As Balwani and Holmes Head To Jail, Others Will Follow In Their Wake.

Posted on | December 8, 2022 | Comments Off on As Balwani and Holmes Head To Jail, Others Will Follow In Their Wake.

Mike Magee

This morning’s headlines seemingly closed a chapter on the story of medical research criminality in America. Ramesh “Sunny” Balwani, former president and COO of Theranos has been sentenced to 13 years in prison for fraud. That’s 2 years more than his ex business and romantic partner, Elizabeth Holmes.

Criminal defense attorney for all things science tech, Michael Weinstein, took the opportunity to trumpet out a confident message that crime doesn’t pay in Medicine with these words, “It clearly sends a signal to Silicon Valley that puffery and fraud and misrepresentation will be prosecuted, there will be consequences and the end result is potentially decades in prison.”

The smooth talking fraudsters played a good hand for years, buoyed by a Board, asleep at the $9 billion valuation wheel, with the likes of George Shultz, Henry Kissinger, Rupert Murdoch and Larry Ellison. But attorney Weinstein and all associated with Health Tech entrepreneurship would do well to read again a classic piece of health journalism from fifty-six years ago.

On June 16, 1966, the New England Journal of Medicine published an article titled “Ethics and Clinical Research.” Written by a highly respected Harvard physician, Henry K. Beecher, the head of anesthesiology at Massachusetts General Hospital, the article referred to “troubling charges” that had grown out of “troubling practices” at “leading medical schools, university hospitals, private hospitals, governmental military departments (the Army, the Navy and the Air Force), governmental institutes (the National Institutes of Health), Veterans Administration hospitals and industry.”

Beecher then reviewed 50 distinct contemporary American clinical studies with ethical violations judged by standards at Beecher’s own Massachusetts General Hospital. These studies were performed in 1964 by academic clinicians in major institutions and published in peer-reviewed journals. In only 2 of the 50 was there any evidence of informed consent by the participants. In one of these studies, 109 servicemen with streptococcus—known to lead to rheumatic fever—had treatment with penicillin withheld as part of a placebo control group. In another study, four hundred and eight “charity patients” with typhoid were split into two groups. One group was given chloramphenicol, known to be effective in typhoid, while the other group received no treatment. Mortality rates in the two groups were 8 percent and 23 percent, respectively.

In yet another study, 50 patients, ages 13 to 39 and drawn from mental institutions and juvenile delinquency facilities, were given an experimental drug, TriA, known to cause liver damage. Significant liver dysfunction occurred in 54 percent of them, and 8 underwent invasive liver biopsies. Even worse, 31 patients were anesthetized and given carbon dioxide through their breathing tubes to create toxic levels that would lead to cardiac arrhythmias, including deadly ventricular fibrillation.

More incredible, 68 patients had their abdominal cavities entered through small incisions. Various organs were then retracted or pushed with instruments to gauge the effects on blood pressure levels. Mentally defective children were purposefully given live hepatitis virus to assess the infectiveness of the agent. Live cancer cells were injected into 22 human subjects to test immunity to cancer. A mother of a child dying from metastatic melanoma agreed to have the child’s melanoma cells injected into her to gain understanding of the disease and possibly help the child. The child died the next day, and the mother died a year and a half later—of metastatic melanoma.

How was this possible? “Since World War II,” Beecher explained, “the annual expenditure for research . . . in the Massachusetts General Hospital has increased a remarkable 17-fold. At the National Institutes of Health, the increase has been a gigantic 624-fold. This ‘national’ rate of increase is over 36 times that of the Massachusetts General Hospital. . . . Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and these resources may be greater than the supply of responsible investigators. All this heightens the problems under discussion. . . . Medical schools and university hospitals are increasingly dominated by investigators. Every young man knows that he will never be promoted to a tenure post, to a professorship in a major medical school, unless he has proved himself as an investigator. If the ready availability of money for conducting research is added to this fact, one can see how great the pressures are on ambitious young physicians.”

Six years after Beecher’s publication, Peter Buxtan, an epidemiologist for the US Public Health Service, finally and officially blew the whistle on the study of African American men being denied penicillin. This led to a July 26, 1972, New York Times report titled “Syphilis Victims in U.S. Study Went Untreated for 40 Years.” Buxtan later said, “I didn’t want to believe it. This was the Public Health Service. We didn’t do things like that.”

The fundamental original sin – an integrated career ladder that allows medical scientists to move from academia to corporate to government and back again as they pursue vast riches – remains intact. For a time Balwani and Holmes were its beneficiaries. Without fundamental reform and reinstitution of appropriate checks and balances, it will continue to undermine public confidence in our medical establishment, and others will follow in their wake.