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Comment on ‘Exaggerating contraceptive efficacy: the implications of the Advertising Standards Authority action against Natural Cycles’
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  1. Emily McIlwaine,
  2. Simon Rowland,
  3. Elina Berglund Scherwitzl,
  4. Raoul Scherwitzl
  1. Medical Communications, Natural Cycles Nordic AB, Stockholm, Sweden
  1. Correspondence to Dr Raoul Scherwitzl, NaturalCycles Nordic AB, Stockholm S-111 37, Sweden; raoul.scherwitzl{at}naturalcycles.com

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We have read with interest the recent opinion article by Hough and Bryce1 in BMJ Sexual and Reproductive Health. We would like to thank the authors for sharing their opinions and we wish to address some misunderstandings.

The ruling delivered by the Advertising Standards Authority (ASA) in August 2018 was based on one Natural Cycles advertisement, which ran for approximately 4 weeks in mid-2017. After the ASA notified the company that three complaints had been lodged, the advert was removed and all content was updated to ensure that a balanced message highlighting the limitations of the method is communicated to all potential consumers. This action was taken more than 1 year ago and therefore this particular critique is outdated.

The authors state that "[Natural Cycles] have not responded to requests for information about how much control they exert over the content of influencer posts", referencing a journalistic article published by CNN.2 To clarify, Natural Cycles did respond to the request in full. We brief the influencers we work with carefully to ensure they understand our focus as a company: that we are committed to expanding contraceptive choice, and do not discourage the use of hormones. We work collaboratively to ensure that our core educational product messages are clearly communicated in all posts about Natural Cycles: including needing to be aged 18+ and that a condom should be used to protect against sexually transmitted infections. We emphasise that no contraception is 100% effective and that the typical-use effectiveness of Natural Cycles is 93%, meaning that with typical use, seven women out of 100 get pregnant over 1 year of use.

The authors raise concerns that the ASA cannot influence marketing strategies overseas. The recent US Food and Drug Administration (FDA) clearance means that the agency evaluates on a continuing basis the device performance, clinical and postmarketing surveillance data, and product labelling. The product claims that Natural Cycles makes, as part of marketing activities in the US, are evidence-based and in line with FDA regulations, which for the avoidance of doubt do cover effectiveness claims in direct to consumer marketing. During the submission process to the FDA, all issues relating to the removed advert were dealt with and amended irrespective of the ASA investigation. The authors should not be concerned about the ASA’s global reach for this medical device.

We could not agree more that "People have the right to know all of the current and most accurate information about contraceptive methods" and advertising directly to consumers is one way to provide appropriate information about contraceptive choices. This app was created to fulfill an unmet need and provide another contraceptive option. We are driven by the desire to widen contraceptive choice and support women to better understand their bodies. In order to achieve this we employ a dedicated Medical Affairs team and regularly host advisory boards and meetings to engage with experts and clinical professionals.

Finally, the authors state that "Natural Cycles should allow independent evaluations to be conducted". Several peer-reviewed studies regarding this app have been published;3–5 however, we fully support the need for independent analysis to be carried out. We are happy to collaborate with researchers interested in validating our data, irrespective of the outcome, and are open to funding clinical trials regarding efficacy as well as psychosocial aspects of the app. Apps for pregnancy prevention and fertility monitoring are a reality for many women of reproductive age, and we encourage more peer-reviewed research in this area.

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Footnotes

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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