Health Highlights: May 26, 2007

Here are some of the latest health and medical news developments,compiled by editors ofHealthDay:

Contact Lens Eye Solution Pulled from Market; FDA Says to Discontinue Use

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Increased incidences of a rare but stubborn eye infection have caused the U.S. Food and Drug Administration to alert the public to discontinue using a solution used to clean contact lenses.

TheAssociated Pressreports that AMO Complete Moisture Plus Multi-Purpose Solution, used for cleaning and storing soft contact lenses, had been immediately and voluntarily recalled by its manufacturer, Advanced Medical Optics Inc., of Santa Ana Calif.

The infection in question is Acanthamoeba keratitis, which is caused by an amoeba, theA.P.quotes Michael Beach, team leader in the U.S. Centers for Disease Control and Prevention's division of parasitic diseases, as saying. If left untreated, the infection could cause permanent vision loss or complete blindness.

Neither the FDA nor Advanced Medical Optics said the contact lens solution caused increased cases of Acanthamoeba keratitis, the wire service reported. Rather, the solution didn't protect against the infection, which usually comes from swimming or showering.

Because Acanthamoeba keratitis strikes only one or two people per million, the situation came to the government's notice because only because a Chicago ophthalmologist, Dr. Elmer Tu, noticed more than a dozen cases of the infection. He usually saw only saw one or two cases a year, theA.P.reported.

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Medicare Won't Cover Artificial Disc Implants in Older Americans

Older Americans won't receive Medicare coverage for artificial disc implants in the lower spine, according to the a report in theNew York Times

The newspaper reports that the decision is preliminary and affects people over the age of 60 who are eligible for the U.S. government's Medicare health insurance. The decision is expected to become final in August, theTimessaid.

The reason given by the Centers for Medicare and Medicaid Services for denying coverage was that none of the clinical trials conducted on whether the artificial discs were effective included people over age 60.

Source : http://www.washingtonpost.com

New pill can eliminate menstrual cycles

A birth control pill which gives women a new way to indefinitely stop the monthly menstrual cycle could soon be available.

The pill, called Lybrel, is the first that can eliminate menstrual cycles forever.

Approved by the FDA in the US today, it's the latest approved oral contraceptive to depart from the 21-days-on, seven-days-off regimen that's been standard since birth-control pill sales began in the 1960s.

The pill, manufactured by Wyeth, is the first designed to put off periods altogether when taken without break.

All birth control pills work by stopping ovulation and suppressing menstruation, and traditionally there's a week off for a period.

Before now, women could, on their own, take pills consistently right through the break.

Lybrel is the first one that's taken year round.

Dr Anne Davis led a clinical trial on the drug.

"What women need to know about Lybrel that makes it different from other pills is that you take it every day," Dr Davis said.

"There's no week off as there is with traditional birth control pills."

However, 41 percent of women trialling the pill still had some bleeding or spotting. That sort of unanticipated and irregular bleeding can be a problem with low-dose pills.

Despite this, Australian family planning expert Dr Edith Weisberg said Lybrel was likely to have appeal here.

"It makes it a bit easier for women and it may be cheaper because you don't have to buy so many packets," Dr Weisberg said.

"As for taking it continuously, it does not make a difference whether a woman has a bleed or not — having an artificial bleed every 28 days is of no consequence whatsoever."

Doctors say Lybrel will particularly help women with severe PMS. The nausea, the cramps and the headaches that often accompany monthly periods will no longer be an issue.

Wyeth plans to start Lybrel sales in the US this July. It is still deciding whether it will introduce the drug here.

Source : http://news.ninemsn.com.au

What Choices Do You Have If You're Taking Avandia?

This week's New England Journal of Medicine is bound to trigger a barrage of calls to doctors from worried diabetics who have been taking Avandia, a pill that helps control blood sugar. An analysis of 42 different studies concluded that people on the drug have an unmistakably higher risk of heart attacks than do those who aren't on the drug.Why wasn't clear. The authors suggested a few possibilities, such as Avandia's tendency to increase levels of LDL cholesterol, the bad variety. What to do if you're taking it? U.S. News asked Bruce Psaty, an internist at the University of Washington Health Sciences Center and coauthor of an editorial in the New England Journal that looked closely at the analysis, to respond to questions that patients might have.

The authors of the New England Journal analysis looked at a lot of different studies. Their conclusion was that Avandia patients had a 43 percent higher chance of a heart attack. What does that mean? What was their risk of having a heart attack if they hadn't been taking Avandia?

Some diabetics who aren't taking Avandia might run a risk of heart attack of roughly 20 per 1,000 per year. This study shows that it would be 28 heart attacks in people taking Avandia, an increase of 8 heart attacks for every 1,000 people. It may not sound like much, but it's a substantially higher risk. Think about it this way: When we use lipid-lowering drugs like statins, we expect to reduce the risk of heart attack by 20 to 40 percent. So there's as much of anadverse effect from Avandia—a 43 percent higher risk—as there is a beneficial effect from statins.

What should I do if I'm taking this drug?

If you have questions about whether to continue, you should talk with your physician about the risks and benefits. Don't try to be your own physician. I myself have never prescribed these drugs. I just don't use them. They improve glucose control, but there was early evidence of weight gain and lipid problems, and it was hard for me to see how this would play out. I'm concerned about physicians who only think in terms of lowering glucose. It's a kind of tunnel vision.

What are a few other options?

The most effective treatments for diabetes are weight loss and exercise. These are difficult to accomplish, but the benefits are legion. They improve lipids, blood pressure, and even mood. They should be part of every diabetic's treatment. There are other drugs, and of course there is insulin.

Avandia is one of two diabetes drugs called glitazones. The other is Actos. Do patients taking Actos need to worry, too?

We need more information about Actos. It's clear that Actos is associated with an increased risk of heart failure. The evidence for increased risk of heart attack doesn't seem to be there, but to my knowledge there hasn't been a complete review of the evidence.

Is there a blood test or other way for my doctor to know if I'm one of the patients who are more likely to have a problem?

The data are so thin—we just know there's a concern about cardiovascular problems, so we lack sufficiently robust information to be able to identify people at higher risk.

Can I reduce the risk by cutting back on the dose?

The data weren't adequate to reach conclusions about higher or lower doses.

Should the Food and Drug Administration take Avandia off the market?

I am not aware of data the FDA and the company may know about. But I don't know of a reason for physicians to prescribe it. Physicians and patients cansuspend the use of the drug until the risks and benefits are clearer.

Source : http://www.usnews.com

Heart Risk Seen in Drug for Diabetes

An article in a leading medical journal yesterday raised serious safety questions about the widely used diabetes pill Avandia and renewed skepticism about the vigilance of federal drug regulators.

The analysis, based on a review of more than 40 existing clinical studies involving nearly 28,000 patients, showed that Avandia significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo.

Both the study’s lead author and the editors of The New England Journal of Medicine, in which the article appeared, cautioned that the research method used left the findings open to interpretation. But they said the study nevertheless raised important concerns.

And the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

The journal’s editor in chief, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.”

The drug’s maker, GlaxoSmithKline, issued a news release defending Avandia’s safety and saying it “strongly disagrees” with the conclusions of the journal article, which it said was based on incomplete evidence.

Glaxo’s stock fell by nearly 8 percent on the news.

While the analysis took Wall Street and many doctors by surprise, Glaxo and the F.D.A. disclosed yesterday that they had known about the signs of potential cardiovascular risk since last August, when the company, on its own initiative, submitted a similar analysis to the agency. That disclosure prompted questions on Capitol Hill about why patients and doctors had not been informed earlier.

Explaining its delay, the F.D.A. said the significance of the studies had not been confirmed and in fact was contradicted by some other studies of the drug.

“We decided we needed to reanalyze the complex dataset ourselves to make a better informed decision,” Dr. Robert J. Meyer, a director of the agency’s office of drug evaluation, said in a news conference yesterday.

Dr. Meyer said that the agency was close to completing its analysis and would convene an advisory panel as soon as possible to review the drug. The F.D.A. is conducting an estimate of excess heart attacks that might be attributed to the drug, but Dr. Meyer said that the results were not final, declining to disclose the number. He noted that Avandia’s label already carries a warning of cardiovascular risks.

Meanwhile, the F.D.A. advised Avandia patients to check with their doctors.

“We’re expecting dozens if not hundreds of phone calls tomorrow,” said Dr. John B. Buse, chief of endocrinology at the University of North Carolina in Chapel Hill. “I’ve told our staff to tell people who call that this is not cause for panic. We can discuss it further at their next visit.”

But Dr. Buse, a president-elect of the American Diabetes Association, said he would not be surprised if some doctors ultimately switched patients to an alternative drug unless additional details were released supporting Avandia’s safety.

The New England Journal of Medicine posted the paper on its Web site, ahead of its planned print publication on June 14. Early Web postings are made by the journal’s editors in matters that they consider to have public health importance.

The study was not supposed to be released until 5 p.m. yesterday, after the closing bell on Wall Street, but it was inadvertently published yesterday morning by two wire services. The company’s stock began falling almost immediately and was down more than 8 percent by midafternoon, before finishing down 7.85 percent, at $53.18.

The research method employed by the lead author, Dr. Steven E. Nissen of the Cleveland Clinic, was a so-called meta-analysis, which combines the data of various studies. Such analyses, generally used to develop hypotheses, are seen as less reliable than uniform controlled studies.

In an interview, Dr. Nissen said that the average diabetic has a 20.2 percent risk of a heart attack over a seven-year period. A diabetic taking Avandia has a 28.9 percent risk during that same seven-year period, according to his analysis.

“It’s a huge risk,” he said, estimating that “tens of thousands of people” had heart attacks as a result of taking the drug.

An editorial that accompanied the article questioned why doctors would continue to prescribe Avandia, which is known generically as rosiglitazone. But the editorial cautioned patients not to stop taking the medication without discussing it with their doctors.

In its news release, Glaxo defended Avandia’s safety.

“The totality of the data show that Avandia has a comparable cardiovascular profile to other oral antidiabetic medicines,” the release said. “GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks.”

In a conference call with reporters yesterday, the company’s chief medical officer, Dr. Ronald L. Krall, said that Glaxo had submitted similar data to the F.D.A. last August after noticing a signal of increased cardiovascular risk. Its data indicated a 31 percent increased risk, based on a similar meta-analysis. That information was also posted on the company’s Web site last year, Glaxo said.

But the company submitted its analysis along with another study that supported the drug’s safety — a look at 30,000 patients taking Avandia and other diabetes drugs enrolled in an unidentified insurer’s managed care plan. And the company also said that a drug safety monitoring committee overseeing a continuing study of the drug’s cardiovascular risks had not raised any red flags.

Avandia, a pill on the market since 1999, is used for the treatment of Type 2, or adult-onset, diabetes. It is sold alone as Avandia and in combination with other drugs as Avandamet and Avandryl. With $3 billion in worldwide sales last year, it was Glaxo’s second-biggest product after the asthma inhalant Advair.

Patients who are newly discovered to have Type 2 diabetes generally receive another oral drug, metformin, as the first-line treatment, with Avandia among several medications recommended when metformin alone no longer works. If those treatments fail, patients typically move to insulin injections.

Some doctors contend that another drug that works by a similar mechanism to Avandia — Actos, made by the Takeda Pharmaceutical Company and jointly marketed by Eli Lilly — has been shown in studies to have a superior cardiovascular risk profile.

The journal editorial, by Dr. Bruce M. Psaty of the University of Washington and Dr. Curt D. Furberg of Wake Forest University, said that they could see no reason doctors would prescribe Avandia, given the alternative treatments available.

“In view of the potential cardiovascular risks,” the editorial said, “and in the absence of evidence of other related advantages, except for laboratory measures of glycemic control, the rationale for prescribing rosiglitazone at this time is unclear.” Glycemic refers to blood sugar.

The editorial said that problems with Avandia had once again spotlighted flaws in the nation’s drug approval and monitoring system. They asserted that those problems had not been fully addressed by legislation recently passed by the Senate that is meant to strengthen the agency’s powers. Both Dr. Psaty and Dr. Furberg have been critical of the F.D.A.’s drug approval process in the past.

On Capitol Hill, several lawmakers questioned whether Avandia could be another Vioxx — a painkiller that Merck pulled off the market in 2004 after it was shown to cause heart attacks in some patients.

Rep. John D. Dingell, the Michigan Democrat who is chairman of the House Energy and Commerce Committee, said the agency’s handling of questions about Avandia might reflect dangerous shortcomings in its drug safety monitoring. Those questions, he said, would figure in his committee’s efforts to force the agency to be a tougher regulator.

“We learned from an F.D.A. briefing that the agency has known about this problem for at least eight months and perhaps even longer,” Mr. Dingell said in a prepared statement yesterday. “What we don’t know is why diabetics and their doctors haven’t been notified of the substantial risk to the heart from a drug prescribed to protect the cardiovascular system.”

Henry A. Waxman, the California Democrat who is chairman of the Committee on Oversight and Government Reform, said yesterday that he had started an investigation of Avandia and would call Glaxo officials and Dr. Andrew C. von Eschenbach, the F.D.A. commissioner, to testify at a hearing on June 6.

The finding — that Avandia raises the risk of heart attack by 43 percent — was based on a review of 44 studies of the drug. The review was conducted by Dr. Nissen and Kathy Wolski of the Cleveland Clinic, where Dr. Nissen is the chief of cardiovascular medicine.

Dr. Nissen, who had been among the first doctors to raise questions about the cardiovascular safety of Vioxx, first publicly raised concerns about Avandia in a letter published last December in the British medical journal Lancet.

Dr. Nissen’s letter noted increased cardiovascular problems in a 5,000-patient clinical study, called Dream. Glaxo had sponsored the Dream trial in an effort to expand the product beyond a treatment for diabetes by using it to prevent the disease.

In the Dream trial, intended to determine if Avandia could prevent diabetes, patients taking Avandia had 66 percent more heart attacks, 39 percent more strokes and 20 percent more deaths from cardiovascular-related problems compared with a placebo. That outcome, Dr. Nissen wrote, “virtually precludes the possibility of an overall benefit and suggest an unexpected mechanism for harm.”

Both Avandia and Actos, the Takeda drug, are members of a class of compounds with a troubled history. One drug in the group, Rezulin , was withdrawn in 2000 because it caused liver problems.

Source : http://www.nytimes.com

White House Says It Will Move Quickly to Replace Wolfowitz

The Bush administration promised Friday to find someone quickly to succeed Paul D. Wolfowitz as president of the World Bank and bring management skills to the job of healing an institution battered by the turmoil over Mr. Wolfowitz’s tenure.

“We want to make sure that we are selecting the best individual for the job,” said Tony Fratto, a White House spokesman. “We want someone who has a real passion for lifting people out of poverty.”

The administration also reiterated that the next bank president should be an American, as has been the case since it was founded in the 1940s. Many European leaders are on record as favoring an international competition and are hoping that the United States will consider people in other countries, but other nations signaled earlier that if Mr. Wolfowitz resigned, they would go along with another American as bank president.

Mr. Wolfowitz told weary colleagues on the World Bank’s board of directors, in a letter released Friday, that “we must move forward in a spirit of forgiveness, both for the sake of each of us as individuals and for the sake of the Bank Group’s mission to serve the world’s poor.”

Although he plans to remain in office until June 30, he said he would not make major personnel or policy decisions and would delegate day-to-day functions to subordinates. “I may make a farewell trip to Africa at the request of a number of leaders, but would consult with you prior to making any plans,” he told the board of directors.

Mr. Wolfowitz resigned Thursday after weeks of furor over a generous compensation package he arranged for his companion, Shaha Ali Riza, when she was transferred from the bank because he had become president. But there was also widespread unhappiness over many of Mr. Wolfowitz’s policies and actions at the bank.

Treasury Secretary Henry M. Paulson Jr. is to lead a search for a new bank president, but ultimately the choice will be made by President Bush, administration officials said. Mr. Paulson’s priority, they said, will be to find a capable and experienced manager, perhaps at a corporation, banking firm or university.

Administration officials, who requested anonymity because they didn’t want to criticize Mr. Wolfowitz on the record, said that one of the reasons he ran into trouble at the bank was that he was not a consensus builder.

Mr. Wolfowitz sought to institute new policies to fight corruption in the countries aided by the bank, for example. But bank officials complained that he failed to lay the groundwork by consulting country managers at the bank and the board of directors before suspending aid to some countries. This year, the board adopted a policy forcing him to consult them before cutting off financing to countries accused of tolerating graft.

The Treasury Department said Mr. Paulson had already begun to consult finance and economic development ministers in other countries about possible choices for the post, or at least about the kind of candidate he was seeking.

In addition, Mr. Paulson’s deputy, Robert M. Kimmitt, discussed the matter on Friday with leading finance ministers from the Group of 8 who are meeting this weekend in Potsdam, Germany.

Among the names being mentioned are Bill Frist, the former Republican senator from Tennessee and former Senate majority leader, and Robert B. Zoellick, a former deputy secretary of state and United States trade representative, now a top executive at Goldman Sachs in New York.

Mr. Zoellick had been a leading candidate to head the bank in 2005 when the job came open after the retirement of James D. Wolfensohn, until the White House selected Mr. Wolfowitz instead.

Mr. Frist, a doctor, has worked on medical assistance programs in Africa and other poor countries.

Also mentioned as a possible successor is Richard C. Levin, the Yale president and economist who is close to President Bush.

There was initial speculation that Paul A. Volcker, former chairman of the Federal Reserve, might be asked to serve as an interim head of the World Bank while a permanent replacement was sought. But that course of action now seems unlikely, given the Bush administration’s determination to pick a long-term chief.

Administration officials are also considered unlikely to turn to Stanley Fischer, the governor of the Bank of Israel, who was also mentioned in early speculation about a successor to Mr. Wolfowitz. Mr. Fischer is identified with liberal positions on lending, administration officials said.

Senior board members spent time on Friday meeting with staff members who are still unhappy that Mr. Wolfowitz was not formally ousted or that the board did not adopt a resolution finding him guilty of violating ethics and governance codes of conduct.

Source : http://www.nytimes.com

Thailand violates drug patents for its own profit

This week, the Office of the U.S. Trade Representative issued its annual review of the protection and enforcement of intellectual property rights across the world. Twelve countries with particularly egregious policies were placed on the report's Priority Watch List, and for the first time, Thailand was elevated to that classification.

This dishonor was expected. Over the last few months, the nation's military-appointed government has issued several ''compulsory licenses'' on patented medicines.

Citing a World Trade Organization rule that permits a country to breach patents during a ''national emergency,'' the Thai government has granted itself the right to produce copies of Kaletra and Efavirenz, two powerful HIV/AIDS antiretrovirals, and Plavix, the popular heart-disease drug. The government has claimed, with much praise from a broad coalition of health activists and nongovernmental organizations, that it would be unable to meet its commitment to universal health care without compulsory licensing.

The truth is that Thailand's decision has nothing to do with lowering costs or compassion. Instead, the Thai government appears to be violating patents for its own profit. And in doing so, the nation is putting Thai citizens at great risk.

Consider: Earlier this month, Abbott Laboratories announced that it would sell to Thailand and dozens of other low-income nations, Kaletra for $1,000 per patient annually. That's about 55 percent less than Kaletra's current cost and cheaper than every copy of the medicine available. In March, Merck similarly offered to drastically reduce the price of Efavirenz.

Yet Thailand has asserted that it will maintain compulsory licenses for both medicines.

Or look at the Global Fund, which recently announced that it would foot Thailand's entire bill for Efavirenz by purchasing a generic version of the drug from a World Health Organization-approved plant in India.

The Thai government rejected the Global Fund's offer, leaving Thai taxpayers to foot the bill for the drug's manufacture.

Clearly, this isn't about improving access to medicines for the Thai people. It's about establishing Thailand's state-owned drug manufacturer -- the Government Pharmaceutical Organization -- as a dominant regional manufacturer of copycat drugs. Only the GPO can sell copycat drugs to the Thai government, which excludes private manufacturers from receiving government contracts.

This leaves the GPO to reap all the cushy rewards, which flow right back to the government and provide further opportunities for the nation's politically connected to enrich themselves.

In 2005, the GPO made a profit of around $35.5 million and reinvested only about 2 percent of that sum into research and development. As one would expect, this money lines the pockets of Thailand's ruling class.

Further, when it comes to producing drugs, the GPO has a terrifying track record. In 2002, the Global Fund awarded Thailand $133 million to test and manufacture its locally produced HIV/AIDS medication, GPO-Vir.

Last August, however, the Global Fund was forced to withdraw its funding because the GPO's manufacturing facilities did not meet international standards and the GPO's drug had yet to gain WHO approval.

But it was too little too late. In July 2005, it emerged that GPO-Vir had caused a rise in drug-resistant AIDS cases because of its poor quality. Despite this track record, Thailand continues to administer GPO-Vir to its HIV/AIDS patients -- which, ironically, is making the virus even more deadly.

Yet instead of denouncing the Thai government's dangerous and self-interested policies, activist groups have urged it to go further and faster. Even worse, many U.S. lawmakers have piled on. Earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for Thailand's use of compulsory licenses.

The public-health impact, as the HIV/AIDS example suggests, will likely prove devastating.

By upgrading Thailand to the Priority Watch List, the U.S. Trade Representative has sternly condemned the Thai government's patent violations. U.S. policymakers should take this opportunity to trumpet the trade representative's report and denounce Thailand's behavior.

Source : http://www.suntimes.com

Mumps outbreak expanding in Canada

An outbreak of the mumps that originated earlier this year is spreading quickly in Canada and has infected more than 200 people, local media reported Saturday.

The disease, which originated in eastern Nova Scotia province and has infected 203 people there, has spread to central provinces, Canadian Broadcasting Corporation (CBC) said.

Ontario is reporting three confirmed cases with five other suspected cases under investigation. New Brunswick also has reported 34 cases and Prince Edward Island had one confirmed case.

Nova Scotia medical officials are calling on Ottawa's Public Health Agency for a national strategy to deal with the outbreaks.

Catching the mumps can have serious consequences. The disease, which causes swollen and tender glands and other flu-like symptoms, can lead to sterility, deafness and viral meningitis.

It is spread by coughing, sneezing, sharing drinks and food, and kissing, and can be contagious for about seven days before symptoms appear, and up to nine days after. 　

Source : http://news.xinhuanet.com

Drugmakers Alerted by U.S. FDA to Watch for Tainted Additive

Regulators in the U.S. are warning drugmakers, suppliers and health professionals to be on the alert for counterfeit medicine additives that substitute a poison used in antifreeze for a common sweetener.

The Food and Drug Administration knows of no contamination cases in the U.S. like those that caused deaths in Panama, Haiti and elsewhere in recent years, the agency said in a statement posted on its Web site.

Some Chinese suppliers have used poisonous diethyline glycol, or DEG, as a substitute for glycerin, a more expensive sweet syrup, in cough medicine, fever medication and injectable drugs, the New York Times reported today. Researchers estimate that thousands of deaths worldwide have been caused by drugs contaminated by DEG, an industrial solvent and an ingredient in some antifreeze, the newspaper said.

The FDA ``is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur,'' the agency said in the statement released May 4.

Tainted cough syrup caused more than 40 deaths in Panama in 2006, and at least 80 children in Haiti died of tainted acetaminophen syrup in late 1995 and early 1996, the FDA said. Similar poisonings were reported in the 1990s in Argentina, Bangladesh, India and Nigeria.

Manufacturing and pharmacist organizations are working with the FDA to ``put into place controls to ensure that this problem does not happen in the U.S. or elsewhere,'' the agency said.

The Federal Food, Drug and Cosmetics Act, giving the FDA much of its authority to regulate drug safety, was enacted after more than 100 people in the U.S. died in 1937 from DEG contamination of a drug used to treat infections.

U.S. agencies also are investigating adulteration of food additives from China in the deaths of cats and dogs that ate pet food containing melamine, used to make plastic kitchen utensils and fertilizers.

Source : http://www.bloomberg.com

Syrupy killer in medicine bottle

A syrupy poison, diethylene glycol, is an indispensable part of the modern world, an industrial solvent and prime ingredient in antifreeze. It also is a killer. And the deaths, if not intentional, are often no accident.

The kidneys fail first. Then the central nervous system begins to misfire. Paralysis spreads, making breathing difficult, then often impossible without assistance. In the end, most victims die.

Many of them are children, poisoned at the hands of their unsuspecting parents.

Over the years, the poison has been loaded into all varieties of medicine — cough syrup, fever medication, injectable drugs — a result of counterfeiters who profit by substituting the sweet-tasting solvent for a safe, more expensive syrup, usually glycerin, commonly used in drugs, food, toothpaste, and other products.

Toxic syrup has figured in at least eight mass poisonings around the world in the past two decades. Researchers estimate that thousands have died. In many cases, the origin of the poison hasn't been determined.

But records and interviews show that in three of the last four cases it was made in China .

Panama is the most recent victim. Last year, government officials there unwittingly mixed diethylene glycol into 260,000 bottles of cold medicine — with devastating results. Families have reported 365 deaths from the poison, 100 of which have been confirmed.

With the onset of the rainy season, investigators are racing to exhume as many potential victims as possible before bodies decompose even more.

Panama's death toll leads directly to Chinese companies that made and exported the poison as 99.5 percent pure glycerin. Forty-six barrels of the toxic syrup arrived via a poison pipeline stretching halfway around the world.

Through shipping records and interviews with government officials, The New York Times traced this pipeline from the Panamanian port of Colon, back through trading companies in Barcelona, Spain, and Beijing, to its beginning near the Yangtze Delta in a place local people call "chemical country."

The counterfeit glycerin passed through three trading companies on three continents, yet not one of them tested the syrup to confirm what was on the label. Along the way, a certificate falsely attesting to the purity of the shipment was repeatedly altered, eliminating the name of the manufacturer and previous owner.

As a result, traders bought the syrup without knowing where it came from, or who made it. With this information, the traders might have discovered — as The New York Times did — that the manufacturer was not certified to make pharmaceutical ingredients.

An examination of the two poisoning cases last year — in Panama and earlier in China — shows how China's safety regulations have lagged behind its growing role as low-cost supplier to the world. It also demonstrates how a poorly policed chain of traders in country after country allows counterfeit medicine to contaminate the global market.

Last week, the U.S. Food and Drug Administration warned drug makers and suppliers in the United States "to be especially vigilant" in watching for diethylene glycol. The warning did not specifically mention China, and it said there was "no reason to believe" that glycerin in this country was tainted.

Even so, the agency called for all glycerin shipments to be tested for diethylene glycol, and said it was "exploring how supplies of glycerin become contaminated."

China is already being accused by U.S. authorities of exporting wheat gluten with an industrial chemical, melamine, that ended up in pet food and animal feed. The FDA recently banned imports of Chinese-made wheat gluten after it was linked to pet deaths in the United States.

Beyond Panama and China, toxic syrup has caused mass poisonings in Haiti, Bangladesh, Argentina, Nigeria, and twice in India.

In Bangladesh, investigators found poison in seven brands of fever medication in 1992, but only after countless children died. A Massachusetts laboratory detected the contamination after Dr. Michael Bennish, a pediatrician who works in developing countries, smuggled samples of the tainted syrup out of the country in a suitcase. Bennish, who investigated the Bangladesh epidemic and helped write a 1995 article about it for BMJ, formerly known as the British Medical Journal, said that given the amount of medication distributed, deaths "must be in the thousands or tens of thousands."

"It's vastly underreported," Bennish said of diethylene glycol poisoning. Doctors might not suspect toxic medicine, particularly in poor countries with limited resources and a generally unhealthy population, he said, adding: "Most people who die don't come to a medical facility."

The makers of counterfeit glycerin, which superficially looks and acts like the real thing but generally costs considerably less, are rarely identified, much less prosecuted, given the difficulty of tracing shipments across borders. "This is really a global problem, and it needs to be handled in a global way," said Dr. Henk Bekedam, the World Health Organization's top representative in Beijing.

Seventy years ago, medicine laced with diethylene glycol killed more than 100 people in the United States, leading to the passage of the toughest drug regulations of that era and the creation of the modern Food and Drug Administration.

The FDA has tried to help in poisoning cases around the world, but there is only so much it can do.

When at least 88 children died in Haiti a decade ago, FDA investigators traced the poison to the Manchurian city of Dalian, but their attempts to visit the suspected manufacturer were repeatedly blocked by Chinese officials, according to internal State Department records. Permission came more than a year later, but by then the plant had moved and its records were destroyed.

"Chinese officials we contacted on this matter were all reluctant to become involved," the American Embassy in Beijing wrote in a confidential cable. "We cannot be optimistic about our chances for success in tracking down the other possible glycerine shipments."

In fact, The New York Times found records showing that the same Chinese company implicated in the Haiti poisoning also shipped about 50 tons of counterfeit glycerin to the United States in 1995. Some of it was later resold to another American customer, Avatar Corp., before the deception was discovered.

"Thank God we caught it when we did," said Phil Ternes, chief operating officer of Avatar, a Chicago-area supplier of bulk pharmaceuticals and nonmedicinal products. The FDA said it was unaware of the shipment.

In China, the government is vowing to clean up its pharmaceutical industry, in part because of criticism over counterfeit drugs flooding the world markets. In December, two top drug regulators were arrested on charges of taking bribes to approve drugs. In addition, 440 counterfeiting operations were closed down last year, the World Health Organization said.

But when Chinese officials investigated the role of Chinese companies in the Panama deaths, they found that no laws had been broken, according to an official of the nation's drug enforcement agency. China's drug regulation is "a black hole," said one trader who has done business through CNSC Fortune Way, the Beijing-based broker that investigators say was a crucial conduit for the Panama poison.

In this environment, Wang Guiping, a tailor with a ninth-grade education and access to a chemistry book, found it easy to enter the pharmaceutical supply business as a middleman. He quickly discovered what others had before him: that counterfeiting was a simple way to increase profits.

And then people in China began to die.

Cheating the system
Wang spent years as a tailor in the manufacturing towns of the Yangtze Delta, in eastern China. But he did not want to remain a common craftsman, villagers say. He set his sights on trading chemicals, a business rooted in the many small chemical plants that have sprouted in the region.

"He didn't know what he was doing," Wang's older brother, Wang Guoping, said in an interview. "He didn't understand chemicals."

But he did understand how to cheat the system.

Wang Guiping, 41, realized he could earn extra money by substituting cheaper, industrial-grade syrup — not approved for human consumption — for pharmaceutical grade syrup. To trick pharmaceutical buyers, he forged his licenses and laboratory analysis reports, records show.

Wang later told investigators that he figured no harm would come from the substitution, because he initially tested a small quantity. He did it with the expertise of a former tailor.

He swallowed some of it. When nothing happened, he shipped it.

One company that used the syrup beginning in early 2005 was Qiqihar No.2 Pharmaceutical, about 1,000 miles away in the far northeastern province of Heilongjiang. A buyer for the factory had seen a posting for Wang's syrup on an industry Web site.

After a while, Wang set out to find an even cheaper substitute syrup so he could increase his profit even more, according to the Chinese investigator. In a chemical book, he found what he was looking for: another odorless syrup — diethylene glycol. At the time, it sold for 6,000 to 7,000 yuan a ton, or about $725 to $845, while pharmaceutical-grade syrup cost 15,000 yuan, or about $1,815, according to the investigator.

Wang did not taste-test this second batch of syrup before shipping it to Qiqihar Pharmaceutical, the government investigator said, adding, "He knew it was dangerous, but he didn't know that it could kill."

The manufacturer used the toxic syrup in five separate drug products: ampules of Amillarisin A for gall bladder problems; a special enema fluid for children; an injection for blood vessel diseases; an intravenous pain reliever; and an arthritis treatment.

In April 2006, one of southern China's finest hospitals, in Guangzhou, Guangdong province, began administering Amillarisin A. Within a month or so, at least 18 people had died after taking the medicine, though some had already been quite sick.

Zhou Jianhong, 33, said his father took the first dose of Amillarisin A on April 19. A week later he was in critical condition. "If you are going to die, you want to die at home," Zhou said. "So we checked him out of the hospital." He died the next day.

"Everybody wants to invest in the pharmaceutical industry and it is growing, but the regulators can't keep up," Zhou said. "We need a system to assure our safety."

The final death count is unclear, since some people who took the medicine died in less populated areas.

In a small town in Sichuan province, a man named Zhou Lianghui said the authorities would not acknowledge that his wife died from taking tainted Amillarisin A. But Zhou, 38, said he matched the identification number on the batch of medicine his wife received with a warning circular distributed by drug officials.

"You probably cannot understand a small town if you are in Beijing," Zhou Lianghui said in a telephone interview. "The sky is high and the emperor is far away. There are a lot of problems here that the law cannot speak to."

The failure of the government to stop poison from contaminating the drug supply caused one of the bigger domestic scandals of the year. Last May, China's premier, Wen Jiabao, ordered an investigation of the deaths, declaring: "The pharmaceutical market is in disorder."

At about the same time, 9,000 miles away in Panama, the long rainy season had begun. Anticipating colds and coughs, the government health program began manufacturing cough and antihistamine syrup. The cough medicine was sugarless so even diabetics could use it.

The medicine was mixed with a pale yellow, almost translucent syrup that had arrived in 46 barrels from Barcelona on the container ship Tobias Maersk. Shipping records showed the contents to be 99.5 percent pure glycerin.

It would be months and many deaths later before that certification was discovered to be pure fiction.

A mysterious illness
Early last September, doctors at Panama City's big public hospital began to notice patients exhibiting unusual symptoms.

They initially appeared to have Guillain-Barre syndrome, a relatively rare neurological disorder that first shows up as a weakness or tingling sensation in the legs. That weakness often intensifies, spreading upward to the arms and chest, sometimes causing total paralysis and an inability to breathe.

The new patients had paralysis, but it did not spread upward. They also quickly lost their ability to urinate, a condition not associated with Guillain-Barre. Even more unusual was the number of cases. In a full year, doctors might see eight cases of Guillain-Barre, yet they saw that many in just two weeks.

Doctors sought help from an infectious disease specialist, Nestor Sosa, an intense, driven doctor who competes in triathlons and high-level chess.

Sosa's medical specialty had a long, rich history in Panama, once known as one of the world's unhealthiest places. In one year in the late 1800s, a lethal mix of yellow fever and malaria killed nearly 1 in every 10 residents of Panama City. Only after the United States managed to overcome those mosquito-borne diseases was it able to build the Panama Canal without the devastation that undermined an earlier attempt by the French.

The suspected Guillain-Barre cases worried Sosa. "It was something really extraordinary, something that was obviously reaching epidemic dimensions in our hospital," he said.

With the death rate from the mystery illness near 50 percent, Sosa alerted the hospital management, which asked him to set up and run a task force to handle the situation.

The assignment, a daunting around-the-clock dash to catch a killer, was one he eagerly embraced.

Several years earlier, Sosa had watched as other doctors identified the cause of another epidemic, later identified as hantavirus, a pathogen spread by infected rodents.

"I took care of patients but I somehow felt I did not do enough," he said. The next time, he vowed, would be different.

Sosa set up a 24-hour "war room" in the hospital, where doctors could compare notes and theories as they scoured medical records for clues.

As a precaution, the patients with the mystery illness were segregated and placed in a large empty room awaiting renovation. Health care workers wore masks, heightening fears in the hospital and the community.

"That spread a lot of panic," said Dr. Jorge Motta, a cardiologist who runs the Gorgas Memorial Institute, a widely respected medical research center in Panama. "That is always a terrifying thought, that you will be the epicenter of a new infectious disease, and especially a new infectious disease that kills with a high rate of death, like this."

Meanwhile, patients kept coming, and hospital personnel could barely keep up.

"I ended up giving CPR," Sosa said. "I haven't given CPR since I was a resident, but there were so many crises going on."

Frightened hospital patients had to watch others around them die for reasons no one understood, fearing that they might be next.

As reports of strange Guillain-Barre symptoms started coming in from other parts of the country, doctors realized they were not just dealing with a localized outbreak.

Pascuala Perez de Gonzalez, 67, sought treatment for a cold at a clinic in Cocle Province, about a three-hour drive from Panama City. In late September, she was treated and sent home. Within days, she could no longer eat; she stopped urinating and went into convulsions.

The decision was made to transport her to the public hospital in Panama City, but on the way she stopped breathing and had to be resuscitated. She arrived at the hospital in a deep coma and later died.

Medical records contained clues but also plenty of false leads. Early victims tended to be males, older than 60 and diabetic with high blood pressure. About half had been given Lisinopril, a blood pressure medicine distributed by the public health system.

But many who did not receive Lisinopril still got sick. On the chance that those patients might have forgotten that they had taken the drug, doctors pulled Lisinopril from pharmacy shelves — only to return it after tests found nothing wrong.

Investigators would later discover that Lisinopril did play an important, if indirect role in the epidemic, but not in the way they had imagined.

A major clue
One patient of particular interest to Sosa came into the hospital with a heart attack, but no Guillain-Barre-type symptoms. While undergoing treatment, the patient received several drugs, including Lisinopril. After a while, he began to exhibit the same neurological distress that was the hallmark of the mystery illness.

"This patient is a major clue," Sosa recalled saying. "This is not something environmental, this is not a folk medicine that's been taken by the patients at home. This patient developed the disease in the hospital, in front of us."

Soon after, another patient told Sosa that he, too, developed symptoms after taking Lisinopril, but because the medicine made him cough, he also took cough syrup — the same syrup, it turned out, that had been given to the heart patient.

"I said this has got to be it," Sosa recalled. "We need to investigate this cough syrup."

The cough medicine had not initially aroused much suspicion because many victims did not remember taking it. "Twenty-five percent of those people affected denied that they had taken cough syrup, because it's a nonevent in their lives," Motta said.

Investigators from the U.S. Centers for Disease Control and Prevention, who were in Panama helping out, quickly put the bottles on a government jet and flew them to the United States for testing. The next day, Oct. 11, as Panamanian health officials were attending a news conference, a Blackberry in the room went off.

The tests, the CDC was reporting, had turned up diethylene glycol in the cough syrup.

The mystery had been solved. The barrels labeled glycerin turned out to contain poison.

Sosa's exhilaration at learning the cause did not last long. "It's our medication that is killing these people," he said he thought. "It's not a virus, it's not something that they got outside, but it was something we actually manufactured."

A nationwide campaign was quickly begun to stop people from using the cough syrup. Neighborhoods were searched, but thousands of bottles either had been discarded or could not be found.

As the search wound down, two major tasks remained: count the dead and assign blame. Neither has been easy.

A precise accounting is all but impossible because, medical authorities say, victims were buried before the cause was known, and poor patients might not have seen doctors.

Another problem is that finding traces of diethylene glycol in decomposing bodies is difficult at best, medical experts say. Nonetheless, an Argentine pathologist who has studied diethylene glycol poisonings helped to develop a test for the poison in exhumed bodies. Seven of the first nine bodies tested showed traces of the poison, Panamanian authorities said.

With the rainy season returning, though, the exhumations are about to end. Dr. Jose Vicente Pachar, director of Panama's Institute of Legal Medicine and Forensic Sciences, said that as a scientist he would like a final count of the dead. But he added, "I should accept the reality that in the case of Panama we are not going to know the exact number."

Local prosecutors have made some arrests and are investigating others connected to the case, including officials of the import company and the government agency that mixed and distributed the cold medicine. "Our responsibilities are to establish or discover the truth," said Dimas Guevara, the homicide investigator guiding the inquiry.

But prosecutors have yet to charge anyone with actually making the counterfeit glycerin. And if the Panama investigation unfolds as other inquiries have, it is highly unlikely that they ever will.

A suspect factory
Panamanians wanting to see where their toxic nightmare began could look up the Web site of the company in Hengxiang, China, that investigators in four countries have identified as having made the syrup — the Taixing Glycerine Factory. There, under the words "About Us," they would see a picture of a modern white building nearly a dozen stories tall, adorned by three arches at the entrance. The factory, the Web site boasts, "can strictly obey the contract and keep its word."

But like the factory's syrup, all is not as it seems.

There are no tall buildings in Hengxiang, a country town with one main road. The Glycerine Factory is not certified to sell any medical ingredients, Chinese officials say. And it looks nothing like the picture on the Internet. In reality, its chemicals are mixed in a plain, one-story brick building.

The factory is in a walled compound, surrounded by small shops and farms. In the spring, nearby fields of rape paint the countryside yellow. Near the front gate, a sign over the road warns, "Beware of counterfeits." But it was posted by a nearby noodle machine factory that appears to be worried about competition.

The Glycerine Factory bought its diethylene glycol from the same manufacturer as Wang, the former tailor, the government investigator said. From this spot in China's chemical country, the 46 barrels of toxic syrup began their journey, passing from company to company, port to port and country to country, apparently without anyone testing their contents.

Traders should be thoroughly familiar with their suppliers, U.S. health officials say. "One simply does not assume that what is labeled is indeed what it is," said Dr. Murray Lumpkin, deputy commissioner for international and special programs for the Food and Drug Administration.

In the Panama case, names of suppliers were removed from shipping documents as they passed from one entity to the next, according to records and investigators. That is a practice some traders use to prevent customers from bypassing them on future purchases, but it also hides the provenance of the product.

The first distributor was the Beijing trading company, CNSC Fortune Way, a unit of a state-owned business that began by supplying goods and services to Chinese personnel overseas and business officials.

As China's market reach expanded, Fortune Way focused its business on pharmaceutical ingredients, and in 2003, it brokered the sale of the suspect syrup made by the Taixing Glycerine Factory. The manufacturer's certificate of analysis showed the batch to be 99.5 percent pure.

Whether the Glycerine Factory actually performed the test has not been publicly disclosed.

Original certificates of analysis should be passed on to each new buyer, said Kevin J. McGlue, a board member of the International Pharmaceutical Excipients Council. In this case, that was not done.

Fortune Way translated the certificate into English, putting its name — not the Glycerine Factory's — at the top of the document, before shipping the barrels to a second trading company, this one in Barcelona.

Li Can, managing director at Fortune Way, said he did not remember the transaction and could not comment, adding, "There is a high volume of trade."

Upon receiving the barrels in September 2003, the Spanish company, Rasfer International, did not test the contents, either. It copied the chemical analysis provided by Fortune Way, then put its logo on it. Ascension Criado, Rasfer's manager, said in an e-mail response to written questions that when Fortune Way shipped the syrup, it did not say who made it.

Several weeks later, Rasfer shipped the drums to a Panamanian broker, the Medicom Business Group. "Medicom never asked us for the name of the manufacturer," Criado said.

A lawyer for Medicom, Valentin Jaen, said his client was a victim, too. "They were tricked by somebody," Jaen said. "They operated in good faith."

In Panama, the barrels sat unused for more than two years, and officials said Medicom improperly changed the expiration date on the syrup.

During that time, the company never tested the product. And the Panamanian government, which bought the 46 barrels and used them to make cold medicine, also failed to detect the poison, officials said.

The toxic pipeline ultimately emptied into the bloodstream of people like Ernesto Osorio, a former high school teacher in Panama City. He spent two months in the hospital after ingesting poison cough syrup last September.

Just before Christmas, after a kidney dialysis treatment, Osorio stood outside the city's big public hospital in a tear-splattered shirt, describing what his life had become.

"I'm not an eighth of what I used to be," Osorio said, his partly paralyzed face hanging like a slab of meat. "I have trouble walking. Look at my face, look at my tears." The tears, he said apologetically, were not from emotion, but from nerve damage.

And yet, Osorio knows he is one of the lucky victims.

"They didn't know how to keep the killer out of the medicine," he said simply.

While the suffering in Panama was great, the potential profit — at least for the Spanish trading company, Rasfer — was surprisingly small. For the 46 barrels of glycerin, Rasfer paid Fortune Way $9,900, then sold them to Medicom for $11,322, according to records.

Chinese authorities have not disclosed how much Fortune Way and the Taixing Glycerine Factory made on their end, or how much they knew about what was in the barrels.

"The fault has to be traced back to areas of production," said Motta, the cardiologist in Panama who helped uncover the source of the epidemic. "This was my plea — please, this thing is happening to us, make sure whoever did this down the line is not doing it to Peru or Sierra Leone or some other place."

A counterfeiter's confessions
The power to prosecute the counterfeiters is now in the hands of the Chinese.

Last spring, the government moved quickly against Wang, the former tailor who poisoned Chinese residents.

The authorities caught up with him at a roadblock in Taizhou, a city just north of Taixing in chemical country. He was weak and sick, and he had not eaten in two days. Inside his white sedan was a bankbook and cash. He had fled without his wife and teenage son.

Chinese patients were dead, a political scandal was brewing and the authorities wanted answers. Wang was taken to a hospital. Then, in long sessions with investigators, he gave them what they wanted, explaining his scheme, how he tested industrial syrup by drinking it, how he decided to use diethylene glycol and how he conned pharmaceutical companies into buying his syrup, according to a government official who was present for his interrogation.

"He made a fortune, but none of it went to his family," said Wang Xiaodong, a former village official who knows Wang and his siblings. "He liked to gamble."

Wang remains in custody as the authorities decide whether he should be put to death. The Qiqihar drug plant that made the poisonous medicine has been closed, and five employees are now being prosecuted for causing "a serious accident."

In contrast to the Wang Guiping investigation, Chinese authorities have been tentative in acknowledging China's link to the Panama tragedy, which involved a state-owned trading company. No one in China has been charged with committing the fraud that ended up killing so many in Panama.

Sun Jing, the pharmaceutical program officer for the World Health Organization in Beijing, said the health agency sent a fax "to remind the Chinese government that China should not be selling poisonous products overseas." Sun said the agency did not receive an official reply.

Last fall, at the request of the United States — Panama has no diplomatic relations with China — the State Food and Drug Administration of China investigated the Glycerine Factory and Fortune Way.

The agency tested one batch of glycerin from the factory, and found no glycerin, only diethylene glycol and two other substances, a drug official said.

Since then, the Chinese drug administration has concluded that it has no jurisdiction in the case because the factory is not certified to make medicine.

The agency reached a similar conclusion about Fortune Way, saying that as an exporter it was not engaged in the pharmaceutical business.

"We did not find any evidence that either of these companies had broken the law," said Yan Jiangying, a spokeswoman for the drug administration. "So a criminal investigation was never opened."

The investigation was subsequently handed off to an agency that tests and certifies commercial products — the General Administration of Quality Supervision, Inspection and Quarantine, according to a drug official.

But the agency acted surprised when it learned that it was now in charge. "What investigation?" asked Wang Jian, director of its Taixing branch. "I'm not aware of any investigation involving a glycerin factory."

Besides, Huang Tong, another investigator in that office, said, "We rarely get involved in products that are sold for export."

Wan Qigang, the legal representative for the Taixing Glycerine Factory, said in an interview late last year that the authorities had not questioned him about the Panama poisoning, and that his company made only industrial-grade glycerin.

"I can tell you for certain that we have no connection with Panama or Spain," Wan said.

But in recent months, the Glycerine Factory has advertised 99.5 percent pure glycerin on the Internet.

Wan recently declined to answer any more questions. "If you come here as a guest, I will welcome you," Wan said. "But if you come again wanting to talk about this matter, I will make a telephone call."

A local government official said that Wan was told not to grant interviews.

A five-minute walk away, another manufacturer, the Taixing White Oil Factory, also advertises medical glycerin on the Internet, yet it, too, has no authorization to make it. The company's Web site says its products "have been exported to America, Australia and Italy."

Ding Xiang, who represents the White Oil Factory, denied that his company made pharmaceutical-grade glycerin, but he said chemical trading companies in Beijing often called, asking for it.

"They want us to mark the barrels glycerin," Ding said in late December. "I tell them we cannot do that."

Ding said he stopped answering calls from Beijing. "If this stuff is taken overseas and improperly used . . . ." He did not complete the thought.

In chemical country, product names are often not what they seem.

"The only two factories in Taixing that make glycerin don't even make glycerin," said Jiang Peng, who oversees inspections and investigations in the Taixing branch of the State Food and Drug Administration. "It is a different product."

One lingering mystery involves the name of the product made by the Taixing Glycerine Factory. The factory had called its syrup "TD" glycerin. The letters TD were in virtually all the shipping documents. What did TD mean?

Spanish medical authorities concluded that it stood for a manufacturing process. Chinese inspectors thought it was the manufacturer's secret formula.

But Yuan Kailin, a former salesman for the Glycerine Factory, said he knew what the TD meant because a friend and former manager of the factory, Ding Yuming, had once told him. TD stood for the Chinese word "tidai" (tee-die), said Yuan, who left his job in 1998 and still lives about a mile from the factory.

In English, tidai means substitute. A clue that might have revealed that the poison was hiding in plain sight.

It was in the product name.

Source : http://www.chron.com

CDC offers advice on citizen use of masks, respirators

Though there is little scientific evidence to go on, wearing a surgical face mask may make sense for people who have to go into crowded public places during an influenza pandemic, federal health officials said today.

Furthermore, people who care for a pandemic flu patient at home or have other close contact with sick people in a pandemic should consider wearing an N-95 respirator, a more elaborate type of mask designed to stop virus-sized particles, the Centers for Disease Control and Prevention (CDC) advised.

CDC officials said avoiding crowded conditions and infected people are the most important precautions in a pandemic, but masks and respirators may provide additional protection. Standard precautions such as hand hygiene and social distancing should also be used, officials said.

"If people are not able to avoid crowded places, [or] large gatherings or are caring for people who are ill, using a facemask or a respirator correctly and consistently could help protect people and reduce the spread of pandemic influenza," CDC Director Dr. Julie Gerberding said in a news release.

For example, says an 11-page guidance document the CDC released, people might choose to wear a face mask when going to a grocery store or a religious service, and they might want to use a respirator when visiting a sick neighbor to deliver food or medicine.

Surgical face masks are simple masks designed to fit across the nose and mouth and catch large respiratory droplets produced by the wearer, but they also offer some protection from others' secretions. They are inexpensive and typically fit fairly loosely.

"Think of it as a way to catch and contain respiratory secretions," Gerberding said at a news briefing today. "These masks are very good catchers of those droplets, they keep your secretions contained within you."

N-95 respirators are thicker masks that are designed to fit tightly to the face and block at least 95% of small airborne particles. They must be specially fitted for the wearer. Surgical masks and N-95 respirators used for infection control in the United States are intended to be discarded after one use, though washable fabric masks are used in a number of countries.

In presenting the CDC guidance today, Gerberding said the agency is doing research to learn more about the role of masks and respirators in blocking flu viruses, but the results won't be available for months or years. "So we decided to gather our best experts to give some practical advice," she said.

Flu spreads mainly when people come in close contact, meaning about 6 feet, with those who are sick, according to the CDC guidance. Long-distance transmission of flu viruses through the air, such as through ventilation systems, has not been proven. Sick people are most likely to spread the virus early in the illness, especially when they first start to cough and sneeze, the document says.

The CDC said people should consider wearing a face mask during a flu pandemic if:

* They have the flu and think they might come in close contact with others.
* They live with someone who has flu symptoms (resulting in possible exposure) and they need to be in a crowded public place.
* They are well and don't expect to have close contact with a sick person, but they need to be in a crowded place.

People should consider wearing an N-95 respirator if they are well and expect to be in close contact with someone who is known or believed to have the flu, and particularly when caring for a sick person at home, the agency said.

The guidance also suggests that, for necessary group meetings, everyone be encouraged to wear a face mask. Another option, it says, is to screen people arriving at a meeting and exclude anyone who has a cough or fever or has been exposed to a sick household member.

Although child-sized face masks are available, children may find it hard to wear them correctly, and the Food and Drug Administration (FDA) has not cleared them, the guidance says. Therefore, other prevention strategies, such as handwashing and social distancing, should be considered for children.

Gerberding said the CDC is not recommending that people stockpile masks or respirators now. However, she said, "This might be a good time to get one and check it out, find out what's comfortable for you. Can you even wear an N-95 respirator?"

Because respirators fit tightly, they make it harder to breathe, which can be a serious problem for people who have heart or lung disease, she said. Also, "For people who have a beard, it's just about impossible to make it fit tight enough to the face to work as an effective filter."

The CDC is stockpiling masks and respirators for use by healthcare workers in a pandemic, mainly because the supply depends heavily on imports. "We have almost 52 million regular surgical masks, and of N-95 respirators we have almost 100 million in the stockpile, with several million more on order," Gerberding said.

If N-95 respirators run short during a pandemic, face masks can be used instead—and should be used when close contact with sick people is expected, the CDC guidance says.

Gerberding acknowledged today that it would be hard for people to properly test the fit of an N-95 respirator on their own, since fit-testing requires training. "We'll be experimenting with others at the FDA and elsewhere to see if there's a way we can help people with that," she said.

She added that a respirator can lead to a "false sense of security," because if it fits poorly so that air can leak around it, it provides less protection. . . . "If you're going to choose a mask right now, it's probably best to think about a simple face mask that prevents your respiratory secretions from infecting someone else" and that also offers some protection from incoming droplets, she said.

"We're not really sure what role an N-95 will play in protection beyond caring for the sick," she added.

In response to a question, Gerberding played down somewhat the role of masks and respirators in business settings. She suggested that employees should follow the same approach the CDC is recommending for the public in general, but said the most important thing in pandemic preparations for businesses is to develop an overall continuity plan.

"Masks may be an extra margin of safety, but none of the masks are likely to make a very big difference," she said. They are "something businesses may consider, but they wouldn't be our priority in terms of preparedness."

The CDC recommendations drew a positive response from two non-CDC public health officials contacted by CIDRAP News today.

"I think the guidance will be useful in the context of getting standardized information out to the public," said Jeffrey Duchin, MD, chief of communicable disease control for Seattle King County Public Health in Washington. Though public health experts don't have definitive answers on how helpful masks and respirators will be in a pandemic setting, the CDC's guidance is a good source of information for people who are interested in their use, he added.

Duchin said he senses that the threat of a pandemic has waned in the public's consciousness. "But when people are engaged in discussing pandemic preparation, masks and respirators are something they ask about," he said.

Paula A. Steib, communication director for the Association of State and Territorial Health Officials, commented, "While masks alone will not eliminate the risk of infection during an influenza pandemic, the CDC interim guidance is a good starting point.

"State and local public health agencies are continuing to work with their communities to prepare for a possible pandemic and to ensure that citizens understand that facemasks and respirators should be used in combination with other preventive measures, such as hand hygiene and social distancing."

Today's interim guidance is intended to augment and supersede information in the Department of Health and Human Services (HHS) Pandemic Influenza Plan, released by the agency in November 2005.

The new guidance was preceded about 3 months ago by CDC recommendations on general nonpharmaceutical community measures to combat a flu pandemic. The new document comes about 6 months after the CDC called for stronger respiratory protection for healthcare workers in a pandemic. In guidance issued in October 2006, the agency said the use of N-95 respirators is prudent for medical staff providing any direct care for pandemic flu patients.

Source : http://www.cidrap.umn.edu

One injection a year to beat brittle bones

A routine annual injection could protect millions of osteoporosis sufferers from broken bones.

Scientists have developed a drug which would be administered intravenously in hospital for 15 minutes, once a year.

They claim it is just as effective as the pills which sufferers take weekly or monthly.

The drug, which could be licensed in the UK as soon as this autumn, may save hospitals millions of pounds in treating fractures.

Osteoporosis is a brittle bone disease which affects around three million elderly - the vast majority of them women. It causes bones to become more porous, raising the risk of fracture.

Although the drugs have been tested only on women, researchers plan to see if men could benefit.

Study leader Dennis Black said: "For the first time, women could have the option of being treated once a year for osteoporosis, instead of having to remember to take a weekly pill.

"Adherence to these weekly and monthly regimens is often a problem, so an annual treatment means patients are far more likely to receive valuable protection against potentially devastating fractures."

Patients on weekly or monthly pills have to follow a number of rules including taking them while standing up and dosing at fixed times of the day.

Half of those prescribed the pills stop taking them within six months and scientists hope sufferers will find the injections much easier.

The study, published in the New England Journal of Medicine, has shown that Aclasta was "very effective" at reducing the incidence of all types of fractures in women with osteoporosis.

The three-year international study of 7,736 post-menopausal women was carried out by the University of California in San Francisco.

More than 130 British women took part in the research with the drug being administered at centres in Aberdeen, Sheffield, Liverpool and Glasgow.

The study found there was a 70 per cent lower risk of spinal fractures and a 41 per cent reduction in the risk of hip fractures.

Broken bones in other parts of the body, such as the wrists, were reduced by 25 per cent.

The results proved Aclasta was as effective as existing treatments, researchers said.

The National Osteoporosis Society estimates that one in six people die within three months of breaking a hip, accounting for around 14,000 deaths per year.

More than 60,000 hip and 120,000 vertebral fractures are treated every year while half of women with osteoporosis after the age of 50 will suffer a break.

The most common existing treatments are Fosamax, Actonel and Boniva, biophosphates which are taken either weekly or monthly as pills.

The Government's Medicines and Healthcare products Regulatory Agency will decide whether to endorse Aclasta, which is also a biophosphate, in the autumn.

The drug is, however, associated with a slightly increased risk of atrial fibrillation, which causes abnormal heart rhythms and increases the risk of stroke.

Professor Black said: "The observed increase in atrial fibrillation was very small - less than one in 100 patients - so it needs to be weighed against the reduction in fracture risk."

There were also slight increases in minor side effects such as fever or muscle pain - but only after the first time the drug was taken.

Iris Swain: Now I can go on a cruise

Iris Swain, who has had osteoporosis for 18 years, said she was euphoric to hear news of the single injection.

The 82-year-old former headmistress said the annual jab would be much easier than worrying about her weekly pill.

"I am absolutely delighted that the once-a-year treatment is now a possibility," she said.

"It can only be beneficial to women of all ages.

"Now I can organise going abroad or going on a cruise. At the moment I can't eat an hour before taking my pill and I have to be so organised.

"I have to go to the doctor every two months for my prescription.

"Some people can't cope with the inconvenience of the treatment so they give up. This would be perfect for them.

"Lots of older women are still trying to work - at least part time - so this would be tremendous for them too."

Mrs Swain, from Wolverhampton, is the chairman of the members' association of the National Osteoporosis Society. She was diagnosed after breaking her wrist in a fall while caring for her mother who also had the illness.

She added: "I feel sure it would save the NHS lots of money.

"I do hope that this treatment might be used to help men as well. Although more women have the disease, the worst cases I have seen have been in men."
Source : http://www.dailymail.co.uk

CDC offers advice on citizen use of masks, respirators

Though there is little scientific evidence to go on, wearing a surgical face mask may make sense for people who have to go into crowded public places during an influenza pandemic, federal health officials said today.

Furthermore, people who care for a pandemic flu patient at home or have other close contact with sick people in a pandemic should consider wearing an N-95 respirator, a more elaborate type of mask designed to stop virus-sized particles, the Centers for Disease Control and Prevention (CDC) advised.

CDC officials said avoiding crowded conditions and infected people are the most important precautions in a pandemic, but masks and respirators may provide additional protection. Standard precautions such as hand hygiene and social distancing should also be used, officials said.

"If people are not able to avoid crowded places, [or] large gatherings or are caring for people who are ill, using a facemask or a respirator correctly and consistently could help protect people and reduce the spread of pandemic influenza," CDC Director Dr. Julie Gerberding said in a news release.

For example, says an 11-page guidance document the CDC released, people might choose to wear a face mask when going to a grocery store or a religious service, and they might want to use a respirator when visiting a sick neighbor to deliver food or medicine.

Surgical face masks are simple masks designed to fit across the nose and mouth and catch large respiratory droplets produced by the wearer, but they also offer some protection from others' secretions. They are inexpensive and typically fit fairly loosely.

"Think of it as a way to catch and contain respiratory secretions," Gerberding said at a news briefing today. "These masks are very good catchers of those droplets, they keep your secretions contained within you."

N-95 respirators are thicker masks that are designed to fit tightly to the face and block at least 95% of small airborne particles. They must be specially fitted for the wearer. Surgical masks and N-95 respirators used for infection control in the United States are intended to be discarded after one use, though washable fabric masks are used in a number of countries.

In presenting the CDC guidance today, Gerberding said the agency is doing research to learn more about the role of masks and respirators in blocking flu viruses, but the results won't be available for months or years. "So we decided to gather our best experts to give some practical advice," she said.

Flu spreads mainly when people come in close contact, meaning about 6 feet, with those who are sick, according to the CDC guidance. Long-distance transmission of flu viruses through the air, such as through ventilation systems, has not been proven. Sick people are most likely to spread the virus early in the illness, especially when they first start to cough and sneeze, the document says.

The CDC said people should consider wearing a face mask during a flu pandemic if:

* They have the flu and think they might come in close contact with others.
* They live with someone who has flu symptoms (resulting in possible exposure) and they need to be in a crowded public place.
* They are well and don't expect to have close contact with a sick person, but they need to be in a crowded place.

People should consider wearing an N-95 respirator if they are well and expect to be in close contact with someone who is known or believed to have the flu, and particularly when caring for a sick person at home, the agency said.

The guidance also suggests that, for necessary group meetings, everyone be encouraged to wear a face mask. Another option, it says, is to screen people arriving at a meeting and exclude anyone who has a cough or fever or has been exposed to a sick household member.

Although child-sized face masks are available, children may find it hard to wear them correctly, and the Food and Drug Administration (FDA) has not cleared them, the guidance says. Therefore, other prevention strategies, such as handwashing and social distancing, should be considered for children.

Gerberding said the CDC is not recommending that people stockpile masks or respirators now. However, she said, "This might be a good time to get one and check it out, find out what's comfortable for you. Can you even wear an N-95 respirator?"

Because respirators fit tightly, they make it harder to breathe, which can be a serious problem for people who have heart or lung disease, she said. Also, "For people who have a beard, it's just about impossible to make it fit tight enough to the face to work as an effective filter."

The CDC is stockpiling masks and respirators for use by healthcare workers in a pandemic, mainly because the supply depends heavily on imports. "We have almost 52 million regular surgical masks, and of N-95 respirators we have almost 100 million in the stockpile, with several million more on order," Gerberding said.

If N-95 respirators run short during a pandemic, face masks can be used instead—and should be used when close contact with sick people is expected, the CDC guidance says.

Gerberding acknowledged today that it would be hard for people to properly test the fit of an N-95 respirator on their own, since fit-testing requires training. "We'll be experimenting with others at the FDA and elsewhere to see if there's a way we can help people with that," she said.

She added that a respirator can lead to a "false sense of security," because if it fits poorly so that air can leak around it, it provides less protection. . . . "If you're going to choose a mask right now, it's probably best to think about a simple face mask that prevents your respiratory secretions from infecting someone else" and that also offers some protection from incoming droplets, she said.

"We're not really sure what role an N-95 will play in protection beyond caring for the sick," she added.

In response to a question, Gerberding played down somewhat the role of masks and respirators in business settings. She suggested that employees should follow the same approach the CDC is recommending for the public in general, but said the most important thing in pandemic preparations for businesses is to develop an overall continuity plan.

"Masks may be an extra margin of safety, but none of the masks are likely to make a very big difference," she said. They are "something businesses may consider, but they wouldn't be our priority in terms of preparedness."

The CDC recommendations drew a positive response from two non-CDC public health officials contacted by CIDRAP News today.

"I think the guidance will be useful in the context of getting standardized information out to the public," said Jeffrey Duchin, MD, chief of communicable disease control for Seattle King County Public Health in Washington. Though public health experts don't have definitive answers on how helpful masks and respirators will be in a pandemic setting, the CDC's guidance is a good source of information for people who are interested in their use, he added.

Duchin said he senses that the threat of a pandemic has waned in the public's consciousness. "But when people are engaged in discussing pandemic preparation, masks and respirators are something they ask about," he said.

Paula A. Steib, communication director for the Association of State and Territorial Health Officials, commented, "While masks alone will not eliminate the risk of infection during an influenza pandemic, the CDC interim guidance is a good starting point.

"State and local public health agencies are continuing to work with their communities to prepare for a possible pandemic and to ensure that citizens understand that facemasks and respirators should be used in combination with other preventive measures, such as hand hygiene and social distancing."

Today's interim guidance is intended to augment and supersede information in the Department of Health and Human Services (HHS) Pandemic Influenza Plan, released by the agency in November 2005.

The new guidance was preceded about 3 months ago by CDC recommendations on general nonpharmaceutical community measures to combat a flu pandemic. The new document comes about 6 months after the CDC called for stronger respiratory protection for healthcare workers in a pandemic. In guidance issued in October 2006, the agency said the use of N-95 respirators is prudent for medical staff providing any direct care for pandemic flu patients.

Source : http://www.cidrap.umn.edu

Import option may threaten drug-safety legislation

The Senate, giving a boost to a measure long favored by congressional Democrats, on Thursday opened the door to letting American consumers save money on prescription medicines by ordering them directly from Canada and other developed countries where prices are lower.

The move could have an unintended side effect -- derailing a long-awaited, bipartisan effort to improve the Food and Drug Administration's faltering system for protecting patients against potentially dangerous medications. The reform plan includes increased funding for drug safety and creation of a nationwide computer surveillance system designed to spot problems with medications approved for the market.

The proposed improvements were developed in response to highly publicized safety lapses, including the belated withdrawal of the diabetes drug Rezulin and the painkiller Vioxx.

Proponents of allowing consumers to buy drugs from Canada and other sources, who have argued that removing the current ban would cut health-care costs, are trying to attach the proposal to the FDA bill. The bill is considered must-pass legislation, because it includes the new safety measures and a new user-fee agreement with industry that is critical for the FDA's overall budget.

Advocates of allowing drug imports, led by Sen. Byron Dorgan, D-N.D., won a 63-28 procedural vote Thursday to allow full debate on their amendment.

As a result, instead of an expected vote to approve revamping the drug-safety system, the Senate put off action until next week and set off new political skirmishing

Pharmaceutical companies -- whose user fees now pay about half the cost of reviewing new drugs -- are determined to stop the import bill.

The industry has powerful leverage. Before the import measure was put forward, it had agreed to support higher user fees to cover most of the cost for improving the drug-safety system. That agreement may now be in jeopardy.

President Bush's advisers have threatened to recommend a veto of the FDA safety and funding bill if the import language remains. Senate Republicans have scrambled to line up support for an amendment that would effectively undo Dorgan's proposal.

The fast-moving developments have put consumer groups in a quandary. Advocates back both a stronger safety system and freer access to medications from abroad.

"It's going to be a long summer," said William Vaughan, a health-policy analyst for Consumers Union, publisher of Consumer Reports. "This could be like the Iraq situation. If we get a veto, then somebody has to blink."

Without a new user-fee bill by the time Congress takes its summer break, the FDA would have to start issuing layoff notices to 2,000 employees, including hundreds of senior-level scientists, physicians and statisticians in its new drugs office.

Dorgan said he was not trying to undermine the safety legislation, but merely to secure the benefits of free trade for U.S. patients, many of whom have no health insurance and must pay retail prices for medications.

"Why should American consumers pay the highest prices in the world?" Dorgan asked during debate on the Senate floor.

Opponents of his bill say lifting import restrictions could result in an avalanche of counterfeit pills, an argument also made by the pharmaceutical companies.

"Allowing the importation of drugs outside the current safety system would pose an immediate and significant risk to the public health in the United States," Health and Human Services Secretary Michael Leavitt said.

The broader FDA funding bill calls for $478 million in industry user fees next year, rising to $841 million in 2012. Of the allocation for 2008, more than $70 million would be used to revamp the FDA's safety system.

The bill would create a new computerized network to scan medical insurance and pharmacy records for signs of trouble with approved drugs, and would significantly bolster the FDA's authority to require that drug companies take steps to protect patients when problems arise.

The House has not yet acted on its version of the legislation.

Source : http://www.latimes.com

Common gene variant linked to heart disease

Caucasians carrying a common genetic variant are up to 60 percent more likely to develop heart disease than those who don't, regardless of lifestyle, according to two new studies.

The studies, involving about 40 000 people in four countries, indicate that genetic factors can play a role in whether a person develops heart disease beyond smoking, diet, exercise or other well-established risk factors.

Heart disease is the leading cause of death in Western countries.

About 25 percent of people of European origin carry this genetic variant, which appears on a region of chromosome 9, the researchers reported.

"If we can identify genetic factors which influence heart disease risk over and above known risk factors, we can do a better job of identifying those people who will benefit most from early intervention to reduce their risk," said Ruth McPherson, director of the University of Ottawa Heart Institute Lipid Research Laboratory and lead author of one of the studies.

McPherson and colleagues scanned the DNA of 1 300 heart patients and 1 500 healthy people in Ottawa for genetic variants.

The results were checked against other large-scale genetic heart studies in the United States and Denmark involving 22 000 patients.

Of the Ottawa patients, about 33 percent of those with early onset heart disease had this genetic variant versus 24 percent of healthy elderly people, McPherson said.

In a separate study, researchers in Iceland reported that this same variant on chromosome 9 accounted for about one-fifth of the incident of heart attack in patients of European origin and one-third of early-onset cases, apart from other risk factors.

That study involved 17 000 people in Iceland and the United States, of whom more than 20 percent of participants carried two copies of the variant.

Patients with two copies of the variant had a more than 60 percent increase in risk of heart attack than those without the variant. Those with one copy had a more moderate risk, the researchers reported.

The variant is "one of the most significant genetic risk factors found to date for heart attack as a public health problem," wrote researchers at deCODE in Reykjavik, Iceland, who led the study.

Source : http://www.iol.co.za

hana confirms first case of bird flu

The deadly H5N1 strain of bird flu has spread to fowl in the West African nation of Ghana, a World Health Organization official confirmed Wednesday.

Earlier this week, Ghanaian officials said they were investigating a suspected outbreak of the disease in birds around the eastern port city of Tema. Though H5N1 had been documented elsewhere in the region, Ghana had not previously had a case confirmed, said Dr. George Amofa, head of public health for Ghana's Health Ministry.

Sophia Twum-Barimah, a spokeswoman for WHO in Ghana's capital, Accra, said the virus was first detected by a Ghanian lab and then confirmed by an Egyptian research center.

H5N1 has killed at least 172 people worldwide since it began its spread through Asian poultry in 2003, according to WHO. Most human deaths come from contact with infected birds, but experts fear H5N1 could mutate into a form that spreads easily among people.

Africa's most populous nation, Nigeria, was the first on the continent to report an outbreak of the disease last year. Outbreaks have also been reported in Cameroon, Djibouti, Egypt, Niger, Ivory Coast, Sudan and Burkina Faso.
FIND MORE STORIES IN: Africa | Egypt | H5N | Nigeria | WHO | Ghana | Ivory Coast | African nation | Burkina Faso | Djibouti | Accra | Ghanian

Ghana had stepped up surveillance to try to prevent incursion of the disease: banning imported poultry and related products from Asia and some neighboring countries, including Nigeria and Ivory Coast.

The virus is particularly worrisome in Africa, where poverty and poor health care means disease spreads quickly.

In January, a young woman became the first Nigerian to die from H5N1. Djibouti and Egypt have also reported infections in humans and eleven people have died of the disease in Egypt.
Source : http://www.usatoday.com

Mad cow disease case confirmed in B.C.

Mad cow disease has been found in a dairy cow in British Columbia, the Canadian Food Inspection Agency confirmed on Wednesday.

The agency said it has the carcass of the 5½-year-old cow and no part of it entered the human food or animal feed systems.

It said the animal's age, combined with the average incubation period of bovine spongiform encephalopathy (BSE), indicates the cow was exposed to a very small amount of infected material, likely during its first year of life.

The agency is now tracing other animals from the same herd and trying to determine how the cow became infected.

In April 2006, another B.C. dairy cow was found to have mad cow disease, which the food inspection agency said was caused by contaminated feed.

The latest case was detected on a farm by a national surveillance program that targets cattle most at risk, the agency said. About 160,000 animals have been tested since 2003.

Although a ban on feed that may contain animal products takes effect in Canada on July 12, the Food Inspection Agency said it still expects to find a small number of BSE cases over the next 10 years as it works toward eliminating the disease.

Source : http://www.cbc.ca

WHO's steps to patient safety

All countries -- from richest to poorest -- can make patients safer by following nine steps, the World Health Organization said Wednesday.

"Healthcare has a ways to go in order to become a high-reliability industry," said Karen Timmons, president and CEO of Joint Commission International, a body that accredits hospitals.

About 10 percent of hospital patients in the developing world are harmed by medical errors, and that figure is likely much higher in the developing world, according to WHO estimates. At any given time, about 1.4 million people worldwide are suffering from infections acquired in hospitals.

For nearly the last decade, efforts have been underway in American and British hospitals to improve the safety of care patients receive, but the WHO announcement marks the first worldwide effort backed by such an influential organization.

The newly released steps range from basics like making sure hands are washed and needles are not reused, to more involved issues like eliminating the confusion that results when different drugs have similar names and appearances.

Healthcare workers also need to do a better job of communicating with each other when patients are handed off, the guidelines say.

Patient safety is a "longstanding issue that has never been seriously addressed," said Sir Liam Donaldson, chief medical officer of England who drafted the WHO resolution that led to the guidelines.

The involvement of the WHO has "raised the discussion of safety to the level of healthcare systems," Donaldson, who is also chairman of the World Alliance for Patient Safety, told United Press International.

Every country should move to implement the changes, which were designed with a broad range of countries in mind, said Timmons, whose organization is part of the WHO Collaborating Center for Patient Safety Solutions, which released the nine steps.

"We set out to identify common but preventable healthcare errors that are prevalent in hospitals around the world," she said.

Healthcare groups from around the world helped develop the guidelines, to make sure they were both pertinent and culturally sensitive, Timmons told United Press International. Nurses in Muslim countries, for example, expressed concern over using alcohol-based rubs to sterilize their hands, because their religion prohibits the use of alcohol.

Less developed countries will likely focus on simpler measures like handwashing and eliminating needle reuse, said Tebogo Kgosietsile Letlape, past-president of the World Medical Association.

Those measures alone could make a huge difference in Africa, he said, where the AIDS epidemic is taking a heavy toll, and infectious diseases cause 40 percent of deaths.

"The importance of handwashing is that it's accessible to everyone," Letlape said.

Other countries may focus more on sophisticated methods of patient identification, like barcodes, Gary Filerman, dean of the Georgetown University department of health systems administration, told UPI.

The guidelines are timely and necessary, he said, but they also include some "wishful thinking," he said.

"Some of the guidelines are more doable in some environments than others. When you move outside well-developed, industrialized countries, no country will move on all nine (guidelines) simultaneously."

Still, with the weight of the international organization behind them, the guidelines could be a useful push for improvement worldwide, he said, especially when it comes to pressuring professional organizations to work on patient safety from within.

"They're blowing the whistle and saying, 'Look world, we've got a problem," Filerman said. "That's a huge step forward."

The recommendations are "all things U.S. hospitals are working on anyway," Nina Shik, infection control specialist at the University of Kansas Hospital, told UPI.

But all nine steps are part of establishing a "culture of safety," she said, and even hand hygiene is still an issue in hospitals in wealthy countries.

In an interconnected world, she added, unsafe medical care is a threat to people everywhere.

"Recent events like outbreaks of SARS and the potential of pandemics has made healthcare providers aware that what happens in one country will have a wide impact," Shik said.

"It's really good to see safety measures endorsed by the WHO."
Source : http://www.upi.com