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    Salmonella Outbreak Prompts Egg Recall by Wisconsin Farm

    Officials said 65 people in nine states have been infected in the outbreak, which has been traced to an egg farm. No deaths have been reported.A salmonella outbreak that has sickened dozens of people in nine states prompted a recall of certain brands of eggs on Friday after officials said they traced the source of the infections to a farm in Wisconsin.State health officials said that 42 of the 65 people infected were in Wisconsin. Many people reported eating eggs at restaurants in the state before they got sick.Officials were able to trace the source of the eggs to Milo’s Poultry Farms of Bonduel, Wis., where they identified the outbreak strain in a packing facility and a hens egg-laying house, the U.S. Centers for Disease Control and Prevention said.All carton sizes and egg types produced at the farm, which either bear the label “Milo’s Poultry Farms” or “Tony’s Fresh Market,” were recalled by the farm, the U.S. Food and Drug Administration said.The eggs were distributed to retail stores and food service suppliers in Illinois, Michigan and Wisconsin, the F.D.A. said. The recall includes all expiration dates. The exact number of eggs recalled was not immediately available.No deaths have been reported in the outbreak, but 24 people were hospitalized. The first case was reported in late May, but most infections were reported in July and August, according to the C.D.C.The reported number of people infected is likely an undercount because it usually takes weeks to determine if an infection is part of an outbreak and because some people may recover without testing for the bacteria, the C.D.C. said.Aside from Wisconsin, infections were reported in California, Colorado, Illinois, Iowa, Michigan, Minnesota, Utah and Virginia. Illinois reported the second-highest number of infections with 11, followed by Minnesota, which reported three.The symptoms of the bacterial infection include diarrhea, fever and abdominal pain and usually begin within three days of ingesting the contaminated food, the F.D.A. said.Symptoms usually clear up within a week, but people with weakened immune systems, including young children and older adults, are more susceptible to severe, and sometimes fatal, infections, the F.D.A. said.The egg recall came after a deadly summer outbreak of listeria that prompted the recall of seven million pounds of Boar’s Head deli meat products.That outbreak has resulted in nine deaths and dozens of hospitalizations and the temporary shutdown of a Boar’s Head plant in Virginia, where inspectors had found black mold, water dripping over meat and dead flies. More

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    FDA Declines to Approve MDMA Therapy, and Seeks Further Study

    The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy.The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments.The F.D.A. said there was insufficient data to allow its use, and it asked the company seeking approval for the treatment, Lykos Therapeutics, to conduct an additional clinical trial to assess whether the drug, commonly known as Ecstasy or molly, would be safe and effective.An additional clinical trial could add years, and millions of dollars, to the approval process.If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. Supporters of psychedelic medicine were deeply disappointed, and some said they were stunned, having assumed the therapy’s promising data would overcome flaws in the company’s clinical trials, which had been designed in consultation with F.D.A. scientists.“This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics. His book, “How to Change Your Mind,” helped catalyze public interest in the therapeutic potential of psychoactive compounds, demonized during the nation’s long war on drugs.But the agency’s decision had not been entirely unexpected, after a group of independent experts convened by the F.D.A. to evaluate Lykos’s data met in June and did not recommend the treatment. On two central questions, the experts voted overwhelmingly that the company had not proven the treatment was effective, and that the drug therapy’s benefits did not outweigh the risks.The agency generally follows the recommendations of its outside panels. Critics, however, have questioned the panel’s expertise, noting that only one of its 11 members had experience in psychedelic medicine.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    FDA Panel Weights MDMA Therapy for PTSD

    An independent group of experts is meeting Tuesday to consider whether to allow use of this illegal drug, also known as Ecstasy, to treat PTSD. The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks.The panel will hear from Lykos Therapeutics, which has submitted evidence from clinical trials in an effort to obtain agency approval to sell the drug legally to treat people with a combination of MDMA and talk therapy.Millions of Americans suffer from PTSD, including military veterans who are at high risk of suicide. No new treatment for PTSD has been approved in more than 20 years.What is MDMA?Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive drug first developed by Merck in 1912. After being resynthesized in the mid-1970s by Alexander Shulgin, a psychedelic chemist in the Bay Area, MDMA gained popularity among therapists. Early research suggested significant therapeutic potential for a number of mental health conditions.MDMA is an entactogen, or empathogen, that fosters self-awareness, feelings of empathy and social connectedness. It is not a classic psychedelic like LSD or psilocybin, drugs that can cause altered realities and hallucinations. Among recreational users, MDMA is commonly known as molly or Ecstasy.In 1985, as the drug became a staple at dance clubs and raves, the Drug Enforcement Administration classified MDMA as a Schedule I substance, a drug defined as having no accepted medical use and a high potential for abuse.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    One in Five Milk Samples Nationwide Shows Genetic Traces of Bird Flu

    There is no evidence that the milk is unsafe to drink, scientists say. But the survey result strongly hints that the outbreak may be widespread.Federal regulators have discovered fragments of bird flu virus in roughly 20 percent of retail milk samples tested in a nationally representative study, the Food and Drug Administration said in an online update on Thursday.Samples from parts of the country that are known to have dairy herds infected with the virus were more likely to test positive, the agency said. Regulators said that there is no evidence that this milk poses a danger to consumers or that live virus is present in the milk on store shelves, an assessment public health experts have agreed with.But finding traces of the virus in such a high share of samples from around the country is the strongest signal yet that the bird flu outbreak in dairy cows is more extensive than the official tally of 33 infected herds across eight states.“It suggests that there is a whole lot of this virus out there,” said Richard Webby, a virologist and influenza expert at St. Jude Children’s Research Hospital.Dr. Webby said that he believed it was still possible to eradicate the virus, which is known as H5N1, from the nation’s dairy farms. But it will be difficult to design effective control measures without knowing the scope of the outbreak, he said.The findings also raise questions about how the virus has evaded detection and where else it might be silently spreading. Some scientists have criticized the federal testing strategy as too limited to reveal the true extent of viral spread.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    Biotech Exec Gets 7 Years in Prison for False Claims About Rapid Covid-19 Test

    Prosecutors said Keith Berman falsely claimed he had invented a blood test that could detect Covid-19 in 15 seconds. His lawyer said he had put “genuine effort” into developing such a test.The former chief executive of a biotechnology company who, during the early days of the pandemic, falsely claimed that he had invented a blood test that could detect Covid-19 in 15 seconds was sentenced on Friday to seven years in prison for securities fraud, federal prosecutors said.From February 2020 to December 2020, the former executive, Keith Berman, 70, of Westlake Village, Calif., engaged in a scheme to defraud people into investing in his company, Decision Diagnostics Corporation, by claiming the test could detect Covid using a finger prick sample of blood, prosecutors said.In March and April 2020, Mr. Berman issued 12 “false and misleading” news releases describing the rapid Covid test, which his company called GenViro, prosecutors wrote. Decision Diagnostics’ stock price jumped by more than 1,500 percent during the period, prosecutors said.In reality, prosecutors said, Mr. Berman had “privately confided in a friend the test could not actually detect Covid-19.”Prosecutors accused Mr. Berman, the sole director of the publicly traded medical device company, of capitalizing on people’s fears about the pandemic in an effort to resuscitate the company’s fortunes.Mr. Berman’s scheme resulted in about $28 million in investor losses, prosecutors said. Mr. Berman was indicted in December 2020, and he pleaded guilty in December 2023 to securities fraud, wire fraud and obstruction of an official proceeding.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    The Persistent Threat to Abortion Rights

    The Supreme Court this week heard the first major challenge to abortion rights since it struck down Roe v. Wade two years ago — an attempt to severely limit access to mifepristone, the most commonly used abortion pill in the country, by a group of doctors who are morally opposed to the practice.The justices seem prepared to throw out the lawsuit. During oral arguments, they questioned whether the doctors had suffered the harm necessary to bring the suit in the first place.But that should come as small comfort to anyone concerned for the future of reproductive freedom in America. Judges at the state and federal level are ready to further restrict reproductive options and health care access. The presumptive Republican nominee for president, Donald Trump, has indicated support for a 15-week national abortion ban. And while the Supreme Court, in overturning Roe, ostensibly left it to each state to decide abortion policy, several states have gone against the will of their voters on abortion or tried to block ballot measures that would protect abortion rights. Anti-abortion forces may have had a tough week in the Supreme Court, but they remain focused on playing and winning a longer game.Even potential victories for reproductive freedom may prove short-lived: The mifepristone case, for instance, is far from dead. Another plaintiff could bring the same case and have it considered on the merits, a possibility Justice Samuel Alito raised during oral arguments.“Is there anybody who could challenge in court the lawfulness of what the F.D.A. did here?” he asked the solicitor general, Elizabeth Prelogar. Such a challenge would be exceptionally weak, given that the F.D.A. provided substantial support for its approval and regulatory guidance on the use of mifepristone, but the right-wing justices on the Roberts court may be willing to hear it again anyway. The justices have already illustrated their hostility to the authority of administrative agencies, and that hostility may persist even in the face of overwhelming scientific evidence.Then there is the Comstock Act, a 151-year-old federal law that anti-abortion activists are trying to revive to block the mailing of mifepristone and other abortion medication. During the oral arguments this week, Justices Alito and Clarence Thomas repeatedly expressed their openness to the use of the law, which was pushed by an anti-vice crusader decades before women won the right to vote. If anti-abortion activists can get themselves before a sympathetic court and secure a national injunction on this medication being mailed, they may well be able to block access to abortion throughout the country, including in states where it is legal.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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    Biden Campaign Sharpens Its Post-Roe Message: Abortion Is About Freedom

    In events next week, the president and vice president will argue that abortion access is crucial to personal freedoms, and warn of what is at stake if Donald J. Trump is re-elected.President Biden and Vice President Kamala Harris will headline events next week centered around protecting abortion rights, throwing more heft behind an issue that has galvanized voters in the 18 months since the Supreme Court struck down Roe v. Wade.On Monday, Ms. Harris will visit Wisconsin to begin a national tour focused on preserving access to reproductive health care as Republicans call for more restrictions. Then on Tuesday, she will join Mr. Biden at a rally for abortion rights in Virginia, where Democrats recently took control of the state legislature and have proposed to enshrine abortion protections in the state constitution.Ms. Harris offered a preview of the administration’s election-year messaging to Americans when she visited “The View,” the most popular daytime talk show in the country.“We are not asking anyone to abandon their personal beliefs,” she said during an appearance on Wednesday, adding that “the government should not be telling women what to do with their bodies.”The idea that preserving access to abortion is tantamount to preserving personal freedoms has been embraced by Biden administration officials, lawmakers and activists who hope it will energize a flagging base and draw independent voters into the fold. They also want to contrast the administration’s policies with the political peril that the Republican Party faces by embracing hard-line measures.“I start from the place that most Americans believe that women should have the freedom to make their own decisions about health care, including abortion, without government interference,” Senator Tina Smith, Democrat of Minnesota, who traveled to the Iowa caucuses as a surrogate for Mr. Biden, said in an interview. (About 69 percent of voters think abortion should be legal in the first three months of pregnancy, according to a Gallup poll last year.)We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber?  More

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    F.D.A. to Issue First Approval for Mass Drug Imports to States from Canada

    The agency authorized Florida to purchase medicines directly from wholesalers in Canada, where prices are far cheaper. Pharmaceutical companies oppose the plan.The Food and Drug Administration has allowed Florida to import millions of dollars worth of medications from Canada at far lower prices than in the United States, overriding fierce decades-long objections from the pharmaceutical industry.The approval, issued in a letter to Florida Friday, is a major policy shift for the United States, and supporters hope it will be a significant step forward in the long and largely unsuccessful effort to rein in drug prices. Individuals in the United States are allowed to buy directly from Canadian pharmacies, but states have long wanted to be able to purchase medicines in bulk for their Medicaid programs, government clinics and prisons from Canadian wholesalers.Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions. Other states have applied to the F.D.A. to set up similar programs.But significant hurdles remain. The pharmaceutical industry’s major lobbying organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which has sued over previous importation efforts, is expected to file suit to prevent the Florida plan from going into effect. Some drug manufacturers have agreements with Canadian wholesalers not to export their medicines, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.“Canada’s drug supply is too small to meet the demands of both American and Canadian consumers,” Maryse Durette, a spokeswoman for Health Canada, wrote in an email message. “Bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.”Congress passed a law allowing drug importation two decades ago, but federal health officials delayed implementing it for years, citing safety concerns, one of the main arguments drug companies have used against it. In 2020, President Donald J. Trump pushed the law forward, announcing that states could submit importation proposals to the F.D.A. for review and authorization. President Biden added momentum the following year, instructing federal officials to keep working with states on importation plans.Florida applied and later sued the F.D.A., accusing the agency of what Gov. Ron DeSantis called a “reckless delay” in approving the request. Friday’s announcement grew out of that lawsuit; a federal judge had set a Jan. 5 deadline for the F.D.A. to act on the state’s application.Dr. Robert Califf, the F.D.A. commissioner, said in a statement that the agency will be vetting additional state applications to be sure they live up to the program’s goals.“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” Dr. Califf said.Eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin — have laws allowing for a state drug importation program, and many are seeking, or planning to seek, F.D.A. approval.Colorado’s application is pending with the F.D.A. New Hampshire’s application was rejected last year. Vermont’s was deemed incomplete; a spokeswoman said the state was waiting to see how the F.D.A. handled the applications by other states before resubmitting.Colorado officials have signaled that states may face challenges from drugmakers in Canada, among them familiar names like Pfizer, Merck and AstraZeneca. Some drugmakers have written contracts with drug-shipping companies prohibiting deliveries to the United States, Colorado officials said in a report.Drug importation has broad political and public support. A 2019 poll by KFF, a nonprofit health research group, found that nearly 80 percent of respondents favored importation from licensed Canadian pharmacies.“Importation is an idea that resonates with people,” Meredith Freed, a senior policy analyst with KFF, said. “They don’t fully understand why they pay more for the same drug than people in other countries.”With the 2024 presidential election on the horizon, candidates are looking to claim credit for efforts to reduce drug prices. President Biden is spotlighting the Inflation Reduction Act, which empowers Medicare to negotiate prices directly with drugmakers for the first time, but only for a limited number of high cost medicines. Mr. DeSantis, who is challenging Mr. Trump for the Republican nomination, is touting his import plan.Several experts in pharmaceutical policy said that importation from Canada would not address the root cause of high drug prices: the ability of pharmaceutical makers to fend off generic competition by gaming the patent system, and the federal government’s broad failure to negotiate directly with drugmakers over cost.“Seems like political theater to me, where everyone wants to say they did something to drive down the price of prescription drugs,” Nicholas Bagley, a health law expert at the University of Michigan Law School, said of Florida’s plan.Both Mr. Bagley and Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said that the Inflation Reduction Act is a more direct path to lowering prices; the law’s price negotiation provisions are expected to save the federal government an estimated $98.5 billion over a decade. Drugmakers are suing to block those provisions from taking effect.A protest outside the Pharmaceutical Research and Manufacturers of America in Washington in 2021. PhRMA is likely to file suit to prevent any plan from going into effect.Saul Loeb/Agence France-Presse — Getty ImagesWith its approval in hand, Florida has more work to do. Before it can distribute Canadian drugs, the state must send the F.D.A. details on those it plans to import. The state has to ensure that the drugs are potent and not counterfeit. It also must put F.D.A.-approved labels on medications instead of those used in Canada.The F.D.A. said it would be watching to see if the state upholds safety rules — such as the reporting of any drug side effects — and delivers significant cost savings to consumers. Florida’s approval to import lasts for two years from the date of the first drug shipment.In Canada, health officials have been casting a wary eye on the push to import from their country. In November 2020, shortly after the Trump administration announced that states could submit importation proposals, the Canadian government published its own rule to prevent manufacturers and wholesalers from exporting some drugs that are in short supply.The Canadian government is likely to further restrict exports if they begin to affect Canadians, said Amir Attaran, a law professor at the University of Ottawa. He said the numbers don’t work out for a nation of nearly 40 million to supply medications for a state with 22 million people, much less for 49 other U.S. states.“If all of a sudden Florida is able to extend a vacuum cleaner hose into this country to take what’s in the medicine chest, the supply disruption will be a completely different category,” he said. Dr. Kesselheim, of Harvard, said the F.D.A.’s authorization was unlikely to make a difference in the price of very expensive brand-name drugs, because manufacturers would block wholesalers from exporting the medicines.“I think it’s going to be hard for states to import drugs like that in any kind of scale that would make a difference in terms of lowering prices for patients,” Dr. Kesselheim said. Even so, he said, the F.D.A.’s announcement is significant because it puts to rest the notion that drug importation cannot be accomplished safely.Mr. Bagley of the University of Michigan said there was a simpler solution to high drug prices than patchwork state importation programs: Having the U.S. government negotiate with drug companies over prices, just as many other nations, including Canada, do.“This whole thing is a jerry-rigged, complicated approach to a problem that’s amenable to a pretty straightforward solution, which is that you empower the government to bargain over the price for drugs,” he said. “So instead, we’re sort of trying to exploit the machinery that Canada has created and that we were too timid to create.” More