Chelsea Polis: SLAPPed for calling out tech company’s false data claims
Chelsea Polis was SLAPPed by Valley Electronics in 2020 for challenging claims they had made about the effectiveness of one of their birth control products. Her answers have been edited for clarity and length. She spoke with Caitlin Howard and Meg Ward from Breach Collective, and Mannal Babar from International Corporate Accountability Roundtable (ICAR).
Please start by introducing yourself with your name, where you are located, your profession, and anything else you’d like us to know about you.
My name is Chelsea Polis. I live in New York City, and work at the Population Council, an international nonprofit research organization. I work in a division called the Center for Biomedical Research, where we develop sexual and reproductive health products, including new and improved forms of contraception and HIV prevention. My PhD is in public health, specifically reproductive health and epidemiology. In my career, I’ve focused on issues around contraception, abortion, HIV and other STIs, and also infertility.
I strongly believe that people deserve clear and accurate information about reproductive health, including about their contraceptive options. Basing contraceptive decisions on high-quality information enables people to plan for the future they want, while using the method best suited to their own values, preferences, and lifestyle.
Some of my work in contraception has focused on how to correctly calculate contraceptive effectiveness so that people understand how well a certain contraceptive method works to prevent unintended pregnancy. I have expertise on a range of different contraceptive methods, including fertility awareness based methods of contraception or “FABMs.” FABMs use different biomarkers (signs in the body) and rules for interpreting those biomarkers to help a user identify the span of days during each menstrual cycle when they are most likely to become pregnant if they have sex without contraception. Using that information, people can then adjust their sexual behaviors during that span of days, according to whether they want to try to avoid pregnancy or try to become pregnant.
There are many misunderstandings about the effectiveness of FABMs when used for contraception, and I’ve done research to help clarify what the data say. While some FABMs are more effective than some people might guess, no FABM will ever be as effective as some other contraceptive options like implants or intrauterine devices (IUDs) – and that’s ok! Some people want to use the most highly effective method, other people want to use a method that might have lower effectiveness but has other features that strongly appeal to them – it’s important to let people decide that for themselves, based on reliable information. This is why a large menu of contraceptive options is so important. As a scientist, I try to support people by helping to ensure that the information on which they base their contraceptive decisions is reliable.
The story of your SLAPP began in 2017 when you took issue with information released by Valley Electronics about one of their products. Can you explain that?
Valley Electronics sells a fertility thermometer called Daysy for approximately $330, which tracks daily temperature patterns and menstrual cycle start dates to try to predict the days a user is most fertile. Around 2017, I noticed that Valley Electronics was marketing the Daysy thermometer on social media as being as effective as an IUD (one of the most highly effective contraceptive methods available). As a scientist, when I see a highly surprising statement like this, I want to understand the evidence behind the claim. So, I looked in the peer-reviewed literature, pulled all the studies I could find on Daysy and its effectiveness, and quickly realized they were calculating effectiveness incorrectly.
You reached out to Valley Electronics directly with your concerns first. How did that go?
Yes, I felt it was important to first try to have a private conversation with them to ensure that I wasn’t missing something, and to give them an opportunity to course correct, if needed. Sadly, the email exchange left me shocked.
My direct and private email exchanges with the company in 2017 confirmed that I had identified all of the relevant published data, and expressed my concerns that they had not done the type of study needed to properly estimate contraceptive effectiveness. They noted interest in such a study, but said that “the costs and benefits are all out of proportion.”
I was horrified by that statement. Yes, a properly designed effectiveness study is costly, but what about the costs to their clients of being told that this thermometer is 99% effective against unintended pregnancy (a substantial over-estimate, I believe)? Making serious claims about a health-related device requires high-quality evidence and care - people’s futures could depend on it.
I relayed to Valley: “I have serious concerns regarding the marketing claims Valley Electronics makes regarding the use and effectiveness of Daysy for pregnancy prevention. I encourage you and Valley Electronics to alert Daysy users and potential customers that at present, Daysy lacks sufficient evidence to be promoted as a tool for pregnancy prevention, and to focus instead on collecting high quality evidence to adequately assess the true effectiveness of this device.” They said they would take my concerns to their board for consideration – but never followed up, and I didn’t note any changes in their practices (at least not until over a year later, when the US Food and Drug Administration (FDA) forced them to make changes, after I had flagged my concerns to FDA).
Before this exchange, were you under the impression that they were more ethical and really trying to bring good products to the market for women? How did this exchange change your understanding?
Certainly before that email exchange I hoped there was a good explanation for all of this. Then when I better understood what they were considering as evidence, I thought that they either just didn’t know what they were doing scientifically, or perhaps worse. After the email exchange I was shocked and concerned.
Talk to us about what it was like to go public and actually publish a peer-reviewed paper calling out the company. Why did you think that was necessary? How did you feel taking that step? Had you ever done anything like that before?
In 2017, Valley was basing their effectiveness claims for Daysy largely on a paper from 1998 about a predecessor device (which is concerning in and of itself!). That paper was so old that it was in a scientific journal that had gone defunct, meaning that there was no way to argue for a retraction of that paper. But in early 2018, just a few months after the email exchange I described, fourteen people - including some affiliated with Valley Electronics - published a new paper on the purported contraceptive effectiveness of Daysy, and it, too, was methodologically fatally flawed.
That's when I knew what to do. Now that I had a venue where I could respond to the flaws in their analyses, I wrote a commentary which detailed the methodological flaws in their paper, and submitted it to the same journal. Mind you, I didn’t have funding for this, it was all on personal time - nights and weekends work. But I felt strongly that this situation was dangerous enough to impact people's lives, and that it would take something like this – a battle waged in the pages of a scientific journal – to try to get any corrective action.
The day my commentary was published – June 25, 2018 – I emailed the authors with a link to my commentary, which laid out my concerns and called for their paper to be retracted. I asked that they take the concerns seriously, and perhaps even join me in calling for their paper to be retracted - any scientist should always be open to the possibility that they've made a mistake.
I never received any response.
The journal considered my concerns, and after independent review, acted upon my call to retract their paper due to “fundamental flaws in the methodology which mean the conclusions are unreliable”. Retractions are rare among academic journals, so there was some media interest in it, which I was grateful for to help ensure that the people who most needed this information might see it. During an interview, I used the words “junk science” to describe their retracted study; this is the kind of thing Valley apparently considered defamatory.
On the day my commentary was published, I contacted the FDA to submit an allegation of regulatory misconduct, stating my regulatory concern that Daysy was being marketed as a contraceptive device, without having been cleared or approved by the FDA for contraceptive purposes - a violation of FDA regulations.
In other words, my concern was not only limited to how effective the company was claiming Daysy to be – but also to the fact that they appeared to be marketing the device as a contraceptive method at all! I later learned that my allegation of regulatory misconduct led to the FDA investigating the company, and ultimately, forcing them to change their marketing language, stop referring to the study I had gotten retracted, and stop representing Daysy as a contraceptive.
How did you find out that you were being sued?
I was at my apartment in Brooklyn. It was May 15, 2020, towards the beginning of COVID. We then lived near a hospital being badly hit, so there were sirens all day and refrigerated trucks on the streets because the morgues were spilling over – just sadness and anxiety everywhere. When I read the complaint, it just didn't seem real. As a scientist you never expect to be sued for your work - at that time I didn’t know anybody that had experienced anything like this. I felt like I had taken every step in a respectful and thoughtful manner, and also felt that, at every step, Valley didn't take the opportunity to do the right thing. They never sent a cease and desist letter, so I had no warning it had heated up to the level of a lawsuit for them. Initially, I just went into complete shock, and then felt disbelief and fury after reading the twisted ways they tried to frame things in the legal complaint. Soon thereafter, I developed some awful physical symptoms, insomnia, anxiety, and depression that lasted for some time. I really had to lean on my husband – my absolute rock and hero – to get through those early days.
Did your commentary reach a really big audience, or why do you think they went this route with you?
During 2018 and 2019, I certainly tried to ensure that the commentary had a wide reach. My goal was not to just publish another scientific article, but rather help people make informed decisions. So, I shared my paper with colleagues, Tweeted, and blogged about it. Since many people using FABMs may not be reading scientific journals, I identified social media forums specific to FABMs, and shared what I’d found. People in those forums had a lot of questions for me, and it was great to be able to engage FABM users directly to try to help translate the science.
I don’t know exactly why they decided to sue me, but their lawsuit claimed that I’d caused the company significant financial damage. If any financial damage occurred, I’d argue it was due to their own actions - publishing a flawed study and marketing a product in a manner that violated FDA regulations - and putting people at greater-than-expected risk of unintended pregnancy.
How did the lawsuit impact you, your family, your community or anyone else in your life you feel like speaking about?
It was terribly stressful for me and for my family, who really supported me. All this work I’d done for free, as a public good to help people control their futures, was now somehow imperiling me and my family’s future. I wondered - did I just bankrupt my family? Did I just ruin my career? I knew in my bones that I was correct about my scientific and regulatory concerns, so how could I be sued for bringing it to public attention? It was very destabilizing and isolating - especially because I couldn’t talk about it while the case was ongoing. I developed anxiety and depression. My husband basically had to pick me up out of bed every day. My family worried about me. I had to step back from work for a few weeks. I had to step away from a funded project that would have helped consumers better understand the quality of the evidence and claims behind these technologies more broadly - something I still think is badly needed. So it also felt like a loss to scientific research and consumer protections.
It’s embarrassing to admit how hard it hit me, because I had an amazing support system. I have an incredibly supportive husband and family, and I am a privileged white woman who does not live in financial precarity and who is not an early career researcher. Although the reproductive health research organization where I then worked declined to help me based on not having been named in the legal complaint, my supervisor was kind to me when I was having a difficult time. So, I had many privileges, and yet, I was knocked out for a time. I shudder to think of how somebody without those privileges would fare in a situation like this, and it reinforces my belief that we really need to support scientists doing this kind of work - which is necessary to protect scientific integrity and people, but which is also generally unfunded, often demoralizing, and sometimes dangerous.
Most incredibly - I wound up being connected with a team of lawyers, led by Dori Hanswirth, at Arnold & Porter – one of the best law firms in the world. They ultimately decided to represent me pro bono - an absolute miracle! I wish everybody who faced a suit like this had that kind of extraordinary luck. My lawyers were such a delight to work with, with their hearts in this case to protect freedom of speech, and just absolute legal geniuses and wonderful human beings. Working with them, and the ongoing support of my family, really helped me start getting back to my senses and trusting in the good work I had done.
In the end, I’m happy to say that Valley Electronics lost their lawsuit against me, and they later lost again on an appeal. And I am now able to say that my scientific and regulatory concerns were acted upon by both a scientific journal and the US FDA.
The entire experience was hard on my family and I. It also radicalized me in good ways. It opened my eyes to SLAPP suits: what what they are, how such suits abuse the legal system and target people speaking out on matters of public interest, the patchwork of anti-SLAPP laws that we have in this country that – just like with abortion access – means that how much protection you have depends on where you live. So after we won, I was like, okay, now I need to do whatever I can to help protect others who might find themselves in a terrible ordeal like this, especially those without the privileges I had. So, I found ways to support other scientists sued for speaking out, looked for ways my story might help advance federal anti-SLAPP legislation, and more.
Did this change how you think about free speech?
It has given me a layer of second guessing. When I say things publicly, there are more questions running in the back of my mind, second guessing if this word or that will be unfairly used against me. I'm a scientist, I try my hardest not to say things without solid evidence, and if I make a mistake, I try to take accountability - so I’m accustomed to a healthy level of second-guessing myself! But this experience introduced a level of second-guessing above and beyond all that, and which should not be necessary. If you're going to speak out about a company in a way that's fair and evidence-based, in a way that's honest and truthful, you should be able to speak freely and plainly – and to do so directly to the people who might be most impacted by the information.
Ultimately, though, would I say that that little voice in the back of my mind actually stops me from saying things I truly believe now? No, because at the end of the day it's the right thing to do. Scientifically and morally, it’s the right thing to do – and it can actually really matter.
