HEALTH

NCI pulls plug on study of supplements and effects on prostate cancer

BY Michael Johnsen

BETHESDA, Md. The National Cancer Institute last week reported that selenium and vitamin E supplements, taken either alone or together, do not prevent prostate cancer, citing an independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial that was funded by NCI and other institutes that comprise the National Institutes of Health.

The data also showed two concerning trends: a small but not statistically significant increase in the number of prostate cancer cases among the more than 35,000 men age 50 and older in the trial taking only vitamin E and a small, but not statistically significant increase in the number of cases of adult onset diabetes in men taking only selenium. 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, NCI noted.

As a result of the review, NCI is pulling the plug on the study. SELECT participants are receiving letters explaining the study review and telling them to stop taking their study supplements. However, participants will continue to have their health monitored by study staff, which may include regular digital rectal exams and PSA (prostate-specific antigen) tests to detect prostate cancer. Investigators intend to follow the participants for about three years to determine the long-term effects of having taken either supplement or placebo and to complete a biorepository of blood samples that will be used in extensive molecular analyses to give researchers a better understanding of prostate cancer, other cancers, and other diseases of male aging.

“SELECT was always designed as a study that would answer more than a single question about prostate cancer,” stated Eric Klein, a study co-chair for SELECT, and a physician at the Cleveland Clinic. “As we continue to monitor the health of these 35,000 men, this information may help us understand why two nutrients that showed strong initial evidence to be able to prevent prostate cancer did not do so.”

SELECT was undertaken to substantiate earlier, separate findings from studies in which prostate cancer was not the primary outcome: a 1998 study of 29,133 male smokers in Finland who took vitamin E to prevent lung cancer surprisingly showed 32 percent fewer prostate cancers in men who took the supplement, and a 1996 study of 1,312 men and women with skin cancer who took selenium for prevention of the disease showed that men who took the supplement had 52 percent fewer prostate cancers than men who did not take the supplement.

Based on these and other earlier findings, in 2001, men were recruited to participate in SELECT. They were randomly assigned to take one of four sets of supplements or placebos, with more than 8,000 men in each group. One group took both selenium and vitamin E; one took selenium and a vitamin E placebo; one took vitamin E and a selenium placebo; and the final group received placebos of both supplements.

SELECT has been funded by NCI for $114 million, with additional monies from the National Center for Complementary and Alternative Medicine, and with sub-studies funded and conducted by the National Heart, Lung and Blood Institute, the National Institute of Aging and the National Eye Institute at NIH. The sub-studies were evaluating the effects of selenium and vitamin E on chronic obstructive pulmonary disease, the development of Alzheimer’s disease, and the development of macular degeneration and cataracts, and will continue without participants taking study supplements. An NCI-funded substudy is looking at the effects of the supplements on men who developed colon polyps.

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Perrigo may have advantage over patent cliff

BY Alaric DeArment

ALLEGAN, Mich. Most people know Perrigo Co. as a leading provider of OTC medications and nutritional products, but it also has a sizeable prescription drug business. With the approach of the patent cliff, when the number of blockbuster prescription drugs losing patent protection will decline, some factors may give Perrigo an advantage.

Because Perrigo focuses its prescription drug business on topical medications, vice president for investor relations and communication Arthur Shannon said the complexity of the business insulated it from the effects of the patent cliff.

“The impending patent cliff doesn’t really apply to our business,” he said.

IMS Health vice president for industry relations Doug Long said there could be a competitive advantage for companies that market topical medications.

“I don’t think there is much difference in patent expirations, but the topical market is less competitive than oral solids,” he said. “There are more generic players in oral solids than in topicals probably because topicals are harder to make.”

Shannon also said the company’s OTC business would help it adapt.

“As we look ahead to the foreseeable future, we see good opportunities present for new product opportunities in our OTC business,” he said.

Shannon said the $25 million purchase of Diba, which will add almost $15 million to Perrigo’s annual sales, would make it the leading manufacturer of private-label medicines in Mexico, though Diba also makes prescription drugs, including antibiotics, hormonal and ophthalmic drugs. Perrigo does not plan to market its products in Mexico through Diba, or vice versa.

Nevertheless, that might not be needed.

“We are very comfortable with the future of our generic business,” Shannon said. “Being focused on topicals, we believe we are well-positioned to continue our growth.”

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Olympian Michael Phelps launches PureSport athletic drinks

BY Michael Johnsen

CHICAGO Michael Phelps, winner of eight gold medals during this year’s summer Olympics, officially launched his PureSport brand of performance beverages here on Saturday.

PureSport features an optimal carbohydrate-to-protein ratio of 2:67-to-1 that was created by University of Texas’ John Ivy. The two PureSport formulations include, PureSport Workout, which is used prior to and during exercise to improve endurance and reduce muscle tissue damage, and PureSport Recovery, which is used within 30 minutes of completing a workout to speed the storage of muscle and liver glycogen and promote muscle tissue repair.  

More than 1,500 fans turned out to meet Phelps and learn more about the sports beverage that was a big part of his success, according to Phelps.

Among the athletes who have incorporated PureSport into their training regimens are world-class swimmers Michael Phelps, Brendan Hansen, Ian Crocker and Aaron Peirsol, as well as Gold medal gymnast, Nastia Liukin.

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