Scientist accused of selling rocket data to China

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Posted on 26th September 2008 by Gordon Johnson in Uncategorized

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Date: 9/24/2008 6:15 PM

NORFOLK, Va. (AP) _ A scientist who heads a high-tech company in Newport News has been charged with illegally selling rocket technology to China and offering bribes to Chinese officials, federal prosecutors said Wednesday.
Shu Quan-Sheng, 68, made an initial appearance in U.S. District Court in Norfolk and is being held in jail until a bond hearing Monday.
Shu, the president of AMAC International Inc., is charged with two counts of violating the federal Arms Control Act and one count of bribery. If convicted, he faces up to 10 years on each arms count and five years for the bribery charge.
It could not be determined whether Shu has hired a lawyer. A phone message left at his company was not returned.
According to a criminal complaint unsealed Wednesday, Shu sold technology to China for development of hydrogen-propelled rockets. The Chinese government is developing a space launch facility in the southern island province of Hainan that will house liquid-propelled launch vehicles designed to send space stations and satellites into orbit.
The complaint also accuses Shu of bribing Chinese officials to award a $4 million hydrogen liquefier contract to a French company acting as an AMAC intermediary.
Shu is a naturalized U.S. citizen who was born in Shanghai. His company also has offices in Beijing.
Federal authorities in recent years have prosecuted more than a dozen cases of either traditional spying or economic espionage related to China. U.S. officials have warned in the last year of increasing espionage efforts by Beijing.

Copyright 2008 The Associated Press.

China milk scandal claims victim outside mainland

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Posted on 22nd September 2008 by Gordon Johnson in Uncategorized

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Date: 9/21/2008 11:37 AM

By SCOTT McDONALD
Associated Press Writer

BEIJING (AP) — A Hong Kong toddler has developed a kidney stone after drinking Chinese milk — the first reported victim outside the mainland affected by a widening scandal over a toxic chemical found in baby formula and other Chinese dairy products.

More than 6,200 infants have become sick and four babies have died in China after being fed baby formula laced with melamine, a banned industrial chemical.

No illnesses had been reported elsewhere until the Hong Kong government said late Saturday that a 3-year-old girl was diagnosed with a kidney stone after drinking milk produced by the Chinese dairy Yili that contained melamine.

The Hong Kong government also announced Sunday that tests found melamine in Chinese-made Nestle milk. The Dairy Farm milk was made by Nestle’s division in the Chinese coastal city Qingdao, it said.

The Swiss food and drinks giant issued a statement Sunday saying that none of its China-made dairy products contained melamine.

“Nestle once again expresses confidence that none of its products in China is made from milk adulterated with melamine,” the statement said. It did not specifically respond to the Hong Kong report of tainted Dairy Farm milk.

Nestle offices in Hong Kong and Geneva did not immediately respond to a message seeking comment. Calls after work hours to its Beijing office and Beijing hot line went unanswered.

Meanwhile, Singapore said Sunday melamine was detected in samples of White Rabbit-brand Creamy Candy. The popular Chinese milk candy was pulled from shelves in the Philippines last year after health officials there claimed it was tainted with formaldehyde.

Chinese candy maker Guan Sheng Yuan Co. denied the Philippine allegations, saying the candy tested was likely a counterfeit version and subsequent tests showed samples of the candy were formaldehyde-free.

Already on Friday, Singapore suspended the sale and import of all Chinese milk and dairy products including milk, ice-cream, yogurt, chocolate, biscuits and candy, as well as any other products containing milk from China as an ingredient.

Japan, Malaysia and Brunei have also recalled or banned Chinese-made dairy products.

Since the problem of tainted milk products became public knowledge less than two weeks ago, the crisis has spread to include almost all of China’s biggest dairy companies.

A top official with the World Health Organization said Sunday that delays in releasing critical information about contaminated Chinese milk had hampered Beijing’s ability to rapidly deal with the problem and warn consumers.

Shigeru Omi, the WHO’s head of Western Pacific operations, told reporters at a press conference in Manila that “some people withheld the information for some time,” but he did not give specifics.

The scandal began with complaints over milk powder by Sanlu Group Co. — one of China’s best-known and most respected brands. But it quickly became a much larger crisis as government tests found that one-fifth of the companies producing baby milk powder had melamine in their products.

A New Zealand stakeholder in Sanlu has said it was told before the start of the Beijing Olympics on Aug. 8 that there was a problem. The dairy farmers’ group Fonterra, which owns 43 percent of Sanlu Group, told the New Zealand government, which informed Chinese officials.

The public was not told until Sept. 11 that the powder, used in baby formula and other products, was laced with melamine.

Melamine is used in making plastics and is high in nitrogen, which registers as protein in tests of milk. Though health experts believe ingesting minute amounts poses no danger, melamine can cause kidney stones, which can lead to kidney failure. Infants are particularly vulnerable.

Some of the farmers who sell milk to Chinese food companies are thought to have used melamine to disguise watered-down milk and fatten profit margins hurt by rising costs for feed, fuel and labor.

The parents of the Hong Kong girl diagnosed with a kidney stone took her for a precautionary checkup because she had been drinking Yili milk daily for the past 15 months. Yili Industrial Group Co. is one of 22 companies whose milk and dairy products were recalled after batches of their products were found to contain melamine.

The toddler was in good condition after receiving medical treatment and had been discharged from the hospital, the government said.

China’s communist leadership has launched high-profile efforts to show it is on top of the crisis, with Premier Wen Jiabao appearing on state-run television Sunday to say dairy companies had to show more “social responsibility.”

Wen was shown visiting a Beijing hospital where children were having health checks. He also stopped at a supermarket to look at dairy products.

“What we need to do now is to ensure that nothing like this happens in the future, not only in dairy products but in all food,” Wen said.

Food and product safety scandals have been a feature of Chinese life. Only last year, the government promised to overhaul inspection procedures after exports of medicines, toys, pet food ingredients and other products killed and sickened people and pets in North and South America.

The chemical in the dangerous pet food was the same as in the milk scandal — melamine.

Many of the largest companies whose products have been recalled, such as Yili Industrial Group Co. and Mengniu Dairy Group Co., did not have government inspections before the problem became public. The government scrapped that exemption this past week.

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Associated Press reporter Min Lee in Hong Kong contributed to this report.

Copyright 2008 The Associated Press.

FDA rejects Schering drug to reverse anesthesia

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Posted on 1st August 2008 by Gordon Johnson in Uncategorized

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Does the below action of the FDA indicate that this year’s Heparin debacle, along with the grilling it received from Congress over the heparin deaths,(http;//heparin-law.com) has had its impact, and big pharmaceutical’s control over such agency is finally being shaken? We can only hope.

Attorney Gordon Johnson
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800-992-9447

Date: 8/1/2008 7:04 AM

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ Government regulators dealt a major setback to Schering-Plough Corp. Thursday, rejecting a highly anticipated drug designed to help patients recover from anesthesia.

The Food and Drug Administration notified the company that it will not approve its drug sugammadex, due to concerns about allergic reactions seen in some patients, according to a company statement.

Schering said it was “surprised and disappointed” by the decision but would “work with the agency to address the issues.”

The rejection letter was unexpected because a panel of outside FDA advisers had unanimously voted in favor of the medication earlier this year. The FDA is not required to follow the group’s advice, though it usually does.

And on Tuesday, European Union regulators cleared the injectable drug, which is designed to reverse the effects of anesthesia in patients after surgery. The drug will be marketed in Europe under the name Bridion, though a commercial name has not been selected for U.S. promotion.

Surgeons typically use muscle-paralyzing anesthetic drugs to make surgery easier and safer for patients.

Despite positive reviews from some experts, FDA scientists voiced safety concerns with sugammadex in their initial review. According to the documents released in March, FDA said additional safety studies could be needed to examine allergic reactions seen in some patients.

However, company representatives argued that the drug’s benefits more than outweigh those risks.

Dr. Ronald Miller, a consultant for Schering, said that sugammadex works better than existing treatments, which carry their own negative side effects, including heart problems and nausea.

“The drugs we currently use produce many more reactions and much more severe reactions than anything that has been demonstrated with sugammadex,” said Miller, who chairs the department of anesthesia at the University of California at San Francisco. “I was quite disappointed with the FDA ruling.”

FDA has rejected several drugs this year that were expected to gain approval, including an allergy drug combining the ingredients of Schering’s Claritin and Merck & Co. Inc.’s Singulair tablets.

Some analysts have speculated that FDA has become more cautious about putting new drugs on the market following the safety concerns around drugs like Merck’s painkiller Vioxx and GlaxoSmithKline’s diabetes drug Avandia. In both cases, there were older medications on the market with more established safety profiles.

Currently there are two anesthesia-reversing drugs on the market that surgeons have used for decades.

Copyright 2008 The Associated Press.FDA

Merck to start Vioxx settlement payouts in August

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Posted on 17th July 2008 by Gordon Johnson in Uncategorized

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Date: 07/17/2008 02:46 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Merck & Co. will start cutting checks for former users of its withdrawn painkiller Vioxx next month after announcing Thursday that it will fund a $4.85 billion settlement expected to resolve roughly 50,000 lawsuits.

The decision marks the beginning of the end of the four-year legal saga, which began when cardiovascular side effects forced Merck to pull Vioxx off the market in 2004, triggering tens of thousands of lawsuits, sullying its once-spotless reputation and forcing out its then-chief executive.

The Vioxx case has cost Merck at least $6.38 billion, including more than $1.53 billion through March 31 on legal costs for defense research and individual trials, most of which it has won.

Vioxx, which was launched in 1999, brought Merck revenue of $2.5 billion at its peak in 2003and $1.3 billion in 2004. Merck has not been disclosing revenue from prior years.

On Thursday, Whitehouse Station, N.J.-based Merck said more than 97 percent of eligible claimants — 48,550 out of 49,960 — have enrolled in the settlement program, surpassing threshold levels the company required for the deal to proceed. Therefore, Merck said that on Aug. 4 it will waive its right to walk away from the deal reached with plaintiffs’ attorneys last fall.

“I’m just glad that it’s almost over,” said Evelyn Irvin Plunkett of Palm Coast, Fla., who sued Merck in 2003 over the May 2001 heart attack death of her first husband, Richard “Dickie” Irvin. “It’s just been a long, hard fight.”

Plunkett’s family had gone through a mistrial, then lost to Merck at a retrial and won the right to a third trial before being allowed to join in the settlement. She does not know how much she will receive.

Settlement amounts can run from the minimum of $5,000 up to a few million dollars. Payments will be decided by a complicated formula that factors in how serious a claimant’s injury was, how much Vioxx was taken and how many other risk factors the person had.

“Long-term users of Vioxx who had a very severe injury will be well compensated,” said lawyer Andy Birchfield, who served on the plaintiffs’ steering and negotiating committees.

He said the number of plaintiffs participating shows the settlement is a good one.

“This is a great day for the plaintiffs injured by Vioxx who will within weeks begin to receive compensation for their injuries,” said lawyer Chris Seeger, a member of the plaintiffs steering committee coordinating the massive litigation. “I couldn’t be happier for my clients.”

“We’re very pleased to be reaching this milestone because we feel it confirms the program is a good one and a fair one,” said Ted Mayer, Merck’s chief Vioxx lawyer.

Roughly 700 more plaintiffs are considering participating, so Merck has extended the deadline for them to enroll until Oct. 30, he said. About 700 more have not been located by their attorneys.

Former Vioxx users, or their survivors, are eligible for part of the settlement if the patient suffered a heart attack, stroke or death. They must have had pending lawsuits or tolling agreements, which suspend the statute of limitations, as of Nov. 9, 2007, the date the settlement was reached.

To ensure that the settlement ended the bulk of the lawsuits, the company had required participation from at least 85 percent of eligible claimants in four groups: those who had used Vioxx for more than 12 months, had a heart attack, had an ischemic stroke or died.

Merck will put $4.85 billion into the settlement fund over time, with the first $500 million payment scheduled for Aug. 6. The company took a charge for the full $4.85 billion last year.

Eligible claimants who enrolled by March 31 and allege a heart attack or sudden cardiac death could then receive an interim payment, expected to be made by the end of August.

Interim payments to people alleging Vioxx caused an ischemic stroke are to begin in or after February 2009.

Mayer said several thousand additional claimants don’t have injuries eligible for the settlement and have been ordered by judges to produce expert reports supporting their claims.

“We expect to be making motions to dismiss a large number of those claims during the coming weeks and months,” he said.

Merck also faces about 260 potential class-action suits, alleging either harm or financial losses related to Vioxx, that still must be resolved.

Merck withdrew Vioxx from the market on Sept. 30, 2004, after its own research showed the once-blockbuster arthritis pill doubled the risk of heart attack and stroke.

U.S. District Judge Eldon E. Fallon in New Orleans, who has been coordinating much of the litigation, said it’s one of the country’s biggest multidistrict litigation cases — those assigned to one federal judge for pretrial purposes and possible settlement.

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Associated Press writer Janet McConnaughey in New Orleans contributed to this report.

On the Web: http://officialvioxxsettlement.com

Copyright 2008 The Associated Press.