STUDY QUESTIONS USE OF STATINS FOR THOSE WITHOUT HEART DISEASE

JOHN ABRAMSON, MD, HARVARD MEDICAL SCHOOL, AND JAMES WRIGHT, MD, BRITISH COLUMBIA, LANCET - The last major revision of the US guidelines, in 2001, increased the number of Americans for whom statins are recommended from 13 million to 36 million, most of whom do not yet have but are estimated to be at moderately elevated risk of developing coronary heart disease. In support of statin therapy for the primary prevention of this disease in women and people aged over 65 years, the guidelines cite seven and nine randomized trials, respectively. Yet not one of the studies provides such evidence.

For adults aged between 30 and 80 years old who already have occlusive vascular disease, statins confer a total and cardiovascular mortality benefit and are not controversial. The controversy involves this question: which people without evident occlusive vascular disease should be offered statins? With about three quarters of those taking statins in this category, the answer has huge economic and health implications. . .

We have pooled the data from all eight randomized trials that compared statins with placebo in primary prevention populations at increased risk. . . Total mortality was not reduced by statins . . .The frequency of cardiovascular events, a less encompassing outcome, was reduced by statins. However, the absolute risk reduction of 1.5% is small and means that 67 people have to be treated for 5 years to prevent one such event. Further analysis revealed that the benefit might be limited to high-risk men aged 30-69 years. Statins did not reduce total coronary heart disease events in 10,990 women in these primary prevention trials. Similarly, in 3,239 men and women older than 69 years, statins did not reduce total cardiovascular events.

Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30-69 years should be advised that about 50 patients need to be treated for 5 years to prevent one event. In our experience, many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall health.

ALEX BERENSON, NY TIMES - Stepping up government investigations into Eli Lilly's marketing of its best-selling drug Zyprexa, state prosecutors in Illinois and Vermont have demanded that the company turn over information about the way it promoted the medication. . . The orders are the civil equivalents of criminal subpoenas, according to Deborah Hagan, the chief of the Illinois consumer protection division.

Illinois and Vermont are now part of a coordinated five-state civil investigation into the way Lilly promoted Zyprexa, a treatment for schizophrenia and bipolar disorder. The states are investigating whether Lilly tried to hide Zyprexa’s risk of causing weight gain and other risks associated with diabetes and whether the company promoted Zyprexa for use in patients who do not have schizophrenia or bipolar disorder. Federal laws prohibit such so-called "off label" marketing, although doctors may prescribe any drug for any disease that they believe the drug will help.

JOHN RUSSELL, INDIANAPOLIS STAR - Drug companies, including Indianapolis-based Eli Lilly and Co., spend lavishly to advertise drugs for insomnia, migraine headaches, dry eye, brow furrow, fungus, high cholesterol, irritable bowels, arthritis and dozens of other maladies. But the huge advertising tide, worth about $4 billion a year, might be turning as a chorus of critics accuse the drug companies of using the ads to bring consumer pressure on doctors to prescribe unnecessary and costly drugs. The industry trade association, Pharmaceutical Research and Manufacturers of America, defends the practice, saying it helps inform consumers and starts "important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated."

But congressional Democrats who have criticized the growing ad campaigns are now in power. Although no bill has been introduced to curb drug advertising, many observers expect it to happen. . .

Drug company spending on direct-to-consumer advertising has increased twice as fast as spending on promotions to physicians or on research and development from 1997 to 2005.