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Ties That Bind
January-February 2008
Vol. 49 No. 1 (p. 20)
AARP Bulletin/www.aarp.org/bulletin
By: Barbara Basler

For years, pharmaceutical companies have courted America's doctors with an ever-growing intensity, showering them with billions of dollars' worth of gifts, consulting fees and trips to persuade them to prescribe their drugs. But now, patient advocates and lawmakers are out to break up those relationships, arguing that physicians - working amid the clutter of the drug industry's free samples, pens, clipboards, calculators and pizza boxes - often lose sight of the patient's best interest.

Even some doctors are speaking out against these gifts and favors on websites such as No Free Lunch and PharmedOut. The Institute of Medicine at the National Academies is drawing up conflict of interest guidelines for doctors, while leading medical schools are tightening their policies on accepting gifts. And legislators in Congress and in statehouses across the country are drafting laws to require drug companies to report these gifts publicly so patients can find out which doctors took what from the industry.

Several states, including Pennsylvania and South Carolina, have hired their own representatives to call on doctors and discuss older drugs and generics. The idea is to counter the sophisticated pitches and gift giving of drug industry sales reps who are promoting their company's latest, most expensive drugs. [See "The Unselling of Brand-Name Drugs," page 24.]

"There are signs of a building momentum to restore a sense of medical ethics, a sense of service to the patient, to our profession," says Howard Brody, M.D., director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.

But Brody points to a national survey published last year in the New England Journal of Medicine, in which 94% of the doctors polled said they had "direct ties" to the drug industry. "So you can see the position we are starting from and how far we have to go."

The drug industry maintains that its voluntary guidelines recommended only "modest" meals and gifts and says that the sales representatives provide vital information to doctors.

But reformers point to the sheer momentum of the industry's massive spending on marketing to doctors - up 275% from 1996 to 2004 - along with the rising costs of health care and the safety problems of such drugs as the painkiller Vioxx.

While few would deny that new drugs have saved lives, new medications are typically more expensive than older or generic versions and can have adverse side effects that were not apparent in initial clinical tests. Prescribing new drugs for older patients is even more problematic because most drugs are approved based on trials in which older patients were woefully underrepresented, says Jerry Avorn, M.D., of Harvard Medical School.

Whether they know it or not, "many doctors have been prescribing according to industry profits rather than the patient's needs," says Brody of the University of Texas.

Sales reps aggressively promoted Vioxx, minimizing unfavorable findings on the drug. Doctors wrote millions of prescriptions for it - right up until the drug was pulled from the market, in 2004, because it raised the risk of heart attack and stroke.

"I stopped seeing all drug reps when the problems with Vioxx hit the news," says Jonathan Mohrer, M.D., a family practitioner in Forest Hills, N.Y., who is one of a small but growing number of physicians swearing off drug reps. "Like every other doctor, I had a closet full of Vioxx pills - free samples for my patients. The Vioxx reps came by every two or three days with samples and other stuff because they were in a marketing war against Celebrex." Reps, he says, would call his office in the morning to see what the staff wanted for lunch: "Nothing fancy - pizza, sandwiches."

Despite a slight dip in spending in 2005, drug makers still spend about $7 billion a year to win the hearts and minds of doctors and another $18 billion on free drug samples for doctors, according to data compiled by the Prescription Project, an effort funded by the Pew Charitable Trust to curb the drug industry's influence.

"I've had doctors say, 'I can't be bought with a slice of pizza,'" says Adriane Fugh-Berman, M.D., a Georgetown University associate professor who has studied industry tactics. "In fact, one drug industry study, for instance, showed that when a drug rep got one minute with a doctor, the doctor's prescriptions for that drug increased 16%. With three minutes - 52%.

Each day more than 101,000 drug company reps - one for every five office-based physicians call on the nation's doctors. Primary care physicians, on average, have 28 interactions a week with drug reps, according to a 2005 report by the Health Strategies Group, a consulting firm for manufacturers of health care products.

"I go to medical conferences and ask, 'Why do you think the pharmaceutical companies are spending all that money and giving you all that free stuff?'" And I get blank stares," says Jerome P. Kassirer, M.D., former editor of the New England Journal of Medicine. "Doctors," he says, "continue to insist they can't be bought."

Even so, Congress is considering a bill that would require big drug companies to report gifts to doctors worth $25 or more, or face substantial fines. The legislation would set up a national website so patients could learn which doctors were taking gifts and fees from the drug companies.

"Right now the public has no way to know whether a doctor's been given money that might affect prescribing habits," said Sen. Chuck Grassley, R-Iowa, who, with Sen. Herb Kohl, D-Wis., introduced the measure last year.

The industry is vehemently opposed to marketing-disclosure legislation, which the Pharmaceutical Research and Manufacturers of America says "offers no extra value to patients and is a costly, unnecessary burden for innovative" drug makers.

"In the end, pharmaceutical marketing is one of several important ways for physicians to receive information they need to make sure patients are safely and effectively treated," Ken Johnson, PhRMA senior vice president, said in a statement to the AARP Bulletin. Others disagree.

"I think all the trend lines are pointing in one direction, showing us we have real problems," says Harvey V. Fineberg, M.D., president of the Institute of Medicine. An IOM committee of consumer, medical and ethics experts is drawing up guidelines for the medical community, which should be ready by the end of the year, he says. While the guidelines are nonbinding, experts say the prestige of the IOM could give them real clout.

In the meantime, the effort to curb industry influence is progressing very slowly. "Doctors say they see the reps for the latest information, but it's also for the food and toys and flattery," says Georgetown's Fugh-Berman, who helped organize PharmedOut.org to counterbalance industry influence. The site aims to offer doctors unbiased drug information and insight into drug company marketing strategies. It's funded by money from a 2004 settlement with 50 states and the District of Columbia of a case alleging improper marketing by the drug maker Pfizer.

Vermont, Maine, West Virginia, California and Washington, D.C., now have drug company gift disclosure laws. And since 2005 Minnesota has limited giving to $50 worth of meals of gifts a year per doctor. The effect of the restriction is dramatic: Primary care doctors there have been seeing far fewer drug reps, according to a firm that tracks pharmaceutical marketing.

But in New York, for example, the state Assembly passed one of the toughest disclosure bills in the country in 2006 and again in 2007, only to have the bill die in a Senate committee after what one supporter called "an army of lobbyists" descended on Albany. The measure, supported by AARP and other consumer groups, will be back this year.

New Hampshire passed a law in 2006 prohibiting drug companies from purchasing information about doctors' prescribing habits, information they use to tailor their sales pitches. The industry challenged the law, and it was overturned in federal court last year. But the state is appealing. Maine and Vermont passed similar laws that also are being challenged in federal courts.

Altogether last year 17 states drafted legislation that would regulate gifts to doctors or require their disclosure, according to the National Legislative Association on Prescription Drug Prices, a non-partisan organization of state legislators who work on ways to reduce drug costs. Not one of these bills became law.

 

Ties That Bind
For years, pharmaceutical companies have courted America’s doctors with an ever-growing intensity, showering them with billions of dollars’ worth of gifts, consulting fees and trips to persuade them to prescribe their drugs. Read more...

Recent Study Results as to the Cause of Vioxx Heart Risk
Researchers believe they have found what actually caused Vioxx to boost heart risks for persons taking the drug. As we all know, the pain reliever was taken off the market in 2004 because it was linked to a high risk of heart attack and stroke. Read more...

Merck Loses Bid for New Trial in New Jersey Vioxx Case
A New Jersey judge has upheld a $13.5 million verdict against drug maker Merck & Co. in a Vioxx case. The August 7th ruling by Atlantic County Superior Court Judge Carol Higbee denied Merck’s request for a new trial or a reduction in the verdict, which included punitive damages of $9 million. Read more...

Vioxx removed from the drug market
The manufacturer, Merck, withdrew Vioxx from the American market on September 30, 2004. Studies indicate that Vioxx can cause constriction of the blood vessels and can promote blood clotting, which can lead to acute heart attack or stroke. Read more...

 

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