Thoughts: What Does National Institute of Health Director Francis Collins get asked in front of Congress?

Source: C-SPAN

Regardless of each opinion held by every person existing in the great nation of the United States, each of us could learn a great deal by watching a hearing held by Congress on any given topic.  The topics are very diverse and surprising when a person decides to look into the variety.  I would even go onto say, there is a tremendous amount of content to mull over when making choices for constituents across every district of the United States.  Our elected politicians have an enormous amount of material to consider for a given topic.  Of course, that is the purpose of hiring aides (in Washington D.C.).



With that being said, what do the people who are asked to testify in front of congress say?  What type of questions are asked of them by congressional leaders?  At the end of the blog post, I will include other posts with links to other congressional testimonies.  Since I am focused mainly on science and the environment, I thought that highlighting the recent testimony of Dr. Francis Collins, the Director of the National Institutes of Health would be appropriate for the present post.  Below are the introductory remarks with a couple of short videos.

NIH Director's Opening Remarks

At the beginning of a congressional testimony, the major players get a chance to give an opening statement or submit opening remarks to be entered for the record.  Below are Dr. Francis Collins opening remarks:

  

Good morning, Chairman Blunt, Ranking Member Murray, and distinguished Members of the Subcommittee.  I am Francis S. Collins, M.D., Ph.D., and I have served as the Director of the National Institutes of Health (NIH) since 2009.  It is an honor to appear before you today.

Before I discuss NIH’s diverse investments in biomedical research and some of the exciting scientific opportunities on the horizon, I want to thank this Subcommittee for your sustained commitment to NIH to ensure that our nation remains the global leader in biomedical research and advances in human health.

I want to personally express gratitude to this Subcommittee and its leadership for its support in crafting and passing the FY 2018 Consolidated Appropriations Bill.  The FY 2018 Omnibus provides an incredible increase of $3 billion for NIH, including funding for opioid- and pain-related research, Alzheimer’s disease, antimicrobial resistance, and development of a universal influenza vaccine.  NIH has immediately set to work to invest those additional resources into groundbreaking research.

As the nation’s premier biomedical research agency, NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance human health, lengthen life, and reduce illness and disability.  As some of you have witnessed first-hand on your visits to NIH, our leadership and employees carry out our mission with passion and commitment.  This extends equally to the hundreds of thousands of individuals whose research and training we support, located in every State of this great country, and where 81 percent of our budget is distributed.

The FY 2019 Budget provides $34.8 billion for NIH to fund the highest priority scientific discoveries while also maintaining fiscal stewardship of Federal resources.  This Budget will consolidate research functions across the Department, optimize available grant dollars to fund research, invest in NIH’s buildings and facilities, and support NIH priority areas including combatting the opioid epidemic, advancing Precision Medicine, and investing in translational research.

The FY 2019 Budget consolidates HHS research programs into three new institutes within the NIH.  The Budget provides $380 million for the activities of the Agency for Healthcare Research and Quality (AHRQ), consolidated into the National Institute for Research on Safety and Quality.  The National Institute for Occupational Safety and Health (NIOSH), including the Energy Employees Occupational Illness Program (EEOCIPA), currently administered by the Centers for Disease Control and Prevention, and the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), currently administered by the Administration for Community Living, are also proposed for consolidation into the NIH.

America’s continuing leadership in conducting biomedical research requires infrastructure and facilities that are safe, compliant with all laws and regulations, and conducive to cutting edge research and research support.  NIH owns 281 facilities, including a research hospital, laboratories, and offices.  NIH’s Backlog of Maintenance and Repair exceeds $1.8 billion.  NIH is currently working with the National Academies of Sciences, Engineering and Medicine to identify NIH facilities and infrastructure most in need of repair.  We look forward to providing that report to the Committee as soon as it is final.

The FY 2019 Budget makes much needed investments in NIH’s facilities.  The Budget proposes $200 million to support multiple biomedical research infrastructure priorities.  The FY 2019 Budget will allow NIH to continue to repair and upgrade deteriorated infrastructure.  In a recent analysis requested by this Committee, the condition of NIH laboratories ranks near the lowest in the federal government due to the high likelihood of floods, power outages, and mechanical failures.  Items on the backlog list include: install steam and chilled water distribution systems; conduct structural repairs to older buildings; upgrade plumbing systems; repair elevators; upgrade heating, ventilating, and air conditioning systems; replace deteriorated electrical systems, and more.  In addition, due to the age and use of NIH facilities, NIH must invest funds in removing contaminants and hazardous waste before construction or capital repairs can begin in most of its buildings.  The Budget will allow NIH to track what contaminants are being cleared from each of our buildings, which will ultimately help NIH do a better job of anticipating the cost and time required to begin new projects in existing buildings.

Truly exciting, world class science is taking place.  I would like to provide just a few examples of the depth and breadth of the amazing research the FY 2019 Budget supports across the Institutes and Centers of NIH.

Over the past 15 years, communities across our Nation have been devastated by increasing prescription and illicit opioid misuse, addiction, and overdose.  This Committee made a historic investment of $500 million in our work in FY 2018, and the FY 2019 Budget builds on that with an investment of $850 million to support a range of activities to advance research on pain and addiction.  NIH has and will continue to support cutting-edge research on pain, opioid misuse, addiction, and overdose.  Drug addiction is a complex neurological condition, driven by many biological, environmental, social, and developmental factors.  Continued research will be key to understanding the crisis and informing future efforts.  Pain is an equally complex condition affecting millions of Americans.  NIH will: explore new formulations for overdose reversal medications capable of combatting powerful synthetic opioids; search for new options for treating addiction and maintaining sobriety; continue to research how best to treat babies born in withdrawal through our ACT NOW trial; develop biomarkers to objectively measure pain; build a clinical trial network for pain research; and attempt to find non-addictive and non-pharmacological approaches to chronic pain.  Thanks to your support, all hands are on deck at NIH for this public health crisis.

Another exciting area of continued investment in FY 2019, building on this Committee’s long-standing support, is Precision Medicine.  On May 6th, NIH officially launched the national roll-out of the All of Us Research Program.  This program will partner with one million or more people across the United States to provide the most diverse biomedical data resource of its kind and gain unprecedented insights into the biological, environmental and behavioral influences of disease.  The FY 2019 Budget, including resources from the 21st Century Cures Act, supports the ramp up of the program. After pilot testing system and forming partnerships with community organizations across the country, national enrollment is about to begin.  All of Us will not focus on only one specific disease.  Rather, it will be a national data resource to inform many research studies on a wide variety of health conditions. The data provided by one million participants will provide opportunities for researchers—including academics and citizen scientists—who want to understand how and why different people experience certain diseases and conditions while others do not, and why many people respond differently to treatments and prevention methods that will help accelerate medical breakthroughs.

NIH is the largest funder of basic biomedical research in the United States, providing a critical research foundation for both the public and private sector.  Building on that solid foundation of basic research, NIH also supports translational research that turns observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public, whether those interventions be diagnostics, therapeutics, medical procedures, or behavioral changes.  For example, Congress created the Cures Acceleration Network (CAN) at the National Center for Advancing Translational Sciences (NCATS) to advance the development of high-need cures and to reduce significant barriers between research discovery and clinical trials.  For example, CAN currently supports NCATS’ Tissue Chip for Drug Screening program, which was designed to revolutionize the process for predicting drug safety.  Researchers developing miniaturized platforms that could support miniature models of living organs — such as the lung, liver, and heart — that could be integrated into connected organ systems.  New Tissue Chip initiatives were funded in FY 2017 and this support will continue into FY 2019.  CAN uses flexible research awards using the special authorization called other transaction authority to attract non-traditional government partners, and to expand, modify, and, if needed, discontinue activities to meet program needs.  The FY 2019 Budget will allow NCATS, through CAN, to continue to invest in high-risk, high reward initiatives designed to address significant scientific and technical challenges that hinder translational research. 

One of my personal priorities is developing the next generation of talented biomedical researchers.  Last year, I shared with the Committee NIH’s plans to build on our support for early-stage investigators through a new initiative known as the Next Generation Researchers Initiative.  The FY 2019 Budget includes a dedicated fund of $100 million in the Office of the Director to incentivize additional Institute and Center support for these researchers.  NIH remains committed to the development, support, and retention of our next generation of investigators. 

We have never witnessed a time of greater promise for advances in medicine than right now.  Your support has been critical, and will continue to be.  Thank you again for inviting NIH to testify today. We look forward to answering your questions.

There is a lot to cover since there is a tremendous amount of research done.  Imagine trying to report on all of the new discoveries which have been accomplished over the year which are funded by the government.  Especially given the wide diversity of funding initiatives.  The information gained during the process of research and discovery are wide ranging and some times uncertain in understanding.  New drug targets could be discovered while the technology to bring to market the medicine might not be available yet. 



Additionally, new companies could be emerging looking to invest and take a new drug to market.  The future is exciting yet unknown and Dr. Francis Collins has to stand up before congress to report and justify the funding -- while always looking to increase the annual budget.  The task must seem monumental given the scope and wide range of projects not to mention the needs of the NIH.

Short Videos of Questions

Now that you have seen the opening statement, a couple of videos might be appropriate.  The first video is of the opening remarks from the committee chair - Senator Roy Blunt.  He gives a good overview of the current state of funding and initiatives that have been considered over the past few years in around 6 minutes of speech:

Wow!  That is pretty impressive.  Dr. Collins mentions that the 'ROI' -- 'Return On Investment' from spending money for research at the National Institutes of Health is $8.38 for every $1 spent (over a five year period).  Remember, the money invested goes to research medical disease at the basic science stage along with grants which help pharmaceutical companies bring a drug to market to treat a disease (when success is shown).



For those concerned citizens who worry about spending needless money on projects which 'seem' to produce nothing, I would argue that every project pursued yields fruits of knowledge.  Whether that yield be as small as the realization of the need for newer technology or the realization that the existing projects will really have to be broken up into many smaller components with each a separate funding cut.  Meaning that there is no money which is wasted in research.  I understand that there are scientists who will disagree with me.  That is not to say that money could be better spent from grants coming out of the National Institutes of health.  What always strikes me as amazing is the wide range of projects (under various sub-agencies throughout the NIH) that are undertaken by scientists throughout our nation.



Senator Roy Blunt mentions the newly launched initiative of the National Institutes of Health guided toward precision medicine called "All of Us."  I just wrote a short blog post with a video embedded in the post to give a reader an introduction into the ground breaking initiative toward understanding unique traits among individuals rather than large populations.



The next video shows Senator Jerry Moran questioning

Dr. Richard Hodes, Director of the National Institute on Aging, spoke briefly about identifying various biomarkers of disease.  Recently, I wrote a short blog post with a video on the mission of the National Institute on Aging (NIA) -- which is worth checking out if you are unfamiliar with the NIA and research conducted within the facility and outside (funded by the agency).



For those who are interested in listening/viewing the entire hearing, here is the link to the Senate Appropriations web page with the embedded video of testimony.

Conclusion...

Congress has a difficult job in front of them when dealing with spending issues on behalf of the entire United States of America.  Each geographical region has different spending needs which require different amounts of funding from the government on an annual basis.  What is not different or unique is that each geographical region is filled with human beings.  Each of us eventually will need hospital services within our lifetime.  Each of us will eventually need a medication which was funded by the National Institutes of Health.  And eventually, each of us will realize that money spent on medical research is important.



Just ask a person with a rare disease for which there is no treatment available.  What would you say to that person from a spending perspective?  Although, just because money is thrown at a project (research problem) does not guarantee positive results.  Unfortunately, the answer may be beyond the reach of our current research capabilities or understanding.  If we do not continue to promote research and discovery across a wide range of fields, then we will never know our limits of understanding.  Research is not an area from which we (as a nation) should be trying to save money.  If anything, an annual increase should be without question.  This statement is backed by a great return on investment as stated above by Dr. Francis Collins.






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Update: EPA Throws Journalists Out Of PFAS Conference - Why?

Source: EPA

The week began with an update (a blog post) regarding the decision of the Environmental Protection Agency to hold 'a conference' to explore the dangers of PerFluoroOctanoic Acid (PFOA) and PerFluoroOctaneSulfonic Acide (PFOS).  This conference was in response to the breaking news last week that the White House was suppressing a health report by the Department of Health and Human Services (HHS) which was about to be released regarding the safety of the chemicals above.  The levels of the PerFluoroAlkyl compounds which were found in various geographical areas were disturbing as uncovered by Politico news.  Below is the disturbing update regarding the conference at the EPA -- which began with quite a hiccup to say the least -- or was it a hiccup?

Day 1 of PFAS Conference at EPA

As I just stated, the two day conference which was held at the EPA started roughly to say the least.  According to early reports by 'Politico Energy' the following disturbing event occurred at the beginning of the conference:

MAKE SOME ROOM — PFAS SUMMIT ENTERS DAY 2: It's the second and final day of EPA's summit on dangerous chemicals cropping up in drinking water supplies around the country. Deputy Administrator Andrew Wheeler will deliver opening remarks, but the rest of today's agenda is pretty vague, mostly listing "open discussions" among the state regulators, federal officials and other participants.

EPA Administrator Scott Pruitt announced Tuesday that he would take the first step toward regulating PFOA and PFOS. Today's proceedings will be closed to the press, an agency spokesman tells ME. EPA initially tried to bar reporters from most of Tuesday's proceedings, before reversing itself a few hours later, but the outcry over that move overshadowed much of the event (more on that below).

'NOBODY EVER ASKED US': Ahead of today's meeting, Pro's Annie Snider and Emily Holden confirmed that a controversial — and still unreleased — HHS chemical safety assessment will find that the contaminants can be dangerous at much lower exposures than EPA has previously said were safe. "Nobody ever asked us to change the numbers," Patrick Breysse, the head of the Agency for Toxic Substances and Disease Registry within HHS, told POLITICO. Breysse, who worked on the study, said the agencies involved were "getting close to finalizing it in January," but paused its release to come up with a better communications strategy to describe its findings. At the time, as POLITICO reported last week, a White House official worried of a "public relations nightmare" if the study were made public and asked EPA to intervene. While speaking on a panel at EPA's summit Tuesday, Breysse said the minimum risk levels reported last week for PFOA, PFOS and two other similar chemicals will remain the same when the assessment is released "soon."

Following up: Republican Sen. Shelley Moore Capito told reporters she is "not totally pleased" with EPA's response to the blocked release of a health study on a nationwide water-contamination crisis and would be following up with agency later this week after a national summit on the issue. "I think the health study that HHS put forward needs to be released," she said. "I want to have the full information and I want to find out what kind of levels are acceptable and then remediate the problems." And does she think Pruitt can adequately respond to her concerns? "Time will tell, honestly," she said.

— Separately, Sen. Tom Udall demanded to know why EPA tried to bar reporters from Tuesday's session — a decision that was eventually reversed a few hours later. Udall sent a letter to Administrator Scott Pruitt to express concern over EPA's "disturbing treatment" of journalists. "This intimidation of journalists seeking to cover a federal official presiding over important policy-making is un-American and unacceptable," Udall wrote, calling on Pruitt to apologize to reporters.

But EPA spokesman Jahan Wilcox defended the agency in a statement, noting an Associated Press reporter who had been physically removed from EPA headquarters, "showed up" after being told ahead of time the event was at capacity. "When we were made aware of the incident, we displaced stakeholders to the overflow room who flew to Washington for this meeting so that every member of the press could have a seat," he said.

Which was after the evening reporting by news agencies which resulted in a tweet by Senator Tom Udall shown below:

Here is the 6 and 1/2 minute video below from CNN:

Wow.  Read more about the event (barring of news) from two additional news sources -- Politico and Reason Blog.  According to reporting on the website 'Reason' the conference was proposed based on chemical levels reported earlier by Politico as shown below:

The Summit is being held on the heels of the revelation in Politico that the EPA is apparently suppressing a new report on the safety of PFAS from the Agency for Toxic Substances and Disease Registry. That report suggested that the EPA's safe level of exposure at 70 parts per trillion is about six times too high. Most of the concerns about exposure to PFAS are based on a large number of epidemiological studies that detect fairly subtle health effects. Subtle, however, does not mean no effects.

Wow.  That was only on the first day of the conference.

Day 2 of PFAS Conference at EPA

After the press being thrown out of the EPA hosted conference on the first day, the EPA took a few heavy hits from congressional leaders and the press -- and rightfully so.  One would think that the possibility of throwing the press out of the conference on the second day would be not possible.  But, leave it to the Pruitt Administration to have the gull to attempt the ejection of the free press from the conference again as reported by Politico:

EPA staff Wednesday morning barred POLITICO and reporters from at least two other publications from entering a national summit on toxic chemicals, a day after a partial media blackout at the same event brought criticism from congressional Democrats and a pledge by the White House to investigate the incident.

The agency on Tuesday had allowed a select group of reporters to cover the first hour of the summit's introductory remarks, including comments by Administrator Scott Pruitt, but then escorted press out. EPA reversed its decision to ban media after news coverage of the policy and reports from the Associated Press that one of its journalists was forcibly ejected from the building by a security guard. Reporters were invited back for Tuesday afternoon.

But on Wednesday, the agency again said no reporters would be allowed to attend.

The event, where attendees are discussing whether and how to regulate a class of chemicals linked to immune disorders and certain cancers, included federal and state officials, health groups and industry interests on Tuesday. On Wednesday, it is limited to the agencies that handle chemical oversight and state regulators, according to an EPA statement.

This was such an outrageous action that Politico's Editor even made a statement on behalf of the press about the restriction of access to the conference:

"The summit was focused on an important public health crisis that has affected drinking water supplies across the country, and chemicals that are present in the bloodstreams of nearly all Americans," she said. "We believe it is important that the news media have access to the entirety of this discussion to keep the public informed with fact-driven, accountability coverage of this important issue — we would much rather be writing about the agency's efforts to address this health problem than about reporters being excluded."

Even more congressional leaders took to their twitter accounts.  Senator Tom Carper of the Environmental and Public Works Committee posted on twitter:

"I can’t believe I have to say this two days in a row, but @EPA works for the American people," Carper wrote. "Unfortunately, it’s clear that this EPA is more concerned with protecting the EPA chemical summit from the public than it is with protecting the public from harmful chemicals."

I am really amazed at the obvious lack of understanding of the current Administration that the government works for the people of the United States.  Their actions are funded by tax-payer money.  The actions of the EPA over the last couple of days have called on the Society of Environmental Journalists to take action and send a letter to EPA Administrator Scott Pruitt which is shown below:

May 23, 2018

Scott Pruitt, Administrator

U.S. Environmental Protection Agency

Mail Code: 1101A

William Jefferson Clinton Building

1200 Pennsylvania Avenue, N. W.

Washington, DC 20460

via e-mail: Pruitt.scott@Epa.gov

Dear Administrator Pruitt:

The Society of Environmental Journalists strenuously objects to the Environmental Protection Agency’s selective barring of news reporters from your “National Leadership Summit” on per and polyfluoroalkyl substances (PFAS) in drinking water, and to the EPA physically forcing an Associated Press reporter from the premises.

It beggars understanding that the EPA would prevent any reporters from covering a topic of such intense nationwide interest and concern. But these are just the latest additions to your pattern of antagonism toward the press, and disregard for the public’s right to know what EPA is or is not doing to protect their health and the environment.

This meeting, organized well in advance to gather input on a critical public health policy initiative, as a matter of course should have admitted news reporters in order to inform the public about what occurred. But as recently as a couple weeks ago, your staff was informing reporters that there would be no room for the press at this invitation-only event, because there was not enough space in the room selected for it.

This is patently ridiculous. Surely, larger rooms were available at the EPA headquarters or in a nearby federal building or hotel.

Evidently your staff relented at some point on May 22 and agreed to admit reporters for some news organizations. But not all: The Associated Press, CNN and E&E News, all highly respected news outlets serving enormous national audiences, were turned away at the door.

A female AP reporter has recounted that when, in response to being barred, she asked to speak with a public affairs staffer, guards instead laid hands on her and removed her from the building by force. This is completely unacceptable.

The livestream of the May 22 event provided by EPA - which has been offered as some sort of alternative to on-the-scene coverage - turned out to be highly selective as well, with most of the summit’s morning session held without being broadcast online.

Finally, though you allowed press coverage the afternoon of the summit’s first day, your agency once again excluded at least some reporters on the session’s second day, May 23.

While informing the public via news media is just good policy, holding the meeting open to the public is also legally required under the Federal Advisory Committee Act (5 USC § 1-16) and the Government in the Sunshine Act (5 U.S.C. §552b). According to your own agency’s press release, the summit included representatives from more than 40 states, tribes and territories, 20 federal agencies, congressional staff, industry groups and non-governmental organizations, and the agency intends to use information from the summit to help it develop a management plan. There is no justification for secrecy here.

On behalf of SEJ’s 1,400 members and all other journalists covering the EPA, we urge you to:

• Repudiate this hostile approach to dealing with the press and public.

• Consistently open up important meetings, announcements and events to the public and press.

• Never discriminate against a news outlet based on the content or editorial slant of its coverage.

• Make arrangements to accommodate rather than restrict access by the press and public — and to answer their questions.

• Withdraw your objections to the publication by the Agency for Toxic Substances and Disease Registry of a draft assessment of water contamination by these chemicals. According to news reports, that study is still being withheld from the public.

Your failure to release this report, along with the difficulties inflicted on reporters trying to cover the summit, inhibit public understanding of how the EPA is regulating water quality and constitutes an abuse of the free press and the public’s right to know. We emphatically urge you to end these practices immediately.

The behavior described (the actions of the EPA officials toward the press) are unprofessional and violate unwritten rules and regulations within the government.  Since when does any EPA official have the right to handle another personal in a physical capacity.  The EPA official could be brought up on charges of assault.  At the very least, the EPA official should have called a security official.  But the above removal of a person in the press are just another reminder that this administration believes that they exist outside or above the law -- which is very unfortunate.

Conclusion...

I would hope that after the unfortunate events, the nation can move on and learn from the events of the past.  The current Administration at the EPA needs a strict reminder from congress regarding the behavior toward the public.  Each public official should remember that ultimately the tax-payer is deciding their course in the future.  Based on the actions over the last few days, the EPA seems to have been taken over and funded exclusively by the Private sector.



The blatant disregard for the public should make any citizen sick to their stomach.  After all, the fall-out of the decisions being discussed and made result in resources which we need for every day living.  No person should have to drink or be exposed to contaminated water just because the federal regulating agency (i.e. EPA) is unwilling to do their job.  Further more, disease needs not be spread due to a lack enforcement on government, state, and local facilities.




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