This blog discusses how Daysy responded after the retraction of their study. Existing/potential customers should be aware of how unethical this company is. This situation also serves as a case study for the public health community.

I'll likely also post a follow up blog when possible, to discuss thoughts around the experience of the retraction process, in hopes of stimulating discussion around whether retraction guidance can be improved to better protect public health and the integrity of the scientific literature.

• Daysy made many other outrageous claims…far too many to list
  • One ridiculous example includes telling their customers that Koch 2018 was retracted due to concerns of an “anonymous reviewer”. I've been anything but anonymous; the retraction note itself, which cites me, makes this rather obvious.

 
I continue to be appalled by the blatant ethical violations by Daysy. Perhaps the single comment that best summarizes Daysy’s lack of integrity came from their Director of Medical Affairs, Dr. Niels van de Roemer. In 2017, I contacted him to privately and directly express concerns about their misleading marketing practices. I asked if Daysy had ever been tested in a prospective study before being marketed for contraceptive purposes. He responded that they’d be interested in such a study but that the “costs and benefits are out of all proportion”.
 
Let that sink in. A company marketing a $330 device as a contraceptive method in over 30 countries did not see it fit to spend money to conduct the appropriate studies, which would have enabled them to market the device honestly, and avoid misleading people into unintended pregnancies. I would not be surprised if somebody who experienced an unintended pregnancy while using Daysy files a class action lawsuit against Valley Electronics for misleading marketing. This company has no shame or integrity, and I am pleased to have played a major role in shining light on their deceptive and dishonest practices.

UPDATE: shortly after posting this blog, I learned that the company has posted a statement on their website about the retraction. It is available here, and repeats many of the problems described above. It's good that they note they will do a study on Daysy effectiveness; I certainly look forward to reading it closely when it is done to see if it provides adequate evidence for the device. But in the meantime, it does not appear that the company plans to stop marketing the device until it has adequate evidence in hand. Perhaps the "costs and benefits" are all out of proportion...

I recently published a peer-reviewed commentary which describes how sloppy science generated unreliable estimates of the effectiveness of the Daysy device, and how such estimates are being used in marketing materials to sell this device. Ultimately, this could place consumers at increased risk of unintended pregnancy.

The commentary examines a paper published in March 2018 by Dr. Martin Koch and colleagues, which purported to measure the contraceptive effectiveness of Daysy and the DaysyView app. Unfortunately, the analytic methods used in the Koch paper were flawed and inconsistent with accurate approaches to estimating effectiveness – making their results void of meaning.

Despite my prior efforts to express similar concerns directly and privately to the company regarding their concerning marketing language, their use of misleading language continued. So, in addition to detailing analytic concerns with the Koch analysis, the commentary describes these prior efforts to communicate concerns and provides examples of the misleading marketing language used by Valley Electronics.

Since the Koch estimates are unreliable (as both peer reviewers of my commentary agreed), I called for a retraction of the Koch manuscript from the scientific literature - to align with best practices in publishing and to protect public health. I'm grateful to the journal (Reproductive Health) for publishing my commentary, and look forward to learning if they will decide to retract the misleading Koch paper.

• (Note: I do not know how long the process will take for the journal to decide whether or not to retract the Koch paper. I submitted the commentary stating my concerns to the journal on April 6, 2018. After peer review, it was accepted for publication on June 14. On June 16, I asked the journal if they planned to retract Koch, and was told on June 22 that they'd decide within approximately a week. However, I didn't hear back for several more weeks. I followed up via email on July 10, and never heard back, so I called by phone to ask on July 18. I am told an investigation is ongoing, and that the journal does not know when a final decision will be available. I hope a decision is made as soon as possible - every additional day that the Koch paper is in the scientific literature is another day that an unsuspecting consumer might place their confidence in the misleading Koch estimates, and potentially put themselves at risk of unintended pregnancy - and another day in which misinformation can spread).

It is unacceptable for an unsuspecting public to be sold an inadequately tested device. In addition to correcting the scientific record, I hope regulatory authorities will investigate Valley Electronics concerning marketing claims.

To my knowledge, Daysy is sold in about 35 countries around the world. If you notice that a company is marketing uncleared or unapproved products in the United States, or using misleading promotional materials, you can report allegations to the FDA at this link.) People in other countries can contact their appropriate regulatory agency to file a complaint, too.

This is a 2016 Tweet from the company that gives a sense of their terrible ethics:

​Furthermore, I am told that a Daysy representative also claimed that my commentary was not peer-reviewed (in fact, the peer review reports are publicly available here); and walked back that false claim only after a diligent forum member corrected them. I am impressed by and indebted to those women who have taken the time to digest the commentary and carry this conversation forward in hopes of holding Daysy accountable to providing accurate information to their customers.

Ultimately, I hope this commentary helps to generate healthy discussion among reproductive health researchers and care providers, FABM/NFP educators, FABM/NFP users, and those with regulatory expertise. The scientific and medical community could think more critically about how to respond to a situation in which some members of the public feel more comfortable trusting claims from companies like Valley Electronics, than they do trusting those with expertise in estimating effectiveness of, and providing evidence-based information on, all options for pregnancy prevention.
​

UPDATE 7-4-18: 
Somebody reached out to me to say that Daysy has released this statement about their study.

It's not entirely clear to me if the statement is supposed to be in response to my commentary, since it does not actually engage with the substantive methodological concerns raised, or rebut them in a way that would make any contraceptive effectiveness expert place more confidence in their estimates. If this is their response to my commentary, their customers and the general public should be even more alarmed.

The statement contains double-speak. For example, it continues to call the study an "independent clinical study" but admits that Dr. Niels van de Roemer (Director of Medical Affairs for Valley Electronics), "analyzed the stored data". Having an employee of the company that manufactures the device be the one responsible for analyzing some or all of the data does not constitute an "independent" study (nor does the study design constitute a "clinical study").

The statement admits that "Daysy is not a contraceptive in the real sense". This message is in stark contrast to how they market the device (selling it as a contraceptive method, claiming a certain level of contraceptive effectiveness, and saying things in the Koch 2018 paper like "The contraceptive effectiveness of the fertility monitor (Daysy) has already been demonstrated in an independent trial.") They mislead consumers with this kind of double-speak.

The paper and statement note that the "data provided by participants were double checked for their correctness from comparison with the internal database. With this measure, it could be further ensured that no doubts had taken part in the survey." This is gobbledygook. What was this magical "internal database" that enabled them to confirm all of the information collected in the survey? And why didn't they use the magical internal database in the first place, instead of going to the trouble of doing a survey? The Daysy device itself collects only temperature and menstrual cycle dates. Saying there could be "no doubts" makes clear that these authors do not understand surveys in general, let alone the important concern that unintended pregnancies are often under-reported in surveys.

The statement concludes by saying that the Valley Electronics team "prides itself on professionalism, transparency, and integrity" - which is doubly shocking given all that I describe above on how they are silencing and blocking customers who are asking questions.

I also note that they refer to "literature" and list 8 sources. A few points:

1. Most titles listed pertain to BabyComp, LadyComp, or Pearly. These devices are ancestors of Daysy, and it is unclear exactly how they differ from Daysy. It does not make sense to list them as evidence on Daysy effectiveness.
2. Titles of some of the papers listed don't even pertain to effectiveness for pregnancy prevention. For example, one is called "Monitoring of ovulation by sophisticated digital electronic BBT recording "Babycomp" in patients with unexplained infertility" - a study on a topic irrelevant to the issue at hand. Listing these here does not bolster their scientific credibility, it makes them look more incompetent and more insulting to the intelligence of their customers and the public.
3. I've read three of the items listed - Koch 2018 (the focus of my commentary), Freundl 1998 (addressed briefly in my commentary), and Demianczyk 2016 (so bad as to be practically illegible) - none provide reliable information on Daysy effectiveness.
4. Note that this list does not indicate the journals in which this "literature" is published. I've been looking in the academic literature trying to locate some of these sources. At least some seem to be conference abstracts, and not peer reviewed publications.

Valley Electronics is digging itself into a deeper hole with documents like these, and continuing to endanger the health and well-being (not to mention trust) of its customers.

At this time, we await word from Reproductive Health on whether they plan to retract the Koch manuscript.
​________________________________________________________________________________________

NOTE: While the commentary is specific to Daysy, I'd like to provide a few resources more broadly on FABMs/NFP, for folks who may be less familiar with these methods.

• Multiple kinds of FABMs exist (see our recent webinar for an overview), and each uses different markers of fertility to identify the days in each menstrual cycle when conception is most likely if unprotected penile/vaginal sex occurs.
• About 3% of female contraceptors in the US report using an FABM, and among those, most report using the rhythm method.
• FABMs have received increased attention recently in the political arena, in part because the Trump administration appears to be prioritizing them over all other contraceptive options – at the expense of full contraceptive choice and client-centered medical care. People should have robust information about and access to all of their contraceptive options, and should be supported in making a decision on which method feels right for themselves.
• This blog from last year aims to help people better understand some of the existing effectiveness estimates for fertility awareness based methods of contraception.
• Our systematic review on the effectiveness of all FABMs as evaluated in prospective studies was recently published in the journal Obstetrics and Gynecology. A pdf of the study is freely available at this link through the end of September. 
• Check out our new webinar on effectiveness of fertility awareness based methods
• Here are a few recent media pieces that mention the Daysy situation
  • Is This Trendy $330 Fertility Thermometer a Ripoff?
  • Truth in Advertising

​A short, accessible summary of this work was also featured in Global Health NOW (a great resource for global health news - sign up for their newsletter)! 

In many parts of the world, the negative effects of infertility are staggering, particularly for women. But research on infertility globally has been relatively limited. Few nationally representative estimates of infertility prevalence exist -- likely in part because measuring infertility in prospective studies is quite expensive.

Drs. Thoma and McLain had recently published two groundbreaking papers (here and here) related to use of a methodological approach (called the "current duration approach") to estimate infertility in the United States. We adapted this approach for use in countries with data available from a Demographic and Health Survey (DHS). These are nationally representative surveys on a range of health issues, supported by the United States Agency for International Development, and conducted in over 90 countries around the world.

Our paper applied the current duration approach to DHS data from Nigeria (2013), and our estimates were consistent with those derived from prospective studies in the region. Thus, our paper represents proof-of-concept that applying the current duration approach to DHS data could potentially enable rapid, cost-effective infertility prevalence estimates for other countries around the world.

This project was a "labor of love" - with all of the work being done without funding, during nights and weekends, over the course of several years. We are grateful that the World Health Organization took an interest in this work, and agreed to support the "Open Access" publication fee, making the paper available without a paywall.

Making informed choices about the number, timing, and spacing of pregnancies is a fundamental human right. Fully enabling this right involves both supporting people to prevent pregnancy when desired, and supporting people to achieve pregnancy when desired. Our hope is that our work helps to advance estimation of infertility globally, and that ultimately, this leads to better knowledge on how to prevent and address this major health concern.

​July 20, 2017

Dear Judge Benningfield,
 
As a reproductive health professional, I was shocked and disappointed to read about your recent ruling, which incentivizes inmates to reduce their jail time by 30 days if they accept a method of contraception (including sterilization or implants).
 
In your interview, you noted that you wish to assist individuals to take "personal responsibility", which I can appreciate. However, empowering people to take responsibility over their reproductive decisions should never be mixed with reproductive coercion, as this program would do. Enticing individuals to base their reproductive health and childbearing decisions on incentives like reduced jail time is coercive and unethical.

There are better ways to empower people in Tennessee to make responsible decisions about their reproductive health. Inmates should have access to voluntary contraceptive services, free of coercion, but more broadly, Tennessee should provide comprehensive sexuality education in schools, and access to affordable, acceptable contraceptive options for all who wish to use a method.
 
In Tennessee, 56% of all pregnancies are unintended (higher than the national average), and in 2010, unintended pregnancies in TN cost the state and federal government over $530 million.
 
While sexual education is mandated in Tennessee, there is no mandate that it be medically accurate, nor that it include information on contraception. Tennessee does, however, require that information on abstinence be stressed, even though abstinence-only education has not been shown to reduce or delay sex, and several studies suggest that it may increase risk of pregnancy and sexually transmitted infections.
 
Unlike 28 other states, Tennessee does not require that insurers provide coverage of FDA-approved prescription contraceptive medications/devices, nor over-the-counter methods, extended supply methods, or male or female sterilization.
 
In your important role as a Judge, I hope you might consider reversing your decision on the coercive program in prisons, and instead, turning your attention to other important reproductive health issues in Tennessee which disempower people from taking personal responsibility in exercising control and personal responsibility over their reproductive health in a fully voluntary manner.
  
Sincerely,
Dr. Chelsea Polis

Update: The email address provided online for Judge Benningfield does not appear to be functional; I received a bounceback message after sending. That said, I also emailed Alan Marsh, Judicial Commissioner of White Country, so hopefully the message will still be heard.

As background, information from a nationally-representative survey, the National Survey of Family Growth (NSFG), is regularly used to estimate contraceptive failure rates for the US. An analysis of 2002 NSFG data was published in 2008 by Kost et al. Information from that analysis is combined with an extensive review of other research on contraceptive effectiveness to produce a chapter on contraceptive efficacy in the regularly updated book, Contraceptive Technology. The table on CDC’s website is adapted from the contraceptive effectiveness table in Contraceptive Technology. (Note: an updated analysis using 2006-2010 NSFG data was recently published by Sundaram et al., and will be included in the next edition of Contraceptive Technology, currently being revised.)

Bullet points below provide clarification on issues that the petition does not adequately represent.
 
1. Typical use effectiveness estimates for several other kinds of contraceptive methods are derived from the same NSFG analysis. Typical use estimates for withdrawal, male condoms, oral contraceptive pills, injectable contraception, and FABMs are all drawn from analyses of NSFG data; FABMs are not treated differently or unfairly.
 
2. NSFG analyses are extremely useful for determining typical use contraceptive effectiveness rates in the general population of the United States. All study designs have strengths and limitations which must be considered in conjunction with the question of interest. For the purpose of deriving typical use estimates of contraceptive use applicable to the general population in the United States, the NSFG analyses referenced above (and cited in Contraceptive Technology and on CDC's website) are based on high quality data and are calculated using rigorous scientific methods specifically designed for population-based data.

Both typical and perfect use pregnancy rates can be measured in clinical trials, but experts generally rely on typical use rates calculated with population-based survey data, in order to monitor the actual experience across a range of contraceptive users with differing demographic characteristics. While one drawback of this approach is reliance upon women’s recall of key information, there are also important drawbacks to calculating typical use contraceptive failure rates in clinical trials. Populations in clinical trials are more highly selected (and thus less generalizable to the wider population), and their behaviors may be impacted by frequent contact with investigators and study staff (this may be particularly true for methods that are highly user-dependent, such as FABMs). Perfect use pregnancy rates are best measured in clinical trials (and it is worth noting that a large proportion of FABM effectiveness studies have incorrectly calculated perfect use rates, as pointed out by Trussell and Grummer-Strawn 1990).
 
3. FABMs are lumped together for calculation of typical use rates for statistical reasons. The petition is correct that NSFG estimates lump FABM methods together, and that >80% of use is composed of “calendar rhythm” (which likely includes a proportion of women who are not even formally using calendar rhythm, but are intending to time intercourse based on their [informed or uninformed] understanding of the fertile period). Thus, it is accurate that the 24% estimate may not be applicable to all individual FABMs. Rather, it is applicable to most women in the US who report that they are using either “rhythm or safe period by calendar” or a “safe period by temperature or cervical mucus test, natural family planning.” It is important to understand that this lumping is done for statistical reasons. Overall FABM use is low in the US (~1% of all women, ~2-3% of all contracepting women, according to NSFG data), meaning there are not enough episodes of use of each individual FABM to generate statistically stable estimates for each method separately. With low use, the choice is to either not calculate an effectiveness estimate for typical use of FABMs in NSFG data or to lump. In other words, data on use of FABMs in the NSFG have been combined in order to shed light on the typical experience of US women using these methods; not in order to mislead.

In the most recent NSFG analysis by Sundaram et al, even when lumping FABM methods, there was an insufficient number of use segments to derive stable estimates. Thus, the paper does not report an estimate for typical use effectiveness of FABMs because the estimate is highly unstable and sensitive to the characteristics of the small number of women who had data on use of these methods in the survey. Again, this is not a decision made with an intent to ignore FABMs, this is based on scientific rigor and integrity.
 
4. CDC does list FABM methods separately for perfect use rates. The petition asserts that CDC is misleading the public, but fails to mention that CDC’s table presents perfect use pregnancy rates separately for Standard Days Method (5%), Two Day Method (4%), Ovulation Method (3%), and Symptothermal Method (0.4%), derived from clinical trials. As perfect use estimates are derived from clinical trials, in most cases, they represent the “best case scenario” for contraceptive effectiveness if the method is used correctly and consistently, all of the time. This is useful, encouraging information for women who may want to try these methods, but perfect use rates are not expected to represent the experience many women will have. Typical use estimates, particularly those generated using population-based data, tell us what the experience of users has been among a range of women with differing demographic and socioeconomic characteristics and under varying conditions of use, and so, they are quite useful, as they represent the challenges women face in using methods perfectly.
 
5. Scientifically robust approaches to providing updated information about FABM effectiveness rates are underway. For example, Contraceptive Technology is revised every few years to reflect the most recent data. The upcoming edition of Contraceptive Technology (21st Edition) includes new clarifications to help readers understand why typical use effectiveness of every individual FABM method cannot be estimated currently in population survey data. In addition, a systematic review of the effectiveness of prospective, clinical studies of all FABMs is underway; more information on this effort is available at this link. (Disclosure: I am involved in both of these efforts). 
 
In sum, the petition asserts bias and lack of scientific rigor in current research findings and implies that the CDC is misleading people, when in fact, there are sound scientific reasons for the CDC’s approach to communicating the range of contraceptive options available and the evidence to-date of their contraceptive effectiveness. It is certainly worthwhile to call for more research into the likely wide-ranging effectiveness of different FABMs, particularly among typical users, but it is not necessary to diminish the value of the research and current body of evidence to do so.

At the same time, it is certainly important to acknowledge that a great deal of misunderstanding exists around FABMs, and that clear communication about these methods is necessary. For example, helping people understand the distinctions between the rhythm method and other FABMs (such as the sympto-thermal method, the TwoDay method, Standard Days method, Billings Ovulation method, sympto-hormonal methods such as Marquette, and other methods) would be useful in dispelling the misunderstanding that all women using fertility awareness based methods (or "natural family planning methods") are using the rhythm method (though again, a very large proportion of women in the US who report using some kind of fertility awareness report using calendar rhythm, although those reports may reflect formal or informal use). Finding productive and accurate ways to communicate about these methods is important, and will take collaborative efforts to achieve.

At the request of the World Health Organization, I've had the opportunity to lead incredible teams of researchers to conduct systematic reviews of the evidence on this issue (as well as on some of the other questions noted above). Systematic reviews collect, evaluate, and summarize all available studies on a given question to try to clarify what the best available evidence tells us. Our first systematic review on this topic was completed in 2012 and published in 2013 in Lancet Infectious Diseases. The evidence base continued to grow, and we were asked to conduct an updated review on this topic in 2014, which we published in the journal Contraception.

In the last two years, the evidence based has continued to grow rapidly, and the quality of studies has continued to improve over time. We were recently asked by WHO to conduct a third systematic review on this issue, which we recently published in the journal AIDS. This updated review includes all scientific studies on this topic published through January 15, 2016 (and at the time of writing this blog in October 2016, I am not aware of any new relevant studies published since January 15, 2016).

The full text of the systematic review is available here (click where it says "Article as PDF" under the "Article Tools" bar on the right), and a press release is available here. In brief, we concluded that existing evidence suggests a reassuring lack of increased risk of HIV acquisition for users of oral contraceptive pills, the NET-EN injectable contraceptive (which is used mostly in South Africa), and contraceptive implants. However, new data on intramuscular depot medroxyprogesterone acetate (DMPA), an injectable contraceptive most commonly sold as Depo Provera, heightens existing concerns about a possible increase in risk of HIV acquisition in women who use the method.

WHO monitors this evidence on an ongoing basis, in efforts to keep guidelines like the Medical Eligibility Criteria for Contraceptive Use aligned with scientific data on a continuous basis. In response to our review, WHO issued a statement, and noted that: ​

People interested in this topic should stay tuned for the results of the WHO meeting. For those interested in some of the other key questions noted above, here are some additional resources:​

• Are women living with HIV who use specific methods of hormonal contraception more likely to transmit their infection to a male sexual partner? Main (2013) systematic review here, with an update here.
• Are women living with HIV and using specific methods of hormonal contraception more likely to experience faster clinical disease progression? Main (2013) systematic review here, with an update here.
• Are drug-drug interactions expected between specific hormonal contraceptive methods and specific antiretroviral medications? Review here, updated review forthcoming.
• Modeling studies to understand the impact of various policy responses to the HC-HIV acquisition issue in various epidemiological contexts: here and here.

​One of the presentations I delivered at the conference was in a panel focused on multipurpose prevention technologies (MPTs).

As defined by the Initiative for Multipurpose Prevention Technologies, MPTs are products that combine protection against unintended pregnancy, HIV, and other sexually transmitted infections such as HPV (which can cause cervical cancer), herpes, gonorrhea, or chlamydia.

​Male and female condoms are the only currently available MPTs. Examples of MPTs in development include intravaginal rings that release a contraceptive along with an anti-HIV medication, or a contraceptive diaphragm that could be loaded with an anti-HIV gel. Developing new MPTs would mean providing women and couples with more prevention options to protect their health.

My presentation provided a brief overview on the epidemiological evidence on whether various hormonal contraceptive methods increase risk of HIV acquisition in women, and also on potential drug interactions between hormonal contraceptive methods and medications used to treat HIV. Along with the excellent introduction to the issue by moderator Dr. Kirsten Vogelsong of the Bill and Melinda Gates Foundation, this motivating example helped to set the stage for why developing products like MPTs is so critical - to empower women to simultaneously prevent multiple risks to sexual and reproductive health. Dr. Anke Hemmerling (UCSF) and Laura Dellplain (CAMI Health) delved into the MPT topics more deeply - discussing some of the challenges faced in MPT development, and the work that the Initiative for Multipurpose Prevention Technologies is doing to accelerate the process. 

We enjoyed doing the panel so much at the International Conference on Family Planning in Indonesia that we decided to do a recap of the entire thing as a webinar, to be shared with a broader audience!

You can find a great description of the focus of the entire panel here, and the webinar is available here. I hope you enjoy it - please spread the word about the need for multipurpose prevention technologies!​

I am enormously grateful to Georgewilliam Kalibbala, Scott Fabricant, and Dr. Ronald Gray for nominating me to the 120 under 40 campaign!

My profile was posted today, along profiles of many other nominees, including Patrick Segawa - who I blogged about just yesterday. Kudos, Patrick!

It's inspiring to read about young folks around the world doing all kinds of important work. I hope everybody interested in building the next generation of leaders in reproductive health will consider making a nomination today!

Tomorrow, I leave for Indonesia to attend the International Conference on Family Planning! This incredible conference began in Uganda in 2009, was in Senegal in 2011, then Ethiopia in 2013, and will be in Bali this year. I've been incredibly fortunate to be able to participate at each one! It always re-energizes me to be surrounded by everyday heroes doing work in international reproductive health!

This year, I had an opportunity to volunteer to be a mentor to a youth attendee. As luck would have it, I was matched with a young Ugandan man who I've been linked with for some time on social media - the incredibly dynamic Patrick Segawa. Patrick's organization, PHAU (Public Health Ambassadors of Uganda), focuses on "edutainment" to raise awareness for sexual and reproductive health and rights in Uganda. Among other incredible activities, PHAU organizes dancing flash mobs in Uganda - please check out their website for more information about this great organization! Patrick was also recently nominated in the 120 under 40 campaign, which highlights young leaders in reproductive health from around the world. He is a rising star in our field, and I am very much looking forward to finally meeting him in person.

Patrick was invited to moderate a session at ICFP this year called "Community-based distribution programs: where the action really is". He is excited to moderate his first conference panel, and asked for a few tips on moderating a good session. I pulled together a few quick suggestions, and thought that they might be useful to share. It'd be wonderful if readers shared additional tips in the comments section! After the conference, Patrick will share thoughts on how things went, and any other tips he might have for others - I'll post those here as well!​


Tips for moderating a conference session
1. Email your speakers before the panel to ensure everybody is aware of how much time they will have to present. Leave 15-20 minutes at the end for Q&A with the audience. 

2. Ask your speakers to send you a few (2-3) short sentences about themselves; this will help you introduce each speaker before his/her presentation. Keep these introductions short - no more than 1 minute per person.

3. In the days leading up to your session, encourage people that you meet at the conference who may be interested in the topic of your panel to attend. Share the day, time, and location of your panel. Consider sharing information about your session on social media to build excitement.

4. Before the session, ensure that all speakers have uploaded their presentations. Familiarize yourself with the technical setup in the room, such as where the presentations are stored on the computer, to avoid any technical mishaps during the session.

5. Ask your speakers to arrive in the room a bit early so that you can introduce yourself and introduce them to each other; this helps to set a nice tone for the session.

6. When the session begins, briefly welcome the audience, clarify what session they are in (in case anybody has wandered into the wrong room), and proceed to introduce the first speaker. Remember to smile and have fun while moderating - you want the experience to be fun and interesting for everybody involved!

7. When the speakers are presenting, it is your responsibility to ensure that they keep to time. That means giving them a 1 or 2 minute warning before their time is up. It is very important to gently but firmly ensure that speakers keep to time, so the panel does not run long. Let them know in advance that you will help them keep to time by giving them a 1-2 minute warning. Often, people make a little sign that says "One minute left", you can quietly hold this up to the speaker when they have that amount of time left, without being too disruptive to their presentation.

8. Decide in advance if you want the audience to be able to ask questions after each presentation, or if you want all questions to be held until all presentations are delivered. One nice way to handle this is to say that 1-2 short, clarifying questions will be permitted after each individual presentation, but that broader questions should be held for the Q&A at the end.

9. After all of the speakers have given their presentation, let the audience know that you will be opening up the session for questions. It is usually helpful to suggest that questions be kept short and to the point. Your role will be to facilitate a smooth conversation between the panelists and the audience, taking care to ensure that no single person dominates the discussion. You may want to ask audience members to state their name before asking their question.

10. It may be a good idea to have a few questions of your own prepared, just to get the conversation started, in case the audience is shy or quiet (usually not a concern at ICFP)!

11. If an audience member asks a broad question and does not direct it to a specific panelist, you can try to help the panelists decide who might be best suited to answer. Try to ensure that each panelist gets an opportunity to respond to a question or two.

12. When the session is over, be sure to thank the panelists for their contributions, and the audience for attending and contributing to the discussion.

13. Celebrate moderating your conference session!

They also claim that, based on "Real Customer Use Experience", a product called ProHP can treat genital and oral herpes.

The site makes numerous other unsupported claims, as detailed by Emmeline Peaches in this blog post, which also includes infuriating quotes from the company on Twitter. 

What can a concerned citizen do in a case like this? When it comes to misleading advertising on health-related products being sold in the United States, "The Federal Trade Commission combats...deceptive advertising in coordination with the Food and Drug Administration". For example, Food and Drug Administration (FDA) has a program called "Bad Ad" where individuals can submit complaints about misleading advertising on prescription products. 

In the case of non-prescription products, like ProLube, individuals can submit complaints to the Federal Trade Commission (FTC) through its FTC Complaint Assistant.

While it takes only a few minutes to do this, the forms may be a bit intimidating. Below is an example of how I filled out the FTC complaint I just submitted on this company, in hopes that it will encourage others to do the same when they see a concerning situation like this arise. 

1.      I went to this website: www.ftccomplaintassistant.gov.

2.      On page that says “Select a category below”, I clicked “Other”.

3.      When a menu pulled up, I clicked “Health and Fitness”.

4.      On page asking “How were you contacted?”, I clicked “Other/Not applicable”.

5.      On page asking "Is your complaint related to”, I clicked “Other Medical Products, Supplies, or Treatments”.

6.      When asked “Do you have a complaint about”, I clicked “Medical Products or Supplies”.

7.      When asked “Did you order an item and have yet to receive it?”, I clicked “No”.

8.      When asked “Do you have concerns regarding the privacy of your information with the company?”, I clicked “No”.

9.      The next page said “In just a few moments, you will be able to tell your story in your own words. But first we would like to collect some additional information”. I clicked “Continue”.

10.   On the “Complaint Detail Information” page, instructions noted “Information on this form may not apply to your complaint. Please fill out only fields that are applicable to your situation.” So, I left all forms blank, because they did not apply.

11.   On “Company Information Page”, I filled in the small bit of information that I had about this company, including the Company Name ("Use to Believe"), the company email (usetobelieve@gmail.com), and the company website (www.usetobelieve.com). [Note that the form is pretty finicky about it being entered in a www.[text].com format.]

(Addendum 1-3-2016: Ziad Fazel kindly provided additional information about the company via WHOIS, which others may be able to use if/when they submit a complaint to FTC about this company. Thanks, Ziad!)

12.   On the “Consumer information” page, I filled out my personal information.

13.   On the “Additional information” page, you can describe your concern. I wrote: “I am a reproductive health professional and concerned citizen. Several individuals on Twitter have raised attention to unsupported claims made by the company "Use to Believe". An overview is provided in this post: http://emmelinepeachesreviews.com/2016/01/02/some-thoughts-on-prolube-and-scam-products/. In brief, the company makes numerous claims, including that their lubricant, ProLube, protects against HIV. For example, the following page (http://usetobelieve.com/sex-workers/) states: "Once ProLube is applied, it will give 12 hours of protection from Sexually Transmitted Diseases including HIV." Another page advertises a product called ProHP with claims that customer use experience indicates that this gel treats genital and oral herpes. I have screenshots available in case of use. There is very little information about the location or management of this company on their website, but they have a Twitter account (@usetobelieve) and request donations via PayPal. I hope FTC will be able to follow up and ensure that consumers do not fall prey to these unsupported and dangerous claims.”


It's that's easy!  Soon after I submitted the complaint on the website, I got an email from FTC with a reference number for my complaint. 

Many thanks to all who raised attention to this issue! I'll sleep better tonight knowing that the FTC is aware, and can hopefully take action to prevent unsuspecting consumers from purchasing unproven, and potentially dangerous, sexual health products.

Addendum 1-4-16: It is somewhat unclear whether this company is based in the United States or not. The website server appears to be in San Jose, California, but the physical address of the domain owner appears to be San Jose, Costa Rica. If I receive any information from FTC on what they are and are not able to do, I will provide updates here.


Addendum 1-12-16: The great folks at Sense About Science asked me to write a short blog on this whole situation as part of their excellent #AskForEvidence campaign. Some interesting updates regarding how the company responded are described in the piece. Thanks to Sense about Science for helping to amplify!

​​Thorn provided this rationale for the conference: "The research is showing over and over that oral contraception is simply not good medicine, but this is motivated by the agendas of population control and controlling our bodies chemically."

As an epidemiologist with knowledge in contraceptive safety research, who attended the symposium with an open mind, I do not think a compelling case for Thorn's statement was made. Nonetheless, students and laypeople in attendance might have been misled with misinformation being metaphorically paraded around in a lab coat.

While a tiny minority of the speakers delivered credible, scientific presentations, the meeting as a whole was not a “scientific symposium”: it included several low scientific quality presentations; materials distributed contained poorly-balanced content; there was a lack of invited speakers with specific expertise in contraceptive research; and the organizers made several inaccurate remarks which were further promoted on Twitter.

In this Storify (update: Storify website is no longer, but click the link below to download a copy of the content that was in the Storify - apologies for imperfect formatting), I review many of the Tweets from and about this conference, which lacked a sincere attempt to strive towards objectivity. I hope it helps to advance the call for more honest, accurate discussions on the risks and benefits of various contraceptive options, so that we can ensure true informed consent, and better support happier, healthier women and couples.

As of April 18, 2015, no information is available on the AZ Department of Health Services' website. In the scientific literature, the only publication on "abortion reversal" is a case series report of seven women (only six of whom provided outcome information), by George Delgado and Mary Davenport. In short, those six women took mifepristone, then had a series of progesterone injections (some women received around 40 or more progesterone injections during pregnancy), sometimes along with oral progesterone. The timing of the first progesterone injection varied widely - ranging from 7 to 72 hours after mifepristone (timing was not documented for one woman).  Of those six women, four eventually delivered healthy newborns. 

Since this manuscript is in a peer-reviewed journal, and since it suggests that about 2/3rds of these women delivered healthy babies, does that mean this so-called "abortion reversal" procedure is evidence-based? 

The lower something is on this pyramid, the less likely it is to provide robust scientific evidence. The higher it is on the pyramid, the more confidence you can generally put in the findings - assuming the methods are sound.  (As an aside: if done poorly, even systematic reviews and meta-analyses can be garbage. A good epidemiologist can help you determine whether the methods of any given study or review look solid. Hug an epidemiologist today!).

Most (um...not all) people know that anecdotes (at the bottom of this pyramid) cannot be used to establish whether a relationship between a drug/intervention and a health outcome is causal.  Case reports and case series are essentially a collection of anecdotes, described in a (hopefully) detailed and systematic manner. They help to generate hypotheses, but can't provide proof of safety or effectiveness, because they do not include information on a comparison group of people unexposed to the drug/intervention in question. 

Moving higher up, observational studies do include a comparison/unexposed group, but for reasons I won't go into here, it isn't always clear whether that comparison group is similar enough to the 'exposed' group to confidently determine cause and effect. Randomized studies aim to ensure better comparability between groups, helping us draw more confident conclusions. Systematic reviews (which sometimes also include a statistical meta-analysis) are super-duper awesome: they consider all studies on an issue, putting the entirety of evidence into better perspective (because sometimes individual studies can have spurious findings).

The Delgado paper is merely a case series (low on the evidence hierarchy), and at that, a very limited case series (only six women, all of whom received a slightly different intervention in terms of timing, dose, and route of progesterone administration). It can't tell us if progesterone injections after mifepristone provide any benefit, as compared to doing nothing (i.e., not taking misoprostol). As David Grimes, a physician-epidemiologist, noted in his recent blog on RH Reality Check - doing nothing might be just as effective (and involve less cost and no need for a potentially large number of injections):

Neither the Delgado paper nor SB 1318 provides any information about potential downsides of interrupting a medication abortion or of receiving an unproven intervention. In short, robust, peer-reviewed scientific evidence does not currently exist to support the idea that any particular procedure can safely and effectively "reverse" the effects of mifepristone. This has not stopped George Delgado from promoting the idea on his website, or from the AZ legislature from acting crAZy.

Since I hate to end on such a depressing note, I'll add one more thing. Discussing these nerdy epidemiological nuances on social media can have an impact. Taking the time to engage can encourage people to reconsider promoting an unproven "abortion reversal" protocol, as suggested in the encouraging Twitter exchange below with Tiana Sakr/@AussieProLife (update: subsequent to the original posting of this blog, her Twitter name was updated to Women&Babies Support/@wombs_intl). 

So, scientists, make your voice heard. We owe it to people seeking information that will allow them to safely and effectively reach their reproductive goals, whatever they may be.

Notes: 
* Women are not the only individuals who may require abortion services; transgender men and other gender non-conforming individuals with an ability to get pregnant may also require abortion services.

Main reference:
Delgado G, Davenport ML. Progesterone Use to Reverse the Effects of Mifepristone. The Annals of Pharmacotherapy 2012;46(12):e36. 

I already have a few New Year's resolutions (hello, my old friend Gym), but recently came across a science-related resolution that I really like and want to share.

#365papers is a challenge to read one peer-reviewed, scientific paper a day and to share something about it on Twitter. It was started by two professors in ecology and evolution, Meghan Duffy and Jacquelyn Gill.

"#365papers" is a hashtag you can use to Tweet updates on your progress.  I love the accountability of this idea (you number each paper that you post about from 1 to 365), and the community-building, knowledge-sharing aspect, which was beautifully described by Pietro Gatti-Lafranconi on his blog:

Pietro extended the concept by compiling edited #365papers collections, such as this one by Paulette. And he's happy to include a series on sexual and reproductive health (SRH) research, if we build up a sufficient collection.

As Andrew Hoffman noted in "Isolated Scholars: Making bricks not shaping policy"...

While there will undoubtedly be times where busy schedules prohibit participation, I'm very excited to attempt the #365paper challenge. There are many controversial SRH-related issues that aren't always handled fairly in media or policy realms. Can a daily challenge like #365papers help scientists keep themselves and their peers more actively engaged with the literature, while making science somewhat more accessible and digestible to the public? Could it positively impact the ways we consume, discuss, and share scientific information? Let's find out together, building towards an SRH-themed #365papers collection.

Update: 2-29-15 - the hashtag creator notes that some folks are doing #52papers or #262papers - which might suit schedules better. As she says "Whatever gets you reading more!"

Walking down the road one day in Kalisizo, I met a young man named Georgewilliam. He struck up a conversation, asking what I was doing in Uganda. When I mentioned being a public health scientist, his eyes lit up! He talked about his love for science, and was eager to discuss his studies in biology and chemistry. He was applying for a program in medical laboratory technology, and wanted advice on the application/interview process. I visited him the next day after work to talk about it, and we became fast friends.

He's also become active on Twitter, and shares information on public health issues and opportunities.

I think Georgewilliam will become a public health leader of tomorrow. It's been exciting to see him progress on his journey, and especially to hear about his efforts to help other Ugandan students identify opportunities to pursue their scientific path.

I'm sometimes contacted by young people from different parts of the world (often thanks to Twitter!) who want to make a difference in public health.  Sometimes, they ask the following question, which I generally feel poorly equipped to answer: "Where can young African students (undergraduate, masters, PhD, or postdoctoral level) who are passionate about science and public health find support for scholarship and training opportunities?"

Luckily, Georgewilliam's role as Information Minister has helped him to develop some expertise on this question. So, we decided to team up and compile some helpful links. If you know of other relevant opportunities or resources, please let me know and we will add them below.

Note: Although we focused on links for African youth interested in public health, identifying opportunities for youth from elsewhere and interested in other topics is important, too! My husband is on the board of an incredible organization called Help Educate, which works with community leaders in Nicaragua to identify students with great potential and provide them with scholarships to leading Nicaraguan universities. Please check out Help Educate, and share any similar opportunities you may know of in the comments section!

PS: I can't blog about Ugandan youth who I find inspiring without mentioning my friend and visionary entrepreneur Walter Wandera, founder of Walter's Boda Boda Tours.  Watch him talk about his company here. He knows nearly everything about Kampala, and his tour is one of the most exciting things I've ever done. If you find yourself in Uganda, don't miss his incredible tours. 

Edit 3-10-15
Joseph Byonanebye, MPH, a doctoral student at the Medical College of Wisconsin, had the following additions to add to this list. Thanks, Joseph!

• The University of People offers free online opportunities for students around the globe to acquire American education. Yes, soon they plan to start bachelor’s degree in health sciences! FYI http://uopeople.edu/
• The Muljibhai Madhvani Foundation Scholarship http://www.madhvanifoundation.com/
• St. George’s University, Grenada http://www.sgu.edu/financial-services/sgu-som-scholarships.html
• Global Health Corps Fellowship http://ghcorps.org/fellows/whats-a-fellow/

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. 

In theory, an interaction could affect the efficacy of either medication, or cause side effects or toxicity. If contraceptive efficacy decreases, the chances of contraceptive failure, unintended pregnancy, and the accompanying consequences increase.  A decrease in ART efficacy could lead to treatment failure, viral resistance, and greater likelihood of subsequent HIV transmission. Increases in side effects or toxicity can affect quality of life and medication adherence. Yet, despite the importance of this issue, relatively few studies (particularly those with clinical outcomes such as ovulation, pregnancy, or treatment failure) have been conducted.

In July 2014, based upon comprehensive systematic reviews and an expert consultation, the World Health Organization released updated guidance on hormonal contraception and HIV. One component of this guidance focuses on potential drug interactions between various hormonal contraceptive methods and ART. Subsequently, the Office of Population and Reproductive Health at USAID and the President’s Emergency Plan for AIDS Relief (PEPFAR) developed a technical brief on drug interactions with technical assistance from FHI 360.

The current guidance notes that women taking ART are eligible for all hormonal contraceptive methods, but special consideration might be necessary for women using some hormonal methods (combined hormonal methods, progestogen-only pills, norethisterone enanthate (NET-EN), or levonorgestrel (LNG) and etonogestrel (ETG) implants) with certain ART regimens (specifically those containing efavirenz or nevirapine, as well as some protease inhibitors). These combinations are ranked as medical eligibility criteria (MEC) Cat­egory 2: The advantages of using that specific contraceptive method (in combination with those specific antiretroviral drugs) generally outweigh the theoretical or proven risks (in this case, because of potentially reduced contraceptive efficacy). For specific details on these potential interactions, interested readers should refer to the documents linked above. For more information on MEC Category meanings, readers should refer to the WHO guidance.

Limited available data suggest that ART efficacy is not impacted by use of hormonal contraceptive methods, and limited data suggest that combined oral contraceptive pills, depot medroxyprogesterone acetate (DMPA, sometimes called Depo Provera), and implants are also unlikely to have an impact on ARTside effects or toxicity.

This raises an interesting situation with regard to DMPA.  Scientific uncertainty exists as to whether DMPA is causally associated with an increased risk of HIV acquisition among HIV-negative women. However, when used by women living with HIV who are on ART, DMPA is not expected to have any drug interactions with ART (unlike oral contraceptive pills and possibly contraceptive implants). Furthermore, ART use greatly reduces the risk of transmission to a sexual partner, which would minimize possible concerns (based on limited data) about DMPA and female-to-male HIV transmission. Therefore, while the scientific community debates how to more definitively assess the impact of DMPA on risk of HIV acquisition in HIV-negative women, including the possibility of a randomized trial, DMPA will likely remain an important option for women living with HIV and using ART, both for their own health and autonomy, and also to reduce perinatal HIV. Other contraceptive options, such as hormonal or non-hormonal IUDs, where appropriate, can also provide important benefits for women on ART.

The global health community must enhance efforts to better understand potential drug interactions between various ART regimens and various methods of hormonal contraception. More than 18 million women currently living with HIV deserve clear, accurate information on which to base lifesaving health care decisions.

By way of background, I've worked for many years on a complicated, contentious scientific question: whether various hormonal contraceptive methods impact various HIV-related risks.  If you are interested in work on this issue, please see this 2012 systematic review (discussed at length below), this 2014 systematic review update, or other resources shared here. Feel free to email any questions about this topic!

The story begins in May 2012, when we submitted a draft of a systematic review on hormonal contraception and HIV acquisition to Lancet Infectious Diseases. The review had already been presented to more than 90 people at a World Health Organization technical consultation, and we looked forward to publishing our work in a peer-reviewed journal.  The Editor-in-Chief of Lancet Infectious Diseases, John McConnell, even originally said he'd fast-track peer review, given the importance of our topic.  

When we received peer review comments in July 2012, Reviewers B and C were supportive and provided useful feedback which helped to improve the manuscript. However, Reviewer A made extremely hostile comments -- accusing us of lying to Africans and putting them at risk of HIV. Startlingly, this reviewer provided absolutely no scientific substantiation for these extreme comments. Nonetheless, Sally Hargreaves (the Lancet Infectious Diseases Editor handling our paper) said she'd specifically "be interested to see [y]our response to this reviewer’s comments”.

I was highly distressed and intimidated by receiving such unprofessional peer review feedback from such a highly respected journal. Lancet Infectious Diseases is a member journal of the Committee on Publication Ethics (COPE). COPE has a code of conduct for journal editors, which encourages "sending reviewers' comments to authors in their entirety unless they contain offensive or libelous remarks" and notes that "Editors should strive to ensure that peer review at their journal is fair, unbiased and timely." To me, the unsubstantiated accusations seemed offensive, unscientific, and unfair, but Lancet Infectious Diseases appeared to want us to take them seriously.

This shook me, deeply.  So deeply that we pulled the paper from consideration and took extra time to go over every sentence and every number with a fine-toothed comb, reconfirming (again, and again) that every word was accurate. At the time, it felt like the most open-minded, scientifically responsible reaction to such an amorphous, blanket condemnation -- one which the highly respected minds at Lancet Infectious Diseases had apparently considered fair game.

After reviewing everything with fresh eyes, I was confident that our review stood on its merits, and that Reviewer A had been extraordinarily unscientific and unprofessional. I felt sheepish for having ever spent time and energy taking his comments so deeply to heart - but had wanted to ensure that this complicated subject had been done justice.  Little did I know -- once his identity later became known (and verbally confirmed) to me, how shocked I'd be that they'd ever selected this person as a peer reviewer in the first place... 

In December 2012, we asked Lancet Infectious Diseases if we could resubmit the paper, attaching responses to the three original peer review comments. The journal agreed to put the paper back under peer review, and assigned six new peer reviewers to it. We received these new comments in May 2013.  We responded to all of them, and the paper was accepted in Lancet Infectious Diseases that month.  I should have been popping champagne (my first publication in a Lancet journal!), but a debacle had only just begun...

In July 2013, just before our systematic review was scheduled to be published online, I saw that a version of our manuscript which could only have come from one of the original three peer reviewers had been leaked to (and posted publicly online by) the Rebecca Project, an unscientific organization which has spread misinformation about contraception. In their (evidence-free) 'report' they accuse my co-author and I of "bartering women's lives to advance our careers" and publicly post our leaked manuscript.

I wondered how our confidential manuscript (accessible only to the Lancet Infectious Diseases and the three peer reviewers) could have been leaked. I was less concerned about the manuscript being publicly available (since it had already been accepted), but was VERY concerned about the flagrant breach of ethics underlying the breach in peer reviewer confidentiality and the violation of copyright. I immediately brought it to the attention of Lancet Infectious Diseases.  

At the same time, I noticed that a member of the (then) Board of Directors of the Rebecca Project for Human Rights (later renamed the Rebecca Project for Justice - due to a change in leadership) had also published a letter on hormonal contraception and HIV acquisition in Lancet Infectious Diseases.  This piqued my interest, but I was doubtful - at the time - that a respected journal would have selected this particular individual, given that his theories have been roundly debunked (in Lancet!). According to Dr. Seth Kalichman (and as evidenced by this person's publication record in PubMed; largely of letters to editors), this individual (who has no institutional affiliation) “has not done research of his own, and selectively reviews past research to support his views" and is viewed as an AIDS denialist. But I digress...

McConnell noted that he would follow up on the matter, but weeks and months went by with no satisfactory response. I checked in periodically, but mostly heard crickets. When I reiterated that COPE guidelines suggest that in cases of peer review misconduct, the peer reviewer's institution should be contacted for an investigation, he told me that the reviewer had no institutional affiliation, so he considered the avenue closed.

To me, this was a great opportunity to highlight this issue to COPE, so they could consider extending their guidance on misconduct by non-institutionally affiliated peer reviewers.  I asked Lancet Infectious Diseases to bring the case formally to COPE, so the wider scientific community could benefit, perhaps stimulating productive discussion on preventing reviewer misconduct (or strengthening procedures for follow up of non-affiliated reviewers).  COPE itself recommends "referring troubling cases to COPE, especially when questions arise that are not addressed by the COPE flowcharts, or new types of publication misconduct are suspected."

To my great frustration, McConnell repeatedly ignored my request. Instead, he told me he’d ask a friend who’d been involved with COPE previously her opinion.  I felt this would deny the chance for the case to be made useful to the broader scientific community, so I escalated the issue to Richard Horton (Editor-in-Chief of Lancet) and Charles Warlow (Ombudsman of Lancet, at that time). 

Nearly five months in, it was finally noted that the case would go to COPE.  You can read how McConnell described the case to COPE, and how COPE responded here. I thought the description lacked important details.  On December 4, 2013, I tried to listen to an online COPE discussion (for which a weblink had been publicly posted), but was contacted and told the meeting was not intended for my participation. Discussion of my case was postponed to happen outside of the publicly accessible session. They later posted audio of at least part of the discussion - pieces of which are quite infuriating. Ultimately, COPE did recommend (as I had, months earlier) that McConnell write an Editor's Note so the case was part of the public record. So, the (rather toothless, IMO) note below was published.

With regard to the violation of copyright and illegal posting of our manuscript, I received no clear answers on how the journal would proceed, other than that McConnell sent a few emails/letters to the Rebecca Project, which went unanswered.  This is how the Rebecca Project eventually spun those events to LifeSitenews.com.

McConnell later told me verbally that they didn't pursue more serious strategies with the Rebecca Project because of "reputational" concerns. Specifically, Lancet did not want to appear to be a big powerful journal coming down hard on a small advocacy organization. Nevermind that this "small advocacy organization" was catching the ear of certain folks in the US Congress (e.g., here and here) with their highly unscientific "report".

At one point, McConnell suggested that I contact the Rebecca Project to request our draft manuscript be removed from their website. Being aware of some concerning history about certain individuals associated with their group, I declined.  I could see that I wasn't getting very far, so held out hope that the Lancet Ombudsman would make some sense out of this mess.

For several months, I tried to get the (then) journal ombudsman, Charles Warlow, to respond to my emails, but was ignored. Eventually, I got a note that Warlow was being replaced by a new ombudsman. Several weeks later, Dr. Wisia Wedzicha wrote to say that she would review the case. A few weeks after that, she sent me her report.  I'd love to share that report here (she agreed with some concerns I'd raised, which continue to be unacknowledged by McConnell or Lancet Infectious Diseases). However, she said: 

So, I was asked to be quiet about this, because THIS was considered a "very serious professional matter" - apparently more serious than addressing the misconduct I had endured, since no concrete actions came of the report.  I've never contacted a journal ombudsman before; so I don't really know - are Ombudsman reports only for authors eyes? What's the point if there is no follow up from the journal (there wasn't) AND I can't discuss the details of it (I haven't...)?

Recently, the journal did a Tweetchat called #AskLancet - and I had some follow up questions on my situation.  How this conversation unfolded is best encapsulated in a Storify; in short, my questions were not responded to, until they were retweeted by a man who shared my concern.  Click here to read the Storify (UPDATE: the Storify website is no longer, but you can click below to download a document containing the content that had been in the Storify).

In sum, Lancet Infectious Diseases failed to perform due diligence in selecting an unbiased and professional peer reviewer, allowed unscientific and offensive comments to move forward in the review process, failed to protect my work from being leaked by an unethical reviewer who the journal was unable to follow up on, dragged their feet in taking my case formally to COPE, failed to fully describe the situation to COPE, and shrugged their shoulders at the violation of copyright given "reputational concerns". They've never apologized for this situation, or shown any interest in implementing more meaningful solutions to prevent this from happening in the future (e.g., telling reviewers that if they breach confidentiality that their names will be publicly shared so that other scientists can avoid being reviewed by them, or putting additional measures in place when asking unaffiliated individuals to serve as peer reviewers). Why not? 


I continue to be, as I have for over two years now, in disbelief of this situation, particularly at a journal of this caliber. My message for Lancet journals?  I respect you enormously and I believe strongly in your mission. But you must be able to do better than this. To protect science and scientists, to promote ethics in publishing, and to discourage future misconduct in publishing - please do better by your contributing authors. 

While I was glad she provided at least something , when I looked at the study shared, the poor quality of the study (for making any causal inference, at least) leapt off the page. This is a cross-sectional study (which can never be used for causal inference), with no control group (meaning, no ability to know if outcomes were related to the pill, or something else), which excluded women who did not report side effects (thereby inflating the reported proportion of those who did report side effects). It was also unclear whether all women reporting mood changes had reported negative mood changes (other studies have found improvements in mood as a result of hormonal contraception, so this is important).

That WOMEN DESERVE BETTER when it comes to having access to accurate, scientifically-based information about important health issues - especially from people who are trusted by the public. We deserve a reliance on evidence (and an openness to valid, methodologically-based critique of evidence!) from journalists, bloggers, advocates, providers, scientists...from everybody. Why? Because relying on rigorous scientific evidence is the only way that we can make true progress towards improved health for all. 

Anecdotal stories are highly meaningful to each individual, should not be ignored by clinicians, and are sometimes important signals for larger issues. But scientists and others must be careful not to rely on anecdotes instead of data when looking at issues on a population level. This article (and the many others like it) risks scaring women away from a method that might otherwise be a good fit for them, which is no laughing matter when over 50% of pregnancies in the United States are unintended (and nearly 50% in England and Wales), and when unintended pregnancy may also be associated with mood disorders or complicate treatment for women with pre-existing mood disorders. Women need options; what works well for you may not work well for me, and vice versa. 

Roberts concluded her article by noting that the whole thing "makes [her] just a little bit angry. Not irrationally angry. Not irritable. Just proportionately, understandably angry."  

You and me both, sister.  You and me both.


References: 
Mood swings? It might be more than PMS… By Alice Roberts.  The Guardian/The Observer. Published July 19, 2014.

Hatcher RA, Trussell J, Nelson A, Cates W, Kowal D. Contraceptive Technology, 20th Revised Edition.  Atlanta, GA: Ardent Media, Inc., 2011.

*Some studies identified on this issue, presented in no particular order, and with no claim that this search was comprehensive or systematic.
http://www.ncbi.nlm.nih.gov/pubmed/24043440
http://www.ncbi.nlm.nih.gov/pubmed/23944249
http://www.ncbi.nlm.nih.gov/pubmed/22467147
http://www.ncbi.nlm.nih.gov/pubmed/17629629
http://www.ncbi.nlm.nih.gov/pubmed/17161120
http://www.ncbi.nlm.nih.gov/pubmed/11479103
http://www.ncbi.nlm.nih.gov/pubmed/3978343
http://www.ncbi.nlm.nih.gov/pubmed/22465115
http://www.ncbi.nlm.nih.gov/pubmed/23864301
http://www.ncbi.nlm.nih.gov/pubmed/24015872
http://www.ncbi.nlm.nih.gov/pubmed/23219471
http://www.ncbi.nlm.nih.gov/pubmed/23121822
http://www.ncbi.nlm.nih.gov/pubmed/23131613
http://www.ncbi.nlm.nih.gov/pubmed/22673038
http://www.ncbi.nlm.nih.gov/pubmed/23152475
http://www.ncbi.nlm.nih.gov/pubmed/22537684
http://www.ncbi.nlm.nih.gov/pubmed/22136510
http://www.ncbi.nlm.nih.gov/pubmed/23833619
http://www.ncbi.nlm.nih.gov/pubmed/22166277
http://www.ncbi.nlm.nih.gov/pubmed/21840911
http://www.ncbi.nlm.nih.gov/pubmed/18288601
http://www.ncbi.nlm.nih.gov/pubmed/18599013
http://www.ncbi.nlm.nih.gov/pubmed/18760521
http://www.ncbi.nlm.nih.gov/pubmed/19041441
http://www.ncbi.nlm.nih.gov/pubmed/17314012
http://www.ncbi.nlm.nih.gov/pubmed/17713839
http://www.ncbi.nlm.nih.gov/pubmed/16580672
http://www.ncbi.nlm.nih.gov/pubmed/16206030
http://www.ncbi.nlm.nih.gov/pubmed/14710055
http://www.ncbi.nlm.nih.gov/pubmed/12128235
http://www.ncbi.nlm.nih.gov/pubmed/22473394
http://www.ncbi.nlm.nih.gov/pubmed/19067135
http://www.ncbi.nlm.nih.gov/pubmed/17688380
http://www.ncbi.nlm.nih.gov/pubmed/17362710
http://www.ncbi.nlm.nih.gov/pubmed/16299641
http://www.ncbi.nlm.nih.gov/pubmed/15236788

As an epidemiologist interested in research on the safety of contraceptive methods, a recent story by Val Willingham on CNN.com entitled "IUD may carry higher risk for breast cancer in certain women" caught my attention. Like many news stories, the study abstract was not directly linked (journalists, can we please fix this?). To Ms. Willingham's credit, she linked to the journal and provided the name of the first author (Dr. Tuuli Soini), so the actual study abstract was not too hard to track down (at least not for someone who regularly mucks around in scientific journals...).

​The abstract clearly noted that among Finnish women treated with use of a levonorgestrel IUD for heavy menstrual bleeding, levonorgestrel IUD use appeared to be associated with several cancer-related outcomes. These outcomes (in the order in which they were reported in the abstract) included: 

(1) A statistically significant 50% decreased risk of endometrial adenocarcinoma (which changed to a statistically significant 75% decreased risk for women who were presumed to have used a second LNG-IUD), 
(2) a statistically significant 40% decreased risk of ovarian cancer, 
(3) a statistically significant 50% decreased risk of pancreatic cancer, 
(4) a statistically significant 32% decreased risk for lung cancer, and 
(5) a statistically significant 19% increased risk of breast cancer.

This information was plainly available in the results section of the abstract, and also quite clearly summarized in the conclusion of the abstract, which reads:

[I'm not even going to scratch the surface of any epidemiological issues in this post, which is focused on the fidelity of what is reported in a scientific study (or even just the abstract!) to what is reported by a journalist. But, to add an obligatory epidemiological disclaimer: None of these associations are definitive; as these are observational data comparing observed cases of cancer to "expected" cases of cancer. To the credit of the study authors this is thoroughly discussed in the manuscript, and to Ms. Willingham's credit, her story notes that: "The research does not say that this type of IUD causes breast cancer" (Sadly, this important detail mattered little to some folks on social media...but that's for another post!)]

Despite the numbers above, Willingham's story focused almost exclusively on the possible 19% increase in breast cancer risk -- and not at all on the possible 32%-75% decreases in risk of other cancers.  

About halfway through the article, Willingham writes: "Investigators found that over time, the device did not significantly raise the risk of uterine cancer or ovarian, pancreatic and lung cancers." 

Err, yes, but!...

Not only did the levonorgestrel IUD "not significantly raise" those particular risks, but it appeared to be associated with a significant decrease in those risks. Is that not information that readers should know, too?  That got lost in Willingham's report (except for a small quote by Dr. Soini buried near the end of the article, which mentions only endometrial cancer). 

So, who cares?  Well, given the current climate around contraception - such as the recent Hobby Lobby decision which stands to have serious consequences on a woman's ability to access the contraceptive method of her choice and on a physician's ability to provide highly effective contraceptive methods such as IUDs, and recent conversations about poorly researched materials focused exclusively on the risks of oral contraceptive pills (which could be more useful if evidence-based and balanced with discussion of method benefits) - there is an awful lot of misunderstanding (or even deliberate misinformation campaigning) around scientific evidence on contraception these days.  I've spent the last few years of my professional life grappling with some of the fallout and confusion that occurred from articles like this one by Pam Belluck in the New York Times. 

When I tried to discuss this issue with Ms. Willingham on Twitter, this was her initial response:

To which I said...

We simply need to expect more from journalists covering scientific issues, especially those in respected outlets like CNN.com.  As Dr. Soini and colleagues note in the concluding sentence of their manuscript: "It is important to always counsel patients about the potential benefits and risks of hormonal therapies."

I couldn't agree more.


References: 
Soini T, Hurskainen R, Grénman S, Mäenpää J, Paavonen J, Pukkala E. Cancer Risk in Women Using the Levonorgestrel-Releasing Intrauterine System in Finland. Obstetrics and Gynecology 2014;doi: 10.1097/AOG.0000000000000356 (in press).

Willingham, V. "IUD may carry higher risk for breast cancer in certain women" Published on CNN Health, July 9, 2014. http://www.cnn.com/2014/07/08/health/iud-cancer-risk/