Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

23andMe and the FDA: Did the government overreach?

James Marroquin, MD
Conditions
December 10, 2013
Share
Tweet
Share

23andMe is a personal genomics and biotechnology company which for $99 conducts a comprehensive analysis of your DNA.  In recent days, the Food and Drug Administration (FDA) instructed 23andMe to halt sales of its main product.  The FDA’s problem with 23andMe does not seem to be the accuracy of their testing methods.

The FDA’s concern is apparently that the company has not met all of the complex regulatory requirements demanded by the type of entity the FDA considers them to be.

In his Slate article, Gary Marchant argues that the FDA’s burdensome regulations essentially make it impossible for companies to provide affordable personalized genetic testing:

The problem is that (the FDA’s) regulatory approval pathways generally require clinical testing that takes several years to complete and costs millions of dollars. 23andMe or any other entrant into this field would have to pursue such approval for each test it offers — and 23andMe offers tests for more than 250 diseases and conditions. Moreover, because of rapid advances in the field of genetics, any such test would likely be outdated, replaced by a more precise and advanced test, before the clinical testing and regulatory approval could be completed for the initial test. In other words, the PMA regulatory pathway is infeasible and impracticable for these types of tests, and the FDA’s insistence on such a step is a death sentence for direct-to-consumer genetic testing.

Beyond debating the technical legalities of the FDA’s action, it is worth considering whether what it did will result in more overall harm or good.  Let’s first consider the benefits of direct-to-consumer genetic testing.  The first is privacy.  As Marchant writes, “To many people, their genetic information is very private, and they prefer to get the results privately at home rather than through their physician, who will likely put the information in the patient’s medical record.”

A second benefit is the low price of 23andMe’s product.  To quote Marchant again, “It is much cheaper to get tested through 23andMe, which is currently offering its entire battery of genetic tests for only $99. It would cost many hundreds if not thousands of dollars to get the same tests through one’s physician, and health insurance does not cover the cost of most genetic tests presently.”

What are the concerns held by the FDA and other critics of direct-to-consumer genetic testing?  One worry is that people might undergo unnecessary tests and procedures based on the information 23andMe provides.  For example, critics worry that a woman who is found to have a false-positive BRCA mutation might have a prophylactic mastectomy inappropriately.  This seems to me to be an impractical concern.  It is difficult imagine a surgeon operating in such a situation without first verifying the genetic testing through another lab and extensively discussing the benefits and risks of such an approach with the patient.

Another concern about direct-to-consumer genetic testing is the psychological impact that the information can have.  How might a person react if he or she finds they have an increased risk of developing Alzheimer’s disease, something which they are powerless to prevent?

When I received my 23andMe results, it was apparent that the company takes this issue seriously.  The results for my risk of developing Parkinson’s disease and Alzheimer’s were locked.  I was required to read through a long explanation of the meaning and  implications of the test results before I could access them.  It turns out, however, that people seem to be less psychologically devastated by adverse genetic test results than many of the experts anticipated.  For instance, a study published in the New England Journal of Medicine found that “in sample of subjects who completed follow-up after undergoing consumer genomewide testing, such testing did not result in any measurable short-term changes in psychological health, diet or exercise behavior, or use of screening tests.”

After considering the benefits and risks of direct-to-consumer genetic tests such as 23andMe, it seems that they likely result in more good than harm.  I reckon our federal government’s resources would be better spent taking on public health risks much greater than those posed by 23andMe.

James Marroquin is an internal medicine physician who blogs at his self-titled site, James Marroquin.

Prev

Are we making progress in the fight against childhood obesity?

December 9, 2013 Kevin 0
…
Next

23andMe is providing data that physicians don't know how to manage

December 10, 2013 Kevin 8
…

Tagged as: Genetics

Post navigation

< Previous Post
Are we making progress in the fight against childhood obesity?
Next Post >
23andMe is providing data that physicians don't know how to manage

ADVERTISEMENT

More by James Marroquin, MD

  • a desk with keyboard and ipad with the kevinmd logo

    Physicians should recognize patients’ spirituality

    James Marroquin, MD
  • a desk with keyboard and ipad with the kevinmd logo

    Health and well-being are holistic concepts

    James Marroquin, MD
  • a desk with keyboard and ipad with the kevinmd logo

    Some patients don’t expect doctors to be miracle workers

    James Marroquin, MD

More in Conditions

  • The truth about sun exposure: What dermatologists want you to know

    Shafat Hassan, MD, PhD, MPH
  • How a South Asian nurse challenged stereotypes in health care

    Viksit Bali, RN
  • Could ECMO change where we die and how our organs are donated?

    Deepak Gupta, MD
  • From Civil War tales to iPhones: a family history in contrast

    Richard A. Lawhern, PhD
  • The hidden dangers of over-the-counter weight-loss supplements

    STRIPED, Harvard T.H. Chan School of Public Health
  • How denial of hypertension endangers lives and what doctors can do

    Dr. Aminat O. Akintola
  • Most Popular

  • Past Week

    • How a doctor defied a hurricane to save a life

      Dharam Persaud-Sharma, MD, PhD | Physician
    • Why primary care needs better dermatology training

      Alex Siauw | Conditions
    • Guilty until proven innocent? My experience with a state medical board.

      Jeffrey Hatef, Jr., MD | Physician
    • Why physician strikes are a form of hospice

      Patrick Hudson, MD | Physician
    • Why medical notes have become billing scripts instead of patient stories

      Sriman Swarup, MD, MBA | Tech
    • Federal shakeup of vaccine policy and the battle for public trust [PODCAST]

      American College of Physicians & The Podcast by KevinMD | Podcast
  • Past 6 Months

    • Why transgender health care needs urgent reform and inclusive practices

      Angela Rodriguez, MD | Conditions
    • COVID-19 was real: a doctor’s frontline account

      Randall S. Fong, MD | Conditions
    • Why primary care doctors are drowning in debt despite saving lives

      John Wei, MD | Physician
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • Confessions of a lipidologist in recovery: the infection we’ve ignored for 40 years

      Larry Kaskel, MD | Conditions
    • mRNA post vaccination syndrome: Is it real?

      Harry Oken, MD | Conditions
  • Recent Posts

    • Federal shakeup of vaccine policy and the battle for public trust [PODCAST]

      American College of Physicians & The Podcast by KevinMD | Podcast
    • Why clinicians must lead health care tech innovation

      Kimberly Smith, RN | Tech
    • The truth about sun exposure: What dermatologists want you to know

      Shafat Hassan, MD, PhD, MPH | Conditions
    • Learning medicine in the age of AI: Why future doctors need digital fluency

      Kelly D. França | Education
    • How a South Asian nurse challenged stereotypes in health care

      Viksit Bali, RN | Conditions
    • Doctors reclaiming their humanity in a broken system [PODCAST]

      The Podcast by KevinMD | Podcast

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 4 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • How a doctor defied a hurricane to save a life

      Dharam Persaud-Sharma, MD, PhD | Physician
    • Why primary care needs better dermatology training

      Alex Siauw | Conditions
    • Guilty until proven innocent? My experience with a state medical board.

      Jeffrey Hatef, Jr., MD | Physician
    • Why physician strikes are a form of hospice

      Patrick Hudson, MD | Physician
    • Why medical notes have become billing scripts instead of patient stories

      Sriman Swarup, MD, MBA | Tech
    • Federal shakeup of vaccine policy and the battle for public trust [PODCAST]

      American College of Physicians & The Podcast by KevinMD | Podcast
  • Past 6 Months

    • Why transgender health care needs urgent reform and inclusive practices

      Angela Rodriguez, MD | Conditions
    • COVID-19 was real: a doctor’s frontline account

      Randall S. Fong, MD | Conditions
    • Why primary care doctors are drowning in debt despite saving lives

      John Wei, MD | Physician
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • Confessions of a lipidologist in recovery: the infection we’ve ignored for 40 years

      Larry Kaskel, MD | Conditions
    • mRNA post vaccination syndrome: Is it real?

      Harry Oken, MD | Conditions
  • Recent Posts

    • Federal shakeup of vaccine policy and the battle for public trust [PODCAST]

      American College of Physicians & The Podcast by KevinMD | Podcast
    • Why clinicians must lead health care tech innovation

      Kimberly Smith, RN | Tech
    • The truth about sun exposure: What dermatologists want you to know

      Shafat Hassan, MD, PhD, MPH | Conditions
    • Learning medicine in the age of AI: Why future doctors need digital fluency

      Kelly D. França | Education
    • How a South Asian nurse challenged stereotypes in health care

      Viksit Bali, RN | Conditions
    • Doctors reclaiming their humanity in a broken system [PODCAST]

      The Podcast by KevinMD | Podcast

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

23andMe and the FDA: Did the government overreach?
4 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...