DHEA Access Threatened?

by John S. James

Summary: DHEA came close to being totally banned in the U.S. in January 2005, when a new law aimed at steroids in sports took effect. Even doctors would not have been able to prescribe DHEA, and medical research on its uses would have become far more difficult. A potentially important treatment could have been lost for a long time -- and could still be lost unless people are vigilant.

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DHEA is the most abundant hormone in the human body. Blood levels peak in early adulthood, around age 20, and then decline greatly during the human lifespan, falling by about 80% in the elderly. Blood levels also decline in many illnesses. Human studies of DHEA supplementation to restore normal levels are promising; for example, a recent small but careful study, not in persons with HIV, found that DHEA was an effective treatment for midlife-onset major and minor depression in both men and women [1].

But there has never been a large, long-term, placebo-controlled trial -- and most doctors want more information before accepting DHEA treatment in standard medical practice. No one is expecting such a trial, because DHEA has long been used so it cannot be patented; therefore no pharmaceutical company will pay for the research, because it could not recoup its investment later by charging monopoly prices. (Governments or nonprofit organizations can in theory develop drugs, but the U.S. system does not encourage that -- and other countries spend far less than the U.S. on medical research overall.) Meanwhile, DHEA has been sold over the counter in U.S. drugstores and health-food stores for years. It is used mostly by the elderly, and by others whose blood level is low. Standard tests for blood levels are routinely available to doctors.

DHEA is chemically an anabolic steroid (in the body it is changed to androstenedione, famous for use by baseball players and other athletes, which in turn is changed into testosterone). But DHEA has not been used by bodybuilders, probably because it is not effective for that purpose; most healthy young people have plenty of DHEA already, and indications are that supplementation helps only by correcting a deficiency, bringing DHEA blood levels into the upper part of the normal range.

Recently Congress passed a law to prohibit androstenedione and other substances that can turn into testosterone or similar steroids in the body; the ban took effect on January 20, 2005. It regulates those substances as anabolic steroids under the control of the DEA (Drug Enforcement Administration). If DHEA had been included, no one in the U.S. could use it, not even with a doctor's prescription. What saved DHEA in this country was the work of Senator Orrin Hatch (Republican of Utah), who refused to support the bill unless DHEA was exempted, and a few others including Senator Tom Harkin (Democrat of Iowa).

The AIDS community, like almost all of the public, was not involved when this legislation was going through Congress, probably because we did not know about it. According to members of Congress quoted in a recent article in The New York Times [2], the only opposition to banning DHEA came from the supplements industry -- while members of Congress who wanted to leave DHEA on the market did not see any significant opposition to doing so.

Comment

What happened here is that a substance with potential uses in HIV, aging, depression, and other conditions was almost banned incidentally, just because it is chemically a steroid, even though it has not been used for bodybuilding. DHEA has not had the systematic research necessary to develop a drug because it is unpatentable, and therefore could not be sold at high prices. Control by the DEA would have made the research far more difficult, by demonizing the drug before new studies were conceived or conducted; look at the barriers today to studies of medical marijuana. Law enforcement does not welcome new medical information that would challenge existing drug-control policy -- and often can block the research that could lead to such discoveries.

One reason DHEA is important is that depression is such a major problem worldwide (note reference [1] below). Most people do not have access to expensive psychiatric and pharmaceutical care -- and will not, due to increasing economic inequality, and high prices of patented drugs even in poor countries. A self-help, evidence-based movement using lifestyle changes including stress reduction, meditation, prayer, social support, diet, exercise, sleep improvement, and nutritional supplements could be available to all social classes, helping people safely prevent or reduce depression and other problems as well, and get control of their lives again. Such a movement could search for and document what might be called "lucky remedies" -- safe, inexpensive, easy-to-try approaches that do not work for most people but make all the difference for a few (for one friend of mine, it's fish oil; for another, a white-noise generator to use at night). Organized medicine largely ignores treatments with unknown mechanisms and no way to predict who could benefit; but individuals can work from a list and try them arbitrarily, looking for any that clearly help them. Many who could afford expensive medical care might also benefit greatly. Especially after the new depression findings [1], a ban on DHEA would be a serious loss to such a grassroots effort.

At this time we do not know how much threat to DHEA remains. Congress often decides crucial measures in secret, passing provisions into law that even most of its own members do not know are there. This is done so that one faction, sometimes only a handful of people, can impose its will in private without debate, writing national law before others know what is at stake. The recent New York Times article [2] is a frightening portrait of arrogance -- people tempermentally disposed to ban, with no compunction about practicing medicine for 293,000,000 people -- trying to take away their autonomy without regard for individual circumstances, and without even analyzing the costs vs. benefits of doing so.

What is most disturbing is how little public awareness and opposition developed in 2004 when the law was written and passed. As many have said, "The price of liberty is eternal vigilance." We cannot rely on the supplements industry, or on a handful of people, to protect legitimate medicine and research from being banned in the war on drugs.

References and Discussion

[1] PJ Schmidt, RC Daly, M Bloch and others. Dehydroepiandrosterone monotherapy in midlife-onset major and minor depression. Archives of General Psychiatry. February 2005; volume 62, pages 154-162. You can read the abstract without charge at http://archpsyc.ama-assn.org/; search for DHEA.

This study at the U.S. National Institute of Mental Health concluded, "We find DHEA to be an effective treatment for midlife-onset major and minor depression" [quote from the abstract]. It compared six weeks of DHEA treatment with six weeks of placebo. It used two doses, 90 mg per day for three weeks and 450 mg per day for the next three weeks, and could not confirm that either dose was better than the other. This study measured baseline DHEA blood levels in order to record the change due to supplementation, but apparently did not screen patients or reject anybody on the basis of that baseline test. Total testosterone decreased for men and increased for women with DHEA treatment, but the change was not statistically significant. Free testosterone increased significantly (for men from 42.5 to 49.9 pg/mL after six weeks of DHEA treatment, for women from 2.3 to 14.1; we are unclear on the interpretation of the statistics, since only one p value is given for free testosterone overall). Most studies report no testosterone increase in men given DHEA.

Fifty two volunteers were randomized, and 46 completed the trial, 23 men and 23 women. For ethical reasons this study excluded persons with major depression of more than moderate severity, those who were suicidal, and those who were judged to need immediate treatment, so it does not provide information about the most seriously depressed. Of the 28 volunteers with major depression who completed the study, 43% were classified as responders -- compared with 61% of the 18 volunteers with minor depression. (This trial used a crossover design, so every volunteer had 3 weeks of DHEA and 3 weeks of placebo.) In this study the authors could not predict who would benefit, either from baseline blood levels or otherwise.

This small but well-conducted trial built on previous work suggesting that DHEA is effective for treating depression in some people. Half of the volunteers responded -- about the same response rate patients get with the first prescription antidepressant they try.

Almost certainly this and most other research would never have been conducted if DHEA had been banned and were in the news primarily for drug raids, arrests, and trials.

[2] Anne E. Kornblut and Duff Wilson, "How One Pill Escaped Place on Steroid List." The New York Times, April 17, 2005. Note: The New York Times requires registration, and also charges for articles more than one week old -- but this article is available free as reprints in other newspapers. Use Google or another search engine to find the title ("How One Pill Escaped Place on Steroid List" -- best without the quotes, as there is at least one variation on the title). The reprinted articles may be shortened without notice, so check the word count; the original has about 1875 words.

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