Bull market for clones studs not stock
Wed, 16 Jan 2008 05:57:45 GMTBy JOELLE TESSLER, AP Business Writer
WASHINGTON - The reaction was fast, furious and expected.
Within hours of the government's announcement that milk and meat from cloned animals was safe, food companies insisted they had no plans to sell such products and consumer groups said Americans had no plans _or desires — to eat them.
The response to the Food and Drug Administration's announcement, however, may prove to be as overblown as it was speedy. Academics and industry officials say the target market for cloning technology is stud farms and breeders — not the rank-and-file dairy farms and cattle ranches that contribute to the nation's food supply.
"The average farmer is not likely to clone animals," said Terry Etherton, a professor of animal nutrition at Pennsylvania State University. "Cloning is not for standard production."
And with an array of far cheaper reproductive technologies at the ready, breeders are likely to reserve the pricey cloning techniques for their most prized and prolific studs.
With costs ranging from $15,000 to $20,000, cloning is just not in the budget for most farmers, says Leo Timms, a professor in the Department of Animal Science at Iowa State University.
That's an investment unlikely to pay off for farmers raising animals for food, Timms added. Even if consumers were comfortable with clone encounters at the grocery store, he said, "that animal's milk and meat aren't worth any more than any other animal."
At the same time, there are plenty of more affordable reproductive technologies, including artificial insemination and in-vitro fertilization. The cost of producing an animal using artificial insemination ranges from $600 to $700, said David Faber, president of Trans Ova Genetics of Sioux Center, Iowa, one of the two main U.S. cloning companies.
Viagen Inc. and Trans Ova Genetics already have produced more than 600 cloned animals for U.S. breeders, the vast majority cattle, including copies of prize-winning cows and rodeo bulls.
Breeding the old-fashioned way and via insemination, say proponents, provides another biological advantage: genetic adaptation.
"You make progress by breeding animals, not cloning them," said Chris Galen, a spokesman for the National Milk Producers Federation, which represents dairy farmers and supports continuing a voluntary industry moratorium on the sale of products from cloned animals. "With cloning, you just get a plateau."
And as reaction to the FDA announcement shows, you also get heightened ethical and moral concerns.
Consumer groups' objections aren't just about food safety but also include animal welfare, since many attempts at livestock cloning still end in fatal birth defects.
"If you have moral objections to a particular food, or ethical objections to them, FDA's saying, 'Tough, you've got to eat it,'" said Carol Tucker-Foreman of the Consumer Federation of America, who pledged to push for more food producers to shun clone-derived ingredients.
For now, Faber said, his company is targeting its cloning techniques at a small market of farmers raising elite breeding stock, what he calls "the rock stars of the barnyard," not those producing animals destined for the grocery store.
"Cloning is for breeding, not eating," he said. "We are making sons and daughters, semen and embryos, not meat and milk."
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AP Business Writer Matthew Perrone contributed to this report.
FDA says cloned animals safe for food
Wed, 16 Jan 2008 03:44:07 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Just over a decade after scientists cloned the first animal, the last major barrier to selling meat and milk from clones has fallen: The U.S. government declared this food safe Tuesday. Now, will people buy it?
Consumer anxiety about cloning is serious enough that several major food companies, including the big dairy producer Dean Foods Co. and Smithfield Foods Inc., say they aren't planning to sell products from cloned animals.
And the industry says most Americans would never eat a cloned animal for sheer economic reasons: At $10,000 to $20,000 per cloned cow — compared with $1,000 for an ordinary steer — they're too valuable. They would be used primarily for breeding, to produce a steady supply of cattle that are particularly tender, for instance, or for prize dairy cows. It would be offspring of clones that consumers would eat.
But it will be hard to tell which foods do contain ingredients originating from cloned animals. The Food and Drug Administration ruled that labels won't have to reveal whether the food comes from cloned cows, pigs or goats, or the clones' offspring, because those ingredients are no different than meat or milk from livestock bred the old-fashioned way.
"We found nothing in the food that could potentially be hazardous. The food in every respect is indistinguishable from food from any other animal," FDA food safety chief Dr. Stephen Sundlof said. "It is beyond our imagination to even find a theory that would cause the food to be unsafe."
Still, the government asked producers to continue a voluntary moratorium on sales of meat or milk from clones for a little longer, for marketing reasons. The Agriculture Department said it needed a transition period to get the safety findings to foreign trade partners and food companies.
"This is about market acceptance," USDA Undersecretary Bruce Knight said, adding that he expected this period to last months.
The two main U.S. cloning companies, Viagen Inc. and Trans Ova Genetics, already have produced more than 600 cloned animals for U.S. breeders, including copies of prize-winning cows and rodeo bulls. They agreed to USDA's call for a continued moratorium Tuesday, but stressed that it applied only to clones themselves, not those animals' conventionally produced offspring, which can begin selling immediately.
The FDA spent six years tracking the safety of cloning, and its decision was long expected, but it came after an emotional fight by opponents. Congress passed legislation last month urging further study of the issue, a call echoed by consumer advocates who also asked that foods from cloned animals be labeled as such.
Their objections aren't just about food safety but also include animal welfare since many attempts at livestock cloning still end in fatal birth defects.
"If you have moral objections to a particular food, or ethical objections to them, FDA's saying, 'Tough, you've got to eat it,'" said Carol Tucker-Foreman of the Consumer Federation of America, who pledged to push for more food producers to shun clone-derived ingredients.
"The FDA did not give adequate consideration to the welfare of these animals or their surrogate mothers," said Wayne Pacelle of the Humane Society of the United States.
This was a day forecast since Scottish scientists in 1997 introduced the world to Dolly the sheep, the first successfully cloned animal. Ironically, sheep aren't on the list of FDA's approved cloned animals; the agency said there wasn't as much data about their safety as about cows, pigs and goats.
The FDA isn't alone in calling cloned food safe. European regulators last week issued a draft report reaching the same conclusion, and the U.S. National Academy of Sciences has found no cause for concern.
By its very definition, a successfully cloned animal should be no different from the original animal whose DNA was used to create it.
Still, FDA isn't surprised by the outcry since it pored over 30,500 comments from the public — many of them negative — before issuing Tuesday's ruling. A September 2006 poll by the Pew Initiative on Food and Biotechnology found that 64 percent of Americans were uncomfortable with animal cloning. And when FDA convened its own focus groups, it found a third of consumers would never eat food from cloned animals, while another third weren't worried and the rest fell somewhere in the middle.
The public should understand that cloning is just another form of breeding, like the artificial insemination that ranchers widely use, Trans Ova President David Faber said.
"Our farmer and rancher clients are pleased, because it provided them with another reproductive tool," he said, pledging to "be a good steward of the technology."
But cloning technology isn't perfected. Aside from birth defects, Dolly was euthanized in 2003, well short of her normal lifespan, because of a lung disease that raised questions about how cloned animals will age.
The FDA's report acknowledges that, "Currently, it is not possible to draw any conclusions regarding the longevity of livestock clones or possible long-term health consequences" for the animal.
But the agency concluded that cloned animals that are born healthy are no different than their non-cloned counterparts during their prime food-producing years, and go on to reproduce normally as well. Moreover, it is working with a group of international scientists that will issue guidelines later this year on how to clone, to minimize risk to the animals.
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On the Net:
Food and Drug Administration: http://www.fda.gov
5 yellow fever deaths in Brazil
Wed, 16 Jan 2008 06:22:36 GMTBy ALAN CLENDENNING, Associated Press Writer
SAO PAULO, Brazil - The government has confirmed that five people have died because of yellow fever in Brazil, including a Spanish citizen, but the president of Latin America's largest nation insisted that the outbreak is under control.
Three of the five cases were confirmed Tuesday, the Brazilian Health Ministry said in a statement, adding that a sixth person contracted the disease but was recovering while undergoing treatment.
Nearly 20 suspected cases of yellow fever, a deadly virus spread by mosquitoes, remain under investigation in Brazil. But government officials have repeatedly said there is no risk of an epidemic or infection in Sao Paulo, Rio de Janeiro and in coastal areas — the parts of Brazil most visited by tourists.
However, many Brazilians have been spooked by the cases, and are lining up for hours at public health clinics to receive free vaccinations.
President Luiz Inacio Lula da Silva told reporters during a trip to Cuba that there is no risk that the yellow fever identified in rural areas will spread to the large population centers where most Brazilians live.
"There is no danger of urban yellow fever," said Silva, according to Brazil's Agencia Estado news service.
But Silva said it's important for people heading to remote parts of Brazil where yellow fever has been a risk for decades to get vaccinated at least 10 days before they travel so the vaccine will take effect.
The Health Ministry reiterated that the deaths and the suspected cases were restricted to people who traveled without vaccination to rural areas and regions of dense forestation.
Tests confirmed that Salvador Perez de La Cal, a Spaniard who was married to a Brazilian woman, died because of the disease on Saturday, the official Agencia Brasil news service said.
He was hospitalized for weeks after visiting a farm in the interior of Goias state.
Hot spots warn of diabetic foot ulcers
Tue, 15 Jan 2008 23:05:17 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Diabetics, watch out: A hot spot on your foot can signal an ulcer is brewing, a wound that could cost your limb. New research shows that using a special thermometer to measure the temperature of their soles can give patients enough early warning to avoid one of diabetes' most intractable complications.
It's a simple-sounding protection for such a huge problem. Foot ulcers each year strike 600,000 U.S. diabetics, people slow to notice they even have a wound because diabetes has numbed their feet.
"They've lost the gift of pain," says Dr. David Armstrong of Chicago's Rosalind Franklin University of Medicine and Science, a diabetic foot specialist.
Worse, foot ulcers are so slow-healing and vulnerable to infection that they're to blame for most of the roughly 80,000 amputations of toes, feet and lower legs that diabetics undergo each year.
So word that an easy-to-use gadget could help is generating excitement. Using the thermometer reduced by nearly two-thirds the number of high-risk patients who got foot ulcers, Armstrong found in a study of 225 diabetic veterans, the third in a series of government-funded research to back the approach.
How does it work?
Inflammation goes along with tissue injury, and inflammation can be measured by a bump in temperature. It's subtle — a minimum 4-degree difference between, say, your right big toe and your left one that can occur days before the skin breaks.
"A wound really will heat up before it breaks down," Armstrong explains.
Patients measure half a dozen spots on each foot. When the thermometer signals a hot spot, they put up their feet for a day or so until the temperature normalizes. Easing pressure before the skin cracks lets the body heal more easily than it can with a full-blown wound.
"Heat is one of the most sensitive things, one of the first things that happens when we begin to have tissue breakdown," says Dr. Crystal Holmes, a University of Michigan podiatrist who has begun prescribing the thermometers.
"It's looking positive that this sort of testing could be quite useful," adds Dr. Theresa Jones, who oversees research on diabetes complications at the National Institutes of Health. "There isn't any other treatment one knows about to at that point before there's an ulcer."
This isn't a standard thermometer, but a $150 infrared one with a tip that digitally measures skin temperature on contact.
Maker Xilas Medical, with an NIH grant, is working to make the thermometer resemble a bathroom scale: Step up, and it would automatically flash any trouble spots to the patient, and to a computer that alerts the doctor.
That's still a few years from market. For now, San Antonio-based Xilas sells the handheld TempTouch by prescription only.
Insurance coverage is mixed. But, "how cheap compared to an amputation," says Dr. Mary Ann Banerji, who heads the State University of New York Downstate Medical Center's diabetes center.
Treating a simple diabetic foot ulcer can cost $8,000, double that for an infected one and even more for an amputation.
"It's basically idiot-proof," Walter Massa of Skokie, Ill., says of the thermometer.
"On the other hand, it's very hard to take your temperature when you don't think there's a problem there," cautions Massa, 53, who has used the thermometer since Armstrong helped him narrowly avoid amputation when the joints in his foot disintegrated. "There's something you have to teach yourself."
Some 21 million Americans have diabetes, meaning their bodies can't properly regulate blood sugar, or glucose. Over many years, high glucose levels seriously damage blood vessels and nerves that lead to, among other things, loss of sensation in the feet and poor blood flow in the lower legs — the ulcer environment.
There is little therapy to avert foot ulcers. Patients are urged to wear proper-fitting shoes and check their feet daily for redness, bumps or other signs of trouble.
But day-to-day changes are hard to spot. In an NIH-funded study last year, Texas A&M College of Medicine researchers reported 30 percent of patients got ulcers even when using a mirror to check their soles, compared with 8.5 percent of thermometer users.
The new study, funded by the Department of Veterans Affairs and published in last month's American Journal of Medicine, is the biggest yet, tracking 225 patients for 18 months. Some 12.2 percent who did standard feet checks got ulcers, compared with 4.7 percent of thermometer users.
Participant Paul Rau of Green Valley, Ariz., had a recurring ulcer on his left big toe for six years, a quarter-inch bone-deep hole that took weeks to heal each time. While using the thermometer, Rau says his ulcer came back far less frequently, and when it did it was a quick-healing shallow crack.
"How it helped me was I checked my feet better," says Rau, 60. "There were so many points on your feet you had to do."
While the results are compelling, the studies are small and NIH's Jones says the thermometer should be included in larger studies to prove long-term benefit.
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EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
