71–80 of 177 posts
The first will lead to correcting bad faith efforts and marketing in the drug companies... the second will lead to fixing the FDA.
To clarify: I'm not calling for less regulation from the FDA. Far from it. Rather, I'm pointing out that in the follow instance where more regulation is being called for, a major influence is again Big Pharma and the motivation is, to my eyes and reading, not primarily consumer protection. ---- There is also the other "half" of this FDA saga. "Supplements" and herbal treatments are a mixed bag, and there are fraudule…
How much of this could be solved by replication? Some sort of rule where we say, formally, not to take any study seriously unless it's been replicated? On the one hand, it's very bad that the FDA has covered this up. But on the other hand, there was science before the FDA. I may be interpreting the article wrong, but it seems as though the FDA is merely failing to prevent bad science. Presumably, journals that cited…
Merely repeating the original experiment might simply repeat the design errors of the original experiment. For example what if I drop a feather a bunch of times and find a value for g (gravitational acceleration) of 3.4 m/s^2? If you drop a similar feather you'll probably get a similar value, but that doesn't make it right.
The real question is not replication, it's whether I've found an accurate value for g. In that respect, science is better advanced if you attempt to confirm this value by designing your own experiment to test it, by dropping something else (a rock, maybe) instead of a feather.
We're well beside the original point of this thread now, but the focus on replication is a bit of a pet peeve of mine.
edit: clarity
Earlier quoted context omitted.
So can we still call it science, or not? And if not, what do we call it?
Well, technically they are replicating the study over 50+ different hospitals until they reach some confidence interval on the safety data. If you get fraud in a small fraction of them, it should not (and if you read the actual testimony, does not) impact the net result.
Think of selfhealing as a coin toss with 50/50 chance and a medication increasing this chance:
a) Medication increases healing chances to 80% -> Only few experiments needed.
b) Medication increases healing chances to 55% -> Many experiments needed to prove that the effect exists.
c) Medication is not effective but 5% fraud is introduced so that data shows 55% healing chances -> The same as in b) but with only "a little" fraud involoved.
I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.
And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the article missed: http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9... Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents…
I'm just wondering something probably very stupid. Shouldn't an FOIA request turn back all information that the article claims the FDA is refusing to give away ? Looking at the FDA FOIA exemption list ( http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm or http://www.foia.gov/faq.html#exemptions ), there's none that seems to match a drug name, a lab's name, a detail on a mistake or even communication between…
Tokenadult, Out of curiosity, given that you've said in your previous comments that you believe medical questions are best answered with 'science-based medicine', which is a philosophy that explicitly rejects evidence-based medicine: do you believe that the FDA covering up scientific fraud is bad, or do you agree with the FDA's argument that it's justified? Also, do you still believe that "It's an exaggeration (contr…
Question (not being sarcastic): what's the difference between 'science-based medicine' and 'evidence-based medicine'? I did a quick Wikipedia search, but the former just redirects to the latter.
Downvoters: Please explain. I have no idea about what any of SBM or EBM is, and I hadn’t even heard about any of them before now. This is genuinely what I what to know when I encounter the terms.
The FDA applied light bans, only on individual manufacturing sites, allowing the company to continue to push out product from other sites. Including making a bunch of pills with glass fragments in it.
The FDA eventually fined them $500M, and the company has since been bought by Sun Pharma, the largest in India. Zero indication that the systemic corruption, fraud, poor quality, etc. have had real change.
How much of this could be solved by replication? Some sort of rule where we say, formally, not to take any study seriously unless it's been replicated? On the one hand, it's very bad that the FDA has covered this up. But on the other hand, there was science before the FDA. I may be interpreting the article wrong, but it seems as though the FDA is merely failing to prevent bad science. Presumably, journals that cited…
Clinical trials are very expensive to run. The only people financially interested in running them are the pharmaceutical companies trying to make new products available. Replication is hard enough to achieve in hard sciences where replicating a study might cost tens of thousands of dollars. Finding the money to replicate or refute a clinical trial for millions of dollars is very difficult.
Yet odds are that most of the people taking it (for any value of "it") have smartphones and could be prospectively matched with people not taking it (I'm an enemy of case-control studies for lots of reasons, but this may be an area where a well-designed one would work.)