July 17, 2017
A Short Non-Update on the TAME Trial
Dear Reader,
Quite a few people have asked for an update on the Targeting Aging with Metformin (TAME) trial. If you’ve been reading my digest, you know that TAME is the effort to get metformin (the common diabetes drug) approved by the FDA as an anti-aging drug.
Though the evidence indicates that metformin can delay or prevent age-related diseases, that’s not really the point. The purpose of TAME is to create a regulatory pathway for more effective anti-aging drugs. As such, the community of biogerontologists is closely following this story.
So why haven’t I written more about the meeting that took place last month? There are two primary reasons.
The Politics of TAME
First, no decision was made on funding the trial at the last committee meeting.
Normally, of course, a company that owns the patents for a drug pays for clinical trials. To be successful, a trial must show that a drug helps patients who have a particular disease. Then, the company can market that drug.
There is, however, no pathway for a drug that “prevents” rather than treats diseases. You might think that taking the profit motive out of a drug trial would make things simpler, but you would be wrong.
The patents on metformin expired long ago. Generic versions are cheap and available all over the world. This means that there is no single party that would reap a substantial share of the increased revenues that would come from approval of metformin as an anti-aging drug.
Drug manufacturers, therefore, have not come forward with the many millions of dollars needed to perform the trial. Though many physicians are aware of evidence supporting the health benefits of metformin, they are reticent to prescribe drugs that lack the official blessings of the FDA. This is the nature of our system whether you like it or not.
This means that the TAME trial needs significant government funding to proceed. If it is funded, it would represent a fundamental departure from the way that government and the pharmaceutical industry view the practice of medicine. I suspect this complicates the decision-making process.
The TAME team was hoping to get a good portion of the money needed to perform the trial from the NIH. Instead, they were asked for more information about the trial, which has been greenlighted by the FDA.
The main reason that I’ve avoided writing about the TAME trial is political. I’ve talked to several scientists who are worried that the NIH committee that holds the purse strings may feel pressured by media coverage.
In theory, the committee is immune to political and public concerns, but the truth is probably more complicated. Undoubtedly, the NIH committee members are aware that they are in a unique historical position.
This week, I’m writing this short note simply to explain that I’m not going to write more about TAME until we have a better picture of its status.
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Sincerely,
Patrick Cox
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