More Than a Slice? No Dice!

New rules put an end to drug company largesse.

BY UDAY DEVGAN, M.D., F.A.C.S.

I've always looked forward to New Year's Day, because it renews my drive and determination to make the next year better than the last. I don't always succeed in my goals or resolutions, but I tend to learn well from my experiences and mistakes. I figure that by the time I'm 85 years old, I'll finally have achieved a reasonable level of wisdom.

In my practice, New Year's Day also ushers in the new fiscal year, the resetting of patient deductibles and the incorporation of any new laws, rules or guidelines. This year, it also marked another milestone, one that many physicians feel was long overdue. On January 1, new guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA) took effect, restricting drug companies' interactions with physicians regarding pharmaceutical marketing. The primary goal of these guidelines (voluntarily created by the industry's trade association) is to ensure that interactions between manufacturers and physicians focus on education and informational exchange benefiting patient care.

This will affect all ophthalmologists, and it will change the way we interact with the field sales representatives and managers. At my practice, we view it as a move in the right direction and have embraced these guidelines. Here's my take on some of the guidelines and how I have incorporated them into my practice.

Modest Meals Versus Fancy Dinners

Physicians are usually very busy, so often the best time to catch up with us is when we are finally sitting down — like at mealtimes. The PhRMA guidelines state that it's fine for a drug rep to have a modest, occasional meal with a physician in conjunction with a presentation or discussion about patient care and pharmaceutical products. If provided by a field sales rep or her immediate managers, these meals are to be limited to in-office or in-hospital settings. The guidelines specifically mention sandwiches and pizza, but I hope it's OK to have a couple of slices — when it comes to pepperoni, one slice just is't enough.

A fancy dinner at a high-end restaurant between the physician and the local drug rep would not be acceptable under the new guidelines, though companies may still hold educational conferences with an expert speaker at the private rooms of restaurants where the atmosphere is conducive to physician education and discussion. Entertainment or recreational activities, such as theater tickets, sporting events and leisure activities, are specifically prohibited in the guidelines.

Physician Consultants

With the guidelines, physician consultants have written contracts that delineate their bona fide activities. They are paid modest hourly rates, often less than what they would earn by doing direct patient care in their own practice. I enjoy being a consultant to multiple ophthalmic companies, giving talks at ophthalmology meetings and writing articles in the ophthalmic press. But I know that I would do far better financially by spending more time in the operating room and less time at the podium. Happiness is my pursuit and I enjoy doing surgery as well as consulting, so I'll continue to do both — but I may not be able to retire until I'm 85.

Pens, Pads and Knick-Knacks

The time-honored tradition of sales reps providing pens, pads and other knick-knacks emblazoned with the drug or company name has come to an end with the adoption of the new guidelines, which prohibit manufacturers from distributing non-educational items. Indeed, a glut of such items soon landed on eBay as sales reps suddenly found themselves with boxes of contraband (see sidebar). While these items are of minimal value, they are not educational and could be used outside of the medical practice.

Educational items worth $100 or less that cannot be used outside the professional medical arena are allowed on an occasional basis. This means that an anatomic model of the eye is fine, but a DVD player, which could be used to play patient educational videos but also movies, is not. Items that benefit patient care but are non-educational, such as a stethoscope or even post-op care kits, cannot be provided.

Chaperoning Doctors and Pharma Reps
By Leslie Goldberg, Associate Editor "In space," says an old movie tag line, "no one can hear you scream." In cyberspace, however, everyone can. And there's been plenty of it in the wake of the new PhRMA guidelines that restrict the interactions between drug reps and physicians. The revised PhRMA code states that "interactions between company representatives and healthcare professionals should be focused on informing the healthcare professionals about products, providing scientific and educational information, and supporting medical research and education." But the guidelines that seek to put this seemingly innocuous principle into practice have been the catalyst for some very heated online feedback, from both doctors (who consider it an affront to their intelligence and integrity) and drug reps (who bristle at the curtailing of civil liberties and commerce). The items quoted below are just a small sampling. The majority are anonymous writings found on pharma rep blog sites. What's your take on the guidelines? To comment for publication in a future issue, please email leslie.goldberg@wolterskluwer.com.
At right: Drug sales reps quickly flooded eBay with listings of promotional items suddenly made obsolete by the new PhRMA guidelines.
"It's pretty amazing that states like Massachusetts and others want ‘gifts’ to the M.D. of >$50 value reported. As one person in academia put it to me, the legislators certainly don't think too highly of the M.D.s in their own state if their ethics can be corrupted for $50!" — A pharmaceutical rep in an online discussion forum "With all that is wrong with medicine, it is a pity that we are wasting time over trinkets and food. So what? The company reps bring in food to get the chance to talk product with the healthcare provider. We let Pharma put ads on TV direct to patients, who are not qualified to make a judgment on the medications." — Quoted from a pharma blog "I do not need the promotional pens. I can afford to buy my own pens. But I do object to the conclusion that physicians are unable to identify a marketing message and therefore are weakened prey that require protection." — Paul Koch, M.D., Ophthalmology Management, February 2009 "The new guidelines are an attempt to set us up for socialized medicine. These government hacks want to take away company-doctor relationships and expect medicine as we know it today to stay the same. Has anyone been to a VA hospital lately? It is run by the government and absolutely stinks! These extreme guidelines are against everything America stands for. They are against the methods of business that have run this country for over 200 years!" — Quoted from a pharma blog "As soon as I hear of a drug rep getting paid a bonus based on degree of adherence to the PhRMA code of ethics, instead of sales quantity, then I will start to believe that this industry leopard intends to change its spots." — Howard Brody, M.D., Ph.D., quoted from a pharma blog

Independence in Decision Making

Physicians should have independence in our patient care decisions and no gifts, grants or support may be made to a physician in exchange for prescribing products. To me, this means that the post-op care kits used after cataract surgery cannot be provided as a reward for prescribing a particular post-op medication. I like the post-op care kits, and the patients appreciate the convenience of having their drops, instructions, sunglasses and assorted eyecare products in a handy bag. We have made the decision in our practice to purchase these kits and provide them to our patients. The cost is nominal and is typically less than the parking validation in our building. (Note: According to the code, it is appropriate to provide product samples for patient use in accordance with the Prescription Drug Marketing Act.)

Physicians should prescribe the products that will best meet the needs of each individual patient based on their experience and knowledge. Any interaction between a drug rep and physician should be a professional exchange that benefits patient care and enhances the practice of medicine. My drug reps know this and present me the information I desire, while leaving the marketing hype at the door.

Pharmaceutical companies and their employees have access to prescribing data, so they know which products and how many prescriptions have been written by each physician. Physicians can block access to this by using the American Medical Association's Physician Data Restriction Program, which is free to all doctors and can be accessed at www.ama-assn.org/ama/pub/category/12054.html.

The 2009 PhRMA guidelines also cover issues like continuing medical education events and corporate sponsorship of physician meetings. I encourage you to read them yourself to see how they'll affect you and your practice. A copy can be found at www.phrma.org/code_on_interactions_with_healthcare_professionals.

The relationship between drug companies and physicians is mutually beneficial, but delicately balanced. I think that we're all smart enough to put patients first – it's a commitment that we made many years ago when we first started medical school. I expect 2009 to be another good year, in which I'll learn a lot, enjoy helping patients and maybe even save a little towards my retirement — at age 85. OM

Uday Devgan, M.D., is a partner at Maloney Vision Institute in Los Angeles, where he specializes in cataract and refractive surgery. He is also chief of ophthalmology at Olive View UCLA Medical Center and associate clinical professor at UCLA School of Medicine. He can be reached at devgan@maloneyvision.com.