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AIDS Treatment News
March 1, 1996

CONTENTS:

Curcumin: Clinical Trial 
Finds No Antiviral Effect

by John S. James
A clinical trial with 40 volunteers, reported at the 3rd Conference on Retroviruses and Opportunistic Infections, found that curcumin, a popular "alternative" treatment for HIV, had no effect in reducing viral load or in increasing CD4 counts.(1) This trial was conducted by the CRI (Community Research Initiative) of New England, a community-based research organization.

Curcumin is an ingredient of turmeric, a spice used in making curry; it is the substance which gives curry its yellow color. Laboratory tests had shown that curcumin has substantial anti-HIV activity in cell cultures, at concentrations not damaging to the cells.(2) A 1994 clinical trial of curcumin by AIDS Research Alliance (named SEARCH Alliance at that time) was inconclusive, largely because of great unexplained variability in the viral load results. [For historical background on curcumin and HIV, see AIDS Treatment News #174 (May 7, 1993), #176 (June 4, 1993), and #198 (May 6, 1994). Our report on the AIDS Research Alliance trial is in issue #198.]

Of the 40 persons entered into the recent trial by the CRI of New England, two dropped out due to adverse events unrelated to the curcumin study. Of the other 38, 23 were randomized to a high-dose group and 15 to a low-dose group. (This study used the popular "Turmeric Power" brand of curcumin; the high dose was four capsules four times a day, and the low dose was 3 capsules three times a day.) Each group was further randomized to begin curcumin either immediately or after 8 weeks; both groups received the treatment for eight weeks. Both groups had at least two viral load tests to establish the baseline viral load value (those in the delayed-treatment group had three tests for their baseline); viral load tests were also given at 4 weeks and at 8 weeks of treatment.

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The following viral load averages were published in the abstract of this study presented at the Retroviruses conference. In the high-dose group, the average viral load was 4.569 logs (37,100 copies) at baseline, 4.226 logs (16,800 copies) at four weeks, and 4.568 logs (37,000 copies) at eight weeks. In the low-dose group, the corresponding figures were: baseline 4.989 logs (97,500 copies), four weeks 4.623 logs (42,000 copies), and eight weeks (4.822 logs, 66,400 copies). On the surface, this looked to us like a statistically significant result; but we contacted the researchers and found that the apparent viral load drop, in both the high-dose and low-dose groups, was caused in each case by a single individual with a single value which was wildly out of range (in one case, more than 100 times any other viral load result from that person); the extreme values were probably due to a laboratory error. When these anomalous values were excluded, no effect on viral load was found.

CD4 cells showed a slight rise in the high-dose group (baseline average 231, four weeks 247, eight weeks 262), and a consistent fall in the low-dose group (baseline 244, four weeks 223, eight weeks 146). But neither result was statistically significant, meaning that these changes were likely due to chance and cannot be taken as evidence of any treatment effect.

Researcher Jim Hellinger, M.D., of the Community Research Initiative of New England, noted in a private communication to us that, "Despite the lack of apparent antiviral or CD4 effects, most participants liked taking curcumin, and felt better taking it, and put up with the minor GI effects. We did not plan any formal analysis of these effects, but there certainly are other ways in which curcumin might be active..." A blood test for curcumin levels, now being developed for a different study, may provide more information about why no antiviral activity was found.

Comment

In 1993 we became interested in curcumin because of its scientific rationale, and the laboratory findings of anti-HIV activity -- plus the fact that the potential treatment was safe, inexpensive, and widely available. We also heard a few early anecdotal reports of viral load reductions in patients who tried curcumin.

One of the biggest problems in AIDS treatment development is that only proprietary drugs tend to get tested -- assuring that any resulting treatment will be very expensive, and also that testing will take a long time, since proprietary substances tend to be new chemicals, not familiar drugs, herbs, or food components already in wide human use. There is a critical need for social organization to screen promising leads which for commercial reasons are not being pursued by pharmaceutical companies. Both the CRI of New England, and the AIDS Research Alliance, are to be commended for their studies of curcumin. Now that viral load testing is becoming more available, and the technology more reliable, small trials to screen for antiviral activity in people are becoming much easier and more feasible than they were in the past.

We must realize that the large majority of potential treatments which have the scientific rationale and/or laboratory or anecdotal information to justify a small trial will turn out not to be useful. But there are many promising leads among substances already available and in human use; the odds are good that at least a few of them will prove helpful. A single one that does will justify all the effort and expense of testing the others.

References

1. Hellinger JA, Cohen CJ, Dugan ME, Day JM, Cavanaugh JF, and Glidden D. Phase I/II randomized, open-label study of oral curcumin safety, and antiviral effects on HIV-RT PCR in HIV+ individuals. 3rd Conference on Retroviruses and Opportunistic Infections, January 28 - February 1, 1996, Washington DC [abstract #140].

2. Li CJ, Zhang LJ, Dezube BJ, Crumpacker CS, and Pardee AB. Three inhibitors of type 1 human immunodeficiency virus long terminal repeat-directed gene expression and virus replication. PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, USA, March 1993; volume 90, pages 1839-1842.


Protease Inhibitor Approvals: 
Will People Be Cut Off Drug? 
Followup Studies 
Proposal Needs Support

by John S. James
The PWA Health Group, the largest AIDS buyers' club in New York, is circulating a sign-on consensus letter asking the FDA, when it approves Merck's Crixivan(R) (indinavir) and Abbott's Norvir(TM) (ritonavir), to require the companies to obtain long-term followup data, by allowing people currently receiving the drugs (in clinical trials, or in the expanded- access lottery programs) to continue their treatment in long- term followup studies.

This proposal addresses two problems. For those now receiving either of these experimental treatments, it would prevent involuntary interruption of therapy if they cannot pay for the drugs when they go on sale. Interruption of therapy might be especially problematic with these drugs, because of concern that it might help a person's virus become resistant to most or all protease inhibitors, greatly reducing the value of this class of drugs for that person.

The other problem -- lack of long-term data -- concerns everybody who uses these drugs. It is widely expected that one or both of them will be approved soon -- as almost everyone wants -- perhaps in the next several weeks. Then thousands are likely to start using them.

But very few people have taken these drugs for more than a year. The fastest way to get the needed long-term data now is to allow those who have already been using the drugs to continue, with monitoring in a followup study. Then, in case some long-term safety problem develops after two or three years of use, the many thousands of people who started the drug when it was approved would have advance warning, and could probably avoid the problem by interrupting or changing therapy if necessary. But there is widespread concern that unless the FDA requires these studies, the companies will stop providing free drug once they can sell it instead, and the studies will not be done.

You can help by signing the consensus letter, and if relevant, getting your organization to do so. To sign on, or for more information, including a copy of the statement, contact Sally Cooper at the PWA Health Group, 212/255-0520 or fax 212/255-2080.


Rolipram: Antidepressant 
Used in Europe and Japan 
Might Have Promise Against TNF, HIV

by Denny Smith

An antidepressant drug known as rolipram has been found to be a potent inhibitor of tumor necrosis factor, which means it might be a useful treatment for HIV infection. Unfortunately, the drug may not reach clinical trials because the companies that control rights to it are not inclined to support further development.

This situation came about last year, when researchers supported by the U.S. National Institute of Allergy and Infectious Disease and led by Paul Skolnik, M.D., at Tufts University and the New England Medical Center, discovered that in laboratory tests rolipram strongly inhibited tumor necrosis factor (TNF), a naturally occurring chemical messenger that the immune system produces to excess in some diseases, including HIV infection. The work was published last October in the journal AIDS.(1)

Many of the symptoms of AIDS that are not caused by an opportunistic illness are at least partly the result of too much TNF: fatigue, fevers, dementia, aphthous ulcers, and, the most threatening, wasting. In fact, TNF is sometimes called cachectin, referring to its cachexia-related, or lean muscle destroying, effects. Many researchers now believe there is an HIV/TNF feedback loop in which TNF enhances HIV replication while HIV progression increases TNF production.

TNF inhibitors would theoretically interrupt that cycle, and several of them have received attention recently in both laboratory research and community practice. NAC, pentoxifylline and thalidomide in particular have been widely discussed in medical reports, including AIDS Treatment News. But only thalidomide has been reported to be clinically valuable. It effectively controls aphthous ulcers and may reverse the loss of lean muscle mass.

At best, however, thalidomide is a problematic drug. It causes sedation, which is why it was developed in the first place. But it can also provoke a serious sulfa-like reaction in many people with HIV, and it can cause neuropathy and neutropenia with extended use. And, of course, it leads to terrible birth defects if taken during pregnancy, which is why it was never licensed in the U.S.

A newer, ostensibly less toxic, generation of TNF inhibitors is under development by Celgene, one of the makers of thalidomide. But animal and human trials of those drugs could take years to complete. Rolipram is available and used now in Japan; it has also been used extensively in Europe.

In his research, Dr. Skolnik found that rolipram was at least 10 and perhaps 600 times more powerful then pentoxifylline at inhibiting tumor necrosis factor. Both drugs are phosphodiesterase inhibitors, although rolipram is more specific in that regard. Rolipram is also known to cross the blood-brain barrier, which is an important criterion for any HIV treatment. It is considered an essentially safe drug, the main side effect being mild gastrointestinal distress at doses approaching 15 mg a day. The dose prescribed for antidepressant use ranges between 0.5 to 1 mg taken three times daily.

Some of the data published by Dr. Skolnik's team seems to suggest that the amount of the drug necessary to inhibit TNF might not be tolerable in practice. The peak plasma concentration of rolipram from a single human dose -- 1 mg, when the drug is used as an antidepressant -- is 0.12 micromolar. But in the laboratory tests, the concentration required for 50% inhibition of HIV was 10 to 60 micromolar -- more than 80 times what is achieved in plasma by normal use of the drug.

In this case, however, the laboratory concentration needed to inhibit TNF may not predict what happens in people. In the body, if rolipram reduces excessive levels of TNF, as it is supposed to do, that reduction should prevent the excess TNF from stimulating HIV replication. Some residual TNF activity may be desirable for normal immune function.

In the laboratory, rolipram is acting on a largely static situation; but in the body, TNF and HIV interact in a constantly changing dynamic in specific locations. Local concentrations of TNF and rolipram may not be paralleled by plasma levels.

Even if the highest tolerated dose of rolipram does not inhibit HIV, inhibiting any amount of excess TNF could be useful for preventing wasting, fatigue, dementia and aphthous ulcers. So while the laboratory data may raise doubts, they do not reduce the need for clinical studies to see if this drug could have a role in the treatment of HIV disease. Only clinical trials with HIV-infected participants can determine if a dose that is tolerable will also produce clinical improvement.

Rolipram was first developed as an antidepressant and marketed in Europe by Schering AG. It is also being investigated as possible treatment for multiple sclerosis. The development rights to rolipram in the U.S. and Japan were licensed to Berlex Laboratories and Meiji Seika Kaisha, respectively. Since rolipram does not inhibit HIV directly, as do drugs which inhibit reverse transcriptase (AZT, ddI, ddC, d4T, 3TC) or protease (saquinavir, indinavir, ritonavir), it would probably not become an enormously profitable first-line treatment for primary HIV infection even if the research proceeds. That is why, after all, any number of potential treatments are not pursued.

But, for reasons discussed above, TNF inhibitors could easily become indispensable supportive therapies, much as acyclovir and testosterone are now. Rolipram or similar drugs could possibly improve the quality of life and even the survival of many people with AIDS.

Even before his research was published, Dr. Skolnik proposed a pilot trial of the drug in HIV-infected patients, and asked Schering for support. For months, the request passed back and forth between Schering, Meiji and Berlex, and responsibility for further development of the drug remained unclear. Finally, it became known that Schering had submitted an Investigational New Drug application to the FDA some years ago (presumably for a non-HIV related indication), and does not now want to pursue the research necessary to bring the IND up to date.

Admittedly, such research could be an expensive commitment. But for a promising agent to be withheld for non-scientific reasons from a legitimate research effort seems distastefully reminiscent of the 1980s. AIDS activists were successful in reversing some similar decisions, but only after unfortunate public confrontations.

An alternative may be for the drug to be imported and carried at HIV buyers' clubs, depending on how much community support rolipram gathers. Readers who have knowledge of, or experience with, rolipram, are encouraged to contact Denny Smith or John S. James at AIDS Treatment News, fax 415/255- 4659, phone 415/255-0588.

Rolipram in Medical Literature

Extensive computer searches failed to find any mention of rolipram in relation to HIV or AIDS, except for the paper by Dr. Skolnik's group. And that paper was omitted from AIDSLINE, apparently in error -- which may have reduced the attention this work received.

We found 475 citations mentioning rolipram in MEDLINE, the general medicine database of the U.S. National Library of Medicine -- and 739 references in EMBASE, a European database which often has more citations than MEDLINE on new or experimental treatments. Most of the recently published work consists of highly technical investigations into the drug's mechanism of action.

References

1. Angel JB, Saget BM, Walsh SP, and others. Rolipram, a specific type IV phosphodiesterase inhibitor, is a potent inhibitor of HIV-1 replication. AIDS. 1995; volume 9, pages 1137-1144.


Study Finds AIDS Patients Live Longer 
When Their Doctors 
Have More Experience Treating HIV

by John S. James
A study of 403 adult men diagnosed with AIDS from 1984 through 1994 within an HMO found large differences in survival depending on physicians' experience (measured in large part by how many AIDS patients they had cared for).(1)

"After AIDS diagnosis, median survival among patients of physicians with the least AIDS experience was 14 months, versus 26 months among patients of physicians with the most experience (P

Other data suggested that the difference may have been largely due to better use of PCP prophylaxis, including better monitoring to know when prophylaxis should begin. "Among 212 patients with CD4 cell counts of

[Note: As this issue went to press, we learned that a full report of this research is due to be published in a couple weeks.]

Comment

This result should reinforce the importance of people finding out if they have HIV, and getting medical care if they do. No treatment at all -- including no PCP prophylaxis no matter how much it is needed -- is worse than treatment by the least experienced physicians. In the U.S. and some other countries, PCP prophylaxis is clearly the most important AIDS-related treatment in reducing the risk of death. And it is inexpensive, so there is seldom any economic obstacle to receiving it.

Also, this result suggests that HIV care does need to be a specialty among physicians, instead of being left to general practitioners. Inexperienced AIDS physicians should be working under supervision so that their patients can be assured of adequate care.

This finding also emphasizes the importance of the development of accepted guidelines and standards of care for HIV treatment. Today the situation is chaotic, with vast differences among physicians, and many patients receiving inadequate care.

References

1. Kitahata MM, Koepsell TD, Deyo RA, Maxwell CL, Dodge WT, and Wagner EH. Physician Experience and Survival Among Patients with AIDS. 3rd Conference on Retroviruses and Opportunistic Infections, January 28 - February 1, 1996, Washington DC [abstract #413].


Protease Inhibitors 
at Retroviruses Conference: 
Agouron's Results

by John S. James
The protease inhibitors now furthest along in human use or testing are saquinavir (Invirase(TM), by Hoffmann-La Roche -- the only protease inhibitor now approved), indinavir (Crixivan(R), by Merck), ritonavir (Norvir(TM), by Abbott), and nelfinavir (Viracept(TM), by Agouron -- the drug was formerly called AG1343). AIDS Treatment News already examined the Abbott (issue #240) and Merck (issue #241) protease inhibitor results presented at the Retroviruses conference. (Little clinical information on saquinavir was presented there -- only one abstract, #155, on reduced viral sensitivity during treatment -- probably because Roche had already presented the available information during the FDA approval process.)

Agouron protease inhibitor is at an earlier stage of development than the other three; about 120 patients have taken nelfinavir in studies so far.

Agouron's latest clinical trial data on nelfinavir became available too late for regular submission to the Retroviruses conference, and was turned down for the Late Breaker session, which had room for less than a third of the abstracts submitted to it -- and established various selection rules under which Agouron's abstracts did not qualify. (An earlier study of nelfinavir was accepted at the Retroviruses conference.(1) Agouron provided some of the results of its recent trials to the press, and at a community meeting on January 31.

One recent small trial found an average maximum reduction of HIV viral load from nelfinavir alone of about 98% at the best doses, after four weeks. Everyone's CD4 count increased.

Also, Agouron reported that an ongoing trial of the combination of nelfinavir plus d4T has found a greater than 99% average reduction in viral load. In a majority of the volunteers using this combination, the viral load was reduced to below the limit of detection (about 500 copies per milliliter, with the assay which was used). In comparison, d4T alone reduced viral load by about 75% in this trial.

Agouron states that nelfinavir has shown an excellent safety profile, with only one of about 120 volunteers having stopped the drug due to adverse effects which possibly were drug related. The most common side effect is loose stools or diarrhea.

Larger trials of nelfinavir are now recruiting at more than 40 sites in over 30 U.S. cities. For more information, see the announcement in AIDS Treatment News #240 (February 9, 1996), or call Agouron's information line, 800/501-2474.

References

1. Webber S, Shetty B, Wu E, and Zorbas M. In vitro and in vivo metabolism and cytochrome p450 induction studies with the HIV-1 protease inhibitor, VIRACEPT(TM) (AG1343). 3rd Conference on Retroviruses and Opportunistic Infections, January 28 - February 1, 1996, Washington DC [abstract #144].


Retroviruses Conference: 
Obtaining Abstracts

There are at least three ways to obtain copies of the published abstracts of the Conference on Retroviruses and Human Infections:
  • Abstract books are still available for $25 from the Infectious Diseases Society of America. For more information, call 703/299-0200.
  • The abstracts are also available at no cost through the World Wide Web, at http://www.idsociety.org. You can quickly search all the abstracts for author, or for any word used.
  • The abstracts will also be available online through AIDSLINE, although they are not there yet as this newsletter goes to press. AIDSLINE is produced by the U.S. National Library of Medicine; accounts are available free to organizations and individuals.

Some AIDS service organizations provide libraries where the public can obtain such information in print or by computer.


DHEA: Threat to Access?

by Tim Kingston

[Note: For background on DHEA, see the article and the interview in AIDS Treatment News #239, January 19, 1996. DHEA has not been found to reduce viral load or increase CD4 count in persons with HIV, but it might improve quality of life for some people, or have other uses. This report investigates the possibility that it could be made illegal in the U.S., on the grounds that it might be abused by athletes -- even though there does not appear to be even a single reported case of such abuse, and no one knows if DHEA would have any effect on muscle building at all.

Our recent coverage of DHEA began when we asked reporter Tim Kingston to investigate the persistent rumors and fears that DHEA was about to be banned. Our coverage in issue #239 began as an effort to write an introduction to this article. JSJ]

For years DHEA has been one of the most popular potential treatments sold by the HIV buyers' clubs. Today there is a danger that it might be largely banned in the United States. This would happen by having DHEA declared a "schedule III" controlled substance, on the grounds that it might be abused by athletes to build muscle, like an anabolic steroid. Controlled substances can only be prescribed for certain uses; and since DHEA has no FDA-approved use, it might become unavailable both for clinical practice and for community- based research. There are no significant safety concerns; the most likely reason for a ban would be that the treatment is becoming too popular outside of the HIV community, where it is being promoted for possible life-extension and "smart drug" benefits in middle aged and elderly individuals.

How serious is the current danger that access to DHEA may be cut off? The short answer is that it is impossible to know. For years there have been rumors that DHEA was to be banned as a controlled substance. That has not happened yet. But when we investigated the rumors, we learned that different enforcement agencies have very different views -- and the outcome could go either way. Some sectors of the FDA (Food and Drug Administration) seem perfectly happy to define DHEA as a food supplement; others insist that it is a drug and therefore subject to FDA drug regulation. And many at the DEA (Drug Enforcement Agency) regard DHEA as an anabolic steroid, subject to abuse by body builders, and therefore subject to stringent government regulation.

DHEA advocates are particularly worried about new government regulation because of an attempt by the New Jersey state prosecutor's office to press charges against a 75 year old man this summer who was using the substance to retard the effects of aging. The charges were dropped, but concern remains high about federal action against DHEA, especially among individuals and groups who advocate DHEA as an anti- aging treatment. There is also concern at the Healing Alternatives Foundation in San Francisco, and the PWA Health Group in New York, major HIV buyers' clubs that carry DHEA.

Steven Fowkes, director of the Cognitive Enhancement Research Institute, a smart-drug research group in Menlo Park, California, asserts that the FDA may be trying to figure out a way to go after DHEA ever since the Dietary Supplement Health and Education Act (DSH&EA) of 1994, defined dietary supplements as foods and thereby prevented the Agency from treating DHEA as a drug without the required hearings. Fowkes says he has a "deep throat" source at the DEA who charges that the FDA has been pushing the DEA to reschedule DHEA as a schedule III drug.

Fowkes says under the DSH&EA, the FDA would have to hold hearings to get DHEA officially classed as a drug and subject to FDA regulation; but that the DEA could define it as a Schedule III substance without a hearing. "If the FDA can pressure the DEA to schedule DHEA as an anabolic, then they are freed of the restraints imposed upon them by the DSH&EA. By getting somebody else to do their dirty work, the FDA can do an end run around the DSH&EA."

FDA sources flatly deny that their agency has applied any pressure on the DEA to redefine DHEA. FDA spokeswoman Janet McDonald tartly noted, "We don't define things. It is either regulated or not regulated. It is either approved or not approved. DHEA is not an approved substance."

One FDA source acknowledges that the agency did instruct manufacturers of DHEA to discontinue selling the substance in April 1985 [for weight loss] because it had not been reviewed for safety and efficacy. FDA sources also contend that DHEA was considered a drug by the FDA because it was "intended or advertised to affect the body's normal functioning."

Meanwhile, over at the DEA, Howard McClain, chief of the agency's drug and chemical evaluation section in Washington D.C., says he is not aware of any request for rescheduling from the FDA, but acknowledges "it is possible they asked someone in the DEA" given that the agency is a huge "worldwide" agency. He asserts that DHEA is under review because it is in the scientific literature and not because of any special interest in the substance by the DEA.

McClain does note that DHEA is now under review by the DEA to see if it can be classed as an anabolic steroid subject to schedule III regulation. "Chemically [DHEA] is very similar to testosterone, but we have not been able to determine if it produces muscle growth," says McClain. "If we determine that it [does]... then it would be an anabolic steroid and would then be schedule III by definition."

While DHEA is not listed as a regulatable anabolic steroid, it could fall under a catch-all phrase that allows DEA action in the case of substances that act like testosterone. [DEA drug scheduling is based on potential for abuse, with heroin as a schedule I drug and cough syrup with codeine as a schedule IV drug.] But McClain says, "We don't have any evidence of illicit activity."

Federal Confusion

Although federal agencies in Washington D.C. appear to have reached a sort of consensus--after some prodding--that DHEA is a drug, but one not yet subject to DEA action or FDA regulation, that message has not yet meandered down the chain of command. Interviews with FDA and DEA offices in San Francisco and Texas indicate that not only does the Federal Government not know how to define DHEA, its various agencies at various levels cannot agree on a single position about the substance.

When AIDS Treatment News first contacted FDA sources in Washington, DHEA was initially described as a food supplement. As one friendly FDA source put it, "Nobody really knows what to call it; the only thing I had got was that it was pretty definite that we don't consider it a schedule III, and that leaves [DHEA] in the realm of dietary supplements. If the agency considered it a drug they would go in and say you can't sell this stuff as a dietary supplement."

Yet after a few more calls from AIDS Treatment News and further research on FDA's part, DHEA was in fact held to be a drug by the agency. But in California, Dr. Wallace Winters, the Pacific region medical officer, said right from the start that DHEA is "basically an anabolic [steroid]; the game is to sell it as a dietary supplement." Winters says that because of the DSH&EA "the FDA has backed off on a lot of stuff... at the present time [DHEA] is in limbo."

Inconsistencies within a single agency are also striking at the DEA. Where Howard McClain at DEA headquarters in Washington D.C. says that DHEA is under review for inclusion in the agency's list of schedule III drugs, DEA offices in San Francisco and Houston have already come to their own diametrically different conclusions about the substance.

In San Francisco one DEA agent initially thought DHEA "sounds" like a controlled substance, but on further review found it was not on the DEA list. Further inquiries were referred to DEA headquarters. But in Texas another DEA officer came to the exactly opposite conclusion, saying determinedly that DHEA is indeed a schedule III anabolic steroid. That same agent also stressed that she was unaware of any enforcement action undertaken by the DEA against DHEA.

The same inconsistency was also evident in comparisons between agencies within those states. In California an official with the State Food and Drug Branch asserts that DHEA is not classified as a drug, but as a chemical. In Texas the Texas Department of Public Health equally vehemently declared that DHEA is soon to be declared a controlled substance. Lydia Gonzales of the Texas Department of Public Health says that she was told that DHEA would be declared a schedule III controlled substances as long ago as summer 1995.

New Jersey Prosecution

Nowhere has the government's confusion about DHEA been more evident than in Bergen County, New Jersey. On August 21 1995 Mr. Paul Gallo, a 75 year old school teacher, went to pick up a shipment of DHEA he had ordered from Germany. He was met by a county narcotics strike force, and arrested and charged "for the dubious crime of importing DHEA," says Gallo's attorney Ralph Fucetola.

Even though charges were dismissed, the Gallo case is of particular concern to DHEA advocates, because they are worried that it may be a way for the federal government to set up a legal precedent to prosecute DHEA distributors. They fear that if state agencies go after DHEA, that could be used as legal precedent for federal action.

According to Fucetola, the New Jersey postal authorities had issued an erroneous import alert on DHEA in June 1995. When Mr. Gallo's package arrived, the post office contacted the state prosecutors office, and the arrest was organized. Gallo was arrested and intimidated into giving up the rest of the DHEA he had. At that point Fucetola was contacted by the Life Extension Foundation, a Florida based rejuvenation group that has tangled with the FDA in the past.

Fucetola conducted a search of the federal register and found no mention of DHEA either as an illegal substance or as an anabolic steroid. Fucetola sent Fred Swhanweed, the Bergen County prosecutor, a letter pointing out there were no legal precedents for prosecution and no evidence available that DHEA was an anabolic steroid. Fucetola also obtained letters from a number of DHEA experts decrying the arrest. Shortly thereafter all charges against Gallo were dropped. The DHEA was given back to him on January 17.

But Swhanweed says the fact that the charges were dropped has nothing to do with the fact that DHEA is not classed as a schedule III drug. Instead, he insists he was told by the state police lab that DHEA is a schedule III drug. He says the charges were only dropped out of compassion for a 75 year old man who did not know that what he was doing was illegal. Swhanweed insisted testily, "The controversy about whether it should or should not be a controlled substance, that did not enter into the decision to dismiss the case."

Other sources suggested that the New Jersey State Police crime lab had made an erroneous determination that DHEA was illegal when it was not, perhaps based on the catch-all phrase in the DEA drug scheduling registry allowing for DEA action against drugs that are like anabolic steroids. Charles Tindall, chief forensic scientist for the New Jersey State Police, acknowledged that DHEA is "not on the books," but he declined to make any further comment on what happened in the Gallo case. Tindall did say that he was in the middle of writing a report that he would be forwarding to the New Jersey Attorney General's office about the Gallo case.

Ralph Fucetola was less circumspect about what he thought happened in Bergen County. "What is going on is bureaucratic incompetence. There was a post office alert based on erroneous information, [and because] the drug war is so great, little niceties like actually scheduling something and reporting it don't matter. [Thus] we have the narcotics squads raiding 75 year old men over vitamins."

The Future

Professor William Regelson, a professor of medicine and microbiology at the Medical College of Virginia and a noted expert on DHEA, describes DHEA as a native hormone that was for many years regarded as a "junk steroid" despite the fact it is one of the most plentiful in the human body. Now, Regelson says DHEA has shown promise in the treatment of lupus and other autoimmune diseases; it balances the immune responses that lupus disequilibrates. He adds that DHEA also blocks the type 2 herpes virus and has possibilities in treating several other conditions. Regelson asserts DHEA "enhances resistance to infection and restores immunity in mice and apparently in older people, and it makes you feel better."

It is as a rejuvenation treatment that DHEA has obtained the most publicity these days -- including national television coverage as a miracle anti-aging treatment. But no one expects conclusive evidence any time soon, since it would be very difficult to conduct a clinical trial to prove that a treatment extended the human lifespan. Also, DHEA has been around so long that it is largely unpatentable, so most companies will be unwilling to spend the money needed to prove that it is effective. [However, Genelabs Technologies Inc., known in the AIDS community for its earlier testing of "compound Q," is developing DHEA as a treatment for lupus.] This leaves DHEA in a twilight zone as far as legality and access go.

It is this lack of data and the fact that DHEA is moving out into the mainstream that may also account for what DHEA advocates say is the FDA's jitteriness about the substance. As long as DHEA use was perceived as restricted to a small class of individuals, the FDA would leave it alone. As one life-extension advocate put it somewhat crassly, as far as the FDA goes, "if you are HIV you can do anything you want, you have total immunity."

"As long as DHEA remained within the HIV community, the FDA could acquiesce," says Steven Fowkes. "But now that it is being promoted as a cure-all for everything under the sun, the FDA feels obligated to take action. DHEA has crossed over from the HIV community into the mainstream where normal healthy voters will be using it en mass." It is that en mass use that Fowkes says worries the FDA most. That is in keeping with the FDA's institutional mandate, to protect the public health; if everyone starts using an unproven substance, the FDA gets nervous.

Future access to DHEA for people with AIDS may now depend on whether or not the DEA defines it as an anabolic steroid. Ironically, if DHEA does help build lean body mass and prevent AIDS wasting, that could be the very thing that makes it almost impossible for U.S. citizens to obtain.




  
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This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
 

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