Drug Manufacturers Blatantly Promoted Improving Muscle Mass and Sex Drive Without Warning of Serious Known Side Effects
According to a study published in November 2013 in the Journal of the American Medical Association, low testosterone treatments have serious side effects, including death. The JAMA study clearly indicates that the risks of testosterone therapy outweigh the benefits, but yet the drug has increased to 432 million prescriptions in 2013. This increase is mainly due to doctors prescribing testosterone treatment off-label and aggressive advertising efforts by the manufacturers to help men fight their decline in testosterone and allegedly strengthen bone density, improve sex drive and build muscle mass. The off-label marketing of testosterone drugs in the USA is illegal.
Under Federal law, the United States Food and Drug Administration (FDA) must approve all prescription drugs. The process typically involves using evidence that the medicine is safe for a particular condition. Drug manufacturers are not allowed to market the approved medicine for any other purposes, but physicians are allowed to prescribe drugs (off-label) to treat a condition for which it is not approved. Antibiotics, heart medicines and antipsychotics are often prescribed off-label. Drugs approved by the FDA for depression are sometimes used to treat chronic pain. Research is used to help patients and physicians weigh the benefits and the risks before prescribing it. There is not always enough evidence to make informed decisions when off-label medicines are used.
Testosterone Treatments and Manufacturers Who Raised Concerns
In September 2009, the FDA placed a black box warning about the risks of AndroGel. Men apply the gel to the upper arms and shoulders. Secondary exposure to testosterone in women and children can occur with the use of the gel. By February 4, 2014, five AndroGel cases were filed in Illinois Federal Court against the manufacturers, claiming AbbVie Inc. and Abbott Laboratories concealed facts about the serious side effects of the gel.
Androderm, a transdermal system that delivers testosterone through the skin, made by Actavis, was approved by the FDA in 1995. A topical solution to treat low testosterone, known as Axiron and manufactured by Eli Lilly, was approved by the FDA in 2010. GlaxoSmithKline’s Bio-T Gel was approved by the FDA in February 2012. Delatestryl, intramuscular agent or testosterone injection treatment, was approved by the FDA in 2003. Delatestryl is made by Savient Pharmaceuticals. Pfizer introduced the intramuscular agent Depo-Testosterone in 2003, claiming the product has been used for more than thirty years in treating men with low testosterone.
Endo Pharmaceuticals made a testosterone spray gel, which received FDA approval in December 2010. Striant is a tablet that slowly releases the testosterone into the mucous membranes of the mouth. Columbia Laboratories, maker of Striant, was purchased by Auxilium Pharmaceuticals in 2011. The FDA approved Striant in 2003. Testim, made by Auxilium, is a gel treatment which was approved by the FDA in October 2002. Slate Pharmaceuticals’ Testopel, testosterone implants, was approved by the FDA in 2008.
All the above manufacturers have been accused of failing to adequately research the risk of heart attack and stroke from testosterone treatment. The manufacturers have also been accused of using advertisements that encouraged men to seek medications for general conditions experienced by men as they age such as decreased sex drive. AbbVie blatantly advertised if men are stressed, bored or aging they probably have low testosterone symptoms. AbbVie was told by the FDA in 2000 that their representation and claims of AndroGel for men with age-associated hypogonadism (a condition in which the body does not produce enough testosterone) are misleading.
Off-Label Promotions Resulted in Millions of Dollars of False Claims
The lawsuit filed against Solvay Pharmaceuticals Inc. in 2003 stated that the drug company allegedly conspired with physicians to prescribe off-label uses of testosterone treatments. Solvay was later bought by Abbott Laboratories. The lawsuit claims that doctors received cash payments, resort weekends and Harley Davidson goods for prescribing off-label uses of the drug. The lawsuit, King et al v. Solvay SA et al., suggested off-label promotions resulted into millions of dollars worth of false claims submitted to government health care plans.
According to a leaked document by Solvay that was included in the lawsuit, the company portrayed doctors as easily influenced, and that they need to expand the market by thirty-six percent. Solvay also stated in the document that physicians in the rural areas are usually more accessible, and should be taught the right way to diagnose and treat as they already have the patients.
Seek Advice if you Have Concerns About Testosterone Treatment
JAMA published statistical information linking the usage of testosterone treatment to an increased risk of myocardial infarction. The study also indicated that many men using the treatment do not suffer from low levels of testosterone. If you do suffer from a decreased level of testosterone, it is possible that you may not know the treatment is off-label. You should ask your doctor if there is evidence showing the off-label treatment can help your condition. Discuss the benefits and risks involved with the treatment. It remains important to ensure your health insurance will cover the off-label treatment.
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