Rigging the game

For men who enjoy a true high-stakes gamble, I’ve got just the thing.

We’ll call the game Prostate Cancer Prevention. And going by the name of the game, you would think that just about any man over the age of 50 would want to play.

Here’s the catch: You have to take Avodart, Proscar, or one of the other drugs in a class known as “5-ARIs.”

This class of drugs was developed to treat enlarged prostate (also known as BPH, or benign prostatic hyperplasia). But you know drug companies — they’re always looking to stretch the use of a drug beyond its approved usage.

In a 2010 New England Journal of Medicine study, about 3,300 men at high risk of prostate cancer took Avodart for four years. A second group of men — also at high risk — took a placebo.

Compared to placebo, the relative risk of any level of prostate cancer was reduced by nearly 23 percent in the Avodart group.

Sounds pretty good, right? I mean…based purely on that number, you wouldn’t blink if your doctor encouraged you to
take a 5-ARI if you’re at high risk of prostate cancer. And keep in mind that every man between the ages of 50 and 75 is considered high risk.

So…is it worth the gamble?

No. Because according to one insider, the NEJM study doesn’t reveal why this is a rigged game.

Taking a risky ride

Patrick Walsh, M.D., is a Distinguished Service Professor of Urology at Baltimore’s Johns Hopkins School of Medicine where he served as Urologist-in-Chief for 30 years. In other words, when it comes to…ummm…plumbing, Dr. Walsh knows his stuff.

In an editorial he wrote that appears in the same NEJM issue as the Avodart study, Dr. Walsh points out that Avodart and Proscar, “do not prevent prostate cancer but merely temporarily shrink tumors that have a low potential for being lethal, and they do not reduce the risk of a positive biopsy in patients who have an elevated PSA level.”

And in 2009, in the journal Prostate Cancer Discovery, Dr. Walsh had this to say about Proscar: “Men will believe that it prevents cancer, will be pleased that their PSA levels fall, and will not understand the potential danger of undiagnosed high-grade disease.”

Speaking specifically about the Avodart study, he said the results showed, “there was a 23% reduction in low-grade tumors that the patients would never have known they had. Does this sound like an indication to take a pill with sexual side effects that costs $4 a day?”

Good point. In fact, the side effects are pretty daunting…

In the NEJM study, sexual dysfunction was higher in the Avodart group, and — even more important — subjects in that group were nearly TWICE as likely to experience heart failure compared to placebo.

So…still on the fence about this gamble?

I can’t imagine you would be. But if you are, consider this: Recently, the FDA confirmed Dr. Walsh’s reservations about 5-ARIs.

Just a few weeks ago, the FDA told makers of the 5-ARI drugs to change the warnings and precautions on all labels to include new safety information about increased risk of diagnosis with high-grade prostate cancer.

So you can avoid low-grade cancer that you probably never would have known you even had but increase your risk of
impotence and high-grade cancer?

Time for the Gambling Commission to shut this game down!

Sources:
“Effect of Dutasteride on the Risk of Prostate Cancer” New England Journal of Medicine, Vol. 362, No. 13, 4/1/10, content.nejm.org

“Dutasteride Results Reignite Debate about Prevention of Prostate Cancer” Zosia Chustecka, Medscape, 3/31/10, medscape.com

“Finasteride: Are the Risks Worth it?” Prostate Cancer Discovery, Vol. 5, Winter 2009, urology.jhu.edu

“FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer” FDA Safety Announcement, 6/9/11, fda.gov


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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