This week’s edition of InnovationRx debuts a new look. In it, we take a look at new rules for medical debt, the raw milk farm at the center of California’s bird flu emergency, the cause of the mysterious disease in Congo and more. To get it in your inbox, subscribe here.
On Tuesday, the Consumer Financial Protection Bureau finalized a new set of regulations governing how lenders consider medical information when making a decision on a loan application. They would remove medical debt from appearing on people’s credit reports and prohibit lenders from considering medical debt as a factor when making a decision on a loan application. This is a big deal as some 15 million Americans have an estimated $49 billion in medical debt.
Although the rules prohibit lenders from using medical information in making any lending decisions, such data can still be considered when verifying relevant requests such as a medical forbearance or to verify healthcare expenses that might be covered by a loan. The regulatory body’s move follows a 2023 decision by credit reporting companies Equifax, Experian and TransUnion to remove medical debts under $500 from credit reports. Once the rule goes into effect, people who have their medical debts removed will likely see an average improvement of 20 points on their credit score, according to the agency.
California’s Raw Farm Doubles Down On Raw Milk Amid Bird Flu State Of Emergency
Mark McAfee hopes to become the chief advisor on raw milk in the next Trump Administration. The cofounder and CEO of Raw Farm, the country’s largest producer that’s been at the center of raw milk recalls in California, said he’s in discussion about the role and hoped to help Robert F. Kennedy Jr., a raw milk proponent who’s been nominated as the next Secretary of Health and Human Services, set standards on raw milk that would ensure safe production, while allowing more distribution of it.
“I’m the raw milk guy,” Mark McAfee, 63, said in a telephone interview, adding, “I’m the only guy that knows this stuff.”
It’s been a moment for the raw milk industry and for Fresno, California-based Raw Farm. First, Raw Farm recalled several batches of its milk and cream after testing by the California Department of Public Health found bird flu virus in samples of its milk. Then it shut its dairies while its herd is under quarantine. Over the past few weeks, the drumbeat of news about bird flu went from bad to worse, as the virus spread to cats and to people, with a child in California testing positive (from an unknown source) and a person in Louisiana being hospitalized with severe illness (likely exposed from a backyard flock). On December 18, with the California state agriculture department having found the virus in 645 dairy herds, California Governor Gavin Newsom declared an emergency. (In January, the Biden Administration committed an additional $360 million to battling the virus, with the money to be distributed before Trump takes office, while the hospitalized man died.)
Raw Farm’s family farmers aren’t backing down in their belief in the benefits of raw milk, which propelled the 100% family-owned business to sales of more than $30 million. With RFK Jr.’s nomination, they’re hoping to sell a lot more. Raw Farm’s president Aaron McAfee, Mark’s 40-year-old son, said that he expected sales to reach $100 million within three years, and that he was already thinking about product expansions. “One of our greatest value adds right now is that we specialize in making a product that everybody in the traditional industry says is impossible,” Aaron McAfee said. “Nobody believes you can do raw milk at scale.”
Read more here.
BIOTECH AND PHARMA
This week, Johnson and Johnson released topline results from its phase 3 study of the combination of Rybrevant and Lazcluze as a first treatment for patients with advanced non-small cell lung cancer with EGFR mutations. This type of lung cancer disproportionately impacts women and has a five year survival rate of about 20%. The company’s study found that its combination of drugs extended patient lifespans over a year longer than those receiving osimertinib, the current standard of care.
“We just made a huge step forward by giving patients another birthday, another anniversary, another chance to celebrate,” Mark Wildgust, J&J VP of global medical affairs for oncology, told Forbes. “It’s a really transformational step forward for patients.”
The study was a randomized controlled trial of 1,074 patients. J&J hopes to make inroads against AstraZeneca’s blockbuster Tagrisso (the brand name of osimertinib), a once-daily pill that previously transformed care for this type of lung cancer. Wildgust told Forbes that it also has ongoing studies of the drug combination for other cancers with EGFR mutations, including colorectal cancer.
DIGITAL HEALTH AND AI
Large language models have made headlines for their ability to get high scores on medical exams. But how well does that ability translate to real patient interactions? The answer, according to a new study published in Nature Medicines, is not that well. To make this determination, a team of medical researchers built an AI agent that simulates patient dialogue based on real medical cases, and used it with four different LLMs. The LLMs asked the “patients” questions about symptoms, medical history and other relevant information, but struggled to obtain an accurate diagnosis compared to their ability to correctly answer exam-style questions.
“Our findings showed that LLMs frequently missed critical details during history-taking, considerably impairing their diagnostic abilities,” the authors wrote. These results, they suggest, highlight the need to develop more realistic assessments of AI models before using them in clinical practice.
MEDTECH
Fixing the performance problems of pulse oximeters on people with darker skin has proved elusive despite significant attention to the problem during the Covid-19 pandemic. On Monday, the FDA announced that it had published long-awaited draft guidance for how makers of pulse oximeters should both test and label their devices.
The draft guidelines call for testing the devices on a “diversely pigmented group” of 150 or more people in clinical studies, up from just 10 previously, with at least 25% of participants falling within medium skin tones and another 25% in dark ones. To gauge skin tone, it called for relying on the Monk Skin Tone scale and a second measurement known as the individual typology angle.
The FDA guidance noted that if the manufacturers could demonstrate equal performance, they should include a package insert stating that it showed comparable performance in “a wide variety of skin tones.”
The non-binding draft recommendations come after years of studies that showed that fingertip pulse oximeters – a standard medical tool, used in every hospital in America and by many patients at home – have significant performance problems on people with darker skin. Their problems giving accurate readings on darker skin mean that a Black patient could have low blood oxygen, a symptom of a worsening respiratory virus or serious lung disease, but the device might indicate normal levels.
The FDA had previously issued a warning about the devices’ problems on darker skin tones and held advisory board meetings, but its slowness to give new guidance had frustrated doctors. New research and editorial published last week in JAMA called for clearer guidance and enforcement.
The federal regulator has requested public comments on the draft within 60 days before it finalizes it. The guidance on pulse oximeters was just one of a number of new guidelines – including on AI in drug development and the use of tissue biopsies in clinical trials – that the agency issued in the final weeks before the Trump Administration takes office.
PUBLIC HEALTH & HOSPITALS
An outbreak of an unknown disease in a remote region of the Democratic Republic of the Congo, ongoing since October, has killed more than 30 people. The World Health Organization, in a published update on the outbreak, has now identified its cause: .a combination of known respiratory diseases like Covid-19 and flu, whose symptoms are exacerbated by an ongoing outbreak of malaria and malnutrition that is endemic in the region. The outbreak, the organization wrote, “highlights the severe burden from common infectious diseases … in a context of vulnerable populations facing food insecurity.”
DEAL OF THE WEEK
Biologic drugs, such as antibodies or pepties, are generally administered as injections or IV infusions. The biotech industry would like to turn them into pills. Copenhagen-based Orbis Medicines announced Monday that it had raised $93 million, led by New Enterprise Associates, to try and do just that. It plans to focus on targets that are already validated by blockbuster injectable biologics. The new funding comes just 11 months after Orbis emerged from stealth with $28 million in seed funding. New investors include pharmaceutical giant Eli Lilly, whose portfolio includes GLP-1 weight loss drugs that must be injected on a weekly basis.
WHAT WE’RE READING
The Fed’s warnings on inflation are bad news for biotech startups
How health insurers racked up billions in extra payments from Medicare Advantage
When your terminal illness makes you a TikTok star
Ten clinical trials to watch in the first half of 2025
Her mental health treatment was helping. That’s why insurance cut off her coverage
UPS seeks $20 billion lifeline from medical supply shipping
Drug company Variant Bio to share revenue with indigenous people who donated their genes
Neumora plunges after major depression drug fails in study
What Covid tried to teach us – and why it will matter in the next pandemic
AMD invests in drug-discovery company Absci in a push to sell AI chips
Why returns have been slow to follow investment in digital health
Ten healthcare names get Shkreli Awards for bad behavior
Clinical trial startup Highlander Health plans to acquire longitudinal datasets startup Target RWE
ACROSS FORBES
Read the full article here