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, arterial wall thickness. The findings pitted raising good cholesterol against lowering bad cholesterol, and found that raising good cholesterol was better.

Over the course of the 14-month study, the bad cholesterol of the patients on Zetia decreased by 19.2 percent, but the patients’ arterial wall thickness stayed the same, the study said. In the niacin group, good cholesterol increased by 18.4 percent and the carotid wall thickness decreased.

But the use of arterial wall thickness 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.

Zetia, he said, lowers bad cholesterol and lowering bad cholesterol is a known good. The study results “should be compared to the overwhelming body of evidence that lowering LDL cholesterol is an important thing to do to improve cardiovascular health,” Dr. Kim said.