Our Medicated Society: Fresh Challenges Posed by Alternative Medicine and Marketing of Psychopharmacologicals By Herbert S. Sacks, M.D. APA President

The American preoccupation with extending life and defeating death has been a boon to health food stores, naturopathy, and alternative-medicine practitioners. Physicians, often plastic surgeons in urban areas, promote cosmetic surgery combined with the use of human growth hormones, testosterone, DHEA, and megavitamin supplements-all as qualify-of-life enhancers and anti-aging strategies.

Alternative medical therapies, such as chiropractic, acupuncture, homeopathy, massage, and herbal medication are in public demand. In 1990, 60 million Americans used alternative therapies at a cost of $13.7 billion. Annual visits to alternative therapy providers (425 million) exceeded visits to all U.S. primary care physicians (388 million). Most importantly, more than 70 percent of patients who acknowledged using alternative therapy never mentioned it to their physicians. Little is known about the safety, efficacy, mechanism of action, and cost-effectiveness of individual alternate treatments.

The allopathic physician has a liability risk in prescribing indicated medication to patients who silently take herbal mixtures with undocumented and unproven effects. Forty percent of patients are noncompliant in taking doctor-prescribed medications, and more than 30 percent do not fill or refill prescriptions. Surveys do not reveal whether the noncompliant cohort includes patients who do not fill or refill prescriptions. Nonetheless, with many patients falling into these categories, the degree of danger to patients' health and to doctors' ability to help them is diminished by these behaviors, as is the loss of potential therapeutic effects of prescribed medications.

The high cost of health care, a special burden to the 41 million uninsured working poor, has caused some Americans to circumvent the existent system of care, seeking accessible self-medication to reduce costs. Many believe that the alternatives of herbal medicine, naturally derived, are without side effects. However, without documented toxicity for certain herbs, supplements, or chemical preparations and absent FDA approval for these substances, there is no assurance of safety for patients or their doctors. Notions that "natural" substances are inherently safe are false.

Psychiatry's expanded use of psycho-pharmacologic agents, often integrated with psychotherapeutic approaches, mandates that we closely query patients who may also be seeing an alternative medicine practitioner or self-medicating. There is a substantial potential for unintended drug interactions and unrecognized side effects. Patients on psychopharmacologic medications should be cautioned, if not dissuaded, from simultaneously using herbal medicines, supplements, and substances with poorly studied or unknown pharmacologic activity, which could inhibit or potentiate medically indicated psychopharma-cologicals we prescribe. In addition, herbal medicine effects upon ego functioning may skew a sensitive diagnostic evaluation by a skilled psychiatrist clinician.

We all have seen patients who are invested in homeopathy, massage, spiritual healing, hypnosis, and relaxation techniques. But any therapy can be detrimental to health if it delays or deters a proven treatment.

APA's Relationship to the Pharmaceutical Industry

In the past few years, some members have expressed concerns about the nature of APA's relationship with the pharmaceutical industry. Indeed, we have been moving forward with the industry in finding fruitful areas of agreement and cooperation. Where there has been dissonance, open and frank discourse has helped us to find common ground in our search for improved quality patient care. These companies have created an extraordinary means of giving respite to the seriously mentally ill and their families. The industry's role has increased its awareness of the public interest, which often is a counterweight to aggressive marketing. The efficacy of the medications combined with marketing efforts led Wall Street analysts to predict that the 1998 sales of Zyprexa will exceed $1.1 billion, Risperdal's will be close to $1 billion, Clozaril's about $450 million, and Prozac's in the realm of $2 billion.

Pharmaceutical Marketing

There are two areas we are currently pursuing with the industry:

• Direct marketing. Last year the companies spent $1 billion on advertising prescription drugs to the general public, up from $50 million six years earlier. Full-page advertisements in the print media promote psychiatric drugs to our patients, bypassing the treating clinicians. The industry explains that the educational thrust of the ads helps suffering people overcome their resistance to pursuing medical help. Further, since only a physician can write a prescription, ethical patient care is safeguarded. But critics comment that patients may seek out physicians who are willing to prescribe drugs that may be contraindicated or ineffective for their plight. Too often those doctors are family physicians and internists who have little knowledge of psychotropic drug interactions, pharmacokinetics, and pharmaco-genetics and who don't ask for psychiatric consultation. JAMA recently reported that 100,000 patients die each year of adverse reactions alone, not due to physician prescribing errors or patients not following directions. Research methodologists believe the number is far smaller, but this finding reflects a serious problem.

  Without psychiatric evaluation, making a diagnosis, entertaining a psychodynamic formulation, and evolving a treatment plan, patients may be ill served and denied the opportunity for amelioration of their complaints. Deferred indicated treatment, in all likelihood, would result in the progression of the patient's condition, adversely affecting him, his family, and his workplace performance.

  One company offered scholarships to patients who used an effective antipsychotic medication to prepare them for normal lives by funding college and professional school courses. Colleagues expressed fears that these marketing efforts could encourage patients to pressure their doctors to change medications, risking ill effects that may follow a switch in psychotropics in marginally stable patients. In addition, unrealistic expectations of academic success may be engendered in those patients with functional disabilities.




• Confidentiality. Companies have found new ways of collecting names of patients with serious emotional disorders as well as other personal information, using Internet sites for updates on these illnesses and programs that include reminder calls to patients to take their medication. One marketing effort sought personal data from patients suffering with depression by the inclusion of postcards in the ads inviting patients to send for information kits. In a box labeled "Privacy Respected," the patient would permit the company to use the data to develop products and services. Obviously the collection of such information is intrusive and invites confidentiality breaches. Computer cross-linkages do not vouchsafe privacy, as we have known for more than 20 years.

Where Do We Go From Here?

Recognize that pharmaceutical companies have long donated funds for research and education, largely unrestricted, and to patient support and advocacy groups. As an example, a proposed APA-industry collaborative investigation would expand our understanding of patient compliance and noncompliance and how psychosocial treatments and a secure ongoing treatment relationship enhance compliance. This kind of project could provide valuable findings to all of medicine.

Considerable expenditures are made by the industry in our publications through ethical advertising and in advancing the success of our annual meetings. At these meetings educational programs are offered by respected scholars in our field screened for conflicts of interest. APA, with the cooperation of pharmaceutical companies, has imposed regulatory controls drawn up by the AMA and the Accreditation Council for Continuing Medical Education designed to avert advertising and promotional excesses at our meetings. Continuing discussions about such matters underscore our obligations to our patients and to our field.