riddlemay wrote:Here's what I'm saying.
The makers of Lipitor have to prove that Lipitor itself, in clinical studies, can lower cholesterol for the FDA to approve that claim. They can't merely show articles--no matter how credible--that state that some of the components in Lipitor have been demonstrated to lower cholesterol, or that drugs of the same type as Lipitor have been demonstrated to lower cholesterol. They have to show that people specifically taking Lipitor Brand statin, versus a control group taking placebo, have experienced these beneficial effects to a statistically significant degree. If they can't show that, they don't get to make the claim.
Similarly, the makers of Diamond Walnuts have to prove that Diamond Walnuts--not somebody else's walnuts, and not some of the ingredients contained in walnuts--have health benefits for the FDA to approve that claim. They can't merely show articles--no matter how credible--that state that some of the components in Diamond Walnuts have been demonstrated as beneficial. They have to show that people specifically eating Diamond Walnuts, versus a control group, have experienced these beneficial effects to a statistically significant degree. If they can't show that, they don't get to make the claim.
Completely level playing field--as it should be.
Reasonably stated, and theoretically solid. However, given that the drug company will make millions of dollars selling a drug they developed and that you can pretty much only get from them, at least initially, is a lot different from a company that sells a natural product that many companies sell and people could even grow themselves, and will therefore bring in very little income. Also, Lipitor has many potential dangers (which is why you need a prescription), while eating walnuts is only an issue if you're allergic to tree nuts.
I actually think it's quite reasonable for someone who invents something to prove it works -- especially when they stand to make millions if not billions of dollars.
I don't think it's reasonable to ask someone to offer the same level of proof for a widely available nutritious food that is sold by many companies that they have simply packaged and not altered in any way to make it different from that same food offered by all those other companies. In cases like this, it should be acceptable only to prove that the "generic" product -- i.e., walnuts -- are safe.
Which raises the question in my mind -- once the drug company proves their drug is safe, does the company producing the generic version have to go through the same process? I checked it out, and according to the FDA site, "The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness."
So generic drugs don't get the same rigorous testing as brand-name drugs, because they have already been shown to be safe. So why can't "generic" foods be approved as a group, rather than by company, as you suggest?