Perspective on OIG Guidelines for Pharmaceutical Companies: An Expert Interview With Arthur Palamara, MD

Laurie Barclay, MD

October 08, 2002

Oct. 9, 2002 — Editor's Note: The Office of the Inspector General (OIG) is reining in the pharmaceutical industry with respect to gifts and other inducements offered to doctors in hopes of increasing sales of their own products. Effective July 1, 2002, the Pharmaceutical Research and Manufacturers of America voluntarily established a Code on Interactions With Health Care Professionals.

On Sept. 30, the OIG went one step further, prohibiting pharmaceutical companies from offering doctors, health plans, or pharmacy benefit managers incentives to encourage or reward the prescribing or purchase of particular drugs. Although these standards have not taken on the force of law, failure to follow them could trigger prosecution for violating anti-kickback laws and other fraud and abuse statutes, both for the pharmaceutical industry and for doctors who collaborate in unethical or even illegal practices.

To find out how doctors should protect themselves as well as their patients from being subject to undue influence by drug companies, Medscape's Laurie Barclay interviewed Arthur Palamara, MD, a vascular surgeon in Hollywood, Florida. He is vice president of the Florida Medical Association (FMA) and serves on their Tort Reform Task Force and Council on Ethical and Judicial Affairs.

Medscape: Do you believe it is appropriate for the government to issue marketing guidelines for the pharmaceutical industry?

Dr. Palamara: Some may question whether drug companies and healthcare providers should be held to a higher standard than are other businesses, which they claim may not be fair in today's economy. But perhaps we should be held to a higher standard, as we have a higher ethical obligation to our patients that goes beyond traditional business ethics and even beyond the letter of the law.

Medscape: Are there guidelines available for physicians regarding their interaction with the pharmaceutical industry?

Dr. Palamara: The Ethics Committee of the FMA set up guidelines for appropriate physician behavior, which in large part are common sense. It's okay to accept educational materials, pamphlets, or other promotional items from a drug company when those items in some way benefit patient care and cost less than $25. There's no problem in attending educational conferences, but all-expense paid vacations are clearly out of the question.

Medscape: Do you think it's appropriate for the government to get involved in prescribing appropriate behavior for physicians as well as for the drug industry?

Dr. Palamara: I think there's a real danger in throwing the baby out with the bath water. Pharmaceutical companies expose doctors to knowledge which is essentially unavailable to them otherwise. Just because this information exchange takes place in a pleasant location, or accompanied by a nice meal or even a few glasses of wine, doesn't necessarily mean there's anything unethical or illegal going on, or even that doctors are being exposed to undue influence. Are we really going to prescribe their products just because they bought us dinner? We're smarter than that. Most of us are extremely cynical and loath to accept ideas offered by a drug rep or expert consultant when we see that they're expressing their parochial interests. But we welcome the opportunity to advance our knowledge about specific drugs, so that we have more bullets in our gun to use against specific diseases or symptoms. As long as the information received is accurate and the need for that information is legitimate, I think it's okay.

Medscape: Could you please comment on the recent prosecution of and guilty plea entered by Saad Antoun, a New Jersey urologist, in conspiring with Zeneca Pharmaceuticals to violate the Prescription Drug Marketing Act by billing patients and insurers for the prostate cancer drug Zoladex, which he received from Zeneca free of charge? Orthe four physicians who pled guilty to criminal charges after accepting payment from TAP Pharmaceuticals for ordering their drug Lupron?

Dr. Palamara: That type of behavior is unethical and illegal, and those physicians deserve to be prosecuted. You just can't do that! It's fine to accept free samples for distribution to patients who can't afford to buy the drug, or to start a new medication to see how it works before committing the patient to buying a full month's supply. With managed care reimbursement being as low as it is, I can feel for the doctor who's struggling to make his malpractice insurance payment or his other overhead, but this type of behavior is just plain wrong.

Medscape: How about the pharmacy benefit managers, now that they are prohibited from accepting incentives to change formulary drugs in favor of a particular drug company?

Dr. Palamara: They should be purer than Caesar's wife! I agree that they should be thinking only about the cost-benefit analysis as it affects the patients. Whether it's doctors or formulary managers who accept financial inducements to switch their patient's drugs to a specific product, it smacks of illegality when there may be an equally or even more effective drug out there.

Medscape: How do you think the pharmaceutical industry will respond to these standards?

Dr. Palamara: One approach some of them are already taking is to hold telephone surveys and focus groups. These are tremendously lucrative for physicians — like $300 for a 20-minute interview — and this practice isn't directly subject to the guidelines because it's termed marketing research rather than an educational presentation.

But sometimes they use a "push-pull" approach, introducing their viewpoint while asking questions. Like in politics, for example, the pollster might ask, "Are you planning to vote for Candidate X?" If you say yes, they might ask, "Would you still vote for him if you knew he beat his wife?" With drugs, it might be, "Do you use drug X?," and if you say no, they ask, "Would you use it if you knew it prevented strokes in 20% of patients?"

There needs to be a legitimate way for drug companies to bring information to physicians, and there's nothing wrong with making it as pleasant as possible. As long as they don't overdo their marketing presentations they can keep it beneficial for both parties.

Medscape: Can you recommend a general approach for physicians to follow to ensure their interactions with the pharmaceutical industry are beyond reproach?

Dr. Palamara: Doctors may be tempted to use drugs which are not the most helpful for their patients, but everything we do must be based on patient welfare. If we lose that integrity, we've lost it all. We exist entirely for our patients. When I was busy giving many speeches at the FMA, I tried to remind doctors of this. We have to retain our autonomy and remain as spokespersons for our patients. Otherwise, we threaten the existence of our profession. Sometimes my comments fell on deaf ears because many doctors are concerned about their own financial struggles. We need to be accountable for everything we do, but it's hard to tell it to someone who's getting reimbursed $22 for a complex consultation and who has to pay $120,000 in malpractice premiums. It's difficult to convince doctors that our own success is entwined with the patient's welfare.

Reviewed by Gary D. Vogin, MD

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