AL 721 Today

AL 721, also called "egg lecithin lipids" or just "lipids", may be getting more public and professional attention
today than any other alternative or experimental treatment for AIDS and ARC. Many people want to know what this treatment is, what evidence supports its use, and how can they obtain it and try it.
We have published several articles on AL 721 (1) since April of last year. Here we summarize its status as of early
October 1987, report recent developments, and answers the questions most often asked.

Background

AL 721 was developed at The Weizmann Institute of Science, Rehovot, Israel, by a team led by Meir Shinitzky, Ph.D., a cancer researcher there. It consists entirely of three ingredients, all of which are found in ordinary egg yolks. The
first formal human trial was a successful test to correct a certain immune deficiency (diminished lymphocyte proliferative
response) in elderly persons, all of whom were over 75 years old. The problem returned when the treatment was stopped.
AL 721 does cross the blood-brain barrier.
Other early medical interests in AL 721 (before any antiviral properties were known) were for treating cystic
fibrosis, and also for reducing the symptoms of alcohol or opiate withdrawal in order to help people quit using these
drugs. These possibilities still look promising.
Theory suggests that AL 721 may also be useful with other lipid-coated viruses, such as Epstein-Barr. We are hearing anecdotal reports of successful use for treating chronic fatigue syndrome.
The first public notice of any connection between AL 721 and AIDS came in a letter published in the New England Journal of Medicine, November 14 1985, by several scientists including Robert Gallo, M.D. of the U.S. National Cancer Institute, one of the world's leading AIDS researchers. The letter reported that AL 721 clearly inhibited AIDS virus infection of human white blood cells in the laboratory. It also mentioned that oral doses had been well tolerated in the preliminary tests on elderly persons mentioned above, and that these doses had indeed shown a medicinal effect comparable to what would be expected from laboratory data.
The fact that a treatment inhibits the AIDS virus in the laboratory certainly does not prove that it will work in people.
But AL 721 not only worked in the laboratory. It had already been given to people with no sign of any toxicity. (And it
consists entirely of food substances, further reducing the risk.) In addition, it had already demonstrated pharmacological benefit when taken orally for a non-viral immune deficiency. The oral medicine had indeed reached the bloodstream, and had shown the expected effect on white blood cells in the human body.
All this was published two years ago, in a letter in the most prestigious medical journal in the United States. Why not
simply try AL 721 for treatment of AIDS or ARC?
In the two years since publication of that information, only eight persons with any AIDS-related condition have received AL 721 in scientific tests. This trial with eight people, sponsored by Praxis Pharmaceuticals (now Ethigen), was conducted at St. Luke's/Roosevelt Hospital Center (affiliated with Columbia University) in New York. It found encouraging results, especially a large reduction in reverse transcriptase, a measure of viral activity. But despite this success, presented at a scientific meeting in the Fall of 1986, no other clinical trials have begun in the last year.
A few days ago the U.S. National Institutes of Health had planned to begin its own clinical trials--almost two years after
the New England Journal of Medicine publication--but these trials were placed on hold, for reasons unknown to the NIH press office. We called the FDA, which said it placed the hold because Ethigen had changed its supplier--the company with which it had contracted to manufacture the AL 721--but that now Ethigen had agreed to use the original supplier, the hold had been released and the trials could start.
The new manufacturer for Ethigen was to have been Abbott Laboratories, surely capable of making AL 721 properly. This incident illustrates the kinds of delays holding up treatment research.
Unfortunately the trials now supposed to begin will be "phase I" (dosage and toxicity) studies, apparently repeating the work of the last two years. They will have room for very few people. Beth Israel Medical Center in New York, which plans to conduct NIH trials of AL 721, is not recruiting at this time.
Except for the eight persons at the St. Luke's/Roosevelt study, no one with AIDS or ARC has received AL 721 in scientific trials anywhere in the U.S.--or anywhere else except Israel (see below).
The problem isn't lack of volunteers. There are widespread reports that hundreds of persons with AIDS or ARC are now on a waiting list for a larger study which was supposed to start at St. Luke's/Roosevelt, and that researchers there are despondent about not being able to let these people begin. We called St. Luke's/Roosevelt to confirm or deny these reports, but were unable to get the permission required to discuss the matter with their researchers before press time.
Scientists looking for in-depth background on the laboratory work which led to the development of AL 721 should see Physiology of Membrane Fluidity, edited by Meir Shinitzky, Ph.D.--the principal developer of AL 721--and published by CRC Press, Boca Raton, FL. This two-volume book, by Shinitzky and 19 other scientists, is a model of thoroughness and careful workmanship. Shinitzky's article, "Membrane Fluidity and Cellular Functions", has over 300 references to relevant scientific papers.
Researchers should also note that the Medline computerized database, produced by the U.S. National Library of Medicine, has over 1,800 articles indexed under "membrane fluidity", the concept on which AL 721 is based.

New Israeli Results

The Baltimore Jewish Times, in a story on AL 721 scheduled for publication today, obtained recent information on the use of this treatment in Israel through its correspondent there.
"Of the 60 AIDS victims (sic) who have been treated with AL 721 in the past year, 48 have shown very considerable improvement in their general well being, sometimes within days of embarking on the treatment. They have lost much of the lassitude associated with AIDS, fevers have been reduced, other symptoms have diminished, and they have suffered no side effects. Three patients who were considered terminal are now in remission. More importantly, clinical tests show that in a phase of the treatment, the deadly virus loses much of its infectivity, in other words its power to spread from one cell to another." Baltimore Jewish Times, October 9, 1987.

Despite these good results, Yehuda Skornick, M.D., one of one of several Israeli physicians using AL 721 to treat AIDS and ARC, emphasized that this treatment is not a cure. "There is as yet no cure for AIDS, and it would be wicked and irresponsible to claim otherwise."
We called Dr. Skornick before going to press; he told us that 52 of the 60 are now showing improvement.

Underground Medicine

For the first 14 months after publication of the New England Journal of Medicine article, AL 721 was completely unavailable in the U.S.; a handful of Americans were treated secretly in Israel. Only in January of 1987 did the first good substitute reach the United States--the "home formula" made from concentrated soy lecithin (see discussion and formula below). Several months later, in May of 1987, the first all-egg version became available, in New York City only, through PWA organizations there. Today people can buy several different all-egg versions, through buyers clubs in some cities, at health-food stores in many areas, or from several different suppliers by mail. Thousands of people are using one or another of these AL 721 substitutes at this time. Three independent surveys have questioned hundreds of these users (see Appendix below), and are finding exactly the same result--that a large majority report substantial benefits or better. Many users have reported dramatic improvement in their health, even some near death when they started, and have attributed their recovery to AL 721.
The original eight-patient study at St. Luke's/Roosevelt did not find any consistent change in T-cell counts. Others have used AL 721 and found that counts did increase, although slowly. T-cell improvement is not a strong point of AL 721; therefore some physicians suspect that the treatment might work especially well in combination with DTC, an immune modulator which is very good at improving T-helper counts, but no trials have been done. Israeli scientists are reportedly developing treatments which combine AL 721 with thymus hormones.
AL 721 seems to be most helpful in improving overall clinical condition. People report more energy, reduced or
eliminated night sweats, clearing of skin conditions, and improved sense of well being. Skin mitogen tests as well as
viral assays improve.
We do know that AL 721 is not a cure; it needs to be continued indefinitely. It does not help everybody; maybe ten to
20 percent of those who try it report that it does nothing for them.
We also know that AL 721 is harmless--although there may be a dangerous "rebound effect" if someone with AIDS or ARC stops taking it suddenly. See discussion of side effects below.
The overwhelming weight of available evidence indicates that AL 721 is a significant benefit to most people who use it--and decisive for many. All the information points in the same direction. But we don't have conclusive proof of efficacy
because no one has done the clinical research necessary to know for sure.
It is almost impossible that Federal approval for general use of AL 721 could happen before 1989--the year after next--if it even happens then. Meanwhile, thousands of people have build a grassroots movement to obtain this treatment for themselves and their friends.

What Went Wrong?

If AL 721 really is good, why has it had to develop as underground medicine? Why has mainstream, official research done so little with it in the U.S.? The answer is that AL 721 (and most other promising treatments) have fallen through many cracks in the current AIDS research system.
Despite the highly touted advances in AIDS research, almost all of the work has been in high-tech studies which could not possibly lead to useful treatments in the near future. Such projects stimulate professional and commercial interest because they generate elegant science, will probably produce Nobel prizes, and tie into the vast economic potential of commercial biotechnology. But for many reasons it takes years to go from a challenging scientific idea to a practical medicine in widespread use. These high-tech studies produce fundamental knowledge of inestimable value, and may lead to an eventual cure for AIDS; certainly they are worth doing.
But they are unlikely to save the lives of those now ill. For that we need competent, speedy testing of a number of
treatments already available and supported by all existing evidence, but largely dropped from official research because no major institution cares enough to push them through the 50 to 80 million dollar process of new-drug approval.
And despite the Wall Street feeding frenzy around AIDS research, most of the commercial interest isn't in treatments at all but in new HIV tests--much easier to develop, gain Federal approval for, and bring to market. And the treatments which do receive financial attention are again the high-tech ones which will take years to be ready for widespread use. Companies can get a better return on their investment by manipulating their stock prices with public relations, than by actually trying to develop and market a treatment for AIDS.
Why haven't physicians insisted on studies of AL 721? First, because the great majority of physicians do not treat
anyone with AIDS, so they are not involved--and neither are their professional associations. Most physicians are too busy treating patients to keep up with research. And the medical literature has carried almost nothing about AL 721--understandably, since the research hasn't been done so there is nothing to publish.
Because AL 721 is patented (U.S. patent #4,474,773, "Lipid Fraction for Treating Disease", October 2, 1984) and unavailable from the patent holder, physicians cannot be involved without bending or breaking the rules--unless they happen to be working in the only existing official trial, with the handful of patients at St. Luke's/ Roosevelt. Physicians don't advance professionally by bending or breaking rules, nor by spending their time learning how, when, and why to do so. They have every professional incentive to simply ignore the matter.
Because of the patent and Federal restrictions, nothing can happen unless the patent holder, the FDA, and a number of other parties including investors, institutional review boards, physicians, and patients can all work together. One problem anywhere can stop all clinical research on a drug.
And no one has investigated or articulated these problems. Until recently the mainstream press blacked out almost all stories about AL 721 and similar treatments. It didn't want to raise false hope, or risk being used in possible quackeries or scams. So newspapers and other media did not allow their reporters to cover medical stories at all until they were published in a professional forum or appeared in official press releases -- and the science which should have been done but wasn't will never appear in these ways.
Even today, most investigative reporting on AIDS treatments is looking very hard for fraud--not because of any great evidence or problem of fraud, but because journalists don't feel safe reporting that an unapproved treatment might possibly be good.
These media policies, predilections, and restraints make it almost impossible for journalists to cover AIDS research in any critical fashion. Instead, the major media has covered treatment research almost exclusively by rewriting official press releases.
For both similar and different reasons, most AIDS activists and organizations, especially those which receive public funds, have completely abandoned treatment and research as issues. They have refused to develop expertise or provide critique or scrutiny. They have refused to support persons with AIDS in any involvement with unapproved treatments. They have left treatment and research--the only way to save the lives of those already infected--solely to the experts and professionals, as they would never do with issues of testing, education, social services, or civil liberties. They have placed the FDA, the NIH, and the research departments of drug companies into an Olympus above criticism, by anyone except the very experts whose professional constraints and dependencies prevent them from speaking freely.
But medical research does not occupy a magic pedestal above the mismanagement, opportunism, and defective national commitment seen elsewhere in the U.S. response to AIDS. Even doctors and scientists with the highest personal motives must make accommodations to national policy--deeply flawed in this case--in order to operate at all.
We have today a near-complete abandonment of persons with AIDS or ARC who are actually trying to save their lives with anything other than the one approved treatment, AZT. Many thousands of people are now building their own treatment movements from scratch because the AIDS, the gay, the medical, the religious and ethical, the political, and all other institutions of our society have refused to support or assist, refused to cooperate, refused to become informed, refused to even discuss the issues. Promising treatments like AL 721 will continue to be underground medicine until physicians, activists, and others have the courage and commitment to look at the evidence, make informed, independent decisions, and speak and act accordingly.

Footnote

(1) The name "AL-721" is a trademark of Ethigen Corp. in Los Angeles (formerly Praxis Pharmaceuticals), and technically refers only to the proprietary product of that company.
The current popular interest in AL 721 developed entirely independently of Ethigen, and probably against its wishes, mainly through PWA organizations mostly in and around New York City. The people in this AIDS treatment movement generally use "AL 721" as a generic term, but acknowledge that technically it refers only to the proprietary product and that "egg lecithin lipids", "lipids", or "AL 721 substitute" would be more correct.
The phrase "AL 721" has been used in the medical literature at least since 1985 (Sarin and others, 1985); "AL" and "active- lipid", other names for the same substance, have been used at least since 1982 (Heron and others, 1982). We will use "AL 721" and "egg lecithin lipids" interchangeably.

To Be Continued

Part II of this article will tell how to use AL 721, what different versions are available, and where to obtain them,
including a list of buyers clubs in different cities. It will address common questions such as the rebound effect, and how to use AL 721 while traveling when refrigeration is not available. It will summarize four different survey studies of persons using AL 721 for AIDS or ARC. It will include technical background and references, including citations to several double-blind clinical studies--largely unknown in the U.S.--which used the main active ingredient of AL 721 successfully for treating several different forms of viral hepatitis.
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