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Recent Articles
There Goes the Downpayment on Health Care Reform
No, I'm not referring to the demise of Tom Daschle's appointment as Health and Human Services Secretary. That's a bump on the road compared to news this morning that the stimulus plan as written is in trouble in the Senate, and Sens. Ben Nelson (D-NE), leader of the blue dog Democrats, and Susan Collins (R-Maine), a leading Republican moderate, headed over to the White House with a hit list of programs that shouldn't be included in the bill. The $1.1 billion for comparative effectiveness topped the list, according to the morning Washington Post.
The big lie campaign, on display yesterday by Republican staffers speaking at the Academy Health conference in Washington, is that comparative effectiveness will be used to have the government establish what procedures and drugs doctors can use in treating sick patients. That's not true, of course. It will be used at the outset to establish scientific standards about what works best. If insurers, whether the government or in the private sector want to use that information to set reimbursement policy, is an issue that will be decided down the road.
But even getting the downpayment of $1.1 billion in money funneled through the National Institutes of Health, the Center for Medicare and Medicaid Services and the Agency for Healthcare Quality and Research has drawn opposition on the Wall Street Journal editorial page (where Scott Gottlieb, a fellow at the American Enterprise Institute is the leading voice), from patient advocacy groups who are the payroll of the pharmaceutical industry, and, I have to presume, the lobbying machine for the drug, device and durable equipment industries. Getting it out of the stimulus bill will be a major victory for all of those forces.
Liberals and left-of-center Democrats in Congress should mount a fight to keep this in the package. Comparative effectiveness research at this level is nothing more than giving study grants, which would provide an immediate stimulus to the economy. Allowing victory for a big lie campaign against comparative effectiveness would not be a positive harbinger for meaningful cost controls in any health care reform bill.
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Comments
The provision to allocate funds to create a Center for Comparative Effectiveness to test whether newer, more expensive drugs work better than their older and cheaper counterparts, went from $300 million to $1.1 billion?
There's an accusation that there is an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as wasteful, the more money Medicare saves.
And what if Medicare starts using flawed studies to determine its list of covered drugs? Hasn't the FDA already used non-inferiority study designs to support efficacy? Treatment is considered "approvable" if it retains 50% or more of the effectiveness of a comparable product.
The FDA has also used surrogate endpoints (biomarkers or laboratory measures) to support approvals without requiring more informative clinical outcome studies.
However, cancer research leadership bought the concept that only one biomarker assay technology is worth studying, rather than carrying out comparative-effectiveness studies of different types of assay technologies, based on different biological endpoints.
They are putting all of their eggs in a single basket, and indeed shackling the whole concept of surrogate endpoints to a single technology. They have dropped the ball again, as they have many times before.
CMS is using flawed studies now: they reimburse for the off-label use of drugs based on listings in compendia written by committees that frequently have substantial conflicts of interest. The question is how to get good objective analysis. I would rather see the government do it as long as the physicians they select to serve on the panels do not have ties to industry.