D.A. Panel Backs Limits on Testosterone Drugs

By SABRINA TAVERNISESEPT. 17, 2014

HYATTSVILLE, Md. — An expert panel voted overwhelmingly on Wednesday for the Food and Drug Administration to impose strict new limitations on the multibillion-dollar testosterone drug industry, recommending that the agency tighten labels for the medicines so they are not prescribed to men who only have problems related to aging, such as low energy and libido. The F.D.A. often takes the advice of such panels.

Once used only to treat serious medical conditions, testosterone drugs are now taken by over two million American men, mostly for symptoms that are largely a result of aging, a pattern that has alarmed some medical experts. If the F.D.A. adopts the panel’s recommendations, it could sharply reduce the number of men prescribed the medicines and clamp down on marketing of them by drug companies. It could also limit coverage from insurance companies for their use, experts said.

“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” said Dr. Michael Domanski, the director of heart failure research at Mount Sinai School of Medicine, who was one of 20 members on the panel who voted to change the labeling. Just one member voted against the change.

Still, some experts were skeptical that usage would change much, because doctors can prescribe the drugs as they see fit, despite indications on the label.

One factor driving treatment is a larger number of easy-to-use testosterone drugs like gels, experts say. One of the items on the F.D.A.’s agenda for Thursday is to ask its expert panel whether it should approve a new oral testosterone drug. AbbVie, the company that makes AndroGel, a testosterone treatment, said: “Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients, and we will work with the F.D.A. during its review.”

The F.D.A. has said that the benefits of testosterone treatments for healthy, aging men are unproven, and that the drugs could be risky. Men who take them have been found to have higher rates of heart problems in some studies.

Testosterone usage has quadrupled since the early 2000s for men in their 40s, driven in part by marketing that suggests the drugs are a solution for low energy, low libido and other ills, many of them associated with aging. By 2011, nearly one in 25 men in their 60s was taking testosterone. In 2013, 2.3 million Americans were being treated with testosterone therapy, according to material distributed at the panel meeting.

“People are looking for the fountain of youth,” said Dr. Aaron Katz, chairman of the Department of Urology at Winthrop-University Hospital in Mineola, N.Y.

Many experts began raising alarms, saying that the benefits and longer-term risks of the drugs were unknown.

This year, the F.D.A. said it was reassessing the safety of testosterone products in light of recent studies and would investigate rates of stroke, heart attack and death in men using the drugs.

One of the stickiest problems had been the vagueness of testosterone drug labels, which many doctors have interpreted to include any man with low testosterone. Panelists said the label should be limited to men with serious medical conditions, such as pituitary gland problems. It was not clear what share of men that represented, though officials said it was a small minority of users.

The panel was also asked to sift through the evidence for safety risks. It concluded that the evidence for risks of heart problems was mixed, and all but one of its members voted to require clinical trials for safety for at least some types of testosterone therapy.

A 2010 clinical trial found an elevated risk of heart attacks and strokes among men who took testosterone, and it was stopped early as a result. Other trials have found no increased risk.

The panel heard surprising facts: A fifth to a quarter of men who are prescribed testosterone have not had a baseline test of their testosterone level. And 60 percent of the prescribing is done by primary care doctors, while just 20 percent of the drugs are prescribed by specialists like endocrinologists and urologists.

“Why did the F.D.A. allow this huge push for the creation and the selling of ‘aging is optional for men,’ when we don’t know the benefits or harms?” said Dr. Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice.

Trung-Hieu Brian Tran, an F.D.A. official, said the agency had issued warning letters to sponsors over inappropriate and misleading promotions. One concerned an ad claiming that patients who had taken a particular testosterone drug “start chasing their wives around the room a little bit — they just feel like guys again,” implying that the product can be used to successfully treat sexual dysfunction, when there is no data to support that, he said.

One potentially major effect of Wednesday’s vote would be to give the F.D.A. more control over the marketing of the drugs, allowing the agency to draw a narrower definition of whom drug companies could target.

Dr. Schwartz said the marketing of what is popularly known as Low-T, or low testosterone, was “eerily reminiscent” of the aggressive promotion of hormone replacement for post-menopausal women. For years, physicians were convinced the treatment protected women from heart disease, and they promoted it as a long-term preventive regimen to treat symptoms such as hot flashes, mood swings and low sexual desire. But a randomized trial, the Women’s Health Initiative, found that the popular treatment actually increased risks of blood clots, strokes and breast cancer, and did not protect against heart disease.

The National Institutes of Health is sponsoring a large randomized trial, called the T trial, to see whether older men who take testosterone have improved physical, sexual and cognitive function, and whether the hormone reduces risks for heart disease and diabetes. Results are expected next year.

Continue reading the main story Write A Comment

But the largest group of men being treated is actually younger than those represented in the trial, and some experts pointed out that the trial may not give all the answers the medical community is seeking. F.D.A. data show that men ages 45 to 64 receive about 60 percent of all testosterone treatment; men over 65 represent just 20 percent.

The label changes will ultimately be up to the F.D.A., which has discretion over wording and application.

“Exactly how the wording will be changed is not yet known,” said Mary Schooling, a professor of public health at Hunter College.

Coming Out of the PrEP Closet

  Each morning, I take a pill called Truvada to protect me from becoming infected with HIV. This strategy, also known as pre-exposure prophylaxis, or PrEP, reduces the risk of HIV infection by up to 99 percent if the pill is taken once a day. This makes PrEP one of the most effective HIV-prevention measures in existence. After consulting with my physician, I went on PrEP to further protect and take personal responsibility for my health. I’m HIV-negative, and I want to remain that way.

I recently decided to be public about my use of PrEP in order to raise awareness about this relatively new tool for preventing HIV. It’s important to encourage people at risk for HIV to talk to their medical providers about all the tools and methods available for preventing infection, including PrEP, and to choose the methods that are best for them.

As an elected official, disclosing this personal health decision was a hard but necessary choice. After all these years, we still see enormous stigma, shame, and judgment around HIV, and around sexuality in general. That is precisely why I decided to be public about my choice: to contribute to a larger dialogue about our community’s health. I have the honor of representing a district that includes the Castro — ground zero for the HIV epidemic. I represent a community that has been profoundly impacted by HIV, with a large number of HIV-positive people — nearly one in four gay men in San Francisco is HIV-positive — and an even larger number of people at risk of becoming positive. As an elected official in this role, I have an obligation to do everything in my power to support those living with HIV, increase public awareness about effective HIV prevention, and reduce stigma and shame.

My journey to PrEP was a long one. I came to terms with myself as a gay man when I was 17 years old in 1987, at the height of the HIV epidemic. Many gay men were getting sick and dying. Like many in my generation, I came of age associating sex with illness and death. That association — with all the fear, anxiety, guilt, and shame that go along with it — is still very real for many of us.

As time has gone by, I’ve seen people become healthier, and I’m continually in awe of those who have survived the epidemic and thrived. Yet new HIV infections continue — 50,000 annually in the U.S., and over 2 million annually worldwide. Despite all our prevention efforts, I continue to know people who’ve remained HIV-negative for 20 or 30 years, only to become HIV-positive. I regularly meet young men, some barely out of high school, who have the virus.

None of this is preordained. People don’t need to continue to get infected, and we know that PrEP has the potential to help stop the epidemic in its tracks by ending new HIV infections. It’s one pill a day, with few side effects for most people.

Condoms remain critically important for HIV-prevention efforts, but they have their limits, as demonstrated by the continuing new infections after 30 years of robust prevention efforts. Only one in six gay men uses condoms consistently and effectively enough to be fully protected from HIV. For those who do use them consistently, condoms offer significant protection but have a failure rate, and condom usage among gay men reduces HIV risk by 76 percent, not 100 percent.

Given the challenges many gay men have with consistent condom use as well as the continued risk of HIV transmission even for those who use condoms, PrEP provides a powerful additional level of protection. It’s not a question of either condoms or PrEP. It’s about both important tools.

PrEP has broad support in the public-health community. The World Health Organization and Centers for Disease Control and Prevention have recommended its use by those at risk for HIV, including gay men. The state of New York and the San Francisco Department of Public Health have adopted PrEP as a core prevention strategy. The HIV advocacy community overwhelmingly supports PrEP. Most insurance companies cover it fully despite its considerable cost, precisely because it is so effective at preventing a serious illness for which there is no cure.

Some aren’t sold on PrEP. Skeptics question whether people will adhere to a daily pill, which is a legitimate concern. Protection decreases if usage is inconsistent. This challenge can be overcome with effective education, and drug adherence is a challenge that isn’t unique to PrEP.

Some critics also view PrEP as a license for people to engage in risky behavior and assert that it will cause non-HIV sexually transmitted infections to increase. No study to date has shown that those using PrEP increase risky behavior — such as reducing condom usage compared with before using PrEP — and there is evidence to the contrary. Indeed, this line of thinking — that promoting an effective prevention method will lead to irresponsible behavior — resembles some of the phony arguments used to attack the HPV vaccine by suggesting that getting vaccinated will lead young girls down a path to promiscuity. And, since PrEP users are regularly screened for HIV and other sexually transmitted infections, PrEP use will increase opportunities for prompt detection and treatment of STIs.

PrEP isn’t only about gay men. Women can benefit tremendously from it as well. Many women are using PrEP to conceive a child with an HIV-positive partner, a new approach dubbed “PrEP-ception.” PrEP can also protect women (and men) in abusive relationships. Too many women — and gay men as well — don’t fully control how or when they have sex, whether their partners use condoms, and what risks their partners are taking elsewhere. People facing these challenges can take control of their infection risk — and essentially eliminate that risk — by using PrEP effectively.

In addition to lack of education and stigma, another significant barrier to fully realizing PrEP’s potential benefits is lack of access. PrEP isn’t cheap, and for the many people who are uninsured or underinsured, cost can effectively deny access. PrEP needs to be easily available to all communities and all income levels through public healthcare programs, including Medicaid. Otherwise we risk accentuating health disparities among our diverse communities.

Many people and organizations have gotten us where we are with PrEP. The University of California San Francisco is responsible for some of the earliest clinical studies of PrEP, and organizations like San Francisco AIDS Foundation, Project Inform, and the AIDS Vaccine Advocacy Coalition have been working on the front lines to ensure that the promise of PrEP is fully realized, including advocating for FDA approval, helping establish expanded access programs from the drug manufacturer, ensuring PrEP is covered by insurance plans, and disseminating information to consumers and clinicians.

We know how to end HIV infection. We simply need the political will to ensure that the community has accurate information about and access to all prevention methods, including PrEP. I hope my disclosure can play a role in moving us toward these goals