American boomers are bombarded with the message that high levels of bad cholesterol lead to an early grave.
Statins, cholesterol-lowering medications, are thought to be so essential that, according to the official government guidelines from the National Cholesterol Education Program (NCEP), 40 million Americans should be taking them.
One dirty little secret of modern medicine is that many drugs work only in a minority of people. Many drugs are most effective in relatively small subgroups of sufferers. With statins, these are the patients who already have heart disease. But that's not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller. "What the shrewd marketing people at Pfizer and the other companies did was spin it to make everyone with high cholesterol think they really need to reduce it," says Dr. Bryan A. Liang, director of the Institute of Health Law Studies at the California Western School of Law and co-director of the San Diego Center for Patient Safety. "There's a tendency to assume drugs work really well, but people would be surprised by the actual magnitude of the benefits," says Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles.
A current TV and newspaper campaign by Pfizer stars artificial heart inventor and Lipitor user Dr. Robert Jarvik. The printed ad proclaims that "Lipitor reduces the risk of heart attack by 36%...in patients with multiple risk factors for heart disease."
So, how can anyone question the benefits of such a drug?
A crucial point is hiding in plain sight in Pfizer's own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says, "That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor." Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit.
Most important, the statin trials of people without existing heart disease showed no reduction in deaths or serious health events, despite the small drop in heart attacks. "We should tell patients that the reduced cardiovascular risk will be replaced by other serious illnesses," says Dr. John Abramson, clinical instructor at Harvard Medical School and author of Overdosed America.
What would work better? Perhaps, urging people to switch to a Mediterranean diet or simply to eat more fish. In several studies, both lifestyle changes brought greater declines in heart attacks than statins, though the trials were too small to be completely persuasive. Being physically fit is also important. "The things that really work are lifestyle, exercise, diet and weight reduction," says UCLA's Hoffman.
"It's almost impossible to find someone who believes strongly in statins who does not get a lot of money from industry," says Dr. Rodney A. Hayward, professor of internal medicine at the University of Michigan Medical School.
Add it all together, and "current evidence supports ignoring LDL cholesterol altogether," says the University of Michigan's Hayward.
Source: BusinessWeek, January 28, 2008