US man who got 1st pig heart transplant dies after 2 months
Baltimore, Mar 9: The first person to receive a heart transplant from a pig has died, two months after the groundbreaking experiment, the Maryland hospital that performed the surgery announced Wednesday.
David Bennett, 57, died Tuesday at the University of Maryland Medical Center. Doctors didn't give an exact cause of death, saying only that his condition had begun deteriorating several days earlier.
Bennett's son praised the hospital for offering the last-ditch experiment, saying the family hoped it would help further efforts to end the organ shortage.
We are grateful for every innovative moment, every crazy dream, every sleepless night that went into this historic effort, David Bennett Jr. said in a statement released by the University of Maryland School of Medicine. We hope this story can be the beginning of hope and not the end.
Doctors for decades have sought to one day use animal organs for life-saving transplants. Bennett, a handyman from Hagerstown, Maryland, was a candidate for this newest attempt only because he otherwise faced certain death ineligible for a human heart transplant, bedridden and on life support, and out of other options.
After the Jan. 7 operation, Bennett's son told The Associated Press his father knew there was no guarantee it would work.
Prior attempts at such transplants -- or xenotransplantation -- have failed largely because patients' bodies rapidly rejected the animal organ. This time, the Maryland surgeons used a heart from a gene-edited pig: Scientists had modified the animal to remove pig genes that trigger the hyper-fast rejection and add human genes to help the body accept the organ.
At first the pig heart was functioning, and the Maryland hospital issued periodic updates that Bennett seemed to be slowly recovering. Last month, the hospital released video of him watching the Super Bowl from his hospital bed while working with his physical therapist.
Bennett survived significantly longer with the gene-edited pig heart than one of the last milestones in xenotransplantation -- when Baby Fae, a dying California infant, lived 21 days with a baboon's heart in 1984.
We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end, Dr. Bartley Griffith, who performed the surgery at the Baltimore hospital, said in a statement.
Other transplant experts praised the Maryland team's landmark research and said Bennett's death shouldn't slow the push to figure out how to use animal organs to save human lives.
This was a first step into uncharted territory, said Dr. Robert Montgomery of NYU Langone Health, a transplant surgeon who received his own heart transplant. A tremendous amount of information will contribute to the next steps as teams at several transplant centers plan the first clinical trials.
It was an incredible feat that he was kept alive for two months and was able to enjoy his family," Montgomery added.
The need for another source of organs is huge. More than 41,000 transplants were performed in the U.S. last year, a record -- including about 3,800 heart transplants. But more than 106,000 people remain on the national waiting list, thousands die every year before getting an organ and thousands more never even get added to the list, considered too much of a long shot.
The Food and Drug Administration had allowed the dramatic Maryland experiment under compassionate use rules for emergency situations. Bennett's doctors said he had heart failure and an irregular heartbeat, plus a history of not complying with medical instructions. He was deemed ineligible for a human heart transplant that requires strict use of immune-suppressing medicines, or the remaining alternative, an implanted heart pump.
Organ rejection, infections and other complications are risks for any transplant recipient. Experts hope the Maryland team quickly publishes in a medical journal exactly how Bennett's body responded to the pig heart.
From Bennett's experience, "we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed, said Dr. Muhammad Mohiuddin, scientific director of the Maryland university's animal-to-human transplant program.
One next question is what evidence, from Bennett's experience and some other recent experiments with gene-edited pig organs, may persuade the FDA to allow a clinical trial possibly with an organ such as a kidney that isn't immediately fatal if it fails.
Twice last fall, Montgomery's team at NYU got permission from the families of deceased individuals to temporarily attach a gene-edited pig kidney to blood vessels outside the body and watch them work before ending life support. And surgeons at the University of Alabama at Birmingham went a step further, transplanting a pair of gene-edited pig kidneys into a brain-dead man in a step-by-step rehearsal for an operation they hope to try in living patients possibly later this year.
Pigs have long been used in human medicine, including pig skin grafts and implantation of pig heart valves. But transplanting entire organs is much more complex than using highly processed tissue. The gene-edited pigs used in these experiments were provided by Revivicor, a subsidiary of United Therapeutics, one of several biotech companies in the running to develop suitable pig organs for potential human transplant.
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Plea in Supreme Court seeks review of EVM VVPAT verdict
New Delhi, May 13: A plea has been filed in the Supreme Court seeking review of its April 26 judgement by which it had rejected the demand for reverting to the old paper ballot system and the complete cross-verification of votes cast using EVMs with a Voter Verifiable Paper Audit Trail (VVPAT).
The review petition was filed by Arun Kumar Agrawal, who had filed the PIL on the issue earlier, through lawyer Neha Rathi.
The review plea filed on May 10 said, "There are mistakes and errors apparent on the face of the impugned order..., and as such there are sufficient reasons which require review of the impugned order/judgment...
"The petitioner respectfully seeks review on the following issues as have been dealt with in judgment dated April 26, 2024: i) Feasibility of counting of all VVPAT paper slips in terms of time to be taken and additional manpower, ii) Vulnerability of SLU (symbol loading units) and iii) Percentage of VVPAT slips counted for tallying with EVM votes after Chandrababu Naidu...Judgment."
The plea dealt with the feasibility of counting of all VVPAT paper slips in terms of time to be taken and additional manpower and referred to the relevant portion of the judgement.
"During the course of hearing, it was suggested that instead of physically counting the VVPAT slips, they can be counted by a counting machine. This suggestion, including the suggestion that bar-coding of the symbols loaded in the VVPATs may be helpful in machine counting, may be examined by the ECI," the top court had said in the judgement.
Seeking physical counting, the plea said the counting of all VVPAT slips can be done “accurately with a fraction of the employees and at a fraction of cost and within five to eight hours”.
It said the VVPAT paper is of the same size as the thermal print out received when a credit or debit card is swiped on making a payment.
"The counting of the slips after they have been sorted candidate-wise, is in fact easier than counting normal paper because the VVPAT paper slip is sightly curled on account of being thermally printed from a roll. The curling makes the picking up of the paper slip from the surface of a table easy.
"Each slip can be counted while being picked to make bundles of 25 slips as mandated under instructions given in the ECI’s Manual on EVM and VVPAT, 2023," the plea said.
It said EVMs do not allow voters to verify that their votes have been accurately recorded.
"Furthermore, given their very nature, EVMs are especially vulnerable to malicious changes by insiders such as designers, programmers, manufacturers, maintenance technicians, etc. Therefore, in light of the above there are apparent errors on the face of the impugned order dated April 26, 2024 and the impugned judgment, is liable to be reviewed," it said.
On April 26, a bench of Justices Sanjiv Khanna and Dipankar Datta had termed the suspicion of manipulation of the EVMs "unfounded" and trashed the demand for reverting to the old paper ballot system.
The bench had said that the polling devices were "secure" and eliminated booth capturing and bogus voting.
However, the judgement had opened a window for aggrieved unsuccessful candidates securing second and third places in poll results and allowed them to seek verification of micro-controller chips embedded in five per cent EVMs per assembly constituency on a written request upon payment of a fee to the poll panel.
It had directed that from May 1, the symbol loading units should be sealed and secured in a container and stored in a strongroom along with the EVMs for a minimum period of 45 days post-declaration of results.
By the judgement, the top court had dismissed the PILs which had also sought a direction to return to the ballot paper system.
"A voting mechanism must uphold and adhere to the principles of security, accountability, and accuracy. An over complex voting system may engender doubt and uncertainty, thereby easing the chances of manipulation. In our considered opinion, the EVMs are simple, secure and user-friendly. The voters, candidates and their representatives, and the officials of the ECI are aware of the nitty-gritty of the EVM system. They also check and ensure righteousness and integrity," the bench had said.
It had said the possibility of hacking or tampering with the agnostic firmware in the burnt memory of EVMs to tutor or favour results is "unfounded".
"Accordingly, the suspicion that the EVMs can be configured or manipulated for repeated or wrong recording of vote(s) to favour a particular candidate should be rejected," the bench had said.
It had said the incorporation of the VVPAT, an independent vote verification system which enables electors to see whether their votes have been recorded correctly, fortifies the principle of vote verifiability, thereby enhancing the overall accountability of the electoral process.
The seven-phase Lok Sabha polls began on April 19 and will conclude with the announcement of results on June 4.
