Drugmakers Knew of Testosterone Risks For Years: NYT

A new report suggests that drug manufacturers may have known about the risk of serious heart problems from testosterone replacement therapy for nearly a decade before the public and medical community was ever told about the potential side effects.

According to report published in the New York Times, a clinical trial conducted nearly a decade ago suggested that use of testosterone treatments may increase the risk of heart attacks and strokes by a factor of five.

As a result of the alarming of rate of heart problems among the clinical test subjects, researchers halted that study early to protect the participants. However, the trial’s data was not published until 2010, and the manufacturers of testosterone treatments still do not provide warnings about the potential risk of cardiovascular problems.

Aggressive Marketing for “Low T” Without Warnings

Despite knowledge of the potential risk, drug makers engaged in aggressive marketing for products like AndroGel, Testim and other similar products. While withholding information about the potential heart risks, sales of testosterone therapy increased dramatically over the past decade, growing into a $2 billion a year industry.

Direct-to-consumer advertisements have encouraged men to ask their doctors about treatments for “low T” if they experience decreased sex drive, weight gain, lack of energy or a number of other symptoms that are common among aging men. While some experts have expressed concerns about the widespread use of testosterone treatments, indicating that many men receive the prescriptions without any real need, many doctors have remained unaware of the potential heart risks and continued to prescribe the drugs for lifestyle reasons.

In August 2013, Drs. Lisa Schwartz and Steven Woloshin had a paper published in the JAMA Internal Medicine called Low “T” as in “Template”: How to Sell Disease that addressed the alarming spread of testosterone use. The paper describes how physicians can be influenced just as much as consumers into believing unverified drug company claims by slanted educational materials, persuasive drug reps, industry-funded studies, and the promise of funding. The paper suggests this is what has happened with the spread of the term “Low T.”

“We must do our own research, ask hard questions, be skeptical about all claims, and question whether our judgment and our words are being subtly skewed by the knowledge that the funder is watching,” the authors stated at that time. “Physicians, for their part, must be equally vigilant, skeptical, and independent.”

One subtle way this has happened is with drug companies putting out lists of questions for men to ask their doctors about “Low T.” In an accompanying opinion piece, titled Don’t Ask Your Doctor About Low ‘T’, the author notes that doctors often aren’t even testing when men ask those questions. They just prescribe testosterone for a condition that is rare, but somehow resulted in three million prescriptions in 2012 for AndroGel alone.

While the drug makers continue to sell testosterone therapy without warning about the potential cardiovascular risks, two recently published independent studies may cause a sharp drop in sales of treatments for “low T”, due to findings that certain men may face an increased risk of heart attacks, strokes and death.

Last week, the FDA announced that it is investigating the potential testosterone risks. In a safety announcement issued by the agency, the FDA indicated that the products were never approved for any use other than to treat men who have a medical condition that’s causing them to have lower testosterone than normal, such as hypogonadism.

In November 2013, a study published in the Journal of the American Medical Association found that testosterone drug side effects were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by another study released last week by the medical journal PLOSOne, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

After these findings, many questions are being raised about why the drug makers did not warn consumers and the medical community after the findings of that aborted study nearly a decade ago. There have also been no long-term studies completed to investigate the potential heart side effects.

As a result of the pharmaceutical industry’s failure to warn, many men who suffered a heart attack or stroke in recent years are now considering potential AndroGel lawsuits and other testosterone injury lawsuits, alleging that they may have avoided serious health problems if information had been disclosed to consumers and the medical community.