Senator Dodd Proposes Sweeping Drug Safety Reform

Forbes.com, Matthew Herper, 01.21.05

NEW YORK - Doers and doings in business, entertainment and technology:

Connecticut Senator Christopher J. Dodd, a Democrat, is proposing a sweeping set

of drug reforms that would give the Food and Drug Administration the muscle to

force pharmaceutical companies to study drug safety after the medicines are

approved. If drug companies ran afoul of the FDA, they might be fined as much as

$10,000 per day. The bill, called the Patient Protection Act of 2005, would have

no effect on the approval process for drugs. Instead, it gives the FDA more

power to regulate medicines after they are approved, filling what he said were

"gaping holes" in the agency's ability to enforce its decisions. "'FDA-approved'

is just about as good a brand as we have," said Dodd. The point of the bill is

to make that brand stronger. He said the bill would "put some real teeth into

the FDA."

Dear Senator Dodd,



The NIH has trained a growing cadre of physician/informatics specialists whose specialty includes electronic medical records; clinical outcome improvement initiatives; biomedical data, information and knowledge management; and optimal approaches to implementing clinical information technology in patient care settings.



For some reason, Sen. Dodd, the pharmaceutical industry nearly ignores this NIH-sponsored specialty. I managed to get in - running a science library while reporting to computer people whose knowledge of medicine did not extend past the local CVS pharmacy - until it was determined that due to budget cuts, first a financial guy and then an IT technologist without a medical background were sufficient for the purpose. I was told by a number of pharma companies that "medical informatics was not needed here", including in an adverse-events reporting department led by a former FDA adverse events official.

It was a peculiar observation that this person's reports, the clinicians and scientists involved in adverse events day-to-day data management, felt 100% differently than their boss. It was also kind of funny when I showed them 10-year-old technology I gave the Saudi Arabians back in 1995. They thought it would be great if they had similar technology - in 2004 - to solve the problems they sometimes had in dealing with data in that good old reliable 1970's format, paper, or else via that other wonder of advanced technology, Microsoft Access.



If I didn't know better, I might think that big pharma is trying hard to avoid incorporating new thinking and doing everything in its power to maintain its ossified practices -- practices that have worked so well in recent years that there are more lawsuits over drug side effects than there are computers in CompUSA.



So, Sen. Dodd, by all means, knock yourself out.



-- SS