Survey: Half of US doctors use placebo treatments

[DuncanONeil]

How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?

A lot of medicines pass trials and then get pulled for safety reasons. So lowering standards to lower costs would be suicidal. Or do we want to forget about all those drugs that the drug companies have been sued over and stopped making for problems. After all these drugs got through testing as is without problems. If anything lowering the standards is going to raise costs because the companies will have more problematic drugs in the market and higher legal damages from said drugs, raising the price of every drug that company makes.

[SadisticNature]

How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?

If you have done no testing of the risks of the product you aren't able to produce the information that would allow an individual to make an informed choice. This would be comparable to making an "informed choice" about cigarette smoking in the 1920's. No one knew much if anything about the health effects so in fact people were making an uninformed choice. In the 1920's people would look at you like you were crazy if you said smoking had negative health effects.

The fact that smokers have won major lawsuits in the states suggests that drug companies would lose similar lawsuits if they don't carry out due diligence on their medications. Having a national standard does a lot to create a higher burden of proof for liability cases.

As for drugs that are in use in nearly every country these statistics can be misleading. For some drugs "nearly every country" means about 60% of the countries on Earth, keeping in mind a sizable portion have very lax standards (much of Africa for instance). In other cases, there are specific health risks that the government raises concerns about, often legitimately. Canada has had a similar situation where there were a few drugs that were approved in a lot of other countries. Some of them were involved in later problems, including voluntary withdrawals by the company and some legal issues.

Regarding legal immunity, I would point to Merck's Vioxx. Where the FDA decided what the drug did was so important they were willing to offer it protection from lawsuits on the basis of this condition and permission to continue providing it. The company decided the fact that people with a certain genetic condition would die from taking it, and no test existed for this genetic condition would do so much damage to its brand that even under these conditions it would not continue offering the drug.

Drug testing standards also limit the damage done by executives who look for short term profits increasing bonuses, at the expense of the long term health of the company. I strongly suspect at least some CEOs that needed to boost profit numbers or face losing their job would be inclined to take a risk on accelerating a drug to market, and possibly cut corners on tests if they weren't held to strict standards. It doesn't have to be every CEO or even most of them. But if even 1 in every 20 CEO's in this situation would do this then you'd be faced with huge problems.

On the other hand if the drug companies kill off a lot of people with shoddy products, people will be too scared to take medicines and health care costs will go down. I guess there is a plus side to everything. Nonetheless I ask you to forgive me for looking at the lead lining.

[DuncanONeil]

If you have done no testing of the risks of the product you aren't able to produce the information that would allow an individual to make an informed choice. This would be comparable to making an "informed choice" about cigarette smoking in the 1920's. No one knew much if anything about the health effects so in fact people were making an uninformed choice. In the 1920's people would look at you like you were crazy if you said smoking had negative health effects.

You really believe that the only entity that is honest and ethical is the Government? You actually believe that? Remember that the current Speaker promised the most ethical and honest ever. That really proved to be true!!
You really believe that people would "look at you like you were crazy if you said smoking had negative health effects." Even my father, born in 1901, called them coffin nails! Hence your statement is inaccurate.

The fact that smokers have won major lawsuits in the states suggests that drug companies would lose similar lawsuits if they don't carry out due diligence on their medications. Having a national standard does a lot to create a higher burden of proof for liability cases.

Again you assume that they do not engage in due diligence with out thousands of pages of Government regulations? And hundreds of hoops to jump through? Do you think aspirin should be removed from the market? Or Dihydrogenmonoxide?

As for drugs that are in use in nearly every country these statistics can be misleading. For some drugs "nearly every country" means about 60% of the countries on Earth, keeping in mind a sizable portion have very lax standards (much of Africa for instance). In other cases, there are specific health risks that the government raises concerns about, often legitimately. Canada has had a similar situation where there were a few drugs that were approved in a lot of other countries. Some of them were involved in later problems, including voluntary withdrawals by the company and some legal issues.

I believe that the data shows that most of the worlds drug come from American labs. And no I have not checked the figures. Besides there are drugs approved for use in the USofA that have the minor little side effect of DEATH. But essentially you are saying that a drug that exists and shown to have a beneficial effect CAN NOT be used by people in the US under ANY CIRCUMSTANCES.

Regarding legal immunity, I would point to Merck's Vioxx. Where the FDA decided what the drug did was so important they were willing to offer it protection from lawsuits on the basis of this condition and permission to continue providing it. The company decided the fact that people with a certain genetic condition would die from taking it, and no test existed for this genetic condition would do so much damage to its brand that even under these conditions it would not continue offering the drug.

Your subject not mine!!

Drug testing standards also limit the damage done by executives who look for short term profits increasing bonuses, at the expense of the long term health of the company. I strongly suspect at least some CEOs that needed to boost profit numbers or face losing their job would be inclined to take a risk on accelerating a drug to market, and possibly cut corners on tests if they weren't held to strict standards. It doesn't have to be every CEO or even most of them. But if even 1 in every 20 CEO's in this situation would do this then you'd be faced with huge problems.

Short term profits?!?! The drug equivalent of a copyright protects any company from competition for 10 years. You the concept of the greedy evil company is moot. As for one in 20 there are not that many in the country.

On the other hand if the drug companies kill off a lot of people with shoddy products, people will be too scared to take medicines and health care costs will go down. I guess there is a plus side to everything. Nonetheless I ask you to forgive me for looking at the lead lining.

If the FDA is voluntary then the choice of the people is not between "good" and "bad" drugs. It is a choice of drugs bearing a seal of approval vs drugs that do not. Heck, do away with the FDA and have somebody like Consumer Reports or UL. Both of whom have a stellar reputation to uphold!

[SadisticNature]

You really believe that the only entity that is honest and ethical is the Government? You actually believe that? Remember that the current Speaker promised the most ethical and honest ever. That really proved to be true!!
You really believe that people would "look at you like you were crazy if you said smoking had negative health effects." Even my father, born in 1901, called them coffin nails! Hence your statement is inaccurate.

Again you assume that they do not engage in due diligence with out thousands of pages of Government regulations? And hundreds of hoops to jump through? Do you think aspirin should be removed from the market? Or Dihydrogenmonoxide?



I believe that the data shows that most of the worlds drug come from American labs. And no I have not checked the figures. Besides there are drugs approved for use in the USofA that have the minor little side effect of DEATH. But essentially you are saying that a drug that exists and shown to have a beneficial effect CAN NOT be used by people in the US under ANY CIRCUMSTANCES.



Your subject not mine!!



Short term profits?!?! The drug equivalent of a copyright protects any company from competition for 10 years. You the concept of the greedy evil company is moot. As for one in 20 there are not that many in the country.



If the FDA is voluntary then the choice of the people is not between "good" and "bad" drugs. It is a choice of drugs bearing a seal of approval vs drugs that do not. Heck, do away with the FDA and have somebody like Consumer Reports or UL. Both of whom have a stellar reputation to uphold!

I'm not claiming the government is perfect or reputable. I'm saying that they can better set standards for testing of drugs then the drug companies themselves who have competing interests. Suggesting the drug companies themselves would be able to do a better job at setting the standards would be akin to suggesting the fox should guard the chicken coup.

And yes I believe, with evidence that some powerful individuals in any business take shortcuts for person gain at the expense of others, including customers, other employees and the companies they work for. I'm not saying this is everyone, but it does exist in every business. Unfortunately we need regulations and they need to be enforced. Madoff got reported to the SEC 10 years before they did anything, if they actually bothered to do their jobs a lot of people wouldn't have lost their life savings to a ponzi scheme.

Things like fraud, cooking the books, and other loopholes and exploits happen all the time. People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time. It may only be a small percentage of people in their worst moments, but people do need protection from said individuals.

Do you honestly believe that every single individual who needs to bump up the revenue figures for the quarter or face losing their job would choose to lose the job over releasing a drug that will work and sell, but may have serious side effects? I think history shows that at least some individuals will choose to release the drug and save the job. Only regulations disallowing this choice (need proper testing to be able to release the drug) save us from these individuals. And these individuals are out there even Bush or Cheney referred to them as "a few bad apples".

The fact is there are people who behave badly, many of them very successful. The regulations can be a pain in the ass for those who behave properly 100% of the time, but that doesn't mean they aren't needed. All it takes is one bad decision in one moment of weakness to cause a serious problem. The regulations do a lot to prevent that.

I'm not saying the drug regulations are perfect, they aren't. But just because they have some problems doesn't mean the solution is to scrap them entirely. That would be like saying the problem with Enron is the damn government financial regulations, they should be able to cook their books if they want to.

Your father born in 1901 may have called them coffin nails, but did he call them that with full intent in 1921? My great grandmother was born at a similar time period, and had all sorts of bad things to say about cigarettes later in life. The fact is in the 1920's and 1930's she smoked, and didn't know a thing about the bad effects of cigarettes. That information was not publicly available until much later. Just because someone who was around in 1920 or 1930 says something in 1960 or 1970 about a product doesn't mean they felt that way in 1920 and 1930.

[DuncanONeil]

I'm not claiming the government is perfect or reputable. I'm saying that they can better set standards for testing of drugs then the drug companies themselves who have competing interests. Suggesting the drug companies themselves would be able to do a better job at setting the standards would be akin to suggesting the fox should guard the chicken coup.

With everything having to be "approved" by the FDA, anything that makes it through the process is considered safe by the people! Since the trials are actually conducted by the producer it is easy to fudge the data if youo so choose.
The fox/hen house is not a suitable analogy. The fox is seeking food, i.e. survival. In business if you "eat" your customers you are out of business. Were "certification" voluntary it is easy to surmise that people will, except in a very few cases, choose that "certified" product. Further if the Government is not directly involved it would likely be quicker and less expensive.

And yes I believe, with evidence that some powerful individuals in any business take shortcuts for person gain at the expense of others, including customers, other employees and the companies they work for. I'm not saying this is everyone, but it does exist in every business. Unfortunately we need regulations and they need to be enforced. Madoff got reported to the SEC 10 years before they did anything, if they actually bothered to do their jobs a lot of people wouldn't have lost their life savings to a ponzi scheme.

"(L)ost their life savings to a ponzi scheme." You mean like Social Security? Yes, bad people do exist. But does that mean that the rest must suffer in an attempt to control the few? It may seem to be not appropriate, but is indicative of the Government thought process. People know that riding a motorcycle without a helmet poses additional risk, They choose to do so. Yet various governments have enacted laws that REQUIRE motorcycle riders to wear helmets. I live in such a place and yet see many riders without helmets. To carry your logic into this arena all manufacturers should be required to make helmets part of the motorcycle.
Were people to have a choice between a "tested" & "certified" product vs one that is not they will choose that which they believe is best for them. If that is the "tested" & "certified" than those concerns that elected to forego such certification would either go out of business or submit to testing.

Things like fraud, cooking the books, and other loopholes and exploits happen all the time. People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time. It may only be a small percentage of people in their worst moments, but people do need protection from said individuals.

First of all a "loophole" implies that regulation is already in place. That is a major problem with regulation! "People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time." I suspect that this is a historical event. The second sentence implies that inspectors are being killed even today!

Do you honestly believe that every single individual who needs to bump up the revenue figures for the quarter or face losing their job would choose to lose the job over releasing a drug that will work and sell, but may have serious side effects? I think history shows that at least some individuals will choose to release the drug and save the job. Only regulations disallowing this choice (need proper testing to be able to release the drug) save us from these individuals. And these individuals are out there even Bush or Cheney referred to them as "a few bad apples".

Approved drugs are on the market that actually have a side effect of DEATH. Seems to me that the process is not serving us as it should!

The fact is there are people who behave badly, many of them very successful. The regulations can be a pain in the ass for those who behave properly 100% of the time, but that doesn't mean they aren't needed. All it takes is one bad decision in one moment of weakness to cause a serious problem. The regulations do a lot to prevent that.

Regulations do nothing to prevent; "people who behave badly" or "one bad decision in one moment of weakness to cause a serious problem". All the regulation can do is provide an additional means to punish that particular individual!
Most regulations on business actually punish said business before the fact!

I'm not saying the drug regulations are perfect, they aren't. But just because they have some problems doesn't mean the solution is to scrap them entirely. That would be like saying the problem with Enron is the damn government financial regulations, they should be able to cook their books if they want to.

Interesting that the support for drug regulation is the problems in a non-drug concern!
If there are problems in the "system of safety" than the "system of safety" needs to be overhauled. Not added to!
Kind of like the failed health bills in Congress. The President's solution? Add to the bill, make it larger and more complicated!

Your father born in 1901 may have called them coffin nails, but did he call them that with full intent in 1921? My great grandmother was born at a similar time period, and had all sorts of bad things to say about cigarettes later in life. The fact is in the 1920's and 1930's she smoked, and didn't know a thing about the bad effects of cigarettes. That information was not publicly available until much later. Just because someone who was around in 1920 or 1930 says something in 1960 or 1970 about a product doesn't mean they felt that way in 1920 and 1930.

Can't accept that rationale. With out a serious research effort it is hard to prove, but the term "coffin nails" for cigarettes as synonymous. There is evidence that prior to "coffin nail" they were known as "coffin tacks" a term in use in the 19th century.

[Thorne]

Approved drugs are on the market that actually have a side effect of DEATH. Seems to me that the process is not serving us as it should!

There's a rather bizarre reason for this. Manufacturer's are required to show as a side effect any reaction which test subjects had while taking the medication, even if it cannot be shown that the medication was responsible! Unless they can show absolutely that the medication did not cause or contribute to the side effect, they must list it. Trying to track down every minor complaint that test subjects make would be prohibitively expensive. It's easier to just record their results as possible side effects.

[DuncanONeil]

But that requirement in and of itself also seems to support the previous supposition that we are not being served well by the process.
Seems that an autopsy, while perhaps not being able to prove drug induced death, should be capable of determine if death cause is not related to drug ingestion.
Does that mean if a member of the drug group dies and a member of the control group dies it is not a side effect of the drug?

There's a rather bizarre reason for this. Manufacturer's are required to show as a side effect any reaction which test subjects had while taking the medication, even if it cannot be shown that the medication was responsible! Unless they can show absolutely that the medication did not cause or contribute to the side effect, they must list it. Trying to track down every minor complaint that test subjects make would be prohibitively expensive. It's easier to just record their results as possible side effects.

[SadisticNature]

With everything having to be "approved" by the FDA, anything that makes it through the process is considered safe by the people! Since the trials are actually conducted by the producer it is easy to fudge the data if youo so choose.
The fox/hen house is not a suitable analogy. The fox is seeking food, i.e. survival. In business if you "eat" your customers you are out of business. Were "certification" voluntary it is easy to surmise that people will, except in a very few cases, choose that "certified" product. Further if the Government is not directly involved it would likely be quicker and less expensive.

"(L)ost their life savings to a ponzi scheme." You mean like Social Security? Yes, bad people do exist. But does that mean that the rest must suffer in an attempt to control the few? It may seem to be not appropriate, but is indicative of the Government thought process. People know that riding a motorcycle without a helmet poses additional risk, They choose to do so. Yet various governments have enacted laws that REQUIRE motorcycle riders to wear helmets. I live in such a place and yet see many riders without helmets. To carry your logic into this arena all manufacturers should be required to make helmets part of the motorcycle.
Were people to have a choice between a "tested" & "certified" product vs one that is not they will choose that which they believe is best for them. If that is the "tested" & "certified" than those concerns that elected to forego such certification would either go out of business or submit to testing.

First of all a "loophole" implies that regulation is already in place. That is a major problem with regulation! "People have killed inspectors to protect mining frauds. It happens in all avenues of life a lot of the time." I suspect that this is a historical event. The second sentence implies that inspectors are being killed even today!

Approved drugs are on the market that actually have a side effect of DEATH. Seems to me that the process is not serving us as it should!

Regulations do nothing to prevent; "people who behave badly" or "one bad decision in one moment of weakness to cause a serious problem". All the regulation can do is provide an additional means to punish that particular individual!
Most regulations on business actually punish said business before the fact!

Interesting that the support for drug regulation is the problems in a non-drug concern!
If there are problems in the "system of safety" than the "system of safety" needs to be overhauled. Not added to!
Kind of like the failed health bills in Congress. The President's solution? Add to the bill, make it larger and more complicated!

Can't accept that rationale. With out a serious research effort it is hard to prove, but the term "coffin nails" for cigarettes as synonymous. There is evidence that prior to "coffin nail" they were known as "coffin tacks" a term in use in the 19th century.

To use your motorcycle example I'm not arguing for attaching the helmet to the motorcycle or having it come with the motorcycle I'm arguing for not abolishing the law that requires helmets.

As for suffering, it is pretty clear to me that rules that mitigate the suffering caused by unscrupulous or negligent actions do far less harm to the general populous than the suffering that is caused when those rules are not in place or enforced.

Regarding the mining fraud it was a historic event, regarding loopholes it does happen all the time. Probably even right now there is some company exploiting a loophole in some regulation as I type. As far as the drugs go, there are already regulations in place.

As for regulations doing nothing to prevent bad behavior, when is the last time a drug company released a drug into the US market without adequate testing and pulled it due to easily anticipated consequences that would have shown up in the studies they never conducted? This is exactly the behavior your proposed changes in the rules would allow, that I suggest needs to be prevented. As far as I can tell the FDA rules have successfully prevented this.

[DuncanONeil]

I objected to the mining reference precisely because it was historical!

If the FDA, and their regulations were so effective there would never be a recall of medications.

If you go back and read my original post I did not advocate for complete anarchy in the production of medications.

To use your motorcycle example I'm not arguing for attaching the helmet to the motorcycle or having it come with the motorcycle I'm arguing for not abolishing the law that requires helmets.

As for suffering, it is pretty clear to me that rules that mitigate the suffering caused by unscrupulous or negligent actions do far less harm to the general populous than the suffering that is caused when those rules are not in place or enforced.

Regarding the mining fraud it was a historic event, regarding loopholes it does happen all the time. Probably even right now there is some company exploiting a loophole in some regulation as I type. As far as the drugs go, there are already regulations in place.

As for regulations doing nothing to prevent bad behavior, when is the last time a drug company released a drug into the US market without adequate testing and pulled it due to easily anticipated consequences that would have shown up in the studies they never conducted? This is exactly the behavior your proposed changes in the rules would allow, that I suggest needs to be prevented. As far as I can tell the FDA rules have successfully prevented this.

[SadisticNature]

How about the FDA process being voluntary rather than mandatory?
Then it is an issue of personal choice as to whether you choose to be safe of choose to take a chance on a medicine that may help. As it is an informed choice there is little to no liability for the provider.

Drugs that are in use in nearly every country but here are prohibited for use by even terminal patients because of not being "approved" by the FDA. In spite of the level of positive outcomes by patients that have used the medicine or procedure! Is it fair for the FDA to condemn these people to death just because ALL of their hoops have not been cleared?

I think condemn to death is hyperbole. The main issue here is actually insurance coverage. You can get unapproved drugs by ordering them through mail order across the border. If there are issues with the drug the lack of FDA approval and the fact that you circumvented the countries regulations will protect the drug provider from liability.

[DuncanONeil]

Nothing in the least hyperbolic in this. People in this country suffering terminal conditions are prevented from choosing any treatment that is available but not approved by the FDA for their condition.
Drugs that are approved by the FDA and found to be effective against something else are prohibited to be used for the second condition. Why? Because the FDA will not allow it to be so used!

I think condemn to death is hyperbole. The main issue here is actually insurance coverage. You can get unapproved drugs by ordering them through mail order across the border. If there are issues with the drug the lack of FDA approval and the fact that you circumvented the countries regulations will protect the drug provider from liability.

[SadisticNature]

You continue to talk about the FDA as if it has this magical power to stop people from ordering drugs by mail across the border and getting them then taking them, and that by doing so it is condemning people to death. The fact is if you want to use drug X to treat disease Y you can order it by mail, pay for it yourself and do so.

You have done nothing to address this point in your statement, rather you continue to claim the FDA is condemning people to death.

As for 1st condition vs 2nd condition:
(i) There needs to be evidence the drug actually works for condition 2.
(ii) There needs to be consideration of side effects and severity of condition. A drug that sometimes causes death might be acceptable for treating a terminal form of cancer, but if the manufacturer also wants to use it to treat headaches that might raise alarm bells.

Nothing in the least hyperbolic in this. People in this country suffering terminal conditions are prevented from choosing any treatment that is available but not approved by the FDA for their condition.
Drugs that are approved by the FDA and found to be effective against something else are prohibited to be used for the second condition. Why? Because the FDA will not allow it to be so used!

[SadisticNature]

You argue that I am wrong to assume that it is not the case that every individual will carry out proper due diligence without regulation. I'd argue the onus is on you to prove that they will.

The fact is the current system has regulations because it requires the companies to carry out due diligence for the benefit of the citizenry. Your unsubstantiated claim is that without the regulations 100% of companies will do this anyways 100% of the time. If you could prove this I'd have no problem with abolishing the regulations, however both history and human nature argue to the contrary.

[DuncanONeil]

I do not argue that 100% of companies will do the right thing, as you freely admit.
Using history as an argument is a bit weak in the modern age, I submit. It is information that allows people to make an informed decision. Information is substantially more available today, than in the past.
Few regulations are designed to require due diligence. They are set up for the purpose of establishing what is considered appropriate and for the purpose of punishment.
Again the actual proposal I made was to do away with the FDA and replace it with something that could move in a manner akin to, say, a motorcycle than a locomotive.

You argue that I am wrong to assume that it is not the case that every individual will carry out proper due diligence without regulation. I'd argue the onus is on you to prove that they will.

The fact is the current system has regulations because it requires the companies to carry out due diligence for the benefit of the citizenry. Your unsubstantiated claim is that without the regulations 100% of companies will do this anyways 100% of the time. If you could prove this I'd have no problem with abolishing the regulations, however both history and human nature argue to the contrary.

[DuncanONeil]

It is illegal to purchase drugs that are not approved by the FDA.
As for cross use drugs. Doctors have patients that have more than one condition. One of which they do not have medication for, or they drug they are taking is less than effective. Prescribed a new med for a different condition that presents efficatious treatmet for the previous condition is of no value to the FDA. Said drug must go through the ENTIRE approval process. As to people dying. People with terminal conditions are being prevented from attempting meds or treatments that have been shown effective for their condition. They are prevented, especially in the treatment arena (because there is a doctor involved, mostly) because the med or treatment is not approved. No consideration that these people, dying, freely choose to accept the chance of relief. The ultimate case of you are too stupid to decide for yourself!

You continue to talk about the FDA as if it has this magical power to stop people from ordering drugs by mail across the border and getting them then taking them, and that by doing so it is condemning people to death. The fact is if you want to use drug X to treat disease Y you can order it by mail, pay for it yourself and do so.

You have done nothing to address this point in your statement, rather you continue to claim the FDA is condemning people to death.

As for 1st condition vs 2nd condition:
(i) There needs to be evidence the drug actually works for condition 2.
(ii) There needs to be consideration of side effects and severity of condition. A drug that sometimes causes death might be acceptable for treating a terminal form of cancer, but if the manufacturer also wants to use it to treat headaches that might raise alarm bells.