The head of the World Health Organization said Tuesday that her decisions about swine flu were not influenced by advisers’ links to pharmaceutical companies, which were pointed out in a critical journal article this month.

The article last week in the BMJ, formerly known as the British Medical Journal, pointed out that WHO did not disclose potential conflicts of interest among some of the experts involved in writing guidelines for pandemic flu preparations. Three scientists out of 22 who worked on the guidelines were named as having received some money from pharmaceuticals. The scientists did not work at the drug companies, but were paid for things like speaking at meetings sponsored by them.

The guidelines recommend, among other things, that countries consider buying antivirals and vaccines to combat a pandemic.

The authors of the BMJ article suggest, without providing direct evidence, that these scientists’ ties to pharmaceutical companies influenced WHO’s recommendation that countries buy drugs and vaccines — adding to those drug companies’ profits.

“Our investigation has revealed damaging issues,” wrote Deborah Cohen of BMJ and journalist Philip Carter. “These conflicts of interest have never been disclosed by WHO.”

WHO’s handling of the outbreak is being reviewed by a 29-member expert panel that will report its findings next year. Critics say many of those panelists are also trusted WHO advisers and government employees who could end up whitewashing any failures.

“At no time, not for one second, did commercial interests enter my decision-making,” WHO Director-General Margaret Chan said.

Chan insisted she was open to the panel’s criticism. “Should this committee decide that the current definition of a pandemic and the phases leading up to its declaration need to be tightened or otherwise revised, this will be another recommendation that we will welcome, and act on.”

The U.S. Health and Human Services department defended the U.N. body.

“WHO handled the outbreak in a very measured and appropriate manner,” said Bill Hall, an HHS spokesman. “Their decisions were driven by the existing and evolving conditions at the time.” He said there was “no indication whatsoever that any of their decisions were influenced by industry.”

Other leading officials agreed.

“There was nothing in those guidelines that was not based on the best science available,” said Michael Osterholm, a flu expert at the University of Minnesota who has advised the U.S. on pandemic preparations. He said the scientists consulted were the world’s top flu experts and to not include them would have been a major flaw.

Osterholm said that because flu viruses are unpredictable, it was impossible for anyone to predict last spring that swine flu would not evolve into a more lethal strain.

He slammed the BMJ article, calling it “irresponsible and reckless,” and said its authors had not substantiated their claims WHO behaved inappropriately during the pandemic. “It’s akin to shouting ‘fire’ in a crowded theatre without regard to the consequences,” Osterholm said.

He said while WHO should be subjected to the highest scrutiny, BMJ’s accusations had done “untold damage to the public health infrastructure of the world.”

Harvey Fineberg, the president of the Institute of Medicine in Washington, said the review panel which he heads will hear from critics of WHO when it next meets from June 30 to July 2.

A report published by the Council of Europe last week said the guidelines from WHO, European Union agencies and national governments led to a “waste of large sums of public money and unjustified scares and fears about the health risks faced by the European public.” The agency is not an EU body.

Technorati Tags: drug companies, Flu, flu viruses, pharmaceutical, WHO

Drug giant GlaxoSmithKline says one of its swine flu vaccines has been certified by the World Health Organization, making it available for donors to buy for developing countries.

In a statement issued Tuesday, GlaxoSmithKline PLC said WHO had approved its Canadian vaccine after examining its quality and safety data. The vaccine contains an adjuvant, a chemical compound to boost the immune system.

Last month, Glaxo advised health authorities not to use one batch of its Canadian-manufactured swine flu vaccine in case it triggered life-threatening side effects like anaphylactic shock.

Several vaccine makers have promised WHO 156 million doses of swine flu vaccine, which it hopes to start shipping to 95 poor countries this month.

Technorati Tags: GlaxoSmithKline, swine flu vaccine, World Health Organization

BASEL, Switzerland (AFP) – Swiss drugs giant Novartis has completed a first batch of swine flu vaccine for pre-clinical trials and aims to make a version available in the fall, the company said.

“Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations,” the company said in a statement.

The 10-litre batch “will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials,” it said.

Novartis hopes to start clinical trials in July and “expects licensure in the fall of 2009,” it said.

It added that “more than 30 governments have made requests to Novartis to supply them with influenza A(H1N1) vaccine ingredients.”

The company used cell-based technology to produce the vaccine, a faster method than the traditional technology that uses eggs, according to Novartis.

Novartis received 289 million dollars (206.8 million euros) last month from the US Department of Health and Human Services for the development of the vaccine.

The World Health Organization declared a swine flu pandemic on Thursday, ratcheting up its alert to the maximum level of six.

Swine flu has infected people almost 30,000 people in 75 countries and claimed 144 lives since it was first detected in Mexico in April.

Technorati Tags: Novartis, swine flu, swine flu pandemic, swine flu vaccine

GENEVA – As swine flu cases topped 6,600 worldwide, vaccine makers and other experts met Thursday at the World Health Organization to discuss the tough decisions that must be made quickly to fight the evolving virus.

Pharmaceutical companies are ready to begin making a swine flu vaccine — but as the virus may mutate, questions abound: How much should be produced? How will it be distributed? Who should get it?

The expert group’s recommendations will be passed to WHO Director-General Margaret Chan, who is expected to issue advice to vaccine manufacturers and the World Health Assembly next week.

WHO’s flu chief said the meeting of industry representatives and independent experts sought to answer questions including when to recommend to manufacturers that they switch from a seasonal vaccine to one that works against the pandemic strain.

“No big decisions, no announcements,” Keiji Fukuda told reporters after the meeting. “These are enormously complicated questions, and they are not something that anyone can make in a single meeting.”

But some feel the main decision has already been made.

“It’s a foregone conclusion,” said David Fedson, a vaccines expert and former professor of medicine at the University of Virginia. “If we don’t invest in an H1N1 (swine flu) vaccine, then possibly we could have a reappearance of this virus in a mild, moderate, or catastrophic form and we would have absolutely nothing.”

Most flu vaccine companies can only make one vaccine at a time: seasonal flu vaccine or pandemic vaccine. Production takes months and it is impossible to switch halfway through if health officials make a mistake.

Vaccine makers can make limited amounts of both seasonal flu vaccine and pandemic vaccine — though not at the same time — but they cannot make massive quantities of both because that exceeds manufacturing capacity.

“What is really going to be wrestled with is that seasonal influenza itself has a significant impact on people,” said Fukuda. “This is an infection which is estimated to kill some hundreds of thousands of people each year around the world, so there is a real trade-off if you just say we’re going to stop making that vaccine.”

At the moment, health officials aren’t sure how deadly swine flu is, and whether they will need more seasonal flu vaccine or swine flu vaccine. And if the swine flu mutates, scientists aren’t sure how effective a vaccine made now from the current strain will remain.

WHO estimates that up to 2 billion doses of swine flu vaccine could be produced every year, though the first batches wouldn’t be available for four to six months.

The U.S. Centers for Disease Control and Prevention is currently working on a “seed stock” to make the vaccine, which should be ready in the next couple of weeks. That will be distributed to manufacturers worldwide so they can start producing the vaccine.

Until vaccine manufacturers get the seed stock, they won’t know how many doses of vaccine they can make or how long that would take. Sanofi Pasteur, the world’s biggest vaccine producer, said Thursday it is waiting for the green light from WHO before it starts making swine flu vaccine.

WHO is also negotiating with vaccine producers like GlaxoSmithKline PLC to save some of their swine flu vaccine for poorer nations. Many rich nations like Britain, Canada, Denmark, France, Switzerland and the United States signed deals with vaccine makers years ago to guarantee them pandemic vaccines as soon as they’re available.

As of Thursday, at least 33 countries reported more than 6,600 cases of swine flu worldwide, with 70 deaths. The figures are based on tallies provided by national governments and WHO. According to the global body’s pandemic alert level, the world is at phase 5 — out of a possible 6 — meaning that a global outbreak is “imminent.”

“It’s a no-brainer,” Fedson said of the decision to make swine flu vaccine. “All that’s being discussed now is the details of how to make sure you have enough seasonal flu vaccine and the logistics of making the switch to H1N1 vaccine production.”

While the vaccine question hangs in the air, WHO has given Indian pharmaceuticals giant Cipla the medical go-ahead to produce a generic version of the anti-viral medication Tamiflu. The drug, also known as oseltamivir, is one of two anti-virals shown to work against swine flu.

WHO said Cipla’s generic version was as effective as the original made by Swiss firm Roche Holding AG and would hopefully make the drug more accessible to poor countries.

North America has been the hardest-hit continent. The United States has reported 3,352 laboratory-confirmed cases of swine flu, including four deaths. Arizona officials reported Thursday the latest case, a woman in her late 40s who died last week from what appeared to be complications from the illness.

On Thursday, New York City closed three schools in response to a swine flu outbreak that has left an assistant principal in critical condition and sent hundreds of kids home with flu symptoms, in a flare-up of the virus that sent shock waves through the world last month.

Mayor Michael Bloomberg said that four students and the assistant principal have documented cases of swine flu at a Queens middle school.

Mexico has 2,656 cases and 64 deaths, while Canada has 389 cases with one death, according to WHO figures.

Mexico confirmed 374 more cases Thursday including four more deaths, but Health Secretary Jose Angel Cordova said the new cases show the virus is appearing less deadly. Mexico’s swine flu deaths now represent 2.4 percent of its confirmed cases, he said.

Spain and Britain have the most cases in Europe, at 100 and 78 respectively.

In Central America, Costa Rica has eight cases and one death and Panama has 29 cases.

___

Maria Cheng contributed from London.

Technorati Tags: pandemic vaccine, seasonal flu vaccine, seasonal influenza, swine flu, swine flu vaccine

ATLANTA (Reuters) – Americans are expressing anxiety about swine flu, and the sale of flu medication and items such as protective face masks are up in some places where cases have been confirmed.

“It’s a weird situation right now,” said Aaron Armelin, a telecommunications technician in Los Angeles.

“Everyone’s a little leery of anyone coughing. Even though the news makes it seem really, really bad, it doesn’t seem like it’s actually that much of a concern,” Armelin added.

Interviews with people around the United States indicated few signs of panic or wholesale changes in behavior due to an outbreak of a new virus that has sickened people in several U.S. states and killed up to 149 people in neighboring Mexico.

Big drug store chain Rite Aid Corp said it had seen a jump in sales of Roche Holding AG’s flu drug Tamiflu in New York, California and New Jersey and a national increase in sales of face masks, thermometers and hand sanitizers.

Some stores in the Walgreen drug store chain had sold out of surgical masks and sales were up elsewhere in prescription Tamiflu and hand sanitizers, a spokesman said.

Some people said they were struggling to balance their concern over the virus with what they saw as media exaggeration of the threat.

“People are fairly skeptical about the whole thing. They are just tired of the media that blows things out of proportion,” said Ron Ladner, who owns a restaurant in the small town of Pass Christian on Mississippi’s Gulf Coast.

“Most people … have other problems. In a normal environment they might be worried, but most people are concerned about the economy and paying their bills,” Ladner said.

‘WHEN IS IT GOING TO STOP?’

The flu outbreak comes at a time when the United States is mired in its worst economic recession in decades, increasing a sense for some people of multiple threats to stability coming all at once.

“It’s on all the media, people with masks on their faces, and it’s frightening,” said Carole Brazsky, who works in a coffee shop in Scottsdale, Arizona.

“First it’s jobs, then it’s foreclosures, now it’s this. It’s just one more thing. It’s like: when is it going to stop?” she said.

A previous event that spurred changes in U.S. consumer behavior was the September 11, 2001 attack, said Michael Walton, an economics professor at North Carolina State University.

That triggered a short-term spike in purchases of bottled water and food because of fears that the population might be deprived of access to basic goods, as well as a drop in the number of people taking flights, Walton noted.

“If we do see this (swine flu) escalate with thousands of cases and perhaps deaths and if we see increasingly cautionary tones from government officials, then consumers would react similar to 9/11. But we don’t see anything like that now,” he said.

Even so, some people said they were taking extra precautions particularly in social environments.

“People are talking more about that — ‘Have we got hand sanitizer?’ and, ‘Everybody wash their hands,’” said Hugo Ospina, who works for a law firm in downtown Los Angeles. He added that people were “a little scared.”

(Additional reporting by Steve Gorman in Los Angeles and Tim Gaynor in Phoenix; Editing by Pascal Fletcher)

Technorati Tags: Anxiety, drug tamiflu, flu medication, prescription Tamiflu, swine flu, swine flu precautions