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

January 14, 2005

Alison Rein, MS
Assistant Director, Food & Health Policy, National Consumers League

Good morning.  My name is Alison Rein, and I am the Assistant Director of Food and Health Policy at the National Consumers League.  I am here today to present some of the key findings from a research project we recently conducted to explore consumer awareness of and attitudes about cholesterol, and possible treatment options. 

I will begin my comments with a brief overview of NCL.  I will then explain our interest in this topic, describe the research methods used, and present a top-line of our findings.  Given the brevity of this presentation, I would ask that you refer to two supplemental documents for more detailed information: one is the full survey instrument (annotated with results) and the second is a set of PowerPoint slides depicting the key findings in graphic representation.  Both of these have been submitted for your review.

Overview of the National Consumers League

The National Consumers League is a private, nonprofit advocacy group that uses education, research, advocacy, investigation, publications, and public/private collaboration to accomplish its mission of representing consumer interests on marketplace and workplace issues.  Formed in 1899, we are the nation's oldest consumer advocacy organization.

For over 100 years, NCL has provided government, businesses, and other organizations with the consumer's perspective on numerous social concerns, including drug safety.  A natural extension of this mission is our recent initiation of the SOS Rx Coalition – a collaborative coalition dedicated to promoting outpatient medication safety, initially among seniors.

The NCL Perspective

To advocate on behalf of consumers requires a baseline level of appreciation about what consumers know; it is in this way that we can develop appropriate programs to advance public awareness of - and acumen about - important issues that affect their wellbeing.   It is from this perspective that NCL often embarks on consumer research. 

NCL commissioned this research effort to explore consumers’ knowledge about the significance of high cholesterol, their attitudes toward the possibility of an OTC statin, there perceptions about the relative benefits of OTC versus prescription treatments, and their perspectives on relevant safety and use issues.  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 hope only that these consumer survey data will help to inform that discussion.

Research Methods Summary

NCL engaged Harris Interactive to conduct this survey with members of the Harris Poll Online Panel, which consists of several million people who have agreed to participate in survey research projects.  Interviews were conducted between August 26 and September 3, 2004.  A total of 2,777 people participated in the survey, 730 of whom were qualified to complete it.  The sample was composed of US residents, aged 35 or older, who were either at known moderate risk for coronary heart disease (CHD) or were at potential moderate risk for CHD based on specified risk criteria.  None of the survey participants were using medical management to treat their cholesterol.

We over sampled Black and Hispanic respondents, and used demographic and propensity weighting techniques to ensure that the data represented the national population of adults aged 35 and older.  Near the beginning of the survey, respondents were asked to consider a full 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

1. American adults still require substantial education about elevated cholesterol and its associated risks.
   1. Almost 40% of all respondents did not know their cholesterol level and,
   2. Almost 30% indicated that they were not concerned about their cholesterol.

                             i.      This lack of concern was more common (50%) among respondents who – despite the presence of multiple risk factors for CHD – did not have confirmed elevated cholesterol.

2. There is interest among consumers in an OTC option for lowering cholesterol.
   1. The majority of respondents indicated that they would be at least somewhat likely to seek out more information on the product (67%), discuss the product with a healthcare professional (69%), and use the product (58%).
   2. The majority of respondents (85%) also agree (strongly or somewhat) that the OTC statin option would be preferable to taking a prescription drug to lower cholesterol.
       

3. While most believe at least somewhat in the effectiveness of the OTC statin, there are concerns about safety.
   1. The large majority (over 90%) believe that the OTC product would be at least somewhat effective.
   2. Almost half do not think that the OTC statin would be more effective at lowering cholesterol than diet or exercise alone. 
   3. Over two-thirds are at least somewhat concerned about the potential side effects of a cholesterol-lowering OTC. 
   4. Almost one-third do not think that the benefit of a cholesterol-lowering OTC outweighs the risk. 
       

4. The OTC statin option is most strongly associated with concepts of prevention and control of health.
   1. It is also perceived as most appropriate for someone with attributes such as:

                             i.      Being interested in preventing heart disease

                             ii.      Taking charge of his/her health

                             iii.      Having an active lifestyle

2. It is less associated with concepts of dependence on caretakers and poor health.
3. However, 56% of respondents indicate that the OTC statin would be appropriate for someone whose heart health needs consistent physician monitoring.  This suggests a real need for education about who should, and should not, be taking an OTC to lower their cholesterol.
    

5. Compared to a prescription option, the OTC statin is seen as more convenient, more natural, less likely to cause side effects, and more appropriate for “someone with my health care needs.”
   1. The prescription option is generally seen as more effective, more reliable, more trust worthy, and more suitable for someone in poor health.
   2. The OTC option is generally seen as easier to buy at a store where they shop, easier to keep taking every day, more natural, and less likely to cause side effects.
       

6. Respondents expressed a greater likelihood to consider taking, recommend to a friend or family member, and seek more information about an OTC statin relative to a prescription statin option.

There is far more detailed information available in the other documents we have submitted, so I would encourage you to review them should you want to learn more about the study inclusion criteria and findings.  Thank you for your consideration of this information.