The direct-to-consumer DNA genotyping company, 23andMe, announced on Monday that it was soon to receive its first patent, one that it had applied for in 2010 (that patent application is here). It has to do with genetic polymorphisms associated with Parkinson's disease (PD), and, while we're not patent lawyers by any means, the application seems to cover genetic variants and testing. This announcement is a surprise to many, including many of its customers (indeed, the consent form says nothing about possible patents), in part because the company has come out against gene patenting in the past.
Ken and I have had issues all along with the scientific merit of what these companies are selling (see this post and this one, e.g.). And we're by far not the only ones. Much of what they report back to consumers are things the consumers already know (e.g., hair color, freckles), and the estimates of most disease risk, which they also report, just aren't ready for prime time for all sorts of reasons that we and others have commented amply upon. So, while it may be fun for people to know their genotypes, and sometimes their ancestry estimates, the information is generally not very useful clinically. And apparently it's not just for public edification or recreation: it is run by Google money, after all. We believe it's unethical for any of these companies to be selling disease risk, no matter how many caveats they include, and this is before considering the profit motive in patenting what they have found apparently on the backs of their customers.
How does 23andMe work? You spit in a tube and send it to the company along with your payment, and they genotype you at selected sites and then give you full access to that data, with some explanation. If you want to take part in the research the company does then you can choose to answer surveys about lifestyle or other risk factors, which is your consent for them to throw that information and your genetic data into their research pool. The company says that most of their customers have chosen to do this, but at the same time, it seems that none of their customers were told that gene patents might result.
Gene patenting has been controversial since the first one was applied for, in part because it is difficult to know how to apply the generic wording on patents in the Constitution to the molecular age. Basically, patents should cover inventions or discoveries, and while scientists may in fact discover genes, the law now says that they can only be patented if the scientist has also discovered a function for the gene. That's a law that had to have been written by not-disinterested geneticists! Legally speaking, the polymorphisms discovered by 23andMe for PD are patentable, but is that really innovation?
But legal or not, many, including us, are still not in favor of gene patenting. To us, patenting should be not getting to own properties of nature, but for innovating value-added products. A medical test, that any beginner who works in a genetics lab for a week could replicate, shouldn't be covered. If the patents were designed to protect against commercialization of naturally occurring genotypes, as NIH once threatened to do, that's a worthy public-domain protectant--against predatory commercial practices--but that's not the idea here.
The gene patenting issue has been endlessly discussed and the discussion is easily accessed online, so we won't repeat the arguments here except to say that our personal concerns are that patenting makes public and often publicly funded information private, for private personal gain. In addition, it can tie the hands of clinicians who want to be able to offer genetic testing to their patients, it can prohibit others from doing research on a gene of interest and so on, and while we may be a minority we're not in favor of the get rich quick motivation for doing research. Some "defensive patenting" has been going on (patenting to protect against genetic profiteering), but in our opinion that should not be necessary -- naturally occurring genes should not be patentable, period.
As if the issue of this 23andMe patent weren't problematic enough, it seems that the company's motivation for focusing on Parkinson's disease is a very personal one. Apparently the CEO's husband, one of the founders of Google, has been found to have a PD risk allele, and the couple has donated millions of dollars to the Michael J Fox Foundation (which will be one of the beneficiaries of this patent, along with Scripps Research Institute) for research. Well, fine, but they should have been up front about their personal interest in mining the 23andMe consumer database for PD variants and asked their customers whether they were willing to
donate spit, and pay for what turned out to be a PD research 'crowd-funding' project (see our post last week on this idea as related to fairer science funding). Instead, they appear to have done it surreptitiously, complicating what's already making many 23andMe customers feel misled, if not betrayed (see comments on Twitter for examples--here's a randomly chosen set of them, e.g.). Not to mention that some of the scientists affiliated with this company have had prior apparent interests in ethics, to boot.
I just wanted to add that if Mr Google wants to foster a cure or preventive for PD, based on genetic risk studies, and if 23'n has a data base that could be useful, then they should make it as openly, loudly, blatantly public as possible. Let all comers do their damnedest to develop a miracle drug! (isn't that what capitalism is supposed to be about, according to its apologists--open competition?)
ReplyDeleteThere is no legitimate reason to limit this to one company (and profits, for whomever). The idea that companies won't touch it without patent protection is like many elitist rationales (like trickle-down economics), designed to legitimize giving more to fewer.
There are various pharmas working on similar disease problems, using public data from the literature and so on, without having to have patent protection (which, of course, they'd naturally like to have).
So there's nothing laudatory or even philanthropic about farming unaware consumers for something to hand off to an insider company, in my view.
They've answered many of the comments at the Spittoon, including mine. They do discuss "intellectual property rights" in the ToS and Consent materials but I never linked that with gene patenting. Forehead slap. I'm clearly not a lawyer or anything close. Shows you how easy it is to mislead people with consent even if they're supposed to be informed pretty well already (like me).
ReplyDeleteNo head-slapping needed. They're smart enough to cover their bets, but that doesn't mean that the consent was really informed, and we all know that informed consent, in general, is often clearly an exaggeration. Often, if not mainly, people are not really informed, and the consent is often carefully crafted with the proverbial small print (to protect the consentor, not the consentee).
DeleteEven if 23'n is technically within the law, as I'd expect they are, they knew very well what they were up to.
NIH has long experience wangling consent for investigators to get what they want from patients or biomedical research subjects (or lab animals, poor things). This doesn't mean studies are typically evil,or commonly abuse the signers--and often it is wholly legitimate.
But anyone associated with IRBs, as with the legal system, knows very well who's interests are mainly being protected. Just as advertisers know very well how to be legal sociopaths: deception is often the art in question.
Even if everything were on the technical up and up, it seems to me personally to be a gross abuse of public trust to patent in this way. 23'n should have shouted it from the Googletops as is said in an earlier comment.
I'd like to see them lay out their analysis for us, showing how they eliminated all other possible means for achieving the same PD treatment/curing potential without gene patenting. I'd like to see how it would be impossible to cure PD, with this knowledge out there, if there wasn't a gene patent. How it would be impossible to treat/cure Mr. Google and MJFox without a gene patent. Show us, scientists at 23andMe! Wouldn't it be nice if they could lead us through all their struggling through this dilemma? That's assuming, however, it was ever a dilemma.
DeleteFrom the spittoon: "Bringing a new treatment to market generally takes more than ten years and costs more than $1 billion (http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html). Due to the time and expense required to develop a drug, pharmaceutical companies typically only invest in developing treatments that are based on patentable findings."
DeleteThat can be convenient accounting and lore put out by Pharma to justify their claims about patents. I was at a meeting when this kind of thing was said (by a VP at a major Pharma), and several gene-therapy startup company scientists sitting next to me just burst out laughing, saying they'd be right out of business if the cost were anything close to that.
DeleteWhy are there several different drugs for various major diseases, if exclusive access to 'the' vital secret were needed? Indeed, spin-off drugs based on the same finding developed by one company, are made by others.
And, if King Google were that concerned, he could give his big donations just to one company, to compensate them for their 'risk' (Pharma is one of the most profitable industries, it is often reported). Or he could use crowd funding, -openly- seeking donations and participation with PD explicitly in mind. And he could ask for the funds to be given to his favorite Pharma.
And, I've heard that Pharma is all for free enterprise. Beyond that, could we dare even to challenge the convenient claim that people will only do good things if they are made rich in the process?
Yep, they crowd sourced the data collection, now crowd source the solution.
DeleteHere's Marcia Angell in The New York Review oF Books, 2004, on how much sympathy we should have for drug companies re. the cost of R&D (and she has said elsewhere that the actual cost is more like a tenth of what they claim):
"[R]esearch and development (R&D) is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits. In fact, year after year, for over two decades, this industry has been far and away the most profitable in the United States. The prices drug companies charge have little relationship to the costs of making the drugs and could be cut dramatically without coming anywhere close to threatening R&D."