Chance News 58

The value of negative data

Little Benefit Seen, So Far, in Electronic Patient Records, Steve Lohr, The New York Times, November 15, 2009.

Study Raises Questions About Cholesterol Drug’s Benefit, Natasha Singer, The New York Times, November 15, 2009.

Seeking a Shorter Path to New Drugs, Steve Lohr, The New York Times, November 15, 2009.

Negative data, data that disproves a commonly held belief about the superiority of a particular medical treatment, is especially valuable from an economic perspective, but doesn't get the respect it deserves.

Providing high tech electronic health records should lead to better care, but apparently it doesn't.

The nation is set to begin an ambitious program, backed by $19 billion in government incentives, to accelerate the adoption of computerized patient records in doctors’ offices and hospitals, replacing ink and paper. There is wide agreement that the conversion will bring better care and lower costs, saving the American health care system up to $100 billion a year by some estimates. But a new study comparing 3,000 hospitals at various stages in the adoption of computerized health records has found little difference in the cost and quality of care.

Previous studies had used a selected subset of health care practices.

The study is an unusual effort to measure the impact of electronic health records nationally. Most of the evidence for gains from the technology, Dr. Jha said, has come from looking at an elite group of large, high-performing health providers that have spent years adapting their practices to the technology. The group usually includes Kaiser Permanente, the Mayo Clinic, the Cleveland Clinic and Intermountain Healthcare, among others.

In another study, an expensive cholesterol lowering drug was found to perform less well than a simple inexpensive alternative.

For patients taking a statin to control high cholesterol, adding an old standby drug, niacin, was superior in reducing buildup in the carotid artery to adding Zetia, a newer drug that reduces bad cholesterol, according to a new study. The results of the study, published in The New England Journal of Medicine, were presented here Sunday night at an annual meeting of the American Heart Association.

This is a rare study that compares two active treatments head-to-head. While comparing two drugs head-to-head seems like a more relevant comparison than comparing a drug to placebo, the lack of a placebo group was a point of criticism.

Dr. Peter S. Kim, the president of Merck Research Laboratories, said Sunday in an interview that the study was limited because it did not compare the groups of patients taking a statin and a second drug to a placebo group.

The study was small (208 patients) and used a surrogate outcome that also led to criticism.

Furthermore, [Dr. Kim] said, a drug’s ability to improve artery-wall thickness has not been proved to automatically correlate with a reduction in heart attacks.

The efficacy of Zetia has also been established on the basis of a surrogate outcome, reduction in levels of bad cholesterol.