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PCORI has devoted 9 million taxpayer dollars and nearly two years focusing exclusively on figuring out what patient-centered outcomes research is. That's like the Department of Homeland Security or Defense Department doing nothing but trying to define what "security" and "defense" is.
Here's the full defintion of patient-centered outcomes research:
Patient-Centered Outcomes Research Working Definition
Patient-Centered Outcomes Research (PCOR) helps people and their caregivers communicate
and make informed health care decisions, allowing their voices to be heard in assessing the
value of health care options. This research answers patient-centered questions such as:
1. “Given my personal characteristics, conditions and preferences, what should I expect
will happen to me?”
2. “What are my options and what are the potential benefits and harms of those options?”
3. “What can I do to improve the outcomes that are most important to me?”
4. “How can clinicians and the care delivery systems they work in help me make the best
decisions about my health and healthcare?”
(Note that for all the hot air about personalized medicine, there is no specific mention of genetic characteristics)
By way of comparison, it took less time to draft and ratify the Constitution of the United States. The excuse given for this over-cost and over-due delivery of a definition that leaves everyone more confused than ever is the following: " the difficulty in managing large numbers of healthcare providers with busy schedules and divergent interests." You see, these board members are much, much busier than Benjamin Franklin, John Adams, and Thomas Jefferson ever were.
And patient centered outcomes research is supposed to timely and scientifically up to date? If it took all this time just to agree on a definition, what can we expect about the effort to develop a research agenda that meets the definition?
As I have noted before, it will take less time to commercialize whole genome sequencing systems that produce same day results for clinical use then it will for PCORI, AHRQ, etc to decide what to study and to pay the groups who control the PCORI and AHRQ apparatus to do the research for the very same organizations. Did I forget to mention the incredible amount of cronyism involved in the entire CER process? But more on that in a future post.
A couple oversight hearings on what PCORI is really doing, how it's being done and whether it should be abolished would be beneficial. I mean, what's a couple more meetings and two days on the Hill when you spend two years defining what your organization should do. And I bet all those busy providers could clear their calendars pretty quick if called to testify.
Last November, the Center for Medicine in the Public held a confab entitled, “PDUFA without the Politics.” Many of the predictions from the event’s expert panelists seem to be coming true.
AS PREDICTED, the current conversation surrounding the reauthorization of the Prescription Drug User Fee Act (PDUFA) must focus on (among other things) the First Principle of Predictability as well as ensuring that the FDA can fulfill its role as an important ally in advancing healthcare in America.
The draft bill extends FDA's mission to include: advancing medical innovation; promoting economic growth and job creation; promoting predictability and allowing flexibility; identifying and using the most innovative and least burdensome tools for achieving regulatory ends; and incorporating a "patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance, including for people living with a life-impacting chronic disease or disability."
AS PREDICTED, the House Republican discussion draft incorporates the Generating Antibiotic Incentives Now (GAIN) Act, which would extend market exclusivity by five years for drugs that treat antibiotic-resistant pathogens
AS PREDICTED, by Representative Michael Burgess at the CMPI conference, the bill also completely removes limits on issuance of conflict-of-interest waivers for FDA advisory committee participation that were enacted as part of the FDA Amendments Act.
The discussion draft also includes language intended to expand accelerated approval. The accelerated approval provisions are similar to those in the FAST and TREAT acts.
Is there still room for a few more Christmas Tree ornaments? Perhaps permanent renewal of the Best Pharmaceuticals for Children’s Act and PREA?
In this regard, the final rule regulating the establishment of "Affordable Health Exchanges" does not disappoint.
Most of the regs deal with how to qualify people living on Indian reservations and setting up systems to determine eligibility and award tax credits to the 9 percent of Americans who might actually get them. But there are some interesting discussions that crop up which might surprise those who regard exchanges as another step towards utopia:
1. If your income changes after you buy a health plan with some tax credits, your costs will go up or down without warning. And you may have the IRS knocking at your door asking for repayment of the tax credits you planned on having but no longer do as your income changes.
2. If your income changes so does your cost sharing. Even a few bucks a month can make a huge difference. Hence: A five percent decrease in income
from $47,018 is $44,667 (190 percent of the FPL), would correspond to a total premium, after advance payments, of $217 per month, for a total difference in premium of around $360 per year. And there's more "... based on the same figures cited above, the difference in cost-sharing between a family at 190
percent FPL and a family at 200 percent FPL is $1,000 per year, due to the change in eligibility for cost-sharing reductions at 200 percent FPL. The difference is $2,000 around 250 percent FPL, which is the upper limit for cost-sharing reductions based solely on household income.
So if your pre-tax income goes up by $2351 you wind up paying an additional $1360. That's an effective marginal tax rate of 68 percent.
3. And since such changes do not keep up with tax information, exchanges will be required to create a system to monitor what we make in other ways. To wit: "the Exchange must use information other than tax data to verify income in cases in which an applicant attests that a change has occurred or is reasonably expected to occur..." What might that information be? Bank accounts? Pay stubs from employers? Undercover informants?
4. If you or I decide to stop paying premiums for three months. Under Obamacare, we still are able to receive health care services. Coverage is terminated retroactively after three months and health plans don't have to pay doctors and other professionals for services rendered. In otherwords, health providers are on the hook for the cost of providing free care if we stop paying premiums. Or as the regs state: Qualified health plan (QHP) issuers.. must notify providers who submit claims for services rendered during the second and third months of the grace period that any such claims will be pended, and potentially not reimbursed by the QHP issuer if the individual does not settle outstanding premium payments."
5. There is other mind-numbing stupidity too. HHS still hasn't figured out how to get accurate information about income and family size without tax information. And it will take the word of people that they are poor enough to get tax credits without checking first.
I am not making any of this up. I wish I were.
'Personalized Medicine' Hits a Bump
Wall Street Journal -
Tumor Evolution More Complex than Imagined
MedPage Today
Personalized cancer treatment: Genetic differences abound in tumors Los Angeles Times
The source of this pessimism? A study in the NEJM: Intratumor Heterogeneity and Branched Evolution Revealed by Multiregion Sequencing
http://www.nejm.org/doi/full/10.1056/NEJMoa1113205?query=featured_home
Here's Ron Winslow of the WSJ passing sentence on why the study is a blog to targeting treatments:
"Tumor's genetic makeup can vary significantly even within the same tumor sample, researchers said, a finding that poses new challenges to the personalized-medicine movement in cancer.
One big implication of the new research, being published Thursday in the New England Journal of Medicine, is that analyzing only a single sample of a patient's tumor—the current practice—may miss important genetic mutations that affect the course of the disease.
That, in turn, could hinder emerging efforts to match patients with drugs that target the mutations affecting their tumors, a basic strategy of personalized medicine.The findings don't diminish enthusiasm for the idea that genetic knowledge about tumors can transform cancer care, the researchers said. But it could make personalized treatment more complex—and more costly."
Winslow and others -- following the bias of the researchers who did the study -- overstate the novelty of finding differences in tumor progression because of differences in mutations identified by exome sequencing and appear to suggest that such subtle changes always mislead.
First, exome sequencing is becoming commonplace, as is deep sequencing of the type provided by Life Technologies and Oxford Nanopore Technologies. The costs and speed of such analysis is dropping rapidly. So cost is not a factor. Second, such sequencing will become commonplace precisely because clinicians know that every cancer progresses differently. Mutations are not always associated with changes in tumor progression. Sometimes they are, sometimes they are not.
Winslow and others present personalized medicine as a single gene-single step process of individualizing treatment. No one who knows anything about the clinical and functional application of sequencing believes that. Hence, the media -- where many 'thought leaders' still get the primary source material on health and science -- perpetuates both an outdated view of personalized medicine and artificially overstates the costs and barriers of the same.
When the Supreme Court's ruling comes down, probably in June, whoever wins will try to make it sound like the final word on the ACA. But everyone knows that just isn't the case. For Republicans, a win would validate their two-year fight against "Obamacare." For Democrats, a win means the ultimate stamp of approval on Obama's signature policy achievement and the chance to accuse Republicans of wasting the past two years fighting a law that's constitutional. If the court strikes the individual mandate but leaves the rest of the law in place, that would leave policymakers in a tough situation. Or, even if the mandate stays, it does nothing to erase the provision's unpopularity.
Those who opposed the health care bill are debating whether “repeal and replace” should be the clarion call in the coming election. Regardless of how this debate turns out, those in favor of doing better should focus their immediate attention on identifying and fixing the most harmful parts of the bill. The Independent Payment Advisory Board, or IPAB, should be a top target.
Sometimes dreams do come true.
IPAB needs to go, but the goal of reigning in Medicare expenses is a worthy one. As is, the program’s costs are spiraling out of control: Medicare is projected to accumulate a $38 trillion budget shortfall during the next 75 years.
Not only does IPAB further grease the slippery slope towards government price controls and rationing -- it doesn’t even have any authority over the biggest cost-drivers in Medicare.
Medicare Part A, for instance, is so expensive its reserves will be empty by 2017, according to the Medicare Trustees. Part A covers in-patient hospitals stays. By 2035, the program’s revenues will only finance about half of promised benefits.
Medicare Part B, which covers out-patient services, has similar cost problems. Administrators just raised Part B premiums on nearly a quarter of beneficiaries because expenses have gotten so high. And an analysis from the Congressional Research Service found that without substantial hikes in Part B premiums, the program’s finances are “at risk of exhaustion.”
Yet the IPAB has no power over Part A or Part B.
If left unaltered, Medicare could literally bankrupt this country.
Last June, HHS launched two important new health care cost-saving initiatives.
First, the HHS announced it would make $42 million available to enhance coordination efforts between primary care physicians and other health care providers treating Medicare patients. The potential savings are estimated at $125 billion over the next 10 years.
Second, the HHS launched a $40 million effort to help states combat chronic disease. Chronic diseases are responsible for 75 percent of our health care costs—diabetes, heart disease and strokes alone account for nearly $1 trillion in medical spending annually.
Both initiatives have the promise to save money and lives. Unfortunately, they represent the opposite approach to Medicare cost control set forth in the Affordable Care Act.
On one hand, the two new HHS initiatives show that the Obama administration is making credible efforts to target the areas of the health care system that could produce the most savings. On the other hand, the Affordable Care Act through IPAB seeks to devalue efforts such as these in favor of squeezing doctors and other providers.
The right way forward is to get rid of IPAB and substitute for it a Medicare cost-savings plan that encourages long-term strategic thinking along the lines of these HHS studies.
Support for IPAB is rapidly and rightly collapsing as citizens become better informed about the danger this all-powerful panel of unelected bureaucrats poses to their health care. It’s time to urge Congress to get rid of IPAB and stand up for real Medicare reform.
In 2004 I was a member of the FDA’s inaugural counterfeit drug taskforce. Our draft report called for stiffer criminal penalties for the purveyors of false profits – but we were told to remove that particular codicil because it was “outside of our jurisdiction.”
Now? Well, better late than never. Here’s the press release from Senator Grassley’s office:
Senate Approves Leahy-Grassley Bill To Increase Penalties For Counterfeit Drugs
WASHINGTON – The Senate Tuesday night unanimously approved a bill authored by U.S. Senators Patrick Leahy (D-Vt.) and Chuck Grassley (R-Iowa) to increase penalties for trafficking counterfeit drugs. The legislation responds to recommendations made by the U.S. Intellectual Property Enforcement Coordinator and the administration’s Counterfeit Pharmaceutical Inter-agency Working Group.
The Counterfeit Drug Penalty Enhancement Act will increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. While it is currently illegal to introduce counterfeit drugs into interstate commerce, the penalties are no different than those for the trafficking of other products, such as electronics or clothing. The Counterfeit Drug Penalty Enhancement Act will target violators that knowingly manufacture, sell or traffic counterfeit medicines to the United States.
“We cannot allow the counterfeiting of life-saving medicine to be just one more low-risk venture from which international organized criminals can profit,” said Leahy. “While we should not expect that enactment of this or any legislation will completely deter the serious problem of counterfeit medication entering the American supply chain, it is an important step in the fight. I urge the House of Representatives to act quickly on this legislation.”
“Worldwide counterfeit medicines are a multi-billion dollar industry, and growing at an alarming pace, especially over the internet. These medicines pose a serious threat to the health and safety of unsuspecting Americans,” Grassley said. “The House should act as quickly as possible to ensure that counterfeit drug traffickers are punished accordingly for putting people’s lives at risk with this serious crime.”
The legislation is cosponsored by Senators Michael Bennet (D-Colo.), Richard Blumenthal (D-Conn.), Sheldon Whitehouse (D-R.I.), Dianne Feinstein (D-Calif.), Jon Kyl (R-Ariz.), Christopher Coons (D-Del.), Amy Klobuchar (D-Minn.), and Robert Casey (D-Pa.). Companion legislation in the House of Representatives was introduced last year by Representatives Patrick Meehan (R-Pa.) and Linda Sánchez (D-Calif.).
It has been reported that counterfeit drugs result in 100,000 fatalities globally each year, and account for an estimated $75 billion in annual revenue for criminal enterprises
Its old news that expanded access to healthcare doesn’t correlate to broader (or wider) use of services. This lesson from (among other places) the United Kingdom hasn’t gotten a lot of attention on this side of the pond. In fact, the reverse is true. Government-mandated access results in a reduction in usage.
Why? The reason is the role of the gatekeeper – otherwise known as the physician. As Nadine Reibling and Claus Wendt (University of Mannheim) write in their paper, Access Regulation and Utilization of Healthcare Services:
“Since cost containment is at the top of the political agenda, efficiency considerations dominate the political discussions on instruments that regulate access to care. This, however, neglects the fact that such measures also have implications regarding equity of access (Saltman and Busse 2002).”
In other words, equity of access isn’t the same as availability of access. What happens, for example, when physicians choose not to accept Medicare or Medicaid patients? What value is equity when there is a physician shortage? And what does this say about how we value – and compensate – our healthcare providers. What unintended consequences arise when we ignore the growing gap between equity and access?
In November 2010, the Physician Foundation released the results of a national survey of physicians intended to gauge American physicians’ initial reaction to the passage of health reform and to learn the ways in which they plan to respond to it.
Key research findings include:
* The majority of physicians (60%) said health reform will compel them to close or significantly restrict their practices to certain categories of patients. Of these, 93% said they will be forced to close or significantly restrict their practices to Medicaid patients, while 87% said they would be forced to close or significantly restrict their practices to Medicare patients.
* 40% of physicians said they would drop out of patient care in the next one to three years, either by retiring, seeking a non-clinical job within healthcare, or by seeking a non-healthcare related job.
* The majority of physicians (59%) said health reform will cause them to spend less time with patients.
* While over half of physicians said health reform will cause patient volumes in their practices to increase, 69% said they no longer have the time or resources to see additional patients in their practices while still maintaining quality of care.
A brand new study from the Health Research and Educational Trust brings the matter to our own shores via a study of the Children’s Health Insurance Program (CHIP).
Objective
To compare the effects of a coverage expansion versus a Medicaid physician fee increase on children's utilization of physician services.
Primary Data Source
National Health Interview Survey (1997–2009).
Study Design
We use the Children's Health Insurance Program, enacted in 1997, as a natural experiment, and we performed a panel data regression analysis using the state-year as the unit of observation. Outcomes include physician visits per child per year and the following indicators of access to primary care: whether the child saw a physician, pediatrician, or visited an ER in the last year, and whether the parents reported experiencing a non-cost-related access problem. We analyzed these outcomes among all children, and separately among socioeconomic status (SES) quartiles defined based on family income and parents' education.
Principal Findings
Children's Health Insurance Program had a major impact on the extent and nature of children's insurance coverage. However, it is not associated with any change in the aggregate quantity of physician services, and its associations with indicators of access are mixed. Increases in physician fees are associated with broad-based improvements in indicators of access.
Conclusions
The findings suggest that (1) coverage expansions, even if they substantially reduce patient cost sharing, do not necessarily increase physician utilization, and (2) increasing the generosity of provider payments in public programs can improve access among low-SES children, and, through spillover effects, increase higher-SES children as well.
With all the discussions of equity, perhaps it’s time we asked “Who lost access?” And, more importantly, what can we do about it? Otherwise we’re just (Doc) fixing a hole in the ocean.
Net/Net? If you want more access you have to pay for it.
Nothing fixes a thing so intensely in the memory as the wish to forget it.
-- de Montaigne
This time it's soda, or as we call it in Rochester NY: pop.
Add soda to the list of other things CSPI believes are dangerous including prescription drugs, french fries, Chinese food, plastic, food coloring and transfat (the latter was something CSPI pushed to get introduced in the food supply during the 1980s.)
What CSPI does is find things that sound scary, link them to cancer and other ills in RATs. It then raises money through newsletters and lawsuits.
There is no evidence, but for the CSPI study, that any of the above cause cancer or heart disease or anything else. As one FDA official said about the soda scare study:
"A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents," said Doug Karas, an FDA spokesman, in a statement.
http://www.reuters.com/article/2012/03/06/us-us-regulators-dispute-idUSTRE8250W620120306
Meanwhile, little infants can swallow dozens of magnets and, thankfully, survive:
PORTLAND — A 3-year-old girl was recovering Monday at Legacy Emanuel Hospital after doctors removed 37 'Buckyballs' magnets from her intestines.
Payton Bushnell complained to her parents of symptoms that resembled the flu, Legacy spokeswoman Maegan Vidal told KGW. Then, they took her in to get checked.
Doctors took an X-ray and found the balls, clustered in her stomach. She was expected to fully recover and was listed in good condition Monday morning. She has been in the hospital since Feb. 21.
The Oregon toddler was fortunate. In 2006 the government warned about risks from magnets used in toys after at least one child died and almost 19 were injured. As a result, the Consumer Product Safety Commission recalled almost 4 million Magnetix building sets and magnets were included in holiday warnings about dangerous toys. The risk occurs when a child swallows one or more small magnets, which can link together in the digestive tract and perforate the intestines.
http://today.com
Could it be that swallowing buckeyballs is less toxic than swallowing junk science from CSPI?
I wouldn't even try that experiment on rats.
BioCentury reports:
PCORI board votes on research definition
The Patient Centered Outcomes Research Institute (PCORI) board voted 17-2, with one abstention, to adopt a definition of patient-centered outcomes research that begins with a broad summary followed by a list of characteristics. According to the definition, such research "helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options." The research evaluates preventive, diagnostic, therapeutic, palliative or health delivery system interventions; focuses on outcomes such as survival, function, symptoms and quality of life; incorporates a variety of settings and diversity of participants; and "investigates optimizing outcomes while addressing burden to individuals, resource availability, and other stakeholder perspectives."
The definition does not mention "comparative effectiveness research." PCORI's methodology committee, which drafted the definition, said the research includes many components of comparative effectiveness but is intended to be "broader."
Several board members voiced concerns about the definition's focus on communication and decision-making. NIH Director Francis Collins said the definition does not emphasize research, which he called the "primary function" of patient-centered outcomes research. However, the members also expressed a desire to adopt the definition to allow PCORI to focus on other goals such as developing research priorities and launching an annual research conference. Created by the Patient Protection and Affordable Care Act, PCORI expects to have about $112 million in funding for 2012, of which $90 million will be used for grants.
Dr. Collins’ concern isn’t new. At past meetings, when the discussion of what PCORI’s “legacy should be, the NIH Director said that if the Institute was looking for a unique and non-duplicative research agenda, it would be “a null set.”
PCORI should not forget about outcomes data. Perhaps the institute should lead the way in coordinating the many large data sets of outcomes data held by both Uncle Sam and private payers. The use of outcomes data needs to go beyond (well beyond) well-intentioned (but relatively small) CMS pilot projects. The United Kingdom has such a nationwide system – but hasn’t been particularly creative or aggressive in using it. PCORI should take the lead. After all, what’s more patient-centered than real world outcomes data?
PCORI should create a program on educating patients, physicians and payers on the use and importance of molecular diagnostics. After all, what’s more patient-centric than early diagnosis and advancing the “four rights” of the right medicine in the right dose to the right patient at the right time?
PCORI should help to advance the nascent science of adaptive clinical trials. After all, what’s more patient-centric than adaptive clinical trial information?
PCORI should stay as far away as possible from discussions of CER as a method for cost controls – as this is a slippery slope to price controls. And price controls equal choice controls. Moreover, PCORI is officially tasked not to pursue comparative effectiveness but comparative clinical effectiveness. Comparative means which treatment (or healthcare technology if you prefer) is “better” (subjective) versus data on real world clinical outcomes. To put it bluntly, “comparative” is subjective. “Clinical” is outcomes-driven. It’s important to remember both the letter and the spirit of the stature.
(In fact, Francis Collins warned the board to “beware of the tension between CER and personalized medicine.)
PCORI should be careful in creating a databank of CER studies because (and particularly when you consider programs such as CATIE and ALLHAT) garbage in, garbage out.
PCORI should beware of information sharing via academic detailing. (Note: 20% of the PCORI budget is ear-marked to AHRQ for “information dissemination.) ‘Nuff said.
PCORI should (indeed must!) define “patient-centered” as care first and cost second – otherwise the “PC” in its acronym will only mean “politically correct.”
In May 2011, PCORI Chairman Eugene Washington introduced Joe Selby as the institute’s first executive director. To which Dr. Selby commented, “For those of you participating in this meeting via webcast, I’m the one who looks like a deer in the headlights.”
Joe – It might be time for those night vision goggles.
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.
