If this drug has a 98% chance of having no effect, 1% chance of preventing heart disease, and a 1% chance of immediately killing me, it's still in the interests of someone with heart disease to take it.
It's definitely in the interests of humanity as a whole - a few hundred people might be killed in the cavalier hunt for effective drugs, but tens of millions every year will be saved.
Why are so many years of studies/paperwork needed? Why not just produce the drug and let people take it (who know the above risks)? That could happen as soon as this afternoon.
That wouldn't be a proper blinded study, but the results of it would be very strong indications for if the drug should go through the full process to become a standard treatment.
How do you determine those percentages? The reason all these studies are necessary is because biology is hard.
Example: cancers where Ras proteins are mutated are common and also predictive of poorer outcomes. Ras signals through several effector pathways including ones involving BRAF. So if someone develops a BRAF inhibitor, we should call it a day and people should just start taking these? Ooops, turns out this paradoxically enhances Ras oncogenic signaling.. Is it better to find that out 6 months when everyone who's taken these dies, or would these people be better served by doing your beta testing and "years of studies/paperwork" in cancer cell lines and mice?
> Why are so many years of studies/paperwork needed? Why not just produce the drug and let people take it (who know the above risks)? That could happen as soon as this afternoon.
We tried this and got snake-oil and Bayer Heroin. Anyone with questionable scruples who wants to make a buck will have a market of sick and desperate people who are quite literally dying to be told "maybe this will save/elongate your life".
There needs to be a check on perverse incentives, and rigorous research and clinical trials are the solution we've come up with.
It's immoral in a lot of cases, but is it immoral in every case? I don't think so.
Take a person who has a heart condition AND cancer that is 100% certainly going to kill him within a month and has no close family/friends to spend his dying days with. Would it be immoral for them to take a 1% chance of losing a couple crappy weeks to possibly make a huge step forward for science?
These things need to be wielded judiciously, but there are cases where the rewards outweigh the risks to a point a person of sound mind should be able to take the risk for the benefit of humanity.
I'm not involved in research, but recall that ethics review specifically looks for beneficence towards participants, the notion that participants themselves have risk minimized, and that one cannot pursue information to their detriment.
I’m a responsible adult who believes in personal responsibility. Provide the data around efficacy and risk, and allow me to make the informed choice myself.
I am okay dying if I make a mistake in my risk assessment. I would not make the choice for someone else.
Everyone dies. Progress is inherently risky, but necessary.
So long the "informed consent" really is truly informed, and not something that is slanted or otherwise concealing evidence or data. In that case, then I do not disagree with you.
However, considering what we know of how PR and Marketing works, I am inclined to err on the side of "Abundance of Caution and Due Diligence", even in the face of personal responsibility.
Definitely. Making the marketing of pharmaceuticals directly to consumers illegal would go a long way, as well as stronger oversight and governance by regulatory bodies.
Informed? How could you possibly make an informed choice without both a Ph.D. and an M.D. and a decade of experience in drug development in the exact same field? Even then, most developments considered highly promising by teams of people having that exact background end up producing nothing useful. And you just want "the" data around efficacy and risk and to make your own decision. Are you supposed to get real-time updates as each new data point comes in? It just makes zero sense to me.
You are basically not qualified to make that decision. There is no amount of informed consent for either the known unknowns or the unknowns present in say a clinical trial. It would also be a net negative to society because we would get no information outside of proper studies and it would be a huge waste of money.
As immoral as giving a placebo instead of a curative treatment to someone to fulfill the standards of a test?
In the case of medicine research, I think it's OK to let people dictate their own moralities. Try to reduce the chances of abuse, and start increasing results.
> In 2007 this compound was tested in humans as a potential treatment for obesity and type 2 diabetes because it improves cell sensitivity to insulin. The studies, regulated by the U.S. Food and Drug Administration, demonstrated that MSI-1436 was well tolerated at high doses and did not harm patients.
That's a great sign, and a really nice target to choose to develop. This doesn't mean that it will be safe in another patient population (though it'll probably be okay), nor do these animal studies guarantee efficacy in humans. Humans have very different regenerative potentials compared to mice or zebrafish, or a more extreme example: axolotl. Additionally, drugs that target regeneration must walk a fine line between regenerating damaged tissue and overstimulating growth pathways (cancer).
Sure, we should do a study to find out what the percentage chance of immediately killing someone. If it's 1%, we'll go for it, if it's 50%, we'll skip endangering anyone with this drug...wait.
> Why not just produce the drug and let people take it (who know the above risks)?
Because terrible things have been conducted in the name of research [1,2,3] which made humanity decide to form IRB and consider the actual impact on the participant. While you open up the "who know the above risks", what about child/prisoners/mentally disabled people? In current research, these are protected groups specifically because they can't really make these decisions for themselves. Furthermore, we don't know the longer term effects of things. Quaker didn't know radioactive oatmeal to track nutrient absorption in orphans would be harmful [3] and even made the case that "at least we were feeding them". Yes, again they are a protected group, but what if, say, this drug had the statistics you presented, but then 10-20 years later it was discovered that it gradually caused dementia? Simply saying "they knew the risks" is not enough.
In the end, human experimentation is a tricky gray area BECAUSE of the possibilities for misconduct. Someone could be coerced into doing something they didn't need/want to. This is both the annoyance and best thing about IRB. Yes, its annoying that I can't just experiment my novel teaching approach on a subset of students without their consent AND IRB approval, but it is ensuring that my control is getting equal learning opportunities AND my experimental is negatively learning.
It's definitely in the interests of humanity as a whole - a few hundred people might be killed in the cavalier hunt for effective drugs, but tens of millions every year will be saved.
Why are so many years of studies/paperwork needed? Why not just produce the drug and let people take it (who know the above risks)? That could happen as soon as this afternoon.
That wouldn't be a proper blinded study, but the results of it would be very strong indications for if the drug should go through the full process to become a standard treatment.