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Blog January 29, 2018

Facilitated Disinformation

Disinformation can be facilitated by government regulatory structures—leading to deception and betrayals of trust, regardless of the structures’ original purpose. Significant regulatory failures in health and environmental areas are discussed here. A subsequent post will discuss broader influences contributing to the failures and how to overcome such problems.

There are connections between health risks and environmental risks. Many of these risks are created to serve various economic interests. Then evidence is used to justify the risks, discount them, or ensure they are not properly assessed. This raises the crucial issue of our trust in the reliability of evidence.

Much of human existence depends on trust and so “at some point we just have to trust,” Onora O’Neill emphasized in her Reith Lectures. “All guarantees are incomplete,” she observed, adding that “deception and betrayal often work” for perpetrators and “efforts to prevent abuse … are always less than perfect.” O’Neill recommended “limiting deception” should be “the more fundamental goal.”[1]

Deceiving the Public

Deception was a significant factor in the current public health crisis caused by widespread opioid addictions and related overdose deaths. It began in the late 1990s, after Purdue Pharma released the opioid OxyContin as a prescription painkiller. Purdue claimed the drug presented very little risk of addiction because its patented tablet formulation was “believed to reduce the abuse liability.” The safety claim was important to approval of OxyContin by the US Food and Drug Administration (FDA), as well as to subsequent promotion and marketing of the drug to physicians and the public.

Promotion and marketing were so successful that by the early 2000s sales of this opioid had risen into the billion dollar a year range. But contrary to the safety claim, many patients who were prescribed OxyContin became addicted to it, and rates of addiction and overdose “soared alongside the rise in prescriptions.” Substantial numbers of those abusing this legal drug then turned to black markets, resulting in further increase in opioid overdoses along with more deaths, especially after fentanyl came into wider circulation by 2014. In addition to adverse effects on addicts and their families, diverse public health and emergency services required additional funding and time allocation to contend with the growing problem.

These effects led to legal actions against Purdue. In 2007 the company “pleaded guilty … to criminal charges that they misled regulators, doctors and patients about the drug’s risk.” It then “agreed to pay some $600 million in fines and other payments.” Subsequently, Purdue reformulated the OxyContin tablet for US sales, but “continued to sell the original formulation of OxyContin in Canada” for more than a year. The crisis continues and additional legal actions against Purdue arose in Canada and the US.

Deception has also been fundamental to growing pollution. In 2017, The Lancet Commission on Pollution and Health found: “Pollution is the largest environmental cause of disease and premature death in the world today … responsible for an estimated 9 million premature deaths in 2015 …” Using the European Union’s definition of pollution, the Commission noted that it also “destroys ecosystems and is intimately linked to global climate change.” Discussing a variety of air, water and soil pollution types the report said, for example, that “the effects of chemical pollution on human health are poorly defined and … almost certainly underestimated.”

The Commission explained this was in part because “fewer than half” of the several thousand “chemicals and pesticides” that are “produced in the greatest volume” and “widely dispersed in the environment” have been subjected to “any testing for safety or toxicity.”

In addition, producers of pollutants have gone to extraordinary lengths to discount scientific evidence of their harm.[2] As illustrated by past instances such as DDT and PCB pollution, deception as well as absence of risk assessments can be exploited for disinformation—in the form of baseless safety assurances—about new generations of chemicals. But even where evidence of risk has been established, it may be discounted by regulatory authorities.

The Lancet Commission concluded “Pollution is one of the great existential challenges … Like climate change … pollution endangers the stability of the Earth’s support systems and threatens the continuing survival of human societies.” Also in 2017, the International Institute for Sustainable Development published a study on health and other costs of pollution in Canada.

Two UNICEF reports described the adverse effects of air pollution on children, with the longer report (2016) discussing diverse aspects. It outlined special physiological vulnerabilities of children, including brain, respiratory system and immune system development, as well as prenatal risks such as low birthweight that can have life-long consequences. The report also reviewed means of reducing pollution and its impacts, stressing the need for action now to avert even worse consequences for future generations.

The shorter UNICEF report (2017) focused on the effects of air pollution on brain development. An example is the organophosphate pesticide chlorpyrifos, which can cause neurological damage in fetuses and children. Despite this risk, it is used extensively in agricultural spraying worldwide, and the American regulator discounted its own scientists’ advice that it be banned in the US.

Regulatory Structures

American regulatory structures, such as the FDA and the Environmental Protection Agency (EPA) with their legislative mandates have been models internationally for decades. The FDA’s origins extend back a century but in 1962 major amendments to its governing Act were passed (Kefauver-Harris bill). The EPA was newly established in 1970. In both cases US government action was in response to mounting public concerns.

Prior to 1962 the FDA lacked sufficient authority to properly assess drugs for safety and efficacy. Pricing practices of drug manufacturers and their patent protections also were at issue. Extensive drug-industry lobbying attempted to restrict the scope of the amendments. Despite the lobbying, a substantial bill was passed soon after the thalidomide (birth-defect) scandal became an international issue. The amendments required manufacturers to provide evidence of efficacy and safety for prescription drugs, and set out criteria for production of such evidence. However, provisions in the draft bill to change patent laws were removed in the final legislated version.[3]

Writing in the 1990s and later, David Healy explained that the Kefauver-Harris bill had weaknesses not fully appreciated in 1962. These contributed to narrowing the conceptions both of healthcare held by physicians and patients and of evidence for FDA approvals.[4] Thus they helped provide a basis for increased influences of drug companies in public and private healthcare delivery systems, influences achieved by “capitaliz[ing] on the very protections put in place by Senator Kefauver.”[5] Despite its beneficial aspects, the post-1962 FDA structure was one of the factors facilitating disinformation on a number of drugs so that risks either were not identified or were tolerated by the regulator.

President Nixon established the EPA in 1970 as “an autonomous regulatory body to oversee enforcement of environmental policy.” Its broad mandate included enforcement of standards, research on effects of pollution and methods for controlling it, developing protection programs, recommending policy changes, and assisting others by grants and technical advice “in arresting pollution of the environment.” As with the 1962 FDA bill, this action was preceded by events generating public awareness and concern.

The Russell-Einstein Manifesto of 1955 initiated worldwide efforts to warn people of the dangers to health and the environment from radioactive fallout caused by nuclear weapons tests. A multi-year campaign made this pollution risk well known. In 1962 Rachel Carson published Silent Spring, an eloquent and compelling account of the importance of the environment and the lack of effective regulation of chemical pollutants such as DDT. Many were carcinogenic and there was a marked increase in US cancer occurrence rates during the previous half century.[6] Another “reason why Silent Spring was an instant success in America is that the thalidomide scandal had erupted there just two months before.”[7] Two later events further increased political pressure for action: the 1968 UNESCO Biosphere Conference in Paris and the massive Santa Barbara oil spill in early 1969.

Political Economy Influences

Beginning around 1980 (when neoliberalism’s rise to ascendancy also commenced), American legislation motivated by political-economy considerations had far-reaching effects on aspects of healthcare. These enactments were influential internationally and among the effects in the US were: growth in the drug industry, and weakening of efficacy and safety standards through flexible interpretation of the 1962 FDA criteria. The FDA’s approval of OxyContin in 1995 was an instance. Another instance involved the anti-depressant Paxil, found capable of causing birth defects when prescribed to pregnant women, ironically the same type of concern that stimulated the 1962 FDA amendments as Healy observed.[8] This generated lawsuits and settlements in the US (including a jury verdict and award) and in Canada.

Two significant legislative changes were the Bayh-Dole Act (1980) and the Prescription Drug User Fee Act (PDUFA, 1992). The former encouraged commercialization of university research and privatization of profits by allowing patents and licences despite much of the research having substantial public funding. The latter was specific to drug regulation, instituting a system whereby drug companies could provide funds to the FDA in return for the regulator expediting its assessment processes for drug approval applications. The PDUFA thereby created potential conflicts of interest. The Canadian drug regulator also “has two masters,” as Olivieri Lecturer Joel Lexchin observed.

In his 2003 discussion of benefits and risks of university commercialization, Derek Bok explained the impetus for Bayh-Dole. There was concern in the late 1970s over slower economic growth and lower corporate profits due to such factors as “industrial competitors in Europe and Japan.” There also was a recognition that advances in biochemistry and genetics “had suddenly made academic research commercially important to industry.” The following decades saw rapid growth in a diverse and prosperous economic sector benefiting universities and industries financially, the latter especially. Thus “these initiatives achieved their purpose,” Bok noted.[9] There were similar initiatives in Canada.

Bok gave examples of the risks to the academy and to the public in the US and Canada, not least from the influences of drug companies on medical education and research. The risks also included individual or institutional conflicts of interest, violations of academic freedom, breaches of professional or scientific integrity, and attempts to weaken institutional autonomy.

Carl Elliott observed that “competition gives industry-backed scientists an incentive to stretch the truth” and various forms of deception arose, including ghostwritten articles in scientific journals.[10] Another possible avenue for disinformation is strategic placement of favorable journal articles about drugs that have come under scrutiny, an approach that could be used for “managing ‘science,’” Healy commented.[11]

Such risks could entail another risk: breaches of agreements with patients who were subjects of clinical research for their informed consent, because of confidentiality provisions in research contracts. A significant contributing factor was that relevant institutional policies were not revised so as to limit deceptions until long after Bayh-Dole.

In 2004 Marcia Angell analysed the effects of these legislative changes on delivery of healthcare. She noted the extensive influences of the large drug manufacturers (“big pharma”): “the heavy hand of big pharma is felt at all levels of government.” Among “the favours big pharma has extracted from a compliant Congress” were “extending drug monopolies” and “huge tax breaks,” as well as not taking action to limit the proliferation of “me-too drugs.” In addition, the 1997 FDA Modernization Act “was a giant giveaway to the pharmaceutical industry” as “it required the agency to lower its standards for approving drugs.”[12]

Around the same time as Angell’s critique, Ray Moynihan called attention to disease mongering: the practice of re-conceptualizing ordinary aspects of the human condition as sicknesses and then marketing drugs purporting to treat them. Angell nevertheless concluded her account on a hopeful note: that because so much of the American healthcare system was adverse to the common good, the electorate would demand action, and Congress would respond by legislating major reforms.

In both the US and Canada a number of policy and procedural improvements were made in order to address specific concerns, but the overall structures were not subjected to major reforms. Meanwhile, annual US prescription drug spending has continued to rise faster than the inflation rate and thus occasional large legal settlements can be accommodated. US Drug spending totaled $323 billion in 2016, having risen 4.8 percent above the 2015 level. This annual pattern is projected to continue for the next five years, during which “several drug makers have pledged to limit annual price hikes to under 10 percent.” (By way of comparison, US military spending totaled $611 billion in 2016.)

Elliott noted that in addition to the political and economic power of big pharma, a second reason for lack of major reforms is the human need to trust, especially where health is concerned. He wrote “Healthcare may be a business now, but it still operates by the old rules,” rules based on trust. “Medical journals still trust authors; patients still trust doctors; … and subjects trust researchers. Nobody wants to admit that the world has changed. Nobody is willing to concede that trust may no longer be warranted.”[13]

A half century after Kefauver-Harris, Healy explained why healthy distrust is warranted:

When it comes to the study of drug treatments, the medical profession has been eclipsed. The public think the FDA has stepped into the breach but in fact pharmaceutical companies now control everything.

Companies decide which trials to conduct, which ones to make public, and what data to release.[14]

The EPA was highly successful during its first decade. Established and initially supported by Republican administrations (Nixon and Ford), the Agency’s effectiveness continued through the following Democratic administration (Carter). However, it was seriously weakened several times after 1980 with the main factors being increasingly persuasive lobbying by the chemical, energy and other industries, and reactionary currents in the Republican Party.

Erosions of the FDA started with Reagan, resumed with Bush (junior), and sharply worsened with Trump, phases that were interspersed with recovery periods. Reagan’s initial EPA administrator showed antipathy to the Agency and its mandate, cutting its budget by 22%, scorning scientific advice, and attempting to weaken standards. She was replaced after being cited for contempt of Congress. The Agency recovered under subsequent Reagan administrators and during the Bush (senior) presidency, as well as during the Clinton and Obama years, but was weakened again during the Bush (junior) years.

Severe weakening of the EPA is a priority of President Trump and his party, which enjoys Congressional majorities. As with Reagan, Trump’s initial EPA administrator shows antipathy to the Agency and its mandate, but the announced and already implemented actions by Trump or his administrator are even more radical. They will have many adverse consequences in both the short and long term. However, as occurred in the early Reagan years, some American citizens and politicians have begun to mount countermeasures, an encouraging sign in otherwise inauspicious circumstances.

In Canada the Trudeau government has undertaken to repair some of the extensive damage to environmental monitoring and protection agencies caused by the Harper government and its policies. Recovery will take years in both environment and climate matters. In healthcare, Canada’s universal public delivery system was not seriously threatened in the Harper years because the electorate was (and remains) sufficiently supportive of universality. However, Canada’s drug regulatory structure is similar to, if not weaker than that in the US, and the eclipse of the medical profession by pharmaceutical companies identified by Healy and others is similar in Canada.

As mentioned above, concerns such as those discussed here will be discussed from broader perspectives in a subsequent post.


[1] Onora O’Neill, A Question of Trust (Cambridge: Cambridge University Press. 2002). viii, 6-8

[2] David Michaels, Doubt is Their Product: How Industry's Assault on Science Threatens Your Health (Oxford: Oxford University Press, 2008); Philip Mirowski and Esther-Miriam Sent (eds.), Science Bought and Sold: Essays in the Economics of Science (Chicago: University of Chicago Press, 2002); Sheldon Rampton and John Stauber, Trust Us, We're Experts! How Industry Manipulates Science and Gambles with Your Future (New York: Centre for Media and Democracy, 2001).

[3] David Healy, Pharmageddon (Berkeley: University of California Press, 2012), 42

[4] David Healy, The Anti-Depressant Era (Cambridge MA: Harvard University Press, 1997), 26-28, 257, 264-265 and David Healy, Pharmageddon, 47-49, 87-88

[5] David Healy, Pharmageddon, 45

[6] Rachel Carson, Silent Spring (: Houghton Mifflin, 1962), Chapter 14 discusses carcinogens.

[7] Joachim Radkau, The Age of Ecology (Malden: Polity Press, 2014), 77

[8] David Healy, Pharmageddon, 44-45

[9] Derek Bok, Universities in the Marketplace (Princeton: Princeton University Press, 2003), 11-12

[10] Carl Elliott, White Coat Black Hat (Boston: Beacon Press, 2010), Chapter 2, 35

[11] David Healy, Pharmageddon, 127

[12] Marcia Angell, The Truth About the Drug Companies (New York: Random House, 2004), 193, 203-204

[13] Carl Elliott, White Coat Black Hat, xv

[14] Healy, Pharmageddon, op. cit., 204

January 29, 2018
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