Technological Innovation in Medical Research and Practice and Ethics: Are the two in conflict?

Technological Innovation in Medical Research and Practice and Ethics: Are the two in conflict?
Dr. Claudewell S. Thomas Psychiatrist RANCHO PALOS VERDES, CA

Claudewell S. Thomas, MD, MPH, DLFAPA, is an established psychiatrist currently retired and living in Rancho Palos Verdes, California. He received his medical degree in 1956 at SUNY Downstate College of Medicine and specializes in social psychiatry, public health psychiatry, and forensic psychiatry. Dr. Thomas was board... more

On June 26th, 2000, the POTUS (Bill Clinton) and the British Prime Minister (Tony Blair) announced the completion of the Human Genome Project, a feat once thought unaccomplishable or vaguely morally improper. Since that time, enormous progress has been made in oncologic chemo/radio/immunology.

Malignancies once beyond the reach of the surgeon's knife and/or radiologic and chemotherapeutic intervention now are subject to specific immunologic targeting. Such intervention is presently enormously expensive and the price of life prolongation (where possible) can be as low as $10,000 per month or as high as $50,000 to $100,000.00 per month (if not per treatment). The natural course of events is that such costs reduce over time and treatments become more widely available, but in this rarefied area, that time period is likely to be long.

In many other areas, technological innovation has exponentially increased the rate of medical progress. A number of devices are available that check blood pressure, pulse rate, heart rhythm, etc. by pushing a button on a wrist-worn device or an easily carried accessible monitor. Blood sugar levels can be determined from a drop of blood; the diagnosing of diabetes from a single blood test is in the offing, and the minute by minute determination of glucose levels in type I diabetes is now (experimentally) available in a limited life device which anticipates the body's rejection of a subcutaneous implant by being programmed to shut down after several days.

The cost of care is also ballooning, and the hope and expectation that the cost of care will be lowered as life is prolonged is being countered by the natural instinct to turn a profit. Regulation then becomes important in limiting the range and profitability of innovative endeavors.

The Theranos case is a recent example of deceptive practice on the boundary of innovation. Founded in 2003 by Elizabeth Holmes, a Stanford non-graduate but a biochemist and entrepreneur, Theranos claimed accuracy from analysis of a single drop of blood and turned around results in hours rather than requiring test tubes full of blood and days before results. This was across a multitude of complex disorders including diabetes, cirrhosis, blood dyscrasias, etc. In 2009, Theranos was valued at a billion dollars and was a favorite of a number of well known and influential people.

In mid-june of 2018, a federal grand jury indicted Theranos' founder and former CEO Holmes and her Chief Operating Officer Ramesh "Sunny" Balwani on two counts of of conspiracy to commit wire fraud and nine counts of wire fraud. These charges were based on ads purchased in Arizona and California to persuade consumers to buy tests from Walgrens despite increasing evidence that the tests were inaccurate and/or invalid. Through the years, how many people were damaged or died as a result of false testing is as yet unknown.

A few days later, the National Institute of Health announced the cancellation of a controversial industry-funded study of moderate drinking and heart disease. The shutting down was based on a task force finding of severe ethical and scientific lapses in the study's planning and execution. The study called The Moderate Alcohol and Cardiovascular Health Trial (MACH) involved the solicitation of $100,000,000 from the alcohol industry through NIH's private Foundation. Scientists planning to lead the study apparently told industry executives that the study offered "a unique opportunity to show that moderate alcohol consumption is safe and lowers the risk of common diseases" and that the randomized controlled multi-site study (MACH15) (fifteensites) would offer "the level of evidence that is necessary if alcohol is to be recommended as part of a healthy diet."

In an era of severely cut funding, NIAAA (NIH constituent institute for alcohol addiction and abuse) staff clearly went too far and hopelessly contaminated any possibility of a fair outcome. The directors of the parent agency and the sub-agency both condemned the study and the practice.

The foregoing examples are in the realm of innovation and exemplify the forages of private and public sectors that have gone awry because of the quest for dollars. They demonstrate the importance of regulation in quelling predatory impulse.
Most inventions are on a smaller scale and represent, for the most part, individual ingenuity that is deserving of reward. In order to claim the reward, the innovator or inventor has to negotiate (successfully) the tangle of patent law (national and international), the risk of theft, the pressure of similar competitive devices, and the many stages of testing before approval for "at large" use.

The intense competition, the personal sacrifice, the display of knowledge, and ingenuity usually result in only limited reward because the cost of development is usually borne by backers or moneymen. The NIAAA solicitation was primarily because of that search, but those who seek a specific outcome from an investigation cannot be trusted with the scales.

The re-branding of old non-FDA-covered medications and the hike in price of the approved product, the elimination or limitation of a previously available product (benzedrex, epipen) because of a limited population of abusers... With governmental relaxation of regulation and enforcement, we can look forward to maximization of abuses if citizens fail to make their representatives at state, local, and national levels truly responsive and responsible for preventing predatory health and illness practices.

It starts with demanding adequate provision for health care.