Throwing a Monkey Wrench into Medical Research
This past week, while donning his horrendously-tailored “soup and fish,” dining with the Windsors and about-to-be former British P.M. Teresa May, commemorating the 75th anniversary of the D-Day Landing, playing golf in Ireland and bashing Senate Minority Leader Schumer, Speaker Pelosi and Director Mueller, ’45 somehow managed to find the time to throw a toxic monkey wrench into the future of medical research. ‘45’s announcement that the federal government is changing its policy on the use of human fetal tissue in medical research sent a collective chill up the spines of clinicians and researchers from Maine to California. His announcement - which has been percolating for quite some time - has precious little to do with science and everything to do with partisan politics. It is obviously designed to please the many anti-abortion groups which have strongly supported ‘45, the very man who once proclaimed on “Meet the Press “I am firmly pro-choice in every sense of the term.”
As mentioned a few sentences above, the push for banning the use of human fetal tissue in government-sponsored research has been percolating for the past several years. The level of controversy around fetal tissue research waxes and wanes. Human fetal tissue research has been done in the United States since the 1930s, and NIH has been funding this type of research since the 1950s. There was a ban on such funding, however, during part of the terms of Presidents Ronald Reagan and George H.W. Bush. Federal money was restored with bipartisan support in a 1993 bill for the NIH. Among the backers of that effort were some strong abortion opponents, such as Sen. Strom Thurmond (R-S.C.), who argued that the research could help people — like his daughter — with diabetes.
NIH spent $115 million on human fetal tissue research in 2018, a tiny fraction of the nearly $14 billion it spent on clinical research overall. NIH currently funds roughly 200 projects that use fetal tissue, according to HHS.
Fetal tissue once again became a hot-button issue in 2015 with the release of doctored videos, later discredited, purporting to show Planned Parenthood officials discussing tissue donation policies and reimbursement. Last fall, the Trump administration announced it was conducting a review of all research involving fetal tissue to ensure it was consistent with statutes and regulations governing it.
Under the new policy, employees at the National Institutes of Health (NIH) will no longer conduct research with human fetal tissue obtained from elective abortions, after using up any material they have on hand. Officials also immediately stopped funding a multiyear contract at the University of California-San Francisco using human fetal tissue in mice to research HIV therapies. Federally funded projects at other research institutions using fetal tissue can continue until their grants expire. But renewal for these projects and future proposals will have to go through a newly established ethics review process to receive funding. It’s not clear yet what standards that process will entail or whether such experiments will be able to proceed under government sponsorship.
Additionally, under the new policy, extramural researchers who submit applications that pass scientific review and score high enough to be funded will now encounter a new and time-consuming layer of review. Under a procedure described in a 2006 law that governs NIH policy, HHS will need to announce in the Federal Register that it plans to assemble an ethics advisory board to review each proposed grant and invite public nominations for that board. The board would be made up of 14 to 20 people from various backgrounds, including at least one theologian, one ethicist, one physician, and one attorney. No more than half of the panel members can be scientists. The HHS secretary must wait at least 30 days after the publication to appoint the board. The board will then have up to 150 days to recommend to the secretary whether the proposed research should be funded.
Even then, the Secretary can overrule the committee if he finds its recommendation “arbitrary and capricious.”
(Truth to tell, it has long been the case that every NIH-sponsored clinical trial must be thoroughly vetted and scrutinized by an Institutional Review Board [IRB] which is made up of physicians, scientists, bio-engineers, ethicists and so-called “public members.” I have been an active member of the largest of these boards for nearly 25 years and have easily vetted more than 2,000 research protocols in that period of time. So this is , in reality, nothing new.)
The anti-abortion (“pro-birth”) crowd has somehow convinced its followers that banning medical research which uses human fetal tissue will somehow keep women from obtaining abortions. Where they ever came up with this idea is beyond me. It has about as much logic behind it as enshrining the Volstead Act in our Constitution (about 100 years ago) , proclaiming that it would greatly reduce the number of people imbibing alcohol. What it did do was create a world of bootleggers, murderous gangs, bathtub gin and the likes of Al Capone, Frank Nitti and Eliot Ness.
Many of these same pro-birth advocates claim - in the name of scientific research - that there are “effective options” to using human fetal tissue, including monkey or hamster cells for vaccines as well as blood collected after birth from umbilical cords that are rich in blood-forming stem cells. They also suggest the use of adult stem cells and “organoids” — artificially grown cells that somewhat mimic organs. Another suggestion made to Alex Azar - the former president and chief lobbyist for Eli Lilly and Company and current Secretary of Health and Human Services - was that using tissue from a miscarriage could be an acceptable alternative to using tissue from an aborted fetus because it’s from “a natural death, not an intentional killing of the child.”
Checking with many of my IRB colleagues, they say that the use of adult stem cells and organoids “aren’t close to being ready for prime time. . . they cannot mimic real tissue.” The use of human fetal tissue in medical research holds out the hope for real progress coming up with therapies and even cures for HIV, Parkinson’s Disease, Diabetes and various forms of neurodegenerative disease such as Alzheimers Hunington’s and Lewy Body Dementia.
Considering the Trump family medical history, one would think that ‘45 would be more interested in doing research which might save his sanity - or that of his children and grandchildren in the future - than scoring electoral brownie points with anti-abortion activists in the present. The United States has long been a world leader in medical research. Creating new, potent and safe drugs, devices and procedures is a long and difficult process which requires scientific brilliance, firmly embedded in ethical practices. It also requires an absolute minimum of partisan politics. Diseases, syndromes and impairments are neither Republican nor Democrat, liberal or conservative. They can strike anyone and everyone.
We owe it to future generations to remember this simple truth and let the researchers get back to their labs and clinics and do what they do best.
516 days till the next election.
Copyright©2019 Kurt F. Stone