| | | | |  | | By Erin Schumaker, Toni Odejimi, Daniel Payne and Ruth Reader | | | | | 
There may come a day you can pick up a cancer test at your neighborhood pharmacy. | AP Photo/Mark Lennihan, File | The Advanced Research Projects Agency for Health wants to enable you to screen for cancer without leaving home. That’s the goal of the agency’s new Platform Optimizing SynBio for Early Intervention and Detection in ONcology, or POSEIDON, program, managed by Dr. Ross Uhrich. While building the program, Uhrich asked people in government, academia and business what they thought the future of perfect cancer care was. Their answer: catching cancer at Stage I. “Typically, people go to the doctor when they’re not feeling well, not when they’re feeling perfect,” Uhrich told Erin. “Creating a paradigm shift, where people can say, ‘I’m feeling OK and I might be no-risk, but it’s at my discretion to determine when I want to screen,’ changes the entire cancer-screening algorithm as we know it,” he said. Since late-stage cancers are hard to treat and carry worse prognoses, catching cancer earlier would change how we treat, or perhaps one day cure, cancer, Uhrich added. The challenge is designing an accurate Stage I cancer screening tool that people will use. The plan: The program aims to create an over-the-counter, self-administered screening tool that uses noninvasive sensors to detect cancer from breath or urine samples for at least 30 solid-tumor cancers, including stomach, gallbladder, pancreatic and colorectal cancers. If someone has strained bowel movements, for example, and wants to check on their health, they could purchase a test at a pharmacy, no prescription needed. Churches, barbershops and libraries could stock them. People who test wouldn’t go it alone. The kit would connect them to a medical professional for results, Uhrich explained. By the numbers: The goal is to make the tests accessible with or without insurance. When the team surveyed people on how much they’d be willing to pay for an optimal cancer test, most said $100. “I’m not going to tell you outright that this will easily cost $100, but our aim is to try to get there,” Uhrich said. Every team must have an affordability plan with specific metrics to reduce costs, and ARPA-H intends to hold them to that plan. What the agency doesn’t want: another $1,000 cancer test that nobody uses. What’s next? An in-person POSEIDON Proposers’ Day for researchers, companies and investors, where participants can trade ideas and form teams, is Sept. 4 in Baltimore.
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Balestrand, Norway | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. Yoga isn’t just good for the joints but for the brain, too, according to The Washington Post. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com, Erin Schumaker at eschumaker@politico.com, or Toni Odejimi at aodejimi@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.
| | |  Pregnant people with opioid use disorder may have more treatment options than previously thought, a study found. | LM Otero/AP | Doctors may have more options for treating pregnant patients for opioid use disorder than previously thought. A new study in JAMA of more than 3,300 pregnant patients on Medicaid from 2008 to 2018 found that those taking buprenorphine and naloxone to treat their disorder were at no greater risk for pregnancy complications than those who took buprenorphine alone. The drugs help control cravings for dangerous opioids like fentanyl and reduce the chance of overdose. Why it matters: Past research suggested that combining medications would cause adverse effects, causing doctors to prescribe just buprenorphine to pregnant people. “More people began looking at the safety and efficacy, and then we did that systematic review … that really showed, all things considered, we have more choices of medications for patients,” said Hendrée Jones, professor at the University of North Carolina’s School of Medicine and a study co-author. Combining the two medications can reduce the risk of addiction to buprenorphine, which is itself an opioid. There were negative outcomes for gastrointestinal development in newborns. However, the combined drugs are still relatively safer, said Krista F. Huybrechts, an associate professor of epidemiology at Harvard T.H. Chan School of Public Health and a study co-author. What’s next? The researchers are studying how to keep patients on those medications during pregnancy and postpartum. “We are looking at basically retention on treatment, because it's so important for these women to be treated during pregnancy and during the postpartum period,” said Huybrechts.
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These MDMA pills aren't effective in treating PTSD, FDA advisers said. | Kenzo Tribouillard/AFP via Getty Images | Drugmaker Lykos Therapeutics is downsizing, less than a week after the Food and Drug Administration rejected its application for a psychedelic PTSD treatment. Lykos announced Thursday it would cut 75 percent of its staff and that Rick Doblin, who pioneered the push to bring MDMA-assisted therapy to the public, would leave the company's board. “After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but am heartened that Lykos will still move forward continuing clinical research that addresses the FDA’s questions,” Doblin said in a statement. How we got here: A week ago, the FDA rocked the psychedelics movement when it turned down Lykos’ application for MDMA and talk therapy as a post-traumatic stress disorder treatment. The FDA told Lykos it can resubmit its application only if it conducts an additional Phase III clinical trial to further study MDMA's safety and efficacy. The rejection came after outside FDA advisers evaluated Lykos’ application in June and cited concerns about missing safety data in Lykos’ trials, allegations of trial manipulation and the potential risk for misconduct among therapy practitioners. Another blow came to Lykos days after the FDA rejection when the journal Psychopharmacology retracted three MDMA-assisted therapy papers by Lykos’ nonprofit arm, citing unethical conduct at a study site the papers’ authors hadn’t disclosed. Lykos told POLITICO it disagrees with the retraction and believes corrections to the papers should have sufficed and that the retracted data wasn’t what the company submitted to the FDA. The path ahead: Lykos has tasked Dr. David Hough, a former Janssen executive, with leading the company’s regulatory effort. Before the FDA's decision, Lykos said it was taking steps to create more oversight, including establishing an independent advisory board of experts in corporate and medical ethics, innovation, psychiatry and military and veteran health. | | | | Follow us on Twitter | | | | Follow us | | | | |
