Sunday, October 17News That Matters

Tag: Food and Drug Administration

How Covid Misinformation Created a Run on Animal Medicine

Technology
Ruth Jeffers, who owns Jeffers, the animal supplies retailer, said she had sold out of ivermectin paste on her website this year. After she restocked with more expensive versions, those tubes sold out, too.So this spring, she limited new customers to five tubes. Partly driven by the demand, she raised prices for Jeffers-branded ivermectin, her cheapest option, to $4.99 a tube from $2.99 — and then to $6.99.“It’s hard having your No. 1 product turn into a circus,” Ms. Jeffers said.At the Horsey Haven Retirement Home in Newcastle, Calif., a boarding stable for retired horses, the lack of affordable ivermectin recently caused a debate about costs. Laura Beeman, Horsey Haven’s owner, said she had long used the drug to kill worms in the stable’s 28 horses. The treatments take place four times a...

Biden Promised to Follow the Science. But Sometimes, He Gets Ahead of the Experts.

Technology
WASHINGTON — As he announced on Friday that booster shots would be available to some Americans, President Biden made a prediction: His administration was likely to soon provide third doses of the vaccine “across the board” to anyone who wanted one.“In the near term, we’re probably going to open this up,” he told reporters in remarks from the State Dining Room at the White House.But that assessment — a politically popular one in a country where most people vaccinated against the coronavirus say they are eager for a booster — was the latest example of how Mr. Biden and some of his team have been ahead of the nation’s top public health scientists, who have emphatically said in recent days that there is simply not enough evidence to suggest that boosters are necessary for the entire American p...

Where Did It All Go So Wrong for Juul?

Technology
‘Move Fast and Vape Things’Producer/Director John PappasReporter/Producer Sheila KaplanReporter Julie CreswellWatch on Friday, Sept. 17, at 10 p.m. on FX, and stream it on Hulu.Adam Bowen and James Monsees, by their own telling, set out to improve the lives of a billion people by getting them off cigarettes.But somewhere on the path from fledgling start-up to Silicon Valley juggernaut, their company, Juul, went tragically off course. Instead of upending Big Tobacco and hastening the end of smoking, Juul’s flavored e-cigarettes became a popular on-ramp for a new generation of nicotine addicts.Attracted by the candy fruit flavors and vibrant marketing, teenagers like Jackie Franklin found that Juul packed an undeniable rush of nicotine, which she increasingly craved. After becoming hooked in...
Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

Technology
Wading into an acrimonious debate over booster doses, researchers in Israel reported on Wednesday that a third dose of the Pfizer-BioNTech coronavirus vaccine can prevent both infections and severe illness in adults older than 60 for at least 12 days.The study, published in the New England Journal of Medicine, is the latest salvo in the conflict over whether booster doses are needed for healthy adults and whether they should be given out, as the Biden administration plans to do, when so much of the world remains unvaccinated.Several independent scientists said the cumulative data so far suggest that only older adults will need boosters — and maybe not even them.Vaccination remains powerfully protective against severe illness and hospitalization in the vast majority of people in all of the ...
The Best Birthday Present in 2021? A Covid Vaccine.

The Best Birthday Present in 2021? A Covid Vaccine.

Technology
Zoe Tu, a seventh grader in Brooklyn, likes to celebrate her birthday with dulce de leche Haagen-Dazs ice cream cake. This year, her 12th, was no exception, but the day was also marked by a treat of another kind: her Covid vaccine.Zoe got the shot the first day she became eligible, on Aug. 2, and it was accompanied by a $100 gift certificate given as a vaccine incentive at the Barclays Center. (Her mother allowed her to spend it on anything she wanted.)“The nurse was really excited about wishing me a happy birthday,” Zoe recalled.Zoe’s mother, Nicole Tu, said she had told her daughter she could wait if she wanted. But, Zoe said: “I knew that was the quickest I could get it. I was excited because I could feel safer.”Many birthdays are rites of passage, especially for young people. Getting t...
Health Officials Advise Biden to Scale Back Covid-19 Booster Shots Plan For Now

Health Officials Advise Biden to Scale Back Covid-19 Booster Shots Plan For Now

Technology
WASHINGTON — Top federal health officials have told the White House to scale back a plan to offer coronavirus booster shots to the general public this month, saying that regulators need more time to collect and review all the necessary data, according to people familiar with the discussion.Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House on Thursday that their agencies may be able to determine in the coming weeks whether to recommend boosters only for recipients of the Pfizer-BioNTech vaccine — and possibly just some of them to start.The two health leaders made their argument in a meeting with Jeffrey D. Zients, the White House pandemic coordinator....
C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

Technology
Dr. Jose U. Scher, a rheumatologist at NYU Langone Health who has studied the effect of vaccines on the immunocompromised, said that the C.D.C. vote — and the guidance from its experts — would help patients who had been agonizing over whether to seek out a third shot. Previously, he said, when people tested themselves for antibodies after vaccination and came up empty, “there were no tools for us to respond to that.”Updated Aug. 14, 2021, 4:41 p.m. ET“We now know that this population was being left behind,” he said.Immunocompromised people will not need a doctor’s permission or a prescription to get a third shot, C.D.C. officials said. They will need only to attest that they meet the eligibility requirements for an additional dose. Anyone else, including people with chronic medical co...
As Virus Cases Surge, Biden Administration Encourages More Use of Antibody Treatments

As Virus Cases Surge, Biden Administration Encourages More Use of Antibody Treatments

Technology
WASHINGTON — Facing overcrowded hospitals and an unrelenting surge of Delta variant cases around the country, the Biden administration on Thursday renewed its call for health providers to use monoclonal antibody treatments, which can help Covid-19 patients who are at risk of getting very sick.Dr. Marcella Nunez-Smith, a White House adviser on racial equity in health, said at a news conference that federal “surge teams” deployed to hard-hit states were working to increase uptake of and confidence in the antibody drugs. They have already been administered to more than 600,000 people in the United States during the pandemic, she said, preventing hospitalizations and helping save lives. President Donald J. Trump received one such treatment when he was diagnosed with Covid-19 last year, before ...
U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

Technology
That decision does not mean the F.D.A. has broadly authorized Johnson & Johnson to distribute doses made by Emergent on an emergency basis. The F.D.A. signed off on previous batches of vaccine made at the Baltimore factory but with a warning that it could not guarantee the company had followed good manufacturing practices. The agency has cleared the equivalent of up to 75 million doses, but tens of millions remain in limbo.In a conference call with investors on Thursday, Emergent executives announced a $41.5 million hit from being forced to discard doses the F.D.A. had deemed unusable, and said the company had spent another $12.4 million to address manufacturing issues in Baltimore.The newly disclosed inquiries from federal and state agencies underscore a dramatic reversal of fortune f...
How an Unproven Alzheimer’s Drug Got Approved

How an Unproven Alzheimer’s Drug Got Approved

Technology
The idea of accelerated approval came up briefly toward the end, raised by Dr. Rick Pazdur, head of F.D.A.’s oncology center, who was not a council member. It was not discussed in detail, but after the meeting, given the council’s rejection of standard approval, accelerated approval appeared to be the only way to make the drug available.On April 26, Dr. Patrizia Cavazzoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, led a smaller meeting about accelerated approval, which had never been used for Alzheimer’s drugs.In fact, the F.D.A.’s most recent guidance for Alzheimer’s drugs, issued by Dr. Dunn in 2018, says “the standard for accelerated approval” had not yet been met for the disease, “despite a great deal of research.” The guidance says that is because “t...