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Selling Stem Cells Honestly

Posted by Pete Shanks on June 25th, 2014

Elena Cattaneo
Elena Cattaneo

Scientists around the world are campaigning in favor of sensible regulation of stem-cell therapies. We have two reactions: (1) kudos for this important work; and (2) it's about time.

The highest-profile selling-stem-cells scandal at present is in Italy, where the Stamina Foundation has been described as a "criminal organization that has defrauded about a thousand patients since 2006 by administering a dangerous and unapproved [stem cell] treatment in exchange for money." A profile in The Verge describes its founder, Davide Vannoni, as a "con man," and a long article in Nature by scientists Elena Cattaneo and Gilberto Corbellini details their exhaustive (and exhausting) efforts to stop him:

We recommend that all scientists stand up for the scientific method. Science depends on public institutions and is done in the public interest — we have a duty to defend both.

The recent conference of the International Society for Stem Cell Research (ISSCR) opened with a panel discussion about how to sort the real from the bogus treatments. (Note: none of this is in any way related to the STAP cells controversy.) ISSCR's website includes a useful fact sheet, a backgrounder on "How Science Becomes Medicine," and even, on the front page, a link to the 2010 60 Minutes investigative report on "21st Century Snake Oil."

ISSCR and twelve other organizations, including the California Institute for Regenerative Medicine (CIRM), worked together last year to issue a "Patient Advisory for Stem Cell Therapy and Medical Tourism." Former CIRM President Alan Trounson wrote a related opinion piece last week in The Scientist, on "Thwarting Medical Tourism":

It's time to take a strong stance against unregistered cellular therapies, which can undermine legitimate research efforts.

Trounson still calls for increased funding of stem cell research. And CIRM is still promoting the development of cures, certainly, but is putting some effort into explaining why they may yet take a while.

This is a welcome change. A little perspective is called for, however: CIRM was sold to the public in 2004 with the strong implication that cures were imminent. The Proposition 71 Voters Guide argument in favor was presented by Cures for California, and the initiative was presented as "Proposition 71, the California Stem Cell Research and Cures Initiative." (It was also going to be an economic miracle.)

Scientists led the way in talking about "life-saving cures" and advocates campaigned under the slogan "Countdown to Cures." Professor and entrepreneur Irv Weissman donned a white coat for commercials, presented himself as a doctor, and assured the TV audience:

The chances for diseases to be cured from stem-cell research are high…. If the promise of stem-cell research comes true, we can hope for a single treatment with the right stem cells to cure diseases every family has.

The hype wasn't limited to California, as Marcy Darnovsky explained in Democracy:

On the national scene, vice presidential candidate John Edwards told a crowd in October 2004 that embryonic stem-cell research would allow people like Christopher Reeve to "get up out of that wheelchair and walk again." In a speech at the Democratic convention, Ron Reagan Jr. predicted that cloning-based stem-cell research could produce for each of us a "personal biological repair kit." The rhetoric grew so heated that Princeton University President and geneticist Shirley Tilghman, a supporter of such research, warned that "some of the public pronouncements in the field of stem-cell research come close to over-promising at best and delusional fantasizing at worst."

Of course, the claims of cures around the corner carefully avoided including a timetable. But in a report published two days after the election, Weissman told the San Francisco Chronicle:

If somebody comes up with a saleable product in five years, I'll be shocked. If we don't have lots of therapies in 20 years, I'll be even more shocked.

Right. There has been a decade of hype about the potential of stem cells. CIRM is approaching the end of its mandate — and money — and looking for more. All of a sudden, they are taking a more … realistic … line. But is it really any surprise than some patients are, well, impatient?

Some scientists have been taking a more balanced view all along. UC Davis Professor Paul Knoepfler's Stem Cell Blog, in particular, has been doing great work for several years critiquing while also supporting the field. Knoepfler designated Elena Cattaneo 2013's Stem Cell Person of the Year; the ISSCR awarded Cattaneo along with Paolo Bianco and Michele De Luca the 2014 Public Service Award.

It's excellent that more scientists are now publicly calling for oversight. Perhaps they will learn a broader lesson: Do not over-promise "cures" in an effort to raise money. Or, as Bianco and Douglas Sipp, another long-time monitor of the field, argued in Nature last week:

Sell help not hope

Previously on Biopolitical Times:

Selling the Next False Hope? How Experimental IVF Techniques Could be Legalized Despite Increasing Evidence of Potential Harm

Posted by Jessica Cussins on June 24th, 2014

Untitled Document

More and more women are speaking out about being sold false hope by the fertility industry. They tell of being encouraged to pay tens of thousands of dollars to put body and psyche through hell, and of never being informed just how low their chance was of ending up with a child, or what the long-term impact of off-label drugs can actually be.

However, the industry’s narratives of choice, empowerment, and healthy babies are well-rehearsed and powerful. And they can already be seen in the promotion of a still-illegal technique known as "three-person IVF," which would combine genetic material from two women and one man in an attempt to create a child without the intended mother’s mitochondrial disease. UK researchers, and their funders, have been lobbying the UK government for years to change the law against human inheritable genetic modification in order to allow this into fertility clinics as soon as possible.

There has been little commentary to date about the economics of "3-person IVF." However, a recent report from the UK Department of Health notes that one of the hopes of legalization is that it would “encourage inflows of foreign direct investment into the industry in the UK.”

According to the report, a woman considering this procedure should expect to undergo at least four cycles of egg extractions, at an estimated total cost to her of 80,000 pounds (about US$136,000.) Although very few women would be candidates for the techniques, the revenue stream to private companies would be on the order of 533,000 pounds (about US$905,000) even if only ten women a year decide to go ahead.

The women who will be encouraged to spend such sums on these experimental and invasive techniques deserve the full story. Although the official line from those promoting the techniques has long been that there is no evidence that they are unsafe, there is in fact a lot of reason to doubt their safety.

First of all, the women who could benefit from these techniques could also be harmed by them. Pregnancy poses risks to women with mitochondrial disorders, and egg extraction (which would be required multiple times from two women in this situation) carries both  known and unknown, immediate and long-term health risks.

The risks to any resulting children include all of the following – notably, the first is new evidence just published this month:

  • According to Jörg Burgstaller and Joanna Poulton, mitochondrial genetics scientists at the Vetmeduni Vienna and the John Radcliffe Hospital in Oxford, even a tiny amount of carryover mutated mitochondria can lead to disease in a resulting child if they are preferentially replicated (a phenomenon that the authors show is more widespread and dangerous than previously believed.) Burgstaller states,

So far it was believed that this minimal ‘contamination’ is of no consequence for the baby. However, our data show that the effect may have dramatic consequences on the health of the offspring.

  • Klaus Reinhardt, Damian K. Dowling, and Edward H. Morrow, three evolutionary biologists working in the UK and Australia, note that there are continuous complex interactions that take place between the nucleus and mitochondria, which could be disrupted by this procedure and lead to adverse outcomes, including potential infertility in males. They have concluded,

There are reasons to believe that it is premature to move this technology into the clinic at this stage.

This person would develop from a fertilized egg in which all but a few genes (those of the mitochondria), not just those of the male parent, come from a source other than the egg itself. This clearly makes any such person a product of wholesale genetic engineering. We do not know nearly enough about the process of embryonic development for the FDA to even contemplate approving this procedure.

Enucleation of eggs is traumatic, and has been compared to major transplant surgery; damage to the developmental potential of eggs from these procedures was observed in both recent papers on MST. There is no body of data that would validate use of these techniques in a clinical setting.

  • Paul Knoepfler, Associate Professor in the Department of Cell Biology and Human Anatomy at UC Davis School of Medicine, states

Moving one oocyte nucleus into the enucleated oocyte of another person could trigger all kinds of devastating problems (most likely through epigenetic changes) that might not manifest until you try to make a human being out of it. Then it’s too late.

  • Even Shoukhrat Mitalipov and other researchers at Oregon Health and Science University working to develop these techniques acknowledge that the majority of human zygotes they have produced showed abnormal fertilization, something that was not seen in their animal models and which they cannot explain.

Both the women who may be offered "3-person IVF" as a viable way to have a healthy child, and the women who would provide their eggs and serve as “mitochondrial donors,” have a right to know that no one can actually say whether these crude manipulations will work. And even if the daunting risks are fully disclosed, it would be wise for anyone considering "3-person IVF" to keep in mind how the fertility industry markets standard IVF: by selling exaggerated hope to desperate patients.

On the New Alphabet of Life

Posted by George Estreich, Biopolitical Times guest contributor on June 6th, 2014

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A recent Biopolitical Times post highlighted a landmark discovery: the expansion of life’s alphabet. To the puny assortment of A, T, G, and C—the nucleotides that are the “rungs” on DNA’s ladder, and whose varying sequences are the basis for life as we know it—scientists in California have now created two new synthetic nucleotides: X and Y. This is great news for synbio Scrabble fans, who, in addition to tag, cat, and Gattaca, can now spell tax and gay.

As a writer, and also as a fan of Darwin’s endless forms most beautiful—the phrase, the theory, the forms themselves—I was curious about the addition of the new letters. The four existing nucleotides were good enough to spell out plane trees, Dimetrodons, coral reefs, Tasmanian tigers, rainbow trout, and us—the endless forms evolved over aeons, some vanished, some vanishing at human speed—so why add more? What new forms will we evolve on purpose, to accompany those evolved by the wisdom of time and accident? Why complicate so simple a beginning?

As Pete Shanks notes, Dr. Floyd Romesburg, the Scripps Institute scientist who led the work, explained his project with a metaphor:

If you have a language that has a certain number of letters, you want to add letters so you can write more words and tell more stories.

Among writers, the second person is not without controversy. It is the plaid-jacketed salesman of narrative, throwing its arm around the reader to tell her what she knows and what she wants, and it often produces recoil where it aims at intimacy. So it is for me: it may be that new nucleotides = new amino acids = new organisms, but it does not follow that new letters = new words = new stories.  I know lots of writers, but none of us have been thinking, “If only there were thirty letters in the alphabet, then I could finish my novel, The Story of Jimβθ!” Newness depends on thinking and imagination, operating on and in the language we have received, an evolved and evolving thing, created by everyone but by no one in particular, and comprehensible because shared. From so simple a beginning, we get endless forms, some more beautiful than others; but the stories are legible and meaningful because they spring from a common alphabet.

Scientists are more media-savvy than they used to be, and metaphor, one of the traditional tools of literature and persuasion, is part of the game. The right metaphor can soothe fears, explain the recondite, familiarize the unfamiliar. It is scary to say, “we want to create, not only new life, but a new kind of life, one fundamentally different from every single organism that has ever lived.” But who could be against telling more stories? Everyone loves stories! We associate stories with entertainment, meaning, and self-expression. Stories are good. You can never have too many of them.

But to have a story, and to be one, are not the same. George W. Bush can have a story, and so can Lassie, or a tapeworm. But none of these creatures is a story, something designed deliberately and in molecular detail by a single creator, written into existence, letter by letter, word by word. So when Romesburg writes “you can write more words and tell more stories,” that assumes that it is okay to design new creatures in the first place. Turning Romesburg’s rhetorical you to a literal one, I would ask, If a new story is a new creature, then what stories do you want to tell? We have no cultural limit on stories, on their complexity or intricacy: will there be any limits on the stories told with the new letters, or on their ability to replicate, or on the ability of the designed creatures to interact with the evolved?

We live in an ecosystem of persuasion. Our words permeate the world and change the world. Until not that long ago, “life writing” was a genre, and “rewriting nature” a metaphor. It is not that humans haven’t directed the evolution of organisms through agriculture and domestication, or tried, at least, to direct our own; it’s that only recently have we been able to literally rewrite the code of life. We live among metaphors, even as the old metaphors collapse, and under the flag of one patented, invented word after another (Synthorx, Editas), our story is being revised.

George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.

Recently on Biopolitical Times:

When and How Will We Regulate Synthetic Biology?

Posted by Pete Shanks on June 6th, 2014

Over the past couple of months, there has been a cascade of proposals for — or at least discussions about — regulating synthetic biology, and they are beginning to be noticed. It’s about time!

The technology is edging into the marketplace, at least as proof of concept, and various stakeholders are establishing positions. Some kind of regulation will eventually happen, but we can expect some major struggles first. For instance, if our present institutions are less than adequate to oversee the new processes — and all but the most starry-eyed boosters agree that they are — should they be replaced or expanded? In the U.S. context, what legislation will be required, and how will it get through Congress?

Perhaps most critically, from the point of view of those of us who are skeptical about utopian promises, how can we ensure that social, economic, ethical and other factors are considered? For too long safety has been very narrowly interpreted, and substantial equivalence far too broadly assumed. Will those definitions really be retained when it comes to governing completely novel organisms whose biological and social disruptions are potentially vast, difficult to predict, and perhaps impossible to reverse?

These are not, in practice, questions with simple answers, and some people have been working on them for years. For instance, two of the four authors of the recent Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (discussed below) were co-authors of the 2007 Options for Governance, and one of the others wrote New Life, Old Bottles in 2009. Other previous reports include From Understanding to Action, the self-regulation proposals discussed at Synthetic Biology 2.0 back in 2006, and the much more rigorous Principles for the Oversight of Synthetic Biology proposed by a coalition of NGOs in 2012.

The two most significant of the five reports listed immediately below are those arising from a process undertaken by the international Convention on Biological Diversity, which is soon to resume, and from the federally funded overview produced by a small team led by members of Craig Venter’s organization; both are likely to be sources of discussion for some time to come.

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