By Philip Landrigan, MD, Chair, HHRA Science Advisory Committee
As the design of the five-year Global Glyphosate Study (GGS) came into focus in 2018-2019, I served as chair of the Ramazzini Institute (RI) Science Advisory Committee. Melissa Perry, MD, then the co-primary investigator the Heartland Study, served with me on this committee. During those early meetings with RI scientists, we learned that the original design of the GGS would have included only two treatment groups: one fed pure glyphosate, and a second fed Roundup BioFlow, the new GBH formulation containing quaternary ammonium surfactants that is now used in Europe. Roundup BioFlow replaced the POEA-surfactant based Roundup brands that were banned by the EU in 2016 over human-health concerns.
As originally designed by the RI, the GGS would have been of limited relevance in the US. Over the last 50 years most applicators and farm workers in the US, and in most other countries outside of the EU, have been exposed to a formulated GBH containing POEA-based surfactants, such as Ranger Pro.
In response, Dr. Perry and I suggested to RI colleagues that they should add Ranger Pro to the GGS. The RI scientists said they could do so, but that additional funding would be needed to cover the added cost. The Heartland Study Management Team requested a budget from the RI that called for payment of about $950k over five years.
The HS Management Team concluded that the scientific and regulatory value of the GGS in the US, and indeed worldwide, would be markedly enhanced if the GGS included a second POEA-based formulation, such as Ranger Pro. The HS MT therefore agreed to provide the requested funding to the RI on the condition that the funding required to meet the RI payment schedule would not come at the expense of sustaining planned Heartland Study clinical research activities.
In mid-2020, the Heartland Health Research Alliance (HHRA) was incorporated and took over governance, administrative functions, and fundraising supporting the Heartland Study. By the end of 2020, HHRA had also taken over management of all then-existing Heartland Study contracts, agreements, staffing and consultant contracts, and fundraising, including all activities arising from the HHRA-RI partnership.
Looking back, the decision by the HSMT to cover the costs of the added GGS treatment group was a risky one, which increased the challenges inherent in concurrently funding both the Heartland Study and the Ranger Pro feeding groups in the GGS.
However, the addition of the RangerPro treatment group has already paid off. It has provided valuable information that would not otherwise be available. Most importantly, it has shown that RangerPro and other POEA-based GBH formulations are among those most likely to cause leukemia
Going forward, the RangerPro exposure groups will help resolve critical questions on whether and how exposures to glyphosate or GBHs might be contributing to reproductive problems, birth defects, and developmental anomalies, as well as cancer and other chronic metabolic diseases.
Given that glyphosate-based herbicides remain by far the most heavily applied pesticides in the US and globally, with well over three-quarters of humankind exposed on a near-daily basis, time is of the essence in seeking clarity on the adverse health outcomes stemming from exposure to this herbicide.