San Francisco hospital suspends kidney donations after death

US health regulators probe Theranos complaints

SAN FRANCISCO, Dec 21, (Agencies): A prominent US medical center has voluntarily suspended its living donor program for kidney transplants after a living donor died last month.

The donor had provided a kidney to a recipient at the University of California San Francisco Medical center in October. Hospital and regulatory officials are still investigating the cause of death, the San Francisco Chronicle reported.

Dr Steven Katznelson, medical director of California Pacific Medical Center’s kidney transplantation program in San Francisco, called the donor’s death a “nightmare scenario.”

“We worry about it every day,” he said. “For a healthy person who goes under general anesthesia, there’s always a risk.”

UCSF officials say the recipient’s new kidney is working properly but they declined to identify the patient or the deceased donor.

Most kidneys used in transplants come from deceased donors, but those received from living donors generally have better outcomes. The risk of a kidney donor death following surgery is about three deaths in every 10,000 cases.

Four kidney donor deaths, including the one at UCSF, have been reported since 2014, according to the Organ Procurement and Transplant Network.

Hospital officials say UCSF has performed more kidney transplants overall than any other center in the US, with more than 10,000 since 1964. Doctors there performs about 350 kidney transplants a year, with about 150 involving living donors.

UCSF says during the investigation it will not conduct the transplant surgeries on donors but it will continue transplanting kidneys from both living and deceased donors into recipients. Physicians at California Pacific will take over the donor side for several transplant surgeries at UCSF the rest of this year.

The US Food and Drug Administration is investigating complaints filed by two former employees of privately held laboratory operator Theranos Inc, the Wall Street Journal reported, citing people familiar with the matter.

In September, a complaint filed by a former Theranos employee to the Centers for Medicare and Medicaid Services stated that the management instructed lab employees to continue testing patients with the company’s devices, despite facing accusations that its devices were flawed and had problems with accuracy, the Journal reported.

Protocol

The FDA received a second complaint earlier this month, which claimed that a study for a herpes test submitted for approval with the FDA violated research protocol, the newspaper said, upon reviewing both the complaints.

CMS auditors had examined the company’s Newark lab, in November, which was part of the regular audit that the company was said to continue, the Journal said.

Theranos Chief Executive Elizabeth Holmes defended her company earlier this year, when the Wall Street Journal published stories suggesting her startup was relying on tools from traditional labs as it struggled with its own technology.

Holmes fought back the claims stating the company has moved away from one of its devices only briefly as it transitions to getting approval from the FDA for all of its tests.

According to the Journal, Theranos spokeswoman Brooke Buchanan said, the company hasn’t been provided with “a copy of any alleged complaint, so we have no basis to evaluate what is in it or even if a complaint has been filed.”

“Agencies have a process for evaluating complaints, and many complaints are not substantiated. We trust our regulators to properly investigate any complaints, and we look forward to continuing our strong and productive relationships with them,” she added in the report.

CMS and FDA spokeswomen have declined to comment to the Journal.

Reuters could not independently reach the FDA, Centers for Medicare and Medicaid Services and Theranos for comment outside regular US business hours.

Shares in India’s largest drugmaker, Sun Pharmaceutical Industries Ltd, skidded more than 7 percent on Monday after US regulators warned of standards violations at a key plant in the latest blow to India’s generic drug industry.

The warning comes barely a month after rival Dr Reddy’s Laboratories Ltd was reprimanded by the US Food and Drug Administration for issues including record-keeping at three of its plants. The company said it was working to resolve the FDA’s lingering concerns about the Halol plant, disclosed in a statement by Sun Pharma on Saturday.

Analysts and investors say the warnings highlight how even the country’s biggest drugmakers are struggling to establish uniform manufacturing standards across their facilities, nearly two years after they set out to revamp their processes.

In a conference call on Saturday, Sun Pharma said it has been implementing remedial actions at the Halol plant since the FDA inspected it in Sept 2014 and highlighted a series of concerns.

India’s largest drugmakers have been overhauling processes and procedures since then-industry leader Ranbaxy Laboratories Ltd in 2013 paid $500 million to settle US charges that it falsified data and misled regulators.

Since then, the FDA has also significantly scaled up inspections of foreign plants, leading to a series of warnings and import bans on manufacturing plants in India over problems ranging from compromising data to hygiene and repair issues.

Some in the Indian pharma industry say standards have become stricter over the past two years, and it has been difficult for companies to keep up. India supplies about 40 percent of the generic and over-the-counter medicines available in the United States.

The latest warning increases the risk the FDA may ban imports from the Halol plant altogether, which would hit Sun Pharma’s US sales, about 15 percent of which come from the plant in question.

Morgan Stanley analysts said in a note on Monday they had lowered their estimates for 2017 and 2018 earnings per share, citing expectations of slower US growth due to delays in Sun Pharma getting US approvals to launch products made at Halol.