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Senate Panel OKs Califf Nomination for F.D.A. Chief

As a cardiologist, Dr. Califf spent decades leading clinical trials at the Duke University Medical Center in North Carolina. Most recently, he led clinical policy and strategy for Verily, the life sciences arm at Alphabet, the parent company of Google. During the hearing, he emphasized the value of existing data, much in patients’ electronic medical records, to help answer difficult questions about the evidence for drugs and devices.

Republicans asked how he would handle rules around medications to induce abortion, which had been relaxed during the pandemic after years of tight restrictions. Two days after the hearing, the F.D.A. — under Dr. Janet Woodcock, the interim commissioner — announced that it would permanently lift restrictions, allowing patients to terminate a pregnancy in the first 10 weeks after a telemedicine visit with medications taken at home.

Senator Tommy Tuberville, a Republican committee member from Alabama, said in a statement that the recent decision informed his committee vote. “I believe Dr. Califf will continue to advance this administration’s pro-abortion agenda, and I cannot support his nomination,” he said.

Senator Mike Braun, a Republican from Indiana, also said he opposed the nomination over abortion policies and opioid concerns. “Under his leadership in 2016, the F.D.A. expanded access to the dangerous chemical abortion drug mifepristone and failed to take action to stem the tide of the opioid crisis ravaging our country,” he said in a statement.

Dr. Califf was previously confirmed in a 89-to-4 Senate vote to lead the F.D.A. during the last year of the Obama administration. If confirmed again, he will face key decisions on tobacco control as he tries to balance e-cigarettes as a tool to help some quit smoking without creating a new generation of users. Scrutiny around accelerated approvals of drugs will be heightened, given the current debate over the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

After Senator Sanders denounced Dr. Califf’s ties to pharmaceutical firms, which include consulting fees and stock ownership amounting to as much as $8 million, the nominee told the Senate panel in mid-December that he would comply with ethics rules set by the F.D.A. and its parent agency, the Department of Health and Human Services.

Senator Hassan of New Hampshire also voted against Dr. Califf’s nomination. She had pressed him in December on the F.D.A.’s failure to update the labeling of opioid medications. Dr. Califf said the agency would continue to review the evidence coming in.

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Ciencias

How The mRNA Vaccines Were Made: Halting Progress and Happy Accidents

“I said, ‘I am an RNA scientist. I can do anything with RNA,’” Dr. Karikó recalled telling Dr. Weissman. He asked her: Could you make an H.I.V. vaccine?

“Oh yeah, oh yeah, I can do it,” Dr. Karikó said.

Up to that point, commercial vaccines had carried modified viruses or pieces of them into the body to train the immune system to attack invading microbes. An mRNA vaccine would instead carry instructions — encoded in mRNA — that would allow the body’s cells to pump out their own viral proteins. This approach, Dr. Weissman thought, would better mimic a real infection and prompt a more robust immune response than traditional vaccines did.

It was a fringe idea that few scientists thought would work. A molecule as fragile as mRNA seemed an unlikely vaccine candidate. Grant reviewers were not impressed, either. His lab had to run on seed money that the university gives new faculty members to get started.

By that time, it was easy to synthesize mRNA in the lab to encode any protein. Drs. Weissman and Karikó inserted mRNA molecules into human cells growing in petri dishes and, as expected, the mRNA instructed the cells to make specific proteins. But when they injected mRNA into mice, the animals got sick.

“Their fur got ruffled, they hunched up, they stopped eating, they stopped running,” Dr. Weissman said. “Nobody knew why.”

For seven years, the pair studied the workings of mRNA. Countless experiments failed. They wandered down one blind alley after another. Their problem was that the immune system sees mRNA as a piece of an invading pathogen and attacks it, making the animals sick while destroying the mRNA.

Eventually, they solved the mystery. The researchers discovered that cells protect their own mRNA with a specific chemical modification. So the scientists tried making the same change to mRNA made in the lab before injecting it into cells. It worked: The mRNA was taken up by cells without provoking an immune response.

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Ciencias

Howard Solomon, 94, Dies; His Business Success Had a Personal Connection

“Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public,” Carmen Ortiz, the U.S. attorney for Massachusetts, said when the settlement was announced.

The company denied the allegations. In a statement at the time, Mr. Solomon said, “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations.”

In 2011, Forest Labs won a proxy fight against the shareholder activist Carl C. Icahn, who had argued that the company had, among other things, lost billions of dollars of shareholder value over the previous decade. Mr. Icahn continued to pursue Forest Labs with a second proxy fight in 2012, which ended with one of his nominees elected to the company’s board.

In a letter to Mr. Icahn during that fight, Mr. Solomon wrote: “Your discourse thus far has shown a striking lack of strategic ideas. Instead, it has been replete with wild and baseless accusations, innuendo and distortion of facts.”

Still, at some point, Mr. Solomon reached out to Mr. Icahn, and they had a series of dinners.

“We got friendly,” Mr. Icahn said in a phone interview. “I thought he was a nice gentleman, a courtly guy.” He added: “I didn’t agree with the way he ran the business necessarily, but he was a nice guy who was thrilled with the outcome. He made a lot of money.”

In 2013, Mr. Solomon announced his retirement as chief executive and was replaced by Brent Saunders, an executive friendly with Mr. Icahn. Then, in early 2014, Actavis (now Allergan) paid $25 billion to acquire Forest Labs. Mr. Solomon, still the chairman, left after the acquisition and formed a family investment firm with his younger son, David, who had been a Forest Labs executive.

In addition to his sons, Mr. Solomon is survived by his wife, Sarah Billinghurst Solomon, a former assistant general manager of artistic affairs at the Metropolitan Opera, and five grandchildren. His first wife, Carolyn (Bower) Solomon, died in 1991.

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Ciencias

The Kunga Was a Status Symbol Long Before the Thoroughbred

In ancient Mesopotamia 4,500 years ago, long before horses arrived in the region, another spirited member of the equine family, the kunga, took a starring role in pulling four-wheeled wagons into battle.

Archaeologists had suspected that these animals — depicted in art, their sales recorded in cuneiform writing, their bodies sometimes laid to rest in rich burial sites — were the result of some kind of crossbreeding. But proof was lacking.

On Friday, a team of researchers reported on more than a decade of research in the journal Science Advances, concluding that studies of ancient DNA showed the kunga was a cross between a female donkey (Equus Africanus asinus) and a male Syrian wild ass (Equus hemionus hemippus).

The kunga is the first known instance of a human-engineered hybrid of two species, a production far beyond the traditional processes of the domestication of animals, the researchers found.

Eva-Maria Geigl, a specialist in ancient genomes at the University of Paris, and one of the scientists who did the study, said the breeding of kungas was really “early bioengineering” that developed into a kind of ancient biotech industry.

Like mules, which are hybrids between horses and donkeys, and which were created much later, the kungas were sterile. Each new kunga was a one-off, a mating between a wild ass stallion and a donkey.

The stallions had to be captured and kept in captivity, even though they were highly aggressive, as modern records have indicated. Dr. Geigl said that the director of a zoo in Austria, where the last captive Syrian wild asses died, described them as “furious.” Archaeological records show that a breeding center in Nagar (now Tell Brak, Syria) shipped the young kungas to other cities. They were costly animals, status symbols, and were used in war and military ceremonies.

Kungas held their high status for at least 500 years, Dr. Geigl said. Horses did not appear until around 4,000 years ago to take their place in battle and ceremony, and to contribute to the creation of other hybrids. Before the current research, the oldest known hybrid was a mule from a site in Turkey dating to 3,000 years ago. Members of the same team reported on that find in 2020.

The research team had to cope with the very poor preservation of fossils from desert areas, but used a variety of techniques to examine ancient DNA. Laurent Frantz, a paleogenomics expert at Ludwig Maximilian University of Munich, who was not involved in the study, said that despite these difficulties, the “results were very convincing,” showing that people “were experimenting with hybrid equids long before the arrival of the horse.”

Fiona Marshall, an archaeologist at Washington University in St. Louis, who has researched the prehistory of donkeys and their domestication, said the study was “enormously significant” partly because it showed that the breeders had clear intentions. The early process of domestication was always murky — probably part accident, part human intervention — but this research showed what the ancient Syrians were after.

“People wanted the qualities of a wild animal,” she said. Donkeys might have been tamer than their ancestors, the African wild ass, but the breeders in Mesopotamia wanted to back breed to other wild asses for strength and speed — and perhaps size. Although the last known living examples of the Syrian wild ass were very small, a little more than three feet at the withers, older animals of the same species were larger.

Dr. Geigl — who collaborated on the research with Thierry Grange at the University of Paris, E. Andrew Bennett, now with the Institute of Vertebrate Paleontology and Paleoanthropology in Beijing, Jill Weber at the University of Pennsylvania Museum of Archaeology and Anthropology and others — said that the team sequenced DNA from numerous sources, including modern donkeys, horses and several species of wild asses, and museum samples.

Of particular importance were the bones of 44 kungas interred at a rich burial site in Syria called Umm el-Marra. Those skeletons had earlier led Dr. Weber and others to hypothesize that they were hybrids and that they were the kungas described in tablets and represented in art.

Their teeth showed bit marks and indicated they had been fed a special diet. The new research used DNA from those kungas to compare to other species and determine that these animals were, as suspected, the result of breeding female donkeys and male Syrian wild asses.

The research team also sequenced DNA from a Syrian wild ass found at Gobekli Tepe in Turkey, an 11,000-year-old site where humans gathered for purposes still being studied, and from two of the last animals of the species, held at a zoo in Vienna.

It is a species that no longer exists. The kunga can’t be recreated, Dr. Bennett said. Donkeys are plentiful, of course, but the last known Syrian wild asses died in the late 1920s. One was shot in the wild and the other died in a zoo in Vienna.

“The recipe for making the kunga was unknown for thousands of years,” Dr. Bennett said. “And we finally decode it not even 100 years since one element has become extinct.”

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