EMPRISE: CONTROVERSY OVER UNORTHODOX-TREATMENT DATABASE

On February 14, ACT UP/New York sent AIDS organizations an "Open Letter to the AIDS Community: Stop the Insurance Industry's Blacklist of Unapproved AIDS Treatments," together with a cover letter and five-page background paper by its Alternative and Holistic Treatment Subcommittee. Later, Grace Powers Monaco, president of Emprise, Inc. which is developing the database, sent a 16-page response. The immediate issue is whether the U. S. National Institute of Allergy and Infectious Diseases (NIAID) should give Emprise a grant to compile the computerized listing of "questionable and unproven" AIDS treatments. (NIAID has already given Emprise a $47,000 start-up grant for the project. In 1988, the National Cancer Institute had given Emprise $315,000 to compile a similar database -- not yet available -- of cancer therapies.)

We cannot fully cover this complex dispute in a short article. We will provide an outline and brief comments, then refer readers to the organizations involved.

The following passages give an example of what the controversy is about. The first is from the ACT UP open letter to the AIDS community, which is currently endorsed by about 20 organizations:

"Monaco describes the Emprise project as an effort to warn doctors and patients against 'the dangers and general worthlessness of unproven approaches' -- not to objectively determine which may have merit and are worthy of scientific study. She and her insurance consultant friends will handpick 'expert panels' to practitioners. The cancer panels, already selected, are stacked with sworn enemies of what they label 'health fraud' and 'quackery' -- by which they generally mean: 1) non-FDA approved treatments not produced by the largest, high-profit drug corporations, and 2) doctors who differ from orthodox, 'approved' treatment approaches. An analysis by an advocacy organization from people with cancer concluded that 'serious ethics violations, severe conflicts of interest and a systemic negative bias...permeate this entire project.' In short, the clear goal is to compile a blacklist.

"This blacklist will be put on every major medical database used by doctors, and leased to insurance companies to 'assist' them in determining which reimbursement claims to deny. As a federally-funded project, it will also greatly influence Medicaid/Medicare policies and future NIAID/NCI priorities on AIDS clinical trials. Indeed, Emprise explicitly told NIAID,
'The proposed grant will provide sufficient critical and evaluative data to demonstrate which AIDS dubious therapies can be expected to be nonproductive and a bad buy for patients without the expenditure of scarce government resources in a clinical trial to 'disprove' a therapy.'"

The ACT UP open letter calls for treatment information developed by community-based clinical trials organizations, not by Emprise.

Here is the Emprise response to the section quoted above. It refers first to the cancer database now being developed:

"The cancer monographs are now under peer review. If the evaluations by the scientific reviewers hold true through peer review, there are a number of herbal and botanical products and two drugs classed in the safely used adjunctively in cancer
treatment and should be put through efficacy screens and potentially studied on clinical trials. The same conclusion was reached about some dietary approaches. Not as cures but as helpful adjuncts.

"Although it is not possible to list those products until peer review is finished, as soon as it is, Ms. Monaco will be communicating this information to the Townsend Letter for Doctors, which is a publication for 'alternative' physicians.

"Does this sound like a blacklist?

"Do you want AIDS patients exposed to true quackery? By shutting Emprise down are you saying that you don't want your
constituency to be informed about the scientific misrepresentations by commercialized unproven methods purveyors?

"Insurers don't pay for 'worthless' products -- do you want them to? Don't you want to keep scarce resources in enhance the process of finding potentially productive adjuncts to care -- not interfere with it."

Background

Grace Powers Monaco, an attorney and the president of Emprise, lost a daughter to leukemia in 1970. She is a founding member of Candelighters, a support organization for parents of children with cancer.

Ms. Monaco has been one of the most prominent opponents of "health fraud" and "quackery" in cancer, and more recently in AIDS. Since 1978, she "has acted as consulting counsel for insurance companies concerning claims made for treatments which are nonstandard, alternative, unproven, questionable, or experimental, primarily advising on the merits of the claim." She had also been a paid consultant to Aetna Life Insurance Company in a racketeering lawsuit against Stanislaw Burzynski, M. D., developer of the "antineoplaston" cancer drug, but has recused herself from contining that relationship until the antineoplaston monograph (for the cancer-treatment database) has been peer reviewed. But despite these ties to the insurance industry, in her volunteer work for Candelighters, Ms. Monaco has strongly criticized insurance companies for denying reimbursement for treatment such as certain "off-label" uses of chemotherapy which are in fact the accepted standard of care -- a serious problem for persons with cancer, as for persons with AIDS, even when they are seeking only accepted, conventional medical care.

Recently some of the alternative-treatment cancer activists who have long been fighting Ms. Monaco met with holistic-treatment AIDS activists to form a coalition to oppose Emprise. A recent meeting (organized by Bob Lederer, co-chair of the Alternative and Holistic Treatment Subcommittee of ACT UP/New York and columnist for Out Week magazine, and Ralph Moss, author of The Cancer Industry) brought together 35 activists from both groups, and laid the groundwork for the ACT UP letter quoted above. Journalists in the cancer group had obtained the Emprise application for the AIDS database pilot study through the Freedom of Information Act; NIAID has not released the application which is now pending. Without the investigation by these journalists, the public would know little about Emprise, as this particular project has had little if any coverage in the general press.

Good friends of the AIDS community have spoken out on both sides of this dispute. A recent editorial in PAACNOTES, the newsletter of the Physicians Association for AIDS Care (PAAC), defended the proposed Emprise database because it "could, if funded, provide physicians with peer-reviewed assessments of all available scientific data on the potential value of nutritional supplements, herbals, biologicals and other therapeutic adjuncts, such as imaging and biofeedback. PAAC has supported the need of such a database for physicians who generally have no scientific source to refer to when answering questions from patients on whether these agents or therapies are helpful or harmful. Information about potential drug interaction with alternative therapies is also a critical need of physicians."

(Gordon Nary, the author of the above editorial, is well known for his advocacy with the John Alden Life Insurance Company to set up a model program which will pay for care not usually covered by insurance, for example acupuncture or biofeedback for pain control, and nutrients, food, and food preparation for patients at risk for malnutrition. The program saves money for the insurance company by paying for home care, including transportation or reimbursement for care from family members or significant others, when other companies would refuse to cover these expenses and instead pay much more for hospitalization.)

But Bernard Bihari, M. D., medical director of the Community Research Initiative in New York, is concerned that the Emprise project could "create a climate in which it is harder to raise money for research, in which researchers are reluctant to test a treatment associated with the label of 'quackery.' The media picks up the most dramatic stories. The result could stifle
scientific inquiry and the development of knowledge." Dr. Bihari noted that an early list of potential AIDS treatments attacked by Ms. Monaco was oriented against substances of natural origin -- even while the pharmaceutical industry itself often turns to natural products to find substances which it develops as drugs. (Dr. Bihari does not see insurance as the problem, however, as companies seldom reimburse anyway until after treatments have official sanction.)

Comment

We are withholding judgment on the Emprise AIDS project at this time. On one hand, we do not see how an unbiased database can come from an organization going into the project with so strongly held an agenda, viewpoint, and commitment as Emprise has in this case. Yet even a negative database could be valuable. For physicians and patients urgently need professional information about all treatments they are considering using. And negative information is often the hardest to find, partly because people are afraid of lawsuits, but even more because usually no one has much motive for researching and publishing the case against a treatment. As a result, the only information available often comes from promoters.

Yet not all treatments evolve on the same straight path starting with academic science, proceeding to peer-reviewed articles, and then to competent, rational development by a major pharmaceutical company able to afford the $120 million average development cost per new drug approved in the United States. Treatments which in fact have value can evolve from systems of traditional medicine, from popular culture, or from a scientific or even unscientific hunch. Any treatment which acquires a popular following before acquiring a professional one is at risk of being labeled illegitimate, and then being ignored by institutions and researchers who are fearful of damaging their reputations. Therefore the treatment remains "unproven."

We have long suspected that the AIDS movement might best stay away from what could be called "the old wars" -- the unending battles between mainstream medicine and unorthodox treatments for cancer and other diseases. For the old wars have gone on for decades and therefore they are locked into a time scale of decades, while AIDS activists do not have that time. We are concerned that the old wars might now have come to us.

Perhaps the best outcome would be for Emprise to produce its database, but do so under a cloud of controversy (fortunately now provided by the open letter from ACT UP/New York). Then the public will know that the project represents not pure Science above the politics of competing views, but rather one view among the others. If the Emprise AIDS database is ever to obtain a reputation for fair and unbiased reporting, then it must earn that reputation. It cannot legitimately be born with it.

Note

As we went to press, Ms. Monaco told us that because of the controversy Emprise is withdrawing the NIAID grant application, and is working with universities and others to determine how an untested-and-unproven-treatment database could be resubmitted under other auspices, so that the project can proceed with a more collegial relationship. She still feels there is a great need for expert, peer-reviewed critiques of the science alleged to support unproven treatments.

She also pointed out that the cancer monographs (on which the AIDS database can be modeled) include suggested future research to answer interesting questions about the proposed treatment -- including the possibility of legitimate uses.

For More Information

Emprise, Inc. may be able to provide their response to the ACT UP mailing, or other information about the database project. It can be reached at 1312 18th St. NW, Suite 200, Washington, DC 20036.

An article by Grace Powers Monaco, "Counseling Patients About Dubious and Rip-Off Remedies for AIDS and ARC," appears in PAACNOTES, May/June 1989, page 80.

For the case against the database project, contact ACT UP/New York, Attn. Alternative and Holistic Treatment Subcommittee, 496-A Hudson St., #6-A, New York, NY 10014, 212/989-1114.