Category: The Lancet

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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Cycling safety concerns grow in US cities

Volume 394       Number 10211     16 November 2019   
WORLD REPORT As more bicycle riding is encouraged for health and environmental reasons, an increase in cycling deaths is causing a public health dilemma in the USA. Susan Jaffe reports.

Photo by Susan Jaffe Copyright © 2019

A record number of cycling deaths in the USA is attracting scrutiny from the US Congress, city officials, and the National Transportation Safety Board (NTSB), the government agency better known for investigating aeroplane crashes and other transportation disasters. …Last year, 859 cyclists were killed in road traffic crashes, the highest number in the USA since 1990, and a 6·3% increase since 2017, according to research from the US Department of Transportation’s National Highway Traffic Safety Administration published last month.
…In a preliminary report issued last week, the NTSB recommended that public officials take several steps to reduce the number of cycling deaths. The last time it examined bicycle safety was 47 years ago. [Continued here]  
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Congress and President Trump take on high drug prices

Volume 394       Number 10204     28 September 2019   
WORLD REPORT Proposals from the White House and Congress to lower prescription drug costs, which both rejected more than a decade ago, are making a comeback. Susan Jaffe reports.  
The Trump administration’s Department of Health and Human Services (HHS) is the first federal health agency to claim they are “open” to the idea of importing cheaper drugs from Canada and overseas. And both Republicans and Democrats in Congress now advocate familiar strategies to rein in drug price increases.  [Continued here]   
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US Planned Parenthood leadership shake-up

  Volume 394       Number 10195       27 July 2019   
WORLD REPORT Planned Parenthood’s board of directors decided to remove Dr. Leana Wen her after only 8 months, igniting a public debate about how the prominent women’s health-care organisation should best protect a woman’s right to abortion.[Continued here] 
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US Congress wants to take the surprise out of medical bills

Volume 393       Number 10191       29 June 2019   
WORLD REPORT A Texas high school teacher gets an unexpected hospital bill for $110,000 that his health insurance policy doesn’t cover. What can Congress do about it?   [Continued here]
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Trump administration limits fetal tissue research

Volume 393    Number 10189         15 June 2019   
WORLD REPORT    The move could threaten medical research advances, say scientists, as acquisition of new fetal tissue for research is substantially hindered. Susan Jaffe reports.              

“Many discoveries now in clinical practice and wide research use have come from human fetal tissue”, said Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine. “For these, there was—and still is—no substitute for human fetal tissue.”

…Anti-abortion groups praised the new policy, which would “separate federal research funding from the abortion industry”, said Melanie Israel, a research associate at the conservative Heritage Foundation… Yet how the new Trump research policy would reduce abortions is still unclear. “They are conflating pro-life issues and abortion with research”, said Jennifer Zeitzer, public affairs director at the Federation of American Societies for Experimental Biology. “But there’s no evidence that women are getting abortions so they can donate fetal tissue for research.”  [Continued here.]  …

Legal battles over abortion heat up in the USA

Volume 393    Number 10184               11 May 2019               
WORLD REPORT   Changes to Title X, several legal challenges, and a change to the Supreme Court composition could mean drastic changes for access to abortion in the USA. Susan Jaffe reports.

“We are the department of life…from conception until natural death, through all of our programmes”, US Department of Health and Human Services (HHS) secretary Alex Azar said earlier this year…. The government’s anti-abortion efforts have ignited lawsuits from Maine to California. Eventually, one or more of these cases are expected to reach the Supreme Court. With its newest arrival—Justice Brett Kavanaugh, whose nomination by Trump was championed by abortion opponents—the Supreme Court’s ideological balance has now shifted towards a conservative majority [raising] opponents’ hopes that a sympathetic court will diminish, if not overturn, Roe v. Wade...

Late last week, lawyers for the HHS appealed decisions by two federal court  judges in Oregon and Washington state to temporarily halt new administration rules that would limit the information about abortion services that federally funded health-care providers can tell their patients.    

“We are fighting back in the courts, we are fighting back in Congress and in state legislatures all across the country”, said Planned Parenthood president Leana Wen, noting that one in four women in the USA will have an abortion in their lifetime. “The public is with us when it comes to defending access to safe legal abortion, which people understand is part of the full spectrum of reproductive health care, which is health care.” [Continued here.]…

Doctors arrested in US crackdown on illegal opioids

Volume 393, Number 10182      

27 April 2019       

 

WORLD REPORT   The multiagency operation hit five states and led to the arrest of 60 people. Perpetrators face up to
50 years’ prison sentence if found guilty. Susan Jaffe reports.

Arrests of 31 doctors, pharmacists, and other health care professionals for allegedly prescribing and distributing illegal opioids affected some 28,000 of their patients. That’s why Department of Justice officials are working with state health departments, the Centers for Disease Control and Prevention and the Department of Health and Human Services to help patients by “… bringing enforcement and [opioid addiction] treatment closer together…than ever before,” says Benjamin Glassman, the US attorney for the southern district of Ohio. [Continued here.]
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