Glaxo's Big Bet on Battling Pandemics

By JEANNE WHALEN

LONDON -- GlaxoSmithKline PLC has spent five years fashioning itself into a one-stop pandemic shop. Now, as the swine-flu virus sweeps the globe, the U.K.-based drug giant will find out whether the world is buying.

Glaxo began delivering doses of its new H1N1 vaccine this week, the biggest push so far in its multipronged effort to combat, and cash in on, virulent virus strains.

The company has spent more than $3.2 billion on research, acquisitions and extra manufacturing in anticipation of a flu pandemic. Ranging from vaccines and antiviral drugs to medicated face masks and diagnostic tools, Glaxo's portfolio sets it apart from rivals that have tended to focus on one aspect of flu-fighting, such as Sanofi-Aventis SA, which makes vaccines, and Roche Holding AG, which makes the antiviral drug Tamiflu.

"Short of putting beds in the labs, we are throwing just about every resource we've got into this situation," says Chief Executive Andrew Witty.

With the new H1N1 strain sparking concern around the world, the company has faced some accusations of profiteering. This summer, Britain's Evening Standard newspaper said Glaxo was set to charge the U.K. about $10 for a shot it claimed cost only $1.60 to make. The politics of pandemic shots are also tricky, because global vaccine supplies can't meet global demand: Antipoverty group Oxfam has said poorer countries will have limited access to vaccines because many wealthy nations have pre-ordered shots from Glaxo and other makers.

Mr. Witty responds that Glaxo is donating 50 million swine-flu shots to the World Health Organization for use in poor countries. That, combined with the high cost of research and production, makes Glaxo's prices fair, he says. Glaxo confirms that the richest countries pay about $10 per shot. It won't disclose its profit margins but says they aren't as high as the British paper reported.

Glaxo's bet is risky because flu pandemics, in which a new or rare virus spreads easily around a large swath of the globe, are relatively rare. "That's the danger of being in this business -- you can't count on demand next year," says Gbola Amusa, a pharmaceutical analyst with UBS in London.

So far, the gamble appears to be paying off. On Tuesday, Glaxo said governments around the globe have ordered 440 million doses of its swine-flu vaccine, which it aims to deliver this year and early in 2010. That represents a 50% increase in orders since the company last disclosed its totals, in August, and could represent revenues of some $4 billion, Citigroup said in a research note Tuesday. Glaxo's global sales last year were about $39 billion.

Glaxo has also received an order from the U.S. for about $250 million worth of bulk-vaccine ingredients and "pandemic products." Sales of antiviral Relenza, the company's rival to Tamiflu, spiked to about $96 million in the second quarter of the year, from less than $5 million a year earlier.

Glaxo's strategy reflects how drug makers are pushing beyond prescription pills as valuable patents expire. The company has faced competition from makers of low-cost generic drugs on several of its big sellers, including antidepressant Wellbutrin and epilepsy drug Lamictal. A business built on vaccines is less likely to be undercut by low-cost producers: Vaccines are complicated to make, factories are expensive to build and maintain, and demand for flu shots can be fickle.

Mr. Witty believes that with governments becoming more concerned about pandemics, the business has staying power.

"We're more than well aware that people don't want to see companies somehow exploiting this situation," the CEO said at a recent press briefing. "We're not trying to generate here some crazy level of profit -- but equally, our shareholders wouldn't want us to do this for anything other than a return."

Glaxo's flu strategy is rooted in the last global flu scare. In 2004, the H5N1 virus was killing scores of birds in Asia. Though it didn't spread quickly from human to human, it killed about half the people it infected. In September of that year, the U.S. Department of Health and Human Services summoned a Glaxo research official to Washington to give a briefing on Relenza, which Glaxo has sold since the late 1990s to ease the symptoms of seasonal flu.

Mike Ossi, an infectious disease expert at Glaxo, recalls telling officials that animal studies suggested Relenza might work against the H5N1 strain, though there had been no human studies. Still, Dr. Ossi recalls, the health officials kept asking: "How much can you make, and how fast?"

That helped crystallize Glaxo's focus. Then-Chief Executive Jean-Pierre Garnier tapped a lieutenant, David Stout, to assemble a team to focus on pandemic flu. The group started opening new production lines for Relenza in Australia, France and the U.S., says Dr. Ossi, who was part of the team. In 2005, the U.S. government placed a large order for Relenza. Other countries followed.

Glaxo also raced to develop an avian-flu vaccine. At its main vaccine center in Rixensart, Belgium, researchers already knew the basic flu-shot recipe: They would isolate the H5N1 virus, allow it to multiply in a hospitable environment -- chicken eggs -- then kill the viruses and blend them together to form the main ingredient in flu vaccine, called antigen.

The challenge was that it takes months to make antigen, and Glaxo's vaccine plants couldn't make unlimited amounts. Should an avian-flu outbreak turn into a pandemic, Glaxo would need to stretch its antigen supply. Also, the company wanted to make a vaccine that would protect people even if the H5N1 virus mutated into new forms, says Thomas Breuer, chief medical officer in Glaxo's vaccine division.

The answer to both of these problems, Glaxo decided, was an adjuvant -- a booster ingredient that makes antigen more powerful. In the summer of 2005, Glaxo paid about $300 million for a Washington state company that made the adjuvant it wanted.

Glaxo increased its potential flu-vaccine output, doubling capacity at a plant in Germany. In September 2005, it announced plans to buy a Canadian flu-vaccine maker, ID Biomedical Corp., for about $1.4 billion.

The investments helped make Glaxo a leading flu-shot maker. France's Sanofi is considered the flu-vaccine industry's biggest producer, followed by Novartis AG of Switzerland and Glaxo. Other large producers are AstraZeneca PLC of the U.K. and CSL Ltd. of Australia.

With its bird-flu vaccine in hand, Glaxo started promoting the shots hard, says David Fedson, a vaccine expert who once worked for Aventis Pasteur MSD, a vaccine venture now partly owned by Sanofi.

The U.S., Switzerland and Finland ordered H5N1 vaccine from Glaxo, helping it sell about $230 million worth in 2007 -- nearly as much as the company's sales of seasonal-flu vaccine that year. Bird flu continued to spread, slowly, among humans. But it failed to be classified a pandemic. In 2008, Glaxo's sales of H5N1 vaccine fell, to about $105 million.

Glaxo kept pushing. It signed contracts with governments, promising to supply millions of doses of vaccine should an H5N1 pandemic -- or any other flu pandemic -- arise. Sweden says it signed such an advance-purchase agreement with Glaxo in late 2007. Denmark, Switzerland and others signed similar deals.

In May 2008, Mr. Witty took over as Glaxo's chief executive and put even more focus on flu. He aimed to make Glaxo a "one-stop shop" for managing influenza, and reorganized Glaxo's marketing effort to emphasize the "integrated package of products and services" the company could offer governments, says Peter Cook, chief executive of Biota, an Australian company that developed Relenza and licensed the rights to Glaxo.

Throughout 2008, as bird flu continued to circulate, Glaxo representatives made frequent house calls to countries' health ministries. At a flu conference in September, Glaxo issued new data on a test of its H5N1 vaccine, arguing that the shots were still valuable to damp a pandemic's impact should one emerge.

When swine flu surfaced in Mexico and the U.S. in April, Glaxo quickly shifted gears. It says it asked governments how much Relenza they needed, and switched on spare factories to churn out more. It also started building new production lines with the aim of tripling overall Relenza production, to more than 190 million packs a year.

Glaxo also doubled the number of people working on pandemic flu vaccines in order to develop an H1N1 shot quickly, Dr. Breuer says. Vaccine-unit members called the governments that had signed advanced-purchase deals. Many activated the orders.

As the swine-flu virus spread, Glaxo flu experts intensified their visits to national health ministries. Some in the industry say the company walked a fine line between educating government officials and making a hard sell.

Glaxo says its visits are aimed at telling governments about the changing state of the swine-flu virus and about the company's progress making vaccine and Relenza. "It's not selling," says Jean Stephenne, head of Glaxo's vaccines business. "You are bringing a public-health solution."

Glaxo is supplying H1N1 vaccine or vaccine ingredients to the U.S., the U.K., France, Germany, Canada and other countries. Last month, it said that in a clinical trial, one dose of its vaccine with adjuvant gave more than 98% of people a high level of protection against the swine-flu virus.

Glaxo sought other angles on the pandemic. From its talks with governments, it saw officials were worried about keeping key workers healthy during a pandemic -- "doctors, nurses, people who work in power plants," says Eddie Gray, president of Glaxo's pharmaceutical business in Europe.

Glaxo decided that a quick flu-diagnosis tool could help hospitals and other workplaces determine whether workers were infected. "We talked to some [governments] and said, 'Does this sound like something you'd be generally interested in?'" Mr. Gray recalls.

The answer was yes. In July, Glaxo announced a deal with Enigma Diagnostics, a U.K. company, to develop a machine that would diagnose flu viruses from swab samples in 60 minutes or less. The partners aim to get the kit on the market by early 2011. [NOTE: THIS MEANS YOU'LL SEE ANOTHER BIG "PANDEMIC" EMERGE IN A COUPLE OF YEARS, SO GSK CAN SELL THESE PUPPIES...]

One of Glaxo's R&D scientists came up with another idea: medicated face masks. When swine-flu fear kicked in this spring, some people sought to protect themselves by donning standard surgical masks in public. Glaxo produced Actiprotect, a mask with a coating that it says helps block viruses by killing them on contact. The company says its own tests have shown the mask kills more than 99% of many types of flu viruses within a minute of contact.

Glaxo is pitching the masks as useful for health-care workers and others, and says it has so far sold 15 million to various governments. The company declined to say how much the masks cost and says it is still deciding whether to offer them to consumers.

 * * *

http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html

Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA violated federal law

Friday, October 09, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor

(NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in Washington D.C. mid-day Friday in an urgent effort to halt the distribution of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary Null and other licensed health care workers of New York State, the lawsuit charges that the FDA violated the law in its hasty approval of four swine flu vaccines by failing to scientifically determine neither the safety nor efficacy of the vaccines.

"The suit will seek an injunction against the FDA from approving the vaccine," attorney Jim Turner told NaturalNews on Thursday evening's Natural News Talk Hour show. "And the core of the argument is that they have not done the proper safety and efficacy tests on the vaccine to allow it to be release at this time."

The suit seeks to not only nullify the FDA's unlawful "approval" of the four H1N1 influenza vaccines, but to also ask the court to issue an injunction that would halt any mandatory vaccination requirements.

"The FDA is required by law to establish that a vaccine is safe and effective before it can be given to the public," said Turner. "We are arguing that they did not establish that the vaccine was effective, and did not establish that it was safe. They are trying to get it on the market by a waiver."

Vaccine / adjuvant combination has never been properly tested

The vaccine / adjuvant combination being referred to as the "swine flu vaccine" has apparently never been safety tested or approved by the FDA. In fact, in many cases the vaccine is being sent to clinics, pharmacies and other health establishments separately from the adjuvant chemical, leaving it up to each local vaccine retailer to properly mix the vaccine with the adjuvant, according to information provided by Turner. With hundreds of millions of Americans potentially being targeted with this vaccine, the potential for improper mixing, improper dosages, and human error is alarming.

If the charges described in the lawsuit are true, it means the FDA has blatantly abandoned medical science and violated its own regulations in approving not only these four vaccines, but the potentially deadly adjuvant chemicals as well. To date, the FDA has produced absolutely no scientific evidence documenting safety tests for any of these swine flu vaccines. There are no published studies, no records of any clinical trials, and no publicly-available paper trail demonstrating that any safety testing was done whatsoever. There is no researcher who has publicly put their name on the record declaring the vaccines to be safe, and no FDA official has ever stated that scientifically-valid safety testing has ever been conducted on the vaccine / adjuvant combinations now being distributed across America.

Normally, when a pharmaceutical achieves "FDA approved" status, there is a considerable paper trail of scientific scrutiny, peer review, clinical trials and other supporting evidence. To our knowledge, no such documents exist for the swine flu vaccines. The FDA's approval of these vaccines appears to be based entirely on a whim.

"What has been tested?" asked attorney Jim turner. "Where has it been tested? Who reviewed the test? Who looked at the test and said yes they proved safety and efficacy? There is no record that we can find that shows these things have been done."

By approving the four vaccines in the absence of such safety testing, the FDA itself stands in direct violation of federal law. "There is a law that they're supposed to follow and they are not following it," Turner added.

Billions of dollars are at stake

Why, then, did the FDA apparently violate the law and push these vaccines into full public distribution without securing the safety testing required by law? Turner suspects a profit motive may be involved: "They're charging $24.95 to get a vaccine. Multiplied by 100 million people, that's a lot of money. If you do the whole society, you're talking about several billion dollars."

In fact, the U.S. vaccination push could ultimately target over 200 million Americans, generating nearly $5 billion in vaccine-related revenues. Cashing in on those revenues, however, requires three things:

1) Spreading fear about H1N1 swine flu by exaggerating its dangers.

2) Quickly making a vaccine available for sale, even if it has never been thoroughly tested for safety and efficacy.

3) Aggressively marketing the vaccines before the H1N1 swine flu fizzles out and can no longer be hyped up as "highly virulent."

All three of these conditions are now being pushed aggressively in the U.S. by pharma-influenced health authorities at both the state and federal level. There is a mad, cult-like rush under way to vaccinate American citizens with an unproven, untested chemical that was thrust into distribution in apparent violation of federal law. And if this vaccine is not stopped, the price that may ultimately be paid in terms of lost lives could be quite dire.

It all harkens back to 1976 when a previous formulation of the swine flu vaccine paralyzed and killed thousands of Americans. Turner was one of the attorneys instrumental in halting that vaccine, and he fears a repeat situation could potentially recur today. He told NaturalNews, "[In 1976] they were intending to inoculate 200 million people. We stopped them... and somewhere between 40 and 50 million people were vaccinated. What ultimately brought it down is that a substantial number of people got 'French Polio' [Guillain-Barre syndrome], a paralysis that goes... through the body, and if it goes far enough you die."

About health freedom attorney Jim Turner

Jim Turner, with Citizens for Health (www.Citizens.org), is one of the most accomplished and respected health freedom attorneys practicing today. His firm, Swankin & Turner, represents businesses and individuals on a variety of regulatory issues relating to foods, drugs and health.

Donations to support this swine flu vaccine lawsuit are greatly welcomed. You can donate to Citizens.org on this page: http://www.citizens.org/?page_id=20

A special fund specifically focused on the swine flu vaccine lawsuit will be announced here on NaturalNews. Watch this story for an update.