[aj04]

It's a longish article and response, but I believe it is an important issue. I have to do some more searching to find out where I can send it in to the Wall Street Journal, which ran the article on 04/15. And my representative gets a copy too.

Push to Compare Treatments Worries Drug, Device Makers
By JANE ZHANG

WASHINGTON -- Federal health-care agencies are getting $1.1 billion in economic-stimulus funds for research comparing the effectiveness of various treatments. But drug and medical-device makers, along with some members of Congress, say they are worried the findings will be used to limit patients' options.

President Barack Obama has emphasized that reining in health-care costs is vital to cutting the budget deficit. The administration believes research could help doctors reduce wasteful and ineffective treatments. The White House's budget blueprint envisions combining data on which treatments work best with electronic health records to deliver "user-friendly pop-up alerts for physicians at the point of care."


The National Institutes of Health has said it will consider research proposals comparing the cost-effectiveness of biologic medications, cancer treatments and preventive measures for chronic illnesses such as diabetes.

Carolyn Clancy, director of the Agency for Healthcare Research and Quality, said "the overarching purpose of the program is to give clinicians and patients information they need to make decisions." That could include, she said, information on effectiveness, safety and costs.

"We don't want [the research] to be used to deny access to care," said Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America.

Teresa Lee, vice president of the Advanced Medical Technology Association, said using "this research to deny access to appropriate treatments for individual patients with individual medical histories and individual needs should not be the objective."

Peter Orszag, director of the White House Office of Management and Budget, told lawmakers last month that the research won't necessarily lead to coverage denials. "At the extreme, if something is shown not to be effective, it could simply not be covered," he said. But he also suggested the government could pay "more for the things that work than the things that don't."

Dr. Clancy, an appointee of former President George W. Bush, said the Centers for Medicare and Medicaid Services, the agency that manages Medicare, already uses AHRQ research to help decide what treatments it will cover. Dr. Clancy said, however, that her agency isn't the one making regulations or insurance-payment decisions, nor does it recommend what treatments are best.

The stimulus law provided $400 million to NIH, $300 million to AHRQ and another $400 million to the Department of Health and Human Services, the parent agency of NIH and AHRQ, for research comparing the effectiveness of medical treatments. HHS set up an advisory group to coordinate research and distribute the money. The group will hold a meeting Tuesday to get public input on how to spend the $400 million.

Some say the government-funded research inevitably will be used to decide insurance coverage. "You see one shoe drop -- what is going to follow?" said Tanisha Carino, a vice president at Avalere Health LLC, a consulting firm in Washington.

Sen. Jon Kyl (R., Ariz.) unsuccessfully pushed a measure recently to bar federal health programs from using comparative-effectiveness research to deny coverage. His amendment got 44 votes, including those of Sens. Charles Grassley (R., Iowa) and Russ Feingold (D., Wisc.), who have played major roles in health-care legislation.

AHRQ already has turned research it funded into guidance for consumers, physicians and policy makers, some comparing costs of various treatments. A 2007 online guide on pain medications for osteoarthritis, for example, lists a variety of pain relievers and their prices, including $2 for 100 aspirins and $170 for a 30-day supply of 400-milligram Lodine.


My comment:

I support the push for comparative studies on efficacy and costs of treatments and devices. As a country, we spend more than any other on health care—drugs, devices, and procedures—without receiving more or better health care in return. According to the CIA’s 2009 estimates, US life expectancy trails Bosnia and Herzegovina as well as the French island territories of Wallis and Futuna, where subsistence agriculture is the mainstay economy, and is just ahead of Guam and Albania, one of the poorest European countries.

Decisions based on cost/effectiveness go on from the instant a drug or device is conceived, I don't see why it shouldn't go on after a drug is on the market or near to. As a matter of fact, since the drug/device companies pay the FDA for processing the approvals, there needs to be some way to check the proliferation of costly, "me-too" drugs/devices. Such decisions could also provide a sensible counter to the demand for high cost drugs/devices/treatments that is created through the world of direct-to-consumer advertising.

I believe it is important to fully incorporate patients—people who are already reliant on these drugs and devices--into this kind of analysis as well as people who may or may not become patients one day. These cost benefit analyses cannot be made solely by people who don’t live on SSDI alone or on a fixed income that plunges below the poverty level after paying medical costs.

I am always making cost-benefit analyses in treating my PD. For example, I take one half of the prescribed amount of one of my six medications and I weaned myself off of a seventh for budgetary reasons. An older, cheaper version of the first is unavailable due to fewer than a handful of reported events that would be taken care of by periodic blood tests. The second has been kept out of the generic market by ongoing lawsuits involving the brand name pharmaceutical company and the first generic-producing company.

Cost/benefit analyses need to be informed by those of us on the ground as well as in the halls of academia, the board rooms of industry and the halls of Congress.