Tuesday October 26, 2021; 2:25 PM EDT
- One of the (many, underappreciated) successes of modern medicine is transforming HIV from a death sentence to a nuisance. Even less appreciated is how much better the drugs are: from complex combinations with strange side effects and many drug-drug interactions to a pill-a-day regimen (or two) that does not wreck as much havoc on your cholesterol, sleep, or drug-metabolizing liver enzymes.#
- But unless you are treating these patients you won't really know this, and people designing non-HIV-related clinical trials certainly don't. Which is why anyone with a positive HIV test is routinely excluded from clinical trials, no matter the viral load, no matter the drug regimen they are on. #
- There are at least two reasons protocols give for the exclusion: that there are drug-drug interactions (which is now generally false, or at least as true as any other drug people are taking so then why not exclude a particular drug not the entire disease category); and that their immune systems are "different" which is why immunotherapy or any drug affecting the immune system would not be safe and/or effective — completely neglecting everyone with undetectable viral loads, normal CD4 counts and a normal lifespan.#
- So, I sit on an Institutional Review Board as an unaffiliated member, and there aren't many things that I keep seeing over and over again. But this is one: blanket exclusions of people with HIV for no good reason. Mind you, most of these protocols had to go through the FDA before coming to an IRB, so for all its guidance the Agency still lets this discrimination slide. #
- IRBs get a bad reputation, and a poorly run review board can certainly slow things down. But here is one small way in which they can make a difference, expanding eligibility without affecting how the trial is otherwise done. These small changes add up. It is all the other levels of oversight that a clinical trial needs to get through to even get to an IRB that worry me: they, too, add up.#