Latest news with #OxyContin
Los Angeles Times
2 days ago
- Business
- Los Angeles Times
FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency's top drug regulator, the agency confirmed Monday. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will serve as director of the Center for Drug Evaluation and Research, one of the FDA's largest and most important divisions with a staff of about 5,700 that reviews the vast majority of new drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency. Tidmarsh, 65, was involved in the development of several approved drugs, likely making him a reassuring choice for a pharmaceutical industry that's facing pressure from the Trump administration to lower prices and move manufacturing to the US. Tidmarsh's appointment 'brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,' Brian Abrahams, an analyst at RBC Capital Markets, said in a note to clients. While recent cuts at the agency have raised concerns about the FDA's drug approval process, 'we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry.' Among the controversies Tidmarsh will contend with is the agency's accelerated approval process. The use of this expedited pathway to get drugs green lit has skyrocketed in recent years and been criticized for sometimes letting unproven treatments linger on the market for too long. Advocates say speeding up the process gets drugs quickly to patients suffering from serious diseases. Tidmarsh is also primed to be a key player in reassessing the agency's approach to regulating prescription drug advertising. Health Secretary Robert F. Kennedy Jr. has long been a critic of direct-to-consumer drug advertising, and Makary has indicated that the agency is reviewing its approach to regulating such ads. During a panel on censorship and scientific speech at Stanford last year, Tidmarsh raised concerns about the FDA's inconsistent regulation of pharmaceutical products. He pointed to the agency's long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers' ads during the pandemic.'This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,' he said. While the FDA's vaccine division has been in the spotlight recently over Covid shots, the drug division has made some of the agency's most controversial decisions. In the '90s, CDER approved language allowing opioid drugs, such as OxyContin, to be widely marketed — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic. The division also caused a firestorm after approving the Alzheimer's treatment Aduhelm that hadn't clearly been proven to work in research studies. On a recent podcast, Tidmarsh said he met Makary at a conference last fall at Stanford. It featured many people critical of restrictions and mandates during the pandemic, several of whom now have top government health jobs. Tidmarsh appears to share Makary's concerns about a lack of dissenting viewpoints in science. In a podcast about a year ago, he said academics foster a culture that is reluctant to question prevailing views and that grantmaking has become concentrated into a few hands. On LinkedIn last year, Tidmarsh wrote that 'academic science has become riddled with fraud, the time has come to root out the corruption.' He funds the Sleuth in Residence program that supports scientific fraud investigators at the website Retraction Watch, which tracks academic journals. At Stanford, Tidmarsh got both his medical degree and a PhD in cancer biology and then worked in the school's clinical faculty. He also had a series of biotech jobs, including chief executive officer for La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now part of Innoviva Inc. Tidmarsh, who was also trained in pediatric oncology, has worked over the years to find solutions to shortages of old lifesaving cancer drugs. In an interview last year with a publication for doctors, he likened the US generic drug market to a 'wild west' where predatory contracting practices can drive out manufacturers. Langreth and Hornblower write for Bloomberg.
New York Post
7 days ago
- New York Post
New text messages fuel Alex Murdaugh's push for new trial
Newly uncovered text messages between disgraced former attorney Alex Murdaugh and his alleged drug dealer could have dramatically altered the defense's trial strategy and possibly prevented a conviction, according to lead defense attorney Dick Harpootlian. Harpootlian, a veteran South Carolina defense attorney and former state senator, told Fox News Digital that the texts between Murdaugh and Curtis 'Eddie' Smith, revealed recently by FITSNews, were not provided to the defense during the trial. Advertisement Their absence, he said, may have contributed to a key decision not to call Smith to the stand. 'One of the big decisions in any trial like this is who you call as witnesses,' Harpootlian explained. 'We were not aware of these texts. Had we been, it may have made a difference in our decision. These messages offer new insight into the timeline of drug distributions, some of them happening the very week of the murders.' 13 Newly uncovered text messages between disgraced former attorney Alex Murdaugh and his alleged drug dealer could have possibly prevented a conviction. serinc 13 Alex Murdaugh gives testimony during his murder trial at the Colleton County Courthouse, Feb. 23, 2023. AP Advertisement Smith, alleged to have been Murdaugh's primary drug supplier, has not been prosecuted, despite what Harpootlian described as evidence suggesting he may have been one of the largest OxyContin distributors in the Palmetto state. 'Everybody else who was indicted pleaded guilty — except Eddie Smith,' he said. The text messages show that Smith and Murdaugh conversed in the days leading up to Murdaugh's murder of his wife Maggie and his youngest son, Paul, on June 7, 2021, on their family's hunting estate in Colleton County, South Carolina. Advertisement 'Hey Brother i need to come get the chech (sic) you got one with you or are you going to be around later,' Smith texted Murdaugh on June 3, four days before the slayings. Murdaugh replied that he would be back that afternoon and that he 'had to deal with some bulls**t this morning.' 13 Alex Murdaugh, right, confers with defense attorney Jim Griffin during his double murder trial. AP 13 A headstone was recently erected for Randolph Murdaugh III and Elizabeth Alexander next to the grave markers for Paul and Maggie Murdaugh at Hampton Cemetery. Daniel William McKnight Advertisement 13 South Carolina Department of Corrections inmate Alex Murdaugh. AP 'Ok Brother just give me a holler,' Smith texted, later adding, 'Leaving the house now.' The day before the murders, Murdaugh texted Smith, 'Call me back.' Within a span of two minutes the morning after the murder, Smith texted Murdaugh, 'Tell me what I heard is not true,' and, 'Call me please.' Those texts went unreturned, and around 6:30 p.m., and Smith cryptically texted Murdaugh, 'At fishing hole.' After that message also went unreturned, he texted, '803 *** **13 it will not go through on my phone.' 'Those texts, the ones we don't have, indicate a little more of the timeline of those distributions, and some of them are the week of the murder,' Harpootlian said. 'And we were not aware of those. Had we been aware of these, it may have made a difference in our decision not to call Eddie Smith to the stand.' He also expressed concern that Smith had not been prosecuted for his alleged role in selling drugs to Murdaugh. Advertisement 13 The day before the murders, Murdaugh texted Smith, 'Call me back.' TNS 13 Disbarred attorney Alex Murdaugh arrives in court in Beaufort, South Carolina. AP 13 Defense attorney Dick Harpootlian holds Buster Murdaugh's .300 Blackout rifle, similar to the one used to kill Buster Murdaugh's mother during double murder trial. AP 'And he has not been prosecuted. [He's] wandering the streets, I heard maybe out of the state, and we're perplexed why Eddie Smith has been given this preferential treatment when once Alex was convicted, there was no reason not to go ahead and prosecute him,' said Harpootlian. 'Everybody else has pleaded guilty. Everybody else that was indicted has pleaded guilty except Eddie Smith. Now these texts would have given us additional information we believe, and I've talked to [co-counsel] Jim Griffin. It might have made the difference in us calling him to the stand or not calling him to the stand. So yes, they're important.' Advertisement Murdaugh is already appealing his conviction, based in large part on accusations of jury tampering by Colleton County Clerk of Court Becky Hill. She was arrested and charged with obstructing justice and misconduct in that incident. She was also charged with perjury in Richland County in relation to the case, after allegedly lying to State Supreme Court Justice Jean Toal during 2024 appellate proceedings. 'We have an appeal based on errors made by the judge during the trial, and of course, the attempt by — or maybe she did — the efforts by the Clerk of Court, Becky Smith, to fix the jury. And that's a huge issue,' said Harpootlian. 'Many of the people we've had look at the appeal believe we have a substantial chance of getting a new trial, just based on the jury tampering.' 13 Defense attorney Dick Harpootlian speaks to the media outside the Colleton County Courthouse after his defendant Alex Murdaugh was sentenced. AP Advertisement 13 Murdaugh is already appealing his conviction, based in large part on accusations of jury tampering by Colleton County Clerk of Court Becky Hill. AP 13 Alex Murdaugh speaks with his legal team before he is sentenced to two consecutive life sentences. AP He said if they do not win a new trial, there is a possibility that they will file a habeas petition seeking to have the conviction vacated on the same grounds. 'The state's brief on the underlying appeal is due Aug. 8,' he said. 'We have up to 30 days to reply. Then the Supreme Court decides whether to have argument, whether to grant it, whether deny it, and that could take months,' he said, adding that if the appeal is granted Murdaugh will get a new trial. Advertisement Harpootlian says he expects the state's high court to have a ruling on the appeal by early next year at the latest. 'And again, there are all kinds of debates about the evidence and how it was allowed in by the trial judge and whether it should have been excluded or allowed in. And those certainly are important. And we think there's several of them, individually, would give us a new trail,' he said. 13 Harpootlian says he expects the state's high court to have a ruling on the appeal by early next year at the latest. Daniel William McKnight 13 Alex Murdaugh arriving at court, flanked by law enforcement. Daniel William McKnight for NY Post 'But more important is a judge, former Chief Justice of Supreme Court, had an evidentiary hearing on Becky Hill's conduct in which she found: A) Becky Hill was not credible, and B) that Becky Hill did attempt to influence jurors to convict Alex Murdoch. She told several of her coworkers that she was writing a book, and it would be better for book sales if Alex was convicted. So we think that, and there is no clear state precedent on whether that's enough, but there's a clear federal precedent that we should get a new trial. So again, I think we should hear something before the end of the year or early next year.' Every morning, the NY POSTcast offers a deep dive into the headlines with the Post's signature mix of politics, business, pop culture, true crime and everything in between. Subscribe here! A retrial would likely look very different, Harpootlian said. With Murdaugh having already pleaded guilty to financial crimes, that aspect would be excluded, narrowing the scope to forensic and factual evidence. The lead attorney believes Murdaugh has a strong defense. 'We had a six-week trial last time because of the financial misconduct. That won't happen again,' Harpootlian said. 'And when you look solely at the forensic evidence, I believe it overwhelmingly proves Alex did not kill Paul and Maggie.' The South Carolina Law Enforcement Division, which led the investigation, and Prosecutor Creighton Waters did not return comment requests.
Washington Post
15-07-2025
- Health
- Washington Post
How states should spend all that opioid settlement money
State and local governments are about to get a lot of money to combat the opioid epidemic. They could fritter it away on nice-sounding programs — or save the most lives. Last month, attorneys general from 55 U.S. states and territories as well as the District of Columbia approved a $7.4 billion settlement with Purdue Pharma, the maker of opioid painkiller OxyContin. If the settlement is finalized, the vast majority of that money would, over the next 15 years, flow to states, local governments and Native American tribes for opioid abatement. The deal would also shut down Purdue and replace it with a public-benefit company committed to combating the crisis, to be run by a court-approved board.
Miami Herald
13-07-2025
- Business
- Miami Herald
UnitedHealth's campaign to quiet critics
Mary Strause, a filmmaker in Wisconsin, logged on to Amazon's video-streaming service in late May so she could share a link to her latest project, a docuseries that harshly criticized the U.S. health care industry. She was surprised to see that her video had vanished. Strause had no way of knowing it, but the video had been taken down after a law firm working for UnitedHealth Group, one of the country's largest health care companies, sent a letter warning Amazon and another streaming service, Vimeo, that the video was defamatory. It was the latest salvo in an aggressive and wide-ranging campaign to quiet critics. In recent months, UnitedHealth has targeted traditional journalists and news outlets, a prominent investor, a Texas doctor and activists like Strause and her father, who complained about a UnitedHealth subsidiary. In legal letters and court filings, UnitedHealth has invoked last year's killing of Brian Thompson, the CEO of the company's health insurance division, to argue that intense criticism of the company risks inciting further violence. The tactics have had an impact. Amazon and Vimeo both removed Strause's film. The Guardian postponed publishing an investigation of the company after UnitedHealth sued over a previous article it said was defamatory. UnitedHealth joins a growing group of companies and wealthy individuals, including President Donald Trump, who are using legal threats and lawsuits to deter or penalize criticism. Over the years, there have been scattered examples of embattled companies -- such as Purdue Pharma, the maker of the highly addictive painkiller OxyContin -- deploying legal offensives against a broad spectrum of journalists and critics, said Lee Levine, a retired First Amendment lawyer who has defended news outlets, including The New York Times. 'Some version of this has been going on for a long, long time,' Levine said. But, he added, 'the incidence of it has increased.' For UnitedHealth, the stakes are high. In recent years, the company has been the subject of extensive investigative reporting into its billing practices and denials of patient care, among other things. It faces a variety of federal criminal and civil investigations, including into potential Medicare fraud and antitrust violations, The Wall Street Journal has reported. 'Negative publicity may adversely affect our stock price, damage our reputation and expose us to unexpected or unwarranted regulatory scrutiny,' UnitedHealth noted in its most recent annual report. The company's shares have declined 40% over the past year. Eric Hausman, a spokesperson for UnitedHealth, defended the company's efforts. 'The truth matters, and there's a big difference between 'criticism' and irresponsibly omitting facts and context,' he said in a statement. 'When others get it wrong, we have an obligation to our customers, employees and other stakeholders to correct the record, including by making our case in court when necessary.' Even before Thompson was fatally shot in December on his way into a Manhattan hotel, the company had been seeking to tamp down negative publicity. In March 2024, The Examiner News in Mount Kisco, New York, published its latest investigation of a UnitedHealth division, Optum Medical Care, that operated in the area. A source had provided Adam Stone, the newspaper's publisher, with a recording of Optum employees, and Stone said he inadvertently posted the whole file, rather than a snippet, with his article. Within hours, he had corrected the mistake -- but not before Optum had noticed. About a week later, Stone received a letter from the executive who ran Optum in New York and New Jersey, saying he had potentially committed a crime by airing audio that included private information about patients. The executive demanded that Stone destroy the audio and said the company might seek a court injunction barring him from continuing to publish it. Stone replied that he would not destroy the audio. An Optum lawyer then wrote a letter reiterating the demand. Stone again refused. It was the last he heard from the company. 'The aim was to use scare tactics to intimidate,' Stone said. UnitedHealth's efforts intensified after Thompson's killing. In early January, Dr. Elisabeth Potter, a plastic surgeon in Austin, Texas, posted a self-made video on TikTok and Instagram that described how she had interrupted breast-reconstruction surgery to respond to a phone call from UnitedHealth about whether the insurer would cover a patient's stay at a hospital. The call had come to the operating room's phone line, leading her to believe it was urgent. 'Insurance is out of control,' Potter said in the video. 'I have no other words.' The short video was viewed millions of times and attracted hundreds of thousands of 'likes' on social media. About a week later, Potter received a six-page letter from the law firm Clare Locke, which UnitedHealth had retained as 'defamation counsel.' The letter claimed that she had distorted the circumstances of the phone call and that her video was libelous. It noted that some commenters were responding to her posts by celebrating Thompson's killing. The letter demanded that she retract her video and apologize. A lawyer for Potter sent a letter to Clare Locke defending the accuracy of the video. The law firm did not respond, Potter said. One of the many people who shared Potter's video was billionaire investor Bill Ackman, who has nearly 2 million followers on the social platform X and regularly wades into controversies. In a post accompanying the video, he suggested that investors should bet against UnitedHealth's stock and that the Securities and Exchange Commission should investigate the company. The post brought even more attention to Potter's video. Ackman soon heard from Clare Locke. He already knew the firm. He and his wife, Neri Oxman, had hired Clare Locke to threaten Business Insider after it reported in 2024 that she had plagiarized parts of her doctoral dissertation. (They did not end up suing.) Now, though, the roles were reversed. One of the firm's co-founders called an aide to Ackman and told him that the video included falsehoods. And UnitedHealth contacted the SEC to complain that Ackman was trying to drive down the company's stock price. Ackman deleted the post. But after he spoke with Potter and looked at notes and call logs provided by her lawyer, he changed course. 'I believe that Dr. Potter told the truth,' he wrote on X in February. He accused UnitedHealth of 'brazen attempts to silence UNH's critics.' Clare Locke never followed up with him. Still, Potter's conflict with the company was not over, she said. She had recently opened her own surgery center and had hired a consultant to help persuade UnitedHealth and other insurers to classify it as an in-network provider. Winning that designation was essential to Potter's business plan. Then Potter's video went viral, and UnitedHealth stopped responding to inquiries from her representative, she said. Potter perceived it as retaliation. Although she said she was still in talks with other major insurers, UnitedHealth is the country's largest. She said she worried that her surgery center might have to close. At the time that she posted the video, Potter hadn't anticipated UnitedHealth's reaction. 'I guess I was naive,' she said. Hausman, the UnitedHealth spokesperson, said the insurer had decided not to designate Potter's center as in-network before she posted her video. In May, The Guardian published an investigation that said UnitedHealth had sought to save money by discouraging nursing homes from sending sick residents to the hospital. The article -- which was based on lawsuits, internal company documents, patient records and interviews -- noted that UnitedHealth disputed its findings. Last month, UnitedHealth sued The Guardian for defamation. The lawsuit accused the news organization of deliberately publishing false accusations and 'brazenly trying to capitalize on the tragic and shocking assassination' of Thompson. The Guardian said it stood by its reporting and was preparing to defend itself against the lawsuit. The timing of the lawsuit was notable. It was filed the day before The Guardian was scheduled to publish a second investigation into UnitedHealth, according to people familiar with the plans. The news organization had informed UnitedHealth about the article's timing. After the lawsuit was filed, editors at The Guardian decided to postpone publication of the second piece, the people said. It hasn't yet run. It was around this time that Strause, the filmmaker from Wisconsin, logged on to Amazon's video-streaming service to get a link to share with a friend. Strause and her father, Dan Strause, who had helped run a small chain of pharmacies in Wisconsin, had hoped that the docuseries, called 'Modern Medical Mafia,' would reveal the inner workings of drug industry middlemen known as pharmacy benefit managers, or PBMs. One of the largest PBMs, Optum Rx, is a UnitedHealth subsidiary. The show's central premise was that PBMs operated like an organized-crime ring, using their dominant market positions to push prescription prices ever higher. The first episode included interviews with two members of Congress and several prominent critics of PBMs and featured computer-generated animations of shadow-cloaked businesspeople and gangsters. A trailer for the series went online late last year, and UnitedHealth learned that it was going to be available on platforms including Amazon Prime Video. In January, Clare Locke flagged UnitedHealth's concerns in a letter to Amazon's outside counsel. The episode nonetheless became available on Prime Video in late March. On May 21, Clare Locke wrote again to Amazon's lawyers. The 16-page letter claimed that the docuseries 'spreads a vociferous and false screed in a thinly-veiled call to violence for anyone who is dissatisfied with the American health care system. Recent history and Brian Thompson's murder demonstrates the devastating and irreversible consequences of ginning up such hatred with false claims designed to inspire violence.' The letter said the video violated Amazon's terms of service and should be removed, in part because it 'doxxed our clients' physical address' by showing a street sign for Optum Way in Minnesota. Within days, the video -- which had no more than a few hundred views -- had been removed from Prime Video. Strause contacted Filmhub, the company that had helped place the documentary on the platform, to ask why. 'Channels occasionally decline and remove titles that they say are not aligned with their ever-changing content policies,' Filmhub responded, noting that Amazon's decision was not subject to appeal. (An Amazon spokesperson, Katie Barker, said in a statement that Filmhub decided to have 'Modern Medical Mafia' removed after Amazon flagged its 'low video quality.' Filmhub executives did not respond to requests for comment.) In early June, Strause received an email from Vimeo, where 'Modern Medical Mafia' had also been available for streaming. 'This content was removed due to a complaint Vimeo received concerning defamation,' the email said. 'Vimeo is not able to evaluate the truth or falsity of such a claim, and it asks that you resolve the dispute directly with the complainants, Optum Rx and UnitedHealth Group.' To Strause, UnitedHealth's determination to get her video taken down showed that she and her father were exposing the truth. 'They're intimidated by what we're saying,' she said. The video remains available on YouTube, which said it had not received a request to remove it, and Strause said she planned to upload the rest of the series to that platform later this year. This article originally appeared in The New York Times. Copyright 2025
Bloomberg
11-07-2025
- Health
- Bloomberg
FDA to Revisit Opioid Labeling for Chronic Pain
FDA Commissioner Dr. Marty Makary says the agency will revisit the labeling system for OxyContin and similar drugs, saying the original approval for chronic pain was 'based on a 14-day study' and tainted by 'regulatory capture.' He plans to ensure that a new system is consistent with the science. The action follows an April Bloomberg Businessweek investigation into how the agency's labeling helped ignite the opioid crisis. (Source: Bloomberg)
