Category: Federal agencies

NIH hopes funding increases will continue

 lancet cover 2Volume 387, Number  10019
13 February 2016
WORLD REPORT   The US National Institutes of Health welcomed a record budget boost that might be the start of more sustained support. The Lancet’s Washington correspondent, Susan Jaffe, reports.

The US Congress recently approved the largest single increase in funding for the National Institutes of Health (NIH) in 12 years—a US$2 billion raise that was twice as much as President Barack Obama requested. But almost as soon as NIH supporters stopped cheering, they began to worry about next year’s budget, and the challenge of a new public health threat, Zika virus.

NIH Director Francis Collins told The Lancet that the funding boost “was enormously gratifying”. But if it is “a one-hit wonder”, he said “it won’t be sufficient to take full advantage of the remarkable scientific opportunities and talent that is out there”.   [Continued here] [podcast here]

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Congress Wrangles Over Funding for Zika Research

Susan Jaffe | Washington Correspondent for The Lancet | 12th February 2016

President Barack Obama asked Congress this week for more than $1.8 billion in emergency funding The Lancet USA blog logoto respond to Zika virus and administration officials wasted no time in explaining why at four congressional hearings less than two days later.

While such Capitol Hill visits are part of the budget process, the looming virus adds a new urgency to the proceedings–though not necessarily enough to deter controversy. [Continued here]…

Shkreli pleads the Fifth on drug price hikes

Susan Jaffe | Washington Correspondent for The Lancet | 10th February 2016

Like many Americans, members of Congress are frustrated and angry about the huge spikes in prescription drug prices. While a congressional hearing held last week to investigate the practice united Democrats and Republicans in outrage, it did not reveal potential solutions.

     The unwilling star witness was Martin Shkreli, the former head of Turing Pharmaceuticals who was responsible for the company’s decision to raise the price of Daraprim, used to treat toxoplasmosis, a parasitic infection that affects HIV patients, from $13.50 to $750 a pill. [Continued here]  …

Budget boon for biomedical research

Susan Jaffe | Washington Correspondent for The Lancet | 31st December 2015

budget 123115The US Congress has become famous for political gridlock  but sThe Lancet USA blog logohortly before going home for the holidays, members approved a 2,009-page budget for fiscal year 2016 with generous increases for some key health and science agencies, most notably the ailing National Institutes of Health. [Continued here.]…

Paris climate change agreement faces hurdles in the USA

Susan Jaffe | Washington Correspondent for The Lancet | 31st December 2015
Only a few hours after thousands of representatives from 195 countries approved the landmark Paris cliThe Lancet USA blog logomate change agreement, President Barack Obama stepped before the TV cameras at the White House to congratulate them. It Paris 2offers the best chance we have to save the one planet we have,” Obama said. “We’ve shown that the world has both the will and the ability to take on this challenge.”
But the international consensus to reduce global warming failed to move the Republican candidates competing for Obama’s job.  {Continued here.]
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As drug prices go up, some point consumers up north

Susan Jaffe | Washington Correspondent for The Lancet | 8th December 2015
Pharmaceutical sticker shock has renewed American interest in drugs sold in other countries, particularly our northern neighbor.
Many Americans and even government health programs are feeling squeezed by rising drug costs, with federal officials reporting last week that US The Lancet USA blog logohealth care spending in 2014 rose at the fastest rate since 2002 “in part due to the introduction of new drug treatments for hepatitis C as well as of those used to treat cancer and multiple sclerosis.”120815
Treatments for hepatitis C, which affects around 3 million people in the USA, can cost more than $100,000, Health and Human Services Secretary Sylvia Matthews Burwell said at an unprecedented day-long conference on drug pricing HHS hosted last month.
“And that’s an issue for both patients and the organizations and governments that serve them. Since more than three out of four infected adults are baby boomers, this disease has become one of the main cost drivers for Medicare’s prescription program.  Impacts have also been significant in state Medicaid programs.”
…Prompted by the HHS conference and recent price hikes, two leading Senate Republicans, Charles Grassley of Iowa and John McCain of Arizona want Burwell to use a provision of a 2003 law to certify that drug importation is safe and would significantly reduce drug prices.  [Continued here.]
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USA grapples with high drugs costs

 lancet cover 2Volume 386, Number  10009 
28 November 2015
WORLD REPORT   More Americans are getting health insurance, including coverage for prescription drugs, but high prices may make them inaccessible. Susan Jaffe, The Lancet’s Washington correspondent, reports.
 Patients in the USA pay more for prescription drugs than almost anywhere else in the world, forcing as many as one in four who can’t afford the high prices to go without their medicine last year, according to a Kaiser Family Foundation survey. So even though more Americans have health insurance, the new therapies and cures that can prevent more expensive health complications might be out of reach.
After several well-publicised, huge spikes in drug prices—including Turing Pharmaceutical’s increase for pyrimethamine (marketed as Daraprim) from US$13·50 to $750 a pill—the problem is drawing unprecedented attention from nearly every quarter: the Obama Administration, Congress, state officials, health insurance companies, drug makers, as well as the physicians and their patients who have clamoured for help for years. It also surfaced during this month’s Democratic presidential debate.
Heather Block, a patient advocate from Delaware who spoke at a day-long pharmaceutical forum hosted by the US Department of Health and Human Services (HHS) earlier this month, pays $9800 a month for the drugs she takes to treat breast cancer that has spread to her liver and lungs. Although she has Medicare coverage, she is still responsible for a share of her medical expenses. “Innovation is meaningless if nobody can afford it”, she said. “I still face financial insecurity and eventually bankruptcy—if I live that long.”     [Continued here ]
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End in sight for revision of US medical research rules

lancet cover 2Volume 386, Number  10000 
26 September 2015
WORLD REPORT   End in sight for revision of US medical research rules US health officials expect to update 25-year-old regulations on human participation in research by the end of next year.  Susan Jaffe, The Lancet’s Washington correspondent, reports.Lancet photo 092615
After proposing massive changes 4 years ago to rules first issued in 1991 protecting people participating  in research studies, federal health officials produced yet another revision earlier this month and say the effort to update the rules is on a fast track.
The revolution in science, technology, medicine, and public involvement that has transformed biomedical research over the past 25 years might be sufficient reason for the latest update, a daunting task that began in 2009, shortly after Barack Obama became president. But now there’s another factor driving the effort. [Continued  here]
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Congressional showdown threatens NIH funding boost

lancet cover 2Volume 386, Issue 9996,  29 August 2015

WORLD REPORT    Bills providing extra funding for the National Institutes of Health while cutting other programmes could a face presidential veto.  Susan Jaffe, The Lancet’s Washington correspondent,  reports.

After years of mostly stagnant funding for the US National Institutes of Health (NIH), two powerful congressional committees that control government spending have approved separate budget bills containing record increases for the agency.
But last month, President Barack Obama’s Office of Management and Budget director Shaun Donovan wrote to the chairman of the Senate Committee on Appropriations warning that he expects the president to veto its bill. Among other reasons, Donovan said it “drastically” cuts money for public health programmes including Medicare for the elderly and Medicaid, serving low-income Americans. And it would deny funds for operating the health insurance exchanges essential to the president’s signature health reform law, the Affordable Care Act. [Continued in full text or PDF ]
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Clean Power Plan

Susan Jaffe | Washington Correspondent for The Lancet   25th August 2015The Lancet USA blog logo
 Before President Barack Obama’s Clean Power Plan can inspire other nations to control greenhouse gases by following the USA’s lead in dramatically reducing carbon emissions, the Administration has to convince West Virginia—and at least 15 other skeptical states. [Continued here]
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21st Century Cures

lancet cover 212 August 2015
A dispatch from our Washington correspondent on the sluggish progress of the 21st Century Cures Act.
lancet test tubes 081215
Republicans and Democrats in the U.S. House of Representatives last month overwhelmingly passed the 21st Century Cures Act  aimed at speeding up drug development.  But the Senate is not expected to vote on its version until next year.
More than 80 percent of the House backed the legislation after it was unanimously — a word rarely heard on Capitol Hill — approved by the House Committee on Energy and Commerce.   In the process, the bill was revised to address concerns that drug approvals would happen a little too quickly, circumventing safety and efficacy standards. [Continued here]
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Planning for US Precision Medicine Initiative underway

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Volume 385, Issue 9986, 20 June 2015

WORLD REPORT    Officials expect to launch the US President’s new health project later this year. But Congress has yet to decide whether to fully fund it. The Lancet’s Washington correspondent, Susan Jaffe, reports.

While continuing to defend his besieged health-care reform law against lawsuits and repeal threats, US President Barack Obama is championing a new health initiative. This one also has a bold goal: to radically change the medical treatment patients receive in the USA. “I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time”, the President said when he unveiled his Precision Medicine Initiative (PMI) in his annual State of the Union address to the nation in January.  …Central to the PMI will be the creation of a research cohort of 1 million US volunteers who agree to provide researchers with biological, environmental, lifestyle, and other information as well as tissue samples….The effort to vastly expand the scope and practice of individually designed treatments based on genetic information could revolutionise medicine, supporters say. But the success of the PMI depends on whether Congress agrees to fund it.  [Continued in full text or PDF ] …

21st Century Cures Act progresses through US Congress

image Volume 385, Issue 9983,    30 May 2015

WORLD REPORT A bill to speed up the translation of biomedical discoveries is getting wide support, but some argue that it is not adequately funded.   Susan Jaffe, The Lancet’s Washington correspondent, reports.

An ambitious bipartisan plan to accelerate medical innovation in the USA is moving ahead in a Congress famous for political gridlock.

The proposed 21st Century Cures Act was approved unanimously on May 21 by the US House of Representatives’ Committee on Energy and Commerce. The massive bill would promote discovery of new medicines and get them to patients more quickly. But the bill’s bipartisan support nearly collapsed when Democrats insisted on additional funds for the two federal agencies intricately involved in carrying out the bill’s far-reaching provisions.

Behind-the-scenes discussions finally yielded an infusion of US$10 billion over 5 years for the National Institutes of Health (NIH). Shortly before the committee vote, $550 million over 5 years was added for the Food and Drug Administration (FDA), which is responsible for ensuring new treatments are safe and effective. …But funding for both agencies did not come easy, is still uncertain, and might fall far short of what is needed.  [Continued full text or PDF]…

Obama steps up US campaign on climate change

lancet cover 2Volume 385, No. 9978     25 April 2015

 

WORLD REPORT   In recent weeks, the Obama Administration has unveiled several new initiatives to tackle climate change. The Lancet’s Washington correspondent,  Susan Jaffe reports.

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Surgeon General Dr. Vivek Murthy and President Barack Obama

With less than half of his final term in the White House remaining, US President Barack Obama is no longer confining his efforts to slow climate change to Congress or the courts, where opponents are trying to block new, tougher environmental rules at every turn.

In the past 3 weeks, his Administration has announced a multifaceted public appeal, including plans to expand public access to tracking the impact of climate change with help from such private sector giants as Google and Microsoft, create a coalition of 30 medical, nursing, and public schools to train health-care providers to respond to the health effects of climate change, and host a climate change and health summit at the White House in the spring….

Last month, the Obama Administration submitted a US climate plan to the UN Framework Convention on Climate Change in preparation for December’s global conference in Paris. But the US pledge to reduce greenhouse gases depends in a large part on power plants reducing their carbon dioxide pollution; the US Environmental Protection Agency (EPA) is expected to finalise limits for power plants this summer. Even before they take effect, 14 states and two coal companies have taken the unusual step of challenging the agency’s still uncompleted rules in federal court.

The President is also making the fight personal, recalling, during an interview on national television, that when his eldest daughter was 4 years old, she had such a severe asthma attack that her parents had to take her to the hospital for emergency treatment. “The fright you feel is terrible”, he said.

Obama warned of increased asthma cases and “a whole host of public health impacts that are going to hit home”, speaking after meeting with the medical and nursing schools coalition. [Continued: full text or PDF ]…

US initiative for prediabetes

 

The Lancet Diabetes logo24 April 2015

IN FOCUS       Health officials in the USA want physicians to help to reduce diabetes by asking at-risk patients to join diabetes prevention programmes.  Susan Jaffe reports from Washington, DC.

“…Clinicians may be talking to patients about their elevated blood sugar, but if it isn’t diabetes, some do not take it very seriously”, Ann Albright, director of the CDC’s Division of Diabetes Translation, told The Lancet Diabetes & Endocrinology. “But the evidence is clear that the earlier you intervene, the greater the likelihood is of either preventing or delaying diabetes or, if someone already has diabetes, preventing or delaying the complications.”  [Continued: PDF ]…

Republicans’ bills target science at US environment agency

lancet cover 2Volume 385, Issue 9974, 28 March 2015

 

WORLD REPORT      Proposed legislation would change how the US Environmental Protection Agency uses science to determine pollution limits. The Lancet‘s Washington correspondent Susan Jaffe reports.

Approval of two controversial environmental bills in the US House of Representatives last week was the latest assault in the Republicans’ “war on science”, according to Democrats. Republicans, however, considered it a big step towards assuring that federal environmental regulations are based on solid scientific research. Despite the sharp difference of opinion along political lines, both sides claim to pursue similar goals—to keep the agency responsible for protecting the nation’s health and environment impartial and closely guided by the best science.

…The Secret Science Reform Act of 2015 would prohibit the US Environmental Protection Agency (EPA) from proposing or finalising any policy “unless all scientific and technical information” officials relied on is “the best available science” and is “publicly available online in a manner that is sufficient for independent analysis and substantial reproduction of research results”.

“The days of ‘trust me’ science are over”, the bill’s lead sponsor, Texas Republican Lamar Smith, told The Lancet. “The American people deserve to see the data.”   [Continued: full text or PDF ]…

Robert Califf: leading cardiologist is new FDA Deputy

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Volume 385, Issue 9970

28 February 2015

As the new Deputy Commissioner for Medical Products and Tobacco at the US Food and Drug Administration (FDA), world-renowned cardiologist Robert Califf arrives at a time when the FDA’s overall responsibilities have grown exponentially.  The Lancet‘s Washington correspondent, Susan Jaffe, reports.  [article continued as full text or PDF] [Podcast with Dr. Califf here.]

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US FDA: the Margaret Hamburg years

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Volume 385, Issue 9970, 28 February 2015

WORLD REPORT US Food and Drug Administration commissioner Margaret Hamburg is stepping down after nearly 6 years in office. The Lancet‘s Washington correspondent, Susan Jaffe, reports on her achievements.

Margaret Hamburg

At the end of March, Margaret Hamburg is leaving what has got to be one of the toughest unelected US Government jobs outside of the Pentagon—commissioner of the US Food and Drug Administration (FDA).

A champion of science-based regulation and streamlined approvals for breakthrough drugs, the Harvard-trained physician is one of the two longest-serving FDA commissioners in five decades.

The FDA is responsible for the safety of 20% of the products Americans buy, including more than US$1 trillion dollars worth of goods that might seem to have little in common, such as artificial hips, dietary supplements, gene therapy, surgical lasers, prescription drugs for human beings and animals, nanotechnology products, cosmetics, blood and biologics products, tobacco, and—last but not least—most of the food we eat (excluding meat and poultry, which are the domain of the agriculture department). The agency has 16 000 employees. [article continued in full text or PDF]

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NIH budget shrinks despite Ebola emergency funds

image Volume 385, Issue 9966, 31 January 2015

WORLD REPORT Even with a boost in funding for Ebola research, the US National Institutes of Health’s fiscal year 2015 budget is the lowest in years. Susan Jaffe, The Lancet’s Washington correspondent, reports.

During last year’s contentious congressional hearings investigating the US response to Ebola, the Obama Administration’s top health officials fended off criticism hurled by both Democrats and Republicans. But in another show of bipartisanship only a few weeks later, Congress granted nearly all of President Barack Obama’s request for emergency funding to combat the disease here and abroad.

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NIH Director Francis Collins

In his State of the Union address earlier this month, the President expressed his appreciation: “In west Africa, our troops, our scientists, our doctors, our nurses, and health-care workers are rolling back Ebola—saving countless lives, and stopping the spread of disease”, he said, drawing applause from both sides of the aisle. “I couldn’t be prouder of them, and I thank this Congress for your bipartisan support of their efforts.”

Congress narrowly approved the US$5·4 billion emergency Ebola funding contained in the $1·1 trillion spending bill that kept the US Government running. But so far, it has done little to loosen the budget constraints on the National Institutes of Health (NIH)—even as a global health crisis such as Ebola reminded many lawmakers of its value. [MORE full text or PDF ] …

US federal health agencies questioned over Ebola response

image Volume 384, Issue 9953, 25 October 2014

WORLD REPORT A congressional inquiry into the handling of Ebola in the USA has sparked new guidance to protect health-care workers. Susan Jaffe, The Lancet’s Washington correspondent, reports.

As US President Barack Obama ramped up the country’s response to the Ebola crisis domestically and abroad (panel), his top health officials attempted, during a tense congressional hearing last week, to address potential solutions to the epidemic ravaging west Africa, which has now reached the USA, confronting emergency medical providers at a well regarded hospital in Dallas, Texas.

But the Republican-controlled House of Representatives’ Committee on Energy and Commerce, which undertook the inquiry, did not seem particularly interested in discussing additional long-term investments in medical research—there is currently no cure for the disease—or the need to shore up, if not create, health-care infrastructure in the west African countries where more than 4500 people have died of the disease.

“To protect the USA, we have to stop it at the source”, said Tom Frieden, director of the US Centers for Disease Control and Prevention (CDC), at the hearing. “There is a lot of fear of Ebola, and…one of the things I fear about Ebola is that it could spread more widely in Africa. If this were to happen, it could become a threat to our health system and the health care we give for a long time to come.” [MORE full text or PDF ] …

US President’s science panel advises on antibiotic resistance

image Volume 384, Issue 9948, 20 September 2014 

WORLD REPORT The US President’s science council will soon publish its long-awaited report on antibiotic resistance. But will it affect the debate? Washington Correspondent Susan Jaffe reports.

Since its reformation 5 years ago, the President’s Council of Advisors on Science and Technology (PCAST) has grappled with some of the most difficult scientific controversies, including climate change and cybersecurity. In the next few weeks, the council will issue recommendations for controlling antibiotic resistance. “Antibiotic-resistant infections are associated with an additional 23 000 deaths in the USA each year”, Eric Lander, the report’s cochair, told The Lancet. The US Centers for Disease Control and Prevention (CDC) has estimated that the economic effect of antibiotic-resistant infections is at least US$50 billion annually in direct health-care costs and lost productivity. [MORE] [PDF]

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Congress stalls on BRAIN Initiative funding

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16 August 2014

 

WORLD REPORT     US Congress is yet to decide next year’s funds for the BRAIN Initiative. Meanwhile, researchers move ahead with initial grants and a scientific plan. Washington correspondent Susan Jaffe reports.

The US National Institutes of Health is expected to announce next month the recipients of the first US$40 million in research grants to be awarded under President Barack Obama’s ambitious brain research project he says will give scientists the tools to discover “how we think and how we learn and how we remember.”

Despite uncertain future funding, Obama’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is moving ahead. At the White House a year ago, the president compared it to the Apollo space mission that landed a man on the moon, GPS technology, and even the creation of the internet. “All these things grew out of government investments in basic research”, he said. [MORE]…

PCORI, NIH Announce Plans For $30 Million Study On Falls

By Susan Jaffe  June 5,2014 KAISER HEALTH NEWS  in collaboration with wapo

The nation’s largest and most intensive study of how to best prevent seniors’ injuries from falling will begin next year under a $30 million grant announced Wednesday by the Patient-Centered Outcomes Research Institute and the National Institutes of Health. A diverse group of 6,000 adults over age 75 or their caregivers will be recruited around the country to participate in the study.

More than 18,000 seniors died as the result of falls in 2010, and thousands more are injured every year, according to the federal Centers for Disease Control and Prevention.

“A serious fall that leads to a bone fracture or hospitalization has been demonstrated to be one of the most devastating events in the life of an older person, comparable to a serious stroke,” said Dr. Thomas Gill, a geriatrician and professor at Yale School of Medicine and one of the study’s three principal investigators. [More from KHN] [More from Washington Post]…

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image Volume 381, Issue 9882, Pages 1975 – 1976, 8 June 2013

WORLD REPORT Health and science agencies in the USA have been operating on reduced budgets, enforced by sequestration, for just over 3 months Susan Jaffe reports from Washington, DC.

The automatic budget cuts known as sequestration that the US Congress approved in 2011 were intended to be so onerous that they would never happen. Lawmakers would surely find a more reasonable way to save at least US$1·2 trillion over the next decade before the cuts would begin in 2013. Instead, Republicans and Democrats could not agree on an alternative, and the first wave of cuts, totalling $85 billion through to September, 2013, are phasing in for most non-defence US Government operations. Everything from White House tours to the most promising cancer research have been limited by a lack of funding.

..Many services provided by the US Department of Health and Human Services (HHS) are affected, including programmes at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), and medical research funded by the National Institutes of Health (NIH). Even the Affordable Care Act (ACA)—President Barack Obama’s landmark health reform law—will feel the impact, with supporters worried that enrolment for next year’s new health insurance coverage will have a difficult start in October. [FULL STORY AS PDF]

 

US sequester hits health and science programmes

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A new law passed in July to strengthen the work of the US Food and Drug Administration may hit some serious barriers to implementation. Susan Jaffe reports from Washington, DC.

image WORLD REPORT   Volume 380, Issue 9852, Pages 1458 – 1459, 27 October 2012

The massive drug and medical device safety bill that won extraordinary near-unanimous support in the US Congress—despite a budget crisis and a contentious political campaign—is facing major challenges less than 3 months after President Barack Obama signed it into law in July. And in the process, prospects may be fading for additional reforms. [MORE]