October 21, 2019

The Bioethics of Data

As an analytical chemist, my professional world revolves around data. Experiments mean nothing without data and furthermore, the experiment doesn’t exist unless the data is fully documented. I analyze data for a living and I’m constantly on the lookout for bias. I routinely remind younger scientists that without data all you have is conjecture. I also remind them that there is no such thing as “good data” or “bad data.” Data just “is.” Ultimately, the only judgment we can really make of data is whether it is whether it is “valid” or “invalid.” Data is meant to be empirical. It is the result of a measurement and methods of measurement matter. Science trains us to “follow” the data. In the data lies the truth of an observation. Nothing is without bias.

I started thinking of the “bioethics of data” after learning that a local pharmaceutical company was being investigated by the FDA for data integrity issues. Reflecting upon this, I wondered whether empirical measurements can have ethical implications. In my mind, the answer is “no.” Data should be fact, not emotion, desire or judgement. Bioethics becomes relevant in how data is manipulated. 

Spinal muscular atrophy (SMA) gene therapy “Zolgensma” recently made all kinds of headlines leading up to and following its approval. Zolgensma is among the most expensive medicines on the U.S. market. The drug has been priced at $2.125 million per its single dose therapy to treat spinal muscular atrophy patients under two years of age. It claims to be a “one and done” lifelong cure. SMA is a rare, pediatric genetic disorder that is nearly always fatal. SMA affects the most fragile of patient populations. Ultimately, its use is determined to be necessary by parents of affected babies who would otherwise perish without treatment.

Recently, the FDA said the Zolgensma drug application was submitted with manipulated data. In addition, the company did not inform regulators of this issue until one month after approval. This meant the company withheld its data integrity issues for at least two months before notifying regulatory agencies. Had the agencies known about the data manipulation, it would have likely delayed its approval until an investigation was completed. 

Experts at FDA have been quoted in the news as saying Zolgensma will stay on the market as the data integrity issues were “limited to only a small portion of the product testing data” relating to testing in animals, not in humans. These assays would be for initial product testing (in-vivo murine potency assay) and not commercial product release. Zolgensma’s sponsor claimed that “the data in question were a small portion of our overall submission and are limited to an older process no longer in use.” Experts maintain that Zolgensma is “safe, pure, and potent” for its approved population.   (Zolgensma info source: FiercePharma)   

Deliberately manipulating experimental data is not bioethics. It is fraud. In the case of Zolgensma, I propose it be tried as manslaughter. Why? Because people don’t realize that the alleged manipulation of data could cost patients their chance of cure/survival. The drug can only be injected once before the body builds up an immunity to it. Thus, a sub-potent dose cannot be re-injected or bolstered. Preclinical trials and resulting data were used to justify drug approval. Thus, humans were involved and, would have been in the trial with the sole hope of treating and curing spinal muscular atrophy. For these patients, such hope may be gone. The bioethics of data here is that greed and blind lust for corporate goals replaced concern for the patient. Fraud took place when data was manipulated to yield a positive conclusion. Manslaughter came when people  betrayed the trust of the public and regulatory authorities.  

Where have we gone in society when greed and a desire for financial gain replaces natural law in protecting life? There are times when the integrity in each of us is challenged. How we respond to this challenge is who we are, not who we profess to be. Data integrity is much more than validity of the numbers. It is the culture and spirit of process, the purpose of the research, and the impact that is ultimately felt. Intent, Action, Impact — all matter! Have we lost sight in the value of life to a point where a personal financial return is more important than a child’s survival?

Sadly, the answer is “yes.”

The example of Zolgensma is just a small indication of how evil our society has become. So yes, scientists at the drug sponsor should take the heat for getting caught cheating the system. Yet, we can’t just lynch them and walk away. No, we need to take measure not only of how pharmaceutical scientists are pressured to find the next billion dollar drug, but measure how each of us contributes to such evil ourselves.

Recreational use of narcotics is rapidly being approved throughout the country and justified based on potential tax revenue. The studies that show the harm this has created in Colorado are being ignored. Children in these states are being introduced to recreational drugs without guidance to the dangers, addictions and destruction these drugs have brought about. As Christians, we know that God had asked us to steward his creation. As stewards we have failed our children in that they are growing up with polluted rivers, polluted air and environment that is being affected by greenhouse gas emissions. Society is now promoting unnatural relationships as a means for “love “while children miss the opportunity to grow up in a traditional family or even worse, to grow up at all as we allow abortion upon demand. We fight the economics of immigration without feeling the hurt our “neighbors” are being exposed to. We promote the “eros” and forget the “agape” love in which lies the true message of Jesus.

When pointing out the hypocrisy of the Pharisees and Sadducees in the Gospels, Jesus is not asking us to look at them. Jesus is asking that we look at us. Do our actions model those whom we are judging? Often we see failures in others without seeing our failure to act as well. Have we become too afraid to look within ourselves and can now only look outward?

Data isn’t sacred. Truth is. As a society we no longer insist on the truth. We distort the truth to sway the vote. We “massage the facts” to promote our gain. If we got back to demanding the truth, there would be no incentive to manipulate the data. Yes, children may die because of the actions of a few industry dissenters. How many more will die by our looking the other way as well?

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Written by
Deacon Gregory Webster

REVEREND DR. GREGORY WEBSTER is a permanent deacon of the Archdiocese of Chicago. He was ordained to the Permanent Diaconate by Francis Cardinal George in May 2014 and is assigned to St. Raphael the Archangel Parish in Old Mill Creek, Illinois. Deacon Greg holds a Ph.D. in Analytical Chemistry from Northern Illinois University, M.A. in Theology from Holy Apostles College and Seminary and an M.A. in Bioethics and Health Policy from Loyola University of Chicago. Deacon Greg and his wife have been married more than twenty-five years and are blessed with three beautiful daughters and two pretty cool terriers.

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Written by Deacon Gregory Webster
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