The Right Prescription
By Robert M. Goldberg on 11.18.09 @ 6:07AM
The American Spectator
Think Congress is regretting having allocated over a billion dollars to let the government generate studies to tell us what medical tests and procedures should be covered under Obamacare?
In the wake of the U.S. Preventive Services Task Force recommendation to tell women in their forties to take a hike on mammograms, and to suggest that other screening technologies aren't worth the money, I bet it won't be long before that budget and the agency that has it and also controls the information the Task Force uses to make such wise decisions, the Agency for Healthcare Research and Quality, are the subjects of congressional hearings.
The breast cancer recommendations come in a 30-page review of 10 studies that even the authors admit cannot be generalized to individual forms of breast cancer and different groups of patients .
But there's more. The Task Force on Monday also issued a second recommendation that has received no media coverage -- on screening for heart disease. Because heart disease kills more women than breast cancer, that decision could be even more dangerous for women because it is based on -- or biased towards -- old, even outdated methods for determining risk for a serious illness.
The Task Force rejected the use of a test for heart inflammation called C-reactive protein (CRP) as a reliable predictor of risk of heart disease. Instead, it said doctors should stick to a rule of thumb called the Framingham Risk Evaluation (FRE).
The FRE uses the number of fatal and nonfatal heart attacks suffered by workers in Framingham, Massachusetts, within a ten-year period, and it is based on a summary estimate of major risk factors for coronary heart disease, such as age, blood pressure, blood cholesterol levels and smoking.
How did the Task Force conclude CRP testing is worthless? The Agency for Healthcare Research and Quality told them so based on "the evidence."
But AHRQ ignored three recent studies demonstrating the importance of CRP. A 2005 study from Johns Hopkins and funded by the National Institutes of Health found that the FRE fails to identify approximately one-third of women likely to develop coronary heart disease. Many women deemed "low risk" by the geniuses at AHRQ had had coronary atherosclerosis, which even the Task Force will admit predicts heart attacks.
Second, it ignored the JUPITER ("Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin") study. That experiment tested whether giving healthy people with low LDL cholesterol levels but high hs-CRP levels would reduce death from heart attacks. It did. Or more to the point, it showed that screening CRP along with cholesterol tests can cut the incidence of heart disease by 40 percent in high risk individuals with statins and reduce death from heart disease by 20 percent.
Third, the Task Force, in a rush to save a buck for Obamacare, skated past the most recent findings from JUPITER that apply particularly to women. Forty percent of JUPITER's participants were women 60 and over with low cholesterol and no history of heart disease but were tested and found to have high levels of inflammation. It turns out that women are more likely to benefit from testing and treatment than men: the incidence of heart disease of any form was cut by 46 percent in women over 60 compared to 42 percent in men over 50.
But that's not the Task Force recommendation. Instead, the Task Force, relying on a review of studies and research that ignored these important findings and stopped looking in 2002, just when the understanding of CRP as a predictor was in its infancy, came to a pre-ordained conclusion that conveniently fits the party line that so-called evidence-based medicine can actually reduce the cost of care even as government creates a new health care entitlement.
The one-size fits all recommendation for breast cancer screening ignored the fact that breast cancer is not just one disease, but many related illnesses with different pathways and signatures. Worse, it acknowledged the wide variation that makes individualized risk assessment essential but went on to claim it wasn't worth the effort. And it failed to estimate the impact of telling women to simply go away. It took years to build up screening rates to where new drugs could have an impact on mortality. Now all that could be undone.
Similarly, the failure to take into account advances in testing and treatment, insights that will save the lives of thousands of women, is hard to explain, let alone justify. Dr. Diane Petitti, vice chair of the Task Force, maintains: "we have to say what we see based on the science and the data."
But if you only see what you are shown, then what you see or say isn't really science. It's politics. And if you think these two decisions were controversial, just wait. With billions to spend and a high profile, the AHRQ and its Preventive Services Task Force will turn prevention into just another word for saying "no" to medical innovation.
Robert M. Goldberg is vice president of the Center for Medicine in the Public Interest and founder of Hands Off My Health, a grass roots health care empowerment network.