I wrote a post below a few months ago but for various reasons got cold feet about posting it. Yesterday made me angry (like Daniel Macarthur), warmed them up and so after sleeping on it decided to go ahead. It is about events of 4 years ago but it needs hardly anything changed to make it perfect for today. I have made some slight modifications and added an introduction specifically about yesterdays US Congress Committee on Energy and Commerce hearing into the direct-to-consumer genetic testing industry.
The Congress hearing was eerily familiar. There were a few differences, in 2006 it in the Senate and was all out attack by a single senator (a committee of 1), yesterday at least there was balance and some sensible questions from some members of congress. I felt Henry Waxman was OK as was Burgess.
The whole hearing was based around the GAO investigation and this was just a mirror image of what happened in 2006. Just the same – selected evidence, highlight the most headline grabbing bits, even if they are false, uncover some truly bad practices and make it look like they apply to the whole industry – the tactics are clear in the title of the actual report (pdf download here):
What we went through was rotten, what those present went through yesterday was rotten. Our reaction was to work quietly with FDA and FTC but keep a low media profile. In hindsight I think we should have had much more aggressive PR, to defend ourselves and expose the flaws in the GAO, but we didn’t and it festered.
There is no point in me going over yesterdays meeting because Dan Vorhaus in a a fantastic post yesterday has done the job (even more impressive as it was posted just after the hearing finished). Daniel Macarthur has a different type of description, very emotional - I share his anger and a lot of his pessimism. Mark Henderson of The Times also had a quick post (you will need to pay a sub, currently £1/30d – I know, I know, Murdoch and all that, but worth it just to read Mark who is by far the most balanced journalist on this subject that I have come across, no surprise that he is one of the few that are prominent on the twitter etc conversations on the subject).
Dan Vorhaus I felt was far too kind to the GAO – for me the GAO are the real problem. First of all though, just to be clear, at face value they did uncover some truly bad stuff – I am not surprised at that, it’s all over the internet. Disappointing that some was from Navigenics and Pathway – they need to sort out their sales / customer services people. There is no defence for the bad stuff the GAO found but there is also no defence for the way it was presented. The bad stuff can be fixed where possible and destroyed where necessary, but only if we know what we are dealing with, how bad, how extensive, who?
It is a tragedy that the GAO avoided the opportunity to produce a real balanced fair and USEFUL report, identifying clearly who did what, giving credit where it is due, calling expert help from both sides rather than relying on a clearly anti-DTC person. There is real rubbish out there, real harm being done. Kutz identified Genewize and actually accused them of fraud. Genewize claim to be making $millions per quarter (see Genelink, the parent company), that’s a lot of fraud, why is it kept quiet, why were they not in the dock? Apart from the 4 companies they tested (23andMe, deCODE, Navigenics, Pathway) they also investigated 11 others, who were they?
What now?
1) For me the most serious thing to fix is the difference in risk predictions for the same diseases. Sure, it happens with non-genetic algorithms for complex disease risk but genetics is supposed to be different. The consumer does not care about the explanations however valid they may be. The 4 above (23DNP!) need to get together and sort it out – maybe they should all agree on a standard chip, all do the same SNPs and differentiate themselves on their services, that’s more or less what they are doing now anyway. Pathway needs to get it’s act together and start being more open. It needs to publish full sample reports, details of risk calc, etc. It won’t even provide the raw DNA data to the paying customer for what I am reliably informed (Daniel MacArthur in Times comment) are absurd reasons – have you got something to hide? Would a standard panel be acceptable to them? Why not, soon we’ll be into whole genome sequencing anyway?
2) 23DNP should as soon as possible create an industry body and introduce principles of self-regulation – come on, you’ve been talking about it since the HGC banged your heads together in 2008, get a move on. Basing it on the HGC code of practice would be a good start. If and when FDA act they may find adopting what you develop to be simple and effective.
3) 23DNP should immediately create their own GTR, they know how to do it best so that it will be accessible to the consumer, maybe then when the NIH get ready (should I hold my breath?) they will operate as a joint venture. Hopefully the NIH GTR will be mandatory as well.
4) Call for transparency from the GAO. They investigated 15 companies. Who are they? What methods exactly did they use? How many calls did they make, how many were met with good responses and how many bad? Give us full transcripts of the calls, not just selected (and edited?) clips. They have done a lot of work, with all the data it should be possible to get a real picture of the actual state of the industry, separate the good from the bad, i.e. protect the consumer. Is it possible to demand this information be made public under freedom of information acts??
5) 23DNP should aggressively defend themselves in the media, criticize and expose the GAO methods, be public about the negative things found and what is being done about them.
OK that’s enough for now, here is the original post with my own GAO history:
The recent post by Linda Avey on the motives of the journalist apparently about to write a negative article on 23andme struck a chord. I have spent many years facing down the anti personal genetics brigade and bear the scars. I began way way back in 2002 (when a genome cost around $1 billion…) when I joined a little UK start up company called Sciona. The way I joined them was ironic – sitting in a pub in London reading a newspaper (The Guardian) I saw an attack dog article all about this unethical, misleading, scam job gene-diet company called Sciona. I sat up because one of the co-founders was a friend and former colleague at UCL, Rosalynn Gill (PGP #9!). I immediately got back in touch with “congratulations” on the press coverage, went down to see Sciona and was presented with a ton of publications that underpinned their work. I knew the reputation of the Sciona people and I was not surprised that they were easily able to prove to me that the Guardian article itself was misleading and based on ignorance (or just ignored most of the facts). Sciona had just won some funding and I joined the company, staying on the (very enjoyable, frustrating, eye-opening, teeth-grinding) roller-coaster until the end of 2008 when Lehman went bust, investment funds collapsed and along with it, a few months later, very sadly, also Sciona (by now located in Colorado).
Sciona was the first to offer this type of genetic testing DTC and boy did we get attacked, from so many sides, relentlessly. But with perseverance we did over the years make many friends in the academic world and managed to gain respect – among the informed. We won public research grants from the UK and EU and were very active in NuGO. We ended up with Jose Ordovas (who I am very happy to count as a good friend) on our scientific advisory board and a certain Wally Gilbert as well. The main investors were BASF, DSM, Burrill and Bioventures – companies whose chips are of the bluest hue and who certainly did not write cheques (or checks) without carrying out the most thorough due diligence. We all believed in personal genetics and we all still do.
Anyway, back to motives – the people who attack these new disruptive technologies, what are their motives? With personal genetics we are interested mainly about improving healthcare (NOT medicine, but healthcare, it’s different) so their motives should be a concern for the health of the consumer, concerns that they are not being mislead etc. But are these the real motives? I don’t think so. In the beginning there was Genewatch who ran a campaign against us from 2002 onwards. Lack of any real concern for the consumer is given away by their ideological and dogmatic attacks against every application of genetics? For them it’s all just an excuse for nasty companies to make money. They were so dogmatic and un-analytical that they became a broken record irrelevance.
Did the GAO really put the people first when it conducted it’s “investigation” into us and others in 2006? If so why was their embargoed report leaked to the press the day before the actual hearing (the press re-leaked it to us to get our comments and the articles were published on the morning of the hearing…I was a Brit staying in the Watergate hotel in DC, it was a surreal experience)? If they really cared and wanted a balanced report why did they include their press release, with their conclusions, in the press pack handed out to the audience and participants as they entered the room where the hearing was to take place? Why did the senator (there was only 1 at this “committee” hearing…OK another did appear, asked a question and left 10 minutes later, pity, I was looking forward to meeting Hillary Clinton and Elisabeth Dole) completely ignore all of the testimony from the participants (just about all of his questions were ably rebutted by Rosalynn Gill, one reply left the senator mumbling for words…)? Why did they allow inaccuracies in their report and in their press release to go ahead uncorrected? The most blatant, and headline grabbing, was the claim about one company offering personalised supplements based on the nutrigenetic test – the report stated that the ingredients in the supplements that had an annual cost of approx $1200 could actually be bought in a supermarket for only $35. My goodness, what a rip off, what a scam… But this was completely false – they had only considered the vitamin and mineral components and completely ignored the herbal and other components, which are much more costly (green tea extract, genistein, bioflavonoids, etc). Whatever you may think about the efficacy of the herbals etc, they cost a lot and to buy all of the components from elsewhere would have cost a lot more than $35 and indeed a lot more than $1200. Of course all this was made clear at the hearing, but it made no difference, that headline was just too good to drop so they continued with the press release and the conclusions remained unaltered. It may have been a mistake originally, maybe they were not so thorough in their investigation and they missed the fact the the supplements were more than just vitamins and minerals, but when they allowed the conclusions to stand it was no longer just a mistake. It caused economic damage to a particular company that was doing nothing wrong.
The press reports then and now are almost all just based on the press release and the conclusions therein – it is still trotted out that the GAO found that the products and services were misleading. Well they didn’t, certainly not ours anyway, I can’t speak for the other companies, although then, as now, there were some obvious rogues. The GAO tactics have been questioned by a couple of influential people at least.
One is David Castle, philosopher/ethicist, in a free academic article…
Another is Ruth DeBusk in the Washintonian, April, 2010
However in most articles the job done by the GAO PR is just lazily and uncritically repeated by just about all the journalists including…you guessed it…Andrew Pollack
I wish the GAO had carried out a proper review, along the lines of the HGC in the UK. The HGC were quite sceptical about Sciona and others, but they produced two balanced reports over the years and are still doing excellent work with their promotion of a Code of Practice. Here is a difference, the HGC is working on making things work, the GAO just made its headline then moved on to the next (hatchet?) job. The real pity is that there really are and were then, some highly dubious and really misleading scammers touting DNA tests with about zero evidence, they were, and are, the real villains. That’s it, I’ve got a lot off my chest and feel better for this rant. Good luck to 23andme, deCODE, Navigenics etc, bad luck to the scammers and real snake oil merchants.
The above paragraph I have emphasised because I wrote it back in March 2010 about the events in 2006 – and I don’t need to change a single word to make it perfectly relevant for yesterdays charade.
The situation in 2010 is a lot better than 2002 but there is still a way to go, investors please note, this is not a “5 year exit-strategy” business, if you just want to make money, go elsewhere, if you want to change the world, stay with us.
The Congress hearing was eerily familiar. There were a few differences, in 2006 it in the Senate and was all out attack by a single senator (a committee of 1), yesterday at least there was balance and some sensible questions from some members of congress. I felt Henry Waxman was OK as was Burgess.
The whole hearing was based around the GAO investigation and this was just a mirror image of what happened in 2006. Just the same – selected evidence, highlight the most headline grabbing bits, even if they are false, uncover some truly bad practices and make it look like they apply to the whole industry – the tactics are clear in the title of the actual report (pdf download here):
DIRECT-TO-CONSUMER GENETIC TESTS
Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices
My title would be: Misleading Conclusions Further Complicated by Deceptive Investigation Techniques and Other Questionable Practices. What was really sleazy was the way it was presented. The highest profile companies were required to attend, they were identified during the hearing but none of the other companies were present and Kutz (GAO investogator) only semi-reluctantly revealed that the dodgy supplements company (he said this was fraud) was Genewize. For the rest of the hearing all we heard about was 23andME, deCODE, Pathway and Navigenics, they were in the dock and everything revealed in the report seemed to apply to them and therefore the whole DTC genetics industry must be rotten. This was the clear intention otherwise the other companies would have been identified and the worst practices would have been attributed correctly. Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices
What we went through was rotten, what those present went through yesterday was rotten. Our reaction was to work quietly with FDA and FTC but keep a low media profile. In hindsight I think we should have had much more aggressive PR, to defend ourselves and expose the flaws in the GAO, but we didn’t and it festered.
There is no point in me going over yesterdays meeting because Dan Vorhaus in a a fantastic post yesterday has done the job (even more impressive as it was posted just after the hearing finished). Daniel Macarthur has a different type of description, very emotional - I share his anger and a lot of his pessimism. Mark Henderson of The Times also had a quick post (you will need to pay a sub, currently £1/30d – I know, I know, Murdoch and all that, but worth it just to read Mark who is by far the most balanced journalist on this subject that I have come across, no surprise that he is one of the few that are prominent on the twitter etc conversations on the subject).
Dan Vorhaus I felt was far too kind to the GAO – for me the GAO are the real problem. First of all though, just to be clear, at face value they did uncover some truly bad stuff – I am not surprised at that, it’s all over the internet. Disappointing that some was from Navigenics and Pathway – they need to sort out their sales / customer services people. There is no defence for the bad stuff the GAO found but there is also no defence for the way it was presented. The bad stuff can be fixed where possible and destroyed where necessary, but only if we know what we are dealing with, how bad, how extensive, who?
It is a tragedy that the GAO avoided the opportunity to produce a real balanced fair and USEFUL report, identifying clearly who did what, giving credit where it is due, calling expert help from both sides rather than relying on a clearly anti-DTC person. There is real rubbish out there, real harm being done. Kutz identified Genewize and actually accused them of fraud. Genewize claim to be making $millions per quarter (see Genelink, the parent company), that’s a lot of fraud, why is it kept quiet, why were they not in the dock? Apart from the 4 companies they tested (23andMe, deCODE, Navigenics, Pathway) they also investigated 11 others, who were they?
What now?
1) For me the most serious thing to fix is the difference in risk predictions for the same diseases. Sure, it happens with non-genetic algorithms for complex disease risk but genetics is supposed to be different. The consumer does not care about the explanations however valid they may be. The 4 above (23DNP!) need to get together and sort it out – maybe they should all agree on a standard chip, all do the same SNPs and differentiate themselves on their services, that’s more or less what they are doing now anyway. Pathway needs to get it’s act together and start being more open. It needs to publish full sample reports, details of risk calc, etc. It won’t even provide the raw DNA data to the paying customer for what I am reliably informed (Daniel MacArthur in Times comment) are absurd reasons – have you got something to hide? Would a standard panel be acceptable to them? Why not, soon we’ll be into whole genome sequencing anyway?
2) 23DNP should as soon as possible create an industry body and introduce principles of self-regulation – come on, you’ve been talking about it since the HGC banged your heads together in 2008, get a move on. Basing it on the HGC code of practice would be a good start. If and when FDA act they may find adopting what you develop to be simple and effective.
3) 23DNP should immediately create their own GTR, they know how to do it best so that it will be accessible to the consumer, maybe then when the NIH get ready (should I hold my breath?) they will operate as a joint venture. Hopefully the NIH GTR will be mandatory as well.
4) Call for transparency from the GAO. They investigated 15 companies. Who are they? What methods exactly did they use? How many calls did they make, how many were met with good responses and how many bad? Give us full transcripts of the calls, not just selected (and edited?) clips. They have done a lot of work, with all the data it should be possible to get a real picture of the actual state of the industry, separate the good from the bad, i.e. protect the consumer. Is it possible to demand this information be made public under freedom of information acts??
5) 23DNP should aggressively defend themselves in the media, criticize and expose the GAO methods, be public about the negative things found and what is being done about them.
OK that’s enough for now, here is the original post with my own GAO history:
The recent post by Linda Avey on the motives of the journalist apparently about to write a negative article on 23andme struck a chord. I have spent many years facing down the anti personal genetics brigade and bear the scars. I began way way back in 2002 (when a genome cost around $1 billion…) when I joined a little UK start up company called Sciona. The way I joined them was ironic – sitting in a pub in London reading a newspaper (The Guardian) I saw an attack dog article all about this unethical, misleading, scam job gene-diet company called Sciona. I sat up because one of the co-founders was a friend and former colleague at UCL, Rosalynn Gill (PGP #9!). I immediately got back in touch with “congratulations” on the press coverage, went down to see Sciona and was presented with a ton of publications that underpinned their work. I knew the reputation of the Sciona people and I was not surprised that they were easily able to prove to me that the Guardian article itself was misleading and based on ignorance (or just ignored most of the facts). Sciona had just won some funding and I joined the company, staying on the (very enjoyable, frustrating, eye-opening, teeth-grinding) roller-coaster until the end of 2008 when Lehman went bust, investment funds collapsed and along with it, a few months later, very sadly, also Sciona (by now located in Colorado).
Sciona was the first to offer this type of genetic testing DTC and boy did we get attacked, from so many sides, relentlessly. But with perseverance we did over the years make many friends in the academic world and managed to gain respect – among the informed. We won public research grants from the UK and EU and were very active in NuGO. We ended up with Jose Ordovas (who I am very happy to count as a good friend) on our scientific advisory board and a certain Wally Gilbert as well. The main investors were BASF, DSM, Burrill and Bioventures – companies whose chips are of the bluest hue and who certainly did not write cheques (or checks) without carrying out the most thorough due diligence. We all believed in personal genetics and we all still do.
Anyway, back to motives – the people who attack these new disruptive technologies, what are their motives? With personal genetics we are interested mainly about improving healthcare (NOT medicine, but healthcare, it’s different) so their motives should be a concern for the health of the consumer, concerns that they are not being mislead etc. But are these the real motives? I don’t think so. In the beginning there was Genewatch who ran a campaign against us from 2002 onwards. Lack of any real concern for the consumer is given away by their ideological and dogmatic attacks against every application of genetics? For them it’s all just an excuse for nasty companies to make money. They were so dogmatic and un-analytical that they became a broken record irrelevance.
Did the GAO really put the people first when it conducted it’s “investigation” into us and others in 2006? If so why was their embargoed report leaked to the press the day before the actual hearing (the press re-leaked it to us to get our comments and the articles were published on the morning of the hearing…I was a Brit staying in the Watergate hotel in DC, it was a surreal experience)? If they really cared and wanted a balanced report why did they include their press release, with their conclusions, in the press pack handed out to the audience and participants as they entered the room where the hearing was to take place? Why did the senator (there was only 1 at this “committee” hearing…OK another did appear, asked a question and left 10 minutes later, pity, I was looking forward to meeting Hillary Clinton and Elisabeth Dole) completely ignore all of the testimony from the participants (just about all of his questions were ably rebutted by Rosalynn Gill, one reply left the senator mumbling for words…)? Why did they allow inaccuracies in their report and in their press release to go ahead uncorrected? The most blatant, and headline grabbing, was the claim about one company offering personalised supplements based on the nutrigenetic test – the report stated that the ingredients in the supplements that had an annual cost of approx $1200 could actually be bought in a supermarket for only $35. My goodness, what a rip off, what a scam… But this was completely false – they had only considered the vitamin and mineral components and completely ignored the herbal and other components, which are much more costly (green tea extract, genistein, bioflavonoids, etc). Whatever you may think about the efficacy of the herbals etc, they cost a lot and to buy all of the components from elsewhere would have cost a lot more than $35 and indeed a lot more than $1200. Of course all this was made clear at the hearing, but it made no difference, that headline was just too good to drop so they continued with the press release and the conclusions remained unaltered. It may have been a mistake originally, maybe they were not so thorough in their investigation and they missed the fact the the supplements were more than just vitamins and minerals, but when they allowed the conclusions to stand it was no longer just a mistake. It caused economic damage to a particular company that was doing nothing wrong.
The press reports then and now are almost all just based on the press release and the conclusions therein – it is still trotted out that the GAO found that the products and services were misleading. Well they didn’t, certainly not ours anyway, I can’t speak for the other companies, although then, as now, there were some obvious rogues. The GAO tactics have been questioned by a couple of influential people at least.
One is David Castle, philosopher/ethicist, in a free academic article…
Although there are several methodological flaws in the report, the conclusion that at-home genetic tests offered to consumers are snake-oil was uncritically repeated. The flaws in the methodology and conclusions of the GAO report are serious and potentially damaging to private interests in nutrigenomics, as well as public confidence in the Food and Drug Administration (FDA).
Another is Ruth DeBusk in the Washintonian, April, 2010
While geneticist Ruth DeBusk concedes that there are “absolutely legitimate issues of concern” about nutritional genetic testing and many genetics labs, she calls the GAO report “irresponsible.”
“It’s clear the GAO investigators did not understand what nutritional genomics was all about,” DeBusk says. She says that some genetic-testing labs are doing solid research and offering legitimate genetic tests.
However in most articles the job done by the GAO PR is just lazily and uncritically repeated by just about all the journalists including…you guessed it…Andrew Pollack
I wish the GAO had carried out a proper review, along the lines of the HGC in the UK. The HGC were quite sceptical about Sciona and others, but they produced two balanced reports over the years and are still doing excellent work with their promotion of a Code of Practice. Here is a difference, the HGC is working on making things work, the GAO just made its headline then moved on to the next (hatchet?) job. The real pity is that there really are and were then, some highly dubious and really misleading scammers touting DNA tests with about zero evidence, they were, and are, the real villains. That’s it, I’ve got a lot off my chest and feel better for this rant. Good luck to 23andme, deCODE, Navigenics etc, bad luck to the scammers and real snake oil merchants.
The above paragraph I have emphasised because I wrote it back in March 2010 about the events in 2006 – and I don’t need to change a single word to make it perfectly relevant for yesterdays charade.
The situation in 2010 is a lot better than 2002 but there is still a way to go, investors please note, this is not a “5 year exit-strategy” business, if you just want to make money, go elsewhere, if you want to change the world, stay with us.
Thanks Keith for posting this. I attended the Human Genetics Commission's meeting in May when they were discussing the revised draft of their Common Framework of Principles for DTC testing. I would hope that the final report should be published shortly. The HGC's approach was very professional and in stark contrast to what we saw yesterday in Washington. The HGC have a whole team of experts with a broad spectrum of opinions. They have canvassed the views of all interested parties and user groups. It's a pity that their efforts seem to have gone completely unnoticed by the FDA and Congress.
ReplyDeleteI am also appalled at the lax standards of journalism in America. All the US newspapers are repeating the misinformation from the GAO without question.
Hi Debbie, thanks for the comment. We worked with the HGC on their first "Genes Direct" DTC consultation and I attended all the meetings - I agree with you completely.
ReplyDeleteRegarding the GAO, they seem to mislead on purpose. One example is this from p16 of their report:
"You’d be in the high risk of pretty much getting it,” is how a representative responded when our fictitious consumer asked if results indicating she was at above average risk for breast cancer meant she’s definitely getting the disease".
On their video the actual question is "So if I am high risk does that mean I will definitely get breast cancer?"
She indicated that she was at high risk, not "above average risk" and the reply, although clumsy, was correct!
On p1, referring to the 2006 investigation:
"...recommended costly dietary supplements that were in reality nothing more than inexpensive multivitamins available at any drug store"
As I explain above, this is simply not true, they know that but continue to repeat it.
Keith
ReplyDeleteI couldn't agree more. The GAO really should publish the entire transcripts of their interviews and make all the audios available online. I'm not even convinced that they got the company names right as they changed their minds a few times in the course of the hearing.
I was very pleased to see that 23andMe did an excellent rebuff of GAO's unscientific methodology:
http://spittoon.23andme.com/2010/07/23/gao-studies-science-non-scientifically/
I don't suppose that any of the newspapers that published the original misleading story will publish a follow up putting the record straight.
Hi Keith,
ReplyDeleteI was approached about joining GeneWize. I googled GeneWize "scam" "ripoff" "fraud" and came up with much fewer results than I would have expected for multi-level marketing. I'm tempted but it still doesn't feel right. If you're comfortable, can you explain to me whether GeneWize is a fraud or are they being unjustly accused of being fraudulent? If they are a fraud is it because their science is faulty or because their business practices are shady, or both? Thanks!
@Anon
ReplyDeleteI would not define Genewize as a scam or a fraud without knowing more about it - it's a serious accusation to make, especially at a congress hearing. I am quite sure that Kutz does not know all the details - just like they made false accusations back in 2006.
However - is it a scam or is it worthwhile, that is the question you need to know. Genwize/Genelink have been around for a long time. The SNPs that they have in their profiles are reasonable, there are gene-diet interactions that have been demonstrated and they do provide a bibliography. The real problem that I have is that the main business is to sell supplements. While there is nothing inherently wrong with that, the Genewize website does not give much information - yes it gives some ingredients, says they are proven, and so on BUT they do not provide the bibliography that connects SNP to supplement to positive effect. They are fairly transparent regarding the genetics but far too opaque regarding the supplements - so the question remains open, it's one you should ask them and expect a satisfactory answer to before engaging in their business.