Doctor Wants FDA to Warn About Testosterone Side Effects

On this episode of Drugwatch Podcast, I welcome a fellow consumer advocate to the show, Sidney Wolfe, M.D., founder of Public Citizen’s Health Research Group. Wolfe founded the group in 1971 and since then, the group has been holding the Food and Drug Administration (FDA) and pharmaceutical companies accountable. Their petitions have been successful in getting many harmful drugs taken off the market.

On this show, Dr. Wolfe and I discuss testosterone replacement therapy products like AndroGel, the No. 1 testosterone drug in the country. Testosterone drugs — used to treat low testosterone or Low T in men — are in the spotlight because of studies that show they pose a risk for heart attacks and strokes.

The problem is the manufacturers of these drugs have not warned the public.

Public Citizen and Wolfe stress that these drugs need stronger warnings because of significant heart attack risks. Another concern is that men who don’t actually have a clinical diagnosis of low testosterone are using these drugs.

On Feb 25, 2014, Public Citizen filed a petition to the FDA demanding the agency immediately require a black-box warning –the FDA’s strongest warning – for cardiovascular risks on all testosterone therapy drugs.

Testosterone Therapy Drugs and Their Troubling Side Effects

Wolfe recently published an article in the British Medical Journal (BMJ) detailing the side effects of testosterone therapy and the troubling trend of overprescription in the U.S.

According to Wolfe, the mounting studies that point to increased risk of heart attacks – including one that involved 55,000 men – should be enough evidence for the FDA to require a warning.

Some of the facts are startling.

The latest NIH-funded study published in PLoS One found that for men aged 65 and older, about 1 in 167 on testosterone could expect to have a heart attack. For those younger than 65 with pre-existing heart conditions, that risk is 1 in 100. Each year, millions of prescriptions are written for these drugs, and that number is quickly increasing.

The FDA responded by saying it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”

Wolfe writes, “In the face of such accumulating evidence to the contrary, this FDA statement is reckless, from a public health perspective.”

He also points out that there are now about 27 studies on testosterone therapy. Thirteen of these, which were funded by drug companies, showed no risk at all. The other 14 studies revealed a risk of heart problems.

The fact that the drug industry didn’t pick up on these risks is not surprising to Wolfe. After all, a large part of the FDA’s budget comes from drug companies.

Wolfe says that it is “the dangerously close connection between the FDA and the [drug] industry” that has slowed down the process of adding warnings to testosterone replacement therapy drugs.

Of course, this is not the first time Abbott Laboratories, parent company of AngroGel maker AbbVie, has seemed to downplay the risks of its products.

Maker of AndroGel, Abbvie, Has Troubling Roots

Wolfe found it ironic that the company that spurred him to leave the NIH and create the Health Research Group is back in the spotlight over four decades later with another questionable product that may end up causing a number of health issues.

While working at the National Institutes of Health (NIH), Wolfe became aware that half of the IV fluids in the country made by Abbott Laboratories were contaminated.

Instead of recalling the contaminated fluids, Abbott convinced the government that they should only be pulled if people got sick, because there would be an IV fluid shortage. This reasoning didn’t sit right with Wolfe.

“I did a little digging and found out there were plenty of other companies making IV fluids, with plenty of stockpiles. The idea that there would be a shortage was ridiculous,” he said.

So Wolfe and Ralph Nader, whom he had known previously, fired off a letter to the FDA demanding it recall the fluids immediately. Initially, the FDA reacted negatively, but two days later it recalled all the IV fluids. These IV fluids caused what is now viewed by the Centers for Disease Control and Prevention (CDC) as the biggest hospital outbreak of infection caused by a product.

Up to 8,000 people suffered blood infections, and hundreds lost their lives.