Risky Rx: Drug maker's secret strategies

Robert Bazell Chief science and health correspondent • Profile • E-mail

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 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. 

2007: Stem cell breakthroughs to superbugs Research rewrites first chapter of AIDS in U.S. Who lives or dies? Doling out health dollars Care for Iraq wounded a national shame Breast cancer drug fails many women Satisfied with your health care? Don't be Global health care fashionable, but falls short More Second Opinion

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. 

MORE FROM SECOND OPINION

Second Opinion Section Front

Dispute behind Nobel Prize for HIV research What's your doc thinking? Web site offers clues Bazell: Why isn't there a cure for breast cancer? More profit than progress in cancer research Mind-body medicine needs a checkup Doctor's legacy is medicine at its best Another flu season, another failure DNA acquittals shaking up forensic science Conveyor-belt cardiology puts profits first 2007: Stem cell breakthroughs to superbugs Second Opinion Section Front   Add Second Opinion headlines to your news reader: