Scientists revived organ cells in dead pigs

Medical science is nowhere near overcoming death, but it might be closer to delaying harm in dying and seriously damaged organs. The New York Timesreports that Yale University researchers successfully revived cells in the organs of pigs that had been dead in the lab for an hour. Hearts started beating, and the pigs’ bodies didn’t stiffen like they normally would. 

The team mixed the animals’ blood and an artificial hemoglobin with OrganEx, a solution that includes anti-inflammatory medicine, nerve blockers (to prevent a return to consciousness), nutrients and drugs that fight cell death. The project is a follow-up to a years-old breakthrough where the scientists revived dead pigs’ brain cells using a precursor solution, BrainEx. After that finding, the group wondered if it could revive an entire body.

The work isn’t close to helping human patients. Further studies will show if the organs are functioning. Researchers will also have to gauge the effects of OrganEx without nerve blockers, and eventually test their work on humans. There are ethical concerns that pigs might regain brain function, and it’s not clear just when it would be viable to experiment with people. If synthetic blood isn’t yet ready for emergency rooms, this is even further away.

The ramifications could be huge if and when solutions like OrganEx are suitable for humans, though. They could extend the viability of organ transplants — it might be possible to collect healthy organs long after the moment of death. That, in turn, could make more transplants available and save additional lives. The technology could also limit the damage to organs after serious heart attacks and strokes. Ideally, this will give people a fighting chance to recover from potentially fatal conditions.

Meta faces lawsuit for allegedly collecting patient health data without consent

Meta may have scooped up sensitive medical information without consent. The Vergereports that two proposed class-action lawsuits accuse the company and hospitals of violating HIPAA, the California Invasion of Privacy Act and other laws by collecting patient data without consent. Meta’s Pixel analytic tracking tool allegedly sent health statuses, appointment details and other data to Facebook when it was present on patient portals.

In one lawsuit from last month, a patient said Pixel gathered data from the UC San Francisco and Dignity Health portals that was used to deliver ads related to heart and knee issues. The second lawsuit, from June, is broader and claims at least 664 providers shared medical info with Facebook through Pixel.

We’ve asked Meta for comment. The company requires that sites using Pixel obtain the right to share data before sending it to Facebook, but the plaintiffs claim Meta refused to enforce its policies. It placed Pixel on the facilities’ websites despite knowing the kind of data it would collect, according to the lawsuits.

The lawsuits aren’t guaranteed to achieve class-action status, and such lawsuits rarely provide large payouts to individuals. If successful, though, the legal action could prove costly for Meta. They’re asking for damages on behalf of all Facebook users whose healthcare providers rely on Pixel, and that could include millions of people.

They also follow a string of privacy-related US legal action against the social media giant. Meta is facing a DC Attorney General suit over Cambridge Analytica’s collection of more than 70 million Americans’ personal data. The company is also grappling with lawsuits over its deactivated facial recognition system, and only this year settled a 2012 class-action over the use of tracking cookies. These latest courtroom battles suggest that concerns about Meta’s data gathering practices are far from over, even as the company makes its own efforts to crack down on misuse.

Synchron says it’s the first to implant a human brain-computer interface in the US

Brain-computer interfaces have become a practical (if limited) reality in the US. Synchron says it has become the first in the country to implant a BCI in a human patient. Doctors in New York’s Mount Sinai West implanted the company’s Stentrode in the motor cortex of a participant in Synchron’s COMMAND trial, which aims to gauge the usefulness and safety of BCIs for providing hands-free device control to people with severe paralysis. Ideally, technology like Stentrode will offer independence to people who want to email, text and otherwise handle digital tasks that others take for granted.

Surgeons installed the implant using an endovascular procedure that avoids the intrusiveness of open-brain surgery by going through the jugular vein. The operation went “extremely well” and let the patient return home 48 hours later, according to Synchron. An ongoing Australian trial has also proven successful so far, with four patients still safe a year after receiving their implants.

It may take a long time before doctors can offer Synchron’s BCIs to patients. The company received FDA approval for human trials in July 2021, and it’s still expanding the COMMAND trial as of this writing. Still, the US procedure represents a significant step toward greater autonomy for people with paralysis. It also represents a competitive victory — Elon Musk’s Neuralink has yet to receive FDA permission for its own implant.

Surgeons at NYU Langone transplanted pig hearts into two brain-dead humans

Earlier this summer, physicians at NYU Langone were able to successfully transplant pig hearts into two recently-deceased humans. The medical team performed the procedures on June 16 and July 6, using special pig hearts that were genetically modified t…

Pressure mounts on FDA to expand pig-to-human organ transplant research

In January, doctors at the University of Maryland School of Medicine made history by successfully transplanting a pig’s heart into a human. The 57-year-old patient may have died two months later due to complications from the experimental procedure, but the case has inspired scientists throughout the medical field to call on the FDA to expand the scope and scale of human-porcine transplantation research. During a two-day conference in late June, policy advisors to the FDA and medical professionals discussed the future of xenotransplantation and “most attendees agreed that human trials are needed to help answer the most pressing research questions,” according to Nature. 

We’ve been stuffing pig organs into sick people since the early 19th century, but the technology has made rapid strides in recent decades thanks in part to the advent of CRISPR technology and more potent immunosuppressives. In 2017, researchers created the first human-pig hybrid embryo as well as devised a solution to potential inter-species viral infections. As of January, 2022, were implanting genetically modified pig kidneys into brain-dead donor recipients with great success.

“Our goal is not to have a one-off, but to advance the field to help our patients,” Dr. Jayme Locke, lead surgeon of the kidney study and director of UAB’s Incompatible Kidney Transplant Program, told the NYT. “What a wonderful day it will be when I can walk into clinic and know I have a kidney for everyone waiting to see me.”

Humans have also conducted numerous experimental pig-organ transplants into primates like baboons. But in order to safely and consistently do it with humans, researchers will have to test the techniques on humans, Caroline Zeiss, a veterinary specialist at Yale School of Medicine, told Nature. For example, doctors found traces of porcine cytomegalovirus (PCMV) in the heart transplant patient who died earlier this year and believe that it may have played a role in his demise, but they won’t know for sure without further tests that a primate model — ones that can’t be replicated in primates.

Researchers are only looking at “small, focused” clinical trials with “appropriately selected patients,” Allan Kirk, a transplant surgeon at the Duke University School of Medicine, told Nature. Researchers will have to answer a number of fundamental questions before the technology can be widely utilized, as well as determine the right mix of breeding and genetic tinkering needed to ensure that recipients’ bodies won’t reject them.

And while the decisions made during last week’s meeting may not have an immediate impact on the agency’s current stance on xenotransplantation, changes are reportedly afoot. The WSJ spoke to a “person familiar with the matter” at the end of June who asserts the FDA is planning to launch pig-organ transplantation trials in an effort ease the shortage of transplantable human organs (*angrily shakes fist at seatbelts*). There’s no word on when such trials would launch as they are being handled on a case-by-case basis, the source said.     

England’s health service will use drones to deliver vital chemotherapy drugs

The UK’s National Health Service has announced that it will test delivering vital chemotherapy drugs via drone to the Isle of Wight. The body has partnered with Apian, a drone technology startup founded by former NHS doctors and former Google employees…

FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants

The Food and Drug Administration has asked COVID-19 vaccine makers to update booster shots to tackle newer Omicron variants that are on the rise. It says the manufacturers should add a spike protein component to shots to target the Omicron BA.4 and BA.5 variants in addition to the original strain.

An “overwhelming majority” of the FDA’s advisory committee voted this week in favor of updating shots with an Omicron component, in the hopes of starting to use those modified boosters in the fall. The advisory is only for booster shots and not primary inoculations.

Vaccine makers are essentially playing whack-a-mole with the various strains of COVID-19. Pfizer and Moderna have created versions of their vaccines that target BA.1, the Omicron variant that caused a significant upswing in COVID-19 cases during the winter.

However, that strain isn’t circulating in the US anymore, according to the Centers for Disease Control and Prevention. Earlier this week, the CDC said BA.4 and BA.5 now account for over 52 percent of COVID-19 infections in the US. That figure is expected to rise in the coming weeks.

As CNBC notes, Pfizer and Moderna released clinical trial data this week showing that the current Omicron shots performed better against BA.1 than the original versions of their vaccines in terms of offering a stronger immune response. While the immune response against BA.4 and BA.5 was still said to be robust, the Omicron inoculations were less effective against those strains. It’s unclear how long it will take vaccine makers to develop shots that take aim at BA.4 and BA.5.

“Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component,” the FDA said. “Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA.4/5 component, as these data will be of use as the pandemic further evolves.”

FDA bans sales of Juul vape products in the US

The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions. 

Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the agency rejected Juul’s application to keep selling tobacco- and menthol-flavored pods, as well as its vape pen. Juul told Engadget that it intends to seek a stay on the decision. It is exploring all other options, including an appeal.

The ban doesn’t apply to Juul products that are already in the possession of the company’s customers. However, it’ll be difficult, if not impossible, to find its pens and pods in the near future.

In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping compared with cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 “electronic nicotine delivery systems” (to give vape pens their formal name).

In Juul’s case, though, the FDA said the company’s application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”

The agency went on to say that it doesn’t have clinical information that suggests there is “an immediate hazard” linked to Juul’s pen or pods. “However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products,” the FDA said. It noted that it’s not possible to grasp the possible harms of using other pods in a Juul vape pen or the company’s pods in third-party devices.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. The vast majority of the company’s revenue comes from the US, The Wall Street Journal noted this week. 

Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and it has faced suits in several other states. 

The company halted sales of mint- and fruit-flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who tried e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall, according to data from 2021. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user’s identity in an attempt to prevent underage use. 

Update 6/23 12:50PM ET: Juul Labs’ chief regulatory officer Joe Murillo provided Engadget with the following statement:

We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being appropriate for the protection of the public health.
We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator. We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.