MorganRants

The Food and Drug Administration’s warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.

Botox is best known for minimizing wrinkles by paralyzing facial muscles — but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have.

However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.

The FDA wouldn’t say exactly how many reports it is probing.

“We’re not talking hundreds. It’s a relative handful,” said Dr. Russell Katz, FDA’s neurology chief.

But the agency warned that patients receiving a botulinum toxin injection for any reason — cosmetic or medical — should be told to seek immediate care if they suffer symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head.

“I think people should be aware there’s a potential for this to happen,” Katz said. “People should be on the lookout for it.”

Friday’s warning came two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc — citing 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

Nor is it the first warning. The drugs’ labels do warn about the potential for botulinum toxin to spread beyond the injection site and occasionally kill, but the warnings link that side effect to patients with certain neuromuscular diseases, such as myasthenia gravis.

That’s what’s different about these latest cases, said FDA’s Katz: The botulism toxin seems to be harming people who don’t have that particular risk factor. (Cerebral palsy involves a brain injury, not a disease.)

Still, the FDA cautioned that its investigation is in the early stages. It has asked Botox maker Allergan Inc. and Myobloc maker Solstice Neurosciences Inc. to provide additional safety records.

Allergan spokeswoman Caroline Van Hove said children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given adults seeking wrinkle care.

In a statement, Solstice said it supports FDA’s probe but stressed that the agency hasn’t concluded the drug poses any new risk.

While the FDA said the problems may be related to overdoses, it also has reports of side effects with a variety of doses.

Public Citizen’s Dr. Sidney Wolfe criticized FDA’s warning as falling short. He asked that the agency order a black-box warning, the FDA’s strongest type, be put on the drugs’ labels and require that every patient receive a pamphlet outlining the risk before each injection.

“Every doctor needs to notified about this, every patient needs to be notified,” Wolfe said. “Children are showing the way, unfortunately some dead children.”

He said drug regulators in Britain and Germany last year required that sterner warnings be sent to every doctor in those countries.

“You’re so vain, I bet you think this ’song’ is about you.”

The four were linked to two espionage conspiracies, which the US Justice Department said posed a “grave danger” to national security.

Pentagon official Gregg William Bergersen, Chinese citizen Yu Xin Kang and Taiwan-born US citizen Tai Shen Kuo were accused of passing classified information to China, mostly pertaining to US military sales to Taiwan, according to Justice Department officials.

Bergersen, 51, is a weapons systems policy analyst at the Pentagon’s Defense Security Cooperation Agency, which implement the US Defense Department’s foreign military sales program.

In another case, former Boeing engineer Dongfan “Greg” Chung, a China-born US citizen, was charged with stealing and turning over trade secrets also to Beijing, including the space shuttle used for US human space flight missions.

Aside from the shuttle, Chung, 72, was charged with economic espionage involving the C-17 military transport plane and the Delta IV rocket — designed to launch manned space vehicles — while he worked at Boeing and, before that, at US defense contractor Rockwell International.

Both FBI-probed cases had a common objective: “to get a hold of our nation’s military secrets,” Assistant US Attorney General Kenneth Wainstein told reporters.

“Such espionage networks pose a grave danger to our national security and to our economic position in the world,” he said.

They were complete with traditional elements of spy tradecraft, including foreign handlers, payoffs, cut-out couriers, intelligence taskings to an aerospace engineer and a “compromised government employee,” he said.

China’s foreign secret service is among the “most aggressive” in trying to steal sensitive US military technology and information, Director of National Intelligence Michael McConnell charged recently.

Chinese and Russian spies, he said, were stalking the United States at levels close to those seen during the tense covert espionage duels of the Cold War.

The four were arrested Monday and, according to Justice Department officials, at least Bergersen and Kuo had made initial court appearances in Alexandria, Virginia, south of Washington.

Their attorneys were not immediately available for comment.

Kuo, 58, is accused of having worked under the direction of an unnamed Chinese official to obtain classified US defense information from Bergersen, who maintains a “top secret security clearance” at the Pentagon.

Kang, 33, who is a US permanent resident, was named as a “conduit of information” between Kuo and the Chinese official.

Kuo and Kang, both of New Orleans, Louisiana, face up to life in prison if convicted for the charge of criminal conspiracy to disclose national defense information to a foreign government.

Bergersen, who resides in Alexandria, Virginia, was charged with disclosing national defense information to unauthorized persons, which could bring up to 10 years in prison.

Chung, 72, who lives in Orange, California, was charged with economic espionage, having allegedly received directives since as early as 1979 from China’s aviation industry telling him to collect specific information.

Chung was charged with eight counts of economic espionage — each of which carries a maximum possible 15 year prison sentence and 500,000 dollar fine — and six other related charges.

The Justice Department said the Chung case is linked to its investigation into California resident and Chinese-born engineer Chi Mak and members of his family, who were convicted last year for providing US defense articles to China.

Chi Mak, 66, who had worked for a US company with several Navy contracts, is scheduled to be sentenced on March 24.

“Mr. Chung is accused of stealing restricted technology that had been developed over many years by engineers who were sworn to protect their work product because it represented trade secrets,” said US Attorney Thomas O’Brien.

“Disclosure of this information to outside entities like the PRC would compromise our national security,” he said.

And whom among you liberal sycophants not want to see these people hung? Waterboarding is not torture. We’re at war - ever heard the saying ‘all’s fair in love and war’. I know this comment of mine is a bit off topic, but it fits in nicely with the above story. If you want to know what true torture is, I suggest you read “Ghost Soldiers” by Hampton Sides, and you could also read Iris Chang’s “The Rape of Nanking”.