I wanted to kill myself. Almost. In my mind I went right to that edge and knew that I wanted to try to kill myself but be found while I was still alive. But someone had to find out how bad it was. Somebody had to know. Before nightfall. The night poised before me promised full-assault fear. There was no way I could get through that night.Unbelievably, Liz, an old roommate of mine, knocked at my door, opened it herself, and came in. Blood was spurt-spurting crimson from my arm.I cringed for doing that to her.
That passage is from the most riveting, courageous, agonizing, and ultimately amazing book I read this year: Speaking to My Madness: How I Searched for Myself in Schizophrenia, by Roberta Payne.
Tom Levenson just reviewed it at Download the Universe. After this suicide attempt, he writes,
Payne’s story goes down hill. We follow her as she pursues the opportunities her clearly formidable mind opens up: graduate studies at Harvard; mastery of language after language (Italian, ancient Greek, medieval Greek, Latin…), Ph.D work at the University of Denver. We wince, and then grieve, as at each stop, panic, depression, fear, alcohol — buckets and buckets of booze — and then full-blown schizophrenia derail this voice, this marvelous, literate voice at once narrating and living the train wreck unfolding across the page.
We learn about the pain of her childhood home, populated by a mother presented initially as uncaring, harsh, terrifying, a distant and uncomprehending father, a sister who, as the book proceeds, is revealed to be almost utterly without empathy — or perhaps better, as thoroughly terrified of whatever existential challenge Payne’s illness seems to embody. Payne describes in detail what happens as her schizophrenia advances, to the point where, in the hospital ward in Ames with which the book opens, she edges toward suicide…and then pulls back.
The second half of the book takes up what comes after her halt at the point of self-murder. It’s a very long way back — years, decades of painstaking, painful, courageous and ultimately successful labor, advanced with the help of modern pharmacology, persistent and sensitive talk therapy, AA, the rooted kindness of an admirable pair of Episcopalian clergy, and, in one of Payne’s most subtly framed challenges to expectations raised earlier in her narrative, the love and care of parents who had seemed near-villainous in the early passages of the book.
By now what Payne’s disease has taken from her is so apparent, so empathetically available, that I found myself rooting for her at every turn — and terribly fearful that something terrible might happen as I flipped each page. But this latter story is one of renewal. As Payne climbs out of the dark years she shows without saying what the reader can clearly recognize as the evidence of her strength, her capacity for restitution, for kindness and restitution and forgiveness. The Roberta Payne who emerges through the final hundred pages of the book is someone it becomes a privilege to know, and one whose virtues make what her illness stole from her the more terrible.
A deeply felt review of a book that, by the nature of its material, should have been almost impossible to produce. Schizophrenia Finds Its Vergil – Download The Universe.
The book is at Speaking to My Madness: How I Searched for Myself in Schizophrenia.
Many have liked “Die, Selfish Gene, Die,” my Aeon piece challenging Richard Dawkins “Selfish Gene” meme. Quite a few readers have objected to and disagreed with the story, sometimes sharply. Some readers have both liked it andobjected to it. At least one objected both rudely and inaccurately; Ianswer that here.
I want to thank everyone who’s read it, and to acknowledge right here at the top (as well as later, at bottom) the extra energy and goodwill extended by those who objected in constructive spirit. The hardest but most necessary sort of reading is to read charitably, and with a sincere, sustained effort to understand, something that sharply challenges you.
Those readers and others, such as some who managed to read my piece as a case for Lamarckianism (which it is not; nay nay nay), make it clear to me that I muddled much of my message. Most crucially, I seem to have not made clear that my challenge was less to an technical account of nature than to a metaphor and story used to describe those technicalities. To put it another way: I apparently did not make clear that “Die, Selfish Gene, Die” is a story less about how genetics and evolution work than about the stories we tell about how genetics and evolution work — and, most crucially, about how those stories about nature percolate out beyond academia and into the minds of the lay public. I could write for pages to try to clarify all this. Possibly I may. But I do want to give here a tl,dr attempt to clarify.
Here then, are first a truly short tl,dr version of “Die, Selfish Gene, Die”; then one slightly longer; and a key passage from the original in which I meant to convey what is here reduced to these tl,dr versions:
“Die, Selfish Gene, Die,” the truly short version
Richard Dawkins’ “The Selfish Gene,” both book and concept, is an achingly beautiful story about how genes and evolution work. Even at almost 40 years old, it’s still mostly right about how genes and evolution work. But as story and meme, its power has come to obscure newer understanding of how genes and evolution work. As a metaphor for how genetics and evolution work, the Selfish Gene needs to be replaced.
For those who want slightly more and bigger words:
“Die, Selfish Gene, Die,” the slightly longer tl,dr version
The dominant story science tells about genetics and evolution these days — certainly the dominant story that reaches the public — comes from Richard Dawkins’ ‘selfish gene’ conceptualization of genetics and evolution. “The Selfish Gene,” both book and concept, is one of the most elegant and powerful framings of genetics and evolution ever published or disseminated. It remains largely correct and accurate about how genes and evolution operate. It’s compatible, if sometimes uncomfortable, with most findings since it was published. Alas, the very power of the selfish gene story, and especially its rhetorical and conceptual focus on the role of the single gene (please note book’s title), so strongly encourage an emphasis on the power of single genes that it is now hindering both scientific and — more dangerously — public understanding of how genes and evolution works. Accordingly, “the selfish gene,” as metaphor and story, needs to go.
For those who want even more, see the real thing: “Die, Selfish Gene, Die”
Again: I offer these now because it seems my Aeon story did not make these things clear. Many readers — both those who loved the story and those who objected — seemed to miss this. So I seem to have muddled something, possibly several things, and even if some people misunderstood because they were bringing to my story a wish to confirm some story they wanted to be true, then I failed to get them to set those stories aside, which is part of my job. Apologies all around. As a couple of generous critics (conscientious objectors?) noted early this morning on Twitter, I was trying to do a lot, and not all of it came clear.
However, if you read my shorter version above and ask yourself, “Why the fuck didn’t Dobbs say that to start with?” I ask you to consider this passage from the original, which is the crux passage of the entire piece, and which is the very spot in which the piece comes closest to saying Dawkins had everything wrong. (It’s what journo-types call ‘the nut ‘graf,’ meaning nut paragraph, which, true to the perversity of that ugly and perversely misspelled jargon, can actually be several paragraphs.) Crucial bits in bold this time around:
By the time you’ve finished his book, or well before that, Dawkins has made of the tiny gene — this replicator, this strip of chemicals little more than an abstraction — a huge, relentlessly turning gearwheel of steel, its teeth driving smaller cogs to make all of life happen. It’s a gorgeous argument. Along with its beauty and other advantageous traits, it is amenable to maths and, at its core, wonderfully simple.
Unfortunately, say Wray, West-Eberhard and others, it’s wrong.
Wray and West-Eberhard don’t say that Dawkins is dead wrong. They and other evolutionary theorists — such as Massimo Pigliucci, professor of philosophy at the City University of New York; Eva Jablonka, professor of mathematics education at King’s College, London; Stuart Kauffman, professor of biochemistry and mathematics at the University of Vermont; Stuart A Newman, professor of cell biology and anatomy at the New York Medical College; and the late Stephen Jay Gould, to name a few — have been calling for an ‘extended modern synthesis’ for more than two decades. They do so even though they agree with most of what Dawkins says a gene does. They agree, in essence, that the gene is a big cog, but would argue that the biggest cog doesn’t necessarily always drive the other cogs. In many cases, they drive it. The gene, in short, just happens to be the biggest, most obvious part of the trait-making inheritance and evolutionary machine. But not the driver.
I recognize that other elements in the story, along with reader expectations set by all sorts of factors, may have led some readers to miss that passage or what I meant to be its centrality. For my failings there, I apologize. I’d likewise ask readers to consider why, if they missed this, they did so.
Some readers have complained that part of the problem is the story’s title and subtitle — that those, by implying or (end of subtitle) that Dawkins had everything wrong, obscure my point above about this being about stories about nature rather than about nature. I stand by the title but agree we might have found a better end to the subtitle — that it might have been wise to run with something other than “it’s wrong.” Fair enough.
Yet in answer to any really strident objections to a title that threatens to obscure a richer aragument — to any charges that I can hardly expect people to hear my deeper argument if I lead with title like “Die, Selfish Gene, Die” —I would answer: Let us examine more closely “The Selfish Gene.”
Finally, let me again thank all the many, many readers who came to both article and ensuing discussion with a sincere wish to understand first, argue second, and to argue, when it seemed necessary, with a continued determination to reach, if not agreement, at least a mutual understanding of the others’ deeper argument and intentions, and a desire not just to change the other’s thinking, but expand their own.
I won’t attempt to name all who’ve done that despite disagreeing with me, but am happy to name as examples of such engagement Graham Coop, Karen James, Aylwyn Scally, Emily Willingham, Razib Khan, and Hopi Hoekstra. Even amid ugly shouting from various corners, these people have engaged in spirited disagreement with the intent not just to tear something down, but to build something new. They have listened as much as they have spoken. They have sought to understand as much as to be understood. Despite discord they have engaged under the noble assumption that drives all the best science and all the best writing: That, absent evidence otherwise, we are all here trying to tell true and constructive stories about a nature gorgeously and maddeningly complicated. Cheers to you lot.
One of the key issues in the dust-up over the FDA’s insistence on regulating 23andMe’s service is the question of how 23andMe’s health-risk results differ from other forms of health-risk information. Today, geneticist Joe Pickrell offers a sharp post that unpacks this a bit. He asks Should the FDA regulate the interpretation of traditional epidemiology? It’s a damned good question.
Many online sites, Pickrell notes, including government sites, offer online “risk calculators” where you enter things like your age, weight, and small bits of medical history and then get a readout of your risk of things like heart attack, stroke, or cancer. These are precisely the sort of things that 23andMe offers assessments of, to the FDA’s alarm. It took me just 15 seconds, for instance, to learn I supposedly stand a 6.3% chance of having a stroke in the next 10 years. It took me another 15 seconds, pretending I was a woman of my demographic profile and with a family-health history that my siblings shere, to be told by the National Cancer Institute that I have a 3.5% risk of getting breast cancer over the next 5 years and a 22.4% lifetime risk.
Okay. A 1-in-5 chance of breast cancer. Worrisome. I’m done having kids and not really using these for anything anymore. Maybe I should get a mastectomy?
This is precisely the nightmare scenario that the FDA raises in its stern letter to 23andMe. It fears 23andMe’s risk assessment will raise alarms that lead people to radical action. But as far as I can see here, the only real difference here is that 23andMe’s assessment is based on a few snippets of genetic information, while the Nattional Cancer Institute’s assessment is based on a few snippets — and I mean a very few — of demographic, health, and family history information. Yet one is regulated because it uses a machine that parses spit, and the other is not, because it just asks the consumer some questions and then plugs those remembered or improvised responses into its risk formulas.
I fully recognize that for the FDA, which is apparently charged with regulating any physical device that takes medically relevant materials from your body, is obligated to look more closely at a DNA spit test than an online risk calculator. I’m not blaming them for doing this job. But from a wider, not-strictly-legal standpoint, one nonlegal, this seems in many ways an arbitrary distinction. The spit test is just a way of obtaining what amounts to demographic, health, and family information that happens to come from chemicals in your spit instead of from (unreliable) memories in your brain. Yet the law (and many people) insist this is fundamentally different. Am I missing something here? Sincere question.
Consider this hypothetical: Let’s say 23andMe wants to deliver its service but avoid the whole device-plus-evidence-based-medical-risk-information-equals-medical-advice dilemma that is bringing the company such grief. It wants to lose what the FDA seems to see as thing requiring regulation: a fairly direct connection between a physical device that analyzes spit and spit-derived risk information that 23andMe then gives the customer.
So the company sets the service up differently: It genotypes your spit, but instead of calculating and listing the health risks automatically, its sends you a sheet of paper or a file with the raw genotype data in it. (You can already download that raw data, which is all Gs, Cs, Ts, and As.) Then they direct you to an online form, much like ones where I just learned my stroke and hypothetical breast-cancer risk, and allows you to enter in those forms specific lines of the raw data to learn, say, your statistical risk of breast cancer. They can separate them further by charging a separate fee — say, $5 — for using the form.
Would that be okay? Do the service remain a medical device, or does it become the more benign thing represented by a information-distributing educational website like the National Cancer Institute’s? You can easily argue it makes them more like the NCI. So would the FDA need to regulate them? If so, how can they regulate them — but not some service that uses an online form to ask you for bits of remembered or improvised information?
I hope these are recognized as rhetorical questions. I offer them because I suspect that to large extent this 23andMe problem is not about medical diagnoses. It’s a problem about how to update regulatory policy and practice in the face of newly available data that is of a sort that was once viewed as the medical profession’s, but is now rightly being viewed as the individual’s.
Below find my ever-growing annotated collection of online responses to the FDA’s recent shot across the bow of 23andMe, the consumer genetics company. Until today, I was adding these links to the bottom of my own first reaction to the FDA’s stern letter. (I published my broader, more studied take, How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing, on Nov 27 at The New Yorker.) I’m moving the ever-growing linkroll here, and arranging them in reverse chronological order (newest responses at top), to make them more accessible. Know a good one I missed? Add the link in the comments below, or email to [email protected], with 23andMe in the subject.
If you’ve time for only five (after you’ve read my New Yorker overview, of course), try these:
23andStupid: Is 23andMe Self-Destructing?, by Matthew Herper. “This is not the way to deal with a powerful government regulator.” Herper’s been covering the FDA for 13 years. The depth shows.
In FDA vs. 23andMe: How do we want genetic testing to be regulated?, Geneticist Michael Eisen with a bullet-point case for why we need direct-to-consumer genetic testing and how it might be regulated.
In When 23andMe gives results that no one knows how to manage. Dr. Jen Gunter considers the dilemma a doctor faces when a patient gets a 23andMe result that suggests risk …no one knows what to do with.
At Slate, Razib Khan argues that FDA letter to 23andme won’t mean anything in the long run.I think he’s right.
At The DNA Exchange, Laura Hercher ponders how she and her fellow genetic counselorsmight use this disruption to find new ways to contextualize genetic information.
The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe. [Dec 3, 2013]. Possibly the best account and commentary yet.
LINK COLLECTION STARTS HERE
Added Jan 16, 2014:
Regulation: The FDA is overcautious on consumer genomics. Well-argued worry by a Robert Green, a Harvard Medical School geneticist, and Nita Farahany, a Duke Law professor, that the FDA overreached with 23andme — and may also be considering regulating simpler health-risk services as well, such as phone apps that analyze your basic demographic, health, and family history information — the sort of stuff you could tell a doctor in an office.
In its recent guidance on mobile health applications, the FDA left open the possibility that it will regulate as medical devices information-based products such as questionnaires that evaluate the risk of a heart attack or the plethora of fitness trackers that help people to follow their weight, body temperature, heart rate, sleep patterns and more.
If that were the case, the FDA would essentially be making analysis of information a medical device. (“I wouldn’t eat that carbonara if I were you; could give you a heart attack.”) Green and Farahany may be overreaching themselves there, but it’s an important point to consider, and one that I’ve not yet seen FDA clarify.
My Risk-Benefit Ratio For Personal Genetics. Virginia Hughes, one of the sharpest followers of genetics, with a spirited second to Green and Farahany, with some interesting scenarios (such as a visit to a Romanian orphanage) mixed in. And do not miss Hughes’s 23 and You, a masterful look at how 23andme geneological information (which the company is still allowed to sell) upended one family’s view of itself.
New evidence shows the FDA was wrong to halt 23andMe testing. A good story on the Nature commentary, with extra data from another study as well.
The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe. One of the most helpful things you can read, from Jennifer K. Wagner, aka @DNAlawyer.
23andMe’s Wojcicki: “We failed to communicate proactively” – Fortune Tech From the CEO’s first public appearance since the story broke. Thin but, well, all we’ve got.
A government ban on 23andMe’s genetic testing ignores reality | Rahul Rekhi | Comment is free | theguardian.com A doc makes a plea for patient access to genetic info. “While the FDA’s paternalistic policy on DTC genomics is admirable, it is also obsolete. The agency’s dictum, at its core, ignores the medical paradigm shift towards patient empowerment that consumer genomics and the internet is advancing each day.”
The Failed Promise of 23andMe A psychiatrist argues for tighter FDA oversight of outfits like 23andMe.
Customers Of Genetic Testing Company 23andMe Are Caught In DNA Limbo | Fast Company | Business + Innovation
23andMe suspends marketing after failing to meet FDA requirements | Science | theguardian.com This was news on Dec 3.
Added on Dec 2:
23andMe’s problems just got a lot worse. GigaOm reports that a customer has filed a class-action suit seeking some $5 million. “According to the complaint, which seeks at least $5 million under various California state laws, 23andMe makes false and misleading claims about the tests’ ability to provide relevant genetic information about breast cancer, diabetes, lactose intolerance and various other conditions.” Longer story at GigaOm
In other news, geneticist Joe Pickrell, expanding on Michael Eisen’s very sharp post of last week about regulating 23andMe specifically, asks Should the FDA regulate the interpretation of traditional epidemiology?, by which he means risk assessments based on things like family and personal health history. As he notes, many sites offer online “risk calculators” of things like stroke or heart attack, where you enter things like your age, weight, and small bits of medical history and then get a readout of your risk. It took me just 15 seconds to learn I supposedly have a 6.3% chance of having a stroke in the next 10 years. It took me another 15 seconds, pretending I was a woman with health history like some people I know well, to be told by the National Cancer Institute that I have a 3.5% 5-year risk of getting breast cancer and a 22.4% lifetime risk. Maybe I should get a mastectomy? This is precisely the nightmare scenario that the FDA raised in its stern letter to 23andMe. The main practical difference is that 23andMe’s assessment is based on a few snippets of genetic information, while the Nattional Cancer Institute’s assessment is based on a few snippets of demographic and health and family history information. Yet one is regulated, because it uses a machine that parses spit, and the other is not. Why?
That’s the question Pickrell asks here. Give his post a go.
Links added Nov 30:
Mike The Mad Biologist’s Thoughts on the FDA Action Against 23andMe.com was one of the best and most thought-provoking posts I read when this story broke on Nov 26; I’m not sure how I managed to leave this link out of this linkroll this long. (A chip-reading error.) We don’t see eye-to-eye on this, but — because of that — he’s a good corrective at thinking 23andMe is innocent victim. This is both a clash of cultures and, more broadly, a society trying to figure out to use an emerging body of information wisely. In any case, read Mike; he’s always lively and fun and smart.
Meet the phenome-wide association. Carl Zimmer focuses his weekly New York Times column on Linking Genes to Diseases by Sifting Through Electronic Medical Records – NYTimes.com. In these new “phenome-wide association studies,” he writes, “scientists start with a gene variant and then search among thousands of conditions for a match.” A nice look at a new approach that might complement the sorts of genome-wide-association studies that have struggled to find links between genes and disease.
Here are three papers on the (highly) limited effect that learning genetic information has on people’s health-related behavior:
Reflections on the Cost of “Low-Cost” Whole Genome Sequencing: Framing the Health Policy.
Changing human behavior to prevent disease
Does communicating DNA-based risk estimates motivate people to change their behaviour?
Apparently knowing one’s genome rarely changes behavior. BUT: 3 things: 1. No other form of information seems to reliably change people’s behavior; it usually takes a good solid heart-attack scare or the equivalent; 2) I still think that examining one’s own genome is a matchless way to come to understand genetics; 3) the burden of proof lies on those who want to control genetic information, not those who want to control it.
But you can’t say 23andMe results are worthless, because Chuck Cody used his to make a song. Seriously.
In a post fun, lively, and smart,,John Wilbanks finds the FDA’s Culture Is Mendelian Dominant Over 23andme’s Business Model. Which is worrisome.
Links added Nov 29:
The editorial director of Entrepreneur.com is not impressed with the FDA’s move.
Cruwys news: 23andMe and the FDA This useful round-up includes 23andMe’s national TV ad, which many feel may have helped provoke the FDA’s move. The ad clearly does make health-related claims about genetic risk findings, and it’s easy to see why this ad might alarm the FDA — and anger them if they’re feeling ignored by the company.
In a comment below my New Yorker story, geneticist Gholson Lyon explains why, in the anecdote described at the end of that article, he was not able to share with the patient’s family his identification of a gene that caused the death of an infant. (A couple of other commenters had said they found that situation implausible.) It has to do with whether a genetic test is done in a lab certified by a federal program known as the Clinical Laboratory Improvement Amendments, or CLIA. As Lyon explains, “[C]urrent law stipulates that genetic test results in America returned to participants must be obtained in CLIA-certified labs, and that much of the research enterprise is NOT performed under such settings. Furthermore, still, the vast majority of exome and whole genome sequencing is NOT performed under CLIA standards, including lack of very rigorous sample tracking and not being performed in any CLIA-certified labs. “
Two particularly sharp posts came today from American Science, a group blog about the history of sciene.First, Science, Regulation, and the Epistemology of Big Data offers that
Although I cannot say so with certainty, I have a strong suspicion that what the FDA is really objecting to here is the use of big data techniques in biomedicine. Traditionally, if a company wants to bring a certain pharmaceutical or medical device to market, it is expected to conduct extensive clinical trials. In so doing, there might not be an expectation that every aspect of the drug or device’s mechanism of action is fully known. However, there would at least be clinical or experimental data to support its safety and efficacy.
But these are precisely the kinds of data that big data will not produce.
In the other American Science post, What’s better than a holiday card? “Possibly the worst FDA letter of all time, tries to clarify what the FDA might be after here:
As FDA has made clear in the past through their correspondence with DTC firms, the worry with a medical device is that it be accurate and reliable. That is FDA’s rationale for post-premarket review. But back in 2010 Guitierrez, the head of FDA’s Office of In Vitro Diagnostics, did not want the agency to be viewed as paternalistic and said, “We really don’t have any issues with denying people information. We just want to make sure that the information they are given is correct.”1 So, now we are back to worrying about analytic validity (the reliability of the actual genetic test, meaning laboratory performance) and clinical validity (whether the genetic variant actually corresponds to the condition or trait).
In this post at Forbes, the author is disappointed that his 23andMe results don’t seem to line up with reality — that is, with his health and family history. I find this a great example of the dissonance between the probabilistic results of genetic effects and the common expectation that genes produce traits in straightforward fashion. The FDA worries that such expectations will lead people to get mastectomies they don’t need. In the comments section, some people are trying to enlighten the author.
Links added Nov 28:
23andMe revealed a condition it took my doctors six years to diagnose. This piece by Shaheen Pasha shows well the value of a test like 23andMe not as a solid diagnosis — which it isn’t — but as information about risk, to help direct diagnostic efforts.
When 23andMe gives results that no one knows how to manage. Dr. Jen Gunter takes a smart and nuanced look at the dilemma a doctor faces when a patient gets a 23andMe result that suggests risk … that you don’t quite know what to do with. Gunter reacts not by suggesting we ban such testing; rather, she accepts it as inevitable, and says “somehow we are going to have to figure out what to do with this kind of raw data.”
In a red letter day for consumer genomics, Dr. Stuart Hogarth, who was in on some of the early FDA-industry meetings on regulating personal genomics kits, ponders what the FDA letter seems to mean, what about the letter mystifies him, what may have gone amiss between 23andMe and the FDA.
Why The FDA Can’t Be Flexible With 23andMe, By Law. Very helpful explainer/contextualizer by @DavidKroll
In this interview at BusinessWeek, Alberto Gutierrez, the FDA official who wrote the warning letter to 23andMe, elaborates on why the FDA feels it needs to call the company to heel. His arguments seem mainly aimed at how scared patients can push their doctors to do unnecessary and sometimes harmful procedures. This reveals an interesting tension: He’s right about fear driving procedures, but that fear comes from many places and is based on many kinds of information, some far, far less solid than even the shakiest of the findings that 23andMe reports. In a world where companies can more readily help people gather information about themselves, where does the FDA draw a line on what constitutes a ‘medical device” that delivers medically relevant information? That’s one of several tough questions that needs a good, thoughtful answer to really solve this dilemma.
Links added Nov 27:
My own Nov 27 piece at The New Yorker, How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing
In FDA vs. 23andMe: How do we want genetic testing to be regulated?, UC Berkeley geneticist and open-science advocate Michael Eisen lays out a concise, bullet-point case for ) why we need direct-to-consumer genetic testing and b) how it might be regulated. A key point that lies at the heart of the dust-up: “Genetic tests are simply not — at least not yet — medical devices in any meaningful sense of the word…. The FDA and companies like 23andme need to come up with standards for accurately and honestly describing the current state of knowledge for genotype-phenotype linkages and their application to individual genotypes.” Those two sentences hit the root of this thing spot on.
Why 23andMe is Not for Me — Yet Writer Ricki Lewis expresses well both some important caveats about genetic testing in general and her own reasons for not getting into it … yet.
23andMe Is Terrifying, But Not for the Reasons the FDA Thinks Charles Seife writes that while 23andMe is indeed using its growing database of genes and health conditions for useful medical research, the company also “reserves the right to use your personal information—including your genome—to inform you about events and to try to sell you products and services.” Seife worries that, while the company so far promises it won’t sell your genetic data to anyone else, there’s good reason to worry that could change.
Nathaniel Comfort adds some long-cycle perspective, including the history of hyping anything genetic: 23andMe, FDA, and the history of hype | Genotopia
23andme CEO Anne Wojcicki elaborates a wee bit with An Update On FDA’s Letter to 23andMe | The 23andMe Blog. Her message is a bit hard to square with the FDA letter saying the company had not communicated with the agency for 6 months. But perhaps the FDA has the company’s attention. “This is new territory for both for 23andMe and the FDA,” Wojcicki writes. “This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.”
Going meta: Here’s a nice wrap-up of by Lindsey Alexander, of MedCity News, of 6 other posts on the FDA-23andMe dustup. They include John WIlbanks, with 23andme Gets A Nastygram For The Holidays and Why 23andMe Terrifies Health Insurance Companies, which may be a bit overwrought … or not, since, historically it has been easy to underestimate the greed or power of the health insurance industry.
Links posted Nov 26:
23andStupid: Is 23andMe Self-Destructing?, by Matthew Herper, who says, “This is not the way to deal with a powerful government regulator.” Herper allows that, by the FDA account, the agency gave 23andme plenty of chances but the company didn’t step up. I hope we’ll get full accounts that make clear whether that was the case, or whether the FDA itself is being less than forthright.
Body blow: How 23andMe brought down the FDA’s wrath | The Verge This provides some needed context on how conversations between the FDA and 23andme may have broken down.
At Slate, Razib Khan argues that FDA letter to 23andme won’t mean anything in the long run: This isn’t the story of one firm. This is the story of government response to very important structural shifts occurring in the medical delivery system of the United States. The government could potentially bankrupt 23andMe, but taking a step back that would still be like the RIAA managing to take down Napster. The information is coming, and if there’s one thing that can overpower state planning it is consumer demand.Unless the US government wants to ban their citizens from receiving their own genetic data they’re just putting off the inevitable outsourcing of various interpretation services.Engagement would probably be the better long term bet, but I don’t see that happening. I think he’s essentially right.
Three years ago at WIRED, Daniel MacArthur expressed concerns that the FDA might make a restrictive move at some point in Did The FDA’s Jeffrey Shuren Mislead A Congressional Hearing?
PS: Title shamelessly stolen from the incomparable Ed Yong, whose weekly “I Got Your Missing Links Right Here” posts are the best and most indispensable weekly round-up of science-y links.
Image: Fencing match, courtesy University of Wisconsin.
Here’s a particularly sharp, context-rich post on that question from from Margaret Curnutte, currently of Baylor University. It seems one of the more deeply informed takes on this fracas. A couple of the key points:
On what 23andMe was offering:
From its inception, [23andMe] has treaded a fine line between claiming to provide something that is ‘health related,’ yet not medical. The reasons for doing this should be fairly obvious. If your business model relies on directly accessing the genomes of consumers, who wants the medical establishment to get in your way of convincing people to put their genome in your proprietary database?
On what the FDA seems to want:
Does the agency’s most recently expressed concern over the analytic and clinical validity of PGS mark a departure from previous concerns? Not really. As FDA has made clear in the past through their correspondence with DTC firms, the worry with a medical device is that it be accurate and reliable. That is FDA’s rationale for post-premarket review. But back in 2010 Guitierrez, the head of FDA’s Office of In Vitro Diagnostics, did not want the agency to be viewed as paternalistic and said, “We really don’t have any issues with denying people information. We just want to make sure that the information they are given is correct.”1 So, now we are back to worrying about analytic validity (the reliability of the actual genetic test, meaning laboratory performance) and clinical validity (whether the genetic variant actually corresponds to the condition or trait). In the most recent correspondence FDA clarified that 23andMe has not provided sufficient evidence to establish the reliability of their service even after the agency’s repeated requests to do so. Although FDA has intervened on medical grounds by classifying PGS as a medical device, their regulatory stance has and continues to translate into concerns about accurate information, not its medical significance.
via AmericanScience: A Team Blog: What’s better than a holiday card? “Possibly the worst FDA letter of all time.”.
I’ve a piece up at The New Yorker on 23andMe’s clash with the FDA: Here’s the opening:
The United States Food and Drug Administration is not known for its prose. So the warning letter that it sent to 23andMe, the direct-to-consumer genetic-testing company, on November 22nd, was a surprise in more ways than one. “It reads like the letter of a jilted lover,” said Misha Angrist, a former genetic counsellor who writes about personal genomics and teaches at Duke University, “ ‘We went on fourteen dates! We exchanged all these e-mails! We held hands in the park! Now you’re telling me, “Fuck you,” and kicking me to the curb.’ ”
Many people who have tracked the rise of what’s known as direct-to-consumer (D.T.C.), or personal genetic testing, have been expecting a conflict between a company in the field and the F.D.A. since at least 2010, when the agency first announced that it considered the spit kits medical devices and consumer genetic-testing services medical interventions, which require regulation. Advocates for easy access to personal genetic information feared that the F.D.A., and the medical establishment vis-à-vis the agency, would use this regulation to gain tight control of genetic data—which has become increasingly sought after, for both medical and personal reasons. Those who advocate D.T.C. genetic testing, even as they fume at 23andMe for letting things go so sour with the F.D.A., suspect that they’re now watching a government power grab.
Much more at How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing : The New Yorker. It has more breakup backstory and, more important, a look at what there is to be gained by tweaking the 23andMe approach — and lost by smashing it.
See also my earlier post, FDA Muzzles 23andMe After Talks Break Down, mainly for the annotated round-up of other opinion, reporting, and insight regarding this multi-facted and highly consequential face-off between FDA and 23andMe.
Many thanks to all who wrote me with information about their experiences with 23AndMe.
Note: If you’re here for the annotated links to other perspectives on the 23andMe/FDA dust-up, you should go instead to I Got Your 23andMe – FDA Food Fight Links Right Here, to which I’ve moved my ongoing curation on the subject. Below, however, you’ll still find first take on this dust-up, written Nov 25. My longer piece at The New Yorker, published late on Nov 27, is a more considered look.
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[Nov 26, 2013] According to reports at Bloomberg, the FDA has ordered the genetic testing company 23andme to halt sales of its DNA kit because said kit is a “medical device.”
Perhaps more information will make this look sensible (Matthew Herper’s perspective, for instance, calls into question 23andme’s end of things here), but my first take is that this is a bone-headed move hostile to public health. (My second take, an hour in: Some in my Twitter feed have argued that the FDA is pushing for a needed check on 23andme’s methodology that 23andme has resisted. If this move is just a push to get 23andme to account for or strengthen its methodology, I’m for it, and will eat some of my words below. If it’s a move — one that many have feared — to lock up evidence-based direct-to-consumer genetic testing, then my objections stand).
It’s insanity to take steps that reduce the public’s knowledge and interest in medicine. This is like forbidding people how to take their pulse and blood pressure. Stethoscopes and blood-pressure cuffs are medical devices too, but I think everyone agrees it’s a good idea to let people have free access to the information they provide. A high-blood pressure might alarm someone; but if there’s no cause for alarm, a medical workup should make that clear. Direct-to-consumer genetic information can play a similar role.
I’m with Razib Khan: History will look back on this as folly:
Unfortunately this is not surprising, as this was foreshadowed years ago. And, 23andMe has been moving aggressively to emphasize its medical, as opposed to genealogical, services over the past year. But this isn’t the story of one firm. This is the story of government response to very important structural shifts occurring in the medical delivery system of the United States. The government could potentially bankrupt 23andMe, but taking a step back that would still be like the RIAA managing to take down Napster. The information is coming, and if there’s one thing that can overpower state planning it is consumer demand. Unless the US government wants to ban their citizens from receiving their own genetic data they’re just putting off the inevitable outsourcing of various interpretation services. Engagement would probably be the better long term bet, but I don’t see that happening.
The FDA says it’s “concerned about the public health consequences of inaccurate results.” I’ve not heard of any harm come to 23andme customers from such inaccuracies— and even if such cases exist. Inaccurate results will inevitably occur (here’s a story of what seems to be one particularly unfortunate such case), and findings of medical relevance should be confirmed before people act on them. But do those apparently rare errors inflict more harm than the sorts of errors our medical system makes every day? Do they inflict more harm than a lack of information about important risk genes inflict? Does any harm done outweigh the great good that people gain from having inexpensive access to lots of information about medical risk?
A person learning the status of hundreds of genes of medical interest (along with information about their ancestry) with a simple spit-test may learn much actionable information — not to mention an education about genetics — that would otherwise depend on … what? Expensive access to doubtless heavily marked-up genetic tests prescribed by physicians and executed by companies happy to charges hundreds of dollars per gene? We need more such information; not less. I pray this will soon be reversed.
Hat tip to Razib Khan, at The FDA and 23andMe – Gene Expression
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Now the links to other perspectives:
For lots of coverage and discussion, track this Twitter search for 23andme
Links added Nov 27:
My own Nov 27 piece at The New Yorker, How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing
FDA vs. 23andMe: How do we want genetic testing to be regulated?. UC Berkeley geneticist and open-science advocate Michael Eisen lays out a concise, bullet-point case for ) why we need direct-to-consumer genetic testing and b) how it might be regulated. A key point that lies at the heart of the dust-up: “Genetic tests are simply not — at least not yet — medical devices in any meaningful sense of the word…. The FDA and companies like 23andme need to come up with standards for accurately and honestly describing the current state of knowledge for genotype-phenotype linkages and their application to individual genotypes.” Those two sentences hit the root of this thing spot on.
Why 23andMe is Not for Me — Yet Writer Ricki Lewis expresses well both some important caveats about genetic testing in general and her own reasons for not getting into it … yet.
23andMe Is Terrifying, But Not for the Reasons the FDA Thinks Charles Seife writes that while 23andMe is indeed using its growing database of genes and health conditions for useful medical research, the company also “reserves the right to use your personal information—including your genome—to inform you about events and to try to sell you products and services.” Seife worries that, while the company so far promises it won’t sell your genetic data to anyone else, there’s good reason to worry that could change.
Nick Comfort adds some long-cycle perspective, including the history of hyping anything genetic: 23andMe, FDA, and the history of hype | Genotopia
23andme CEO Anne Wojcicki elaborates a wee bit with An Update On FDA’s Letter to 23andMe | The 23andMe Blog. Her message is a bit hard to square with the FDA letter saying the company had not communicated with the agency for 6 months. But perhaps the FDA has the company’s attention. “This is new territory for both for 23andMe and the FDA,” Wojcicki writes. “This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.”
Going meta: Here’s a nice wrap-up of by Lindsey Alexander, of MedCity News, of 6 other posts on the FDA-23andMe dustup: Six smart takes on the 23andMe FDA standoff. Some of those are already listed above. Non-overlapping items include John WIlbanks, with 23andme Gets A Nastygram For The Holidays, and Why 23andMe Terrifies Health Insurance Companies, which may be a bit overwrought … or mnot, since, historically, I’ve found it easy to underestimate the greed or power of the health insurance industry.
Links added Nov 28:
23andMe revealed a condition it took my doctors six years to diagnose – Quartz This piece by Shaheen Pasha shows well the value of a test like 23andMe not as a solid diagnosis — which it isn’t — but as information about risk, to help direct diagnostic efforts.
When 23andMe gives results that no one knows how to manage | Dr. Jen Gunter A smart and nuanced look at the dilemma a doctor faces when a patient gets a 23andMe result that suggests risk … that you don’t quite know what to do with. Gunter reacts not by suggesting we ban such testing; rather, she accepts it as inevitable, and says “somehow we are going to have to figure out what to do with this kind of raw data.”
A red letter day for consumer genomics | Gene Values Illiminating post by Dr. Stuart Hogarth, who was in on some of the early FDA-industry meetings on regulating personal genomics kits, on what the FDA letter seems to mean, what in it mystifies him too, what may have gone amiss between 23andMe and the FDA.
Why The FDA Can’t Be Flexible With 23andMe, By Law. Very helpful explainer/contextualizer by@DavidKroll
Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe – Businessweek Features bits from an interview with Alberto Gutierrez (the FDA official who wrote the warning letter to 23andMe), in which Gutierrez elaborates on why the FDA feels it needs to call the company to heel. His arguments seem mainly aimed at how scared patients can push their doctors to do unnecessary and sometimes harmful procedures. This reveals an interesting tension here: He’s right about fear driving procedures, but that fear comes from many places and is based on many kinds of information, some far, far less solid than even the shakiest of the findings that 23andMe reports. In a world where companies can more readily help people gather information about themselves, where does the FDA draw a line on what constitutes a ‘medical device” that delivers medically relevant information?A woman could very well use Ancestry.com and some newspapers searches to find that many of her female relatives died of breast cancer, and then take that info to a doc and convince the doc to do a double mastectomy. Does that make Ancestry.com a medical device that the FDA should regulate?
Posted Nov 29:
In Taking Aim at 23andMe, Regulators Missed the Mark | Entrepreneur.com The editorial director of Entrepreneur.com is not impressed with the FDA’s move.
Cruwys news: 23andMe and the FDA A useful round-up . It includes what the author says is the23andMe national TV adthat may have helped provoke the FDA’s move. It does make medical claims about genetic risk findings, and it’s easy to see why this ad might alarm the FDA — and why it might anger them if they’re feeling ignored by the company.
Here ’tis:
Some followers of this mess have noted that the FDA letter ordered the company from “marketing” the test. What does that mean? Does that mean just “to expose for sale,” as in advertise? Or does that usage include selling? Some have wondered if the FDA’s foremost complaint is not the sale, but the marketing; if that’s the case, this might be a simpler mess than it appears. It’s clear from the FDA letter that much of the language there draws on the context of 4 years of conversations we’re not privy to. Much remains obscured here.
In a comment below my New Yorker story about the 23andMe – FDA standoff, Cold Spring Harbor geneticist Gholson Lyon explains why, in the anecdote described at the end of that article, he was not able to share with the patient’s family his identification of a gene that caused the death of an infant. (A couple of other commenters had said they found that situation implausible.) It has to do with whether a genetic test is done in a lab certified by a federal program known as the Clinical Laboratory Improvement Amendments, or CLIA. As Lyon explains, “[C]urrent law stipulates that genetic test results in America returned to participants must be obtained in CLIA-certified labs, and that much of the research enterprise is NOT performed under such settings. Furthermore, still, the vast majority of exome and whole genome sequencing is NOT performed under CLIA standards, including lack of very rigorous sample tracking and not being performed in any CLIA-certified labs. ”
Since the lab doing the assay for that patient, however rigorous and accurate it is, was not CLIA-certified, Lyon was forbidden from sharing its results with the family. Many other medical labs are likewise constrained, at least officially.
This pertains to the support that Lyon and others have for 23andMe, for 23andMe says it uses labs that are CLIA certified — which is part of why Lyon and many doctors feel confident using some of the 23andME results as useful information about risk.
And here are two particularly sharp posts from American Science, a group blog about the history of American Science:
AmericanScience: A Team Blog: Science, Regulation, and the Epistemology of Big Data:
What’s at root in the disagreement here might be more than meets the eye. Although I cannot say so with certainty, I have a strong suspicion that what the FDA is really objecting to here is the use of big data techniques in biomedicine. Traditionally, if a company wants to bring a certain pharmaceutical or medical device to market, it is expected to conduct extensive clinical trials. In so doing, there might not be an expectation that every aspect of the drug or device’s mechanism of action is fully known. However, there would at least be clinical or experimental data to support its safety and efficacy.
But these are precisely the kinds of data that big data will not produce.
AmericanScience: A Team Blog: What’s better than a holiday card? “Possibly the worst FDA letter of all time.”:
Does the agency’s most recently expressed concern over the analytic and clinical validity of PGS mark a departure from previous concerns? Not really. As FDA has made clear in the past through their correspondence with DTC firms, the worry with a medical device is that it be accurate and reliable. That is FDA’s rationale for post-premarket review. But back in 2010 Guitierrez, the head of FDA’s Office of In Vitro Diagnostics, did not want the agency to be viewed as paternalistic and said, “We really don’t have any issues with denying people information. We just want to make sure that the information they are given is correct.”1 So, now we are back to worrying about analytic validity (the reliability of the actual genetic test, meaning laboratory performance) and clinical validity (whether the genetic variant actually corresponds to the condition or trait).
And at Forbes, 23andMe: A Fumbling Gene In Its Corporate DNA?
The author is disappointed in his 23andMe results because they don’t seem to match up with reality — that is, with his health and family history. I find this interesting because it’s a great example of the dissonance between, on one hand, the probabilistic results of genetic effects and the limited powers of any one gene, and on the other, the expectation that genes produce traits in a straightforward fashion, so that if I carry a gene raising my risk for baldness (I do) then I’ll be bald (I’m not). The writer of this post seemed to carry those expectations — which is just the sort of expectations the FDA worries will lead people to get mastectomies they don’t need. In the comments section, some people are trying to enlighten him. It’s what we might call 23andMe’s FDA problem (one of them, anyway) playing out before us.
Scientists 100 feet underground at the Rising Star excavation carefully remove part of a hominid skull buried there for ages. Photo by Garrreth Bird, used with permission of National Geographic.
One of my favorite things this week: John Hawks on the magnificent open-science real-time-science excavation of a newly discovered human fossil dig going on right now in South Africa. Do read the whole thing; what they’re doing there is radical, disruptive, inspiring, and wonderful:
In my last post (“In the hot seat”), I explained how we are making this the most open paleoanthropological excavation ever. In this one, I’ll explain why we aren’t answering many of the questions people have been asking on Twitter, by Facebook, and email. “What species is it?” “How old are the fossils?” “How many individuals are there?”
It’s simple: We don’t know. Believe me, we wish we did!
The usual approach to paleoanthropology — what I’ll call “legacy paleoanthropology” — is to keep all details quiet until a first publication appears. For a major discovery, that first publication is usually in a high-profile journal like Science or Nature. That publication may be years after the fossils are found.
The first publication answers those basic questions, “What species is it?” “How old are the fossils?” “How many individuals are there?” The millions of people who follow paleoanthropology usually find out about the research second- or third-hand, by press release.
That highly controlled approach creates the misconception that fossils come out of the ground with labels attached. Or worse, that discovery comes from cloaked geniuses instead of open discussion.
We’re hoping to combat these misconceptions by pursuing an open approach. This is today’s evolutionary science, not the science of fifty years ago.
It will take many months, even years, to make the careful comparisons needed to answer these elementary questions. This isn’t the kind of science that can be crowdsourced. Just as it takes training to go into that cave, it takes training to be able to carry out the kind of analyses we’ll be doing on these fossil remains. Our approach will bring in young scientists to work with the collection, building a collaborative team and documenting our work as we go.
That’s another way that our approach differs from legacy paleoanthropology. After the initial publication appears, the legacy model continues to keep many details quiet, as a small group of scientists assemble a fuller description of the fossils. During this twilight period, some teams allow outside scientists to examine their collections. Other teams bar outside scientists altogether, sometimes for many years.
That hasn’t happened with the Malapa Project, and it will not happen with Rising Star.
Hawks follows with a fascinating FAQ about what it’s like to work one of these sites. The answers to many of the FAQs — questions such as “What species do these fossils represent” and “Will there be DNA in the fossils?” — are variations on “We don’t know. We really don’t.”
Which sets up my favorite:
So if you don’t know any of the answers, what use is it to release anything?
We’re here sharing science. Science isn’t the answers, science is the process.
Go check this out at What We Know and Don’t Know So Far, explore the story further there, and follow Hawks on Twitter. This is just splendid stuff, a bold, all-in attempt to do open-science anthropology from the first touch of the first tool.
I find this clip amazing and unsettling. I’ve not read David and Goliath, the book they discuss here. But according to reviews and Gladwell’s own description, it follows the template of his prior books, which mine social science and psychology to create seemingly counterintuitive just-so stories about how people behave and society works. There’s often a moral component to these workes, stronger in some stories than in others. Many readers — and many high-paying lecture audiences — eat these stories up, and even change their behavior (or at least mean to). Most don’t recognize how poorly Gladwell uses the science.
My objection to Gladwell’s technique all along has been that he builds those stories atop cherry-picked, sometimes unreplicated science. And make no mistake: Gladwell does not use science to ‘augment’ his fables, as he claims; he uses science as the foundation for his stories and arguments, drawing on science’s credibility while deploying it in non-credible ways. Many reviewers share my concern; see the snip of Steven Pinker’s review in the link below, for instance, or Christopher Chabris’s devastating takedown in Slate.
This bugged me plenty before. Now it bugs me worse. For if, as Gladwell suggests in this interview, his book is really about the power of faith rather than the power of science (its opposite in many ways), but he is building his argument atop science, while mentioning little if anything about his faith in the book (see update below), then he may be using science not just to sell feel-good fables about behavior and society, but to sell masked religious stories as well. I don’t mind people telling religious stories. I very much mind people telling religious stories disguised as scientific stories. Having not read David and Goliath, I can’t say with certainty that Gladwell is doing that here. But I’m disturbed at his suggestion in this interview that he’s doing so, and at the prospect of how he may exercise this agenda in future writings.
In any case, this is one of the weirdest bro-hugs I’ve seen in quite some time.
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Update: Isaac Chotiner, for a nice piece about this Gladwell-Beck interview, actually phoned Gladwell to ask him about faith’s non-explicit presence in the book, and received an email afterwards. Here’s the relevant passage:
What most interested me was Gladwell’s claim about the book’s religious content. On this subject, Gladwell seconded what he had said to Beck, essentially arguing that different people read the book in different ways. “It’s a very interesting experience—I was in Salt Lake City…and everyone read the book that way,” Gladwell told me. “I must have done six interviews and all they talked about was the faith part. I think it depends where you stand.” He added, in a phrase that one could hear Beck uttering, that “people on the coast” seemed to be ignoring the faith-based aspects of the book….
Gladwell’s book has an index: Neither “faith” nor “God” nor “religion” appear in it. Faith is not mentioned on the cover flap. It’s true that some of the stories he tells involve religious people, but he shies away from religious language and lays almost no stress on the religious dimensions of the various tales.
When I pressed him to identify the spiritual aspects of the book, he more than once mentioned the epigraph, which is a quote from the first Book of Samuel. (There is also the title, of course.) When I pressed for more, he said there was not a “specific passage of the book,” but that the idea of faith coursed through it. He used none of the language that he used with Beck, where he stated, “Sometimes people of faith don’t understand how powerful their faith makes them.”
Chotiner’s piece is well worth the short trip over.
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Also: Marc Abrahams, editor of the improbably named Annals of Improbable Research (type that carefully, folks) and ringmaster for the IgNobel Prizes, tweeted that the Gladwell-Beck conversation above reminds him — ignoble suggestion, this — of the Weird Sisters from Macbeth. Here is that scene as directed by Roman Polanski. Personally I think the sisters here don’t very closely resemble Gladwell or Beck. But the look on Macbeth’s face as he listens to them? Mine, as I listened to Gladwell and Beck, probably held one alike.
Links in this story:
Malcolm Gladwell finds his faith, by Jerry Coyne
Malcolm Gladwell critique: David and Goliath misrepresents the science, by Christopher Chabris
Malcolm Gladwell Visits Glenn Beck, Finds Religion | New Republic, by Isaac Chotiner
As it turned out, Lou and I didnt live far from each other in New York, and after the festival Lou suggested getting together. I think he liked it when I said, “Yes! Absolutely! Im on tour, but when I get back – lets see, about four months from now – lets definitely get together.” This went on for a while, and finally he asked if I wanted to go to the Audio Engineering Society Convention. I said I was going anyway and would meet him in Microphones. The AES Convention is the greatest and biggest place to geek out on new equipment, and we spent a happy afternoon looking at amps and cables and shop-talking electronics. I had no idea this was meant to be a date, but when we went for coffee after that, he said, “Would you like to see a movie?” Sure. “And then after that, dinner?” OK. “And then we can take a walk?” “Um . . .”
From then on we were never really apart.Lou and I played music together, became best friends and then soul mates, traveled, listened to and criticized each others work, studied things together butterfly hunting, meditation, kayaking. We made up ridiculous jokes; stopped smoking 20 times; fought; learned to hold our breath underwater; went to Africa; sang opera in elevators; made friends with unlikely people; followed each other on tour when we could; got a sweet piano-playing dog; shared a house that was separate from our own places; protected and loved each other. We were always seeing a lot of art and music and plays and shows, and I watched as he loved and appreciated other artists and musicians. He was always so generous. He knew how hard it was to do. We loved our life in the West Village and our friends; and in all, we did the best we could do.
More at Laurie Andersons Farewell to Lou Reed | Music News | Rolling Stone.
I’ve a piece up at The New Yorker on 23andMe’s clash with the FDA: Here’s the opening:
