Tell patients about gifts? Or just say no?
■ A column that answers questions on ethical issues in medical practice
Drug and medical device manufacturers cultivate physician relationships with the help of complimentary gifts and services. Some say that disclosing to patients the value of these gifts resolves the physicians' possible conflicts of interest. Others say no gifts at all is the only ethical course.
Research has shown that physician-industry interactions are associated with problematic changes in prescribing behaviors, additions to hospital formularies, and increased perceptions of conflict of interest. The purpose of a gift, after all, is to establish the identity of the donor in the mind of the recipient and to oblige the recipient to reciprocate.
Almost 10 years ago, researchers discovered that patients found gifts less appropriate and more influential than did physicians. These researchers called for broader dissemination of ethical guidelines for changing physician behavior. The AMA, the Pharmaceutical Research and Manufacturers of America and other professional organizations have guidelines on gifts to physicians from the pharmaceutical industry. In 2001 the AMA launched an educational initiative for physicians, physicians in training, and pharmaceutical representatives, in the belief that the guidelines would minimize conflict of interest and preserve integrity and trust in the patient-physician relationship. PhRMA accepted a voluntary code on gifts, but gift-giving practices have continued.
Due to the implication that gifts lead to changes in physician prescribing patterns, physicians might use disclosure to patients as a valuable tool in preventing erosion of trust in the patient-physician relationship. Or they might outline their personal policies on accepting gifts from industry.
States such as Maine, Minnesota, Vermont and West Virginia require drug manufacturers to report all payments made to physicians. If the proposed federal Physician Payment Sunshine Act (S 2029) passes, pharmaceutical manufacturers will be required to report gift-giving practices for all gifts more than $25 in value.
While Congress considers the possibility of disclosure, the medical profession as a whole could adopt the concept of disclosure.
My research found that some physicians develop their own policies on accepting gifts or policies regarding their interactions with industry representatives, while others choose to comply with a professional organization's ethical codes.
A professionwide consensus might suggest the following methods of disclosure:
On-site disclosure: Physician offices could post signs indicating the days and times they agree to see pharmaceutical representatives. A brief statement could also be posted, directing the patient to the physician or an office representative for further clarification or information.
An example might say: "In an effort to provide you with the best care possible, your physician or the physicians at this site make(s) every effort to comply with the AMA [or whatever agency the group chooses] guidelines on gifts to physicians. For a list of the guidelines and the nature of gifts that we receive, please see our office staff." Individual physician policies on accepting gifts can either be discussed with the patients or compiled along with the list of policies of other physicians in the group.
Mailed notice on disclosure: A one-page letter from the physician or the group might be mailed to patients, briefly describing the controversy surrounding gifts to physicians and steps the physician or practice is taking to curb gift-giving and provide the most unbiased care for their patients. Doing so will let patients know the matter is being considered seriously within the profession and give them an idea as to what they can expect from their physician or the practice.
Following one of these suggestions makes patients aware of their physicians' interactions with the pharmaceutical industry. As the saying goes, "If there is nothing to hide, why hide it?" Efforts at transparency may create a sense of trust between the physician and the patient, thereby facilitating their relationship.
Disclosure of gifts is thus a blessing in disguise for physicians.
Sharrel Pinto, PhD, assistant professor and director, Pharmaceutical Care and Outcomes Research Laboratory, Pharmacy Health Care Administration, College of Pharmacy, University of Toledo, Ohio
The disclosure of potential conflicts of interest assures patients that their physician is aware of biases that might compromise care. Some might find that reassuring. For me, the need to disclose a potential conflict of interest is itself morally wrong.
Convictions of right and wrong are emotion-laden. To some degree, we feel righteous or condemnatory. If I do something I find morally wrong, I feel shame or guilt. If you do something I find morally wrong, my disapprobation is equally visceral, ranging from disappointment to outrage.
Let me be clear. There is an important distinction between moral judgments and conventional judgments. Guidelines for acceptable conflicts of interest are an exercise in conventional judgment about which I can countenance debate. The following syllogism, however, expresses my moral judgment:
- No physician should knowingly enter into any arrangement that might compromise trustworthiness in any treatment act.
- Any physician who does not share this moral judgment is a compromised healer.
Given my stringent, intensely personal sentiment, it has been decades since I have acquiesced to being "detailed" by pharmaceutical representatives, let alone allowed samples to be part of my practice. The hardware sales force has limited interest in this rheumatologist, and I have none in them.
I shun all sorts of "freebies," and have no interest in participating in any industry-supported educational undertaking in which my participation might promote a sponsor's hidden agenda. In my practice, I have no conflicts to declare and no need to declare their absence. Furthermore, there is no need for any physician who shares my moral judgment to declare a conflict of interest. The absence of such conflict is a given.
The seeds of these particular moral judgments were planted in my youth by my father as I accompanied him on house calls. They germinated when I worked in proprietary hospitals a half-century ago.
I have had lapses, and I have been fooled on occasion. But these moral judgments have accompanied me on every patient contact for 40 years.
Are they anachronistic? Am I a Luddite?
Medicine is no longer a cottage industry. It is a complex industrial enterprise. Medicine's front line, whatever it is called and whomever we are, is blurred. Physicians march to so many drums, many of which demand a degree of fiscal savvy if not the occasional quick step.
Yet isn't the modern physician a match for whatever biases might distort sophisticated pharmaceutical detailing and for agendas that might slant educational events? Whose prescribing habits are perturbed by the convenience and putative beneficence of drug samples, let alone participation in flawed drug trials or marketing exercises masquerading as drug trials? What physician's clinical perspective can be bought with pizzas or trips to Monte Carlo?
Isn't it insulting to suggest that it can? And doesn't the implication that the accompanying gifts and other largesse are forms of bribery aggravate the insult?
Of course it does. And so it should.
In 2005 Minnesota officially limited pharmaceutical gifts to $50 per physician per year, effectively eliminating lunches and much else, including whatever was appealing to physicians about meeting with pharmaceutical sales representatives.
Is this much ado about very little? Not to my way of thinking. Disclosure by the practitioner is nothing but a symptom of a pernicious ethos. The profession I love has been enveloped in a cloud of conflicting interests. The opinions of "thought leaders" are valued and rewarded by the purveyors who benefit from these opinions. Surgeons and other interventionists are similarly rewarded by purveyors of the widgets and gizmos these physicians are wont to advocate.
Professional societies appear more and more like industry subsidiaries, and professional meetings, more and more like market days. Academic health centers and similar large medical institutions seem more interested in throughput and supping at the translational research troughs than in valuing bedside excellence. And all this is sanctioned, even applauded, by oversight bodies.
The FDA has no constraints on the consultancies of advisers; medical journals find "declarations" of conflictual relationships to be cleansing (sometimes stipulating the sum that is excusable); academic health centers bid for drug trials to fuel their translational profit centers; and interventionists are coddled if they regale the uninitiated with their technological prowess. The ethos is so entrenched that even the patients of spine surgeons see no problem if they are offered a device purveyed by a manufacturer for whom their surgeon is a paid consultant.
Well, I see a problem for which no degree of disclosure is a match. The only match is for the members of my profession to learn to wear, with pride, the moral judgments I detailed above, and to decry the behavior of any physician not so inclined. Disclosure should not seem necessary and never is sufficient.
Nortin M. Hadler, MD, professor of medicine and microbiology/immunology at University of North Carolina School of Medicine and attending rheumatologist at University of North Carolina Hospitals, Chapel Hill