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Science Policy Around the Web June 8th, 2020

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By Tam Vo, PhD

Image by pearson0612 from Pixabay 

Abortion opponents protest COVID-19 vaccines’ use of fetal cells

A group of anti-abortion activists recently raised ethical concerns about the use of cells derived from human fetal tissue in COVID-19 vaccine development. While the tissues were obtained during elective abortions performed many years ago, in a letter addressed to Stephen Hahn, commissioner of the U.S Food and Drug Administration (FDA), a group of religious, medical, and political organizations urged the agency to consider ethical issues surrounding the development of vaccines for COVID-19 using those cell lines. The letter states that: “ It is critically important that Americans have access to a vaccine that is produced ethically: no American should be forced to choose between being vaccinated against this potentially deadly virus and violating his or her conscience.” In Canada, a similar letter was addressed to Prime Minister Justin Trudeau on May 17. Currently, there is no response to these letters from either the US or Canadian governments. 

Using cells derived from human fetuses collected from elective abortions is hardly new. In fact, HEK-293, a cell line derived from human fetal tissue, has been widely used in many research projects including vaccine development for diseases such as rubella, chickenpox, and Hepatitis A. There are currently at least five COVID-19 vaccines that have entered clinical trials that were developed using HEK-293 and PER.c6, another fetal cell line owned by Janssen, a pharmaceutical subsidiary of Johnson & Johnson. The Trump administration plans to back two out of the five candidate vaccines with the total investment up to $1.7 billion through Operation Warp Speed, a program aimed to accelerate the COVID-19 vaccine development by January 2021. 

Fetal cell lines are crucial in the development of many vaccines. Andrea Lambotto, a lead vaccine scientist for the candidate developed by the University of Pittsburgh School of Medicine, said that the HEK-293 cells are essential for the production of protein subunit type vaccines. He also stated that the alternative nonhuman cells can produce a different type of sugar molecules compared to their human counterparts. This complication could decrease the effectiveness of the vaccine to trigger a specific immune response in the host. 

Opinions from experts are mixed. David Prentice, the Vice President and Research Director at the Charlotte Lozier Institute, argues that the use of fetal cell lines to develop vaccines is unethical and provided a list of vaccines developed by using alternative methods in a paper published on May 6, 2020. Contrarily, Arthur Caplan, a bioethicist at the NYU Grossman School of Medicine, argues that the fact the cell lines were derived from fetal tissue is irrelevant as these fetal cell lines are now decades old. 

Last year, the Trump administration established a policy to abolish the use of new fetal tissues in government-funded research at the National Institutes of Health. However, the policy did not rule out the use of currently-established fetal cell lines. The two controversial candidate vaccines that used HEK-293 and PER.c6 in their development are on the shortlist for approval funding from the administration. 

(Meredith WadmanScience)

Written by sciencepolicyforall

June 9, 2020 at 11:17 am

Science Policy Around the Web – June 7th, 2019

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By: Mary Weston, Ph.D.

Source: Pixabay

Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world?

Last Tuesday, the Washington Post reported that the biopharmaceutical company Pfizer had hints that their rheumatoid arthritis drug Enbrel might reduce the risk of Alzheimer’s disease, but chose not to report these findings to the public.

In 2015, after analyzing hundreds of thousands of insurance claims, a team of Pfizer researchers observed that their anti-inflammatory drug Enbrel might also decrease the risk for Alzheimer’s by 64%. They recommended that the company conduct a costly clinical trial to prove the link but, after several years of internal debate, the company decided not to pursue the lead.  The question remains: why did Pfizer not release these findings to the scientific community?

Pfizer claims they did not pursue the research due to scientific considerations – they argue that since Enbrel cannot cross the blood-brain barrier and directly reach brain tissue, it is unlikely to prevent the debilitating neurodegenerative disease. Further, Pfizer claimed that they did not to report the research because the statistical findings did meet “rigorous scientific standards” and were concerned about misleading researchers down a false path. However, Pfizer is also losing its patent protection on Enbrel soon, meaning that generics will become available and the drug will be much less profitable, reducing any financial incentive for further research or clinical trials (likely to cost around $80 million).

Some in the scientific community are questioning Pfizer’s justification. Keenan Walker, an assistant professor of medicine at Johns Hopkins, argues that the scientific community benefits when the data is available, stating that ““[w]hether it was positive data or negative data, it gives us more information to make better informed decisions.’’

Several scientists argue that Pfizer’s results should be release because they could provide clues to combating the disease and slowing cognitive decline in its earliest stages. Specifically, recent research is hinting that inflammation may promote Alzheimer’s disease. Further, neurodegenerative research is notoriously challenging and there are no major drugs that treat Alzheimer’s. Even several recent phase 3 clinical trials have been halted because the drugs were not effective. Due to a lack of progress in the field, a couple large pharmaceutical companies, including Pfizer, have just closed their neurology-related research programs.

 (Christopher Rowland, Washington Post)

Trump administration halts fetal-tissue research by government scientists

The Trump administration has announced that government scientists will stop using human fetal tissue for research and is placing new limitations on researchers in academic settings who use federal funding from the NIH.

It is not entirely known how many research projects will be affected by the new regulations. Government scientists will be allowed to continue their current work, but are prohibited from acquiring new tissue samples. Current extramural research at universities and privately funded work can continue but any new grant proposals or renewals of existing projects must be approved by an ethics advisory board that will be formed.

In addition to halting government fetal tissue research, the administration has decided to cancel an ongoing HIV research contract with the University of California San Francisco, effectively ending a 30-year partnership. The project involves using fetal tissue to develop mouse models with human-like immune systems to develop new HIV therapies.

Use of fetal tissue is essential to for studying certain human biological processes, such as kidney development. Often biomedical research uses mice as substitutes of people, but in this case, murine kidney development is too different from their human counterparts to be of use. Some researchers fear that these new restrictions will set back certain research for years to come. Important areas of research that depend on using fetal tissue including HIV, neurodegeneration, human organ growth and regeneration, Zika (determining how/why the virus affects developing fetuses so severely), and certain types of vaccine development.

POLITICO reports that this decision was made after much debate between the White and the Department of Health and Human Services (HHS), which wanted a less restrictive policy. In a statement released Wednesday, HHS said that “promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration.” HHS is now reviewing whether sufficient alternatives to human fetal tissue exist and will be supporting the development and validation of these models. However, good alternatives for certain fetal tissue research are elusive and many scientists say that the tissue is essential for some fields.

 (Sara Reardon, Nature)

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Written by sciencepolicyforall

June 7, 2019 at 6:11 pm