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Old 10-10-2013, 02:15 PM   #1
'lizbeth
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Post Clinical Trials Continue Only at a Crawl

Clinical Trials Continue, but Only at a Crawl

By SABRINA TAVERNISE

Published: October 9, 2013



WASHINGTON — The federal government has continued to enroll critically ill people in clinical trials at the National Institutes of Health since the government shutdown began last week, but the pace has slowed drastically, and many other sick people are having to wait for treatment.
As elected officials try to sway public opinion on which party bears responsibility for the shutdown, lawmakers, advocates and news reports have raised the specter of children with cancer being kept from potentially lifesaving treatments because financing has been cut off.
While enrollment has slowed significantly, it has not stopped. On Wednesday, more than a week into the shutdown, N.I.H. officials said that the agency had continued to admit critically ill patients to existing clinical trials, of which more than 1,400 run at any given time. About 12 patients were enrolled between Oct. 1, when the government shutdown began, and Oct. 8. Most were cancer patients, said Renate Myles, an N.I.H. spokeswoman.
That is substantially fewer than would have been enrolled had there been no shutdown. In a typical week, the agency enrolls roughly 200 new patients. About 30 of those are children, a third of whom have cancer.
Officials stressed that only patients in imminent danger of dying were being waved through during the shutdown. Those patients still have to fit the criteria for the trial, and the researchers have to conclude that the treatment — a new drug therapy, for example — would offer hope for an improved outcome.
Karen Armenta, a 5-year-old from Wisconsin, is one of the lucky few. She was found to have leukemia when she was 4, said her mother, Tania Santillan, but after intensive treatment, including chemotherapy, she seemed to have beaten it. But last week, a blood test turned up bad news: the cancer had come back. Her doctors immediately contacted researchers at the N.I.H., but they were unsure if Karen would be admitted.
“They said, ‘We don’t know if they are going to admit her because of the government shutdown,’ and I was like, ‘Oh my gosh,’ ” said Ms. Santillan, whose contact information was provided by the Children’s Inn, a private, nonprofit residence on the N.I.H. campus.
To Ms. Santillan’s relief, the researchers called her daughter’s doctors back later that day and said they would admit Karen, as she was critically ill and met the criteria for a study.
“I’m feeling pretty good about it now,” her mother said.
The shutdown has drastically reduced the level of staff at the N.I.H. About three-quarters of its employees, more than 13,000 people, are furloughed. So while the agency continues to provide treatment to patients who were already enrolled in trials, they are not enrolling many new patients because they do not have the staff to complete the process. No new studies are being started during the shutdown, and at least seven new trials had been delayed as of Wednesday.
Clinical trials are not the only public health worry that has emerged as the shutdown continues. More than two-thirds of employees at the Centers for Disease Control and Prevention are furloughed, leaving no staff members to conduct important monitoring activities. For example, there are no employees to track the flu virus or to conduct genetic testing on it, leaving researchers with no information about how it is spreading or where it is most intense.
“Last flu season was early and severe,” said Barbara Reynolds, a spokeswoman for the C.D.C. “This flu season, we are not going to know.”
Ms. Reynolds said the agency had been monitoring about 30 food-borne illnesses at the time of the shutdown. Its small team of eight illness sleuths was reduced to one for the first few days, but quickly went back up to seven when officials decided that more workers were needed to perform all of the critical monitoring tasks. Among the illnesses the C.D.C. is tracking is a salmonella outbreak traced to raw chicken from facilities in California.
Other types of monitoring are also impaired. The Food and Drug Administration said nearly 1,000 of its approximately 1,600 investigators, who inspect everything from food facilities to drug makers, were furloughed.
The N.I.H., with its 27 institutes and centers, is the largest source of financing for medical research in the world. It processes thousands of grant applications every year, but during the shutdown, that work has ground to a halt.
The timing — the beginning of the fiscal year — is particularly bad, researchers said. Some experts worry that future research will be at risk if the shutdown drags on for weeks. Financing is also suspended for N.I.H. employees to travel to scientific meetings and for the training of graduate students and postdoctoral fellows at N.I.H. facilities.

Last edited by 'lizbeth; 10-10-2013 at 02:16 PM.. Reason: clean up
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