This article is more than 5 years old. Information may no longer be current.
Commentary: Evidence-empty regulations hinder patient care
An ungainly, expensive approval process for ophthalmic medications and devices has caused the U.S. to lose its technological edge.
Click Here to Manage Email Alerts
 Johnny L. Gayton |
In medical school I quickly fell in love with the concept of alleviating suffering by my words and deeds. Shortly thereafter, I developed a love for teaching others ways to improve patient care. As I write this, I am on a plane headed to Eugene, Ore., to do a talk. To make this trip, I cut my surgery day short, drove 2 hours, checked in an hour before my flight, went through TSA, flew 5 hours to Seattle, flew 2 hours to Eugene and rode to the meeting site. Obviously, if I did not love teaching, I would not do this. I am definitely not motivated by financial gain, for the honorarium that I will receive is nowhere near what I would have earned in my practice.
Because of recent regulatory decisions, I am not allowed to share information with attendees freely. I cannot mention any off-label use of any device or medication, unless someone asks a question. Even then I am supposed to quickly direct the conversation back on label. The attendees will not receive the benefit of my experience and success with using various items off label. This is despite medicine’s long, rich heritage of off-label use of approved devices and medications to help patients.
Guidelines
Last year, the Centers for Medicare and Medicaid Services approved new infection control guidelines. Those guidelines make it more difficult for us to care for our patients. Here are two changes that our ASC was required to make: We had to discontinue our preoperative medication pledget, resulting in poorer dilation and more postop keratitis due to the need to administer numerous individual drops, and due to the requirement that we have our intracameral injection mixed in a compounding pharmacy every 4 hours, we had to discontinue the same. The closest compounding pharmacy is 40 to 60 minutes away. We had successfully mixed our own medications for more than 10 years with no issues. Since adopting these new anti-infection guidelines, we have had two cases of endophthalmitis. Not long ago, there were two compounding pharmacies within 1 mile of the ASC; both have been forced to stop compounding due to increased regulations and costs.
A few months ago, the two largest ophthalmic pharmaceutical companies made the decision to no longer sample antibiotics to ophthalmic practices because they were being used in an off-label fashion to prevent postoperative infections. This is in direct contradiction to medicolegal guidelines, which state that postoperative antibiotic usage is the standard of care. It also contradicts the CMS anti-infection guidelines, which insist that appropriate protocols be established to prevent health care-related infections, especially those with resistant organisms. Last year, CBS News did a special report on the future of treating bacterial infections. The comments were echoed by James P. McCulley, MD, at Hawaiian Eye 2011. Due to the difficulty of getting antibiotics approved and the limited indications granted, pharmaceutical companies are limiting their investment in developing new antibiotics. Patients and the medical profession will be seriously harmed because of this development.
Conversely, in February, KV Pharmaceutical was given U.S. Food and Drug Administration approval to market hydroxyprogesterone to prevent preterm labor. This drug was originally approved in 1956 and for decades has been safely given in weekly injections, supplied by compounding pharmacies at a cost of about $10, without problem. Although KV invested nothing in research and development, it now charges $1,500 per dose and the FDA will enforce its monopoly, based only on the presumption that a commercial drug is safer than a compounded one.
Last year I operated in the Philippines and in Mongolia. In both countries I could correct more than 4 D of astigmatism with lenses developed and manufactured in the United States. When faced with a similar patient in the U.S. last month, I could only treat 2 D with the lens. I treated the rest with relaxing incisions, which unfortunately markedly overcorrected this particular patient. This would have been avoided if the higher-powered toric IOLs were available here. Due to the cumbersome, expensive process of approving medications and devices in the U.S., we clearly are no longer state of the art.
At Christmas, I received my usual gifts from a sweet woman who received a Morcher lens with an artificial pupil many years ago, after we spent a year obtaining “compassionate use” approval. She is so grateful for the reduced glare that she thanks me at each visit. Now, due to a recent decision by the FDA, we have to tell similar patients that there is nothing we can do for them.
Educational efforts
Many eye surgeons, including me, have benefited from the educational efforts of Robert H. Osher, MD. Last year, he was reprimanded for mentioning brand names during his lectures. Last year at the American Academy of Ophthalmology meeting, I was informed by one drug company that future programs for the company had to be completely on label, using its lawyer-vetted slides in the order that they were provided with no additions or deletions. The attendees said it was the worst lecture they ever heard me give.
What do all of these events have in common? They illustrate that the pendulum has definitely swung too far. The baby is being thrown out with the bath water. Well-intentioned regulators are creating solutions to nonexistent problems. We are encouraged to practice evidence-based medicine while we are hindered by evidence-empty regulations. Innovation is hampered, education is handcuffed and ultimately patient care is being adversely affected. Our FDA performs many needed functions. However, major changes need to be made in how devices and medications are approved and how indications are granted. Regulatory agencies need to have input from practicing physicians before establishing medical practice guidelines and before restricting the information that is shared in conferences, seminars and lectures. The future of medicine and ultimately patient care in the U.S. depends on significant, common sense change in today’s regulatory climate.
- Johnny L. Gayton, MD, and Henry Schneider, MD, can be reached at Eyesight Associates, 216 Corder Road, Warner Robins, GA 31088; JLGayton@aol.com.