Happy Tuesday! President-elect Donald Trump's decision to steer the Food and Drug Administration appears to allay fears that there may very well be significant disruption within the biotech and pharmaceutical industries over the subsequent 4 years.
Trump on Friday nominated Dr. Marty Makary, a pancreatic surgeon at Johns Hopkins University, as FDA commissioner. If confirmed by the Senate, Makary could be accountable for regulating food, 1000’s of vaccines and other drugs, medical devices and tobacco products.
He would reply to Trump's more controversial selection to go the Department of Health and Human Services, Robert F. Kennedy Jr., a distinguished vaccine skeptic and former environmental lawyer who also needs Senate confirmation.
Both Kennedy and Makary have openly criticized federal health officials, each of them last struck the federal government for not prioritizing chronic diseases.
But unlike Kennedy, Makary comes from a more traditional health care background as an experienced physician. Makary can be an executive at telehealth company Sesame, which connects consumers with doctors who can prescribe compounded versions of popular weight-loss medications.
Makary will likely take a “more sensible approach than has been feared” in leading the FDA, BMO Capital Markets analyst Evan Seigerman wrote in a note on Sunday, adding that Makary “is good across the entire continuum of U.S. health care appears to be informed and supportive of an evidence-based medical intervention.”
“All in all, we believe the FDA's election could provide a reprieve for BioPharma investors, removing uncertainty and reversing significant declines in the week RFK Jr. was named head of HHS,” Seigerman said .
Some health experts and investors feared that Trump would select someone to steer the FDA who lacked sufficient medical background and will politicize the drug regulatory process on the agency, jeopardizing the approval of latest products and innovations basically.
“We expect Makary to promote technology/innovation in a way that provides some relief to those who do so.” [are] “I worry about a department becoming more focused on different virtues,” Jared Holz, health equity strategist at Mizuho, said in an email last week.
He added that Makary's “familiarity with the [healthcare] Industry that we believe gets a lot of attention.”
So what are Makary's views on health in the US?
Makary has long challenged the U.S. medical establishment by researching and publishing books about the high cost of health care, the lack of transparency in medicine and medical errors.
Makary does not appear to hold the same anti-vaxxer views as Kennedy, but has recently made statements expressing support for Kennedy's “Make America Healthy Again Platform.” Makary said earlier this year: “The biggest perpetrator of misinformation has been the United States government with the food pyramid.”
Makary has been a controversial figure in other ways too, particularly during the Covid-19 pandemic. He somewhat agreed with traditional public health experts, Support universal masking and early doses of the vaccines.
But Makary also opposed vaccination mandates and questioned the value of booster shots for children. He also questioned lockdowns, among other tools pushed by public health officials. Additionally, he has emerged as a critic of the FDA during the pandemic, criticizing the agency for moving too slowly in approving certain products for Covid.
Seigerman said Markary's support of informed patient choice could lead to a lower hurdle for product approvals. This is likely to be offset by a higher barrier to disclosing a medicine's risks and benefits to patients, as well as higher requirements for monitoring treatments once they have been approved.
“From our point of view, Dr. “Makary’s willingness to be critical of the system, flexible and reasonable in his opinions and support of patient decisions is a positive,” Seigerman said.
But Seigerman noted that he is much more cautious about Trump's choice to lead the Centers for Disease Control and Prevention: Rep. Dave Weldon, a doctor and Republican congressman from Florida. This is due to Weldon's longstanding criticism of vaccinations.
We'll be watching closely to see if Trump's health recommendations are confirmed by the Senate, so stay tuned for our coverage.
You can send tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest technology in healthcare: Company says Neuralink is approved for new studies
Elon Musk's neurotech startup Neuralink announced Monday that it has been approved for a new trial to test whether patients can use a brain implant to control an assistive robotic arm.
Neuralink is developing a brain-computer interface (BCI) that allows paralyzed people to control external devices such as computers and smartphones with their minds. According to Neuralink, the company's flagship implant records neural signals using 64 “threads” that are inserted directly into the brain website.
Two human patients have so far been implanted with the BCI as part of Neuralink's “PRIME study,” which aims to prove the system is safe and useful. Neuralink's new study, called the CONVOY trial, will examine whether patients can use the same BCI to operate a robotic arm, the company said in a statement Post on Xwhich also belongs to Musk. Patients can mutually enroll in both studies.
“This is an important first step toward restoring not only digital freedom, but also physical freedom,” Neuralink said in the post.
It is not immediately clear when the trial will begin or how many patients will participate. According to the X post, Neuralink plans to release more information about the study.
The company did not respond to CNBC's request for comment.
Neuralink also announced last week that it had received approval to begin its first international trial in Canada. As with the PRIME trial, the goal of the Canadian trial is to demonstrate the safety and effectiveness of Neuralink's technology, it said in a blog post.
Patients with quadriplegia due to spinal cord injury or a degenerative disease such as amyotrophic lateral sclerosis (ALS) may be eligible to participate, and recruitment is already open, Neuralink said a contribution on X
BCIs have been studied in academia for a long time, and competition throughout the industry has intensified lately. In addition to Neuralink, corporations reminiscent of Synchron, Paradromics and Precision Neuroscience are developing their very own BCI systems.
Several of those groups are conducting human trials, but no BCI company has received approval from the U.S. Food and Drug Administration to commercialize their devices.
Feel free to send suggestions, suggestions, story ideas and data to Ashley at ashley.caroot@nbcuni.com.
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