Wednesday, December 2, 2009

The Conflicts in Comparative Clinical Effectiveness

There were two articles today regarding the mammography flap. The first was in Science, an article somewhat balanced in favor of the HHS group assigned to deal with CCE, namely AHRQ. The article states:

"Such turmoil in the medical ranks could become more common if an evidence-rich kind of analysis backed by the economic stimulus bill takes off. It’s known as comparative effectiveness research (CER), and it received a windfall of $1.1 billion in February under the American Recovery and Reinvestment Act. CER employs methods similar to the approach that produced the new advice on mammography.

CER draws data from many sources to reach an evidence-based judgment on the value (or lack of value) of medical techniques and strategies.The process must be rigorous, according to a definition of CER hammered out in June by a federal coordinating group. Its scope is broad, ranging from comparing drugs in a clinical trial to studying behavior modification methods to dissecting the impact of health policies. The aim is the same, however: to survey a patient’s choices and determine which course works best. The results of a CER study are somewhat like a consumer’s guide and often as confusing."

The last sentence is the key. It is all too often confusing. The article also highlights Carolyn Clancy, the career civil servant, albeit trained as a physician, who heads up AHRQ, what was once an obscure branch hidden in the Medicare and Medicaid area, and now becoming the potential focal point for the rationing one could envision under the new health care bill, the good Congressman Dingell and his complaints to the contrary not withstanding.

As for Dingell one should remember that he was the one who persecuted David Baltimore a decade or so ago when David was the then head of Rockefeller, and one could envision that the pressure on that brilliant mind and all those around him may have delayed cures for decades as well. Thus Dingell brings a somewhat unclean baggage to the health care debate.

The Science article continues:

"The health care reform bills now before Congress may also determine how CER is managed. The House of Representatives–passed bill and the version drafted by Senate Democrats both seek to reduce friction over CER findings by ensuring that the government consults with takeholders— patients, doctors, and industry representatives—before making big investments in CER or acting on research findings. But the House and Senate proposals differ on who calls the shots. The House plan would rely essentially on AHRQ to set research policies, with input from advisers. The Senate approach would vest authority in an independent, nongovernment corporation."

In either case the CER effort in AHRQ or its successor will become the Harrison's of medicine in the new era if the Democrats have their way.

Also today as the Radiologist meet in Chicago at RSNA a panel of real practicing physicians, ones with real patient's lives in their hands came forth with their assessment of the mammography issue. As reported in Aunt Minnie:

"A panel of breast cancer screening experts today told a special news briefing at the RSNA annual meeting that the new U.S. Preventive Services Task Force (USPSTF) guidelines recommending against routine annual mammograms are flat-out wrong.

RSNA members who peppered the briefing applauded as the University of Cincinnati's Dr. Mary Mahoney, vice-chair of the RSNA Public Information Committee, introduced the panel members, saying "These truly are the experts in mammography. It's unquestionable: Mammography saves lives."

The panel members were expressing their dissatisfaction with the newly revised guidelines from the USPSTF that recommend against routine mammography screening for average-risk women in their 40s. USPSTF also recommends women ages 50 to 74 have mammograms every two years instead of every year."

One can now see the divide beginning. For here is a meeting of the men and women on the front lines of medicine who see the day to day impact of the result of mammography, not some Government panel of alleged non experts, reporting to career Government Civil Servants. The good Congressman Dingell should pay attention to this a bit more. The facts really do speak differently, and as he blundered in the David Baltimore case, perhaps he is doing so again here.

The report from RSNA goes on:

""The net effect of the new guidelines is that screening would begin too late and its effects would be too little. We would save money, but lose lives," said Dr. Stephen Feig, professor of radiology at the University of California, Irvine and president-elect of the American Society of Breast Imaging.

The breast-screening panel said the guidelines would represent a major setback, wiping out decades of progress.

"Deaths from breast cancer have dropped by 30% since 1990 when mammography screening beginning at age 40 became more widespread," said Dr. Daniel Kopans, professor of radiology at Harvard Medical School."

The debate will continue on this issue but if the Government has its way many lives will be lost. As we reported last week, the same process is common practice in the UK. Hopefully it does not become so here. Hopefully, at last, physicians will begin to speak out and not line up in white coats for a photo op!

One need just read what Dingell placed on his web site today:

"“Based on the evidence to date, the USPSTF now advises that women between the ages of 40 and 49 should decide on an individual basis whether or not to get periodic mammograms, a change from their 2002 population-wide recommendation that women should get routine screening. Other new recommendations include biannual instead of annual mammograms for women age 50 to 74; a statement of insufficient evidence for the need for mammograms for women over 75; and new advice against teaching of breast self-examinations.

These recommendations were based on scientific studies, not political agendas or cost cutting measures. Some of the panelists today disagree about the final recommendations, but we can all agree is that the evidence to date is inconclusive about the effectiveness of traditional mammogram screenings, especially for women in the age group of 40 to 49. Furthermore, we can all agree that the decisions for these types of diagnostic screenings should be made between individuals and their doctors.

“I want to remind all of my colleagues that our purpose today is not to politicize or attack the USPSTF. Instead, we are here to understand the recommendations, and the science that guided the decision making of the task force. "

First the Congressman is wrong. The USPTF states on its web site:

"The USPSTF recommends against routine screening mammography in women aged 40 to 49 years."

The Congressman is grossly misrepresenting what was said. Someone should have fact checked the web site. In plain English this says no mammograms between 40-49! None! Second, if one looks behind the RSNA talks one sees volumes of evidence. As to making this political, Congressman Dingell had done that to the extreme with Dr. Baltimore, a Nobel Prize Winner in Medicine, one of the real Nobel prizes!

This small skirmish is but the first of many as Congress tears apart the health care system as we know it.