Real-Life True Blood: Synthetic Blood Is Coming

Season 6 of HBO’s vampire drama True Blood premieres on Sunday night, presumably following up on last year’s cliffhanger where the factory that produces Tru-Blood — the bottled synthetic blood that allows vampires go “vegetarian” — was burned to the ground, destroying the product that made it possible for vampires to non-violently co-exist with people. But out here in the real world, the future of synthetic blood is just beginning.
Devon Maloney
http://www.wired.com/underwire/2013/06/real-true-blood-synthetic/
Wired
June 14, 2013
HBO

Season 6 of HBO’s vampire drama True Blood premieres on Sunday night, presumably following up on last year’s cliffhanger where the factory that produces Tru-Blood — the bottled synthetic blood that allows vampires go “vegetarian” — was burned to the ground, destroying the product that made it possible for vampires to non-violently co-exist with people.

But out here in the real world, the future of synthetic blood is just beginning. After decades of global research, controversies, and failed approval petitions, the UK’s Medical and Healthcare products Regulatory Agency finally gave researchers at the Scottish Centre for Regenerative Medicine the go-ahead late last month to start developing synthetic blood with adult stem cells.

The license allows the researchers to use already-recognized stem cell technology to create a compound that would both eliminate the risk of infusion-transmitted infections and supplement (if not eventually take the place of) chronically limited blood banks worldwide. After years of partial synthetic successes at best, it will permit the first-ever human clinical trials of synthetic blood. Oh, also? The license permits blood manufacturing “on an industrial scale.” Cue the True Blood overture (albeit sans vampires).

And according to Ruha Benjamin, a sociologist at Boston University, the arrival of synthetic blood is also likely to come with some serious socioeconomic and ethical issues, including ones that have complicated many medical advances before it.

Benjamin is the author of People’s Science: Bodies and Rights on the Stem Cell Frontier, a new book that explores the social forces that inform and arise from scientific research, especially controversial medical practices like stem cell trials. Though her research focuses specifically on the politics of paying clinical egg donors in California, the patterns of structural inequality she outlines are in danger of repeating themselves in Scotland – and later, in the rest of the world. The two major quagmires, she told Wired, lie in how clinical trials for synthetic blood are conducted and in the potential patenting of the technology.

Testing Tru Blood
According to its statements in The Scotsman, the Scottish Centre for Regenerative Medicine will produce synthetic blood for the trials using induced pluripotent stem cells – adult cells that can be forced to act like embryotic stem cells. That means they’ll need stem cell donors as well as, later on, transfusion recipients, and neither of those come free.

“Most clinical trials offer some compensation,” said Benjamin. “They don’t call it payment; they consider it a stipend, ‘to offset the burden of participating.’ That means that, for the most part, people who are well off are not participating. People signing up on websites for clinical trials are often working-class people.”

This sort of compensation is substantial enough, she says, that it has resulted in professional guinea pigs: transient “workers” who make a sparse living ($15,000 to $20,000, roughly) by participating in clinical trials. They know where trials are held, who is conducting them, and where communal housing is available to them across the country, and they rack up “paychecks” as they go. A decent percentage of clinical trials include these participants, said Benjamin, at least in the U.S.

“It’s a case in which people who can’t find any other kind of work discover that the little bit of compensation you get through participating ends up being enough,” she said. Those people, again often working classes, “are willing to bear the risks of the trials.” She says that there’s no reason to think that the participants in the testing of synthetic blood will be any different.

Clinical trials for any foreign substance like synthetic blood also need to be performed on “pharmaceutically naïve” subjects: people whose bodies aren’t already full of drugs. Again, that often means exploiting the working class, as well as outsourcing to developing countries.

“It’s a regulatory question [researchers] have to ask: ‘What kind of place will allow us to come in and gather data and not put up as many barriers?’” Benjamin explained. “Often, these tend to be countries that have weaker governments, or that don’t have their own research community that would feel threatened by outside researchers coming in.” This reproduces the global North-South dynamic, the divide that allows richer, “northern” countries to regularly take advantage of “southern” second- and third-world nations.

Tru Blood to the Highest Bidder
And then there’s the potential danger of ownership. If the researchers at the SCRM choose to patent their technology (the way it would seem the sole manufacturers of the fictional Tru Blood did) they could stand to make a fortune off the stuff–and destroy a lot of potential future research in the process.

Consider the very recent Supreme Court case, Association for Molecular Pathology v. Myriad Genetics, Inc. Myriad had patents on two genes their researchers identified as being hereditarily linked to breast cancer: the genes themselves, not the method of finding them. (If you’ve heard of this case before, it’s probably thanks to the work Myriad did for Angelina Jolie.) Myriad’s patents not only made testing for the gene very expensive, but rendered second opinions impossible.

On June 13, the Supreme Court ruled in the AMP’s favor, saying that Myriad could not patent actual DNA, which is found in nature; the company could, however, patent cDNA (or complementary DNA), synthetically engineered clones of said genes. The Myriad ruling applies almost solely to genetic research, however, which means that synthetic blood–which is similar to cDNA in that it’s created using biological templates–is still likely to be patented.

If the SCRM’s synthetic blood tests are successful and it does get patented and sent to an international market, it’s likely that pricetags will be set high. (Want some precedent? Myriad Genetics’ patents allowed them to charge upwards of $3,000 for a test that would generically cost about $300.) That cost could seriously impact patients, especially in the U.S. and other nations with non-nationalized healthcare.

Ironically, if Benjamin’s research says anything, it’s that the people who can’t afford a medical breakthrough are often the people who secured its success in the first place.

“If a patient doesn’t have insurance, for example, you can imagine a doctor deciding, ‘Okay, do we use the synthetic blood that works faster and better [than real blood], and is more expensive? Or are we going to use the cheaper, real blood with this patient—if the patient doesn’t have insurance?’ It’s very likely doctors will choose the lower-quality product. The very same population who are the substrate for the research are, because of the class and racial dynamics, the same population denied access to it later because they’re uninsured.”

She says the Affordable Care Act may change this disparity, depending on what tests and treatments it covers.

Of course, none of this has yet come to pass in the case of the Scottish synthetic blood trials, since the trials themselves haven’t begun. Admittedly, there’s an outside chance that its potential success could still go the way of the polio vaccine; as its inventor Jonas Salk told a reporter in 1955 when asked who owned the patent for his discovery, “Well, the people, I would say. There is no patent. Could you patent the sun?”

But that magnanimity is unlikely in this day and age. As Benjamin points out, “The context in which synthetic blood is coming to market is a far cry from the days of Jonas Salk.”
 

June 14, 2013