 |
| |
 |
|
 |
| |
Hwang Tries for a Comeback
Posted by Pete Shanks on February 5th, 2010
| Recent news from Korea indicates that Hwang Woo-Suk is making active efforts to salvage his reputation, and to reestablish himself as a force in science. He has resolved at least three court cases and is publishing in peer-reviewed journals. Given his previously demonstrated expertise in public relations, this may be worth watching.
Hwang's legal troubles may be over:
- His criminal trial ended with a surprisingly lenient sentence.
- Seoul National University (SNU) has recently decided not to appeal against a judgment that Hwang is now using new technologies that do not infringe SNU's patents.
- A court ruled in December 2009 against an egg donor who sued for damages, saying that she was informed "of the procedures and possible side effects" and had not demonstrated that she suffered harm because of the procedure.
Meanwhile, Hwang and his team have been at work in the lab. They have cloned several dogs, and published at least three peer-reviewed papers on the subject (1, 2, 3), plus others on related techniques (4, 5). They have also been working with pigs, and published several papers (6, 7, 8).
Hwang has not, however, lost his knack for PR. He cloned a bomb-sniffing police dog, which made good press. And he claimed in May 2009 to have derived embryonic stem cells from cloned pig embryos. A paper on this has been submitted for publication, possibly to Zygote, and is expected later this year. He also announced "a deal with the Gyeonggi provincial government for research on genetically modified pigs to be used for organ transplants."
There have been several rumors that Hwang continues to work with human cloning and deriving ESCs, perhaps in Thailand or elsewhere (China was denied by an associate), though these have not been substantiated. That he intends to do so if he can is certain. In August 2009, at the end of the evidence phase of his criminal trial, he said:
I made a promise to the Korean people in my last press conference on Jan. 12, 2006. I will keep the promise of creating genuine patient-specific stem cells. I would keep the promise in the not-so-distant future if I were given another opportunity.
Moreover, he continues to insist that the stem cell line featured in the retracted 2004 Science paper was in fact derived from a clonal embryo, and not the result of parthenogenesis; there is a recent report that a paper to that effect is under review.
It must be stressed that if that stem cell line was indeed derived from a clonal embryo, it was defective. It seems not be disputed that 8 of 48 markers did not correspond with those that would be expected from a somatic cell donor. That led to the suggestion of parthenogenesis, but some of the experts that supported that have since accepted that it may have been clonal. However, Prof. Seo Jeong-sun told the Korea Times (link no longer available):
First and foremost, Hwang doctored data and that is the most important point without doubts. ... In addition, the No. 1 line would be of little use for experiments or therapeutic applications because it was damaged too severely.
Hwang Woo-Suk's comeback may be under way, and he may be doing some genuine science, but his announcements should be read very carefully and treated with considerable skepticism.
Previously on Biopolitical Times:
|
| LA Times columnist's concerns over CIRM echo our own
Posted by Jesse Reynolds on February 3rd, 2010
|
 | | Michael Hiltzik |
One of the most prominent political commentators in the state has again taken on California's controversial stem cell research program. Michael Hiltzik, a Pulitzer-prize winning columnist at the Los Angeles Times, has critiqued the California Institute for Regenerative Medicine at least three times before. Weeks before voters approved Proposition 71, the initiative which created the CIRM, he suggested its promoters were overplaying the immediacy of cures and the resulting streams from profitable inventions while intentionally dodging the "process by which elected representatives decide whether, say, $3 billion in state debt capacity should all go to stem cell research or to a broader biomedical research program, or even to highway construction or schoolroom renovation instead."
Six months after its passage, Hiltzik rhetorically asked, "Did it have to live down to our expectations so quickly?" He pointed to the the agency's hostility toward the legislature, "overwrought reaction" to lawsuits challenging the constitutionality of the initiative, and its dangerous haste.
And last year, he said the program was "rife with conflicts of interest," and called "for a fundamental rethinking of the stem cell program."
The occasion for his latest salvo was a remarkable exchange between CIRM leadership and a secondary committee established by Proposition 71. The closest thing to oversight of CIRM by elected officials may be the its Citizens Financial Accountability Oversight Committee, which is chaired by the state Controller and acts as something of an audit board. Last week, that committee unanimously endorsed the recommendations of the state's Little Hoover Commission, which last year issued recommended changes to Proposition 71 and CIRM policy. The CIRM's leadership, and particularly its board chair Robert Klein, vociferously denounced and fought the Little Hoover Commission's recommendations, even threatening legal action if the Legislature took them up. So it wasn't surprising that the CIRM firmly brushed off this latest recommendation.
Now, Hilzik encourages the Legislature to use CIRM's wish for more staff, which would require a modification to Proposition 71's cap, to push through broader reforms, including those recommended by the Little Hoover Commission.
Here's an excerpt, echoing my my invited 2008 testimony to that body:
[T]he leadership of the California stem cell program... entrenched itself in almost unassailable control of its $3 billion in funding, and has self-righteously fought every attempt to improve public oversight over its disbursement of what is, after all, the people's money....
CIRM mouthpieces love to claim that the "voters' intent" should be honored by keeping the program rigorously free of political oversight -- but then the voters' intent was also to give it 50 staff members, and not a soul more.
Nothing requires the Legislature to crack open the door on Proposition 71 only as far as CIRM wishes. The Legislature should let the program have the additional staff, but on its own terms. These should include a change in CIRM's board structure and imposition of the sort of oversight the program should have had in the first place -- including a reduction in the requirement for legislative amendments from 70% to a bare majority and giving Chiang the broader authority he requested. That's the way to create a public stem cell research program that exemplifies not only good science, but good government.
Of course, I couldn't agree more.
HT to the California Stem Cell Report.
Previously on Biopolitical Times:
|
| Two More "Lazarus" Projects
Posted by Pete Shanks on February 3rd, 2010
| The idea of reviving extinct species just won't go away. Genomics is being used in attempts to revive both the aurochs (as painted some 30,000 years ago in Lascaux) and a species of Galápagos tortoise.
The last known aurochs, a huge ox that weighed two tons but is the ancestor of domesticated cattle, died in Poland in 1627. Lately, however, an Italian group has analyzed aurochs DNA from bones and is trying to recreate the species through back-breeding. They have already crossed three different breeds from different parts of Europe, and intend to analyze the calves and continue breeding until they can produce "animals nearly identical to aurochs." Donato Matassino of the Consortium for Experimentation, Dissemination and Application of Innovative Biotechnologies (ConSDABI) in Benevento, Italy, is quoted (translated here) as saying:
We will rebuild, step by step, the genetic combination of primitive ox. This is a first crossing of a series. This newborn animal will give us material to use in future crosses. It will take some years to reach the closest animal ancestor of the ox. We may also use different techniques such as artificial insemination, embryo production in vitro and, eventually, cloning.
Another team is also reported to be currently working on resuscitating the aurochs. (Previous attempts were made in the 19th and 20th centuries but obviously without the benefit of genetic technologies.) Matassino's justification for reviving the aurochs is that "today, our focus is sustainability and bigger animals will be a help with that." There may, however, be issues with "an animal which boasts a size and temper akin to a tetchy rhinoceros."
Meanwhile, scientists at Yale have been analyzing the DNA of 156 tortoises living in captivity, and samples from remains of the now-extinct Chelonoidis elephantopus, which used to live on Floreana Island in the Galápagos -- and found that it's not quite extinct after all. They identified nine individuals as descendants, probably grandchildren, one of whom is a male "with high assignment probability to C. elephantopus based on microsatellite genotypic data [and] a 'Floreana-like' mitochondrial DNA haplotype."
Breeding tortoises takes a while, but in a century or so they hope to produce a tortoise genetically identical to the species generally considered extinct. Says Gisella Caccone, "Theoretically, we can rescue a species that has gone extinct. Our lab calls it the Lazarus project. ... We won't be around to see it, but it can be done."
Neither of these projects seems to involve genetic modification, though the aurochs re-creation may involve cloning eventually. Both of them, however, seem to encourage a purely genetic view of life, and species, while stretching the definition of species in a way that contradicts the supposed certainty of genetic analysis. Is "nearly identical" close enough? Is this, in any case, a useful way to proceed? Or are these examples of the maxim that to those with a hammer, all problems look like nails?
Previously on Biopolitical Times:
|
| Whither personal genomics?
Posted by Jesse Reynolds on January 29th, 2010
| Two years ago, direct-to-consumer (or personal) genomics was the all the buzz. Media coverage was rampant, often the result of 23andMe's remarkable PR blitz of celebrity-laden "spit parties" in Davos and New York. Flash forward to the present: coverage is slim and the companies are suffering, including layoffs and one major bankruptcy. To where does the fledgling industry go from here? Three companies offer contrasting examples: The most visible one may be using a flawed business model and product. The oldest, and bankrupt, one has a troubling track record of privacy and consent. And a new one takes a new, and potentially problematic, approach.
Recent in-depth articles in The Times (UK) and The Washington Post explore the current status of the still-young industry. The former frames it:
Personal genetics was the next big thing: what celebrities and moguls were buying today, the masses would be buying tomorrow. 23andMe and rivals such as [bankrupt] deCODE Genetics, Navigenics and Pathway Genomics would do for DNA what Google and Amazon did for the internet. The genetic future was now.
Eighteen months on, that future stands postponed. Many doctors have rejected the hype about a new era of personalised medicine, arguing that most genetic screening is as likely to mislead as to inform. Neither have the public taken to consumer genomics: 23andMe, the market leader, has signed up only 30,000 subscribers in two years and has endured two rounds of redundancies....
Have science entrepreneurs such as [23andMe's Anne] Wojcicki and Kári Stefánsson, deCODE's founder and chief executive, jumped into a market for which the world is not ready? Will their companies prove to be the genome's Googles and Amazons, or its Boo.com?
I've long been of the mind that, just as the traditional business model of newspapers is to get revenue not from readers but from advertisers, personal genomics companies see the potential profit not from the consumers themselves but from the compiled databases--likely in the form of selling access to them. One key question is, just how reliable is this data? For example, 23andMe uses consumers' self-reporting:
But there is disagreement about the scientific worth of such a database. Stefánsson thinks [23andMe's data] will be useless because self-reported traits are unreliable and customers will object to the release of information. However, 23andMe says that the plan is already working and has led to the discovery of genetic variants linked to traits such as the curliness of hair. If this approach can be repeated with, say, responses to drugs, it's easy to see how a pharmaceutical company might bite.
This strikes me as wishful thinking at best. Consumers can likely self-report the curliness of their hair with significant accuracy. But I am skeptical about their ability to do the same for reactions to drugs, considering, for example, the remarkable (and rising) effectiveness of placebos.
What interests me more is the fate of the databases. As pressures to turn a profit mount during the Great Recession, and as companies such as deCODE, which recently filed for bankruptcy protection, are saved by new investors and subsequently restructured, what becomes of the data?
23andMe insists it will never release identifiable information to a third party without the explicit consent of the person concerned. "I'm always careful when I say we're going to have a revenue stream from the database," Wojcicki says. "We will not sell individuals' data, but the database as a whole will have enormous value."
Explicit, informed consent when purchasing a product online is difficult to truly obtain. When was the last time you read a user agreement when installing software?
The case of deCODE is even more troublesome, and not just because of its restructuring. At the Genomics Law Report blog, Dan Vorhous notes:
Stefansson and deCODE have been adamant that the change in ownership will not affect how the company uses data from customers of its deCODEme service, or the security of that data, but this is an issue that will continue to bear watching. As I’ve written elsewhere, deCODE’s new owners remain (legally) free to alter or expand their use of genetic data within a range of allowable uses.
The company’s announcement also refers in several places to genomic sequencing, and as Jocelyn Kasier first reported last fall, deCODE is planning to sequence the complete genomes of 2500 individuals from its Icelandic database by mid-2011 as it continues to search for the rare variants that may contribute some of the so-called “missing heritability” to common diseases and traits. According to Stefansson, deCODE “will not need to recontact these individuals for consent because their original consent agreements cover whole genome sequencing.”
As Stefansson and others continue to note, genomic research has already begun the transition from genotyping to whole-genome sequencing. Moving from examining a handful – even thousands – of an individual’s genetic markers to the sequencing of his or her entire genome creates the potential to understand that individual in much greater detail. It also carries with it a new and expanded set of considerations and risks that should impact any informed consent process....
What I do know is that deCODE has a history of aggressively interpreting when and where individualized informed consent is not required. The failed Icelandic Health Sector Database, which deCODE was instrumental in designing, relied on the now-discredited principle of “presumed consent.”
Just today, The New York Times profiled Counsyl, a new entrant into the field that is just now moving into the public eye. It explicitly targets prospective parents, arguing that preconception genetic testing can prevent the transmission of some diseases. In fact, the company (among whose advisors and investors in Henry Louis Gates (1,2)) frames their work as a "Campaign to End Preventable Genetic Disease."
To their defense, Counsyl emphasizes and currently tests for fatal and serious genetic diseases (although I am admittedly unfamiliar with many of these rare conditions). Furthermore, it backs up its argument that genetic testing is a right by offering financial aid for those who can't afford the $350 test, emphasizing that "Underserved groups and families with a history of genetic disease will receive priority."
But on the other hand, Counsyl makes a couple of significant misrepresentations. Its website says "Everyone is supposed to get genetic testing before pregnancy," even though the American College of Medical Genetics (or ACMG, who is cited) makes more cautious recommendations [PDF] about a limited number of diseases. Moreover, the ACMG recommends [PDF] that "A knowledgeable professional should be involved in the process of ordering and interpreting a [direct-to-consumer] genetic test." Finally, as the Times article notes, "The company calls its product the Universal Genetic Test, for example, even though there are thousands of genetic diseases, not just the 100 Counsyl tests detect."
More troubling is the eugenic potential of a direct-to-consumer genetic test aimed at potential parents. Although Counsyl currently emphasizes serious diseases, it is foreseeable that it will seek to expand its customer base by adding less serious--and even nonmedical--conditions. Moreover, its financial interests align well with those of the $3 billion baby business:
The test is already offered by more than 100 fertility clinics around the country...
Fertility centers have an economic incentive to promote the test because one of the best ways to avoid having a baby with a genetic disease is to test embryos created by test-tube fertilization before implanting them. This pre-implantation genetic diagnosis costs $3,000 or more, in addition to the roughly $10,000 fee for in vitro fertilization.
Notably, Counsyl's website recommends preimplantation genetic diagnosis and donor gametes, but not adoption, as responses to a double-carrier test result.
23andMe may have a defective product, despite its publicity. And deCODEme may raise serious privacy concerns. But Counsyl may represent the next step toward a consumer driven, technologically based, new eugenics.
Previously on Biopolitical Times:
|
|
|
|
|
 |
 |
 |
| |
|
