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Progressive Research

Fundamentals


A controlled, logical, and regulated process.

A hallmark of good scientific research is a controlled process. Variables are anticipated, controlled for, and measured. There is a clear hypothesis, a well-developed plan, and a testing schedule. Incremental changes are made so that each factor can be observed and better understood.

Medical research in the modern era is a heavily regulated endeavor. Internal structures, peer review bodies, and governmental organizations vet, review, and analyze any treatment before it is approved for use in the marketplace.

An exciting element to biomedical research is how products are developed for one specific purpose, only later are found to be beneficial for other conditions. Botulinum toxin A, better known as Botox, is widely known for its use in cosmetic applications among the rich and famous. Over a decade after the Food and Drug Administration (FDA) approved Botox for cosmetic purposes it was discovered that it could help to treat chronic migraine patients.

Science itself is amoral, neither good nor evil. It requires an ethical code to be placed onto its aspirations in order to keep it in the service of mankind. In the research and development stages of any new drug therapy or treatment protocol, bioethics plays an outsized role.

Treating the Terminally Ill
There has been recent interest in speeding FDA approvals of experimental drugs and treatments for terminally ill patients. The compassion behind this drive is commendable. In many cases, we are close to breakthroughs. Many people today who are near death have conditions that in the next decade could be curable. The idea of hastening approvals is a double-edge sword.

In the ethical affirmative, if clinical trials have been conducted, and the FDA gives a preliminary approval for a therapy to be deployed in limited trials, a fast approval process could be a net positive. Presumably, the research is in its final stages before submission for final FDA review. This limited trial allows for researchers to validate their previous findings using actual, advanced stage cases. Lives may very well be saved.

In the ethical negative, this is a precarious proposal. A preliminary approval, even a limited one, is metaphorically cutting corners. Clinical trials and the FDA approval process, though cumbersome, have been astoundingly successful in preventing harmful treatments from making it to market. The cumbersome nature is most poignantly seen in the veto authority of the review panel. Should any expert on an FDA review panel disapprove a therapy, even in the face of otherwise unanimous consent, the therapy is rejected.

Further, it could be reasonably argued that allowing drugs and therapies to be deployed before a full approval could present problems in the future. Over time, a substantially lower standard could be established to gain preliminary approval for treating the terminally ill. This kind of human experimentation is particularly morbid because it reduces the value of a person to their contribution in a clinical trial.

In the summer of 2017, British infant Charlie Gard was in the middle of an international medical, ethical, and legal firestorm. Diagnosed with a terminal, systemic genetic disorder, his parents sued the hospital treating Charlie to allow him to be transported to another country to try an experimental treatment. The case was complex, but the treatment therapy had never been tried on a human with his particular disorder.

The danger in these limited approvals is that it could lead us to very real systematic human experimentation. In at least some of those cases, experimentation without first gaining informed consent could result.

Trust the Process
Research is a painstaking, and expensive, process. It’s distressing that people continue to suffer each day with terminal illnesses for which there are no approved treatment options. It is tempting to open up limited trials before final approvals are given. However, the risk of that kind of system devolving into full-blown human experimentation is too great of a risk to run.

As hard as it may be, we must refrain from making a massive ethical gamble on a fleeting glimmer of hope. Experimental treatments may be used on patients, terminally ill or otherwise, but only if they have followed the standardize progressive research system under strict regulation and control. Only after there is a statistical track record of clinical success should trials be opened up to more patients.

About the Author

CHET COLLINS is a full-time sidekick to three small humans. He gets his best creative work done during their nap time. He’s had a keen interest in bioethics since 2003.

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