AL 721 Today, Part III: Surveys, Technical, References

Part I (AIDS Treatment News #42) gave an overview of the experimental AIDS treatment AL 721, also called egg lecithin lipids. Part II answered specific questions such as how to use AL 721, and where to find buyers clubs or distributors. Part III gives technical information and references.

Surveys of AL 721 Users

Three surveys have asked persons who are using AL 721 about their experience with it. All are finding comparable results.
AIDS Treatment News mailed a questionnaire to its 898 subscribers in July 1987, and published results in issue number 39, August 28, 1987. Of the 147 completed questionnaires we received, 110 were from persons who had used some form of AL 721 for at least three weeks. Only the soy-based "home formula" and the all-egg product distributed by New York's PWA Health Group had enough users to allow meaningful statistics. Of those using the soy version, 43 percent found it helpful and 22 percent not helpful; with the egg version the percentages were 58 percent helpful and 8 percent not helpful. The remaining persons in both categories were those who checked "uncertain" or otherwise
expressed uncertainty, said it was too early to tell, or left the question blank. For more information on this survey, see AIDS Treatment News number 39.
The PWA Health Group in New York did a telephone survey of 168 randomly-selected purchasers who had used the lipids for two or more months; it summarized the results in a two-page breakdown dated September 22, 1987. 42 percent of the 168 described themselves as better, 43 percent as the same; 12 percent said they were worse (or were reported to have died). 4 percent had discontinued the lipids. The percentages total 101 instead of 100 because of rounding approximations.
Eighty eight of the 168 people had AIDS. 43 percent of those with AIDS reported that they were better, 39 percent the
same, and 18 percent worse. 45 people had ARC; 36 percent said they were better, 42 percent the same, 9 percent worse, and 13 percent had discontinued the lipids. Of the 35 people who were HIV positive but described as healthy and asymptomatic, 46 percent described themselves as better and 54 percent as the same; no one said they were worse or had discontinued the lipids. For more information, contact the PWA Health Group in New York.
The third survey is keeping track of about 40 clients of the AIDS Assessment Clinic of the Community Health Project in New York--about 20 using lipids and 20 not. As of early October the study had been going for three months. Results were not yet available, but the impression of those doing this survey is that it is confirming the other ones: persons on the lipids feel better, and objectively improve.
A fourth survey is an ongoing study conducted by Project Inform. We don't have results yet, but mention this study
because in is the only one still open for participation. If you are using any version of AL 721 or substitute, you could help by filling out a questionnaire available from Project Inform, (800) 334-7422 within California, (800) 822-7422 from other states, or (415) 928-0293 from anywhere. Project Inform is particularly interested in long term information, from persons using AL 721 or any substitute for three months or more.

Technical Background

AL 721, a form of lecithin, consists entirely of a mixture of three substances, all of them extracted from ordinary egg
yolk. These ingredients are phosphatidylcholine (abbreviated PC) phosphatidylethanolamine (PE), and neutral lipids (NL), which are ordinary fats similar to those found in butter or olive oil, but from egg yolk instead. AL 721 consists of a 7:2:1 ratio, 70 percent NL, 20 percent PC, and 10 percent PE. (Hence the name; 'AL' stands for 'active lipid'.)
AL 721 is a brown, viscous liquid at room temperature. It readily disperses but does not dissolve in water.
Laboratory tests by the Israeli developers of the mixture found that the 7:2:1 ratio had a much greater effect on human
white blood cells than other ratios tested. AL 721 removed cholesterol from the cell membranes, increasing the "fluidity" of the membrane, the degree to which protein molecules there can move freely.
AL 721 is believed to make it harder for lipid-coated viruses (a group which includes HIV, herpes, Epstein-Barr, and
CMV) to attach themselves to the T-4 receptor site on the cell. Unless the virus can attach to this molecule, it cannot enter the cell. AL 721 does not kill the virus, but may make it less able to infect healthy cells, probably by removing cholesterol from the lipid coat of the virus.
When dispersed in water, AL 721 forms tiny spheres visible with an electron microscope. These spheres are believed to have the neutral lipid in the center, and a layer of PC and PE one molecule thick on the surface. In the laboratory, this spherical structure works especially well for removing cholesterol from cell membranes, changing the fluidity of cell membranes toward the more-fluid end of its normal range.
What happens when AL 721 is eaten and digested? Most physicians believe that the spheres would be broken up, and the three ingredients absorbed separately into the bloodstream. Many think that AL 721 could not possibly work, because it would be separated into its three components and treated by the body like ordinary food. But the fate of ingested AL 721 is poorly understood; it may get into the bloodstream as the spheres, or it may work anyway even if it doesn't. The theory which says that AL 721 could not work is far from infallible. But it seems to have kept many physicians and scientists from giving this treatment the attention it would otherwise have received.
Some professionals suspect that another reason mainstream scientists have been slow to pay attention to AL 721 is that its developers are not microbiologists. They are experts in cell membranes, not viruses, and their laboratories are not equipped to work with HIV. The link to viruses comes from the work of a few virologists such as R.R. Wagner, on reducing the infectivity of lipid-coated viruses by removing cholesterol from the coat. Apparently other virologists have been slow to recognize the importance of this work, so the developers of AL 721 were placed in the politically difficult role of outsiders telling other scientists that they had overlooked the importance of work in their own field.
For more technical information on AL 721, see the references below.


Appendix I: Hepatitis and Phosphatidylcholine

In the U.S., persons with hepatitis are usually told that there is no specific treatment. But in Europe and elsewhere a
number of published studies, including double-blind trials with dozens of patients, have shown that phosphatidylcholine, one of the ingredients of AL 721, is clearly useful in treating several kinds of hepatitis, including acute hepatitis A and B, and HBsAg negative chronic active hepatitis. Few of these studies have been published in English; they seem to be largely unknown in this country.
Most of these trials have used "Essential Phospholipid" ("Essential Forte", Nattermann, Germany), which contains several common vitamins, mostly B vitamins, in addition to phosphatidylcholine. The dose used was about three grams per day, sometimes less. The studies found improvement in clinical condition, laboratory parameters, and absence of relapses in patients receiving the phospholipid, compared to controls.
We don't know how the polyunsaturated phosphatidylcholine in the Nattermann preparation compares to the kind of
phosphatidylcholine in AL 721, or to the kind in ordinary soy lecithin. ("Phosphatidylcholine" refers to a class of closely
related substances, not to a single chemical.)
These studies do not prove that AL 721 could be helpful for persons with hepatitis, although they suggest that it might. But their results do strengthen the case for AL 721 by showing that orally administered phosphatidylcholine can be effective as a treatment for a viral disease, as shown by controlled, double- blind trials. We are not aware of any studies which failed to show efficacy.
Four clinical studies are cited in the references below (Atoba and others 1985, Jenkins and others 1982, Kosina and
others 1981, and Visco 1985). Several other animal and clinical studies of phospholipids and liver diseases have been published recently. For a packet of technical information, including an unpublished English translation of the Kosina paper which was published in Czech, send a large self-addressed envelope with 90 cents postage to: John S. James, P.O. Box 411256, San Francisco, CA 94141.

The Home Formula

This soy-lecithin preparation, easily made in a kitchen, was the best AL 721 substitute we had until the all-egg versions became available. A widespread consensus of persons using these materials is that this soy formula does work, but the egg products are better. Many people still use the soy substitute because it costs a quarter as much, can be easier to obtain, and may work as well as the egg version for some people.
Steve Gavin developed this formula. It was first distributed in January 1987, at PWA meetings in New York. AIDS
Treatment News reprinted it on January 30. We don't know how many people have used the formula by this time, but there are reasons to believe there have been thousands.
"PC-55 (tm) is a high-strength lecithin concentrate made by Twin Laboratories, Inc., Ronkonkoma, NY, and sold in health-food stores. It contains two of the three ingredients of AL 721; they are in a 5:2 ratio, close to the 2:1 used in AL 721. Neutral lipids can be added to PC-55 making it a membrane fluidizer comparable to AL 721. This material is a food nutrient, it is not a drug. It is safe.
"Combine five tablespoons of PC-55 and 12 tablespoons of water in a bowl, and whip with an electric mixer or blender. Slowly add 6 tablespoons plus one teaspoon of butter (6 1/3 tablespoons butter) which has been melted (measure the butter before melting). Whip thoroughly three to five minutes. This mixture divided into ten even doses gives slightly over 10 grams of the lipids per dose. Each dose should weigh about 30.4 grams or 1.06 ounces.
"The individual doses can be placed into plastic sandwich bags for freezing. If you don't have a scale, you can measure out two tablespoons to each bag, then add a much smaller amount to divide the remainder. One person separates the doses in an ice-cube tray. Move each dose from the freezer to the refrigerator a few hours before use. This preparation spoils very rapidly at room temperature; it must be frozen unless used immediately.
"(An earlier version of this formula used cooking oil instead of butter. The proportions are 5 tablespoons PC-55, 5
tablespoons + 1 teaspoon oil, and 10 tbsp water.)
"The material is best eaten in the morning, spread on fat- free bread or mixed with fruit juice. The user should eat a fat- free breakfast which might consist of fat-free cereals, skim milk, fruits, or vegetables. There are no restrictions on lunch or dinner. An additional dose might be taken before going to bed. Patients treated in Israel are given two doses a day for about four weeks, then single doses indefinitely. Some people with AIDS might experience diarrhea with this membrane fluidizer, especially with the additional dose. Eat brown rice and other solid foods.
"You can help others and yourself by keeping a record of your experience -- doses, dates, and any resulting effects."

References

Atoba MA, Ayoola EA, Ogunseyinde O. Effect of essential phospholipid choline on the course of acute hepatitis-B
infection. Tropical Gastroenterology volume 6 number 2, pages 96-99, April-June 1985.
Bell, JM, Lundberg PK. Effects of commercial soy lecithin preparation of development of sensorimotor behavior and brain biochemistry in the rat. Developmental Psychobiology volume 18 number 1, pages 59-66, 1985.
Davis H. AIDS Patients Flock to Israel for Experimental Egg Yolk Drug. Baltimore Jewish Times, October 9 1987.
Heron D, Shinitzky M, Samuel D. Alleviation of drug withdrawal symptoms by treatment with a potent mixture of natural
lipids. European Journal of Pharmacology volume 83, pages 253-261, 1982.
Jenkins PJ, Portmann BP, Eddleston ALWF, Williams R. Use of polyunsaturated phosphatidyl choline in HBsAg negative chronic active hepatitis: results of prospective double-blind controlled trial. Liver volume 2, pages 77-81, 1982.
Kosina F, Budka K, Kolouch Z, Lazarova D, Truksova D. Essential cholinephospholipids in the treatment of virus
hepatitis. (English translation of title.) Casopis Lekaru Ceskych volume 120 (31-32) pages 957-960, August 13 1981.
Lyte M, Shinitzky M. A special lipid mixture for membrane fluidization. Biochimica et Biophysica Acta volume 812, pages 133-138, 1985.
Ma, Wen-Chao. A Cytopathological Study of Acute and Chronic Morphinism in the Albino Rat. Chinese Journal of Physiology volume 5, pages 251-274, 1931. (This study, overlooked for 50 years, suggested use of lecithin for treating drug addiction.)
Moore NF, Patzer EJ, Shaw JM, Thompson TE, Wagner RR. Interaction of Vesicular Stomatitis Virus with Lipid Vesicles: Depletion of Cholesterol and Effect on Virion Membrane Fluidity and Infectivity. Journal of Virology volume 27 number 2, pages 320-329, August 1978.
Rivnay B, Bergman S, Shinitzky M, Globerson A. Correlations Between Membrane Viscosity, Serum Cholesterol, Lymphocyte Activation and Ageing in Man. Mechanisms of Ageing Development volume 12 number 2, pages 119-126, February 1980.
Sarin PS, Gallo RC, Scheer DI, Crews F, Lippa AS. Effects of a novel compound (AL 721) on HTLV-III infectivity in vitro. New England Journal of Medicine volume 313, pages 1289-1290, November 14 1985.
Shinitzky M. (ed) Physiology of Membrane Fluidity, volumes 1 and 2, CRC Press, Boca Raton, Florida 1984.
Shinitzky M, Lyte M, Heron DS, Samuel D. Intervention in Membrane Aging--The Development and Application of Active Lipid. In Intervention in the Aging Process, Part B: Basic Research and Preclinical Screening, pages 175-186. Alan R Liss, Inc., New York, 1983.
Skornick Y, Yust I, Zakuth V, Shinitzky M. Treatment of AIDS Patients with AL 721 in an Open Trial. Available from M.
Shinitzky, Department of Membrane Research, The Weizmann Institute of Science, Rehovot, Israel. 1987.
Visco G. Polyunsaturated phosphatidylcholine in association with vitamin B complex in the treatment of acute viral hepatitis B. Results of a randomized double-blind study. (English translation of title). Clinica Terapeutica volume 114 number 3, pages 183-188, August 15 1985.
Wood JL and Allison RG. Effects of consumption of choline and lecithin on neurological and cardiovascular systems.
Federation Proceedings volume 41, pages 3015-3021, 1982.
For those who want more information, the Medline database produced by the National Library of Medicine has over 1800 scientific papers indexed under "membrane fluidity". Those interested in the relevance of these concepts to viruses should check the work of R. R. Wagner, who has authored or co-authored over 100 scientific papers.