Today's New York Times editorial, "Moving Toward Greater Drug Safety," makes some good points and some bad ones.
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right?
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right?
