The Heart of the Battle
How the Medical Establishment Sabotages the Fight Against Chronic Infections (Part 3)
By 2017, when Rick Martin purchased Pathogenius and consolidated its commercial arm, Apollo Health Technologies, into one company, the newly named MicroGenDX, he knew two things:
First, the adoption of Next Generation Sequencing as the standard of care for chronic bacterial and fungal infections would relieve a lot of people of their suffering.
Second, the medical establishment would strongly resist its adoption.
Medicine’s risk-averse nature has a positive side, Rick understood. It provides a powerful defensive shield against false claims and outright quackery. Spectacular cases like Elizabeth Holmes’s Theranos, when medicine lets its guard down, underline the need for skepticism.
Dr. Michael Schmidt, Professor of Microbiology and Immunology at The Medical University of South Carolina and the host of the influential podcast, This Week in Microbiology, comments: “Medicine being risk averse, [it] doesn't like to change its Standard Operating Procedure. Not until there's overwhelming evidence that it's not going to make physicians look silly, look stupid, or more importantly, lead to bad outcomes.”
Along this line, Infectious Disease Specialist Dr. Clifford Martin recalls with what difficulty doctors have accepted other innovations: “I remember when we first started using BNPs (B-type natriuretic peptide) to diagnose and treat congestive heart failure, you would have thought that they had asked everybody to dance round naked. It was very shocking to everybody that you could use a lab test to do this—what about the physical exam and blah, blah, blah. Twenty years later we use BNP without exception.”
Rick Martin remembers, of course, his own experience of recommending fluconazole over “shake ‘n’ bake” amphotericin in the first years of the AIDS epidemic. As a young firebrand, he had virtually thrown a fit to save that one young woman’s life. Today’s generation of doctors might laugh at the idea of using “shake ‘n’ bake” amphotericin instead of fluconazole, but the generation before them was slow to adopt a new drug, even with a mountain of data in hand.
Medicine’s risk averse nature has a long history. It literally took hundreds of years between the time that lime juice as a remedy for scurvy was known and when it was adopted by the British—just in time for Lord Nelson to win the battle of Trafalgar.
An immense amount of work lay ahead. How would MicroGenDX redirect the entire medical establishment? Turning an ocean liner in the opposite direction mid-ocean seemed far simpler; this was more like getting the Orient Express to leap its tracks, turn in mid-air, and head North.
The medical establishment’s resistance to MicroGenDX’s molecular testing came from every quarter and still does.
As the CEO of MicroGenDX Martin ramped-up activity on the two-pronged approach he had been pursuing since founding the company’s commercial arm: research to prove the technology’s therapeutic utility and using his sales experience to build a robust network among leading physicians while educating them in the technology’s capabilities and use.
As noted, Martin began commissioning research studies even before becoming MicroGenDX’s CEO.
The first such research was a randomized control and outcome study led by Dr. Michael McDonald and Dr. V. Mouraviev (“An implementation of next generation sequencing for prevention and diagnosis of urinary tract infection in urology”). It compared NGS versus culture in treating UTIs and was published in The Canadian Journal of Urology. Reviewers savaged it. They seemed to take offense at anyone questioning the “gold standard” of traditional cultures. The data were plain to see, but commentators simply could not believe NGS out-performed traditional culture, with patient symptom scores coming down faster in the NGS group.
Rick Martin thought NGS might gain a fairer hearing if subsequent studies were led by top physicians in their field. Nameplate associations might accelerate acceptance. For the next study he turned to Dr. J. Curtis Nickel, whose qualifications positioned him as the “dean” of urological studies for all of North America, with over 625 publications to his credit. Professor Emeritus, CIHR Tier 1 Canada Research Chair in Urologic Pain and Inflammation, at Queens University, he had received multiple achievement awards from the American Urological Association.
Even so, Rick warned Dr. Nickel there might be pushback. Dr. Nickel laughed good-naturedly and assured Rick they’d have no trouble publishing.
The study complete, Rick Martin received a phone call from Dr. Nickel. He had never seen anything like this—the journal to which they had submitted the paper, PLOS-One, rejected it, citing several reasons, the first among them being: “They did not like our technology platform (MicroGen DX).”
Dr. Nickel sadly concluded that the opposition to MicroGenDX’s and his research may have been, in part, politically motivated. Dr. Nickel comments: “I've seen the politics in other fields, such as, you know, oncology, prostate cancer research, new biologics. That was never ever the case in infectious diseases in my experience for 35 years. But for some reason—and I don't understand why—but politics, academic politics, has crept into the field.”
This cannot be written off as merely special pleading on Dr. Nickel’s part. Such politics are now rife in the world of scientific research journals. No less an authority than Dr. Marcia Angell, former Editor-in-Chief of The New England Journal of Medicine has said, “…conflicts of interest and biases exist in virtually every field of medicine…I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”