DTC says "Steal your baby's genome....it's fun!"

One of the big things 23andMe has emphasized in the past is that their data is not to be used to make medical decisions.....

"23andMe's services are not medical ... they are educational," argues 23andMe spokesman Paul Kranhold.

This from Forbes when the regulatory heat was on in the spring.

Then their consent notes that their kit is not for medical use:

Furthermore, 23andMe's service is not a test or kit designed to diagnose disease or medical conditions, and it is not intended to be medical advice

Then their blog lists their terms of service which includes.......

23andMe does not recommend or endorse any specific course of action, resources, tests, physicians, drugs, biologics, medical devices or other products, ...

So naturally when I read the interview of Linda and Anne with Emily Singer at TechReview I was a little surprised....to say the least

TR: What will be one of the first examples of genetic information someone might use to make a medical decision?

Wojcicki: One of the areas we've talked a lot about is pharmacogenomics--being able to say, should you take ibuprofen? Or if you have a new baby and you're flying to Europe, should that child take Benadryl, or will it make them hyper?

Ok, Ok, this is the hype that will kill genomics. Unless I have been asleep for the last 6 months, some things have changed.

1. 23andMe is now stating that people can use their tests to make medical decisions......

2. They are moving into pharmacogenomics, but not providing medical advice

3. They are using a BOGUS example (Benadryl response) and not stating that this is not a genetic reality TODAY.

4. Lastly, the implication is that as a parent, you can test your child's genome without their consent is abhorrent and unethical. Even the remote possibility of being able to do that with their kits is scary and needs to be investigated.

This is where the straw breaks the camel's back.

Anne, are you serious? Do you really think it is ok to test your child for a hypothetical benadryl response(which has no basis in any reality out there)? Have you lost it? Have you heard of informed consent? OMG! This is crazy!!!!!

This, ladies and gentlemen is precisely why I am so concerned about what is going on with this and other companies. The CEO of this company thinks it's ok to take a swab or saliva from your child and test it for millions of SNPs just so you can dope the kid up on a trip to Europe. Most likely without their consent! Is it for any health benefit at all???? Oh, I guess we should allow parents to have their kids drug tested "just because", or force our kids to have pregnancy tests, or better yet, let's just call this what it is "Stealing your child's genome and exposing it to discrimination and risk without their consent"

You see, I knew this would come out. There is a lack of maturity at the highest levels in this company and a significant lack of concern for privacy and personal risk.

The Sherpa says: Wojcicki: One of the areas we've talked a lot about is pharmacogenomics--being able to say, should you take ibuprofen? Or if you have a new baby and you're flying to Europe, should that child take Benadryl, or will it make them hyper? I am appalled and speechless. Stealing a genome, to make a faulty prediction and expose your child to risk. I hope Linda will set this one straight......and a "No one was implying that it is ok to steal a person's genome" quote just won't cut it. This could kill DTC completely if the regulators read about this!

Uh Oh......the FDA sets the bar

In an editorial from the Lancet,

Medical groups have expressed doubts about the validity, effectiveness, and clinical usefulness of direct-to-consumer genetic testing. More harm than good is done, for example, by false reassurance from unproven genetic tests or by unreliable information that could lead patients to terminate a pregnancy or seek surgery.

These are the concerns from the field and they may be valid. They may also not be valid. Let's examine each:

1. Doubts about validity-

What exactly is valid? Is valid the genotype? Is it the validity of the phenotype which the genotype is said to "predict" Is it the validity of the studies which back up the test? In the case of genotype, I would say the test is valid. In the case of the 2 others...it clearly is not.

2. Doubts about effectiveness-

Effectiveness in what? Predicition? Prevention? Guidance of therapy. On all of these counts, the doubts of effectiveness are valid.

3. Doubts of clinical usefulness-

Well, what IS clinical usefulness? Is it, the ability to derive a new use/diagnosis from a test result? Is it the ability to put into action a clinical plan to prevent or treat disease? If it is either of these, the data is not there for most DTC tests....But I also have said that clinical usefulness could just be the ability to plan for future risk or future care. In this case predisposition testing for Alzheimer or Parkinson Disease may be useful......depending on the test and its clinical evidence....To answer this question a genetic test needs:

A. A clinical study showing predictive outcome. I.E. in a prospective manner, that would be very nice. Especially if I am to tell a patient how likely they are to get this condition and when....

B. Some clinical data showing outcomes in treating patients with genetic predisposition. I.E. in the case of the BRCA1 or BRCA2 genes.

C. Some clinical data showing that an intervention on persons with a certain SNP or mutation, prevents the prior expected outcome.

Even if we had none of these things......some may say "Why not let people buy this sort of information to do with it what they wish" That is not clinically useful. It may be socially useful, but some have real questions about that as well...

In my humble opinion, this buyer beware is a very libertarian/conservative view. Which may or may not be so bad. Unless we have harm being done to citizenry.

So, is harm being done?

Some would argue no. Others argue yes.

But these data revolve around clinically valid tests. Most importantly, almost all medical societies are against DTC testing b/c of possible harm. But some argue that these motivated genetic test subjects wishing for DTC testing, self select to minimize the harm....which could be the case. But that assumes the tests are actually valid.

So what happens when the tests do not meet the criteria above? Well, no one knows the answer. But there are a ton of ethicists who are arguing against such testing. Why is this important?

Well, put simply. Medical Ethicisists most often fall along the lines of patient autonomy. In fact alot of people debate about this principle seeming to be absolute. So if most ethicists think the patient should have ultimate choice in their care, why are they against DTC testing???? Good question.

So here we are, in a position with not much data, and we won't likely have it for several years. We have ethicists who put patient autonomy first, against DTC testing. We have doctors, against DTC testing. We have government against DTC testing. Now, with the recent FDA warnings to labs promoting tests without evidence, the writing is on the wall.

“Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,”

That could just as easily be any other genetic test marketed to physicians or consumers. The FDA has weighed in and DTC is likely to be in its sights. Despite their detractors, the FDA is unstoppable here.

So, the answer is simple....we all have to await clinical data and trials for a clinical tool. Is that such a stretch? Is that such a bad thing? Well, it very well may be if your investors are on your case. Or if you need to pay your bills and your university salary is paltry. Or it may be if you have a mortgage whose rates are climbing? I hope you see what I am saying.....money clouds medicine, most importantly genomic medicine.

The Sherpa Says: In a time when Wall Street has a black eye from its fraud and scandal let's not let Genomic Medicine get punched too. It already has too many detractors....

Everything that's great comes from blogging!

Today, I want to point out what Webicina is and why it is important. You may be asking yourselves....webicina? What the heck is that? and Why should I care....

Here's why. Just about everything in my professional life has gotten light years' better since I started blogging. Some notable achievements.....

1. Invited to participate on the Coriell Personalized Medicine Collaborative's ICOB
2. Invited to speak on a panel with Navigenics, 23andMe, deCode, DNADirect
3. Inivited again to speak on a panel with Linda Avey (this one for the second time)
4. Invited to speak to the National Society of Genetic Counselors about personal genomics
5. Working on a scientific collaboration with OSU (and many others) because of blogging
6. Interviewed by Karen Shughrue of 60 Minutes and the NYT and the LA Times and MSNBC and CBS.........
7. I met some great friends
8. I have been asked by 3 web health companies to help them create genomics resources
9. I have formed 2 companies because of blogging
10. I have learned to handle the masses of people who disagree with me in much better fashion
11. I have sparked a national debate when everyone was cheering something that was not quite of value.

I could go even further but I won't b/c I want to talk about how it all started.

There was this guy named Bertalan Mesko.

He saw that I started a lowly blog back in March of 2007. He stepped in and said, "Let me help you build your blog" First you have to get HON Coded, next you have to join a group, then you should do 1,2 and 3..........Why was this important?

You see, Berci (as his friends call him) was starting his company without even knowing it. What he did for me, he had most certainly done for dozens of other blogger....the fruits of his labor are now called Webicina!

What can Webicina offer you? exactly what it offered me.


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Online courses
The world is at your fingertips. If you would like to know
how to follow the medical papers of your field of interest more easily
how to create a medical blog, how to be up-to-date in your field and more productive in your practice,Webicina's E-Learning Tools are made for you.

You tell us what your problems are with effectiveness and we provide the online materials and tutorials through which you can easily learn to use the tools and methods you need to improve your service or work.

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It is pretty plain and simple. Berci (Webicina) launched the Gene Sherpa! There is no reason why they can't launch you too.......

The Sherpa Says:
Hopefully Webicina will collaborate with Helix Health of Connecticut of CT to create online educational conferences this coming year........

A broken watch and deCode's test

I am posting today away from home. In case you didn't know, my family is a BRCA family and a wonderful lady who was hit with not one but 2 breast cancers and metastases just passed.

I am sad today. But even with that, I am bolstered by the amount of work being done in this field. Soon we will have tests which can identify risk for non BRCA breast cancer. But that day is not today.

Why? I just finished looking over some more of the SNPs which deCode is testing for....

rs1219648 the SNP associated with FGFR2 and Breast Cancer. Published in the "Highly respected" Nature Genetics!!!

1. Populations-1142 European/Caucasian with postmenopausal breast cancer
2. Penetrance- unk, but OR was 1.23 and for Hmz 1.79
3. Function- unk, but could be a splice site variation.
4. Prevalence- Not reported here.

There was another study in Jewish (Ashkenazi and Sephardic) and Arab women......about time
Here's why it gets confusing. They cover these SNPs as a haplotype study. What's a haplotype? A subset of SNPs that are linked together. In this case, the AAGT haplotype and the AAAC haplotype. The wildtype is GGAC. You see it turns out in the AAAC haplotype puts Sephardic women at increased risk for breast cancer, but not Ashkenazi Jews. It actually reduces risk in the Ashkenazi population!!! Huh?

I hope you see what I am getting at.

"Each of the genetic markers in this risk test have been replicated in between 5 and 30 different populations in studies by deCODE genetics, the National Cancer Institute, and UK Cancer Research."

Dr Gulcher's words, not mine.

That is just not true. Some of these SNPs are protective in some and risk creating in others. That data has NOT been replicated in truth. But, if you mean replicated in the same study........then you could stretch that to maybe 5 populations. But when you say population, do you mean the few hundred women from the US Multi-Ethnic Cohort that was lumped in with the Swedes? This is the frustration I have and why I started HelixGene.

The days of silver tongued scientific shenanigans are over. I will personally read every study I can about each test and report turthfully and give clinical meaning to each study. I hope you will join me.

We have very few tools to assess risk properly in breast cancer care. But we should not put a tool in the chest which will not get the job done and that could result in improper guidance or significant medical misinformation. Clinical tools require much more refinement than one or 2 studies published in NEJM.

The Sherpa Says: Perlegen is also developing a breast cancer test. I hope they get the data before bringing a test to market. Here's a riddle, what does a broken watch and 2 of the SNPs from the deCode test have in common? Answer: They are both right, twice a day......

deCode Versus Arthur Caplan PhD.

To attempt to sort out the hype from the hope, Sherpa Style. I will review each and every SNP that deCode is using for it's Breast Cancer Test. This weekend I will cover the first 2. But first some hype from both sides.

Dr Caplan from MSNBC

Genetic testing for all sorts of conditions is all the rage these days. Everywhere you turn, some company is urging you to spit in a cup, take some blood or swab your cheek so your DNA can reveal your health risks, know who your long-dead ancestors are, pick the right mate or help you design a diet that is perfect for your genetic makeup. But, "spitomics" has gotten way ahead of genomics.

Sadly, the tests Decode and other companies are offering are more likely to empty family pocketbooks and leave women with a false sense of security than they are to prevent breast cancer.

Dr Gulcher from deCode

Arthur Caplan stresses caution in the application of the new genetic risk tests for common diseases and I certainly agree that genetic testing should be applied with care. However, he goes too far when he says that the new deCODE BreastCancer genetic risk test is only useful for women who have two or more close relatives with breast cancer, is not based on large enough studies to be accurate, and is not regulated........Each of the genetic markers in this risk test have been replicated in between 5 and 30 different populations in studies by deCODE genetics, the National Cancer Institute, and UK Cancer Research.

These studies have been published in the most prestigious, peer-reviewed journals, including Nature Genetics and the New England Journal of Medicine. Altogether almost 100,000 patients and controls have been studied to define the marker risks. We made this test available for physicians to order for their patients through our reference laboratory which is regulated under CLIA by the US Federal government.

There are two major types of breast cancer: the rare, early onset form that occurs in certain families and for the detection (for which the Myriad Genetic test is well suited), and the common form which accounts for 95 percent of breast cancer.

Well, Dr. Jeff, you are making the case for BRCA smaller than the data shows.....So right off the bat I am a little suspect.....The number for familial breast cancer is 10-12% and BRCA has the majority of that......Oh and you do read the economist don't you? Famous is not always better buddy.

Ok, so who is right. The chances are high that they both are. But let's go to the tape!

What are the SNPs they test for? On limited weekend hours I will review 2 SNPs.

1. rs13387042 when looked up in a pubmed search only shows one article in Nature, by guess who? deCode.....still waiting for this "Well replicated SNP"

What does this SNP reveal and for whom?

Population: Icelanders, replicated on Northern Europeans (Sweden, Spain, Holland, US MEC)

Prevalence: 25% of Europeans, widely varied in other ethnicities

Function: Unknown, no genes known in this linkage disequilibrium block.

Penetrance: Unknown, OR is 1.2 for ER positive and 1.06 for ER negative

This study isolated 10 SNPs and only 2 SNPs replicated, I don't see the unreplicated ones in the paper. Importantly, this SNP did not replicate perfectly in the Swedes.... The SNP varied widely between ethnicities in the Multi-Ethnic Cohort in the US.......They observed no interaction between the 2 SNPs that replicated in Caucasians.....The effect seems that it could be recessive.....

The study even acknowledges that this was a limited effort in finding risk SNPs....."However as the relative risks remain low, they (these SNPs) can only account for a small fraction of the familial clustering of this disease.

2. rs4415084 guess what, the same thing happened with this SNP. Only one article, by guess who? deCode. This time in the Brief Communications of Nature Genetics......I look forward to the Independant Replication...

Population: Iceland first, then replication in (Sweden, Spain, Holland, US MEC). It flopped in Nigerians!

Prevalence: Not reported in this one and only paper on this SNP

Function: Unknown, but maybe linked to FGF10 which is amplified in 10% of breast cancers. Also MRPS30 is in this area....but really, we have no freakin' clue.

Penetrance: Unknown, but the OR for ER positive breast cancer is 1.27, for total breast cancer is OR of 1.14

So let me translate. These are 2 of the seven SNPs DeCode claims will help show risk of common (Read as not BRCA related) breast cancer. If this is any indication of the rest, I am sad to say that they are out on a limb here.

Several clinical questions come up when I want to order this test.

1. Who do I test? In the case of these SNPs, I would guess white women.

2. How common is this risk? Not very common in the case of Asians or Africans. In fact in one of these papers, a SNP being tested for didn't show increased risk, it actually showed protection from breast cancer.

3. How do I counsel a positive test? Tough to say. We don't know the penetrance, we know an odds ratio for a certain group.

4. Can I see deCode's data on their magical risk calculator thingy that includes these SNPs? Or is that a trade secret?

5. How reliable is this science? Not very, the studies were replicated by deCode and not by other groups.....

6. Is this "test" validated? I would love to review the seven panel test publication....oh wait, I couldn't find it.....

Not all of these SNPs are that thoroughly validated or as "replicated" as Dr Gulcher said. So this is the case of rushing to market with a test.

The Sherpa Says:

This test is Hype until proven otherwise. I await the future studies on these SNPs. Dr Jeff does a good job on deCode's blog of promoting it though. I know early detection is key and pre-disease is the new disease, but a clinician has to have confidence in their tools. This one is a little primitive for me.......and at worse could give patients a false sense of security. So guess what......Jeff and Art, you are both correct.

October and November is Personalized Medicine 2 Months!

That's right. Personalized medicine is such a hot topic that we deserve 2 months! Why Not? I will get W. on the phone and make it so!

Seriously though, there are some excellent conferences on the horizon. I was asked to speak at a couple but couldn't do it and am now pulling out of another. But don't worry, the Sherpa will still be speaking at the Burrill and Company conference in November.

W2W4

1. Ohio State University Medical Center is having its inaugural conference in Personalized Medicine. I am so sorry to not be able to attend nor speak. But we will be collaborating ;)

2. Harvard and my colleague Mike Murray are now having their CME conference on the Genetic Basis of Adult Disease. I will be speaking there and am on Faculty at this wonderful conference. I will be traveling Sunday at 2am to get there in time! Mike and Mark, Bruce and Dick will all be there! All should attend, Internists, Specialists, PAs, NPs and CGCs!

3. ASHG is in Philly. For those who don't know what (Ay-Shag) is, it is the American Society for Human Genetics and it is a must attend conference for EVERYONE. I will be flying in from San Francisco where I will speak at.....

4. The Burrill Personalized Medicine Meeting!!! Where I will be presenting with Linda Avey and Peter Vitulli from Sciona. I am super excited about this conference as well.

5. I will not be able to go up to Boston again for Harvard's Personalized Medicine Conference

:( sorry Raju!!! But it is yet again, another great conference to put on your radar.

Lastly, I am sad that I will be unable to speak at the NSGC Education Conference, unfortunately a personal commitment precludes me from flying to L.A. I was so hoping to catch up with my friend Brandon Colby there, but will have to defer. Oh well, there is always next year. I was looing forward to going over the Navigenics and 23andMe reports with counselor and explain what would be needed to interpret and counsel on risks of complex diseases like heart attack and multiple sclerosis.

So you see....Personalized Medicine is so big that it deserves 2 months!!!

The Sherpa Says: Have a great Columbus Day everyone. Remember, Columbus was ridiculed by all aspects of what was considered rational society for wanting to travel across the globe. He had an idea and criticized conventional thinking. Unfortunately, his own country wouldn't support him. I kind of consider myself to be just like him. Risk taker, lightning rod and discoverer of a New World. We ARE headed to that New World. Why don't you join me? I can't wait to get there, we are already underway!!!

CGCs, NPs and Me!!! Genetics will never be the same!

After about 50 emails, it became crystal clear. CGCs think I am bashing them when I point out their limited clinical training.

They also think I am bashing them when I point out that they should not be giving advice on medications that they do not know all the side effects or risks.

They also think I am bashing them by promoting the role of nurses in clinical genomics.

Wow! I never thought this would raise such chaos! I first would like to point out what Genetic Counselors are trained in. From the ABGC competencies.

An entry-level genetic counselor must demonstrate the practice-based competencies listed below to manage a genetic counseling case before, during, and after the clinic visit or session. Therefore, the didactic and clinical training components of a curriculum must support the development of competencies that are categorized into the following domains: Communication Skills; Critical-Thinking Skills; Interpersonal, Counseling, and Psychosocial Assessment Skills; and Professional Ethics and Values.

I highlight Communication skills because of what the ABGC demands.

From the site:

Can convey genetic, medical, and technical information including, but not limited to, diagnosis, etiology, natural history, prognosis, and treatment/management of genetic conditions and/or birth defects to clients with a variety of educational, socioeconomic, and ethnocultural backgrounds.The student is able to demonstrate knowledge of clinical genetics and relevant medical topics by effectively communicating this information in a given session.

What happens when that genetic condition is stroke? What about Left Main Coronary Disease? How about Inflammatory Bowel Disease? Coumadin metabolism???? There are a small cohort of counselors who know about these topics through workshops, or perhaps working with a doctor who studies these diseases....but that is a small few......like Karen Greendale. Who BTW is doing a wonderful job of getting this group together.

I hope you see what I am getting at.....most never trained for these things, but will soon be expected to handle this........BTW, this IS genomic medicine.

I just don't see how we rationally can expect someone who hasn't worked with coumadin or taking care of patients in a telemetry unit, to explain the workings of the heart or the cytochrome p450 system without some sort of medical clinician involved. It is just not fair or realistic.

This is not bashing your profession. It is pointing out the shortcomings of inappropriate utilization of manpower. Trust me. You will have more than enough work. But when it comes to these fields, I think a little more clinical training would help CGCs carry out Genomic Medicine counseling. Is that too much to ask?

I don't think so.

I want to remind all Genetic Counselors, you are part of the solution, not the problem. Yet, the comments and emails I received were reminiscent of the 100s of emails and comments from the Silly-Con Valley types when I said that they should have some sort of genetic counseling pre and post SNP scan and when the Government agreed with ME.......You are part of the solution CGCs, I never said you weren't. I just see your role evolving, and that evolution requires change.

Despite what Drew Y at ThinkGene says, you will not be programmed away. I have never seen Python code hand someone a tissue when they are crying, or comfort them with a caring voice.

Now some comments from my wonderful readers...

Anonymous

Yes, a CGC should have a year (or two) of clinical training. When I was shadowing a GC a couple of years ago, the doctor asked the GC if she had any thoughts for what genetic condition the patient may have. The GC said: "I don't have any idea." Some GC's will continue to learn at a much deeper level than other GC's.You couldn't have said it any better: "They don't even speak the clinical language very well. In order to take accurate medical and family histories, they need to know the genetic implications of sudden death, stroke, heart attack, coumadin metabolism, protonix efficacy, alzheimer disease, COPD, I could go on and on. But if they never saw it and talked about it, how could we ever ask them to learn this stuff through Osmosis or "Clinical Workshop"?????"
The way a CGC is trained needs to be adjusted

I agree completely

Anonymous

I am a CGC and I appreciate your honest and well-articulated comments on our limited clinical training. CGCs have some important skills that most physicians do not. Our professional organization (http://www.nsgc.org/) defines our scope of practice very nicely, recognizing these limitations. However, CGCs are not licensed providers in most states, nor are we recognized as allied providers by CMS.


This means that our scope of practice is not regulated or even on the radar of a regulatory body. So, what happens in practice is that the role of the CGC in a given case is determined by the physician s/he works with (usually medical geneticists). The physician is in the position of being the CGC's boss, the lines are muddied, and the role of the CGC is at the whim of the MD.


This is a terrible position for the only workforce that right now DOES have the genetics knowledge to provide to patients in the age of genomic medicine.

Our scope of practice needs to be better embraced by the health care system, with our role being one of providing risk assessment, genetic testing options and educators of patients and providers. Most CGCs feel very uncomfortable discussing management, but are put in that position by geneticists who frankly rarely manage

Thanks for the comment
I agree, clinical geneticists need to stop getting on conference calls for grants or in the lab, and get their asses into the clinics and on the floors. They have failed all CGCs out there. You could have used their clinical education!


Anonymous

Gosh, I find it awful ironic that you BASH genetic counselors so harshly on your blog, yet have them listed on your “Helix Health of Connecticut” website in the very first sentence about the healthcare team. Do you really think that your silly attempt at an apology to your “excellent CGC colleagues” will be sufficient? And gee, while we’re talking about “clinical ineptness”, I thought I should also throw out the fact that you specifically list services such as “preconception genetic evaluation” but I see no one on your team with an obstetrics background. (Haven't updated the site yet)

I guess having someone with that type of “clinical training” wouldn’t be necessary since you’re just helping a couple plan for a PREGNANCY.

Luckily, it seems as though the only patients that are going to be able to seek your great “expertise” are the few economically elite. For the rest of the population, we’re going to have to settle for consultations with all those well-educated, compassionate, hard-working genetic counselors out there.

Anonymous


No one said you weren't educated or hard working. I just think you shouldn't be forced to practice medicine because no physician will work with you......simply due to the fact they have grant deadlines.....As for our fee for service practices. We do this to keep our doors open, rather than have physicians who refuse to see patients and instead put the CGCs out on an island to either bill for 60 dollars per visit or commit insurance fraud.

I repeat. Genetic counselors are a valued part of the "team". I pejoratively put out there that there wouldn't be room for you.......If you continue educating counselors the way that you have always done it this could push you away from pharmacogenomics or chronic adult disease and personlaized medicine. Listen, the same is true for pediatric geneticists. The same is also true for non-genetically educated internists......

We have to get a grip on what we can and cannot do without some sort of formal education.....because if we don't, then we will have CGCs giving bad advice about medications or adult diseases.........or Internists misinterpreting genetic tests. Can't you see that it is just as bad????

The Sherpa Says: There will always be a great role for counselors. But unless they start learning the fields most affected by personalized medicine, they will find themselves forced to do things they aren't prepared to. We have to fix the broken genetics system AND the broken medical system. Because if we don't, a whole heap of people like Drew Y will point to our flaws and try to write code to "fix" us!!