Showing posts with label National Institutes of Health (NIH). Show all posts
Showing posts with label National Institutes of Health (NIH). Show all posts

Monday, May 23, 2016

Democratic Committee Investigation Finds NFL Improperly Attempted to Influence NIH on Brain Injury Research



FOR IMMEDIATE RELEASE
May 23, 2016


Report Concludes NIH Maintained the Integrity of the Grant Review Process But FNIH Did Not Properly Serve Its Role As Intermediary


Washington, DC – Congressman Frank Pallone, Jr. (NJ-6), the top Democrat on the House Energy and Commerce Committee released a report today concluding that the National Football League (NFL) improperly attempted to influence the grant review process for a National Institutes of Health (NIH) brain injury study that the NFL had agreed to fund as part of a $30 million donation.

Despite the NFL’s attempts to influence the applicant selection process, the report states that the integrity of NIH’s grant review process was preserved. The report also concludes the Foundation for NIH (FNIH), a non-profit charitable organization whose mission it is to direct funding from public and private donors to NIH projects, did not adequately fulfill its role of serving as an intermediary between NIH and the NFL.

The report is the result of an ongoing Democratic Committee staff investigation, which began shortly after ESPN published an article in December 2015 alleging that the NFL had backed out of funding a NIH study due to the League’s objections to the grantee selected by NIH to conduct the study.

“This investigation confirms the NFL inappropriately attempted to use its unrestricted gift as leverage to steer funding away from one of its critics,” Pallone said. “Since its research agreement with NIH was clear that it could not weigh in on the grant selection process, the NFL should never have tried to influence that process.”

“The NFL’s troublesome interactions with NIH fit a longstanding pattern of attempts to influence the scientific understanding of degenerative diseases and sports-related head trauma. The NFL must recognize the importance of this ongoing, impartial research, and live up to its funding commitments to NIH,” Pallone concluded.

The investigation found that:

1. The NFL improperly attempted to influence the grant selection process at NIH.
2. The NFL’s Head, Neck and Spine Committee members played an inappropriate role in attempting to influence the outcome of the grant selection process.
3. The NFL’s rationalization that the Boston University study did not match their request for a longitudinal study is unfounded.
4. FNIH did not adequately fulfill its role of serving as an intermediary between NIH and the NFL.
5. NIH leadership maintained the integrity of the science and the grant review process.
6. The NFL did not carry out its commitment to respect the science and prioritize health and safety.


The Democratic Committee staff offered several recommendations to address the investigation’s findings:

1. FNIH must establish clearer guidelines regarding donor communications with NIH.
2. FNIH must come to a mutual understanding with donors at the beginning of the process regarding their degree of influence over the research they are funding and remind donors that NIH policy prohibits them from exerting influence at any point in the grant decision-making process.
3. FNIH should provide donors with the clear, unambiguous language from the NIH Policy Manual, which states that a donor may not dictate terms that include “any delegation of NIH’s inherently governmental responsibilities or decision-making,” or “participation in peer review or otherwise exert real or potential influence in grant or contract decision-making.”

4. NIH and FNIH should jointly develop a process to address concerns about donors acting improperly.
5. The NFL, FNIH, and NIH should amend their current agreements to ensure that each party has a clear understanding of its role for the remainder of this partnership.


In September 2012, FNIH announced that the NFL had pledged $30 million in support of research on “serious medical conditions prominent in athletes” that are also relevant to the general population. The program involved agreements between NIH, the NFL, and FNIH, which made clear that NIH retained responsibility and control over the scientific aspects of the program, including the review and awarding of scientific grants. Over the course of the following year, NIH moved forward with four research plans funded by the NFL.

In 2014, NIH recommended a fifth study of high-risk adults to characterize Chronic Traumatic Encephalopathy (CTE) in individuals with a history of repetitive head impacts over a three- to five-year period. The study was expected to cost about $17.5 million, with $16.3 million coming from the NFL. The NFL agreed to the plan in July 2014.

In May 2015, after a grant review process, NIH’s National Institute of Neurological Disorders and Stroke (NINDS) determined that Dr. Robert Stern of Boston University, had the highest ranked proposal. The report details an attempt over three months by both the NFL and members of the NFL’s Head, Neck, and Spine Committee to argue that Dr. Stern was biased, and that the grant application process had been tainted by conflicts of interest.

At a September meeting, NIH decided to move forward with the BU proposal. NIH concluded that the CTE study was vitally important to public health and safety, and if necessary, NIH would fund it in its entirety using NINDS funds. Ultimately, NFL did not fund the study.

The Democratic Committee staff’s review included requests for information from NINDS at NIH, FNIH, and the NFL, briefings with staff from NIH, FNIH, and the NFL, as well as a review of relevant documents and communications.


Friday, September 19, 2014

The Fourth Amendment: the Age of Snowden

The following is from Congressman Rush Holt's newsletter

I am not a lawyer or a constitutional scholar; I only play one on C-SPAN. But this week, as we observe Constitution Day, I was pleased to give a talk sharing my thoughts about the Fourth Amendment in the Age of Snowden. The Fourth Amendment was added in 1791 and established the right of the people to be secure in their persons and effects, against unreasonable searches and seizures by the government.

Too often discussions of the Fourth Amendment refer to protection of privacy. Such a discussion misses the
larger significance of protection against unreasonable search and seizure. No person in America should be placed under suspicion, even provisionally, without probable cause. To do so destroys the founding presumption of equality. It is more subtle than profiling people of swarthy complexions at airports, but it is no less pernicious. The technological capability to break down, figuratively, a million computer memory doors does not, or at least should not, make that any more permissible than breaking into a hundred homes without warrants looking for scandalous attacks on the King.

The bulk collection of personal data about Americans surely degrades their privacy, but worse, it says to them, “Your government wants to make sure that you are not in that class of people suspected of doing harm. We’ll get back to you after we are sure.” In today’s society of sharing details of one’s life on social media, arguments of privacy lose saliency. Let us hope the principle of equality does not lose its saliency.

As we commemorate the signing of the document that underpins our representative democracy, I am happy to send you a free, pocket-sized copy of the Constitution. I always carry one. To receive a copy, please request one by clicking here.

ISIS in Iraq and Syria

This week, Congress approved an amendment that authorizes aid to “moderate” Syrian rebels. The idea of arming the Syrian opposition has been discussed and debated over the last several years. Until now, Congress has rejected military involvement with Syrian opposition groups because Americans and our leaders did not really understand the size, composition, abilities, and intentions of the various opposition groups, and we were concerned that the unforeseen consequences of our involvement could easily ruin any advantages there might be. The surprising success of the vicious Islamic State (ISIS) forces only demonstrates that we really did not understand the situation in Syria.

The President's proposed strategy seems very similar to what we have pursued in previous conflicts: arm and train local forces in the region and plan to turn over responsibility for the fight to those governments. That strategy failed spectacularly in Iraq, and in Soviet-occupied Afghanistan, and in Vietnam. During his trip to the region earlier this month, Secretary of State Kerry came up short when he sought concrete military commitments from other countries--even countries directly threatened by ISIS ideology. I voted against training the yet-to-be determined Syrian opposition fighters and against putting more American lives at risk on the ground in Iraq and Syria.

The NIH Challenge

By now, the ALS (amyotrophic lateral sclerosis, also called Lou Gehrig’s disease) Ice Bucket Challenge has garnered the attention of celebrities and citizens everywhere, increasing awareness of this debilitating disease, and raising over $100 million to fund research for a cure.

However, I believe that there is an issue going relatively unnoticed in the uptick of donations: federal funding for the National Institutes of Health (NIH), the federal agency devoted to funding biomedical research, has been slipping. Over the past five years, the NIH has directed over $225 million to ALS research. Yet this figure would be significantly higher had Congress not voted to implement budget cuts across the board. Today, the NIH budget is at the same level as in 2003, and its Director, Francis Collins, has stated that NIH has lost 25 percent of its purchasing power over the last decade. While the Ice Bucket Challenge is raising awareness and money to cure a terrible disease, we should also be demanding that Congress reverse course, supporting increased funding for NIH and investing in basic research at the National Science Foundation. The best way for us to tackle difficult-to-treat diseases such as ALS is to fund biomedical research fully.

Sincerely,

Rush Holt
Member of Congress


Tuesday, April 2, 2013

Pallone Denounces Cuts to Research and Programs on World Autism Awareness Day





New Brunswick, NJ – Today, Congressman Frank Pallone, Jr. (NJ-06) marked World Autism Day by touring the Rutgers University, Douglass Developmental Disabilities Center (DDDC) and speaking out against the across the board budget cuts known as sequestration that slashed critical funding to autism research and programs. Pallone was joined by Linda Brzustowicz, Acting Senior Associate Vice President of Research and Economic Development and Chair of Genetics, Rutgers University; Lara Delmolino, Director, DDDC & Clinical Associate Professor, Graduate School of Applied and Professional Psychology at Rutgers University; Bob Titus, Public Policy Director, Autism New Jersey; a parent of an autistic child and other New Jersey autism advocates.

Those with autism and related disorders face a long-term loss of billions of dollars in services and supports as a result of the $85 billion federal spending cut that took effect March 1, 2013. This is the first in a series of annual cuts intended to reduce federal spending by $1.2 trillion by 2021 or until Congress and the President can agree on more targeted cuts.

“The work being done at the DDDC is extraordinary and helping so many families,” said Pallone. “That’s why it is so important that the DDDC has the tools it needs to continue its good work. Unfortunately, Republicans in Congress chose to use funding for programs like these for political maneuvering rather than investing in the futures of those with autism when they allowed extreme across the board spending cuts to go into effect last month. Budgets are about more than numbers and dollars – they are real-life expressions of priorities, choices and values. These choices have an impact on the lives of millions of Americans, and that includes the million families that are currently coping with autism. I voted against these cuts and I will continue to speak out in opposition to this blind, slash and burn approach because New Jersey and the nation deserve better from Congress than a plan that inflicts so much harm to so many people.”

Among the agencies affected are the National Institutes of Health (NIH), which funds autism research, the Centers for Disease Control and Prevention (CDC), which monitors the prevalence of autism in America, and the Human Resources and Services Administration (HRSA), which helps fund the Autism Treatment Network.

“The impact of these cuts would affect all people with autism regardless of age or range of ability, reaching into special education, housing, research and even employment support. While none of these impacts will be felt immediately, they will grow more apparent and worse each day that the federal budget crisis goes unresolved,” said Pallone.

Autism spectrum disorder widely affects children in the United States, and a new survey of parents released by the CDC last week suggests that one in 50 school age child has autism. This new report indicates that the prevalence of autism is on the rise. The CDC previously estimated that one in 88 children in the country has autism, and in New Jersey, that number is one in every 48, the second highest prevalence in the nation.

“Families and individuals are overcoming significant challenges on a daily basis,” said Pallone. “We must treat autism as an urgent public health concern and raise awareness of the disorder, which is why World Autism Day is so important, and why Congress must prioritize policies that will help.”