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.

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.

Montreal Neurological Institute Goes Full Open Science

The Montreal Neurological Institute (MNI) at McGill University announced that it will be the first academic research institute to become what it calls ‘Open Science.’  As Science is reporting, the MNI will make available all research results and research data at the time of publication.  Additionally it will not seek patents on any of the discoveries made on research at the Institute.

While some universities have established open access repositories for research results, the declaration that the MNI will not seek patents makes its version of open science as closer to a government model.  I’m sure some university technology transfer departments might blanch at the notion, as making a research institute’s output and intellectual property available for free and without expectation of financial return seems contrary to at least American research and development policy from the last few decades.  Perhaps the current state of neurological research, where technology developed for a mass market is still some time away, makes the choice to forego patents easier.

But this kind of open access seems a natural evolution of the perspective taken by some units within the MNI.  This release from the Brain Imaging Centre at McGill suggests that data sharing and open source software projects have been part of the university’s mission.

The new policy reflects an institutional perspective, individual participation is voluntary, and those researchers can still pursue patents.  They simply can’t benefit from university support in navigating that process.

Will this catch on?  I have no idea if this particular combination of open access research data and results with no patents will spread to other university research institutes.  But I do believe that those elements will continue to spread.  More universities and federal agencies are pursuing open access options for research they support.  Elon Musk has opted to not pursue patent litigation for any of Tesla Motors’ patents, and has not pursued patents for SpaceX technology (though it has pursued litigation over patents in rocket technology).  Perhaps more institutes will try and combine these choices, and it will be interesting to see how they do.

Well, That Didn’t Take Long

A day after the World Health Organization declared Liberia free from the Ebola virus, it confirmed that a new case has emerged in Sierra Leone. That country was still under a period of enhanced surveillance following the November 7 declaration that it was free of disease transmission.  What follows now is tracking of the new case and the contacts with that person to determine the lines of transmission and identify other possible infected people.

Hopefully what comes next is that the patient is successfully treated and any who came in contact either test negative or are effectively treated.  Flare ups are likely to happen again in each of the affected countries, but hopefully transmission can be limited, if not eliminated.

Just Because It’s No Longer An Epidemic

Today the World Health Organization (WHO) declared the Ebola outbreak over in Liberia.  This means that it has been 42 days since the last known Ebola patient in the country had tested negative for the disease twice.

This means that there are currently no new cases in each of the three countries hardest hit by the outbreak – Liberia, Guinea and Sierra Leone.  However, this does not necessarily mean an end to the disease in the region.  Since cases were first disclosed in March 2014, there have been several flare-ups of the disease.  Today’s announcement is not the first time Liberia was declared free of the disease, and it’s possible that future flare-ups could happen.

That is why, even though each of the most affected countries have been declared free of the disease, they are each in a 90-day period of heightened surveillance.  The first one of those will end early next month.

President Obama referenced the Ebola epidemic in his State of the Union address this week, but the U.S. involvement was known much, much more for fear and hysteria over less than a handful of cases in the country than any significant impact on the progress of the disease.  The ‘czar’ appointed by the President to coordinate the U.S. response left the job nearly a year ago and he focused primarily on the domestic cases.

While the disease may be stopped in West Africa, the damage remains.  Three countries have been decimated, with more than 28,000 infected and over 11,000 dead.  Then there is the impact on the countries’ health systems and infrastructure.  Should there be another outbreak in these countries before they have had time to recover, they may be more affected.

China Looking At Possibility Of Its Own Precision Medicine Initiative

Nature is reporting that the Chinese government is giving serious attention to conducting its own version of the U.S. Precision Medicine Initiative.  Details are thin, and second-hand, at least until any formal announcements from the government, which are anticipated in March.

What I think is valuable to consider from the Nature piece are the differences expected between the two programs.  Funding levels are expected to be larger for the Chinese program, and the million person cohort planned in the U.S. program will be done by a single institute in China.  So the ambition is there.

The Nature article notes that one possible challenge is the lack of enough medical personnel to effectively implement some of the planned projects.  Between a high demand for patient visits and a relative lack of specialization, it’s possible there might not be enough people to do the work in the way it needs to be done.

It raises a larger question about China’s research enterprise in general.  While its numbers are often cited in this country to try and stoke competitive fires, the quality of that research output may make such comparisons problematic.  That is, can a random selection of 100 Chinese researchers be as effective in their work as a selection of 100 American researchers.  I don’t know, but the challenges the Chinese system faces with fraud, combined with a lack of sufficient specialists, may mean that its investment in a precision medicine initiative may not go as far as they (or we) think.

Scientists Under Investigation In Italian Xylella Outbreak

Scientific American has reported that a formal investigation is underway concerning nine scientists and one public official concerning an outbreak of Xylella fastidiosa in and around Puglia, Italy.  The outbreak (first noted in 2013) has affected olive trees in the area, and efforts to contain the outbreak have prompted both protests from activists and investigation from the European Union.

The case involving Italian seismologists and the L’Aquila earthquake of 2009 was long and complicated, so I already expected that the investigation into these scientists – suspected of introducing and/or allowing the spread of the Xylella strain – would be a challenge to follow.  Now that the EU is involved, I think a long, complicated legal case is assured.

The scientists are under suspicion for introducing the strain because of a 2010 training course where a strain of Xylella was used.  That claim is being refuted because the strain considered the cause of the outbreak is distinct from the Californian variety used at the course.

Some of the criticism is prompted in part due to the measures the scientists are calling for in order to combat the strain.  Several parties object to the destruction of trees (many of them quite old) and the use of pesticides in the area.  The prosecutors in the case have called for a halt to such measures when they announced the formal investigation.  Aside from placing the scientists under suspicion of causing the outbreak (either intentionally or through neglect), it has been contended that the actual cause of the outbreak is not the Xylella, but a fungus.

The European Union is involved because of concerns over the possible spread of the pathogen to other countries.  As part of EU rules, Italy is obligated to develop and implement a containment plan.  However, some of the measures have been blocked by the courts, and it is possible that the contentions against the scientists are another means of fighting against the EU rules.

I am concerned that the length of any Italian court proceeding may make it difficult to effectively address the outbreak.  With the final appeals of the L’Aquila case stretching things out to at least six years following the 2009 quake, there may be at least another three years before the Italian courts adjudicate the matter (regardless of how the EU enforcement and judicial mechanisms may act).  Perhaps the outbreak can be contained in time, but it’s tough to see this case as helping.