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My friendly pharmaceutical rep came calling last week with the news that he could no longer bring gifts or treat me to dinner. He asked whether I was sad about that. I think he wanted to commiserate about the passing of the “good old days.” What caused this, of course, was the implementation of new Pharmaceutical Research and Manufacturers of America (PhRMA) rules governing industry-physician relationships.
I’m sure you received an Academy e-mail about this, and you can read more about it in the feature on page 43. The new rules were apparently prompted by the concern that such gifts and meals are being targeted for prosecution by the U.S. Department of Justice and states’ attorneys general under the federal False Claims Act and antikickback statutes. Their argument is that gifts, no matter how small, represent inducements to prescribe medicine more expensive than generic alternatives, and that costs the government money. Judgments in the billions of dollars (most as the result of settlements) have already been levied against major PhRMA companies for various types of activities, including improper use of gifts, and that gets their collective attention enough to change their behaviors. The new PhRMA code was apparently drafted in consultation with attorneys from the Department of Justice, so companies following the rules will enjoy a safe harbor within which to do their marketing.
It happens that these new rules coincide with an increasing awareness among physicians of all specialties that there are ethical dilemmas in their relationships with industry. As professionals, our pledge to put the patient’s best interests above all others is challenged by various inducements to prescribe certain drugs or use certain devices. I’m not talking about the flagrant abuses you read about in The Wall Street Journal but the everyday interactions between physicians and industry we all experience. The American Ophthalmological Society recently hosted a symposium on the topic, including experts from internal medicine, that makes interesting viewing for those who have trouble understanding what the fuss is about (www.aosonline.org/annualmeeting/knapp08_video.html).
As I read the new rules from PhRMA and the Advanced Medical Technology Association (AdvaMed) on the device side, there remain some sacred cows. Drug representative visits to physicians, distribution of sample drugs, speakers’ bureaus and training for speakers are still allowed.
Thank goodness the new rules do allow for the essential interaction of doctors and companies as new drugs and devices are developed for the benefit of patient care. Even detractors who complain that the new rules don’t go far enough have to admit that they are a big step in the right direction.
But as the just-retired EVP of the Academy, Dunbar Hoskins, is fond of saying, it’s all about an ophthalmologist’s integrity, defined as a consistent pattern of behavior that engenders trust. All the rules and regulations in the world won’t correct a lack of integrity, and conversely, if you have integrity, rules serve only to constrain desirable behaviors. And as I like to think, most ophthalmologists will do the right thing if they remain aware of potential challenges to their integrity. But even if you don’t think the free pens were a threat to your integrity, it might help to remember they never worked as well as the ones you bought.