For years, pharmaceutical companies have tried to influence how doctors fill out their prescription pads.

        They've offered everything from free meals and tickets to shows and sporting events to the occasional junket to warm and sunny places to attend sponsored medical conferences.

        But much of that marketing activity will have to stop, according to warnings issued by the federal government, because many perks of the business could be seen as violations of anti-kickback laws.

        “We're not talking about note pads and pens here. People don't go to jail for that. We're talking about things that involve significant amounts of money, things that are hurting taxpayers,” said Katherine Harris, spokeswoman for the U.S. Department of Health and Human Services' Office of Inspector General.

        It's a crackdown that Tristate doctors say they've seen coming for several years. And they have mixed reactions about how much the new emphasis on business ethics will actually change the medical industry.

        Dr. Michael A. Thomas, a Cincinnati infertility specialist, says the new rules appear to be a reaction to the “old days” of drug company marketing.

        As recently as five years ago, doctors could show up early at the Aronoff Center for the Arts for a brief presentation from a drug company, then take the whole family for free to the show. They could meet with salespeople for 15 minutes, then go home with half a dozen Montgomery Inn rib dinners.

        In some doctor offices, the staff could count on free lunch almost every day as competing sales reps stopped by to promote the latest medications. And offices would be flooded with trinkets as small as pens and paperweights to as valuable as golf clubs.

        “You don't see as many of the little trinkets anymore. Now, instead of Montgomery Inn, they bring bagels from Panera Bread. They've really scaled back,” Dr. Thomas said.

The guidance

        Sparking the latest ethics discussion about drug company promotions is a draft compliance guidance document issued Tuesday by the Office of Inspector General.

        The 44-page document spells out voluntary measures that drug companies can take to reduce their risk of prosecution for violations of federal anti-kickback law.

        The guidance was issued about a year after TAP Pharmaceutical Products Inc. agreed to pay $875 million to settle federal criminal conspiracy charges that the company paid kickbacks to doctors to prescribe Lupron, a prostate cancer drug.

        Among the allegations in that case: the company gave doctors free samples, then coached them to bill Medicare and Medicaid at $500 per dose.

        Among the marketing activities considered “suspect” under the new standards:

        Offering free or discounted billing assistance programs or reimbursement consultation, but only to high-volume purchasers.

        Guaranteeing a minimum “spread” between the initial purchase price and the resale price, such as the billing price to Medicare.

        “Switching arrangements” such as paying cash to doctors when patients switch from a competing product.

        Paying doctors for consulting services, sitting on advisory boards, or to speak at meetings. Drug companies are responsible for ensuring that such fees are not merely token arrangements, nor beyond fair market value.

        “Other remuneration” beyond nominal value, including entertainment, recreation, travel, meals, sponsoring educational conferences, scholarships, research grants, gifts and other business courtesies.

        Some doctors welcome the changes. Among them is Dr. Derek van Amerongen, chief medical officer for the local office of Humana Inc., a health insurance company.

        “There has been a lot of awareness about the $2 to $3 billion a year that the pharmaceutical companies spend on direct-to-consumer advertising. Every night on TV, it seems like half the ads are for Prilosec, Claritin or some other new drug,” he said. “But what doesn't get any attention is the $8 billion a year that the pharmaceutical companies are also spending to get to the physicians.

        “I know some doctors will say, "It doesn't influence me.' But if it doesn't work, why would they do it?” he said.

        Dr. Walter Matern, a Cincinnati surgeon and long-time leader in local and state units of the American Medical Association, says the AMA's ethics guidelines already say doctors shouldn't accept gifts beyond $100 in value.

        “At Jewish Hospital, they come in a lot to bring in lunch for the residents and staff. And the detail person talks about their drug. For a piece a pizza? That's not out of line.”

        Some worry that the new guidelines will interfere with valuable functions, such as sponsorship of continuing education courses for doctors or reducing patient access to free samples.

        “Everybody is in a quandary about these guidelines,” said Linda Raterman, administrator for Cincinnati Sportsmedicine. “These have far-reaching implications.”

        Dr. Rebecca Bechhold, an oncologist, said she is disturbed as much by the accusatory tone of the debate over perks as the guidelines themselves.

        The government guidelines imply wrongdoing for perks as tiny as a free dinner.

        “That does annoy me. Ninety-nine percent of doctors work hard every day, but they can't go to Carlos and Johnny's to hear a good speaker?” Dr. Bechhold said. “I'm sure no one in the legal or corporate worlds get any free tickets or trips.”

        E-mail tbonfield@enquirer.com

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