Latest Drugwonks' Blog
Commonwealth comes to it's usually conclusion...
U.S. scores dead last again in healthcare study
Wed Jun 23, 2010
WASHINGTON (Reuters) - Americans spend twice as much as residents of other developed countries on healthcare, but get lower quality, less efficiency and have the least equitable system, according to a report released on Wednesday.
How could the media allow the bogus, made to order, results of the Commonwealth Funds survey of health systems remain unexamined? Laziness, bias and just too busy? Here is the gist of the study:
The report looks at five measures of healthcare -- quality, efficiency, access to care, equity and the ability to lead long, healthy, productive lives. Britain, whose nationalized healthcare system was widely derided by opponents of U.S. healthcare reform, ranks first in quality while the Netherlands ranked first overall on all scores, the Commonwealth team found.
U.S. patients with chronic conditions were the most likely to say they gotten the wrong drug or had to wait to learn of abnormal test results.
"The findings demonstrate the need to quickly implement provisions in the new health reform law," the report reads.
Critics of reports that show Europeans or Australians are healthier than Americans point to the U.S. lifestyle as a bigger factor than healthcare. Americans have higher rates of obesity than other developed countries, for instance.
"On the other hand, the other countries have higher rates of smoking," Davis countered. And Germany, for instance, has a much older population more prone to chronic disease.
Some thoughts:
It is easy in any health system to find people who are happy with their health care, in Europe particularly. That permits Commonwealth from avoiding the real analytical work or confronting the reality that Britain’s NHS has severe structural problems or, that despite the market-based reforms Netherlands has instituted (oops, Commonwealth ignores that) significant health disparities between urban and rural, rich and poor, immigrants and citizens persist. The British medical journals and media are awash with studies showing that disparities are widening. Sir Michael Rawlins of NICE told me as much last year. Somehow, somewhere Commonwealth Foundation the 200 people in Britain who think the NHS is great. Maybe Karen Davis just interview Donald Berwick 200 times.
Of course the findings lead to the conclusion that Obamacare should be adopted. This is the same organization that claimed comparative effectiveness research based on the Dartmouth Atlas would save over a trillion dollars between 2010-2020. It’s easy if you use survey data instead of carefully designed studies that rely on data sets, including biomarkers, that permit reliable international comparisons over a period of time. Such as five year survival rates for various forms of cancer by stage, treatment for asthma, access to psychiatric care (mental illness is the fastest growing disease), ability for people over 65 to live without disabilities, etc. access to new treatments. If you don’t do serious research and the media just laps up your claims and findings uncritically you can say anything you want.
Pursuant to yesterday's discussion of the HHS IG's report on FDA's oversight of non-US based clinical trials, some commentary from Leslie Ball, director, division of scientific investigations, Office of Compliance, FDA Center for Drug Evaluation and Research:
"As a consequence of that report, I think we will be looking, internally, at the quality of data a little bit more critically that's conducted outside the U.S. ...That might result in some additional analysis and soul-searching about whether or not requirements need to be put in place."
A new site-selection model already is under development that will move the agency to a more risk-based approach to determine which sponsors will be inspected, Ball said.
The factors that could trigger an inspection include the drug application and trial design, or site-specific risk attributes like enrollment and drop-out rate. FDA Principal Deputy Commissioner Joshua Sharfstein said in his response to the report geography also is a risk parameter in the formula.
"We are expecting that to be a little more complex," she said. "We also want to say that just when the regulated community figures out what our risk algorithm is, we will change it. So don't get too comfortable."
FDA also already is looking to expand its partnerships with other regulators, as was recommended in the report to maximize its resources. A pilot program with the European Medicines Agency to conduct joint inspections and share other information, if successful, could lead to more collaborations with other foreign regulators.
When it's a medguide ... maybe.
FDA is searching for a way out of imposing a REMS when only a medication guide is required.
According to John Jenikns, director of the Office of New Drugs (and the best dressed man at the FDA), having to develop and then assess the impact of medication guides as part of the REMS program is a burdensome administrative task for the agency, as well as for sponsors and pharmacies and society at large.
"We are looking to try and be creative in how we interpret that part of the statute, so stay tuned to see if we're able to find some creative ways around this," he said.
In the meantime, medguides remain a component of a REMS and "until we work through this further, there are a lot of medication guide-only REMS - a lot of burden on us, a lot of burden on you - that we'd like to try to get out of."
As of June 3, FDA had listed 123 REMS on its website. Eighty-four consist only of a MedGuide, while another 25 involve a medguide and communication plan. The other 14 REMS require sponsors to adopt elements to ensure safe use. Five of those also involve a MedGuide; three also have a communication plan; and the other six also require both a MedGuide and a communication plan.
If FDA does not find a solution it can implement itself, the next reauthorization of the Prescription Drug User Fee Act in 2012 offers an opportunity for legislative change. Industry and other stakeholders already have cited REMS as an area for focus during PDUFA V.
(And, hopefully, that's "V" like in "victory.")
The NY Times rejoinder to Elliot Fisher is devastating and could have been even more complete if Reed Abelson and Gardiner Harris had not pulled their punches on such aspects of the Dartmouth empire as it's deep involvement in and financial dependency on Health Dialog...
It also raises the stakes on the Berwick nomination since Berwick's love and faith in Dartmouth is well known and has been reciprocated. From an earlier NPR report"
ROVNER: So at first glance, the person President Obama has chosen, Donald Berwick, seems an unlikely candidate. He's a mild-mannered pediatrician and Harvard Medical School professor. But Dartmouth health policy researcher Elliot Fisher, who's worked with Berwick for years, says he's the perfect choice to implement some of the most sweeping changes to the nation's health care system in generations.
Dr. ELLIOT FISHER (Researcher, Dartmouth Health Policy): Don Berwick is a visionary leader who not only understands health care, but also understands and has shown that he can help physicians, nurses and hospital leaders work together to improve the care that patients receive.
www.npr.org/templates/story/story.php
I smell hypocrisy and an unwillingess to respond to this important question.
Congressman Todd Tiahrt (R,KS) from CMPI on Vimeo.
Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
