Congress Seeks to Ban DHEAJune 2007
By William Faloon
Animal Study Data Misused to Discredit DHEA’s Well-Established Safety Profile
One way scientists evaluate for toxicity is to have animals consume large amounts of a compound and then carefully assess them for organ damage. However, different animal models need to be used in different situations—a “one-size-fits-all” approach makes for bad science.
One such example is the use of animal models to assess for liver toxicity with compounds that are peroxisome proliferators. Peroxisome proliferators are potent rat carcinogens in the liver. However, this experimental model is not valid to assess human liver toxicity for these types of compounds.
There are significant species differences in response to peroxisome proliferators. Rats and mice are very sensitive to the toxic effects of these compounds, but peroxisome proliferators do not produce toxicity in species like guinea pigs, monkeys, and humans at dose levels that produce a dramatic toxic response in rodents.99
Scientists have published research papers indicating that peroxisome proliferators do not pose a liver toxicity risk to human beings. One researcher noted, “it is reasonable to conclude that the encountered levels of exposure to these non-genotoxic agents (peroxisome proliferators) do not present a hepatocarcinogenic hazard to humans.”100
Since DHEA is a peroxisome proliferator, it comes as no surprise that liver damage ocurred when scientists administered huge doses of a well-known carcinogen, N-nitrosomorpholine, and huge doses of DHEA in the diets of lab rats, roughly the human equivalent of 6774 mg of DHEA daily! Contrast this enormous amount of DHEA with the typical 15-75 mg per day of DHEA used by healthy aging humans.101
Valid animal models that have been used to assess the liver toxicity risk of DHEA in humans have found no evidence of liver injury or toxicity. For example, a study showed that rats and mice given large amounts of DHEA in the diet displayed increased liver enzyme levels associated with lipid accumulation in rodent liver, but no such increase was shown in guinea pigs.102 Another study showed evidence of increased liver enzyme levels when DHEA was administered to mice at a human-equivalent dose of about 1700 mg per day of DHEA. However, in guinea pigs, a valid animal species for comparison to humans in this context, there was no evidence of toxicity at a human-equivalent dose of over 4500 mg per day of DHEA.103
Even ignoring the fact that rats and mice are invalid models to assess for liver toxicity risk in humans with supplements like DHEA, and ignoring the fact that appropriate animal models for extrapolation to humans do not show any evidence of liver injury risk with DHEA, the rat-mouse DHEA studies on liver toxicity use enormous amounts of DHEA—doses equivalent to 130 times the average 50 mg of DHEA per day used by healthy adults.
It is ludicrous to suggest that DHEA be banned on the basis of invalid animal models that use human-equivalent doses of DHEA that are more than 100 times greater than those used by healthy adults. An important study in JAMA in 2006 showed signs of liver damage in patients who consumed 4 grams daily of Tylenol® (acetaminophen) for two weeks.104 This means that taking two Extra Strength Tylenol® caplets, four times daily, can generate evidence of liver damage. Yet the misleading press release being circulated in Congress suggests that DHEA should be outlawed because it causes “liver damage.” This is an egregious distortion of the facts—especially when there are no reported human cases of liver damage caused by DHEA in the scientific literature.
DHEA Can Cause Acne in Women— When the Dose Is Too High
Women tend to require less DHEA than men. When a woman takes too much DHEA, acne can result, but this dissipates when the DHEA dose is lowered.
We at Life Extension have never heard of “severe acne” being caused by DHEA, as the biased press release being circulated in Congress asserts. If the worst that can happen to women is temporary acne in response to excessive intake of DHEA, this would appear to be a small price to pay in relation to the multiple health benefits DHEA has been shown to confer.
The potential acne effect of DHEA on women has been long known, and women usually stay at moderate 15-50 mg/day DHEA doses and avoid acne altogether.
DHEA Does Not Cause Hair Loss
We could find no reports that DHEA causes hair loss. While one could propose a theoretical basis that somehow orally ingested DHEA would increase dihydrotestosterone (DHT) enough to promote hair loss, there is no evidence to show that this has ever actually happened.
If DHEA were to increase dihydrotestosterone, the solution would be to take a 5-alpha reductase inhibitor (like low-dose Proscar®) or possibly saw palmetto extract to block this effect.
DHEA Does Not Cause “Wild Mood Swings and Aggressiveness”
DHEA’s role as an antidepressant has been rigorously examined for years. During these many trials, researchers routinely found that when taken daily, DHEA supplements effectively reduced depressive episodes and enhanced mood. In fact, according to one major study in the UK, as many as 67% of men and 82% of women reported a noticeable decrease in their depressive symptoms while taking as little as 25 mg per day of DHEA.65 In addition, women suffering from adrenal insufficiency have reported an improved sense of well-being and an associated increase in both sexual interest and sexual satisfaction while taking DHEA.50
Sexual function is closely linked with emotional health and well-being, and scientists now know that DHEA levels are strongly associated with healthy sexual function. Two recent studies found that sexual function105 and overall self-reported health and functional status106 were better among women with relatively high levels of DHEA. Even low-dose DHEA supplementation may be effective in providing these benefits. For example, in a group of women with systemic lupus erythematosus, daily doses of DHEA as low as 20-30 mg improved health-related quality of life and sexual interest and activity compared to placebo.61 Other researchers have reported notable improvements in libido and mood in women who supplemented with DHEA.107,108
Even more promising are studies suggesting that, in addition to its positive impact on depression and sexual function, DHEA may help to manage symptoms of schizophrenia. Based on their preliminary findings demonstrating DHEA’s efficacy in reducing symptoms of schizophrenia,84 researchers further noted improvement in illness severity and anxiety in a group of schizophrenic patients who received DHEA in addition to their anti-psychotic medications.97 The study authors attributed this specific anxiety-reducing effect to DHEA’s influence on the brain’s GABA receptors, which are central to regulating mood.97
To characterize DHEA as causing “wild mood swings and aggressiveness,” as was done in the press release circulating in Congress, is the exact opposite of the beneficial psychological effects that DHEA exerts on the body.
DHEA and Cancer
No human study in which DHEA was administered as a supplement or drug has ever shown that it causes cancer. Petri dish and live animal studies show that DHEA may protect against certain cancers.41-46,109-145 Human studies that measure DHEA blood levels and correlate them to future cancer risk are contradictory and not representative of the DHEA protocols used by health-conscious people today.
Why Laypeople Confuse DHEA with Synthetic Steroid Drugs
DHEA is produced mainly in the adrenal glands and serves as a natural precursor and balancer to many hormones in the body. While DHEA is defined as a “steroidal hormone,” that does not equate to an “anabolic steroid drug.”
By way of example, the bioactive form of vitamin D in the blood (calcitriol) is a “steroid hormone,” but no one is yet suggesting that vitamin D be banned. In fact, both vitamin D and DHEA are synthesized from cholesterol, the most common sterol found in the body.
DHEA exerts very weak androgenic (testosterone-like) and estrogenic (estrogen-like) activity, and can be converted into metabolites, depending on the body’s need and hormone balance.146 Under normal conditions, the conversion of DHEA to testosterone is tightly controlled by the body. DHEA has been consistently shown to not influence testosterone levels in young men.147-149
If DHEA did function as an anabolic androgenic steroid, then aging men would not be seeking prescription testosterone drugs to reverse certain symptoms of aging.
Since medical science defines DHEA as a “steroidal hormone,” some lawmakers in Congress now think it should be classified as a “controlled substance” and removed from the marketplace. This is quite an allegation when one considers that DHEA has been freely sold in the United States for over 10 years, with no reports of serious adverse events.
The problem is that members of Congress are not scientists, and they are unable to differentiate between natural steroidal substances in the body (such as cholesterol, vitamin D, and DHEA) and the synthetic anabolic steroid drugs that are abused by some bodybuilders.
What Is an “Anabolic Steroid Drug”?
According to the United States government’s own Medline Medical Dictionary, an anabolic steroid is defined as:
“Any of a group of usually synthetic hormones that are derivatives of testosterone, are used medically especially to promote tissue growth, and are sometimes abused by athletes to increase the size and strength of their muscles and improve endurance.” (Medline-March 12, 2007)150
Based on the government’s own definition of “anabolic steroid,” DHEA does not fit into this category. Controlled clinical trials indicate that its use in young adults does not result in performance-related gains, and it is not associated with the myriad side effects that accompany anabolic steroid abuse.147-149,151-153 DHEA is sold as a natural (not synthetic) hormone and is not a derivative of testosterone.154
Anabolic steroid drug abuse is purported to result in cardiovascular conditions such as hypertension, atherosclerosis, and blood clotting, liver conditions such as jaundice and hepatic carcinoma, tendon damage, reduced fertility and breast enlargement (in males), and adverse psychological and behavioral effects. DHEA does not exert these effects.155,156
Moreover, surveys of weightlifters and other athletes conducted by Harvard University researchers show that DHEA is rarely used to increase muscle size or strength or to improve endurance.157 Therefore, the notion that DHEA is in any way comparable to controlled anabolic steroid drugs is scientifically unfounded and legally invalid.
Let Your Voice Be Heard on Capitol Hill
There is at least one pharmaceutical company lobbyist for each member of Congress. Drug lobbyists function solely to persuade Congress to enact laws that make pharmaceutical companies more money. They have no interest in protecting the American public’s health.
If DHEA is classified as a “controlled substance,” pharmaceutical companies stand to earn enormous profits from the drugs Americans will need to treat disorders as diverse as:
Members of Congress have been victimized by a misinformation campaign designed to disparage DHEA for the purpose of having it reclassified as an “anabolic steroid drug.” Consumers must rally to overcome this deceptive attempt to deny Americans continued access to this scientifically validated supplement safely used by millions of Americans each day.
Another troublesome aspect about this charade to discredit DHEA is that it could provide a springboard for pharmaceutical companies to attack other supplements that compete against their drug sales. So whether you use DHEA or not, the hoax being perpetrated in Congress is a genuine threat to health freedom across the board.
The Senate bill that seeks to ban DHEA is S.762. The companion House bill is H.R.1249. To register your opposition to these bills, call 1-202-224-3121.
To write your Senators and Representative, use the form letter on page 35 following the scientific references for this article, or log on to www.lef.org/lac to conveniently send this letter via email to your members of Congress.