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
> 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...
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.
'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.
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.
I just skimmed the article but I think this is partly due to a controversy over medical device failures. Investigative journalism TV shows discovered a high rate of failure in medical devices.
A large number of implanted devices like hip joints, pacemakers, insulin pumps,catheters were failing. That information wasn't public and when it was made public people freaked out.
Keeping this information from the public, even if people freak out, is dangerous. It would be like car companies not telling you about a recall on your vehicle. The main reason they don't want it public is economic/competitive impacts to the companies that lobby to block it.
The medical industry does deal with these cases and let people know when they have the issue. However, if you keep information from everyone, it doesn't always get to the people it affects.
Being more transparent could also lead to better product development iteration on medical devices if feedback is more available.
Hiding information on problems suppresses solutions. Suppression of information can be catastrophic, ask the FAA.
IIRC FTFY means "Fixed That For You". AFAICT it's pretty common to use abbreviated phrases like that here in HN but maybe TPTB will say otherwise. FWIW abbreviations have a long history
Acronyms are typically used for long-winded domain-specific terminology not easily typed common-language terms. Why create all these acronyms? Is typing not easy on a modern swipe keyboard?
> 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