The 14-2 vote to add years to the time patients will get new diabetes drugs to search for potential CV risks is a direct attach on the Critical Path. Long term studies are not needed when new biomarkers and predictive systems can be developed. But of course, that won't pass muster with the dimwits who followed Nissen off the Critical Path in a 14-2 vote or the media or pols who construed the choice as follows:
Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.
The Critical Path is all about determining who should get what drug based on predictive markers... Nissen, the media and the pols are all about fearmongering. Test 'em all.
"The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars."
Oh really? And which patients will you expose to the additional risk while being treated to diabetes? Or the so-called risk since it is unclear if there is a risk at all or which patients are at greater risk. This is the result of Tabloid Medicine driving out good science and medical progress.
Meanwhile Nissen made this incredibly ignorant statement:
FDA is operating under ''the irrational belief that lowering blood sugar using virtually any pharmacological means will produce'' better results for patients."
Actually, that is what Nissen said -- we already have enough drugs to do the job. The FDA has never practiced medicine but has data showing that reductions in blood sugar do keep people alive longer. Nissen care to dispute that?
The danger of course is that this brutalization of medical science will spread to other diseases....Will the grownups at the FDA do the right thing and strike a balance for science?
''The fallacy here is that we will never know everything we'd like to about a drug before it goes on the market,'' Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview Tuesday. ''If we held up drugs until we did know everything a lot of people would die.''
www.nytimes.com/aponline/health/AP-Diabetes-Drugs-Heart-Risks.html
Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.
The Critical Path is all about determining who should get what drug based on predictive markers... Nissen, the media and the pols are all about fearmongering. Test 'em all.
"The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars."
Oh really? And which patients will you expose to the additional risk while being treated to diabetes? Or the so-called risk since it is unclear if there is a risk at all or which patients are at greater risk. This is the result of Tabloid Medicine driving out good science and medical progress.
Meanwhile Nissen made this incredibly ignorant statement:
FDA is operating under ''the irrational belief that lowering blood sugar using virtually any pharmacological means will produce'' better results for patients."
Actually, that is what Nissen said -- we already have enough drugs to do the job. The FDA has never practiced medicine but has data showing that reductions in blood sugar do keep people alive longer. Nissen care to dispute that?
The danger of course is that this brutalization of medical science will spread to other diseases....Will the grownups at the FDA do the right thing and strike a balance for science?
''The fallacy here is that we will never know everything we'd like to about a drug before it goes on the market,'' Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview Tuesday. ''If we held up drugs until we did know everything a lot of people would die.''
www.nytimes.com/aponline/health/AP-Diabetes-Drugs-Heart-Risks.html
