3 ms·

I've been on the science side of a number of FDA clinical trials for a few years now. The FDA is too conservative with many metrics, and too aggressive with ot

I've been on the science side of a number of FDA clinical trials for a few years now. The FDA is too conservative with many metrics, and too aggressive with others. The clinical trial pipeline is tortuously slow for everyone involved-- the EU equivalent agency has done a lot to accelerate the process fruitfully. Eclipsing these FDA malregulations is the problem of transparency; if the FDA forced clinical trials to publish 100% of their data rather than only the positive results, we'd have a better medicine producing industry.

minthd 11y ago
Is there any realistic possibility Americans could use drugs approved in Europe ?
- dragonwriter 11y ago
  Americans can obviously use drugs approved in Europe in Europe; drugs approved in Europe but not the USA cannot generally legally be imported, sold, or prescribed in the USA, however.
- kirsebaer 11y ago
  Any American MD can ask the FDA for "expanded access" to use a medication not approved by the FDA. 99% of the time the FDA grants expanded-access requests. However, a recent review in NEJM explained how it is time consuming and expensive to apply for expanded-access and often the pharmaceutical companies refuse to distribute the drugs even after the FDA grants expanded-access. http://www.nejm.org/doi/full/10.1056/NEJMhle1409465 http://www.nejm.org/doi/full/10.1056/NEJMhle1409465 "Compassionate use" is a separate, but related concept with different rules than "expanded access". And in the EU expanded access is often called "named-patient".
  - minthd 11y ago
    Thanks. You really know this stuff. Why is there dependence on drug companies ? distributing drugs bought in Europe or elsewhere is pretty easy.And as for drug companies being protected from american litigation - if they don't sell it on u.s. soil, they are not responsible in u.s. courts, right? As for the process being complex and expensive, is there work being done to solving this, with regards to EMA approved drugs ?
- vitd 11y ago
  Yes. My wife was given medication not FDA approved by her doctor. She had to order it from a pharmacy in Canada, but it was all legit. The (US) doctor wrote her a script and filled out some sort of paperwork for the government, as I understand it. And no, her doctor isn't some quack who regularly prescribes unapproved medicine. Apparently this particular drug is approved in Canada and Europe, but the company that makes it is small enough that they haven't yet decided to apply for FDA approval because of the cost. (Or at least, that's what I've been told.)
astazangasta 11y ago
>if the FDA forced clinical trials to publish 100% of their data rather than only the positive results, we'd have a better medicine producing industry. I thought this was actually already the case with clinicaltrials.gov and it is apparently having a profound effect: http://www.nature.com/news/registered-clinical-trials-make-positive-findings-vanish-1.18181 http://www.nature.com/news/registered-clinical-trials-make-p...

minthd 11y ago

Is there any realistic possibility Americans could use drugs approved in Europe ?

dragonwriter 11y ago
Americans can obviously use drugs approved in Europe in Europe; drugs approved in Europe but not the USA cannot generally legally be imported, sold, or prescribed in the USA, however.
kirsebaer 11y ago
Any American MD can ask the FDA for "expanded access" to use a medication not approved by the FDA. 99% of the time the FDA grants expanded-access requests. However, a recent review in NEJM explained how it is time consuming and expensive to apply for expanded-access and often the pharmaceutical companies refuse to distribute the drugs even after the FDA grants expanded-access. http://www.nejm.org/doi/full/10.1056/NEJMhle1409465 http://www.nejm.org/doi/full/10.1056/NEJMhle1409465 "Compassionate use" is a separate, but related concept with different rules than "expanded access". And in the EU expanded access is often called "named-patient".
- minthd 11y ago
  Thanks. You really know this stuff. Why is there dependence on drug companies ? distributing drugs bought in Europe or elsewhere is pretty easy.And as for drug companies being protected from american litigation - if they don't sell it on u.s. soil, they are not responsible in u.s. courts, right? As for the process being complex and expensive, is there work being done to solving this, with regards to EMA approved drugs ?
vitd 11y ago
Yes. My wife was given medication not FDA approved by her doctor. She had to order it from a pharmacy in Canada, but it was all legit. The (US) doctor wrote her a script and filled out some sort of paperwork for the government, as I understand it. And no, her doctor isn't some quack who regularly prescribes unapproved medicine. Apparently this particular drug is approved in Canada and Europe, but the company that makes it is small enough that they haven't yet decided to apply for FDA approval because of the cost. (Or at least, that's what I've been told.)

astazangasta 11y ago

>if the FDA forced clinical trials to publish 100% of their data rather than only the positive results, we'd have a better medicine producing industry. I thought this was actually already the case with clinicaltrials.gov and it is apparently having a profound effect: http://www.nature.com/news/registered-clinical-trials-make-positive-findings-vanish-1.18181 http://www.nature.com/news/registered-clinical-trials-make-p...