Genomics will play a huge part in that, as we will be able to determine
1) Which patients will even respond to the product, and
2) Engineer the product to target specifcally those individuals.

And, if we don’t move more toward a European style of conducting and approving clinical trials, this industry will comprise 95% of our GDP within the next 20 years or so.

Sound nutty? Print and save.

Mr. Blue

So when you say:
“It would be unethical and probably illegal to not provide such relevant information to the FDA in order to compose labeling info.”

I say that- for a reformulated branded drug to be approved by the office of generics, based on a couple of one dose studies, does not allow for the FDA to make a fully informed decision. And they seem perfectly okay with that.

What happens to consumers if a new sub-population is created through the reformulation of a drug? Or rather, what if a known sub-pop is ignored by these very limited studies?
Is it ethical then?

Our doctors do not get to select only patients without a narrow therapeutic index. And they sure don’t get to give their patients only one pill. The very least they should get is information so that they know that what was successful yesterday may not work tomorrow. With ANDAs they do not get that information and it is dangerous.
I don’t know where that falls under the term ‘ethical’ but it does make our drug supply untrustworthy.

No..

It would be dangerous…

It’s the same with drugs…

Whether you do that purposely or it goes over your head I have no idea…

So maybe, I should make it clear for you..

If for example a drug company does 5 clinical trials for a new drug…
And let’s say 4 of them failed and the results were negative in terms of efficacy , side effects , effectiveness etc, and lets say one study performed slightly better than placebo and this study is the only one published..

Does that mean the drug is safe? Does that mean efficacy has been proven? Does that mean that the drug should automatically hit the market? ..

Of course it doesn’t, what it actually proves is that the drug failed more times than it passed…

It’s bad science, fluke and pot luck..

Paxil is a perfect example of this kind of thing…

I’ve no idea, but it should certainly be available if a drug is licensed, based on successful (dare I say “cherry-picked”? Clearly I do), trials. In the UK, only the regulator gets to demand all trials data. How is a frontline clinician supposed to prescribe accurately, on that basis? And what hope has the patient got?

Look, Nathan, the bottom line is that there’s no trust left, and the Worshipful Company has brought that state of affairs upon itself. You may argue all you like about the propriety of not publishing this negative material, but that won’t change anybody’s perception.

Matt

http://www.marcusevans.com/html/eventdetail.asp?sectorID=32&EventID=11612

Matt

http://www.clinicaltrialstoday.com/2008/08/merck-report-co.html

Matt

Absolutely - I agree. It would be unethical and probably illegal to not provide such relevant information to the FDA in order to compose labeling info. However, publishing in a scientific journal is another story. I agree it makes sense to do what you suggest when there is relevant negative info about a subpopulation. I doubt that very many people in industry would disagree with you. I also doubt that this scenario accounts for a very large percentage of the unpublished work. Also, you have to consider another point that someone made above: Many times trials are halted when such side effects or lack of efficacy is observed. This constitutes an “incomplete” experiment. What journal would publish such material?

Oh, gee, Nathan - you got me! I don’t subscribe to any of the esteemed organs that you mention.

But the marketing “professionals” certainly understand the value of a clinical trial:

http://www.researchandmarkets.com/reports/301981/successfully_marketing_clinical_trial_results

Matt