Patients Cut Off From Cheaper Obesity Drugs as FDA Halts Sales of Copycats

Hundreds of thousands of Americans stand to soon lose their access to cheaper weight-loss drugs, with a federal crackdown on copycat versions threatening to disrupt treatment and raise costs.The Food and Drug Administration has ordered producers and sellers of the less expensive products to wind down operations in the coming weeks now that it has declared there are no longer shortages of the blockbuster drugs Wegovy and Zepbound.Produced through a process of mixing drug ingredients known as compounding, the copycat medications had spawned a booming multi-billion-dollar industry. Patients turned to compounding because their health insurance would not pay for the brand-name drugs and they could buy the compounded versions for less than $200 a month in some cases.Eli Lilly and Novo Nordisk now offer the brand-name drugs for $500 a month in most cases to patients who pay with their own money instead of going through insurance. Until recently, patients sometimes had to pay over $1,300 a month.The F.D.A. ordered compounding for versions of Eli Lilly’s Zepbound to end last month. Small compounders have until April 22 to stop making and selling versions of Novo Nordisk’s Wegovy; large compounders have until May 22.It is not clear how the F.D.A. will enforce these deadlines. The Health and Human Services Department, which oversees the F.D.A., declined to answer questions for this article.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.

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WHO agrees legally binding pandemic treaty

Members of the World Health Organization (WHO) have agreed the text of a legally binding treaty designed to better tackle future pandemics.The pact is meant to avoid the disorganisation and competition for resources seen during the Covid-19 outbreak.Key elements include the rapid sharing of data about new diseases, to ensure scientists and pharmaceutical companies can work more quickly to develop treatments and vaccines.For the first time, the WHO itself will also have an overview of global supply chains for masks, medical gowns and other personal protective equipment (PPE).WHO director general Dr Tedros Adhanom Ghebreyesus described the deal as “a significant milestone in our shared journey towards a safer world”.”[Member states] have also demonstrated that multilateralism is alive and well, and that in our divided world, nations can still work together to find common ground, and a shared response to shared threats,” he said.The legally binding pact reached early on Wednesday came after three years of talks between member states.It is only the second time in the WHO’s 75-year history that an international agreement of this type has been reached – the first being a tobacco control deal in 2003.It still needs to be formally adopted by members when they meet for the World Health Assembly next month.US negotiators were not part of the final discussions after President Donald Trump announced his decision to withdraw from the global health agency, and the US will not be bound by the pact when it leaves in 2026.Under the terms agreed, countries will have to ensure that pandemic-related drugs are available across the world in a future outbreak.Participating manufacturers will have to allocate 20% of their production of vaccines, therapeutics and diagnostics to the WHO. At least 10% will have to be donated with the rest supplied at affordable prices.Countries also approved the transfer of health technologies to poorer nations as long as it was “mutually agreed”.That should also enable more local production of vaccines and medicines during a pandemic. but that clause had been extremely contentious.Developing countries are still angry at the way wealthy nations bought up and hoarded vaccines during Covid-19, while countries with large pharmaceutical industries worry mandatory transfers might undermine research and development.At the core of the agreement is a proposed Pathogen Access and Benefit-Sharing System (PABS), allowing the faster exchange of data between pharmaceutical companies. That should enable those firms to start working on new drugs more quickly in any future outbreak.

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to be fixed/rewritten

John once fielded customer complaints for a telecommunications company. Now he usually hangs out with friends in the courtyard of a center offering services to help people who use drugs, hitting his pipe, or as he calls it, “getting methicated.”He usually lives outdoors, though he can sometimes handle a few days at a shelter. By noon, he tries to stop smoking meth, so he can get to sleep later that night. Quitting is not on his radar: meth rules his life. “We cannot ride on the railroad, the railroad rides upon us,” he said, with a nod to Henry David Thoreau.Most weekdays, Bill Burns, an addiction and mental health specialist with the Portland police, walks the Bayside neighborhood, checking in on folks. On Thursdays, he rewards the regulars he drives to addiction treatment clinics with his own homemade jolts of dopamine: sugar-dense, Rice Krispie-style treats.Recently, he encountered a young man in full meth psychosis, wild-eyed, bare-chested and bleeding, flinging himself against concrete barriers in an alley. Mr. Burns slipped between the man and a brick wall and wrapped his arms protectively around him.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.

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What to Know About Today’s Meth

Fentanyl overdoses have finally begun to decline over the past year, but that good news has obscured a troubling shift in illicit drug use: a nationwide surge in methamphetamine, a powerful, highly addictive stimulant.This isn’t the ’90s club drug or even the blue-white tinged crystals cooked up in “Breaking Bad.” As cartels keep revising lab formulas to make their product more addictive and potent, often using hazardous chemicals, many experts on addiction think that today’s meth is more dangerous than older versions. Here is what to know.What is meth?Meth, short for methemphetamine, is a stimulant, a category of drugs that includes cocaine. Meth is far stronger than coke, with effects that last many hours longer. It comes in pill, powder or paste form and is smoked, snorted, swallowed or injected.Meth jolts the central nervous system and prompts the brain to release exorbitant amounts of reinforcing, feel-good neurotransmitters such as dopamine, which help people experience euphoria and drive them to keep seeking it.Meth is an amphetamine, a category of stimulant drugs perhaps best known to the public as the A.D.H.D. prescription medications Adderall and Vyvanse. Those stimulants are milder and shorter-lasting than meth but, if misused, they too can be addictive.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.

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As Fentanyl Deaths Slow, Meth Comes for Maine

Something worrisome was happening at Spurwink, a mental health clinic in Portland, Maine. Many patients being treated for opioid addiction had gone missing for days, even weeks, skipping prescription refills and therapy appointments.The counselors feared their patients were relapsing on fentanyl. But those who reappeared did not show the telltale signs — no slurred speech, pinpoint pupils or heavy eyelids. On the contrary, they were bouncy, frenetic, spraying rapid-fire chatter, their pupils dilated. They warned of spies lurking outside the building, listening devices in ceiling tiles, worms in their throats.In Portland, where the fentanyl can be both diluted and even costly, another drug, cheap and plentiful, has been surging to meet demand: methamphetamine, a highly addictive stimulant that electrifies the brain and grips the central nervous system.This pretty foodie mecca has become yet another American city to be overwhelmed by meth — not the home-cooked biker party drug from the ’90s, but a far more dangerous concoction, mass-produced in Mexican cartel labs. In recent years, it has been spreading across the country, increasingly becoming a drug of first choice in many locations.Portland’s meth onslaught came on as the city’s drug treatment community was starting to taste hope: echoing a national trend, deaths from opioids have been declining, largely because of medications that reverse opioid overdoses and those that dull cravings.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.

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Trump Seeks to Lower Drug Prices Through Medicare and Some Imports

President Trump signed an executive order on Tuesday outlining a series of actions intended to lower drug prices, including helping states import drugs from Canada.The policies were more modest than proposals to reduce drug prices that Mr. Trump offered in his first term.And one of his new directives could increase drug prices. It calls for the Trump administration to work with Congress to change a 2022 law in a way that could defang a negotiation program meant to reduce Medicare’s spending on commonly used or costly drugs.Such a change has the potential to increase costs for the government, because it would most likely delay the existing timetable for some drugs to become eligible for Medicare price cuts.Depending on how it is structured, it could increase Medicare’s drug spending by billions of dollars compared with outlays under the current law. The negotiation program was approved by a Democratic-controlled Congress and supported by former President Joseph R. Biden Jr.The executive order says that changes to the Medicare price negotiation program should be “coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries.”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.

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