Last week news broke that a significant study into the effects of hydroxychloroquine for treating COVID-19 relied on data that has now been called into question. The effects of this study, and other studies that relied on data from the same source, were profound, leading to changes in planned studies and in treatments for COVID-19 being prescribed to patients. The fact that this data comes from an unaudited source highlights the ethical concerns that stem from having an increased corporate role in science.
In late May a study published in the elite medical journal The Lancet suggested that COVID-19 patients taking chloroquine or hydroxychloroquine were more likely to die. The study included over 96,000 patients, relying on electronic health data from the company Surgisphere run by Dr. Sepan Desai, who was also included as a co-author of the article. It found that at 671 hospitals where COVID-19 patients had been prescribed hydroxychloroquine, the risk of death was over twice as great as patients who were not prescribed the drug. An additional study using data from Surgisphere investigated the uses of blood pressure medication and was published in a paper for The New England Journal of Medicine. A third paper using Surgisphere data was available as a preprint which suggested that ivermectin significantly reduced mortality in COVID-19 patients. All three papers have been retracted.
The retractions occurred after discrepancies were noticed in the data. The reported doses of hydroxychloroquine for American patients was higher than FDA guidelines and the number of Australian deaths were higher than official statistics. There was also a discrepancy between the small number of hospitals included and the vast number of patient records. Following this, independent auditors were asked to review the data provided by Surgisphere; however, the company refused to provide the data, citing confidentiality requirements with the hospitals. Yet investigations found that no hospitals located in the US admitted to participating with Surgisphere.
Surgisphere itself is also a suspect source. The company was founded in 2007 but has little online presence. Their website does not list partner hospitals or identify its scientific advisory board. It claims that the company has 11 employees. Their enormous database doesn’t seem to have been used by peer reviewed studies until May. Desai himself also has a colorful history, including a record of three outstanding medical malpractice suits against him.
The studies had significant impact world-wide. Following the report that hydroxychloroquine increased mortality rates in patients, the WHO announced a “temporary” pause into their studies of hydroxychloroquine (they have since resumed their efforts). The studies also played a role in the national conversation about the drug in the United States following President Trump’s announcement that he had been taking it to combat the virus. The preprint on ivermectin was never officially published but it did lead to changes in treatment protocols in South America. In Bolivia a local government planned to hand out 350,000 doses of the drug after receiving authorization from the Bolivian Ministry of Health. The drug was also cited as a potential treatment in Chile and Peru.
This episode highlights several general moral issues. Retraction scandals at a time when the public is looking to and relying on medical science are dangerous. The situation is intensified by the fact that these controversies are tied into the political debate over hydroxychloroquine, as it may undermine science along partisan lines. Polls show that Democrats are far more likely than Republicans to have a great deal of confidence in scientists to act in the best interests of the public — yet such scandals further undermine public trust and make science seem more partisan or politicized.
The matter also raises ethical issues within the sciences. According to Ivan Oransky from Retraction Watch, the case represents larger systematic issues within the sciences, noting that even leading journalists rely too heavily on an honor system. For example, the pandemic has led to warning signs about the use of preprints in journals, which have moved away from a means of getting feedback while studies are being finalized to a means of sharing “breaking data” as fast as possible, despite the lack of peer review.
The Surgisphere episode highlights the ethical pitfalls of science relying on private sector companies for research. Since the twentieth century the private sector has been an increasing source of scientific funding. In the United States, private funding accounts for 65% of research and development spending in 2013. There are good reasons for private sector investments and corporate-university level partnerships. The public sector has shown less willingness to supply the needed funding. As Ashtosh Jogalekar points out in an article for Scientific American, investments by private interests have allowed for many projects to be funded which might not be funded otherwise. He notes, “For these billionaires a few millions of dollars is not too much, but for a single scientific project hinging on the vicissitudes of government funding it can be a true lifeline.” It has also been noted that private funding can ensure cost-effective replication studies are possible, especially important since efforts to produce reproducibility were only successful in 40% of experiments published in peer-reviewed journals.
On the other hand, according to Sheldon Krimsky, the author of Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?, has observed several problems that occur when scientists work together with private corporations. Krimsky finds that publication practices have been influenced by commercial interests: the commercialization of science has led to a decline in the notion that scientists should work in the public interest, and sharing data becomes more problematic given the use of paywalls and intellectual property protection. This makes it more difficult to verify and check data that is used.
There are many examples where a corporation can make sharing data problematic. Such scenarios could include a company that chooses not to release their findings if they are unwelcome, or a corporation that claims data as intellectual property, making it difficult for others to use research (Diamond v Chakrabarty began the precedent for allowing genetically modified organisms to be patentable). And, of course, the Surgisphere episode is an example of university level researchers working in collaboration with a private company where the company has control of the data. Such cases allow for fraud and a lack of oversight.
One of the proposed solutions is to move towards “open science,” making publications, data, and other information open and accessible to everyone. Such a move would allow for both increased transparency and accountability and more rigorous peer-review. Under such a system, falsified data would be more difficult to provide and caught more easily.
While many of these issues have been brewing for years, it is not every day that a single published study can have the kind of global impact or public notoriety that came with investigations into the effectiveness of hydroxychloroquine, even while other independent studies have also demonstrated its ineffectiveness. The ethical fallout from this scandal is thus far more obvious to the public, both due to the speed of events and the publicity surrounding the studies. Indeed, there have already been calls to stop private speculation into COVID-19 research; part of this call includes the position that all intellectual property should be made available for free to the international scientific community for fighting coronavirus. The question now is what specific reforms should be implemented to prevent scandals like this from happening again?