News in brief - May 15, 2006

Statin drugs going generic - Research trial benefits: Public health gains and lower health care costs - GAO calls for expansion of FDA's postmarketing authority - Study: Wait to take blood pressure

Statin drugs going generic

A generic version of Pravachol, or pravastatin sodium, one of the top-selling cholesterol-lowering drugs, was approved by the Food and Drug Administration April 24. Pravachol lost patent protection April 20. Similar action is expected next month for another top seller, Zocor, or simvastatin, when that drug goes off-patent.

Pravastatin, manufactured in 10 mg, 20 mg and 40 mg, is one of several popular cholesterol-lowering medications. In 2005, Pravachol was the 22nd highest-selling brand-name drug in the United States, with sales totaling $1.3 billion. Insurers already are asking physicians to begin to switch patients from brand name to lower-price generic statins.

said Christie Ballantyne, MD, director of Baylor Medical College's Center for Cardiovascular Disease Prevention -- a not unusual occurrence with a change to any generic medication.

Physicians whose patients have been prescribed brand-name statins for many years are likely to find varying efficacy rates among the brands making it necessary to recheck liver functions and step up monitoring for muscle pain, at least initially, he noted.

It is likely that generic statins will save patients as well as the health care system a great deal of money, Dr. Ballantyne noted. An analysis by Consumers Union indicated that if Medicare Part D beneficiaries alone were prescribed effective generic statins instead of brand-name medications, the savings could mount to $8.2 billion next year.

Pricing information for the new generic pravastatin was expected shortly.

Research trial benefits: Public health gains and lower health care costs

A systematic evaluation of whether government investment in medical research yields gains in public health has found that new discoveries have been responsible for about 70,000 additional healthy years of life for the population.

The findings were reported in the April 22 issue of The Lancet.

The evaluation, sponsored by the National Institute of Neurological Disorders and Stroke, estimated the economic benefit to the United States from eight phase III trials exceeded $15 billion over the course of 10 years. Among the eight trials was one of tissue plasminogen activator for ischemic stroke that showed the tPA could prevent brain damage if used within the first three hours after a stroke begins.

The study is thought to be one of the first to analyze the impact of a publicly funded research program on medical care, public health and health care costs.

The investigators evaluated the costs and public health benefits of all 28 phase III trials that were conducted between 1977 and 2000. The total cost of funding the trials was $335 million. Information on the utilization of the tested therapies and their impact on societal costs and savings or quality of life was available for eight of the trials.

GAO calls for expansion of FDA's postmarketing authority

The Food and Drug Administration's system for monitoring drug safety after approval is inadequate, according to a report issued last month by the Government Accountability Office. In addition, the report concluded that the steps the agency has taken to improve it will not be able to address all of its failings and that Congress should consider expanding the agency's authority to require drug companies to complete postmarketing studies.

The GAO initiated its review of the FDA's postmarketing drug safety system in the wake of several high-profile drug-safety cases that raised concerns about the agency's ability to monitor and regulate medications after they hit the market. The agency has taken several steps to address this issue, including establishing a Drug Safety Oversight Board, increasing communication between its Office of New Drugs and the Office of Drug Safety, and working to identify new ways to detect safety problems. The GAO, however, did not find that these efforts went far enough and called for legislative action to expand the agency's regulatory ability.

The FDA responded that the GAO conclusions were reasonable.

Study: Wait to take blood pressure

A patient's blood pressure is lower when taken after he or she has been waiting for a few minutes in a chair with their feet on the floor than if it is taken upon his or her immediate arrival to an exam room while sitting on an examination table with feet dangling, according to a study presented at the Preventive Cardiovascular Nurses Assn. meeting in Denver last month.

Researchers at the University of Virginia Health System in Charlottesville took two blood pressure readings for 100 patients who presented to an ambulatory cardiology clinic. Those who had their blood pressure initially measured while they were sitting in a chair, which is in line with American Heart Assn. guidelines, had a five-point increase in their systolic when it was later taken while they were sitting on the exam table. Those who had their blood pressure measured initially while sitting on the exam table had a average of a 14-point decrease in the systolic when it was taken while they were in a chair. The difference in the diastolic was not statistically significant.

The authors suggest that greater efforts be made to ensure that a patient is in a relaxed comfortable position before blood pressure is taken. "All too often, this doesn't happen," said Melly Turner, RN, lead author and a staff nurse at the university.