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By Michelle Meadows and Mitchell Weitzman
Whether the goal is ensuring the safety of the food supply or speeding the development of new medical treatments, the Food and Drug Administration often depends on its strong relationships with other organizations.
The FDA's collaborations range from informal work agreements on projects of mutual interest to financial partnerships that support state-of-the-art medical technology. Here's a look at some of the major partnerships in which the FDA is involved.
Aquaculture, also called fish farming, involves raising fish in enclosed areas to be sold as food. The FDA is interested in ensuring that farmed fish are safe for human consumption, says Renate Reimschuessel, V.M.D., Ph.D., a research biologist who joined the Center for Veterinary Medicine (CVM) in 1999 to develop an aquaculture research program.
Examples of diseases that are a threat to the fish farming industry are infectious salmon anemia and enteric septicemia of catfish, a bacterial infection that can cause rashes and bleeding. Only seven drugs are approved by the FDA to treat diseases in farm-raised fish. And, as the aquaculture industry grows, there is a need to develop safer and more effective drugs for fish diseases.
Reimschuessel and Badar Shaikh, Ph.D., a research chemist in the CVM, are collaborating on a project with Andrew Kane, Ph.D., associate professor at the University of Maryland School of Medicine and director of the university's Aquatic Pathobiology Center in College Park.
Shaikh is leading a study at the CVM to investigate the metabolic profiles of model drugs in various fish species. The study will be used to determine the marker residues for which analytical methods will be developed to measure drug residues in aquaculture-raised fish. This research should help with regulatory monitoring so that fish destined for human consumption are safe.
Kane is looking at liver enzyme patterns in different fish in response to the same model drugs. This research collaboration, as a potential way to spur drug development, is funded through the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a partnership between the FDA and the University of Maryland.
Bacteria, parasites, and viruses can contaminate produce in many ways. The improper use of manure, water, and soil are just a few. Since 2000, a program called the Good Agricultural Practices (GAPs) International Training Program has been working to minimize microbial food safety hazards for produce during production, packing, and transportation.
Over the past six years, GAPs has been taught in Brazil, Mexico, Thailand, Chile, El Salvador, Trinidad, Puerto Rico, Honduras, and Korea. One expert from the FDA's Center for Food Safety and Applied Nutrition (CFSAN) and three university representatives lead the GAPs five-day training programs.
Most of the people who take the trainings work with either farmers or food packaging houses, and they in turn train others. Both basic and advanced levels are offered. Participants break into small groups and work on case studies covering hygiene, water quality, proper packaging, proper collection and disposal of farm waste, and other food safety issues.
GAPs is a major program of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a partnership between the FDA and the University of Maryland that was established in 1996 to advance food safety research, education, and outreach. CFSAN also has other formal academic partnerships, including:
The National Center for Food Safety and Technology. This research consortium was founded in 1988 as a collaboration involving the CFSAN, the Illinois Institute of Technology, and the food industry. The emphasis is on ensuring food safety and security through research on both novel and conventional food processing and packaging technologies.
The University of Mississippi's Thad Cochran National Center for Natural Products Research. Established in 2001, the center helps the FDA assess the safety of botanical dietary supplements.
A curriculum called "Science and Our Food Supply" is part of a professional development program in food science. The program is a partnership between the FDA's CFSAN, the U.S. Department of Agriculture Graduate School, and the National Science Teachers Association (NSTA).
Each year, 25 middle school and 25 high school science teachers are selected to attend a week of immersion training in food safety. In a six-day summer program, teachers work on experiments, hear presentations by CFSAN experts, and tour a seafood processing plant, among other activities—all without cost to the participants.
"Workshops include activities that allow teachers to more fully understand how pathogenic bacteria can grow in food that is not stored, handled, or cooked properly," says Louise Dickerson, the program's project officer at the CFSAN. "Teachers then return to their schools in the fall and teach this very important public health topic to their students, many of whom will work at entry-level jobs in food service."
So far, 340 teachers from all 50 states, the District of Columbia, the U.S. Virgin Islands, Guam, and Puerto Rico have participated in the program, which began in 1999. As part of their agreement to complete this summer training, participants train other teachers. This development effort has reached more than 6,000 teachers nationwide. As of May 2006, the program had reached more than 1.7 million students.
The Science and Our Food Supply curriculum kit includes middle school and high school teaching guides, an A–Z glossary of food safety terms, and a video called "Dr. X and The Quest for Food Safety." Dr. X is a food scientist who leads students on a journey through the food supply chain. In 2001, the video won an Emmy from the National Academy of Television Arts & Sciences in the category of Outstanding One Time Children's Television Programming.
"My seventh grade class loved the labs, and they were fairly easy to implement," says Nancy Miller, a science teacher at the Potter-Dix Schools in Potter, Neb., who participated in the professional development program in food science in 2005. In June 2006, Miller was named one of two Nebraska Agriculture in the Classroom Teachers of the Year by the Nebraska Farm Bureau Federation.
As part of the Science and Our Food Supply curriculum, students designed their own handwashing experiment. "Some tested hot versus cold water to wash their hands in 20 seconds in one group and 20 seconds in another group," Miller says. "They liked the ‘glo germ' and black light which showed how well their hands were washed."
It's always fun to carry out labs instead of only doing book work, says Kaleb Thomas, a seventh grader who participated in Miller's class. Kaleb says he particularly enjoyed an experiment in which they fed rats to see whether dairy foods helped growth. "One rat was fed foods from all food groups and the other was fed all food groups except dairy. I learned that the dairy foods helped the one rat grow bigger," he says. "I liked playing with the rats, but did not like cleaning the cages."
The FDA's critical path initiative aims to bring medical discoveries to patients faster by modernizing product development. This modernization effort includes creating new tools to assess new drugs and medical devices.
For example, cutting-edge imaging techniques hold potential for staging cancerous tumors and for assessing response to therapy. New imaging technologies may also contribute to powerful new biomarkers for drug distribution and metabolism. Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests and tests on blood, tissue, and other biologic samples.
"As we improve product development, we also want to make sure that we are protecting people who participate in clinical trials that test new therapies," says Isaac Montoya, Ph.D., clinical professor in the University of Houston's College of Pharmacy. In April 2005, Montoya coordinated and moderated a conference titled "The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects."
The national conference was cosponsored by the FDA, the University of Houston's College of Pharmacy, and the Office of Human Research Protections of the U.S. Department of Health and Human Services. More than 150 researchers and other health experts explored topics such as research ethics, informed consent, data collection, and federal regulations.
The critical path conference was part of a larger collaboration between the FDA and the University of Houston that began in 2003. The CDRH is the lead FDA center for the partnership, and the College of Pharmacy is the lead institution for the University of Houston. Other University of Houston colleges that are part of the partnership include the Cullen College of Engineering, the College of Optometry, and the College of Technology. The collaboration encourages University of Houston experts to experience training at FDA and vice versa.
In September 2003, the FDA entered into a confidentiality arrangement with the European Commission (EC) and the European Medicines Agency (EMEA). The arrangement has been extended through 2010. This type of cooperation promotes global harmonization—a movement to harmonize information and requirements between regulatory authorities in different countries.
The EC is composed of representatives from the 25 member countries of the European Union, including Spain, France, Germany, Italy, Sweden, and the United Kingdom. The EMEA coordinates the evaluation and supervision of most new drugs throughout the European Union.
"This confidentiality arrangement covers human drugs, biologics, and veterinary products, and helps improve public health by strengthening our interactions," says Matthew Eckel, staff director for Europe, Harmonization, and Trade in the FDA's Office of International Programs. "It gives us an avenue to exchange non-public information and perspectives to assure that we both have as much information as possible when making regulatory decisions. We may develop shared approaches, if appropriate."
The agreement provides for the exchange of otherwise nonpublic information between the FDA and the EMEA during the review of drug and biologic applications and after drugs and biologics get on the market. Examples of documents that may be exchanged are draft guidance papers, impending regulatory actions, inspection reports, and adverse event reports.
"We use this mechanism to give each other advance notice of significant regulatory actions that are of mutual interest," Eckel says. "So confidentiality is important." There may also be occasions when experts will visit each other's agencies and have access to nonpublic information. Two components of the agreement involve:
Parallel scientific advice. The EMEA and the FDA can communicate with sponsors simultaneously and exchange views between all three parties (the EMEA, the FDA, and the company) on scientific issues during the development of new products.
Submission of pharmacogenomic data. The EC, the EMEA, and the FDA have agreed to a procedure for joint FDA–EMEA meetings with sponsors after voluntary submission of pharmacogenomic data. Pharmacogenomics is the blending of drugs with genomics. It's a science that allows researchers to predict the probability of a drug response, both good and bad, based on a person's genetic makeup.
The FDA's Office of Surveillance and Epidemiology routinely monitors adverse events for all drugs, and also taps into outside resources. One such collaboration involves Harvard Pilgrim Health Care Inc., a large health insurer based in Wellesley, Mass.; the Kaiser Foundation Research Institute in Oakland, Calif.; Vanderbilt University in Nashville, Tenn.; and Ingenix Inc., a division of UnitedHealth Group, another large health insurer based in Eden Prairie, Minn.
Each of these organizations maintains databases that contain information on outpatient prescription drug use, and medical claims from physician visits, hospital admissions, health maintenance organizations, state Medicaid programs, and other sources. Together, the databases contain data on 23.5 million people.
Judy Staffa, Ph.D., R.Ph., an epidemiologist with the FDA's Office of Surveillance and Epidemiology, says that once the FDA identifies a safety signal of concern, the collaborating organizations may be asked to determine whether an epidemiological study is possible. This approach helps experts learn more about the problem and how it can be managed. In many instances, these studies require going back to individual medical records to put pieces of the puzzle together. Records are kept confidential.
Drugs that treat attention deficit hyperactivity disorder (ADHD) are being studied under this collaboration. Adderall (amphetamine-dextroamphetamine) is one of several FDA-approved drugs for children with ADHD who are ages 6 and older. In September 2003, during a review of Adderall for a possible adult indication, FDA scientists identified a cardiovascular safety signal. Several advisory committee meetings were held to discuss potential warnings on the product label of Adderall, as well as the need for further research on cardiovascular events in children.
Joe V. Selby, M.D., M.P.H., director, Division of Research for Kaiser Permanente in Northern California, says, "We realize that we are in a nearly unique situation in being able to follow large populations of members in whom we can identify both drug exposures and possible consequences while protecting patient confidentiality."
He hopes that research on ADHD drugs will give "a much clearer idea of whether there is a risk for sudden cardiac death associated with use of drugs that treat ADHD, whether any such risk varies by the choice of drug, and, if there is a risk, what the size of that risk really is. In that way, parents and patients may make more informed decisions about whether to start or continue the drug."
When the volume of ads consumers see each day on television, the Internet, and in print is considered, direct-to-consumer (DTC) ads have become the "face" of medicine for many Americans. So the public health stakes are high to ensure that these ads accurately convey information about the risks and benefits of prescription medications.
The FDA has conducted its own research on DTC ads, and has also formed relationships with groups outside of government, including Prevention magazine, a monthly consumer health publication with 11 million readers.
The relationship between the FDA and Prevention began in 1997 when the magazine's corporate parent, Rodale Inc., informed the FDA about the results of a national survey that included questions on consumer perceptions of DTC ads. Since then, the Prevention survey team has routinely met with the FDA to refine its survey instrument and to discuss trends that arise from the survey findings.
"The Prevention survey data have afforded us valuable additional resources we might otherwise not have been able to obtain easily," says Kathryn Aikin, Ph.D., a social science analyst with the FDA's Division of Drug Marketing, Advertising, and Communications. "A current issue of interest is how the inclusion of a celebrity or doctor in an ad impacts consumer behavior," Aikin says. Adding to the complexity of the issue, she notes, "What if the ‘doctor' is an actor?"
The FDA's most recent survey findings, released in November 2004, indicate that DTC advertising has both positive and negative effects. For example, DTC advertising seems to increase consumer awareness of conditions and treatments and to motivate patients to ask their doctors better questions. But both patients and physicians indicated that DTC advertisements often overstate the effectiveness of a drug and do not present a fair balance of benefits and risks.
The FDA and Prevention magazine surveys have a somewhat different focus, which adds to the complementary nature of the relationship. Prevention's survey measures consumer awareness and understanding of DTC advertising; the FDA survey focuses on how DTC ads affect the doctor–patient relationship.
Human genes are small pieces of information recorded on a molecule called deoxyribonucleic acid (DNA). Genes determine certain physical characteristics such as eye color, and can also play a role in some diseases. Gene therapy involves the use of normal genes or genetic material to replace or cancel out the "bad" or defective genes in a person's body that are responsible for a disease.
Few endeavors in health care have generated more excitement than gene therapy. Its promise to cure, not just treat, diseases such as cancer, diabetes, and cystic fibrosis fuels boundless optimism. Yet much about gene therapy is still unknown; its short- and long-term risks are still the subject of considerable study. The FDA has not approved any gene therapy products yet, but there are numerous clinical studies ongoing.
To help manage some of the unknowns about gene therapy, the FDA and the National Institutes of Health (NIH) launched the Genetic Modification Clinical Research Information System (GeMCRIS) in 2004. This Web-accessible database on gene therapy gives the public information about ongoing clinical trials and encourages the reporting and analysis of adverse events connected to those trials.
The FDA and the NIH have complementary responsibilities with respect to gene therapy. Both agencies review proposed gene therapy studies. The FDA's primary job is to ensure that manufacturers produce safe gene therapy products and that these products are properly studied in human subjects. The NIH's primary job is to evaluate the quality of the science involved in gene therapy research and to fund the scientists who invent and refine the tools used for clinical studies.
GeMCRIS enables patients, researchers, scientists, product sponsors, and the public to become better informed about gene therapy research. Through drop-down menus and pre-formatted reports, individuals can navigate the GeMCRIS site to view information on particular characteristics of clinical gene therapy trials.
For example, GeMCRIS users can learn where trials are taking place, which diseases or health conditions are being studied, and what investigational approaches are being taken. Those conducting gene therapy trials can report adverse events using a secure electronic interface. Because toxicities can occur well after administration of a gene therapy product, monitoring adverse events is important.
In the not-too-distant future, scientists will determine radiation exposure from the next generation of magnetic resonance imaging (MRI) machines and other sources of electromagnetic waves, not by probes and prods into the body, but via computer-generated models.
Dubbed the "Virtual Family," the development behind the scientific advances is already taking place under a research agreement between the FDA and the Foundation for Research on Information Technologies in Society (IT'IS), says Wolfgang Kainz, Ph.D., an electrical engineer with the FDA's Office of Science and Engineering Laboratories. Based in Zurich, Switzerland, IT'IS is a leading research organization engaged in assessing the impact of electromagnetic exposure on health and in developing information technologies for diagnostic and life-supporting systems.
Currently, good computer models of humans that could serve as a proxy for testing radiation exposure are rare. By creating more sophisticated computer models, engineers and scientists can assess electromagnetic exposure for such common procedures as MRIs and computed tomography (CT) scans without invasive probing. New practice guides could be drafted, and new products could be developed.
How could this technology impact consumers? Consider, for instance, that a patient with an implanted pacemaker may not be able to undergo an MRI because the metal in the pacemaker may be affected by the MRI fields. By using a computer model, engineers and scientists can test and improve a pacemaker's design to minimize such exposure.
The Virtual Family is one of the keys to potential advances in this area. It is a set of four high-resolution, anatomical, whole-body computer-aided design (CAD) models, consisting of an average man, woman, and two children (ages 3 to 6 and 7 to 14 years).
In the past, computer-generated anatomical models hardly resembled humans. And there were no accurate anatomical models for children, frustrating efforts to measure their electromagnetic exposure. The latest generation of models more precisely defines individual organs and can help evaluate adult and child radiation exposure in both medical and non-medical environments. The Virtual Family models being developed by the FDA and the IT'IS promise even greater sophistication.
Fish Medicine and Research
www.fda.gov/cvm/aqualibtoc.htm
Academic Alliances for Food Safety
www.jifsan.umd.edu/ (University of Maryland)
The National Center for Food Safety and Technology
www.ncfst.iit.edu/main/home.html
The Thad Cochran National Center for Natural Products Research
www.olemiss.edu/depts/pharmacy/ncnpr/index.html
Bringing Food Science to Teens
www.foodsafety.gov/~fsg/teach.html
Fostering the Critical Path Initiative
www.fda.gov/oc/initiatives/criticalpath/
International Communications
www.fda.gov/oia/homepage.htm
Managing Drug Safety Risks
www.fda.gov/cder/Offices/ODS/default.htm#Other Resources
The Impact of Advertising
www.fda.gov/cder/ddmac/researchka.htm
Advancing Gene Therapy
www.gemcris.od.nih.gov/ (NIH)
www.fda.gov/cber/genetherapy/gttrack.htm
Medical Devices: Reducing Radiation Exposure
www.fda.gov/cdrh/index.html
www.itis.ethz.ch/itiswelcome.html (Foundation for Research on Information Technologies in Society)
This article has been condensed from the original article as it appears in FDA Consumer magazine and edited for the FDA Web site. The print version of FDA Consumer is available by subscription.