W. Steven Pray

Health fraud and the resurgence of quackery in the United States: A warning to the European Union

Prior to the 1906 Pure Food and Drug Act, medicine in the United States was in a deplorable state. Predatory patent medicine hucksters preyed on a medically unsophisticated population, hawking worthless and dangerous remedies that promised to cure every disease known to man, including cancer. The practice of selling unproven remedies was known as “quackery.” Quackery was once a well-respected and widely understood term. Virtually all legitimate health professionals deplored quackery, often understanding that it contained elements that were intentionally fraudulent in nature. In 1906, the legal machinery to stop quackery was put into place with the Pure Food and Drug Act. The Food and Drug Administration (FDA) continued to gain the power necessary to control quackery during the ensuing century. However, since the 1990s, unproven products have had an unparalleled resurgence of popularity among the American public. This is partly due to the 1994 Dietary Supplement Health and Education Act (DSHEA), a law that granted unprecedented legitimacy to “dietary supplements,”a broad group of heterogeneous products that had not gone through the prestigious and well-respected FDA OTC review process, and therefore, were wholly lacking in sufficient proof of safety and efficacy. The FDA is the leading agency charged with determining safety and efficacy of nonprescription products, but one of the effects of DSHEA was to nullify its powers in regard to unproven products. FDA cannot require that dietary supplements be proven safe or effective. These unproven products would once have been held up as prime examples of quackery by pharmacy journals and professional organizations. However, in the years since DSHEA, pharmacy’s journals and professional organizations often embrace these products through several means. For instance, they seldom address the issue of quackery in regard to dietary supplements, they recommend their use in editorials and related articles, they help boost their sales by accepting their advertising revenue, they allow their manufacturers to rent booth space at their conventions, and they publish textbook chapters that present uncritical, one-sided, biased views of

Orrin Hatch and the Dietary Supplement Health and Education Act Pandora’s Box Revisited

Products of unknown safety and efficacy were once referred to as “quackery,” and the US Food and Drug Administration (FDA) was empowered to protect public health by preventing their sale and forcing them from the market. However, in 1994, the Dietary Supplement Health and Education Act legitimized their sale as “dietary supplements.” Sales increased dramatically, and many Americans now use herbals, homeopathics, and other so-called supplements. The Food and Drug Administration cannot act against them until patients have already been harmed, a dangerous situation. Furthermore, no governmental agency has the authority to force the manufacturers to furnish proof of efficacy. It is vital for physicians to warn their patients that they should use these unproven products only with great caution, and must never discontinue legitimate medical therapy in lieu of unproven products.

The Pharmacist as Self-Care Advisor: The pharmacist has an important role in helping patients select safe and effective nonprescription medications.

A patients decision to purchase a nonprescription product is driven by several factors, including the manufacturers advertising claims, the advice of friends or relatives, and past experience with the product. Pharmacists must be well-versed in product- and patient-related factors governing the appropriate use of nonprescription products in order to make appropriate recommendations to their patients and to direct them to a physician or other health care professional when necessary.

OTC product: Loratadine for urticaria.

Claritin Non-Drowsy Hives Relief (ScheringPlough HealthCare Products, Inc.) Active Ingredient: Loratadine 10 mg Indication: Relief of itching due to hives (urticaria) Availability: Bottles of 10 or 30 tablets Discussion: Urticaria (hives) are raised, pruritic lesions on the skin caused by triggering factors such as insect stings, poison ivy, foods, medications, stress, or extremes of temperature.1–3 They may persist for several weeks, causing intense itching. One fourth of the U.S. population will suffer from them at least once during their lifetimes.4 No nonprescription product was approved as safe and effective for hives until the introduction of Claritin Non-Drowsy Hives Relief in 2004. Patient Information/ Instructions5: ■ This product is for treatment; it will not prevent hives or allergic skin reactions. ■ Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following: trouble swallowing, swelling of tongue, trouble speaking, wheezing or problems breathing, dizziness or loss of consciousness, swelling in or around mouth, drooling. These symptoms may be signs of anaphylactic shock. This condition can be life-threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. ■ This product is not a substitute for epinephrine. If your doctor has prescribed an epinephrine injector for anaphylaxis or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. ■ Do not use to prevent hives from any known cause such as foods, medicines, insect stings, or latex or rubber gloves, as this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for OTC Product: Loratadine for Urticaria

Issues in Implementation and Enforcement of Hospital Pharmacy Policies and Procedures

Policies (a type of long-range plan) and procedures (a type of short-range plan) are corporate statements that reflect the organizations objectives. Whereas policies are guidelines for guiding a work effort, procedures represent an acceptable set of steps for carrying out the specific policy. As such, it is vital to orient new employees as to the content of policies and procedures. Flexibility in enforcement of policies and procedures helps encourage employee creativity and innovation, although any departure from established policies and procedures may be viewed as a breach of the hospital pharmacys standards of practice. Furthermore, in a civil lawsuit, a lawyer may argue that various hospital documents, such as memoranda or notes related to policies or procedures, are part of policies and procedures. Policies and procedures are vital segments of institutional life that should be communicated to all employees. Failure to follow them may create liability risk.

The Hospital Pharmacist as an Expert Witness

An expert witness provides knowledge from his or her field of specialization to participants in a trial, to help them clarify the issues presented to them. The hospital pharmacist is a natural choice as an expert witness in cases of alleged negligence within the hospital pharmacy. The hospital pharmacist who intends to become an expert witness should consider issues such as credentialing, obtaining employment, and developing a fee schedule. From the outset, the expert witness must keep accurate records, and he or she may be called upon to review documents, write opinions, render affidavits, and assist attorneys in questioning opposing experts. The expert witness may also create documents and may testify during a deposition. The culmination of the process is the trial itself, in which the expert must strive to present issues clearly and professionally, during both the direct examination and the cross-examination. The trial may be won, lost, or settled out of court — and this outcome can be influenced by the testimony rendered by the expert witness.