November 12, 2015 at 5:00 am ET
Access to the latest scientific information is critical to the practice of medicine. However, because of the FDA’s increasingly oppressive regulations on information, sharing between biopharmaceutical companies and health care professionals attempts at the latest information in the name of better patient outcomes has become an increasingly burdensome venture. In August of this year, a federal court in New York issued a ruling that has the potential to improve medical communication, but questions remain. Broader action needs to be taken to create an open dialogue between biopharmaceutical companies and health care professionals and increase access to critical data.
Clinical trials that are conducted to obtain FDA approval of drugs and devices are designed to obtain their approval in the most efficient possible way. The inclusion criteria for these trials typically do not reflect all scientifically supported, safe and effective clinical uses of these products. For example, topical antibiotics are virtually always approved on the basis of their efficacy for the treatment of conjunctivitis and are not approved for the treatment of corneal ulcers or postoperative prophylaxis against infection. When the FDA approves products for medical use in the US, they approve a label describing their use based strictly on the protocol used in the clinical trial.
In actual practice, ophthalmologists use drugs and devices off-label on a daily basis. Such uses include refractive lasers for PRK when they were approved for LASIK (or vice versa), antibiotics for corneal ulcers, mitomycin for various surgical procedures, and excimer lasers for enhancements of corneal refractive procedures. In fact, most ophthalmologists would be guilty of malpractice if they did not use drugs and devices off-label. Off-label use of medications is common not only in ophthalmology, but in all of medicine. A 2006 study by the Archives of Internal Medicine revealed that 21 percent of all prescriptions are issued for off-label uses.
FDA clinical trials are rigid, well-designed, well-monitored, appropriately analyzed, and reliable. The FDA approval process is, however, too cumbersome, slow, and expensive to reflect the safe and effective use of all drugs and devices. Information may come to light after the approval process that expands the indications, supports modification of dosage, or even limits the indications for a treatment after marketing of a drug or device. The quality of this information may not be as good as that obtained from an FDA clinical trial, but my colleagues and I are all skilled in analyzing scientific data. We are capable of evaluating the reliability of scientific publications, and we can appropriately apply this information to our clinical practice. In fact, this is an important element of our responsibility to patients and the public.
Current FDA regulations impede our search for scientific knowledge by interfering with the flow of information from drug and device manufacturers to practitioners and even among physicians themselves. They limit discussions in public forums and limit the ability of drug and device manufacturers to interact with physicians who request information about their products. These regulations ignore the realities of the FDA approval process and the appropriate practice of medicine. Over past decades, billions of dollars have flowed from drug manufacturers to the government for alleged promotion of off-label uses. These costs are eventually passed on to consumers in the form of increased prices of drugs.
Many patients simply cannot afford to have treatment options taken off the table for lack of information; this is especially true for those with rare diseases and those with conditions that may exclude them from FDA clinical trials—like children and pregnant women. In fact, no FDA approved treatment exists for 95 percent of rare diseases.
Physicians are savvy consumers of medical information. Data are critical to the practice of medicine, and the limitations on the exchange of certain forms of scientific data put an unnecessary burden on patients and physicians. Barriers to communication between health care professionals and industry experts imposed by FDA significantly affect patient care. The limited state of information sharing denies physicians access to valuable forms of real-world evidence, which can provide tremendous insight into the effects of medicines.
I need all available information to paint a clear picture of the utility of a particular drug, device, or treatment plan. The FDA has the ability to open the lines of communication, to better enable physicians to do their jobs and provide the best possible patient care. While the court system is taking action, it’s time for the FDA to facilitate, rather than impede, the flow of scientific, data-driven information among health care professionals.
Dr. R. Doyle Stulting is the co-founder of the Stulting Research Center and the Director of Corneal Disease & Research at Wolfson Eye Institute. His 30-year career has focused on researching treatments for corneal disease, corneal transplantation and refractive surgery.