on a new code of conduct that would be
preferable to federal regulation.

The FDA has moved against scores of ads that it found to be inaccurate or
misleading. In 2001, it warned Merck and Co. that its ads for the arthritis drug
Vioxx were misleading and did not adequately warn viewers of cardiovascular risks.
After Merck took Vioxx off the market last September, Pfizer Inc. aggressively
increased advertising for its competing painkiller, Celebrex, but also got a warning
from the FDA.

~~~
http://jama.ama-assn.org/cgi/content/short/293/16/1995
Influence of Patients' Requests for Direct-to-Consumer Advertised Antidepressants
- A Randomized Controlled Trial 

Richard L. Kravitz, MD, MSPH; Ronald M. Epstein, MD; Mitchell D. Feldman, MD,
MPhil; Carol E. Franz, PhD; Rahman Azari, PhD; Michael S. Wilkes, MD, PhD; Ladson
Hinton, MD; Peter Franks, MD 

JAMA. 2005;293:1995-2002. 

Context  Direct-to-consumer (DTC) advertising of prescription drugs in the United
States is both ubiquitous and controversial. Critics charge that it leads to
overprescribing, while proponents counter that it helps avert underuse of effective
treatments, especially for conditions that are poorly recognized or stigmatized. 

Objective  To ascertain the effects of patients' DTC-related requests on
physicians' initial treatment decisions in patients with depressive symptoms. 

Design  Randomized trial using standardized patients (SPs). Six SP roles were
created by crossing 2 conditions (major depression or adjustment disorder with
depressed mood) with 3 request types (brand-specific, general, or none). 

Setting  Offices of primary care physicians in Sacramento, Calif; San Francisco,
Calif; and Rochester, NY, between May 2003 and May 2004. 

Participants  One hundred fifty-two family physicians and general internists
recruited from solo and group practices and health maintenance organizations;
cooperation rates ranged from 53% to 61%. 

Interventions  The SPs were randomly assigned to make 298 unannounced visits, with
assignments constrained so physicians saw 1 SP with major depression and 1 with
adjustment disorder. The SPs made a brand-specific drug request, a general drug
request, or no request (control condition) in approximately one third of visits. 

Main Outcome Measures  Data on prescribing, mental health referral, and primary
care follow-up obtained from SP written reports, visit audiorecordings, chart
review, and analysis of written prescriptions and drug samples. The effects of
request type on prescribing were evaluated using contingency tables and confirmed in
generalized linear mixed models that accounted for clustering and adjusted for site,
physician, and visit characteristics. 

Results  Standardized patient role fidelity was excellent, and the suspicion rate
that physicians had seen an SP was 13%. In major depression, rates of antidepressant
prescribing were 53%, 76%, and 31% for SPs making brand-specific, general, and no
requests, respectively (P<.001). In adjustment disorder, antidepressant prescribing
rates were 55%, 39%, and 10%, respectively (P<.001). The results were confirmed in
multivariate models. Minimally acceptable initial care (any combination of an
antidepressant, mental health referral, or follow-up within 2 weeks) was offered to
98% of SPs in the major depression role making a general request, 90% of those
making a brand-specific request, and 56% of those making no request (P<.001). 

Conclusions  Patients' requests have a profound effect on physician prescribing
in major depression and adjustment disorder. Direct-to-consumer advertising may have
competing effects on quality, potentially both averting underuse and promoting
overuse. 

Author Affiliations: Center for Health Services Research in Primary Care (Drs
Kravitz, Franz, Azari, Wilkes, Hinton, and Franks) and Departments of Internal
Medicine (Drs Kravitz and Wilkes), Statistics (Dr Azari), Psychiatry (Dr Hinton),
and Family and Community Medicine (Dr Franks), University of California, Davis,
Sacramento; Departments of Family Medicine and Psychiatry and Center to Improve
Communication in Health Care, University of Rochester School of Medicine and
Dentistry, Rochester, NY (Dr Epstein); Division of General Internal Medicine,
Department of Medicine, University of California, San Francisco (Dr Feldman).