PHA-Exch> Drug Promotion in guise of research

[Gopal Dabade]

http://www.hindu.com/seta/2008/10/16/stories/2008101650751500.htm

*THE HINDU, 16th October 2008*

*Vioxx: drug promotion in guise of research *

R. PRASAD

The real aim was to lure physicians into the habit of prescribing Vioxx



Phase IV trials for postmarketing surveillance of drugs are common and are
permitted by the regulators. But it is a different matter when trials are
done primarily to promote prescriptions of the drug. They are called the
'seeding trials.'

"The main point of the seeding trial is not to get high-quality scientific
information: It is to change the prescribing habits of a large number of
physicians," notes an Editorial in the *Annals of Internal Medicine *journal.


Primary objective

The latest online issue of *Science* shows how Merck undertook one such
trial and what its primary objective was.

The conclusions were arrived at by studying Merck's internal documents,
notes and emails that became available following the litigation.

The pharmaceutical company enrolled about 5,500 arthritis patients for the
1999 ADVANTAGE seeding trial to compare the safety of Vioxx with an existing
drug. "But the internal company documents suggest that the trial had little
to do with science and much to do with marketing," notes *Science*.

No science

According to the paper published in the *Annals of Internal Medicine*, the
marketing division had "designed and executed the ADVANTAGE trial."

It states: "the trial was designed by Merck's marketing division to fulfil a
marketing objective; Merck's marketing division handled both the scientific
and the marketing data, including collection, analysis and dissemination."

First evidence

Though the reasons for companies conducting seeding trials are well known,
Merck documents "provide the first strong documentary evidence." An email
sent by a Merck employee in the marketing division noted: "It may be a
seeding study, but let's not call it that in our internal documents."

The seeding trial was done around the same time the company undertook the
VIGOR trial — a definitive study of gastrointestinal toxicity. The FDA
required Merck to undertake the VIGOR trial before the company could "claim
of improved gastrointestinal safety on the Vioxx label."

"The purpose of ADVANTAGE was neither to seek a new indication nor to
perform postmarketing surveillance," notes the paper. It was more to "lure
physicians into the habit of prescribing Vioxx."

The real purpose of the trial was not made clear to patients, doctors or
regulators.

No specialists

And the reason for choosing 600 primary care physicians was deliberate, as
the company memo revealed.

"The clinical trial program for Vioxx focussed primarily on specialists.
While they would be critical to the early uptake and advocacy for Vioxx, the
large majority of the prescriptions in the arthritis and analgesia market
(about 60 per cent) come from primary care physicians. The ADVANTAGE trial
utilized this important group of prescribers as investigators."

The paper in the *Annals of Internal Medicine*, which has a note by the
Editor, states: "Seeding trials deceive trial participants and their
protectors [doctors]."

But it is an irony that the ADVANTAGE trial results were published in
the *Annals
of Internal Medicine *in 2003. But the Editor of the journal now says that
it "would not have published the results had it known of the trial's
apparent purpose."

But can journals shirk their responsibility so easily? Is it not their duty
to find out the real intention and refuse to publish the results? Is it not
the peer reviewers' job to detect and expose the real intent of the study?

Deception the key

"Deception is the key to a successful seeding trial," notes the Editorial in
the *Annals of Internal Medicine*. But it adds a rider, though.

"It's up to the reviewers, doctors, and even the patients to ask questions
that might reveal when promotion is masquerading as research."

This news on Merck's manipulation comes a few months after new evidence
published in the *Journal of the American Medical Association *(JAMA)
revealed how Merck was aware of the dangers of the drug much before it
withdrew it from the market (*The Hindu*, April 24, 2008).




-- 
http://novartisboycott.org/petition

Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270
www.jagruti.org
http://aidanindia.wordpress.com/
www.daf-k.cjb.net
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20081017/e3b68210/attachment-0001.html>