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The Direct-to-Consumer Stem Cell Industry in the US

Posted by Pete Shanks on July 15th, 2016


Image via Figure 1 of the paper by Turner and Knoepfler (see text).

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Stem-cell clinics can be found around the world: Mexico, South Korea, the Philippines, China and many other countries. Several have been exposed as scams, and others are suspect, while several high-profile patients (not all) have claimed to have been cured, or at least helped, by them. Two competing storylines have become standard. One is that desperate Americans go abroad for treatments because they were conned; the other is that the FDA is over-cautious and withholding life-saving treatments.

Both narratives assume that few, if any, of these clinics are in the US. That may have been true some years ago: 60 Minutes ran an exposé in 2010 that eventually led to arrests, and another in 2012. Introducing the second one, Scott Pelley made it clear that these were meant as examples, that their team had found “hundreds of credible-looking websites offering stem-cell cures at overseas clinics.”

It seems fair to suggest that up till now many Americans have assumed that the FDA was keeping us safe. That is now in serious question.

Leigh Turner and Paul Knoepfler recently published an important paper in Cell Stem Cell on stem cell clinics in the US. Turner is a University of Minnesota bioethicist and expert on medical tourism; Knoepfler is a stem cell professor at UC Davis who also runs a very well-regarded blog about stem cell research.

They identified 351 businesses, operating 570 clinics, all over the country (see map above, which is a reduced version of Figure 1 in their article). Some of these clinics may be offering services that do not require FDA approval, but in many cases, Knoepfler explained on his blog,

... there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.

At almost the same time, a horrifying story broke about someone who had traveled to Mexico, China and Argentina for stem cell treatment to help him recover from a stroke. Eventually he developed painful symptoms, which led to surgery that revealed a huge mass of rapidly growing cells in his spine, which were not cancerous, but were "predominantly composed of non host cells,” according to a letter to the New England Journal of Medicine:

Thus, although the lesion may be a considered a neoplasm (i.e., a “new growth”), it could not be assigned to any category of previously described human neoplasm on the basis of the data we gathered.

Stem cell treatments are by no means the only ones that can have unexpected and tragic outcomes, as recent headlines attest. Juno Therapeutics' small clinical trial of an immunotherapy approach to leukemia was abruptly halted last week after it announced that three subjects had died. (Juno later ackowledged a fourth death that occurred last year in a trial of a similar immunotherapy.) Fewer than 20 patients had been enrolled, and “only a minority” of them had the treatment that at first seemed responsible.

The protocol involved taking some of a patient’s own immune cells, performing gene editing on them to target cancerous growths, and then replacing the the rest of the immune cells with the genetically engineered ones. The clinical trial was being conducted under FDA regulations, and the FDA immediately stepped in.

To widespread amazement, it took only two days (the company had expected at least a month) before the FDA agreed that the problem involved a drug interaction and the trial could continue without using the incompatible chemotherapy drug. It’s unusual for the agency to move so fast, but — assuming they were right — it shows that bureaucracy can adapt.

Nevertheless, there are efforts to weaken the system of oversight. Senator Mark Kirk (R, Illinois) has introduced the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness), which is meant to speed up FDA approval for stem cell treatments. Knoepfler, who called a previous version of the bill “an attack on science-based stem cell trial oversight" remains skeptical:

it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole.

The Alliance for Regenerative Medicine also opposed the Act, at least in its original form. However, the California Institute of Regenerative Medicine (CIRM) has been campaigning for the FDA to loosen its regulations, even claiming that “patients are dying” because we are “so careful about safety.” CIRM President Randal Mills co-wrote an opinion piece for Fox News with former Senate Majority Leader Bill Frist demanding the the FDA make the approval of “cell therapies” (the word “stem” is not mentioned) easier.

Nature disagrees, in an editorial that references the Turner and Knoepfler article:

FDA should stand firm on stem-cell treatments [headline]
US regulators must regain the upper hand in the approval system. [short]

The pull quote accompanying the editorial is harsh but fair:

"The assumption that these treatments work is at the heart of the problem.”

Previously on Biopolitical Times:

Image via Figure 1 of the paper by Turner and Knoepfler (see above).





Puffing Cryonics in New Scientist?

Posted by Pete Shanks on July 13th, 2016


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New Scientist is a British-based popular science magazine. It’s been around for 60 years, which is long enough to stumble and recover a few times. For instance, in 2009 it published a cover story with the startling headline “Darwin Was Wrong.” (Not so, even if his concept of the “tree of life” was simplistic.) The story is mostly behind a paywall but still on-site; the cover image can be found elsewhere.

To be fair, New Scientist has also published informed and incisive commentary by experts such as Donna Dickenson and our own Marcy Darnovsky. The magazine has also been, at least on occasion, sensitive to questions of ethics, as in this 2014 editorial on “three-parent babies.”

But they just stumbled again. The July 2 issue featured on the cover “The Resurrection Project.” The articles included:

Ark of the immortals: The future-proof plan to freeze out death
A visual tour of the weird world of the cryogenically frozen
I want to put your death on ice so that you can live again

The perpendicular pronoun in the third title refers to Max More, the transhumanist who currently runs the Alcor Life Extension Foundation. We last mentioned More and Alcor in March, when we referred you to Corey Pein’s excellent article in The Baffler. Pein describes the folks behind Alcor as “technophilic necromancers” and digs deep into the risible history of More’s Extropy Institute and “proactionary principle.” As science (and business) goes, cryonics is on the quackery side of reality.

It would not surprise me to learn that, behind the paywall (I’m not paying) there was criticism of cryonics. But the topic was on the cover, not to mention featured in at least three email blasts, two of which used the term immortals. How should we understand those choices by a publication that calls itself a science magazine? As the writer of the aforementioned Darwin article admitted in response to complaints registered then:

Well, the cover is designed to sell the magazine. If we run very straight, sober covers, we sell fewer mags, we get fewer clicks and nobody blogs about us, so fewer people read what we produce.

What they think of us, the readers, is hard to tell. But here are the subject lines of the four most recent email blasts, as of this writing:

Self-promotion comes naturally to narcissists (July 10)
Your ultimate guide to reality’s true strangeness (July 9)
How to be a successful narcissist (July 8)
Embrace your inner narcissist (July 7)

And here is a worrying piece from the archives, 23 October 1999, to be precise. (So long ago, it took the Techno-Eugenics Email List, a distant ancestor of this blog, months to note it!) It’s a New Scientist Editorial titled “The Last Taboo,” in response to reports that scientists had, in principle, invented artificial chromosomes. The speculation around them was that they could be used to introduce heritable changes, in mice and theoretically in people. The technology was not then ready for use, by any means, but the editorial concludes:

For all these reasons, it would be a mistake to expect the taboo on human genetic engineering to last forever. Some day someone will want to try it. The invention of artificial chromosomes doesn’t make that desirable—only people can make that judgment. But it does add to the forces that are now beginning to make it seem inevitable.

As for taboos, they are simply a bad excuse for not thinking.

Apparently, sales are a good excuse for not thinking. Or perhaps the editors just suffered a brain freeze.

Previously on Biopolitical Times:

Image via New Scientist





Two Decades After Dolly

Posted by Pete Shanks on July 12th, 2016


Dolly’s remains are on display sat the National Museum of Scotland. (Even in death, an object of the human gaze.)

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Ten years ago last week, on what would have been the tenth birthday of the first cloned mammal, the soon-to-be-world-famous sheep, CGS published a 16-page Report [pdf] titled A Decade After Dolly.

This is how it opened:

It’s been nearly a decade since the birth of Dolly the cloned sheep in the summer of 1996—followed by the announcement of her existence in February 1997—put the prospect of cloning human beings clearly before us.

Since then, a near consensus has emerged: Cloning human beings is a very bad idea, and should be prohibited. In the past ten years, more than forty countries have adopted prohibitions against human reproductive cloning. But the United States has not.

The past decade has seen the development of techniques that could produce not only cloned children, but also a “designer baby” world of genetically modified humans. Again, unlike many other countries, the US has not put in place binding regulations to prevent this

Mutatis mutandis, it holds up pretty well as a summary. Gene editing and cellular reprogramming have emerged as collaborators with cloning. Concerns about genetically modified humans have therefore become even more realistic and pressing.

On this the twentieth year, Nature published perhaps the most interesting anniversary article, which told the story of Dolly’s conception, birth, life and death entirely in the words of the people who were actually there (plus a few closing comments from other experts). Scientific American had a multi-part feature, covering science, ethics and endangered species (also picked up by GEN). Stat had a piece by Sharon Begley that focused on human cloning, or the lack of it. And Pravda declared that pet cloning is the most profitable business in South Korea.

The last word should go to Ian Wilmut, who led the team that made and reared the first cloned mammal, quoted in Nature:

It would be wrong to say my name's known all the way around the world — but Dolly's is.

Previously on Biopolitical Times:

Image license for non-commercial use.





Frozen Eggs and Heated Debates

Posted by Angel Petropanagos, Biopolitical Times guest contributor on July 12th, 2016


A close-up shows ice crystals growing atop a darkened shape.

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Public debates about social egg freezing overemphasize the rights and responsibilities of individual women who delay childbearing and also misrepresent their reasons for doing so. These debates largely ignore the broader social and institutional structures and norms that shape and constrain the reproductive choices of men and women. Egg freezing is mistakenly framed as a solution to the risk of infertility that accompanies delayed childbearing.

* * *

Social egg freezing is becoming more widespread as a result of increased media coverage, clever marketing strategies, employer benefits from companies including Apple and Facebook, and government funding in Japan. 

I’ve been thinking and writing about the ethical issues surrounding social egg freezing and delayed motherhood (and fatherhood) for several years. And the public debates on these topics haven’t really changed.

Proponents of social egg freezing argue that this technology can promote women’s reproductive autonomy by affording them the option of delaying genetic reproduction and parenthood in order to pursue higher education or advance their career— an option that is generally available to men on the assumption that childcare is women’s work (so there will be a woman somewhere to care for his children while he pursues his education or advances his career).

Critics of social egg freezing raise concerns about the health risks to individual women and any resulting offspring. They also worry about the fact that most women who freeze their eggs likely will never use them for reproduction. This points to a service that is characterized by unnecessary physical risks to women and needless expenditures by them, and results in a surplus of stored biological material. Further, critics worry about “false hope” that can result from the use of a technology that is not guaranteed. Some feminists worry that social egg freezing detracts attention from broader social changes, such as improved parental leave, subsidised or universal daycare, and flexible work schedules that can make it easier for women (and men) to choose to have children at a younger age.

A few weeks ago I participated in a panel discussion about social egg freezing and delayed motherhood hosted by the Progress Educational Trust in Edinburgh, Scotland. The discussion included mention of all of the ethical considerations listed above. We also discussed the role of the media in promoting social egg freezing and spreading misleading information, as well as the importance of language for framing this technology. Despite these discussions, I was disheartened to see that much of the public discussion and the media coverage of this event focused on mistaken assumptions about the women who might use this technology. Media coverage also framed reproductive health education within a pronatalist mandate, that is, as targeting girls and young women to educate them about age-related infertility in order to prevent them from “the risk of missing motherhood.”

First, many people mistakenly assume that women delay childbearing because they are “picky” and waiting for “Mr. Right.” The reasons for delayed coupling that facilitates childbearing are complex. For example, women who have graduate degrees and demanding careers may have relocated several times, which can make it difficult to find a partner. The financial and time demands of work can leave some women without enough resources or energy to have kids at a younger age. Many women may be on second or third marriages and childbearing didn’t work out. Or, they may have children and want additional children with their new partner.

A second problem is the heteronormativity that permeates discussions of social egg freezing. Not all women who delay childbearing or contemplate social egg freezing are looking for Mr. Right. Some women may be looking for Ms. Right, while others may be choosing to parent alone, within polyamorous relationships, queer kinships or committed friendship communities. Discussions about social egg freezing should not assume or reinforce heteronormative nuclear family structures for raising children.

Third, people often assume that delayed motherhood is all about individual women’s choices. Indeed, public discussions typically fail to adequately address the role that men play in reproductive decision-making. Men also make choices around delayed parenthood, and for women who want to have children with men, this matters.

Fourth, women’s and men’s reproductive decisions are embedded within social contexts that help to shape their reproductive desires and values. For example, there is a pervasive social pressure to have genetically related children and “real” womanhood is often equated with motherhood. These pressures occur alongside social education and employment structures that make actually raising children really difficult, especially for people who lack adequate financial or social supports.

Finally, not all women want children. Discussions about social egg freezing assume that women without children, particularly those with advanced degrees or careers, have chosen to delay childbearing in order to achieve education and employment goals. Seldom do public discussions recognize that remaining childfree is a valuable option for some women. Widespread social pressure to freeze one’s eggs undermines the validity of this option.

Advancing public discussions of the ethics surrounding social egg freezing requires that we move beyond analyses of individual women’s choices. Social egg freezing is the result of social and systemic structural problems that influence decision-making. As such, addressing the concerns surrounding delayed motherhood (or parenthood more generally, for that matter) requires widespread social change.  

Angel Petropanagos is a Research Associate at Novel Tech Ethics at Dalhousie University and a Visiting Scholar at the Joint Centre for Bioethics at the University of Toronto. @APetropanagos

This blog is cross-posted at Impact Ethics.

Previously on Biopolitical Times:

Image via Pixabay






 


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