Latest Drugwonks' Blog
Didn't we hear that in the 1970s when people like Emanuel were predicting insurance companies would become obsolete and be replaced by HMOs that would manage health and improve outcomes?
The faith in administrative changes or addition of regulation to improve, shape, control human behavior is particularly strong among health care policy experts of all stripes. I believe that it is technological progress that makes certain types of care -- fee driven, intermediate or palliative treatments produced through hardware or in hospitals -- obsolete. Think of how infectious diseases were generally treated less than 50 years ago, the use of medicines instead of institutions for people with mental illness, same day surgery vs. the 5 day stay.
ACOs were designed to be conduits for government produced guidelines that are biased against new technology. They are organized against innovation, not to capitalize on it.
As a result, I believe by 2020 not only will the current form of underwriting be obsolete -- because of advances in personalized medicine and direct to consumer delivery of healthcare -- but so will ACO's and Obamacare. If you think it was surprisingly easy to overthrow Arab dictators wait till you and I know more about our health sooner than government bureaucrats who produce outdated guidelines and mandates.
Here's a link to Zeke's article:
http://opinionator.blogs.nytimes.com/2012/01/30/the-end-of-health-insurance-companies/?nl=opinion&emc=tya1
It's true that the cost of sequencing continues to follow Moore's law -- exponential decline in material and equipment costs and increased computing power -- so that what Illumina does with supercomputers is something that doctors and patients will be able to do with smartphones. But Roche is not interesting in the hardware of sequencing. If it did, it could just buy a bunch of machines for a lot less that $5.7 billion.
In fact, Roche knows that sequencing will become commonplace. I think it wants Illumina because of it's partnerships with clinical labs worldwide to perform sequencing. Distribution for Roche diagnostics and products -- as the firm focuses on targeted therapy -- is more valuable than equipment or sequencing. Roche also sells glucose kits too and find that marketplace pretty lucractive.
Should Illumina sell? I don't know and have no opinion. However, I remember when Yahoo snubbed a Microsoft acquisition for a hefty premium over it's share price. Now Yahoo is scrambling to find a buy at a share price far below that offer. Information is quickly becoming a commodity in health care. In 10 years drug companies will be delivering individual content directly to consumers to treat illness. Perhaps Roche believes it can be a source of revenue growth. In any event, acquiring Illumina is about how medical care will be organized in the future, not about it's microarrays now.
Update on the Office of the Center Director and Office of Drug Evaluation1
CDER Staff:
I want to update you on recent changes in my Immediate Office to further enhance medical and scientific decision-making across CDER. These changes also affect the Office of Drug Evaluation 1 (ODE1), Office of New Drugs.
I have asked Robert (Bob) Temple, M.D., to give up his role as the Acting Director of ODE1, so that he can devote more of his time and vast expertise to his other role as the Deputy Center Director for Clinical Science. Ellis Unger, M.D., currently the Deputy Director of ODE1, will serve as Acting Director of ODE1. Bob will continue as Acting Deputy Director of ODEI and plans to maintain substantial (but somewhat less) involvement in ODEI activities.
In November 2009, due to the growth of the Center’s responsibilities, I appointed Bob as the Deputy Center Director for Clinical Science with primary responsibility for high level initiatives and programs related to clinical science and clinical trial methodology issues. At that time, Bob agreed to wear two hats and continue as Acting Director of ODE1.
As Deputy Center Director for Clinical Science, Bob has played and continues to play a major role in directing and executing many cross-cutting CDER functions, which enhance the quality and consistency of our operations. Now he will have more time to further provide valuable regulatory input and methodological assistance across the Center.
I am grateful to Bob for serving ODE1 with excellence and superb leadership. I also am grateful that we have someone like Ellis to step in and assume the Office Director position on an Acting basis. Ellis has been with CDER since 2004, serving in various leadership roles, and in the ODE1 Deputy Director capacity since August 2008. I am confident that he will continue to serve ODE1 exceptionally well.
Janet Woodcock
Really interesting issue brief from CBO regarding approaches taken in various projects that help in attainment of demonstration goals:
Gather timely data on the use of care, especially hospital admissions. Programs that collected timely data on when their patients’ health problems developed or became exacerbated and where they were treated seemed better able to coordinate and manage their patients’ care. Those efforts could be strengthened if CMS improved its capability to provide programs with timely data on their patients’ use of services.
Focus on transitions in care settings. Programs that smoothed transitions (for example, by providing additional education and support to patients moving from a hospital to a nursing facility or between a primary care provider and a specialist) tended to have fewer hospital admissions.
Use team-based care. Demonstrations that provided close collaboration between care managers and physicians -- especially those with larger teams that included pharmacists, who could help patients manage their medications-- appeared to have fewer hospital admissions.
Target interventions toward high-risk enrollees. Programs that targeted interventions to beneficiaries they identified as being at greatest risk of being hospitalized—on the basis of medical condition, prior hospitalization, or predictive modeling—appeared to have fewer hospital admissions.
Limit the costs of intervention. To achieve federal budgetary savings, a program’s fees or bonuses must be smaller than its reductions in regular Medicare expenditures. There was nearly a threefold difference in the Medicare fees paid to different organizations that combined telephone and in-person contact to coordinate care, an indication that some organizations were able to deliver such interventions much more efficiently than others.
The complete CBO brief can be found here.
Bella Santorum, Amelia Rivera and ‘marginal’ children who prove no child is marginal
Republican presidential candidate Rick Santorum with his wife Karen. (Matt Rourke - AP) GOP presidential candidate Rick Santorum’s youngest daughter, Isabella, is recovering at Children’s Hospital of Philadelphia after a bout of pneumonia forced her family to rush her to the hospital this weekend and her father to temporarily abandon the campaign trail.
Known as “Bella,” the 3-year-old was born with the genetic disorder Trisomy 18, which is often fatal for infants and leads to physical deformities and cognitive deficiencies.
In a strange coincidence, Bella is being treated at the same hospital that earlier this month made the news for its treatment toward another 3-year-old girl, Amelia (Mia) Rivera, who has the genetic disorder Wolf-Hirschhorn syndrome.
Rivera’s family said Children’s Hospital of Philadelphia officials told them their daughter was not eligible for a life-saving kidney transplant because she was “mentally retarded.” (I wrote about her story in a previous post here.)
Hospital officials will not comment directly on the case, but have said they do not have a policy of denying transplants to children with developmental delays. (Studies have shown such policies are a common, if unspoken and unethical, practice at many transplant centers.)
Hospital officials and the transplant team have also agreed to meet with Mia’s family.
Besides their conditions, ages and the venue in which they are being treated, the little girls share something else: Their stories have touched a public nerve.
In Bella’s case, her story was already well-known. Santorum has said that after she was born, doctors told him and his wife that they should let the girl die because she would never live a normal life. Controversially, he has linked that experience to his criticism of the Democrat-backed healthcare reform.
Santorum critics point out that healthcare reform expands coverage and will, in fact, help families in similar situations.
For Mia, her family’s fight to make her eligible for a transplant has brought her fame. Her plight has prompted tens of thousands to protest both her treatment and also the broader issue of discrimination in medical care.
Politics aside, if that’s possible, what’s most amazing about both these stories and all their similarities is that these two little girls, Bella and Mia, who have both been deemed marginal throughout their lives, are now part of the public discourse.
They are reminding us that children come in all shapes, sizes and forms. That even soft voices have merit. That children cannot be ranked for worth. Marginal? Not them.
The only problem with this beautiful essay is that under health care reform there are people who think that the plight of such children cause, well, a misallocation of resources. In otherwords, why waste money on screening these kids, especially when they drive up health care costs.
Such is the attitude of Jean Slutsky, who is a senior offical at the Agency for Healthcare Quality and Research (AHRQ) and is on the PCORI methodology committee, which will determine how PCORI should conduct CER and what it should measure. Slutksy, like other methodology committee members believe CER should be used to control health care costs. (I will post on these other members in the future.) Here's Slutsky opining on kids like Bella Santorum:
"Compelling stories of children who died from very rare metabolic disorders that might have been detected with newer, more expensive equipment have created powerful momentum for expanded screening of newborns. But in an era of constrained budgets, state policymakers need to weigh the benefits and costs of new screening programs against those of other equally important programs. Nonetheless, it remains politically risky to frame a health policy decision as being based primarily on cost or cost-effectiveness."
http://content.healthaffairs.org/content/24/1/102.full
Maybe it's politically risky because, as Slutsky's statement indicates, such decisions seem to focus on children with rare diseases who would be cheaper to care for if they weren't screened. Sadly Slutsky's view about rationing care based on cost is shared among PCORI methodology mavens.
And taxpayers pay for her salary? Slutsky should resign from PCORI and AHRQ.
The Wyden–Ryan proposal—a foundation for realistic Medicare reform
Joseph Antos | The New England Journal of Medicine
The need for significant Medicare reform is increasingly evident, even to policymakers long accustomed to avoiding this politically explosive topic. A host of commissions and expert groups, ranging from the President’s National Commission on Fiscal Responsibility and Reform to the Heritage Foundation, have argued that the United States is on an unsustainable fiscal path. Medicare is at the center of our fiscal crunch, with outlays that have grown about twice as fast as the economy over the past decade, according to the Congressional Budget Office (CBO).
Even if the substantial reductions in payments to health care providers included in the Affordable Care Act (ACA) are fully implemented and Congress allows the 27.4% reduction in physician payments required under current law to go through, Medicare spending will continue to grow at unsustainable rates. It is more likely that Congress will not enforce such large reductions in provider payments, making Medicare’s drain on the budget that much greater. With the retirement of 76 million Baby Boomers over the next two decades, the program will consume an ever increasing share of the federal budget unless policies are adopted to bend Medicare’s cost curve.
On December 15, 2011, Senator Ron Wyden (D-OR) and Representative Paul Ryan (R-WI) released a Medicare reform proposal based on the concept of premium support.[1] Under their proposal,
Medicare would be converted from a defined-benefit to a defined contribution program. Instead of guaranteeing to pay for services as they are rendered, as fee-for service Medicare does, the program would give beneficiaries a subsidy (“premium support”) to purchase coverage from one of multiple competing health plans. The motivation behind the approach is to give plans a clear incentive to provide necessary services in a cost-effective manner, which can result in lower premiums or other beneficiary costs, attracting enrollees and increasing the plan’s share of the market.
The new proposal gives minimal bipartisan credibility to a concept that has long been championed by Ryan and that, in various forms, has been supported by experts on both sides of the political aisle.[2] It also represents a considerable compromise from Ryan’s earlier proposal, which was advanced as part of the House budget resolution last spring.[3]
Under the Wyden–Ryan proposal, seniors would have a choice of private plans competing alongside traditional fee-for-service Medicare. All plans, including traditional Medicare, would bid against each other, with premiums based on the plan’s cost of providing the full package of Medicare-covered services. The federal subsidy would be tied to the cost of the second-least-expensive plan in each market, which means that beneficiaries would have the option of enrolling in a less expensive plan and receiving a cash rebate. Anyone choosing a more expensive plan would pay the full additional premium out of pocket.
The subsidy would be greater for beneficiaries with greater health needs or lower incomes, and the average payment would increase with the growth in the gross domestic product (GDP) plus 1%. In addition, low-income beneficiaries who qualify for both Medicare and Medicaid would be protected from premium increases and would receive additional subsidies to cover their out-of-pocket expenses. As has been the approach with other reforms, this premium-support system would not take effect until 2022.
Wyden–Ryan is more realistic in some respects than Ryan’s earlier reform proposal. The most important change is allowing beneficiaries to opt for traditional fee-for-service Medicare if they so choose. Some conservatives criticize this change as backsliding.[4] They correctly see the traditional
Medicare program in its current form as inefficient and anticompetitive. But pretending that the program will disappear in 10 years feeds the worst tendencies of politicians, who would avoid making important but difficult decisions needed to set traditional Medicare on a fiscally sustainable path.
The reality is that traditional fee-for-service Medicare will probably have about 57 million enrollees in 2022, and it could remain a dominant force in the health sector for decades if seniors continue to enroll.[5] That is likely in rural locales and other markets that are dominated by a small number of providers. In such cases, health plans have little bargaining power and thus little ability to compete on price. In other markets where there is less concentration and more competition among providers, health plans should be better able to contract selectively and offer lower-cost options to seniors.
Ryan and Wyden hint at the need for commonsense reforms to traditional Medicare, including a new structure of deductibles and copayments, a cap on catastrophic costs, and a new physician-payment system. They skirt the central problem: a disorganized fee-for-service system and top-down limits on prices paid for services drive the use of more, and more complicated, services. The program’s survival depends on our willingness to make substantial changes over the next few years — before the major reform is implemented — so that traditional Medicare can provide cost-effective care without draining the Treasury.
The current proposal also offers a more politically palatable fiscal target at the cost of achieving fewer “scoreable” savings. Under Ryan’s earlier proposal, the federal subsidy would grow only with general inflation (1.5% in 2012, according to the CBO) instead of the more generous target of GDP plus 1% (a rate projected to total 4.8% in 2012). Not coincidentally, that is the same fiscal target established for the Independent Payment Advisory Board (IPAB) under the ACA.
A 3.3-percentage-point difference in fiscal targets translates to a 1-year increase in program spending of about $20 billion, or about $300 billion over 10 years. Adopting the weaker target means a substantial loss of budget savings, but only if Congress would actually enforce the stricter limits. That may be unlikely given recent history. Over the past 8 years, Congress has overridden even relatively small reductions in physician payments called for by the sustainable growth rate formula. Clearly, a favorable score from the CBO does not guarantee lower program spending.
Will this premium-support proposal based on full competition among private plans and traditional Medicare work? Some critics argue that premium support simply shifts the cost of care to seniors without improving the efficiency of health care delivery. That would be true only if there were no room to improve health care efficiency or if plans ignored opportunities to cut costs, increase market share, and improve their bottom lines.
Under a premium-support system, each additional test or procedure would not generate additional reimbursement from the government. Most Medicare beneficiaries live on fixed incomes and are not in a position to pay more. That reality will force health plans and providers to coordinate patient care and find other efficiencies rather than perpetuating the current fragmented system.
The Wyden–Ryan proposal offers a safety valve. If its critics are correct, then traditional Medicare, with its price controls and government regulations, will be the low-cost plan in every market. Beneficiaries will shift back to traditional Medicare when the cost differences become apparent, and the competition experiment will be declared a failure.
But one should not be fooled. If the alternative to market incentives is price controls wielded by the IPAB, access to necessary services will inevitably be limited, as providers seek more lucrative business.
Given the serious fiscal problems facing this country, slowing the growth of Medicare spending is no longer optional. The only question is how to do it. The Wyden–Ryan proposal outlines a strategy for Medicare reform that harnesses market forces to control costs. It provides a real alternative to the top-down controls favored in the ACA. Paul Ryan and Ron Wyden have defined the policy parameters that could be the basis for real Medicare reform in 2013.
Antos is the Wilson H. Taylor Scholar in Health Care and Retirement Policy at AEI. He also is a commissioner of the Maryland Health Services Cost Review Commission and a health adviser to the Congressional Budget Office.
[1] Wyden R, Ryan P. Guaranteed choices to strengthen Medicare and health security for all: bipartisan options for the future. December 15, 2011 (http://budget.house.gov/UploadedFiles/WydenRyan.pdf).
[2] The Debt Reduction Task Force. Restoring America’s future: reviving the economy, cutting spending and debt, and creating a simple, pro-growth tax system. Bipartisan Policy Center, November 2010 (http://www.bipartisanpolicy.org/sites/default/files/BPC%20FINAL%20REPORT%20FOR%20PRINTER%2002%2028%2011.pdf).
[3] House Committee on the Budget. The path to prosperity: restoring America’s promise. Fiscal Year 2012 budget resolution (http://budget.house.gov/UploadedFiles/PathToProsperityFY2012.pdf).
[4] Suderman P. Paul Ryan’s Medicare compromise. Reason.com. December 15, 2011 (http://reason.com/blog/2011/12/15/paul-ryans-medicare-compromise).
[5] 2011 Annual report of the boards of trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. May 13, 2011 (https://www.cms.gov/ReportsTrustFunds/downloads/tr2011.pdf).
Tax on sugary beverages projected to have broad health benefits
A penny-per-ounce excise tax on beverage makers would mean reduced sales and rates of type 2 diabetes and associated health problems, a study says.
By Carolyne Krupa, amednews staff. Posted Jan. 24, 2012.
From the article reporting on the 'study'
"Forty states have sales taxes on soda, but they are too low to impact sales, said Dr. Y. Claire Wang, lead study author and assistant professor at Columbia University's Mailman School of Public Health in New York. California's tax is the highest at 7.3%. In many states, profits from the taxes are used to benefit health-related programs and low-income families."
Dr. Wang fails to tell us that while California has the tax rate on food as well as soda the prevalence of kids classified as either obese or overweight (10-17) increased in the state while it decline in other states where the tax on food and soda is non-existent or lower.
Social engineers like Wang want us to believe -- absent clear evidence -- that raising taxes on soda will reduce obesity and healthcare costs. A glance at tax rates and obesity prevalence shows that it not so.
http://archpedi.ama-assn.org/cgi/content/full/164/7/598
And of course every assumes an increase in obesity. But is that absolutely true? It turns out the prevalence of obese adults has remained the same from 2003-2008 with differences in the change of prevalence within enthnic and racial groups (as well as within states among similar ethnicities) according to a most recent CDC study that received almost NO media attention.
Prevalence of Obesity and Trends in the Distribution of Body Mass Index Among US Adults, 1999-2010.
Another question is: how many kids are like I was.. chunky or overweight until I began in 6th grade to focus on my goal of playing for the New York Yankees. Changes in human development due to better access to food, medicine, safer environments do have changes in utero that can affect the prevalence of metabolic disorders. Indeed, there is a pretty solid case behind the claim that BMI as a measure fails to take into account physiological improvements in food and other technological advances. Americans are heavier and taller now than they were a century ago. We live longer too. The crusade against soft drinks and obesity fail to adjust for what economist Robert Fogel demonstrates is "a positive effect of stature and BMI on" life expectancy and output.
Now I am not saying that obesity isn't a problem or not linked to increased morbidity. What I am suggesting is that the way to keep weight under control is the combination of education, awareness, exercise and diet. Taxes that target any one food or drink or any amount thereof are not only an invasion of freedom but they will be useless.
This week a single study, "Serum Vaccine Antibody Concentrations in Children Exposed to Perfluorinated Compounds" was published in JAMA http://jama.ama-assn.org/content/307/4/391 this week claiming that "elevated exposures to PFCs were associated with reduced humoral immune response to routine childhood immunizations in children aged 5 and 7 years. " The research is the only study to look at PFC levels over time in humans. The handful of other studies have only looked at the relationship betwee immune suppression in rats at human PFC levels. Blood samples in this study were taken to measure PFC levels in maternal pregnancy serums and then at age of 5 and 7. There was no regular monitoring of serum levels from birth to age 5 or 7 nor from age 5 to 7. The group was not compared to controls with different serum levels and antibody response. So the results are just as likely to be random as they are to be suggestive.
But that didn't stop JAMA or media outlets to sound the alarm using the heuristic of representativeness and small sample sizes to draw conclusions about probablities that are not supported by the evidence:
Chemical Contaminants Linked To Low Immune Response To Vaccines MedicalNewsToday
Chemicals linked to lower vaccine response in children AFP
Vaccine effectiveness reduced by common environmental toxin . Boston Globe
However, Liz Szabo at USAToday provides the most balanced evaluation of the study and frames the coverage by calling to the limited sample size and the absence of causality.
http://yourlife.usatoday.com/health/story/2012-01-24/Chemical-exposure-may-compromise-vaccine-response/52774114/1
Chemical exposure may compromise vaccine response
"Children exposed to chemicals called PFCs — used in some non-stick cookware, stain-resistant coatings, fast-food packaging and microwave popcorn bags — have a reduced response to vaccines, raising the possibility that the compounds could prevent children from being adequately protected against disease, a new study shows..."
She goes on to cite Paul Offit, a straight shooter and great guy (even though he is a Phillies fan) and to point out that PFC levels are decreasing:
"Grandjean acknowledges that his study's design doesn't definitively prove that PFCs compromise children's vaccine response. It's possible that something else affected their response, says Paul Offit, chief of infectious disease at Children's Hospital of Philadelphia. For example, it would help to know if children with higher PFC levels have any basic immune system problems, independent of vaccines.
The EPA and chemical industry phased out U.S. production of one of these compounds, PFOS, or perfluorooctane sulfonic acid, in 2002. Since then, blood tests show that exposure to this chemical have declined, Grandjean says. Manufacturers are in the process of phasing out another major compound, called PFOA, or perfluorooctanoic acid.
"But other PFCs may be increasing," Grandjean says. "PFOS is now produced in large amounts in China."
In the past, Ms. Szabo has also been relentless in her coverage about the science behind the public health benefits of vaccines. Great work then and now.
More vaccine coverage:
Continuous coverage by health reporter Liz Szabo on the myths and benefits of vaccines.
- Common myths about vaccines
- Measles returns as some parents refuse vaccines
- Parents describe pain of losing children to vaccine-preventable diseases
- Adult vaccines can hold down health costs
- More kids skip school shots in 8 states
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In my previous post I wondered by the National Pharmaceutical Council would hold a conference on asymmetries in information coming out of PCORI and made a somewhat snarky comment about not knowing what asymmetry is with respect to PCORI unless it mean dividing up it's grant money to stakeholders.
It was explained to me that 'asymmetry' has to do with an extremely important issue: Namely while that PCORI, AHRQ, etc will not only determine what information is sent out to doctors, patients, health plans but will also control the means of production and distribution. Unlike NIH, what PCORI will put out can and will be used in determining what health plans should and will pay for. But given PCORI and AHRQs financial focuse on dissemination it begs the question of whether the mostly outdated information that will be distributed via government web sites, conferences and academic detailers will crowd out other forms of information and studies.
The NPC event on asymmetry will be important if it raises these questions http://www.npcnow.org/Public/Education___Events/Events/2012_events/Asymmetry_2012/asym12.aspx
Further, PCORI is loaded with what are called a heuristic biases. I encourage anyone who doesn't think that PCORI is designed to establish asymmetries to read Judgment under Uncertainty: Heuristics and Biases Amos Tversky; Daniel Kahneman Science, New Series, Vol. 185, No. 4157. (Sep. 27, 1974), pp. 1124-1131. http://links.jstor.org/sici?sici=0036-8075%2819740927%293%3A185%3A4157%3C1124%3AJUUHAB%3E2.0.CO%3B2-M
Tversky and Kahneman describe how subjective assessment of probabliities leads to systematic and severe errors in judgment. Even more so if the subjective assessement is also systematic.
Why? As T and K explain: judgments are all based on data of limited validity, which are processed according to heuristic rules.
What are these heuristics? The first one of representativeness is used to assess a person, product, or event based on how similar it seems to be of stereotypes or preconceptions we already have in mind. PCORI uses representativeness by assessing, funding and disseminatiing CER in terms of how well it fits the subjective belief that all CER will lead to lower costs and better health. That is, if a particular approach to research and dissemination fits the pre-existing stereotype of CER then PCORI assumes it will improve health delivery. Moreover, any objectiion raised to CER by introducing information basedon the prior probability, or base-rate frequency, of the outcomes of CER is ignored. Simply stated, PCORI never looks at the actual relevance and impact of CER to determine if it effective. Rather, the problem is one of poor dissemination, not design or scholarship. This insensitivity to prior outcomes is a hallmark of representative bias and explains the total lack of PCORI's self criticism.
Second, PCORI and AHRQ institutionalize insensitivity to sample size. If a study compares two products and is representative of the desired CER outcome then it is accepted. It adheres to the law of small numbers," according to which even small samples are highly representative of the populations from
which they are drawn. PCORI's is framed by the expectation that a valid hypothesis about a population will be represented by a statistically significant result in a sample- with little regard for its size. So for instance Steve Pearson and Sean Tunis, two people who's organizations stand to be enriched by PCORI cash cite clinical trials that 'concluded' injection of medical cement into compression fractures of the spine produced no better pain relief than "sham" injections and the FDA's withdrawing approval of Avastin for advanced breast cancer (claiming there were no benefits given the risks) as examples of good CER.
But both ignore the extremely small sample sizes of studies for both issues. Rather, the small studies are not only highly representative of the population as a whole but representative of what good CER is. And this exposes another, more profound bias institutionalizd by PCORI, name that of availability. We remember and regard as true based on what information happens most often or is more available. Hence, because PCORI and AHRQ will produce and deliver most of the information on medical treatments and will control the outlets for such information it uses the heuristic of availability to create the perception that the CER it produces is the "right" path. Or as Kahneman quips: "What we see is what it is."
Finally, PCORI reinforces the view that only CER and evidence based medicine it produces should be talked about, shared and acted upon. So what if consumers with their own genetic information, companies that produce novel results, or physicians want to learn more about individualize care want to share and use such knowledge. It turns out that they can't: Under the health care law all the actionable information for benefit coverage and reimbursement is channelled through AHRQ and PCORI. It's ok for AHRQ funded academic detailers to wine and dine docs about the blessings of CER but it is illegal for innovators to talk about and share scientific knowledge about the novel uses of their products. In otherwords some medical knowledge (PCORI/AHRQ produced CER generated by the people who have a subjective bias that CER is wonderful) is more equal than others.
There is more to discuss regarding asymmetry and there will be more to come. But as you can see, I believe I was wrong to dismiss asymmetry as a Beltway slogan. Asymmetry is a real problem. As Tversy and Kahneman note: "The rational judge will nevertheless strive for compatibility,
even though internal consistency is more easily achieved and assessed. In particular, he will attempt to make his probability judgments compatible with his knowledge about the subject matter, the laws of probability, and his own judgmental heuristics and biases."
The way PCORI Is structured and the way in which AHRQ generates and produces CER, incentivizes the use of these biases. By seeking to generate acceptance of CER and embedding results into clinical decision tools, PCORI and AHRQ makes "internal consistency" of the research it's funds the foundation of medical decsionmaking. It thereby institutionalizes several errors in judgment that will leave patients less healthy.
Deborah Weinstein
January 24, 2012
Medical Marketing & Media
Senator Chuck Grassley (R-IA) put 34 Medicaid programs on notice that they are not doing enough to rein in over prescription of certain drugs and he wants to know why. He has issued a 12-point questionnaire that includes questions about how and if the states track their prescriptions and or provider prescription rates. They have until February 13 to reply, but the letter does not indicate whether there are consequences for not responding.
“Mental health drugs continue to be prescribed at astounding rates and pain management clinics are turning into a hotbed for black market painkillers. When these drugs are prescribed to Medicaid patients, it is the American people who pay the price for over-prescription, abuse, and fraud” he wrote.
The targeted drugs fall into three categories: anti-psychotics, anti-anxiety and pain-killing medications. Most of the cited programs had two to four over-prescribed medications. Some states, like Nevada, which was cited for eight drugs, and Illinois, which was cited for five, were outliers. The painkiller oxycontin and the anti-psychotic Abilify were among the most overprescribed among the 33 states and the District of Columbia.
Grassley says the prescription rates are astounding – and expensive. His letter to Illinois says doctors cost the state Medicaid program $2.9 million in prescriptions for Geodon, Xanax, Abilify, Zyprexa and Seroquel, and that high prescription rates cost Florida's Medicaid program over $4 million in 2009.
The senator's request is actually part two of an inquiry he kicked off in 2010, when he asked these same programs to identify their top 10 Medicaid prescribers of Abilify, Geodon, Seroquel, Zyprexa, Risperdal, Oxycontin,Roxicodone and Xanax. He said his inquiry, as the ranking member of the Senate Finance Committee, was to ensure the $317 billion states spend on Medicaid annually were legitimate expenses, as opposed to being applied to fraudulent prescriptions.
Monday's letter letter to California explained the appeal; the senator explained that addicts use the antipsychotic drug Zyprexa to enhance and lengthen an opioid's effects Two doctors wrote 2,300 scripts for the drug in 2009. Cost: $879,000.
Propublica reports that the 13,825 Abilify prescriptions by a single Ohio provider in 2009 equals 54 prescriptions per weekday and cost the state $6.7 million.
Grassley's letters acknowledge that there is room to misinterpret the data, but that he is still concerned about “the oversight and enforcement of Medicaid abuse in your state. While I am sensitive to concerns about the potential for misinterpretation of the data you provided, the numbers themselves are quite shocking.”
His inquiry is not necessarily welcome.
“To commence an inquisition into any given physician's choice of patient care is ill-considered. Doctors should not have their choices for patient care either dictated or influenced by a politician's hunt for headlines. Senator Grassley should be smart enough to understand the unintended consequences of such an ill-considered act,” Center for Medicine in the Public Interest founder Peter Pitts wrote in an email.
John Kamp, executive director for the Coalition for Healthcare Communication, agrees, and told MM&M in an email that the Senator is off course. “I'd prefer he would help patients get the scrips they need for critical care . .. Good prescribing habits coupled with patient adherence would do more for the public health than these nasty accusations that cast shadows over health care professionals" he wrote.
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.
