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The unfortunate nature of the seen and the unseen is that we will always notice the times we approved a drug too early or tested too aggressively, but we will n
by kauffj 11y ago
The unfortunate nature of the seen and the unseen is that we will always notice the times we approved a drug too early or tested too aggressively, but we will never notice the deaths that happen because we were too timid or cautious in our approach.
While this case should be studied to ascertain whether process changes could prevent it, the solution is absolutely not further testing, control, and regulation. Hundreds of thousands of people already die or suffer every year because of the paternalistic, conservative policies governing medicine.
- fixermark 11y agoThe solution may very well be more testing, control, and regulation. But there's a difference between minor tweaks to address the root causes of this issue (hypothetical: maybe the drug got contaminated in transit and post-shipping verification of contents needs to be done) and a "Shut it down, shut it all down" reaction. To draw a thin (but perhaps appropriate analogy): after the hijackings of airplanes on September 11th, the United States responded by expanding the air marshall program, significantly jacking up security and restrictions on passengers, and putting combination locks on airplane cabins. Only the last policy, I think, is actually necessary to address what happened on September 11th, and it's all they should have done.
- mkaziz 11y agoPersonally, I like the idea of air marshalls as well. It makes feel safer while flying. The TSA, on the other hand, definitely makes me feel less safe.
- richmarr 11y agoInterestingly air marshalls get arrested more frequently than they make arrests (as of 2010 at least). https://www.schneier.com/blog/archives/2010/04/the_effectivene.html https://www.schneier.com/blog/archives/2010/04/the_effective...
- ared38 11y agoI hate how politicians pander to the base with vague promises to increase or decrease regulation instead of debating to find which regulations are the most effective. Same situation for welfare programs, use of military power overseas, and taxation. There are undoubtedly better ways to use or collect the resources government currently has or even do more with less but they are never considered.
- ocdtrekkie 11y agoThis is pretty much where gun control is right now. Obama was in 'tears' using the Sandy Hook shooting to justify his executive orders, but those executive orders changed nothing that would've prevented the shooting from occurring. The shooter hadn't gotten his weapons through the supposed/alleged 'gun show loophole', for example. It just lets him claim he 'did something', and makes the base democratic voters happy.
- mjevans 11y agoIt is harder and more difficult for me to legally drive a car than it is for me to legally own a gun. All of those things which we require of drivers should be required of those who operate guns.
- JoeAltmaier 11y agoThat's a blanket statement with no supporting argument? How about toasters? How about kitchen knives? Knives actually were controlled devices in many nations. In America, there's this confounding problem of that Amendment. To change anything, that's got to change too.
- refurb 11y agoDriving a car is not a constitutionally protected right.
- ocdtrekkie 11y agoIt certainly isn't here in Illinois, yet gun violence certainly isn't any better here. But the point is, the political rhetoric was completely disingenuous, and unrelated to the laws in question. We need to fix our violence problem, nobody disagrees about this. But it seems like many Democrats, like Obama, are convinced the only right way to do that is making it more difficult for gun owners to buy guns. Rather than say, targeting actual problems with a clearly defined link to the crime: Many school shooters steal guns from family members. If Obama actually wanted to reduce shootings, he'd look into how to solve that, rather than pursuing a party agenda instead.
- knodi123 11y ago> after the hijackings of airplanes on September 11th, the United States responded by creating the air marhsll program No, just expanding it. It has existed since the 60s.
- fixermark 11y agoThank you for the correction. Updated the original.
- Retric 11y agoIf you actually look at lives saved from each years new drugs per year it's vastly smaller than drug related deaths in that year. We might push back a few months or toss caution to the wind and add ~2 years, but the costs in lives and healthy would be very high. Where do you draw the line? PS: Prescription drugs already make some top ten killers lists in the US, there far less safe than generally assumed.
- vonmoltke 11y agoWhat percentage of those are intentional misuse?
- woah 11y agoIs an opiate addiction acquired medically "intentional"?
- Retric 11y agoDepends, an estimated 50% of prescribed drugs are proving zero benefit to the patent. Doctors frequently just pick something to get people out of their offices. So, misuse by someone is very high, but hard to pin down.
- MBCook 11y agoI know opiate addiction and death is a real problem, but do you have a source for the "kills more than saves per year" claim? I've never heard that before.
- Retric 11y agoThey are very different numbers. A small number of new drugs get on the market every year vs. every drug that ever entered the market. One way of comparing these numbers is to look at changes in life expectancy. But that changes very slowly suggesting minimal change per year from one years new drugs. Actual deaths from prescription drugs are also hard to measure, but generally assumed at well over 20,000 per year. http://www.voxeu.org/article/genuine-innovation-new-drugs-save-lives http://www.voxeu.org/article/genuine-innovation-new-drugs-sa... Call it ~6-12 months lost vs. ~1-2 months gained. Though the clear upside is those gains should stack year over year. Just not when you compare introducing drugs a few months early as they would have made it to the market anyway. PS: The clear conflict of interest is the fairly short lifespan of drug patents.
- tomkinstinch 11y agoPrimum non nocere (first, do no harm[1]) Medical research is conservative, cautious, and regulated because we strive to move beyond the ugly abuses of our past[2]. It should not be the Wild West. For insight into modern medical ethics, read the Belmont Report[3]. It's what contemporary researchers must read before conducting any studies involving human subjects. Where I work, we're tested on it. (This is opinion, but...) Harm today is in research guided more by profit than by benefit. Chronic disease is more profitable than cures or prevention. With rapidly-emergent antibiotic resistance there is little private incentive to develop new antibiotics. We must rely on and expand research in the public interest (funded by NIH, philanthropy, and so on) to balance private biomedical research. 1. https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere 2. https://en.wikipedia.org/wiki/List_of_medical_ethics_cases https://en.wikipedia.org/wiki/List_of_medical_ethics_cases 3. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
- burke 11y ago> Primum non nocere As kauffj eludes to though, it's also worth considering the implicit harm done through inaction. It should not be the wild west, but conversely, articles like this are indicative of a bias toward increasing prevention of active, explicit harm at the expense of more unseen, implicit harm through inaction. As with anything, there's a happy medium.
- scarmig 11y agoA happy medium is good, but I'd say that that "medium" falls closer to the conservative side. A lot of the value of "First, do no harm" comes from the point that we have a bias toward action over inaction. Humans, including doctors, want the ability to control our futures. So the temptation is constantly to do something instead of saying "well, that sucks, but we don't have strong reason to believe anything we do will substantially improve things." That's why we perform way too many interventions (particularly, invasive and surgical ones) that at best marginally improve average outcomes at incredible cost and substantial risk. Doctor and patient both want a magic fix. And all too often the fix is more harmful than helpful to the individual patient, even if on average it might be slightly beneficial. Obviously there's a place for heroic surgical efforts and research into exotic drugs. But we over invest in those compared to the alternatives of prevention and palliation. Conservatism is useful in medicine.
- curun1r 11y agoMaking no point about whether further control/regulation is appropriate, I'm not sure I like your logic. Treating lives as some fungible resource where the ends justify the means and whatever process results in the most living people at the end shouldn't be correct. I sympathize with all the sick people who will die, but they were mostly selected for death naturally. The man who died (or will, as soon as life support is removed) was healthy prior to this study. Much like our justice system is supposed to value not punishing the innocent over punishing the guilty, our medical system is supposed to value not hurting the well over helping the sick. The hippocratic oath embodies this "first do no harm" principle.
- logingone 11y agoThere's a train on the tracks, heading for a group of people, and on a fork on the tracks one person.... etc. (trolley problem).
- kens 11y agoI recommend this amusing parody of the trolley problem: http://www.mindspring.com/~mfpatton/Tissues.htm http://www.mindspring.com/~mfpatton/Tissues.htm
- eanzenberg 11y agoFalse analogy. These were healthy individuals who opted into a drug study.
- RHSeeger 11y ago> Treating lives as some fungible resource where the ends justify the means and whatever process results in the most living people at the end shouldn't be correct. To be fair, while that is generally considered the "right thing", it is reasonable to debate it. The question of "at what point does the welfare of the many outweigh the welfare of the few" is a rather complex one. One question that I think highlights this well is... > There's a train headed for a group of 5 people that it will kill. You can flick a switch and make it take another track. However, doing so will make it run over 1 (different) person. Do you flick the switch? Edit: To be clear, I'm not saying I believe that the needs of the many always outweigh the needs of the few. I'm only saying it's not as cut and dry as some people seem to say it is. It's something that should sometimes be discussed based on the situation.
- mikeash 11y agoIf we don't notice those deaths, how do you know they number in the hundreds of thousands?
- nnq 11y ago100% agree, and I'd add the fact the there are not enough trials for drugs that instead of curing illness do thing like slowing aging or improving mental performance or otherwise improving physical or mental performance for healthy people, simply because most people are retarded enough to think that it's not ok to risk lives for purposes like "improving IQ by 10%" or "increasing lifespan by 10%". We should absolutely make drug trials easier and cheaper to do, and also make it easier to test drugs that seek to do other things than fixing illnesses. Not freak out because of some accidents and add even more regulation. And yeah, we probably need more regulation, but for things like production, use and sales (like state-imposed price ceilings would come to mind for drugs). But we definitely want LESS regulations for research and testing! Despite tragic incidents like this one.
- pmiller2 11y agoThis drug was tested on chimps before humans. It's right in the article.
- nnq 11y agoMy bad. I've read about this from a different source, not the linked article, and it omitted this piece of information. I've deleted my last line comment concerning this, but it doesn't affect what I was trying to say, which was more in relation to the parent comment than to OP's linked article anyway.
- anonymfus 11y agoPeople participate in drug trials as volunteers. Lowering their risks is important for increasing number of them.
- yAnonymous 11y agoMaybe if the pharma industry wasn't one of the most disgusting, untrustworthy and despicable industries around, there'd be more tests. The way things are, it's good to be careful.
- Gatsky 11y agoYour argument misses one crucial issue: what is the probability that a drug at this stage of testing will A) work and B) be safe such that it becomes a valid standard of care treatment? If the probability is really low, then less caution will result in cases like these outcompeting the incremental benefit to humanity. I'll give you a hint. The probability is really low.
- deleted 11y ago[deleted]
- anigbrowl 11y agowe will never notice the deaths that happen because we were too timid or cautious in our approach Garbage. We already know about the death toll from disease, because that's what motivates us to develop drugs in the first place. We are in fact well aware of the opportunity cost, and the notion of opportunity cost is fundamental in economics, and the people who work at regulatory agencies are in fact quite familiar with the the cost:benefit ratios involved. You know, one of the really irritating things about libertarians is their habit f going about restating basic truisms of economics as if they're some great new discovery. Your approach has already been tried and found wanting. Every time I hear this argument I think of all the people I saw with horrific deformities growing up because their mothers were prescribed Thalidomide during pregnancy. Your economic argument falls apart as soon as you start accounting for externalities instead of waving them away as the price of progress.