UC Berkeley

Cal’s DNA testing idea that took on a life of its own

May 24, 2010 3:06 pm by Tracey Taylor

Mark Schlissel

Mark Schlissel didn’t know what hit him last week. The Dean of Biological Sciences at UC Berkeley says he was “swallowed up” by the media’s reaction to the news that the university planned to ask students to conduct a DNA test over the summer in lieu of the traditional summer reading assigment.

“We did not anticipate the response at all,” he said on Monday morning having weathered a week fielding calls from a broad range of media outlets, including the New York Times and national TV channels.

The frenzy blew up after the university’s College of Letters and Science announced it would be asking this year’s incoming freshman to send in a DNA sample using a cotton swab in their cheek as part of its On The Same Page program where students come to class with a shared experience — last year was reading Michael Pollan’s The Omnivore’s Dilemma.

But several groups, including the Berkeley based Center for Genetics and Society and the Center for Bioethics at the University of Pennsylvania, were uncomfortable with the  idea of genetic testing outside a medical setting.

Dean Schissel said the university always takes ethical and privacy concerns seriously and that the program had been through an approval process with the Institutional Review Board for Human Subjects Research.

Schlissel said there were no plans to suspend or modify the program — which will analyse whether students with certain genetic markers may be able to lead healthier lives by drinking less, avoiding dairy products or eating more leafy green vegetables. However a plan to award prizes of commercial DNA tests kits to students in a related contest has been dropped. Instead small cash prizes will be awarded. “We don’t want to be overwhelmed or skew the conversation towards the important issue of commercial DNA testing,” he said.

And on Friday, a list of FAQs compiled by Schlissel appeared on the On The Same Page website. Topping the list: “Why did Berkeley decide to tackle the topic of Personalized Medicine?” Dean Schlissel may well be asking himself that one.

10 Comments

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  • http://basiscraft.com Thomas Lord

    By way of some background, the original prizes were services from the comapany “23andme”.

    They are somewhat famous.

    For example, if you’ve seen the tourist blimp that sometimes flies near Berkeley you’ve probably seen an ad from 23andme on the side. Or, another example: one of the founders is the life partner of one of the Google founders and, indeed, the corporate relation between the firms is tighter than most.

    You might also have heard of “23andme” because for a while, the Attorneys General of California and a few other states were trying to shut them down for the crime of practicing medicine without a license (these shut-down efforts essentially failed).

    In the scientific field, the success of the human genome project was a key milestone. Since then, the emphasis has been on trying to lower the cost of getting the complete genetic sequence of a person (the most talked about target is to try to get it down to $1,000). The kind of genetic testing being done in this Cal thing or by 23andme is not the measurement of the complete sequence but just the examination of a few small parts of the sequence. (On the other hand, one criticism of the Cal project is that it is unclear what will become of the physical swabs that kids submit and, perhaps later, they could be examined for more than just few genes advertised today.)

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  • laura menard

    Daily CAL editors get it right using logic to sort out the various concerns.
    I am in favor of more and better information in support of personalized medicine. 23andMe has contributed greatly to the understanding of gene mutations and biomarkers in Parkinson Disease. They are currently collecting data voluntarily from patients that will help define the disease rate of degeneration, prevalence, and geographic hotspots.

    A Genetic Storm
    The nationwide criticism provoked by L&S’s voluntary genetic testing program is unwarranted and off the mark.

    By Senior Editorial Board
    Monday, May 24, 2010

    UC Berkeley is used to getting a lot of attention for its scientific breakthroughs. It is also used to getting a lot of flak on issues of scientific ethics. Although these questions often relate to serious issues, such as a multi-million dollar deal with an oil company or a professor who denies that HIV causes AIDS, last week saw a storm of nationwide controversy based on … a cotton swab.

    Perhaps that oversimplifies the issue too much. The theme for the College of Letters and Science’s On the Same Page (OSP) program for incoming freshmen will be personalized medicine. The most notable aspect of the program is a cheek swab for DNA that would analyze how well participants can tolerate alcohol, metabolize lactose and absorb folic acid.

    Genetic testing is an issue of legitimate controversy. For example, access to one’s genetic information can allow insurance companies to discriminate against those predisposed to certain diseases. Those suspicious of the OSP program have also raised concerns regarding the lack of personalized genetic counseling.

    The concern over this genetic test is overblown. This program offers a relevant platform for students to engage the very questions of bioethics that the critics are so concerned about. And it appeals to science-oriented students who would’ve felt left out by the more humanities-oriented OSP offerings of the past.

    These critics may have had a point if the gene markers tested for how likely one was to develop cancer or heart disease. But in fact, the markers are for innocuous conditions that do not indicate the likelihood of developing a disease.

    Moreover, the campus Institutional Review Board has approved the program, indicating it meets basic ethical standards for informed consent. The testing is confidential: Its design makes it difficult for anybody to be able to match the results to a particular student.

    Genetics has been a loaded issue for more than a century, so this controversy is not surprising. But it is unfortunate that a safe program with strong educational potential would inspire such vocal opposition.

  • http://basiscraft.com Thomas Lord

    Ms. Menard,

    Not so fast in your praise of 23andme, please. Let’s look at this logically. There are a number of topics to consider and I’ll mention just a few.

    The Parkinson’s study to which you refer is, per reports, not “business as usual” by 23andme. It’s main source of funding is via the Michael J. Fox foundation from a contribution made by Sergey Brin. Brin is one of the cofounders of Google and, so far as I know, an investor. His wife is one of the cofounders of 23andme. Thus it is privately funded with most of the funding being conveniently converted into revenues to a for-profit firm in which the donor has a personal stake. We can neither take that study to be indicative of 23andme’s conduct towards Cal students nor fail to cast a critical eye on the questions of conflict of interest.

    As a matter of technology, 23andme brings little to the study in question that was not already available in more conventional forms. For example, the particular forms of testing they conduct are a commodity product: they buy that testing, they didn’t invent it and they don’t make the machines or run the labs that do it. In that sense, 23andme is pure overhead cost to the effort. I will qualify that, however, because 23andme does contribute to the effort the value of their R&D into creating the “spit kits” and physically processing those. The IT resources they bring to the project may prove to be better than those typically available to more conventional research and, then again, might not. In any event, aside from being a conduit through which to throw money, it is unclear that 23andme per se is actually creating any value here.

    On the science side you should have very little trouble finding the ample amounts of informed criticism of 23andme’s approach on scientific and clinical grounds. Clinically, they offer what amounts to fully unregulated medical advice to patients to whom they have no clinical access other than the contents of the spit tube and what the patient fills in on web pages. Clinically and scientifically, the particular form of genetic testing they are doing is not yet verified as, well, useful and informative (other than in a kind of vague curiosity-seeking way).

    As an example of the clinically dubious nature of their service: Experiments have been performed in which researchers submit samples to 23andme as well as their competitors – only to receive back contradictory results and “advice”. There is no regulatory agency watching over these firms. They are essentially free to, with the best or the worst of intentions, more or less make stuff up.

    Shall we talk privacy? Of course 23andme swears up and down that consumers are protected and yet their is no other guarantee other than that smiling assurance. There is no auditing. There is no disinterested oversight committee needed to approve this human subject research. It strikes me that particularly problematic with their service is the potential impact it has for the privacy of relatives of their customers – people who do not choose to use the service at all and yet whose privacy is compromised.

    There are right ways and wrong ways to do things, yes? Science and medicine are two areas where the difference between right and wrong is the difference between progress and a world of hurt.

    23andme was founded at a time and out of a community of rich investors who were intrigued by recent rapid development in genetic assay technology. It is part of an investment “gold rush” that started roughly coincidently with the completion of the first full genome sequencing of the human genome. In the scientific, financial, and trade press of that time you’ll find plenty of bold predictions (which are partly true) about how the cost of genetic testing was about to enter a golden period of year over year exponentially diminishing costs. Also contemporary with that, even before Obama announced his candidacy, the financiers were deeply engaged in planning for health care reform – especially, the presumed windfall of IT profits it would bring from changes to the management of on-line medical records. Firms like 23andme hit a speculative sweet-spot in those trends because they are at a junction between managing on-line personal health care records and exploiting the falling costs of genetic testing. Such firms, in my view, are best understood as experiments in business models aimed at making a huge profit, and as marketing experiments aimed at effecting policy formation at the highest levels of government. Thus, it is hardly at all surprising to see their fingerprints on the new student kits mailed out from a nearby major university and all the more reason to look thrice, with a critical eye, over exactly how the many conflicts of interest, dubious science and clinical practice, and vulnerable population of subjects interact here.

    The article you copied has this quote:

    This program offers a relevant platform for students to engage the very questions of bioethics that the critics are so concerned about. And it appeals to science-oriented students who would’ve felt left out by the more humanities-oriented OSP offerings of the past.

    and later this one:

    But it is unfortunate that a safe program with strong educational potential would inspire such vocal opposition.

    There are two things (at least), deeply wrong there.

    First, to the extent that these students will now “engage the very questions of bioethics” at stake here, it is because of such vocal opposition. The article strongly contradicts itself right there. It is an incoherent article in that respect.

    Second, the incoming students are, pretty much by definition, not competent to critically analyze the bioethics concerns and apply them to the personal decision to participate or not participate in the study. To be sure, the Institutional Review Board did approve this one. I only wish I could have more confidence in them. My purely anecdotal experience in recent years is with a similar board at Harvard. I was consulting with a genomics research project and, having spotted some sever problems and failed to find satisfaction resolving them with my principal investigator (“boss’ boss”) had to take several steps to hit the red button. Formally, that board was the proper first stop. I found them to be useless in that particular matter and had to go beyond them. My impression is that, while they may once have been and still might sometimes be proper disinterested oversight, more often these days they are distracted by inattention, lack of relevant competence, and in some cases conflicts of interest.

    As genomic research continues to explode (both analytic – like this study, and synthetic – like making GMOs), given the huge impact those programs of research are going to have (positively or negatively) – the sorry state of oversight of them is a bit of a crisis these days.

  • AB

    @Thomas Lord

    I can get conflicting advice from two board certified specialists. So, what’s your point in trashing 23 and another company for giving different analyses? Why not write about the doctors who use cook book medicine and flow charts vs intelligent observation and experience? Those 2 groups would probably come up with different diagnoses, and outcomes and treatment. (Give me group 2).

    Doctors are the third leading cause of death. Why not go after that instead of 23andme who kills no one.

    I am my own health care provider and as such I don’t want medical doctors – or even 23andme for medical information, though I have it. They are simply one data point amongst many. I read the journal articles they use to back up disease risks. They are just pieces of information to be used with many others. If 23 thinks they are the final word they are not giving that impression. If the consumers believe everything they read its because they have been trained to. Unlearning is possible.

    Privacy? I don’t go to doctors for so many reasons and privacy is one of them but I spit in a heartbeat. I know Google and 23 are somehow going to profit from my spit, and maybe with pharmcos, but this is going to happen anyhow – google and 23 think they are going to cure Parkinsons – I doubt it, but they will come up with a drug of sorts. But meanwhile I have info, and it’s interesting and I downloaded my dna in a zipped file and sent it to my kids. You see, I had my identity stolen a long time ago and no one knew who my parents were. 23andme is restorative justice for adoptees, and sperm and egg donation kids – we all are victims of identity theft and now we have something that can’t be taken from us again except in an aggregate way.

    It’s much more trustworthy than walking into Stanford Hospital. I give out a false social if I ever have to go there and then when the govt forces me to buy their care of course I will not.

    The real problem is the nuts running the government health care program – that’s the lack of privacy and intelligence. Too many tests, too many drugs and they are killing people.

    I’d rather spit. Over the years I have cured all the incurables I was told I had. I am NOT going back to dumbed down medical doctors when they have been profoundly, consistently wrong. I will get my own tests if I want them – right now I do not – and do what is necessary for my health which falls outside the knowledge base of MD’s

  • laura menard

    Agree with much of your sentiments, only correction is 23 and google do not think they are curing PD, they are collecting much needed genetic data, population ( there is currently no real understanding of how many people have PD, rates of degeneration, and geographic distributions. This will help define the one of the most probable triggers in PD, toxins exposure.

    Sure they will make $$, but I also think this is a service to the community.

  • http://basiscraft.com Thomas Lord

    To AB and Ms. Menard,

    Boy, oh, boy, there are a lot of bogus bad licensed medical practices out there: you folks are right about that. Look at the troubles that doctor in the Michael Jackson case was alleged to be having in the years leading up to the famous death. And, hey, I hear a rumor that the VA Hospital system has their radiation licenses in jeopardy because of some big screw-ups. Oh, and then there’s doctor in Australia recently reported to have lost his license for conducting primarily prurient and utterly medically unjustified procedures on some female patients. The list goes on ad nauseum. Most of us have probably had very bad experiences directly or in our close friends and family.

    Privacy? Ha! Darn straight that the mainstream medical establishment has serious problems. Nurses getting fired for looking up the records of celebrities. My very own provider getting into some trouble for losing a laptop with lots of patient records on it. Big mess.

    So, what have I got against personal genomics firms like 23andme? Well:

    How do I know VA had trouble with their handling of radioactive materials? Because regulatory auditing exposed the problem. Same thing with the snooping nurses. Same thing with the missing laptop. Regulatory complaint procedures pull the reigns on bogus doctors.

    And, what about bogus therapies? When there’s a medical test that, after approval, proves to do more harm than good we have a regulatory system set up to notice that and pull it. Same thing for bad medicines. It doesn’t work perfectly but it works.

    And what about bogus testing? Again, in a medical setting there are regulations and public checks. A highly imperfect regulatory regime, I’m sure, but one that does more good than harm.

    What do we have with the personal genomics firms, on the other hand?

    We have the complete absence of any of that kind of patient-centric regulation. Are the results accurate? Well, *they* say so, even while giving inconsistent results. Anyone over there in those orgs peeking at your records or losing laptops? How would you know? Anyone tying your records to the records of, say, your kids who have not signed up for the service? How would you know? Are there any tests conducted on your samples that you didn’t order? Or are your samples retained? Why have any confidence they aren’t or won’t in the future?

    Are the personal genomics medical interpretations helpful? I’ll bet they can tell you your eye color pretty accurately. Suppose they pin you at a risk for breast cancer, though: now what? Is it true? Unclear, the science isn’t that solid yet. Starting getting more frequent mammograms? That can make your risks worse. Worry about it? That can make your risks worse. So here’s what you do: eat healthy, get exercise, avoid smoking, do your self exams, get checked out by a doctor on the recommended schedule (that’s not medical advice – consult your doctor). So what do you need that test for?

    When I was 12 or so, in science class, we did some experiments that are quite common in schools for kids that age. In one, we pricked our own fingers for a drop of blood and tested for blood type. Very cool! And, we chewed up starchy crackers and spit into a tube and tested for conversions of starch to sugar. Neat!

    Now, do I want to use that blood type result if I need a transfusion in a hospital? I think not. It was an uncontrolled experiment. We were learning how a lab test was done, procedurally, and seeing a vivid illustration of the *concept* of blood type – we weren’t taking reliable measurements of blood type. As for spitting crackers, well, we washed those tubes out when we were done and that was that, we weren’t handing our samples over to firms who are in the business of gathering surveillance data.

    Finally, about the research potential of these firms. We have to draw a distinction, I think, between 23andme’s Parkinson’s research and their research agenda in general. In their PD stunt they are mostly dealing with patients who are participating via their treating doctors – patients under clinical care where a doctor is in the loop. In their larger research agenda, they just get lots of samples from folks who mainly self-report on medical history and self-advise – and then look for patterns. The former is potentially good science but 23andme here is acting mainly as nothing more than an inefficient conduit for funding of that testing conducted by a third party. The latter is lame and potentially dangerous “research” – hardly worthy of the name.

    Sure they will make $$, but I also think this is a service to the community.

    Well, pretty much like any such endeavor, they create harms, risks, and benefits. As with the Mayo Clinic or your favorite snakeoil salesman, they have to be evaluated on a balance of those factors. And, as with those other examples, its reasonable that governmental social policy comes into play.

    The science of measuring and interpreting the genetic information they work with is quite young and poorly understood. There are studies that suggest giving subjects inappropriate information in these areas causes harm and is poor *clinical* practice. There are also the logical privacy problems which implicate not only subjects but their relatives. (Ever see the movie GATTACA?) These firms score particularly high on the “risks” category, in my view, and non-negligably in the “harm” category.

    Meanwhile, these firms have actively fought against scrutiny and regulation. They’re founded by and advised by people with quite complex and somewhat problematic political agendas and economic conflicts of interest in these tricky areas.

    It’s good that we’re building micro-arrays to measure SNPs; that we’re building those and other technologies for complete sequencing; that we are trying to organize BIG datasets to start to make sense of this incredibly complicated thing. These firms are on an irresponsible course, imo, in the way they are leveraging their ability to sublet commodity lab time.

  • Transparency

    What more can we expect from Chancellor Birgeneau. UCB Chancellor Birgeneau Loss of Credibility, Trust
    The UCB budget gap has grown to $150 million, and still the Chancellor is spending money that isn’t there on expensive outside consultants. His reasons range from the need for impartiality to requiring the “innovative thinking, expertise, and new knowledge” the consultants would bring.

    Does this mean that the faculty and management of a world-class research and teaching institution lack the knowledge, impartiality, innovation, and professionalism to come up with solutions? Have they been fudging their research for years? The consultants will glean their recommendations from interviewing faculty and the UCB management that hired them; yet solutions could be found internally if the Chancellor were doing the job HE was hired to do. Consultant fees would be far better spent on meeting the needs of students.

    There can be only one conclusion as to why creative solutions have not been forthcoming from the professionals within UCB: Chancellor Birgeneau has lost credibility and the trust of the faculty as well as of the Academic Senate leadership that represents them. Even if the faculty agrees with the consultants’ recommendations – disagreeing might put their jobs in jeopardy – the underlying problem of lost credibility and trust will remain.

  • http://basiscraft.com Thomas Lord

    We had some discussion in this thread about 23andme and whether or not it was problematic that it is unregulated and such. Something from today’s news to toss into the mix:

    “Genome scan customers sent the wrong results” from NewScientist:

    http://www.newscientist.com/blogs/shortsharpscience/2010/06/personal-genome-customers-sent-1.html

    The article begins: “Imagine receiving the results of a genetic test that suggests that your son is not your son. Was there a mix-up in the maternity ward?

    “Fortunately, in this case it was a slip-up in the genetics lab contracted by personal genomics company 23andMe to process its customers’ samples”

    I just don’t get their use of the word “fortunately” there nor their attributing the error to the lab when, truly, redundant checks should be in place (as the article later notes another critic as pointing out).

    And this kind of error just scratches the surface.

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