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Are physicians limited by government guidelines?
Douglas Katsev, MD, and Alice T. Epitropoulos, MD, FACS, discuss how pharmaceutical guidelines and FDA requirements affect physician education.
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Welcome to another edition of CEDARS/ASPENS Debates. CEDARS/ASPENS is a joint society of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.
Pharmaceutical guidelines and FDA requirements continue to become more restrictive in the educational setting. Physicians and industry are significantly limited in what they can say in these settings. While the goal may be to maintain transparency and lack of bias, the consequence may be limitation of physician education. Have the restrictions gone too far? This month, Douglas Katsev, MD, and Alice T. Epitropoulos, MD, FACS, will discuss this controversial topic. We hope you enjoy the discussion.
Kenneth A. Beckman, MD, FACS OSN CEDARS/ASPENS Debates Editor
Better quality learning with less control over lectures
Is the U.S. government getting in the way of learning in ophthalmology? Somehow politicians think they can take campaign contributions and not be biased, yet think physicians have no morals and would blindly follow a physician on the podium. Politicians are afraid that we might be easily influenced and controlled by small gifts (even a pen), dinners or, God forbid, a golf game.
Unfortunately, the government’s efforts to control the ophthalmic industry have a major effect on our profession. Ophthalmic sales representatives used to come to our office with samples and pens and speak to us directly over lunch or dinner when we had time to talk. I could ask questions and get to know them and their products. Now they rarely come by and usually invite us to some inconvenient dinner with a fixed menu a month away. The speaker (physician) will read the slides that are written by the company. When someone asks a good clinical question, they must usually respond that it is off label or not studied in the FDA trials so they cannot discuss it further. They may have a good clinical answer that they know from personal experience but cannot discuss per government/pharma guidelines.
Industry spends time where it is safe to promote but not actually allowed to teach new trends. It focuses on getting its promotional message through articles in the throwaway journals and promoting old FDA study results that often have minimal clinical relationships at present time. The message is controlled by professionals who know exactly how to present, staying on point to the satisfaction of the government and the detriment of our learning experience.
Twenty years ago, I used to say the American Society of Cataract and Refractive Surgery was 50% ahead of itself and 50% hot air. I was always willing to figure out which was which because the 50% was really good stuff and worth the work. We moved at a very progressive rate then with major advances every meeting. Now most advancements are developed in other countries and very minimal is learned at most U.S. meetings. Hopefully this will change, but I do not see anyone willing to lead the charge. Often when we find a problem, we overreact. I hope we can return to better quality learning and less control over content of lectures so physicians can state what works for them in the clinical setting. I think this is worth the risk that physicians can control their own bias.
- For more information:
- Douglas A. Katsev, MD, can be reached at Sansum Santa Barbara Medical Foundation Clinic, 29 W. Anapamu St., Santa Barbara, CA 93101; email: katsev@aol.com.
Disclosure: Katsev reports he is a consultant for Bausch + Lomb, Sun, Omeros, AMO and Shire.
Well-intentioned but ineffective guidelines
Some health care practitioners have complained about attending medical dinner programs where physician speakers are restricted from answering certain questions that are asked by attendees. Oftentimes an excellent clinical question is asked but cannot be answered because the speaker must abide by the same regulations as the companies do. This can cause an outstanding opportunity of medical education to be lost between physician speakers and the physician attendees. In some circumstances, these regulations are inhibiting more than helping to disseminate information, with the unintended consequence of silencing medical communication.
Pharmaceutical industry guidelines are generally voluntary, but the threat of government action can handcuff industry and how it interacts with physicians. Is it possible that some career bureaucrats hold a grudge against physicians for the high esteem their patients have for them?
If we turn on the television today, you might very well view a commercial by a pharmaceutical company by famous athletes such as Arnold Palmer and Chris Bosh to actresses Jennifer Aniston and Cheryl Ladd. Advertisements pertaining to ailments such as erectile dysfunction, dry eye and stroke tell viewers why a certain drug works for them and why they should ask their health care provider for more information on their products.
Are we to believe that identifying with celebrities who may share a common ailment does not influence patients who view these commercials? Make no mistake, these ads cost tens of millions of dollars and go straight to the consumer. This can put physicians in an awkward position when patients ask for a certain medication over the physician’s preference. It often seems that the government thinks physicians can be influenced by trivial gifts such as pens and calendars but not by commercials that target patients who have little or no medical education. We must ask ourselves whether the medical profession and the pharmaceutical industry are strong enough to push back against guidelines that are well intentioned but ineffective. There is no doubt that professional ethics and strong industry practices can be an effective solution in which exchanges of medical information can produce a basis of mutual trust.
- For more information:
- Alice T. Epitropoulos, MD, FACS, can be reached at The Eye Center, 262 Neil Ave. #430, Columbus, OH 43215; email: eyesmd33@gmail.com.
Disclosure: Epitropoulos reports she receives grant/research support from Bausch + Lomb, Kala Pharmaceuticals, Ocular Therapeutix and TearLab; and is a consultant/speaker for Allergan, AMO, Bausch + Lomb, Omeros, Physician Recommended Nutriceuticals, Shire Pharmaceuticals, Sun, TearLab and TearScience.