Generation Lab urged to test its “age reversal” claims in a controlled trial
Generation Lab urged to test its “age reversal” claims in a controlled trial
Aging researcher Michael West proposed testing Generation Lab’s claim that its injectable 1 Generation combination regenerates the body in a controlled trial. Matt Kaeberlein supported the call for precise language, while the company offered to share data from its pilot study and discuss the study design.
On September 1, Michael West reviewed the portion of a presentation available to him in a post. The presentation concerned 1 Generation, an injectable combination offered by Generation Lab. According to West, the excerpt included data from eight people, one participant’s report of increased energy, and a change in a single blood marker. The presentation linked the therapy to regeneration of the body and improved function across several tissues.
“How can we know whether this improves human health, let alone reverses aging, without controlled studies of safety and efficacy?”
Several days before the exchange, Generation Lab began prescribing 1 Generation to a limited group of people without disclosing the names of the two drugs. In a controlled trial, participants are randomly assigned to two groups. One receives the intervention, while the other receives a placebo, which is an injection without the drug under investigation. Neither the participants nor the physicians know who is receiving the drug until follow-up is complete. Differences between the groups in prespecified measures can then link a change to the intervention rather than to expectations or random variation.
Matt Kaeberlein supported the criticism of “hype and imprecise language,” but separately stated that the combination has a genuine scientific basis. According to him, it consists of two FDA-approved drugs and is supported by published animal studies. Kaeberlein distinguished the rationale for studying the combination from the next question: which changes in humans will be confirmed by comparison with a placebo.
On September 2, Generation Lab CEO Alina Su responded that the video was an excerpt from a longer scientific session. She offered to show West the pilot study data and discuss its design and endpoints, which are the measures selected in advance to assess the outcome. In response to West’s question, the company proposed relying on the pilot data and a prespecified trial design.