{"id":15673,"date":"2013-12-03T09:00:01","date_gmt":"2013-12-03T14:00:01","guid":{"rendered":"http:\/\/pmedicine.org\/epatients\/?p=15673"},"modified":"2013-12-02T20:28:09","modified_gmt":"2013-12-03T01:28:09","slug":"matthew-katz-on-23andme-return-to-sender-genome-unknown-seven-reasons-i-will-return-my-personal-genome-kit","status":"publish","type":"post","link":"https:\/\/participatorymedicine.org\/epatients\/2013\/12\/matthew-katz-on-23andme-return-to-sender-genome-unknown-seven-reasons-i-will-return-my-personal-genome-kit.html","title":{"rendered":"Matthew Katz on 23andMe: “Return to Sender, Genome Unknown: Seven Reasons I Will Return My Personal Genome Kit”"},"content":{"rendered":"

\"MatthewRadiation oncologist Matthew Katz is a lifetime member of SPM who blogs regularly for the\u00a0American Society of Clinical Oncology<\/a>\u00a0and\u00a0Mayo Clinic Social Media Health Network<\/a>. In this guest post he offers\u00a0<\/em>his view of 23andMe<\/a>, the personal genomics service that’s in the news because of the FDA’s recent ruling.<\/em><\/p>\n

That ruling has generated enormous controversy, on the SPM member listserv as well as in the general media. Matt’s not on the member listserv, so he didn’t know that, but he offers these views … which, as with all guest posts, are his own, not SPM’s. What do you think?
\n____________<\/em><\/p>\n

Given recent controversy about the U.S. Food and Drug Administration\u2019s letter<\/a> to the personal genome services company 23andMe, I just had to learn more about what was truly involved. After buying a kit on Thanksgiving, I\u2019ve gone from being a skeptic to wanting a full refund for seven reasons:<\/p>\n

1. Lack of transparency. <\/b>The company apparently wants to reach out to the health care market for revenue, but seems to claim it is only an \u201cancestry\u201d company to avoid regulatory scrutiny. Dr. Michael Eisen, on the scientific advisory board, writes: \u201cGenetic tests are simply not \u2026 medical devices in any meaningful sense of the word<\/a>. They are far closer to family history than to an accurate diagnostic.\u201d So why the slogan \u201cHealth and ancestry start here<\/a>\u201d?\u00a0 Targeting patients through direct-to-consumer marketing might boost sales, but will also guarantee FDA involvement. Why would I buy a personal genome product from a company that refuses to acknowledge it is selling a medical test?<\/i><\/p>\n

2. Lack of adequate testing and subsequent data. <\/b>The FDA issued a \u201ccease and desist\u201d letter explaining that because \u201cmore than 5 years after [23andMe] began marketing, [23andMe] still had not completed some of the studies and had not even started other studies necessary to support a marketing submission.\u201d In addition, 23and me doesn\u2019t do the testing itself, but outsources it to LabCorp. Unfortunately, that company has made at least one publicized mistake with 96 samples<\/a>. Why should I pay for a test that I don\u2019t know works?\u00a0<\/i><\/p>\n

3. Privacy risks. <\/b>23andMe frames testing as self-empowerment: \u201cKnowledge is power<\/a>.\u201d\u00a0 But its privacy policy<\/a> makes it clear that de-identified information may be shared with third parties. It begins by sending your DNA to a different company, LabCorp, before transferring it to 23andMe. Recent research shows that 45% of healthcare organizations had more than five security breaches in a two year period.<\/a>\u00a0 It could happen with 23andMe despite its best efforts. Another privacy concern is that genetic information may be shared with the NSA or legal enforcement<\/a>. Why would I take a test whose results could be used against me for insurance, employment, or in legal matters?<\/i><\/p>\n

4. Am I a research subject or not?<\/b>\u00a0 23andMe highlights the opportunity to participate in \u201ca new way of doing research<\/a>.\u201d\u00a0 As a cancer specialist, I\u2019m all for new research, but what is involved with giving the company my genetic information? To buy the kit, I didn\u2019t have to read the terms of service<\/a> (TOS) or review the risks and benefits of genomic testing. I didn\u2019t see a consent form to review. Why should I pay for testing without being certain if I was consenting to unknown research on my genome?<\/i><\/p>\n

5. Possible research on vulnerable populations. <\/b>Children are considered a vulnerable population in the Belmont Report<\/a>, which guides ethical clinical research in the US. I previously raised concerns<\/a> about the ethics of social networks data mining health information, thinking mainly about cognitively intact adults.<\/p>\n

Apparently 23andMe permits testing on minors. Buried in the Customer Care section, the company is advising how to swab children<\/a>. 23andMe isn\u2019t the only company doing this, and there are medical reasons to consider genetic testing, but offering a discount on extras kits for family members seems a bit off. Clearly it\u2019s in the financial interest of the company<\/a> to get the whole family tested, but is it in mine?\u00a0 Why would I risk making my children research subjects when they are otherwise healthy?<\/i><\/p>\n

5. Problematic content organization. <\/b>The website design is frustrating. Not only did the TOS not show up as required reading before purchase, I had to dig through the site map to find \u201cBefore You Buy<\/a>.\u201d The cool video on the process<\/a> doesn\u2019t mention that they outsource the testing — it\u2019s \u201cour lab.\u201d That they really use LabCorp is hidden.<\/p>\n

6.\u00a0 Lack of balance in presentation. <\/b>Technically the company can say it thoroughly lists possible risks. In medicine, it\u2019s an obligation to educate patients with a balanced view for informed decision-making. 23andMe doesn\u2019t do that, as the examples above demonstrate. Why should I give my money to a company that doesn\u2019t give a balanced view from the outset?<\/i><\/p>\n

7. Eugenics. <\/b>A company that collects genomic data and then files for a patent for designer babies<\/a>, raises additional concerns for me. Even if 23andMe doesn\u2019t use it now, I do not want my genome to become part of a eugenics<\/a> debate. And if the company practices what it preaches, it should be equally as transparent in its practices<\/a> as it encourages its customers to be. Why would I risk that my genomic information might be used for a different kind of genetic discrimination?<\/i><\/p>\n

I am not an expert on the FDA\u2019s regulatory process, and it has its much-deserved share of critics, but many of my concerns are reflected in its letter to 23andMe. The purpose isn\u2019t to stop personal genomics, but to ensure testing doesn\u2019t hurt people.. This must begin with a valid test supported by clear and easily understandable marketing materials developed to reassure customers that it\u2019s a trustworthy steward for genetic information.<\/p>\n

As a citizen, I expect corporate transparency for any new health product. As a patient, I think the risks of taking the test outweigh the benefits for my health. As a doctor, I have my concerns for people with distress or misinformation from results of an unproven genomic test. As a human being, I worry about misuse and unintended social consequences of our genetic heritage.<\/p>\n

With time, the pro-autonomy advocates and more conservative skeptics will find middle ground. But for now, I\u2019ll send my kit back unopened.
\n_______________<\/p>\n

Those are Dr. Katz’s concerns, obviously including a lot of participatory \/ empowered thinking. Many of our members feel strongly similar or opposite. What do you think?<\/em><\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

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