right to try'/expanded access

[ellie2211]

has anyone made use of the "right to try'" law?

[j-o-h-n]

Ai Overview…

Right-to-try laws allow terminally ill patients to access experimental drugs that have completed Phase I testing but have not yet been approved by the Food and Drug Administration (FDA). The laws are intended to give patients more options and to avoid requiring federal government approval to try to save their lives.

Good Luck, Good Health and Good Humor.

j-o-h-n

[traxcavator]

Hello Ellie,

Speaking about the US, there are two sets of laws. There is a federal right to try about which I know little. There are also state right to try laws.

The state laws vary from state to state. I know the New Hampshire law is in the process of being liberalized. The existing law subordinates everything to the FDA. The bill in the works (which has passed the state house and senate, and only needs the governor's signature) provides that willing, fully informed patients and willing practitioners may try any approved or in trials medication for any condition for which there is no present curative option. This would apply to prostate cancer at any stage beyond where surgery can be a curative option. Existing NH law allows practioners to use any approved medication or treatment 'off-label'.

In the 3 years since I got the verdict, I've done three treatments that appeared to be potentially curative. So far it's been 'whack a mole': We've killed a lot of tumor, and I'm very healthy, but the previous treatments did not elicit the hoped for immune response. The jury is still out on the latest treatment (Irreversable ElectroPoration). If it fails, there are other treatments I'll want to try.

Having been talked at by many oncologists, I think they are not the practioners who may be willing to try things. Interventional radiologists and some urologists and possibly others are much more willing to try. If they are in a state where there is a liberal 'right to try', they don't have to be in fear of losing their license because state medical boards are concerned with state rather than federal law.

I've talked to Amgen about the agent that was called AMG509, and now has an unpronouncable name. They only seem interested in MCRPC. My way of looking at it is: If it's effective for MCRPC, it's likely to be more effective in patients who are healthier and at an earlier stage. Besides which, the pot of gold for early stage disease is likely to be much bigger.

John (If anyone wants to discuss further, I'm very interested in the subject.)

[j-o-h-n in reply to traxcavator]

Thank you for the offer.... but you see, you're an excavator who digs into subjects, I'm just a humorvator who digs into silliness...

Good Luck, Good Health and Good Humor.

j-o-h-n

[fast_eddie]

I know this answer isn't in the spirit of your inquiry but I would 'like to try' psilocybin. Still very much illegal where I live and likely to stay that way. I believe it could help my mental outlook and the evidence is piling up in that direction. It is known to help people with PTSD, addiction and end of life anxiety issues. I voted for marijuana legalization. I wish I could vote for this being legalized even if only in a therapeutic, monitored setting.