The paper evaluated two studies that involved answering questionnaires via internet invitations. The first study analyzed data for 801 women reporting at least one menopausal symptom and the second study looked at data for women who were ever users of hormone therapies. The paper raised great concern because a low number of respondents using compounded bioidentical hormone therapies answered correctly when asked if they knew that their therapies were not FDA-approved. Interestingly, the women who took manufactured hormone therapies were not asked about their knowledge of whether their therapies were FDA-approved. Therefore, one cannot determine if the women using manufactured hormone therapies would have answered the same question correctly.
Bias is of significant concern in this paper considering the source of the funding is a pharmaceutical company focused on the development and commercialization of FDA-approved hormone replacement products.
Compounded medications are not required to be approved by the FDA, nor should they be. The individualized nature of compounded medications makes it impossible to submit each customized combination to the FDA for approval. Compounding is regulated at the state level by State Boards of Pharmacy. The FDA oversees the quality of the ingredients used in compounding, and the manufacturers of these ingredients must be registered with the FDA. Prescribers are authorized to choose the therapy that best suits their patients’ needs and pharmacists, in turn, are authorized to provide these therapies.
The paper uses the data from the studies to estimate the number of women who use compounded bioidentical hormone therapies. Although many approximations were made to calculate the final estimate, one thing is clear: the number of women choosing this form of personalized medicine is considerable. Science is moving in a direction that makes more information about human individuality available for use in caring for patients. Soon we may be able to individualize most medical treatment options. Practitioners and their patients who choose customized bioidentical hormone therapies are working at the cutting edge of a healthcare revolution.
