A critically important activity, clinical research struggles on the “trust front” as there is a growing perception among large segments of the public that bias and undue commercial influence hijack what is purported to be a science-based system. This unfortunate perception is reinforced with the news that clincial researchers, who violated law and ethical principles, are still getting large payments from industry. But should these researchers, often incredibly gifted individuals, be banned from capitalizing on their skill, expertise and experience for economic benefit moving forward? Should the research firms that employ such individuals share the rational for why they did so with the public? Or are there internal quality-management systems, which promulgate policies and pressures for this issue?
Recently, Science published a piece authored by Charles Piller probing scenarios in which clinical investigators were in the past complicit in legal or ethical violations and consequently were in some cases banned from conducting human trials, at least in the United States. Yet Science shares examples where these researchers still enjoy sizeable payouts from industry. How can that be possible? Is it right? The author utilized the data now available thanks to the Sunshine Act and the Open Payments database.
The James Vestal Case
Mr. Piller writing for Science introduces the case of Texas urologist James Vestal. Back in 2008, the FDA filed a public notice announcing the disqualification of Dr. Vestal after inspections revealed all sorts of problems with the clinical trials the doctor was conducting. For the details TrialSite refers the reader to Mr. Piller’s article in Science, made possible thanks to the support of the Science Fund for Investigative Reporting. The Science-funded investigation revealed that despite these actions back in 2008, Vestal was getting paid big money from 27 pharmaceutical sponsors from 2013 through 2019. He was renumerated about $422,000, including a $340,000 consulting and teaching gig. Mr. Piller apparently attempted to engage with Dr. Vestal for his side of the story, but no luck.
The Farber Case
Piller introduces the reader to the case of Harold Farber, a Philadelphia-based dermatologist disqualified by the FDA in 2005 for illegal possession of anabolic steroids and making “false, fictitious, or fraudulent statement or representations” to a clinical trial sponsor (that is, a drug company that pays for a trial). Dr. Farber committed a “no-no” in GcP, FDA-compliant research: delegating patient exams to an assistant. Sentenced to probation and medical supervision, the doctor had to pay fines and restitution totaling $220,000, primarily to the pharmaceutical sponsor, which happened to be a company producing a dermatological cream. Since that unfortunate milestone in research history, Farber has been compensated approximately $665,000 from 45 medical research firms. Science asked if Farber informed the pharmaceutical company clients about the 2005 incident, but he refused to comment.
Science Survey of Drug Companies
Apparently, Science went directly to the drug companies to get their side of the story regarding both Vestal and Farber. Piller and team sought to understand if the sponsors were aware of the past incidents. Apparently, of the 22 sponsors that actually responded, the party line appears to be that the two are qualified physicians, and they weren’t hired for clinical trials. None would share whether they were aware of the past FDA sanctions, including Farber’s criminal conviction. Science shared comments by Vinay Prasad, a hematologist-oncologist at the University of California, San Francisco suggesting in a best-case explanation that perhaps the vetting process for finding consulting services is “deeply broken.” A more pessimistic interpretation, suggests Dr. Prasad, is that the companies “turned a blind eye because the investigators were not disqualified for something that hurts the companies’ bottom lines.” That is, the companies look past these unfortunate marks in the researcher’s record because they have an important need for particular skills, experience, or knowledge.
A Systemic Problem
What we don’t know from the article is what these researchers have done since then. Have they truly “paid their dues”? Have they committed themselves to helping as many patients as they can, including those that perhaps don’t even have insurance coverage? Have they contributed knowledge or insight that have helped companies with working on challenging new healthcare solutions? As individuals fail, they can redeem themselves if they commit to the great cause of medical progress. TrialSite offers another perspective as well; in many cases the entire research system, driven by intense competition and a race for profits—the costs and risks involved can be astronomical– leads to what can be a frantic and even cut-throat race to achieve the desired results. In such a system one’s values are of paramount importance. There should be lines that neither a company nor a specific researcher should cross for economic gain. Why? Because all you have to leave behind is your legacy—what kind of person were you; What did you contribute; How you treated others; Your attention to quality and integrity; the outcomes—how your work contributed to the health and benefit of others.
People make mistakes, and scientists, doctors, and clinical investigators are human. Yes, they are held to a high standard, as they should be. If they acknowledge their wrong-doing and pay their dues—hopefully giving back to the research and medical community, as well as to the larger society as a whole– -should they be banished from participating in any economic activity in perpetuity? Doctors, scientists, and researchers are, in all reality, in short supply. The schools and universities just don’t produce enough of them. They should be encouraged to share their knowledge, expertise and, hopefully, wisdom as well for the good of society, research and their specific domains or subject areas, and for specific firms engaged in their line of research. Research and development are a high risk, high cost proposition necessitating access to very specialized expertise and skills in many cases for survival.
If a specific drug company identifies an individual that possesses particular knowledge, skill, or expertise that would add value to their research and development endeavors, they should be able to access that for the benefit of research and patients (and shareholders). Researchers that have made past legal or ethical mistakes should be punished accordingly, and the more onerous the wrongdoing the more severe the punishment. Companies should vet carefully, and if they find a reported problem they should inquire into the nature of that incident, the severity and the character of the expert—did they work to make amends and pay their dues, so to speak? But should such researchers be permanently banned from conducting business with research firms?