FDA to study phone number to report side effects

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Posted on 25th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/25/2008

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects.

The regulatory agency is considering requiring TV promotions to carry a toll-free number where patients can report serious problems with their medication. However, some critics argue the toll-free number could distract viewers from other important safety information about the drugs.

Print advertisements already include contact information for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that information should also be mandatory for TV ads.

But the agency requested more time to complete its work and is expected to soon begin a formal study of the question — well over a year after the drug safety legislation was signed into law.

On Tuesday the agency laid out plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical information.

Pharmaceutical “ads are already quite dense when compared with ads for other products,” the agency states in documents posted online. “The risk information should not be compromised by the addition of the toll-free statement.”

Drug promotions are already required to list a drug’s benefits and risks.

For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the information they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension.

Regulators did not say when they would launch the study, but the FDA said it would accept comments on the proposal for the next two months.

The Pharmaceutical Research and Manufacturers of America has not yet taken a stance on the issue. However, the group — which represents Merck & Co. Inc., Pfizer Inc., Wyeth and other drugmakers — supported adding the language about side effects to print ads.

TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on commercials last year.

But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.

By the time the FDA completes its study of the toll-free number, policymakers in the now Democrat-dominated Washington may have already moved ahead with even stricter regulations.

Rep. Rosa DeLauro, D-Conn., introduced a bill this spring that would ban consumer-directed advertisements during the three years after a new drug’s launch. The proposal is aimed at limiting the use of new drugs until they have been demonstrated safe.

The legislation would also require drugmakers to mount public awareness campaigns about the risks of certain types of drugs. DeLauro is expected to reintroduce the measure next year.

“The FDA has important drug oversight responsibilities, and the push to promote new drugs and devices should not get in the way,” DeLauro said, upon releasing the bill.

Copyright 2008 The Associated Press.

FDA: Epilepsy drug may be risky for Asians

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Posted on 24th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/24/2008

WASHINGTON (AP) _ Treatment with certain epilepsy drugs may expose some Asian patients to serious skin reactions, federal health officials warned Monday.

The Food and Drug Administration said it is investigating whether medications like Dilantin, Phenytek and Cerebyx, which are used to control epileptic seizures, can lead to severe skin blisters and bleeding for some Asian patients.

Patients who test positive for a gene known as HLA-B1502 appear to be at increased risk of developing the skin problems, preliminary data indicate. About 10 percent to 15 percent of patients from parts of China, Thailand, Malaysia, Indonesia and the Philippines may carry the gene, as do 2 percent to 4 percent of South Asians, including Indians.

The FDA urged doctors to monitor patients closely, but said there is not enough information yet to recommend genetic testing. In most cases, patients who develop the skin problems do so in the first few months after starting to take the medications.

Because of the problem with skin reactions, the FDA last year recommended genetic testing for Asian patients taking another epilepsy drug, carbamazepine, sold under several brand names including Tegretol and Carbatrol. Doctors should also avoid Dilantin and the other medications for patients who have already tested positive for the gene, the FDA said.

___

On the Net:

FDA safety alert: http://tinyurl.com/5fcnlf

Copyright 2008 The Associated Press.

Roche ordered to pay $13M to users of acne drug

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Posted on 20th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/20/2008

ATLANTIC CITY, N.J. (AP) _ A jury has ordered drugmaker Roche to pay nearly $13 million to three patients who claim they developed a chronic bowel disorder because of the company’s acne drug Accutane.

Roche’s U.S. subsidiary Hoffman-La Roche said it would appeal the verdict.

The money, handed down in New Jersey State Superior Court on Thursday, will be split among the three Florida residents, their attorneys said in a statement. All three began using Accutane a decade ago to treat teenage acne. One of the group is expected to soon have his colon surgically removed while the others will require long-term drug therapy, the attorneys said.

The award is the latest stemming from a wave of lawsuits that accuse Roche of downplaying a link between Accutane and inflammatory bowel disease, which afflicts about 1.4 million people in the U.S. and Canada.

Accutane’s warning label notes that the drug is “associated with” chronic bowel problems, but the company has argued that there is no direct connection between its drug and the disease.

Lawyers representing the three patients presented internal Roche studies that they argue show the company knew Accutane caused damage to the intestinal tract that leads to inflammatory bowel disease.

“This is an important outcome and consistent with the recognition by the medical community that Accutane is a trigger for IBD,” said David Buchanan, a partner with Seeger Weiss in New York who helped argue the plaintiffs’ case.

Nutley, N.J.-based Hoffman-La Roche reiterated in a statement “there is no reliable scientific evidence that Accutane actually causes” inflammatory bowel disease. The company pointed out that the disease often occurs in patients 15 to 35 years old — roughly the same group of patients who take Accutane.

More than 13 million people worldwide have used the drug since it was approved in 1982, according to Roche.

Copyright 2008 The Associated Press.

FDA panel:Tell consumers about facial filler risks

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Posted on 18th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/18/2008

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ Hundreds of thousands of baby boomer women who think they’ve found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday.

A panel of independent advisers urged the Food and Drug Administration to revise the labeling to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars.

“It is almost a no-brainer,” said Dr. Michael Bigby, a Harvard Medical School dermatologist. “The current label is not adequate.” The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But Tuesday’s FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The hearing was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help the government track safety, improve training and provide clearer information to consumers.

Women, and even some men, are drawn to skin fillers by the promise of youthful good looks at far less cost and trouble than a face lift. A touchup two or three times a year can boost deflated middle-age egos. Unfortunately, for some patients, the result can be blotchy skin, bumps on the face and worse.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they’re injected into the face. They include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There are also questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

“The trouble is that once this material is in the hands of physicians, there’s really not much control over how it’s used and where it’s placed,” said Dr. Scott Spear, a Washington plastic surgeon. “That creates the potential for a certain amount of mischief.

“But the good news is that, by and large, these are very safe materials,” Spear added. “They have a very healthy risk profile.”

FDA scientists will present the advisory panel with data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

Most reactions involved minor swelling and redness, complications that could be expected. But the FDA said it also received reports of “serious and unexpected” problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

A small number of patients — 19 — went to the emergency room with life-threatening allergic reactions, such as difficulty breathing. Twelve developed infections that required hospitalization.

“The FDA has been rushing these products to market as if they were lifesaving medical products,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. “They should be requiring better studies since these products have only cosmetic benefits but potentially lethal risks.”

Some problems reported to the FDA may be due to unapproved or “off-label” use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.

Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.

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On the Net:

Food and Drug Administration: http://tinyurl.com/5jtuxv

Copyright 2008 The Associated Press.

Their economy booming, Chinese students head to US

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Posted on 17th November 2008 by Gordon Johnson in Uncategorized

Date: 11/18/2008

By ANDREW WELSH-HUGGINS
Associated Press Writer

COLUMBUS, Ohio (AP) _ Chinese students are enrolling in U.S. universities in record numbers, encouraged by aggressive recruiting combined with China’s booming economy and growing middle class.

Their enrollment grew by 8 percent in the fall of 2006 and by 20 percent last year, according to Institute of International Education figures released Monday.

Individual universities surveyed by The Associated Press also are reporting high growth this year.

Chinese enrollment increased 300 percent this year at Lehigh University in Pennsylvania. George Fox University in Newberg, Oregon, accepted 65 students from China, more than double its 2007 figure.

Purdue University in West Lafayette, Indiana, already boasting a strong international student program, is enrolling 290 Chinese students, up from 127. The spike was more than 400 percent at Ohio State University, the nation’s largest campus, with 115 undergraduates from China compared with 20 last year.

Xiaoli Liu, an Ohio State freshman from Beijing, said Chinese universities offer solid academics but can’t compete with the overall experience of an American college, including more opportunities for out-of-class activities, an open learning environment and diversity.

“In China you can seldom find people from the U.S., but in the U.S. you find people from all over the world,” Xiaoli said.

The influx is part of a solid and welcomed rebound in the number of international students coming to the United States, with its giant pool of 4,000 colleges and universities.

Numbers of international students had dropped alarmingly due to competition from other countries and tighter visa procedures after the September 2001 terrorist attacks. But the latest report from the Institute of International Education finds 7 percent more students at U.S. universities than a year ago, at an all-time high of 624,000.

India again sent the most students, followed by China and South Korea. Enrollment from Saudi Arabia jumped 25 percent, putting the country back into the top 10 for the first time since 1982, thanks to a new Saudi government scholarship program.

A snapshot survey the institute did of campuses this fall found that 55 percent reported increases in students from China, the most from any country.

“The misperceptions have finally been laid to rest — that it’s impossible to get a visa,” said Peggy Blumenthal, the institute’s chief operating officer. Students choosing schools “are looking strictly at academic issues, because there’s no reason to believe they’ll have any more trouble getting to the States than getting to Australia.”

Kansas State enrolled 199 Chinese undergraduates, up from 65 last fall.

“There is a whole emerging middle class of Chinese, well over 300 million, many of them with one-child families who are interested in sending their son or daughter abroad with higher educational experience,” said Duane Nellis, provost of Kansas State University. “We’re trying to capitalize on that and also enrich our campus community.”

International students and their families contribute more than $15 billion annually to the U.S. economy, according to a separate survey by NAFSA, the Association of International Educators, also released Monday. And they typically pay higher out-of-state tuition, so they’re an important revenue source for colleges at a time when the supply of college-age American students is beginning to crest.

Out-of-state students pay an average $515 more per credit hour at Michigan State University, where the number of new undergraduate Chinese students soared from 95 last year to 327 this year.

Universities also like the international students’ cosmopolitan flair.

“We’re thrilled about the cultural benefits, the educational benefits it brings to our resident students,” said Mike Brzezinski, Purdue’s associate dean of international programs. “It gives them a study abroad experience right here on campus.”

The number of Americans studying abroad is also at a record high, the Institute of International Education reports, increasing 8 percent to 242,000 in 2006-2007 — according to the latest year figures available. Students continued the trend toward more untraditional destinations, with increases of more than 20 percent each to China, Argentina, South Africa, Ecuador and India.

Next year’s increases may slow as a reflection of the struggling economy and weak dollar, but Blumenthal says U.S. colleges are committed to study abroad and keeping it no less expensive than college in the United States.

The number of new Chinese students still represents a fraction of overall enrollment: just 2 percent of the Ohio State freshman class, for example. They must meet the same entrance requirements as anyone else, including passing an English-language test.

Siyi Chen, a freshman from Changsha in China’s central Hunan province planning to study finance, was especially impressed by Ohio State’s array of 32 libraries.

But like Xiaoli, she has no interest in staying on after graduation.

“I probably will go back to China to work there and find more opportunity there,” she said. “I didn’t know any reason for me to stay here than staying with my family. That’s more important.”

___

AP Higher Education Writer Justin Pope contributed to this report.

Copyright 2008 The Associated Press.

Jury awards nearly $16.6M in Ill. skin patch case

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Posted on 17th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/18/2008

By MEGAN REICHGOTT
Associated Press Writer

CHICAGO (AP) _ Two Johnson & Johnson subsidiaries that make and distribute a painkilling skin patch must pay nearly $16.6 million to the family of a suburban woman who died from a drug overdose while using the product, a jury ruled Monday.

Janice DiCosolo, 38, of Cicero died on Feb. 15, 2004, while using a Duragesic patch that her doctor prescribed to reduce pain caused by a neurological condition called reflex sympathetic dystrophy, her attorneys said.

The mother of three died because the patch delivered a fatal dose of its main ingredient, the powerful narcotic pain reliever fentanyl, jurors ruled Monday in Cook County Circuit Court following a three-week trial.

The defendants, Titusville, N.J.-based Janssen Pharmaceutica Inc. and Mountain View, Calif.-based ALZA Corp., knew about problems with the Duragesic patch that allowed it to leak fentanyl in doses large enough to kill patients, the lawsuit claimed. Both companies are subsidiaries of New Brunswick, N.J.-based Johnson & Johnson.

“They knew this patch was dangerous and defective but they continued to sell it and make money, and that’s the only reason Janice DiCosolo is dead,” Jim Orr, an attorney for DiCosolo’s family, said in a statement.

Greg Panico, a spokesman for Janssen and ALZA, said Monday that the companies sympathize with DiCosolo’s family but disagree with the jury’s verdict.

The companies are considering options for an appeal, Panico said in a statement.

“This is a very unfortunate case for everyone, but we maintain that the patch was not defective,” he said.

An independent expert and company expert inspected the patch that DiCosolo used and concluded there was no defect, Panico said. The companies believe DiCosolo’s cause of death was polypharmacy, “a mix of multiple and potentially incompatible medications,” he said.

Duragesic is a prescription-only product that is intended for cancer patients and others with chronic pain and is designed to dispense the medicine slowly through the skin.

The verdict is the fourth trial loss for the companies since 2006, DiCosolo’s attorneys said.

A Sanford, Fla., jury last month awarded $13.3 million to the family of Susan Hodgemire, 34, who died after undergoing back surgery and using the Duragesic patch. In June 2007 a federal jury awarded $5.5 million to the father of a 28-year-old man who died in 2003 while wearing the patch.

The Food and Drug Administration issued two warnings in two years about improper use of fentanyl patches.

Some of the deaths came after doctors prescribed the patches to the wrong patients, the FDA said in December 2007. Patients could also accidentally overdose by using the patches wrong, the FDA said.

Some patches containing fentanyl were recalled in February 2008 because of a flaw that could cause them to leak. Those patches were sold in the United States by Actavis South Atlantic LLC and had both that name and the company’s former name, Abrika Pharmaceuticals Inc., on the packaging.

Also in February, PriCara, another Johnson & Johnson division announced a recall of fentanyl patches manufactured by ALZA Corp.

The patches were first approved under the brand name Duragesic in 1990. A generic version hit the market in 2005.

Copyright 2008 The Associated Press.
Summary

Deaths in China milk scandal go uncounted

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Posted on 17th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/16/2008

By CHARLES HUTZLER
Associated Press Writer

LITI VILLAGE, China (AP) _ Li Xiaokai died of kidney failure on the old wooden bed in the family farmhouse, just before dawn on a drizzly Sept. 10.

Her grandmother wrapped the 9-month-old in a wool blanket. Her father handed the body to village men for burial by a muddy creek. The doctors and family never knew why she got sick. A day later, state media reported that the type of infant formula she drank had been adulterated with an industrial chemical.

Yet the deaths of Xiaokai and at least four other babies are not included in China’s official death toll from its worst food safety scare in years. The Health Ministry’s count stands at only three deaths.

The stories of these uncounted babies suggest that China’s tainted milk scandal has exacted a higher human toll than the government has so far acknowledged. Without an official verdict on the deaths, families worry they will be unable to bring lawsuits and refused compensation.

So far, nobody is suggesting large numbers of deaths are being concealed. But so many months passed before the scandal was exposed that it’s likely more babies fell sick or died than official figures reflect.

Beijing’s apparent reluctance to admit a higher toll is reinforcing perceptions that the authoritarian government cares more about tamping down criticism than helping families. Lawyers, doctors and reporters have said privately that authorities pressured them to not play up the human cost or efforts to get compensation from the government or Sanlu, the formula maker.

“It’s hard to say how the government will handle this matter,” said Zhang Xinkui, a Beijing-based lawyer amassing evidence of the contamination for a possible lawsuit. “There may be many children who perhaps died from drinking Sanlu powdered milk or perhaps from a different cause. But there’s no system in place to find out.”

In the weeks since Xiaokai’s death, her father and his older brother have talked to lawyers and beseeched health officials, with no result.

“My heart is in pain,” said her father, Li Xiaoquan, a short, taciturn farmer with hooded eyes. From a corner of his farmhouse courtyard in central China’s wheat and corn flatlands, he pulls a worn green box that once held apples and is now stuffed with empty pink wrappers of the Sanlu Infant Formula Milk Powder that Xiaokai nursed on. “We think someone, the company, should compensate us.”

In coal-mining country 450 miles (725 kilometers) to the northwest, Tian Xiaowei waits for his wife to leave their newly built house before removing five small photos of a wide-eyed baby boy from a brown plastic document folder. “She breaks down when she sees them,” Tian said. The photos are the only mementos left of year-old Tian Jin, who died in August.

“I want these people who poisoned the milk powder to receive the severest punishment under law. I want an explanation and I want consolation for my dead child,” said Tian, a broad-shouldered apple farmer and part-time truck driver. “I feel like we could die from regret. If we knew that it was contaminated, we would never have fed him that.”

Since September, when the scandal was first reported, Beijing has said that Shijiazhuang Sanlu Group Co., the dairy, knew as early as last year that its products were tainted with melamine and that company and local officials first tried to cover it up.

The government has promised free medical treatment to the 50,000 children sickened, and unspecified compensation to them and families of the dead. The Health Ministry, which is coordinating the government’s response, declined to answer questions about the compensation plan and whether it was investigating deaths and illnesses not yet counted by the government.

Melamine, a chemical used as a flame retardant and binding agent to make cooking utensils and industrial coatings, is rich in nitrogen. As such, it makes an attractive low-cost additive to milk and other foods; nitrogen registers as protein on many routine tests.

Though melamine is not believed harmful in tiny amounts, higher concentrations produce kidney stones, which can block the ducts that carry urine from the body, and in serious cases can cause kidney failure.

All eight babies who died were diagnosed with kidney failure, according to the families, medical records or state media accounts. All also supposedly drank Sanlu infant formula or powdered milk.

The fathers of Li Xiaokai and Tian Jin both wave inch-thick sheaves of medical reports and tests from their children’s stays in hospitals. Xiaokai, a twin older than her sister Xiaoyan by three minutes, was fed with Sanlu formula while the younger girl nursed on breast milk because their mother did not have enough for both, family members said.

An ultrasound examination of Xiaokai’s kidneys at the Zhengzhou Children’s Hospital on Aug. 21 found a stone in each kidney that was about the size of a small marble and 2½ times larger than what doctors consider a critical threshold.

Tian Xiaowei, the apple farmer, sent bags of Sanlu infant formula to a government laboratory in September. The Xi’an Product Quality Supervision Institute’s report, dated Oct. 8, found melamine levels of 1,748 milligrams per kilogram, more than 800 times the government-set limit.

Then there’s Wang Siyu, the daughter of an accountant and proprietor of an Internet cafe in the central city of Shangqiu. Siyu was fed Sanlu products from birth and developed recurring kidney problems in May last year, at age 3, said her mother, Li Songmei.

Twice hospitalized, she was taken off Sanlu milk and started to recover, only to fall ill again when the family began to give her Sanlu products, Li said. Sick for a third time and swollen, she died of kidney failure at the Zhengzhou Children’s Hospital on May 2, said Li.

“Ever since she was born, she had been using Sanlu milk. Only when she felt sick and couldn’t eat did she stop taking Sanlu,” said Li.

Others among the five include an infant in far western Xinjiang province, whose story was posted on the provincial government Web site, and a 6-month-old boy in southeastern Jiangxi province, reported by the New Legal Daily. A reporter who worked on the article and would give only his surname, Liu, said the newspaper was careful not to blame Cai Cong’s death on Sanlu formula because “the local government has not yet reached a verdict.”

Medical experts say kidney stones in infants are rare. Doctors in several parts of China first noticed a rise in cases in the past two years. Pediatric urologist Feng Dongchuan tried to sound an alarm, posting an item on his blog in July about a spike in cases at his hospital in the central city of Xuzhou and in nearby Nanjing city. Feng pinpointed infant formula as the likely cause.

Feng at first refused requests for interviews, then responded in a terse e-mail: “The chance for infants or small children to come down with kidney stones is very small, and having stones that obstruct both kidneys is even more rare.”

Like the others, the Li family grew distressed when Xiaokai started to become fussy in July. With their two-acre (8,000-square-meter) farm in Liti Village, her parents never had much money and already had a child, a son. But they wanted a larger family, bucking the one-child family planning limits. Xiaokai was “the more active” of the twins, said her 70-year-old grandmother, Li Xuan.

By August, Xiaokai was running a high fever, unabated by ever higher doses of medicine. Alarmed after she stopped eating and urinating, the family took her to the nearby Runnan county hospital on Aug. 18. The doctors diagnosed kidney failure and rushed her overnight by ambulance to Zhengzhou Children’s Hospital, three hours away and the best in Henan province.

“They knew right away,” said the father, Li. Xiaokai was run thr
ough tests and put on intravenous solutions to try to shrink the kidney stones. Unable to stay with her or afford a hotel, Li and his mother slept on the pavement outside the hospital. After five days, the hospital said it could do no more.

“The doctors wouldn’t operate because they said ‘she’s too small,’” said Li. They suggested taking Xiaokai to Beijing or Shanghai. Hospital officials declined comment and refused to make Xiaokai’s doctor available.

The hospital stay in Zhengzhou cost 7,331 yuan, or $1,070 — about a year’s cash income for the family — and they had already borrowed money to pay for Xiaokai’s care.

So Li brought Xiaokai home to die. They took her to a traditional medicine doctor in the village, who gave her an herbal medicine and confirmed the grim prognosis. “The old doctor told us ‘the child will die in 10 to 18 days,’” Li said.

Early on Sept. 10 while it was still dark, the grandmother called Li into the side room where she and Xiaokai slept. “Her stomach was puffy” — a sign of kidney failure — “and she wasn’t breathing,” he said.

In many parts of north China, the death of a child is considered a misfortune that can bring bad luck on a family and is best suppressed. Accordingly, Li Haiqin, a cousin, and three other men took Xiaokai to a creek on the far side of the village fields. They put a brick in the blanket with the body and placed it in a shallow hole under a path between rows of poplar trees. Then they walked back in silence beneath a gray dawn and a light rain. No close family members were there and none was told where the grave is.

Xiaokai’s family says Beijing had waived regular inspections of Sanlu because its quality controls were said to be excellent. “The government should shoulder its responsibility. This was a national brand, inspection-exempt products,” said Xiaokai’s uncle, Li Shenyi.

Since the death, Li Shenyi approached the Runnan county Health Bureau to classify Xiaokai’s death as caused by tainted formula. “They said the upper levels (of government) were working on it,” he said.

The county health bureau referred calls to its supervisors in Zhumadian city, who said ultimately it was up to Beijing.

“Right now, the Health Ministry has no clear explanation on how the victim’s families should be compensated,” said a Ms. Shang at the Zhumadian Health Bureau’s medical affairs office. “Nobody knows.”

Copyright 2008 The Associated Press.

6 teenagers die after drinking sour milk in India

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Posted on 14th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/14/2008

PATNA, India (AP) _ At least six teenagers died from suspected food poisoning after drinking sour milk at their boarding school in eastern India, an official said Friday.

Teachers panicked when the students started vomiting Thursday and rushed them to a hospital on the outskirts of Ranchi, the capital of Jharkhand state, said A.K. Basu, the state chief secretary.

The students, aged 12 and 13, initially refused to drink the unpasteurized milk, complaining to a school administrator that it had soured, Basu told The Associated Press.

But the official, Ram Jaleswar Sahu, encouraged them by drinking some himself. Sahu also became sick and was hospitalized, Basu said.

In addition to the six who died, 65 students were sickened. Most were sent home after being cleared by doctors, but 21 remained in a hospital, Basu said.

The milk was provided unpasteurized from a local dairy, and police seized samples of the milk as part of an investigation, Basu said. Unpasteurized, or raw milk — banned in several countries — does not undergo heating aimed at destroying bacteria and other pathogens, but it is commonly sold in India.

Nearly 1,000 people, including the parents and relatives of the school children, took to the streets on Friday and blocked a highway near Ranchi, demanding prosecution of the school management, police said.

There was no indication the milk had been tainted with melamine. Milk contaminated with the industrial chemical has been blamed in the deaths of four Chinese babies and the sickening of thousands more, setting off bans worldwide on dairy imports from China.

Copyright 2008 The Associated Press.

FDA questions Alpharma's abuse-proof pain pill

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Posted on 12th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/12/2008

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ Federal regulators questioned Wednesday whether Alpharma Inc. has provided enough evidence to show that its experimental morphine pill cannot be abused.

Alpharma has asked the Food and Drug Administration to approve Embeda as a tamperproof medication for patients with moderate to severe chronic pain. The pills are formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Patients often abuse pain pills by grinding them up to snort or inject.

Friday, the FDA will ask a panel of outside advisers how effective Embeda is likely to be at discouraging such abuse.

Alpharma only studied the drug’s resistance to abuse when it was taken by mouth, but FDA reviewers noted that drug addicts often abuse pain pills by injecting them.

Embeda contains morphine along with an antagonist, a drug that neutralizes the effects of the narcotic when it is used inappropriately. However FDA reviewers questioned whether exposing patients to low levels of the antagonist might cause safety problems.

In its own studies, Alpharma said the most common side effects associated with the chemical were nausea and vomiting.

Cowen and Co. analyst Ian Sanderson wrote in a research note that the FDA’s review documents seemed favorable toward Embeda, and he expected a positive ruling from panelists on Friday. According to Sanderson, the agency is mainly looking to the panel for “advice on label language and risk management plan design.”

In its own briefing documents posted online, Alpharma said it planned to distribute pamphlets on the risks of morphine abuse to physicians who prescribe Embeda. The company also noted that the FDA has already demonstrated its commitment to approving similar medications that reduce the risk of abuse. Pills already on the market include Sanofi-Aventis SA’ Talwin NX and Reckitt Benckiser Pharmaceuticals’ Suboxone.

Bridgewater, N.J.-based Alpharma submitted Embeda to the FDA in late June. The agency agreed to give the application “priority review,” which takes six months, instead of the usual 10 months.

If Embeda is approved it would help offset lost sales of Alpharma’s morphine drug Kadian, which is expected to lose patent protection in 2010. The drug was Alpharma’s best-selling product last year with sales of $167.7 million.

Rival drugmaker King Pharmaceuticals Inc. is trying to buy Alpharma for $37 per share, or about $1.6 billion. Sanderson said that if Friday’s panel meeting goes poorly, King could drop that offer, which would sink shares of Alpharma. However, he said that outcome is unlikely unless the FDA panel “absolutely rejects” Alpharma’s application, which is not expected.

Shares of Alpharma rose $1.81, or 6.3 percent, Wednesday to close at $30.66.

Copyright 2008 The Associated Press.

Altria to cut jobs due to economic uncertainty

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Posted on 12th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/12/2008

By VINNEE TONG
AP Business Writer

NEW YORK (AP) _ Altria Group, the owner of the biggest U.S. cigarette maker, confirmed on Tuesday that it has started to cut jobs because of the widespread economic turmoil.

A spokesman declined to say how many cuts would be made but said they were planned for employees of parent company Altria and its cigarette unit, Philip Morris USA. Both are based in Richmond, Virginia.

Altria Group Inc. also owns cigar maker John Middleton and is also buying smokeless tobacco company UST Inc. to pursue growth outside of cigarettes, which are in less demand from American consumers.

Spokesman David Sylvia confirmed that the company is cutting jobs and said it is deciding how many layoffs there will be between now and February. He said departments that would lose employees have been told that there would be cuts.

Shares of Altria fell 49 cents, or 2.8 percent, to close at $17.33 Tuesday.

Altria said in August 2007 that it would cut as many as 400 positions when it moved its headquarters out of New York and spun off Philip Morris International in March of this year. The cuts were designed to save $250 million annually. An undisclosed number of those employees moved to work in the Richmond office.

The latest cuts — first reported in the Richmond Times-Dispatch — are in addition to those layoffs.

Altria and its subsidiaries employ more than 10,500 people.

Tobacco proved to be one of the more resilient sectors during the latest round of quarterly profit reports. Altria’s former unit Philip Morris International did especially well since it is positioned to capture growth in emerging markets, where cigarette sales are growing.

But when Altria reported results last month, it said the volume of Philip Morris USA’s cigarette shipments fell 4.8 percent during the quarter from a year ago. Chief Executive Michael Szymanczyk said then that “because of the economic uncertainties we all face, Altria is taking steps now to continue adding value to shareholders over the long term.”

Altria also said that because of difficulties in the credit markets its $10.4 billion purchase of UST had become more expensive to finance. The company plans to schedule a shareholder vote in December and hopes to close the deal by the first week of January.

Copyright 2008 The Associated Press.