Zika Is Still An Underfunded Problem

Since the Centers for Disease Control and Prevention (CDC) issued guidance for travel to the Wynwood in Miami affected by mosquito-borne Zika, a total of 43 such cases have been reported in South Florida (compared to more than 3300 travel-related cases of Zika reported across the United States since January 2015) as of this writing.  There have been no other reported mosquito-borne cases in the 50 U.S. states, but there are over 19,000 mosquito-borne cases in U.S. territories (primarily Puerto Rico).

The latest news on the mosquito-borne virus spread in Florida is mixed.  While the Wynwood neighborhood is no longer considered an area of active virus transmission (it was active from roughly June 15-September 18), Miami Beach is still active (and has been since about July 14).  To be extra cautious, CDC is encouraging those who are pregnant or are partners of pregnant women to avoid unnecessary travel to Miami-Dade County.  Those who may have been exposed to the virus should avoid sex for a minimum of 8 weeks to minimize the chances of either transmitting the disease or increasing the chances of birth defects for any pregnancy following exposure.

Meanwhile, Congress has done little more than posture over passing a funding package for combating the virus.  With the fiscal year officially closing on Friday, any continuing resolution (CR) that is passed (the most likely way the government will stay funded on October 1) would need Zika funding added in order for it to be effective.  I am not optimistic.  The Department of Health and Human Services has done what it can to move money around within existing appropriations, but a CR without Zika language would not provide much relief, as the Department can likely do little more than continuing to cannibalize research on other diseases and viruses.  Regrettably, it seems that with most affected Americans also lacking direct representation in Congress, that Zika will remain something that can be ignored and delayed due to lack of concentrated legislative effort.

Cancer Moonshot Experts Submit Recommendations

Today the Cancer Moonshot Blue Ribbon Panel submitted its report to the National Cancer Advisory Board (H/T The Guardian).  Appointed in April, the panel was tasked with providing recommendations on how to best advance the broad goals of the Cancer Moonshot, which is focused on improving detection, treatment and prevention of cancer.  Specifically, the Moonshot is focused on better using the existing resources of public and private entities involved in cancer research and treatment to make it accelerate advances against the various forms of the disease.

The panel divided the topic into seven broad topics, and there are recommendations in the report from each area.  They are:

  • Clinical Trials
  • Enhanced Data Sharing
  • Cancer Immunology
  • Implementation Science
  • Pediatric Cancer
  • Precision Prevention and Early Detection
  • Tumor Evolution and Progression

Where practical, some recommendations were merged into the final draft.  A common theme in many of the recommendations was the sharing of information and the increasing of communication between parties that aren’t currently doing so.  Another common theme was the development of promising research resources as well as specific therapies and/or technologies.  The recommendations (consult the report for additional details) are:

  • Network for Direct Patient Engagement
  • Cancer Immnotherapy Clinical Trials Network
  • Therapeutic Target Identification to Overcome Drug Resistance
  • A National Cancer Data Ecosystem for Sharing and Analysis
  • Fusion Oncoproteins in Childhood Cancers
  • Symptom Management Research
  • Prevention and Early Detection: Implementation of Evidence-Based Approaches
  • Retrospective Analysis of Biospecimens from Patients Treated with Standard of Care
  • Generation of Human Tumor Atlases
  • Development of New Enabling Cancer Technologies
The panel also identified some policy issues that will pose challenges to implementing the recommendations.  The issues aren’t part of their report, but they have been forwarded to the Vice President’s task force and other relevant entities.  Those policy issues aren’t discussed in detail in the report (you can find some discussion of them in the recommendations), but are:
  • Coverage and reimbursement
  • Privacy and consent with regard to patient data
  • Fragmentation of the delivery of patient care in the community
  • The need to improve the clinical trials system
  • Incentives to encourage pediatric drug development
  • New federal research funding models
  • Barriers to data sharing
Critical to all of these issues and recommendations is funding for the Cancer Moonshot.  But that may not come.  As ScienceInsider reports, neither the House nor the Senate appropriations legislation contains anything resembling the $680 million requested by the Obama Administration to support the Moonshot.  Depending on how this year’s kabuki theater/budget brinksmanship unfolds, there may be a new President by the time Congress has fully funded the government for the 2017 Fiscal Year (which starts this October 1).
While developed by cancer experts, the recommendations are presented in a way that should be accessible for all audiences, even the lay public that does not have direct or indirect (through family or friends) experience with the disease.  I’d encourage other report-generating bodies to copy that style when practical for their own work.
The National Cancer Institute has more material on the report and the panel at its website, including videos for each of the recommendations.

USPTO Opens Patent Data For Cancer Purposes

Yesterday the U.S. Patent and Trademark Office (USPTO) announced a Cancer Moonshot Challenge.  It runs from now until 5 p.m. Eastern on September 12.

The Challenge involves using a curated data set of nearly 270,000 patent documents going back to 1976.  The goal is to analyze, sift and visualize this data to see what insights might be there to speed up progress on cancer cures.  Entrants will develop a visualization to represent these insights, along with a story (1,000 words or less) that supports the visualization and access to the visualization for testing purposes.

Submissions will be judged on five criteria (each weighted equally):

  • Creativity and Innovation – how unique is the approach to the issue and/or the issue itself
  • Evidence Base and Effectiveness – the strength of the evidence and the impact the story has on cancer R&D and/or the public policy process
  • Value to Public – how much value is provided to policymakers and stakeholder communities
  • Usability – visualization should encourage engagement by policymakers and the public
  • Functional Product – visualization should be interactive and function as described

Non-Travel Zika Emergence In Florida Likely To Increase Your Cynicism

Yesterday the Florida Department of Health announced that there was a high likelihood that four cases of the Zika virus in the Miami-Dade County area were due to local transmission.  This marks the first time that non-travel related cases were found in the continental United States.  There are currently just under 400 cases of Zika confirmed in the state that are travel-related (contracted due to travel in areas outside of the continental United States).  The Health Department will continue to update its Zika virus information each weekday at 2 p.m. Eastern time.

At this time the area of transmission is quite small – roughly one square mile.  However, two of the infected individuals live in neighboring Broward County.  The Department has instituted a serious canvass effort in the transmission area to determine if there are additional cases that have not caught the attention of medical personnel (which was the situation for the four cases reported to date).  As the mosquito bites that transmitted the virus took place in early July, additional cases seem likely.  However, the Centers for Disease Control and Prevention (CDC) does not anticipate widespread transmission at the present time.

As of July 27, there were 1,658 cases of Zika in the continental United States and Hawaii, all of which were travel related (thought some cases were spread via sex or in one case, a laboratory accident).  However, the situation in Puerto Rico is serious, with over 5,500 cases in the commonwealth as of July 7.  The CDC has been working with Puerto Rican health agencies for months, but its impact has been limited.

As Congress is not in session (and won’t be until September), the anemic federal response (mainly redirecting unspent money for the Ebola virus) will continue.  Members of Congress from Florida have been diligent in advocating for funding, and the Obama Administration had provided $8 million before the President informed Governor Scott that another $5.6 million was on the way.  It’s a lot less than what share Florida would receive under the various Zika aid packages that Congress tried and failed to pass earlier this year.

That said, I would expect the newly reported cases would spur some action, even if it’s only campaign rhetoric in connection with the upcoming elections.  Florida is once again expected to be a major battleground in the presidential race, and it would not surprise me to see one or both of the major party candidates to try and wring some advantage from the situation.  Whether it will be well informed remains to be seen, but the campaign to date leaves me skeptical.

The change in action following the Florida cases, however slight, will also point out the dramatic difference in attention that our outlying territories receive compared to the states.  Congressional representation matters, especially in situations like this.

What About The Privately Owned Research Chimps?

In 2015 The National Institutes of Health ended its support for invasive research on chimpanzees, continuing the retirement of federally owned research chimpanzees it started in 2013.  In 2015 the Fish and Wildlife Service reclassified research chimpanzees as endangered, further restricting chimpanzee research under a permitting system.

The research chimpanzees retired by the NIH (a process that has not gone well) have been guaranteed spots in a Louisiana sanctuary.  Research chimpanzees not held by the government do not have such a guarantee, but a reserve in Georgia has been redeveloped to fill that need.  It’s not the only option for those 300 or so chimps that need a home.  They could retire in place, or be transferred to other research centers or zoos.

Project Chimps spearheaded the effort, which should help address this need.  The sanctuary has taken its first group of chimps, and expects to host over 250 animals.

Congressional Inaction Doesn’t Stop FDA, NIAID And CDC From Dealing With Zika

Congress managed once again to do nothing when something was necessary, this time with a funding bill to deal with the Zika virus.  The executive branch, however, does not have the luxury of inaction, especially with a lack of resources.  And once Congress returns, the combination of a chronically broken appropriations process and the November elections makes it nearly certain that instead of a new budget there will be a continuing resolution.  Such a resolution would continue spending at the prior year’s levels, which typically means new proposals like Zika funding are shut out.

The Food and Drug Administration (FDA), the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC) have been active in the vacuum of Congressional leadership.  The FDA has taken steps on protecting the blood supply, supporting potential diagnostic tests, dealing with potential Zika-related fraudulent devices and addressing the mosquitoes that carry the virus.  But as of this writing there are no FDA-approved diagnostic tests, vaccines or treatments in the advanced stages of development.

The CDC has been active in developing resources for state and local health agencies, as well as various stakeholders.  They are assisting the Utah Department of Health in a case of virus transmission, and may assist other states as the number of U.S. cases grows.  The NIAID has been active in researching the virus since before the current outbreak, but started expanding that work in the beginning of 2016.

However, without additional resources (using Ebola funds that have not yet been spent could be counterproductive), the impact of this work will be necessarily limited.  With almost 800 pregnant women with Zika in the United States, perhaps the microcephaly associated with Zika births will motivate Congressional action.  But I’m not optimistic.

 

 

PCAST Breaks Pattern By Meeting On A Wednesday

Today the President’s Council of Advisers on Science and Technology (PCAST) met in Washington, D.C., breaking its usual pattern of meeting on Fridays.  As is customary, a webcast is available.

The public agenda was focused primarily on ongoing projects, with presentations on studies PCAST is conducting on forensics and biological defense.  PCAST also heard from members of the National Academies Committee on Accessible and Affordable Health Care for Adults.  PCAST issued a letter report on innovation in hearing technologies in late 2015, and the Academies released its report last month.  As you might expect, the Academies’ report is longer, with more detailed research and recommendations than the PCAST letter report.

For once, there was some detail about the private session that PCAST (likely) held with the President.  Per the Federal Register, PCAST was to meet with the President for an hour to discuss a report on “Action Needed to Protect Against Biological Attack.”  The meeting was to be held in a secure location and the contents of that report may not be made public due to national defense or security interests.  (Pardon the verb tense, as I’m not sure whether the scheduled meeting took place, and may never know given the security concerns.)

The next meeting of PCAST is likely in September.  And yes, you may have noticed that I haven’t posted about the May meeting of PCAST.  I will rectify that shortly.