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Bitter Pill Awards 2006:The "Got Cholesterol?" Award: For Overpromoting Expensive Brand-Name Statins
<Bitter Pill Awards
Winners: Lipitor (Pfizer) and Crestor (Astra Zeneca)
Statins for treating high cholesterol are the best selling drugs in the U.S. , with over $16 billion in 2005 sales. They are also one of the most competitive classes of drugs, with seven drugs competing for more than 140 million annual prescriptions in the U.S. The enormous potential market for these drugs, which patients take (and pay for) for years, has caused our award winners to significantly overpromote their drugs.
The most expensive brand-name statins are important primarily for people who already have heart disease or who are at serious risk of developing heart disease (smokers, people who are obese, diabetics). Yet millions of people who have only elevated cholesterol are taking these expensive brand-name statins drugs every day, often at great expense.
The marketing campaigns for Lipitor and Crestor have created the impression that anyone and everyone with even slightly high cholesterol needs them. This marketing gives short shrift to the much cheaper but effective generic statins, as well as to lifestyle changes, such as better diet and more exercise, that should be the first line of treatment for millions of people who have high cholesterol but no other major risk factors.
Like most so-called "me-too" drugs, there are no significant advantages for most patients from taking one statin over another. A meta-analysis of clinical trials of three different statins - Pravachol, Zocor and Lipitor - found that all three had similar cholesterol-lowering results, and that there was no statistically significant difference in their reduction in fatal coronary heart disease or nonfatal heart attacks. The FDA just approved a generic version of Pravachol, and a generic version of Zocor is expected to become available later this year.
Rather than focusing on the genuinely at-risk patients who really do need these particular statins, Pfizer and AstraZeneca have engaged in enormously broad promotional campaigns that have made Lipitor the bestselling statin in the U.S. and Crestor the 4 th bestselling. Meanwhile, many patients who would genuinely benefit from them are not taking them, in part because of their high cost.
Consumer Reports Best Buy Drugs recommends a generic statin, lovastatin, for patients who need to reduce their "bad" LDL cholesterol by less than 30%. Yet millions of people for whom this generic would work fine are taking Lipitor and Crestor, due to the aggressive marketing campaigns. Statins vary widely in price, from about $33 a month for generics (about $1 a day) to $162 a month for the highest-priced brand-names ($5.33 a day). The additional cost of a high-price brand-name statin adds up and can be a significant burden, particularly for low-income people and seniors on fixed incomes.
Pfizer recently launched an aggressive new ad campaign for Lipitor featuring Dr. Robert Jarvik, creator of the artificial heart. The new ad, like virtually all drug ads, does not distinguish between those who need Lipitor and those would do fine on a cheaper generic.
This type of marketing is an excellent example of what's wrong with DTCA. It is far more profitable for drug companies to sell expensive drugs to a large group of people, whether they need the drugs or not, than to sell them only to those who really need them and be satisfied with merely high profits rather than obscene profits. At the very least, Pfizer and AstraZeneca have a scientific responsibility to research whether these drugs are truly effective for the millions of people who take them who don't already have heart disease, diabetes or other risk factors. For instance, additional studies should be done on women and seniors with high cholesterol but no history of heart disease or diabetes in order to draw better conclusions about the effectiveness of statins for these patients.
Finally, Crestor deserves special mention for conduct that earned it two warning letters from the FDA. The first was in late 2004, for downplaying rare but very serious muscle conditions associated with Crestor. In fact, the consumer group Public Citizen has been calling since 2004 for Crestor to be pulled from the market because of higher risks of kidney failure and muscle damage. The second warning letter was in 2005 for misleadingly claiming that Crestor is more effective than other statins in a television ad when there was no medical evidence that that claim was true.
PROFILE: LIPITOR (PFIZER)
Brand Name : Lipitor