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Riding Herd on Mad Cow Disease
From European-made herbal supplements to candy and vaccines, a growing number of imported products from Europe and other regions of the world are coming under official scrutiny for fear that they might cause the human version of mad cow disease.
European products are being targeted in specific because mad cow disease, officially known as bovine spongiform encephalopathy, or BSE, has spread across that continent. Once predominately found in the U.K., cases have now been documented in France, Germany, Spain, Portugal, and other nations.
Mad cow is a cattle disease, but scientists have been able to establish a strong association between this cattle disease and the recent emergence of a new version of a human brain disorder called variant Creutzfeldt-Jakob disease. Moreover, about 90 Europeans, all of whom reportedly ate tainted meat, have died of this disorder since the mad cow epidemic began there in the mid-1990s.
The fear that these other imported products also might cause the deadly brain disorder is due to the fact that, in some instances, these products were made using cattle parts. This fear has been compounded in part by the fact that no one knows how long it takes for the human version to incubate before the disease develops. This has created uncertainty about how many cases eventually will be reported, and whether tainted meat alone will account for all of these incidents.
For example, if it takes over a decade for the disease to incubate within a person, then we could just be seeing the tip of the iceberg, scientists say. Overall, scientists estimate the present risk of contracting the human form of mad cow in a country with tainted meat at about one in 40 million.
The risk that these other products might contain the infectious mad cow agent is at best "theoretical," says Murray Lumpkin, MD, a senior official of the FDA. But in some cases, he says, there is a good reason to believe that those products might pose at least a relative risk.
"When you get into some of these products, then you begin to run a full spectrum of risk," Lumpkin tells WebMD.
For instance, there is little reason to believe that vaccines might contain the infectious mad cow agent, Lumpkin says. But there is, he says, a good reason to believe that a small number of European dietary supplements may pose a risk because they are made with highly infective cow tissues, such as brain parts.
As a result, state and federal authorities already have stepped up their surveillance. In New York City, for example, officials recently banned the sale of German-made candy because it was made with gelatin derived from beef.
Although the local officials eventually concluded that there never was any real danger, Lumpkin says those officials acted appropriately because of the potential public impact.
"To a degree, when you compare the risk of this entity to other risks people are asked to take every day -- it pales in comparison," he tells WebMD.
The good news, Lumpkin says, is that federal regulators have now taken a number of steps to prevent the emergence of mad cow disease in the U.S. At present, he notes, federal law already prohibits the practice of feeding animal proteins to cattle, which is believed to be the original cause of the European epidemic.
In response to the heightened public concern, the FDA also is considering banning blood donations from long-term residents of France and Portugal, and tightening the oversight of dietary supplements made with animal parts from countries with confirmed cases of mad cow disease, Lumpkin says.
Meanwhile, the American Red Cross, which collects half the nation's blood supply, is considering an even tighter ban on blood donations from people who have spent time abroad.
With blood safety paramount, "in our judgment, it makes sense to us to include all of Europe, because that's where BSE has spread, and spread extensively," American Red Cross President and CEO Bernadine Healy, MD, tells WebMD. "We are going to extend the ban to Europe. We are still finalizing the time periods, but we think it will be one year in Europe. We are still trying to decide if it will be 3 or 6 months for U.K."
Going beyond FDA mandates is not unusual, adds Healy. "We think we're making the right call for our patients," she says. "These are very crude actions we're taking in the face of uncertainty, but hopefully they are only temporary steps until we get a test to screen blood."
Other consumer advocates maintain that there still are significant gaps in the U.S. safety net.
"We are mainly worried about dietary supplements," explains Peter Lurie, MD, MPH, a deputy director of the consumer advocacy group Public Citizen and a member of the FDA expert advisory committee on BSE. "But we are also concerned about the high rate of noncompliance with federal regulations."
According to a recent FDA investigation, about 28% of American plants that grind cattle parts were unable to ensure that those bits would not get mixed into cattle feed. The FDA also found that 20% of American feed mills, where the food is packaged, failed to include a label to warn livestock farmers about the presence of the ground animal parts.
While it is forbidden to feed animal parts to cud chewing animals, such as sheep and cattle, because of mad cow disease, federal law still permits the feed to be made for poultry.
Since no cases of mad cow disease have been documented here, these facts do not necessarily mean that the U.S. inevitably will suffer from a mad cow epidemic, Lurie says. However, he says, these facts do demonstrate that federal regulators have failed to exercise their full authority.
This lack of enforcement is especially evident in terms of vaccines, for which the FDA has chosen to issue a guidance document rather than new regulations, Lurie says. "The FDA, unfortunately, has the predilection for giving advice rather than regulation," Lurie tells WebMD.
But considering that these regulations were passed just three years ago, Lumpkin says these figures demonstrate that American processors actually are moving toward 100% compliance with FDA regulations. Lumpkin says that the FDA often elects to issue guidance documents rather than regulations because the rule-making process takes considerable time.
"With time, as our knowledge base becomes stronger, regulations could also be passed," he tells WebMD.
Still, there is a chance that a case of the human form of mad cow disease could occur in the U.S., despite the federal regulations, Lumpkin warns. "One thing we have learned about this disease is nothing is a 100%," he tells WebMD.
But Lumpkin says that case of the disease, should it occur, would not necessarily mean that federal regulations had failed Americans. In fact, the origin might not even be American cattle, he notes.
The federal government is fairly confident that it can at least minimize that type of risk, he tells WebMD.
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