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Vitamin E Scare Hurts Cancer Trial; Doctors Say Their Study on Supplement, Prostate Cancer Prevention is Safe

Posted on: Friday, 12 November 2004, 15:00 CST

Vitamin E scare hurts cancer trial

Doctors say their study on supplement, prostate cancer prevention is safe

One of the largest vitamin E disease prevention trials ever undertaken is in jeopardy of losing participants because of a new report that says high doses of the supplement increased the risk of death.

Doctors associated with SELECT, a North American trial involving 35,000 men looking at whether vitamin E and selenium can prevent prostate cancer, were scrambling Thursday to reassure study participants that they could safely continue the regimen.

At the Medical College of Wisconsin, one of 400 sites taking part in the trial, more than 60 men called Thursday, wondering if they should drop out, said Heather Engelke, research coordinator.

"We're in quite a bind," she said. "I've got 154 guys in the study. I hope all my guys don't back out. I'll do my best to keep them in."

The 12-year trial, which is being funded by the National Cancer Institute, has been going on for three years.

Most of the men who called were worried that taking vitamin E would cause a heart attack, a concern that is not substantiated, said Robert Donnell, an associate professor of urology and lead investigator for the Medical College's part of the trial.

Donnell said he is concerned that the vitamin E report could make it difficult for researchers to find out if the supplement actually can prevent prostate cancer.

"Given that it's the second-leading cause of cancer death in the U.S., that's a big issue," Donnell said.

In addition to the prostate cancer trial, there are several other prevention trials going on, including one looking at whether vitamin E and selenium can prevent Alzheimer's disease. The Alzheimer's trial, which is part of the SELECT trial, involves 10,400 participants.

On Wednesday a large review of 19 earlier trials involving vitamin E found that those taking 400 international units or more had a 10% increased risk of dying compared with people who did not take the vitamin.

The study concluded that high doses of the vitamin should not be taken.

However, doctors associated with the prostate cancer trial said there were several problems with the analysis, which was presented at the American Heart Association's Annual Scientific Sessions in New Orleans and published online in the Annals of Internal Medicine.

First, it was a backward-looking analysis that combined numerous trials with different types of patients, including many who already had chronic ailments such as heart disease, said Eric Klein, national coordinator of the prostate cancer trial and head of urologic oncology and professor of surgery at the Cleveland Clinic.

"Most of the trials didn't look at healthy populations," Klein said. "SELECT is all healthy men. We don't think they are comparable."

In addition, many of the deaths were from just two trials involving doses of vitamin E of 500 IU or more, Klein said.

In the prostate trial, the dose is 400 IU of vitamin E and 200 micrograms of selenium.

Klein said the vitamin E story ran in papers all over the country and had caused worries among many prostate cancer trial participants. The prostate trial is being conducted in the U.S., Canada and Puerto Rico.

However, he said the prostate trial has its own safety committee of independent doctors who continually monitor the trial for adverse effects. The committee met last month and found no cause for concern, Klein said.

"We don't believe the report should cause any alarm in participants of SELECT," he said.

Source: Milwaukee Journal Sentinel

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