Category: The Lancet

US CDC begins agency-wide changes after pandemic failures

Volume 400, Issue 10365
19 November 2022 

 

WORLD REPORT  An independent review made several recommendations for improving the public health agency. Susan Jaffe reports from Washington, DC.

The US Centers for Disease Control and Prevention (CDC) is on a mission to reorganise and modernise itself, so that its mistakes during the pandemic will not happen again. The aim is to make the nation’s leading disease detective more nimble and accountable, and fortify its role as public health protector. But although some changes have been made, progress will be limited without support from Congress. [Continued here.] 
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FDA panel says preterm birth drug should be withdrawn

Volume 400, Issue 10362
29 October 2022 

 

WORLD REPORT  Makena has been given to hundreds of thousands of patients over the past 11 years. Susan Jaffe reports from Washington, DC.  

The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee. The recommendation has renewed scrutiny of a special drug approval process that raises patients’ hopes by allowing them to take medications that have not been fully tested for efficacy and safety [Continued here.] 

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Health organisations welcome US climate crisis law

Volume 400, Issue 10354
3 September 2022 

 

WORLD REPORT  The recently passed Inflation Reduction Act will provide billions of dollars of incentives to reduce greenhouse gas emissions. Susan Jaffe reports.

There are no emission limits or pollution penalties in the landmark Inflation Reduction Act that Congress approved in August. Instead of forcing cuts, the climate change and healthcare law provides US$370 billion worth of incentives to ratchet down the planet-warming greenhouse gases from fossil fuels that have caused record-breaking heat waves, wild fires, droughts, and floods.  …The law provides $60 billion for communities that have been disproportionately affected by toxic hazards and the consequences of climate change.  [Continued here.] 

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US Congress lets Medicare negotiate lower drug prices

Volume 400, Issue 10352
20 August 2022 

 

WORLD REPORT  A new law also targets climate change in a major victory for Democrats and President Joe Biden. Susan Jaffe reports from Washington, DC.

Shattering decades of opposition from the pharmaceutical industry and its allies, slim Democratic majorities in the US House of Representatives and Senate have passed landmark legislation to begin to control runaway drug prices for almost 50 million older Americans with Medicare’s pharmaceutical benefit. The bill also provides the largest federal investment in US history—US$370 billion—to slash greenhouse gases by 40% below 2005 emissions and respond to the devastating effects of climate change…. The legislation also ensures that no Medicare beneficiary pays more than $2000 a year for drugs. “That means you will have more money in your pocket”, said Tatiana Fassieux, education and training specialist at California Health Advocates. [Continued here.]
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“Chaos” for patients and providers after US abortion ruling

Volume 400, Issue 10346
9 July 2022 

 

WORLD REPORT  A patchwork of state laws replace abortion rights once guaranteed by Roe v Wade. Susan Jaffe reports from Washington, DC.

The US Supreme Court’s bombshell decision overturning Roe v Wade on June 24, 2022, assures Americans that each state can choose whether and under what conditions its residents have a right to a safe and legal abortion. So far, the result is an incoherent and volatile jumble:16 states have severely restricted or banned the procedure and bans in ten more states are likely to take effect in a matter of weeks. [Continued here.]  

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Federal abortion rights end, but not legal challenges

Volume 400, Issue 10345
2 July 2022

WORLD  REPORT  The US Supreme Court’s decision to overturn Roe v Wade is due to spark further court cases. Susan Jaffe reports from Washington, DC. 

The Supreme Court’s momentous decision to abolish the half-century-old federal right to abortion not only rapidly reconfigures the political and legal landscape in the USA, threatening a host of other long-held personal freedoms. The seismic shift also ignites new legal battles within states that ban or severely restrict abortions, only 4 months before the mid-term elections that will establish which party controls Congress for the next 2 years.  Put simply, the ruling is “the legal equivalent of a nuclear bomb”, according to legal affairs correspondent for National Public Radio and veteran Supreme Court observer, Nina Totenberg. [Continued here.] 

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US Infant formula crisis increases scrutiny of the FDA

Volume 399, Issue 10347
11 June 2022 

 

WORLD REPORT Both Republican and Democrat legislators have called for changes following a shortage of breastmilk substitute. Susan Jaffe reports from Washington, DC..  

The leading US producer of infant formula resumed partial operations on June 4 following a 4-month shutdown, but it may take several more weeks before supplies return to normal, along with the shortage-induced panic and desperation of American parents. When the US Food and Drug Administration (FDA) can regain trust in its ability to police the nation’s food manufacturers is another matter.

The agency’s failure to respond quickly to health hazards at the Abbott Nutrition facility in Sturgis, MI, that released potentially contaminated formula across the country has provoked rare bipartisan outrage in Congress and equally rare apologies from the manufacturer. The shutdown and resulting shortage have also prompted calls for major changes in the FDA’s food safety division, along with questions about why one supplier dominates the market. [Continued here.]  

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Health organizations fear effects of US abortion ruling

Volume 399, Issue 10338
14 May 2022 

 

WORLD REPORT Health and human rights groups are concerned that many states would outlaw abortion if the Supreme Court topples Roe v Wade. Susan Jaffe reports. 

Protests and celebrations erupted across the USA following the unprecedented leak of a draft Supreme Court decision that would overturn the court’s 1973 landmark Roe v Wade ruling establishing a woman’s right to a safe and legal abortion. …“States are already working together to create enormous abortion deserts that many people will not be able to cross”, said Nancy Northup, president and CEO of the Center for Reproductive Rights. [Continued here.]

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Califf takes the helm at the US FDA, again

Volume 399, Issue 10330
19 March 2022 

WORLD REPORT   Robert Califf will have to face several controversial health issues in his second tenure as commissioner. Susan Jaffe reports from Washington, DC.  

Califf takes over amid a lull in the COVID-19 pandemic and an array of hotly debated issues 9 months before a congressional election. The
election results could shrink, if not eliminate, the Democratic majority President Joe Biden needs to propel his health agenda, including the relaunched cancer moonshot and the Advanced Research Projects Agency for Health that would accelerate the development of medical treatments. [Plus new COVID-19 tests and treatments, opioid misuse, accelerated approval process, abortion pill conflict, continued here.] 
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Biden’s science adviser resigns over bullying

Volume 399, Issue 10326
19 February 2022

 

WORLD REPORT   Experts say that Eric Lander’s resignation should not affect the President’s plans to reboot the cancer moonshot project. Susan Jaffe reports.…

The next steps for US vaccine mandates

Volume 399, Issue 10323
28 January 2022 

 

WORLD REPORT   As the Supreme Court blocks one of the Biden Administration’s plans to raise COVID-19 vaccination rates but approves another, Susan Jaffe looks at the next steps.

President Joe Biden’s efforts to encourage the most reluctant Americans to get fully vaccinated against COVID-19 have hit one legal roadblock after another. About one in four adults have still not received either the two-dose or single regimen of the vaccine, according to the Centers for Disease Control and Prevention. However, the path to greater vaccination uptake is shrinking as federal courts muddy his Administration’s pro-vaccine message, cases of infection driven by the Omicron variant continue to rise in many parts of the country, and the president’s popularity ratings fall. …In the first of two rulings on Jan 13, the Supreme Court decided 6–3 to block the Biden Administration’s mandate for private companies with more than 100 employees to require weekly COVID-19 tests for employees who have not been fully vaccinated. ,,,Yet in a pair of lawsuits the court heard along with the employer mandate cases, the court came to the opposite conclusion. In a 5–4 decision, they upheld the Biden Administration’s requirement of vaccination for 10·4 million workers at 76 000 health-care facilities that treat patients covered by the government’s Medicare or Medicaid health insurance.[Continued here.] 

 

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Holmes verdicts prompt questions over justice for patients

Volume 399, Issue 10321
15 January 2022

 

WORLD REPORT   The founder of Theranos was found guilty of defrauding some investors, but cleared of charges that she misled patients. Susan Jaffe reports.

On Jan 3, a federal jury in California found Elizabeth Holmes, creator of the blood-testing startup Theranos, guilty of lying to some of her investors about a portable blood analyser that she claimed would transform health care. It could run dozens of tests from a fingerprick of blood, she said, and deliver dependable results quickly. However, government prosecutors’ account of Holmes’s empty promises and hype failed to convince the jury that she also deceived patients and their doctors who depended on her device’s inaccurate readings. [Continued here.]  
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US Supreme Court expected to weaken abortion rights

Volume 398, Issue 10317
11 December 2021

 

WORLD REPORT   The US Supreme Court, now dominated by conservatives, heard arguments last week on the legality of a Mississippi law banning abortion after 15 weeks of pregnancy. However, the justices signalled that they are likely to do more than uphold the law. .[Continued here.]

 

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Theranos founder counters fraud charges in federal trial

Volume 398, Issue 10315
27 November 2021

 

WORLD REPORT   Federal prosecutors charged Theranos’ founder Elizabeth Holmes and former Theranos president Ramesh Balwani with wire fraud and conspiracy to commit wire fraud, alleging that they deceived investors and patients and their doctors by claiming that Theranos’s machine could produce accurate test results from blood collected in its tiny “nanotainer” device instead of several vials. But witnesses for the prosecution testified that the devices did not operate as promised…. “When something is brought forward as the next new thing regardless of whether it’s a drug or device, it needs to go through the process of rigorous scientific and clinical testing, then presented to the scientific community for peer review and ultimately publication”, said Roy Silverstein a haematologist and chair of medicine at the Medical College of Wisconsin. “And I’m not aware of any single publication that ever came out of this Theranos technology.” [Full story here.]  

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Legal challenges threaten Biden’s COVID-19 vaccine rule

Volume 398, Issue 10314
20 November 2021

 

WORLD REPORT  Almost a year after the first COVID-19 vaccine was approved for emergency use in the USA, roughly a third of adults have still not received it. After urging Americans to get vaccinated, US President Joe Biden has taken a tougher approach: under his administration’s new workplace safety standard, people must get vaccinated or undergo weekly tests for the virus if they work for companies with at least 100 employees. “The rule will protect more than 84 million workers from the spread of the coronavirus on the job”, said Jim Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health. …A day after OSHA’s announcement on Nov 4, 2021, multiple lawsuits to block the rule started rolling in to federal courts across the country.[Continued here.]  

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New 9/11 casualties strain health-care programme

Volume 398, Issue 10304
11 September 2021

 

On this 20th anniversary of the September 11th attacks, first-responder Terence Opiola won’t be attending any memorial events. “I’ll go to church and pray that people remember and understand that it’s not over,” he said. “We’re losing people every week.”

Now a funding shortfall threatens the World Trade Center Health Program, which provides free medical monitoring and treatment for Opiola and increasing numbers of other 9/11 survivors and first responders.  [Full story here.]…

Chiquita Brooks-LaSure: innovative US federal health director

Volume 398, Issue 10300
14 August 2021

 

PROFILE  
Chiquita Brooks-LaSure, President Joe Biden’s choice to lead the Centers for Medicare and Medicaid Services, presides over an agency with a US$1 trillion budget that provides health insurance to more than 154 million people. Tackling health-care inequities is one of her top priorities. “These disparities have long existed, but COVID-19 has illuminated them in a way that is really unprecedented”, she said. [Full story here.]

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US FDA defends approval of Alzheimer’s disease drug

Volume 398, Issue 10294
3 July 2021

 

WORLD REPORT An avalanche of criticism has forced the US Food and Drug Administration to defend its decision to grant accelerated approval for aducanumab, the first new Alzheimer’s disease treatment in two decades. “It will be a very long time before we ever figure out whether or not this drug really works”, said Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School who resigned in protest from an FDA advisory panel that recommended against approval.[Continued here.]

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US drug importation plan hits snag

Volume 397, Issue 10291
12 June 2021

WORLD REPORT The Biden administration says it has “no timeline” for deciding if states can import cheap drugs from Canada. 

President Joe Biden’s administration said last week that it won’t decide whether to allow states to import drugs from Canada anytime soon, if ever. Biden supported drug importation during the presidential campaign, as did his opponent, Donald Trump, to mitigate sky-rocketing drug costs in the USA. Americans pay more per capita for prescription drugs than any other country…. [Continued here.]

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$6·5 billion proposed for new US health research agency

Volume 397, Issue 10288
22 May 2021

WORLD REPORT The Advanced Research Projects Agency for Health would fund high-risk, high-reward medical research, but its short-term planning could stymie basic research. Susan Jaffe reports.

During his first address to a joint session of Congress last month, US President Joe Biden drew little applause from Republicans in the physically distanced, masked audience. A rare exception to their steadfast silence came when he unveiled an ambitious plan to eradicate cancer.

To help reach this goal, Biden would establish a new biomedical research agency within the National Institutes of Health (NIH) called the Advanced Research Projects Agency for Health (ARPA-H). The agency would provide a fast track for transforming basic science into real-world applications. [Continued here.]

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Biden’s first legislative victory: $1·9 trillion for COVID-19

Volume 397, Issue 10279
20 March 2021

WORLD REPORT US President Joe Biden’s first legislative triumph will fund the COVID-19 response and economic recovery, and address social determinants of health. Susan Jaffe reports from Washington, DC. 

By narrowly approving a massive COVID-19 response and economic relief package last week, Democrats in Congress handed President Joe Biden his first legislative victory after only 50 days in the White House. The US$1·9 trillion, 628-page, American Rescue Plan Act is a signature achievement so monumental that it has been compared to President Lyndon B Johnson’s sweeping Great Society legislation that raised many Americans out of poverty, with a safety net of social and health services, including the Medicare and Medicaid insurance programmes.

…As the government begins to roll out these benefits, Biden promised “fastidious oversight to make sure there’s no waste or fraud, and the law does what it’s designed to do. And I mean it: we have to get this right… because we have to continue to build confidence in the American people that their government can function for them and deliver.” [Full story with “where the money goes” sidebar here.]

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Biden unwinds Trump health-care policies

Volume 397, Issue 10272
30 January 2021

 

WORLD REPORT A Democrat in the White House and a Democratic Congress could bring big changes to US health policy, but challenges remain. Susan Jaffe reports from Washington, DC. 

…Before the Biden Administration can tackle other health priorities, the first order of business is the fight against the COVID-19 pandemic, which has killed more than 420 000 Americans—a death toll higher than that of any other nation—and has exposed health-care inequities and crippled the economy. …Although Biden will have a lot of support for his health-care agenda, “that doesn’t mean that it’s smooth sailing”, said Lanhee Chen, a public policy fellow at the Stanford University’s Hoover Institution. “I think there are still a lot of people who are very upset about the outcome of the election.” [Full story here.]…

New leadership at the US CDC

Volume 397, Issue 10270
16 January 2021

 

WORLD REPORT Rochelle Walensky, an infectious diseases expert, promises to provide transparency, accountability, and restored trust at the embattled organisation. Susan Jaffe reports from Washington, DC.  [Full story here.]

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Rochelle Walensky: New Director of the US CDC

Volume 397, Issue 10271 
14 January 2021
PROFILE  Rochelle Walensky 

A highly respected researcher, Walensky has published nearly 300 papers, many focused on the cost-effectiveness of HIV interventions and aimed at improving patients’ care. “I call the research that I do policy motivating”, Walensky says. One example is a 2006 landmark study showed that advances in HIV treatment in the USA added nearly 3 million years to patients’ lives.[Full story here.]…

US Supreme Court poised to keep the Affordable Care Act

Volume 396, Issue 10263
21 November  2020

 

WORLD REPORT A lawsuit to overturn the Affordable Care Act may be floundering after Supreme Court justices questioned why the law should be dismantled. Susan Jaffe reports from Washington, DC.

The fate of the Affordable Care Act (ACA) is again in the hands of the US Supreme Court, after close calls in lawsuits in 2012 and 2015. But last week’s hearing was different: justices who once voted to overturn the law— along with President Donald Trump’s recent court appointees—bombarded opponents with sceptical questions. 

After oral arguments in the case, known as California v. Texas, legal experts believe President Barack Obama’s signature health reform law is not in mortal danger.  [Continued here.] 

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