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.
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 a 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.
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, "—those whose opinions influence the prescribing pattern of other doctors. Those whose views converge with the company goals are then showered with rewards, 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 innocent 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.
Using MECCs, Parke-Davis set up conference calls so that doctors could talk to one another about the drugs. The moderators of the calls, often thought leaders or their younger assistants, received $250 to $500 a call. Drug company reps were on the line, instructed to stay in a "listen only" mode, but monitoring to be sure the pitch met their expectations.
Clearly, 'many of the physicians in these schemes are not innocent bystanders. Whether it is ghost writing, making telephone calls to colleagues or leading a CME session, many of the doctors got paid well. Others received a free meal or transportation to a resort to listen to an "educational session".
Physicians often claim they are not influenced by payments from the pharmaceutical industry. But with the methods so thoroughly detailed in these papers, drug companies clearly believe they are getting their money's worth.
The drug companies are willing to pay leading doctors to
A．manipulate medical education sessions.
B．improve the individual health-care service.
C．have personal contact with physicians.
D．help promote the drugs they produce.
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