FDA Repays Industry by Rushing Risky Drugs to Market
propublica.org
propublica.org
Yes, all drugs have side effects and yes, some drugs will be approved and later pulled from the market when we have more data. It is impossible to fully vet a drug in clinical trials. It’s meant to reduce the risk, not eliminate it.
And yes, drug manufacturers pay most of the FDA budget. That’s by design and there is zero evidence that it has an impact on the FDA’s independence.
I'm curious, what would actually count as evidence to you? It seems to me this article has plenty.
This is a strong claim. Do you have any proof? Has anyone studied this?
Generally manufacturers are scared of the FDA. They have a lot of power and aren’t afraid to use it.
Do you happen to know what law congress passed or otherwise how this became "by design"? News to me. Doesn't the government have enough money to fund these kind of public agencies? Is this true of others too? Does the USDA get funded by farmers too?
And am I the only one that sees potential conflict of interest that would lead to threats to public safety arising from this "design" you speak of?
http://www.slate.com/articles/health_and_science/science/201...
If one looks on the other side, for sure he finds zero evidence. /sarcasm
There are some negative side effects, but overall, so long as there is full disclosure of known issues (we may need to improve upon this) I think people are better served by having a wider choice of medicines to address their ailments. Pro publica, here, is not being pro public but more anti pharma for unknown reasons.
It’s distateful when public interest orgs transform into political orgs with agendas.
No, the consensus in medial ethics is that patient outcomes are the only thing that's relevant. "Choice" is an important symbol in American Civil Religion, but it's not relevant, we are talking medical ethics here.
Let’s say drugX works well enough on 85% of patients and drugY works well enough on 5% of patients. It’s better to have both drugs available than just the one that treats the majority of patients.
The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements — such as shrunken tumors — instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.
So what, there's going to be a 10 year period where patients are unable to evaluate what their best shot at treatment is? We often forget that markets and rational decision-making require good information to produce good outcomes. Allowing drugs into the market that are opaque and expensive isn't going to make things better for patients, it's going to make it worse.
I mean, there is no way that can be true, is there? The FDA is allowing private, for-profit companies (many with an already checkered past) to utilize citizens as their motherfucking lab rats? Ummmmmmmm.....no way.
Don't we (the people, right?) get to vote on this or something? This doesn't seem very just.
Okay, so what exactly do you think public interest orgs are?
I expect them to work on behalf of the public, rather than being anti something without good reason.
They all believe they're working on behalf of the public in some form. Anti-tax groups are helping billionaires which will something-something trickle-down and help everyone!
Certainly you realize whether they are working on behalf of the public depends on your relative viewpoint?
Public interest organizations represent the diffuse general public against concentrated power, e.g. when the EFF pushes back against Hollywood lobbying for retroactive copyright term extensions.
The issue is to avoid an "us vs. them" frame, because not everything MegaCorp wants is against the public interest. There is a public interest in having access to more medicine. It's counterproductive to fight something that helps everyone just because it also helps MegaCorp.
The EFF is in fact, a political org with a political agenda. They don't pretend otherwise.
Whether they are working on behalf of the public all depends on your relative viewpoint.
Pretty much all of them believe they are working on behalf of the public, even the ones HN would classify as industry lobbying orgs, etc.
There is a difference between political in the sense that all legislation is political, and politics as an "us vs. them" tribal conflict where anything which is bad for your opponents is good for you and vice versa. Having anyone, but public interest orgs especially, participate in the second kind of politics is distasteful.
Only if it provides benefit and doesn't cause harm, and that's not clear with these medications.
Public interest orgs all have agendas. They also often take just as much liberty with the truth as private organizations, because outrage bait drives donations. (E.g. I'm an ACLU member, but I unsubscribed from Anthony Romero's emails because of how often I'd read through some story to realize it was misleadingly presented.)
See, for example, the English results of the Cancer Drugs Fund. https://www.bmj.com/content/357/bmj.j2097
> It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured
At least the article didn't try to imply it's a new problem, which might drum up some clicks. Kudos for integrity that way.