Latest Drugwonks' Blog
As the saying goes, "A joy that's shared is a joy made double." And that may now be the case via more coordinated FDA and CMS actions.
A June 23 memorandum of understanding on data sharing (signed by FDA Commissioner Peggy Hamburg and CMS Acting Administrator Marilyn Tavenner), could serve as a first step toward parallel reviews by FDA and CMS. CDRH Health Director Jeff Shuren announced the pact at a June 24 public workshop on device innovation.
The memorandum "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions," commented Shuren.
As part of the new effort, the two agencies are "seriously exploring the ability to start, at a manufacturer's request, a Medicare national coverage determination process while the medical device is still under pre-market review at FDA," for example, Shuren explained at the meeting. "Such an approach could reduce the time from FDA approval to CMS coverage and payment for some devices."
He also noted that the agencies may eventually consider defining certain circumstances when an FDA determination on safety and effectiveness is adequate for CMS to pay for a new technology "without additional evidence."
Shuren stressed, however, that only expanded information sharing has been agreed upon at this point. Parallel review is "not a done deal," he said
CMS' coverage-with-evidence-development policies, for instance, could help with FDA post-market data collection, he explained. FDA is already exploring use of Medicare claims data as a post-market surveillance tool as part of its Sentinel initiative.
In California, failure is not an option -- almost.
Pending legislation AB 1826, which prohibits “fail first” practices by insurers, has been steadily moving through the California Assembly and will go for a vote in the Health Committee on Wednesday, June 30.
According to the legislative language, “This bill would require a health care service plan or contracts and health insurer covering insurance policies that cover outpatient
CMS has already issued a 2010 Call Letter to limit step therapy in health plans for Medicare patients.
AB 1826 will help physicians do what they do best practice the art and science of medicine.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.
As
In California -- indeed across the entire United States -- access to care must be matched with quality of care.
Update on AHA Scientific Sessions Regarding ACCME Discussions
DALLAS, June 23, 2010 –The AHA has long believed in the integrity of science that is rigorously peer reviewed by content experts, and is absolutely independent in the positioning and delivery of its content. As noted in the ACCME statement of 6/23/10, in which they stated their belief in the value of constructive debate and input about their policies and all issues related to managing conflict of interest in accredited CME, the ACCME is committed to setting fair and reasonable standards that support education about scientific research and developments, while ensuring that accredited CME is independent and free of commercial influence. During in-depth discussions with the AHA, and after thoughtful deliberation, the ACCME agreed that AHA’s extensive internal controls assure independence, and are appropriate for CME accreditation for a scientific meeting.
Thus, there will be no variance from past Scientific Sessions and CME will be available for all presentations within the scientific program. This will insure that the flow of science will remain unfettered as it always has been and as would be in keeping with the mission of the AHA.
For those submissions that were withheld, we will reopen abstract submissions shortly and enter the newly submitted material into our ongoing peer review process.
There’s an article in today’s edition of the New York Times headlined “Debate Over Industry Role in Educating Doctors.”
Yes – there is a debate. And it’s an important one. But the article doesn’t report on the debate – it takes a stance. Consider the first 17 words of the reportage:
“In the latest effort to break up the often cozy relationship between doctors and the medical industry …”
That’s not an article – that’s an editorial.
The article throws around a lot of big numbers. For example;
“Continuing medical education has become a big business in the United States, with more than 700 accredited providers. Total spending on such courses peaked at $2.5 billion in 2007, including a record $1.2 billion paid by companies, according to the Accreditation Council for Continuing Medical Education, a nonprofit regulatory group.”
But these are numbers out of context. Statistics, as the saying goes, is like a bikini – what it shows you is interesting but what it conceals is essential. Here’s a statistic mysteriously absent from the Times story: 42 percent of CME activities have no industry support at all. Two-thirds of providers get less than 10 percent of their total revenue from drug and device companies.
Citation for that last bit of information – ACCME.
Selective reporting of the facts is unworthy of our national newspaper of record. As my grandmother used to say, “A half-truth is a whole lie.”
The complete New York Times article can be found here.
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.
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.
