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Medicare and Medicaid patients with a chronic condition will be able to review all their medications in one-on-one sessions with pharmacists under a bill introduced Tuesday by Sen. Kay Hagan (D-N.C.). The Medication Therapy Management (MTM) Expanded Benefits Act would also reimburse pharmacists to follow up and educate patients about their medication regimen.
"This bill will allow seniors with one chronic condition, such as diabetes or heart disease, to bring all of their medications to the pharmacy and ensure they are following doctor's orders," Hagan said in a statement. "If more seniors properly follow their medication regimens, we can save lives and Medicare dollars."
Currently 12.9 percent of seniors in the Medicare prescription drug program — all of whom have multiple chronic illnesses — are eligible to participate in MTM programs. Hagan's bill would allow seniors with only one chronic illness to participate in the program at pharmacies, hospitals and other entities that distribute pharmaceutical drugs and provide MTM services.
Wither comparative effectiveness?
"We are now right on the cusp of an era where we can get all the data we want," but getting the research methods and analytics right "is going to be quite critical," said Carolyn Clancy, director of the Agency for Healthcare Research and Quality.
But data, as the saying goes, is like a bikini – what it shows you is interesting, but what it conceals is essential.
Clancy believes (and appropriately so) that data could help, say, a newly diagnosed cancer patient who wants to know, "What happens to people like me if I choose this path, that path or another path?"
They don’t call it the Critical Path for nothing.
Clancy: "Increasingly we're seeing in legislation the opportunity to inform policy with science, but the details really matter in getting it right."
Indeed. And those details need to lead us towards the “four rights” – the right medicine in the right dose at the right time for the right patient.
And that’s not comparative effectiveness – that’s clinical effectiveness.
Canada’s solution to ever-longer hospital queues: “Technowait” -- a program that allows patients to register at the front desk, then through a phone line, check in periodically to determine when the doctor is “really” ready to see them.
"Several unplanned, post hoc analyses were performed to evaluate the failure of some Cox proportional hazards models to meet the proportional hazards assumption. These unplanned analyses included those restricted to patients who entered the study before or after publication of a widely publicized meta-analysis of rosiglitazone randomized trials on May 21, 2007,1 and partitioning of follow-up time into intervals of 0 through 2 months, more than 2 through 4 months, and more than 4 months."
Read the full JAMA article here.
Translation:
"Post-hoc analysis, in the context of design and analysis of experiments, refers to looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is sometimes called by critics data dredging to evoke the sense that the more one looks the more likely something will be found. More subtly, each time a pattern in the data is considered, a statistical test is effectively performed. This greatly inflates the total number of statistical tests and necessitates the use of multiple testing procedures to compensate. However, this is difficult to do precisely and in fact most results of post-hoc analyses are reported as they are with unadjusted p-values. These p-values must be interpreted in light of the fact that they are a small and selected subset of a potentially large group of p-values. Results of post-hoc analysis should be explicitly labeled as such in reports and publications to avoid misleading readers.
In practice, post-hoc analysis is usually concerned with finding patterns in subgroups of the sample."
In other words, Graham, et. al. tortured the data to get it to say what it wanted. And even then it found a slightly elevated risk for those on Avandia over a year period, a difference so slight that it could be easily explained by, say, severity of illness or blood sugar levels, neither of which Graham and company cared to measure.
What they did do was, after discovering no difference in risk, a post hoc subgroup analysis to find risk. That's cheating by their own admission since in the entire group they studied their were only 15,000 people on Avandia compared to 100,000 or so on Actos. But they still subdivided the two groups into two smaller groups (2-4 months on each drug and 4-6 months) and finally found what they claimed were "significant differences" in hazard ratios but only in composite scores.. And even then it was a difference of 20 percent or so. Not really statistically significant. Hey, why not test in between trips to the bathroom? It would be more fitting giving the quality of the research.
I can't believe JAMA published this nonsense with an accompanying editorial warning against use of Avandia instead of an editorial tearing about the questionable data mining.
My guess is the FDA will see right through the charade.
http://www.boston.com/bostonglobe/editorial_opinion/oped/articles/2010/06/28/the_myth_of_the_perfect_drug/
FDA report reveals airline food could pose health threat:
http://www.usatoday.com/travel/flights/2010-06-28-1Aairlinefood28_ST_N.htm
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.
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.
