By MIKE MAGEE
What will be the lasting impact of the Covid 19 pandemic?
We still don’t know the answer to that question in full. But one thing that can be said with some certainty is that it has strengthened the hand of Big Tech and all things virtual. Consider the fact that within the Biden White House administration, 13 senior aides have Big Tech resumes with time spent in firms like Google, Facebook, Twitter, Apple, Amazon, Microsoft and more.
This pandemic-induced scrape with mortality has instigated widely varied responses ranging from existential re-awakenings to explosive entrepreneurship.
In health care for example, health tech start-up’s are altering research, education, care delivery and coordination, data mining, patient privacy and financing.
As we know well from health care, intermingling profit, policy and politics can eventually lead to conflict and recrimination. The current controversy over NIH indirect funding of Shi Zengli’s Wuhan “gain-of-function” viral research through Peter Daszak’s New York based EcoHealth Alliance is a case in point.
But we’ve been there before. In the 1990s, James M. Wilson received a PhD and an MD degree from the University of Michigan, then completed an internal medicine residency at Massachusetts General Hospital and a postdoctoral fellowship at MIT. By 1997, he was one of the leading stars in the new gene-therapy movement, directing his own research institute at the University of Pennsylvania.
The institute focused on adjusting the genes of children born with a hereditary disease called ornithine transcarbamylase deficiency (OTD), which prevents the normal removal of ammonia in the body. Wilson’s experimental technique involved genetic engineering, splicing therapeutic genes into supposedly harmless viruses that, once injected into the body, could carry their payload to defective cells and repair the genetic errors.
Dr. Wilson was attempting to determine the maximum dose of genetically modified material that could be safely injected into affected youngsters. He had enlisted 18 participants, including a teenager named Jesse Gelsinger who had a version of the genetic disease in which some of his liver cells carried the genetic abnormality but other cells were entirely normal. Those who have the full-blown disorder die in early childhood. But with his mosaic, Jesse most of the time felt well, as long as he continued to take 32 pills a day.
Jesse and his parents heard about the experiments in nearby Philadelphia and were anxious to help those less fortunate who had the full-blown disease. When he arrived at the clinic on September 13, 1999, to begin the study, his blood ammonia levels were above normal, which in and of itself should have blocked his participation. Nonetheless, Wilson’s team infused Jessie’s bloodstream with 38 trillion colonies of a virus carrying genes engineered to reprogram his cells. Eight hours later, Jesse’s fever hit 104.5 degrees. Two days later he was brain-dead.
The patent for the technique of genetic modification being studied was owned by a company called Genovo, cofounded by the above mentioned James M. Wilson, the institute director. Wilson owned a 30 percent stake valued at over $30 million, and the University of Pennsylvania, which under the rules of the National Institutes of Health, was responsible for ethical oversight of the research protocol design and execution, was a hidden investor. The informed consent Jesse had signed made no mention of Wilson’s financial conflict of interest, or the university’s, or the fact that some of the prior 17 participants had suffered significant liver inflammation, or that three laboratory monkeys had died from massive inflammatory immune responses to injections of the very same agent.
But the perverse financial incentives and conflicts of interest that led to such risk-taking went further up the academic food chain. Dr. Bill Kelley, an accomplished and aggressive medical researcher from the University of Michigan, had assumed the top post at the University of Pennsylvania in the early 1990s. Kelley’s goal was to achieve dominance in a crowded and competitive local medical market that included six medical schools. The age of genomics was just gaining steam, and Kelley wanted Penn to lead the way and share the rewards. His rapid expansion and heavy investment in technology and personnel had resulted in a reported $198 million loss by the University of Pennsylvania’s health system in fiscal year 1999. No doubt Kelley harbored hopes that Penn’s investment in Dr. Wilson’s gene company, bolstered by NIH grants and private investors, might help balance the books. Jesse Gelsinger’s death ended not only that research but Bill Kelley’s tenure as well.
The point being that regulatory boundaries, full transparency, and self-imposed brakes on profit-infused optimism protect researchers, the public, and society overall. As Big Tech’s romance with Big Health flowers and blooms, our leaders need to step back and consider where we are going, and not just how fast we can get there.
Coming Next: Health Tech: Part II – Powering Up The Vision.
Mike Magee, MD is a Medical Historian and Health Economist and author of “Code Blue: Inside the Medical Industrial Complex.“