And how can they be properly informed of the risks without empirical data from trials? Regulations exist to prevent malicious sellers from taking advantage of sick patients, who are making decisions under duress, about things way more complex than they can handle.

I realize it sounds paternalistic, and I can appreciate your point about giving people freedom to make the choice, but sometimes it’s not really a choice in the true sense you describe (no pressures from failing health; proper time to research everything; ability to weigh benefits and risks correctly).