Category: The Lancet

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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US election 2020: the future of the Affordable Care Act

Volume 396, Number 10260     31 October 2020 

WORLD REPORT   President Donald Trump pledges to replace the Affordable Care Act while his Democratic opponent Joe Biden offers detailed proposals to improve it. Susan Jaffe reports from Washington, DC.

Since winning the presidency in 2016 in large part by promising to eliminate Obamacare, otherwise known as the Affordable Care Act (ACA), Donald Trump has promised more than a dozen times that his replacement plan would be ready soon. The plan would be released in 2 weeks, a White House spokeswoman said 2 months ago.

“We’re going to have a health-care plan that will be second to none”, Trump said in 2017. “It’s going to be great and the people will see that.” And at last week’s final presidential debate, he vowed “to terminate Obamacare, [and] come up with a brand new beautiful health care”.

A decade after the ACA—President Barack Obama’s signature achievement—became law, repealing and replacing Obamacare is again central to Trump’s re-election. And improving and expanding the law is a crucial part of the campaign of his challenger, former Vice President Joe Biden. [Continued here.]     

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US election 2020: research and health institutions

Volume 396, Number 10259

24 October 2020

 

WORLD REPORT   How will the NIH, CDC, and FDA change if President Donald Trump wins a second term or if his Democratic challenger, Joe Biden, defeats him? Susan Jaffe reports from Washington, DC. 

Whoever wins the presidency needs to “restore the CDC and improve it by letting [scientists] know that they will have an opportunity to do the best science and make the best recommendations…” says James Curran, dean of the Rollins School of Public Health at Emory University in Atlanta. [Continued here.]…

US election 2020: public health

Volume 396, Number 10256

3 October 2020

 

WORLD REPORT   In the race for the White House, where do US President Donald Trump and his Democratic challenger, former Vice President Joe Biden, stand on public health? Susan Jaffe reports from Washington, DC. 

Analyzing the candidates’ plans to address the opioid epidemic, gun violence, women’s health, global health and COVID-19.

Unlike more conventional presidential candidates, Trump does not intend to issue formal policy proposals or position papers. With less than 5 weeks remaining before the election, his campaign says he will share “details about his plans through policy-focused speeches on the campaign trail”. …Joe Biden’s campaign has released a total of 51 policy proposals outlining how he will accomplish his goals if he wins in November. [Continued here.]…

Media reports reveal political interference at the US CDC

Volume 396, Number 10255

26 September 2020

 

WORLD REPORT  News accounts say that Trump administration officials wanted to edit and approve COVID-19 studies and publish guidance without the usual scientific review. Susan Jaffe reports.

After news stories about attempts by members of the Trump administration to manipulate COVID-19 reports published by the US Centers for Disease Control and Prevention (CDC) and over-rule its scientists, one top official is taking a sudden leave of absence for health reasons. Another’s government contract has abruptly ended. The 2-month absence of Michael Caputo, chief spokesman for the US Department of Health and Human Services (HHS), comes after he claimed that a CDC “resistance unit” seeks to undermine Trump. He and an adviser reportedly demanded the right to revise and approve COVID-19 studies published in the CDC’s highly respected Morbidity and Mortality Weekly Report journal.  [Continued here.]…

US Supreme Court upholds abortion rights, for now

Volume 396, Number 10244

11 July 2020

 

WORLD REPORT The court’s decision means that Louisiana’s three abortion clinics will remain open. Susan Jaffe reports.

The US Supreme Court delivered the Trump administration’s third defeat in as many weeks when it overturned a Louisiana law requiring physicians who provide abortions to have local hospital-admitting privileges.

In an opinion written by Justice Stephen Breyer, the court declared on June 29 that “enforcing the admitting privileges requirement would drastically reduce the number and geographic distribution of abortion providers, making it impossible for many women to obtain a safe, legal abortion in the State and imposing substantial obstacles on those who could”.  [Continued here.]…

LGBTQ discrimination in US health care under scrutiny

Volume 395    Number 10242     
27 June 2020                          
WORLD REPORT  A US Supreme Court ruling could undermine the Trump Administration’s plan to roll back some protections against sex discrimination. Susan Jaffe reports. 

The Trump administration suffered a major defeat last week a major defeat last week in the US Supreme Court, which could undermine its attempt to scrap protections under the Affordable Care Act (ACA) against sex discrimination. In a landmark decision on June 15, the court ruled that the Civil Rights Act protects gay and transgender workers from discrimination by their employers. But days later, Trump Administration officials at the Department of Health and Human Services (HHS) finalised a more permissive standard for discrimination in health care. [Continued here.]  

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Federal Regulators split on antimalarials for COVID-19

Volume 395    Number 10231     
11 April 2020                          
WORLD REPORT   US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and WHO say the science doesn’t support the decision. Susan Jaffe reports. 
With no “adequate, approved and available” alternative, the US Food and Drug Administration (FDA) is allowing the use of the antimalarial drugs hydroxychloroquine and chloroquine to treat coronavirus disease 2019 (COVID-19).

The FDA’s emergency use authorisation (EUA) issued last week gives physicians the option to prescribe the drugs, which President Donald Trump has recommended. However, both drugs are unproven and untested for COVID-19, and have rare but potentially deadly side-effects.  The decision bypassed the usual drug approval process including doubleblind, placebo-controlled clinical trials, stoking a worldwide debate about whether the drugs are appropriate for treating the disease.

“I think it was resorted to more out of a sense of desperation”, said Joseph Masci, an infectious disease specialist and director of global health at Elmhurst Hospital in Queens, a borough of New York City, which is at the centre of the epidemic in the USA. “It is just an indication of how sudden and massive this outbreak has been.” [Continued here.]  

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Leadership changes at USAID

Volume 395    Number 102295     28 March 2020                          
WORLD REPORT  Mark Green, the respected head of the US Agency for International Development, has resigned. Susan Jaffe reports from Washington.  
“The timing is unfortunate”, said Jen Kates, senior vice president and director for global health and HIV policy at the Kaiser Family Foundation. “The agency is going to be significantlychallenged by the COVID-19 pandemic, potentially at a level that it has not seen before.” [continued here]
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Medicare for All scrutinised in Democratic primaries

Volume 395       Number 10225     29 February 2020                          
WORLD REPORT  On March 3, 14 states will pick their nominees for the US presidential election. The feasability of a single payer insurance plan is a key issue. Susan Jaffe reports from Washington, DC.
Anxiety about rising health-care costs— the top issue for Democratic voters, according to recent polls—propelled Bernie Sanders to the head of the pack in last week’s Democratic primary contest in Nevada. Of the six leading candidates vying for the party’s presidential nomination, Sanders, a Vermont senator and self-described democratic socialist, has proposed the most radical solution for lowering medical bills and reaching universal coverage. His signature policy initiative, the Medicare for All single-payer programme, would eliminate private health insurance, including employment-based plans that cover about half of the US population. [Article compares Medicare for All and the public option proposal favoured by former Vice President Joe Biden; continued here]
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Decisions to be made on US gun violence research funds

Volume 395       Number 10222     8 February 2020   
WORLD REPORT  The National Institutes of Health and the Centers for Disease Control and Prevention will decide how to spend new federal funds later this year. Susan Jaffe reports from Washington, DC.
After a hiatus of more than two decades, Congress and President Donald Trump agreed to add funding for gun violence research to the federal budget in December. With grants expected to be awarded in September, the priorities for research and its potential impact are crucial for halting the US’s record-breaking gun-related death toll. [Continued here.]   
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Will Trump snuff out e-cigarettes?

Volume 394       Number 10213     30 November 2019   
WORLD REPORT President Trump promised to ban flavoured e-cigarettes, but 11 weeks later, they are still on the shelves. Susan Jaffe reports from Washington. 
When US President Donald Trump announced a plan on Sept 11 to prohibit the sale of most flavoured electronic cigarettes, more than 450 people in the USA had a mysterious lung disease associated with vaping, and six had died, according to the Centers for Disease Control and Prevention (CDC). The ban would be finalised within 30 days, said Health and Human Services Secretary Alex Azar.
The number of cases of the lung disease has since soared to 2290, as of Nov 20, in 49 states, Washington, DC, and the US Virgin Islands. 47 e-cigarette smokers (vapers) have died, according to the CDC. However, as this report went to press, officials from the Trump administration would not disclose when the promised ban would be issued.
…The decision [to implement] a nationwide ban is up to President Trump. “It is a chain of command”, said Robert Califf, a professor of cardiology at Duke University School of Medicine and the FDA commissioner under Trump and former President Barack Obama. “The commissioner reports to the Secretary of Health and Human Services [HHS]and the secretary reports to the president. FDA policies are de facto policies of the Executive Branch, so if the HHS secretary or president chooses to do so, they can intercede.”  [Continued here]  
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