s***@lipshitz.net
2009-01-16 17:12:09 UTC
Forget Pot Smokers; What Does It Take to Lock Up Drug Company Execs?
By Bruce E. Levine
A recent article in the New England Journal of Medicine reveals the
shocking extent of how corrupt drug companies are.
"Laws are like cobwebs, which may catch small flies, but let wasps and
hornets break through." - Jonathan Swift
After reading "The Neurontin Legacy -- Marketing through
Misinformation and Manipulation" in the January 8, 2009 issue of the
New England Journal of Medicine, one may conclude that (1) America's
prisons would be put to better use incarcerating drug company
executives instead of pot smokers, and (2) society may need a return
of public scorn via the pillory for those doctors who are essentially
drug-company shills.
Drug-company corruption of American medicine is of course not news.
What is news is that such corruption has become so egregious, so
transparent, and so embarrassing that the New England Journal of
Medicine, perhaps the most influential American medical journal, is
now stating that "drastic action is essential to preserve the
integrity of medical science and practice and to justify public
trust."
Neurontin was approved by the Food and Drug Administration (FDA) in
1993 in doses of up to 1800 mg per day as adjunctive therapy for
partial complex seizures. How did U.S. annual sales of Neurontin
increase from $98 million in 1995 to nearly $3 billion in 2004? The
answer is "off-label" marketing, in which Neurontin manufacturer
Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000)
marketed Neurontin to doctors for uses not approved by the FDA
(because doctors can legally prescribe drugs for uses not approved by
the FDA).
While aggressive off-label marketing to doctors is standard among drug
companies, it is routinely kept quiet. But thanks to a Parke-Davis
whistle blower, we have first-hand evidence of off-label marketing --
and how the Neurontin financial bonanza was created.
In 1996, David Franklin, a young biologist, took a sales
representative position for Parke-Davis. But shortly after beginning
the job, Franklin grew concerned that he was participating in the
illegal marketing of Neurontin. Franklin reports that a Parke-Davis
executive informed him and his fellow sales reps:
"I want you out there every day selling Neurontin. . . .We all know
Neurontin's not growing for adjunctive therapy, besides that's not
where the money is. Pain management, now that's money. Monotherapy
[for epilepsy], that's money. . . . We can't wait for [physicians] to
ask, we need [to] get out there and tell them up front. Dinner
programs, CME [continuing medical education] programs, consultantships
all work great but don't forget the one-on-one. That's where we need
to be, holding their hand and whispering in their ear, Neurontin for
pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for
everything. I don't want to see a single patient coming off Neurontin
before they've been up to at least 4800 mg/day. I don't want to hear
that safety crap either, have you tried Neurontin, every one of you
should take one just to see there is nothing, it's a great drug."
Franklin left Parke-Davis and filed suit (ultimately, United States of
America ex rel. David Franklin vs. Pfizer, Inc., and Parke-Davis
Division of Warner-Lambert Company) alleging that off-label marketing
of Neurontin constituted false claims designed to elicit payments from
the federal government. In 2004, Warner-Lambert resolved criminal
charges and civil liabilities by agreeing to plead guilty and pay $430
million -- less than 15 percent of the $3 billion the drug company had
grossed on Neurontin in 2004.
The current New England Journal of Medicine article concluded that the
marketing of Neurontin involved "the systematic use of deception and
misinformation to create a biased evidence base and manipulate
physicians' beliefs and prescribing behaviors." This is one of many
examples:
"In a recently unsealed 318-page analysis of research sponsored by
Parke-Davis, epidemiologist Kay Dickersin concluded that available
documents demonstrate 'a remarkable assemblage of evidence of
reporting biases that amount to outright deception of the biomedical
community, and suppression of scientific truth concerning the
effectiveness of Neurontin for migraine, bipolar disorders, and pain.'
For example, publication was delayed for a report on a multi-center,
placebo-controlled study that found no effect of Neurontin on the
primary outcome measure for neuropathic pain because 'we [Parke-Davis
employees] should take care not to publish anything that damages
neurontin's marketing success.'"
Exactly what does it take for drug executives to do jail time?
And let's not kid ourselves about the innocence of doctors. The
tactics used by Parke-Davis and other drug companies to manipulate
doctors make it clear that too many doctors have been willing
participants in the corruption of their profession.
The New England Journal of Medicine discusses some of the practices
used by Park-Davis (and commonly used by other drug companies):
recruit local physicians who are then trained and paid to serve as
speakers in "peer-to-peer selling" programs; financially cultivate
renowned professionals, so-called "thought leaders;" financially
influence academics with educational grants, research grants, and
speaking opportunities worth hundreds of thousands of dollars; create
drug "advisory boards" to launder pay offs to "friendly" physicians;
provide doctors employed by medical-education companies with
"unrestricted educational grants" to produce programs that promote
off-label (unapproved) uses of drug; fund doctors' "research" that in
fact is designed and commissioned to promote a specific drug; and
credit doctors as authors for ghost-written research articles that
downplay drug ineffectiveness or lack of safety.
The New England Journal of Medicine is now warning physicians that
medicine's corruption by drug companies has threatened public
confidence in their profession. If those physicians who are not
drug-company shills want to save their profession, they might want to
start taking aggressive actions against their colleagues who are on
the take. Perhaps it will help motivate clean physicians to be
reminded that history shows that any institution -- no matter how
large and powerful -- can arrogantly cross those lines leading to its
demise.
By Bruce E. Levine
A recent article in the New England Journal of Medicine reveals the
shocking extent of how corrupt drug companies are.
"Laws are like cobwebs, which may catch small flies, but let wasps and
hornets break through." - Jonathan Swift
After reading "The Neurontin Legacy -- Marketing through
Misinformation and Manipulation" in the January 8, 2009 issue of the
New England Journal of Medicine, one may conclude that (1) America's
prisons would be put to better use incarcerating drug company
executives instead of pot smokers, and (2) society may need a return
of public scorn via the pillory for those doctors who are essentially
drug-company shills.
Drug-company corruption of American medicine is of course not news.
What is news is that such corruption has become so egregious, so
transparent, and so embarrassing that the New England Journal of
Medicine, perhaps the most influential American medical journal, is
now stating that "drastic action is essential to preserve the
integrity of medical science and practice and to justify public
trust."
Neurontin was approved by the Food and Drug Administration (FDA) in
1993 in doses of up to 1800 mg per day as adjunctive therapy for
partial complex seizures. How did U.S. annual sales of Neurontin
increase from $98 million in 1995 to nearly $3 billion in 2004? The
answer is "off-label" marketing, in which Neurontin manufacturer
Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000)
marketed Neurontin to doctors for uses not approved by the FDA
(because doctors can legally prescribe drugs for uses not approved by
the FDA).
While aggressive off-label marketing to doctors is standard among drug
companies, it is routinely kept quiet. But thanks to a Parke-Davis
whistle blower, we have first-hand evidence of off-label marketing --
and how the Neurontin financial bonanza was created.
In 1996, David Franklin, a young biologist, took a sales
representative position for Parke-Davis. But shortly after beginning
the job, Franklin grew concerned that he was participating in the
illegal marketing of Neurontin. Franklin reports that a Parke-Davis
executive informed him and his fellow sales reps:
"I want you out there every day selling Neurontin. . . .We all know
Neurontin's not growing for adjunctive therapy, besides that's not
where the money is. Pain management, now that's money. Monotherapy
[for epilepsy], that's money. . . . We can't wait for [physicians] to
ask, we need [to] get out there and tell them up front. Dinner
programs, CME [continuing medical education] programs, consultantships
all work great but don't forget the one-on-one. That's where we need
to be, holding their hand and whispering in their ear, Neurontin for
pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for
everything. I don't want to see a single patient coming off Neurontin
before they've been up to at least 4800 mg/day. I don't want to hear
that safety crap either, have you tried Neurontin, every one of you
should take one just to see there is nothing, it's a great drug."
Franklin left Parke-Davis and filed suit (ultimately, United States of
America ex rel. David Franklin vs. Pfizer, Inc., and Parke-Davis
Division of Warner-Lambert Company) alleging that off-label marketing
of Neurontin constituted false claims designed to elicit payments from
the federal government. In 2004, Warner-Lambert resolved criminal
charges and civil liabilities by agreeing to plead guilty and pay $430
million -- less than 15 percent of the $3 billion the drug company had
grossed on Neurontin in 2004.
The current New England Journal of Medicine article concluded that the
marketing of Neurontin involved "the systematic use of deception and
misinformation to create a biased evidence base and manipulate
physicians' beliefs and prescribing behaviors." This is one of many
examples:
"In a recently unsealed 318-page analysis of research sponsored by
Parke-Davis, epidemiologist Kay Dickersin concluded that available
documents demonstrate 'a remarkable assemblage of evidence of
reporting biases that amount to outright deception of the biomedical
community, and suppression of scientific truth concerning the
effectiveness of Neurontin for migraine, bipolar disorders, and pain.'
For example, publication was delayed for a report on a multi-center,
placebo-controlled study that found no effect of Neurontin on the
primary outcome measure for neuropathic pain because 'we [Parke-Davis
employees] should take care not to publish anything that damages
neurontin's marketing success.'"
Exactly what does it take for drug executives to do jail time?
And let's not kid ourselves about the innocence of doctors. The
tactics used by Parke-Davis and other drug companies to manipulate
doctors make it clear that too many doctors have been willing
participants in the corruption of their profession.
The New England Journal of Medicine discusses some of the practices
used by Park-Davis (and commonly used by other drug companies):
recruit local physicians who are then trained and paid to serve as
speakers in "peer-to-peer selling" programs; financially cultivate
renowned professionals, so-called "thought leaders;" financially
influence academics with educational grants, research grants, and
speaking opportunities worth hundreds of thousands of dollars; create
drug "advisory boards" to launder pay offs to "friendly" physicians;
provide doctors employed by medical-education companies with
"unrestricted educational grants" to produce programs that promote
off-label (unapproved) uses of drug; fund doctors' "research" that in
fact is designed and commissioned to promote a specific drug; and
credit doctors as authors for ghost-written research articles that
downplay drug ineffectiveness or lack of safety.
The New England Journal of Medicine is now warning physicians that
medicine's corruption by drug companies has threatened public
confidence in their profession. If those physicians who are not
drug-company shills want to save their profession, they might want to
start taking aggressive actions against their colleagues who are on
the take. Perhaps it will help motivate clean physicians to be
reminded that history shows that any institution -- no matter how
large and powerful -- can arrogantly cross those lines leading to its
demise.