On the heels of Steve Usdin's great piece on the outdated approach FDA critics are takig to drug safety comes an excellent piece by the Newark Star-Ledger's Kitta MacPherson.
Pretty inteilligible quote by yours truly on the failure of second-guessers to call for more funding for Critical Path and to accelerate use of biomarkers and other approaches to identify safety signals before drugs are on the market and to "tag" people before they are prescribed. For Bruce Psarty to say -- "yes, pharmacogenomics is an exciting tool but not ready for prime time so let's spend billions on even larger clinical trials and reviewers and risk management programs" is to simply make it even more difficult to create better tools. And since the IOM report does claim that the most important recommendation it makes is to INTEGRATE safety and efficacy evaluation, why is everyone suggesting steps that separate them instead of supporting science-based techniques that achieve that goal.
Here's the link to the Star-Ledger article
http://www.nj.com/search/index.ssf?/base/news-9/1160455110190710.xml?starledger?ntop&coll=1&thispage=2#continue
And one more thing: Curt Furberg's article on drug safety in the Archives of Internal Medicine.... Here's Furberg explaining his reasoning for putting a "black box" or additional risk warning on drugs for ADHD:
"On the surface, it is hard to believe( so many children really have ADHD)," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."
In otherwords, Furberg decided to scare people away from using "these drugs" because he thinks most kids don't need them.... That follows the bogus cancer scare and Psaty ginned up regarding calcium channel blockers... And we are supposed to follow his lead on how to reform the FDA.
Pretty inteilligible quote by yours truly on the failure of second-guessers to call for more funding for Critical Path and to accelerate use of biomarkers and other approaches to identify safety signals before drugs are on the market and to "tag" people before they are prescribed. For Bruce Psarty to say -- "yes, pharmacogenomics is an exciting tool but not ready for prime time so let's spend billions on even larger clinical trials and reviewers and risk management programs" is to simply make it even more difficult to create better tools. And since the IOM report does claim that the most important recommendation it makes is to INTEGRATE safety and efficacy evaluation, why is everyone suggesting steps that separate them instead of supporting science-based techniques that achieve that goal.
Here's the link to the Star-Ledger article
http://www.nj.com/search/index.ssf?/base/news-9/1160455110190710.xml?starledger?ntop&coll=1&thispage=2#continue
And one more thing: Curt Furberg's article on drug safety in the Archives of Internal Medicine.... Here's Furberg explaining his reasoning for putting a "black box" or additional risk warning on drugs for ADHD:
"On the surface, it is hard to believe( so many children really have ADHD)," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."
In otherwords, Furberg decided to scare people away from using "these drugs" because he thinks most kids don't need them.... That follows the bogus cancer scare and Psaty ginned up regarding calcium channel blockers... And we are supposed to follow his lead on how to reform the FDA.
