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Ponesse: The elephant in the room: Regulatory capture?

Posted by Dr. Julie Ponesse

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Fri, Mar 11, 2022

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01:36 AM

Problems arise when regulatory bodies are financially incentivized to do what is not clearly in our best interests

Ponesse: The elephant in the room: Regulatory capture?

In a perfect world, there would be no deception or manipulation, no ulterior motives, and no conflicts of interest. In this world, doctor’s goals and interests would be clear, transparent, and perfectly aligned with those of their patients. Drugs would be prescribed only when needed and surgeries assigned only when there is no safe, effective alternative. Health care would be apolitical, and pharmaceutical companies wouldn’t have marketing divisions.

Is this the world in which we live? How you answer that question likely depends on how you feel about a number of other issues: Whether state intervention in health care is good, whether the mainstream media is unbiased in its delivery of information about health, and whether or not there are conflicts of interest in medicine.

Three key ideas have fueled the acceptance of the COVID narrative over the last 2 years: 

  1. pharmaceutical companies and governments are functionally independent
  2. both are motivated solely by the public good
  3. pharmaceutical companies create products in response to human need (and not the other way around)

But there is much that undermines these ideas. Consider the following example. 

Medical “regulatory capture”:

The managed care giant Kaiser Permanent is one of the largest employers to implement a COVID-19 vaccination mandate for its 300,000 employees. Kaiser claimed that it was simply following CDC guidelines, but it is the predominant member of the CDC’s Vaccine Safety Datalink (VSD) collaborative project, and a leading member of the Advisory Committee on Immunization Practices (ACIP). Therefore, Kaiser has an integral role in creating the guidelines that it claimed only to be following. And the two chief public health institutions in the United States, the CDC and FDA, are not impartial, independent decision-makers guiding health policies only for the sake of the public good. Rather, they are influenced by entities with financial interests that potentially conflict with public interest.

Another example comes from north of the border. In 2021, Health Canada released a video which was made to encourage COVID-19 vaccination. It was produced by “19 to Zero,” which describes itself as an independent, non-profit organization, but its sponsors include the Vaccine Confidence Project, GSK, and the vaccine manufacturers Pfizer and Moderna.

Nothing new under the sun:

Medical “regulatory capture” — the phenomenon that occurs when a regulatory agency that is created to act in the public interest instead advances the interests of corporations or others groups that the agency is charged with regulating — is not a new phenomenon. In fact, FDA, CDC, and Data and Safety Monitoring oversight have been overly influenced by the pharmaceutical industry for some time. 

Consider the opioid epidemic, which has conservatively caused the deaths of 500,000 American lives since 1999. Although the abundance of harm caused by the overprescribing of opioids is clear, that harm has been obscured by the efforts of the pharmaceutical industry to shape patient perceptions of pain, and influence how doctors think about the safety and effectiveness of these drugs. Purdue spent $207 million marketing OxyContin which, five years after its release, generated an annual revenue of more than $1 billion.

Fabricated desires:

Where do your desires come from? How do you make decisions about how to satisfy those desires?

Regulatory capture in health care isn’t really possible unless we are convinced that we have desires, and even needs, that we wouldn’t otherwise have.

In The Affluent Society (1958), John Kenneth Galbraith explained how corporations use advertising not just to inform us about products that satisfy our independently determined desires, but also to “bring into being wants that previously did not exist.” 

Companies often sell their products, in other words, by fabricating desires: first, they create the desire for the product, and then they offer the customer a way to satisfy that desire. Desires, in other words, are created by the very processes through which they are satisfied. Instead of making products customers want, companies are making consumers who want their products. It is like a doctor routinely running over pedestrians in order to keep the hospital beds full. 

The presence of competing interests doesn’t necessarily create bias in decision-making. A corporation can have a financial interest in a certain outcome without being motivated primarily by that interest (e.g. The case of Merck Pharmaceuticals mentioned in my first column, “To begin is half the work…”). But problems arise when regulatory bodies are financially incentivized to do what is not clearly in our best interests. This “regulatory capture” can make things like vaccine mandates appear more scientifically, legally, and ethically justified than they are, and can ultimately cause downstream harms that can happen when human health decisions are subject to the profit motive.

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine but also in terms of teaching and research.” 

—Arnold S. Relman (Professor, Harvard Medical School, and former editor of the New England Journal of Medicine)

 

Until next week,

Julie

Julie Ponesse, PhD

Ethics Scholar

The Democracy Fund

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