JRM Editorial

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Volume 54	August 2009	Number 8

A Note from the Editor-in-Chief
Lawrence D. Devoe, M.D.

Welcome to the August 2009 Editor-in-Chief’s page. In this issue, I will focus on 2 articles relevant to the assisted reproductive technologies. These summaries will be accompanied by my overall commentary.

In This Issue:

Consumer Concerns for Those Seeking Reproductive Assistance?

Over-the-Counter Ovulation Prediction Devices: Do Accompanying Instructions Adhere to Low-Literacy Guidelines?

V. J. Homewood, N. B. Zite, L. S. Wallace

Ovulation prediction devices (OPDs) have moved from the laboratory to the pharmacy, where they can be purchased by patients as over-the-counter products. The authors evaluated 6 such products, with specific focus on the intelligibility and user-friendliness of their accompanying instructional materials. While these OPDs varied in their ratings for these criteria, all were found to need improvement in their format and reading comprehension levels to meet the FDA-recommended sixth-grade reading levels for most medical products. This thoughtful analysis also provides specific areas for improvement of the instructional materials and concludes that most of these manuals supplied with the OPDs would require a modest amount of revision to ensure enhanced usefulness for potential users.
Proteomic Analyses of Recombinant Human Follicle-Stimulating Hormone and Urinary-
Derived Gonadotropin Preparations
Y. Kuwabara, K. Mine, A. Katayama, T. Inagawa, S. Akira, T. Takeshita

Commercial use of gonadotropin preparations to enhance ovulation has a long history in infertility practice. Originally, human menopausal gonadotropins (hMGs) and follicle-stimulating hormone (FSH) were derived from the urine of postmenopausal women. More recently, FSH has been synthesized using recombinant techniques (rFSH), freeing the source of this hormone from traditional biologic sources. Kuwabara and colleagues address an important and possibly an understudied aspect of these hormonal preparations—that of biochemical purity. Using proteomic analyses, they assayed the more traditional preparations, hMG and highly purified urinary FSH (uFSH-HP) as well as the newer rFSH. These analyses yield an assortment of protein impurities in hMG and a variety of alpha-subunit isohormones in the FSH preparations. The importance of these findings suggest that urine-derived sources of gonadotropins may have protein-associated impurities that include prion proteins which are not found in the more highly purified or recombinant products. While in the latter case, the relative quantities of isohormones may affect their potency, the presence of prion proteins may be important for patient health reasons.

Editor's Commentary: While many medical practices are affected by commercial concerns, assisted reproduction has been impacted significantly both by the availability of products that are available directly to patients without prescription as well as by those that must be prescribed. Homewood and co-authors have provided a potentially valuable service to the industry of home ovulation prediction kits. A recent Google search showed over 300,000 listings for online reviews of these products by consumers. This is as good an indication as any that OPDs are a big business in spite of the shortcomings in the accompanying instruction manuals. What we do not know is whether the higher-than-recommended reading comprehension level of OPD instructions creates a significant problem for most consumers who purchase these kits. It is also uncertain whether this leads to misuse of these products since such information is also lacking. Most important, would there be harm caused to the consumer from product misuse due to failure to understand OPD instructions? While this may not be the case for those attempting pregnancy, although mistiming ovulation could delay the desired result of pregnancy, it might be the case for those using OPDs as an adjunct to natural family planning. In either situation, a good argument could be made for improving product literature.

Is it time for reproductive specialists to move away from traditional gonadotropin sources and toward recombinant formulations? Pursuant to their findings, Kuwabara et al make a potential argument for reconsideration of this practice. While this study did not address product efficacy, it did raise the product safety issue associated with finding of prion proteins in the urinary hMG preparation. The specter of Creutzfeldt-Jakob disease, a prion-based neurologic disorder, also known as “mad cow” disease, led to the banning of beef from countries such as the United Kingdom, where it was detected in herds. This has a human analog as the United Kingdom recently banned the sale of uFSH-HP when a case of Creutzfeldt-Jakob disease was detected in Italy, a major supplier of this hormone. To my knowledge, no such cases have been associated with the use of either urine-derived preparation. However, I would tend to agree with the authors’ conclusion that the future will see more use of recombinant preparations which do not carry such theoretical concerns.

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