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Do PhRMA Code Revisions Benefit the Patient?

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On Jan. 1, my Alcon pharmaceutical representative informed me that the company was no longer going to provide complimentary kits to patients after cataract surgery. These kits (which contain an eye shield, tape, sunglasses and drug samples of the physician’s choice) help organize patients after their cataract surgery and ensure they have the basic medication necessary to begin a proper recovery.

In discontinuing the kits, Alcon referenced new revisions to the Pharmaceutical Research and Manufacturers of America’s (PhRMA) “Code on Interactions with Health-Care Professionals” as its reason for making this controversial change. Anticipating the negative response from my patients, who had previously received these kits for free, I decided to read my own copy of the revisions and find out why they had been made.

The code and its predecessor that went into effect July 1, 2002, were written by PhRMA in an effort to self-regulate and prevent government regulation after public credibility had been damaged. The preamble of the code establishes an ethical guideline “to reinforce [the industry’s] intention that interactions with healthcare professionals are professional exchanges designed to benefit patients [my emphasis] and to enhance the practice of medicine.”

The most recent revision was triggered by continued consumer perception that the industry overcharges patients and uses profits to influence physicians. This sentiment was highlighted in a recent Kaiser/USA Today/Harvard survey, “The Public on Prescription Drugs and Pharmaceutical Companies,” whose number one, key finding stated, “Americans love the products that pharmaceutical companies produce, but they are less favorable towards the companies themselves, mainly because they feel they are getting ripped off by high prices driven by high drug company profits.”

The study also found that 44 percent of respondents held an “unfavorable view” of pharmaceutical companies. This put the pharmas behind only health care companies (54 percent) and oil companies (63 percent) in terms of respondents citing an unfavorable view. PhRMA’s response was to introduce revisions to its ethical code guidelines that outline changes in three major categories: gifting, consulting and enforcement of the code.

Changes We Can Expect
The change that most physicians will immediately notice is the prohibition on gifting. Educational restaurant meals, entertainment and any non-educational items, such as pens, mugs or pads of paper will no longer be allowed. However, items of nominal value (under $100) that are judged to be beneficial to the patient are allowed on an occasional basis. In-office educational meals will still be allowed at reasonable intervals. While these changes may seem trite — even counterproductive to how basic marketing is done — it shows PhRMA’s commitment to appearing ethical to the public.

The second area that will be affected is cash payments to physician consultants. This seems to be the biggest area where ethics is questioned, since “experts” paid by pharmaceutical companies are often tainted in the public eye. Consulting agreements will still be allowed, provided that compensation is of “fair market value.”

Also, PhRMA will still be allowed to sponsor continuing medical education and professional meetings as long as all payments go toward reducing the registration fee for all attendees of an event. Speakers for these events will not receive any direct compensation for their time or travel expenses, in order to ensure that educational events will not be perceived to have bias.

Do These Changes Benefit the Patient?
Ensuring ethical relationships between physicians and pharmaceutical companies is an important issue that deserves attention. However, we must not lose sight of what drives us to explore these ethical questions in the first place. That is, why do patients hold a negative perception of pharmaceutical companies? The appearance of overly cozy relationships between doctors and drug companies is one response to this question, but it’s also a shallow one. As the USA Today survey found, after all, the primary factor that influences public opinion on this issue is the affordability of prescription drugs.

We should also ask ourselves, will a new policy on PhRMA ethics actually benefit patients and change their perception? The simple answer here is that public opinion on pharmaceutical companies is unlikely to change until prices are perceived as affordable. Even if PhRMA and doctors agree to completely wall themselves off from one another, the public will pay little attention to this extreme measure if it doesn’t alter drug prices. Until we reach a balance where patients feel drugs are affordable and pharmaceutical companies can earn a reasonable profit for their efforts, public opinion is unlikely to change.

Cutting out complimentary cataract kits and company pens will not materially affect the economics of the pharmaceutical industry, and thus is unlikely to benefit patients through lower drug prices. In this respect, changes in the PhRMA code will ultimately miss their mark in bolstering a more positive public opinion of the pharmaceutical industry. However, these changes should at least cause each physician to thoroughly examine the reasons that drug choices are made. This is at the heart of the ethics issue. Thus, the Academy has issued revisions to its own policy on gifts to physicians, which match the PhRMA guidelines. See also the revised advisory opinion, “Disclosures of Professionally Related Commercial Relationships and Interests.”

As physicians, our ultimate duty is to our patients, not to shareholders. We must be proactive in letting the public know that we have their best interests in mind, especially when we are working with the pharmaceutical industry to develop the next generation of drugs and devices.

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About the author: Natasha L. Herz, MD, is a cataract and refractive surgery specialist practicing in the Washington, D.C., area, and a member of the YO Info editorial board.