Ilena Rose
2008-10-16 14:41:41 UTC
News from Health Lover, Ilena Rosenthal:
http://ilenarose.blogspot.com
My opinion is this is their modus operandi ... much like they have
done with Gardasil.
Vioxx: drug promotion in guise of research
http://www.thehindu.com/thehindu/seta/2008/10/16/stories/2008101650751500.htm
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 Mercks 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 Mercks marketing division to
fulfil a marketing objective; Mercks 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 lets 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 trials 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.
Its up to the reviewers, doctors, and even the patients to ask
questions that might reveal when promotion is masquerading as
research.
This news on Mercks 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://ilenarose.blogspot.com
My opinion is this is their modus operandi ... much like they have
done with Gardasil.
Vioxx: drug promotion in guise of research
http://www.thehindu.com/thehindu/seta/2008/10/16/stories/2008101650751500.htm
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 Mercks 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 Mercks marketing division to
fulfil a marketing objective; Mercks 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 lets 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 trials 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.
Its up to the reviewers, doctors, and even the patients to ask
questions that might reveal when promotion is masquerading as
research.
This news on Mercks 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).