Day: December 1, 2017

The first birth as a result of a womb transplant in the United States has occurred in Texas, a milestone for the U.S. but one achieved several years ago in Sweden.

A woman who had been born without a uterus gave birth to the baby at Baylor University Medical Center in Dallas.

Hospital spokesman Craig Civale confirmed Friday that the birth had taken place, but said no other details are available. The hospital did not identify the woman, citing her privacy.

Baylor has had a study under way for several years to enroll up to 10 women for uterus transplants. In October 2016, the hospital said four women had received transplants but that three of the wombs had to be removed because of poor blood flow.

The hospital would give no further information on how many transplants have been performed since then. But Time magazine, which first reported the U.S. baby’s birth, says eight have been done in all, and that another woman is currently pregnant as a result.

A news conference was scheduled Monday to discuss the Dallas baby’s birth.

A doctor in Sweden, Mats Brannstrom, is the first in the world to deliver a baby as a result of a uterus transplant. As of last year, he had delivered five babies from women with donated wombs.

There have been at least 16 uterus transplants worldwide, including one in Cleveland from a deceased donor that had to be removed because of complications. Last month, Penn Medicine in Philadelphia announced that it also would start offering womb transplants.

Baylor transplants

Womb donors can be dead or alive, and the Baylor study aims to use some of both. The first four cases involved “altruistic” donors — unrelated and unknown to the recipients. The ones done in Sweden were from live donors, mostly from the recipients’ mother or a sister.

Doctors hope that womb transplants will enable as many as several thousand women born without a uterus to bear children. To be eligible for the Baylor study, women must be 20 to 35 years old and have healthy, normal ovaries. They will first have in vitro fertilization to retrieve and fertilize their eggs and produce embryos that can be frozen until they are ready to attempt pregnancy.

After the uterus transplant, the embryos can be thawed and implanted, at least a year after the transplant to make sure the womb is working well. A baby resulting from a uterine transplant would be delivered by cesarean section. The wombs are not intended to be permanent. Having one means a woman must take powerful drugs to prevent organ rejection, and the drugs pose long-term health risks, so the uterus would be removed after one or two successful pregnancies.

The American Society for Reproductive Medicine issued a statement Friday calling the Dallas birth “another important milestone in the history of reproductive medicine.”

For women born without a functioning uterus, “transplantation represents the only way they can carry a pregnancy,” the statement said. The group is convening experts to develop guidelines for programs that want to offer this service.
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A dazzling discovery in northwestern China of hundreds of fossilized pterosaur eggs is providing fresh understanding of these flying reptiles that lived alongside the dinosaurs, including evidence that their babies were born flightless and needed parental care.

Scientists said Thursday that they had unearthed 215 eggs of the fish-eating Hamipterus tianshanensis — a species whose adults had a crest atop an elongated skull, pointy teeth and a wingspan of more than 11 feet (3.5 meters) — including 16 eggs containing partial embryonic remains.

Fossils of hundreds of male and female adult Hamipterus individuals were found alongside juveniles and eggs at the Xinjiang Uygur Autonomous Region site, making this Cretaceous Period species that lived 120 million years ago perhaps the best understood of all pterosaurs.

“We want to call this region ‘Pterosaur Eden,’ ” said paleontologist Shunxing Jiang of the Chinese Academy of Sciences’ Institute of Vertebrate Paleontology and Paleoanthropology.

Pterosaurs were Earth’s first flying vertebrates. Birds and bats appeared later.

Until now, no pterosaur eggs had been found with embryos preserved in three dimensions. Researchers think up to 300 eggs may be present at the Xinjiang Uygur site, some buried under the exposed fossils.

The embryonic bones indicated the hind legs of a baby Hamipterus developed more rapidly than crucial wing elements like the humerus bone, said paleontologist Alexander Kellner of Museu Nacional in Rio de Janeiro.

“Some birds can fly on the same day they break out from the egg, while some others will need a long period of parental care. Our conclusion is that a baby Hamipterus can walk but can’t fly,” Jiang said, an unexpected finding.

The researchers believe these pterosaurs lived in a bustling colony near a large freshwater lake. Kellner cited evidence that females gathered together to lay eggs in nesting colonies and returned over the years to the same nesting site.

They suspect the eggs and some juvenile and adult individuals were washed away from a nesting site in a storm and into the lake, where they were preserved and later fossilized.

The oblong eggs, up to about 3 inches (7.2 centimeters) long, were pliable with a thin, hard outer layer marked by cracking and crazing covering a thick membrane inner layer, resembling soft eggs of some modern snakes and lizards.

There had been a paucity of pterosaur eggs and embryos in the paleontological record because it is difficult for soft-shelled eggs to fossilize.

The research was published in the journal Science.
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The recent calving of a large iceberg from a southern Chilean glacier threatens local ship navigation and could result in flooding for costal communities, experts said.

An iceberg measuring some 350 by 380 meters (1,150 by 1,250 feet) broke from the Grey glacier in far southern Chile in late November.

The size of the break surprised local scientists who monitor the glacier.

“Events like this are part of a short-term irreversible tendency” due to rising global temperatures, said Raul Cordero, a climate change expert at the Universidad de Santiago.

The iceberg now seems like a large chunk of ice, “but it will become a threat” since it will move out to sea and break up into smaller pieces, said Ricardo Jana, a glaciologist at the Chilean National Antarctic Institute.

Given its size, the smaller icebergs likely to break off can create problems for area navigation, Jana said.

The icebergs will also contribute to a rise in the sea level, “putting coastal communities at risk for possible flooding,” Jana said.

The Grey glacier is located at the Torres del Paine National Park, some 3,200 kilometers (2,000 miles) south of the capital Santiago.

Over the past 30 years the glacier — now measuring some 270 square kilometers — has lost about two square kilometers of ice.

The glacier is part of the Southern Patagonia Ice Fields, the third largest land-based ice field after Antarctica and Greenland. The Ice Fields straddle southern Chile and Argentina.
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U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumor and aiding efforts to match treatments to those flaws.

The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

The dual decisions, announced late Thursday, will make tumor-gene profiling available to far more cancer patients than the few who get it now, and lead more insurers to cover it.

“It’s essentially individualized, precision medicine,” said Dr. Kate Goodrich, chief medical officer for the Medicare oversight agency.

Currently, patients may get tested for individual genes if a drug is available to target those mutations. It’s a hit-and-miss approach that sometimes means multiple biopsies and wasted time. In lung cancer alone, for example, about half a dozen genes can be checked with individual tests to see if a particular drug is a good match.

The new FoundationOne CDx test can be used for any solid tumor such as prostate, breast or colon cancer, and surveys 324 genes plus other features that can help predict success with treatments that enlist the immune system.

“Instead of one or two, you have many” tests at once from a single tissue sample, said the FDA’s Dr. Jeffrey Shuren. The tests give better and more information to guide treatment and can help more patients find and enroll in studies of novel therapies, he said.

“This will be a sea change” for patients, said Dr. Richard Schilsky, chief medical officer of the American Society of Clinical Oncology, the association of doctors who treat the disease.

“On balance I think this is good,” but there is a risk that spotting a mutation will lead doctors and patients to try treatments that haven’t been proven to work in that situation and promote more off-label use of expensive drugs, he said.

A better outcome in those situations is to guide people into studies testing drugs that target those genes, Schilsky said.

Foundation Medicine, based in Cambridge, Massachusetts, and others have sold tumor profiling tests for several years under more lax rules governing lab-developed tests. But insurers have balked at paying for the tests, which cost around $6,000.

Now, the FDA’s approval gives assurance of quality, Shuren said, and the government’s proposed coverage for Medicare and other public insurance programs means private insurers will more likely follow.

Public comments on the coverage proposal will be taken for 30 days. A final decision is expected early next year followed by setting a price for reimbursement.

Coverage is proposed for patients with recurrent, widely spread or advanced cancers, in people who have decided with their doctors to seek further treatment and who have not previously had a gene sequencing test.

“A lot of these folks have run out of treatment options,” but the tests may point to something new that might help, Goodrich said.

The impact is expected to be greatest on lung cancer, since so many of those tumors are found at an advanced stage and multiple gene-targeting drugs are available to treat it.

Evidence isn’t strong enough to warrant using these gene profiling tests for earlier stages of cancer. Patients get standard, guideline-based care in those cases.

In mid-November, the FDA also approved a gene-profiling test developed by Memorial Sloan Kettering Cancer Center, but it’s used almost exclusively on patients at that cancer center and is not envisioned to be a widely available commercial test.

The federal decisions will make gene sequencing a more routine component of cancer care, “just like we normally look with a microscope” to classify the stage of a patient’s disease, said Dr. David Klimstra, pathology chief at the cancer center.

Another leader in this field, Caris Life Sciences, says it also intends to pursue FDA approval for its widely used tumor profiling test, sold now through lab certifications. It’s also working on a newer tool to profile tumor genes from a blood sample. Many companies already sell these so-called liquid biopsy tests, though none are FDA-approved yet.

This Associated Press series was produced in partnership with the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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President Donald Trump is donating his third-quarter salary to the Department of Health and Human Services to help fight the opioid epidemic.

The White House did not immediately announce the amount of the check that acting Health Secretary Eric Hargan accepted Thursday. Trump previously donated salary in the amounts of $78,333 and $100,000 to the National Park Service and the Education Department, respectively.

Hargan says the donation will be put toward the planning and design of a large-scale public awareness campaign about the dangers of opioid addiction.

Trump announced the ad campaign in October, the same time he declared opioid misuse a national public health emergency. The declaration included no new federal funding to combat the epidemic.

Hargan says 175 people die every day from drug overdose.
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