Today, Melissa White, the CEO of an online condom retailer, attacked the findings of a study that found a small number of the condoms she sells on her website contain a chemical carcinogen called nitrosamines. In her piece, “Cigarettes Cause Cancer; Condoms Don’t,” she critiques the methodology of a report that my organization, the Reproductive Health Technologies Project (RHTP), published in partnership with the Center for Environmental Health (CEH) this past September. She also claims that I declined to comment for her article “on the study’s methodology, the evidence that several brands targeted in their study had undetectable nitrosamines, or on the implications of publicizing or promoting the ‘condoms contain carcinogens’ argument.” I would like to take the opportunity to address her misleading statements directly.
Our report found that progress is being made on eliminating nitrosamines from condoms.
This issue of nitrosamines in condoms is one that requires a delicate balancing of public health concerns. Therefore, I thought it might be helpful to start by setting the context for why RHTP and CEH commissioned the testing of condoms for the presence of nitrosamines.
No governing body has set specific limits for the levels of nitrosamines in condoms, but in 2010 the World Health Organization (WHO) and the United Nations Population Fund (UNFPA) recommended that manufacturers minimize the presence of nitrosamines in male latex condoms. There has been little follow-up testing to see if the WHO and UNFPA recommendation has been implemented. Thus RHTP, in partnership with CEH, commissioned testing to determine if condoms available in the U.S. released nitrosamines.
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What we found was encouraging: Of the condoms we tested, almost one-third did not release any detectable levels of nitrosamines, including some well-known brands with large market shares. Approximately another third released levels that fall below an EU standard for certain rubber toys (the best proxy we could find), meaning that some nitrosamines were detected but at low levels. The remaining third exceeded the EU threshold, some by twice as much. But of those, the makers of half have already indicated to RHTP that they are aware of the issue and taking steps to monitor and reduce the levels of nitrosamines in their products.
Our report acknowledged all manufacturing changes that had been reported to us at the time of publication
Given these results, I find it odd that Ms. White claims that we failed to comment on “the evidence that several brands targeted in their study had undetectable nitrosamines.” We specifically highlight in Figure 2 of our report the seven condoms we tested that had undetectable levels of nitrosamines. We also acknowledge in the footnotes to Figure 1 that one of the manufacturers had provided evidence to us that it had changed its manufacturing process to reduce the nitrosamine levels in its product but its updated product was not yet available for sale in the U.S.; that another manufacturer provided evidence to us that one of its products that has a similar manufacturing process to the product we tested released low amounts of nitrosamines; and that a third claimed it had changed its manufacturing process to reduce the level of nitrosamines in its product but had not provided documentation to us to substantiate that claim. Moreover, we also state that we removed one of the products from the report because its maker had provided documentation to us that it had lowered the nitrosamine levels in the product and the new version was already on the U.S. market.
RHTP provided extensive comments to Ms. White in response to her questions
I personally responded to 3 rounds of questions from Ms. White and repeatedly directed her to the parts of our report that detail our methodology and acknowledge where evidence of manufacturing changes had been supplied to us. Of particular relevance to Ms. White’s claims, the methodology section of the report states:
The condoms we selected for testing varied by color, flavor, feature (i.e., warming or tingling sensation), texture (i.e., ribbed), and thickness (i.e., ultrathin). We also chose condoms based on high in-store availability, large number of units sold in the United States according to the market research company IRI, and with input from issue and industry experts. In addition, we tested condoms that were previously found to have higher levels of nitrosamines and condoms that are marketed as “organic” or “natural.” We acquired the selected condoms by purchasing them from retail pharmacy chains or ordering them from online condom vendors and then shipped them to the Tun Abdul Razak Research Centre laboratory for testing, with one exception. Pre-market samples of Sustain condoms were shipped directly from the company to the laboratory for testing as they were not yet available for purchase at the time.
Furthermore, in an email exchange with Ms. White, dated Nov. 20, 2014, I stated:
We made a great effort to be as transparent as possible in our report and the majority of the questions you’ve asked are available in the methodology section, the footnotes to the tables and text, and the acknowledgments. You are of course welcome to follow up with the lab we used and confirm with them that they conducted the testing for us, the dates of the testing, and the sample size, and to ask them any questions you have about the testing method they used.
We established several firewalls to ensure the independence and integrity of our report. RHTP and CEH staff and consultants were solely responsible for final decisions about the selection of the products tested and the design of the study; with the exception of the Sustain sample sent directly to the lab, all samples were purchased and handled solely by RHTP staff before being sent to the lab; test results were not shared or discussed with anyone associated with Sustain prior to the release of the report; and no one associated with Sustain had any editorial control over the report.
In response to her question, “How do you account for the complete lack of even one medical study demonstrating cause or correlation of condoms with reproductive cancers?” I replied: “To have cited data suggesting condom use can cause reproductive cancers would have been in direct contradiction with our conclusions” and cited our statement in our report that repudiates the use of our study to suggest otherwise:
RHTP and CEH recognize that some people with an anti-condom agenda or a sensationalist bent may seek to distort the results of this study and erroneously claim that condoms cause cancer. Anyone who does so – be it the media, politicians, or advocates – is acting irresponsibly and not in the best interests of public health. Our perspective on this issue is similar to that on contaminants in breast milk. The presence of chemicals in breast milk should not discourage women from breastfeeding their children. On the contrary, the health benefits of breast milk are indisputable, even when the potential for exposure to environmental toxins exists.
Our only interest is in furthering public health
There are a lot of claims being made on both sides of the debate about nitrosamines in condoms by those with a financial stake in the matter. RHTP and CEH have no interest in promoting one particular condom brand over another. We simply want people to have the information they need to protect their health and well-being. That includes knowing that 1) condoms are safe and effective and should be used to prevent HIV/AIDS, sexually transmitted infections, and unintended pregnancy; and 2) there are options on the market to reduce exposure to a substance that is found in food, water, and a variety of consumer products and is unnecessarily present in some condoms.
RHTP and CEH adhere to the values of scientific integrity, evidence-based decision making, and the right to accurate information. And we believe these standards should apply as much to journalism as to policy. Debate on challenging issues is welcome; the intentional spreading of misinformation is not.