Nissen Auditions for FDA Commissioner

If anyone in Washington who covers the FDA was paying attention yesterday to Steve Nissen's "compromise" on how to regulate new diabetes drugs they got an idea of how new drug development would fare under Nissen if he had more control over the FDA or became commissioner:

From today's WSJ:

"Cardiologist Steven Nissen of the Cleveland Clinic said the FDA should require companies to prove their drugs don't raise risks of cardiovascular disease before they are approved.

Dr. Nissen said there are more than enough diabetes drugs on the market that lower blood-glucose levels, and now is the time for the FDA to raise its standards.

"Merely lowering blood-glucose levels in diabetes is too simplistic," Dr. Nissen said. "We must reduce the complications of diabetes, including cardiovascular disease."

online.wsj.com/article/SB121495996433621583.html

Dr. Nissen suggested that in addition to requiring more preapproval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease.

Why stop at diabetes drugs?  If you apply Nissen's logic to any illness "there are more than enough drugs" out there to treat everything under sun.  And since every drug has some cardiac risk, why not subject them all to increased long term clinical trials (that Nissen would conduct of course) to look at the problem. 

Let's set aside diabetes which is not just killing people here but worldwide.  And let's set aside Nissen's failure to acknowledge that by claiming there are more than enough drugs he is ignoring the fact that diabetes requires individualized treatment but that new medicines will be developed (we hope) around more particular and preventive approaches, etc., etc.  and that diabetes is not just a cardiovascular disease but part of a larger disorder that must be treated with as many tools as possible.   Would you want an FDA commissioner who would say "we have enough drugs for...."?  I am sure there are some who believe that, including Marcia Angell, but not many real physicians and scientists. 

I would love to see that statement thrown back at him.

Next, what are the implications of his approach to access to medicines for patients?

Here's what the lead medical officer who reviews diabetes drugs at the FDA said according to a reporting in Bloomberg News

"Conclusive evidence of cardiovascular benefit hasn't been established for any drug for Type 2 diabetes, despite several large, long-term trials," Hylton Joffe, lead medical officer in the FDA's Division of Metabolism and Endocrinology Products, told the FDA panel yesterday.

Requiring heart assessments, especially before FDA approval, would add years to drug development because it takes that long for damage to show up. There also are ethical and logistical questions about how to organize studies because patients don't want to be in a comparison group getting a dummy pill and usually require multiple medicines as their disease progresses, Joffe said."

www.nj.com/business/ledger/index.ssf
Frankly, I don't think Nissen -- who simply engaged in fearmongering over Avandia and drugs for ADHD -- couldn't care about the ethics of the matter. 

If Nissen were FDA Czar, here's what patients could expect:

Add years and billions to the cost of new drug development.
Say good-bye to the Critical Path.
Let millions of people who are dying of and suffering from any illness with a drug in development that may have a cardiac side effect that can be found in any amount of any correlation wait while some pet meta-analysis is verified.  So that includes drugs for:
Cancer
Alzheimer's
Schizophrenia
Parkinson's
HIV
Diabetes

And stem cell research of any kind...

I hope at least patients are paying attention.