Emergent BioSolutions was awarded a $628 million federal contract with no competitive bidding. Top executives received big bonuses while factories mostly sat idle and tens of millions of Covid-19 doses were thrown away.
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
The F.D.A. advised Johnson & Johnson on Friday that it should throw out the equivalent of 60 million doses produced at the Baltimore plant.
With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing without a permanent commissioner.
The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.
Regulators allowed a new antifungal treatment, but critics say it is unneeded and costs too much.
Vaccine requirements were designed mostly for American students. That is presenting hurdles for many international students without access to one of the eight vaccines approved by the W.H.O.
The insects have emerged by the billions this year across the Eastern United States and have curious foodies salivating. But their similarities to crustaceans makes them an allergy risk, health officials warned.
According to prosecutors, the F.D.A. learned that at least five children had experienced acute non-viral hepatitis, which can lead to liver failure, after drinking the father and son’s Re²al Water products.
About 17 million children in the age group are newly eligible for the vaccine, the biggest indication yet that life could soon return to something more like normal for American teenagers.
Covid-19 may end up inadvertently speeding up abortion progress in America — and exposing conservative hypocrisy along the way.
The hope is that new treatments will encourage people to think of obesity as a chronic disease, like high blood pressure or diabetes.
The F.D.A.’s authorization of Pfizer’s Covid shot for 12- to 15-year-olds is a milestone in battling the coronavirus, but actually getting them vaccinated involves new challenges.
The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.
A new study shows that MDMA, known as Ecstasy or Molly, can bring relief when paired with talk therapy to those with severe post-traumatic stress disorder.
In the early 2000s, Jeff Bezos gave a seminal TED Talk titled “The Electricity Metaphor for the Web’s Future.” In it, he argued that the internet will enable innovation on the same scale that electricity did.
We are at a similar inflection point in healthcare, with the recent movement toward data transparency birthing a new generation of innovation and startups.
Those who follow the space closely may have noticed that there are twin struggles taking place: a push for more transparency on provider and payer data, including anonymous patient data, and another for strict privacy protection for personal patient data. What’s the main difference?
This sector is still somewhat nascent — we are in the first wave of innovation, with much more to come.
Anonymized data is much more freely available, while personal data is being locked even tighter (as it should be) due to regulations like GDPR, CCPA and their equivalents around the world.
The former trend is enabling a host of new vendors and services that will ultimately make healthcare better and more transparent for all of us.
These new companies could not have existed five years ago. The Affordable Care Act was the first step toward making anonymized data more available. It required healthcare institutions (such as hospitals and healthcare systems) to publish data on costs and outcomes. This included the release of detailed data on providers.
Later legislation required biotech and pharma companies to disclose monies paid to research partners. And every physician in the U.S. is now required to be in the National Practitioner Identifier (NPI), a comprehensive public database of providers.
All of this allowed the creation of new types of companies that give both patients and providers more control over their data. Here are some key examples of how.
Allowing patients to access all their own health data in one place
This is a key capability of patients’ newly found access to health data. Think of how often, as a patient, providers aren’t aware of treatment or a test you’ve had elsewhere. Often you end up repeating a test because a provider doesn’t have a record of a test conducted elsewhere.
Agency leaders say the move is a science-based approach to curbing addiction and will save hundreds of thousands of lives over time.
The move has been long sought by public health and civil rights groups, after decades of marketing aimed at Black smokers.
Between 1920 and 2020, the average human life span doubled. How did we do it? Science mattered — but so did activism.
President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a four-alarm fire.”
Sesame becomes a “major allergen,” joining milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.
A Florida grand jury indicted a man and his three sons, accusing them of marketing an “unproven and potentially harmful” solution as a remedy for Covid-19, cancer, autism and more.
Top federal health officials said in interviews this week that the number of rare blood clotting disorders in recipients of the Johnson & Johnson vaccine has remained small.
Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.
The U.S. government invested $800 million in plasma when the country was desperate for Covid-19 treatments. A year later, the program has fizzled.
Arizona follows a model that lets the government ignore questions of cruelty.
An advisory committee debated the very few cases of a rare blood disorder and worried about the suspension’s effect on global needs for a one-shot, easy-to-ship vaccine.
There might have been better ways to handle the situation, but officials did what they had to do.
Health departments scrambled to postpone vaccine clinics and rebook patients after the one-dose offering from Johnson & Johnson was sidelined.
Some public health officials fear that the pause on the Johnson & Johnson vaccine may fuel vaccine hesitancy and expose more Americans to a bigger danger: the coronavirus.
The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or hospital.
Out of an “abundance of caution,” the F.D.A. is advising doctors to pause the Johnson & Johnson vaccine while it investigates extremely rare blood clots.
The Food and Drug Administration and the Centers for Disease Control will stop using the vaccine at federal sites and urge states to do so as well while they investigate the safety issues.
Relatively simple technology and a change in government policy could unleash more innovation for Americans who have difficulty hearing.
The most common questions about vaccination side effects, answered.
I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis on helping people in distress today.
The debate among doctors, epidemiologists and economists is still going strong.
A manufacturing subcontractor in Baltimore mixed ingredients from the coronavirus vaccines of Johnson & Johnson and AstraZeneca, setting back U.S. production of the “one-and-done” shot.
A clinical trial found no symptomatic infections among vaccinated children ages 12 to 15, the companies said, and there were no serious side effects. The data have not yet been reviewed by independent experts.
Vibrant, a medical technology company that’s developed a disposable vibrating pill to treat chronic constipation, today announced its Series E for $7.5 million. The company is based in Tel Aviv and is lead by Lior Ben-Tsur, a startup veteran. Since its founding in 2007, the company has raised a total of $25 million. This round is being led by Unorthodox Ventures with participation by Sequoia.
Vibrant, which is going through its third and final round of Food and Drug Administration (FDA) testing, plans to launch in the U.S. in the next year. The capsules are about the size of a multi-vitamin, Ben-Tsur said.
“Patients are used to taking drugs day in and day out, so this wouldn’t be a different experience in that regard, but this pill doesn’t have any medication,” Ben-Tsur said. While Ben-Tsur is not a founder, he was brought on about 10 years ago to serve as the company’s CEO.
According to a study published in the American Gastroenterological Association, about 16% of American adults suffer from constipation, and the number jumps to 33.5% in adults between the ages of 60-101. Also, constipation is 1.5 times more common in women than in men.
The most common way to treat constipation is through the use of over-the-counter or prescription drugs, most of which target the nerves in the colon which in turn prompt a bowel movement. The Vibrant Capsule, however, “once swallowed, kickstarts the natural impulses of your intestinal wall to contract, relax and get things moving again — without the use of chemicals,” the company said in a statement.
In addition to being medication-free, the value of Vibrant over laxatives, according to the company, is that the bowel movements are more controlled, whereas laxatives can cause unexpected diarrhea and long-term side effects. Also, while laxatives are meant to be taken on a daily basis, the disposable capsule can be used anywhere from 2-5 times per week. The capsules connect to an app that automatically records when you take a pill, and upon having a bowel movement, the person notes it in the app which then sends a monthly report to the patient’s doctor, allowing them to monitor and adjust the treatment protocol as necessary.
In a 2019 human trial organized by Vibrant, 250 patients were enrolled in a double-blind study (Vibrant Capsule = 133, placebo = 117). The results showed that those who took the Vibrant Capsule were more likely to experience a bowel movement within three hours. The trial details and the results were published in the journal of Neurogastroenterology and Motility.
Several years ago a group of doctors and engineers performed a test in a live pig’s colon, and accidentally pinched the side of the colon wall. As a result, they noticed that the pig promptly had a bowel movement. The test was actually about something totally unrelated to constipation, and the results were a random discovery. To replicate the effects, the team created a vibrating belt that when worn for about three hours, would also cause a bowel movement.
“The problem is no one wants to shake for three hours to have a bowel movement,” said Ben-Tsur. With this information in hand, the group set out to develop a treatment for constipation in humans that would produce similar results but where the vibrations couldn’t be felt. There were other mechanical capsules already on the market such as the Smart Pill, a mechanical diagnostic capsule that reports on generalized motility through the entire digestive tract and aids doctors in diagnosing motility disorders, so the team knew that people could safely swallow and excrete capsules.
According to Ben-Tsur, there hasn’t been any development in the treatment of constipation in the last 20 years — the treatment protocol has continued to focus on medication. When he learned about the market size, the lack of innovation in the space, and the potential, he was convinced that he wanted to lead Vibrant.
Vibrant plans on using this round of funding to take the capsule to market in the U.S. — its first market. The company is currently speaking with healthcare providers and insurance companies so that the capsule will be covered by insurance starting at the time of launch. The Smart Pill, while only used once as a diagnostic test, is still not covered and costs, on average, about $1,400 out of pocket. Ben-Tsur and his team aim to offer a product that is accessible. “From day one we were on a mission to build something that wouldn’t be more expensive than existing drugs,” he said.
Bobby Wayne, a retired reverend, called the state seeking help getting the vaccine. He said he was told there was no evidence the vaccine was effective.
Advocates are hoping that President Biden will soon come out in favor of banning mint-flavored cigarettes and other tobacco products.
The vaccine maker is preparing to apply for emergency authorization from the Food and Drug Administration. But the vaccine may not be needed in the United States.
As coronavirus infection rates decline, fewer are getting tested for the virus. The Biden administration wants to reverse that to ensure that schools and workplaces can reopen safely.
The United States has more vaccines lined up than it needs. It should be distributing them to countries that have little to none.
There is no evidence so far of a link between the AstraZeneca shots and a few new cases in Europe of serious illness and deaths. But investigations are underway.
He was the first hospital official to question the use of an unregulated vitamin injection linked to the deaths of 38 infants. He died of coronavirus complications.
Those tens of millions of doses from AstraZeneca are waiting for trial results, while countries that authorized the vaccine beg to have them.