A baby formula maker’s ‘bizarre’ response to the infant botulism outbreak
ByHeart has recently issued a nationwide recall of all its products in the U.S. after 15 infants were hospitalized with botulism linked to the consumption of the company’s formula. Despite the clear connection, ByHeart initially contested the regulators’ findings in their reaction to the recall. This response has led to criticism from customers who feel that the company has been downplaying, concealing information, and misleading parents throughout the process.
With a substantial backing of $908 million in venture capital, ByHeart made a significant entrance into the market in 2016 with a formula boasting “clean ingredients” targeted at health-conscious mothers. The formula gained popularity within the Make America Healthy Again movement as well.
However, ByHeart’s track record raises concerns, with a previous recall in 2022 and a warning letter from the Food and Drug Administration following an inspection the following year. How did the company address the recent nationwide recall? For more insights on this matter, refer to STAT’s Sarah Todd’s coverage.
More Americans use weight loss drugs like Ozempic than live in Texas
A recent KFF poll on GLP-1 drugs and drug prices has revealed a significant surge in the prevalence of weight loss drugs in recent years. The poll indicates that nearly 13% of adults are using a GLP-1 drug such as Ozempic or Wegovy to manage chronic conditions, lose weight, or both. This figure represents more than double the percentage reported in the previous year.
Despite the potentially high costs associated with these drugs, with nearly 30% of users with health insurance bearing the entire financial burden, their popularity continues to rise. The poll’s findings come shortly after a recent deal by Trump aimed at making these popular drugs more affordable for the general population.
To delve deeper into the world of GLP-1 drugs, known for their diverse applications in treating diabetes, obesity, addiction, and more, explore further. Additionally, if you missed STAT’s Alex Hogan’s breakdown on why Ozempic’s widespread recognition could make it vulnerable to “genericide,” watch the informative video.
Wild polio, continued
New details have emerged regarding the detection of wild poliovirus in wastewater in Germany. Authorities in Hamburg disclosed that Type 1 virus was detected in sewage, with the genetic sequence closely resembling viruses circulating in Afghanistan, one of the remaining countries where wild polioviruses are still endemic. (Pakistan being the other country, with both nations reporting 39 cases of paralytic polio this year so far.)
The Robert Koch Institute, Germany’s public health agency, suggested that the virus was likely excreted by an infected individual in Hamburg. While no symptomatic cases have been reported, the virus can still be shed by individuals without causing illness, contributing to its potential transmission. Despite high polio vaccination rates in Germany, health officials view the risk of further spread and subsequent cases as very low. — Helen Branswell
Former FDA commissioner talks new drug director, building trust
Robert Califf, the former FDA commissioner during the Biden and Obama administrations, engaged in a discussion on trust and medical ethics with STAT’s Matthew Herper. Califf commented on the recent appointment of Richard Pazdur, a long-time cancer therapy chief, as the top drug regulator at the FDA, viewing it as a move to stabilize the agency amidst declining morale and staff departures.
Califf expressed his concerns about the growing influence of politics on science within U.S. health agencies and emphasized the need to rebuild trust with the American public within the medical establishment. He also highlighted the potential lessons that healthcare professionals could learn from influencers like Mr. Beast, the popular YouTuber, on capturing people’s attention.
“My grandkids all follow Mr. Beast carefully, and whatever he says, a few million people are likely to try to do it,” Califf noted. “Now we can say, ‘That’s ridiculous,’ or we can say, ‘wait a minute, this is affecting what people do.’”
Precision medicine — but for psychiatry
The pharmaceutical industry’s approach to mental health treatments is undergoing a transformation, moving away from conservative strategies that resulted in a market flooded with variations of existing antidepressants and antipsychotics with limited efficacy. A shift is underway towards developing new drugs that act as “precision tools,” targeting novel pathways such as muscarinic receptors in conditions like schizophrenia.
Updated FDA guidelines have revolutionized the landscape of drug development in psychiatry, altering the cost, timeline, and strategic planning involved. These changes signal the end of conventional approaches in psychiatric medicine and could have profound implications for investors, insurers, and the entire healthcare economy. Dive deeper into the evolving landscape of mental health treatments with insights from Khutaija Noor, a corresponding member of the scientific committee at the American Psychiatric Association and the clinical trial lead for studies at Amicis Clinical Trials.
What we’re reading
- Life in beige, The Cut
- US bishops officially ban gender-affirming care at Catholic hospitals, AP
- Going against the gut: Q&A with Kevin Mitchell on the autism-microbiome theory, The Transmitter
- Republicans want to replace enhanced ACA tax credits with direct payments. Their think tank allies aren’t so sure, STAT
