Hypothetical FDA debate

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Aedl Foxe
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Hypothetical FDA debate

Postby Aedl Foxe » Tue May 03, 2011 7:58 pm UTC

Suppose, for the sake of this argument only that the following statistics are true:

Probably fictional source wrote:The FDA's long approval process prevents 10,000 casualties per year by screening off medications found to be harmful, and causes at least 20,000 casualties per year just by delaying approval of those beneficial medications that are still developed and eventually approved.


Should this probably fictional FDA shorten and relax its approval process, so as to save the 20,000 at the cost of the lives of the 10,000? Or does the FDA have a duty to "do no harm", and therefore it's more morally important to protect the 10,000 than cure the 20,000?
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Re: Hypothetical FDA debate

Postby Роберт » Tue May 03, 2011 8:01 pm UTC

Perhaps the fictional FDA should have some sort of partial-approval process for drugs that aren't safe but could save lives. Isn't there already something like this, though?
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Re: Hypothetical FDA debate

Postby broken_escalator » Tue May 03, 2011 8:21 pm UTC

I think getting into drug trials for not-released drugs could be what you're thinking of. But you run the risk of being in the control group, assuming you even get in. I know that for Parkinsons drug tests they do it for Phase II or III testing, as opposed to Phase I on healthy people to make sure the medicine dosages are right and stuff.

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Re: Hypothetical FDA debate

Postby Dark567 » Tue May 03, 2011 9:03 pm UTC

Роберт wrote:Perhaps the fictional FDA should have some sort of partial-approval process for drugs that aren't safe but could save lives. Isn't there already something like this, though?

From my understanding of pharmaceutical testing, generally the more life threating your illness, the more likely they will proscribe you a test drug that could kill you. If your going to die unless you a experimental drug might work, why not try the risky experimental drug?

That doesn't work for all situations though. Liptor has probably saved a few thousand lives, yet isn't something you could give to someone who was near dying and expect to save their life. So preventing testing on things like that could be currently preventing lives being saved. Its hard to say though. But if your fictional stats are right for a drug like this, than yes, I would say relax the approval process.
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Re: Hypothetical FDA debate

Postby Little Richie » Wed May 04, 2011 1:09 am UTC

Роберт wrote:Perhaps the fictional FDA should have some sort of partial-approval process for drugs that aren't safe but could save lives. Isn't there already something like this, though?


My grandpa was prescribed a few "trial" treatments throughout his lifetime. He was friends with a few of his doctors, and in that time, he tells me getting approval for the drugs was much easier. He had some odd side effects on some of the treatment, but overall the net effect was positive.

Personally, I think, if you accept the risks, experimental drugs should be administered. This "open" process could accelerate the approval rate of drugs, as well as potentially increase the feasibility and accuracy of studies.
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Re: Hypothetical FDA debate

Postby Goplat » Wed May 04, 2011 1:27 am UTC

Aedl Foxe wrote:Should this probably fictional FDA shorten and relax its approval process, so as to save the 20,000 at the cost of the lives of the 10,000?
Not necessarily. The statistics say that no approval process is better than a long process, but maybe a super long process could be even better! As long as we're making up statistics, imagine a situation like this, where the current process is too short to recognize most bad drugs:

Code: Select all

Approval   | Deaths from | Deaths caused |     Net
process    |   bad drugs |   by delaying |   lives
length     |   prevented |    good drugs |   saved
-----------+-------------+---------------+--------
None       |           0 |             0 |       0
Short      |       2,000 |        10,000 |  -8,000
Long       |      10,000 |        20,000 | -10,000
Super long |      50,000 |        30,000 | +20,000

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Re: Hypothetical FDA debate

Postby Aedl Foxe » Wed May 04, 2011 1:36 am UTC

Goplat wrote:

Code: Select all

Approval   | Deaths from | Deaths caused |     Net
process    |   bad drugs |   by delaying |   lives
length     |   prevented |    good drugs |   saved
-----------+-------------+---------------+--------
None       |           0 |             0 |       0
Short      |       2,000 |        10,000 |  -8,000
Long       |      10,000 |        20,000 | -10,000
Super long |      50,000 |        30,000 | +20,000


*snerk* Point noted.
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Re: Hypothetical FDA debate

Postby Abgrund » Wed May 04, 2011 4:15 am UTC

I'm betting the "fictional" source is funded in one way or another by drug companies...

I wonder how they estimated how many people would have used the bad drug that was kept off the market, or the good drug that was delayed. It's not like everyone who has X ailment is guaranteed to use Y brand new treatment.

Another factor, which I suspect was not included, is the number of people killed by using drugs which were harmless or even somewhat beneficial, but were approved even though superior treatments were available.

The numbers are also likely to be skewed by time bias. They are based on drugs which have presently been approved or rejected, but there are sure to be approved drugs, now in use, which turn out to kill (perhaps have already killed) some people.

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Re: Hypothetical FDA debate

Postby BattleMoose » Wed May 04, 2011 4:26 am UTC

I am not entirely familiar with how the FDA operates, but going to guess that an important part of their mandate, "is to approve safe drugs," rather than to save the most, net, amount of lives.

As an individual seeking medical treatment, you want to know or at least be very confident that the drugs being prescribed to you are going to be safe. The net benefit to society matters very little on an individual level. And if you are like me, viewing the rights of the individual as being paramount in all moral situations, then it would be immoral to issue a potentially unsafe drug, to an individual with the reasoning that this behavior will save more lives on a societal level.

I do of course view it as being perfectly acceptable for the individual to take the risk of taking an unsafe drug for treatment, fully understanding the risks involved.

If it takes a long time to determine whether or not a drug is safe, then it takes a long time.

Of course, how safe is defined is really going to be a new and potentially detailed discussion...

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Re: Hypothetical FDA debate

Postby Dark567 » Wed May 04, 2011 5:07 am UTC

BattleMoose wrote:I am not entirely familiar with how the FDA operates, but going to guess that an important part of their mandate, "is to approve safe drugs," rather than to save the most, net, amount of lives.
That's a bug not a feature of the FDA. Besides, if you viewed individualism as strongly as you do, there wouldn't be bans on bad drugs. The FDA would only make recommendations, not mandates.
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Re: Hypothetical FDA debate

Postby Randomizer » Wed May 04, 2011 5:28 am UTC

I think the number of deaths alone isn't a sufficient metric. Are we protecting 10,000 people who would have taken a medication which is "beneficial" rather than "necessary for survival", and would have 4-6 more decades of life without it? And is this at the expense of 20,000 people who are terminally ill, and by "saving them" we really mean extend their lives by a year? Then the FDA is saving 380,000 - 580,000 life-years with their lengthy approval process, and going by that measure it should stay in place.
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Re: Hypothetical FDA debate

Postby Iulus Cofield » Wed May 04, 2011 10:24 am UTC

I'm going pitch a tent in the "these statistics are misleading" camp.

Let's consider alternatives to the current FDA process. Obviously drug companies will still want to do at least some testing, as a totally ineffective(oh wait) clearly harmful drug won't sell for long and ultimately damage their profit margins. So some testing would still happen, even in the absence of FDA regulations. My fear in that environment is that only enough testing will be done to show that there are not particularly horrible short term side effects and at least mild efficacy. Any mere reduction of the FDA approval process would probably have a similar result, with drugs that could potentially give you a heart attack after a few years still going onto the market because they weren't tested adequately.

So, is that so bad? I think so, although I'd love to hear counter-arguments. The problem with the numbers presented are they assume way too much. If a drug doesn't pan out, which happens a fair amount of the time (I assume?), then delaying its release doesn't mean 20k people's lives were lost meaninglessly. It means 20k people who would have died with an ineffective drug died without using an ineffective drug. How could so many to-be-tested drugs turn out to be winners that OP's numbers are right? Does that number include drugs that never get to the first stage of FDA testing because early tests by manufacturers indicate they are likely to have too many side affects or lack efficacy? Would manufacturers push these likely to be faulty products through if FDA testing was more lax?

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Re: Hypothetical FDA debate

Postby Aedl Foxe » Wed May 04, 2011 5:04 pm UTC

Dark567 wrote:Besides, if you viewed individualism as strongly as you do, there wouldn't be bans on bad drugs. The FDA would only make recommendations, not mandates.


I'm not entirely sure if you're right on that point. Most individuals don't interact with the FDA directly; they interact with their doctors (and with advertisers). If the FDA didn't issue mandates, they'd be placing the burden of responsibility onto the shoulders of the doctors, which not only would be unfair to said doctors, but would give advertisers the ability to take horrid advantage of the malleability of the consumer's opinions. I reckon the FDA plays a very important role in protecting people.
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Re: Hypothetical FDA debate

Postby rigwarl » Wed May 04, 2011 5:54 pm UTC

I'm a bit biased as an FDA employee so I won't say too much (some of the comments in here offend me, despite intending to be 100% benign as far as I can tell), but I do want to point out that these factors are certainly taken into consideration- that's an understatement really to how much work is being done to evaluate drug risk. As for the hypothetical numbers, they could go either way as Goplat noted and there is no way for anyone to know for sure, so we humans do the best we can.

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Re: Hypothetical FDA debate

Postby Роберт » Wed May 04, 2011 6:27 pm UTC

rigwarl wrote:I'm a bit biased as an FDA employee so I won't say too much (some of the comments in here offend me, despite intending to be 100% benign as far as I can tell), but I do want to point out that these factors are certainly taken into consideration- that's an understatement really to how much work is being done to evaluate drug risk. As for the hypothetical numbers, they could go either way as Goplat noted and there is no way for anyone to know for sure, so we humans do the best we can.

I'm curious what here was offensive to you.
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Re: Hypothetical FDA debate

Postby iChef » Wed May 04, 2011 7:16 pm UTC

I'm a little curious on where the cut off is for saving a life. Let's say we have a new drug for treating eyebrow cancer. Untreated your average eyebrow cancer patient only lives another 5 years. In this study we are going to give our new drug (Ojopelocil) to 100 patients. The results were:

2 patients died two weeks into the study from a severe side effect of our drug.
18 more died after three years of treatment.
40 patients died 5 years after.
35 patients died after 6 years of treatments.
5 patients died after 12 years of treatments.

So how many lives did our drug save? Was it 40 lives, the total number of people who lived longer than expected? Do we only count the 5 who lived much longer than the expected time? What about the total number of years of life. We reduced the life span of 20 of our test subjects by a total of 64 years. Over 3 years per person, but we increased the life span of 40 patients by 95 years, a little over 2 years per person.

My question here is in the original post we saved 10,000 lives and caused 20,000 deaths. Of these 20,000 how many years off their lives did they lose? If each of these 20,000 would have only been spared for another year or so would it be worth it to rush a drug to market that might harm people that otherwise would have had many years ahead of them.

The FDA's job is much harder than the media makes it out to be. I would rather have them intensively test each drug on the market, than rush them out haphazardly. I'm going to say the FDA doesn't cause any deaths by withholding drugs. It is sad that people die of diseases, the the science of curing said diseases is tricky and it is better to get it right rather than throwing a bunch of pills against the public and seeing which ones stick. I don't know how much at ease I would be with a treatment that gave me an extra year of life knowing that several people gave a decade of theirs before all the kinks were worked out.
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Re: Hypothetical FDA debate

Postby zookap » Wed May 04, 2011 9:21 pm UTC

rigwarl wrote:I'm a bit biased as an FDA employee so I won't say too much (some of the comments in here offend me, despite intending to be 100% benign as far as I can tell), but I do want to point out that these factors are certainly taken into consideration- that's an understatement really to how much work is being done to evaluate drug risk. As for the hypothetical numbers, they could go either way as Goplat noted and there is no way for anyone to know for sure, so we humans do the best we can.


You're an FDA employee? How can you feign offense at any of this? The FDA's "approval process" works to protect the economic interests of food companies, specifically Monsanto, not to protect the health interests of people. Just look at the kinds people who get the join the FDA.

Michael Taylor, who left his first position at the FDA to spend a couple decades in a law firm that represented Monsanto now returns to the FDA as the "food czar."

Then there is Margaret Miller, a researcher for Monsanto. In order to evaluate whether or not Monsanto's rBGH was safe for humans, a scientific report was required. Margaret Miller wrote that report and shortly before Monsanto submitted it, she left to be hired at the FDA where her first job was to decide whether or not to approve the report she wrote.

The list goes on but that is not even the important part. For chist's sake the USDA is in the middle of allowing Monsanto to preform it's own GMO food studies! Look up senate bill 510, the "food safety and modernization act" and tell me that food corporations had nothing to do with it. Now take a look at some of the poisons that it is legal and "safe" to put into our foods. Do your own research. You will be overwhelmed with the amount of studies that have been done showing that ingredients like aspartame, msg, hydrogenated oils, and even colorings like red 40 are ANYTHING but safe. Now take a look at some of the pharmaceuticals that get approved. These drugs are some of the most toxic chemicals on earth.

Come on people how has nobody said any of this stuff yet? The first or second reply should have brought it up. You all just TRUST them...? I mean, when I hear "FDA" the first thing that comes to mind is not "oh do you think maybe they should shorten or ease up on their approval process?" it is "How can anyone be stupid enough to put the approval process solely in their hands in the first place? We all need to be looking over their shoulders RIGHT NOW!" The FDA's approval holds literally no merit as far as I am concerned. If they can approve aspartame and rat poison (the most common active ingredient in pharmaceuticals is RAT POISON) for human consumption then they have no business existing. They are their to keep us safe and that simply isn't happening. I am pretty sick and tired of not being able to but anything I see in the supermarket because I KNOW that it causes cancer or literally causes by brain to disintegrate. Stop falling for their bullshit! Much of it is done out in to open and everyone still fucking falls for it?! COME ON PEOPLE!!!
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Re: Hypothetical FDA debate

Postby Aedl Foxe » Wed May 04, 2011 9:26 pm UTC

zookap, please remember that this is a hypothetical debate over probably falsified statistics, and has no bearing upon the real FDA in the real world. Please keep your rants against the politics and morality of the real-world FDA out of this discussion; it has no place here.
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Re: Hypothetical FDA debate

Postby zookap » Wed May 04, 2011 9:37 pm UTC

Aedl Foxe wrote:zookap, please remember that this is a hypothetical debate over probably falsified statistics, and has no bearing upon the real FDA in the real world. Please keep your rants against the politics and morality of the real-world FDA out of this discussion; it has no place here.


I know this debate has no bearing on reality but I don't understand why allusions to reality would be unwelcome. My post was not so much a reply to this hypothetical debate as it was a response to the FDA employee taking offense to it.

P.S. What is it with xkcd forums and people constantly whining about what specific arguments they do not want tainting the perfection of unimportant threads?

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Re: Hypothetical FDA debate

Postby Aedl Foxe » Wed May 04, 2011 9:46 pm UTC

zookap wrote:I know this debate has no bearing on reality but I don't understand why allusions to reality would be unwelcome. My post was not so much a reply to this hypothetical debate as it was a response to the FDA employee taking offense to it.

P.S. What is it with xkcd forums and people constantly whining about what specific arguments they do not want tainting the perfection of unimportant threads?


Because the format of the OP-response implies that replies should relate directly to the OP, or at least the debate that stems from the OP. The Private Message system was built specifically for side conversations. You're not responding to the hypothetical debate, you're responding to the FDA employee.

This is, I believe, a well-accepted tenant of forum etiquette. If I'm incorrect, would someone else please correct me, so I might modify my expectations accordingly?
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Re: Hypothetical FDA debate

Postby Роберт » Wed May 04, 2011 9:57 pm UTC

zookap wrote:
Aedl Foxe wrote:zookap, please remember that this is a hypothetical debate over probably falsified statistics, and has no bearing upon the real FDA in the real world. Please keep your rants against the politics and morality of the real-world FDA out of this discussion; it has no place here.


I know this debate has no bearing on reality but I don't understand why allusions to reality would be unwelcome. My post was not so much a reply to this hypothetical debate as it was a response to the FDA employee taking offense to it.

P.S. What is it with xkcd forums and people constantly whining about what specific arguments they do not want tainting the perfection of unimportant threads?

Basically, he was offended by what was said on this thread (even though nothing offensive had been said yet), so you decided to post something actually offensive for him?

Funky theories about how the real world FDA is corrupted by lobbyists in legislators' pockets completely detracts from the ethical discussion we are trying to have in Serious Business, regardless of the truthiness of those theories.

Really, the question boils down to a morality question that comes up a lot in different forms, and adds an interesting perspective. "Is it okay to do harm in order to do more good?" Examples would be: Pro-life people deciding if it is okay to kill a "baby" that is probably going to die to protect a mother that is probably going to die. http://www.nytimes.com/2010/05/27/opini ... ice&st=cse
Clearly, some choose yes, and some choose no.

Or the Morality in Watchmen thread: killing millions of innocents to save the world.

However, the situation in this thread is, IMO, somewhat different since it's a weird probability game. I think that someone following Deontological Ethics could well say that it is wrong to kill to save (in the pro-life abortion argument and the morality in watchmen argument) and yet say that it is okay to give risky experimental drugs in order to save.

My view is, if the probabilities are right and the person in question (or whoever is legally responsible for the decision) is informed of the risks, it's perfectly ethical to give them drugs that may kill them in an attempt to save them, even if you are deontologically saying that killing is wrong.
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Re: Hypothetical FDA debate

Postby zookap » Thu May 05, 2011 3:36 am UTC

Роберт wrote:Basically, he was offended by what was said on this thread (even though nothing offensive had been said yet), so you decided to post something actually offensive for him?

Funky theories about how the real world FDA is corrupted by lobbyists in legislators' pockets completely detracts from the ethical discussion we are trying to have in Serious Business, regardless of the truthiness of those theories.


I did not post what I posted because I thought it would offend him, I posted it because it is TRUE.

What is the purpose of this hypothetical discussion? Is it to just talk about a 100% hypothetical situation that has literally no point in reality or is it so once the discussion comes to a close (and hopefully to a conclusion) we can apply what we have learned to real life? I posted these things because I thought it was the later. If I am not allowed to talk about reality, then how is this a "weighty issue" or a "worldly matter?" It's really hard to detract from this discussion if we aren't ever supposed to compare it to reality.

Now, go look up what I said before you imply that it isn't true. Calling the fact that aspartame is causally linked to pancreatic cancer, brain lesions, blindness, impotence, birth defects, memory loss, and fucking shit like that is like calling the fact that our president is black a "theory."

Aedl Foxe wrote:This is, I believe, a well-accepted tenant of forum etiquette. If I'm incorrect, would someone else please correct me, so I might modify my expectations accordingly?


It's also a well-accepted tenant of forum etiquette that I will kick you right the hell out if you're unwilling to maintain a modicum of decorum. Insulting other posters needs to stop.

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Re: Hypothetical FDA debate

Postby Aedl Foxe » Thu May 05, 2011 3:46 am UTC

zookap wrote:What is the purpose of this hypothetical discussion? Is it to just talk about a 100% hypothetical situation that has literally no point in reality or is it so once the discussion comes to a close (and hopefully to a conclusion) we can apply what we have learned to real life? I posted these things because I thought it was the latter.


You're close, but slightly off the mark. Hopefully we will all come away having learned something from this exercise, but in its essence, that thing we're trying to learn has nothing to do with the FDA. Our topic transcends the FDA; I'm using this fictional FDA as a tool to facilitate understanding of the core question being asked, which has nothing to do, at its core, with the FDA.

Coming into this thread with complaints about the real-world FDA is almost as bad as if we were modeling a theory of predatory patterns using velociraptors, and the discussions included illustrations, and you came in and complained that velociraptors actually had feathers. You're just missing the point.
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Re: Hypothetical FDA debate

Postby pizzazz » Thu May 05, 2011 4:08 am UTC

There's lots of talk of the FDA "saving lives." In reality, I don't see how the FDA can possibly save lives. It can't make anyone take anything, it can only prevent them from taking it. The choice to take a particular drug lies entirely with the patient and his or her doctor. The only thing the FDA can do is to take away an option that might or might not save that person's life. That is a strictly worse choice than having more options.

And before I get jumped on by people pointing out that companies would sell dangerous or ineffective drugs... they already do. "Herbal supplements" and related products abound, despite having no known benefit. Someone else already linked to homeopathy. Who knows what's available on the black market, or over the border.

The other factor that must be taken into account is the research that just never happens. Similarly to how taxes causes inefficiencies and losses in the economy, massive required costs added on to every drug produced reduces the research that is done on medicines. Looking at Goplat's example, I can only think that if the approval process were really that long (it's already long enough to catch plenty, and I would expect diminishing returns on regulation anyway, since the longer a drug has survived the process, the more likely it is to be safe), there would be no drugs for the FDA to approve. Backup facts: the cost of approving new drugs already averages in the hundreds of millions, and the FDA has only approved 9 new antibiotics in the last 15 years (only 2 of which utilize new mechanisms, which is essential for combating antibiotic resistance) (http://www.osnsupersite.com/view.aspx?rid=76681).

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Re: Hypothetical FDA debate

Postby Aedl Foxe » Thu May 05, 2011 4:16 am UTC

pizzazz wrote:There's lots of talk of the FDA "saving lives." In reality, I don't see how the FDA can possibly save lives. It can't make anyone take anything, it can only prevent them from taking it. The choice to take a particular drug lies entirely with the patient and his or her doctor. The only thing the FDA can do is to take away an option that might or might not save that person's life. That is a strictly worse choice than having more options.

And before I get jumped on by people pointing out that companies would sell dangerous or ineffective drugs... they already do. "Herbal supplements" and related products abound, despite having no known benefit. Someone else already linked to homeopathy. Who knows what's available on the black market, or over the border.


I won't answer the point I didn't quote, because I have no rebuff; it's a good point. However: the problem with the scenario above is the question of trust. Even though companies will sell dangerous or ineffective drugs, no competent doctor would recommend them. And doctors can't read every medical journal to see which drugs have been positively peer-reviewed, so they rely on the FDA to tell them what is and isn't safe, to some degree. So the FDA endorsing an unsafe product violates the trust of the doctor, and in turn the trust of the patient in the doctor's credibility.
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Re: Hypothetical FDA debate

Postby ++$_ » Thu May 05, 2011 4:26 am UTC

zookap wrote:I did not post what I posted because I thought it would offend him, I posted it because it is TRUE.

What is the purpose of this hypothetical discussion? Is it to just talk about a 100% hypothetical situation that has literally no point in reality or is it so once the discussion comes to a close (and hopefully to a conclusion) we can apply what we have learned to real life? I posted these things because I thought it was the later. If I am not allowed to talk about reality, then how is this a "weighty issue" or a "worldly matter?" It's really hard to detract from this discussion if we aren't ever supposed to compare it to reality.

Now, go look up what I said before you imply that it isn't true. Calling the fact that aspartame is causally linked to pancreatic cancer, brain lesions, blindness, impotence, birth defects, memory loss, and fucking shit like that is like calling the fact that our president is black a "theory."
Dude, you're actually 100% wrong. Perhaps you've been mislead by the aspartame chain letter hoax?

Here's a fairly recent meta-analysis of the aspartame data: http://informahealthcare.com/doi/abs/10.1080/10408440701516184

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Re: Hypothetical FDA debate

Postby Seraph » Thu May 05, 2011 5:40 am UTC

iChef wrote:I'm a little curious on where the cut off is for saving a life. Let's say we have a new drug for treating eyebrow cancer. Untreated your average eyebrow cancer patient only lives another 5 years. In this study we are going to give our new drug (Ojopelocil) to 100 patients. The results were:

2 patients died two weeks into the study from a severe side effect of our drug.
18 more died after three years of treatment.
40 patients died 5 years after.
35 patients died after 6 years of treatments.
5 patients died after 12 years of treatments.

So how many lives did our drug save?

I don't think your example shows the FDA's job is hard. Assuming I understand my statistics right - If I were the FDA and you presented me with this data and asked that question the answer would be some variation on "no lives were saved", probably something like "The data provided is insufficient to show that your drug is an effective treatment for extending the lives of eyebrow cancer patients".
Untreated patients average 5 years. A quick test suggests the 95% confidence interval for the mean of your sample is 4.84 - 5.64, which includes the 5 year life expectancy of untreated patients.

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Re: Hypothetical FDA debate

Postby Randomizer » Thu May 05, 2011 6:24 am UTC

pizzazz wrote:There's lots of talk of the FDA "saving lives." In reality, I don't see how the FDA can possibly save lives. It can't make anyone take anything, it can only prevent them from taking it. The choice to take a particular drug lies entirely with the patient and his or her doctor. The only thing the FDA can do is to take away an option that might or might not save that person's life. That is a strictly worse choice than having more options.

I disagree with it being "strictly worse". See Gov't: Some Products Falsely Claim to Treat STDs - Agencies Warn Makers of Unproven Treatments for Sexually Transmitted Diseases
“These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” the FDA’s Deborah M. Autor, JD, says in a news release. “Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners.”

I think the odds of these companies making up the claims to sell snake oil to people are a lot higher than them actually having a working treatment that they just couldn't afford to do the testing for.

Anyway, it's not like people can't buy weird stuff in an attempt to self-treat, it's just that companies can't claim their products do things they haven't been proven to do. I mean, what's the difference between rat poison, which anyone can buy, and an anticoagulant drug made of rat poison which you'd need a prescription for? For the drug version, they tested it to make sure they got the dosage right.
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Re: Hypothetical FDA debate

Postby biodomino » Thu May 05, 2011 6:34 am UTC

This is actually a pretty common demonstration of the concept of risk prevention. I read a good article that explores this concept recently. Ah, the scintillating world of actuaries.

Personally I believe they should lax their standards to promote the optimal outcomes. Realistically, however, they could probably lax the process WHILE increasing their consumer literacy efforts, to prevent these delay-of-treatment deaths through making consumers better aware of when they should terminate the treatment, seek medical help, or general contraindications-- and simultaneously reduce some of their liability, real or ethical.

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Re: Hypothetical FDA debate

Postby AvatarIII » Thu May 05, 2011 9:19 am UTC

iChef wrote:I'm a little curious on where the cut off is for saving a life. Let's say we have a new drug for treating eyebrow cancer. Untreated your average eyebrow cancer patient only lives another 5 years. In this study we are going to give our new drug (Ojopelocil) to 100 patients. The results were:

2 patients died two weeks into the study from a severe side effect of our drug.
18 more died after three years of treatment.
40 patients died 5 years after.
35 patients died after 6 years of treatments.
5 patients died after 12 years of treatments.

So how many lives did our drug save? Was it 40 lives, the total number of people who lived longer than expected? Do we only count the 5 who lived much longer than the expected time? What about the total number of years of life. We reduced the life span of 20 of our test subjects by a total of 64 years. Over 3 years per person, but we increased the life span of 40 patients by 95 years, a little over 2 years per person.

My question here is in the original post we saved 10,000 lives and caused 20,000 deaths. Of these 20,000 how many years off their lives did they lose? If each of these 20,000 would have only been spared for another year or so would it be worth it to rush a drug to market that might harm people that otherwise would have had many years ahead of them.

The FDA's job is much harder than the media makes it out to be. I would rather have them intensively test each drug on the market, than rush them out haphazardly. I'm going to say the FDA doesn't cause any deaths by withholding drugs. It is sad that people die of diseases, the the science of curing said diseases is tricky and it is better to get it right rather than throwing a bunch of pills against the public and seeing which ones stick. I don't know how much at ease I would be with a treatment that gave me an extra year of life knowing that several people gave a decade of theirs before all the kinks were worked out.



i think in this case "saving lives" is a bad way to word it, what this drug has essentially done by my calculations has pushed average life span up from 5 years to almost 8 (7.78 years)
since you can't know how quickly the patients would die untreated you can't say you extended some lives and reduced others, all you can say is you increased the average by almost 3 years, which i calll a success, depending on how the treatement affects quality of life during the 8 years (is 8 years of pain and discomfort better or worse than 4 years of normality and 1 year of pain and discomfort?)

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Re: Hypothetical FDA debate

Postby Soralin » Thu May 05, 2011 1:07 pm UTC

AvatarIII wrote:i think in this case "saving lives" is a bad way to word it, what this drug has essentially done by my calculations has pushed average life span up from 5 years to almost 8 (7.78 years)
since you can't know how quickly the patients would die untreated you can't say you extended some lives and reduced others, all you can say is you increased the average by almost 3 years, which i calll a success, depending on how the treatement affects quality of life during the 8 years (is 8 years of pain and discomfort better or worse than 4 years of normality and 1 year of pain and discomfort?)

I think you need to recheck your calculations, I get the average of the above as 5.24

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Re: Hypothetical FDA debate

Postby AvatarIII » Thu May 05, 2011 1:29 pm UTC

Soralin wrote:
AvatarIII wrote:i think in this case "saving lives" is a bad way to word it, what this drug has essentially done by my calculations has pushed average life span up from 5 years to almost 8 (7.78 years)
since you can't know how quickly the patients would die untreated you can't say you extended some lives and reduced others, all you can say is you increased the average by almost 3 years, which i calll a success, depending on how the treatement affects quality of life during the 8 years (is 8 years of pain and discomfort better or worse than 4 years of normality and 1 year of pain and discomfort?)

I think you need to recheck your calculations, I get the average of the above as 5.24


yes you're right, not sure how i messed that up, i'm thinking i didn't press shift once when doing brackets in windows calculator,
in which case, it's a pretty pointless drug, it has only little measurable increase on patients life spans, and a 2% chance of a fatal side affect,

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Re: Hypothetical FDA debate

Postby savanik » Thu May 05, 2011 10:42 pm UTC

broken_escalator wrote:I think getting into drug trials for not-released drugs could be what you're thinking of. But you run the risk of being in the control group, assuming you even get in.


Just to point out:
1. You are assuming this is a clinical double-blind study - not all of them are.
2. If you are in a study, nobody knows whether or not the drug works yet - that's the whole point. It could just outright kill you. Being in the control group might be a good thing.
3. If you're in the control group, it's the same as not having any medication at all. This generally assumes that you've already exhausted all the viable traditional therapies; otherwise you wouldn't be in an experimental drug test. You're still probably better off having a chance of maybe getting a drug that might give you a few extra years.

So the idea of 'what if you're in the control group' really doesn't hold much water as an argument to me.
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Re: Hypothetical FDA debate

Postby fr00t » Fri May 06, 2011 12:46 am UTC

Aedl Foxe wrote:Suppose, for the sake of this argument only that the following statistics are true:


That came from lesswrong, right? Just wondering. If It was, I read the article, I seem to recall it not having very much (any?) substantive justification for the claim, but it was just used to illustrate a point.

Anyways, the actual details of the issue are probably not so simple but it seems almost like a version of the trolley problem... essentially (assuming the statistics are true) are acts of commission morally distinguishable from acts of omission?

I don't think so. If the evidence the FDA has is statistically solid, that is, either 10,000 people will die, or 20,000 people will die (+/- epsilon)... they don't have an option that doesn't involve sentencing at least 10,000 people to death. For us humans, math and morality don't intuitively mix... but when your talking about real human life, philosophy and moral intuition have to take back seat.

BattleMoose wrote:then it would be immoral to issue a potentially unsafe drug, to an individual with the reasoning that this behavior will save more lives on a societal .


It's also immoral to not issue a potentially life-saving drug. You're right that statistics don't directly apply on the individual level... but the only question you can ask is which society you would rather be born into, all other things being equal: one where you had an X or 2X chance of death.

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Re: Hypothetical FDA debate

Postby ++$_ » Fri May 06, 2011 12:53 am UTC

pizzazz wrote:There's lots of talk of the FDA "saving lives." In reality, I don't see how the FDA can possibly save lives. It can't make anyone take anything, it can only prevent them from taking it. The choice to take a particular drug lies entirely with the patient and his or her doctor. The only thing the FDA can do is to take away an option that might or might not save that person's life. That is a strictly worse choice than having more options.

And before I get jumped on by people pointing out that companies would sell dangerous or ineffective drugs... they already do. "Herbal supplements" and related products abound, despite having no known benefit. Someone else already linked to homeopathy. Who knows what's available on the black market, or over the border.
It seems to me that the second part of your argument works against the first. People die all the time due to taking "herbal supplements" and other non-treatments in place of actual medicine. If the FDA decided to ban these herbal supplements, that would save lives, wouldn't it? Certainly, banning the "herbal supplements" wouldn't be strictly worse, right?

EDIT: Grammar
Last edited by ++$_ on Fri May 06, 2011 1:06 am UTC, edited 1 time in total.

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Re: Hypothetical FDA debate

Postby Aedl Foxe » Fri May 06, 2011 1:05 am UTC

fr00t wrote:That came from lesswrong, right? Just wondering.


o.o Actually, yes. I changed the numbers, but the idea is the same.
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Re: Hypothetical FDA debate

Postby pizzazz » Fri May 06, 2011 3:37 am UTC

++$_ wrote:
pizzazz wrote:There's lots of talk of the FDA "saving lives." In reality, I don't see how the FDA can possibly save lives. It can't make anyone take anything, it can only prevent them from taking it. The choice to take a particular drug lies entirely with the patient and his or her doctor. The only thing the FDA can do is to take away an option that might or might not save that person's life. That is a strictly worse choice than having more options.

And before I get jumped on by people pointing out that companies would sell dangerous or ineffective drugs... they already do. "Herbal supplements" and related products abound, despite having no known benefit. Someone else already linked to homeopathy. Who knows what's available on the black market, or over the border.
It seems to me that the second part of your argument works against the first. People die all the time due to taking "herbal supplements" and other non-treatments in place of actual medicine. If the FDA decided to ban these herbal supplements, that would save lives, wouldn't it? Certainly, banning the "herbal supplements" wouldn't be strictly worse, right?

EDIT: Grammar


Of course it would. Strictly speaking, removing options cannot make your choice better. Perhaps more importantly, the entire idea behind the FDA doesn't seem like it necessarily helps. You are essentially sacrificing those who would be saved by any drug you ban, because they are actually sick, to save those who would kill themselves by taking something they don't know is safe. To me, this is not a good trade-off, and has lots of pitfalls which may end up reducing its overall number of lives "saved." As a result, I don't think the loss of freedom from having a government agency tell adults what they can and cannot put in their own body is worth the benefits. Especially if the reasoning is, "these aren't harmful, but if you take them, you're less likely to take actual medicine, so we're going to just not let you put harmless plants in your body." That's a really, really dangerous road to go down.

And the point with the herbal supplements was more that some people will always make poor decisions, but I don't think other people should have to suffer because the government is trying to protect idiots from themselves.

Aedl Foxe wrote:I won't answer the point I didn't quote, because I have no rebuff; it's a good point. However: the problem with the scenario above is the question of trust. Even though companies will sell dangerous or ineffective drugs, no competent doctor would recommend them. And doctors can't read every medical journal to see which drugs have been positively peer-reviewed, so they rely on the FDA to tell them what is and isn't safe, to some degree. So the FDA endorsing an unsafe product violates the trust of the doctor, and in turn the trust of the patient in the doctor's credibility.


The FDA would still only endorse products that it has tested, it just wouldn't stop companies from selling other things. It's certainly within a doctor's power to check to see if a drug has been tested by any independent groups.

Randomizer--I sort of answered your point above, responding to ++_$, and I don't really see what your point is supposed to be, other than that the government should sacrifice some citizens to protect others from themselves.

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Re: Hypothetical FDA debate

Postby alexh123456789 » Fri May 06, 2011 4:21 am UTC

I don't know whether something like this already exists, but wouldn't the best solution to this problem be to allow drug companies to sell drugs currently on trial, but require the companies to tell the FDA how well the drug is doing so far? That way drugs that appear to work really well could be rushed out really fast, but you'd have to have doctors explain to patients that the treatment is experimental, and have them sign wavers or something. It'd basically be like currently getting added to a trial, but people would be able to be sure they'd not be in the control group.

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Re: Hypothetical FDA debate

Postby ++$_ » Fri May 06, 2011 4:34 am UTC

pizzazz wrote:Strictly speaking, removing options cannot make your choice better. Perhaps more importantly, the entire idea behind the FDA doesn't seem like it necessarily helps. You are essentially sacrificing those who would be saved by any drug you ban, because they are actually sick, to save those who would kill themselves by taking something they don't know is safe.
First of all, the FDA makes sure that drugs are safe AND effective. Ineffective drugs on the market do not save any lives. All they can do is hurt people if they take them instead of the regular drug.

It seems like the claim "removing options cannot make your choice better" is not based on observations of actual humans, but rather on idealized, perfectly informed H. economicus. In the case of actual humans, if you give people the option to take a homeopathic placebo instead of an effective drug, some of them will take that option, mostly because they have been told it the placebo is effective. Removing the option causes them to make better choices, so the claim is false.
And the point with the herbal supplements was more that some people will always make poor decisions, but I don't think other people should have to suffer because the government is trying to protect idiots from themselves.
Is it only idiots who take herbal supplements? Consider all the reasons someone might take a homeopathic medication instead of an actual drug:

1. The person is an idiot.
2. The person's doctor is a quack who prescribed the homeopathic medication.
3. The person was convinced by a slick practitioner of homeopathic medicine that the "all-natural" product was healthier.
4. The person's friend told him or her that the actual drug contained rat poison, and presented seemingly reliable (but actually fraudulent) sources.
5. The person's doctor prescribed the drug, but the person went to a lecture given by a prominent doctor, where he cited his study from the Lancet (since discredited, but he didn't mention that in the lecture) that showed the drug was unsafe, and recommended the homeopathic alternative. Since the person's doctor is not as eminent as the prominent British doctor, it seems more reasonable to trust the prominent doctor.
6. The person read a study published by a group at a large public university that claims the homeopathic treatment is effective, and, while not an idiot, doesn't have the scientific background needed to understand the study's flaws.

If the medication is not blatantly fraudulent like homeopathy, but merely ineffective, there are several other potential reasons:

7. The person's doctor was convinced by a well-designed study that suggested effectiveness, but the result was actually a statistical fluke that will be exposed with more testing.
8. The person's doctor explained to the patient that a new medication of unknown effectiveness was available as an option, and the patient overestimated the likelihood that the medication would in fact be effective.

And there is one really important huge one:

9. The person's insurance company refused to pay for the administration of the effective drug, citing the relatively lower prices of the new (but unbeknownst to anyone, ineffective) drug.

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Re: Hypothetical FDA debate

Postby achan1058 » Fri May 06, 2011 4:49 am UTC

pizzazz wrote:Of course it would. Strictly speaking, removing options cannot make your choice better. Perhaps more importantly, the entire idea behind the FDA doesn't seem like it necessarily helps. You are essentially sacrificing those who would be saved by any drug you ban, because they are actually sick, to save those who would kill themselves by taking something they don't know is safe. To me, this is not a good trade-off, and has lots of pitfalls which may end up reducing its overall number of lives "saved." As a result, I don't think the loss of freedom from having a government agency tell adults what they can and cannot put in their own body is worth the benefits. Especially if the reasoning is, "these aren't harmful, but if you take them, you're less likely to take actual medicine, so we're going to just not let you put harmless plants in your body." That's a really, really dangerous road to go down.
I think you should remember that research time (as in finding information about which drug is more likely to be effective) is also a resource, and a very limited one at that. It's like playing a chess game, I can give you the version with all moves given, or a list of moves where 90% of the worst moves removed. Unless you and your consultants are grandmaster players or something, the latter game is probably much better off for you. While one can possibly question whether out right banning the bad moves are a good thing, (I would argue it is) one cannot deny the value of the information given by the FDA on this matter.


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