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      Heat Wave in Gaza Challenges Pharmacists Ability to Store Medicine

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      A heat wave in the Gaza Strip this week, with temperatures soaring above 100 degrees Fahrenheit the past few days, has not only made life intolerable for the hundreds of thousands of displaced people trying to rebuild their lives in tent cities but has made it hard for some businesses to operate.By Saturday, the heat had significantly eased and the forecast was for more moderate temperatures in coming days. But the recent highs offered a vision of what the summer likely holds.“This hot weather is a challenge for us,” said Mohammed Fayyad, a displaced pharmacist who started selling medications from a tent he built out of wooden slabs, curtains and metal scraps at a camp for displaced people in Al-Mawasi.With no electricity or alternative sources of power, Mr. Fayyad, 32, said that he could not keep the medicines — which he buys from pharmacies that have had to shut down — stored at cool enough temperatures to keep them from being damaged.“Fifty percent of the medicines for chronic diseases are not available because we do not have any source of power to keep them cool,” said Mr. Fayyad, speaking from his makeshift pharmacy that he named after his 3-year-old daughter Julia.Mr. Fayyad is trying to find ways to generate power for a refrigerator to store medication.“I hope I can find those solar panels, which are very expensive, to make the options wider for the displaced people,” he said.Mr. Fayyad was displaced with his wife and only daughter from Khan Younis, where they lived and owned a pharmacy. They have been in Al-Mawasi for more than two months. When they recently went back to Khan Younis after the Israeli military withdrew from the area, he found his pharmacy had been burned and looted.Nearly two million Palestinians in Gaza were forced to flee their homes under Israeli bombardment and military evacuation orders. Many had to live in tents that provided little protection from the cold and rainy months earlier in the war and that offer them no protection against the scalding heat and humid weather now.Parents across the Gaza Strip are relying on water to keep their children cool when it is already not easy to get. The hot weather is also bringing insects that help spread disease.“My children were stung by insects and mosquitoes because there is no sanitation around, and sewage is leaking almost everywhere,” said Mohammed Abu Hatab, a father of four, including a 7-month-old. His family has been spending their days outside, under the shade of nylon tents, which trap heat and make the tents more unbearable.“I had to undress my children to their underwear only,” said Mr. Abu Hatab, 33. He added: “The tent, the heat wave, and the horror of this war are all a nightmare. How can my children live healthily and safely?” More

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      The Psychedelic Evangelist

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      Before he died last year, Roland Griffiths was arguably the world’s most famous psychedelics researcher. Since 2006, his work has suggested that psilocybin, found in magic mushrooms, can induce mystical experiences, and that those experiences, in turn, can help treat anxiety, depression, addiction and the terror of death.Dr. Griffiths and his colleagues at Johns Hopkins University received widespread recognition among scientists and the popular press, helping to pull the psychedelic field from the deep backwater of the 1960s hippie movement. This second wave of research on the hallucinogenic compounds bolstered political campaigns to decriminalize them and spurred biotech investment.Dr. Griffiths was known to friends and colleagues as an analytical thinker and a religious agnostic, and he warned fellow researchers against hype. But he also saw psychedelics as more than mere medicines: Understanding them could be “critical to the survival of the human species,” he said in one talk. Late in life, he admitted to taking psychedelics himself, and said he wanted science to help unlock their transformative power for humanity.Perhaps unsurprisingly, he held a vaunted, even prophetic role among psychonauts, the growing community of psychedelic believers who want to bring the drugs into mainstream society. For years, critics have denounced the outsize financial and philosophical influence of these advocates on the insular research field. And some researchers have quietly questioned whether Dr. Griffiths, in his focus on the mystical realm, made some of the same mistakes that doomed the previous era of psychedelic science.Now, one of his longtime collaborators is airing a more forceful critique. “Dr. Griffiths has run his psychedelic studies more like a ‘new-age’ retreat center, for lack of a better term, than a clinical research laboratory,” reads an ethics complaint filed to Johns Hopkins last fall by Matthew Johnson, who worked with Dr. Griffiths for nearly 20 years but resigned after a charged dispute with colleagues.Roland Griffiths, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins, in 2021.Matt Roth for The New York TimesWe 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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      6 Reasons That It’s Hard to Get Your Wegovy and Other Weight-Loss Prescriptions

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      An array of obstacles make it difficult for patients to obtain Wegovy or Zepbound. Finding Wegovy is “like winning the lottery,” one nurse practitioner said.Talk to people who have tried to get one of the wildly popular weight-loss drugs, like Wegovy, and they’ll probably have a story about the hoops they had to jump through to get their medication — if they could get it at all.Emily Weaver, a nurse practitioner in Cary, N.C., said she told her patients that finding Wegovy was “like winning the lottery.”Here are six reasons why.1. Demand is very high.Fueled in part by TikTok videos and celebrity testimonials, people are increasingly seeking prescriptions for appetite-suppressing medications. The drugs in this class have long been used to treat diabetes but more recently have been recognized for their extraordinary ability to help patients lose weight. The medications are injected weekly and have sticker prices as high as $16,000 a year.About 3.8 million people in the United States — four times the number two years ago — are now taking the most popular weight-loss drugs, according to the IQVIA Institute for Human Data Science, an industry data provider. Some of these prescriptions are for diabetes. The medicines are Novo Nordisk’s Ozempic and Wegovy (the same drug sold under different brand names), and Eli Lilly’s Mounjaro and Zepbound (also the same drug).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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      F.D.A. to Issue First Approval for Mass Drug Imports to States from Canada

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      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

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      The Republican Alternatives to Trump

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      More from our inbox:Whatever Happened to Civil Presidential Debates?Questions for HamasQuestions for IsraelAdvice for These Fraught TimesAntipsychotic Drugs and Weight GainThe presidential hopefuls seemed content to aim for second place behind former President Donald J. Trump and deliver digs at President Biden.Maansi Srivastava/The New York TimesTo the Editor:Re “If You’re Going to Win the Nomination, Here’s Step 1,” by Kristen Soltis Anderson (Opinion guest essay, Nov. 8):Ms. Anderson says that many Republicans are open to opponents of Donald Trump who can articulate a new direction for the party, but that those candidates are running out of time to make their case.Ms. Anderson mentions the former South Carolina governor Nikki Haley as a viable alternative to Mr. Trump. But in terms of good fiscal governance and foreign policy, I believe that Ms. Haley is even more misguided than Mr. Trump.For example, she has recommended ending the federal gas tax, enacting a new middle-class tax cut and extending the 2017 Trump administration tax cut. While such policies might attract some voters to Ms. Haley, they would greatly diminish the revenue needed to pay for essential services, not to mention blowing up the national debt.As for international affairs, she has recommended sending special forces to “take out the cartels” in Mexico. Imagine how Mexico and other countries might react to such an invasion.Serious Republicans don’t need to look far to find a better presidential candidate than Ms. Haley.Eric MurchisonVienna, Va.To the Editor:Ron DeSantis, Nikki Haley and the other G.O.P. candidates must know that the most likely path to a nomination for them is if Donald Trump is convicted or forced to drop out of the race. In that scenario, many Republican voters are likely to be very angry, and they will rally behind the candidate who can most compellingly channel their indignation. Anyone who has been seen as significantly anti-Trump will be out of the running.It is strategically savvy of them not to level any direct harsh criticism at Mr. Trump. If the time comes that Mr. Trump is forced out of the race, the last thing his competitors will do in that situation is suggest that the charges against him are anything other than politically motivated.William ShermanHuntington, N.Y.To the Editor:This guest essay suggested that the candidates explain why they are running against Donald Trump, which in fact was one of the questions asked during Wednesday’s debate. Perhaps the reason they have not yet done so convincingly is that they are not running “against” Mr. Trump.Several of them are likely running for vice president, and that would preclude discussing their differences.Carolyn BrossBloomingdale, N.J.Whatever Happened to Civil Presidential Debates? To the Editor:Re “From Substance to Shouting: The Demise of Political Debate in America” (Opinion video, nytimes.com, Nov. 7):Our view of politics has shifted dramatically from the days when presidential debates were respectful discussions of platforms and ideologies. I am a high school junior, and my classmates and I are worried about the future of the American presidency.Presidential debates, once characterized by thoughtful discussions, have transformed into heated contests where candidates pick one another apart in hopes of winning a few more percentage points. Genuine discourse is rare, and recap videos showcase the biggest insults or the funniest moments.How does it affect our country’s future when presidential candidates can’t engage in respectful discussion? What does it mean for American society when our ideology divides us completely? A president’s priority should be to represent the people and work toward the betterment of our nation. We cannot afford to lower this standard.As the future generation of voters and leaders, it falls on us young people to advocate a return to civil and meaningful discussion in our political debates. The strength of our democracy depends on it, and young voices need to be part of the solution.Maia DietzSan Jose, Calif.Questions for Hamas Ronen Bergman/The New York TimesTo the Editor:Re “Hamas’s Goal for Oct. 7: A Permanent State of War; Group’s Leaders Say Carnage Was Needed to Restore Focus on Palestinians” (front page, Nov. 9):After reading your interviews with Hamas leaders, one wonders:1. Are the Palestinian citizens of Gaza OK with a permanent state of war?2. Where is that permanent state of war supposed to lead?3. What cause was “slipping away”? Certainly not peace or a two-state solution; so what is left?4. If the cause and the policy of permanent war mean the destruction of Israel, are all those chanting “Free Palestine” or “From the river to the sea” supportive of that?Scott BenardeWest Palm Beach, Fla.Questions for IsraelTo the Editor:Israel’s stated war objective, repeated often by Prime Minister Benjamin Netanyahu, is to “destroy Hamas.” Hamas is a movement, a political-military organization with the backing of Iran and other entities.Might one ask what exactly does “destroy Hamas” look like? Is it every member of Hamas surrendering, or is it the death of the leadership, much of which does not even live in Gaza? How does one measure success when the stated aim is impossible to measure, let alone manage?I think that if we are paying for the arming of Israel — and make no mistake, we are — we are entitled to a straight answer.Geoffrey D. BatrouneyRye Brook, N.Y.Advice for These Fraught Times Photo illustration by The New York TimesTo the Editor:Re “How to Stay Sane in Brutalizing Times,” by David Brooks (column, Nov. 5):What amazing advice from Mr. Brooks on how people can stay sane in these perilous times. His emphasis on humility, prudence and caution is inspiring. I would add just one thing: self-compassion. Today public leaders need to be kind to themselves for the nearly impossible jobs they are often called on to do.Jerome T. MurphyCambridge, Mass.The writer is a retired Harvard professor and dean who taught courses on leadership.To the Editor:David Brooks reaches back thousands of years, integrating diverse cultures and quoting appropriate phrases from several authors, to emphasize the vast depth of his subject matter. Yet after all that, he does not cite the one that summarizes the entire concept: “Love one another. As I have loved you, so you must love one another.”Mary Ann McGinleyWilmette, Ill.Antipsychotic Drugs and Weight Gain Derek AbellaTo the Editor:Re “Psychiatric Drugs Add Pounds. Some See Solution in Ozempic” (front page, Nov. 6):Like other clinical psychiatrists, I use a simple, low-tech solution for my patients who gain weight on their antipsychotic drugs. In consultation with our patients, we find another antipsychotic, one that doesn’t cause weight gain. There are many to choose from.Together with our patients, we look for the most effective drug with the least side effects, at the lowest possible dose. To be on the safe side, we weigh our patients at each visit to guard against weight gain.Of course, this requires continuing follow-up visits with our patients, to form a trusting relationship and a common goal of healing. But with a new patient it’s essential to provide such close attention.Some might object that such frequent office visits for follow-up care are too expensive. But compared with the monthly cost of Ozempic, good care is a bargain.Alice FellerBerkeley, Calif. More

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      Biden’s Aid, and Pointed Advice, to Israel

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      More from our inbox:How to Unify, and Save, the CountrySadly, CBC Ends a Time-Honored TraditionOver-the-Counter MedicinesPresident Biden was greeted by Prime Minister Benjamin Netanyahu on his arrival in Israel on Wednesday.Kenny Holston/The New York TimesTo the Editor:Re “U.S. Backs Israel, as Cause of Blast Remains Disputed” and “Biden Urges Caution in War on Hamas” (front page, Oct. 19):President Biden offers good advice that one hopes will be heard by all: Do not let shock, pain and rage lead to counterproductive decisions, decisions that cause unnecessary loss of innocent life and squander the world’s sympathy.Palestinians and Israelis have each been failed by their leaders. Palestinians and Israelis have each suffered unspeakable harm.We pray that Palestinians and Israelis and their respective leaders and all of the people who empathize with them will remember that in the midst of righteous anger, ill-conceived actions can make matters much, much worse for everyone.Ron BoyerEugene, Ore.To the Editor:As an American Jew, I am horrified by President Biden’s response to Hamas’s horrific murder of Israelis on Oct. 7. By providing military aid to Israel, the U.S. government is fueling the Israeli government’s vastly disproportionate response, in which it has already killed more Palestinian civilians than Israeli civilians were killed by Hamas.Mr. Biden may have urged the Israeli people not to be consumed by the rage they feel about the Hamas terror attacks, but that statement is completely contradicted by his sending the very weapons that the Israeli military is using to kill civilians.The U.S. can stop this immoral violence, but instead is fanning the flames by providing support for the autocratic Israeli government. I am joined by many other American Jews in condemning the Israeli government’s killing of thousands and threatening millions of innocent lives in the name of the Jewish people.Miriam ShakowNarberth, Pa.To the Editor:In this time of unbelievable misery and loss, it may be naïve to talk about international law. But some of the participants in the current fighting in Israel (and their allies) have represented that they are trying to respect the laws of war. Since many observers may not be familiar with those laws, I write simply to report two indisputable principles.First, the same rules of conduct apply to the “aggressor” and to its victims. “They started it” is no excuse for doing things that would otherwise be illegal.Second, the fact that the overall objective is permissible (like self-defense) or even laudatory does not excuse using methods that result in disproportionate harm to civilians.Applying these principles, it is a violation of the laws of war to knowingly cut off food, water, fuel and medical supplies to entire trapped localities. The harm would fall disproportionately on civilians who have even less access to whatever supplies exist than those in authority. It cannot be justified.Lea BrilmayerBranford, Conn.The writer is an emeritus professor of international law at Yale University.To the Editor:As an American Israeli living in Israel with a son in the Israel Defense Forces, I feel that I must speak out.It was uplifting for Israelis to hear President Biden’s remarks after the attacks on Oct. 7. Israelis everywhere felt encouraged by the president’s unequivocal support, and the unambiguous message that the events of Oct. 7 constituted “pure, unadulterated evil” — because they truly did.It is clear to Israelis that in carrying out these atrocities, Hamas was seeking to draw Israel into precisely the actions that Israel is now engaged in. The justification for those actions could be debated endlessly, but the world must know that Israel considers itself in existential peril. And in our hour of trial, we derive incredible strength from American support.The objective of Israel’s war with Hamas is not the suffering of Gazans or Palestinians but the crippling of a murderous terrorist organization that has caused unprecedented suffering for Israelis and Palestinians alike.David GilmoreHolon, IsraelHow to Unify, and Save, the Country Doug Mills/The New York TimesTo the Editor:These are unprecedented times. Democracy, national security and the world order are at stake. Our nation has never been so divided.While our young experiment in democracy faces a challenge to its very existence, our world faces heightened conflict from dangerous leaders who present existential threats, and our planet faces increased temperature extremes, violent destructive storms and devastating wildfires.Considering all that is at stake, our nation must find its way to tamp down the noise from the extreme sides of both parties, the disinformation promulgated by partisan media and the contempt for others fueled by social media.I propose a unique approach to ensure the continued success of our republic. As much as I respect and admire Vice President Kamala Harris, I would ask that for the greater good of our nation and the world, she step aside as President Biden selects a moderate Republican (such as Larry Hogan, the former Maryland governor) as his 2024 running mate.Not only would this virtually guarantee his re-election, but it would also be a giant step in uniting the country.Bradley S. FeuerWellington, Fla.Sadly, CBC Ends a Time-Honored TraditionThe “long dash,” as the CBC’s daily announcement of the official time was known to generations of Canadians, was broadcast for the final time on Oct. 9.Geoff Robins/Agence France-Presse — Getty ImagesTo the Editor:Re “After 84 Years, Time Abruptly Runs Out on Canadian Radio Tradition” (news article, Oct. 18):CBC’s dropping of its 84-year tradition of announcing the precise time at 1 p.m. day in and day out may seem like a trivial matter in the current world environment. But find me a Canadian who cannot finish the sentence “The beginning of the long dash …” (for the non-Canadian readers: “indicates exactly 1 o’clock Eastern Standard Time”).It’s as common as eight months of winter and hockey, and always saying “I’m sorry.”It was enough of a collective jolt when the middle of the announcement (“following 10 seconds of silence”) was abandoned. We grew up counting down that 10 seconds of radio silence while at the ready to instantly adjust our watches if necessary. And now we are completely on our own.Go easy on us, world, if the lone Canadian invited to the party is now always early or late. We’re sorry.Mary E. CampbellOttawaOver-the-Counter Medicines Jackson GibbsTo the Editor:Re “We’ve Known for 20 Years This Cold Medicine Doesn’t Work,” by Randy C. Hatton and Leslie Hendeles (Opinion guest essay, Oct. 1):Nonprescription, over-the-counter (O.T.C.) medicines are a cornerstone of our nation’s health care system, yet your essay draws sweeping conclusions and disregards decades of regulatory oversight, scientific review, and real-world evidence supporting their safety and efficacy.Phenylephrine, the only O.T.C. oral decongestant available without purchase restrictions, has decades of use as a safe and effective option for temporary nasal congestion relief. The Food and Drug Administration has twice determined phenylephrine to be “generally recognized as safe and effective,” the regulatory standard for O.T.C. medicines.However, the authors’ assessment discounts this history, and other evidence, while elevating their own limited research. No medicine works equally for everyone, and every medicine has unique considerations for therapeutic selection. Providing Americans with options that offer freedom of choice for personal health care needs is a core attribute of our health care system.Consumers can have confidence in their O.T.C. medicines, and the regulatory framework that oversees them.Scott MelvilleWashingtonThe writer is president and C.E.O. of the Consumer Healthcare Products Association. More

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      Biden Makes Lower Drug Prices a Centerpiece of His 2024 Campaign

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      President Biden’s Inflation Reduction Act allows Medicare to negotiate some drug prices, a change that the pharmaceutical industry and Republicans have opposed for decades.As he heads toward a re-election campaign next year, President Biden is betting that his success in pushing for policies intended to lower health care costs for millions of Americans will be rewarded by voters at the ballot box.In speech after speech, Mr. Biden talks about capping the cost of insulin at $35, putting new limits on medical expenses for seniors, making some vaccines free and pushing to lower the prices of some of the most expensive drugs in the world.At the White House, Mr. Biden and his advisers have already begun to elevate the issue as a centerpiece of his agenda. And at his campaign headquarters in Wilmington, Del., aides are preparing television ads, talking points and speeches arguing that Mr. Biden’s push for lower health care costs is a stark contrast with his Republican opponents.“The president will have a very strong case to make,” said Senator Amy Klobuchar of Minnesota, a member of the president’s national campaign advisory board. “Not only will people want to keep the benefits they have seen, they are going to want to get the benefits that are coming their way.”On Tuesday, the White House announced that the Biden administration will negotiate on behalf of Medicare recipients for lower prices on 10 popular — and expensive — drugs that are used to treat diabetes, heart disease and other chronic illnesses.The move was made possible by passage last year of Mr. Biden’s Inflation Reduction Act, which for the first time allows Medicare to negotiate drug prices for older adults, a change that has been opposed by the pharmaceutical industry for decades.Republicans also generally oppose giving the government the right to negotiate drug prices. But the candidates for the Republican presidential nomination have said little about the cost of medication, focusing instead on abortion, transgender medical issues and Covid lockdowns.In his speeches, Mr. Biden rails against the industry and his Republican adversaries in Congress, all of whom voted against the law that included the prescription drug provisions. Aides say it is an effective message.“Today is the start of a new deal for patients where Big Pharma doesn’t just get a blank check at your expense,” the president said at a White House event celebrating the change.Since signing the law a year ago, Mr. Biden has repeatedly called it one of his proudest legislative victories. But his approval numbers have hardly budged. And while polls show that the new policy is widely popular among Americans who know about it, they also suggest that far fewer people are even aware that the change was made.That is most likely because prices on just the first handful of drugs are not scheduled to actually drop until 2026 at the earliest, assuming Mr. Biden’s program survives legal challenges. Drug companies have filed numerous lawsuits against the administration that claim the law is unconstitutional. Court cases could drag on for years.In its lawsuit against the administration, the Pharmaceutical Research and Manufacturers of America, an industry trade group, called the plan for negotiated prices “a government mandate disguised as negotiation.”Even if Mr. Biden’s plan goes into effect, older adults who have made the choice to ration their drugs will have to continue doing so until more than a year after the 2024 presidential election.Danny Cottrell, 67, a pharmacist who owns his retail pharmacy group in Brewton, Ala., said he regularly advised his Medicare patients on the ins and outs of the government’s prescription program. He welcomed Mr. Biden’s changes, but said it would be up to people like him to explain the complicated process.“I got to remind them, this doesn’t start till 2026,” Mr. Cottrell said. “And then also remind them this thing will change several times between now and then.”Neera Tanden, Mr. Biden’s top domestic policy adviser, said the White House was confident that the plan would survive the legal challenges.“It is absurd to argue that negotiation is unconstitutional,” she said in an interview. “There’s nothing in the Constitution that says Medicare negotiating drug prices is unconstitutional.”But more broadly, Ms. Tanden said that she and the president’s other advisers in the West Wing were determined to make the push for lower health care costs a central part of Mr. Biden’s message to Americans.And next September, just weeks before Election Day, the administration will announce the results of the yearlong negotiations over the first 10 drugs.“We plan to work extensively, to really remind folks of this issue,” Ms. Tanden said.For the people leading Mr. Biden’s re-election campaign, the political benefits of focusing on lower health care costs are clear.Some polls show that 80 percent of Americans support giving the government the ability to negotiate lower prices for Medicare, much the way it already does for veterans and members of the military.Campaign aides said talking about lower costs of drugs or limits on out-of-pocket medical expenses is one way to help Mr. Biden win support among seniors, who traditionally have voted for Republicans in greater numbers. That is especially important in battleground states like Michigan, Arizona, Georgia and Ohio, where increasing support among older adults will be critical in close contests.The campaign’s early television ads have included numerous references to the president’s efforts to lower health care costs. A spokesman for the campaign said the issue of health care would be a central feature of a $25 million ad blitz focusing on what the president has done to lower costs overall and make economic progress.Kate Bedingfield, who served as Mr. Biden’s communications director for the first two years of his presidency, said the issue had political benefits even when it came to appealing to people who do not benefit directly from the specific cost reductions.“It draws a really clear contrast with the Republicans, who have stood in the way and continue to stand in the way of getting more done on this,” she said.Representative Michael C. Burgess, Republican of Texas and a doctor, said Mr. Biden’s drug price negotiations were akin to government-imposed price controls that would lead to drug shortages.“This administration’s approach goes beyond ‘negotiation,’” he said in a statement. “Instead, it holds pharmaceutical companies hostage, jeopardizing their future innovation and the well-being of American patients.”Mr. Biden’s campaign aides said a debate with Republicans about the cost of medical care was one they were eager to have.“MAGA Republicans running for president want to repeal the Inflation Reduction Act, which would deliver a massive win for Big Pharma and increase costs for the American people,” said Julie Chávez Rodríguez, the president’s campaign manager, referring to Republicans loyal to former President Donald J. Trump.She said the choice in the election was between Mr. Biden and “a slate of candidates focused on extreme policies that put their wealthy donors first.”Robert Jimison More

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      How Vivek Ramaswamy Made the Fortune Fueling His Presidential Run

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      On the campaign trail, as he lays out why he is a different kind of presidential candidate, Vivek Ramaswamy calls himself a Harvard-trained “scientist” from the lifesaving world of biotechnology.“I developed a number of medicines,” Mr. Ramaswamy, an entrepreneur and conservative writer, told a gathering at a construction firm this month in Davenport, Iowa. “The one I’m most proud of is a therapy for kids, 40 of them a year, born with a genetic condition who, without treatment, die by the age of 3.”The reality of Mr. Ramaswamy’s business career is more complex, the story of a financier more than a scientist, and a prospector who went bargain hunting, hyped his vision, drew investment and then cashed out in two huge payouts — totaling more than $200 million — before his 35th birthday.Mr. Ramaswamy’s enterprise is best known for a spectacular failure. As a 29-year-old with a bold idea and Ivy League connections, he engineered what was at the time the largest initial public offering in the biotechnology industry’s history — only to see the Alzheimer’s drug at its center fail two years later and the company’s value tank.But Mr. Ramaswamy, now 37, made a fortune anyway. He took his first payout in 2015 after stirring investor excitement about his growing pharmaceutical empire. He reaped a second five years later when he sold off its most promising pieces to a Japanese conglomerate.The core company Mr. Ramaswamy built has since had a hand in bringing five drugs to market, including treatments for uterine fibroids, prostate cancer and the rare genetic condition he mentioned on the stump in Iowa. The company says the last 10 late-stage clinical trials of its drugs have all succeeded, an impressive streak in a business where drugs commonly fail.Mr. Ramaswamy’s resilience was in part a result of the savvy way he structured his web of biotechnology companies. But it also highlights his particular skills in generating hype, hope and risky speculation in an industry that feeds on all three.“A lot of it had substance. Some of it did not. He’s a sort of a Music Man,” said Kathleen Sebelius, a Democrat and former health secretary during the Obama administration who advised two of Mr. Ramaswamy’s companies.For his part, Mr. Ramaswamy said that criticism that he overpromised was missing the point. Although he promoted the potential of the doomed Alzheimer’s drug, he now says he was actually selling investors on a business model.“The business model was to develop these medicines for the long run. That’s the punchline, that’s the most important point,” he said.Mr. Ramaswamy’s wealth is now underwriting a long-shot run for the Republican nomination that includes a campaign jet, plush bus and $10.3 million of his own money and counting. On the campaign trial, he sells what he calls “anti-woke” capitalism, skewering environmental, social and corporate governance programs and dismissing debates about racial privilege.He is the child of Indian immigrants, and “privilege,” he said recently in Iowa, “was two parents in the house with a focus on education, achievement and actual values. That gave me the foundation to then go on to places like Harvard and Yale and become a scientist.”With an undergraduate degree in biology from Harvard, Mr. Ramaswamy isn’t really a scientist; he made his name in the world of hedge funds and his graduate work was a law degree from Yale.Along the way, he invested in biotech and became enamored with an idea for developing high-risk prescription drugs: scour the patents held by pharmaceutical giants, searching for drugs that had been abandoned for business reasons, not necessarily for lack of promise. Buy the patents for a song, and bring them to market.Mr. Ramaswamy made his name in the world of hedge funds and his graduate work was a law degree from Yale.Forbes MagazineIn 2014, Mr. Ramaswamy founded Roivant Sciences — incorporated in the tax haven of Bermuda and backed by nearly $100 million in funding from investors including QVT, a hedge fund that employed Mr. Ramaswamy after college.Using his connections and his confidence, Mr. Ramaswamy assembled a star-studded, bipartisan advisory board. A friend from Harvard helped him recruit Democrats, including Ms. Sebelius; Tom Daschle, a former Senate majority leader; and Donald M. Berwick, a former administrator of the Centers for Medicare and Medicaid Services.The Republicans included former Senator Olympia Snowe of Maine and Mark McClellan, a prominent former health regulator.Ms. Sebelius said she was swayed by Mr. Ramaswamy’s promises of bringing critical drugs to market affordably.“It was an entrepreneurial view of how to lower drug prices,” she said of his pitch. “We shared a lot of the mission and vision.”But in making his pitch to a different crowd, Mr. Ramaswamy was blunt about Roivant’s chief aim.“This will be the highest return on investment endeavor ever taken up in the pharmaceutical industry,” he boasted in a cover story in Forbes.The “Roi” in the company’s name stands for return on investment.In late 2014, the Roivant subsidiary that would be called Axovant bought for $5 million upfront — pocket change in the biotech industry — an Alzheimer’s drug that GlaxoSmithKline had given up on after four failed clinical trials.Mr. Ramaswamy speaking in 2015 at the Forbes Under 30 Summit.Lisa Lake/Getty ImagesSix months later, before starting any new clinical trials for the drug, Mr. Ramaswamy took Axovant public in a debut that sent the company’s market value to nearly $3 billion.Around that time, the company reported it had just eight employees, including Mr. Ramaswamy’s mother and brother, both of them physicians.Mr. Ramaswamy was a powerful salesman. He talked up the Alzheimer’s drug, intepirdine, as a potential breakthrough that “could help millions” of people. “The potential opportunity is really tremendous for delivering value to patients,” he said on CNBC.Patrick Machado, a former director of Roivant and Axovant, described Mr. Ramaswamy as “brilliant and audacious.” Others said Mr. Ramaswamy was overpromising.Thanks to the public stock offering, Mr. Ramaswamy held a large and suddenly extraordinarily valuable stake in Axovant through its parent company Roivant, which was still privately held and controlled about 80 percent of Axovant.With the drug headed into a crucial clinical trial, he set out to raise more money to finance his broader ambitions with Roivant.In late 2015, Mr. Ramaswamy sold off a portion of his Roivant shares to an institutional investor, Viking Global Investors, that wanted in. The sale was a major payday: On his 2015 tax return, Mr. Ramaswamy claimed more than $37 million in capital gains.In an interview, Mr. Ramaswamy said he cashed out only to make room for Viking, not to hedge his bets ahead of intepirdine’s clinical trial.“We were forced to sell,” he said, “and in some ways it’s a regret because the shares would be more valuable today if they hadn’t been sold.”In 2017, Mr. Ramaswamy made his pitch to Masayoshi Son, the founder of the Japanese conglomerate SoftBank who runs the world’s largest tech investment fund. His presentation included slides mimicking ones Mr. Son is known for, with charts showing an arrow shooting up and to the right, according to a person familiar with Mr. Ramaswamy’s pitch who was not authorized to speak publicly.In August 2017, SoftBank led an investment of $1.1 billion in Roivant. The investment wasn’t about getting in on Axovant; SoftBank thought intepirdine was unlikely to succeed, the person said. But SoftBank was seeking to invest in Mr. Ramaswamy’s wider drug portfolio, according to two people with knowledge of the matter.SoftBank declined to comment.A few weeks later, the Alzheimer’s drug’s clinical trial failed. The stock price plunged, losing 75 percent of its value in a single day. The stock slid further in the months that followed and never recovered before the company was dissolved this year.Mr. Ramaswamy declined to disclose how much he lost on paper because of the drug’s failure.Thanks to the way he structured his biotechnology empire, he did not hold a direct stake in Axovant. His personal stake was through Roivant, allowing Mr. Ramaswamy to weather the storm. QVT, the hedge fund where Mr. Ramaswamy once worked, had also invested in Roivant, insulating it from much of the fallout. QVT did not respond to a request for comment.But some investors lost real money on Axovant. One large public pension fund, the California State Teachers’ Retirement System, sold its stake months later, when it was worth hundreds of thousands of dollars less than in the days leading up to the disappointing clinical trial news. (The fund declined to comment.)But for many Axovant shareholders who lost money, many of whom were sophisticated institutional investors, the loss was one missed gamble on a high-risk, high-reward stock within a large portfolio of safer bets.Mr. Ramaswamy campaigning in Iowa this month. On the campaign trail, he sells what he calls “anti-woke” capitalism, skewering environmental, social and corporate governance programs and dismissing debates about racial privilege.Jordan Gale for The New York TimesWith intepirdine’s failure, Mr. Ramaswamy ran into the hard reality of biology, said Derek Lowe, a longtime pharmaceutical researcher and industry commentator. “The patients’ diseased cells that you’re trying to treat don’t really care how hard-charging you are,” he said.“I think whipping people up into thinking this was a wonder drug was unconscionable,” he said. (Mr. Lowe bet against Axovant’s stock and made about $10,000 from the drug’s failure, he said.)Mr. Ramaswamy has expressed regret for years about the failure of his drug for Alzheimer’s, a disease that has long bedeviled researchers. And the criticism that he profited while his investors lost angers him, he said.“On a personal level, it grates on me a little bit,” he said. “The business model of Roivant was to see these drugs through the market, and we could have cashed out big, and employees could have cashed up big, but that was not the business model.”But Mr. Ramaswamy did eventually cash out on Roivant.In 2019, Roivant sold off its stake in five of its most promising spinoff companies to Sumitomo, a giant Japanese conglomerate.That proved to be Mr. Ramaswamy’s biggest payday. His 2020 tax return included nearly $175 million in capital gains.In recent years, Mr. Ramaswamy has stepped back from Roivant, leaving his roles as chief executive in 2021 and chairman in February. He remains the sixth largest shareholder in the company, with a stake currently valued at more than $500 million. (He has yet to file personal financial disclosures for his presidential run, but he has released 20 years of tax returns, which were provided to The Times by Jeffrey A. Sonnenfeld and Steven Tian, two Yale Business School academics who have studied Mr. Ramaswamy’s business record. The candidate has also called for his competitors in the Republican race to do the same.)Mr. Ramaswamy’s pitch that his business model would lead to affordable drug prices has not come to pass. One example is the product for which he has said he is most proud, a one-time implant for children with a rare and devastating immune ailment. When Enzyvant, the Roivant spinoff company by then controlled by Sumitomo, won regulatory approval in 2021, it set a sticker price of $2.7 million.Sumitomo declined to comment. More