Does anyone know the legality of using these cancer drugs for off-label uses? What would be the medical implications for doing so? (i.e. risks, side-effects, etc.)

Well, I was half-wrong about off-label use. Apparently the FDA cannot prohibit Off-label use – a physician can proscribe specific drugs for off-label use, and apparently they do so frequently. However, the manufacturing companies cannot legally promote the drug for off-label use (no print ads, no TV commercials, no advocacy).

So the makers of decitabine and gemcitabine would have to reapply for New Drug Application in order legally promote them in HIV treatment, but in the interim, a physician could prescribe the drugs for off-label use.

I’m not a physician, so I couldn’t comment on the side-effects/risks.

But then, I’m reminded of former HHS Secretary Margaret Heckler who boldly announced that because they had discovered the virus which causes AIDS, “We hope to have a vaccine ready for testing in about two years.” That was in 1984.

Does anyone know the legality of using these cancer drugs for off-label uses? What would be the medical implications for doing so? (i.e. risks, side-effects, etc.)

The two drugs, decitabine and gemcitabine — both FDA approved and currently used in pre-cancer and cancer therapy

Neither of these drugs are currently used to start lethal mutagenesis in the cancer cells they are used to treat. Their agency in fighting cancer is by a different mechanism. I imagine that they would need to be re-certified for use in HIV treatment.