People are very good at convincing themselves their treatments are working. So much so even the survival rates can go up from placebo's. Patients are both less likely to experience symptoms and less likely to complain about them when they think they are already doing something about it. This is the reason medicine tests use double blind trials.
That's all true, which is why a reputable physician wouldn't prescribe a placebo until he'd exhausted all other possibilities. But in the end, if you have a patient with inconsistent symptoms who has no testable problems, you might prescribe a placebo. Let's face it: the patient's reaction to the placebo can be as informative as any other tests the doctor may have done.
The key point, though, is that the placebo is not prescribed lightly but only after a thorough familiarization with the patient. And this may (possibly, should) include a psychiatric analysis.
"A casual stroll through the lunatic asylum shows that faith does not prove anything." - Friedrich Nietzsche
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.
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.
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 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.
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!
There are currently 1 users browsing this thread. (0 members and 1 guests)