FDA Get Out of the Way: Free to Choose Medicine 3/11/15 A petition by Tomorrow's Cures Today Fndtn

[*GG*]

The non-profit Tomorrow's Cures Today Foundation aims to open patient access to innovative drugs and treatments in advance of Food and Drug Administration approval. The group has launched an online Change.org "Free to Choose Medicine" petition to Congress urging lawmakers to create a new drug development and testing system—one that would allow patients to try not-yet-approved drugs in a more open and transparent process. Approvals could even be speeded up based on the what’s learned from treatment outcomes for patients who choose to use not-yet-approved drugs.

The Foundation outlines three principles for Free To Choose Medicine:

1. Some patients and their doctors only want medicines tested and approved in the traditional way, and for them nothing would change. But others are not just willing, but eager to try not-yet-approved drugs. They should not be denied the right to choose a viable medical treatment. So, after safety testing is completed, patients should be free to choose a not-yet-approved drug if its developer is willing to make that drug available. After all, patients, under care of their physicians, and with access to detailed reports describing all prior test results, are in a better position than government bureaucrats to decide whether the risks are worth bearing.

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http://reason.com/blog/2015/03/11/fda-get-out-of-the-way-free-to-choose-me

 

[Valentijn]

Apparently their proposal is to allow people to purchase the drug sometime after phase II trials begin. At that point, all that is really known is that the drug won't kill healthy people quickly. It's not known if it will have negative effects on patients with specific health problems, and they have no idea if it will work at all for patients in treating them.

The patient would also be providing their health data to the relevant pharmaceutical company, so this also looks like a nice way for big pharma to get a lot of data while the patient pays for it. I don't think this is necessarily a bad model, if used to create cheap drugs not driven by a profit motive, but it smells a bit fishy when involving companies which create huge mark-ups and and can prevent other manufacturers from benefiting for years or decades.

The non-profit group pushing this proposal is also part of "Heartland Institute", which is a rather conservative group with a history of aggressive climate-change denialism. Their basic goal is less federal regulation of pretty much anything, especially if less regulation is beneficial to business interests. They also do not disclose the sources of their funding.

I think the general proposal is interesting, but only if done in a clearly pro-patient manner. I'd love to see government or non-profit organizations use this type of scheme to create cheap and effective drugs at a very low cost to patients. But I think it's inappropriate to give profit-driven pharmaceutical companies this increased power and decreased oversight.