Robinson Bradshaw

Topic: Francis Collins

Updating the DTC Debate: Trial by Press Release, More FDA Letters, the Problem of Pleiotropy and New RUO Guidance

Later today I will join several colleagues here in Chicago, IL at the American Society of Clinical Oncology (ASCO) annual meeting for a panel discussion on Direct-to-Consumer Genetic Testing for Cancer: What Physicians Need to Know (pdf). (Daniel MacArthur and Misha Angrist will not be on the panel, although each joined us in authoring the […]

The Next Social Media Revolution Will Occur In…Personalized Medicine?

Social media – including Facebook, Twitter and other social networking platforms – are widely credited with fundamentally altering the nature of political discourse and, in some instances, credited as catalysts of political revolution. But social media’s ability to affect change need not be limited to politics, as recent developments in the arena of personalized medicine […]

Clearing a Path for DTC Oversight

In a few hours, the FDA will kick off a two-day public meeting to consider the future of clinical direct-to-consumer (DTC) genetic tests. Few corners of the personal genomics landscape have generated as much attention from regulators, consumers and, especially, the media as DTC genetic testing. Thus, when the meeting was first announced last month, […]

2011 Personal Genomics Preview: It’s Déjà Vu…

Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked: 1. Will the $1,000 genome live up to the hype? 2. Will personal genomics stay DTC? 3. How will the ongoing gene patent debate affect the progress of personalized medicine? 4. […]

HHS Pulls the Plug on Genetics Advisory Committee

The clock has run out the Secretary’s Advisory Committee on Genetics, Health, & Society (SACGHS). As reported by Turna Ray of Pharmacogenomics Reporter, the committee, which reports to Health and Human Services (HHS) Secretary Kathleen Sebelius, will have its charter extended only long enough to conduct one final meeting next month. According to Ray, SACGHS […]

The Genomics and Personalized Medicine Act Returns to Congress

Meggan Bushee is a student at the Wake Forest University School of Law. This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

The Wild, Wild East of DTC Genomics and the Need for Meaningful Self-Regulation

Earlier this month CNN reported on the launch of a new program by the Chongqing Children’s Palace (CCP), in Chongqing, China, “that uses DNA testing to identify genetic gifts and predict the future.” In a story seemingly more appropriate for the Onion than for CNN, the article reports that Chinese scientists at the CCP are […]

The Scientific Foundation for Personal Genomics: Recommendations from the Joint NIH-CDC Workshop

Last December, some of the true heavyweights in the field of personal genomics convened for a two-day workshop cosponsored by the CDC and NIH to review the science and implementation of personal genomics. Participants included scientific luminaries (e.g., Francis Collins, George Church and Bob Green), personal genomics companies (e.g., 23andMe, Knome, Navigenics, deCODE Genetics and […]

NHGRI Commits $9.5 Million to Spur Innovation

This week, the National Human Genome Research Institute (NHGRI) committed an additional $9.5 million to fund advancements in genome-sequencing in pursuit of its goal to “reduce the cost of sequencing a mammalian-sized genome to approximately $1,000.” Through its “Revolutionary Genome Sequencing Technologies—The $1,000 Genome” program, the NHGRI continues to drive a remarkable decline in the cost […]