National health care: present state and ideas for the future

In JAMA researchers examine the safety of medical products, as well as the status of uninsured children.

Data from two recent studies offered insight into the “health of the nation” this week in JAMA.

One of the studies revealed that one in four medical products approved since 1995 in the United States or Europe has received safety-related regulatory action; and the other revealed that more than 4% of children with insured parents had a gap in insurance coverage for part of the year.

Biological product safety

In the first study, researchers from Utrecht Institute for Pharmaceutical Sciences and other sites in the Netherlands examined a group of biological products approved between January 1995 and June 2007 in the United States and European Union.

The researchers aimed to establish the nature, frequency and timing of safety-related regulatory actions taken for biological products after approval.

“Ensuring drug safety is an essential component of the health of the nation,” said Phil B. Fontanarosa, MD, MBA, executive deputy editor of JAMA. He presented the findings on behalf of the researchers at a media briefing in Washington yesterday.

During the study, 174 products were approved — 136 in the United States and 105 in the European Union, 67 of which were approved in both regions. Eighty-two safety-related regulatory actions were issued for 41 of the 174 products approved (23.6%). Such actions included 46 “Dear health care professional” letters, 17 direct communications with health care professionals in the European Union, 19 black box warnings and no withdrawals. Mean time to safety-related regulatory action was 3.7 years after approval.

Using Kaplan-Meier analyses, the researchers determined that the probability of a first safety-related action three years after approval was 14% and 10 years after approval the probability was 29%. Compared with products receiving first-in-class approval, those approved later in the same class were at a lower risk for a first safety-related regulatory action (12/1,000 months vs. 2.9/1,000 months; HR=3.7).

According to the researchers, most of the actions were taken due to general disorders, administration site conditions, infections and infestations, immune system disorders and benign, malignant and unspecified neoplasms.

Based on their findings, the researchers suggested that pre-approval evaluations be more in-depth, and they advocated vigilant post-marketing surveillance.

Uninsured children and adolescents

In the United States, at least 46 million citizens, including more than 9 million children, are uninsured, according to Jennifer E. DeVoe, MD, DPhil, of the department of Family Medicine at Oregon Health & Science University, who presented the results of a cross-sectional, full-year analysis at the briefing.

DeVoe and her colleagues used a representative sample of 39,710 children from the Medical Expenditure Panel Survey between 2002 and 2005. The sample was representative of the 72 million children nationwide aged younger than 19 years who live with at least one parent.

According to their findings, more than 4% of children were not insured for part or all of the year, meaning they had a gap in coverage ranging from one month to all year, despite having at least one parent fully insured.

Uninsured children were more than 1.5-times more likely to be from middle-income households than from high-income households, nearly 2.5-times as likely to be from low-income households and 65% more likely to be Hispanic, DeVoe said. These children were also 85% more likely to have parents with private vs. public insurance coverage.

“For a lot of us, these are numbers, but what do these numbers mean? These are painful realities (for parents) and choices to forego and delay care every day,” DeVoe said.

Based on the findings, DeVoe proposed a short-term solution, although she recognized its incremental nature and its inability to solve a large problem.

“We need to close the family income gap and we need to close it now. We need to expand the State Children’s Health Insurance Program to provide relief for low- and middle-income families who are falling into a family income gap. Many families are earning too much to qualify for public insurance, but not enough to afford private coverage,” she said.

Tax reform to lead health care reform

Two accompanying editorials in JAMA offered potential solutions for resolving the health care finance system and the role of state government in health care reform.

Samuel Y. Sessions, MD, JD, assistant professor of psychiatry in the department of psychiatry and biobehavioral sciences at Harbor-UCLA Medical Center in Torrance, Calif., said during the briefing that the current health care finance system may be improved by switching to universal health insurance vouchers funded with a value-added tax.

Providers participating in the voucher system would be required to enroll anyone, no matter their health status. The system would do away with Medicaid and continue Medicare, though no new members would be accepted.

Introducing the new tax would cause a tax reform, consequently raising issues of composition, distribution, revenue and technicality, Sessions said. However, he said the following are potential benefits of such a reform:

• health care costs would be more evident to the public;
• artificial constituencies would be eliminated and consolidation would be under one political “roof;”
• it would allow the opportunity for significant tax cuts; and
• consumption tax would even the “dependency ratio.”

“Reform of this gargantuan tax base can serve as a direct and powerful impetus for health care reform — not serve merely as a revenue source,” Sessions said.

A state’s role in health care reform

Also at the briefing, Ezekial Emanuel, MD, PhD, chair of the department of Bioethics at the National Institutes of Health, presented his commentary on the role of the state government in health care reform. The commentary was coauthored by Ron Wyden, JD, of the U.S. Senate.

“One of our aims is to dispel the notion that states are going to lead in health care reform — they just can’t lead, especially if what we’re looking at is comprehensive reform,” Emanuel said.

Despite the opinions of many commentators who believe health care reform should be led from the state level, too many limitations keep the state from even being able to access core components of a comprehensive reform, Emanuel said.

“States are inherently limited, both with the authority they have and the fiscal capacities to address the problem,” he said. “States cannot reform most of the private, employer-based insurance and they have no control over the federal tax code that provides a $210 billion subsidy to employer-based coverage — no state can change that.”

In the past, efforts to allow for state-led tax reform have failed, according to Emanuel. Such plans include the Quest program from Hawaii, the Health Services Act from Washington and Tennessee’s Tenn Care.

However, Emanuel pointed out the positive roles of state government in health care reform, such as running state-based insurance exchanges, overseeing insurance companies and enacting innovative programs such as wellness and preventive initiatives.

“States can do little experiments around the edges of reform, but that is much different than a big initiative. However, there are things they can do briefly and we would encourage thinking about that as we progress into the health care reform era,” he said. – by Stacey L. Adams

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