Category: The Lancet

Planning for US Precision Medicine Initiative underway

June 20, 2015

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

May 30, 2015

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

April 25, 2015

Volume 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

April 24, 2015

24 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

March 28, 2015

Volume 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

February 28, 2015

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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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NIH budget shrinks despite Ebola emergency funds

January 31, 2015

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.

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 ] …

Second round of enrolment begins under Affordable Care Act

November 15, 2014

Volume 384, Issue 9956, 15 November 2014

WORLD REPORT Ahead of the next phase of enrolment for insurance plans, Republicans vowed to target the health law following their election win. Susan Jaﬀe, Washington correspondent, reports.

Federal health officials promise that last year’s embarrassing enrolment problems will not be repeated when the sign-up season begins on Nov 15 for 2015 health insurance policies offered under the Affordable Care Act (ACA). But even as more insurance companies and millions more Americans enter the second year of the health insurance programme, the opportunity for critics to chip away at it will never be better when Republicans regain control of Congress in January.

…Under the law, all adults are required to have health insurance and, with some exceptions, those without it are penalised. People who don’t get health coverage through their jobs can buy policies through the online state or federal insurance exchanges from Nov 15 to Feb 15. To minimise the delays many experienced last year, federal officials who run the exchanges in 37 states have shortened the application and no longer require shoppers to spend time setting up accounts before they can review the plans.

Although this month marks the second enrolment period, US Department of Health and Human Services (HHS) Secretary Sylvia Matthews Burwell has been eager to stress that it won’t be a rerun of last year. “It’s not year two”, she told reporters recently, because this is the first time the exchanges will be renewing current policies while also handling first-time applications. [MORE full text or PDF ] …

US federal health agencies questioned over Ebola response

October 25, 2014

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

September 20, 2014

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

August 16, 2014

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]…

Diabetes, obesity, and the Affordable Care Act

June 9, 2014

Diabetes & Endocrinology, 9 June 2014

Under the new health law, Americans with chronic disorders cannot be denied health insurance. Susan Jaﬀe reports from Washington, DC.

Before President Barack Obama’s landmark health law took effect, obtaining affordable health insurance could be difficult for Americans with diabetes or obesity, if not impossible. Insurers that didn’t turn diabetic patients away could charge higher rates because these individuals had a pre-existing health problem, or they could exclude coverage for certain treatments for diabetes or other chronic disorders. Now such practices are prohibited under the Patient Protection and Affordable Care Act (ACA)…but some insurers’ “bad habits” still linger. [MORE]…

Challenges loom for US health law as new insurance begins

May 2, 2014

Volume 383, Issue 9928, 3 May 2014

WORLD REPORT Millions of Americans met the mid-April extended deadline to enrol in coverage under the Affordable Care Act; now the real test of the law begins. Susan Jaﬀe reports from Washington, DC.

Just a few days after April’s extended enrolment deadline, President Barack Obama announced that some 8 million Americans had signed up for health insurance under his health-care law, exceeding the predictions dampened by a rocky rollout 6 months ago that prompted jokes on late-night talk shows, fuelled the opposition, and ultimately led to the resignation of his Health and Human Services secretary, Kathleen Sebelius, the nation’s top health official.

“The repeal debate is and should be over”, Obama proclaimed, referring to the 54 times Republicans in the US House of Representatives have voted to repeal or modify the law. “The Affordable Care Act [ACA] is working.”

But even the programme’s supporters say the next few months will be crucial to its success. [MORE] [PDF]…

The Affordable Care Act’s insurance programme takes effect

January 10, 2014

Volume 383, Issue 9912, 11 January 2014

WORLD REPORT Coverage kicked in for millions of Americans on Jan 1 under the Affordable Care Act while officials urged others to enrol before the 2014 sign-up deadline.Susan Jaﬀe reports from Washington, DC.

The Obama Administration faces what might be its most daunting challenge under the law: making sure an untested programme functions—will newly insured patients be able to get medical treatment or fill prescriptions?—while continuing to encourage people to sign up before the March 31 deadline for 2014 coverage, guaranteeing that the upgraded online sign up system keeps pace with demand, and fighting the latest lawsuit and political attack as the 2014 mid-term election campaign heats up. [MORE] [PDF]…

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Volume 382, Issue 9892, 17 August 2013

WORLD REPORT Despite delaying some provisions of the Affordable Care Act, the US Government says it is on target to begin enrolling millions of Americans in the law’s new health coverage. Susan Jaﬀe reports.

Less than 7 weeks before millions of Americans begin enrolling in the new health insurance plans offered under President Barack Obama’s landmark Affordable Care Act (ACA), critics claim that his Administration isn’t ready and will preside over a monumental failure and a waste of taxpayer dollars.

…While federal officials continue to fend off Republican attacks on the law (unabated despite Obama’s re-election and the Supreme Court’s ruling upholding most of the law) they are also trying to complete work on the system needed to help Americans choose and enroll in an insurance plan and to determine their subsidy eligibility. …“Let me be clear”, US Health and Human Services (HHS) Secretary Kathleen Sebelius told reporters on Aug 5. “We are on target and ready to flip the switch on Oct 1.” [MORE] [PDF]

Obama Administration races to meet key ACA deadline

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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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Volume 381, Issue 9872, Pages 1087, 30 March 2013

WORLD REPORT America’s new global health chief says “diplomatic discourse” will encourage countries to take ownership of US-funded health programmes. Susan Jaﬀe reports from Washington, DC.

In his first US public appearance since outgoing Secretary of State Hillary Clinton appointed Ambassador Eric Goosby to lead the new Office of Global Health Diplomacy in December, a gathering of policy experts, health-care advocates, and government officials asked him about its goals and challenges.

…Among the challenges for sustainability is the human resource deficit, Goosby explains. “The countries in which we work, virtually every one of them, do not have the tools to effectively manage and oversee programmes”, he says. “They have leadership that is well educated and ready but the minister of health then turns around to nobody to implement the idea.” [MORE] [PDF]

The USA and global health diplomacy: goals and challenges

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Volume 380, Issue 9855, Pages 1727 – 1728, 17 November 2012

WORLD REPORT Implementation of the Patient Protection and Aﬀordable Care Act is unlikely to run smoothly despite the Nov 6 election result. Susan Jaﬀe reports from Washington, DC.

Just 3 days after President Barack Obama’s re-election preserved his signature legislative achievement, the Patient Protection and Aﬀordable Care Act (ACA), his administration reset a deadline for states to take a crucial step toward implementing it. The delay in the wake of the health law’s dramatic aﬃrmation—ﬁrst by the US Supreme Court and then at the polls—is another reminder that the way forward may still encounter obstacles, even if the most serious threat was eliminated on Nov 6. [MORE] [PDF]

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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.

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]

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Volume 380, Issue 9848, Pages 1133 – 1134, 29 September 2012

WORLD REPORT Comprehensive domestic health-care reform is one of the top defining issues in the campaign, overshadowing global health. Susan Jaffe reports from Washington, DC.

President Barack Obama and his rival Republican Mitt Romney would agree that the American health-care system is unsustainable, providing some of the world’s most expensive and yet fragmented care. But as they campaign for the presidency, the two candidates offer profoundly different solutions.

“The Affordable Care Act helps make sure you don’t have to worry about going broke just because one of your loved ones gets sick”, said Obama, describing his signature legislative achievement at a recent campaign stop in Colorado. “I don’t think a working mom in Denver should have to wait to get a mammogram just because money is tight”, he continued. “That’s why we passed this law. It was the right thing to do.” [more, as PDF]

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Volume 380, Issue 9846, 15 September 2012

WORLD REPORT Additional new health benefits for women began under the US Affordable Care Act last month, which experts hope will remain after the Nov 6 election. Susan Jaffe reports from Washington, DC.

Republican presidential candidate Mitt Romney promises to dismantle President Barack Obama’s landmark health-care reform law if elected. But as the presidential campaign progresses, various provisions of the law continue to kick into gear…. [more]
Panel: Abortion and the Aﬀordable Care Act

In the ﬁnal days of the congressional health reform debate, abortion coverage nearly derailed the legislation…. [more]

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7 July 2012 lancet cover 2

The US Supreme Court decided last week that most provisions in the 2010 Patient Protection and Affordable Care Act were constitutional. Susan Jaffe reports from Washington, DC.

Last week’s historic ruling by the US Supreme Court preserving nearly all of President Barack Obama’s landmark health law may have finally settled some legal questions, only to shift a re-energised debate about improving the American health-care system to the political arena.In addition to providing health coverage to some 32 million uninsured Americans, other changes in the Patient Protection and Affordable Care Act will affect nearly every patient as it overhauls the US$2·7 trillion health-care system. MORE

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Volume 379, Issue 9828, Page 1775, 12 May 2012

The US Food and Drug Administration is calling for greater reliance on global partners to improve the safety of America’s foreign imports. Susan Jaffe reports from Washington, DC.

In its latest effort to promote a global strategy for protecting Americans against unsafe imported pharmaceutical, food, and medical products, the US Food and Drug Administration (FDA) has called for unprecedented international cooperation to cope with seemingly overwhelming challenges. FULL STORY

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