Some wary of BWH fueled expansion of heart drug market

The trend toward giving drugs to healthy people deemed at risk for disease continues. 

This troubles some, who think the risk reduction is not always worth a lifetime of possibly dangerous side effects.  Others see is as a way to use science not just to treat disease, but to prevent it.

So, one doctor’s prevention is another’s “disease mongering.” 

 Much of the debate centers on how to define risk, as is the case here. 

The FDA is about to approve statins for people without high cholesterol — based on research from BWH.   Duff Wilson explains in a recent story in The New York Times.

With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.

Some medical experts question whether this is a healthy move.

They point to mounting concern that cholesterol medications — known as statins and already the most widely prescribed drugs in the United States — may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes.

Maggie Mahar at The Health Beat Blog saw the lead this way:

It is such a rare pleasure to run into intentional understatement in the mainstream media.  Kudos to NYT reporter Duff Wilson for not only recognizing irony, but managing to incorporate it into the lead of a NYT story.

The article goes on to point out that cholesterol-lowering drugs, known as statins, “may not be as safe as doctors previously thought.”  Meanwhile, the benefits for healthy patients are . . .  well, “slim to none” is the phrase that comes to my mind. 

Health  journalist (and former Globe writer) Alison Bass gives Wilson a laurel for explaining why that sounds so much worse than what suppoerters say; i I comes down to the difference elative risk and absolute risk.   

Relative risk is the statistical difference in outcome between a control group and a group taking an active drug in a study, whereas absolute risk is the actual number of people who might actually benefit from the drug. Most randomized clinical trials only report relative risk, which often inflates the benefits of the drug being studied.

 

 Back to Wilson’s explanation of the drug’s 50 percent reduction in heart attack risk:

 The rate of heart attacks, for example, was 0.37 percent, or 68 patients out of 8,901 who took a sugar pill. Among the Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between the two groups translates to only 0.2 percentage points in absolute terms — or 2 people out of 1,000.

Stated another way, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack. Stroke numbers were similar.

“That’s statistically significant but not clinically significant,” said Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y., who is one of many practicing cardiologists closely following the issue.

The Globe has been following this story as it developed over the years.

Jan 09  Report on protein test to predict heart attack sounds cautious note

Nov. 08  Statins cut risk of stroke, heart attack in study

Jan. 05  Financial ties raise questions about heart studies

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