Category: The Lancet

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]  …

Some Congress members say a 1980 law may curb rising drug prices

Susan Jaffe | Washington Correspondent for The Lancet | 13th January 2016

No single federal agency reviews US drug prices, but 51 members of  the U. S. House of Representatives have discovered a 35-year-old law that allows the governmeThe Lancet USA blog logont to control huge hikes in drug costs.  And they want the Department of Health and Human Services and National Institutes of Health (HHS) to use it.  Earlier this week the group led by Texas Democrat Lloyd Doggett wrote to HHS Secretary Sylvia Matthews Burwell and NIH director Dr. Francis Collins to explain why. [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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Can you hear me now?

The President’s science advisors say innovative technology can provide low-cost alternatives to pricey hearing aids.
Susan Jaffe  |  Washington Correspondent for The Lancet  |  11th November 2015
Almost The Lancet USA blog logo30 million Americans over 60 years old have difficulty hearing, but less than a third can afford hearing aids, according to a report to President Barack Obama by his Council of Advisors on Science and Technology two weeks ago. Even though hearing loss is often part of the natural aging process, the council did not recommend that Medicare, pay for hearing aids, which can cost an average of $5,000 to $6,000 for a pair. [Continued here]
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USA gears up for next round of enrolment under the ACA

lancet cover 224 October  2015

WORLD REPORT    As enrolment begins for the Affordable Care Act’s health insurance, officials cut estimates of how many Americans will get coverage.  Susan Jaffe, The Lancet’s Washington correspondent,  reports.
The past 2 years of President Barack Obama’s landmark health insurance programme haven’lancet 102415t been easy—surviving two Supreme Court challenges, nearly done-in by embarrassing technical glitches, and more than 50 congressional votes attempting to dismantle it. But its troubles are not yet over: enrolling new beneficiaries “is going to be tougher than last year”, warned Health and Human Services (HHS) Secretary Sylvia Mathews Burwell.
Burwell and other Obama Administration officials are damping down enrolment expectations just days before the 3-month sign-up period for 2016 coverage begins on Nov 1.  [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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U.S. House of Representatives possibly “injured” by ACA spending, judge OKs lawsuit

 

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 Susan Jaffe | Washington Correspondent for The Lancet | 15th September 2015      
                            lawsuit photo
A new threat to the Affordable Care Act emerged last week when a federal judge decided to allow an unusual lawsuit by Republicans in the U. S. House of Representatives against President Barack Obama, claiming that his Administration violated the U. S. Constitution by spending billions of dollars for the Affordable Care Act that Congress did not approve.  [Continued here]  House of Representatives 091515
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Billions served but Cleveland Clinic says no thanks to McDonald’s

The Lancet USA blog logo
Susan Jaffe | Washington Correspondent for The Lancet                               9th September 2015
McDonald’s, the giant fast-food restaurant chain, has been adding healthy options to its menu of burgers, fries and shakes, but the new choices are too little, too late for the Cleveland Clinic.
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After 20 years of serving patients, visitors, and Clinic employees in Cleveland, Ohio, the restaurant’s last day will be September 18. The world renowned hospital is not renewing its contract with McDonald’s.
“As a part of Cleveland Clinic’s commitment to health and wellness, we have made a number of changes across our health system over the past ten years that promote healthy food choices, exercise, and a smoke free environment,” said Eileen Sheil, the Clinic’s executive director for corporate communications,  explaining why McDonald’s had to go.  [Continued here]
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Home-Care Workers

Susan Jaffe | Washington Correspondent for The Lancet | 28 August 2015

Home-care workers are excluded from the federal law requiring most employees to receive a minimum wage—currently $7·25 an hour—and 150% of that pay when they work overtime. After 40 years, the US Department of Labor (DOL) issued rules eliminating that exemption. The new rule was supposed to take effect last January but it was blocked by a lawsuit filed by associations representing companies that hire these workers. [Continued here.]  [with video of Illinois Congresswoman Jan Schakowsky shadowing home-care worker Gilda Pipersburgh]…

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.
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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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50 Years of Medicare

lancet cover 2Volume 386, Issue 9992,  1 August 2015

WORLD REPORT    In July, 1965, Medicare, America’s landmark national health insurance programme, became law. Today, it covers 55 million people.  Susan Jaffe, The Lancet’s Washington correspondent,  reports.

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An American woman thanks President Lyndon Johnson for Medicare, April, 1965.

Richard Troeh joined a very busy solo family medicine practice in 1966 but even with two doctors, their offi ce in Independence, Missouri, seemed just as hectic. The year before, President Lyndon Baines Johnson came to town to sign the Medicare legislation into law at the Truman library. Former President Harry Truman—an advocate of national health insurance since the 1940s—and his wife attended the event and were among the fi rst Americans to receive Medicare cards.
50 years later, the Social Security Amendments of 1965 provide health care for 55 million people older than 65 years or disabled receiving Medicare and nearly 73 million low-income adults, children, pregnant women, and people with disabilities receiving Medicaid, an optional programme also created under the same law.
And in the process, the government programmes have transformed health care in the USA. Medicare is the nation’s largest single purchaser of health care, consuming 14% of last year’s federal budget, or US$505 billion. And it also has a fiercely loyal following that opposes efforts to cut benefits. Speaking earlier this month at the White House Conference on Aging, President Barack Obama drew laughs when he said, “And now we’ve got [protest] signs saying, “Get your government hands off of my Medicare”. [Continued in full text or PDF ] [listen to podcast here]
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US Supreme Court upholds ACA subsidies

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Volume 385, Issue 9988, 4 July 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.

ACA supporters celebrate outside the Supreme Court following the judgment on June 25 (Bloomberg)

ACA supporters celebrate outside the Supreme Court following the judgment on June 25 (Bloomberg)

Although critics still deride it as Obamacare, President Barack Obama’s Supreme Court victory last week

enshrined the Affordable Care Act (ACA) as one of his greatest domestic accomplishments. The court might have also effectively disarmed the opposition, shifting the debate to next year’s campaign for the presidency as the next chance for critics to try to dismantle the law.

But for 6·4 million Americans who could have lost the health law’s insurance subsidies—the key issue before the court—the historic ruling has a different meaning. “Thank God, I can still get my medical care”, said Jacqueline Clay, a New Jersey woman receiving treatment for breast cancer who turned 61 years of age the day the court upheld the subsidies. “I am not going to die.” [Continued in full text or PDF ]…

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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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 ] …