Earlier this summer there were a series of incidents involving pathogens (anthrax, H5N1 influenza, and smallpox) in both Centers for Disease Control (CDC) and National Institutes of Health (NIH) facilities (the Food and Drug Administration was responsible for the NIH lab where the smallpox was found). Perhaps overshadowed by the Ebola outbreak in Africa, the lapses in security were notable and prompted institutional reviews, at least one congressional hearing and increased calls for oversight. So far those efforts have been focused on the agencies directly affected by the lapses. The CDC has issued a report on the anthrax incident, and the Government Accountability Office has been asked to assess how well federal agencies manage the pathogens under their control.
The Executive Branch joined the fray last week. Posting to the Office of Science and Technology Policy blog, OSTP Director John Holdren and Deputy National Security Adviser Lisa Monaco described the August 18 memo distributed to several federal agencies (any agencies operating facilities that may use, transport, or possess biomedical toxins or infectious agents; a longer list than you might expect). Amongst the recommendations:
- Conduct a ‘Safety Stand-Down’ – a review of biosafety and biosecurity best practices and protocols – within 30 days of the issuance of the memo. This should happen for both federal facilities and non-federal facilities that use federal funding. Documentation of these activities should be submitted by October 15.
- Interagency reviews of federal practices and protocols in biosecurity will run in parallel with a non-federal review (presumably the one initiated by the Department of Health and Human Services described on the bottom of page 3.
More information should be available as the reviews called for in the memo take shape.
In March the U.S. Patent and Trademark Office (USPTO) released a guidance memo on patents involving natural processes, natural products, or laws of nature. This is the second such memo USPTO has issued connected to the Myriad and Mayo cases. Those decisions dealt with medical tests (genetic in the case of Myriad and diagnostic in the case of Mayo) and whether or not the work done with various natural products and processes was sufficient to warrant patent protection. The USPTO requested comments on the guidance memo, which were due by July 31.
Reaction to the guidance memo suggests many feel the memo goes much further than the Supreme Court intended with respect to its decisions. To wit, the USPTO guidance would apply to patents involving natural processes, natural products or laws of nature outside of the genetic and medical testing contexts of the Myriad and Mayo cases. This inference is made from the examples cited in the guidance, which include derivatives of natural products. The Supreme Court has not ruled on such patents, and some comments argue that absent Supreme Court rulings on that subject matter, the USPTO should not provide guidance to its examiners that would constrain patent activity.
However, USPTO has recently taken more active measures in terms of evaluating what can be patented. In the amicus brief (highlights by The New York Times) USPTO filed in the Myriad case the agency argued for distinguishing between products that were merely isolated from natural processes, natural products or rules of nature and those products that represented additional work. than mere isolation. It may see this guidance as an extension of that approach in areas outside of genetic tests.
Again, I am not a lawyer. Readers who are should feel free to complain in the comments.
It’s too soon after the close of the comment period to know exactly what USPTO might do in response to the comments. It’s conceivable that parties opposed to the current guidance may take the office to court should any revisions are not to their liking.
The next meeting of the Presidential Commission for the Study of Biomedical Issues is in Washington on next Wednesday, August 20. The agenda is now available, and the meeting will be webcast via a link on the meetings page of the website.
The focus of this one day meeting is on neuroscience. Panels will focus on cognitive enhancements, direct-to-consumer neurotechnology and neuroscience research. As I speculated in May, these topics are part of the second volume of the Commission’s report on the brain. Perhaps the Commission will hint at when Volume 2 will be ready (I’d guess by the end of the year.)
Public comments will be accepted before the meeting. Email the commission at info at bioethics dot gov.
Last week The Wall Street Journal reported on a new project from Google.org – the Baseline Study (H/T ScienceInsider). Starting with a pilot group of 175, the study would collect anonymous genetic and molecular information (according to the article) to construct a more comprehensive data-based model of what a human is. Such a picture would ideally help researchers better identify symptoms and causes of various diseases. A desired outcome would be the ability to find markers of various diseases much earlier in people than is currently possible.
Of course, such a long-term study is not new. What would be different here is the potential scope of the project, should it expand beyond the initial population of 175. The project is lead by Dr. Andrew Cohen, a molecular biologist whose previous major achievement has been in high-volume HIV tests of blood plasma. Working in volume is something he’s comfortable with. The project is mindful of the need to preserve anonymity, and has stated information will be used strictly for health and medical purposes and not shared with insurance companies. Institutional review boards will be involved with the study, and once it grows beyond the initial group of 175, boards at the medical schools at Duke and Stanford Universities will be involved in controlling access and use of the information.
For reasons that escape me, I can find little mention of the project on the Google.org website. Even the mentions found on Google + don’t connect to the organization. It would seem to me that the Wall Street Journal article, and the subsequent press on it, could be part of an effort to gauge public interest and concerns with the project. The lack of details (the articles have little more to go on than the information provided to The Wall Street Journal) are frustrating.
And then there’s 23andMe. Continue reading
The National Institutes of Health (NIH) will stop requiring special review of gene therapy trials (H/T ScienceInsider) currently conducted by the Recombinant DNA Advisory Committee (RAC). NIH Director Francis Collins justified the decision, which is based on recommendations from a study it requested of the Institute of Medicine, by noting the progress in the field since the formation of the RAC over 40 years ago, as well as the additional regulatory reviews in place for this kind of research. The RAC would remain to review special kinds of gene therapy trials, provided they meet the following requirements:
- The protocol review could not be adequately performed by other regulatory and oversight processes (for example, the institutional review boards, institutional biosafety committees, and the FDA).
- One or more of the following criteria are satisfied:
- Protocol uses a new vector, genetic material, or delivery method that represents a first-in-human experience, thus representing unknown risk.
- Protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value.
- Proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for local and federal regulatory bodies to evaluate the protocol rigorously.
I understand the idea that the RAC likely conducts a certain amount of review that is redundant. Given the challenges facing other bodies with NIH-relevant ethics responsibilities, I would certainly understand if anyone took pause in response to the decision. Especially since the NIH has yet to decide whether to follow another IOM recommendation – to replace the RAC with another body focused on gene therapy and other kinds of risky research.
The Presidential Commission for the Study of Bioethical Issues has a lot to say about the BRAIN Initiative. So much that the Commission report will take at least two volumes. The Commission released Volume One of Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society today. It’s the seventh report of the Commission since it was formed in late 2009.
The report was prompted by a request from President Obama to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.” The recommendations in Volume One of the report are focused on achieving a more explicit integration of ethics into neuroscience research throughout the life of a research program. There are four main recommendations:
- Integrate ethics early and explicitly throughout research
- Evaluate existing and innovative approaches to ethics integration
- Integrate ethics and science through education at all levels
- Explicitly include ethical perspectives on advisory and review bodies
Of specific application to the BRAIN Initiative is the need to include professionals with expertise in ethics in advisory boards and similar entities conducting research in this area.
Volume Two will focus more on the social and ethical implications of neuroscience research, topics likely to appear on the agenda of the Commission’s next meeting. As a hint of what may be in that report, the Commission notes four examples that demonstrate the need to better integrate ethics throughout the course of neuroscience research:
- Neuroimaging and brain privacy;
- Dementia, personality, and changed preferences;
- Cognitive enhancement and justice; and
- Deep brain stimulation research and the ethically difficult history of psychosurgery.
The Commission did not give a deadline for when Volume 2 would be ready, but it may provide some insight on that front during the June meeting in Atlanta.
Continuing from its last meeting (in February 2014), the Presidential Commission for the Study of Bioethical Issues will continue working on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative in its June 9-10 meeting in Atlanta, Georgia. An agenda is still forthcoming, but the Federal Register notice confirms that the Commission will have BRAIN as the main focus of the meeting, also covering relevant work in neuroscience. The event will be webcast, so check the Commission’s website on June 9 and 10 for the relevant link.
I speculated recently that the successful in vivo replication of synthetic DNA with artificial base pairs would attract the Commission’s attention. Without an agenda, it’s harder to be sure, but it seems that this development may have to wait for the next next meeting of the Commission.
In other developments, Commission staff are apparently going to examine some efforts to engage bioethical issues through plays. Continue reading