AIDS TREATMENT NEWS No. 052 - March 11, 1988

(March 15) On March 2 the U.S. Food and Drug Administration (FDA) ordered Houba, Inc. of Culver, Indiana to stop manufacturing and selling its lipid product EL 1020 (which some have compared to AL 721). The letter said that "...promotional activities which accompanied the initial shipment of EL 1020 suggested that the article was intended for use in the treatment of acquired immunodeficiency syndrome (AIDS). Because such promotional activities included statements which represented and suggested that th is article was intended to be used in the cure, mitigation, treatment, or prevention of disease, or was intended to affect the structure or any function of the body of man, this product is a drug within the meaning of Section 201(g) of the Federal Food, Drug, and Cosmetic Act." The letter also said that the product was "misbranded in that its labeling does not contain adequate directions for use as this term is defined in 21 CFR 201.5 since the conditions for which it is offered are not amenable to self diagnosis and treatment by the laity; therefore adequate directions cannot be written under which the layman can use this drug safely and for the purposes for which it is intended." The letter gave Houba ten days to answer detailed questions concerning how it was going to discontinue its manufacturing and marketing of EL 1020.

No one has alleged that there is anything harmful about the product; the dispute concerns how it was marketed.

This FDA action caused great concern in the AIDS community, as nobody knows exactly why Houba was singled out, and whether the FDA will try to cut off all supplies of egg lipids, which are used by thousands of people. In the week since the FDA action became known, AIDS advocates have conveyed community concerns to high officials in the FDA. Fears have eased somewhat, although the final outcome is still unknown.

Background On Houba Houba differs from all other suppliers of egg lipid products in several ways: * Its subsidiary, Rachelle Laboratories, Inc., which manufactures and sells the EL 1020, is a pharmaceutical company which deals routinely with the FDA.

* Until last year, Houba had manufactured the official AL 721 for Ethigen Corporation (formerly Praxis Pharmaceuticals), which holds worldwide licensing rights acquired from the Weizmann Institute of Science in Israel, which developed the product, and also holds the copyright on the term "AL 721". Houba's new product provides the egg lipids in a syrup form which differs from AL 721.

* Houba planned to sell its product primarily or exclusively through HIV-positive buyers clubs, such as the PWA Health Group in New York, or the Healing Alternatives Buyers Club (HABC) in San Francisco. (The New York group has sold one of two forms of EL 1020; the San Francisco-based HABC has not carried either.) * At about the same time as the three-month FDA investigation of Houba, the company was subjected to sensationalized newspaper articles in a South Bend, Indiana paper. The first article said that Houba was doing secret AIDS research, and that a resident of Culver, Indiana, where the factory is located, was concerned that there may be a health hazard from materials used. A source within Houba told us that this article raised such panic that the AIDS virus may be on the premises that there was fear that the factory could be burned down.

To avert possible violence Houba gave the newspaper information on what they were in fact doing, which had nothing to do with the AIDS virus. The publication of this information reduced the panic, but it may also have constituted some or all of the "statements which represented and suggested" that the product was to be used for AIDS. The newspaper followed up with a headline and story that Houba's "AIDS drug" lacked FDA approval. According to a source within Houba, the newspaper later learned about the FDA order against Houba before the company itself did.

AIDS Community Concerns Official approval of AL 721 is one to several years away. Almost no progress has been made toward approval in the last two years. Meanwhile, several thousand people with AIDS or ARC have started using egg lipid food products; the current generation first became available in April of last year. Many are convinced that these have been a major help to them, while others have found no effect.

So far the FDA has avoided direct attacks against the AIDS treatment community, so the first concern about the Houba action was whether this policy was changing. A war between the FDA and persons with AIDS could seriously harm both. The AIDS community fears increased difficulty in access to treatments, and diversion of energy which should go to better use in the AIDS crisis. The FDA fears bad publicity, as it knows that Congress can enact laws to take some of its powers away, as it has done at least once in the past (when the FDA tried to make vitamin pills exceeding government-recommended dosages into prescription drugs). Both sides have strong incentives to compromise.

The AIDS community is also concerned about what precedent this case sets. The FDA has the power to declare that a product is a drug (when it would otherwise be a food) even in the absence of any medical claims by the manufacturer--if the manufacturer's marketing targets a specific group such as persons likely to use the product as a drug. This means that the mere fact that a manufacturer sells a product to AIDS treatment organizations could be used against it--setting up a new kind of AIDS discrimination, government inspired or even government required, whereby private manufacturers are forced to boycott AIDS groups and cut off supplies of potential treatments.

The same situation could apply to persons with other diseases. But with AIDS at least, this problem is far from academic; it has already had serious consequences. The availability of egg lipid products was delayed last year, probably for several weeks, when the first manufacturer found to have a suitable product refused to sell to anyone involved with persons with AIDS. And today, the only company in the world which makes the old Salk polio vaccine is refusing to sell it to physicians who want to try it as an AIDS treatment, despite serious scientific interest in this possibility and good early results. The FDA, which may NOT be responsible for the problem in this case, has no legal right to stop physicians from using an approved drug for a non-approved use, which physicians can legally do; but a private company can refuse to sell its product to anyone, even physicians engaged in the completely legitimate practice of medicine, even when it is the world's sole supplier. The history of the AIDS epidemic is loaded with obstacles to treatment access and prompt treatment research. The AIDS treatment community wants to handle these problems in ways that avoid unnecessary fighting on the one hand, and compromises embodying destructive precedents on the other.

We interviewed two AIDS treatment advocates who are FDA experts and have been in close touch with FDA officials in the week since they learned about the Houba case. Both have different views of a murky situation. It is clear that the outcome has not yet been determined.

To Martin Delaney, co-founder of Project Inform in San Francisco, the key issue is whether the FDA pursues the case against Houba only on the basis of statements made by Houba -- facts which apply to that immediate case and do not spill over to involve the larger AIDS treatment community. But if the FDA chooses to prosecute Houba because it sold its product largely or exclusively to HIV-positive buyers clubs, the precedent would contribute to discrimination by telling suppliers that their products could be classified as drugs and banned if they sold them to AIDS groups, even though the identical products would remain foods if sold in health-food stores or otherwise to the public in general.

At this time Delaney has heard that the FDA has weighed the various considerations and chosen not to use the sales to buyers clubs against Houba in this case.

Another FDA expert, Jay Lipner, a volunteer attorney who works with Lambda Legal Defense in New York and has worked closely with Martin Delaney on this issue, sees the outcome as still to be determined. He sees only that some progress has been made in clarifying for the FDA what the viewpoint is of some members of the gay community.

"The facts and the law remain complex and confusing," said Lipner. "The one clear message so far is that the AIDS community must have long-term, ongoing, professionally assisted advocacy on treatment and research issues. Otherwise even the most basic interests of persons with AIDS will not be protected."