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UPDATE 9/9/19: The company that manufactures Daysy is now the subject of a legal investigation. More information is available here: http://www.khuranapc.com/daysy-investigation. If you purchased a Daysy, please be sure to read about the investigation and determine if you would like to speak with these lawyers to share your experience. (NOTE: as of 9/20/19 that link is no longer functional. I will share additional updates as they become available.)
In May 2019, 404 days after I submitted a commentary detailing egregious flaws in data collection and analysis of a study purporting to estimate contraceptive effectiveness of the Daysy thermometer -- that study was retracted from the journal Reproductive Health. The retraction note says: “Independent post-publication peer review has confirmed that there are fundamental flaws in the methodology which mean that the conclusions are unreliable due to selection bias and the retrospective self-reporting of whether pregnancies were intentional.”
Science reporter Stephanie Lee covered the retraction story in Buzzfeed. Prior writings had investigated Daysy and detailed unethical behaviors by Valley Electronics (Daysy’s manufacturer) – including that the company kicked people out of online forums for asking questions, and used manipulative language in their marketing materials. In a comment on PubPeer, I also detailed unethical behaviors by Valley Electronics.
I’m glad to have helped to remove junk science from the literature. Hopefully, fewer people will be made vulnerable to unintended pregnancy via misleading, unsupported claims. While the retraction was very important, it does not fully solve the problem. Elsewhere, I’ve described the concerning asymmetry between the rapid spread of misinformation on social media and the long, slow process of addressing misinformation in the scientific literature, and how this mismatch can ultimately impact public health.
So, I have more to say.
In May 2019, 404 days after I submitted a commentary detailing egregious flaws in data collection and analysis of a study purporting to estimate contraceptive effectiveness of the Daysy thermometer -- that study was retracted from the journal Reproductive Health. The retraction note says: “Independent post-publication peer review has confirmed that there are fundamental flaws in the methodology which mean that the conclusions are unreliable due to selection bias and the retrospective self-reporting of whether pregnancies were intentional.”
Science reporter Stephanie Lee covered the retraction story in Buzzfeed. Prior writings had investigated Daysy and detailed unethical behaviors by Valley Electronics (Daysy’s manufacturer) – including that the company kicked people out of online forums for asking questions, and used manipulative language in their marketing materials. In a comment on PubPeer, I also detailed unethical behaviors by Valley Electronics.
I’m glad to have helped to remove junk science from the literature. Hopefully, fewer people will be made vulnerable to unintended pregnancy via misleading, unsupported claims. While the retraction was very important, it does not fully solve the problem. Elsewhere, I’ve described the concerning asymmetry between the rapid spread of misinformation on social media and the long, slow process of addressing misinformation in the scientific literature, and how this mismatch can ultimately impact public health.
So, I have more to say.
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The letter below was sent to Judge Sam Benningfield, in response to this news story. Access to contraception is critical to ensure reproductive health, and inmates who desire it should be provided with access to it. However, any form of reproductive coercion is unacceptable, and enticing inmates to use contraception in exchange for reduced jail time is coercive.
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In May 2017, Natural Womanhood and FACTS put out a call for people to sign their petition asking CDC to “update its website to reflect the best data available and to cite the individual effectiveness rate of each unique type of evidence-based fertility awareness based method (FABM)”, asserting that the CDC website currently “misrepresents the actual effectiveness of individual modern FABMs” by reporting a typical failure rate for all FABMs of 24%. They state that data on effectiveness of FABMs on the CDC website is based on “one study with a low quality research design, which explains why its conclusions are so far from what quality studies show us”. They posit “bias” in this estimate as it is based on a retrospective survey, and as it lumps together variants of calendar rhythm plus other FABMs. The assertions in this petition raise multiple concerns (outlined below).
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For many years, scientists have tried to answer several questions about whether various hormonal contraceptive methods (i.e., pills, injectables, implants, hormone-releasing IUDs, patches, and vaginal rings) impact various HIV-related risks. Key questions on this subject include:
The first question is the most controversial, and is a critically important question for women's health - particularly for those living in high HIV prevalence countries, including many in Eastern and Southern Africa. However, for a number of methodological reasons (many of which are detailed in this paper), it is extremely complex to design studies that will provide definitive answers.
- Are HIV-negative women who use specific methods of hormonal contraception more likely to acquire HIV?
- Are women living with HIV who use specific methods of hormonal contraception more likely to transmit their infection to a male sexual partner?
- Are women living with HIV and using specific methods of hormonal contraception likely to experience faster clinical disease progression?
- If a woman living with HIV is using antiretroviral therapy (i.e., medications to treat HIV), will using any specific method of hormonal contraception result in drug interactions. In other words, could using both medications at the same time make either medication less effective, or more likely to result in side effects?
The first question is the most controversial, and is a critically important question for women's health - particularly for those living in high HIV prevalence countries, including many in Eastern and Southern Africa. However, for a number of methodological reasons (many of which are detailed in this paper), it is extremely complex to design studies that will provide definitive answers.
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In January 2016, I attended the fourth International Conference on Family Planning. I've been very fortunate to be able to attend all four of these incredible gatherings: in Uganda in 2009, in Senegal in 2011, in Ethiopia in 2013, and in Indonesia in 2016.
At these conferences, I'm always reminded what it feels like to be surrounded by everyday heroes working in reproductive health, and I inevitably come home more inspired and reinvigorated. This year was particularly energized because of the large youth delegation that brought incredible spirit and talents to the conference!
At these conferences, I'm always reminded what it feels like to be surrounded by everyday heroes working in reproductive health, and I inevitably come home more inspired and reinvigorated. This year was particularly energized because of the large youth delegation that brought incredible spirit and talents to the conference!
Hanging out with incredible youth delegates! Left to right: Francis Oko Armah (Ghanaian), Chelsea Polis (American), Patrick Segawa (Ugandan), and Maureen Odour (Kenyan)
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This summer, Georgetown University hosted a meeting, organized by Vicki Thorn, founder of the National Office for Post Abortion Reconciliation and Healing, entitled Contraceptive Conundrum: A Symposium of Scientific Research.
But slapping the word "scientific" on the event title does not ensure a balanced, accurate discussion of data.
But slapping the word "scientific" on the event title does not ensure a balanced, accurate discussion of data.
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This blog was written in conjunction with Kavita Nanda of FHI 360 and originally posted here on the K4Health website. It is republished here with permission. Disclaimer: Dr. Nanda and I were both directly involved in work on the 2014 WHO HC-HIV guidance and the USAID/PEPFAR briefer on hormonal contraception and antiretroviral medications.
Extraordinary gains have been made in the last decade towards increasing access to antiretroviral therapy (ART) for HIV. With an eye towards ending the AIDS epidemic by 2030, UNAIDS recently released bold targets related to HIV diagnosis and treatment. By the year 2020, their aim is to have 90% of all people living with HIV aware of their status, 90% of people diagnosed with HIV receiving sustained ART, and 90% of people on ART achieving viral suppression. As we move closer to these laudable public health goals, we must also consider how expansion of ART may affect and be affected by other health issues, such as prevention of unintended pregnancy among women living with HIV.
Among all people living with HIV in low- and middle-income countries, 52% are women (57% in sub-Saharan Africa). Most are of reproductive age, and many may wish to use a hormonal contraceptive method to prevent unintended pregnancy, such as oral contraceptive pills, injectables, implants, or hormonal intrauterine devices (IUDs). Access to highly effective contraception has other health benefits as well; it reduces maternal and infant morbidity and mortality, and is a necessary component in ending mother-to-child HIV transmission.
Therefore, an increasingly important issue is whether certain ART regimens are expected to have drug interactions when used with certain hormonal contraceptive methods.
Among all people living with HIV in low- and middle-income countries, 52% are women (57% in sub-Saharan Africa). Most are of reproductive age, and many may wish to use a hormonal contraceptive method to prevent unintended pregnancy, such as oral contraceptive pills, injectables, implants, or hormonal intrauterine devices (IUDs). Access to highly effective contraception has other health benefits as well; it reduces maternal and infant morbidity and mortality, and is a necessary component in ending mother-to-child HIV transmission.
Therefore, an increasingly important issue is whether certain ART regimens are expected to have drug interactions when used with certain hormonal contraceptive methods.
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This past weekend, Dr. Alice Roberts published an article on the combined oral contraceptive pill in The Guardian. I was excited to see a media article on contraception by a scientist and a Professor of Public Engagement, assuming it'd be evidence-based and teach me more on writing about science for lay audiences.
The article implies a link between premenstrual dysphoric disorder (PMDD) and oral contraceptive pills, based in part on the opinion of Peter Greenhouse, a consultant in sexual health who sat next to Roberts at a conference dinner. Roberts writes:
"[T]here was something else that Greenhouse said that immediately caught my attention: for some women with more extreme cyclical mood changes, going on the pill could be disastrous."
A strong assertion! Intrigued, I kept reading, eager for a discussion of the epidemiological evidence behind this statement (which contradicts information in resources like the evidence-based, frequently-updated book, Contraceptive Technology).
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When reporting on new scientific research, journalists sometimes seem to sacrifice accurate representation of scientific data for an eyeball-catching headline/story. The scarier the news, the more compelling the headline.
To my understanding, journalists don't always get to write their own headlines, but they do have control over the balance of reporting within the story. When reporting on issues related to contraception, some stories seem to focus exclusively on risks (or present risks out of context), without reporting the benefits of a given contraceptive method.
Women deserve to know both the risks and the benefits (and any lingering scientific uncertainties!) related to any contraceptive method they may consider using.
To my understanding, journalists don't always get to write their own headlines, but they do have control over the balance of reporting within the story. When reporting on issues related to contraception, some stories seem to focus exclusively on risks (or present risks out of context), without reporting the benefits of a given contraceptive method.
Women deserve to know both the risks and the benefits (and any lingering scientific uncertainties!) related to any contraceptive method they may consider using.