Many rare book collectors keep an eye out for an original copy of Seduction of the Innocent, a cause célèbre when it was published back in the 1950s by psychiatrist Fredric Wertham. The tome purported to show that the root cause of juvenile delinquency in the U.S. was comic books! Sensationalistic congressional hearings followed in its wake, with concerned parents tuning in to see comic book publishers berated for their “degenerate” magazines. This was the dark, seamy side of the 1950s: fear, witch-hunts, accusations, and public humiliations. The hearings led to the drafting of a code of conduct that the publishers used for decades to self-censor their comics. The net result was a significant decrease in readership for certain comic book genres, even though the data in Seduction of the Innocent contained, according to a later analysis, “manipulated, overstated, compromised, and fabricated evidence.”
The book title and this last phrase came to mind while I was reading Richard Ablin’s new exposé, The Great Prostate Hoax: How Big Medicine Hijacked the PSA Test and Caused a Public Health Disaster. Ablin, the researcher who discovered prostate specific antigen (PSA) in 1970, lays out a very convincing case that innocent men, fearing cancer, have been seduced for decades into taking a nearly worthless screening test with virtually no predictive value by a corrupt medical system. As a result, many of them were subjected to needle biopsies (which can result in serious infections) and then radical prostatectomies (surgery to remove the prostate gland). There is significant morbidity associated with these procedures. They leave many men impotent and/or incontinent, and these physical problems are often compounded by a loss of psychological well-being.
So how, exactly, were men led astray by the PSA test? According to Ablin’s tale, they were beguiled by the virtuous image of their primary care physicians as highly competent, all-knowing individuals who wouldn’t suggest a screening test if it really wasn’t a good idea. Many men were given the test without their knowledge as part of a standard blood workup. They didn’t know that the test has an arbitrarily-defined cutoff score and can’t distinguish between the numerous reasons why someone’s PSA levels may be elevated. They bought in to the hype surrounding high tech treatments such as $200 million proton beam therapy machines and $2 million surgical robots, even though there is no evidence that these technologies produce better overall survival outcomes than conventional treatments. They do, however, cost patients and insurers a great deal more.
The question often gets asked: isn’t it worthwhile to screen large numbers of people if it will lead to a few lives saved? Some medical screening tests are widely accepted (e.g., the Pap test for cervical cancer), but others are viewed as having a sufficient number of problems that their use is not universally accepted. These issues are generally tied to the overall financial costs to society as well as health problems affecting individuals that arise from the process of being tested. How many people do you have to screen to find someone who has the disease being sought? What is the morbidity associated with subsequent tests and treatment? How often does the test provide false positives and negatives? In the case of prostate cancer, the vast majority of men will die from other causes before their slow-growing prostate cancer becomes problematic. For most men, “watchful waiting” has now become the most appropriate course of action.
The FDA originally approved the PSA test in 1986 only to monitor PSA levels in men; it was not to be used for the detection of prostate cancer. Political pressure from men’s health advocacy groups and the general idea borrowed from mammography that “early detection saves lives” eventually led to approval of the PSA test for the detection of prostate cancer (following a controversial advisory panel review) in 1993. The company that originally developed the test also advocated for its expanded use. The cutoff level for normal PSA blood levels was originally set at 4 nanograms per milliliter of blood. However, higher levels of PSA are not specific indicators of cancer. As Ablin sums it up, “the ability of the PSA test to identify men with prostate cancer is slightly better than that of flipping a coin.”
So how is it that the test was approved for the detection of cancer? According to Ablin, “big money lubricates the prostate cancer machine.” The urology community strongly supported its adoption because of their desire to profit from the biopsies and prostatectomies that would result from the test. According to Michael Greenspan, a Canadian urologist, “without radical prostatectomies, more than half of all urology practices in the United States would go belly-up.”
Urologists were not the only ones to profit from the approval of the PSA test for diagnosing prostate cancer. TAP Pharmaceuticals developed leuprolide acetate (Lupron), a drug used to treat prostate cancer by suppressing the production of testosterone, which fuels tumor growth. Whistleblower lawsuits alleged in the mid 1990s that TAP’s sales reps gave urologists kickbacks to prescribe Lupron to men simply on the basis of their having elevated PSA levels. TAP was also charged with illegally inflating the wholesale price of the drug, bilking Medicare out of … Next Page »