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Are consumers ready for an OTC statin cholesterol drug?

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NCL recently presented the Food and Drug Administration with a sampling of key findings from research conducted to explore consumer perceptions and attitudes about an over-the-counter cholesterol-lowering drug as an option for those with moderately high cholesterol.

Testimony Regarding Consumer Data Relevant to the Proposed Use of MEVACOR OTC

Joint Meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee

December 13, 2007

Ria Eapen, MPH, Health Policy Program Associate, National Consumers League

Read the formal comments submitted to the FDA by NCL's Sally Greenberg, January 18, 2008

Good afternoon. My name is Ria Eapen, and I am from the National Consumers League (NCL). Today I will be presenting some of the key findings from research we recently conducted to explore consumer perceptions and attitudes about an over-the-counter cholesterol-lowering drug as an option for those with moderately high cholesterol.

Given the time constraints of this presentation, please refer to the two supplemental documents that have been submitted for additional information.

NCL is a private, nonprofit advocacy group that uses education, research, advocacy, and public/private collaboration to accomplish its mission of representing consumer interests on marketplace and workplace issues. While my presence at this meeting is independent of the sponsor; NCL does receive funding from a variety of sources, including government grants and pharmaceutical companies. For more than a century, NCL has provided government, businesses, and other organizations with the consumer's perspective on numerous social concerns, including drug safety.

NCL commissioned this study, as a follow-up to a similar study conducted in 2004, to explore consumers’ attitudes toward the possibility of an OTC statin and the relative benefits of OTC versus prescription treatments. In exploring this topic, NCL is not lending support to the approval of an OTC statin; we look to the FDA to consider all of the clinical and consumer use data, and offer these consumer survey data to help to inform that discussion.

To achieve our research goals, NCL commissioned Harris Interactive to conduct a national online survey between October 25 and November 5, 2007. Included in the survey were 710 U.S. residents, aged 35 and older, who were at known moderate risk for developing high cholesterol (180-240 mg/dL). None of the survey respondents were using medical management to treat their cholesterol. African Americans and Hispanics were oversampled, and results were weighted as needed.

Near the beginning of the survey, respondents were asked to read a description of the proposed OTC statin product. In OTC/Rx comparison sections of the survey, respondents were instructed to consider a “similar low-dose cholesterol-lowering medication that is available only by prescription from a doctor.

Key Findings

  • Overall, the survey data indicate that people are interested in an OTC statin option.
    • Eighty-two percent responded that an OTC statin would be preferable to an Rx statin.
    • And respondents reported being much more likely (64% to 36 %) to discuss the OTC product than the Rx product with their doctor.
  • Since 2004, there has been a decrease in the percentage of people who are most likely to use the OTC stain after reading a description of the product. This number dropped from 20 percent in 2004 to 11 percent in 2007.
    • African Americans report the lowest likelihood of using an OTC statin compared with white and Hispanic respondents.
    • And women are less likely than men to report that they are very or extremely likely to use an OTC statin.
  • Survey respondents most inclined to use the OTC statin include those with greater levels of concern about cholesterol, those with higher known cholesterol levels, and those who take vitamins or supplements daily.
    • 98% of those who reported being most concerned about their cholesterol said that the OTC product would be appropriate for someone with health care needs much like their own.
    • And 94% reported that the OTC product would be appropriate for someone who takes charge of his or her health.
  • Those who say they are more likely to consider taking the OTC product than an Rx product report that the OTC is more appealing largely because of convenience factors.
    • OTC statins are viewed as safer, more natural, more suitable for someone who takes charge of his or her health, and less likely to cause side effects than Rx statins.
    • Those who prefer the Rx option have a greater trust in the product and the fact that a doctor prescribed it. The Rx version is viewed as more effective, more reliable, more trustworthy, and more suitable for someone in poor health than is an OTC statin.
  • Since 2004, respondents reported being more health conscious, less concerned about cholesterol, and less comfortable relying on medications to handle health concerns.

 

To learn more about the findings from the survey, please review the supplemental documents we have submitted. Thank you for your time and consideration of this information.