Bulletin of Experimental Treatments for AIDS, No. 28; March, 1996
Mark Bowers, Managing Editor of Treatment Publications at the San Francisco AIDS Foundation.

AIDS fraud may be difficult to identify. The Food and Drug Administration (FDA) established a definition of health fraud on June 17, 1993: "The deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, cure, treat or mitigate disease (or other conditions), or to provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article." Many of the people responsible for such fraud are impostors who pose as physicians or scientists. Vast sums of money can be made in exchange for the right marketing ploy and a veneer of scientific credibility. Confidence men (and women), with and without medical degrees, can often effectively conceal fraud behind the respectable mantle of caring physician.

Why Do People Turn to Charlatans?

Increasing barriers to medical access and burgeoning mistrust of physicians have encouraged many to take desperate measures to manage serious and incurable disease. The current climate of suspicion and conflict can be traced to recent political events. Last year, universal health care in the United States was rejected in favor of a corporate takeover of health care. Partisan rhetoric predicted that universal health care would lead to an assembly-line system where choice is lacking and care is rationed and subject to spending limits. These predictions have in fact come true under today's for-profit system. Meanwhile, the ranks of the uninsured have swelled by an additional 2 million, to total more than 41 million Americans today.

Bureaucracy has intervened in the physician-patient relationship. Corporations impose gag rules on physicians, preventing them from disclosing the existence of some medical treatments, in direct violation of the principle of informed consent. Cases have been brought against corporate giants for failure to provide needed drugs, tests and procedures. Americans now need legal protection from their HMOs. In this climate of aggressive cost-containment at the expense of patient rights, people increasingly turn to alternative medicine for the emotional and psychological support that their physicians can no longer provide in the 7 minutes typically allotted to a primary-care visit. Thus they put themselves at increased risk of exposure to AIDS fraud. Those who seek to persuade patients to rely on fraudulent cures take their time, listen sympathetically, say what patients want to hear and provide hope, however illusory and misplaced that hope may be.

Opportunists who sell "cures" seldom offer more than one specific product. Some products may be recycled, having previously been sold illicitly to cure cancer, but with no results. One such drug is laetrile, once offered as a "safe and effective cure for most types of cancer" at border clinics in Mexico; widespread publicity and government intervention eventually discredited the drug, but not before millions of dollars were ill-spent. Laetrile resurfaced in the early 1990s as a cure for AIDS. It was not. Some products are new and have not been rigorously evaluated in carefully controlled clinical studies. These products may be harmless, but they could also result in fatalities.

AIDS Fraud Task Forces

AIDS fraud in California is not a crime in itself, but rather is controlled by the application of state and federal laws that govern other crimes and the permissible uses of unapproved drugs and substances. Because of the broad range of possible fraudulent activities, FDA initiated the formation of the California AIDS Fraud Task Force (CAFTF) in 1990. Members include representatives of local community AIDS organizations throughout the state, physicians and representatives of public health and law enforcement agencies. For 4 years, discussions about what constituted AIDS fraud were heated. The issue was resolved when an informational brochure was created and distributed throughout the state. The philosophy of the task force is that people can and do make wise and informed decisions for themselves about their HIV/AIDS healthcare if they are given complete information about strategies and products they might choose. HIV/AIDS fraud in California is subsumed under the broader category of false advertising. AIDS fraud task forces in 10 states (see sidebar) investigate reports of AIDS fraud and refer them to law enforcement agencies when appropriate.

A national consortium of state task forces meets annually to discuss incidents of fraud and their resolution, and to increase outreach efforts to prevent AIDS fraud before it occurs. Each state provides information to its residents via statewide hotlines. Illinois and California have established targeted outreach to communities of color. These communities are considered to be at greater risk for AIDS fraud; they have historically had less access to healthcare in the United States.

A Case of Fraud

When opportunists sell a harmful substance of no proven therapeutic benefit as a medical cure, law enforcement agencies may prosecute. The Consumer Protection Unit in San Diego has prosecuted 2 cases of HIV/AIDS fraud in the last 10 years. Tricia Johnson, deputy city attorney, handles the criminal prosecution of fraudulent claims for San Diego. She emphasizes that people are not prosecuted for injecting, ingesting or applying unapproved substances to themselves. Her office and others like it around the state focus on false advertising claims and the illegitimate exercise of the profit motive. Making false statements about the effectiveness of substances that are sold for profit is consumer fraud. For example, false claims that FDA has tested and approved a substance, or claims that a substance will cure a wide range of diseases when the only evidence consists of unverifiable anecdotes, would constitute fraud. Usually such claims are accompanied by exorbitant prices and requests that information about the products not be shared with other physicians.

Johnson has recently completed the successful prosecution of the operators of the Taylor-Stacey Center for Advanced Medicine. William Stacey and Lawrence Taylor, MD, were charged, tried and convicted of selling and injecting Immunostim to more than 108 patients with severe diseases, including AIDS. According to written testimony by a relative of one man who received Immunostim, "David and I were assured of several things: that Immunostim was 'FDA-approved,' 'completely safe,' 'contained 4 common ingredients,' one of which was Bill Stacey's own 'discovery,' and that Bill had documented case histories of 'cures'. David died March 4, 1995, just 4 days short of his 36th birthday." According to the testimony of Donald Stevenson, MD, Chairman of the Department of Medicine at Scripps Clinic in La Jolla, Immunostim is composed of quaternary amines that "have never been approved for injection into veins. [It] caused inflammation in the veins as it was dripped into [patients'] bodies...The inflammation in the veins led to painful swellings and then a complete closure of the veins with a resulting hard knot where a vein had previously existed." Quaternary ions are the basis for some household cleansers.

The original complaint against Stacey was lodged with the USA Television Network as part of a program called "Case Closed.". The program series invited viewers to describe wrongs that remained unresolved. The mother of a North Carolina man who had been "cured" with Immunostim injections at great financial expense called the network to fulfill a promise she made to her son on his deathbed: she would see that his tormentor, Stacey, would be punished for his cynical exploitation of her son during his desperate quest to locate an AIDS cure. Alerted to Stacey's sale of Immunostim and potentially illegal activities, the San Diego Office of Consumer Protection located him at the Taylor-Stacey Center for Advanced Medicine in San Diego.

In February 1994, a sting operation was set up. On 3 occasions, hidden cameras recorded Stacey's and Taylor's miraculous claims about Immunostim. By March, search and arrest warrants were issued, and the 2 were taken into custody. In May 1995, pleas were entered, and plea bargaining led to a reduced charge for Taylor: maintaining a nuisance. He was sentenced on August 18, 1995 to pay restitution to his victims, serve 150 days in jail and pay a $2,000 fine. He is on probation for 3 years, during which time the court has directed him not to treat anyone with AIDS or cancer unless they are referred to him by another physician. The California Medical Association subsequently withdrew Taylor's license to practice medicine in the state.

Stacey jumped bail, left the state and set up shop in South Carolina. He continued to sell Immunostim to desperate and vulnerable people as far away as Australia and Bermuda. Stacey was finally extradited and imprisoned in December 1995. At that time, 55 of the 108 patients who had been "cured" with Immunostim were dead.

How Can Fraud Be Avoided?

The Immunostim example illustrates many important considerations about AIDS fraud. FDA-approved drugs are listed in the Physicians' Desk Reference (PDR) and other standard pharmaceutical reference works. Dosages, routes of administration, side effects and pharmacological properties are fully disclosed. Immunostim is not included in the PDR, and no clinical testing had been done. The product was available from only one source. The claim that Immunostim was FDA-approved was not substantiated by any published research. The ingredients were never approved for any use other than household cleansers. Verify claims that a product is FDA-approved.

Products that are sold to cure or prevent cancer and other illnesses as well as AIDS are always suspect. Immunostim was guaranteed to "cure" any fatal illness. There is no treatment so effective that it can cure all fatal illnesses. Anyone who makes such claims intends to take advantage of people who are desperate and willing to suspend rational judgment and disbelief. On one occasion, Stacey paraded a woman patient through the crowded waiting room at his clinic, proclaiming that she was being sent home because her cancer was now cured. She died of cancer shortly thereafter.

Printed material about Immunostim was available, but it only included personal success stories and testimonial evidence, claims which could not be independently verified. Potential consumers should carefully question any product or treatment that relies on personal success stories or testimonials. Promotion for a product that relies on testimony from people who are not medically or scientifically trained is a warning sign of AIDS fraud. Look for objective data.

Immunostim was very expensive. In 22 months, Taylor collected $238,181.10 and Stacey received $431,945.40 from the sale of Immunostim. However, some AIDS treatments that are legitimately approved or at some stage of the approval process are also exorbitantly expensive: foscarnet (Foscavir), a treatment for CMV retinitis, costs about $26,000 a year before additional infusion costs, and human growth hormone (Serostim), an experimental drug for AIDS wasting, costs $60,000 a year. The more a treatment costs, the more evidence one should demand that the product works.

Be wary of the promotion of a therapy for uses other than those for which the therapy was approved. Sometimes, the "off-label" use of a drug can be beneficial and is supported by published research and wide community experience. Usually, such use is not reimbursed by insurance carriers. In early 1995, Taylor placed advertisements in San Diego newspapers promoting chelation therapy for heart disease, high blood pressure, arthritis, impotency and other conditions. None of these were approved uses, and a court order was issued against Taylor, ordering him not to perform that therapy. Off-label use of any drug should be carefully researched and evaluated.

Be suspicious of any drug or treatment that requires you to stop taking other prescriptions or seeing other healthcare providers. Fraudulent practitioners often argue that anything that they did not sell or create must be bad for people. They may ask for secrecy and exclusive medical control for fear of confrontation with other accredited physicians who may reveal their fraud.

Insist on full disclosure of the risks and benefits of any drug or treatment. Informed consent is the cornerstone of patient rights in the United States. No physician may legally prescribe any drug or perform any procedure without fully informing you of the associated risks, benefits and alternatives.

Reliable treatment information can be obtained from national treatment hotlines and from treatment publications. When unsure about a drug or treatment, seek a second opinion. Consult the CDC Drug Information and Clinical Trial Hotline at 1-800-874-2572, Project Inform at 1-800-822-7422 or your local AIDS hotline.

If you think you have been the victim of AIDS fraud, contact your state's AIDS task force or Attorney General's office (see sidebar) or the California AIDS Fraud Task Force at 1-800-459-4503. The best defense against fraud is knowledge.

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Copyright © 1996 - San Francisco AIDS Foundation. Reproduced by permission. Reproduction of this article (other than one copy for personal reference) must be cleared through BETA: PO Box 426182, San Francisco, CA 94142-6182. Tel: 415 487 8060 Fax: 415 487 8069 URL: http://www.sfaf.org/beta E-mail: beta@sfaf.org

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