Last year, I attended FDA’s first science writers’ symposium, an interesting program that I’m looking forward to again this year. I wrote up a brief report on the event and took some very amateur videos of scientists’ presentations, envisioning the construction of some grand documentary on FDA's new lab facilities . . . then, my laptop was stolen during a trip, the article was lost and material never made it onto our web site.
In the spirit of “better late than never” a few weeks before this year's program, here is a quick reconstructed glimpse at what happened during that program, as well as links to videos showing some of the people working (not at CDER, but at CDRH) to advance FDA’s scientific mission. FDA had the right idea in publicizing some of its scientists’ pioneering work, particularly the work of Dr. Renate Reimschuessel from the Center for Veterinary Medicine, whose team was instrumental in tracing the causes of melamine contamination in 2007.
Below are quick notes from the program . . . which suggests that, even before the change in its leadership, FDA was becoming much more savvy about interacting with the media. This trend appears to be continuing, since the Commissioner will reportedly be speaking at this year's program.
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Dr. Torti gave a welcome speech, as did Larry Kessler (no relation to David), an industrial health scientist and Director of CDRH’s Office of Science and Engineering Laboratories. David Acheson, Associate Commissioner for Foods spoke at the end of the program, as did Steven Musser, who discussed responses to salmonella outbreaks.
Other FDA scientists discussed recent issues and research projects. Suzanne Epstein, Associate Director for Research at the Center for Biologics, talked about flu pandemic vaccine development, and the potential of vaccines that could impart broad immunity and partially protect against more than one virus subtype, offering a first step in protecting the public in case of a pandemic.
The next two presentations were very significant, in light of the heparin recall, during which FDA’s managers and administrators were under intense public scrutiny, and didn’t look good. The Chinese plant where the heparin was contaminated, for example, had never been inspected, due to a recordkeeping error. However, these same disasters allowed FDA scientists to shine, as they cut through red tape, galvanized other research groups and tackled challenging cases on very tight time frames, in a way that hasn’t always been conveyed effectively in the news. This was evident both in the heparin case and in the case of melamine contaminated pet foods the year before.
At the symposium, CDER Director Janet Woodcock reviewed FDA scientists’ response to last year’s heparin contamination. Within remarkably little time, a team led by CDER’s Moheb Nasr performed analytical risk assessment and gathered an international team of experts to determine the cause of contamination. CDER’s studies began on February 25, the recall was issued three days later, after a first rough identification. By March 5, preliminary findings were made public and by the middle of that month, the identity of the contaminant was confirmed. Scientists dropped everything to work on this project, Dr. Woodcock said. Virginia Tech professors collaborating with the team even worked on the anniversary of last year’s tragic shooting.
Melamine Sleuthing
Renate Reimschuessel from the Center for Veterinary Medicine then recapped her team’s research into the causes of contaminated pet food in 2007. The scientists first puzzled over why melamine would have led to any problems, since it is not toxic. Dr. Reimschuessel looked at veterinary pathology samples of the crystals that had formed in kidneys of affected pets, and noted that they looked familiar to the needle-shaped crystals of uric acid that form in people affected with gout. After further study, she hypothesized that uric acid or cyanuric acid must be present with the melamine. The Center had very little time in which to develop methods for testing this hypothesis. Working with Animal Drugs Research Center in Denver and the Forensic Chemistry Center in Cincinnati, the researchers began dosing animals with chemicals that might have been used overseas. They fed melamine and cyanuric acid to fish, and those who received both chemicals developed crystals, where those receiving either melamine or cyanuric acid alone did not. Researchers evaluated crystal response to formalin or HCl. Crystals were analyzed by the Forensic Chemistry center using microscopy, Raman and FTIR spectroscopy, confirming that the crystals were cyanurate.
Her team also found out why pathologists were seeing so few crystals in affected kidneys. It turned out that formalin, used to preserve tissue samples, was dissolving the crystals before they could be studied. Based on her team’s work, FDA could address the problem and develop screening methods What would have taken six months or more for most industrial contract research labs was accomplished in weeks, Dr. Reimschuessel said, and researchers were able to provide tissues to chemists for analysis.
The significance of this research continues to be seen, since contaminated wheat and rice have moved beyond hog, chicken and fish feeds and the pet food chain, to human foods as well, evidenced by contamination of Chinese baby formula, and, in far lower levels, U.S. formula.
At the time of the symposium, Dr. Reimschuessel said she would soon be on her way to China, to help train regulatory and quality professionals in test methods and techniques.
Other high points were presentations by Jim Kaput, Director of the Division of Personalized Nutrition Medicine, on the challenges of accounting for genetic diversity, differences in health and diet in examining nutritional supplements.
Dr. John Karanian, Director of the cardiovascular therapeutics lab in CDRH, offered an overview of determining predictive safety of drug-device combinations. This work clearly advances the concept being promoted pharma’s Quality by Design. For a brief video clip from his presentation, click here.
Most revealing was a visit to FDA’s CDRH laboratories, with presentations (very brief video clips one and two) on nanoparticle characterization, toxicology and molecular dynamics, clips one and two on ultrasound imaging, and clips one and two of a tour of the electromagnetics and wireless lab, including a look at FDA’s anechoic chamber, as well as presentations (one and two) on nanoshells and tomography.
What emerged from this trip was an image of hard-working and motivated scientists and engineers who are good at what they do and are often extremely effective. The public and the industry need to hear more about, and from, them. I hope there will be other programs like this in the future.
AMS
