Last week, an FDA committee voted 20 to 1 to make it more difficult for doctors to prescribe testosterone products. The committee also recommended that pharmaceutical companies selling testosterone products be forced to perform additional safety tests, based mostly on a few studies indicating that patients with heart problems are more likely to experience cardiac events when they start using testosterone.
This isn’t the first time testosterone has been threatened with regulatory displeasure. At one time, it was believed that testosterone significantly increased the risk of prostate cancer. The prostate cancer link has been largely discredited and the hormone is now prescribed widely.
As aging boomers flood into the realm of andropause, the number of testosterone users has increased rapidly. Men who use the products often experience an increase in muscle mass, bone density, libido, and a sense of well-being. Among my friends, the benefit I hear about most often is an improvement in sleep. If true, this raises even more questions, because the inability to sleep is linked to all manner of conditions including Alzheimer’s, diabetes, and heart disease.
Many people report an improvement in their body mass index. A presentation, for example, given at the American Urological Association Annual Scientific Meeting in 2012 reviews two studies that demonstrated dramatic improvements in body mass for subjects taking testosterone undecanoate, a long-acting form of the hormone available in Germany. The weight loss reported in studies could significantly improve health for overweight men.
On the other side of the scale, some people with preexisting heart conditions might experience an increase in cardiac problems during the first few months of usage. The science, however, remains unsettled.
A number of studies, including this one from the University of Texas, have refuted the thesis. That study, published July 2 in the Annals of Pharmacotherapy, found that testosterone therapy was heart-protective even for individuals with increased cardiac risk factors. As reported in WebMD here, “men at greater risk for heart problems who used testosterone actually had a lower rate of heart attacks than similar men who did not receive this treatment, the researchers said.” This Harvard Medical School article points out that men with the lowest testosterone have higher levels of cholesterol, a risk factor for heart disease.
To be clear, I’m not saying that testosterone does not have risks. Everything has risks. A very good friend of mine died from a heart attack while jogging. This does not mean jogging is bad for you. Regulators, however, are institutionally risk averse even when dealing with therapeutics that have substantial benefits. I think this bias was reflected in the makeup of the FDA panel. A panel of 21 members, with only one voting no, doesn’t reflect opinions of many in the healthcare profession who would like to see the FDA lighten up on regulation.
Another indicator that the deck was stacked comes from an article written by journalist Dennis Thompson. According to the article,
The FDA review pointed out there’s no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging. Yet the “Low-T” craze has been aided by consumer advertising for remedies that promise renewed vitality and strength for aging men, the report said. It also noted that there’s growing evidence many men who are receiving testosterone replacement therapy do not need it.
The last sentence is true. Young bodybuilders, for example, don’t technically need to take testosterone supplements for health reasons. It is absurd, however, to say there is “no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging.” You can raise valid questions about the safety of testosterone, but to say it has no effect on age-related loss of muscle or libido is just puzzling given the experiences of millions of older men as well as a multitude of studies. It reminds me of claims made in the old days that anabolic steroids should be banned because they didn’t work.
In the same article, the writer quotes a University of Washington endocrinologist, who said, “There’s a large group of men out there who are getting older, and they are looking for ways to evade the consequences of aging.” The word “evade” is telling.
In tax law, tax avoidance is permitted. Tax evasion is not. The clear implication of this statement is that men who would like to put off the symptoms of aging are illegitimately “evading” the natural order. My guess is that the endocrinologist who made this statement is not yet in his 50s. My prediction though is that he’ll change his mind about age “evasion” when his own hormonal levels drop.
Perhaps not, though. This editorial by one of the primary architects of the Affordable Care Act, Ezekiel J. Emanuel, argues that the elderly should stop fighting to live at some point. His article is titled “Why I Hope to Die at 75“ and subtitled “An argument that society and families—and you—will be better off if nature takes its course swiftly and promptly.”
In the first paragraph of the essay, Emanuel gives the counterargument to his thesis. “This preference drives my daughters crazy. It drives my brothers crazy. My loving friends think I am crazy. They think that I can’t mean what I say; that I haven’t thought clearly about this…”
He persists, however, in the belief that it would be more of a tragedy for him to live beyond 75 than it would be for his family to suffer premature loss. I think he’s wrong.
Emanuel opposes legalized euthanasia and outright suicide but intends to reject treatment for whatever ailments he contracts at some point. This will probably work about as well as suicide, though it will likely be slower and more painful. At one time, tooth decay was a leading cause of mortality.
Emanuel believes that cutting his life short makes sense because older people lose function, becoming less productive and creative. He also points out that medical costs rise dramatically during end-stage treatments, which burdens younger people. The second point is true at least. Half of our healthcare costs go to the five percent of the population that is in the process of dying. Healthcare budgets could probably be balanced if the elderly refused the cost of those expensive final efforts.
Emanuel rejects “death panel” mandates but supports and intends to practice a voluntary version. His promised rejection of medical care would, I suppose, set an example. I confidently predict, however, that there will be no mass movement arising from supporters of the Affordable Care Act to follow his lead.
The alternative to his “solution” is an idea that he dismisses in the editorial. It is “compression of morbidity,” an idea postulated by Stanford professor of medicine James F. Fries. In Emanuel’s words, “[Fries’] theory postulates that as we extend our life spans into the 80s and 90s, we will be living healthier lives—more time before we have disabilities, and fewer disabilities overall. The claim is that with longer life, an ever smaller proportion of our lives will be spent in a state of decline.” I would add that much longer productive lives would also pay for the increased cost of health care, even with much lower birth rates and smaller, younger working populations.
Emanuel goes on to explain rightly that this trend, while happening, has not yet been completed. Older people are healthier and more productive than they were in the past but less so than they were when they were in their 40s. So he essentially gives up.
He admits that there are things that can be done to accomplish James Fries’ vision, concentrating more research “on Alzheimer’s, the growing disabilities of old age, and chronic conditions—not on prolonging the dying process.” Nevertheless, he decides in the end not to help fix the problems that would provide sufficient compression of morbidity (life extension) and simply gives up.
This is unfortunate because, unlike Emanuel and others like him who live only in the world of policy and politics, I talk regularly to the people who are actually solving the medical problems that could extend lives even further than we need to fix our entitlement problems. This includes leaders in the field of Alzheimer’s research as well as other areas, especially regenerative medicine, and I see the state of science very differently than he does.
While we need more research to restore youthful productivity and creativity to older people, a lack of research funds is not the biggest bottleneck in the process. It is government policy and bureaucratic inertia, neither of which was addressed by the Affordable Care Act.
Medical progress is not linear. It is exponential and the curve is sloping upward so fast right now that it’s nearly impossible to keep up. Most people don’t understand how biotechnology has accelerated in the last few decades, but Emanuel is a medical ethicist and should at least make an effort to get outside of the ivory tower.
I would be happy to introduce Emanuel to scientists who have completely overthrown the roadmaps to “compression of morbidity” as viewed by most policy makers. In reality, many diseases that still enfeeble older people already have solutions, but innovators are forced to waste time and resources pleasing bureaucrats instead of bringing these therapies to people.
Many of the conditions that Emanuel cites as reasons that he does not want to live could be effectively cured in just a few years, if government would focus on fighting mortality instead of wasting massive time and financial resources trying to stamp out every trace of risk in health care. The FDA’s ridiculous focus on testosterone is one example. “First do no harm” may or may not be a good motto for physicians, but it’s absolute lunacy for regulators in a society facing the “gray tsunami.”
Lest you think I’m a pessimist, I’m not. Fortunately, there are people outside the United States who understand this and are acting accordingly. Japan is probably the leader, but there are others and they will eventually force the US government, through example, to turn its resources to accelerating biotechnology rather than controlling it.
Emanuel has enormous influence with government and the healthcare bureaucracy. If he would change his focus to accelerating transformational biotechnologies, he could help people live much longer and more creative lives. It would also create the human capital, using Gary Becker‘s terminology, to fully fund health care for the very young and disadvantaged.
It would, of course, require that he change his mind and reassess some of the basic principles that he’s lived his life by. Maybe that’s too hard a trick for an old dog.
To learn more about the new research driving Patrick's investigations at his Transformational Technology Alert letter for Mauldin Economics, click here.