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Search resuls for: "Christina Jewett"


14 mentions found


☆ How the Shortage of a $15 Cancer Drug Is Upending Treatment
  + stars: | 2023-06-26 | by ( Christina Jewett | ) www.nytimes.com   time to read: +1 min
The nation’s monthslong shortage of highly potent cancer drugs is grinding on, forcing patients and their doctors to face even grimmer realities than those cancer typically presents. Thousands of patients like Mr. Shepard have been confronting gut-wrenching options, delays in treatment and potentially bleaker futures. Oncologists are concerned that the alternatives to two crucial chemotherapy drugs are far less effective in treating certain cancers, and are sometimes more toxic. Some companies that sell the medications are projecting that the shortage will last through the fall or later. So far, neither a group of experts organized by the Biden administration nor prominent medical organizations have found a way to avoid rationing the crucial chemo drugs.
Persons: Shepard, Biden, chemo Locations: China
☆ E-Cigarette Sales Tapered Off Last Year After Big Surge
  + stars: | 2023-06-22 | by ( Christina Jewett | ) www.nytimes.com   time to read: +1 min
The increase over that period occurred while teenagers and young adults reported in surveys that they had recently tried e-cigarettes at much higher rates than older adults did. According to the C.D.C., about 4.5 percent of all adults said they used e-cigarettes. But the rates went up as the age dropped. About 14 percent of high school students and 11 percent of young adults reported using the devices within the last 30 days of the survey, the C.D.C. Sales were still growing through May of last year, but then dropped by 12 percent through December.
Organizations: Centers for Disease Control Locations: United States
☆ F.D.A. Panel Advises Vaccine Makers to Aim at Only One Covid Variant
  + stars: | 2023-06-15 | by ( Christina Jewett | ) www.nytimes.com   time to read: +2 min
The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines. It remains unclear whether or when the vaccine makers or the F.D.A.
Persons: ”, Peter Marks, Natalie Thornburg Organizations: Pfizer, Moderna, Centers for Disease Control, World Health Organization, Agency Locations: United States
☆ F.D.A. Approves Pfizer’s R.S.V. Vaccine for Older Adults
  + stars: | 2023-05-31 | by ( Christina Jewett | ) www.nytimes.com   time to read: +3 min
Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under agency review. The GSK vaccine, called Arexvy, was nearly 83 percent effective against severe R.S.V. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4.
Persons: Miller Fisher, Jerica Pitts Organizations: Disease Control, GSK, Pfizer, Infants, R.S.V
☆ F.D.A. Panel Recommends R.S.V. Vaccine to Protect Young Infants
  + stars: | 2023-05-18 | by ( Christina Jewett | ) www.nytimes.com   time to read: 1 min
An advisory panel to the Food and Drug Administration voted on Thursday in favor of approving a vaccine by Pfizer to prevent the severe respiratory virus that is a potentially deadly threat to infants. The vaccine would be the first to protect babies from respiratory syncytial virus, or R.S.V., which is the reason many infants are admitted to children’s hospitals each year and kills several hundred under 5 each year. Fourteen agency advisers unanimously agreed that the vaccine was effective, and the F.D.A. typically follows the recommendations of its advisory panels. Ten of the 14 agreed that the vaccine was safe, with some airing concerns about elevated rates — not all statistically significant — of preterm births among mothers who got the vaccine compared to those who received a placebo.
☆ Prescription Drug Shortages
  + stars: | 2023-05-18 | by ( German Lopez | ) www.nytimes.com   time to read: +1 min
Americans are confronting a shortage of several major drug treatments. medication shortage, which is reflective of many of the broader drug supply problems. The Food and Drug Administration first acknowledged the shortage in October. Patients complain that they have to shop around at pharmacies to get their medications, if they can find them at all. After a week without the drug, he went to bed one day at 7 a.m. “It’s a bit of a curse to not have control over your own energy,” he said.
☆ Drug Shortages Near an All-Time High, Leading to Rationing
  + stars: | 2023-05-17 | by ( Christina Jewett | ) www.nytimes.com   time to read: +1 min
The Society of Gynecologic Oncology sent out a nationwide survey in recent weeks. In response, doctors in 35 states said they had little to no supply of key chemotherapy drugs, even at large cancer centers and teaching hospitals. “Our patients are in a war, and what we’re doing is we’re taking their weapons away,” Dr. Timmins said. Dr. Kevin Schulman, a professor at Stanford Medicine who has studied the generic drug industry, said he had urged the White House team to examine how much power the intermediary companies have in contracting with generic drug makers. He said they demand rock-bottom prices, but unlike a customer-facing company like Apple that contracts with suppliers worldwide, the drug intermediaries face no accountability when shortages arise.
☆ F.D.A. Approves New Drug to Treat Hot Flashes
  + stars: | 2023-05-12 | by ( Christina Jewett | ) www.nytimes.com   time to read: +3 min
“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, an official with the F.D.A. Background: Symptoms have long been enduredHot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said. And the complaints of those who experience severe hot flashes and other symptoms of menopause are often dismissed in the workplace and elsewhere. Because signs of liver damage emerged in some patients during study of the drug, the F.D.A. What’s Next: The drug price may be prohibitiveAstellas said that the drug would cost $550 for a 30-day supply, not including rebates.
☆ R.S.V. Vaccine Approved for Older Adults
  + stars: | 2023-05-03 | by ( Christina Jewett | ) www.nytimes.com   time to read: +3 min
advisory panel reviewed data from trials for two vaccines aimed at older adults, one from GSK and one from Pfizer. The virus can lead to pneumonia, which is far more worrisome for older adults and especially for those with underlying medical conditions like heart and lung disease or diabetes. vaccine for older adults is also expected to receive F.D.A. in older adults and said it expected authorization in the first half of this year. Last week, the European Medicines Agency did recommend approval of GSK’s vaccine for adults 60 and older.
☆ National Academies Members Demand Answers About Sacklers’ Donations
  + stars: | 2023-04-28 | by ( Christina Jewett | ) www.nytimes.com   time to read: +1 min
More than 75 members of the National Academies of Sciences, Engineering and Medicine demanded on Thursday that the organization explain why it has for years failed to return or repurpose millions of dollars donated by the Sackler family, including some who led Purdue Pharma. The company’s drug, OxyContin, helped set in motion a prescription opioid crisis that has claimed hundreds of thousands of lives. The New York Times reported this month that even as the Academies advised the government on opioid policy, the organization accepted $19 million from the Sackler family and appointed influential members to its committees who had financial ties to Purdue Pharma. One report issued by the Academies claimed that 100 million, or 40 percent of Americans, were in chronic pain. The figure, later found to be inflated, was cited by drugmakers to convince doctors to write large numbers of opioid prescriptions.
☆ Sacklers Gave Millions to Institution That Advises on Opioid Policy
  + stars: | 2023-04-23 | by ( Christina Jewett | ) www.nytimes.com   time to read: +1 min
For the past decade, the White House and Congress have relied on the National Academies of Sciences, Engineering and Medicine, a renowned advisory group, to help shape the federal response to the opioid crisis, whether by convening expert panels or delivering policy recommendations and reports. The opioid crisis has led to hundreds of thousands of overdose deaths, spawned lawsuits and forced other institutions to publicly distance themselves from Sackler money or to acknowledge potential conflicts of interest from ties to Purdue Pharma. The National Academies has largely avoided such scrutiny as it continues to advise the government on painkillers. “I didn’t know they were taking private money,” Michael Von Korff, a prominent pain care researcher, said. “It sounds like insanity to take money from principals of drug companies and then do reports related to opioids.
☆ Supreme Court Ensures, for Now, Broad Access to Abortion Pill
  + stars: | 2023-04-21 | by ( Ava Sasani | Christina Jewett | Charlie Savage | ) www.nytimes.com   time to read: +5 min
The Supreme Court temporarily halted court orders that would have impacted the availability of an abortion drug. A Supreme Court decision Friday to keep available — for now — the widely used abortion pill mifepristone was met with relief from one side of the debate, disappointment from the other and a vow from both to keep fighting. Maura Healey of Massachusetts called the court’s decision a “victory” for abortion patients and providers. While statements of muted celebration poured in from elected Democrats and groups supporting abortion rights, comment from Republicans and anti-abortion groups was noticeably sparser. Attorney General Andrew Bailey of Missouri, who opposes abortion, said through a spokesman that the decision was a disappointment.
☆ A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement.
  + stars: | 2023-04-16 | by ( Anna Kodé | ) www.nytimes.com   time to read: +1 min
A Supermodel SuesIn 2021, Ms. Evangelista, one of the most recognizable supermodels of the 1980s and ’90s, said she had gone into a long seclusion after developing P.A.H. Ms. Evangelista declined to comment for this article. received over 1,100 reports of adverse events from CoolSculpting treatments — more than in the entire previous decade. was, she would work out constantly, trying to lose the fat that had emerged after CoolSculpting. Research was contributed by Sheelagh McNeill , Kitty Bennett , Alain Delaquérière , Kirsten Noyes and Jack Begg .
☆ Drug Company Leaders Condemn Ruling Invalidating F.D.A. Approval of Abortion Pill
  + stars: | 2023-04-10 | by ( Christina Jewett | ) www.nytimes.com   time to read: +1 min
Senior executives of more than 250 pharmaceutical and biotech companies on Monday issued a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, and they called for the decision to be reversed. “The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders of some of the industry’s most prominent companies, including Albert Bourla, chief executive of Pfizer, and Alisha Alaimo, president of Biogen. The ruling, by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, “has set a precedent for diminishing F.D.A.’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” the letter argues. The letter also said that pharmaceutical companies rely on the F.D.A.’s autonomy to bring products to market under a “reliable regulatory process for drug evaluation and approval.”
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