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US stock market daily report (September 04, 2014, Thursday)

September 5, 2014, Friday, 05:34 GMT | 00:34 EST | 10:04 IST | 12:34 SGT
Contributed by Millennium Traders


Advertisements for prescription gels like Androgel and Fortesta which promised relief to men for a condition linked to low libido, fatigue and weight gain, known as 'Low-T' [low testosterone] - are facing intense scrutiny from the Food and Drug Administration. On Wednesday, the FDA released a report that indicates there is little evidence that testosterone-boosting drugs, such as those mentioned, are beneficial to the millions of men who take them.

Scrutiny from the FDA comes amid the marketing blitz of manufactures, for supposed treatment for Low-T new pills, patches and formulations. Medication to treat Low-T is a multibillion-dollar market - and the treatments are likely to do nothing for the men who take them. On September 17, FDA will convene a meeting after two federally funded studies found links between testosterone therapy and heart problems in men. The public meeting will entail the FDA discussing benefits and risks of treatments that reportedly raise levels of testosterone levels in men.

The first FDA approved testosterone injections occurred in the 1950s for men who had been diagnosed with hypogonadism - abnormally low testosterone caused by injury or medical illness.

While testosterone levels naturally decline after age 40, it remains unclear whether lower "T" levels actually lead to the signs commonly associated with aging including - decreased energy and loss of muscle. FDA reviewers state that "the need to replace testosterone in these older men remains debatable." The recent advertising push from manufacturers of testosterone-boosting drugs is focused on otherwise healthy men who simply have lower-than-normal levels of testosterone. The FDA memo calls testosterone drug use in these patients "controversial" and notes that "there are no reliable data on the benefit in such a population."

FDA panelists will also be asked to weigh in on two recent studies that showed higher rates of cardiovascular problems in men using testosterone drugs. A U.S. Veterans Affairs study published in November 2013 showed a 30% increase in strokes, heart attacks and death among older men taking testosterone drugs. In January 2014, a federally funded study of 45,000 men with an existing heart condition suggested testosterone therapy could double the risk of heart attacks in men 65 and older. The FDA will ask its panel of outside experts at the meeting, whether the prescribing information on testosterone drugs should be revised to focus on a narrower group of patients. Additionally, the FDA will ask the panel of experts whether drugmakers should be required to conduct long-term follow-up studies to assess heart risks with testosterone drugs.

In a separate memo, 12 manufacturers of testosterone drugs acknowledged the lack of long-term studies of testosterone drug therapy, making it difficult to gauge benefits and risks. The same companies pledged to educate doctors and patients about the drugs "so that they can make informed treatment decisions." Two other studies reviewed by the FDA associate testosterone with longevity. Per the FDA, available studies "do not provide convincing evidence that testosterone replacement therapy is associated with adverse cardiovascular events."

According to the FDA data, roughly 2.3 million U.S. patients received a prescription for testosterone drugs during 2013, an increase of 77% from 2010. The FDA noted that over 20% of the men who received a prescription had no record of their testosterone levels.

Public Citizen - a consumer advocacy group - said the FDA downplayed the evidence of heart risks with the use of testosterone drugs. In February, Public Citizen petitioned the FDA to add a boxed warning - the most serious type - to all testosterone drugs, about potential heart risks. The FDA rejected that proposal. Public Citizen's Dr. Sidney Wolfe says he expects the recent studies about heart risks to be added to testosterone drug's label. Dr. Wolfe said, "There will be a warning and once it happens the prescribing will drop way down, and that will be to the betterment of the public health in this country." Wolfe noted that prescriptions for Androgel, the best-selling testosterone drug from Abbott Laboratories (ABT-NYQ) have already fallen 23% since July 2013.