09.05.18

In Rejecting Data from Human Subject Research EPA Endangers the Future and Disrespects the Past

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This blog was written by Jennifer S. Bard, J.D., M.P.H., Ph.D., Professor of Law, University of Cincinnati College of Law (on academic leave), Scholar, the O’Neill Institute

By its own analysis, the  EPA predicts that its loosening of the restrictions on pollution emitted by coal-fired power plants will result in “ 1,400 premature deaths annually by 2030 from an increase in the extremely fine particulate matter that is linked to heart and lung disease, up to 15,000 new cases of upper respiratory problems, a rise in bronchitis, and tens of thousands of missed school days.”

But this is a small number compared to other proposals waiting in the wings which will increase the danger that Americans face from the EPA’s increased tolerance for toxins in our air and water.  Recently, two Harvard professors, David Cutler, a public-health economist, and Francesca Dominici, a biostatistician, published an essay in JAMA in which they used EPA’s own estimates to conclude that the collective impact of currently proposed policy actions would result in an additional  80 Million  premature deaths over ten years.

Perhaps anticipating how concerned the public is likely to be when they hear of  death tolls large enough to fill Cowboy Stadium, EPA has taken the remarkable step of protecting itself from the bad press by engaging in a whole sale rejection on the human harm data on which such estimates are currently made.

It has done so by proposing a rule “Strengthening Transparency in Regulatory Science” that would reject existing scientific data on the toxic effects of pollution by only allowing the EPA to calculate potential loss of life or illness from studies “for which the underlying research data” are “”publicly available in a manner sufficient for independent validation.” 

As Paula Dinnerstein https://www.peer.org/news/news-releases/epa’s-new-scientific-transparency-exempts-pesticides.html of Public Employees for Environmental Responsibility describes  it “Under a false flag of scientific transparency, Pruitt’s scheme hobbles scientific work used to protect the public but shields industry data that may demonstrate the public health peril.”  Dr. Robert Asch used the same phrase in an editorial in the Journal of Internal Medicine.

In particular, to demand the identify of research subjects,  the EPA  seeks to undermine the entire statutory framework for protecting the safety and privacy of the volunteers who are the foundation of all scientific and medical progress—and without them we would be moving forward in a world devoid of reliable information.

It is no wonder that the EPA has been flooded with thousands of letters from the country’s most eminent medical and scientific institutions, as well as  dozens of organizations like the Climate Science Legal Defense Fund, the American Association for the Advancement of Science, and the Ecological Society of America, urging them not make a decision that would effectively erase fifty or more years of careful scientific research.  Among those studies that would no longer qualify is the highly influential An Association between Air Pollution and Mortality in Six U.S. Cities that was published in the New England Journal of Medicine in 1993 and has been cited 3500 times since then.

Representative of these letters is the one from Harvard University explaining that  “[c]ontrary to EPA’s stated goal of improving the basis for its regulatory decisions, requiring the  public availability of all raw data will instead undermine EPA’s ability to make reasonable decisions. This requirement will effectively prohibit EPA from considering studies that by design are based on data that  cannot  be made publicly available due to laws and contracts designed to protect patient and human subject privacy and ensure willingness of people to  participate in research by sharing their private information with researchers.”

One of the many structural flaws with this proposal is that it discards existing data as unreliable without any attempt to verify it using other methods.  In a very recent essay in the New England Journal of Medicine, Dr. Joel Schwartz  both details the challenges of protecting the privacy of individuals who contribute information to a study on the effects of air pollution and makes an additional important point: “the ‘gold standard’ of science is not reanalysis but replication.”  While existing regulations that limit exposure to pollution means that people living in the U.S.A. are not exposed to the same levels of toxins as those in the past, there are areas of the world where people live with air and water quality that should be the stuff of nightmares.  

But even if there were some justification for demanding new data on the harm caused by air and water pollution, let alone throwing away information  from studies that the government itself commissioned and payed for, the assault on scientific research through the rejection of the laws designed to protect those who volunteer as research subjects has the potential to be catastrophic.    What follows from a government proposal to reject data collected under current human subject protections—a decision to stop funding human subject research?

As DePaul Professor Dr. Craig Klugman wrote recently, “By…saying that protecting people is “secret science” then one has a catchy phrase and essentially dismisses all research on human health.“ He notes that demanding access to the private information of research subjects would essentially “ban health research based on actual people and records from being considered in environmental rule setting.”

No matter how great its distaste for the research findings of the past, EPA’s proposal to reject the existing data on the harms of pollution unreasonably disrespects the dignity, altruism, and often bravery of individuals who, with no possible benefit to themselves, subjected themselves to additional study, poking, and prodding as well as sharing their most private and personal health information.  Nor does it make it possible to develop future scientific policy on data acquired from humans.  As Drs. Sharona Hoffman and Andy Podgurski explain, even research that involves review of  de-identified medical records triggers concerns about privacy and dignity of those involved

Looking beyond EPA, rejecting data based on “unidentified” research subjects is effectively pulling the thread that would unravel the greatest advances in  gene therapy, treatment for premature infants, organ donation  and thousands of other scientific and medical advances on which we rely.  

In 2001, the National Bioethics Advisory Commission (NBAC)  explained the importance of respecting and protecting those who put themselves at risk for others by volunteering to be research subjects  writing that “[f]or many citizens, scientific discoveries have alleviated the suffering caused by disease or disability. Nonetheless, the prospect of gaining such valuable scientific knowledge need not and should not be pursued at the expense of human rights or human dignity. In the words of philosopher Hans Jonas, “progress is an optional goal, not an unconditional commitment, and…its tempo… compulsive as it may become, has nothing sacred about it” (Jonas 1969, 245).”

No one benefits from willful ignorance or deliberate disregard of the facts. Erasing the altruism of past research subjects in order to disregard data that may slow  rollbacks of existing environmental protections is wasteful, shortsighted and, above all, disrespectful. 

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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