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drug companies 26 articles

New study raises questions about safety of testosterone replacement therapy

A new study raises questions about the link between testosterone replacement therapy and heart attacks. Researchers at the University of Texas, Medical Branch at Galveston, studied more than 25,000 men, all Medicare beneficiaries older than 65 who were treated with testosterone injections for up to eight years. These men were compared to about 19,000 men of the same age who did not use testosterone treatments. Researchers found that testosterone users were not at greater risk of having a heart attack compared to nonusers of testosterone therapy. Researchers did not track strokes, blood clots, dementia or death. The results contradict several ... Read More

California Senate committee passes bill requiring drug companies to collect, dispose of unused drugs

A bill was passed by a California Senate committee to start the first statewide medicine take-back program in the United States. The measure would require drug manufacturers to pay for the collection and discarding of unwanted over-the-counter and prescription drugs. Proposed by state Sen. Hannah-Beth Jackson, D-Santa Barbara, S.B. 2014 was approved by the state Senate Environmental Quality Committee in a 5-1 vote. The state Senate Business, Professions and Economic Development Committee will be hearing the bill on April 21. If the measure is passed, a statewide collection and disposal of unused drugs sold in California would have to be ... Read More

Drug companies to blame for pushing testosterone replacement products

If drug companies want to reclaim their “one-time highly respected status,” Forbes contributor John LaMattina says, “it needs to use less testosterone in promoting its products.” Mattina’s criticism centers on drug companies that have launched massive marketing campaigns to promote their testosterone replacement products, such as Abbott/AbbVie’s AndroGel. The ads encourage men to ask their doctors if they could be suffering from “Low T,” a phrase coined by drug companies to explain symptoms such as low sex drive and weight gain caused by low levels of testosterone. The drugs can help restore libido and build muscle mass, which is a ... Read More

More men getting testosterone treatment but may not need it

Many older American men start testosterone therapy without a real medical need, according to a study published in the Journal of Clinical Endocrinology & Metabolism. Levels of the male hormone testosterone typically drop as men age, causing symptoms such as low sex drive, weight gain and a lack of energy. Many drug companies now offer testosterone replacement products, such as AndroGel, Testim, and Axiron. These drugs require a doctor’s prescription after blood tests confirm that testosterone levels are below average. Many men in the United States have been lured by drug companies’ marketing campaigns that tout the benefits of testosterone ... Read More

People with Neanderthal genes more likely to develop type 2 diabetes

Researchers focused on gaining a deeper understanding of the pathway to find new drugs to treat type 2 diabetes have discovered a gene variant that appears to increase the risk of developing the disease that dates back to Neanderthals. Researchers in Mexico and the U.S., in the largest genetic study in Latin American populations to date, found that people who carry a higher risk version of the gene are 25 percent more likely to develop diabetes than those who do not have the gene. And those who inherited the variant from both parents are 50 percent more likely to have ... Read More

Doctor: Adequately testing testosterone levels a complicated process

Aggressive marketing campaigns by drug companies peddling testosterone replacement products have prompted many men to ask their doctors if their low libido and lack of energy may be caused by low testosterone levels. A “simple” blood test can determine if a man is a candidate for testosterone supplementation. However, testing for “Low T” in men can be tricky, says Dr. Anthony Komaroff, physician and professor at Havard Medical School who also has a column in the Times Standard. Testosterone is a male hormone that decreases in men as they age. For some men, testosterone levels can drop low enough that ... Read More

FDA lays out new rules to measure impurities in medications

The Food and Drug Administration (FDA) has laid down new rules for drug companies that detail acceptable levels of impurities – such as arsenic –allowed in medications as well as the processes for detecting them. The 81-page guidance outlines five different classifications for various elements including potentially dangerous ones like lead to relatively safe ones like zinc. The FDA created the guidance along with drug regulators in Europe and Japan as part of the International Conference on Harmonisation, an effort to establish “permitted daily exposure” (PDE) standards for potentially dangerous elements. The guidance details whether elements should be included in ... Read More

Supreme Court considers legality of drug companies’ pay-for-delay deals

An attorney for the Federal Trade Commission (FTC) urged the Supreme Court to stop so-called pay-for-delay deals among pharmaceutical companies that keep generic drugs off the market longer and keep costs to consumers high. “It’s unlawful to buy off the competition,” said Malcolm Stewart, an attorney for the FTC and the Justice Department, arguing that the practice among drug companies is “presumptively illegal.” The hearing will determine whether there is a violation of antitrust laws when brand name drug companies pay generic drug makers of the same drug to postpone launch of their products. New brand-name drugs to hit the market ... Read More

Drug companies ignoring FDA’s requirement to warn about drug side effects

Pharmaceutical companies have largely ignored recent federal requirements to compile data and warn doctors and patients of possible side effects caused by their drugs, according to a report from the Department of Health and Human Services’ (HHS) Office of Inspector General. The report is the first independent report into requirements put in place in 2008 allowing the Food and Drug Administration (FDA) to require drug makers to develop risk-management plans for new drugs. These Risk Evaluation and Mitigation Strategies (REMS) require drug companies to produce patient brochures warning about drug side effects, provide specialized training for doctors who prescribe some ... Read More

Updated HIPPAA guidelines aimed at protecting consumers’ privacy

Tighter restrictions are being placed on medical service providers who use patient information for marketing. The new guidelines were unveiled this week by the Obama administration and aim to strengthen privacy protections that previously did not exist for consumers. The updates will be applied to the Health Insurance Portability and Accountability Act, known as HIPPAA, which was established in 1996. Under the new plan, doctors who are being paid by drug companies or medical device manufacturers to promote a product to their patients must first get the patient’s approval before making the pitch. Previously, doctors could talk to patients about ... Read More