Trump, Science and Social Justice
Posted by Pete Shanks on December 8th, 2016
It has not escaped our notice that the specific process we have witnessed in the last month immediately suggests a possible alteration of the regulatory and ideological landscape. As with genomics, however, the devil is in the details and many of them remain obscure. Some general outlines have emerged, and they are frightening to anyone who cares about social, economic or environmental justice.
It seems certain that the Electoral College will confirm Donald Trump as the winner of the Presidential Election, although a few “faithless electors” might cast protest votes. It is absolutely certain that Hillary Clinton won the popular vote; at this writing, she is leading by 2,7 million votes and seems likely to have attracted more votes than any Presidential candidate in history except then-Senator Obama in 2008. Nevertheless, Trump and Vice-President-elect Mike Pence are not only claiming a mandate, they are backing their talk up with extraordinarily reactionary appointments.
In part, this may be down to Trump’s inexperience: He seems to be picking people he knows. And Generals. Reuters is running a list of top appointments, and Nature had a useful summary of possible science-related appointees last week. But what other criteria does he have?
All men are created equal; well, it’s not true, ’cause some are smart, some aren’t. … You have to have the right genes. … I’m a gene believer … I'm proud to have that German blood. There’s no question about it. Great stuff.
And white supremacy. Of course, that is denied, for instance by a founder of The American Conservative:
The United States is entering into [a] period of demographic transformation, where whites, politically and demographically dominant for all of the nation’s history, will become a smaller majority, and perhaps then a plurality. Whether this transformation will be assimilative or anti-white, peaceful or violent, remains to be seen. Those in the upper reaches of the Democratic Party throwing around loose charges of “white supremacism” are certainly doing nothing to make it go smoothly.
So what’s the nice, polite way to describe Steve Bannon, set to be Trump’s Senior White House Counselor, and former chairman of what the Southern Poverty Law Center has called a “white ethno-nationalist propaganda mill”? The New York Times gave it a go:
Mr. Bannon is in some ways a perplexing figure: a far-right ideologue who made his millions investing in “Seinfeld”; a former Goldman Sachs banker who has reportedly called himself a “Leninist” with a goal “to destroy the state” and “bring everything crashing down.” He has also called progressive women “a bunch of dykes” ...
Nope, can't be done.
But science, of course, is politically neutral. (Just the facts, ma’am.) So it should not be a concern that the Environmental Protection Agency will be run by a “close ally” of the fossil fuel industry, Scott Pruitt. Or that the Health and Human Services Secretary, Tom Price, has been focusing for years not just on dismantling the Affordable Care Act but also barring funds for Planned Parenthood; and opposing abortion. Or that running the Centers for Medicare and Medicaid Services will be Seema Verma, a close advisor of Pence, who worked to make Indiana’s Medicaid plan "one of the most punitive in the country.”
It could get worse. The Food and Drug Administration may go to Jim O’Neill, a colleague of the execrable Peter Thiel. Bloomberg notes:
O’Neill also could push the agency in new directions. In a 2014 speech, he said he supported reforming FDA approval rules so that drugs could hit the market after they’ve been proven safe, but without any proof that they worked, something he called “progressive approval.”
What could possibly go wrong? (Don’t all speak at once.) We should note that this is apparently a trial balloon. Scott Gottlieb of the American Enterprise Institute is said to be the other candidate. He has some FDA experience, under George W. Bush, but the editor of the New England Journal of Medicine said in 2005:
Gottlieb has an orientation which belies the goal of the FDA.
A quick glance at his Forbes columns shows he really hasn’t changed. But he regularly appears on Fox News, so Trump may know who he is.
The Union of Concerned Scientists are concerned enough to organize a 2300-signature letter, supporting “unfettered science.” Heads of 29 scientific societies (including the AAAS) politely called for a meeting to advise Trump. Another ad-hoc group of scientists called “Not Who We Are” has their own open letter, with climate scientist Michael Mann at the head of the list of signatories. They are all right, of course, but may be, um, waving into the wind.
To be fair, as we must, there is one surprising suggestion: Four key Republicans in Congress, all chairs of committees or important subcommittees, sent a letter to Trump urging the President-elect to keep Francis Collins as Director of the National Institutes of Health. Since Collins is a gentleman, there is no word of this on his blog or Twitter feed. But really, why would he need the grief?
Update: Francis Collins said on Friday, December 9, that he was flattered by the letter and would consider it a privilege to remain in his post.
Previously on Biopolitical Times:
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Review of Blame: A Novel
Posted by Abby Lippman, Biopolitical Times guest contributor on November 28th, 2016
Because it is a central theme of this novel, it seems appropriate for me to start this review with my own “conflict of interest” – or as I prefer to see it, my “competing interest.” So I note that my parents and Tony's parents were friends when we were young children and though he and I were never friends, we were colleagues in adulthood insofar as we attended the same medical/human genetics meetings and conferences and kept in touch with our separate critiques of these issues, even discussing them, when we met.
Readers, therefore, can make their own assessments of my comments about Blame as to whether or not they are “fair” or even unbiased. Readers should also know that though I have a long history of writing and publishing book reviews, both in print and online, with only one exception these have been works of non-fiction; critiquing a novel is something I vowed not to do once the first was complete, but here I am....
Enough about me; the book is what is important here, and it is an important book – especially for those who are not trained in or otherwise familiar with human/medical genetics and the range of ethical, social, legal, and political issues raised by the applications of what is learned in a lab. It is a novel of fiction and a novel of science, often eerily portraying not only what is happening now but what is possibly very soon to come as new technologies are normalized, “monetized,” and enter “ordinary” medical practice.
Blame is fueled by these issues, with the characters propelled by the concerns raised and their own ambivalences about what is “right” and useful to do. It is a kind of hybrid book, combining an introduction into the intrigues of (and intriguing nature of) genetic research with a compelling story of (some) good people who go – and are led – astray. Thus, while the characters are well-limned, they can at times seem to represent an issue at least as much as appear to be fully-fleshed individuals.
As a result, the reader may feel, as I did, deeply drawn to but still hungry to know more about the central figure and his wife, in order to better understand just why he (a solid scientist doing careful research) and she (a strong woman with feminist leanings) do what they do. Unfortunately, to provide details here would likely give more away what readers should better discover for themselves.
Watching the characters who incarnate a range of roles (investigative journalist, African-American woman harmed in a commercially-funded clinical trial, university administrators and faculty, et al.) also affects us strongly on gut levels but can nevertheless sometimes seem forced to meet Holtzman's political agenda when the latter is given priority over the deep development of characters per se. Why do some key players make the turns in behavior and in practices that they do? Hubris? Insecurity? Money? Love? All are at play, and we don't necessarily need these all spelled out. Yet while it's very clear that the central characters do change, it might enrich the novel if the why of this was easier to sense without feeling that some turns are plot-driven to make a point.
But despite these quibbles, no doubt the book is a page-turner and the reader is driven along.
There is also no doubt that Holtzman has a stand on the issues he raises, a stand I probably almost entirely share with regard to the evils of profit-driven science, the corruption of academia and corrosive effects on science (and people and relationships) that ensue, the hyped promises of predictive medicine, the dilution of fully informed consent, and the lingering oppression of societal racism. He brings all this, including their historical grounding, into the novel with clarity and expertise. And accompanying all this are generally easily digested details of genome analysis, medical interventions, and other “science” matters. As background these are essential elements of Blame; however, when these are foregrounded, they risk becoming ersatz major “characters.” This, in turn, can make some of the fictional people simply potential “issue-bearers,” embodiments, that is – but possibly with bodies that are thinner-than-needed to fully satisfy a reader.
Because it is a challenge for a reviewer to talk of the actual “plot” of the book without revealing its ending, and wanting not to spoil the experience for readers, I will only note that there is lots here to keep a reader engaged and turning pages, perhaps even in one sitting. Blame is properly titled; much and many bear this load in the novel's exploration of how genetic testing of asymptomatic people can reveal DNA patterns suggestive of the later appearance of highly undesired diseases (in this book Alzheimer); of how lucrative for companies it can be to patent these DNA segments/patterns for the commercial development of tests they can sell; etc. To this are added references to other sources of blame: past racist research, sexual harassment, spousal violence, the lifestyles of rich and privileged whites in the US, inadequate even lax regulations and laws related to genetics and genetic technologies in law and legal regulations....a full set of the blameworthy from which to choose.
This book is as important to read and then discuss with others to foster the important public input into decision-making re how genetic technologies are developed, funded, used, provided, and governed, as it is to read simply for oneself: it will surely give everyone several hours of pleasurable page-turning. I hope these two “applications,” the collective and the private, will merge– and Blame will be an essential basis for this merging as science continues to seek ways to read our futures and to extend lives. While a work of fiction, Blame is definitely not science-fiction.
Abby Lippman has spent decades following developments in applied genetic and reproductive technologies. Her main interests as a feminist researcher, writer and activist center on women's health and the politics of health. She is also Professor Emerita in the Department of Epidemiology, Biostatistics and Occupational Health at McGill University.
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18 Years Later: First Update on Children Born Using 3-person IVF Precursor
Posted by Leah Lowthorp on October 27th, 2016
On October 26, an Associated Press story broke with the headline, “The Kids are All Right: Children with 3-Way DNA are Healthy.” Riding the wave of recent controversies surrounding 3-person in-vitro fertilization (IVF) in Mexico and the Ukraine, the widely syndicated article plainly misrepresents the source study, which as we shall see, is not at all certain of the reliability of its results.
On October 24, Reproductive BioMedicine Online published the first follow-up study of children born in the late 1990s and early 2000s using a precursor to 3-person IVF known as cytoplasmic transfer. Developed for age-related infertility, this technique, also known as ooplasmic transfer or transplantation, involves injecting mitochondria-rich cytoplasm from donor eggs into the eggs of intending mothers prior to fertilization. Fertility doctors used this experimental technique in human subjects without clinical trials, with at least two dozen babies born as a result. In 2001, researchers from St. Barnabas Medical Center in New Jersey published a study announcing live births resulting from this procedure, and claiming the world’s “first case of human germline modification.”
Scientists, medical professionals, and public interest advocates raised a number of serious concerns at the time, ranging from the children’s increased risk of severe mitochondrial disease resulting from mitochondrial heteroplasmy to ethical concerns about human inheritable genetic engineering. Shortly after the study was published, the U.S. FDA halted the procedure, citing lack of evidence of safety and efficacy and requiring clinics to seek the agency’s approval to continue. No such request was made at the time, and no formal studies to track the effects of this technique upon the resulting children were conducted.
The recent Reproductive BioMedicine Online study documents an attempt to follow up on the seventeen children, now ranging in age from 13-18, born as part of the St. Barnabas Medical Center research cited above. The study is inconclusive due to a number of serious limitations, including the fact that it is based entirely on limited email surveys completed only by parents. None of the children participated in the survey, nor were they subject to any follow-up testing. In fact, only one of them has been informed of their participation in this experimental procedure. In addition, the parents of quadruplets that represent 25% of the total number of children never replied to the survey.
The authors are open about the flaws of their study, writing that it “is limited because the information from the quadruplet delivery is essential for providing firm conclusions,” and that their findings “are based on subjective assessment criteria and no standardized instruments were used.” In the end, the researchers conclude that they were unable to discern an effect of cytoplasmic transfer on the children, but attach the clear disclaimer, “but the power of the investigation was low.”
In light of this, it is disappointing that media coverage of the study was so unbalanced and celebratory. Mostly syndications of the Associated Press story mentioned above, it both severely downplayed the study’s frankly-stated limitations, and misconstrued the authors’ tentative conclusion as evidence that not only this specific technique but somehow all forms of mitochondrial manipulation are safe.
Previously on Biopolitical Times:
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3-person IVF and Infertility: What Kind of Slippery Slope is This?
Posted by Leah Lowthorp on October 26th, 2016
3-person IVF and Infertility: What Kind of Slippery Slope is This?
Reacting to two breaking news stories about 3-person in vitro fertilization (IVF) in less than two weeks, Paul Knoepfler, professor and stem cell researcher at UC Davis, recently tweeted:
On September, 27, 2016, news broke that NYC-based fertility doctor John Zhang and his team had delivered a baby the previous April that they created using a controversial mitochondrial manipulation technique, also known as 3-person IVF, that results in an embryo with DNA from three people. The baby was born in Mexico in order to avoid US regulation, as Zhang explicitly admitted. Despite the multiple violations of medical ethics involved, the media craze that followed largely heroized Zhang, depicting him as a doctor altruistically seeking to prevent the transmission of mitochondrial disease.
The prevention of mitochondrial disease has been the core justification cited all along for permitting these controversial, high-risk techniques that represent a form of inheritable genetic engineering, also known as human germline modification.
On October 10, news broke that Valery Zukin, a fertility doctor at the Nadiya Clinic in Kiev, Ukraine, had used 3-person IVF not to lower the risk of mitochondrial disease, but as a treatment for infertility.
The media in this case was surprisingly quiet, perhaps because Zukin had supplied no published evidence of his claim, although the BBC did publish a somewhat critical piece entitled “3 person baby ‘race’ dangerous.”
On October 19 Nature News reported a claim that yet another baby conceived using some kind of mitochondrial manipulation technique has been born, this time in China. A paper is said to be under review at another journal.
What kind of slippery slope is this? It’s been clear from the beginning of the controversy surrounding 3-person IVF that it would be difficult to control its commercial uses beyond disease prevention. This is especially true when it comes to introducing these genetic manipulation techniques into the multi-billion-dollar global fertility industry, a venture that could be extremely lucrative for all involved.
To what extent has anticipation of this possibility been part of the story from the start? While we can’t know for sure, here are several points that might help make this connection:
- In the late 1990s and early 2000s, a precursor to 3-person IVF known as ooplasmic transfer, also known as cytoplasmic transfer, was developed for age-related infertility and put into use without clinical trials. In 2001, the U.S. FDA stopped the procedure after at least two dozen babies had been born, citing lack of evidence of safety and efficacy. No such evidence was produced at the time. On October 24, 2016, Reproductive BioMedicine Online published the first follow-up study of these children. Despite the inconclusive nature of the study, which the authors admit is based on limited, subjective survey data from only 75% of the children’s parents, and with zero follow-up testing of the children themselves, they conclude that the procedure has not produced any long-term effects.
- In February 2012, Shoukhrat Mitalipov, professor at the Oregon Health & Science University, filed a patent for maternal spindle transfer (MST) as a technique for providing prenatal treatment for mitochondrial disease in humans. In November 2012, he founded MitoGenome Therapeutics to reportedly commercialize his work.
- On February 25 and 26, 2014, the FDA held a public meeting to discuss using 3-person IVF techniques for “the prevention of transmission of mitochondrial disease or treatment of infertility”. Although the FDA does not make information from its applications public, this strongly suggests that someone applied for permission to conduct clinical trials towards both of these aims.
- In January 2015, Mitalipov and MitoGenome Therapeutics teamed up with Chinese stem cell banking company Boyalife and the Korean company H-Bion, led by disgraced cloning researcher turned dog-clone entrepreneur Hwang Woo-suk, to start a lab in China. In a Nature News article, Mitalipov described the collaboration as a way to move his 3-person IVF research forward, stating, “Fertility and mitochondrial disease are a big clinical opportunity.”
- In February 2015, Mitalipov confirmed that he had requested permission from the FDA to conduct two clinical trials using 3-person IVF techniques in the United States, the first to treat mitochondrial disease and the second to treat age-related infertility.
- In February 2016, John Zhang of New York City-based New Hope Fertility Center released a video in which he lauded the technique’s usefulness as a fertility treatment, only briefly mentioning its potential use in the prevention of mitochondrial disease (see video at 3:05). This video was released only a few months before Zhang and his team delivered the aforementioned baby in Mexico for a Jordanian couple at risk of transmitting Leigh Syndrome.
- In September 2016, Norbert Gleicher, a fertility specialist at the Center for Human Reproduction in New York City, says he sought a meeting with the FDA to discuss 3-person IVF for U.S. patients, including as a treatment for infertility.
CGS and others have criticized moving forward with 3-person IVF, even to prevent the transmission of mitochondrial disease, because of the unknown health consequences for resulting children and future generations, because safer options for forming families are already available, and because permitting mitochondrial manipulation in humans could open the door to other forms of human inheritable genetic modification. Throughout the policy considerations in the US and the UK about these techniques, the notion that they would be taken up as a treatment for infertility has been downplayed as unlikely or even fanciful. Yet here we are. When fame and fortune come into play, the slide can become very slippery indeed.
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