Category Archives: Biomedical Research

ZIKA virus funding fails: Partisan Politics 1, Public’s Health 0!

ZIKA virus funding fails: Partisan Politics 1, Public’s Health 0!

 

Bipartisan compromise fails again.  Once again, Republicans and Democrats in the Congress demonstrate that they would rather quibble and argue than act in the best interests of the people they serve.  In February, the White House requested $1.9 billion in emergency funding to combat an emerging Zika virus public health crisis.  In an effort at bipartisan compromise, funding not directly related to the ZIKA crisis was removed from the original Administration request leaving $1.1 billion of new funding for prevention, research, education, health services, international aid, and vaccine development.  This bipartisan compromise measure passed the Senate in May by an 89-8 vote in favor of the compromise.  This week, the House-Senate conference report compromise, which had just passed in the House of Representatives, was rejected by the Senate on a vote of 52-48 in favor of the compromise bill.  However, to pass Senate procedural hurdles, the vote in favor of the compromise bill needed 60 or more votes, so fell 8 votes short.

This 52-48 vote in favor of the compromise bill still fails to achieve the required Senate threshold. However, this does not necessarily mean the bill is totally dead.  The bill could come up for another vote when the Senate returns after the July 4 holiday break.  However, is there reason for optimism?  If the bill succeeds, then additional compromise will almost certainly be required—so will either party “compromise” to achieve a vote in favor of the public’s health.  If the bill fails again, then there will not be adequate funding for Zika research or infection prevention and no extra funds for mosquito eradication as we enter the mosquito season, especially in the deep South.  Funds from unused Ebola appropriations, and some unused ACA appropriations funds, could be allocated to Zika eradication and research—approximately $622 million, or about half that contained in the current bill and about a third of the original Administration request.

In any piece of legislation, there are always numerous points of disagreement. This is just one reason that bipartisan cooperation is always so important, institutionalizing the never-ending need for compromise.  Two of the issues that upset Democrats about the bill include some so-called “poison pills” in the current legislation. For example, the bill from the House of Representatives directs funds through hospitals and public health clinics, but excludes women’s health clinics like Planned Parenthood.  This is a “hot-button” issue for the Democrats who argue that those at greatest risk for serious adverse effects from Zika infection are the children of pregnant women!  So how can any bill exclude women’s health clinics from the funding stream?  But the Republicans have an intense disdain for that organization, Planned Parenthood.  Another point of difference is that part of the bill waves the EPA permitting process for use of certain pesticides for a 180 day period for emergency mosquito eradication.  Democrats argue that this component of the bill weakens the clean water and air protections.  But the Democrats have an intense disdain for any restrictions placed on the EPA.

Of course, there are other issues of mutual disagreement. The only matter that seems to be in short supply is a desire to compromise, with both parties getting some of what they want but not all they demand. So can our long serving, experienced, intelligent and clever, political leaders sublimate their political priorities to forge a compromise solution that serves the public good?  Stay tuned!  We should know the answer to this question within the next 30 days.

21st Century Cures Act

HR 6, the 21st Century Cures Act:  Renewed optimism for patients and researchers.

What is this 21st Century Cures Act?

This new bill in the House of Representatives is in the early stages of the legislative process. However, it has gone through more than a yearlong developmental process.  The latest version of the bill has been reduced to 199 pages.  Importantly, the Energy and Commerce Committee approved the bill unanimously on May 21 by a vote of 51-0, with obvious and enthusiastic bipartisan support!  When the bill came up for consideration before the entire House, the vote remained overwhelmingly bipartisan—members who voted in favor 344, against 77, abstain 12.

What is the Congress proposing in this new bill?

The current iteration of the bill has three main components: Discovery, Development, and Delivery.

Title 1 focuses on “Discovery”.

The 21st Century Cures Act has several goals that should energize academic physicians and scientists.  The bill proposes to re-invest in discovery research by increasing the NIH budget—currently $30.3 billion.  The committee proposes to increase the NIH budget to $31.8 billion in 2016; $33.3 billion in 2017; and $34.8 billion in 2018.  Importantly, the proposed NIH budget grows predictably over the next 3 years:  total increase is $4.5 billion (nearly 15%).

The 21st Century Cures Act also creates a dedicated innovation fund of an additional $2 billion/year from 2016 through 2020. This represents another $10 billion “to support biomedical research through funding of basic, translational, and clinical research” at the NIH.  This component of the NIH budget allows congressional appropriators to invest additional resources in scientific research without impacting current budget caps (per sequestration).

The 21st Century Cures Act is prescriptive in that it directs the NIH to invest in specified priority areas.  The bill specifies support for innovative research in such areas as biomarkers, precision medicine, infectious diseases, and antibiotics, for example.  In other priority areas, the 21st Century Cures Act directs the NIH to reserve funding specifically for “young emerging scientists”.  This subtitle in the Act includes also specific language regarding improved loan repayment programs.  Furthermore, the bill directs the NIH to create “capstone awards” to support the work of particularly outstanding scientists previously funded by the NIH.

Another priority area in the 21st Century Cures Act includes pediatrics research and directs the NIH to establish a “national pediatrics research network”. The network would be composed of research institutions operating as a consortium in order to pool resources and coordinated activities related to research on rare diseases or birth defects.  The bill also declares a “sense of Congress” that directs the NIH and FDA to work together and with the European Union, industry, and others to establish a “global pediatrics clinical trials network”.

The 21st Century Cures Act identifies other priority areas.  The bill specifies the need for the NIH to engage “in scientifically based strategic planning implemented in support of research priorities”.  This is a recurring requirement to be repeated at 5-year intervals.  In addition, the bill directs the NIH to improve access to clinical trials data by creating and then releasing de-identified clinical trials data sets, from qualified clinical trials, for use by other medical investigators.

These budget issues and priority areas represent some of the key features included in the current version of the 21st Century Cures Act.  Now that the House has acted, what will the Senate choose to do?

For additional information visit: http://energycommerce.house.gov/cures

COMING next: The 21st Century Cures Act, Title 2 “Development”