4 ms·

Anything measured improves. The more data and metrics, the better safety of drugs can be observed. It is always a good thing to get more insight and information

Anything measured improves. The more data and metrics, the better safety of drugs can be observed. It is always a good thing to get more insight and information to help harm reduction and safety. > Transparency advocates say clinical study reports need to be made public in order to understand how regulators make decisions and to independently assess the safety and efficacy of a drug or device. They also say the reports provide medical societies with more thorough data to establish guidelines for a treatment's use, and to determine whether articles about clinical trials published in medical journals — a key source of information for clinicians and medical societies — are accurate. There really is no reason why this data should not be more public at the FDA. Transparency improves safety, and that is their stated mission. > FDA Mission > The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation

darawk 7y ago
I suppose one counter-argument might be that if the data is public, drug companies would have more transparency into the FDAs methods, that might allow them to tailor their trials in a way to target the FDA's criteria in a way that would be bad for outcomes? Maybe? But I come down on the same side, more transparency is probably better, and the FDA really probably only resists transparency here to avoid their own accountability to the public.
- crankylinuxuser 7y ago
  'Your account has been banned for violation of policies. You are not allowed to know why you are banned. You know what you did. All your data has been deleted and is no longer accessible to you." ---Any cloud provider Is that kind of secrecy useful in any way? No. It, instead serves to cover up abuses and oversights. Transparency, especially in government is essential. People should have privacy as their right, but the government should not.
  - darawk 7y ago
    Ya, I agree. Just trying to come up with the strongest possible counter-argument. Which may be that the FDA depends on some level of secrecy in order to prevent drug companies from overly tailoring their trials to their internal criteria. To be clear, I don't find that argument convincing, it's just the best one I could think of.
- refurb 7y ago
  Drug companies already tailor their trials for the FDA. There are IND meetings with the FDA where they give you feedback on trial design. Pretty much any “recommendation” they give is not really optional.
- michaelhoffman 7y ago
  Which part of the FDA new drug evaluation process is secret? I have never heard of such a thing.
ws66 7y ago
> Anything measured improves. The more data and metrics, the better safety of drugs can be observed I agree in theory. However in practice, when the data is relatively complex, there will be some people that will take the data and do their own (lacking) interpretation and sometimes create more harm. Like what we are seeing with global temperatures from public records and how this is interpreted by the different parties... But I have no solution to this issue...
refurb 7y ago
Clinical trial data that the FDA makes decisions on is summarized in the label. You might argue we need more detail.

darawk 7y ago

I suppose one counter-argument might be that if the data is public, drug companies would have more transparency into the FDAs methods, that might allow them to tailor their trials in a way to target the FDA's criteria in a way that would be bad for outcomes? Maybe? But I come down on the same side, more transparency is probably better, and the FDA really probably only resists transparency here to avoid their own accountability to the public.

crankylinuxuser 7y ago
'Your account has been banned for violation of policies. You are not allowed to know why you are banned. You know what you did. All your data has been deleted and is no longer accessible to you." ---Any cloud provider Is that kind of secrecy useful in any way? No. It, instead serves to cover up abuses and oversights. Transparency, especially in government is essential. People should have privacy as their right, but the government should not.
- darawk 7y ago
  Ya, I agree. Just trying to come up with the strongest possible counter-argument. Which may be that the FDA depends on some level of secrecy in order to prevent drug companies from overly tailoring their trials to their internal criteria. To be clear, I don't find that argument convincing, it's just the best one I could think of.
refurb 7y ago
Drug companies already tailor their trials for the FDA. There are IND meetings with the FDA where they give you feedback on trial design. Pretty much any “recommendation” they give is not really optional.
michaelhoffman 7y ago
Which part of the FDA new drug evaluation process is secret? I have never heard of such a thing.

ws66 7y ago

> Anything measured improves. The more data and metrics, the better safety of drugs can be observed I agree in theory. However in practice, when the data is relatively complex, there will be some people that will take the data and do their own (lacking) interpretation and sometimes create more harm. Like what we are seeing with global temperatures from public records and how this is interpreted by the different parties... But I have no solution to this issue...

refurb 7y ago

Clinical trial data that the FDA makes decisions on is summarized in the label. You might argue we need more detail.