Task Force Calls For More Safety Oversight At NIH Research Hospital

Apr 21, 2016
Originally published on April 22, 2016 2:10 pm

The largest research hospital in the world, the National Institutes of Health Clinical Center in Bethesda, Md., needs reform so that patient safety is always the priority — and never subservient to the demands of science.

That's the conclusion of a sweeping review by a task force of independent experts convened by the NIH. The team has made a slew of recommendations, including the creation of an outside hospital board to oversee the clinical center and a new central office to coordinate research quality and safety oversight.

"The emphasis on research is so great, and on trying to save people's lives, that there became a cultural attitude that overshadowed handling some of the details that are important details," says Norman Augustine, former CEO of Lockheed Martin, who chaired the task force.

NIH Director Dr. Francis Collins tells NPR that he intends to immediately respond to those recommendations.

Indeed, Collins told a meeting of his advisory committee on Thursday afternoon that he is forming a new hospital board, to be chaired by Dr. Laura Forese, chief operating officer of New York-Presbyterian Hospital. Collins is also setting up a new compliance office and making other changes to strengthen safety oversight.

In a written statement posted on the NIH website, Collins says "patients who come to the Clinical Center can be confident that they will continue to be cared for by highly dedicated medical professionals. Continuous improvement is an essential part of hospital management, and this is an opportunity to strengthen our patient safety framework."

"We are an exceptional place, a research hospital with 240 beds," Collins tells NPR. "Patients who come to the clinical center are all on experimental protocols. It makes us rather different than any other hospital you could think of."

He says the doctors and nurses there are working hard to develop new treatments for terrible diseases. "Their focus is on research, and understandably so," says Collins. "And I think in some instances that took precedence over thinking very carefully about, 'Do we have every other kind of oversight in place to be sure that we're not putting people at any kind of unnecessary risk?' "

The NIH safety review comes following embarrassing problems that last year forced the closure of part of the pharmacy service at the Clinical Center. The facility manufactured sterile medical products to be given to people at the center. But inspectors found everything from vials contaminated with a fungus to insects in the ceiling lights to flaws in the air handling system.

"That was, for me, the darkest moment since I've been NIH director, which is now going on seven years," says Collins.

The report from the task force notes that problems in that facility were long-standing, and workers apparently raised concerns regularly but they were never reported beyond the pharmacy department. "People at the bottom were aware of problems and they didn't get up to where the people who could really solve them had a chance," says Augustine.

Since then, the agency has hired outside companies that specialize in quality assurance for manufacturing to review about a dozen other NIH facilities that make materials intended to be injected or infused into people.

Earlier this week, the NIH announced that it was temporarily halting work at two facilities. One of them was the cell therapy lab of Dr. Steven Rosenberg, chief of surgery at the National Cancer Institute, who makes experimental treatments for cancer. The other was a facility at the National Institute of Mental Health that makes imaging agents given to people who are getting PET scans for research studies — mostly healthy volunteers.

"The good news is that we have no evidence that any patients have been harmed," says Collins."Certainly the motivation here is to find the problems and fix them as quickly as possible."

Rosenberg is famous for his pioneering work in immunotherapy — harnessing people's own immune systems to fight cancer. He has spent four decades at the NIH and has given infusions of immune cells to more than 1,000 people with metastatic cancer.

The results can be dramatic. Some people with metastatic melanoma, for example, have seen complete regressions that have lasted for years. Rosenberg's work was featured in a recent Ken Burns documentary on cancer.

In that documentary, one man's infusion of cells is delayed because the first batch of cells got contaminated by a virus. "The cells from the gentleman in the Ken Burns program was one of the rare instances of contamination — and the cells were discarded," Rosenberg tells NPR via email. "We started over, generated new cells that passed all tests, and the cells were administered. That patient has experienced a complete regression of his cancer ongoing to the present time."

Are the safety problems found in Rosenberg's lab worth putting his clinical trials on hold, given that they involve sick people who may have no other options? Collins tells NPR the risks are difficult to quantify but significant enough to hold off enrolling new volunteers for now.

Rosenberg says he totally supports the NIH effort to improve its facilities and minimize potential risk. "Although it is not ideal to temporarily pause treatments to improve the facility, I firmly believe that these renovations will further minimize risk and patients will benefit," he writes in an email. "I am working very hard, with the full support of the NIH leadership, to complete these renovations as soon as possible."

He further notes that his lab has procedures in place to try to detect any contamination that might make someone ill: "We culture the cells three days prior to the infusion and analyze the cell cultures microscopically on the day of infusion. If there is any evidence of contamination, the cells are discarded and we start over. In addition, a sample of the actual infused product is sent to our microbiology department for culture, and none have ever had evidence of contamination."

Rosenberg says he looks forward to enrolling new patients in his studies in the very near future.

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KELLY MCEVERS, HOST:

Sick people who have run out of options often seek help at the National Institutes of Health. Its Clinical Center in Maryland is the largest research hospital in the world. Now safety concerns have forced one of its most high-profile physicians to stop his experimental treatment. NIH officials say this is part of a larger problem at the Clinical Center. NPR's Nell Greenfieldboyce reports.

NELL GREENFIELDBOYCE, BYLINE: Steven Rosenberg is a rock star in science. He's chief of surgery at the NIH's National Cancer Institute, the guy who treated President Ronald Reagan's colon cancer and a pioneer in fighting cancer by harnessing a patient's own immune system. Here's him in a recent Ken Burns documentary telling a man with cancer that his experimental treatment seemed to be working.

(SOUNDBITE OF DOCUMENTARY, "CANCER: THE EMPEROR OF ALL MALADIES")

STEVEN ROSENBERG: When we see this kind of regression at one month, it very often continues until everything disappears.

GREENFIELDBOYCE: Rosenberg's research has produced dramatic results in dozens of people with metastatic cancer. He takes certain immune cells from their bodies and grows them up into an army of billions of cells. Then, he puts those cells back in the body to fight the disease. Francis Collins is director of the NIH.

FRANCIS COLLINS: This is a laboratory that, in many ways, has been on the very cutting edge of developing what many people consider to be one of the most exciting things that's happening in cancer.

GREENFIELDBOYCE: But the lab's work has been halted after an inspection found that it didn't meet safety standards. The concern was that cells could get contaminated in a way that could make people ill.

COLLINS: The good news is that we have no evidence that any patients have been harmed

GREENFIELDBOYCE: But if his lab can no longer produce materials for these trials, what happens to the people who wanted to try this? Is what's been seen worth taking that hope away from them?

COLLINS: Well, you're asking the tough question that we have to wrestle with.

GREENFIELDBOYCE: He thinks the lab's deficiencies were significant enough to stop taking new volunteers for now.

COLLINS: Certainly, the motivation here is to find the problems and fix them as quickly as possible.

GREENFIELDBOYCE: Last year, fixing problems meant permanently shutting down another NIH facility. It was a pharmaceutical service that made a host of medical products given to people at the Clinical Center until inspectors found everything from vials contaminated with a fungus to insects in the lights of clean rooms.

COLLINS: That was, for me, the darkest moment since I've been NIH, which is now going on seven years.

GREENFIELDBOYCE: The mess is what prompted reviews of about a dozen other NIH facilities that make stuff to put in people. So far, in addition to Rosenberg's lab, work has been halted in a facility at the National Institute of Mental Health. It made imaging agents given to people who are getting PET scans for research studies, mostly healthy volunteers. Beyond checking manufacturing facilities, the NIH has also undertaken a sweeping review of safety at its research hospital.

It convened a red team of prominent outside experts chaired by Norman Augustine, former CEO of Lockheed Martin. Augustine says the NIH is a remarkable place, but the needs of research were sometimes put ahead of safety.

NORMAN AUGUSTINE: The emphasis on research is so great and on trying to save people's lives that there became a cultural attitude that overshadowed the handling some of the details that are important details.

GREENFIELDBOYCE: His team made a slew of recommendations for improvements, including an outside board to oversee the Clinical Center and a new office of compliance. Francis Collins, the director of the NIH, said he would immediately make those changes. Meanwhile, Steven Rosenberg told NPR by email that he totally supports the NIH effort to improve and is working to renovate his facilities as quickly as possible. Nell Greenfieldboyce, NPR News. Transcript provided by NPR, Copyright NPR.