Robert W. Yelverton, MD, FACOG
Retail Clinics, Supplements, Herbs, and Off Label Medications: Ethical Challenges in the Changing Paradigm of Health Care
Several interesting items have been in the news recently. The first is a report in The New York Times discussing the New York attorney general’s office investigation that resulted in charging four major retailers with selling fraudulent and potentially dangerous herbal supplements. The retailers, two giant drug store chains, one huge nutritional supplement retailer, and a general merchandise giant with in-store pharmacies, were accused of the bad deed. Studies conducted found that 80 percent of the top-selling store brands labeled as herbal products did not contain any of the herbs listed on their labels. For example, products labeled as Ginkgo Biloba, St.John’s Wort, and valerian root, contained little more than cheap fillers like powdered rice, asparagus, and houseplants. The results of this study came as no surprise to healthcare experts who have long complained about the quality and safety of dietary supplements that have been free form the strict regulatory oversight applied to prescription drugs since supplements became exempt from the U.S. Food and Drug Administration’s (FDA) approval process by federal law in 1994.Another newsworthy item discusses the growth of retail clinics. This will be of interest to those physicians struggling financially as a result of real and anticipated diminished reimbursement from healthcare reform. This article detailed the growth of retail clinics after a slow start a decade ago. Strategically located and well-financed organizations like drugstore chains, big box stores, and giant retailers have now opened more than 1,500 retail clinics competing for the primary care dollar. While these stores were originally opened to treat minor “walk-in” problems like sore throats, many are now beginning to do chronic disease management. Florida is a major target state for such clinics. Of note, two of the drug store chains that have opened retail clinics in Florida are on the New York attorney general’s list of stores selling the alleged “herbless” herbs.
You may be asking how these two pieces of news relate. As you might guess, most of these in-store clinics are adjacent to their in-store pharmacy, and are surrounded by shelves of over-the-counter (OTC) medications and, you guessed it, nutritional supplements, all lining the narrow aisles leading to the cash register. These clinics are almost always staffed by non-MD professionals who may write prescriptions for drugs or recommend OTC drugs or a handy supplement. The store, of course, hopes retail clinic patients will purchase these items on the way out the door. Research shows that these retail clinics and their relationship to their parent company are minimally regulated. Touted by lawmakers and healthcare pundits as frontline inexpensive and efficient alternatives to traditional primary care, these clinics, seemingly not concerned by the potential for conflicts of interest, are seldom encumbered by the same regulators and legislators who maintain strong regulatory oversight of medical practices maintained by physicians.
Appropriately, physicians are bound by a code of ethics enshrined within the Hippocratic Oath and modified over time by scientific discovery and the changing mores of our society. The unique relationship between a patient and her physician allows for confidence that decisions concerning managing her care are made in her best interest and based only on the physicians desire to heal. In the event that a physician becomes lax on applying modern principles of ethics to their practice, both the American Medical Association (AMA) and the American Congress of Obstetricians and Gynecologists (ACOG) have published principles of ethics that remind physicians that they should not profit from such relationships or even position themselves in situations that present the potential for a conflict of interest. Physicians may fail to realize that many patients are uncomfortable with even the potential conflict of interest that exists when they attempt to boost their income by pitching products to them. It seems apparent that the creators of the retail clinic concept were not taught from the same book of ethics that molded the principles of medicine. Medical ethics that bind physicians by their unique relationship with patients seems not to carry over to medically related business conducted by many business professionals.
But times ... they are changing. The drive to find legitimate commercial enterprises designed to enhance the income in a medical practice is putting tremendous pressure on physicians who are being forced to compete with non-physician healthcare entrepreneurs. Many have questioned and others have ignored well established ethical dogma. Several published surveys reveal that more than 60 percent of healthcare providers (medical doctors, osteopaths, chiropractors, and naturopaths included) sell nutritional supplements directly out of their office. Ob/Gyn physicians are constantly pressured by companies marketing supplements, anti-aging products, and other spa-related items for exclusive sale in physicians’ offices, promising healthy, cash-only income. Right or wrong, it is not uncommon to see such products featured in the waiting rooms of Ob/Gyn offices around the state.
Some physicians, angered by the pharmacy industry’s intrusion into providing direct healthcare within retail clinics, have attempted to counter the trend by dispensing prescription medications to patients. While legal in most states, dispensing programs may run afoul of the same principals governing the ethics of selling supplements. Neither the AMA nor ACOG consider dispensing prescription drugs from a doctor’s office an ethical practice except under very limited circumstances. Ethics aside, some physicians, including Ob/Gyn practices, have started self-dispensing programs. While an occasional practice can generate profit by dispensing prescription drugs, many that have attempted to do so have been unsuccessful for a variety of reasons. State laws limiting the practice, lack of liability coverage for dispensing, lack of health insurance coverage, limited formulary, rising cost of generic drugs, and lack of profit in commercial turnkey operations all play a part in limiting the Ob/Gyn’s chance of success in a dispensing enterprise.
Without question, in-office dispensing is considered ethical when it is necessary to administer a drug in a professional setting— vaccinations are one example. A “cash only” enterprise such as the controversial insertion of subcutaneous pellets containing compounded “bioequivalent” estrogen and non-FDA approved testosterone in women, is an example of a practice that is ethical if safe and effective but not ethical if it is not. This procedure, now commonly available in many Ob/Gyn offices, anti-aging clinics, medical spas, and weight loss clinics across Florida, is championed by some as cutting-edge management of menopausal symptoms and sexual dysfunction but criticized by others, including several national and international endocrine organizations, as untested and potentially unsafe. Is the practice unethical by the AMA or ACOG standards? The answer depends on medical facts and should be debated within our profession and, in time, will be.
Given the rapid changes in healthcare, and the increasing control of the business of medicine by business professionals— some unschooled in the difference between what is legal and what is ethical— should physicians re-examine our ethical principles governing commercial enterprises in an effort to level the playing field? Or should we stand by our ethics as the single set of principles that distinguish our profession from those who challenge us?
My personal bias is that we stand our ground and maintain our high ethical standards but review those standards continuously. As for the independent Ob/Gyn, I believe our efforts are better served by reviewing the new practice models available and mastering the one most attractive to our practice. Independent practice and maintaining autonomy is still a viable alternative to selling your practice but will require adaptation to the new payment models and may include big decisions such as changes like consolidation. In my opinion, changing our cherished principles is not the answer.
Opinions expressed in this column are those of the author and not ACOG.