9 December 2002

PRODIGENE FINED $3 MILLION +/A CLONED COW IN HAVANA?

Some poorer countries are wasting valuable resources aping the follies of richer countries - item 2:

'"I am worried," Fidel Ovidio, who oversees the project, told a group of international scientists in Havana last week for a biotechnology conference.

"Anyone have a magic bullet?"

...Ovidio is under enormous political and scientific pressure to succeed... Yet nobody anywhere has reported producing viable medicines ready for human use from cows, and U.S. companies that have sunk millions of dollars into cloning are now struggling for survival.'

1.Ag Dept. penalizes biotech company
2.Cuba failing in effort to clone medicine-yielding cow

***

1.Ag Dept. penalizes biotech company

The Associated Press
http://www.clarionledger.com/news/0212/08/b03.html

WASHINGTON - The leader of a biotechnology company that mixed genetically engineered corn containing an animal vaccine with soybeans meant for humans issued an apology.

"We're very sorry for the mishap and have corrected it," said Anthony G. Laos, CEO and president of ProdiGene.

The Agriculture Department imposed more than $3 million in penalties Friday on ProdiGene Inc.'s contaminated soybeans, and fined the company $250,000.

Agriculture Secretary Ann Veneman said ProdiGene also will pay for the 500,000 bushels of contaminated soybeans, valued at $2.7 million, and the cost to destroy them.

Bobby Acord, administrator for the USDA's Animal and Plant Health Inspection Service, said it's the first time the agency has levied a fine against a biotechnology company for violating the Plant Protection Act, a law written in 2000 that regulates the transportation and planting of genetically engineered plants.

ProdiGene also has agreed to post a $1 million bond to pay for any future problems resulting from its products, Acord said.

The company, based in College Station, Texas, makes pharmaceutical and industrial enzymes and proteins by growing them in genetically modified corn. The government has strict guidelines for planting and removing such crops to make sure those products do not mix with the food supply or mingle with neighboring crops.

ProdiGene failed to remove all the corn that contained a protein for a swine vaccine before planting soybeans in fields in Pocahontas County, Iowa, and Hamilton County, Neb. Government inspectors discovered stray corn plants and ordered the company to remove them.

The Iowa corn was burned and the Nebraska crop was impounded at a warehouse.

The government is working with ProdiGene to improve its compliance by setting up a stringent program, which Laos said he hopes "would set a benchmark for the rest of the industry to follow."

"We have learned some valuable lessons, and we hope the entire industry will benefit from our endeavors as we work with USDA on an enhanced compliance program," he said.

USDA officials will increase inspections of ProdiGene's test sites.

***

2.Cuba failing in effort to clone medicine-yielding cow

Detroit News
By Paul Elias / AP Biotechnology Writer
http://www.detnews.com/2002/business/0212/07/business-29651.htm

HAVANA -- Even though Cuba boasts some of the world's best-equipped laboratories and talented scientists, its high-profile efforts to clone a cow are proving much more difficult than originally imagined.

"I am worried," Fidel Ovidio, who oversees the project, told a group of international scientists in Havana last week for a biotechnology conference.

"Anyone have a magic bullet?"

The Cuban scientist's goal is to someday clone a cow with the seemingly magical ability to produce human medicines in its milk. Cuba's communist government -- which is far from unique in such research -- hopes it brings scientific prestige, and leads to inexpensive medicines it can dispense to its people for free and export for badly needed cash.

There are also hopes the project will produce a line of prodigious dairy cows in a country that rations its milk.

Ovidio is under enormous political and scientific pressure to succeed. But because this poor country is barred from buying vital research tools directly from U.S. manufacturers, the task is downright Herculean.

Cuba's cattle herd diminished from 10 million head in the 1980s to less than half of that today, most starving to death for lack of feed.

Forty years of U.S.-enforced economic isolation, dubious breeding decisions and the Soviet collapse motivated Cuba to seek creative means of self-sufficient food production, including permitting a small number of private farms nearly 10 years ago.

After the birth of Dolly the sheep in Scotland in 1997, Cuba saw great potential in biotechnology. So far, though, the high-profile cloning project has been a failure.

Despite continued encouragement and advice from some of the world's most experienced experts, Ovidio and his colleagues on the project remain frustrated. For each of the past three years, Cuban scientists have announced they were close to producing Latin America's first cloned cow. But Brazil beat them to it last year.

One major hurdle for Ovidio is, in fact, the nation's cow shortage. Because Cuban officials are loath to sacrifice young and healthy cows needed for the food supply, Ovidio and his colleagues are limited to using eggs culled from only the oldest and sickest donors.

Ovidio has smelled success -- once losing a cloned embryo after 55 days of pregnancy.

"They're close to getting a cloned calf on the ground," said Steven Stice, a University of Georgia cloning expert who consults with Ovidio. "All they really need is a little luck."

Cuba boasts one of the most advanced biotechnology programs in the developing world. It has created marketable vaccines and is working on two promising cancer drugs.

But cloning is another story. The technology is expensive, risky and continues to meet with mixed results in the world's laboratories.

In the United States, about 500 cows have been cloned -- and most are nothing more than scientific novelties. Just one in 10 cloned embryos yields a live birth, each at a cost of about $20,000. Many of those calves develop serious health problems.

And while Cuban scientists proudly showed off their cloning project to former U.S. President Jimmy Carter when he visited Havana's Center for Genetic Engineering and Biotechnology in May, some are now echoing foreign colleagues in downplaying its value.

"It's a big milestone in biotechnology," said Carlos Borroto, the center's vice director. "But it's not a priority."

Cuba's quest to clone the perfect cow began not with medicine, but with Ubre Blanca, a spectacularly impressive animal that had Cuban officials salivating over the promise of a herd of major milk producers.

In 1982, Ubre Blanca, Spanish for White Udder, produced 241 pounds of milk in a single day. That's four times more than the average cow and was recognized by the Guinness Book of World Records.

Castro referred to Ubre Blanca's prodigious output in speeches as evidence of communism's superior breeding skills, and the cow's triumphs were splashed throughout Cuba's government-controlled newspapers.

Before Ubre Blanca died, eggs and tissue samples were taken from her and frozen. Cuban scientists studied her DNA under microscopes to see if they could find the milk genes that set Ubre Blanca apart.

"We're not cloning Ubre Blanca," Borroto said. "But she was a motivation to start the project."

Yet nobody anywhere has reported producing viable medicines ready for human use from cows, and U.S. companies that have sunk millions of dollars into cloning are now struggling for survival.

"The applications aren't as broad as once thought," said James Robl, president of South Dakota-based Hematech LLC, which is cloning genetically engineered cows to produce medicines in their blood. "The cost of cloning is high and its not moving as fast as some would like."

And though many international scientists question the project's wisdom, Cuba remains intent on cloning a cow -- and is looking for partners in the effort.

The co-founders of Canadian company TGN Biotech Inc. were among scientists who traveled to Havana for the recent conference. TGN is genetically engineering pigs to create human fertility drugs in their semen and wanted to talk to Cuban officials about moving some of their pig-breeding facilities to Cuba.

Instead, all the Cuban delegation wanted to discuss was how to clone a cow, said TGN's Marc-Andre Sirard.

"They didn't like what we had to tell them," Sirard said. "Cloning cows is not the solution for Cuba."