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David Cundiff, MD: Bias Issues Inherent in Bravewell's Focus on Evidence-Based Medicine in Reform PDF Print E-mail
Written by John Weeks   
Saturday, 18 April 2009

David Cundiff, MD: Bias Issues Inherent in Bravewell's Focus on Evidence-Based Medicine in Reform

Summary:  In this response to the Bravewell Collaboration's listing of evidence-based medicine (EBM) and reimbursement reform as key factors in any healthcare transformation, David Cundiff, MD points out that "randomized controlled clinical trials and other tools of EBM are mostly funded by special interests and interpreted by researchers paid by those special interests." Thus "the evaluation of EBM trials is and will remain controversial." Cundiff, author Money Driven Medicine, argues that one-third of the HEDIS measures which shape insurer decisions on what get covered, are "highly questionable." Sponsors of these measures, Cundiff notes, include a who's who of major pharmaceutical firms. Can one even imagine a level playing field for an evidence-based inclusion of integrative, natural therapeutic approaches?
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for inclusion in a future Integrator.

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David Cundiff, MD
David Cundiff, MD, was first present in the Integrator in a column in which he took on the Cochrane Collaboration. (See
Cochrane Collaboration, High Court of Evidence-Based Medicine, Blasted for Bias in Medscape, June 22, 2007.) His core focus, then as here, is on controversies surrounding the objectivity of nominally objective evidence-based medicine (EBM).

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Cundiff's book
In this column, Cundiff, author of Money Driven Medicine, focuses on two of the eight key factors in health reform which were listed by the Bravewell Collaborative following the recent Bravewell-funded Institute of Medicine Summit on Integrative Medicine and the Health of the Public.
(For the eight Bravewell factors, see Forum on the IOM: Bravewell's Post-Summit Statement on "Key Factors" in Any Health Reform Plan.) The two are use of EBM and the needed for reimbursement reform. Cundiff focusing on significant issues related to the value of the HEDIS outcomes which shape behavior of 90% of the nation's healthplans. He suggests that up to a third of their key indicators - the evidence upon which coverage of humans are shaped - "are highly questionable," providing evidence to back his assertions. This is stimulating, if despair-inducing, reading.
_____________________________

Challenges in Bravewell's Focus on Evidence-Based Medicine and Reimbursement as Reform Factors


David Cundiff, MD

Of the Bravewell Collaborative’s eight "key factors that should be included in health reform," six would probably appeal to the vast majority of stakeholders. However, the two factors that relate to allocation of resources present major challenges to finding a practical way forward with health care reform:
(1). Evidence-based medicine (EBM) is the only acceptable standard.  Researchers and practitioners alike concurred that health care should be supported by evidence and urged further research and testing to expand the evidence base for integrative models of care.

(2). The reimbursement system must be changed to a system that rewards outcomes rather than procedures with changes that incentivize physicians to focus on the health outcomes of their patients.
Let me address a major problem with basing medical resource allocation on EBM.

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Sponsor of the HEDIS measures
Randomized controlled clinical trials and other tools of EBM are mostly funded by special interests and interpreted by researchers paid by those special interests. For that and other reasons, the evaluation of EBM trials is and will remain CONTROVERSIAL. Therefore, health care reform should not be predicated on being able to find the right, all-knowing, unbiased experts to draw up government-endorsed guidelines determining what interventions should and should not be covered by insurance.


For example, the National Committee for Quality Assurance (NCQA), a private, non-profit organization markets “Health Plan Employer Data and Information Set” (HEDIS), a tool used by more than 90% of America’s health plans to measure performance on important dimensions of care and service. Employers, consultants and consumers use HEDIS data to help them select health plans. HEDIS data also are the centerpiece of most health plan "report cards" that appear in national magazines and local newspapers. Corporate financial sponsors of HEDIS include the following drug companies: Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Pfizer Inc., Daiichi Sankyo, Inc., Sanofi Pasteur, Abbott, Lilly, Bristol-Meyers Squibb, and Novo Nordisk.

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Of the clinical indicators by which physician organizations and health plans are rated by HEDIS, many are based on good evidence in the peer reviewed medical literature or based on common sense such that randomized trials would be unethical. However, the following guidelines, about one-third of the HEDIS quality measures, are highly questionable:


  • Immediate beta-blocker pills for heart attack patients: In 1999, a HEDIS report extolled the value of this quality measure: “One shining example is use of beta blockers after a heart attack. Since 1996, plans' combined performance on this measure has jumped from 62.5 percent to almost 80 percent. Considering the amount of attention given this measure in the last two years, it could be argued that HEDIS has done more to elevate awareness of beta-blocker use as a proven and relatively inexpensive way for physicians and health plans to save lives than did all of the relevant clinical guidelines that preceded it.” However, in 2007, HEDIS quietly withdrew this quality measure saying widespread achievement of near maximum use of beta-blockers in post-MI patients and little variance among health plans resulted in it having little value as a quality measure to differentiate health plans. Then, in December 2008, the American Heart Association and American College of Cardiology withdrew this guideline with a euphemism indicating that the guideline was never valid: Guideline deleted because of “Increased complexity of decision making and controversy about the magnitude of net benefit.” A New York Times article indicated that the Centers for Medicare and Medicaid Services (CMS) sent hospital administrators around the country received “a short, unceremonious e-mail” withdrawing this quality indicator a month later. However, a search of the CMS website for “beta-blocker and heart attack” is negative.

  •    
    This uncontrolled vaccination
    experiment may result in an
    epidemic of adults getting severe
    chicken pox in 10 – 20 years.


     
    Vaccination against chicken pox (varicella) for children: Immunity from varicella vaccination lasts no more than 5 years compared with lifetime immunity from having chicken pox (usually a mild uncomplicated early childhood illness). The older the age of acquiring chicken pox the worse the complications and the higher the risk of death. This uncontrolled vaccination experiment may result in an epidemic of adults getting severe chicken pox in 10 – 20 years.

  • Treatment of depression with antidepressant medication: The efficacy of selective serotonin uptake and release drugs (SSRIs, the most widely prescribed antidepressants) is not more than placebo. They clearly increase suicidal attempts and may cause some suicides. Non drug treatments like aerobic exercise, stress management techniques (yoga, meditation, etc.), communing with nature, and gardening are not mentioned in the HEDIS guidelines.


  •    
      The “Dr. Dean Ornish Program” including
    a similar diet, reduces adverse
    cardiovascular events by > 50% in 5
    years compared with < 30% with pills.

     
    Blood cholesterol screening and drug treatment to lower low density lipoprotein (LDL) cholesterol: A trial of treatment of hypercholesterolemia with Mevacor (a statin drug) in subjects eating the American Heart Association diet compared with a “portfolio diet” (i.e., fruits, vegetables, almonds, soy protein foods, oats, barley, etc) alone showed no significant difference in lowering of LDL cholesterol. The “Dr. Dean Ornish Program to Reverse Heart Disease” including a similar diet, reduces adverse cardiovascular events by > 50% in 5 years compared with < 30% with pills.

  • Treating stage 1 high blood pressure (systolic BP 140 – 159 or diastolic BP 90 – 99) with drugs: Published trials have not shown that drug treatment of mild hypertension saves lives or reduces adverse events. The widely reported ALLHAT trial comparing 4 blood pressure lowering drugs for stage 1 hypertension showed that subjects taking water pills (thiazide diuretics) had fewer adverse clinical outcomes than those on the newer patented meds. However, none of the 15 placebo-controlled randomized trials of thiazide diuretics involved exclusively stage 1 patients. Five of those 15 trials showed no benefit with thiazides, and The Oslo trial, combining stage 1 and 2 hypertension subjects, reported a significant INCREASE in deaths with thiazides at 10 years (14 versus 3).

  •    
    For type 2 patients with no
    symptoms of diabetes, a
    more aggressive diet and
    exercise prescription would
    be a reasonable alternative
    to drugs. 

     
    Treating people with type 2 diabetes who have no symptoms (frequent urination, excessive thirst, blurry vision etc.) with blood sugar lowering drugs: Of at least 15 complications of diabetes studied in the largest type 2 diabetes trial, only one was significantly benefited with drugs. Patients on sugar lowering drugs required fewer laser treatments for diabetic eye disease.  However, drug treatment increased weight and episodes of hospitalization due to diabetic coma (hypoglycemia). For type 2 patients with no symptoms of diabetes, a more aggressive diet and exercise prescription would be a reasonable alternative to drugs.


   
Pay for performance (P4P) schemes
based on HEDIS are flawed in many
process quality measures and are
worthless at predicting clinical outcomes.

 
 
Pay for performance (P4P) schemes based on HEDIS are flawed in many process quality measures and are worthless at predicting clinical outcomes. In addition, about half of Medicare beneficiaries over 65 have at least three chronic medical conditions, and, therefore, would have been ineligible for the clinical trials that form the basis of the HEDIS quality indicators. Many of these elderly patients will have trouble keeping track of multiple HEDIS mandated medications and will be at increased risk of drug interactions. The few randomized trials that have been done with P4P schemes based on HEDIS indicators have not shown conclusive benefits to patients.

As currently practiced based on HEDIS standards, P4P is bad medicine. Clinical trials and EBM definitely have a place in health care, but it should be to inform the clinical decisions of individual physicians about individual patients. Given the inevitable controversy involved in many clinical decisions, they should not be the basis of government and academic medicine experts, many with financial conflicts of interest, to determine a one-size-fits-all system of resource allocation.

David Cundiff, MD


Comment: When members of the integrative practice community think about shifting national policy, we typically focus on making changes via members of Congress or the White House. Yet there are huge additional playgrounds for lobbyists, for "government affairs" and "public affairs" professionals which shape the policy soup. This include entities such as NCQA and its crowning EBM glory, HEDIS. Cundiff underlines the importance of being present in these playgrounds. Corporate and industry lobbyists certainly know their way around these money bars.

Ciondiff notes that he is focusing on the two of the eight Bravewell "factors
that relate to allocation of resources." I am reminded of Holistic Primary Care editor Erik Goldman's commentary on the IOM meeting (see Forum on the IOM Summit: Holistic Primary Care's Erik Goldman and JMPT's Claire Johnson, March 8, 2009: 
"Until we really start talking about WHY the current system behaves as it does, why it rewards who it rewards and excludes who it excludes, until we speak plainly about who's benefiting from the status quo (and someone is clearly benefiting), we'll never really get anywhere."
Well-said. And fully-affirmed by Cundiff's column. EBM, as practiced, is not what it is cracked up to be.


 
Last Updated ( Saturday, 18 April 2009 )
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