Physicians, Managed Care Disapprove of Consumer-Direct Advertising

By Lori Malvey

With the growth of managed care organizations, consumers are expected to become more actively involved in their health care decisions; thus the rise of direct-to-consumer (DTC) prescription drug advertising. Spending on DTC drug advertising is estimated at $1.3 billion for 1998. However, 65% of physicians surveyed would prefer less direct-to-consumer (DTC) prescription drug advertising or a discontinuation of the practice altogether, up from 61% last year, according to IMS Health (Plymouth Meeting, PA), a market research firm. In addition, one fourth of surveyed physicians say that while the patient requests for brand name drugs are increasing as a result of the ads, doctors are receiving specific directions from managed health care programs against prescribing non-covered brands.

"The concept that led to the approval of DTC drug advertising -- consumer awareness of new treatment -- in theory is a sound thing," commented Ray Woosley, MD at Georgetown University's Center for Education & Research in Therapeutics. "But I don't think drug companies should show glowing advertisements of people wandering through life forever happy because of some new medicine that's been approved, and for which they then immediately demand from their doctor. The public, including nurses, physicians, and all medical personnel has a tremendous need for a true and unbiased message about prescription drugs. Most medical schools allocate only one semester to teach students about medicines and how to use them, so we haven't done our job in preparing physicians. What I would like to see is drug advertising in the form of a public service announcement. Alert the public to the availability of a medication and its efficacy, but include additional general messages such as: drugs can interact with over-the-counter medicines, herbal remedies, natural products, etc. and that people must advise their doctor and pharmacist of all products they are presently taking. The messages should also tell consumers to request counseling from their doctor and pharmacist on the use of any medicine."

Woosley pointed out that GAO estimates society loses $20 billion/year as a result of the misuse of medications. "Seldane, for example, is a very safe and effective drug when used as instructed. Because it was not being used properly the producer had to pull it from the market. It is in the best interest of the drug manufacturers to educate the public better. This would result in fewer product recalls, fewer people would be harmed, and fewer product-related lawsuits."

When asked about the physician being in the middle of managed care recommendations and consumer requests, Woosley commented, "The FDA wants to be notified if therapeutic switching (drug substitution) is harming people, which it likely is. The physician is often placed in a position of having to change a prescription to a drug he or she may know nothing about, or he/she may know a lot about it but the medical record is not available at that time (for example, getting paged during the car ride home by the pharmacist). For busy physicians, this happens all day long, and goes against everything we teach doctors. We teach doctors to know all about the particular medicine being prescribed for a patient, and to make sure that it is the right one for that particular patient."

Richard Waltermire of Pharmacy Gold, Inc., a St. Paul MN based pharmacy benefit management services firm and affiliate of Aware Integrated, parent company of Blue Cross Blue Shield of Minnesota, challenged both the FDA and pharmaceutical manufacturers on their DTC positions at a July 14 speech given in Washington during the "Managed Pharmaceutical Benefits: Impact of the FDA Modernization Act" conference. "The problem with prescription drug advertising is that a 30-second commercial cannot begin to touch the complexity of a person's medical problem or the risks of the medication's side effects," Waltermire stated. "These consumer commercials foster the attitude that there is a pill for every ill. I don't think this is the drug-seeking behavior we want our children to learn." Another concern raised by Waltermire was the fact that newer drugs have not been thoroughly studied for potential adverse reactions, and that many manufacturers conduct Phase 3 trials only on the lowest-risk, best-case patients (i.e., those with little or no history of adverse drug reactions and whose illness is not as severe as other cases). "Fifty-one percent of approved drugs have serious adverse effects not detected prior to FDA approval. 100,000 people die from adverse drug reactions every year, while 1.5 million require some hospitalization. A Phase 4 surveillance needs to be implemented whereby newly marketed drug-drug and drug-food interactions are studied, analyzed, and results disseminated to physicians."

Waltermire went on further to suggest FDA improvements in the area of new drug safety. "Currently, 1400 FDA employees are assigned to approve new drugs, but only 52 monitor the safety of already approved 5,000 drugs. It is unreasonable to expect this group to keep up, notwithstanding the potential for even more drugs to come to market this year."

For more information: Ray Woosley, Georgetown University Medical Center, Room SE 402, Medical & Dental Building, 3900 Reservoir Road, Washington, DC 20007. Tel: 202-687-1064.

Richard Waltermire, Pharmacy Gold, Inc. P.O. Box 64812, St. Paul, MN 55164. Tel: 651-456-1000.