UK must change Alzheimers drug advice
Fri, 10 Aug 2007 19:28:26 GMTBy JILL LAWLESS, Associated Press Writer
LONDON - A judge ruled Friday that Britain's state-run health service must change the way it advises doctors on supplying some Alzheimer's patients with drugs to treat the brain-destroying disease.
However, the judge upheld an argument by the government medicines monitor that the drugs are only cost-effective for patients in later stages of the illness — defeating an attempt to force authorities to prescribe the medicines to those with early-stage Alzheimer's.
The case is the latest in a series of legal challenges to Britain's National Health Service, which offers free health care and low-cost medicines to all Britons, but is regularly accused of rationing access to treatment. The dispute does not concern patients who choose — and can afford — private treatment.
Pharmaceutical companies and Alzheimer's advocates had asked the High Court to overturn a decision by the National Institute for Health and Clinical Excellence, which declined to approve a group of drugs known as acetyl cholinesterase inhibitors for patients in early stages of the disease.
Judge Linda Dobbs said NICE's recommendation that doctors use language-based tests to assess the severity of the disease — and thus whether a patient was eligible for the drugs — "creates confusion and the potential for discrimination" against people with learning disabilities and those whose first language is not English. She ordered NICE to change its guidance.
NICE, which regulates use of prescription drugs, recommended last year that three drugs — donepezil, rivastigmine and galantamine — not be prescribed for patients with early stage Alzheimer's.
It said the treatment was not particularly effective for people with mild Alzheimer's and at about $5 per patient per day was not cost effective. It recommended the drugs for patients with moderate-stage Alzheimer's.
Drug companies Eisai Co. Ltd. and Pfizer Inc., along with the Alzheimer's Society, challenged NICE's decision.
In a statement, Eisai and Pfizer said the court ruling was "a major victory for the many critics of the process by which NICE reaches its often seemingly clinically perverse decisions."
But NICE claimed victory, saying the judge had dismissed five of the six arguments in the case against it.
"Our guidance stands and the drugs continue to be recommended only for people with moderate Alzheimer's disease, but the court has asked us to clarify our guidance when it is used for certain groups," said chief executive Andrew Dillon.
Virus outbreak contained in Uganda
Fri, 10 Aug 2007 01:46:28 GMTBy KATY POWNALL, Associated Press Writer
KAMPALA, Uganda - An outbreak of a deadly Ebola-like disease at a mine in western Uganda has been contained, health officials said Thursday.
The Marburg virus, a rare hemorrhagic illness, killed a 29-year-old last month. The country had not seen a Marburg outbreak for 30 years.
Health Minister Dr. Stephen Mallinga said the 21-day maximum incubation period has passed with no new cases reported.
"Theoretically the transmission chain has been broken, the transmission has been stopped and the outbreak contained," he said.
The disease has a death rate that can be higher than 90 percent and no treatment or vaccine. Marburg can cause headaches, nausea, diarrhea and vomiting. In severe cases, the central nervous system is attacked, and patients may bleed from the eyes, ears and elsewhere.
Since Marburg was first identified in 1967, large outbreaks have been reported in Congo, Angola and elsewhere.
Virus hunters swathed in protective gear plan to enter the lead and gold mine in Uganda to search for bats they believe may be the source of the latest outbreak. The medical investigators will take blood samples to look for antibodies of the Marburg virus, before killing the animals and removing their livers and spleens.
Scientists are not sure how the virus is transmitted to humans, but believe people may become infected by being bitten by bats or by insects or other animals that have been infected by bats. Another possibility is that people catch it by breathing in air carrying virus particles from bat feces.
FDA Heartburn drugs seem OK for heart
Fri, 10 Aug 2007 01:35:30 GMTWASHINGTON - The popular heartburn drugs Prilosec and Nexium don't appear to spur heart problems, say preliminary U.S. and Canadian probes announced Thursday.
The Food and Drug Administration and its Canadian counterpart began reviewing the drugs, used by tens of millions of people, back in May, when manufacturer AstraZeneca provided them an early analysis of two small studies that suggested the possibility of a risk.
Those studies compared treating the chronic heartburn known as gastroesophageal reflux disease, or GERD, with either of the two drugs or with surgery, and tracked patients for five to 14 years. The company's initial analysis counted more patients treated with drugs who had had heart attacks, heart failure or heart-related sudden death.
The FDA followed up on those studies, and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting the heart link was a coincidence.
While the studies' designs make safety assessments difficult, many of the participants who developed heart problems had risk factors before starting the drugs, Health Canada said Thursday.
The FDA then looked at 14 additional studies of the drugs, and found no evidence of heart risks. In fact, in a few studies where patients received either medication or a dummy pill, those who took the heartburn drugs actually had a lower incidence of heart problems.
The FDA plans to complete its probe within three months, but issued a public notice Thursday that it "does not believe that health care providers or patients should change either their prescribing practices or their use of these products at this time."
Health Canada reached the same initial conclusion. It also urged doctors and patients to make no changes until its own probe is finished by year's end, noting that untreated GERD can lead to serious complications.
The drugs are among a family of acid-reducers known as proton pump inhibitors. FDA's Dr. Paul Seligman said Thursday that while the agency's focus is on Nexium and Prilosec, it is "interested in the data from all similar products" as it looks for all available evidence to settle the heart question.
Nexium is the world's No. 2 selling drug, with 2006 sales of $6.7 billion, according to health care research firm IMS Health.
Tainted toothpaste took unchecked route
Thu, 09 Aug 2007 22:59:29 GMTBy MIKE STOBBE and AUDRA ANG, Associated Press Writers
ATLANTA - Each week, prison guards brought Sherri Painter a fresh tube of SpringFresh toothpaste. She was OK with the spearmint taste, plus it was good at removing stains and cleaning shoes.
Then one day in June, guards told her to turn in her SpringFresh because it was among more than a dozen brands of Chinese-made toothpaste found to contain a poisonous chemical used in antifreeze.
Georgia officials had stocked SpringFresh in 39 prisons and dozens of other state facilities. One tube was found to contain one of the highest concentrations of the poison in any toothpaste shipped to the U.S., according to the Food and Drug Administration.
"I was blown away," said Painter, a 31-year-old convicted carjacker at Atlanta's Metro State Prison.
At the request of The Associated Press, a New Jersey company traced the shipping of the SpringFresh toothpaste, demonstrating how it followed an unchecked route from a Chinese factory to Painter's prison cell. Federal regulators did not look for the poison until they saw news reports about it being found in toothpaste in Panama, the Dominican Republic and Australia.
The manufacturer substituted toxic diethylene glycol — or DEG — for a more expensive sweetener. The Chinese government did not see it as a hazard and let it pass through customs.
Experts say it's unlikely that anyone — even a child — could ingest enough tainted toothpaste to become seriously ill. But the disagreement between Chinese and U.S. officials about the chemical reflects many of the issues in the U.S.-China import crisis.
Chinese goods now account for 60 percent of all consumer-product recalls in the United States. Safety scares such as the one involving toothpaste have become an all-too-common problem, said Donald Mays, a product-safety expert for Consumers Union.
"It is indicative of a major concern we have about unscrupulous business practices in China," Mays said.
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CHINA
The SpringFresh toothpaste was made in a manufacturing plant in the eastern city of Suzhou, a tourist spot famed for its gardens. The nondescript two-story facility is an industrial area about a 30-minute drive from the heart of town, tucked in a maze of factories.
Some 90 people live and work in the plant, operated by the Suzhou Qingxin Daily Chemical Co. Ltd. The company has been making SpringFresh for at least five years, the manager said.
Under U.S. standards, America-made toothpaste is customarily made with glycerin, a sweetener that holds together other ingredients. But the Suzhou plant substituted DEG, which also is used in industrial solvents.
U.S. scientists discovered the chemical's dangers in 1937, when at least 105 people died after taking a medicine made in Tennessee that contained DEG. It has periodically resurfaced as a deadly additive, including last year in Panama, when DEG-tainted cough syrup and other medicines triggered the deaths of at least 90 people.
It's not clear where Suzhou Qingxin Daily Chemical got the DEG. After speaking to The Associated Press once, the company's general manager, Liu Changqing, could not be reached about that question.
In China, DEG is traditionally cheaper than glycerin, and there was no government prohibition against using it.
The FDA allows only trace amounts of DEG in toothpaste. But Chinese officials maintain that toothpaste containing less than 15.6 percent DEG, by weight, is harmless.
"This may be just a case of different standards and opinions," Liu said.
The Chinese government does not check DEG levels in products like toothpaste, said Mengshi Lin, a University of Missouri food scientist who in the late 1990s was a Chinese government export inspector.
Chinese inspections instead focus on human food, he said.
China's food inspections have come under fire, too. U.S. inspectors this year banned or recalled a number of Chinese food exports, including drug-laced frozen eel and juice made with unsafe color additives.
Global customers' concerns gradually seem to be pushing Chinese officials to make changes, experts said. On July 11, Beijing banned DEG from toothpaste.
Meanwhile, large U.S. retailers have been placing inspectors in Chinese factories to watch for safety or quality problems, Mays said.
Dollar stores and smaller retailers that received much of the DEG-tainted toothpaste generally cannot afford to place inspectors overseas, he added.
Since 9/11, the U.S. Department of Customs and Border Protection has placed inspectors at ports in 19 countries. But the agency has no one in China because officials do not have a necessary agreement with the Chinese government.
Even if customs inspectors were in China, their focus would be explosives and weapons of mass destruction — not toiletries. The FDA is responsible for toothpaste, and has no inspectors permanently stationed in China.
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SEATTLE AND TACOMA
PIERS Global Intelligence Solutions, a commerce data company based in New Jersey, traced the shipping of the SpringFresh toothpaste for The Associated Press. The company found 17 shipments of SpringFresh to the United States in 2006 and 2007, on vessels that departed Shanghai, Yantian and Hong Kong. All came in through the ports of Tacoma or Seattle.
American Amenities, a family-owned importing business based in Woodinville, Wash., received the shipments.
The FDA has seven full-time inspectors at the port of Seattle and three in Tacoma. But the agency was not testing toothpaste until DEG was discovered in Chinese-made toothpaste by Panamanian officials.
In late May, the FDA began pulling tubes from U.S. retailers, importers and distributors. Ultimately, 140 samples of Chinese toothpaste were tested, with 38 percent positive for DEG.
On June 1, the FDA issued a warning about more than a dozen brands of Chinese-made toothpaste.
SpringFresh was not on the initial list, but American Amenities did its own tests and found DEG in some tubes. Company officials declined to release the test results.
The FDA looked at SpringFresh in late June, checking samples from 12 tubes, including nine from American Amenities in Washington State and three from Georgia. One Georgia tube was 6 percent DEG — one of the highest levels seen in the United States, an FDA spokesman said.
Even at those levels, the chemical would rarely be deadly. According to an FDA calculation based on 6-ounce tubes of toothpaste that are 3 percent DEG, a 150-pound adult would have to eat more than 175 tubes to receive a fatal dose. A 22-pound child would have to eat 25 tubes.
American Amenities rejected a June shipment after testing stock in the U.S. and sending contracted workers to the Chinese manufacturer to check the product at the plant.
The company stopped buying SpringFresh. "They're out of the Chinese toothpaste business," said Jesse Lyon, a lawyer acting as American Amenities' spokesman.
The company stands to lose at least $100,000 from the recall and associated costs — a big hit to a business that employs just six people, Lyon said.
American Amenities has not sued the manufacturer, but is negotiating to get the Chinese company to help offset the losses, the lawyer said.
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GEORGIA
In 2002, Georgia contracted with American Amenities to provide low-cost toiletries and other items. The state got the toothpaste for about 9 cents per 1.5-ounce tube.
The biggest buyer was the Georgia Department of Corrections, which runs Metro State Prison, a 900-inmate facility for women in south Atlanta. Each week, the prison distributed SpringFresh tubes.
Inmates liked its versatility.
"With SpringFresh, if you had a spot on your shirt, you could take out the spot. You could clean shoes with it. You could clean anything with it," Painter said.
Toothpaste is generally good for cleaning shoes and metal objects. "It may not be related to the DEG," said Mays, of Consumers Union.
American Amenities told the state about the DEG problem, and corrections officers collected the toothpaste on June 12. Inmates said they knew it was serious because anyone who did not turn in the tubes would lose privileges or face other penalties.
No one at the prison reported illness from SpringFresh, and some inmates were more unhappy about the chalky, India-made Nature Mint toothpaste distributed in its place.
"Makes you want to throw up. It's nasty," Painter said.
At least one inmate liked it well enough, though. The prison's only recall-related grievance came from an inmate who wanted more Nature Mint. It's distributed just once every two weeks — not often enough to sustain her brushing, she complained.
The prison now has 14,939 tubes of recalled SpingFresh, bundled into 104 cartons and loaded on a pallet outside its warehouse. They probably will be dumped into a landfill, a corrections official said.
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Associated Press writer Audra Ang reported from Suzhou, China, and Mike Stobbe reported from Atlanta.
