King,
I'm not a fan of the FDA at all. I believe if a drug developer develops a drug to be a monotherapy, fine, test it that way, but if they always intended the drug to be used with other therapeutics, that's how it should be tried. The FDA likes to run Phase 1's that are monotherapies, even when the product isn't intended to be used that way. I understand they're emphasis on safety, but if the combination of drugs they want to use their product with is already SOC, the safety profile is known, why not add the experimental product.
What the FDA does adds tremendously to the cost of trials as monotherapy trials are done as Phase 1/2 and if safe, but not effective enough for consideration of approval, they essentially repeat the trials in combinations which they wished to use in the first place. The time and money spent is foolish if all the preclinical work the company has done demonstrates that for efficacy it should be combined with other products.
I know medical professionals will disagree with me, they like the cautious approach taken by the regulators. I'm of the belief that historical data is adequate for comparison, and all who volunteer for a trial should get the experimental treatment.
I believe the control in our trial was worthless, with all but about 30 crossing over I believe we'll find that those who didn't cross over died to early to do so. Some who crossed over are probably among the living, but more may have been had they received the vaccine up front. All sorts of K-M plots can be developed from the trial, I don't think it will matter how you look at the data, people will be living longer, and some people may be considered cancer free. It's sad to me that such a trial takes well over a decade. I suspect that after 5 years the clinicians could have said we're seeing something that looks very good. Why not approve it and conduct a giant Phase 4 Trial where every time it's used, including all off label uses are included.
I believe that if we want to bring down the cost of medicine, you start with cutting the costs involved in gaining the approval of new drugs. I agree with knowing a drug is safe, but after that less time and money should be spent proving it's better than others as long as it's been shown to have some benefits. A drug that only benefits say 10% of the target population, but is the only one that does, is awfully important if you're a member of that target class. In most cases, I think such a drug would fail in trials.
Gary
