The PhRMA Marketing Code: Has it Had An IMPACT?
Critics perceived drug companies as winning physician loyalty with perks. The ophthalmology community says abuses were isolated.
BY JERRY HELZNER, ASSOCIATE EDITOR

One year after the pharmaceutical industry adopted voluntary guidelines spelling out appropriate relationships between physicians and drug companies, many ophthalmologists are either unaware or only vaguely aware of the guidelines. That may be because members of the ophthalmology community interviewed for this article say that the specialty has been relatively free of marketing abuses.

The guidelines, created by The Pharmaceutical Research and Manufacturers of America (PhRMA), set down specific limits for appropriate drug company interactions with physicians. More recently, the federal government's Office of the Inspector General (OIG) has issued its own compliance guide. The OIG guidelines praise the PhRMA Code, but also warn both drug companies and physicians that inappropriate marketing arrangements initiated by overly aggressive sales reps could violate antikickback laws. Here, I'll let you know what some members of the ophthalmology community are saying about ophthalmic drug company marketing practices and the need for ethics guidelines.

"The ophthalmic pharmaceutical companies have traditionally been quite above board in their marketing to physicians," says Rosemarie Vertullo, vice president of sales, Santen Inc. "If there were infractions, they were more likely to be associated with nonophthalmic drugs."

Ophthalmologists who responded to an Ophthalmology Management survey on this issue tend to agree with Vertullo's assessment.

"I have trouble even getting a pen from my (pharmaceutical company) reps, so I've never perceived a problem in this area," says Thomas V. Claringbold II, D.O., of the MidMichigan Physicians Group in Clare, Mich., and a national leader in the adoption of LASEK as a major refractive procedure.

"I would have to see some evidence that there's a big problem here," adds a North Carolina ophthalmologist who asked that his name not be used. "Where is the evidence, or are we dealing with a few high-profile instances? My decisions are always in the best interest of the patient."

"I've never been approached in a distasteful manner and I've never received anything that seemed overly excessive," offers Michael Korenfeld, M.D., of Comprehensive Eye Care in Washington, Mo. "The reps I deal with let me know they're following the new guidelines and they're almost apologetic about it."

The ophthalmologists we surveyed who've provided services to drug companies say they've received payment about equal to, or even less than, what they would have earned had they used the time to see patients.

"I think reimbursement has been commensurate with the services we've provided to drug companies," says a Washington state ophthalmologist in private practice. "When you look at the cost of an M.D. taking even one day off just to travel and give a sponsored presentation, I would be out over $5,000 with my lost income and overhead."

"I've been a consultant, advisor and speaker to -- and for -- multiple companies," adds Frank Weinstock, M.D., of Canton, Ohio. "Although the fees may sound as if they're large, they usually don't compensate me sufficiently for the time lost from patient care and the time away from my family."

Luther Fry, M.D., who's in private practice in Garden City, Kan., had a different type of experience. He says he's never personally received any excessive fees but once was paid $1,000 "for a talk that I would have given for free."

A few ophthalmologists said that they had in the past been offered benefits that seemed overly attractive and declined them.

"A company offered to pay my way to a fancy resort to attend a short course on their product," says a Colorado ophthalmologist. "It sounded too good to be honest, so I said 'no thank you.'"

Awareness Is Low

But even if the overwhelming majority of physician/ pharmaceutical company relationships are ethical, it's troubling that there's not more ophthalmologist awareness of the PhRMA Code.

A survey taken by ophthalmologists at Wills Eye Hospital in Philadelphia showed that 26% of the ophthalmologists who responded were totally unaware of the Code and that most of the respondents who were aware of the guidelines knew few specifics. Consistent with the findings of the Wills study, a majority of the ophthalmologists surveyed by this magazine also said they had only vague knowledge of the provisions of the PhRMA code.

Meanwhile, all of the pharmaceutical representatives surveyed by the Wills doctors knew about the Code and as a group graded 90% in answering specific questions about the guidelines encompassed by the Code.

"Our sales reps are totally aware of the Code," says Santen's Vertullo. "The reps were required to read it, sign it, and review it during a formal program with our regulatory department. We answered their questions and clarified some issues for them. They do know and abide by the Code."

The PhRMA Code actually replaces a previous set of ethical marketing guidelines that were adopted by the industry in 1990.

"Some senior drug industry executives wanted the guidelines updated," says Jeff Trewhitt, a spokesperson for PhRMA. "They felt that industry critics had created a perception that lavish spending on physicians was common, when in fact it was not. And these executives felt that one way to remove that perception was to make the guidelines more definitive."

Trewhitt says the new guidelines put the focus entirely on providing useful information to physicians.

"Entertainment is out. Distractions like taking doctors to ball games are out," says Trewhitt. "The idea is to put everyone in an environment where the sales reps can impart important educational information."

William Sarraille, a healthcare partner with the Washington, D.C., office of Sidley, Austin, Brown & Wood LLP, believes that ophthalmologists appreciate the need for strong marketing guidelines, but that some have concerns that the Code is too restrictive.

Some Doctors Have Doubts

"Some physicians believe there won't be as many educational opportunities, and that's a realistic fear," says Sarraille. "But both the PhRMA Code and the federal guidelines speak positively to the continuation of educational support. Companies will be able to provide a variety of educational opportunities."

Sarraille says ophthalmologists have also voiced concerns that the advance of eyecare technology will be slowed if companies have to limit consulting arrangements. He believes that fear is misplaced, as well.

"The guidelines provide room for consultant relationships, but bona fide services must be provided at a fair market price and the choice of consultant must be appropriate," asserts Sarraille. "In other words, a drug company can't hire an ophthalmologist as a consultant just because he's a good customer."

Aside from being paid for actual consulting, what can ophthalmologists accept from drug companies these days? They're entitled to modest meals that can only be provided during meetings that focus entirely on education, and small, practice-related promotional gifts such as coffee mugs, pens and notepads.

For some ophthalmologists, that's more than enough.

"What we, as physicians, really need is the education, and a pen or pad seem a reasonable enough way to be reminded of a good product," says Amir Arbisser, M.D., co-founder of Eye Surgeons Associates PC, in Davenport, Iowa.