When a prestigious medical journal publishes test results detailing the effectiveness of a particular drug, it can be a feather in the cap of the drugmaker–or it might prompt the company to pull the hat down a little farther and keep on walking.
Such appeared to be the case last week when the New England Journal of Medicine published the test results of prostate drugs manufactured by Abbott Laboratories and Merck & Co.
Abbott got the feather, but Merck insists it has no reason to hide under the fedora. Indeed, a Merck spokeswoman says the company plans to get the results to as many doctors as possible and let them make up their own minds.
The episode itself provides an interesting glimpse into the world of medical research, pointing up once again that one set of findings can be interpreted in many ways.
In its Aug. 22 issue, the New England Journal of Medicine published results of tests conducted among 1,229 patients from Veterans Affairs hospitals around the country.
The study, which was financed by the two pharmaceutical companies, concluded that Hytrin, made by North Chicago-based Abbott, eased discomfort of men suffering from benign prostatic hyperplasia–an enlarging of the prostate commonly seen as men get older– by a third.
But the study, led by Dr. Herbert Lepor, of the Department of Urology at the New York University Medical Center, found Whitehouse Station, N.J.-based Merck’s Proscar to be no more than “an expensive placebo.”
The U.S. market for these two drugs plus a third–Cardura, made by Pfizer Inc.–totals about $800 million a year. Abbott’s Hytrin controls about 55 percent of the market, according to an Abbott spokesman, with Proscar and Cardura splitting the difference.
The results, while interesting to the public, especially sufferers of benign prostatic hyperplasia, or BPH, came as no surprise to urologists, said Dr. William D. Belville, associate professor of urology in the department of urology at the University of Michigan’s medical center.
It is estimated that 1 in 3 men will suffer from BPH at some time in their lives. Symptoms include frequent urination, slowing of the urine stream, nighttime urination, straining to urinate and incomplete emptying of the bladder.
The two drugs, while designed to treat BPH, work in different ways. Abbott’s Hytrin, an alpha blocker, works to relax the smooth muscles of the prostate. Merck’s Proscar shrinks enlarged prostates.
Belville, who says he was involved with studies of Proscar in the early 1980s and early ’90s, said researchers asked Merck “why they thought the drug would work. Their reply was that it shrunk the prostate. And our reply was, `So what?’ “
Urologists have “known for some time that size (of the prostate) and obstruction aren’t related,” said Belville. “Somebody with a small prostate can have severe obstruction and can end up with his kidneys ruined.”
Dr. Claus G. Roehrborn, a urologist with the Southwest Medical Center at the University of Texas in Dallas, offers a somewhat different medical opinion.
“It is well known to urologists that symptoms (of BPH) can occur” without regard to size, that “if you take 1,000 men and measure symptom and prostate size there will be almost no correlation,” said Roehrborn.
But, he added, Proscar “was never targeted to improve non-specific symptoms. . . . A patient who has symptoms and has a significantly enlarged prostate will be helped by taking Proscar.”
He does question the study itself. The average prostate size in this study was 36.2 grams, which is in the normal range, Roehrborn said. An enlarged prostate is 40 grams or larger, he added. “Why is this study entitled efficacy in treating BPH if these men didn’t have this particular condition?”
Actually, “BPH is kind of a misnomer to start with,” says Dr. Richard Harris, a partner with Midwest Urology Associates, with several offices in the near west suburbs, who prefers to use prostatism.
Harris’ response to the study was more along the lines of Belville’s: The VA study, he said, “parallels what we have seen,” that “virtually everybody who tries Hytrin or Cardura (another blocker) does better.”
Roehrborn said the VA study and one just under way commissioned by the National Institutes of Health, involving him and Lepor, will “form a beautiful picture” that will help doctors to more accurately target the prostate medications to certain conditions.
As for Merck, Roehrborn said the company must change its labeling and marketing and advertising campaign. “It has to stand there and take it like a man,” Roehrborn said.
Dr. Lepor, who headed the study, is out of the country and couldn’t be reached for comment.
Dr. Marcia Angell, executive editor of the New England Journal of Medicine, noting that the publication has a “very low acceptance rate and a very rigorous peer review” process, said the information is put “out there for doctors to make what they want of it.”
Which is exactly what Merck intends to do. Merck will send the findings to as many physicians as possible “so they can make their own clinical judgment about what is appropriate for their patients,” said Jan Weiner, senior director of public affairs for Merck’s U.S. pharmaceutical group.
Nor does Merck plan to alter its marketing and advertising campaigns, she said.
Weiner said the VA study is in line with five earlier studies conducted on Proscar, in which Roehrborn was involved. Those studies “suggest the size of a man’s prostate is an important factor that a physician is going to want to take into consideration when deciding what medicine is prescribed.”
