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In this week’s edition of InnovationRx, we look at the policy uncertainty around vaccines, sex differences in GLP-1 drug side effects, the challenges of using AI to predict epidemics and more. To get it in your inbox, subscribe here.
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One of the major concerns expressed by Senators during Robert F. Kennedy, Jr.’s confirmation hearings was his longstanding activism against vaccines, and how that might affect his tenure as Secretary of Health and Human Services. Since he was confirmed in the role, the messages from HHS and the White House have been decidedly mixed.
On the one hand, Kennedy said in an interview with conservative TV host Sean Hannity that the measles vaccine causes deaths every year, a claim that is decidedly false. On the other hand, the nomination of vaccine skeptic and former Florida Congressman Dave Weldon to run the CDC was pulled at the last minute over concerns that the Senate would not confirm him thanks to his vaccine views.
That same CDC has reportedly been directed to conduct a new study investigating the claim that vaccines cause autism, despite multiple studies over the past few decades that showed they do not. But the NIH this week also lauded the beginning of a clinical trial of a vaccine for Lassa Fever, a viral hemorrhagic fever endemic in West Africa, which is sponsored by the agency.
Further chaos reigned at the end of February and early March when key FDA and CDC advisory panels about the composition of next year’s flu shot were cancelled, leading some to worry that the FDA would not issue recommendations for a flu vaccine this year. But late last week, the FDA issued a recommendation based on a closed door meeting of scientists from the FDA, CDC and Department of Defense.
This policy uncertainty for the vaccine market, which has about $77 billion in global sales, comes as vaccine uptake levels have fallen. That’s a lot of headwind for vaccine makers and for people who rely on them to stay healthy over the next few months.
Study Finds That Women Experience More Side Effects Than Men From GLP-1 Drugs
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Women are the primary patients for GLP-1s. They also experience more nausea and vomiting, according to new research which aimed to understand why that’s the case.
The new paper, conducted by researchers at biotech company Olio Labs and a scientist from the University of Washington Medicine Diabetes Institute, found that women experienced 2.5 times higher rates of nausea and vomiting than do men when prescribed GLP-1 drugs, based on real-world data from electronic medical records. While women represent nearly 70% of patients seeking treatment, this represented the first effort to report sex differences in efficacy-to-tolerability, according to the paper.
To uncover a potential cause, the researchers injected different groups of male and female Wistar rats and mice with both semaglutide and tirzepatide. The study found that female rodents have nearly double the GLP-1 receptor expression in brain regions linked to nausea. If that result is consistent in humans, it could help explain why women experience higher rates of nausea and vomiting on the drugs than do men, the authors wrote in the study. Higher estrogen levels also correlate with more severe side effects, pointing to the role of hormonal cycles in drug response.
“The paper is highlighting what the problem is,” said David Tingley, founder of Olio Labs, who has a Ph.D. in neuroscience from NYU and was among the paper’s researchers. “If you look at the weight you lose versus the nausea you feel, if you look at that ratio, [the treatment] is quite a bit more effective in men than women.”
For patients taking GLP-1 drugs to treat obesity or type 2 diabetes, nausea and vomiting can sometimes be severe enough to stop taking treatment. The results “underscore the value of including female subjects in pre-clinical studies, ensuring robust effects across sexes at an earlier stage in the development pipeline,” according to the paper.
BIOTECH AND PHARMA
AstraZeneca has agreed to to purchase the outstanding equity of Belgian biotech company EsoBiotec, which is developing cell therapies for certain cancers. AstraZeneca will pay the firm $425 million up front with additional payments of up to $575 million if it hits certain milestones. EsoBiotec is developing viruses that can reprogram immune cells to treat cancers as a cell therapy, rather than producing cells that are later introduced into the body.
DIGITAL HEALTH AND AI
AI healthcare company Hologen AI, cofounded by former Google CEO Eric Schmidt, signed a joint venture with gene therapy company MeiraGTx to commercialize its drug candidate for Parkinson’s disease. Under the terms of the arrangement. Hologen will pay $200 million upfront to MeiraGTx and commit up to $230 million more for the joint venture, called Hologen Neuro AI.
PUBLIC HEALTH AND HOSPITALS
Epidemics are inevitable, but they’re also hard to predict. The context, data and variables needed to forecast them dwarf currently available approaches in machine learning and AI. But that need not be the case, according to a paper published in Nature this week that outlines potential approaches to utilize AI for these predictions.
One major issue facing development is the fragmentation of data systems, but the paper authors noted that AI models have gotten much better at enhancing “the accuracy of and speed of data extraction from semi-structured/unstructured sources.” That said, building AI systems for this kind of work is still extremely costly, the authors wrote, and it’s not always clear when they provide superior results to existing methods.
For that reason, the paper also recommends developing clear benchmarks for AI model performance to determine “where AI might provide the greatest effect in the field.”
DEAL OF THE WEEK
Testing company LabCorp has agreed to acquire the cancer business of BioReference, a subsidiary of Opko Health, for $192 million. The deal comes a year after LabCorp bought Opko’s reproductive women’s health and other testing assets for $237 million. Revenue for the cancer testing business is around $100 million a year.
WHAT WE’RE READING
New studies show that people are leaving states with bans on abortion for states that allow them, and employers report that these bans are making it more difficult to recruit talent.
A Wall Street Journal investigation digs into the dark side of Xanax. Some patients who try to quit benzodiazepines suffer extreme anxiety, memory loss and intense physical pain.
Purdue Pharma submitted a new bankruptcy plan to give its creditors more than $7.4 billion in cash—including up to $7 billion in payments from the billionaire Sackler family—to compensate victims of the opioid crisis after the Supreme Court struck down the company’s previous settlement plan.
The Trump Administration cancelled funding for landmark diabetes study, in a move likely tied to the cutting of grants to Columbia University. The study had been ongoing for 30 years.
Texas’s rural hospitals are struggling to handle the ongoing measles outbreak due to older infrastructure, the distances separating labs and test sites, and a shortage of primary care doctors.
AI drug discovery company Insilico Medicine raised $110 million at a valuation of more than $1 billion to continue to develop its drug portfolio.
A federal judge ordered the Trump administration to restore the U.S. Agency for International Development’s functionality, ruling that Elon Musk’s role in dismantling the agency was unconstitutional. A separate ruling ordered HHS to reinstate over 3,200 probationary employees who had been fired. Meanwhile, HIV could infect 1,400 infants every day as survey data showed more than one-third of organizations that relied on U.S. funding for HIV services had closed by February.
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