Bioethics questions as experimental drug is used in Covid-19 treatment

Bioethics questions as experimental drug is used in Covid-19 treatment

The treatment that President Donald Trump has received to fight Covid-19 has turned the focus on an experimental drug that shows promise in combating the coronavirus but is raising ethical questions about the cell line that helped researchers develop the medicine.

At the centre of attention is the ‘cocktail’ of antibodies in the drug called REGN-COV2 manufactured by New York-based Regeneron Pharmaceuticals.

The drug is in the middle of clinical testing but exhibited enough promise that it was administered to the president.

Preliminary results show that if administered early in the course of the Covid-19 illness, it can help people fight the disease through the introduction of antibodies that mimic an immune system response, said Dr Paul Carson, director of the Center for Immunisation Research and Education at North Dakota State University and a member of the Catholic Medical Association.

Queries about the treatment Mr Trump has received emerged soon after he reported feeling better two days following his admission to Walter Reed National Military Medical Center, where he was taken by helicopter from the White House October 2.

It is unknown whether REGN-COV2 alone is the reason for his quick recovery or whether its use in combination with other drugs has apparently worked. Those other drugs include remdesivir and the steroid dexamethasone, which is commonly used to treat asthma, rheumatoid arthritis and certain cancers.

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The questions surrounding the REGN-COV2 treatment arose from reports the drug was developed using a cell line from tissue taken in the 1970s from an aborted foetus. The cell line has lived in laboratories since then and has undergone a series of changes over the years.

In April, the chairmen of four US Conference of Catholic Bishops’ committees and groups opposed to abortion sent a letter to Food and Drug Administration Commissioner Stephen Hahn expressing concern over the development of “dozens of vaccines ..some of which are being produced using old cell lines that were created from the cells of aborted babies”.

The letter asked Mr Hahn to “encourage and incentive pharmaceutical companies to use only ethical cell lines or processes for producing vaccines”.

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Meanwhile, the Trump admin-istration has moved to eliminate federally funded research that relies on foetal tissue from elective abortions. The Department of Health and Human Services in cooperation with the National Institutes of Health has imple-mented an ethics advisory board to screen proposals seeking federal dollars.

Established early this year, the Human Fetal Tissue Research Ethics Advisory Board voted July 31 to withhold funds from 13 of 14 research proposals that involved the use of foetal tissue.

The 15-member board exists “to advise, consult with and make recommendations to, the secretary of HHS, regarding the ethics of research involving human foetal tissue”.

Archbishop Joseph F. Naumann of Kansas City, Kansas, chairman of the US bishops’ Committee on Pro-Life Activities, applauded the Trump administration “for moving NIH in a direction that shows a greater consideration for medical ethics in research and greater respect for innocent human life.”

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REGN-COV2 is the result of pains-taking research since the 1970s that began with a cell line known as HEK293 that is commonly believed to have been derived from an aborted foetus. HEK293 cells are widely used in medical research.

It is unfortunate that these testing tools, which were developed by non-Regeneron researches, rely on foetal cell lines from abortions”

Over the years, researchers have transformed the cell line into what today is known as HEK293T, leading to the determination that it is no longer foetal tissue.

Alexandra Bowie, senior director of corporate communications at Regeneron, told Catholic News Service that “foetal tissue was not used” in the company’s research using the HEK293T cell line.

“We did not use human stem cells or human embryonic cells in the development of REGN-COV2,” Ms Bowie added.

The company applied on October 7 to the FDA for emergency approval for the experimental drug.

Fr Tadeusz Pacholczyk, director of education and ethicist at the National Catholic Bioethics Center, agreed with the company’s stance, saying in an email to CNS the drug is manufactured in hamster cells, “not cells derived from human abortions”.

Concern

His concern, however, arises from the use by researchers of a biological assessment tool on REGN-COV2 that relies on the HEK293 cell line that originally was derived from an abortion. The tool, developed years ago, allowed Regeneron to determine which antibodies that had been developed might be most effective against Covid-19, he said.

“It is unfortunate that these testing tools, which were developed by non-Regeneron researches, rely on foetal cell lines from abortions,” Father Pacholczyk said. “This fact serves to remind us how the abortion mindset has infiltrated all sectors of our society, including many sectors of pharmaceutical research and development. The Church has long been protesting this fact, and encouraging the use of alternatives.”

Dominican Fr Nicanor Austriaco, writing May 26 in Public Discourse, the journal of the Witherspoon Institute, recognized that HEK293 cells “are simply the best” for culturing many of the viruses that are commonly used in biotechnology.

The Witherspoon Institute describes itself as an independent research centre focusing on enhancing public understanding of the moral foundations of free and democratic societies.

If the appropriation of the past evil action does not contribute to future evil acts, it could be justified for a grave proportionate reason”

The priest, an associate professor of biology and theology at Providence College, acknowledged that the original foetal tissue from which the cell line was derived is “long gone”. He said that while “only distinct, new cells derived from the original foetal cells remain”, ethical questions persist surrounding the use of the HEK293 cell line for any Covid-19 medical treatment, including the development of a vaccine.

The article raised the question of a person benefiting from a past “evil act”, abortion, and whether such an “appropriation of evil is morally justifiable”.

Fr Austriaco discussed the concept of grave proportionate reason as justifying acceptance of the benefits of an act such as abortion. He wrote that “if the appropriation of the past evil action does not contribute to future evil acts, it could be justified for a grave proportionate reason”.

Noting that some people may object to using treatments, including vaccines, that may be developed from the original HEK293 cell line even if it is ethically justifiable, Fr Austriaco said that they have a right to refuse such medical options.

“However, society also has a right, and indeed, a moral obligation, to protect its citizens from illness and death. Therefore, justice demands that we balance these competing interests in our communities,” he said.

Those who do not become vaccinated because of their moral concerns should also expect to be prohibited from entering public spaces such as schools, restaurants, shopping centres and airports “where they may unwittingly catch or spread the disease”, he wrote.

Denis Sadowski is a correspondent with CNS.