Fight Aging!

Montana state regulators now allow any drug candidate that has passed a phase 1 safety trial to be provided to patients. This is a step in the right direction of allowing patients and developers greater freedom to figure out how to cost-effectively generate human data and bring promising therapies to the clinic. It allows patients to choose their own level of risk tolerance. That said, it remains the case that guiding a novel therapy through even a phase 1 clinical trial requires a great deal of time and funding, even if conducting the trial in Australia, where local authorities require only partial compliance with the very burdensome Good Manufacturing Practice rules, and where centralized government authority is replaced with a competing market of institutional review boards and hospitals specialized in running clinical trials.

It is hard to have a rational discussion about how much cost and effort is actually required for reasonable safety, even as the cost and effort required by the FDA and equivalent regulators has increased dramatically over time. Yet most institutions and individuals react poorly to the idea that present standard practices are far more than is needed to assure a high degree of safety for most drugs. Propose any reduction in requirements and additional testing and alarm bells start to ring. This is how Good Manufacturing Practice ratchets into ever greater cost and complexity over the years, far past what is actually good practice, and certainly far more costly and burdensome.

The first US hub for experimental medical treatments is coming

A bill that allows medical clinics to sell unproven treatments has been passed in Montana. Under the legislation, doctors can apply for a license to open an experimental treatment clinic and recommend and sell therapies not approved by the Food and Drug Administration (FDA) to their patients. Once it's signed by the governor, the law will be the most expansive in the country in allowing access to drugs that have not been fully tested. The bill allows for any drug produced in the state to be sold in it, providing it has been through phase I clinical trials-the initial, generally small, first-in-human studies that are designed to check that a new treatment is not harmful. These trials do not determine if the drug is effective.

The bill essentially expands on existing Right to Try legislation in the state. But while that law was originally designed to allow terminally ill people to access experimental drugs, the new bill was drafted and lobbied for by people interested in extending human lifespans - a group of longevity enthusiasts that includes scientists, libertarians, and influencers. These longevity enthusiasts are hoping Montana will serve as a test bed for opening up access to experimental drugs. Ultimately, they hope that the new law will enable people to try unproven drugs that might help them live longer, make it easier for Americans to try experimental treatments without having to travel abroad, and potentially turn Montana into a medical tourism hub.