5/31/2000 – Profit Motive Creates Conflicts in Drug Trials

Here are another couple of articles on the close ties between the drug
industry and medicine have become even closer. From these articles we learn
what has gone wrong with the clinical trials that we thought were protecting
us from big profit motives. The overall general attitude now seems to be:
“Approve all drugs in exchange for profits and let the general population be
the true clinical trial.”

Please note that I have highlighted the statement about Dr. Angell leaving
the New England Journal of Medicine as a doctor with very close ties to the
pharmaceutical companies comes in to replace her as the journal’s editor. So
much for any honesty coming from the New England Journal of Medicine now. As
Dr. Angell leaves her prestigious post she is basically airing the industry’s
dirty laundry. The subject of her article that follows this e-mail is Dr.
Bodenheimer’s journal article mentioned below – a long needed followup to Dr.
Seymour Fisher’s classic article, “Hanky Panky in the Pharmaceutical
Industry.” (Dr. Fisher’s article has been posted at www.pssg.org if you would
like to read it.)

Free speech? Protection from conflicts of interest that could cost consumers
their lives? You will not fine either in this industry! Clearly patients need
to understand that medicine in America has become just another very big
business.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
________________________________

http://www.drkoop.com/news/stories/may/r/trials_money.html

Profit Motive Creates Conflicts in Drug Trials

May 21, 2000

Reuters Health Information

NEW YORK — Pharmaceutical companies that pay researchers to design and
interpret drug trials sometimes spin or suppress unfavorable findings, The
New England Journal of Medicine reported on Wednesday.

The scathing new report discusses tactics used to mask negative results and
warns that the profit motive of commercial research outfits threatens to
further corrupt the high-stakes process of translating science into
marketable drugs.

The report, “Uneasy Alliance — Clinical Investigators and the
Pharmaceutical Industry,” was written by Dr. Thomas Bodenheimer of the
University of California at San Francisco (UCSF) School of Medicine.

Bodenheimer’s interviews with people involved in the drug trial process
highlight the conflicts that arise in the process of
testing new drugs and publishing those results.

An accompanying editorial by Dr. Marcia Angell, the journal’s editor,
picks apart the cozy relationship that has developed between clinical
researchers and industry.

“Academic institutions and their clinical faculty members must take care
not to be open to the charge that they are for sale,” she writes.

The articles come a week after the peer-reviewed journal’s publisher,
the Massachusetts Medical Society, announced that it had named Dr. Jeffrey M.
Drazen, a prominent asthma researcher with strong ties to the drug industry,
as its new editor. He replaces Angell, who will be retiring.

Jeffrey Trewhitt, a spokesperson for the drug industry’s lobbying
group, the Pharmaceutical Research and Manufacturers of America, told
Reuters that “the articles overlook many safeguards in the system, including
the fact that the FDA (US Food and Drug Administration) reviews all the study
data.”

Trewhitt said that the FDA issued financial disclosure rules 18 months
ago “and they help to avoid conflicts of interest.” But six investigators
interviewed by Bodenheimer cited cases in which a sponsor actually halted
publication or altered a report’s content.In one instance, Dr. Steven
Cummings, professor of medicine and epidemiology at University of California,
San Francisco, said that a company held up the prepublication review process
for more than 6 months, secretly penning a competing article that favored the
company’s point of view.

Another investigator who found adverse reactions while studying a drug
was told by the sponsor that it would never fund his research again. It
published a competing article that barely mentioned the adverse reactions.

Critics have long questioned the integrity of drug research funded by
the pharmaceutical industry. But Bodenheimer warns of a deepening conflict as
more and more of those studies are farmed out to commercial research outfits.

When academia conducts drug studies, there is at least the potential
that researchers’ scientific goals will offset the pharmaceutical industry’s
commercial interests, he notes. “In contrast, trials conducted in the
commercial sector are heavily tipped toward industry interests, since
for-profit CROs (contract-research organizations) and SMOs (site-management
organizations), contracting with industry in a competitive market, will fail
if they offend their funding sources,” he argues.

Bodenheimer’s article recalls the time Dr. Curt Furberg, a professor of
public health sciences at Wake Forest University School of Medicine, refused
to place his name on published results of a study because the sponsor was
“attempting to wield undue influence on the nature of the paper.” Furberg
describes the effort as “so oppressive that we felt it inhibited academic
freedom.”

Furberg noted, “Companies can play hardball, and many investigators
can’t play hardball back. You send the paper to the company for comments, and
that’s the danger. Can you handle the changes the company wants? Will you
give in a little, a little more, then capitulate? It’s tricky for those who
need money for more studies.”

SOURCE: The New England Journal of Medicine 2000;342:1539-1544, 1516-1518.

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