We know that physicians
meet a parade of drug company sales representatives
from their first days of medical school to retirement
and that they see drug ads every time they pick
up a medical journal.
At
least that is represented as the advertising it
is.
But a study in this week's issue of the Annals
of Internal Medicine provides
extensive detail about how drug companies
push their products in far more subtle ways.
Some drug makers pay key
leaders in a field of medicine, such as chairs
of departments in medical schools, tens of thousands
of dollars if they are saying the right things
about their product. They manipulate medical education
sessions, lectures, articles in medical journals,
research studies, even personal conversations
between physicians to get their product message
across.
"It
is very disturbing," says lead author Dr. Michael
Steinman of the University of California, San
Francisco and the San Francisco VA Hospital. "It
really does a disservice to patient care."
Reliable
estimates put the drug industrys expenditure
on promotion to doctors at $18.5 billion that's
about $30,000 a year for every physician in the
U.S. Companies conceal the specifics of those
efforts with a jealousy worthy of a state secret.
Now
a huge collection of drug company internal documents
revealed as part of a lawsuit offers a
wealth of detail.
In
1996, Dr. David Franklin, an employee of the drug
company Parke-Davis, filed the lawsuit under federal
whistleblower statutes alleging that the company
was illegally promoting an epilepsy drug called
Neurontin for so called off-label uses.
Under federal law, once the FDA approves a drug,
a doctor can prescribe it for anything. But the
law specifically prohibits the drug company from
promoting the drug for any unapproved uses.
In
2004, the company, by then a division of Pfizer
admitted guilt and agreed to pay $430 million
in criminal and civil liability related to promoting
the drug for off-label use.
Spokespeople
for Pfizer say that any wrong doing occurred before
Pfizer acquired the company. But Pfizer fought
hard to keep all the papers related to the suit
under seal. A judge denied the request and they
are now part of the Drug
Industry Document Archive at the University
of California, San Francisco.
Steinman
and his team summarized some of the key findings
from the extensive collection in their paper.
It is obvious why the company wanted to keep the
documents from public view.
'Thought
leaders'
What is most interesting is not the illegal actions
they reveal, but the details of activities that
are perfectly legal. And according to people familiar
with the industry, the methods detailed in these
company memos are routine.
One
tactic identifies certain doctors as thought
leaders, key influencers and movers
and shakers those whose opinions influence
the prescribing pattern of other doctors. Those
whose views converge with the company goals are
then showered with honoraria, research and educational
grants. In the Parke-Davis case 14 such big shots
got between $10,250 and $158,250 between 1993
and 1997.
Medical
education drives this market, wrote the author
of one Parke-Davis business plan in the files.
Many state licensing boards require physicians
to attend sessions in what is called continuing
medical education (CME) to keep current in their
field.
At
one time, medical schools ran most CME courses.
Now, an industry of medical education and communications
committees (MECCs) run most of the courses. These
companies with innocuous sounding names like Medical
Education Systems set up courses, sometimes in
conjunction with medical meetings, at other times
often in fancy restaurants and resorts. The drug
companies foot the bill, with the program usually
noting it was financed by an unrestricted educational
grant from the company.
