Hacker News Reader

Comment by dekhn | Hacker News Reader

Typically what happens is that the new treatments with bad side effects are given to the sickest patients (who have exhausted all other mechanisms), rather than to the bravest souls with less dire current circumstances.

This makes some sense in terms of compassion and matching new experimental techniques with patients with no hope, but it skews the results highly negative because the patients are already very close to death's door. It does not provide an accurate signal for what the results would be if we gave them to less sick people.

I don't think any of this can be changed without large-scale social acceptance of greater risk in clinical trials and significant support from the government.

View on HN

> It does not provide an accurate signal for what the results would be if we gave them to less sick people.

It provides an excellent signal because we want to prove that these drugs are doing something that the standard of care is unable to.

There's this sense that medicine is easy and some evil cabal are limiting health to their cronies. Most medications never get to trial for their intended indications, and most fail trials. There's no reason to believe oncology medications are somehow uniquely unlikely to go through this well-described process of failure.

I think you misunderstood my point. Results in extremely ill patients don't correlate well with results in mildly ill patients (in cancer), so the signal you get from extremely ill patients is not predictive- it may be a drug fails in extremely ill patients, but would have worked great on the mildly ill patients- basically a false negative.

> I don't think any of this can be changed without large-scale social acceptance of greater risk in clinical trials and significant support from the government.

I agree with you about significant financial support from the government if that support is financial and given to smaller groups.

I disagree about societal acceptance though. I feel like your point of view may be missing clinical trials and treatments in the USA. The laws we have are written in blood, and the laws more sophisticated than I think you appreciate.

There are various options for fast-tracking drug development if the conditions are serious enough or the drugs promising enough. I suggest actually reading about how these processes work, and the history of what happens when we don't have these protections, before deciding that approvals are overly cautious.

You are explaining clinical trials to somebody who works in pharma (speccifically a company with many cancer drugs that already got approved). I'm pretty familiar with the area already- for example, I know the drug thalidomide, which was part of the origin story of the FDA, is still prescribed widely as an anti-cancer drug.

Reply on news.ycombinator.com