Latest news with #Vioxx
Politico
07-03-2025
- Health
- Politico
FDA nominee pitches AI application review
WASHINGTON WATCH 'There's a number of opportunities with AI right now that we have that we've never had before,' Dr. Marty Makary, President Donald Trump's nominee to lead the Food and Drug Administration, told a panel of lawmakers he hopes will confirm him. In particular, AI could assist FDA staff to review drug and device applications, he told senators on the Health, Education, Labor and Pensions Committee. He was quick to add that AI would assist reviewers, not replace them. He also said AI could be used to aid with data monitoring after a drug has been approved. 'So that we don't learn five years after Vioxx was approved that 38,000 Americans died from it,' he said. Vioxx was a pain killer that was removed from the market after it was found to raise the risk of heart attack and stroke. Dr. David Graham, former associate director in the FDA's Office of Drug Safety, estimated that between 88,000 and 139,000 Americans had heart attacks and strokes as a result of taking the drug, some of which were fatal. Open questions: But the Johns Hopkins surgeon also said the FDA could potentially share data with drug developers that might help them 'train machine learning models, to help design AI systems that can predict toxicities, adverse events, and even cures for some conditions.' Drug developers are also thinking about how AI can help prevent the advancements of drugs that could ultimately get pulled. It's unclear how the FDA could play a role in that. One question is: What data could FDA provide that wouldn't be proprietary to the companies? Background: Former Commissioner Robert Califf also talked about using AI internally at the FDA, particularly for compliance monitoring. But those plans were dashed after Trump won the election and Califf left the FDA. So far, the Trump administration has unwound much of the Department of Health and Human Services' work to lay a foundation to use and regulate AI. Recently, it took down a public-facing document laying out HHS's AI strategy. WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. Butterflies are vanishing from America, with potentially dire impacts on pollination that sustains plants and crops, the Washington Post reports. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@ Daniel Payne at dpayne@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Are you a current or former federal worker who wants to share a tip securely? Message us on Signal: CarmenP.82, DanielP.100, RuthReader.02 or ErinSchumaker.01. WORLD VIEW America's sudden freezing and subsequent termination of most foreign aid funding is crippling tuberculosis services in countries with the highest number of cases and risks reversing decades of progress against one of the world's top infectious disease killers, the World Health Organization warned Wednesday. To date, thousands of health workers have been suspended and face layoffs, and that has impacted essential health services and drug supply chains. Laboratory testing services are 'severely disrupted,' the WHO said, due to delays in sample transportation and shortages of essential laboratory materials, halting efforts to diagnose more people with the disease. 'Community engagement efforts — including active case finding, screening, and contact tracing — are deteriorating, reducing early TB detection and increasing transmission risks,' the WHO added. The Trump administration has terminated multiyear grants, contracts or agreements on tuberculosis worth at least $820 million, according to a POLITICO analysis of a document it obtained listing all terminations. The figure doesn't include programs focusing on both tuberculosis and HIV/AIDS or on tuberculosis and other conditions. Research on tuberculosis has also been impacted, since the U.S. Agency for International Development, which the Trump administration has gutted, has halted all the clinical trials it was funding, the WHO said. USAID was among the top three research funders in the world for tuberculosis, according to the WHO. Why it matters: Tuberculosis has consistently been the world's top infectious disease killer, besides the years where Covid-19 took its spot. More than 10 million people globally fell ill from tuberculosis in 2023, the latest year for which data is available. Around 1.2 million people died of tuberculosis that year. Just over two dozen countries account for most of the world's tuberculosis cases — including India, Indonesia and the Philippines — and 18 of them depend significantly on U.S. funding. America has provided between $200 to and $250 million yearly in bilateral funding for tuberculosis. This funding represented about one quarter of the total amount of international donor funding for tuberculosis, the WHO said.
Yahoo
06-03-2025
- Health
- Yahoo
Opinion - Through ‘radical transparency,' Kennedy can finally rein in Big Pharma
The health of America is in jeopardy. Doctors do not have access to the full safety and effectiveness data for the treatments we rely upon. Pharmaceutical companies control and hide information from their clinical trials, preventing health care professionals from making the most informed decisions to best treat patients. The newly confirmed secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., can take immediate action as part of his prioritization of 'radical transparency' to aid his mission to 'Make America Healthy Again.' In order to get a drug on the market, the Food and Drug Administration (FDA) has to determine that it is safe and effective for at least one specific use and patient population. Pharmaceutical companies sponsor and fund clinical trials to test their products, and the FDA analyzes the results when making an approval decision. However, the pharmaceutical companies own the data from their trials, meaning that those outside the FDA cannot see the full results. Medical journals — the gold standard of medical knowledge for doctors — publish articles describing the results of drug trials. Yet the manuscripts that the peer reviewers scrutinize only include limited, selected summary pieces of information rather than the full data. Thus, clinical trial results published in peer-reviewed medical journals are not truly vetted. This lack of transparency grants drugmakers incredible power over the decisions of doctors, patients and even governments through controlling the information they see. From 1999 to 2014, pharmaceutical company Roche raked in $18 billion globally from Tamiflu, a drug to prevent and treat influenza, even though it offered minimal benefits and caused harmful reactions like vomiting. Roche achieved success based on hiding the results from their sponsored trials and promotion from the American Medical Association's journal JAMA Internal Medicine. After years of Cochrane Collaboration investigators hounding Roche, they got access to their trial data, and they were able to expose the scam in 2014. In the early 2000s, an estimated 40,000 to 60,000 Americans died from the anti-inflammatory drug Vioxx, after pharmaceutical company Merck hid serious cardiovascular adverse events such as heart attacks and strokes. Different published articles in the New England Journal of Medicine did not disclose or downplayed Vioxx's risks. Merck had reported even more serious cardiovascular risks to the FDA. Fortunately, independent investigators like Drs. Jennifer Hrachovec and John Abramson were able to find the discrepancies in publicly available FDA review documents; however, the case reveals the dangerous consequences of poor transparency. To get access to full trial data, people mainly file Freedom of Information Act requests to the FDA. These requests are inherently reactive, where investigators must petition and wait long periods of time and spend lots of money. For example, the FDA attempted to punt the request to release clinical trial information for Pfizer's COVID vaccine by determining it would take 75 years to release the data. Ultimately, a judge forced the agency to begin releasing data in 2022. That result was better than many FOIA requests; the FDA has historically sided with industry to keep clinical trial data locked away. FOIA Exemption 4 allows agencies to protect commercially confidential information and trade secrets. The FDA has consistently accepted industry objections to requests to release clinical trial information under Exemption 4 when it is under no legal obligation to do so. The Supreme Court has ruled that FOIA exemptions are optional and do not prevent disclosure. While Kennedy could direct the FDA to increase transparency by simply releasing more trial data requested under FOIA, he can go much further. He has the full authority to prospectively release clinical trial data (de-identified to protect trial participant privacy) for medical products upon FDA approval, and to retroactively release clinical trial data from previously approved products. The Supreme Court has upheld that under the Federal Housekeeping Statute, federal agencies can disclose their 'records, papers, and property' as long as they are not violating other laws that explicitly bar certain disclosures like the Trade Secrets Act. Clinical trial data providing full results demonstrates safety and efficacy and decidedly does not constitute trade secrets. In fact, Congress instructed the Department of Health and Human Services to increase drug data transparency in the 2007 Food and Drug Administration Amendments Act. During his confirmation hearing, Kennedy discussed his desire to bring the public health agencies under his purview to the gold standard, partly through ensuring 'that all the science is published with the raw data.' Ensuring medical decisions are informed by correct information is critical: The United States alone accounts for 60 to 80 percent of global spending on drugs. Americans are increasingly taking more medications, and the country suffers from far worse health outcomes compared to peer nations. Through releasing clinical trial data upon approval, Kennedy can provide doctors and healthcare professionals with the information they need to truly determine if a drug is safe, effective and reasonably priced compared to alternative treatments. Research shows that pharmaceutical companies do not spend the most on advertising drugs that actually provide the most medical benefit, and drugmakers have a history of paying billions in fines for fraudulent behavior. As head of HHS, Kennedy can use his existing power to bolster transparency, protect patients and help 'Make America Healthy Again.' Brandon Novick is the domestic program outreach assistant at the Center for Economic and Policy Research, where he conducts health policy research and educates federal policymakers on issues like Medicare, private equity in healthcare, and industry control of medical research. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
06-03-2025
- Health
- The Hill
Through ‘radical transparency,' Kennedy can finally rein in Big Pharma
The health of America is in jeopardy. Doctors do not have access to the full safety and effectiveness data for the treatments we rely upon. Pharmaceutical companies control and hide information from their clinical trials, preventing health care professionals from making the most informed decisions to best treat patients. The newly confirmed secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., can take immediate action as part of his prioritization of 'radical transparency' to aid his mission to 'Make America Healthy Again.' In order to get a drug on the market, the Food and Drug Administration (FDA) has to determine that it is safe and effective for at least one specific use and patient population. Pharmaceutical companies sponsor and fund clinical trials to test their products, and the FDA analyzes the results when making an approval decision. However, the pharmaceutical companies own the data from their trials, meaning that those outside the FDA cannot see the full results. Medical journals — the gold standard of medical knowledge for doctors — publish articles describing the results of drug trials. Yet the manuscripts that the peer reviewers scrutinize only include limited, selected summary pieces of information rather than the full data. Thus, clinical trial results published in peer-reviewed medical journals are not truly vetted. This lack of transparency grants drugmakers incredible power over the decisions of doctors, patients and even governments through controlling the information they see. From 1999 to 2014, pharmaceutical company Roche raked in $18 billion globally from Tamiflu, a drug to prevent and treat influenza, even though it offered minimal benefits and caused harmful reactions like vomiting. Roche achieved success based on hiding the results from their sponsored trials and promotion from the American Medical Association's journal JAMA Internal Medicine. After years of Cochrane Collaboration investigators hounding Roche, they got access to their trial data, and they were able to expose the scam in 2014. In the early 2000s, an estimated 40,000 to 60,000 Americans died from the anti-inflammatory drug Vioxx, after pharmaceutical company Merck hid serious cardiovascular adverse events such as heart attacks and strokes. Different published articles in the New England Journal of Medicine did not disclose or downplayed Vioxx's risks. Merck had reported even more serious cardiovascular risks to the FDA. Fortunately, independent investigators like Drs. Jennifer Hrachovec and John Abramson were able to find the discrepancies in publicly available FDA review documents; however, the case reveals the dangerous consequences of poor transparency. To get access to full trial data, people mainly file Freedom of Information Act requests to the FDA. These requests are inherently reactive, where investigators must petition and wait long periods of time and spend lots of money. For example, the FDA attempted to punt the request to release clinical trial information for Pfizer's COVID vaccine by determining it would take 75 years to release the data. Ultimately, a judge forced the agency to begin releasing data in 2022. That result was better than many FOIA requests; the FDA has historically sided with industry to keep clinical trial data locked away. FOIA Exemption 4 allows agencies to protect commercially confidential information and trade secrets. The FDA has consistently accepted industry objections to requests to release clinical trial information under Exemption 4 when it is under no legal obligation to do so. The Supreme Court has ruled that FOIA exemptions are optional and do not prevent disclosure. While Kennedy could direct the FDA to increase transparency by simply releasing more trial data requested under FOIA, he can go much further. He has the full authority to prospectively release clinical trial data (de-identified to protect trial participant privacy) for medical products upon FDA approval, and to retroactively release clinical trial data from previously approved products. The Supreme Court has upheld that under the Federal Housekeeping Statute, federal agencies can disclose their 'records, papers, and property' as long as they are not violating other laws that explicitly bar certain disclosures like the Trade Secrets Act. Clinical trial data providing full results demonstrates safety and efficacy and decidedly does not constitute trade secrets. In fact, Congress instructed the Department of Health and Human Services to increase drug data transparency in the 2007 Food and Drug Administration Amendments Act. During his confirmation hearing, Kennedy discussed his desire to bring the public health agencies under his purview to the gold standard, partly through ensuring 'that all the science is published with the raw data.' Ensuring medical decisions are informed by correct information is critical: The United States alone accounts for 60 to 80 percent of global spending on drugs. Americans are increasingly taking more medications, and the country suffers from far worse health outcomes compared to peer nations. Through releasing clinical trial data upon approval, Kennedy can provide doctors and healthcare professionals with the information they need to truly determine if a drug is safe, effective and reasonably priced compared to alternative treatments. Research shows that pharmaceutical companies do not spend the most on advertising drugs that actually provide the most medical benefit, and drugmakers have a history of paying billions in fines for fraudulent behavior. As head of HHS, Kennedy can use his existing power to bolster transparency, protect patients and help 'Make America Healthy Again.' Brandon Novick is the domestic program outreach assistant at the Center for Economic and Policy Research, where he conducts health policy research and educates federal policymakers on issues like Medicare, private equity in healthcare, and industry control of medical research.
