Personal Genomics Takes a Bashing on Physician Oversight, Financial Backing, and Privacy

by Dr. Hsien-Hsien Lei
Posted April 21, 2008 in Business of DNA, DNA Testing, DNA and the Law

Direct-to-consumer genetic testing just can’t catch a break lately. We can expect blogs to be snarky but who knew Forbes and BusinessWeek could invoke a similar tone when writing about personal genomics?

First up, Forbes reveals that New York State’s Department of Health has sent letters to a number of personalized genetic testing companies threatening fines and jail time if they’ve been offering their services without a doctor’s involvement. The concern is that customers may not be able to understand their results and be potentially misled as to their risk of disease.

Both 23andMe and DeCode, which has not received a warning letter from New York so far, argue that the lab testing laws don’t apply because their products are not medical tests. “23andMe’s services are not medical … they are educational,” argues 23andMe spokesman Paul Kranhold.

That argument doesn’t mean spit to the New York regulators, who are concerned about the reliability of the online tests and their potential to send people rushing to their doctor demanding a cure for a fatal disease they may never get. [emphasis added]

BusinessWeek focuses on the financial aspect of the big players in personal genomics–23andMe and Navigenics–pointing out that both companies have received funding from Google. The company’s spokesman, Andrew Pederson, says that Google is “interested in supporting companies and making investments in companies that [bolster] our mission statement, which is organizing the world’s information and making it universally accessible and useful.” The difference between the offerings of 23andMe and Navigenics is portrayed as being interesting, broad-based information vs. valuable, medical-based information.

[Navigenics co-founder David] Agus, director of the Spielberg Family Center for Applied Proteomics at Cedars-Sinai Medical Center in Los Angeles, treats Hollywood celebrities, Saudi royalty, and others with deep pockets, but he conceived the company as a way to avert costly diseases.

Neither article mentions concerns over genetic discrimination and privacy which underlie discussions about regulation and access to genetic data. Two comments to the BusinessWeek article debate the issue.

Nicholas Bolibruch:

To all the naysayers, if you want nothing to do with this, just don’t use the service. Google cannot become big brother unless you voluntarily offer genetic material and make accounts on their system. The benefits of preventative health far outweigh the potential privacy violation. If you don’t like it, don’t use it, simple as that. I’m sure the person who gets genetic screening done and finds out they have a predisposition to some form of disease will be happier knowing they maybe able to prevent the problem in advance. When this saves someone’s life, all the naysayers will certainly have egg on their face.

Gerald:

You cannot say “if you don’t want it, don’t use it.” This creates a negative discrimination for non-users, making them suspicious to insurance companies, employers, etc. It’s the same reasoning totalitarian governments all over the world have always been using: “If you have no reason to hide, let yourself get registered by the authorities.” This opens all the door to neo-facist social structures and as a German for sure I will do all what I can to see history repeating itself, although with different names and forces of a globalised company now behind the same scheme of domination of personal liberties.

But perhaps privacy, confidentiality and consent for research will be moot in the future according to the proposal for an open-consent framework put forth by Lunshof et al. in Nature Reviews Genetics. More from DNA Network members:

• A new model for genetic privacy: you don’t have any at Genetic Future
• Private parts at Genomeboy
• Piracy or Privacy? Some Thoughts. at Gene Sherpas

If anyone ever organizes a biosciences startup school, they need to put regulatory affairs, investment choices, and privacy concerns on the syllabus!

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6 Comments »

Comment by Deepak

2008-04-21 18:12:14

Absolutely. I know how clueless I was when I got done with grad school. Whether you like IP law or not, you need to be aware of what it is and bioethics is another area where you need to have some level of awareness.

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Comment by Hsien-Hsien Lei, PhD

2008-04-22 14:57:13

Deepak, I’m the worst when it comes to anything related to practical business management. If there were a short seminar series specific to biotech/bioscience, I would go for it. But I’ll leave the MBA’s to others!

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Comment by Trisha

2008-04-21 20:09:47

“The concern is that customers may not be able to understand their results and be potentially misled as to their risk of disease.”

That’s just insulting!

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Comment by Steven Murphy MD

2008-04-21 20:48:47

Trisha,
Insulting for whom? The barely health literate lay person. Or the barely genomically literate physician?

These mistakes were all rookie mistakes, that we at Helix Health saw and averted. Wait till they figure out the malpractice issues……hmmm bet that’ll fry Sergey’s brain for a while….
-Steve
http://www.helixhealth.org
p.s. how’s that for snarky?

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Comment by Hsien-Hsien Lei, PhD

2008-04-22 14:58:08

Steve, You’re in no danger of losing your position as the king of genetic snark.

(Comments wont nest below this level)

Reply here

 

 

Comment by Hsien-Hsien Lei, PhD

2008-04-22 14:58:53

I know what you mean, Trisha. Steve is right to some extent that much of the science and health knowledge you and I take for granted is beyond many people.

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