For God's sake, another article that conflates Europe and the EU! Lazy, lazy journalism.
Europe votes for clinical trial transparency
41–46 of 46 posts
Re: Europe votes for clinical trial transparency
#42As far as I know, US laws require that the `x` number of trials demonstrate the effectiveness of the drug and failured dont need to be reported. But this does not make sense to me, and I welcome the European laws. In the US system, even if I have a coin biased badly against coming up heads, if I toss it enough number of times I will get `x` heads. The tosses cost money and that is then used to justify the patent syst…
> even if I have a coin biased badly against coming up heads, if I toss it enough number of times I will get `x` heads. I'm pretty sure a "trial" is a statistically significant study of many patients. So in this case, your analogy to the coin is flawed. A better analogy would be x groups of 10,000 coin flips, and to take the average of each group in x. Now, no such average would favor the less probably side of the co…
No, grouping over many patients does not eliminate the loop hole at all. The 'coin' was my analogy for the event that a trial was deemed successful (according to some statistical test of hypothesis). If all that I need is to demonstrate is 2 trials that show statistically significant benefits, I can do that expenses permitting (unless the probability of benefit using my candidate drug is exactly 0). The key is that I am allowed unlimited trials where my candidate may not only show no statistically significant benefit but also show worse performance. If only the decision to accept my candidate is based on all the trials together is this hole plugged. My understanding is that FDA does not do this. 2 strikes and you are in, regardless of failure in the other trials.
Re: Europe votes for clinical trial transparency
#43Earlier quoted context omitted.
In the US you need two trials showing that a drug is effective, but you can have an unlimited number showing that it's not effective. Also it doesn't need to be shown to be effective against a disease, it can just be effective at reducing some number that correlates with a disease. And you don't need to show that it's effective in the longterm, only for up to 6 weeks - it could make the disease dramatically worse in…
Wow, there is a long that is incorrect in your comment. 1. You are right that typically you need two registrational trials for approval and yes you can have many trials that show it doesn't work. 2. You are incorrect that you don't need to show it works against a disease. Sometimes you can show that you are impacting a biomarker (which I assume is what you mean by "some number"), but there must be evidence that chang…
2) C.f. statins. There are any number of books that talk about this. Overdosed America comes to mind, but you'd be hard pressed to find any recent book about the pharma industry that doesn't talk about statins.
3) C.f. SSRIs, and Robert Whitaker's book anatomy of an epidemic.
Re: Europe votes for clinical trial transparency
#44Earlier quoted context omitted.
Wow, there is a long that is incorrect in your comment. 1. You are right that typically you need two registrational trials for approval and yes you can have many trials that show it doesn't work. 2. You are incorrect that you don't need to show it works against a disease. Sometimes you can show that you are impacting a biomarker (which I assume is what you mean by "some number"), but there must be evidence that chang…
2) C.f. statins. There are any number of books that talk about this. Overdosed America comes to mind, but you'd be hard pressed to find any recent book about the pharma industry that doesn't talk about statins. 3) C.f. SSRIs, and Robert Whitaker's book anatomy of an epidemic.
2) You are correct that new drugs can be approved by showing a lowering of LDL (biomarker), but that's only because the link between LDL lowering and cardiac risk reduction has already been demonstrated.
The best example I can give you right now are the drugs in development to treat Duchenne's muscular dystrophy. These drugs work by increasing the levels of a biomarker called dystrophin. The FDA recently came back and said "nope, not enough evidence that increasing dystrophin will improve patient's conditions, therefore we will not approve your drug".
As for the length of depression trials, it has been established that 6-week trials provide enough evidence to support an improvement in patients. [1]
Therefore, a 12-week trial is not necessary for all older patients; rather, the degree of improvement in the first 4 to 6 weeks identifies patients who are highly likely to benefit from continuing antidepressant treatment as well as those who very probably should have their treatment regimen altered at that point.
However, the depression drugs also run trials for long-term use: "Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)]."
Re: Europe votes for clinical trial transparency
#45This is great news - no more pharmaceutical profit projects getting pushed to the forefront, only to discover a few years later that the adverse affects were buried in 'company proprietary confidental' reports .. makes it safer to live in Europe!
The EMA should work on discovering the drugs that already have publically reported serious side effects. It took the EMA how long to pull Mediator?
Corruption also happens in Europe, friend! Big steps, one step at a time.
Re: Europe votes for clinical trial transparency
#46Earlier quoted context omitted.
Albert Einstein said something along the lines of if you can't explain a concept to your grandmother, you don't know it well enough . I'm sure he didn't have a molecular biologist with a Ph.D. kind of grandmother in mind. You can explain everything if you have the patience and will to break it down to pieces for others to understand.
Yeah I'm sure his grandmother had no problem understanding the general theory of relativity. Do you have other end all discussions quotes to share?
> Yeah I'm sure his grandmother had no problem understanding the general theory of relativity.
Here[1], try and see if you can understand it. I'm sure you can, I'm sure your grandmother can too. Also if you have any specific questions about pharmacology, molecular biology or anything related feel free to ask, I might be able to come with a reasonably simple answer.