FDA far too conservative in approving new drugs, research finds, leading to more deaths from disease

[Axulus]

You don't seem to understand how the criteria currently works. The FDA rejects drugs unless they can prove beyond a 97.5% confidence level that they are safe enough and effective. For pancratic cancer, this is absolutely nuts. Drugs that have an 80% chance of being safe and effective should be getting through. An 80% chance is 4 out of 5 chance of extending someone's life. Just because a drug only has an 80% chance does not mean it isn't a favorable gamble to approve it for those suffering from this disease.

How many drugs didn't meet the standard and were rejected?

How many trials or promising lines of research were stopped early because of difficulty and cost involved in meeting the 97.5% confidence threshold? The FDA has rejected many drugs due to not enough confidence. It happens all the time. The company either decides to run another expensive trial or abandon the drug all together.

The point is that, for some diseases, the death rate from the disease is so high that the FDA should allow for much riskier treatments. And of course, there are patients and doctors involved in the process. Why should the government step in between a patient and their doctor when the disease is something deadly like pancriatic cancer?

 

[NobleSavage]

So how does the FDA compare to the European Medicines Agency or other countries around the world?

 

[Loren Pechtel]

How many drugs didn't meet the standard and were rejected?

How many trials or promising lines of research were stopped early because of difficulty and cost involved in meeting the 97.5% confidence threshold? The FDA has rejected many drugs due to not enough confidence. It happens all the time. The company either decides to run another expensive trial or abandon the drug all together.

The point is that, for some diseases, the death rate from the disease is so high that the FDA should allow for much riskier treatments. And of course, there are patients and doctors involved in the process. Why should the government step in between a patient and their doctor when the disease is something deadly like pancriatic cancer?

Rejected or sent back for more testing? As it stands some pretty marginal drugs are getting approval.

It occurs to me, one more thing the FDA should do: When dealing with a drug that is closely related to an existing one the company should be required to show that it's an improvement. As it stands all too often we get "new" versions of old drugs to restart the patent clock when in reality they made a chemical change that will have absolutely no effect in the body.

 

[NobleSavage]

Answered my own question:

Between 2001 and 2010, the FDA's typical review of a new drug was about 15 percent faster than those by the European Medicines Agency and Health Canada, its counterparts abroad, according to a study published Wednesday by the New England Journal of Medicine.

http://www.huffingtonpost.com/2012/...er-united-states-canada-europe_n_1524527.html

 

[bilby]

How many trials or promising lines of research were stopped early because of difficulty and cost involved in meeting the 97.5% confidence threshold? The FDA has rejected many drugs due to not enough confidence. It happens all the time. The company either decides to run another expensive trial or abandon the drug all together.

The point is that, for some diseases, the death rate from the disease is so high that the FDA should allow for much riskier treatments. And of course, there are patients and doctors involved in the process. Why should the government step in between a patient and their doctor when the disease is something deadly like pancriatic cancer?

Rejected or sent back for more testing? As it stands some pretty marginal drugs are getting approval.

It occurs to me, one more thing the FDA should do: When dealing with a drug that is closely related to an existing one the company should be required to show that it's an improvement. As it stands all too often we get "new" versions of old drugs to restart the patent clock when in reality they made a chemical change that will have absolutely no effect in the body.

Sure, but this can also be used to get around patents and introduce generics earlier.

I recall one SSRI where the hexa-hydrate was patented, but the anhydrous polymorph was not - the patent holder was aware that the anhydrous form would revert to the hexa-hydrate very rapidly in the presence of moisture, and believed that the anhydrous form would be impractical to manufacture in worthwhile quantities. A smart guy at a generic manufacturer came up with a very low humidity manufacturing process, and registered the anhydrous form as a new formulation. The FDA approved it, and the courts ruled that as the two formulations were detectably different up to the point of administration to the patient, the original patent didn't cover the anhydrous form - even though it would be fully converted to hexa-hydrate as soon as the tablet reached the duodenum and the enteric coating dissolved - so by the time of uptake, the two drugs were identical.

 

[Loren Pechtel]

Rejected or sent back for more testing? As it stands some pretty marginal drugs are getting approval.

It occurs to me, one more thing the FDA should do: When dealing with a drug that is closely related to an existing one the company should be required to show that it's an improvement. As it stands all too often we get "new" versions of old drugs to restart the patent clock when in reality they made a chemical change that will have absolutely no effect in the body.

Sure, but this can also be used to get around patents and introduce generics earlier.

I recall one SSRI where the hexa-hydrate was patented, but the anhydrous polymorph was not - the patent holder was aware that the anhydrous form would revert to the hexa-hydrate very rapidly in the presence of moisture, and believed that the anhydrous form would be impractical to manufacture in worthwhile quantities. A smart guy at a generic manufacturer came up with a very low humidity manufacturing process, and registered the anhydrous form as a new formulation. The FDA approved it, and the courts ruled that as the two formulations were detectably different up to the point of administration to the patient, the original patent didn't cover the anhydrous form - even though it would be fully converted to hexa-hydrate as soon as the tablet reached the duodenum and the enteric coating dissolved - so by the time of uptake, the two drugs were identical.

So what?

 

[ronburgundy]

Exactly how do the researchers measure the harmful effects that would have occurred had the FDA not rejected or prompted improvements to a new drug? What about drugs that would have been harmful but don't even get sent to the FDA or fully developed because the companies know that the won't get past the current standards?
What about the indirect harmful effects of drugs that are merely ineffective, but as a result people are less likely to undergo other treatment because they and their doctor believe they are already doing something by taking those drugs?

I will tell you how they measure these negative impacts of Type 1 errors, they don't, because it is impossible to accurately measure these. They are not observable, because they didn't actually happen due to the FDA standards preventing them.

Regardless, the "research" only applies to tiny % of FDA evaluated drugs related to highly fatal conditions, not the 99% that range from only slightly fatal to things that are not diseases at all and do not require any treatment like the inability to get a 4 hour boner.

 

[bilby]

Sure, but this can also be used to get around patents and introduce generics earlier.

I recall one SSRI where the hexa-hydrate was patented, but the anhydrous polymorph was not - the patent holder was aware that the anhydrous form would revert to the hexa-hydrate very rapidly in the presence of moisture, and believed that the anhydrous form would be impractical to manufacture in worthwhile quantities. A smart guy at a generic manufacturer came up with a very low humidity manufacturing process, and registered the anhydrous form as a new formulation. The FDA approved it, and the courts ruled that as the two formulations were detectably different up to the point of administration to the patient, the original patent didn't cover the anhydrous form - even though it would be fully converted to hexa-hydrate as soon as the tablet reached the duodenum and the enteric coating dissolved - so by the time of uptake, the two drugs were identical.

So what?

Oh, I'm sorry, I didn't realise you were averse to rambling anecdotes that are at best tangential to the point of the discussion.

 

[dismal]

As a simple thought experiment, what would cause a bureaucrat responsible for drug safety more problems:

A) 100 people die of some disease because they didn't get a drug
B) 100 people die because they got a drug that killed them

 

[untermensche]

I don't think some people appreciate the complexity in assuring drugs are safe and effective.

It would be a lot easier if corporations weren't trying to distort the evidence to the greatest extent possible.

Drug development should not be linked to the drive for profits. It should be done by government agents not seeking profits.