If you sell products that make medical claims not approved by FDA, you are participating in fraud. Maybe better take another look at your pharmacy's shelves.
Steven PrayEvery pharmacist is familiar with the meaning of “fraud” as deception or misrepresentation on the part of a seller. Fraud is a prosecutable criminal activity. Used-car salesmen cannot sell an automobile and fail to disclose that the engine does not work. To do so is fraud, and the unwary purchaser has the right to pursue legal redress.
Fraud abounds in medicine. FDA defines health fraud as “the deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes.” (This definition does not include legitimate vitamins and minerals such as calcium and iron. They are proven safe and effective in certain situations, according to data submitted to the FDA.)
Thousands of nonprescription products fit the definition of fraudulent, especially if unsupported medical claims are made. They include “dietary supplements,” herbals, and homeopathics. Bee pollen, cinnamon for diabetes, St. John’s wort, colloidal silver … the list goes on and on, and includes every homeopathic remedy ever marketed. The FDA has never received adequate data to prove that any of them is safe and effective for any illness (with certain very rare exceptions, such as psyllium for constipation).
Two words explain why unproven products can be sold to unwary patients: special interests. In the case of homeopathics, it was the work of Royal Copeland, a prime mover behind the Food, Drug, and Cosmetic Act of the 1930s. He inserted a clause into the act that exempts homeopathic products from normal requirements for proof of efficacy. Copeland was a homeopathic physician, so this clause was clearly inserted to protect his branch of medicine.
In the case of dietary supplements and herbals, the leading force was Orrin Hatch, a U.S. senator from Utah, where certain dietary supplement companies are located. They contributed to Hatch’s political career, and he championed a law that was tailor-made to ensure their profitability. That law, the 1994 Dietary Supplement Health and Education Act, allowed the sale of dietary supplements and herbals without requiring manufacturers to submit proof of safety or efficacy to the FDA before the products were marketed.
Driven by special interests, Copeland and Hatch created two sets of unproven nonprescription products that get a free ride, and by doing so they also increased the risk for fraud in the pharmacy.
The definition of fraud has two sections. One involves lack of efficacy.
Pharmacists inherently wish to help people who are ill. If a pharmacy sells dietary supplements, herbals, or homeopathics, it is intentionally selling products that fail to meet the modern standards of evidence-based medicine.
Even worse, if a pharmacist or any employee of the pharmacy verbally represents any of these unproven products as effective for any medical condition, the pharmacy has committed legally prosecutable health fraud.
In other words, stocking products not proven to help people who are ill is one element of the fraud equation. Providing a verbal warranty as to their efficacy virtually ensures a pharmacy’s liability.
The second element of the fraud definition is safety, and the safety of these products is also unknown. Manufacturers seldom include drug interactions, precautions, and warnings on their labels. As a result, there are many instances in which patients have been harmed by using them. (A quick internet search uncovers law firms aggressively soliciting patients who have been harmed by unproven pharmacy products.)
The sale of unproven dietary supplements, herbal products, and homeopathics represents blatant disregard of the precepts of pharmaceutical care. Such products have not been proven to help our patients; they have harmed patients without warning; and they open the pharmacy to legal liability.
Unproven products are more than just bad business. They are the pharmacy equivalent of selling a car without an engine.
Steven Prayis Bernhardt Professor in the College of Pharmacy at Southwestern Oklahoma State University. Contact him firstname.lastname@example.org.