ofonorow wrote:So I take you would not think it is the FDA's business to prevent a company from marketing bottled water as a cure for cancer?
Are you asking my opinion whether I believe there should be an FDA? My answer is no. I believe the FDA has cost thousands if not millions of lives. (In your contrived example, you must think people are generally pretty stupid.)
The bottled water example actually isn't that far a stretch, when you look at some of the kinds of things that are sold by fraudsters as "cancer cures". I wouldn't say people are stupid, but sometimes scientifically illiterate. And if someone is dying from cancer or has a close friend or family member dying from cancer, they can be susceptible to the quacks who prey on them.
I'm glad that there is oversight here in Canada, and that people cannot claim have a product that cures cancer without documented evidence. But unfortunately people still get away with it before the law catches up with them.
And how does the FDA, a government bureaucracy, know whether the drug works for liver cancer?
The same way the medical community "knows" whether a drug works for liver cancer - based on clinical trial data.
And as you probably know, once a drug is approved for any purpose, a doctor in the USA can legally prescribe it for anything. (At least that is how it used to be, and I am not aware of any recent changes.)
That's true - a doctor can prescribe a drug for off-label uses, but it is illegal for companies to market their products for off-label uses.
The discussion here is why a bureaucracy would endeavor to keep vitamin C out of cold medicines. I cannot think of any action more absurd on its face.If the issue was merely marketing, I would not have such a problem with this action. But I infer that the government is preventing P&G from adding vitamin C because the "combination has not been proven safe and effective." The issue is the government using force to prevent companies from adding vitamin C to cold meds, not the "marketing" of a benefit as such, even though it is crazy not to allow that. (Now I haven't watched or read the regular media for years. Has anyone seen a Vick's commercial? Are they touting any special benefit from vitamin C? I doubt it, because it wouldn't be worth the money and effort. Anyone could simply take vitamin C separately)
I agree that the "safe" part does seem a little absurd given that vitamin C's safety has been extensively studied, but the "effective" part is not a foregone conclusion, although I can understand why you would think it is. Reading the FDA's letter it seems that one of their issues is that when you combine two compounds in one formulation, the new formulation's safety and efficacy should be evaluated. Vitamin C is safe on its own, but it is possible that when combined with certain drugs, it alters the behaviour of these other drugs. For instance, it could lead a drug to stay in the bloodstream longer, thereby increasing its risks of side effects - even if vitamin C alone is safe. Now, vitamin C in combination with the drug ingredients in Nyquil may be perfectly safe, but the onus is on the company, not the FDA, to show that.
The other issue the FDA has, as I see it, is the marketing of the combination as a cold & flu medicine. If they are selling Dayquil or Nyquil plus Vitamin C in a package marked with "Cold & Flu", I would think that this constitutes marketing. Marketing isn't restricted to DTC ad campaigns on television.But you are comfortable with the idea of having to prove every benefit before it is allowed on the market? In this case, that argument is patently absurd. The only substance studied more than vitamin C the past century is aspirin. [/color]
I'm uncomfortable with private companies marketing products for specific indications without regulatory oversight. I think doctors should be given the freedom to prescribe drugs off-label judiciously, but I don't think companies should be able to market them for off-label uses.If it were a foregone conclusion that the vitamin C in Nyquil is effective, then their warning would be based on a mere technicality. But there's more to it, and it's the same legislation that aims to keep drug companies in check and ensures that snake oil salesmen don't have their way.
You focus on whether vitamin C is effective (which it is!) but why is that even an issue? Why shouldn't a private firm be entitled to add the vitamin for reasons of safety, if not efficacy reasons. It is simply nuts, and you seem quite satisfied with the nut house.
What do you mean "by reasons of safety"? I don't see why any company should add vitamin C to the product unless it is shown to be effective in what it is being marketed for. If the FDA disagrees, then the onus is on the company to provide evidence to the contrary.
Don't get me wrong, I think the FDA has plenty of problems. I just agree in principle with their raison d'etre. There ought to be oversight in order to protect consumers. Nobody likes bureaucracy, but a certain level of bureaucracy is unavoidable. It's like entering another country without a visa, and then when apprehended, saying that you have all the necessary documents to be issued a visa.
Who exactly do you think it is that is "exerting an influence" on the FDA??
I don't know. However, I plan to use the United States Freedom of Information Act to try and find out
When you do find out, please let us know. It could have the makings of a good spy novel.