Low Medicaid reimbursements play a role in

Pig kidney recipient Towana Looney is visited by transplant surgeon Dr. Robert Montgomery at NYU Langone Health, in New York City. (AP Photo/Shelby Lum)Pig kidney recipient Towana Looney is visited by transplant surgeon Dr. Robert Montgomery at NYU Langone Health, in New York City. (AP Photo/Shelby Lum)

Looney’s surgery marks an important step as scientists get ready for formal studies of xenotransplantation expected to begin next year, said Dr. Robert Montgomery of NYU Langone Health, who led the highly experimental procedure on Nov. 25.On Tuesday, NYU announced that Looney is recuperating well. She was discharged from the hospital just 11 days after surgery although she was temporarily readmitted this week to adjust her medications. Doctors expect her to return home to Gadsden, Alabama, in three months. If the pig kidney were to fail, she could begin dialysis again.“To see hope restored to her and her family is extraordinary,” said Dr. Jayme Locke, Looney’s original surgeon who secured Food and Drug Administration permission for the transplant.

More than 100,000 people are on the U.S. transplant list, most who need a kidney. Thousands die waiting and many more who need a transplant never qualify. Now, searching for an alternate supply, scientists are genetically altering pigs so their organs are more humanlike.Looney donated a kidney to her mother in 1999. Later pregnancy complications caused high blood pressure that damaged her remaining kidney, which eventually failed. It’s incredibly rare for living donors to develop kidney failure although those who do are given extra priority on the transplant list.

But Looney couldn’t get a match — she had developed antibodies abnormally primed to attack another human kidney. Tests showed she’d reject every kidney donors have offered.

Then Looney heard about pig kidney research at tThe FDA’s credibility has long rested on the independence of its scientific decisions. While the agency is led by a handful of political appointees, approval decisions are almost always handled by career scientists.

But that standard appears to be shifting. FDA staffers were poised to approveearly last month but the decision was delayed by administration officials, including Makary, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss agency matters. The shot was approved late Friday with unusual restrictions.

Dr. Tracy Beth Hoeg — a political appointee serving as Makary’s special assistant — was involved in the unprecedented demand that Novavax conduct a new clinical trial of its shot after approval, according to the people. The requirement came shortly after the agency’s longtime vaccine chief,, was forced to resign.