Confusion, Conflict and Conflicts of Interests Grandfathered Into New Comparative Effectiveness Proposal

  • by: |
  • 03/04/2008
Senators Baucus and Conrad have introduced the “The Comparative Effectiveness Research Act of 2008”. It has all of the conflicts and biases towards cost containment that other similar entities have.

1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.

But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.

2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?

3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "

Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...

Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."

Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.

4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.

Is there any evidence that these two assumptions are true?

How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...

And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?

How about a study about that?

All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.
CMPI

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.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog