By Christopher Doering WASHINGTON (Reuters) - Genetically engineered animals moved closer to the dinner table on Thursday as the U.S. Food and Drug Administration made the process it will use to review new proposals public. The FDA published proposed detailed guidelines that producers of genetically engineered animals would have to follow to determine whether there are any risks to humans, the environment and the animals themselves. The guidelines bring the decades-old technology of genetic engineering for animals one step closer to the market. Genetically modified cattle, pigs, fish and goats are being produced for a variety of uses. Some produce pharmaceuticals in their milk or blood. Others are resistant to diseases such as mad cow or produce healthier meat or milk. "Many kinds of genetically engineered animals are in development, although none has yet been approved by the agency for marketing," FDA Deputy Commissioner Randall Lutter said. It was important to formalize procedures the FDA uses to regulate genetically engineered animals, Lutter said, "because the technology has evolved to a point where commercialization of these animals is no longer over the horizon." The agency is inviting public comment on its proposals until November 18 and could modify them before they become final. SEVERAL QUESTIONS Consumer groups called the FDA's action a good first step, but said the guidelines fail to answer several important questions. One concern is the approval process, which would be secretive to protect companies' proprietary interests. "It's unclear whether FDA has the authority and expertise to address the full range of risks," said Gregory Jaffe of the Center for Science in the Public Interest. Foods produced from some bio engineered animals will not have to be labeled, the FDA said, also drawing some ire. "It is incomprehensible to us that FDA does not view these animals as different from their conventional counterparts," said Jean Halloran, director of food policy initiatives at Consumers Union. "Consumers have a right to know if the ham, bacon or pork chops they are buying come from pigs that have been engineered with mouse genes." But the FDA said labeling would be required if there is a significant change in the food. For example, pork from pigs engineered to produce meat with higher levels of omega-3 fatty acids would need a label. Producers will be required to describe what DNA they have inserted into the animal, and how it behaves in the animal, the impact on the animal's health, and show the product is not different from traditional food. Companies also would have to tell the FDA how they would track the animals and dispose of them when they die. If there is a high risk, the FDA might require the animals to be sterilized. The FDA said it has the authority to regulate genetically engineered animals through the Federal Food, Drug and Cosmetic Act. The measure identifies a drug as anything that changes the "structure or function" of the person or animal. (Reporting by Christopher Doering; Editing by Patricia Zengerle)
By Maggie Fox, Health and Science Editor
WASHINGTON (Reuters) - Cancer experts who probed every gene in tumors from two of the hardest-to-treat cancers found that cancer is much more complicated than anyone thought -- and say they found why a cure is so unlikely after a tumor has spread.
But they also discovered a potential new way to treat a common and fatal form of brain cancer, and opened the door to finding cancer before it has spread, when it can still be cured surgically, they reported on Thursday in the journal Science.
"Cancer is very complex -- more complex than we had believed. It is not going to be easy to develop therapies," said Dr. Bert Vogelstein of Johns Hopkins University in Baltimore and the Howard Hughes Medical Institute.
"If you have 100 patients, you have 100 different diseases."
The findings suggest that popular new targeted therapies such as Novartis's Gleevec may not work broadly, because they affect only one mutated gene, while cancer is caused by dozens.
A better approach would be to find the pathways -- networks of genes -- that control a tumor's uncontrolled growth and spread, they told reporters in a telephone briefing.
The international team sequenced the more than 20,000 genes in cells from 24 patients with advanced pancreatic cancer and from 22 patients with glioblastoma multiforme.
The typical pancreatic tumor had 63 genetic mutations, while the average brain tumor had 60, they found.
The good news is they found just 12 pathways that were abnormal in most of the tumors. Some were in expected areas, such as the regulation of programmed cell suicide, or apoptosis, the process by which abnormal cells self-destruct.
COMMON PATHWAYS
"Often what appeared to be mutations in disparate genes turned out to be working in common pathways," said Dr. Kenneth Kinzler of Johns Hopkins, who worked on the study.
One surprising discovery was a new gene called IDH1 found in glioblastoma multiforme, the most common type of brain tumor and one that usually kills patients within a year, said Dr. Victor Velculescu, also of Hopkins.
Massachusetts Sen. Edward Kennedy, 76, was diagnosed in May with this type of brain tumor.
The patients with these mutations were younger and lived longer than the typical brain tumor patient.
"Glioblastoma multiformes used to be thought of as one disease. It is now clear they are two," Velculescu told the briefing.
Vogelstein said the findings suggest that pharmaceutical companies should change their approach to developing new cancer drugs. While Gleevec, a pill, transformed the treatment of a blood cancer called chronic myeloid leukemia, "our work suggests that most solid tumors are really nothing like CML," Vogelstein said.
"It is extremely unlikely that drugs which target a single gene like Gleevec will be active against a major fraction of solid tumors. Instead of screening for drugs against single proteins, our work suggests that it may be more productive to screen for drugs that act against core pathways," Vogelstein said.
The findings also suggest better ways to screen for cancers, Vogelstein said.
"Our group as well as others have found that you can detect mutations outside of cells, just floating in the plasma, in virtually all patients with advanced colorectal cancer and about two-thirds of those with relatively early tumors," he said.
"It will be possible soon to detect them in many other samples from patients, say in their blood, even when the tumors are early. Almost all tumors and even those of the brain and pancreas would be curable if they are caught early."
RSS Feed