Healthy Skepticism Library item: 334

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Publication type: news

Japsen B.
Medicine's gift culture put in an uncomfortable light
The Chicago Tribune 2004 May 16

Full text:

While prosecutors put the pharmaceutical sales practices of a Lake Forest drugmaker on trial here this spring, testimony is shining a spotlight on doctors who demanded expensive gifts ranging from Rolling Stones tickets to European vacations.

The physicians themselves are not on trial.

But their behavior provides an insight into a rampant gift culture in medicine in which, according to several studies and even admission by the American Medical Association, the choice of medication patients are prescribed can be influenced by the gifts doctors receive.

In the trial of 11 current or former sales staffers of TAP Pharmaceutical Products Inc., prosecutors and witnesses have said that physicians extracted gifts by threatening to switch patients from TAP’s Lupron—a prostate cancer drug that costs more than $400 a dose—to a rival drug, Zoladex, that was $100 a dose cheaper and just as effective.

At least one doctor, according to testimony, wrote out a list of what he wanted.

Cleveland urologist Dr. Kalish Kedia allegedly provided TAP’s sales staff with a list of perks he wanted during the mid to late 1990s.

Prosecutors said Kedia, who prosecutors claim purchased nearly $1 million of Lupron annually, demanded company-paid airline tickets and trips to resorts.

He also charged more than $7,000 to the credit card of a TAP sales representative for dinners for himself and his physician friends, prosecutors said.

“He was a doctor who always had his hand out,” said Susan Winkler, an assistant U.S. attorney in Boston. “He kept threatening to switch to Zoladex. He always wanted something.”

Kedia declined to comment when reached at his office.

Not every doctor got what he wanted.

When Pittsburgh urologist Frank Costa could not make a TAP-paid trip to reward high-volume prescribers of Lupron, he asked the company to fly him and his family to Italy for a vacation, according to a former TAP sales executive and related trial testimony.

But the company balked, allegedly because sales representatives felt his demand “crossed the line” of what was appropriate. Attorneys for defendant salespeople at TAP say the company often drew the line at physicians’ demands it believed went too far.

In a telephone interview, Dr. Costa said he didn’t recall interactions with TAP sales officials. “I don’t have any recollection of this, and I am not going to talk about this over the phone,” Costa said.

Defendants’ attorneys have said any gifts that were provided to physicians were for educational benefit, which is allowed under American Medical Association ethics guidelines.

The guidelines say that doctors should only accept gifts worth less than $100 and only if they primarily benefit patients.

The 11 current and former TAP employees on trial in Boston federal court are fighting allegations that they gave gifts as payments to win physician loyalty to Lupron, and by doing so caused the government to pay more for treatments.

Prosecutors characterize the gifts as bribes and illegal payments or kickbacks aimed at eliciting doctors’ help in bilking the government into paying for a more expensive drug when a cheaper and just as effective drug could have been provided.

Business expenses

Attorneys for the defendants say that trips given to doctors were legal business expenses or were educational events. Organizers planned meetings so doctors could learn about Lupron’s benefits as a life-saving cancer drug, they said.

To curtail potential unethical behavior and gift acceptance, the AMA and several large drugmakers in 2001 began a joint educational effort of doctors and pharmaceutical salespeople on what is acceptable.

TAP in October 2001 paid a record $885 million settlement and pleaded guilty to conspiring with doctors to bill insurers for free samples of Lupron.

That case also drew attention to physician behavior. Four urologists have pleaded guilty in the case and are cooperating with prosecutors and await sentencing. A Massachusetts physician awaits a trial on similar charges as the TAP sales managers.

Gifts limited

TAP would not comment on alleged actions of physicians, how the company markets to physicians or the trial involving its current and former employees.

TAP and other drugmakers recently have reined in gift-giving practices in the face of prosecutors’ focus on the industry.

The U.S. drug industry trade group, Pharmaceutical Research and Manufacturers of America, in 2002 established voluntary guidelines to curb certain sales tactics such as entertainment and “dine and dash” dinners that drug companies order at restaurants so doctors can pick them up at no charge. TAP was one of the first companies to adopt the guidelines.

TAP said several companies have since copied their compliance efforts.

In 2001 TAP hired a leading compliance executive, L. Stephan Vincze. The company also has an interactive training program, updated yearly, that puts sales representatives “through real-life scenarios so that it is not just a textbook educational program,” TAP spokeswoman Katherine Stueland said.

Still, some doctor groups advocate that physicians disclose any business relationships they have with drug firms to prevent ethical breaches or the appearance of conflicts of interest.

“People need to know that we are acting in their best interest rather than the interest of the drug company,” said Dr. James Webster, president of the Institute of Medicine of Chicago. “Those of us in the practice environment have to step up and make disclosures and make sure the patients know that I am giving you Lupron because it is the best thing for your prostate cancer and not because I got a kickback or a present.”

`Despite the best intentions’

Even small gifts like pens, pencils and notepads can influence doctors’ decisions on what drugs they choose for patients, researchers at the University of South Carolina School of Medicine found in a study last year.

Such items have “subliminal” effects, and doctors are more likely to prescribe the drug name in front of them. The study was published in the Archives of Internal Medicine.

“Several studies have shown that physicians’ behavior can be influenced through gifts of substantial value despite the best intentions,” said Dr. Michael Goldrich, chairman of the American Medical Association’s Council on Ethical and Judicial Affairs.

Goldrich suggested that physicians have copied from other industries in which customers routinely accept gifts, trips and dinners.

“In many other cultures, this is the basis of business relationships, but when it comes to physicians, the physicians’ only obligation is to the patient and their best interest.”