Prescription Drugs to Fight Aging—Entirely Experimental

Prescription Drugs to Fight Aging—Entirely Experimental

Meet Dr. Alan Green. He has a tiny but lucrative practice in Queens. His patients travel from around the country to get prescriptions to drugs they believe will fight aging. Who are his patients? An estimated 5% are fellow doctors. Others have backgrounds in science or are in the upper-income bracket. He charges $350 for an initial visit and doesn’t accept insurance. Many fly to their appointments in their own airplanes. One 85-year old drove through a Midwest snowstorm to keep her appointment. Dr. Green is 76 and has been taking the drugs for three years himself.

Taking off-label drugs to fight aging

Green is among a small but growing number of doctors who prescribe drugs “off-label” for their possible anti-aging effects. In this case, the drugs are metformin, commonly prescribed for diabetes; the other drug is rapamycin, prescribed to prevent organ rejection. Now these drugs are being prescribed for their anti-aging powers, though there’s little evidence to support their premise.

Taking these drugs is entirely experimental

Patients get the drugs legally off-label or illegally from a foreign supplier. This methodology is much easier than it is for researchers to launch clinical trials. To date, no rigorous, large-scale clinical trials have been conducted for aging. Pharmaceutical companies have little incentive to fund costly, large-scale trials because aging is systemic—there is an infinite number of ways that aging takes place—and metformin and rapamycin are generic, cheap and accessible for seniors.

The National Instititue for Health (NIH) rejected a $77 million grant proposal by a prominent group of researchers to determine whether metformin could target multiple age-related diseases at once. It was the second rejection of the ambitious but unorthodox bid.

Advocate for rapamycin and Alzheimer’s study

Studies show that rapamycin extends animal life spans. It also has been shown in such studies to stave off age-related diseases, from cancer to cardiovascular diseases to cognitive diseases. “There should have been a clinical trial for rapamycin and Alzheimer’s disease years ago,” said Matt Kaeberlein a professor of pathology at the University of Washington medical school, who has publicly urged the NIH to use a historic boost in Alzheimer’s funding to study the drug’s effects. But clinical trials are expensive and difficult to fund.

Changing the model: Tackling aging as a whole rather than as one disease at a time

Alexander Fleming, a former FDA official and advocate for the metformin proposal, said he believed it was difficult for regulators and funders to grasp that aging can be tackled as a whole — not just one disease at a time.

In fact, NIH reviewers who rejected the metformin proposal cited problems with the project’s aim of testing multiple age-related diseases at once. The researchers considered appealing the decision, asserting those reviewers were biased against studying aging as a whole. The NIH, which declined to comment, discouraged the attempt.

Researchers have moved ahead with clinical trials focused on specific age-related conditions

  • Researchers have shown that a “cousin” of rapamycin boosts the effectiveness of flu shots and lowers the incidence of upper respiratory infections in seniors by up to 30%.
  • This group has licensed it from Novartis and is now working on getting approval to target Parkinson’s disease.
  • At a recent forum on aging, a NIH researcher asked the 300 people in attendance to raise their hands if they were already taking metformin for aging. “Half the audience raised their hands,” recalled Nir Barzilai,director of the Institute for Aging Research at the Albert Einstein College of Medicine. “And a pharmaceutical rep estimated that metformin sales are up 20%.”

To be successful, clinical trials are necessary

Barzilai contends that researchers in the longevity field first need to set up a framework for testing in clinical trials. Even if metformin doesn’t pan out as the most effective drug, he asserts a model like the metformin proposal is needed for any major clinical trial to proceed. His group is now trying to secure about half the amount of funding it requested from NIH from a mix of nonprofit and private investment.

Proceeding with caution

While Dr. Green plans to continue prescribing his drugs, other doctors who may be open to prescribing metformin are holding off on rapamycin due to side effects in higher doses. Meanwhile, we’re a society obsessed with youth, and supplements with purported anti-aging effects routinely enter the market with little scrutiny and less evidence. There will be more on this one.

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