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Genelabs, a biotech company headquartered near San Francisco, has been conducting clinical trials for a product it hopes to market for treating systemic lupus erythematosus (SLE). This potential product has gone through several name changes during the development process — currently it is Prestara™, but has also been known as Aslera™, or GL701. In fact, the product is a formulation of DHEA, the nutritional supplement that millions of people use for reversing symptoms of aging and for various other ailments, including lupus. Prestara is now undergoing a final clinical trial that will end in early 2004, and then may receive FDA approval as a prescription drug in the U.S.
At first glance it might seem like a pleasant surprise that a pharmaceutical company has acted counter to the prevailing opinion that supplements can’t get corporate research attention because they can’t be patented, or because they would have to compete with the existing supplement industry. However, looking into the matter more deeply one finds a very different picture.
DHEA has been studied as a treatment for lupus since 1985 — these studies were done in mice. In the early 1990s researchers at Stanford University did a clinical study in humans and confirmed that DHEA at 200 mg/day “… shows promise as a new therapeutic agent for the treatment of mild to moderate SLE.” They promptly patented the use of DHEA for treating lupus. In 1993 Genelabs bought a license to use this patent for their lupus product. They sponsored a number of clinical studies, and are still struggling to get FDA approval for the product.
Meanwhile, Genelabs’s management decided that they did not want their product to have to compete with inexpensive DHEA products that are available at every vitamin store. So they petitioned the FDA to remove DHEA from the supplement market, and made an effort to get the DEA (Drug Enforcement Administration) to make it a controlled substance — i.e., to make criminals out of anyone who sells or uses it as a nutritional supplement.
If the substance at issue were, say, aspirin, we could be confident that the FDA and the DEA would refuse to go along with such a sleazy, underhanded scheme — not because these agencies’ managers give a hoot about the public’s right of access to medical and nutritional substances, but because they know there would be a public outcry that might result in Congressional action against the agencies. A substance like DHEA, however, has a smaller political constituency than aspirin does; the outcome is therefore less certain.
I won’t try to predict what the FDA will do in this case, but if it decides to connive with Genelabs to remove DHEA from the supplement market, the announcement would probably be made in early 2004, around the time Prestara receives approval, if it does. And then the entire range of supplements, herbal substances, and traditional medicines would be up for grabs by any company that is willing to sponsor the required clinical trials. This would convert all of the most effective substances from relatively inexpensive, accessible supplements into outrageously expensive drugs that one can obtain only by getting the permission of an outrageously expensive physician.
As for Genelabs’s hopes that the DEA will criminalize DHEA sales and possession, as it has done for so many other useful substances, the future is equally unclear. Law enforcement bureaucracies like the DEA are generally eager to criminalize anything they can, since their budgets and influence rise accordingly, but they also have to be careful not to tread on too many of the wrong toes. It is nevertheless disturbing to see efforts being made to create new classes of criminals in order to increase sales of someone’s product. We can thank supporters of the War on Drugs for exposing our legal system to this particular form of corruption.
Link to 1985 study of DHEA for lupus in mice:
Prevention of autoantibody formation and prolonged survival in New Zealand black/New
Zealand white F1 mice fed dehydroisoandrosterone.
Link to Genelabs’s account of the history of their product:
Prestara™ Background
Link to another account of the history of Prestara (here called Aslera):
Aslera™ for Systemic Lupus Erythematosus
Link to Genelab Quarterly Report mentioning their efforts to
illegalize DHEA supplements:
Genelabs Quarterly Report to investors, 2003.May.15
Link to an article about Genelabs’s petition:
Genelabs pushes FDA to close out DHEA as new drug
Note: Although I am not an expert in patent law, I don’t see how Stanford’s
patent could hold up if taken to court. One of the requirements a patent must
fulfill in order to be valid is that the product, usage, or process being
patented must be original and not obvious from other people’s prior work.
The patent on DHEA for lupus does not fulfill this requirement since Stanford’s
clinical study was based prior knowledge that DHEA had shown promise as a
treatment for lupus. The extension of prior research from mice to humans was
a perfectly obvious step and required zero ingenuity or originality.
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