Psychiatr News October 20, 2006
Volume 41, Number 20, page 5
© 2006 American Psychiatric Association
Health Coalition Wants Government Less Involved in Drug Decisions
Rich Daly
A patient advocacy coalition says that patients and their
physicians—not the government—should be responsible for making
medication decisions and balancing risks against benefits.
As various groups urge changes to the regulation and coverage of
medications in Medicare's Part D prescription drug benefit, an umbrella
organization representing about 100 million Americans with chronic conditions
and disabilities cautioned Congress to make access to all needed medications a
priority.
The National Health Council (NHC), a collective of more than 50 patient
advocacy groups, including the National Mental Health Association, told
congressional staff at a September briefing that patients prefer that they and
their physicians, rather than government regulators, be allowed to decide a
drug's relative risk for them.
"The burden of living with chronic disease often far outweighs drug
risks," said Margaret Kirk, CEO of the Y-ME National Breast Cancer
Organization.
The patient-advocacy push on this issue comes after several years of
mounting criticism that the federal government provides insufficient safety
monitoring of approved medications. In response, federal regulators have
mandated black-box warnings for some drugs, including antidepressants, over
concerns about potentially dangerous side effects, and some drugs were
voluntarily pulled by their manufacturers due to such concerns.
Pressure to improve drug safety has led one pharmaceutical company, for
example, to withhold an antiseizure drug from the market after research
indicated it could result in blindness, according to Eric Hargis, president
and CEO of the Epilepsy Foundation.
"The important thing is that we always look at it from a risk-benefit
perspective," Hargis said. "This was a drug for children with up
to 100 seizures a day."
An Institute of Medicine (IOM) report issued in late September also made
recommendations to improve drug safety, including a requirement that the Food
and Drug Administration (FDA) "reevaluate the safety and effectiveness
of new prescription drugs within five years of approval" (see
page 1).
Myrl Weinberg, president of NHC, told Psychiatric News that she
applauded the IOM report for requesting more FDA resources and postmarket
surveillance but cautioned that any improvements in safety required "an
appropriate balance" with patient access.
Patient-Driven Care Is Key
An NHC report released at the congressional briefing noted that better
patient access to health care information has allowed an increasing number of
patients to work as a team with their physicians and other health care
professionals in making treatment decisions. The report cautioned physicians
that patient-driven health care is limited by patients' inclination to make
inferences beyond the information provided to them, so clinicians "must
actively participate in the patient's information processing and decision
making."
Better evidence-based information on medications is needed, said the NHC
report, so patients can better prepare questions for their physicians about
medications, and physicians can better explain risk-benefit information to
their patients.
Among the steps Congress was urged to take to improve patient access to
medications was removing the legislative exclusion from Medicare coverage of
medications such as benzodiazepines and barbiturates prescribed for disorders
such as epilepsy, Alzheimer's disease, depression, and bipolar disorder.
The coverage exclusion has fueled concern by psychiatrists and other
physicians about the medication choices available to their patients under Part
D formularies.
"Denied access to these drugs has resulted in breakthrough seizures
and increased hospitalization," said Hargis, of the Epilepsy
Foundation.
The patient advocates also urged Congress to continue "all or
substantially all" Part D policies protecting the availability of
several classes of medicines, including anti-depressant and antipsychotic
medications.
Concern About Dual Eligibles Expressed
Although the advocates said Medicare's prescription program has been a
success overall, they found indications that drug access has worsened for
so-called dual eligibles, those who qualify for both Medicare and
Medicaid.
Few data have been collected on how Part D has served these patients, who
often have low incomes and chronic health conditions. Advocates said they were
concerned that many dual eligibles do not use their Part D benefits because of
higher deductibles and copays than they had under Medicaid. Hargis and other
advocates said that they have heard many individual cases of low-income
beneficiaries stopping needed medications after relatively small fee
increases.
The advocates urged changes to the program to ensure access to medications
through gap coverage that includes both branded and generic choices, offering
the "lowest tiering payments" for drugs that do not have a generic
equivalent, and eliminating copayments for dual eligibles.
"We don't think Congress intended for people to have to make choices
between food and their needed medications," Hargis said.
Other steps that could improve patients' access to needed medications, the
NHC report noted, are reauthorization of the Prescription Drug Fee User Act
and increased funding for the FDA's drug-approval process to provide
"safe and effective medicines as quickly as possible for people living
with chronic conditions."
Congress also could help those with chronic illness through more funding
and expanded FDA use of the Critical Path Initiative, which aims to foster
innovation in the drug-approval process.
Further information on the NHC reports and recommendations is posted
at
<www.nhcouncil.org/newsroom/20060926_NR_congressional.pdf>.
Related Article:
-
FDA Overhaul Needed to Ensure Drug Safety, IOM Says
- Jim Rosack
Psychiatr News 2006 41: 1-27.
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