Some people enrolled in clinical trials with the US National Institutes of Health (NIH) continue the use of experimental drugs despite the possibility compounds have fungal contamination.
NIH suspended operations yesterday at a plant that makes experimental drugs for clinical center of the body following an investigation by the Food and Drug Administration (FDA) that revealed multiple problems that could expose sterile drugs to contamination. Forty-six trials currently underway receive the materials of the installation, and the NIH is looking for other sources of products for about 250 patients involved in the studies. In some cases, however, find other sources will not be possible, and some tests will be delayed, says Lawrence Tabak, principal deputy director of NIH.
In addition, some test subjects, after being informed of the risks, asked to continue their experimental treatments made by the now closed facility. The Director Francis Collins NIH has granted exceptions to those whose conditions could be severely compromised if they receive their next scheduled dose. They will be monitored for signs of infection. "Many of them have taken products for some time, without adverse effects. The risk of infection is low, but we still want to be careful," said Tabak.
"This is a painful and unacceptable situation," Collins said in a statement. "the fact that patients may have been put at risk due to non-compliance with standard operating procedures in the Development section pharmaceutical NIH clinical Center is deeply troubling. I will personally supervise the measures necessary to protect patient safety and to remedy the position as soon as possible. "
In April, an employee of Clinical Center had noticed what appeared to be a fungal infection in a vial of albumin used in the administration of interleukin drugs in experimental-after studies was unable to get the liquid out of the bottle. visual inspection of about 650 bottles of the same batch has revealed additional contaminated vial. Six patients from three studies were given bottles of the same lot, although it is unclear if these bottles or others were infected. At this point, none of the six have developed signs of infection or disease.
After the episode in April, an internal review was conducted, says Tabak, who noted several problems with the physical installation. Although the exact date is unknown, at some point the FDA received an anonymous complaint and conducted an unannounced inspection of the facility located on the NIH Bethesda, Maryland, campus between May 19 and May 29. Their 14-page assessment identifies a number of shortcomings, both physical and operational. An exhaust duct leading from one of the "clean rooms" of the installation on the roof was missing a filter or screen, for example, and flaws in the air handling system could expose the sterile products microbial contamination during processing. The report noted deficiencies in the processes of cleaning and disinfection (insects were found in two of the five cleanroom ceiling light berries), and examples of the formation of apparently insufficient staff (laboratory workers with clothes that have left part of their face, neck and arms exposed).
to date, all the facility's products were visually inspected, and no obvious additional contamination was observed. NIH is attempting to send products to a contracting laboratory outside of further testing, which could take several weeks. They are also in the process of contacting and monitoring of patients in the 43 remaining studies. Treatment studies for autoimmune diseases and rare genetic as well as various forms of cancer are among those likely to be affected.
A full review with external experts in engineering, microbial practices, and sterility practices is expected, and the NIH is intended to provide a temporary corrective action plan to the FDA on 19 June.
0 Komentar