We're unable to sign you in at this time. Please try again in a few minutes.
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Viewpoint |

Preventing Mitochondrial DNA Diseases One Step Forward, Two Steps Back

I. Glenn Cohen, JD1; Eli Y. Adashi, MD, MS2
[+] Author Affiliations
1Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts
2The Warren Alpert Medical School, Brown University, Providence, Rhode Island
JAMA. 2016;316(3):273-274. doi:10.1001/jama.2016.4930.
Text Size: A A A
Published online


This Viewpoint summarizes a 2016 Institute of Medicine report on the safety, ethics, and legal implications of using mitochondrial replacement therapy to prevent mitochondrial DNA diseases.

On February 3, 2016, the Institute of Medicine (IOM) released its Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases report.1 Commissioned by the US Food and Drug Administration (FDA), the report provides important information for the agency, which is considering the approval of mitochondrial replacement therapy for the prevention of mitochondrial DNA diseases.1 Expansive in its purview and thorough in its scrutiny, the report concludes that it is “ethically permissible” to embark on clinical trials involving human beings, subject to rigorous safety and efficacy imperatives.1 The report further recommends that initial clinical trials be limited to male embryos whose mitochondria cannot be transmitted to their progeny.1 In so doing, the IOM is seeking to preclude transmission of unintended outcomes to the progeny.1 In an unforeseen turn of events, the release of the IOM report was preceded by the enactment of a federal statute that prohibits the FDA from considering research applications for the conduct of this therapy.2 This Viewpoint seeks to contextualize the IOM report by describing the drive to bring mitochondrial replacement therapy to the clinic and the statutory constraints blocking its adoption.

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview




Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.


Some tools below are only available to our subscribers or users with an online account.

0 Citations

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles