While “[w]e . . . understand that in epidemiology hardly any study is ever conclusive, and we do not suggest that an expert must back his or her opinion with published studies that unequivocally support his or her conclusions,” here there is simply too great an analytical gap between the data and the opinion proffered. And the bases for the experts’ conclusions pass none of the applicable Daubert tests: that [the drug] causes problem gambling is not generally accepted, has not been subjected to peer review and publication, and is not backed by studies meeting requisite scientific standards. Without the expert testimony, Wells cannot prove general causation – and judgment must be entered for GSK.Slip op. at 8-9 (footnotes and other stuff omitted). "[T]he scientific knowledge is not yet there." Id. at 9.
The Institute for Reproductive Health (IRH) at Georgetown University is working with partners in California and Massachusetts to seek answers to this question. IRH, the Center for Health Training, and John Snow Inc. have been working with selected clinics to integrate CycleBeads®, an easy to use, highly effective fertility awareness-based family planning option, into their offerings. The experience is being evaluated to determine whether including CycleBeads in the method mix is beneficial, from the perspective of both providers and clients. This work is funded under a grant from the U.S. Department of Health and Human Services’ Office of Population Affairs.
Right now, the study is still following up with clients. However, preliminary results from the needs assessment and evaluation have been positive and were presented last month at the American Public Health Association’s annual meeting in Denver. Thus far, the experience has shown that:
Lise Ching, Center Manager of one of the participating clinics, feels good about their experience offering CycleBeads so far. She states, “Planned Parenthood Mar Monte’s Modesto Health Center is proud to include the Standard Days Method using CycleBeads as part of the array of birth control options for our patients. We feel strongly that increasing provider and staff member knowledge about this method has allowed us to inform our patients about this wonderful, natural method. We’ve had a number of patients say that they’ve been looking for something that’s easy to use and contains no hormones. We’ve also found that providing this method has opened up our Center to women who may not have ever thought to access Planned Parenthood before. Through their interest in CycleBeads, we’ve been able to link these women to additional services such as breast and cervical cancer screening.”
So far, this experience suggests that it is feasible and beneficial to offer a fertility awareness-based family planning option like CycleBeads in U.S. clinics. Like all birth control options, CycleBeads is not appropriate for all clients, but was chosen by some looking for a non-hormonal option. More evaluation results will be required before conclusions can be drawn about continuation, correct use, and satisfaction among CycleBeads users.
In the meantime, CycleBeads can be obtained at the following participating clinics:
Beverly, MA 01915
101 Amesbury Street, Suite 202
Lawrence, MA 01840
Planned Parenthood Mar Monte
Modesto Health Center
1431 McHenry Avenue, Suite 100
Modesto, CA 95350
Marin Community Clinics
6100 Redwood Boulevard
Novato, CA 94945
Marin Community Clinics
3110 Kerner Boulevard
San Rafael, CA 94901
Source of data: Lavoie K, Jennings V., Marshall R, et al. Strategic Approach to Contraceptive Introduction: Offering CycleBeads/SDM in Title X Clinics. Poster presented at APHA in Denver, November 2010.