Prolia and Fracture Risk Reduction

FDA approves denosumab for postmenopausal women at increased risk of fractures.
The Wall Street Journal (6/2, Gryta) reports that the Food and Drug Administration has approved Amgen's Prolia (denosumab) for postmenopausal women who face an increased risk of fractures.
The Los Angeles Times (6/2, Olivarez-Giles) reports that the drug, "which has been in development for about 15 years, will be available to the public within the next week, Amgen said in a statement."
The AP (6/2, Perrone) reports that "pill-based osteoporosis drugs, such as Fosamax [alendronate] and Zometa [zoledronic acid], have been available for more than a decade." However, "Amgen Executive Vice President Dr. Roger Perlmutter said many women can't tolerate those drugs or have trouble remembering to take a daily medication." The drugmaker "said in a statement that Prolia is the first drug to target a cellular pathway that breaks down bones."
Bloomberg News (6/2, Waters) reports that "Amgen will follow more than 4,500 women who started taking denosumab in clinical trials for up to 10 years and will create a monitoring program to solicit reports and compile records about any adverse events in women taking the drug, the company said in a statement." The drugmaker "asked the FDA in a separate application to approve denosumab for reducing fractures in cancer patients whose tumors have spread to their bones." Amgen is also "conducting studies to see if the drug can stop cancer from spreading to bone."
The Ventura County Star (6/2, Hoops) notes that "the FDA's approval is ahead of schedule -- the target date was July 25 -- but comes on the heels of the European Union's granting of marketing authorization, which came Friday." Reuters (6/2, Berkrot) also covers the story.

Viagra Alternative

Experimental spray may prolong time to ejaculation in men.
The Wall Street Journal (6/1, Mathews) reports on an experimental spray of anesthetics lidocaine and prilocaine that was shown to improve sex for some men who experience premature ejaculation, according to two studies that will be presented at the Tuesday at the American Urological Association's annual meeting. In the studies of 539 men, those who were randomly assigned to the spray or a placebo version, reached orgasm a mean of three minutes 18 seconds after beginning sex, compared with about 56 seconds for those who got the placebo. Japan's Shionogi & Co. Ltd., which owns the drug, said it hopes to apply for FDA approval and announced it is already in discussions with the agency.

Blood Sugar Testing and Video Games

Blood-sugar meter that connects with gaming systems may help children with diabetes.
The Washington Post (6/1, Kritz) reports that the FDA "recently approved Bayer HealthCare's Didget, a blood-sugar meter that can connect with the Nintendo DS and DS Lite gaming systems." Children "who test their blood sugar as prescribed by their doctor get access to higher levels in certain games, as well as entry into a 'diabetes world' where they can communicate with other gamers who have the condition." Although "points are awarded for staying within ranges, not for reaching specific numbers...no additional points are given after a child has tested four times in a 24-hour period, a common goal set by physicians."

Prostate Surgery Update

Only surgery produces improvement in symptoms among patients with enlarged prostate glands.
The Los Angeles Times (5/29, Maugh) reported, "Medications, laser treatment, and surgery can all arrest the growth of an enlarged prostate gland, but only surgery can produce an improvement in symptoms, particularly a reduction in incontinence," Mayo Clinic researchers asserted. In fact, "'only the surgical intervention group reported a decrease in incontinence,' from 64.5% to 41.9%." Indeed, "transurethral resection of the prostate, or TURP, is generally reserved for those who have failed to respond to drug treatment or who cannot tolerate the medications." But findings presented during the American Urological Association's annual meeting also indicate that "it might be useful to introduce it earlier in the course of the disease."

Vitamin D Update

IOM to release updated recommendations for vitamin D.
The Boston Globe (5/31, Lazar) reported that "a growing body of evidence suggests that substantially boosting a person's intake of vitamin D...may offer protection against heart attacks, high blood pressure, various cancers, falls and fractures in elders, and even depression." However, a study published May 12 in the Journal of the American Medical Association "found that a large, single annual dose of vitamin D, given in roughly 1 1/2 times the amount an adult would typically take during an entire year, actually increased the number of falls and fractures among older women, especially in the first three months after the dosing." Later this year, the Institute of Medicine "is expected to release updated recommendations" for minimal daily requirements of vitamin D.

HPV Vaccine in Men

CDC says HPV vaccine is safe, effective in men.
Time (5/28, Park) reports in its Wellness blog that the CDC has "confirmed its provisional recommendation from 2009 that the HPV vaccine (Gardasil) against human papillomavirus infection is both safe and effective in males in preventing genital warts." Notably, the "HPV vaccine was approved by the Food and Drug Administration in 2006 for use in females from age nine to 26 to prevent cervical cancer and genital warts. Soon after, the CDC's Advisory Committee on Immunization Practices (ACIP), which helps to set the US's vaccination policies, recommended that Gardasil become part of routine vaccination for all girls 11 to 12 years old." Then, in 2009, "the ACIP added males to the population who can benefit from Gardasil vaccination, but stopped short of advising routine immunization."

Exercise and Molecular Fitness

Researchers identify 21 molecules in bloodstream that respond to exercise.
The Boston Globe (5/28, Johnson) reports that, according to research published in the May 26 issue of the journal Science Translational Medicine, cardiologist Dr. Gregory Lewis, of the Massachusetts General Hospital, and colleagues from MIT and Harvard, have "begun to unravel the secrets of exercise, in part by analyzing blood samples taken minutes after runners crossed the Boston Marathon finish line. The findings, they say, could begin to reveal how exercise achieves its potent effects and could lead to ways of improving athletic performance or treating disease." So far, they found that "exercise affects fit people differently than those who are less fit, and they identified 21 molecules in the bloodstream, called metabolites, that respond to exercise."
HealthDay (5/27, Goodwin) reported, "A better understanding of" metabolites, which burn fat, "may not only boost athletic performance, but help prevent or treat chronic illnesses such as type 2 diabetes and heart disease by correcting metabolite deficiencies."