Public Sessions Announced For Input On Revising Biotechnology Product Regulations

In the summer of 2015 the Obama Administration announced a process to update the regulatory system for biotechnology products.  After a request for information a series of public consultation events started with an October meeting in Washington, D.C.  It marks the first major update to the process since 1992.  It is the first of three public sessions planned.

Earlier this week the dates and locations for the other two sessions were announced.  One will take place on March 9 at the Environmental Protection Agency’s (EPA) Region 6 office in Dallas, and the other will take place on March 30 at the University of California in Davis.  The specific details for how to participate will be available in the Federal Register soon, but I suspect that the process used at the October 2015 meeting will be instructive.  You will likely have the opportunity to submit comments for up to two weeks following the meeting, whether or not you can attend.

Part of the process involves how best to clarify the roles and responsibilities of the EPA, the Food and Drug Administration (FDA), and the Department of Agriculture (USDA) in the regulation of biotechnology products.  While this is a bit of an oversimplification, at present the EPA is involved with regulating these products as they relate to pesticides and applications of microbial technology.  The USDA is interested in these regulations from the perspective of impacts on plant and animal health, and the FDA is concerned with genetically engineered foods, animals and other products under its domain derived from genetically engineered sources.

Following the three meetings and the associated public comment periods, the agencies will work on an update of their common regulatory framework.  That update will also be subject to public review and comment.  The timeframes for each of these steps will eventually be published in the Federal Register, most likely by the Office of Science and Technology Policy.

Governments Step Up On Earthquake Resilience

On February 2 the Obama Administration hosted an Earthquake Resilience Summit and announced several actions intended to improve the nation’s response to earthquakes.  Per a 2015 assessment by the U.S. Geological Survey (USGS), over 140 million Americans are currently exposed to potentially damaging earthquakes.  This is nearly double the estimate in 2006, and reflects both population growth in earthquake-prone regions and improvements in earthquake science.

The Summit was an opportunity to announce a number of federal, state and local initiatives to increase earthquake preparedness.  They include developments in creating a federal standard for earthquake resilience and the beta testing phase of a west coast earthquake early warning test system (ShakeAlert).  The announced projects included support from private organizations and utility companies.

From my perspective in a non-earthquake prone portion of the country, I think the most visible aspect of these efforts will be the integrated west coast earthquake warning system.  The warning is for the heavy shaking, based on early detection of fast-moving, low-damage waves that precede the big shakes.  While it will provide just seconds of warning, it would allow for preparations (like stopping trains and other mass transportation systems) that could seriously mitigate property damage and loss of life.  There’s a lot of work ahead to extend and refine this system, and I hope that it can get the attention it needs through this summit to get the resources it needs to be effective.

Cancer ‘Moonshot’ Task Force Holds First Meeting

While I’m on record about having problems with the rhetoric of moonshots, I am encouraged by other aspects of the cancer initiative pushed by Vice President Biden mentioned in the 2016 State of The Union address (though started last year).  On Monday the Task Force for the effort held its first meeting, just days after the White House circulated this memo concerning the Task Force.

Chaired by the Vice President, the task force is big and composed of top level executive branch and White House officials.  Members include heads of the Departments of Defense, Commerce, Health and Human Services, Energy and Veterans Affairs.  Members also include heads of the Office of Management and Budget, the Office of Science and Technology Policy, the National Economic Council, the Domestic Policy Council, the Food and Drug Administration, the National Cancer Institute, the National Institutes of Health, and the National Science Foundation.  The National Cancer Board is not represented in the Task Force, but is named as one of the many experts the Task Force could

Perhaps the number of different agencies involved demonstrates the breadth of cancer research across the federal government and underlies the challenges in coordinating those efforts.

The Task Force must act quickly.  Per the memorandum, it has until December 31 of this year to conduct its review of existing cancer research, therapy and treatments and provide its recommendations.  They will cover, at a minimum, how to:

  • Accelerate our understanding of cancer, and its prevention, early detection, treatment, and cure;
  • Improve patient access and care;
  • Support greater access to new research, data, and computational capabilities;
  • Encourage development of cancer treatments;
  • Identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms;
  • Ensure optimal investment of Federal resources; and
  • Identify opportunities to develop public-private partnerships and increase coordination of the Federal Government’s efforts with the private sector, as appropriate.

This does appear to be a long list, but keep in mind that the Vice President was inquiring about this effort at least as early as last fall, and the focus of the project – all moonshot notions to the contrary – is to focus on changes that can be done relatively easily.

The Task Force meeting was paired with another White House announcement – of increased federal money for the effort.  The initiative will have $195 million of the fiscal year 2016 National Institutes of Health (NIH) allotment, and $755 million of dedicated cancer money in the fiscal year 2017 budget from the NIH and the Food and Drug Administration.  With additional investments from the Defense and Veterans’ Affairs Departments the total investment will top $1 billion over two years.

And while that is a large amount, the expense of biomedical research highlights how much this project isn’t really a moonshot.  The money is going to support increased access and availability at least as much as it will boost new research and treatments.  The goal is to make finding the cure(s) easier, not to find those cures.  And by the time people become disappointed that this project didn’t really get to the ‘moon’ everyone directly involved will be out of office.

New European Commission Scientific Advice Mechanism Meets

Today the High Level Group of the newly constituted Scientific Advice Mechanism (SAM) of the European Union held its first meeting.  The seven members of the group met with Commissioner for Research, Science and Innovation Carlos Moedas and Andrus Ansip, the Commission’s Vice-President with responsibility for the Digital Single Market (a Commission initiative focused on making a Europe-wide digital market and improving support and infrastructure for digital networks and services).

The High Level Group selected officers and determined subjects for its first advice to the Commission.  The chair is Professor Henrik C. Wegener, Executive Vice-President and Chief Academic Officer of the Technical University of Denmark.  Professor Elvira Fortunato, Professor of Materials Science, New University of Lisbon, was selected as deputy chair of SAM.  At the request of Commissioner Moedas and Vice-President Ansip, the Group will focus on cybersecurity (linked to the Digital Single Market) and vehicle emissions of carbon dioxide.

Minutes and background documents are supposed to be made available on the SAM website, so check that link in a week or so.  They may provide information on when the advice on those topics is expected and when the next meeting of the High Level Group will take place.

Is The Vice President’s Cancer ‘Moon Shot’ Really A Moon Shot?

As part of President Obama’s State of the Union address this year, he placed Vice President Biden in charge of an effort to boost the ongoing war on cancer.  From the prepared remarks:

“Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources that they’ve had in over a decade. So tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us on so many issues over the past 40 years, I’m putting Joe in charge of Mission Control.”

So, press reports to the contrary, this ‘moon shot’ isn’t really new to the President’s remarks  The Vice President first announced his intentions last October.  And as with most things in a State of the Union, the details are found elsewhere.  Vice President Biden describes the plan in this Medium post.  The large goal is to achieve a decade’s work of advances in half the time.  To that end the Vice President is going to increase resources for cancer research and make it easier for researchers and others in the fight against cancer to share information and communicate.

I’ve expressed my disdain for the rhetoric of the moon shot before and nothing has changed for me since then.  What the Vice President wants to do make sense.  Boosting resources can help, but making it easier to use those resources and to make it easier for thousands of disparate researchers share progress and information helps stretch those resources even further.

But the details don’t mesh well with the concrete goal and timeframe of the Apollo project.  The original declaration of the ‘war on cancer’ in President Nixon’s 1971 State of the Union was closer in rhetoric to Apollo, but not as specific in its goals.

And, bottom line, while rocket science is complicated, ending just one kind of cancer is at least as hard.  And I think the history of the actual moonshot downplays that complexity.  So no, the Vice President’s ‘moon shot’ isn’t really one.  It’s another example of the politics of a program not matching the policy goals.  Aside from my cognitive dissonance over this mismatch, I just don’t know if it helps to invoke this rhetoric.  The Vice President was already working on this effort, and the vast majority of the researchers involved know how complex the endeavor is.  Why simplify it for the masses?  I don’t think it’s necessary, but I suppose it helps make a better speech.

Defense Department Calls On American Psychological Association To Reconsider Ban

The New York Times is reporting that a Pentagon official has requested that the American Psychological Association (APA) reconsider its blanket prohibition on having its members participate in what it calls ‘national security interrogations’ at facilities like Guantanamo Bay in Cuba.  The ban is a result of an investigation into APA conduct that concluded that APA officials colluded with the Defense Department on torture techniques used by the U.S.  (See this timeline of APA activities related to this report.)

The ban was overwhelming approved (157-1) by the Association’s Council of Representatives in August 2015, but it has yet to be incorporated into the APA Code of Ethics.  There have been rebuttals to the independent report that focus on the Defense Department putting into place policies and procedures intended to prevent future abuses involving detainees.  They do not directly address the matter of APA collusion with the Department.

At the moment, the APA policy is only permitting member psychologists to work at Defense Department facilities in caring for military members and their families, for a third party protecting human rights, or directly for any detainees.

In the letter, Acting Principal Deputy Secretary of Defense for Personnel and Readiness Brad Carson argues against the ban for a number of reasons, and would like the opportunity to discuss revising the prohibition in order to minimize the licensing uncertainty that current exists for military psychologists and those providing psychological care to detainees.  That concern explains a lot of the language in the letter seeking clarification about what is a matter of policy and what is a matter of ethical conduct.

(Should the blanket prohibition be incorporated into the APA’s Code of Ethics, a document that influences the state licensure of psychologists, members participating in national security interrogations face the possibility of having their licenses revoked.)

Carson further argues that current Defense Department policy is consistent with the intent of the APA resolution to do no harm.  He suggests that APA guidelines need to be consistent on this point, focused on the well-being of the patient and not on courtroom evidence rules.  My interpretation is that Carson’s preferred perspective would make meaningless the APA policy, which allows for work with law enforcement due to the implicit Miranda and other Constitutional protections.

The APA policy specifically forbids participation at Guantanamo Bay except to provide care for military personnel.  It cites United Nations reports related to activities at Guantanamo to support it stance.  Surprising possibly nobody, the Defense Department notes that it is acting consistent with U.S. law and Supreme Court decisions, which disagree with the U.N. reports.

And I think here is where there might be the biggest pushback from the Association.  Part of the effort to revise policy was to demonstrate support of U.N. guidance on the humane treatment of detainees.  While members may be willing to find appropriate grounds to maintain ethical standards of detainee patient care, they may be unwilling to be seen as supporting policies inconsistent with U.N. guidance.

Throughout the letter, Carson seeks to distinguish between policy preferences and ethical standards.  But I think some members of the association will indicate that their ethical standards should dictate policy preferences.  Further stung by the impact of the collusion described in the independent report, enough APA members may be willing to stand firm on compliance with U.N. policy, and see the threat to detainee patient care as motivation for the Department of Defense to change its policies.

The fight, if there is one, will have two components.  Discussions between the APA and the Defense Department will take place, but changes in APA policy will be conducted through the membership (which has a section of military psychologists).  As it has taken the APA years to get to this point, a final resolution likely will not be quick.

One Chief Scientist Hands Off To Another

Professor Ian Chubb is a neuroscientist, and until January 22, the Chief Scientist of Australia, a position he assumed in May of 2011.  He came to the position from a long career as a researcher and university administrator.  While the Australian executive branch recently went for a few months without a science minister, the Chief Scientist position has been a part of the Australian government for a few decades.

One of his achievements in office has been developing recommendations for a national strategy for science, technology, engineering and mathematics (STEM).  His successor, Doctor Alan Finkel, will be Chief Scientist as the Turnbull government seeks to implement such a strategy, something Australia has lacked.

Finkel will come to the office with training as an engineer and a neuroscientist.  He has also founded a scientific instruments company and is just ended several years of service as Chancellor of Monash University (located in Melbourne).  He has been outspoken about climate change and the need for more nuclear power.  Whether or not these positions will lead to conflict with the Turnbull government remains to be seen.  According to this Sydney Morning Herald article most of the search process was conducted prior to Prime Minister Turnbull assuming office.  While Turnbull may be sympathetic to Finkel’s positions, it is possible that Finkel could chafe at the advisory constraints of the role of Chief Scientist.