Weekly Rundown: New at-home tool to screen for cervical cancer

Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.

New at-home tool to screen for cervical cancer

The FDA approved Teal Health’s Teal Wand™ to allow women to collect their own cervical cancer screening sample at home and mail it to a lab — no Pap smear required. This women’s health procedure is often uncomfortable and requires a doctor’s visit, but the new Teal Wand™ tests for the human papillomavirus (HPV) that causes cervical cancer and provides women with an alternative way to stay on top of their health care. In a press release, Kara Egan, Chief Executive Officer and Cofounder of Teal Health, said, “It’s not just about an innovative new product, it’s about finally giving women an option that makes sense for their lives — something that can be done quickly and comfortably at home. Because when we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day.” The approval is based on the SELF-CERV clinical trial which showed that the at-home test provides results that are just as accurate as going to the doctor’s office. – Allison Whitten

Executive order aims to lower prescription drug prices

On Monday, President Trump announced his “most-favored nation” plan to lower prescription drug prices in the United States such that they match what other nations pay for the same medications. The order will likely be challenged in the courts, and the reactions from the pharmaceutical industry were varied. John Crowley, the Chief Executive Officer and President of the Biotechnology Innovation Organization said in a statement, “Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies — the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s biotechnology leadership.” In reaction to the news, Roche told Endpoints News that they may rethink their $50 billion dollar manufacturing plan in the US. However, on Monday, biotech stocks were up four percent, signaling that investors may not be worried about the plan coming to fruition. – Stephanie DeMarco

New head-to-head comparison of GLP-1 drugs

In a new Phase 3b clinical trial published in NEJM, researchers led by Louis Aronne at Weill Cornell Medicine directly compared tirzepatide and semaglutide to determine which one was more effective for weight loss in adults with obesity (1). Their study showed that tirzepatide came out ahead with participants taking the drug being more likely than those in the semaglutide group to reduce their weight by at least 10, 15, 20, and 25 percent. In a news release, Aronne said, “Doctors, insurance companies and patients are always asking, ‘which drug is more effective?’ … This study allowed us to do a direct comparison.” Aronne said that the greater efficacy of tirzepatide is likely due to its dual mechanism of action, as semaglutide acts only on glucagon-like peptide-1 (GLP-1) receptors while tirzepatide also acts on glucose-dependent insulinotropic peptide (GIP) receptors. – Allison Whitten

FDA plans to remove fluoride prescription drugs from the market

In a statement released Tuesday, the FDA announced that the agency plans to remove ingestible fluoride for children from the market. The statement cites the reasoning behind the move as, “Ingested fluoride has been shown to alter the gut microbiome.” However, two pieces of scientific literature on the effect of fluoride on the gut microbiome cited at the end of the statement do not support this conclusion. The abstract of one of the papers investigating the connection between fluoride and the microbiome states, “Unfortunately, none of the studies retrieved examined the effects of ingested fluoridated water on the human microbiome” (2). The other paper found that concentrations of fluoride less than 2 mg/L were beneficial to the human microbiome and only levels higher than 10 mg/L were detrimental to the gut flora (3). According to the same study, people’s typical range of daily fluoride intake is only between 0.46 and 3.6-5.4 mg. Furthermore, FDA Commissioner Martin Makary is quoted in the statement saying, “For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” which is an inaccurate statement. Fluoride doesn’t kill bacteria. It fortifies the enamel on teeth, which helps protect teeth from acids produced by bacteria in the mouth. At a budget hearing on Wednesday, Republican Congressman from Idaho and former dentist Mike Simpson also corrected this statement about how fluoride works and told Robert F. Kennedy Jr. that if he succeeds in banning fluoride, the US will need to increase its investment in dental education “because we’re going to need a whole lot more dentists,” he said in an NBC News clip of the hearing. – Stephanie DeMarco

Living close to a golf course increases risk of Parkinson’s disease

To keep their well-manicured greens in pristine condition, golf courses often spray them with pesticides. These chemicals, however, can leech into ground water and contaminate nearby water supplies. Now, in a new case-control study, researchers found that people who lived within one to three miles of a golf course had the highest risk of developing Parkinson’s disease (PD) compared to those who lived farther away (4). Specifically, people who lived within one mile of a course had 126 percent increased odds of developing PD compared to those who lived six miles away. The researchers found this association in data collected in the Rochester Epidemiology Project from 1991 to 2015. They controlled for age, sex, race and ethnicity, and urban versus rural location among other variables. The results support prior research studies that have linked pesticide exposure to PD (5). – Stephanie DeMarco

Adding a new drug after chemotherapy improves survival in breast cancers

Researchers led by Jean Abraham at the University of Cambridge demonstrated that a new strategy could help treat aggressive breast cancers by adding in olaparib, a poly-ADP ribose polymerase (PARP) inhibitor, after chemotherapy but before surgery (6). They showed that adding the drug led to improved survival outcomes in early-stage breast cancer patients with mutations in the BReast CAncer genes 1 and 2 (BRCA1 and BRCA2). In a press release, the team reported that only one patient relapsed in the group who received chemotherapy followed by olaparib and 100 percent of patients survived compared to nine patients who relapsed in the control arm (chemotherapy only), and 88 percent survived three years after surgery. Their work was published in Nature Communications on Tuesday. – Allison Whitten

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