26 June 1997
UROT97\DHEA.MS
1,300 words (main story)
550 words (sidebar)
By Norman Bauman
(This story was originally published in a slightly different version in Urology Times.)
I'm a 70 year old generally active and healthy male. I decided to start taking DHEA because it has been touted as a sort of "youth" pill. Six months ago, I had a PSA of 6.3. Recently, had a new PSA reading of 9.9. Shook me up. Of course an elevation like that can portend cancer -- and my Urologist is watching closely.
I've also stopped taking DHEA and intend to have another PSA reading in a month, after the effects of DHEA have left the system. A friend of mine went through this same effect, i.e., his PSA shot up after he started taking DHEA. When he stopped, the PSA came back down.
Anybody out there have this experience?
Here's a new computer game. Go to an Internet search engine. Type in "DHEA". Try to find a false, misleading, or fraudulent claim.
It's easy.
"FEEL YOUNGER AND SEXIER WITH THIS AMAZING ANTI AGING PILL," says the web site of ICT Inc., Orlando, FL. "DHEA is proven to help with Reverse aging... Weightloss (without dieting)... Tumors... Cardivascular disease... Reduced hair loss... Increased energy ... Increased Vitality... Increased muscle growth... Increased endurance... Increased libido...."
ICT sells DHEA in 25 mg capsules, $11.95 for a bottle of 90, and you can click on the page to order.
Like other web sites, ICT claims, "Dr. A. Schwartz, a researcher at Temple University, has now proven beyond question, DHEA's effectiveness in weight control."
"That's totally false," said the much-quoted microbiology professor Arthur Schwartz, Ph.D. "I wish they wouldn't use my name."
Dehydroepiandrosterone (DHEA) has annual sales of $75 million, or, at 25 mg/day, over a million users, including women, bodybuilders, and older men. But researchers speculate that it could stimulate prostate cancer. Because of a 1994 law, manufacturers of "dietary supplements" need not prove safety or efficacy, even for powerful hormones. The U.S. Food and Drug Administration is supposed to monitor reports of adverse reactions, and urges doctors to report reactions to its MedWatch hotline, (800) FDA-1088. In reality, reporting rates are low.
Mr. Turley's PSA had been fluctuating in the range of 6 to 8 before he took DHEA, and he had BPH for 10 or 15 years, said his urologist, W. Bruce Bucklew, MD, Santa Barbara, CA (who spoke with his patient's permission). In January 1994, his PSA was 6.1. A biopsy showed some prostatitis, but the remaining tissue was benign. "So we attributed the PSA to BPH," said Dr. Bucklew. In June 1994, his PSA was 8.4, and 6 months later it was 6. In January 1997, it was 9.9, "and he stated that he was on DHEA." He discontinued DHEA, and in April, it was 7.5.
Did DHEA raise Jack Turley's PSA? Did the rising PSA indicate growth of benign glandular tissue, or malignant transformation?
"It could be coincidental," said endocrinologist Frank Bellino, PhD, of the National Institute on Aging, and co-chair of a 1995 conference on DHEA sponsored by the New York Academy of Sciences.
"If he went off DHEA and the PSA dropped, that could still be coincidental," said Dr. Bellino. "But it's a little stronger evidence that maybe the DHEA had something to do with it. The more cases you can accumulate, the stronger the evidence. But it doesn't replace a controlled study."
Thirty percent of men over 50 have microfocal cancers, noted William J. Catalona, MD, Director of the Division of Urologic Surgery, Washington University School of Medicine in St. Louis, Missouri. Some are quiescent because hormone levels have fallen off with age. "Then he starts taking DHEA, that gets metabolized to dihydrotestosterone, and that stimulates a latent cancer," he hypothesized.
Dihydrotestosterone is harmful to patients with prostate cancer, "and therefore we can assume that it could be harmful to some patients with latent prostate cancer as well," said Dr. Catalona.
"As long as they don't stir things up they might live out their normal lifespan," said Dr. Catalona. "But if they start fooling around with DHEA, it might be like pouring gasoline on some smoking embers."
Or it might not. "The other explanation is more innocent," said Dr. Catalona. The DHEA "would be restoring, to a normal prostate, the PSA expression that had declined with age."
Washington University screens 30,000 men every 6 months. "We have seen men, perhaps 1 or 2, whose PSA had jumped up from previous levels, and the only ready explanation was that they started on DHEA," said Dr. Catalona. "And it returned to the previous levels after stopping DHEA."
"They didn't have any obvious symptoms of prostatitis," said Dr. Catalona. "But sometimes the symptoms of prostatitis are very subtle," and hard to rule out. It is "not uncommon" for PSA to rise from 2 to 12. "I have thousands of men whose PSA levels bounce around."
So it's hard to prove that DHEA was the culprit, said Dr. Catalona.
Dr. Catalona discourages his patients from taking drugs like DHEA, and saw palmetto, which confounds PSA tests.
"But you've got a hard core group of men out there" who think that doctors oppose these products because it's in the doctor's interest for people to be sick, said Dr. Catalona.
Some unorthodox medicine advocates have orthodox credentials.
William Regelson, MD, professor of internal medicine with an oncology specialty at Virginia Commonwealth University, is author of the best-selling book, The Superhormone Promise. DHEA "has beneficial effects upon virtually every major body system," and "rejuvenates the immune system, improves brain function, receives stress, and may be the most potent anti-cancer drug of all time," he wrote.
Fact-checkers have bedeviled Dr. Regelson. "We have heard from colleagues of Dr. [Richard] Weindruch that the DHEA mice are actually doing much better than the control mice, and they are very optimistic that DHEA will prove to be a tool which will extend life," he wrote.
"Not true," said Dr. Weindruch, associate professor of medicine, University of Wisconsin, Madison. "DHEA does not prolong the lives of my laboratory mice, and may even shorten their life span," he told Nutrition Action Healthletter.
That mistake was the result of reporting early, unpublished data, explained Dr. Regelson.
"Dr. Schwartz and his colleagues have documented DHEA's cancer-fighting powers" in hundreds of animal and in vitro studies, wrote Dr. Regelson.
"The likelihood people will get anticancer and antiaging effects is very remote," said Dr. Schwartz.
Dr. Regelson, 71, has been taking DHEA for 11 years (50 mg every 2 days). He says that his personal experience, the experience of his and other patients, and studies in humans, animals and cell culture show DHEA's benefits. Because DHEA can't be patented, pharmaceutical companies won't invest in controlled trials, while the "nutriceutical companies" who make millions selling (and sometimes overpromoting) DHEA are just as bad, he said.
In Dr. Regelson's own study of DHEA for multiple sclerosis and advanced cancer, "we looked very thoroughly at the prostate," although PSA testing wasn't available then, he said. "We were concerned."
"If you have a primary cancer of the prostate, as DHEA is converted to testosterone, DHEA might be stimulating the growth of prostate cancer," acknowledged Dr. Regelson. "So you have to be very careful that you don't have prostate cancer." Does he say that in his book? "It's in there somewhere," he said. What about the 30% of men over 50 with micrometastases? The significance of prostate carcinoma in situ is "still confused," he said.
"DHEA is perfectly safe," said Dr. Regelson. "They've been using it for 20 years in Europe to treat menopause."
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SIDEBAR (550 words)
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"Before somebody markets a, quote, 'medication,' they should have to prove that it's safe and effective," said William J. Catalona, MD, Director of the Division of Urologic Surgery, Washington University School of Medicine in St. Louis, Missouri. "That shows you how important the FDA is."
The U.S. Food and Drug Administration has no jurisdiction over ICT's web page or Internet advertising, or books that misquote researchers, says a spokesperson. "It's not considered labeling. It's not regulated by the FDA."
The U.S. Dietary Supplement Health and Education Act of 1994, sponsored by Orren Hatch (R-UT), allows products like DHEA to be sold as "dietary supplements," provided they don't make any drug claim--on the label. Formerly, if a dietary supplement was not an established food, or an approved drug, the seller had to demonstrate safety. Now, to remove a dietary supplement from the market, the FDA has to demonstrate danger.
"If we find a product that is causing harm, we must prove that the harm is caused by taking that product as directed," says the FDA spokesperson. The FDA would have to prove, for example, that DHEA caused the rise in PSA.
"It's a very tough burden of proof," she said.
So the Westerly Pharmacy in New York City can stock Schiff Products' DHEA, 25 mg tablets, $4.89 for a bottle of 30, two aisles away from books like Dr. William Regelson's The Superhormone Promise.
The FDA has no jurisdiction over books, said the FDA spokesperson.
But a member of Sen. Hatch's staff disagreed. Under the Act, if the Secretary of Health and Human Services declares that a product is an "imminent hazard to public health and safety," the Secretary can then immediately take the product off the market, said the staffer.
The Secretary, said the staffer, "defines what is an imminent hazard," with complete, "absolute," discretion.
The law says that marketers "could hand out a publication including an article, chapter, book, or official abstract of peer review scientific publications that appears in an article and was prepared by the author or the editors and which was reprinted in its entirety," said Sen. Hatch's staffer, reading from the law. "It cannot be false or misleading," she said, and "it must be displayed or presented either on its own or with other items on the subject matter to present balanced scientific view."
"If a drug store is giving out literature that is false in connection with the sale of a dietary supplement, that's a violation of Section 403(B) of the Food, Drug & Cosmetic Act," said Sen. Hatch's staffer. The FDA "can take action against the store," by sending a letter or stronger action.
However, according to Section 403(B), that provision "shall not apply to or restrict a retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books or other publications."
"We have to respect the First Amendment," said Sen. Hatch's staffer.
So if the Westerly Pharmacy sells a copy of Dr. Regelson's book, which Dr. Weindruch says misrepresents his work, and which does not detail the theoretical risks of DHEA, can the FDA send the pharmacy a letter?
"I can't comment on any specific situation," said the staffer.
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