How the Covid-19 pandemic upended the American health care system
My colleague Lev Facher spoke to some of America’s leading health care thinkers, from Donna Shalala and Don Berwick to Billy Tauzin and Brian Blase, about the impact of Covid-19 on the U.S. health care system. They all agreed: The pandemic has shattered some long-standing assumptions about America’s health care system and could seriously shake up everything from how we care for our elderly to where our drugs are made.
For more, check out Lev’s story here.
Unpacking the FDA’s role in Operation Warp Speed
On Friday, President Trump formally unveiled Operation Warp Speed, the administration’s new effort to accelerate development of potential covid-19 treatments and vaccines. The effort is headed by Army General Gustave F. Perna and former GlaxoSmithKline executive and venture capitalist Moncef Slaoui. Already, there have been cries from activists over Slaoui’s potential conflicts of interest; He has investments in many of the companies rumored to be involved in the effort. But STAT is paying attention to another potential conflict of interest too: At the FDA.
Janet Woodcock and Peter Marks, who head the FDA’s drug and biologic centers, respectively, will oversee Warp Speed’s efforts on therapeutics and vaccines. The inclusion of top FDA brass in the effort is already concerning activists who have long sounded the alarm over industry influence at the FDA — an agency with a mission to skeptically review safety and efficacy evidence for drugs, not push for their approval.
“For such senior FDA officials to be serving on the public-private partnerships blurs the line between the FDA and regulatory industry to an unprecedented degree,” said Michael Carome, director of Public Citizen’s health research group. “Such relationships could undermine the integrity of the FDA’s review of medical products that result from this partnership.”
Another advocate, National Center for Health Research President Diana Zuckerman called the news “beyond frightening.”
Already the FDA is attempting to assuage these concerns. Both Woodcock and Marks will continue as the director of their centers, but will “recuse themselves from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to COVID-19,” according to an FDA-wide email sent to staff from Commissioner Stephen Hahn on Sunday, which was obtained by STAT.
Carome says that’s not enough. “The problem is that other FDA staff below Woodcock and Marks will be involved in these approval decisions, and it is doubtful that an effective firewall can be created between these agency leaders and those below them," he added.
Janet Woodcock and Peter Marks, who head the FDA’s drug and biologic centers, respectively, will oversee Warp Speed’s efforts on therapeutics and vaccines. The inclusion of top FDA brass in the effort is already concerning activists who have long sounded the alarm over industry influence at the FDA — an agency with a mission to skeptically review safety and efficacy evidence for drugs, not push for their approval.
“For such senior FDA officials to be serving on the public-private partnerships blurs the line between the FDA and regulatory industry to an unprecedented degree,” said Michael Carome, director of Public Citizen’s health research group. “Such relationships could undermine the integrity of the FDA’s review of medical products that result from this partnership.”
Another advocate, National Center for Health Research President Diana Zuckerman called the news “beyond frightening.”
Already the FDA is attempting to assuage these concerns. Both Woodcock and Marks will continue as the director of their centers, but will “recuse themselves from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to COVID-19,” according to an FDA-wide email sent to staff from Commissioner Stephen Hahn on Sunday, which was obtained by STAT.
Carome says that’s not enough. “The problem is that other FDA staff below Woodcock and Marks will be involved in these approval decisions, and it is doubtful that an effective firewall can be created between these agency leaders and those below them," he added.
Democrats’ coronavirus wish list
The House passed its fourth coronavirus response package, the HEROES Act, on Friday. The sweeping $3 trillion package is likely to go nowhere in the Senate, and the president has already indicated he will veto the package. But the bill provides a telling roadmap of how House Democrats would rework America’s health care system if they controlled the Senate and the White House. Here’s a few big-picture items that stood out to me:
Medicaid, no longer America’s neglected health program.
The HEROES Act would seriously ramp up federal support for the Medicaid program, which advocates say has long suffered from federal neglect and underfunding.
There’s a number of Medicaid-related provisions in the HEROES Act — 50 pages worth, in fact. The bill would increase federal funding for Medicaid in every state and territory, and restore Medicaid eligibility to residents of the so-called freely-associated states, like the Marshall Islands, which were promised Medicaid coverage nearly 40 years ago. The legislation would also prevent the Trump administration from finalizing a sweeping regulation that hospitals and Medicaid advocates claim would have forced states to seriously cut back their Medicaid programs.
What happened to Medicare For All?
Medicare for All activists have insisted that the coronavirus pandemic is as good of a time as ever to expand Medicare coverage. Already Sen. Bernie Sanders has introduced a bill that would cover uninsured Americans under Medicare until a Covid-19 vaccine is widely available. But instead of taking Sanders up on that idea, Democrats decided to prop up COBRA, the transitional insurance program that allows newly unemployed people to keep their previous employers’ health insurance for a short period. The HEROES Act would direct the government to fully pay COBRA enrollees’ insurance premiums. The proposal is being slammed by Medicare For All backers, including Sanders, as a “massive giveaway to health insurance CEOs.”
More money for BARDA!
Democrats are proposing another $4.5 billion in funding for BARDA, the tiny federal office that has been roiled by controversy after its director Rick Bright claimed he was ousted for refusing to prop up scientifically dubious Covid-19 treatments.
The funding bump is all the more striking given Congress already more than tripled BARDA’s budget as part of the last coronavirus response package. Prior to the coronavirus pandemic, BARDA was operating with a roughly $1.4 billion budget. Under Democrats’ plan, the office would have more than $9 billion to play with.
More coronavirus coverage from STAT
STAT pieced together one state’s eyebrow-raising embrace of hydroxychloroquine — and its subsequent efforts to correct course.
STAT’s Helen Branswell unpacks some good news from Moderna Therapeutics.
Peer inside the lives of the army contract tracers studying the spread of Covid-19.
Alex Azar had some particularly pointed words for the World Health Organization.
What’s a reasonable price for remdesivir? There’s little agreement among experts, according to STAT’s Damian Garde and Ed Silverman.
ALS Activists bring the fight back to the White House ... with body bags
The activist group “No More Excuses ALS,” which has been pushing for early access to experimental ALS treatments, including BrainStorm Cell Therapeutics’ NurOwn, will be protesting outside the White House and the Department of Health and Human Services this Wednesday. The protest will include activists lying outside the buildings in body bags emblazoned with messages like: "Killed by Congress, the FDA, and ALSA," a reference to the ALS Association’s acronym. Other signs will proclaim the "FDA is committing murder by not approving these ALS trials now.”
Already, the group is pointing to the FDA’s efforts to fast track approval of potential Covid-19 treatments as evidence that the FDA can further accelerate the approval of ALS treatments.
Already, the group is pointing to the FDA’s efforts to fast track approval of potential Covid-19 treatments as evidence that the FDA can further accelerate the approval of ALS treatments.
STAT stories you may have missed
STAT has the exclusive on BIO’s new CEO, Michelle McMurry-Heath.
Pfizer says efficacy of its Duchenne gene therapy outweighs side effects.
A new analysis from Tufts University finds that women and Black people are poorly represented in pivotal drug trials.
CVS’s long-term care pharmacy has been ordered to pay $15 million for failing to adequately track opioids and allowing the substances to be dispensed without valid prescriptions.
No hay comentarios:
Publicar un comentario