Friday, September 8, 2017

It’s not just one suspect herpes vaccine trial: Most experimental drugs are tested offshore — raising concerns about data

By Rebecca Robbins

Molly Ferguson for STAT

The clinical trial for a herpes vaccine flouted just about every norm in the book: American patients were flown in to the Caribbean island of St. Kitts for experimental injections. Local authorities didn’t give permission. Nor did the Food and Drug Administration. Nor did a safety panel.

That’s why the trial — run by a startup that has since received funding from billionaire investor Peter Thiel — prompted widespread alarm and censure when it was reported last week by Kaiser Health News.

By Ed Silverman

Richard Drew/AP

In a move that is capturing imaginations, Allergan has transferred patent rights to one of its biggest-selling drugs to a Native American tribe in hopes of thwarting challenges to its intellectual property.

The deal between the drug maker and the Saint Regis Mohawk tribe involves patent rights for the Restasis eye treatment, which generated $1.4 billion in sales last year and is responsible for about 15 percent of earnings. Under the terms, the tribe is getting $13.75 million, plus another $15 million in annual royalties, and Allergan was granted an exclusive license to market the product.

By Jennifer Adaeze Okwerekwu

Mike Reddy for STAT

I’ve been thinking a lot lately about two little girls, one 6 and the other 8.

Both girls came to America with their parents, who were looking for better opportunities in health care. Both girls watched their parents navigate the American health care system — in one case, as a patient in need of advanced medicine, and in the other, as providers in a profession uneasily reliant on immigrant doctors. Both girls took those experiences to Harvard, and then medical school, and finally, residency, serving patients from disadvantaged backgrounds.

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A silly web series with a serious aim: to find Gene a kidney donor

By Leah Samuel

Courtesy Lindsey Leifken

In the videos, two burly guys in red bodysuits are uncomfortably close to Gene Okun. They eat food off his plate, snuggle up with him in bed, and accompany Okun on a date, even hugging his companion as the date ends. And the whole time, the guys in red are loudly laughing and arguing.

In actual life, those actual kidneys — which Okun has nicknamed Big and Dumb — do cause him a lot of trouble. Okun, 53, has polycystic kidney disease, or PKD, which has caused his midsection to grow large and rounded, as if he were pregnant.

By Christopher Lee Bennett

APStock

Somewhere around the eighth hour of my 28-hour shift in the hospital, a nurse told me that a patient had just been transferred from the intensive care unit to my floor. I stopped by the patient’s room to introduce myself. It was just after lunchtime, and Ms. S’s room was overflowing with family members who had flown in to be nearby because she was in critical condition; they were now celebrating her improvement.

I chatted with Ms. S, examined her, reviewed her medications, and answered questions that she and her family had. At some point, the conversation turned nonmedical. Standing by the window, I remarked on the view of Boston’s Charles River below. I mentioned to the family that whoever was still in her room the next morning would be treated to a beautiful view of the boat-laden Charles at sunrise.

By Meghana Keshavan

Daniel Berman for STAT

PORTLAND, Ore. — Biologist Shoukhrat Mitalipov knew he’d done something pretty big: He’d conducted the first experiment in the U.S. to edit a dysfunctional gene in a viable human embryo. That was sure to spark a debate about designer babies and draw ire from the anti-abortion groups that so vehemently oppose such research.

What Mitalipov didn’t expect, however, was the furious response from fellow researchers — who have aggressively picked apart not the ethics of his work, but his scientific conclusions.