6 ms·

FDA Repays Industry by Rushing Risky Drugs to Market

46 points by onychomys 8y ago

refurb 8y ago
Wow. What a terrible and one-sided article. It’s apparent the author has little understanding of how the FDA and drug approval works. 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.
- frgtpsswrdlame 8y ago
  >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.
- XalvinX 8y ago
  > drug manufacturers pay most of the FDA budget. That’s by design 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?
- deweller 8y ago
  > there is zero evidence that it has an impact on the FDA’s independence This is a strong claim. Do you have any proof? Has anyone studied this?
  - refurb 8y ago
    I think the fact the FDA has rejected plenty of drugs for companies who have been “working the system” is proof enough. Generally manufacturers are scared of the FDA. They have a lot of power and aren’t afraid to use it.
- pizza234 8y ago
  The FDA systematically hides misconduct. Here's an investigation: http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html http://www.slate.com/articles/health_and_science/science/201... If one looks on the other side, for sure he finds zero evidence. /sarcasm
mc32 8y ago
The new regime began in earnest in 2011. The FDA is also now making it easier to obtain experimental drugs for terminal illnesses. 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.
- HarryHirsch 8y ago
  People are better served by having a wider choice 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.
  - mc32 8y ago
    My bad, by choice I meant a wider array of drugs whereby this larger array implies better matches of drugs to treat illnesses more effectively. 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.
    - frgtpsswrdlame 8y ago
      I don't think it's so clear cut. First of all with these drugs it's actually impossible to say what percentage of patients our new drugY will work on or who they are. Instead they're going to be marketed to everyone. In fact the article makes the case that these faster approvals may actually slow down our ability to get this information: 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.
XalvinX 8y ago
Related article some may find interesting: http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html http://www.slate.com/articles/health_and_science/science/201...
- mmt 8y ago
  This is probably the best refutation to the (currently top) sub-thread about this article being one-sided. > 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
RickJWagner 8y ago
"Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency." 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.

46 points by onychomys 8y ago

Wow. What a terrible and one-sided article. It’s apparent the author has little understanding of how the FDA and drug approval works. 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.

frgtpsswrdlame 8y ago
>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.
XalvinX 8y ago
> drug manufacturers pay most of the FDA budget. That’s by design 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?
deweller 8y ago
> there is zero evidence that it has an impact on the FDA’s independence This is a strong claim. Do you have any proof? Has anyone studied this?
- refurb 8y ago
  I think the fact the FDA has rejected plenty of drugs for companies who have been “working the system” is proof enough. Generally manufacturers are scared of the FDA. They have a lot of power and aren’t afraid to use it.
pizza234 8y ago
The FDA systematically hides misconduct. Here's an investigation: http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html http://www.slate.com/articles/health_and_science/science/201... If one looks on the other side, for sure he finds zero evidence. /sarcasm

mc32 8y ago

The new regime began in earnest in 2011. The FDA is also now making it easier to obtain experimental drugs for terminal illnesses. 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.

HarryHirsch 8y ago
People are better served by having a wider choice 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.
- mc32 8y ago
  My bad, by choice I meant a wider array of drugs whereby this larger array implies better matches of drugs to treat illnesses more effectively. 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.
  - frgtpsswrdlame 8y ago
    I don't think it's so clear cut. First of all with these drugs it's actually impossible to say what percentage of patients our new drugY will work on or who they are. Instead they're going to be marketed to everyone. In fact the article makes the case that these faster approvals may actually slow down our ability to get this information: 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.

XalvinX 8y ago

Related article some may find interesting: http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html http://www.slate.com/articles/health_and_science/science/201...

mmt 8y ago
This is probably the best refutation to the (currently top) sub-thread about this article being one-sided. > 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

RickJWagner 8y ago

"Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency." 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.