LTE: Policies for essential goods and public health

Norman Wang, Op-Ed Contributor

In a recent op-ed, Caleb Nunes expressed concerns about comments and proposals by former President Donald Trump on the economy, characterizing them as “reckless.” One item discussed in Trump’s Feb. 27 speech was the support by “Biden and the globalists” for “massive, anti-American, multinational agreements that send our wealth and factories overseas.” It should be noted that offshore manufacturing of “essential goods” not only has public health ramifications, but also has raised concerns among members of the Democratic Party.

As a practicing cardiac electrophysiologist at a major health system, I can attest that overreliance on foreign manufacturing of critical medical products exposed vulnerabilities within the American health care system. Stark examples of early shortages were masks and mechanical ventilators. 

On Aug. 6, 2020 Trump signed Executive Order 13944 to decrease foreign dependence on essential medical items related to “emerging infectious disease and chemical, biological, radiological, and nuclear (CBRN) threats.” As the pandemic progressed, it became evident that medical goods outside of these classes are at risk due to offshore manufacturing.

Iohexol is a pharmaceutical commonly used during radiological imaging as a contrast agent. It was not on the final list of “essential” medical items created by the U.S. Food and Drug Administration in response to Executive Order 13944. 

On April 19 of last year GE HealthCare, one of the largest producers of iohexol, announced that their production facility for contrast agents in Shanghai was suddenly shut down due to China’s coronavirus mitigation policies. As described by Vizient, a health care consulting company, “nearly all of the U.S. supply for this product comes from the Shanghai plant.”

Iohexol is routinely used for patients undergoing catheter ablation for atrial fibrillation. Situations include computed tomography (CT) scans to define the anatomy prior to ablation and during the ablation procedure itself. To conserve our health system’s supply, physicians in my group stopped performing CT scans except when absolutely necessary and minimized use during the procedure. Substantial time was required to address the change in workflow, including switching to alternative options.

For other critical procedures, there are limited available and comparable substitutes. Interventional cardiologists use iohexol during coronary angiography to identify and open blocked arteries. Some heart attacks are emergencies where rapid treatment can save lives.

Sen. John Hickenlooper (D-Col.) and Sen. Tina Smith (D-Minn.) issued a letter on June 30, 2022 to cardiologist and FDA Commissioner Dr. Robert Califf expressing concerns about the situation. In it, they referred to Califf’s prior comment that the iohexol shortage was “unbelievable,” saying “a patient experiencing a stroke or heart attack in this country might not be able to receive an angiogram.”

The iohexol shortage was not a Republican versus Democratic party issue. It impacted patients irrespective of their political leanings. Moreover, high percentages of politicians from both parties receive financial contributions from pharmaceutical company lobby groups, such as PhRMA. In an interview with NPR, current Vice President of Lachman Consultants John McShane said the offshoring of pharmaceutical manufacturing in the past decades has largely been the result of favorable foreign tax incentives, less expensive labor costs, and less stringent environmental laws in other countries. Thus, American politicians can be financially incentivized to create policies that encourage outsourcing production. 

Although the Shanghai facility resumed full operations in June 2022, the iohexol supply did not return to normal until early 2023. GE HealthCare Technologies Inc. is a publicly traded company based in Chicago with a market capitalization of approximately $36 billion. In response to this incident, it announced expansions in their facilities in Ireland and Norway. There were no plans to begin domestic production. It is not without irony that the National Heart, Blood, and Lung Institute, supported by American taxpayers, funded some of the early clinical research on iohexol. 

Medical companies are part of an indispensable pillar that drives research and health care delivery within a partnership between academia, government and industry. Nunes touted a number of favorable metrics associated with high ranking on The Heritage Foundation’s Index of Economic Freedom. Historically, the United States and peer nations clustered within this group, which have economies best characterized as mixed capitalist, have been responsible for countless breakthroughs in cardiovascular care that have been exported around the globe to save lives and alleviate suffering. Thus, medical innovation may be a reason life expectancy has been positively associated with economic freedom.

In a 2017 conversation about the tension between profits and purpose within the pharmaceutical industry, published in the Harvard Business Review, former Allergan CEO David Pyott said, “A lot of the unrest we’ve seen over the past year is rooted in the idea that wealthy, powerful people are disproportionately benefiting from the changes happening in society.” While the responsibility of publicly-traded companies is often focused on maximizing shareholder value, recent events exacerbated by the COVID-19 pandemic should cause reflection on what, if any, are their responsibilities to the American public.

Free trade between nations does not exist when one country can unilaterally and immediately halt the production and shipping of vital items that citizens of their trading partner depend upon. International trade policies to disincentivize offshore manufacturing are sometimes more than, as Nunes described, “protectionist nonsense.” Absence of domestic production of essential medical goods is a glaring problem in the public health supply chain. 

Norman Wang is a McCormick and Feinberg alum. He can be contacted at [email protected]. If you would like to respond publicly to this op-ed, send a Letter to the Editor to [email protected]. The views expressed in this piece do not necessarily reflect the views of all staff members of The Daily Northwestern.