Latest Drugwonks' Blog
Watch the interview here:
In recent weeks many pundits and think tank types have raised questions about whether Governor Mitch Daniels is a 'real' conservative. Or more transparently put: there are many conservatives who don't agree with Daniels on specific issues and therefore categorize him as not conservative enough.
I won't go into pre-positioning around his so-call called for a truce on social issues. (He didn't say surrender or truce but a timeout and he suggested that the most immediate threat to our nation's future is the rocketing debt.)
And I will only note in passing that playing to most ideological elements of a party is par for the course of running for president.
My concern is the allegation that Daniels health care programs in Indiana is either creeping socialism or warmed over Medicaid. This argument is advanced by Michael Cannon’s article: “ Mitch Daniels’s Obamacare Problem: His state’s health-care plan promotes dependence on government.” www.nationalreview.com/articles/261285/mitch-daniels-s-obamacare-problem-michael-f-cannon
Cannon’s major claim is that under Daniels the number of people on Medicaid have increased and the creation of a program to provide health savings accounts for Hoosiers that cant afford insurance (and have not had it for 60 days) and do not qualify for Medicaid. The Healthy Indiana Plan is funded by a combination of Medicaid dollars and an increase in the state tobacco tax.
Cannon’s complaint is “Like Obama, Daniels increased cigarette taxes to expand government-run health care. Whereas Obamacare requires states to open their Medicaid programs to families of four earning $31,000 (138 percent of the federal poverty level), Daniels expanded Indiana’s Medicaid program to families of four earning $44,000 (200 percent of poverty). From 2008 to 2010, Indiana’s Medicaid enrollment spiked: Adult enrollments grew 21 percent, a rate nearly double the national average. By 2010, Daniels had enrolled another 62,000 Hoosiers in government-run health care. “
First, Cannon should get his facts straight. Indiana’s adult Medicaid enrollment increased 17 percent from 2008-2010, slightly higher than the national average of 14. 6 percent. And between 2009-2010 the rate of increase in Indiana's adult Medicaid enrollment declined (as it did in only 16 other states) and did so more dramatically than most. Second, Cannon cites Indiana’s income eligibility levels for families when he should have cited the income levels for adults. But that would undermine his argument since Indiana caps eligibility at 50 percent of poverty.
Cannon believes Daniels ultimate sin is that he “made Medicaid more attractive: Under his plan, the government hands out coverage plus something a lot like cash.”
Do Cannon and other Daniels denialists regard the governor’s proposal to convert public education funding into a statewide school voucher program an example of making “public education” more attractive by handing out coverage and cash. Cannon dismisses the shift in personal responsibility, the creation of competition, the cost savings and the qualitative differences that vouchers and health savings accounts bring.
Daniels can push such a change because he has control over state funding of schools. As of now, Daniels and other governors that would want to turn Medicaid into a voucher program must wait years and face a hostile Obama administration.
I know Cannon works for the Cato Institute and is therefore more likely to object to any expansion in government. But governing is not ideology. And policy disagreements should be based on facts.
And facts matter. And the facts show that Indiana's Medicaid population did not double compared to the national average. Healthy Indiana has enrolled the most chronically ill and chronically un-insured Hoosiers since 2006. Over that time costs have stabilized and not exploded. Those who have found jobs don’t forfeit the coverage they have. They can keep it, along with the health savings accounts they have created. Which might be one reason that Indiana has more business startups than other states and its workforce and population has increased.
CMPI believes in and supports patient-centered, portable and affordable health care coverage. We don't accept the status quo. We believe we can do better but that Obamacare is an obstacle to innovations in medicine, technology and funding that are essential to improving the healthcare system. That doesn't mean some features of the law shouldn't be preserved. It means that to preserve them will likely mean repeal takes the form of substantial reform.
That's an honest difference of opinion that we are welcome to debate and discuss anytime.
So when MM responds to our interview with Michele Bachmann (See the Media Matters response and the video at politicalcorrection.org/blog/201103040003 ) by first accusing us of being paid to be part of a "front" to kill healthcare reform it suggests that Media Matters is more interested in silencing CMPI rather than engaging in debate. It would be easy to respond by pointing out that MM's funding is from George Soros, whose non-profit empire could be considered a "front" of sorts.
Conflict of interest is a canard that cuts both ways. It scores points and generates heat but little light.
It's fine for MM to take issue with Congresswoman Bachmann and CMPI's interest in her views. However it seems that Media Matters is more interested in repeating talking points than in substantive discussion.
I will debate or discuss Obamacare with anyone from Media Matters or ThinkProgress any time or any place. But I don't think they will take up the challenge. They seem too obsessed with reassuring themselves that the rejection of Obamacare is the result of a well-financed campaign to lie about how wonderful the new healthcare law is.
If and when Media Matters and ThinkProgress snaps out of that disassociative state, I will be happy to engage them.
The proposition of the FDA’s “Safe Use” initiative is that the way to make a drug “safer” is to better educate prescriber, dispenser, and user about the product.
At a meeting of the FDA’s Risk Communications Advisory Committee (February 26-27, 2009), there was open public comment on the issue of how to improve the written information currently provided to patients about the medicines they receive (aka “consumer medical information” or “CMI).
(PS/ per full disclosure, while I did not participate in this meeting I am a Special Government Employee consultant to this advisory committee.)
The meetings complete comments can be found here.
I found the remarks of Pam Budny, a regulatory affairs manager at Eli Lilly of particular interest.
Some extracts from her comments:
Patients should be able to locate, interpret, and act upon information in written patient labeling. It should facilitate or reinforce the communication between the patient and the prescribing and/or dispensing healthcare professional.
Patient labeling should be prepared by the sponsor just as is the case for physician labeling. Physician and patient labeling are inextricably linked in terms of the information they contain on benefits and risks.Sponsor-prepared patient labeling ensures consistency of information provided to patients in multiple venues.
For example, patient labeling received at the time the medication is dispensed would have the same content as the “full disclosure” accompanying promotional materials for patients.
Testing with patients and or caregivers prior to submission is a critical way to determine the usefulness of patient labeling prior to patient use.
Patient labeling should be developed by sponsors, tested with patients, approved by FDA, and delivered in ways that are compatible with pharmacy dispensing workflows. This information should be made available to patients each time they receive their medication.
These comments reinforce the concept of a sponsor-developed, FDA approved, “label detailing guide.” Assuming that healthcare providers both read and understand the PI is, well – wrong.
Consider the report out of the University of Chicago (a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008) indicates there is confusion among physicans about what is or is not “on-label.”
According to the abstract, the average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use.
The study’s senior author, Dr. G. Caleb Alexander (assistant professor of medicine at the University of Chicago) said a concern was that off-label uses often did not have the same level of scientific scrutiny as FDA-approved uses.
All the more reason for the FDA and the pharmaceutical industry to jointly develop (as part of the agency's Safe Use initiative) better ways to make the PI more user-friendly.
The time for sponsor-created and FDA-approved label “detailing aids” is now.
“Sometimes the questions are complicated and the answers are simple.
Dr. Seuss“Newspeak,” as you Orwellian cognoscenti know, is the official language of Oceania – the land ruled by Big Brother. Newspeak was designed “not to extend but to diminish the range of thought” (author’s original italics). Its goal was to “make all other modes of thought impossible.”
Further, per Mr. Orwell, “A Newspeak word was simply a staccato sound expressing one clearly understood concept.”
Some well-known examples of Newspeak are Bellyfeel (a blind, enthusiastic acceptance of an idea), Duckspeak (meaning literally to quack like a duck or to speak without thinking), Crimethink (the Newspeak word for thought crime) and Goodthink (or “political orthodoxy”).
All of which brings us from the nightmare fantasy of 1984 Newspeak to the healthcare debate of 2011, the concept of comparative effectiveness research, and a new term we must all become familiar with -- “Cost-think” (which defines everything that reduces short-term costs as a benefit to the patient).
The Recovery Act of 2010 (aka – “the stimulus package”) gave the Agency for Healthcare Research and Quality (AHRQ) $1.1 billion to conduct (according to the HHS press release) “comparative effectiveness research” into various “healthcare interventions.”
Except that’s not what Congress funded. Per the Recovery Act, that $1.1 billion was earmarked for clinical comparative effectiveness not comparative effectiveness research. And this is not splitting hairs. Enter cost-think.
Those in favor of comparative effectiveness research favor large scale trials to "compare" drugs and other healthcare “technologies, striving to show which medicines are most effective for any given disease state. Is there a “more effective” statin? A “more effective” treatment for depression?
But how do you compare two molecules (or three or more) that have different mechanisms of action for patients that respond differently to different medicine based on their personal genetic make-up?
Comparative effectiveness relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely, if ever, will tell us which treatments are “best” for any given patient.
Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE), study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study, were two such “practice-based” clinical trials, sponsored in part by the National Institutes of Health, to determine whether older (cheaper) medicines were as effective in achieving certain clinical outcomes as newer (more expensive) ones.
The findings of both CATIE and ALLHAT were highly controversial, but one thing is not: even well-funded comparative effectiveness trials are swiftly superseded by trial designs based on better mechanistic understanding of disease pathways and pharmacogenomics. And, since most comparative effectiveness studies are underpowered, they don’t capture the genetic variations that explain differences in response to medicines by different patients. Comparative effectiveness in its current form leads to a “one-size-fits-all” approach to healthcare, which means that it doesn’t fit anyone all that well.
Clinical effectiveness, on the other hand, measures outcomes on an individual patient level. Clinical effectiveness studies help us to understand how to design treatments based on patient variation rather than cost. The very definition of personalized medicine.
All this to say that the differences between comparative and clinical effectiveness studies are profound and that by changing the actual legislative verbiage, the legislative intent is likewise altered.
As Mr. Orwell wrote, no word in the Newspeak vocabulary was “ideologically neutral” and a great many were “euphemisms.” Welcome to cost-think, where anything that has to do with healthcare reform cannot be spoken about in terms of cost but must be entirely based on the philosophy of reducing short term costs.
And nowhere is cost-speak more crucial than when it comes to publicly bankrolled dissemination of the findings of tax-payer-bank funded and AHRQ-fielded comparative effectiveness research.
The first question to ask is whether or not these studies will be peer-reviewed before they are allowed to be released? (CATIE and ALLHAT were not.) Another query is to whom will the studies be communicated – and how? Will physicians be “academically detailed?” And if so, will they be required to be detailed? Will physicians be given incentives to spend time with AHRQ’s comparative effectiveness angels (i.e., CME credits) and punished if they do not (via Medicare and Medicaid restrictions)? And how will Uncle Sam decide which doctors are to be visited? Will “high prescribers” of on-patent medicines be on a priority list, identified by mechanisms being developed to enforce multiple state physician “sunshine” laws?
Congressional oversight must be required for the $42.3 million that AHRQ has already awarded for public and physician outreach.
And relative to academic detailing (aka, “counter-detailing”), what safe guards are in place to certify that physicians are being presented information that is unbiased? Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low cost therapies.
Asked another way – how can an “academic detailing” program funded by our nation’s largest payer (Uncle Sam) be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent. Who will be the arbiters of transparency?
Who will decide what these detailers can say or not say? Will these government “reps” have to play by the same rules as their pharmaceutical counterparts? And, importantly, what is the oversight mechanism? If academic detailers stray into off-label conversations, to whom does DDMAC send a letter? Whom does the Department of Justice investigate? Who pays the fine?
Most importantly, who will determine the difference between “communicating” these findings and “promoting” them? Alas, such finesse is unlikely under a regime of cost-think. As Orwell commented, Newspeak was constructed as to “give exact and often very subtle expression to every meaning that a Party member could properly wish to express, while excluding all other meanings and also the possibility or arriving at them by indirect methods.”
As currently organized, comparative effectiveness research will be used to increase government control over the practice of medicine and is a slippery slope towards the introduction of price controls.
Government sponsored comparative effectiveness research is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans – with step one in the process being unfettered (and unregulated) communications efforts. Unless we are aware and vigilant, such cost-think may very well lead to a single-payer system referred to in cost-think as “universal coverage” – but in reality will be nothing short of healthcare rationing.
As Rudyard Kipling said to London's Royal College of Surgeons in 1923, "Words are, of course, the most powerful drug used by mankind ... They enter into and colour the minutest cells of the brain."
We allow them to be usurped and corrupted at our own peril.
Via BioCentury ...
Republicans urge Obama to withdraw Berwick CMS nod
Sens. Orrin Hatch (R-Utah) and Mike Enzi (R-Wyo.) and 40 other Republican Senators sent a letter to President Obama urging him to withdraw his nomination of Donald Berwick as administrator of the Centers for Medicare & Medicaid Services (CMS). Berwick was re-nominated for the position in January. Obama appointed Berwick to the position last July while Congress was in recess, allowing Berwick to serve until Dec. 31, 2011, without a Senate confirmation vote.
The Senators said Berwick's "lack of experience in the areas of health plan operations and insurance regulation raise serious concerns about his qualification for this position." Berwick's nomination can be prevented if at least 40 senators vote against it during the confirmation process.
Berwick has started to assemble his own team at CMS. Patrick Conway is on his short list of possible replacements for Barry Straube, who stepped down as the chief medical officer of CMS in January. Conway is currently chief medical officer in the Office of the Assistant Secretary for Planning and Evaluation at HHS. He is the former director of HHS' Agency for Healthcare Research and Quality.
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.
