FDA Continues Its Murderous Rampage and Still Violates the First Amendment

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 7 No. 2 • April 2004

FDA Continues Its Murderous Rampage and Still Violates the First Amendment

Whitaker v. Thompson, in which we are coplaintiffs, is still ongoing. In it we argue that FDA suppression of a truthful, nonmisleading claim that 320 mg of saw palmetto per day can reduce the symptoms of benign prostatic hypertrophy (BPH) is a violation of the First Amendment. The FDA argues that this is a “drug” claim, since it concerns treatment, a category of speech that they wish to restrict to just OTC and prescription pharmaceuticals. Of course, the First Amendment allows no such restriction of certain speech to just particular speakers of the government’s choosing. However, Whitaker v. Thompson lost in the court of appeals (which was expected), and we have appealed to the U.S. Supreme Court. If the Supremes won’t take the case (expected), we have another strategy, which we will tell you about as soon as we start doing it.

Proscar® (finasteride), an FDA-approved treatment for BPH, has now been reported to increase (possibly by 200 times) the risk of breast cancer in men. This is normally a very rare disease. A letter1 in the Feb. 18, 2004 Journal of the National Cancer Institute reports that “Proscar shrinks androgen-dependent prostate tissue by inhibiting steroid 5-alpha-reductase, an enzyme that converts testosterone to dihydrotestosterone. However, inhibition of DHT production alters the estrogen-to-androgen ratio and may also increase the risk of gynecomastia [breast enlargement] and male breast cancer. Reports to the U.S. Food and Drug Administration (FDA) from June 1992 through February 1995 showed that gynecomastia had been observed in 214 men receiving Proscar therapy. Two of these men were subsequently found to have invasive ductal breast carcinoma. There was also a higher incidence of gynecomastia in men participating in the Prostate Cancer Prevention Trial. The rate of gynecomastia was 426 (4.5%) of 9423 subjects randomly assigned to the Proscar arm, compared with 261 (2.8%) of 9457 subjects randomly assigned to the placebo arm. There was one case of breast cancer in each arm of the trial.

“Evidence of the association of Proscar with male breast cancer comes from the Medical Therapy of Prostatic Symptoms (MTOPS) study, a National Institutes of Health (NIH)-sponsored study of about 3047 men that compared Proscar, doxazosin, and the combination for the treatment of BPH. . . . According to a letter from the NIH to the MTOPS principal investigators, one man in the Proscar/doxazosin group and three in the Proscar-alone group developed male breast cancer. The rate of breast cancer in this trial for men taking Proscar either alone or with doxazosin was therefore 4 in 1554, or nearly 200 times that of the general population.”

It is also noteworthy that the FDA has approved the use of finasteride (under the name Propecia®), at half the dose for treating BPH, for treating male-pattern baldness!

The authors of the above letter strongly recommend that the FDA include this information in the manufacturer’s patient information leaflet for Proscar and in its advertisements. To our knowledge, this has not been done.

A major active ingredient in the herb saw palmetto is beta-sitosterol, which is found in large quantities in soy products. Epidemiological studies in people and countries where they consume large amounts of soy products show a lower incidence of both breast cancer and prostate cancer. Saw palmetto has been used for perhaps thousands of years as a food. There is no evidence that it increases the incidence of either gynecomastia or breast cancer.

Unfortunately, the FDA is in bed with the pharmaceutical companies, and vice versa. Pharmaceutical companies have been corrupted by being able to use the guns of the FDA to stave off possible competitors, such as dietary supplement saw palmetto. Likewise, the FDA has been corrupted by being able to use pharmaceutical companies as sources of money (hundreds of millions per year) and power. This sort of two-way corruption is typical of all the regulatory agencies and was, in fact, first noted by the Marxist economist Gabriel Kolko at the turn of the twentieth century (who proposed the “capture” theory of regulatory agencies, where the very industry intended to be regulated took over the agency). To support their client companies, the FDA is suppressing free speech so that manufacturers and vendors of competitive products (such as saw palmetto) cannot market them to consumers by truthfully telling what they can do. The FDA is also willing to overlook drug risks, such as what appears to be a 200-times increased risk of breast cancer in men using Proscar, a billion-dollar-plus per year drug, at the same time that they are attacking dietary supplements containing ephedrine alkaloids, which pose much less risk.

The sad ending to this story will be a tidal wave of class action lawsuits against the company manufacturing Proscar by men who develop breast cancer as a result of taking it, and it will be the pharmaceutical company, not the FDA, that will have to pay all of these costs. In the meantime, those of us who desire freedom of informed choice will have to fight on as best we can. As most of the FDA’s power comes from suppression of information, the First Amendment is our best ally in this battle.


  1. Lee and Ellis. Male breast cancer during finasteride therapy. J Natl Cancer Inst 96(4):338 (2004).

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