Myriad Genetics Refuses To Accept That People Have A Right To Access Their Own DNA Sequences

from the just-because-it's-your-genome,-don't-think-you-own-it dept

One of the biggest victories on the patent front was when the US Supreme Court finally ruled that naturally-occurring DNA cannot be patented. The company involved in this case, Myriad Genetics, didn’t give up at this point, but tried to claim that despite this ruling, its patents on genetic testing were still valid. Fortunately, the courts disagreed, and struck down those patents too.

However, as we noted at the time, there’s another issue that remains unresolved, which concerns the huge database of DNA that Myriad Genetics has built up over years of sequencing the BRCA1 and BRCA2 genes that have variants linked to cancer. Because of Myriad’s unwillingness to provide that important data to the people whose DNA was sequenced, the American Civil Liberties Union (ACLU) has decided to take action:

On May 19, 2016, the ACLU filed a complaint pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”) with the U.S. Department of Health & Human Services (“HHS”) on behalf of four patients against Myriad Genetics, a genetic testing laboratory based in Utah. The complaint was filed by patients who have experienced cancer, including breast and bladder cancers, or who are members of families with substantial histories of cancer.

All of the patients received genetic testing from Myriad Genetics in order to determine their hereditary risk for various forms of cancer and to guide treatment decisions. They later asked for all of their genetic information, not just the results, but Myriad refused to provide it. As the ACLU explains:

The patients want full access to their genetic information because they know that the understanding of genes and their variants is constantly evolving, and they want to be able to proactively monitor their own cancer risk and that of their family members as scientific knowledge and clinical interpretation of genomic information advances. Most importantly, the patients, many of whom have uncommon genetic variants, are concerned that Myriad controls much of the data about BRCA1 and BRCA2 genetic variants in a proprietary database. This impedes the ability of researchers to better understand whether these variants are connected with various types of cancer. The patients want to have the option of sharing their data with the broader research community.

The last point is key. Myriad is sitting on a wealth of information that might well lead to new treatments and even cures for the many cancers involved. Instead, it is asserting its proprietorial right over DNA that comes from other people. That’s particularly egregious since the scientists who first sequenced DNA on a large scale were pioneers in data sharing. As early as 1996, laboratories taking part in the Human Genome Project not only agreed to share their data, but to do so immediately, and with no restrictions. Myriad Genetics’ action is totally at odds with the ethos of sharing that lies at the heart of genomics.

As a blog post on the ACLU site notes, on the eve of the HIPAA complaint being filed, Myriad suddenly agreed to provide the information requested, but only on a “voluntary” basis. That is, it refused to recognize the broader rights of patients to their own genetic information. However, the ACLU believes that the law is straightforward here:

Patients are guaranteed access to their health information — including their genetic data — under HIPAA. In 2014, the U.S. Department of Health and Human Services amended the HIPAA regulations to make clear that all laboratories, which were previously exempted, are subject to this obligation. And earlier this year, HHS released guidance stating that with respect to genetic testing, patients have a right to access “not only the laboratory test reports but also the underlying information generated as part of the test,” including “the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test.”

Let’s hope this case leads to yet another defeat for Myriad, and establishes once and for all that DNA sequences belong to the people from whom they were obtained. That way they will be free to make data available to researchers for the benefit of everyone, not just for a few companies like Myriad Genetics.

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Comments on “Myriad Genetics Refuses To Accept That People Have A Right To Access Their Own DNA Sequences”

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25 Comments
Anonymous Coward says:

“And earlier this year, HHS released guidance stating that with respect to genetic testing, patients have a right to access “not only the laboratory test reports but also the underlying information generated as part of the test,” including “the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test.”

All good but doesn’t solve the problem that doctors frequently act as gatekeepers to tests and some doctors are still not happy to believe that DNA results can be helpful, instead choosing to patronize ‘users’ and refuse to recommend tests. While many specialized tests are still expensive for an individual, it is still the case that many are unable to get a doctor to authorize even if they want to spend their own money. As costs come down perhaps this situation can ease in the longer term but the guild mentality is still acting as a bar to increased testing in the short term.

AJ says:

Re: Re:

“All good but doesn’t solve the problem that doctors frequently act as gatekeepers to tests and some doctors are still not happy to believe that DNA results can be helpful, instead choosing to patronize ‘users’ and refuse to recommend tests.”

“Citation Needed”

Perhaps my families doctors are just paranoid or something, as it’s all I can do to keep them from running every test in the book every time we have even a minor issue.

“While many specialized tests are still expensive for an individual, it is still the case that many are unable to get a doctor to authorize even if they want to spend their own money.”

Again “Citation Needed”

5 minute google search revealed multiple DTC (Direct To Consumer) genetic testing labs that quickly revealed paying out of pocket is a snap, and doesn’t require a doctor to authorize. It is fairly new, so your results may not be as accurate as you would like, or be more accurately read by /or with a physician, but it is not required.

I.T. Guy says:

Re: Re: Re:

AJ appears to be a young fellow not having spent much time around older people.

“quickly revealed paying out of pocket is a snap”
Sure, AJ, if you have an extra 1595.00 laying around for a BRCA1/2. In addition to whatever you ALREADY pay for “health” insurance.

“It is fairly new, so your results may not be as accurate as you would like” Ha ha ha yeah sure… I’ll throw out 1500 for that. /s Oh and “Citation needed”

“”While many specialized tests are still expensive for an individual”
You said you spent 5 minutes searching google… you didnt see the hundreds of pages denouncing the costs of medical tests? Sure ya didnt.
https://www.sciencebasedmedicine.org/32293/

“doctors are still not happy to believe that DNA results can be helpful”
Again… AJ… another 5 min Google search would have enlightened you as to the mixed opinions doctors have for DNA sequencing.

Shouldnt you be on Y00T00be harassing Truthers?

AJ says:

Re: Re: Re: Re:

“AJ appears to be a young fellow not having spent much time around older people.”

Stop assuming, it makes you look like an ass.

“Sure, AJ, if you have an extra 1595.00 laying around for a BRCA1/2. In addition to whatever you ALREADY pay for “health” insurance.”

I had one procedure this year that cost me $3500 out of pocket, and I have good insurance. If a BRCA1/2 would have helped me to identify any predisposition early, perhaps I could have have utilized preventative medicine to prevent the need for that procedure. It would have been worth it.


“It is fairly new, so your results may not be as accurate as you would like” Ha ha ha yeah sure… I’ll throw out 1500 for that. /s Oh and “Citation needed”

http://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet

http://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet#q9

https://ghr.nlm.nih.gov/primer/testing/directtoconsumer

https://www.23andme.com/service/

https://www.qiagen.com/us/shop/sample-technologies/dna/dna-preparation/generead-dnaseq-gene-panels-v2?catno=NGHS-102X&cmpid=QFDKadwordsBRCAGA_SEM&kwid=brca1%20brca2%20breast%20cancer&gclid=CPGbu5bPpc0CFQgoaQodbmMMOA#orderinginformation

You can spend as little as $200, and as much as $5,000 or more depending on what you want done.

“Shouldnt you be on Y00T00be harassing Truthers?”

Why? Your dumb ass remarks are quite a bit more fun to read.

I.T. Guy says:

Re: Re: Re:2 Re:

Poor AJ…. Like I said in response to your questioning the cost of specialized tests and your asking for a citation of said costs… you have little experience in those matters and a second of searching would have revealed that. Troll harder kid. I suspect you DID see it but excluded your findings to make it look like it needed citation. It didn’t.

“Sure, AJ, if you have an extra 1595.00 laying around for a BRCA1/2. In addition to whatever you ALREADY pay for “health” insurance.”

“I had one procedure this year that cost me $3500 out of pocket”
Potato? WTF does that have anything to do with, and you MADE MY POINT thank you, that PPL already pay for insurance and may not have an extra 1500 disposable income laying around. Obviously you don’t have the insurance you should. You may think it’s good, but sounds like you need to reevaluate your plan.

Did you actually read the links you sent? You sent them in response to accuracy, or should have, but none of them even come close except:
http://www.cancer.gov/about-cancer/causes-prevention/genetics/genetic-testing-fact-sheet#q11
So… “Citation STILL needed.”

“”Shouldnt you be on Y00T00be harassing Truthers?””
Even the Truthers get the best of ya huh wiLLie?

Anonymous Coward says:

Re: Re: Re:2 Re:

“AJ appears to be a young fellow not having spent much time around older people.”

Stop assuming, it makes you look like an ass.

I am just pointing out that the only person looking like an “ass” is thee. If you want to make a salient point, you need to be a lot more comprehensive. Otherwise, you end up looking as uninformed as the trolls who inhabit the various forests around techdirt.

An observation was made, a comment was made as per the observation, your response has simply reinforced the observation and comment. If the observation is incorrect, you will need to provide significant clarification as to who and what you are and why you are taking the stand you are trying to portray?

Arrogance can be attributed to anyone (including myself). In this you have just come across as uneducated and arrogant. You could consider being a little more civil and constructive by providing more content on which we can base your argument.

Or you could be like some here, whose lack of rigour in defending their points of view is summed up by their common use of “Is that the truth” as the limit of their ability to discuss their point of view.

At this point, I suppose, I will have lost you and so, in consideration of that point, I will finish here.

Anonymous Coward says:

Just because the courts are ruling against Myriad doesn’t necessarily mean that they are going to give up those records to those patients they belong to. Companies like Myriad are well known for refusing to comply with court orders. After all, what are the courts going to do about it? Levy a punitive fine against the company? Revoke their patents?

Only way I see the company complying is if the court appoints an administrator.

Rigorous Ron says:

“Instead, it is asserting its proprietorial right over DNA that comes from other people.”

Nope. It’s asserting its right to the information it created by testing DNA that comes from other people. A judge will almost certainly state the same, and ask the ACLU attorneys, “So don’t you think that Myriad has the right to CHARGE people for the results of the work it has done?” ACLU attorneys, “Er, uh, well this is America, so I guess so…” Judge: “So then it follows that Myriad owns that information. And if these people don’t want to pay Myriad’s price, aren’t they free to pay someone else for the same service?”

Anonymous Coward says:

Re: Re: Re:

IANAL but I don’t think that charging twice for the same work is legal.

Of course it is, that is the great financial foundation of the USA. “Don’t let the suckers out of the door until we have drained them of all the currency we can” is the motto of your housing, copyright, medical, governmental, etc institutions.

profsteven (profile) says:

Photography analogy?

I’m not sure ACLU will prevail here. If a photographer takes a photo of me, I still own the rights to “me”, but the photographer owns the rights to his photograph of me. I can ask for that photograph, and even the rights to that photograph, but the photographer isn’t under any legal obligation to provide that (as far as I understand).

How is that different to this case? MG made a “sample” (for lack of a better word) of a person’s genetics, and they own the copyright to the database expression of that “sample”. The person still owns their genetic information, but why does MG need to hand over the database, if that was not the contract at the time the sample was made. After all, the patient can go and get another sample that they do own the rights to any time.

You may not be able to copyright facts, but you can certainly take a photograph which displays the “fact” of how I appeared at one particular moment in time, and own the copyright to that photograph.

Am I missing something? Why does ACLU think they will win here?

klaus says:

Re: Photography analogy?

Your photograph analogy only works so far. Patients are guaranteed access to their health information — including their genetic data — under HIPAA.

So in terms of your analogy, subjects are allowed under law to view a photograph of them. Copyright has nothing to do with this. Under European law, this would come under data protection, where people are guaranteed access to their own data.

RRogers (profile) says:

Myriad Genetics

Glyn Moody did not contact Myriad for comment on this article. Unfortunately, most of what appears in this article is false and inaccurate. Myriad has a long track record of putting patients first. Learn more by viewing this video:

Watch “Patient Privacy and Access to Test Results” by Myriad Genetics: https://vimeo.com/170663046

Jeff says:

What am I missing

The people who sent in their DNA want it back? Ummm, can’t they just spit in a bottle, cut their hair,etc. it seems to me if they, of their own free will, paid Myriad to analyze their DNA and Myriad performed on that agreement isn’t the relationship legally over?

Whether Myriad can patent DNA is a separate issue that has been resolved against the company.

Seems to me if Myriad discovers other variants, isn’t that a product of their labor.

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