How To Address Spiritual Experiences

[Noggy]

Scary. Weird. Interesting.

[Vigile]

I'm confused as to why it would be wrong to subject the drug to a double blind study. What am I missing?

 

People would get placebos and have a 90% chance to die because of it. Of course, they CHOOSE that, but still. Their death would kinda be on their hands. I wouldn't want to be the guy who picks who gets the placebo and who doesn't.

 

The alternative is to not properly test the drug, which, if common practice, would lead to far more deaths and other complications.

[DesertBob]

I'm confused as to why it would be wrong to subject the drug to a double blind study. What am I missing?

 

People would get placebos and have a 90% chance to die because of it. Of course, they CHOOSE that, but still. Their death would kinda be on their hands. I wouldn't want to be the guy who picks who gets the placebo and who doesn't.

 

The alternative is to not properly test the drug, which, if common practice, would lead to far more deaths and other complications.

I think the point is that it was pretty clear the drug was salvaging a lot of kid's lives. Given the near-certainty of death, whatever side effects might not yet have been revealed were well worth the risk. When the equation is that far to the positive side of the ledger, double-blind studies are arguably immoral.

 

The drug was studied elsewhere on other, non-fatal immune system disorders and approved for wider use. In that context, such studies make sense. It was the FDA's bureaucratic need to test the drug on the exact illness it was originally designed for before allowing it to be approved even provisionally for that or any other use, that was the problem.

[freeasabird]

I'm confused as to why it would be wrong to subject the drug to a double blind study. What am I missing?

 

People would get placebos and have a 90% chance to die because of it. Of course, they CHOOSE that, but still. Their death would kinda be on their hands. I wouldn't want to be the guy who picks who gets the placebo and who doesn't.

 

The alternative is to not properly test the drug, which, if common practice, would lead to far more deaths and other complications.

I think the point is that it was pretty clear the drug was salvaging a lot of kid's lives. Given the near-certainty of death, whatever side effects might not yet have been revealed were well worth the risk. When the equation is that far to the positive side of the ledger, double-blind studies are arguably immoral.

 

The drug was studied elsewhere on other, non-fatal immune system disorders and approved for wider use. In that context, such studies make sense. It was the FDA's bureaucratic need to test the drug on the exact illness it was originally designed for before allowing it to be approved even provisionally for that or any other use, that was the problem.

 

Sorry I find this entire discussion preposterous. They are NOT giving anybody an illness here. If you have the disease you voluntarily choose to participate in the study. Even if you are selected for the placebo and have a 90% chance of dying, you are no worse off than Joe Blow walking the street who also has the disease, and also has a 90% chance of dying. By refusing to go through the trials you are preventing all future sufferers from being helped. You have NOT taken the high road and the greater good HAS NOT been served. There are medical trials for a reason. What if the drug has a 100% cure rate but it causes people to become homicidal? You can only measure and analyze these types of things by going through trials.

[DesertBob]

Sorry I find this entire discussion preposterous. They are NOT giving anybody an illness here.

Well obviously the FDA felt that way too, and I suppose for similar reasons. However if your child were dying and you knew there was a drug that would probably save their lives, how would you feel if the only way to access that drug was through a trial where there was a 50% chance your child would not get the drug they need and would die as a result?

 

The point is that the drug is widely available worldwide and ultimately proved harmless enough to be sold OTC in many countries. If it could be available elsewhere, it could be available in the US. The reason it's not available in the US isn't because the rest of the western world has crappy equivalents to the FDA; it's because of bureaucrats and their invested egos and rigid thinking.

[freeasabird]

Sorry I find this entire discussion preposterous. They are NOT giving anybody an illness here.

Well obviously the FDA felt that way too, and I suppose for similar reasons. However if your child were dying and you knew there was a drug that would probably save their lives, how would you feel if the only way to access that drug was through a trial where there was a 50% chance your child would not get the drug they need and would die as a result?

 

The point is that the drug is widely available worldwide and ultimately proved harmless enough to be sold OTC in many countries. If it could be available elsewhere, it could be available in the US. The reason it's not available in the US isn't because the rest of the western world has crappy equivalents to the FDA; it's because of bureaucrats and their invested egos and rigid thinking.

 

Had they gone through the trials back in the 70s we would not even be discussing this. The drug would be available at every pharmacy in America today. I understand that your wife got her supplies from overseas, but the reality of that is the following:

 

Buying drugs from overseas:

 

1. Risks the potential purchase of counterfeits.

2. Is not covered by insurance.

3. Can come with prohibitive costs.

4. Is not even known that it can be done by a significant portion of the public.

5. Has only been a reality for the past few years (meaning untold number of patients with this disease certainly died over the course of the last 4 decades before importing became possible with the internet).

6. Could be illegal.

 

I will restate what I find obvious - I can say with near certainty that the patients who would have gone through the trails for this drug you mentioned almost certainly had no option in the 1970s to import the drug from overseas. Therefore they died an early death anyway, while many more continue to unnecessarily die decades later. If I'm missing something in your argument then please point out my error but this just seems so painfully obvious.

[mwc]

In order to obtain FDA approval in the US, however, it was required to run double-blind, placebo-controlled trials. The CEO of the small drug company responsible for Isoprinisine said, "Hell, no, it would be wrong". You do NOT say things like that to the FD fucking-A. The drug was never approved in the US as a result. So the upshot was that people like my wife would smuggle the drug in through the mails from places like Ireland or Italy.

While this is clearly an emotional issue for you it is clear from looking around old articles that the big problem with this drug the FDA requires the drug does what it is advertised to do and so these folks did not wish to do this with their product. They hoped the FDA would pass the drug because others did. Countries like Canada have stated in articles related to this drug that they approved it for use not because it was demonstrated effected but because it appeared to not be harmful. Statements like this are at nearly the opposite end of the spectrum. They may well approve a placebo as they're not harmful either. Placebo's have the ability to "cure" people as well but they would not likely pass the FDA's far stricter policies for demonstrating that the drug does as it says.

 

mwc

[DesertBob]

While this is clearly an emotional issue for you it is clear from looking around old articles that the big problem with this drug the FDA requires the drug does what it is advertised to do and so these folks did not wish to do this with their product. They hoped the FDA would pass the drug because others did. Countries like Canada have stated in articles related to this drug that they approved it for use not because it was demonstrated effected but because it appeared to not be harmful. Statements like this are at nearly the opposite end of the spectrum. They may well approve a placebo as they're not harmful either. Placebo's have the ability to "cure" people as well but they would not likely pass the FDA's far stricter policies for demonstrating that the drug does as it says.

The FDA spun the story a certain way, obviously. I knew a couple of people plugged into the original trials and got a different spin, although, I tend to believe it was closer to the truth.

 

At the end of the day it was no great skin off my back in the great scheme of things. It was out of pocket but it wasn't an exotically expensive drug. It was definitely a grey market situation to obtain it but not a cloak and dagger operation either. I just found it odd that people then -- and now, apparently -- can't see the slightest moral ambiguity in deliberately withholding known salvation from a fatally ill patient in the name of slavishly and mindlessly fulfilling a sacred scientific ritual as if it's some magic totem. While at the same time, drugs of highly questionable safety are approved all the time when someone really wants / needs them to be. The synthetic quinine drug that was rushed through without "proper" trials during the Vietnam war and is still prescribed today despite high incidence of serious side effects (name escapes me at the moment) comes to mind. Any number of drugs from major pharmaceutical firms that have been shown to have seriously doctored trial results and are later pulled from the market.

 

The reason this drug wasn't approved was because it was an orphan drug from a small manufacturer, pure and simple. There was no compelling financial interest for anyone to manipulate. In my wife's case it was only something that helped 10%. Another orphan drug that might have actually saved her life, Ampligen, was only available in double-blind trials that dragged on for years in part because the original trails were bungled because the tiny manufacturer partnered with big pharma (Upjohn, if memory serves) for a joint marketing deal and that company cut corners and did not follow the clear protocol for administering the drug -- it was not dispensed in glass intravenous bottles as specified with the result that this very unstable substance reacted with the more typical plastic bags and its potency was negated. Rather than fess up, they covered up and lawsuits flew back and forth while more people frittered away their years, sick, if in fact they survived at all. We knew one woman who recovered almost full function and then relapsed when the trials were stopped.

 

And then there's the whole issue of how seriously ill people who by definition haven't been able to earn a living for years are going to be able to afford to move to a test center and participate in such trials anyway -- even assuming they are physically capable of dealing with the stress.

 

The value of double blind trials is well known, but promising treatments for people who are dying or in protracted suffering need to be allowed on an experimental basis with full disclosure so that desperate people who are fully informed of any known risks and potential unknown risks can do what they need to do.

 

Yes, it's an emotional issue for me. Why wouldn't it be. Science needs to be objective but there needs to be room for common sense, compassion and empathy too. In my experience, medical researchers are often people who failed in clinical settings or avoided them in the first place because they detest working with that messy, unpredictable aspect of life called "people". Researchers, with notable and blessed exceptions, tend to want everything regimented for their convenience and comfort so they can have a nice orderly experiment completely disconnected from the human beings involved and their constant whining and demands. That is an attitude I encountered all too often.

[freeasabird]

While this is clearly an emotional issue for you it is clear from looking around old articles that the big problem with this drug the FDA requires the drug does what it is advertised to do and so these folks did not wish to do this with their product. They hoped the FDA would pass the drug because others did. Countries like Canada have stated in articles related to this drug that they approved it for use not because it was demonstrated effected but because it appeared to not be harmful. Statements like this are at nearly the opposite end of the spectrum. They may well approve a placebo as they're not harmful either. Placebo's have the ability to "cure" people as well but they would not likely pass the FDA's far stricter policies for demonstrating that the drug does as it says.

The FDA spun the story a certain way, obviously. I knew a couple of people plugged into the original trials and got a different spin, although, I tend to believe it was closer to the truth.

 

At the end of the day it was no great skin off my back in the great scheme of things. It was out of pocket but it wasn't an exotically expensive drug. It was definitely a grey market situation to obtain it but not a cloak and dagger operation either. I just found it odd that people then -- and now, apparently -- can't see the slightest moral ambiguity in deliberately withholding known salvation from a fatally ill patient in the name of slavishly and mindlessly fulfilling a sacred scientific ritual as if it's some magic totem. While at the same time, drugs of highly questionable safety are approved all the time when someone really wants / needs them to be. The synthetic quinine drug that was rushed through without "proper" trials during the Vietnam war and is still prescribed today despite high incidence of serious side effects (name escapes me at the moment) comes to mind. Any number of drugs from major pharmaceutical firms that have been shown to have seriously doctored trial results and are later pulled from the market.

 

The reason this drug wasn't approved was because it was an orphan drug from a small manufacturer, pure and simple. There was no compelling financial interest for anyone to manipulate. In my wife's case it was only something that helped 10%. Another orphan drug that might have actually saved her life, Ampligen, was only available in double-blind trials that dragged on for years in part because the original trails were bungled because the tiny manufacturer partnered with big pharma (Upjohn, if memory serves) for a joint marketing deal and that company cut corners and did not follow the clear protocol for administering the drug -- it was not dispensed in glass intravenous bottles as specified with the result that this very unstable substance reacted with the more typical plastic bags and its potency was negated. Rather than fess up, they covered up and lawsuits flew back and forth while more people frittered away their years, sick, if in fact they survived at all. We knew one woman who recovered almost full function and then relapsed when the trials were stopped.

 

And then there's the whole issue of how seriously ill people who by definition haven't been able to earn a living for years are going to be able to afford to move to a test center and participate in such trials anyway -- even assuming they are physically capable of dealing with the stress.

 

The value of double blind trials is well known, but promising treatments for people who are dying or in protracted suffering need to be allowed on an experimental basis with full disclosure so that desperate people who are fully informed of any known risks and potential unknown risks can do what they need to do.

 

Yes, it's an emotional issue for me. Why wouldn't it be. Science needs to be objective but there needs to be room for common sense, compassion and empathy too. In my experience, medical researchers are often people who failed in clinical settings or avoided them in the first place because they detest working with that messy, unpredictable aspect of life called "people". Researchers, with notable and blessed exceptions, tend to want everything regimented for their convenience and comfort so they can have a nice orderly experiment completely disconnected from the human beings involved and their constant whining and demands. That is an attitude I encountered all too often.

 

Once again please correct my errors where they may be but it seems evident you have a bone to pick with the medical research field. You seem to be completely avoiding the sad reality that when a new drug has just been developed, the sufferers for which it is intended have been dying of said ailment for all of eternity. I may sound cold but these are the facts we are dealing with and when you're dealing with science it's best not to get emotional (how many times do we non-believers reject the emotional pleas of believers in lieu of only accepting concrete factual data?). Is it not worth a (relatively) scant amount of extra time to complete the process of testing? It seems rather selfish to say "give it to me now, I don't care about your effing trials or anyone else who's suffering or the future of all others who will suffer from this disease". Do you not see that if they allowed the sale of the drug before it underwent trials then were would be the incentive for people to participate in the trials?

 

Even following extensive animal trials, it's not always imminently clear on the correct dosing for potency, frequency, method of delivery, timing of delivery, and these are just the examples I can come up with as a laymen. You even proved this with your comment on the drug being in a plastic bag vs. glass vial. I'm sure medical experts have a much greater list of things they are looking for. I can conclude no other result that sheer chaos if a formal clinical trial were subverted and replaced with an administering of the drug before trials were complete.

[DesertBob]

I can conclude no other result that sheer chaos if a formal clinical trial were subverted and replaced with an administering of the drug before trials were complete.

It's pretty obvious that you can't conclude anything else.

 

We'll have to agree to disagree on this one, but just to be clear, I was not proposing that clinical trials shouldn't happen, only that there should be guidelines to allow people to sign liability waivers upon full disclosure and get the drug to their doctors for their personal use when it's a matter of either life and death or protracted suffering that can be alleviated.

 

Due to cost, the need for personal physician buy-in, and the fact that patient risk vs reward judgment calls will not always go in favor of risking the use of a not-fully-tested drug, I would expect plenty of people not to take the option I'm suggesting; and that it will not have a significant impact on the pool of people who might be willing to submit to the controlled setting of a clinical trial. I just think the option should be available at least in certain situations.

 

Absent that, it would help if the whole process were not barnacled with politics, egos, greed, and paperwork so that it could move ahead a lot faster and with a lot more sense of urgency than it presently does. It would be nice if the government would subsidize some of these trials that have "orphan" status, so that if you are saddled with a rare enough illness that there is too small a market for the cure you seek to ever see any research or the light of day, that would be nice too. A lot of things would be nice ... in my wife's case it's all a moot point now anyway, she's SOL and the fact that I think some people shouldn't sleep well with that knowledge isn't going to prevent them sleeping the sleep of the just; as your point of view illustrates, there are plenty of "it's not my problem" rationalizations to allow it.

[freeasabird]

Absent that, it would help if the whole process were not barnacled with politics, egos, greed, and paperwork so that it could move ahead a lot faster and with a lot more sense of urgency than it presently does. It would be nice if the government would subsidize some of these trials that have "orphan" status, so that if you are saddled with a rare enough illness that there is too small a market for the cure you seek to ever see any research or the light of day, that would be nice too. A lot of things would be nice ... in my wife's case it's all a moot point now anyway, she's SOL and the fact that I think some people shouldn't sleep well with that knowledge isn't going to prevent them sleeping the sleep of the just; as your point of view illustrates, there are plenty of "it's not my problem" rationalizations to allow it.

 

There's a lot here we can agree on. I would also like to see the role of testing be shifted more to government rather than, as I understand it, being performed by the drug companies as it is today. I would also like to find some compromise on your take with the special case life threatening patient scenarios. What we need to keep in mind though is that I would presume (full disclosure I don't know) that these would ordinarily be part of the clinical trials as well, so you are effectively removing this end of the spectrum from the trials which will affect the results. Maybe the compromise comes with requiring them to participate or be monitored during the administration of the drug.

 

I appreciate your passionate stance - it's how progressive change is made. I don't know that there is a perfectly right answer, I just don't want people to see the value dininished in allowing future patients to have the information available to them in order to work with their doctor and make the best decisions about their future medical care. This solid information comes from the type of trials we are discussing.