FDA, Covid vaccine list, football brain health: morning rounds
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Hello everyone. Now that we’ve all narrowly survived a non-World Cup day at work, we can finally return to our new normal this afternoon for France 3-1 Morocco.
A father’s quest to heal his daughter
Matt Wilsey dedicated a decade of tireless work and spent approximately $70 million to find a drug for his daughter’s ultra-rare genetic disease. After a scientific odyssey, Wilsey is close to achieving his goal. His next challenge – convincing a skeptical Food and Drug Administration – will ripple across an entire field of medicine.
Wilsey’s daughter, Grace, suffers from NGLY1 deficiency, a life-threatening condition that leads to a cascade of profound developmental challenges. His life’s work was shaping a gene therapy that could allow him to live longer, a process that attracted Nobel laureates, deep-pocketed investors and families around the world affected by the disease. Ten children, including Grace, were treated with gene therapy. Wilsey thinks it works.
The FDA might not approve it. As STAT’s Jason Mast and Matthew Herper write, Wilsey is asking for extraordinary flexibility from regulators, who typically demand more data on manufacturing and effectiveness than he can currently provide. And after tapping into his rich network, Wilsey can’t afford to generate more evidence.
What happens next could be crucial for the rare disease community and for the dozens, if not hundreds, of parents who are following in Wilsey’s footsteps and trying to develop their own treatments. Learn more.
Who will run the FDA?
We might find out soon, as the finalists for the FDA commissioner position have been sent to the White House for final review. As STAT’s Daniel Payne reports, the shortlist includes White House adviser Heidi Overton; Jeffrey Vacirca, oncologist and health system executive; and Stephen Ferrara, health affairs manager at the Department of Defense.
Whoever gets the job will inherit an agency in turmoil following massive layoffs, political reversals and a revolving door of top regulators under former Commissioner Marty Makary. The FDA, which regulates nearly a fifth of the nation’s economy, is currently led by top food regulator Kyle Diamantas in an acting capacity. Learn more.
Professional football players are nearly four times more likely to die from a neurodegenerative disease than the average American, according to a study conducted by Mass General Brigham in Boston. In the largest study of its kind to date, researchers looked at data from nearly 20,000 former National Football League players and found that the longer a player’s career, the more likely he was to die of dementia, Parkinson’s disease or another form of neurodegeneration.
And the study, published Wednesday in eMedicineClinicalmight actually underrepresent the dangers of professional football, researchers say. Elite athletes exhibit genetic, environmental and behavioral traits associated with long lifespan and lower risk of brain disease, making the data from NFL players even more dramatic.
RFK Jr. lists Covid vaccine injuries
Federal authorities are compiling a list of injuries that may be linked to COVID-19 vaccines, a process that will make it easier for people to obtain compensation through a federal program.
At first glance, this is a completely normal administrative measure on the part of the Department of Health and Social Services. But given Health Secretary Robert F. Kennedy Jr.’s long history of making unfounded claims about vaccine safety, experts told STAT’s Chelsea Cirruzzo that they worry his HHS is offering too broad a list of purported Covid vaccine injuries to stoke doubts about the shot. Learn more.
The Plot to Consolidate Control of American Science
The first year of the Trump administration has brought unprecedented upheaval to the scientific world, with massive layoffs and sweeping funding cuts. The effect was destabilizing, researchers say, but many of these initiatives have since been overturned by the courts, and others may yet be overturned.
The next round of policy changes will likely be more lasting. As STAT’s Anil Oza reports, the administration is now going through a longer — and legally defensible — process to impose new rules on federally funded research, including changes that would expand the executive branch’s power to direct research, end grants at will and ignore advice from external scientific reviews.
“What the Trump administration is trying to do is set these priorities in stone, and they become part of the regulatory infrastructure instead of time-based directives,” said Andrew Twinamatsiko, director of the Center for Health Policy and Law at Georgetown University. Learn more.
“MHFH” doesn’t exactly roll off the tongue
Either way, it stands for “Make Hospital Food Healthier” and is Kennedy’s latest effort to change the way America eats. The initiative is a voluntary commitment, calling on hospitals across the country “to lead by example in serving nutritious, minimally processed meals that help patients heal, reduce chronic disease and make America healthy again,” Kennedy said in a statement Wednesday.
The word “voluntary” is important. Earlier this year, HHS reviews sent to hospitals across the country, urging them to adopt the recently revised dietary guidelines “in order to continue to benefit from Medicare and Medicaid payments,” as Kennedy said. The implied threat – that hospitals would lose federal funding if they did not embrace the virtues of beef tallow – far exceeded the agency’s legal authority, experts saidand the softer language of Wednesday’s announcement appears to reflect that.
What we read
- The epidemic of parasites responsible for diarrhea amounts to more than 1,000 cases, P.A.
- Bryan Johnson’s chronic illness is notoriously difficult to diagnose, STATUS
- Patients are faced with a multitude of administrative formalities in an attempt to maintain consistent health coverage, KFF Health News
- Opinion: Who benefits from classifying obesity as a disease? STATUS
PakarPBN
A Private Blog Network (PBN) is a collection of websites that are controlled by a single individual or organization and used primarily to build backlinks to a “money site” in order to influence its ranking in search engines such as Google. The core idea behind a PBN is based on the importance of backlinks in Google’s ranking algorithm. Since Google views backlinks as signals of authority and trust, some website owners attempt to artificially create these signals through a controlled network of sites.
In a typical PBN setup, the owner acquires expired or aged domains that already have existing authority, backlinks, and history. These domains are rebuilt with new content and hosted separately, often using different IP addresses, hosting providers, themes, and ownership details to make them appear unrelated. Within the content published on these sites, links are strategically placed that point to the main website the owner wants to rank higher. By doing this, the owner attempts to pass link equity (also known as “link juice”) from the PBN sites to the target website.
The purpose of a PBN is to give the impression that the target website is naturally earning links from multiple independent sources. If done effectively, this can temporarily improve keyword rankings, increase organic visibility, and drive more traffic from search results.
