The scientist who discovered the prostate specific antigen in 1970 explains emphatically why he considers use of the PSA test for routinely screening healthy men for cancer to be a profit-driven national disaster.

With the assistance of science writer Piana, Ablin (Pathology/Univ. of Arizona Coll. of Medicine) pulls no punches in this attack on what he sees as the misdeeds of the urology community, the biotech industry and the Food and Drug Administration. The author explains that PSA is not a cancer-specific biomarker, and he asserts that the use of the PSA as a diagnostic test has crippled millions of healthy men, afflicting them with incontinence and impotence. A high PSA number leads to a biopsy, which leads to surgery. The author charges the FDA with negligence for allowing the profit-motivated biotech industry to market the PSA test as a cancer test and greedy urologists in directing frightened men to undergo unnecessary biopsies and prostatectomies. Ablin’s account is replete with names of specific individuals, companies, agencies and organizations, and he provides excerpts from documents and letters to back up his charges. Conversations with men who have undergone prostate surgery put a human face on the alarming statistics he provides. In addition to the human suffering that their stories reveal, the cost to Medicare of prostate surgery is hefty. While misuse of PSA is Ablin’s central theme, he sees this situation as representative of a larger problem: science for sale. Citing the revolving door between the FDA and big medicine, the author asserts that those charged with protecting American health care consumers are often in tacit collusion with those who come before them for approval of their products.


Original article found here



Editor’s note: The following was written in response to a blog post by Henry Rosevear, MD (“The great prostate cancer ‘hoax’: A call to arms”), which discussed the book, “The Great Prostate Hoax: How big medicine hijacked the PSA test and caused a public health disaster.” Dr. Ablin is a co-author of the book.

Dr. Henry Rosevear’s blog post about my recently published book, “The Great Prostate Hoax: How big medicine hijacked the PSA test and caused a public health disaster,” does a disservice to the readership of the Urology Times by mischaracterizing the book’s central message. I welcome healthy debate, as long as it is fact based.

As noted, the PSA test was first approved in 1986 to monitor men with prostate cancer and later in 1994 as a screening tool. Dr. Rosevear argued that after giving a historical perspective, “The book quickly leaves historical reality and begins to make unfounded, usually illogical comparisons between PSA screening and, among others, the tobacco industry.” With due respect, Dr. Rosevear needs a “historical reality check.” As I discussed in “Hoax,” in 1986, the PSA test was also used off-label and promoted illegally to screen countless millions of men each year for prostate cancer, leaving several million men debilitated by unnecessary surgical procedures. Jules Harris, MD, a member of the FDA expert advisory panel during the 1993 PSA approval meeting, said in an interview, “The misuse of the PSA test is the biggest medical story of the past 30 years.”

After that, Dr. Rosevear dismissed the rest of the book, noting that it can be summarized in one passage he lifted from the introduction: “But in a large sense, the situation dramatized by John [a patient described earlier as being harmed by PSA screening] illustrates the grim reality of the health care system itself: encouraged by perverse incentives, many of the tests and procedures that doctors do are unnecessary, and quite a few are downright harmful.”

Dr. Rosevear obviously takes exception to that statement, so I’ll clear it up for him. In the early 1990s, RAND Health reported data showing that up to one-third of health care services were unnecessary. Most recently, Donald Berwick, MD, MPP, former head of the Centers for Medicare & Medicaid Services, stated that upward of 30% of all health care was wasteful. I would argue that one-third equals many, and that our fee-for-service payment system, coupled with a bloated bureaucracy, encourages perverse incentives. The massive waste, fraud, and abuse in our health care system is not unfounded; it is a matter of public record. And yes, many unnecessary procedures are “downright harmful.”

In an attempt to jade his readers’ image of my book, Dr. Rosevear used terms like “conspiracy theories,” “unfounded,” and “illogical.” Sorry, there are no “grassy knolls” in “The Great Prostate Hoax.” In fact, every charge, whether involving a person, industry, or government agency, is backed by referenced data. To wit, there are more than 300 references in the “Notes” section. Moreover, prior to publication, my editor sent the manuscript to the New York law firm Satterlee Stephens Burke & Burke LLP for a month-long, line-by-line review to ensure that no statement was “unfounded.”

Dr. Rosevear made his own unfounded remark: “Clearly, Ablin and Piana have never seen a man expire from metastatic prostate cancer.” As detailed in Chapter Three, my father died of prostate cancer and I supervised his care from diagnosis to watching him go from a 185-pound frame to 95 pounds 1 year later at the time of his death.

At the beginning of his post, Dr. Rosevear said he’d recently read a “very disturbing book.” Rest assured, he’ll have plenty of company in that department. I wrote “The Great Prostate Hoax” to expose the public health disaster caused by the misuse of PSA and to hold the forces behind that human catastrophe accountable. So, in that regard, yes, it is a very disturbing book.

Dr. Ablin is professor of pathology at the University of Arizona, Tucson.

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Serious charges voiced in strong language, certain to be met with rebuttals from those whose ox has just been gored, and a must-read for any man concerned about his prostate.