Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk

The move follows recalls of other medications found to have higher levels of potential carcinogens.Pfizer is recalling some shipments of its blood pressure drug Accuretic, as well as authorized generic versions of the medication, saying that a cancer-causing compound in those lots exceeded the acceptable daily intake level.The compound in the medication is nitrosamine, which is also found in water and beer as well as some foods including bacon and grilled meats. It is believed to pose a small risk of cancer in patients taking the drugs for an extended time.Such recalls have become common in recent years as private labs and companies have detected cancer-causing impurities and set off wide recalls, especially in blood pressure drugs. In September 2020, the Food and Drug Administration urged companies to look for these compounds on a regular basis. The agency announced another nitrosamine-related recall on Wednesday for a Sandoz drug meant to reduce discomfort related to painful musculoskeletal conditions.In 2018, the F.D.A. announced a recall of medications that contain valsartan after NDMA, a probable carcinogen, was discovered in them.A wave of recalls ensued after Valisure, then a pharmacy company that regularly tests medications for impurities, indicated the presence of nitrosamine in ranitidine, an ingredient in the heartburn drug Zantac. Valisure petitioned the F.D.A. to broaden testing after ranitidine was found to have a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is considered a probable carcinogen.Drugs such as metformin, for people with diabetes, and Chantix, for those trying to quit smoking, have also faced recalls related to probable carcinogens.Accuretic has relatively few users: About 1,300 people took it in 2020. Its generic formulation has more, about 192,000 users, according to data from IQVIA, an analytics company. The generic drug comprises the ingredients quinapril and hydrochlorothiazide and generated about $4.7 million in sales in 2020, IQVIA data show.Accuretic is used to treat hypertension, or high blood pressure.Food and Drug AdministrationPfizer said in a news release that it was not aware of any adverse events related to the Accuretic recall. It said the benefits of taking the drug outweighed the risks, adding that the drug lowered blood pressure and reduced the risk of strokes and heart attacks. The company advised patients to talk to their doctors about alternative treatment options.On Wednesday, David Light, a founder of Valisure, said: “We’re now over three years after the initial discoveries of nitrosamine impurities in major medications and continuing to see the ripple effects grow.”He also noted that his team had discovered benzene, a known carcinogen, in consumer products including sunscreen and body sprays and that the F.D.A. even more quickly began asking industry to broaden its own benzene testing.

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Fauci Predicts Uptick in U.S. Cases From BA.2 Subvariant

Dr. Anthony S. Fauci, the Biden administration’s top adviser on the pandemic, predicted on Sunday an “uptick” in coronavirus infections similar to the current increase in Europe, despite the current decline in cases, hospitalizations and deaths in the United States.It is “no time at all to declare victory, because this virus has fooled us before and we really must be prepared for the possibility that we might get another variant,” Dr. Fauci said on ABC’s “This Week.” “And we don’t want to be caught flat-footed on that.”While anticipating a new rise, Dr. Fauci said that at this time he does not expect a surge. Still, the BA.2 subvariant has been shown to be a more contagious version of the Omicron variant, though it, too, causes less-severe illness in most people.Epidemiologists have said the current lull in U.S. cases mirrors the dip that Europe enjoyed before many officials in the region relaxed restrictions like indoor masking.Global coronavirus cases by regionThis chart shows how reported cases per capita have changed in different parts of the world.

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Senate Panel OKs Califf Nomination for F.D.A. Chief

A split committee vote revealed concerns about the opioid epidemic and abortion policies, foreshadowing a likely close vote on confirmation by the full Senate.A divided Senate committee on Thursday advanced the nomination of Dr. Robert Califf to become commissioner of the Food and Drug Administration to the full Senate, with some Democrats citing concerns over the nominee’s commitment to combating the opioid epidemic.The committee’s vote of 13 to 8 suggests that the full Senate vote will be close. A date for the Senate’s vote on confirmation has not been set.Four Republican members of the Senate Committee on Health, Education, Labor and Pensions, including Senator Richard Burr of North Carolina, voted in favor of Dr. Califf’s nomination. Senator Burr, the ranking Republican member, noted that the commissioner’s role was one of the “most significant public health positions in the federal government” and that the agency had been without a Senate-confirmed leader for nearly a year. He urged other Republicans to support Dr. Califf, citing his “unparalleled experience” and willingness to support innovation in the medical field. G.O.P. committee members who voted against him mostly cited concerns about abortion policies.Senator Bernie Sanders, independent of Vermont, and Senators Maggie Hassan of New Hampshire and Edward Markey of Massachusetts, both Democrats, indicated they planned to vote against confirming Dr. Califf for the post. They are all from New England states hard-hit by opioids, though Senator Sanders also criticized Dr. Califf’s journey through the “revolving door” from the F.D.A. to private industry.Senator Joe Manchin, Democrat of West Virginia, a state which was particularly devastated by overdose deaths, had condemned Dr. Califf’s track record on opioids and said he would vote against confirmation. If confirmed, Dr. Califf would lead an agency that had been under intense scrutinyduring the pandemic, as it weighed the safety of coronavirus vaccines and treatments, and reviewed dozens of masks and tests.Most recently, the agency has been criticized for what some consider the sluggish approval of rapid at-home tests, which has led to shortages as the Omicron variant has caused a spike in infections, and as demand has soared for tests for schoolchildren and workers. The agency said that it had concerns about the tests’ sensitivity but not the overall accuracy.High-risk patients who test positive for Covid-19 are also facing severe shortages of medications that are effective against the variant — even as the agency remains the gatekeeper to therapies and diagnostics that could help.On Dec. 14, Dr. Califf appeared before the Senate committee, answering questions about the pandemic, the opioid crisis and other topics.As a cardiologist, Dr. Califf spent decades leading clinical trials at the Duke University Medical Center in North Carolina. Most recently, he led clinical policy and strategy for Verily, the life sciences arm at Alphabet, the parent company of Google. During the hearing, he emphasized the value of existing data, much in patients’ electronic medical records, to help answer difficult questions about the evidence for drugs and devices.Republicans asked how he would handle rules around medications to induce abortion, which had been relaxed during the pandemic after years of tight restrictions. Two days after the hearing, the F.D.A. — under Dr. Janet Woodcock, the interim commissioner — announced that it would permanently lift restrictions, allowing patients to terminate a pregnancy in the first 10 weeks after a telemedicine visit with medications taken at home.Senator Tommy Tuberville, a Republican committee member from Alabama, said in a statement that the recent decision informed his committee vote. “I believe Dr. Califf will continue to advance this administration’s pro-abortion agenda, and I cannot support his nomination,” he said.Senator Mike Braun, a Republican from Indiana, also said he opposed the nomination over abortion policies and opioid concerns. “Under his leadership in 2016, the F.D.A. expanded access to the dangerous chemical abortion drug mifepristone and failed to take action to stem the tide of the opioid crisis ravaging our country,” he said in a statement.Dr. Califf was previously confirmed in a 89-to-4 Senate vote to lead the F.D.A. during the last year of the Obama administration. If confirmed again, he will face key decisions on tobacco control as he tries to balance e-cigarettes as a tool to help some quit smoking without creating a new generation of users. Scrutiny around accelerated approvals of drugs will be heightened, given the current debate over the agency’s approval of the controversial Alzheimer’s drug Aduhelm.After Senator Sanders denounced Dr. Califf’s ties to pharmaceutical firms, which include consulting fees and stock ownership amounting to as much as $8 million, the nominee told the Senate panel in mid-December that he would comply with ethics rules set by the F.D.A. and its parent agency, the Department of Health and Human Services.Senator Hassan of New Hampshire also voted against Dr. Califf’s nomination. She had pressed him in December on the F.D.A.’s failure to update the labeling of opioid medications. Dr. Califf said the agency would continue to review the evidence coming in.“The evidence has been here for a long time,” she responded. “It’s the evidence of thousands of people, hundreds of thousands of people, dying in this country.”Senator Markey of Massachusetts, who is not on the committee that voted on Thursday, also issued a statement citing opioid policy failures and saying he would vote against Dr. Califf. The F.D.A. “repeatedly rubber-stamped new prescription opioids,” and “acted too slowly to remove them from the market or place restrictions on their labels,” he said.Senator Markey said he was dissatisfied after meeting with Dr. Califf late last year, noting that he “did not commit to the decisive and comprehensive action necessary” to regulate opioids.

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With No Way to Identify Omicron and Delta Patients, US Doctors Struggle With Treatment Decisions

Most U.S. doctors have no way to determine which variant of the coronavirus a patient is carrying, a distinction that could mean the difference between life and death.High-risk patients carrying the Delta variant could benefit greatly from two particular monoclonal antibody treatments shown to reduce hospitalization and death. But those medications would most likely do nothing for patients with Omicron, who would only respond to a third antibody treatment that is in very short supply.While U.S. officials have endorsed using a workaround test that can identify Omicron’s genetic signature, experts say it’s not feasible for large health systems facing a crush of patients to employ in each case.That makes treating patients challenging in places like Maryland, where cases are spiking and Omicron accounts for roughly 58 percent of them. The Delta variant is also holding strong in the Great Plains and swaths of the West, including California.While there is no approved test to determine each individual’s variant, a national network of state and other labs use genome-sequencing tests to track variants broadly in communities. Health systems then use those regional estimates or their own data to decide which antibody treatments to use in their clinics and hospitals.Many of them concluded that a community of largely Delta patients would benefit most from the antibody drugs made by Regeneron and Eli Lilly, while communities where Omicron patients are predominant would benefit from antibodies from GlaxoSmithKline and Vir Biotechnology.Preparing Covid-positive samples for genomic sequencing at the Washington State Department of Health in Shoreline, Wash.Ted S. Warren/Associated PressFederal officials have dabbled with making the decision for the nation. On Dec. 23, they stopped shipments of antibody treatments by Eli Lilly and Regeneron after the Centers for Disease Control and Prevention said 73 percent of U.S. Covid cases were Omicron.An outcry followed from Republican political leaders, who argued that some people in their states were still infected with Delta. And on Tuesday, the C.D.C. slashed its estimate of national Omicron cases to 59 percent. On Dec. 31, federal officials resumed national shipping all of the antibody treatments.For the next few weeks, as the country grapples with this uneven mix of both variants, tailoring treatments to each patient will be “extraordinarily difficult,” said Dr. Alex Greninger, assistant director of the clinical virology laboratories at the University of Washington Medical Center.Dr. Greninger is credited with developing one of the first tests to detect the coronavirus in the United States. But he is pessimistic that health systems can pivot quickly to sort out which patients have Delta or Omicron. And although a shortcut test can detect Omicron, there’s no simple way to report the results in bulk, he said.What’s more, the genome sequencing used by public health officials takes nearly a week — too long to target the early antibody treatments that have been found to reduce the need for hospitalizations. That makes patient care particularly difficult right now, said Dr. Mark Siedner, an infectious disease clinician and researcher at Massachusetts General Hospital.In Massachusetts and nearby states, an estimated 44.5 percent of cases are Omicron. Dr. Siedner said his health system has stopped using the Regeneron and Eli Lilly antibodies that are not effective against Omicron and are “anxiously awaiting” more doses of the effective treatment by GlaxoSmithKline and Vir Biotechnology.“We’re in a holding pattern and it’s a terrible time to be in that place,” he said.

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U.S. Doctors Struggle to Identify Variants in Patients, Complicating Treatment

Most U.S. doctors have no way to determine which variant of the coronavirus a patient is carrying, a distinction that could mean the difference between life and death.High-risk patients carrying the Delta variant could benefit greatly from two particular monoclonal antibody treatments shown to reduce hospitalization and death. But those medications would most likely do nothing for patients with Omicron, who would only respond to a third antibody treatment that is in very short supply.While U.S. officials have endorsed using a workaround test that can identify Omicron’s genetic signature, experts say it’s not feasible for large health systems facing a crush of patients to employ in each case.That makes treating patients challenging in places like Maryland, where cases are spiking and Omicron accounts for roughly 58 percent of them. The Delta variant is also holding strong in the Great Plains and swaths of the West, including California.While there is no approved test to determine each individual’s variant, a national network of state and other labs use genome-sequencing tests to track variants broadly in communities. Health systems then use those regional estimates or their own data to decide which antibody treatments to use in their clinics and hospitals.Many of them concluded that a community of largely Delta patients would benefit most from the antibody drugs made by Regeneron and Eli Lilly, while communities where Omicron patients are predominant would benefit from antibodies from GlaxoSmithKline and Vir Biotechnology.Preparing Covid-positive samples for genomic sequencing at the Washington State Department of Health in Shoreline, Wash.Ted S. Warren/Associated PressFederal officials have dabbled with making the decision for the nation. On Dec. 23, they stopped shipments of antibody treatments by Eli Lilly and Regeneron after the Centers for Disease Control and Prevention said 73 percent of U.S. Covid cases were Omicron.An outcry followed from Republican political leaders, who argued that some people in their states were still infected with Delta. And on Tuesday, the C.D.C. slashed its estimate of national Omicron cases to 59 percent. On Dec. 31, federal officials resumed national shipping all of the antibody treatments.For the next few weeks, as the country grapples with this uneven mix of both variants, tailoring treatments to each patient will be “extraordinarily difficult,” said Dr. Alex Greninger, assistant director of the clinical virology laboratories at the University of Washington Medical Center.Dr. Greninger is credited with developing one of the first tests to detect the coronavirus in the United States. But he is pessimistic that health systems can pivot quickly to sort out which patients have Delta or Omicron. And although a shortcut test can detect Omicron, there’s no simple way to report the results in bulk, he said.What’s more, the genome sequencing used by public health officials takes nearly a week — too long to target the early antibody treatments that have been found to reduce the need for hospitalizations. That makes patient care particularly difficult right now, said Dr. Mark Siedner, an infectious disease clinician and researcher at Massachusetts General Hospital.In Massachusetts and nearby states, an estimated 44.5 percent of cases are Omicron. Dr. Siedner said his health system has stopped using the Regeneron and Eli Lilly antibodies that are not effective against Omicron and are “anxiously awaiting” more doses of the effective treatment by GlaxoSmithKline and Vir Biotechnology.“We’re in a holding pattern and it’s a terrible time to be in that place,” he said.

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