There is this "emperor has no clothes" sense that pervades the whole report which no one in the media has yet to penetrate. The same thing seems to be going on with the Iraq Study Group report which appears to have taken on an aura of authority well beyond either the expertise or direct investigation of the members. Indeed, at the press conference when the report was released one reporter asked the ultimate question: Since none of the study group members had been beyond the Green Zone in Iraq and had only visited the country once (with the exception of one member) what makes their observations more valid than the commanders on the ground?
It was a really uncomfortable moment. Messrs. Baker and Hamilton hemmed and hawed and talked about how the ISG was the only bi-partisan group and how it had reached a consensus. And then the went back to explaining how if Israel gave back the Golan Heights that would guarantee that Syria would seal the Iraqi border from terrorists. For this we waited 8 months.
The same goes for the IOM study. Not one member of the panel went beyond the Green Zone when it came to drug development: no one who had been involved in clinical trials at any level, no one who had been involved in doing drug reviews or submitting them, no one who had been involved in designing or conducting phase IV clinical trials.
So the question is: why should we follow their advice as opposed to people who are actually in the business of looking at drug safety. How about all the folks who are in charge of Drug Safety Boards like those who had the responsibility of looking at drugs from Phase III to Phase IV? How about companies like Quintiles that have the largest body of Phase IV data in the world?
Sheila Burke claims that she couldn't use any of this expertise because they all had existing involvment with drug companies. That is nonsense. Everyone of the people on her panel had existing or pre-existing ties to insurance companies who do business with drug companies and will benefit from the panel's recommendations to buy insurance company administrative claims databases. Did anyone see anything in the report about the value of such databases relative to other sources of data for improving prescribing and managing risk/benefit. The IOM panel focuses largely on looking for safety signals with such databases, the worst possible use for such datasets since they rarely adjust for severity of illness, comorbidity, etc.
And the IOM report caves in to the unscientific demand for large multi-year randomized clinical trials like ALLHAT and CATIE that ignore patient variation at the genetic level. That means IOM wants to move the FDA in the exact opposite direction from the Critical Path and personalized medicine. Is anyone out there paying attention to this idiocy? Why all the bowing and scraping to recommendations that are retrograde?
Policymakers should listen instead to the reasonable safety reforms put forth by the agency's deputy commissioner for medical and scientific affairs, Dr Scott Gottlieb. According to SCRIP World Pharmaceutical News, Gottlieb told the Windhover FDA/CMS summit in Washington, DC, that legislative and regulatory proposals aimed at promoting continued learning about newly approved medicines had to be flexible to account for changes in the way medicine is practised. "
"Congress and some safety advocates are moving towards multi-decade postmarket study commitments," Dr Gottlieb said. "They may be setting society up for failure because the medical and pharmacological landscape will change so much that most studies designed today will not yield useful data and it will not be feasible or maybe even ethical to complete them...."
So much for the IOM recommendation for ALLHAT like studies.
"Dr Gottlieb suggested that prospective databases, such as those of insurance claims, could present greater opportunities for fulfilling Phase IV commitments for drugs. The agency recently announced plans to develop a series of guidance documents describing the best approaches for using epidemiological datasets to analyse postmarketing safety.
There need to be incentives for collecting and analysing epidemiological data in a more rigorous fashion, the deputy commissioner said. "Prospective databases have really only been used in a punitive way to look for problems and not look for opportunities," he said. "Unless we find a way to allow these things to be used for opportunities, you're not going to have everyone aligned behind the same goal."
There's the difference: Gottlieb is clearly making recommendations beyond the Green Zone. Insurance claims that are beefed up and supported with more rigorous observational studies for Phase IV commitments . The IOM wants to buy claims data to allow David Graham to go fishing for safety problems in order to address the imbalance between safety and efficacy that the IOM panel believes exists. And while other FDA officials want to make Phase IV part of a continuous feedback loop to improve clinical trial design and create predictive drug models, the IOM just regards their recommendations as separate and apart from the drug approval process.
Less reverence and more analysis is in order.