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It is becoming increasingly un-PC (“Pharma Correct”) to say that $1.1 billion earmark for a “Federal Coordinating Council for Comparative Effectiveness Research” is a bad idea.
Well, it’s a bad idea.
And cozying up to the powers-that-be isn’t going to change the fact that this is a giant first step towards a U.S. version on NICE.
Whether or not you agree that such a notion is a bad idea, we should ALL agree that it’s important enough to debate on its merits – and not become law through legislative legerdemain; hidden deep within the bowels of the stimulus package.
Wither transparency?
Senator Feinstein says that, “the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.”
Senator Baucus promises that, “Its charge should not go beyond that.”
Indeed, Senate Finance Committee documents detailing health provisions in the Senate's economic stimulus package say that the bill "specifically prohibits the government from making any coverage decisions based on this research, or even from issuing guidelines that would suggest how to interpret the research results."
But the House language has no such limitations in mind:
“By knowing what works best and presenting this information more broadly to patients and health care professionals, those items, procedures and interventions that are most effective to prevent, control and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”
The problem is that “comparative effectiveness,” as it is currently designed, places into conflict the short-term budgeting dilemmas of governments elected for relatively short periods of time with the ever-lengthening life spans of their electorates. Us.
As currently organized, comparative effectiveness will be used to increase government control over the practice of medicine and introduce price controls.
Let's get real folks. All rhetoric to the contrary -- this is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans. Step Two is to do away with the Non-Interference Clause so that comparative effectiveness measures can be used to offer a VA-style formulary. And Step Three is to make that the model for the "universal care" we'll all be paying increased taxes to support.
(Note: The VA formulary offers 1,300 drugs, compared with 4,300 available under the average Part D plan -- prompting more than one-third of retired veterans to enroll in Medicare drug plans.)
Broader access to mediocre care? “Just like in
We need a new model. We need to develop proposals that modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA Critical Path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, we must establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.
For instance, the FDA, in cooperation with many interested parties, has developed a Critical Path opportunities list that provides 76 concrete examples of how new scientific discoveries in fields such as genomics and proteomics, imaging, and bioinformatics could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.
We need a Critical Path for Comparative Effectiveness to begin the process of developing a similar list of ways new discoveries and tools (such as electronic patient records) can be used to improve the predictive and prospective nature of comparative effectiveness.
It’s a complicated proposition—but such a goal is as simple as it is essential—cost must never be allowed to trump care, and short-term savings must not be allowed to trump long-term outcomes. Just as we need new and better tools for drug development, so too do we need them for comparative effectiveness measurements.
A comparative effectiveness model for the 21st Century should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new healthcare paradigm capable of providing for its needs in the 21st Century. Equality of care must be matched with quality of care.
In an era of personalized medicine, one-size-fits-all treatments and reimbursement strategies are dangerously outdated. We are early in this debate, but at least we can all agree that this is not, and must not be exclusively, a debate about saving money. It must be about patient care.
For more on this issue, have a look at this new policy paper from the Washington Legal Foundation.
If you like the legislation -- you'll love the movie.
Have a look at our new 16 minute documentary, "Off Label: Universal Healthcare." Just click here and then click on the picture of our very own Uncle Sam.
Please share this video with all your contacts, friends, relations -- and elected representatives. And send along your comments as well.
Increasing choices, decreasing costs
The Medicare Prescription Drug Savings and Choice Act of 2009 proposes increasing beneficiary choice and driving down costs by creating a Medicare-administered drug plan as an alternative to privately administered Part D plans. Additional provisions include:
- The Medicare-operated drug plan or plans would be available nationwide with a uniform monthly premium.
- The Agency for Healthcare Research and Quality would assess clinical effectiveness and safety of drugs and recommend medications that should be included on the plan formulary.
- Drugs cannot be removed from a formulary during the plan year except in the case of safety concerns.
- An advisory committee would review petitions and make recommendations on whether to add drugs to the formulary.
- For drugs that provide similar benefits, the formulary would use incentives to encourage Medicare beneficiaries to choose the drug for which the HHS secretary was able to negotiate the lowest price.
http://www.ama-assn.org/amednews/2009/02/09/gvsc0209.htmBack to top.
Here’s a colloquy that includes Senators Baucus, Enzi, Hatch, Roberts, and Feinstein. The date, February 6, 2009. The topic, $1.1 billion for a “Federal Coordinating Council on Comparative Effectiveness.” The highlights are mine. The words are their own.
Mr. BAUCUS. I understand Senator ENZI has comments regarding the provisions for comparative clinical effectiveness research included in The American Recovery and Reinvestment Act of 2009 which is being considered in the Senate this week.
Mr. ENZI. I am pleased to see that in its consideration of this bill, the Appropriations Committee made sure this research will evaluate comparative clinical effectiveness, not comparative cost-effectiveness. In addition, the committee’s report language references provisions of the existing comparative effectiveness research program at HHS that ensure that the agency developing comparative information does not use it to set national practice standards or coverage restrictions. I also believe that comparative effectiveness research must be conducted using an open and transparent process, and must consider differences in how people respond to treatment. It is my understanding that the Comparative Effectiveness Research Act of 2008, which you introduced with Senator CONRAD last Congress, is consistent with these principles. I would like to see the $1.1 billion used consistently with these principles, and ask that you advocate for these principles in conference.
Mr. HATCH. I agree that the primary focus of comparative effectiveness research should be clinical effectiveness not cost. We can all agree that the ‘‘one size fits all’’ approach is the wrong approach for the American health care system. Based on our own personal experiences we all know that what works best for one person, does not always work the same for another. I look forward to working in a bipartisan and inclusive manner to come up with prudent legislation that will not only help us realize the true potential of comparative effectiveness but also preserve patient choice and innovation—the two hallmarks of our health care system.
Mr. ROBERTS. I would associate myself with the remarks of Senator ENZI, and would underscore that it is very important to require full openness, transparency and accountability in how research priorities are set and how studies are conducted and communicated. Without this openness, patients have no assurance that their voice will be heard in the process, and no ability to understand how results are being used in decisions that directly affect their health. I look forward to working with my colleagues to ensure that strong provisions for openness, transparency, and accountability are put in place.
Mrs. FEINSTEIN. I thank my colleagues for their efforts on this issue. I agree that comparative effectiveness research holds great promise to improve medical care by giving physicians and patients valuable information on treatment options. It is my understanding that the new Federal coordinating council included in the language is intended to coordinate the comparative effectiveness research efforts taking place across Federal agencies and with funds we are providing in this bill. However, there is some concern that the language, as currently written, allows the council to expand its activities beyond mere coordination. I think my colleagues would agree that the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.
Mr. BAUCUS. I thank Senator FEINSTEIN for pointing that out. I agree. The coordinating council should look across agencies to coordinate resources and activities of the federal government with respect to comparative effectiveness research. Its charge should not go beyond that. The language of the bill could be clarified to make that point clear. And I will support clarification of it in conference.
(Here’s the complete colloquy.)
$1.1 billion to “coordinate” resources and activities? That’s a lot of mazuma. And not a single job created. Well, maybe one coordinator and a few assistants. And at $1.1 billion, they’ll be earning more than any GS-14 I ever met.
And that’s with benefits.
And speaking of $1.1 billion, that also happens to be the mid-range savings projected for what implementation of FDA-recommended genetic testing for warfarin will deliver in one year. (The savings will be realized through the prevention of 85,000 serious bleeding events and 17,000 strokes annually.) Yet FDA is not slotted to receive a single shekel from the stimulus package.
“Clarification in conference,” indeed.
Well, I read in a major US daily that the $1.1 billion for comparative effectiveness research (via AHRQ) had been stripped from the Senate version of the stimulus package. And opined on this accordingly.
Wrong. The monies are indeed in the Senate version.
Apologies for the mistake. But a bigger mistake would be for Congress to pass a stimulus package with this earmark for cost-effectiveness.
Once again with feeling -- here's why:
1. The additional spending does not stimulate the economy. The money would be spent on consulting contracts for health care economists.
2. The way the money would be spent is neither transparent nor clearly defined. Indeed, nearly a half a billion dollars would be spent at the discretion of the HHS secretary without outside review, establishment of research goals or methodologies.
3. The rest of the money ($700 million) is a slush fund payoff to insurance companies and health plans. The group advising the government on which research organizations should get the money is made up mostly of HMOs, insurers and Medicaid directors. And the entities that would conduct the research are run by either by the health plans themselves or by consultants who work for them directly and who want the government to take over the job of deciding what technologies consumers should get and what doctors should get paid. This is a cost-based crowd.
Giving over a billion dollars for a small cadre of appointees who could dictate and determine medical practice and the future of the life sciences industry is a risky and unwise use of tax payer dollars under any circumstance. To suggest that it would stimulate the economy only adds insult to injury.
And again, please excuse the earlier mistake. Hope springs eternal.
The Senate version of the stimulus package has excised the House’s proposal for a $1.1 billion “Federal Coordinating Council on Comparative Effectiveness.”
1. The additional spending does not stimulate the economy. The money would be spent on consulting contracts for health care economists.
2. The way the money would be spent is neither transparent nor clearly defined. Indeed, nearly a half a billion dollars would be spent at the discretion of the HHS secretary without outside review, establishment of research goals or methodologies.
3. The rest of the money ($700 million) is a slush fund payoff to insurance companies and health plans. The group advising the government on which research organizations should get the money is made up mostly of HMOs, insurers and Medicaid directors. And the entities that would conduct the research are run by either by the health plans themselves or by consultants who work for them directly and who want the government to take over the job of deciding what technologies consumers should get and what doctors should get paid. This is a cost-based crowd.
Giving over a billion dollars for a small cadre of appointees who could dictate and determine medical practice and the future of the life sciences industry is a risky and unwise use of tax payer dollars under any circumstance. To suggest that it would stimulate the economy only adds insult to injury.
Liz Mansfield has been tapped to be the FDA’s point person on coordinating and upgrading the agency’s activities involving genomics and related fields (including the analysis of complex DNA, protein and small molecular expression platforms).
1. The additional spending does not stimulate the economy. The money would be spent on consulting contracts for health care economists.
2. The way in which the money would be spent is neither transparent or clearly defined. Indeed, nearly a half a billion dollars would be spent at the discretion of the HHS secretary without outside review, establishment of research goals or methodologies:
Directs $400 million to be made available for comparative effectiveness research to be allocated at the discretion of the Secretary of HHS. Funds appropriated shall be used to accelerate the
development and dissemination of research assessing the comparative effectiveness of healthcare treatments and strategies, including efforts that 1)
conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used
to prevent, diagnose, or treat diseases, disorders, and other health conditions; and 2) encourage the development and use of clinical registries, clinical data
networks, and other forms of electronic health data that can be used to generate or obtain outcomes data:
3. The rest of the money is a payoff to insurance companies and health plans who want the government to take over the job of deciding what technologies consumers should get and what doctors should get paid. The group advising AHRQ on what research organizations should get the money is made up mostly of insurers and Medicaid directors and the entities that would conduct the research are run by health plans themselves or consult for them directly. Another $700 million would go directly to AHRQ to be allocated by it's comparative effectiveness research "stakeholders" group to a group of "technology evaluation centers" that do most of the comparative effectiveness research for the agency. This is akin to giving the EPA money to evaluate air quality standards and turning the decision of which research to fund over to car makers and limiting the pool of research organizations to those supported by or consulting to the Big Three auto companies.
4. In other countries comparative effectiveness has has the effect of hurting patients and killing biotechnology, a leading source of economic growth and jobs. The National Institute of Clinical Excellence (NICE) in Britain is the model for the "coordinating council." It has been recently cited by patients in Britain for denying access to cancer drugs. The UK's BioIndustry Association recently noted: "an independent inquiry is necessary to assess NICE's long-term impact on the cost, access to, and uptake of medicines in the UK. As you know, NICE has been aggressive about rejecting expensive medicines that it says don't offer sufficient advantages over older, less costly drugs." This announcement came after it was discovered that the British health system had a $3 billion surplus and biotech companies were going broke.
http://www.bioindustry.org/biodocuments/BIGTR2/BIGT_Review_and_Refresh.pdf
http://www.fiercebiotech.com/story/uk-biotechs-ask-tax-breaks/2009-01-22
Giving over a billion dollars for a small cadre of self-interested appointees who could dictate and determine medical practice and the future of the biotechnology industry is a risky and unwise use of tax payer dollars under any circumstance. To suggest that it would stimulate the economy is to only add insult to injury.
Joining Dr. Konstam on the rostrum were Dr. Bob Temple and Dr. John Jenkins -- two FDAers whose job it is to help advance the practice of personalized medicine.
Yes we can.
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.
