By Robert Bazell Chief science and health correspondent
NBC News
updated 8/15/2006 10:27:06 AM ET 2006-08-15T14:27:06
Commentary

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.

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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 industry’s 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. 

Not innocent bystanders
The records in this case reveal in precise detail how the company attended planning sessions for the meeting and were allowed to tailor the content to meet their commercial goals.

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.

The papers also reveal a “publication strategy” where the drug company would sponsor small trials of the drug and get the results published only if they met the company’s expectations. If the “core marketing team” found that results did not conform to the company’s goals, "the results will not be published," the documents reveal.

Besides arranging for its own favorable studies, Parke-Davis also contracted with MECCS to develop articles, review papers and letters to the editors of medical journals putting its product in a favorable light.

The company paid the MECC $13,375 to $18,000 for each article, but the reader would not know the drug company or the MECC authored the article. The MECC paid $1,000 each to friendly doctors and pharmacists to sign their names to the articles — creating ghostwriters to make the material appear independent.

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 and perks 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.

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