Jake's wife on FDA deregulation
https://bessstillman.substack.com/p/the-drugs-killing-dying-...
https://bessstillman.substack.com/p/the-drugs-killing-dying-...
Because those rules are in place for reasons. And some of those reasons are to prevent drug companies from turning the poor into lab rats with no regard to their safety. And I guarantee you, you let "terminal" patients skirt rules, there will be a hell of a lot more "terminal" patients.
And I'm sure there are some non-regulation reasons to limit various therapies. They are trying to see if thing X can help. And if thing X only helps when combined with thing Y, you don't exactly get that information when focusing on thing X. Or the worse scenarios of thing Y making thing X ineffective or harmful.
This was written from a very emotional place, and understandably so. But that state means they are not exactly in a position to consider all the reasons. And it must be frustrating as hell to have tried 40 things that didn't work to only be denied the 41st because you tried too many other things. Especially if that 41st thing turns out to be something that works.
But I don't think the answer is let terminal patients take whatever they feel like.
However, it is probably not socially or politically tenable to kill or harm people with experimental drugs even if it saves a greater number of people. Realistically, I don't see things changing much.
I don't think its fair to dismiss this perspective as "written from an emotional place." As Alex Tabarrok wrote above, both Jake and his wife (a medical doctor) were involved with this issue before his diagnosis.
I don't think anyone has the moral authority to tell anyone else what they can take, especially terminal patients.
I do, however think governments have a responsibility to regulate how drug companies conduct trials so as to minimize harm to patients. This probably has the same outcome in practice, but I find the moral distinction important.
Just because one is terminal, it does not make one an expert in medicine or pharmaceuticals. So it shouldn't be used an exception to the processes in place.
My guess is that consumer safety is being used as an excuse by those who want to control the market via regulatory gatekeepers, to reduce competition. But regardless of what's motivating it, it's illiberal.
Desperation can make us short-sighted and reckless. It’s why most people who are prevented from committing suicide often don’t try again. It’s an act of desperation. We shouldn’t allow drug companies to exploit desperate people.
Assisted suicide has several hurdles you have to jump through. You have to be completely sure from a sound state of mind.
Desperation can cloud even the most rational of minds.
Fraud is one risk -- the much bigger one is well-intentioned people trying to save lives seeing positive outcomes where there aren't any.
These molecules generally don't do anything of substantial value because it's incredibly difficult and expensive to produce a molecule that does anything of value. If you're going to undertake that billion dollar effort, then you're going to want consumers to trust it, pharmacies to carry it (near the medications, not the unproven supplements), and most critically: insurers to pay for it.
You do not have to seek FDA clearance to sell your molecule to consumers. To achieve marketing objectives necessary to recoup the development costs of a working molecule, you choose to seek FDA clearance.
What exactly do you think distinguishes an "experimental drug" that's not going to be put through trials from the thousands of other unproven molecules typically sold on aisles labeled "Supplements" or behind the counter at gas stations? Your hope, belief, or presumption that it actually works?
Actually the way that we prevent pharma companies from using trials to commit fraud of this type is by tightly (very tightly) controlling the language they use to describe drugs that are still under evaluation. Basically every sentence that a researcher makes to a trial participant needs to pass an ethics review board to make sure it's not overselling the promise or underselling the risk.
Yeah it happens a lot more than you think - the entire everything - about USA pharma is absolute evil.
I've pissed off a lot of people in my statements about how chemists are a very unscrupulous profession, and many are downright evil. (you need to really learn about the history of Sandoz, Bayer, Novartis, Du Pont, J&J, Monsanto, and all the others.... <--- LONG history of chemical weapons, chemical poisons, super-sites, deformed babies. The lack of regulation and oversight in the chemical industry has enabled these scandals to occur.
Watch the Devil We Know, for example about Teflon
https://i.imgur.com/vGIcL0d.png
--- [0] https://www.forbes.com/sites/conormurray/2023/09/12/heres-wh...
Yet euthanasia is a very fraught subject in the land of the free. The country may be coming less religious, but the puritanical values remain; every life is precious, even one that's in unbearable, irreversible agony, and those who suffer probably deserve it.
On the other side, my wife worked for a mid-sized pharma in the past. After several rounds of trials that each cost tens of millions of dollars, the FDA couldn't be convinced to approve the drug, despite hearings full of people who were either alive because the drug saved their lives or were hoping to have it approved for future use. After a couple more trials, the company ended up cutting losses and moving on to something else. Again, it feels like there should be some pathway here. Such a drug shouldn't be the first option if others are available, but if there's nothing else or other treatments haven't worked, what's the real harm in letting someone who's going to die anyway give it a shot.
I'm not sure how trust would be eroded by the failure of an experimental drug to treat a terminal case where no other drugs are working.
Their views on clinical trials were understandable given the circumstances. Those regulations were written in blood, miscarriage/birth defects, autoimmune conditions, genetic damage, and other horrors. This is a complicated ethical topic because clinical trials can harm patients and families of patients as much as they can help, and sometimes many years after the fact of the trial. It's not an appropriate discussion in a memorial post.
When else do we discuss it? This is bound to just disappear into history and the government will carry on with business as usual. I feel now’s the time to get people educated and discussing it at depth, when they care about it.