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How do you botch a multi-million dollar clinical trial?

E is for Exasperating

How do you botch a $114 million study and manage to set back the advancement of prostate cancer research?

Why it’s easy as pie. I’ll let the National Cancer Institute (NCI) show you how it’s done.

Statistically insignificant

Let’s start with the most important detail: Men, don’t stop taking your vitamin E and selenium supplements just because you may have heard the recent news about the cancellation of a major prostate cancer study.

The study, known as SELECT (Selenium and Vitamin E Cancer Prevention Trial), involved more than 35,000 men over the age of 50. Divided into four groups, subjects were given a daily vitamin E supplement and a placebo, or a daily selenium supplement and a placebo, or a combination of the two supplements, or two placebos.

About five years in, the trial was abruptly stopped just a few days ago. Officials for NCI, the trial’s sponsor, explained that the supplements were not preventing prostate cancer. In addition, two “concerning trends” had emerged: 1) a statistically insignificant increase in prostate cancer cases in men taking only vitamin E, and 2) a statistically insignificant increase in type 2 diabetes cases among men taking only selenium.

Odd. Selenium has been shown to play a role in insulin efficiency by improving glucose metabolism. And vitamin E has been shown to reduce prostate cancer risk.

Here’s how a note on the NCI website addresses these surprising outcomes: “Because this is an early analysis of the data from the study, neither of these findings proves an increased risk from the supplements and both may be due to chance.”

Or at least in the case of the vitamin E supplement, it might be due to a glaring blunder.

What were they thinking?

More than four years ago, in the e-Alert “Taking Yourself Off the List” (4/22/04), I told you about an NCI review of data collected from a large cancer-prevention study conducted in Finland.

Earlier research of the Finland data showed that men who took 50 mg of alpha-tocopherol vitamin E daily for more than five years reduced their prostate cancer risk by almost a third. The 2004 NCI study expanded on that research. Data was collected on 200 men who were prostate cancer-free, and 100 who were diagnosed with the disease. Blood samples revealed that men with the highest levels of alpha-tocopherol lowered their risk of prostate cancer by more than 50 percent, while those with the highest levels of gamma-tocopherol lowered their risk by nearly 40 percent.

So when the NCI researchers designed their SELECT trial, did they use the alpha-tocopherol form of vitamin E, or the gamma-tocopherol form, or even the mixed tocopherol form that combines the alpha-, gamma-, and beta-tocopherol forms (just as they’re combined in spinach, almonds, and other natural sources)?

No. The NCI researchers used dl-alpha tocopherol.

In a 2005 e-Alert, here’s how HSI Panelist Allan Spreen, M.D., described dl-alpha tocopherol – a synthetic form of vitamin E: “This is a molecule shape that the body is not designed to handle… It is important to use the ‘dl’ form only topically.”

They used an inferior form.

Clearly they were aware of the better forms used in the Finland study, but they didn’t use those, they used the inexpensive synthetic form. They devoted millions of dollars and recruited thousands of subjects…and they used an inferior form.

What in the world were they thinking?

Sources:
“Review of Prostate Cancer Prevention Study Shows No Benefit for Use of Selenium and Vitamin E Supplements” National Cancer Institute, 10/27/08, cancer.gov
“Questions and Answers – Selenium and Vitamin E Cancer Prevention Trial (SELECT)” National Cancer Institute, 10/27/08, cancer.gov

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