TV Ads For Statins Lead To Overdiagnosis And Overprescribing: Study
Do television ads for cholesterol-lowering pills cause overprescribing? The debate over widespread advertising of prescription medicines is hardly new, but some say the issue remains unresolved. Proponents maintain direct-to-consumer advertising informs people who may not be aware of health risks, while critics argue ads prompt some patients to seek medicines unnecessarily.
And statins, of course, have been among the most widely advertised treatments for more than a decade. A new study, however, suggests there is, indeed, an unwanted side effect. Adults who were exposed to such ads were 16 percent to 20 percent more likely to be diagnosed with high cholesterol and 16 percent to 22 percent more likely to be using a statin.
Here is another wrinkle: the likelihood of having such a diagnosis and increased use of cholesterol-lowering pill was driven almost exclusively by men and women who were at low risk for having a cardiac event. Meanwhile, those at a high risk of heart disease and exposed to TV ads for stains were not more likely to be taking one of the pills.
“This study provides no evidence of favorable associations between direct-to-consumer advertising exposure and statin use among those at high risk for future cardiac events. The results raise questions about the extent to which DTC ads may promote over-diagnosis and over-treatment for populations where risks (of statin use) may outweigh potential benefits,” the authors conclude (here is the abstract).
The study, which was published in the Journal of General Internal Medicine, reviewed how often 106,685 American adults viewed DTC ads for statins between 2001 and 2007 on national, cable and local television stations. The researchers also gathered data on whether adults reported being diagnosed with high cholesterol, whether they had taken a statin within the previous and their risk for heart disease.
Risk level was a strong predictor of both high cholesterol diagnosis and statin use. Overall, the odds of a high cholesterol diagnoses were 20 percent higher for men exposed to 75 to 150 statin ads and 16 percent higher for men who exposed to 150 or more ads than those with low ad exposure. The associations were driven by men at comparatively low risk for future cardiac events, the study states.
The pattern of results for statin use was very similar. The odds of using a statin were higher for men exposed to 75 to 150 ads and 150 or more ads – 21 percent and 22 percent, respectively – than those with low exposure to ads. The associations were also driven by men at low risk of developing cardiac disease in the future.
Among women, risk level was also a strong predictor of high cholesterol and statin use. The odds of a diagnosis of high cholesterol were 17 percent higher for women exposed to 40 to 74 statin ads and 20 percent higher for women exposed to either 75 to 149 ads or 150-plus ads. Again, these associations were driven by low risk.
And DTC exposure was associated with greater statin use among women overall, but predominantly those at low and moderate risk heart disease. But there were lower odds of statin use among women at a high risk, the study noted. This is ironic because the high risk group would presumably include those with the most to gain from statin use.
In any event, the authors are quite clear that their findings bolster earlier studies suggesting that DTC ads are not necessarily beneficial. To what extent this will matter for the brand-name cholesterol category is unclear now that the Lipitor pill sold by Pfizer (PFE) faces lower-cost generic competition. But the results clearly suggest the wider issue of DTC ads, in general, will remain a subject of heated debate.
Not surprisingly, some experts are taking exception to the findings. “The fact that advertising led to more diagnosis should not be a cause for concern,” writes Bob Ehrlich of DTC Perspectives, an industry consulting firm, in his blog. He adds that the over-prescribing conclusion is a “stretch,” and the fact that 20 percent more people responded to the DTC statins ads is further proof that such advertising works.
“We do not know who will get the heart attack so we treat the many to prevent a few heart attacks… This is an issue with all prevention efforts. Society makes an economic and risk/reward decision on all such preventive care. DTC may raise the number treated and in fact that is the goal of advertisers. We rely, however, on the physician community to decide the risk/benefit of such a preventive medicine.”
In defense of the study, Jeff Niederdeppe, the lead co-author and assistant professor in the Department of Communication at Cornell University, writes this to us: "We did not measure physician behavior, only self-reports of cholesterol screening and statin use. We also do not have a full picture of each person’s medical history, or the results of their cholesterol screening tests, so we cannot say whether or not those who were prescribed statins are 'over prescribed per se. [EDITOR'S NOTE: The paper uses the word 'overtreatment,' however].
"The study’s design also precludes us from making strong causal claims, since it is impossible to randomly assign people to receive DTCA or not in real-world settings. At the same time, there are significant risks to statin use among those without a history of cardiac events. There is also other research suggesting that requests for DTC advertised drugs lead to prescriptions more often than not."
"Certainly, we shouldn’t be surprised that exposure to DTC ads is associated with increased use of those pharmaceuticals – companies wouldn’t advertise them to consumers in this way if they weren’t trying to increase sales. My question is whether or not, on balance, from a public health perspective the good outweighs the bad, or vice versa. Our study looks only at cholesterol screening and statin use, issues for which there is some degree of scientific/medical debate about the degree to which subscribing is appropriate. On balance, our results suggest that effects were not isolated to those at high risk of future cardiac events, which suggests that these ads are reaching and resonating with a broader market."
STORY ENDS HERE
And statins, of course, have been among the most widely advertised treatments for more than a decade. A new study, however, suggests there is, indeed, an unwanted side effect. Adults who were exposed to such ads were 16 percent to 20 percent more likely to be diagnosed with high cholesterol and 16 percent to 22 percent more likely to be using a statin.
Here is another wrinkle: the likelihood of having such a diagnosis and increased use of cholesterol-lowering pill was driven almost exclusively by men and women who were at low risk for having a cardiac event. Meanwhile, those at a high risk of heart disease and exposed to TV ads for stains were not more likely to be taking one of the pills.
“This study provides no evidence of favorable associations between direct-to-consumer advertising exposure and statin use among those at high risk for future cardiac events. The results raise questions about the extent to which DTC ads may promote over-diagnosis and over-treatment for populations where risks (of statin use) may outweigh potential benefits,” the authors conclude (here is the abstract).
The study, which was published in the Journal of General Internal Medicine, reviewed how often 106,685 American adults viewed DTC ads for statins between 2001 and 2007 on national, cable and local television stations. The researchers also gathered data on whether adults reported being diagnosed with high cholesterol, whether they had taken a statin within the previous and their risk for heart disease.
Risk level was a strong predictor of both high cholesterol diagnosis and statin use. Overall, the odds of a high cholesterol diagnoses were 20 percent higher for men exposed to 75 to 150 statin ads and 16 percent higher for men who exposed to 150 or more ads than those with low ad exposure. The associations were driven by men at comparatively low risk for future cardiac events, the study states.
The pattern of results for statin use was very similar. The odds of using a statin were higher for men exposed to 75 to 150 ads and 150 or more ads – 21 percent and 22 percent, respectively – than those with low exposure to ads. The associations were also driven by men at low risk of developing cardiac disease in the future.
Among women, risk level was also a strong predictor of high cholesterol and statin use. The odds of a diagnosis of high cholesterol were 17 percent higher for women exposed to 40 to 74 statin ads and 20 percent higher for women exposed to either 75 to 149 ads or 150-plus ads. Again, these associations were driven by low risk.
And DTC exposure was associated with greater statin use among women overall, but predominantly those at low and moderate risk heart disease. But there were lower odds of statin use among women at a high risk, the study noted. This is ironic because the high risk group would presumably include those with the most to gain from statin use.
In any event, the authors are quite clear that their findings bolster earlier studies suggesting that DTC ads are not necessarily beneficial. To what extent this will matter for the brand-name cholesterol category is unclear now that the Lipitor pill sold by Pfizer (PFE) faces lower-cost generic competition. But the results clearly suggest the wider issue of DTC ads, in general, will remain a subject of heated debate.
Not surprisingly, some experts are taking exception to the findings. “The fact that advertising led to more diagnosis should not be a cause for concern,” writes Bob Ehrlich of DTC Perspectives, an industry consulting firm, in his blog. He adds that the over-prescribing conclusion is a “stretch,” and the fact that 20 percent more people responded to the DTC statins ads is further proof that such advertising works.
“We do not know who will get the heart attack so we treat the many to prevent a few heart attacks… This is an issue with all prevention efforts. Society makes an economic and risk/reward decision on all such preventive care. DTC may raise the number treated and in fact that is the goal of advertisers. We rely, however, on the physician community to decide the risk/benefit of such a preventive medicine.”
In defense of the study, Jeff Niederdeppe, the lead co-author and assistant professor in the Department of Communication at Cornell University, writes this to us: "We did not measure physician behavior, only self-reports of cholesterol screening and statin use. We also do not have a full picture of each person’s medical history, or the results of their cholesterol screening tests, so we cannot say whether or not those who were prescribed statins are 'over prescribed per se. [EDITOR'S NOTE: The paper uses the word 'overtreatment,' however].
"The study’s design also precludes us from making strong causal claims, since it is impossible to randomly assign people to receive DTCA or not in real-world settings. At the same time, there are significant risks to statin use among those without a history of cardiac events. There is also other research suggesting that requests for DTC advertised drugs lead to prescriptions more often than not."
"Certainly, we shouldn’t be surprised that exposure to DTC ads is associated with increased use of those pharmaceuticals – companies wouldn’t advertise them to consumers in this way if they weren’t trying to increase sales. My question is whether or not, on balance, from a public health perspective the good outweighs the bad, or vice versa. Our study looks only at cholesterol screening and statin use, issues for which there is some degree of scientific/medical debate about the degree to which subscribing is appropriate. On balance, our results suggest that effects were not isolated to those at high risk of future cardiac events, which suggests that these ads are reaching and resonating with a broader market."
STORY ENDS HERE
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