DHEA: Threat to Access?

[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.