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Christopher Fleming

What’s Riskier: Driving In A Car Or Taking Aspirin To Prevent A Heart Attack? New Health Affairs Study By Tufts-New England Medical Center Researchers Tries To Answer The Question

Thematic Health Affairs Issue on Managing Risk And Benefits Also Addresses Hospital Charges, Malpractice Liability And Spending, And More

Bethesda, MD -- Amid growing debate about appropriate regulation of drug safety by the Food and Drug Administration (FDA), a new study released today in the journal Health Affairs compares mortality risks posed by drugs to risks related to work, transportation, and recreation.

The mortality risks posed by Vioxx to treat arthritis and Tysabri to treat multiple sclerosis --drugs that have recently received scrutiny -- are comparable to or exceed the risk of dying in a car, working as a truck driver, or rock climbing. Even the widespread prophylactic use of aspirin poses a fatality risk on par with the risk associated with driving a car or working as a fire fighter, say study coauthors Joshua Cohen and Peter Neumann of Tufts-New England Medical Center. http://content.healthaffairs.org/cgi/content/abstract/26/3/636

Cohen and Neumann argue that risks cannot be properly evaluated without also considering the associated benefits. They point out that some surveys of patients who take Tysabri indicate that they would tolerate considerably higher risks to alleviate their multiple sclerosis symptoms. The need for the FDA to systematically and quantitatively evaluate both the risks and benefits of drugs may soon grow. The Institute of Medicine (IOM) has recommended that the FDA undertake more intensive postmarket surveillance of medications, and Congress is considering legislation in this area. Cohen and Neumann suggest that such surveillance would likely reveal that many more drugs have serious, although relatively rare, side effects.

What’s in the issue. Cohen and Neumann’s study is one of many in the new Health Affairs issue, which was supported by an unrestricted educational grant from Johnson and Johnson, to explore risks and benefits in health care. In the May/June issue of the journal, a thematic volume titled “The Shifting Benefit-Risk Landscape,” leading thinkers grapple with questions such as who is responsible for safeguarding our health and how much responsibility rests with the individual patient, physician, caregiver, insurer, or regulatory authority.

Other risk-benefit highlights:

Gottlieb, lawmakers debate regulation of drug distribution. As a result of concerns about drug safety, the Institute of Medicine and congressional lawmakers have called on the FDA to more aggressively monitor safety over the life cycles of drugs and, when necessary, to impose restrictions on the way some medications are distributed.

Some experts say that calls for the government to more actively regulate the way drugs are prescribed are misguided. Scott Gottlieb, a resident fellow at the American Enterprise Institute and former deputy FDA commissioner for medical and scientific affairs, says that these proposals would not improve drug safety but rather would constrain medical decision making. “When it comes to improving on drug safety, our challenge is not to directly manage the way drugs are used but to seek out better tools for how they are evaluated,” he writes. Some of these tools include a better system for accumulating postmarket data on drug safety and real-time surveillance for potential drug safety issues, he says. http://content.healthaffairs.org/cgi/content/abstract/26/3/664

In a responding article, Sens. Michael Enzi (R-WY) and Edward Kennedy (D-MA) argue that the FDA should more aggressively manage drug risks. Legislation introduced by Kennedy and Enzi that Congress is considering would codify the FDA’s authority to impose restrictions on the distribution and use of a drug after it has been approved. It also would require those restrictions to be adapted to new information about the safety of the drug. Kennedy and Enzi argue that the legislation strikes the appropriate balance between managing a drug’s risk and restrictions on medical practice. “Our legislation reflects the view that when the FDA must step in to manage risk, it should do so in a way that ensures access to a drug, if that is possible,” they write. http://content.healthaffairs.org/cgi/content/abstract/26/3/678

Understanding numbers is key element of health literacy. People who cannot easily comprehend the meaning of numbers and percentages are hampered in their ability to understand complex health information and cannot competently evaluate the risks and benefits of treatments. About half the U.S. population has some difficulty deriving meaning from numbers. Those who lack numeric skills are more likely than others to make choices based on little information or on extraneous information, write Ellen Peters and Paul Slovic, senior research scientists at Decision Research in Eugene, Oregon.

“However, the way information is presented and formatted can help those with limited numeric skills,” Peters said. “This means that careful thought must be devoted not only to the content of health information but also to the format in which it is presented.” http://content.healthaffairs.org/cgi/content/abstract/26/3/741

Other issue highlights:

Uninsured face highest hospital charges; gap is widening. People who lack health insurance and those who pay for care out of their own pockets were charged an average 2.5 times more for hospital services in 2004 than what health insurers pay and three times more than Medicare-allowable costs, reports Gerard F. Anderson of the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. The gap between what uninsured and other self-pay patients are charged for hospital services and what Medicare pays has more than doubled over the past twenty years, from 1.35 in 1984 to 3.07 in 2004.

Despite their efforts, few hospitals recoup the full charge amount from patients. In 2004, for every $100 hospitals charged, they collected $39. http://content.healthaffairs.org/cgi/content/abstract/26/3/780

Physician liability costs raise Medicare spending. Findings by Katherine Baicker of the University of California, Los Angeles (UCLA) and coauthors show that when malpractice awards and premiums increase, so does Medicare physician spending, particularly for the imaging services that are often believed to be driven by physicians’ fears of malpractice suits. Using 1993-2001 state-level data, the researchers found that a 10 percent increase in average malpractice payments per physician within a state was associated with a 1.0 percent increase in total Medicare physician spending, a 2.2 percent increase in the imaging component of these services, and a small decrease in the use of major surgical procedures. They obtained similar results using malpractice premiums as an alternative measure of liability costs. http://content.healthaffairs.org/cgi/content/abstract/26/3/841

Do newer drugs really pay for themselves? Widely cited research suggesting that newer drugs “pay for themselves” is unreliable and should not guide policymakers until more valid research is undertaken, say Yuting Zhang and Stephen Soumerai of Harvard. http://content.healthaffairs.org/cgi/content/abstract/26/3/880

In Health Affairs and elsewhere, Frank Lichtenberg of Columbia University has claimed that in the aggregate, using newer medications reduces spending on other health care items, such as hospitalizations, by much more than it increases prescription drug spending. However, Zhang and Soumerai say that Lichtenberg failed to eliminate “potential selection biases, especially whether the use of a given medication precedes, is contemporaneous with, or follows nondrug health care costs in a given year.” Zhang and Soumerai say that no aggregate-level analysis of new versus old drugs can yield valid estimates of cost offsets. What is needed, they say, is rigorous research looking at how specific drugs or drug classes influence costs and outcomes for patients over time.

Lichtenberg responds in a Perspective on Zhang and Soumerai’s paper. http://content.healthaffairs.org/cgi/content/abstract/26/3/887


Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org.


©2007 Project HOPE–The People-to-People Health Foundation, Inc.