AL 721 Vs "Workalike" Products--Background Note

AL 721 has looked promising for almost three years, and safety has never been an issue. Nevertheless for most of this time persons with AIDS or ARC have been unable to obtain the treatment, as it was tied up in the process of seeking approval from the U.S. Food and Drug Administration (FDA) as a drug--a process originally expected to take four years, but which will probably take longer than that (even if AL 721 is in fact effective). Both Ethigen Corporation (the company which holds worldwide rights to AL 721, under license from the Weizmann Institute), and the FDA, can make a case that the delays are not their fault. Meanwhile the treatment, known to be safe and widely suspected to be significantly helpful to many people, remained unavailable.
During the last 15 months, especially the last year, self- help groups of persons with AIDS and ARC have found sources of comparable products through food-processing and pharmaceutical companies. This treatment underground has grown almost overnight until now thousands of people are using these products, commonly called "egg lecithin lipids", or just "lipids". Several informal surveys, including one which this writer conducted of over 100 users of AL 721 workalike products, have all found comparable results: roughly half of those who have used them are convinced they are helping, less than a quarter are convinced they are not, and the others are uncertain. (For our survey results, see SF Sentinel, August 28 1987.)
We asked Dr. Shinitzky what he thought about how these products compared to the official AL 721 as he made it in
Israel. The question puts him in a difficult position, as his institution licensed exclusive worldwide rights to AL 721, and
he didn't have a simple answer. He did indicate that some of the "generic" products he has seen are considerably closer than others. But the only product named in our conversation, an egg-lecithin capsule sold in health-food stores, was a "straw man" as no one considers it an AL 721 equivalent.
Shinitzky has examined the manufacturing and quality control now used for the "official" AL 721, and is happy with it.
We asked what we should look at when comparing the generic products with AL 721:
"There are two important factors that contribute to the activity of this compound. The first one is obvious: the correct ratio, 7:2:1. But even if you have separate components hypothetically and you mix them together to get the ratio 7:2:1, it won't necessarily be as potent as the original AL, because the process of production of AL, the acetone extraction, is critical, in my view.
"There is a chemical rationale. The reason we started with acetone extraction is that if you take lecithin and dissolve it in acetone, and cool it, you get separation between two components; one precipitates and the other stays in solution. We collect just one of them, this is the part that is included in the 7:2:1. Other extractions do not discriminate. I didn't realize this could be a big difference between the materials, but it turns out it's indeed so. So both the composition and the process of manufacturing are critical."
Shinitzky warned that acetone extraction can be dangerous because this solvent is highly flammable.
(At least one of the "workalike" products--the "Nutri PE9+" from Nutricology, Inc. in San Leandro, CA--does use an
acetone extraction step in its manufacturing process.)

Preparing AL 721

We asked Shinitzky if it was true that AL 721 may work better if well mixed with water or orange juice, as with a
blender.
Shinitzky said that there were still unanswered questions about how AL 721 is absorbed from the small intestines. But he does think that mixing the substance well in liquid (orange juice or water are often used) may make it easier to absorb. He thought that one minute in a blender would be plenty--and that one can see a change visually when the lipids are mixed well, as the mixture takes on a lighter, milkier appearance.

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