Tuesday, May 31, 2011

More illnesses reported in E. coli outbreak (AP)

BERLIN � Germany's national disease control center says the number of people falling ill in connection with a mysterious bacterial outbreak linked to tainted vegetables continues to rise.

Robert Koch Institute said Tuesday that more than 1,150 people have been affected by the bacteria and that it has confirmed nine deaths.

German media has reported a total of 14 people are suspected to have died from the enterohaemorrhagic E.coli, also known as EHEC, bacteria, which has been found on cucumbers imported from Spain though the exact source is unknown.

Hundreds of people also have been sickened in other European countries, and Russia's chief sanitary agency on Monday banned the imports of cucumbers, tomatoes and fresh salad from Spain and Germany, pending further notice.



Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

Monday, May 30, 2011

Europeans trade blame over E.coli outbreak (AP)

BRUSSELS � Europeans traded blame Monday over the source of a mysterious bacterial outbreak that has killed 14 people and sickened hundreds across the continent and forced Russia to ban imports of some fresh vegetables from Spain and Germany out of fear they could be contaminated.

Austrian authorities sent inspectors to supermarkets to make sure Spanish vegetables suspected of contamination have been taken off shelves, while in Italy the country's paramilitary Carabinieri has been on the lookout since Saturday for suspected contaminated imports from Spain, the Netherlands and other European countries.

Pia Ahrenkilde Hansen, a European Union spokeswoman, said German authorities had identified cucumbers from the Spanish cities of Almeria and Malaga as possible sources of contamination and that a third suspect batch, originating either in the Netherlands or in Denmark and traded in Germany, is also under investigation.

In Germany, which has recorded the most infections and all known deaths, officials said they know that at least some Spanish cucumbers tainted with enterohaemorrhagic E.coli, also known as EHEC, have carried the bacteria, although they still have not been able to determine the exact source.

An EU official who spoke on condition of anonymity due to standing regulations, said the transport chain was long, and the cucumbers from Spain could have been contaminated at any point along the route.

Spain, meanwhile, went on the defensive, saying there was no proof that the E. coli outbreak has been caused by Spanish vegetables.

"You can't attribute the origin of this sickness to Spain," Spain's Secretary of State for European Affairs, Diego Lopez Garrido told reporters in Brussels. "There is no proof and that's why we are going to demand accountability from those who have blamed Spain for this matter."

The World Health Organization described the outbreak as "very large and very severe," and urged countries to work together to get to the root of the problem.

"Almost all cases being reported in other countries have a link to travel or residence in Germany," WHO food safety expert Hilde Kruse said, noting that cases of bloody diarrhea caused by EHEC have also been reported in Denmark, Sweden, France, the UK, the Netherlands and Switzerland.

Andreas Hensel, president of Germany's Federal Institute for Risk Assessment, told ZDF television that "we have found the so-called EHEC pathogens on cucumbers, but that does not mean that they are responsible for the whole outbreak."

Spanish Health Minister Leire Pajin stressed there were no Spanish cases reported and urged Germany to speed up its probe and establish proof of what has caused the outbreak. Germany's allegations "create alarm and affect the producers of a country without any evidence," she said.

The Danish Veterinary and Food Administration said there was "great uncertainty" about the suspicion that Danish cucumbers may be involved but carried out a lab test to reassure consumers. Results are expected Tuesday.

In the Netherlands, which exports more than half of the 1.6 billion cucumbers it produces each year to Germany, panicked growers went into damage control mode after all shipments were stopped.

While the National Agricultural Association met with the deputy agriculture secretary to discuss the situation, a group of cucumber growers invited an independent German institute to carry out tests in hopes it would prove their produce is safe.

Marian Bestelink, spokeswoman for the Dutch Food and Wares Authority, said investigations of a Dutch cucumber grower and Dutch warehouse did not uncover any traces of the bacteria.

"So we can definitely cross this Dutch wholesaler and this Dutch grower off the list of possible sources for the infection," she said.

With the cause of the outbreak still unclear, some countries have taken precautionary measures.

Russia's chief sanitary agency on Monday banned the imports of cucumbers, tomatoes and fresh salad from Spain and Germany pending further notice. It said in a statement that it may even ban the imports of fresh vegetables from all European Union member states due to the lack of information about the source of infection.

Austrian authorities sent inspectors to 33 organic supermarkets Monday to make sure Spanish vegetables suspected of contamination have been removed. The move came after a recall and ban on sales of cucumbers, tomatoes and eggplants that originated in Spain and were delivered to stores in Austria by German companies.

Italy's agriculture lobby, Coldiretti, used the outbreak to urge Italians to support their local growers and avoid imports.

Currently, Italian supermarkets are full of peaches, apricots, cherries and plums from Spain. As for pickles and cucumbers, Italy imported some 8 million kilograms (17 million pounds) from Spain last year.

Czech officials said tests on 120 potentially tainted Spanish cucumbers pulled off shelves on Sunday are expected to be concluded in two days. No illnesses have been reported.

In Poland, officials said Monday that a woman has been hospitalized in serious condition after returning from a trip to the northern German city of Hamburg, where at least 467 cases of intestinal infection have been recorded.

On Sunday, authorities said those included 91 cases of the more severe hemolytic uremic syndrome, known as HUS, but the officials noted on Monday that the number of new diarrhea cases was declining. HUS is a rare complication arising from infection associated with the E. coli bacterium.

EU spokesman Frederic Vincent said Sunday that two greenhouses in Spain that were identified as the source of the contaminated cucumbers had ceased activities. The water and soil there are being analyzed to see whether they were the problem, and the results are expected Tuesday or Wednesday, Vincent said.

____

Oleksyn reported from Vienna. Karel Janicek in Prague, Monika Scislowska in Warsaw, Poland, Frances D'Emilio in Rome, Ciaran Giles in Madrid, David Rising and Geir Moulson in Berlin, Frank Jordans in Geneva, Jan M. Olsen in Copenhagen, Denmark, Vladimir Isachenkov in Moscow and Toby Sterling in Amsterdam contributed.



Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

Hospitals hunt substitutes as drug shortages rise (AP)

WASHINGTON � A growing shortage of medications for a host of illnesses � from cancer to cystic fibrosis to cardiac arrest � has hospitals scrambling for substitutes to avoid patient harm, and sometimes even delaying treatment.

"It's just a matter of time now before we call for a drug that we need to save a patient's life and we find out there isn't any," says Dr. Eric Lavonas of the American College of Emergency Physicians.

The problem of scarce supplies or even completely unavailable medications isn't a new one but it's getting markedly worse. The number listed in short supply has tripled over the past five years, to a record 211 medications last year. While some of those have been resolved, another 89 drug shortages have occurred in the first three months of this year, according to the University of Utah's Drug Information Service. It tracks shortages for the American Society of Health-System Pharmacists.

The vast majority involve injectable medications used mostly by medical centers � in emergency rooms, ICUs and cancer wards. Particular shortages can last for weeks or for many months, and there aren't always good alternatives. Nor is it just a U.S. problem, as other countries report some of the same supply disruptions.

It's frightening for families.

At Miami Children's Hospital, doctors had to postpone for a month the last round of chemotherapy for 14-year-old Caroline Pallidine, because of a months-long nationwide shortage of cytarabine, a drug considered key to curing a type of leukemia.

"There's always a fear, if she's going so long without chemo, is there a chance this cancer's going to come back?" says her mother, Marta Pallidine, who says she'll be nervous until Caroline finishes her final treatments scheduled for this week.

"In this day and age, we really shouldn't be having this kind of problem and putting our children's lives at risk," she adds.

There are lots of causes, from recalls of contaminated vials, to trouble importing raw ingredients, to spikes in demand, to factories that temporarily shut down for quality upgrades.

Some experts pointedly note that pricier brand-name drugs seldom are in short supply. The Food and Drug Administration agrees that the overarching problem is that fewer and fewer manufacturers produce these older, cheaper generic drugs, especially the harder-to-make injectable ones. So if one company has trouble � or decides to quit making a particular drug � there are few others able to ramp up their own production to fill the gap, says Valerie Jensen, who heads FDA's shortage office.

The shortage that's made the most headlines is a sedative used on death row. But on the health-care front, shortages are wide-ranging, including:

_Thiotepa, used with bone marrow transplants.

_A whole list of electrolytes, injectable nutrients crucial for certain premature infants and tube-feeding of the critically ill.

_Norepinephrine injections for septic shock.

_A cystic fibrosis drug named acetylcysteine.

_Injections used in the ER for certain types of cardiac arrest.

_Certain versions of pills for ADHD, attention deficit hyperactivity disorder.

_Some leuprolide hormone injections used in fertility treatment.

No one is tracking patient harm. But last fall, the nonprofit Institute for Safe Medication Practices said it had two reports of people who died from the wrong dose of a substitute painkiller during a morphine shortage.

"Every pharmacist in every hospital across the country is working to make sure those things don't happen, but shortages create the perfect storm for a medication error to happen," says University of Utah pharmacist Erin Fox, who oversees the shortage-tracking program.

What can be done?

The FDA has taken an unusual step, asking some foreign companies to temporarily ship to the U.S. their own versions of some scarce drugs that aren't normally sold here. That eased shortages of propofol, a key anesthesia drug, and the transplant drug thiotepa.

Affected companies say they're working hard to eliminate backlogs. For instance, Hospira Inc., the largest maker of those injectable drugs, says it is increasing production capacity and working with FDA "to address shortage situations as quickly as possible and to help prevent recurrence."

But the Generic Pharmaceutical Association says some shortages are beyond industry control, such as FDA inspections or stockpiling that can exacerbate a shortage.

"Drug shortages of any kind are a complex problem that require broad-based solutions from all stakeholders," adds the Pharmaceutical Research and Manufacturers of America, a fellow trade group.

Lawmakers are getting involved. Sen. Herb Kohl, D-Wis., is urging the Federal Trade Commission to consider if any pending drug-company mergers would create or exacerbate shortages.

Also, pending legislation would require manufacturers to give FDA advance notice of problems such as manufacturing delays that might trigger a shortage. The FDA cannot force a company to make a drug, but was able to prevent 38 close calls from turning into shortages last year by speeding approval of manufacturing changes or urging competing companies to get ready to meet a shortfall.

"No patient's life should have to be at risk when there is a drug somewhere" that could be used, says Sen. Amy Klobuchar, D-Minn., who introduced the bill.

___

EDITOR'S NOTE � Lauran Neergaard covers health and medical issues for The Associated Press in Washington.



Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

Man celebrates 85 years of living with diabetes (AP)

LOS ANGELES � When Bob Krause turned 90 last week, it was by virtue of an unflagging determination and a mentality of precision that kept his body humming after being diagnosed with diabetes as a boy.

A leading diabetes research center named the San Diego resident the first American known to live 85 years with the disease, a life that has paralleled � and benefited from � the evolution in treatment.

Krause's wife of 56 years, his family and friends celebrated his longevity Sunday with a party and a medal from the Joslin Diabetes Center to commemorate his 85-year milestone.

"Bob has outlived the life expectation of a normal healthy person born in 1921," said his physician, Dr. Patricia Wu, attributing Krause's success to his strong character. "He knows that he has to deal with this and he sees this as a part of his life, he doesn't let this get him down."

The trim, white-haired Krause puts it more succinctly: "I'm a stubborn old man. I refuse to give up."

That trait certainly plays into how closely he has tracked his body's chemistry and become expert in the life-saving math that has kept his diabetes under control.

About 18.8 million Americans have been diagnosed with diabetes and an estimated 7 million more live with the disease unwittingly. Krause's form of diabetes, type 1, was once known more commonly as juvenile diabetes, and the more common form of diabetes often tied to obesity is type 2.

About 3 million Americans live with type 1 diabetes, a chronic illness in which their bodies don't make enough insulin, which is needed to convert blood sugar into energy. The exact cause is unknown, though genetics and autoimmune problems are thought to play a role.

Life expectancy is diminished for many diabetics because they face a higher risk of serious health complications, including heart disease, stroke, blindness, kidney damage and limb amputations. Many struggle to manage blood pressure.

The former University of Washington mechanical engineering professor says he's succeeded because he treats his body like a car and he only eats enough food to fuel the machine.

"To keep your diabetes under control you only eat the food you need to before you have activities to perform," Krause said. "I eat to keep me alive instead of eating all the time, or for pleasure."

He says he's not as active as he once was, so he doesn't need a lot of fuel � or variation in diet. For breakfast every day, he eats a bowl of nuts and five pitted prunes. He usually skips lunch and eats a salad with some lean meat for dinner.

"I was surprised when they told me I was the oldest, because I knew there were others out there. I certainly didn't think I was a loner," Krause said after being presented the medal.

The first time Krause met Dr. Wu at Kaiser Permanente San Diego, he came into the endocrinologist's office with a briefcase full of meticulous hand-drawn graphs charting months of his blood sugar levels, caloric intake and insulin doses.

He tests his blood up to a dozen times a day and he brings in updated charts every visit, Wu said.

"I think that's a testament of why he is successful in living with this very difficult to live with condition," she said. "Because of his persistence, his consistency, his hard work."

Krause's careful attention is not unlike many others who have been awarded by Joslin for successfully living with the illness for decades, according to researcher Stephanie Hastings.

The Boston-based center has honored long-time diabetes survivors since 1948, and 34 have earned 75-year medals.

Hastings said Krause is like many longtime successful diabetics, who "always have more information than we need."

If anything, Wu has worked with Krause over the past three years to be a little less rigid so that he doesn't overdose himself with insulin and push his blood sugar too low.

It can be tough to change the patterns of a patient who has dealt with an illness for so long.

Krause was lucky to be diagnosed with diabetes not long after the commercial production of insulin made it widely available. It was 1926, and he was 5 years old and living in Detroit where his father worked for the U.S. Rubber Co.

Krause's younger brother Jackie died of diabetes after being diagnosed a year earlier because insulin wasn't yet available.

Before the discovery of insulin, a diabetes diagnosis was a death sentence, with an expected survival of a couple years at most if patients undertook starvation diets to buy more time.

"I watched Jackie die by starving to death," Krause said. "Before insulin, diabetics would just die because eating doesn't make any difference: anything that you ate couldn't be converted and you literally starved to death because your body couldn't absorb anything."

Canadian scientists Frederick Banting and John Macleod made the discovery in 1921 through experiments with a mixture of ground cow pancreas water and salts that eventually became insulin.

When experimenting with the mixture in humans began in 1922, scientists found they were literally injecting life into people who were wasting away. The discovery led to a Nobel Prize in 1923.

When Krause began taking insulin, diabetics had to boil glass syringes with long needles, sharpening the point when it would go blunt with wear.

Krause remembers how his mother, having lost one child to diabetes, weighed every piece of food Krause ate and kept him on a strict diet. By the time he was 6, he was giving himself injections in the arms or legs at every meal.

Back then, blood sugar testing was imprecise, messy and inconvenient. Krause would boil his urine in a test tube and drop a tablet into it that would turn different colors based on how much blood sugar was in the sample.

Since 1978, Krause has relied on his insulin pump to administer his dosages into his stomach, though he enters the amount of the dose himself rather than relying on automated doses of insulin that pumps can give throughout the day.

Krause's son, Tom Krause, said his engineer father has always been precise, measured and calculated � down to the box of sugar cubes he always kept next to his bed in case he felt faint.

"Having a sugar cube is a precise measurement � that's how much he kept track, down to the cube of sugar," said Tom Krause, 50.

And though Tom Krause inherited his father's diabetes, he doesn't share his father's regimented control of the illness.

"My dad, he is just a machine in how well he cares and manages his diabetes, with his willpower and how long he's been doing it," Tom Krause said.

Krause praises the advent of blood testing as one of the most life-changing moments in diabetes medicine, since it allows him to get a more precise reading of his blood sugar levels by pricking his finger for a test strip that is read by a machine.

"It's easier to control things today than it was back then. Back then you just ate a meal and that's all you ate all day long, you didn't eat anything in between and if your blood sugar got low, you would feel faint and drink orange juice and wait," Krause said.

Though they've worked together to make sure his treatment keeps up with the times, Krause reminds Wu of the same thing each time he leaves her office.

"He'll say, `I've been doing this for 80-number of years and it has gotten me this far and I'm still here, so who are you to tell me how to do this? I've been doing this since before you were born,'" Wu recalls with a laugh.

___

Shaya Tayefe Mohajer can be reached at http://twitter.com/APShaya.

___

Online:

Joslin Diabetes Center: http://www.joslin.org



Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

Saturday, May 28, 2011

UNICEF discloses vaccine prices for 1st time (AP)

UNICEF is for the first time publicizing what drugmakers charge it for vaccines, as the world's biggest buyer of lifesaving immunizations aims to spark price competition in the face of rising costs.

On Friday, UNICEF posted on its website the actual prices that it has paid individual drugmakers for 16 vaccines purchased over the last decade. It's a move that a few Western pharmaceutical companies don't support. Novartis AG and Merck & Co., which only sells one of its many children's vaccines to UNICEF, both declined to have their prices published.

UNICEF said it will continue to disclose pricing of future vaccine deals, with the hope that the transparency will push drugmakers to cut prices and thus allow the organization to vaccinate more children and save more lives.

"Transparency will also help foster a competitive, diverse supplier base," said Shanelle Hall, director of UNICEF's supply division. She noted that it also will help UNICEF's partners and those governments that buy vaccines on their own to make more informed decisions in price negotiations with drugmakers.

UNICEF last year spent $757 million to provide 2.5 billion doses of vaccines to 99 countries, reaching an estimated 58 percent of the world's children.

Its price list shows significant disparity, with Western drugmakers often charging UNICEF double what companies in India and Indonesia do. Just as striking is the steady rise in prices in the last decade, with the cost of vaccines against measles, polio and tetanus roughly doubling between 2001 and 2010. Prices of a few vaccines have remained flat or declined as additional competitors entered the market.

There's also a huge spread in prices among various vaccines.

As might be expected, shots that have been around for some time and those vaccines made by multiple companies cost just pennies per dose, such as tetanus and tuberculosis shots and oral polio vaccine. But a combination shot for immunization against diptheria, tetanus, whooping cough, hepatitis B and haemophilus influenza can run UNICEF $3 or more per dose. The dual vaccine against 10 or more strains of pneumococcal disease, which causes ear infections and meningitis, costs $3.50 a shot. And some of the vaccines require more than one booster shot, adding to the cost.

The cost is partly justified by the complex manufacturing process used to make combination vaccines. And UNICEF still pays far less than the $71 and $114 per dose, respectively, that is charged in the U.S. for those two vaccines. But given that the organization's mission is to immunize entire populations of at-risk children, any savings means more can be vaccinated.

British drugmaker GlaxoSmithKline PLC said in a statement that it "always offers UNICEF our vaccines at our lowest price as they are targeted at the people who need them the most, but are least able to pay. We welcome UNICEF's move to publish retrospective prices for tenders and hope that this will help inform decisions for future vaccine procurement." Messages left with other Western vaccine makers seeking comment weren't immediately returned Saturday afternoon.

Daniel Berman, deputy director of the Doctors Without Borders Campaign for Essential Medicines, called the new price disclosures "a real step forward."

"By getting access to these prices, buyers will be able to take advantage of the increasing capacity of emerging countries to develop and produce quality vaccines at significantly lower costs," he said in a statement.

He added that GAVI, the Global Alliance for Vaccines and Immunization, "should flex its purchasing muscles to encourage manufacturers" to produce vaccines that don't require refrigeration and can be administered through patches or liquids, rather than needles.

GAVI, which is supported by contributions from developed nations and the Bill & Melinda Gates Foundation, is the primary funder of vaccines purchased by UNICEF. Helen Evans, interim CEO of the GAVI Alliance, said in a joint statement with UNICEF that GAVI "strongly believes in timely, transparent and accurate information on pricing."

Many of the largest global pharmaceutical companies � most recently Johnson & Johnson � have jumped into the vaccine business in recent years to diversify revenue as many of their blockbuster pills are facing generic competition. Vaccines are all but immune from generic competition in developed countries, and some newer shots, such as Pfizer Inc.'s Prevnar pneumococcal vaccine, now bring in billions of dollars in revenue each year.

Those big companies are looking to less-developed countries for future sales growth, and vaccines against crippling and deadly childhood diseases are cost-effective purchases for countries with small health budgets.

AIDS groups and advocates for affordable health care in developing countries have campaigned for years for big pharmaceutical companies to sell their patented medicines to those countries at drastically reduced prices, or to allow generic drug makers in countries such as India to do so. They've had some success, so UNICEF's new price plan is a logical strategy.

UNICEF's Hall said the organization hopes to expand the transparency initiative to other essential products that it buys for children. UNICEF supports child health and nutrition, good water and sanitation, and quality basic education for boys and girls across the globe.



Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials

UNAIDS to Vatican: Pope's HIV-condom view helpful (AP)

VATICAN CITY � The head of the U.N. AIDS agency told a Vatican conference on AIDS Saturday that Pope Benedict XVI's comments about the use of condoms in preventing HIV transmission had opened new prospects for dialogue with the U.N.

Dr. Michel Sidibe, executive director of UNAIDS, said it will help strengthen the fight for greater access to treatment for those afflicted. Sidibe said Benedict's views were important, even if differences remain between the U.N. and Catholic Church.

The U.N. says condoms should be an integral part of HIV prevention programs; the Vatican opposes condoms as part of its overall opposition to artificial contraception.

But Benedict said last year that a male prostitute who intends to use a condom might be taking a first step toward greater responsibility by looking out for the welfare of his partner, even if condoms aren't a moral solution.

"This is very important," Sidibe told the conference. "This has helped me to understand his position better and has opened up a new space for dialogue."

While Benedict's comments in the book "Light of the World" drew near-universal praise within the AIDS community, conservative Catholics insisted he wasn't altering church teaching and that the church's ban on condoms remained. After three attempts at clarification, the Vatican eventually issued a definitive ruling from the Congregation for the Doctrine of the Faith saying the pope in no way was changing church teaching.

Nevertheless, the impression left at least within the AIDS community was that he had made an opening � and Sidibe latched onto that in his comments Saturday.

Sidibe said previously the AIDS community and Catholic Church were "talking over" one another and often held opposing views about how to deal with the AIDS crisis. But he said Benedict's words had opened a new possibility for working together, particularly in agitating for greater access to anti-retroviral treatments for the world's poorest patients.

"Yes, there are areas where we disagree and we must continue to listen, to reflect and to talk together about them. But there are many more areas where we share common cause," Sidibe said.

Increasing access to treatment has become an even greater rallying call following the recently published results of a nine-nation study showing that HIV-positive patients who received early treatment were 96 percent less likely to spread the virus to their uninfected partners.

Sidibe called the research a "game-changer" in the fight against AIDS and Vatican officials said it gave new hope to couples where one partner is HIV-positive and want to have children.

While there had never been an official Vatican policy about condoms and HIV, some Vatican officials had previously insisted that condoms not only don't help fight HIV transmission but make it worse because they gave users a false sense of security. Some claimed the HIV virus could easily pass through the condom's latex barrier.

Benedict himself drew the wrath of UNAIDS and several European countries when, en route to Africa in 2009, he told reporters that the AIDS problem couldn't be resolved by distributing condoms. "On the contrary, it increases the problem," he said then.

The comments drew fierce criticism in Africa, where an estimated 22.4 million people are infected with HIV, two-thirds of the global total.

With his revised comments, the Vatican debate seems to have changed ever so slightly. The fact that Sidibe was even invited to speak at the Vatican was significant; usually only like-minded outsiders are invited to speak at Holy See conferences.

That said, the Vatican officials present made clear that condoms weren't the answer to fighting AIDS and that changing sexual behavior to emphasize marital fidelity was the best answer. Monsignor Zygmunt Zimowski, head of the Pontifical Council for Health Care Workers which hosted the meeting, didn't even refer to Benedict in his keynote speech.

Rather, he cited Pope John Paul II on three separate occasions, quoting him as speaking about the "crisis of values" that was behind the AIDS crisis.



Powered By WizardRSS.com | Full Text RSS Feed | Amazon Plugin | Settlement Statement | WordPress Tutorials