| ||David Cundiff, MD: Bias Issues Inherent in Bravewell's Focus on Evidence-Based Medicine in Reform ||
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
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.
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.
This uncontrolled vaccination
experiment may result
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.
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
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.
||The “Dr. Dean Ornish
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).
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.
For type 2
patients with no
symptoms of diabetes, a
more aggressive diet and
be a reasonable alternative
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.
Pay for performance (P4P) schemes
on HEDIS are flawed in many
process quality measures and are
predicting clinical outcomes.
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 b
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