Rudy Giuliani wants FDA to fast-track a stem cell therapy for Covid-19; critics see political meddling
Rudy Giuliani, President Trump’s personal attorney, is urging the Food and Drug Administration to fast-track clinical trials of an experimental stem cell therapy in Covid-19 patients, prompting fears of political meddling in a scientific process meant to protect patients.
In recent days, Giuliani has used his Twitter account and podcast to tout the stem cell treatment being developed by a New Jersey biotech company, Celularity, despite scant evidence to date that its therapy will benefit Covid-19 patients.
On top of the overwhelming shortages of medical equipment required to combat Covid-19, there are now signs that medicines needed for patients who are placed on ventilators are also in short supply.
The medicines include more than a dozen sedatives, anesthetics, painkillers, and muscle relaxants, and the shortages raise the possibility that it could become more difficult for health care providers to place these patients on ventilators. This is because the drugs are used to help manage patient pain and comfort levels so they can benefit from mechanical ventilation.
Five years ago, I was working in Kono, a district in Sierra Leone, on projects to strengthen and reopen local health systems following the worst Ebola outbreak in history. The tasks included installing a basic electronic health record system in a local clinic, tracing contacts of people diagnosed with Ebola, and stimulating local economies. All of these activities depended on hiring, training, and mobilizing community health workers.
The results of that work impress me to this day. We should learn from them and consider employing them against Covid-19.
There is only a small window of time in which we can prevent widespread transmission of Covid-19 among people who are living on the streets or in shelters. Once the disease begins to spread in these groups, it will likely accelerate rapidly and be uncontainable, creating a crisis for the homeless and the entire community. This will undermine all efforts to slow the pace of the epidemic and will increase the disastrous consequences of Covid-19.
We offer a radical solution: Use suddenly empty and available living spaces — empty dorm and hotel rooms, abandoned offices — to provide safe, private housing for individuals and families who are living on the street or in shelters.
STAT Plus: Pharmalittle: A TB vaccine is tested against the coronavirus; FDA doesn’t punish Novartis over data integrity scandal
Hello, everyone, and how are you coping this morning? We are doing just fine, thank you, as we continue to adjust to this new world. Although we have largely worked in the confines of the Pharmalot campus for the better part of more than a dozen years, we are also altering certain routines and, of course, relying more than ever on the latest whiz-bang technologies. Even so, some things just do not change — such as firing up the coffee kettle for a cup of stimulation. We remain stuck on maple bourbon, by the way. So pick up your own cup and join me as we dig in for another busy. Stay safe and stay in touch.
A vaccine that has been used to prevent tuberculosis is being given to health-care workers in Melbourne, Australia, to see if it will protect them against the novel coronavirus, Bloomberg News writes. The bacillus Calmette-Guerin, or BCG, shot has been used widely for about 100 years, with a growing appreciation for its off-target benefits. The World Health Organization says it’s important to know whether the BCG vaccine can reduce disease in those infected with the coronavirus, and is encouraging international groups to collaborate with a study.
An embarrassing scandal that Novartis (NVS) endured over data integrity has quietly come to a close, with the Food and Drug Administration instructing the drug maker to correct the problem at its AveXis unit, but without imposing any penalties.
At issue was a delay in the disclosing to the agency that manipulated data existed for its Zolgensma gene therapy. Novartis became aware of the problem in March 2019, but did not inform the FDA until after the drug was approved last May. Zolgensma, which costs $2.1 million, is used to treat a type of spinal muscular atrophy and was developed by AveXis, which Novartis bought in April 2018.
As the pandemic deepens, physicians face an agonizing decision — to medicate or not to medicate?
Here’s the dilemma: Over the past few weeks, some small studies suggested a decades-old malaria drug called hydroxychloroquine may have the potential to combat the novel coronavirus known as Covid-19. And as the results trickled out, the tablet has become more valuable than gold.
Which is a better proxy for estimating the Covid-19 infection rate in the United States: the infection rate in the NBA or the infection rate in China or Italy? The answer to that question reveals some of the pitfalls of diagnostic Covid-19 testing.
Kevin Durant, Rudy Gobert, and at least eight other NBA players have tested positive for Covid-19. The Jazz, Pistons, Nets, Lakers, and Celtics have all reported at least one positive test result for an active player, with 10 detected cases among the roughly 75 standard contract players on these teams. If this is representative of the rest of the NBA, then 13% of players are positive. Even if every other NBA team tested all its players and found no other positive results (a strong and doubtful assumption), the prevalence of Covid-19 in the league would be about 2%. And that is the low end of the possible range.
As coronavirus impact grows, volunteer network tries to help health care workers who have ‘helped us’
It started with a need: With the closure of schools and a shortage of household supplies in local stores, health care professionals responding to the Covid-19 pandemic were struggling to support their families.
In Minneosta, a couple of medical students came up with an idea. Why couldn’t they help try to relieve the burden?
The coronavirus outbreak has rapidly accelerated the nation’s slow-moving effort to incorporate artificial intelligence into medical care, as hospitals grasp onto experimental technologies to relieve an unprecedented strain on their resources.
AI has become one of the first lines of defense in the pandemic. Hospitals are using it to help screen and triage patients and identify those most likely to develop severe symptoms. They’re scanning faces to check temperatures and harnessing fitness tracker data, to zero on individual cases and potential clusters. They are also using AI to keep tabs on the virus in their own communities. They need to know who has the disease, who is likely to get it, and what supplies are going to run out tomorrow, two weeks from now, and farther down the road.
STAT Plus: ‘It’s the disparity in who gets affected’: A sickle cell doctor tracks dollars and drug development
Sickle cell disease and cystic fibrosis are both rare, genetic diseases. While there are three times as many people (predominantly of African ancestry) in the U.S. with sickle cell disease compared to people (predominantly of European ancestry) with cystic fibrosis, research dollars are the same, after tallying federal funding from the National Institutes of Health and disease-specific foundations.
That per-patient funding gap has been known for decades. A new study, published in JAMA Network Open, translated those differing amounts into results: funding for researchers, scientific publications presenting discoveries, and drugs to treat patients. A team led by Duke hematologist John Strouse found a similar number of clinical trials but more scientific papers and drugs for cystic fibrosis.
Streets in cities and towns across the country are eerily quiet. Car traffic has dropped so substantially air pollution is abating. In many places, people are hunkered down indoors, trying to avoid contracting Covid-19.
But the true battle against the SARS-CoV-2 virus, which causes the disease, is playing out in hospitals that are currently — or will soon be — engulfed in an onslaught of patients struggling to breathe.
In Lake Success, a village on the border of suburban Long Island and the New York City borough of Queens, there is a building that was erected to house defense engineers during World War II. It was designed to withstand enemy bombing, with a pool of water on the roof to help camouflage it in the event of airstrikes.
Today, it is on the front line of a very different war.
What explains Covid-19’s lethality for the elderly? Scientists look to ‘twilight’ of the immune system
Researchers on Monday announced the most comprehensive estimates to date of elderly people’s elevated risk of serious illness and death from the new coronavirus: Covid-19 kills an estimated 13.4% of patients 80 and older, compared to 1.25% of those in their 50s and 0.3% of those in their 40s.
The sharpest divide came at age 70. Although 4% of patients in their 60s died, more than twice that, or 8.6%, of those in their 70s did, Neil Ferguson of Imperial College London and his colleagues estimated in their paper, published in Lancet Infectious Diseases.
Amarin shares fell sharply Monday evening after a federal judge ruled that key patents covering its heart drug Vascepa were invalid.
The decision is a victory for two drug makers, Hikma Pharmaceuticals and Dr. Reddy’s Laboratories, seeking to make and sell generic versions of Vascepa.
Opinion: It’s past time to fully deploy the U.S. Public Health Service Commissioned Corps to fight Covid-19
Controlling a pandemic like Covid-19 requires both the intervention of government agencies and changes in the lives of ordinary Americans.
One thing the federal government should do, but hasn’t, is fully deploy the U.S. Public Health Service Commissioned Corps (USPHS). Not only can the Corps support health systems in rapidly scaling medical care, it can also advise state governments on the judicious use of state police powers to help slow the spread of the virus and limit economic damage.
Biotech VC Bob Nelsen called it right on the coronavirus. Now he has thoughts on therapeutics — and masks
Bob Nelsen was right.
The co-founder and managing partner of Arch Venture Partners is one of biotech’s most successful venture capitalists. He’s also deeply wary of unchecked viruses, a fear he shares regularly with friends, family, and his Twitter followers. “Flu. Get shot. Get antivirals. Don’t die,” Nelsen tweeted right before Christmas.
STAT Plus: Pharmalittle: Drug pricing legislation is on the back burner; FDA issues emergency use for old malaria drugs
Good morning, everyone, and welcome to another working week, although it may not quite seem that way, if only because you most likely have not moved very much since waking this morning. Nonetheless, we hope the weekend respite provided some sort of respite from the deluge of headlines and anxieties afflicting our world. In any event, the time has come to assume what resembles the usual routine of online meetings and deadlines. So grab a cup of stimulation and get started. On that note, here are a few tidbits to help you along. Stay safe and stay in touch.
A recent $2 trillion relief package that lawmakers passed on Friday could mean drug pricing advocates might be waiting a long while for legislation, possibly until November, weeks after Election Day, STAT reports. Until now, late May was widely viewed as a final 2020 deadline for lawmakers to take action on key health policy issues, including legislation to lower the price of prescription drugs. “I think Nov. 30 is the new May 22,” says Ben Wakana, the executive director of the advocacy group Patients for Affordable Drugs Now.
A team of academic and industry researchers led by Jennifer Doudna, the researcher best known for her role in the discovery of the gene editing technology called CRISPR, has turned a 2,500-square-foot scientific laboratory into a facility for running medical tests to detect the novel coronavirus that causes Covid-19.
The laboratory, which plans to serve hospitals in the San Francisco Bay Area, says it will be able to process more than 1,000 patient samples a day with a 24-hour turnaround, Doudna announced Monday. The lab will ramp up to processing 3,000 samples a day if necessary.
STAT Plus: AC Immune bets that its Alzheimer’s trial design could provide a cleaner test of the amyloid hypothesis
The fate of aducanumab, a potential Alzheimer’s treatment from Biogen, is widely seen as the last hope for an aging idea: that targeting toxic brain plaques can arrest the progress of the disease.
But there’s a similar, less-discussed Alzheimer’s treatment working through a pivotal trial. And its outcome, positive or negative, could shift the yearslong debate over how best to target Alzheimer’s. The drug is crenezumab, and like Biogen’s treatment, it’s meant to bind to beta-amyloid plaques in the brains of patients with Alzheimer’s. But AC Immune, the company behind crenezumab, is taking a novel approach to testing its worth. Instead of casting a wide clinical net for people with Alzheimer’s symptoms, the company has recruited only patients with a rare genetic mutation that almost guarantees they will develop the disease — and will treat them before any signs of dementia emerge. The study, conducted in Colombia, is expected to generate data in early 2022.