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By Susan Heavey

WASHINGTON, Nov 20 (Reuters) - It's not just spending on U.S. healthcare that is breaking records. Drugmakers, insurers and industry groups are on track to spend an all-time high of more than $500 million this year to influence Congress' revamp of the healthcare system.
Lobbyists for the healthcare sector will likely smash previous spending records by tens of millions of dollars this year as Democratic lawmakers try to reshape the industry by expanding coverage and shaving costs.
"If current trends continue, the health sector is likely to spend more than a half-billion dollars on lobbying in 2009," said The New England Journal of Medicine's Dr. Robert Steinbrook.
As Congress makes a final push for a bill to overhaul the $2.5 trillion healthcare system that fuels one-sixth of the U.S. economy, health companies and industry groups are trying to shape the outcome.
The Senate is headed for a test vote on Saturday that will determine if it can proceed to three weeks of floor debate followed by a final vote on an $849 billion, 10-year bill. The House of Representatives has already approved its $1 trillion version of healthcare reform.
Differences between the two bills would have to be reconciled in a long negotiation process and lobbyists have been jockeying for time with members of Congress and their staff.
Lawmakers, especially Democratic Senators up for re-election next year, have seen a flood of campaign donations from hospitals, device makers and others with billions at stake.

$400 MILLION IN NINE MONTHS
The healthcare sector spent $486 million on lobbying last year and nearly $400 million through September of this year, according to the non-profit Center for Responsive Politics.
For drugmakers, always among the top spenders in Washington, reform could mean higher sales because more Americans will have insurance coverage to pay for medications.
Drug companies like Pfizer Inc, Merck & Co Inc and others spent $237 million on lobbying in 2008 which they nearly surpassed in nine months to end-September.
"They're on pace to obliterate their totals ... due to health reform undoubtedly," said Dave Levinthal, a spokesman for the Center for Responsive Politics.
The Pharmaceutical Research and Manufacturers of America, which represents big drugmakers, is on track to spend more than $30 million this year, Levinthal said.
"It should come as no surprise to anyone that we stepped up our efforts this year," said Ken Johnson, senior vice president of the group which backs most of the Democrats' measures and cemented a $80 billion, 10-year deal of rebates and discounts to help pay for it.
"We have a lot at stake right now. We're talking about fundamentally changing our healthcare system," said Johnson.
Insurers such as UnitedHealth Group Inc and WellPoint Inc also ramped up spending to oppose Democrats' plan for a public insurance option that could rival private plans. Insurers along with other health service companies spent $52.8 million on lobbying so far this year after spending $63.1 million in all of 2008.
"In all cases, these would be record annual expenditures," said the New England Journal of Medicine's Steinbrook.
The U.S. healthcare sector has generally favored Republican candidates in doling out political campaign cash.
That trend changed in the 2008 election that ushered Democrat Barack Obama into the White House with his party controlling the House and the Senate.
The industry gave 54 percent of its political contributions to Democrats in the 2008 cycle, up from 37 percent just two years earlier, according to the Center for Responsive Politics. For the cycle under way ahead of next year's mid-term elections, 59 percent has gone to Democrats.
"They're trying to influence the people who have the power," said Josh Israel, a campaign finance expert at the nonprofit Center for Public Integrity.

(Editing by Chris Wilson) Keywords: USA HEALTHCARE/LOBBYING (sheavey@thomsonreuters.com; +1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net)

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LONDON, Nov 20 (Reuters) - British health officials are investigating the likely person-to-person spread of a drug-resistant strain of swine flu, the Health Protection Agency said on Friday.
There have been five confirmed cases in Wales of patients infected with H1N1 resistant to oseltamivir -- the generic name of Roche AG and Gilead Sciences Inc's antiviral drug Tamiflu, the agency said.
Four other patients are infected with H1N1 with the same genetic mutation but one was helped by Tamiflu and the status of three others is not clear. Another antiviral, GlaxoSmithKline and Biota Inc's Relenza, was effective in the patients, the HPA said.
The patients had serious conditions that suppressed their immune systems, which can give the virus a better than usual opportunity to develop resistance, the HPA added.

"Although further epidemiological investigation is underway, it would seem likely that transmission of oseltamivir-resitant H1N1 virus has taken place," it said in a statement. "At present we believe the risk to the general healthy population is low."
John McCauley of the Medical Research Council said the patients involved were in an at-risk group.
"It is well established that patients with immunodeficiency do have problems with eliminating virus, giving it a greater chance to acquire resistance," he said in a statement.
The World Health Organisation has reported 57 cases of Tamiflu resistance worldwide. There have not yet been any confirmed cases of person-to-person transmission, although a possible case in the United States is under investigation.
The British government launched a national pandemic flu service in July to allow people to get a diagnosis and prescription online or over the phone without visiting a doctor.
It said on Friday it was taking the development of a Tamiflu-resistant strain seriously but it would continue to offer the antiviral to all patients.
"Our strategy to offer antivirals to all patients with swine flu is the right one, to help prevent complications and reduce the severity of the illness," the Department of Health said in a statement.
British officials have confirmed the H1N1 virus has killed 214 people, but experts note that most people who are made sick by the virus are not tested.
A nationwide vaccination programme began last month, initially targeting those considered high risk, such as pregnant women and front-line healthcare workers.
Norwegian health authorities reported a mutation of H1N1 in some patients with severe disease but other officials noted quickly that other patients infected with the same mutant have had mild disease.
(Reporting by Kylie MacLellan; editing by David Stamp) Keywords: FLU BRITAIN/STRAIN

(kylie.maclellan@thomsonreuters.com; +44 207 542 0401)

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LONDON, Nov 20 (Reuters) - British health officials are investigating the likely person-to-person spread of a drug-resistant strain of swine flu, the Health Protection Agency said on Friday.
There have been nine confirmed cases of an H1N1 variant among patients on a ward in a hospital in Wales, it said, five of which are known to be resistant to oseltamivir -- the generic name of Roche AG's antiviral drug Tamiflu.
The cases occurred in people with a serious underlying health condition that is known to cause Tamiflu resistance in flu cases, the HPA added.

"Although further epidemiological investigation is underway, it would seem likely that transmission of oseltamivir-resistant H1N1 virus has taken place," it said in a statement.
The HPA said the swine flu variant remained sensitive to alternative antiviral drug Relenza, made by GlaxoSmithKline , and that patients were responding well to it.
"At present we believe the risk to the general healthy population is low," it said.
The World Health Organisation has reported 57 cases of Tamiflu resistance worldwide. There have not yet been any confirmed cases of person-to-person transmission, although a possible case in the United States is under investigation.
The British government launched a national pandemic flu service in July to allow people to get a diagnosis and prescription online or over the phone without visiting a doctor.
It said on Friday it was taking the development of a Tamiflu-resistant strain seriously but it would continue to offer the antiviral to all patients.
"Our strategy to offer anti-virals to all patients with swine flu is the right one, to help prevent complications and reduce the severity of the illness," the Department of Health said in a statement.
The H1N1 virus has so far killed 214 people in the United Kingdom.
A nationwide vaccination programme began last month, initially targeting those considered high risk, such as pregnant women and front-line healthcare workers.
Norwegian health authorities have discovered a potentially significant mutation of H1N1 that they said could be responsible for causing the most severe symptoms among those infected but that they do not believe has any implication for the effect of flu vaccines or antiviral drugs.

(Reporting by Kylie MacLellan; editing by Philippa Fletcher)

((kylie.maclellan@thomsonreuters.com; +44 207 542 0401))

Keywords: FLU BRITAIN/STRAIN

(Adds details and reaction)
* Five H1N1 patients resistant to Tamiflu
* Possible person-to-person spread of resistant strain

LONDON, Nov 20 (Reuters) - British health officials are investigating the likely person-to-person spread of a drug-resistant strain of swine flu, the Health Protection Agency said on Friday.
There have been five confirmed cases in Wales of patients infected with H1N1 resistant to oseltamivir -- the generic name of Roche AG and Gilead Sciences Inc's antiviral drug Tamiflu, the agency said.
Four other patients are infected with H1N1 with the same genetic mutation but one was helped by Tamiflu and the status of three others is not clear. Another antiviral, GlaxoSmithKline and Biota Inc's Relenza, was effective in the patients, the HPA said.
The patients had serious conditions that suppressed their immune systems, which can give the virus a better than usual opportunity to develop resistance, the HPA added.

"Although further epidemiological investigation is underway, it would seem likely that transmission of oseltamivir-resitant H1N1 virus has taken place," it said in a statement. "At present we believe the risk to the general healthy population is low."
John McCauley of the Medical Research Council said the patients involved were in an at-risk group.
"It is well established that patients with immunodeficiency do have problems with eliminating virus, giving it a greater chance to acquire resistance," he said in a statement.
The World Health Organisation has reported 57 cases of Tamiflu resistance worldwide. There have not yet been any confirmed cases of person-to-person transmission, although a possible case in the United States is under investigation.
The British government launched a national pandemic flu service in July to allow people to get a diagnosis and prescription online or over the phone without visiting a doctor.
It said on Friday it was taking the development of a Tamiflu-resistant strain seriously but it would continue to offer the antiviral to all patients.
"Our strategy to offer antivirals to all patients with swine flu is the right one, to help prevent complications and reduce the severity of the illness," the Department of Health said in a statement.
British officials have confirmed the H1N1 virus has killed 214 people, but experts note that most people who are made sick by the virus are not tested.
A nationwide vaccination programme began last month, initially targeting those considered high risk, such as pregnant women and front-line healthcare workers.
Norwegian health authorities reported a mutation of H1N1 in some patients with severe disease but other officials noted quickly that other patients infected with the same mutant have had mild disease.
(Reporting by Kylie MacLellan; editing by David Stamp) Keywords: FLU BRITAIN/STRAIN

(kylie.maclellan@thomsonreuters.com; +44 207 542 0401)

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OSLO, Nov 20 (Reuters) - Norwegian health authorities said on Friday they have discovered a potentially significant mutation in the H1N1 influenza strain that could be responsible for causing the severest symptoms among those infected.
"The mutation could be affecting the virus' ability to go deeper into the respiratory system, thus causing more serious illness," the Norwegian Institute of Public Health said in a statement.
There was no reason to believe the mutation had any implication for the effectiveness of flu vaccines or antiviral drugs made by groups such as Roche, GlaxoSmithKline , Novartis and AstraZeneca, the authorities said.
The World Health Organisation said that the mutation did not appear to be widespread in Norway and the virus in its mutated form remained sensitive to antivirals and pandemic vaccines.
A similar mutation had been detected in H1N1 viruses circulating in several other countries, including China and the United States, in severe as well as in some mild cases, it said.
"Although further investigation is under way, no evidence currently suggests that these mutations are leading to an unusual increase in the number of H1N1 infections or a greater number of severe or fatal cases," the WHO said in a statement.
H1N1, a mixture of swine, bird and human viruses, has killed at least 6,770 people globally, according to its latest update.
In Norway the mutation was found in the bodies of two people killed by the virus and of one person made seriously ill. The two infected by the mutated virus who died were among the first fatalities from the H1N1 pandemic in Norway, the institute said.
It was unclear whether the mutated virus was transmitted among humans, the health authorities said.
"Based on what we know so far, it doesn't seem like the mutated virus is circulating in the population, but rather that spontaneous changes have happened in the three patients," director Geir Stene Larsen at the public health institute said in the statement.
Norway has seen relatively more fatalities in the flu pandemic compared to the size of the population versus other European countries, with 23 confirmed deaths.
Public health authorities have said this could be due to the country being hit early in the pandemic's northern hemisphere winter wave, before a mass vaccination programme got underway.

"Nevertheless, it is important to study if there's still something about the Norwegian fatalities that separate us from other countries, and that make us learn something that strengthens our treatment of the seriously ill," director Bjorn-Inge Larsen at the Norwegian Directorate of Health said.
Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said, "This mutation has been seen sporadically."
She said it is sometimes seen in patients who have mild influenza symptoms.
"I think it is just too soon to say what this might mean long term," Schuchat told reporters in a telephone briefing.

(Reporting by Richard Solem; Additional reporting by Stephanie Nebehay in Geneva and Maggie Fox in Washington; Editing by Matthew Jones and Louise Ireland) Keywords: FLU NORWAY/ (richard.solem@thomsonreuters.com; +47 22 93 69 71; Reuters Messaging: richard.solem.reuters.com@reuters.net)

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LONDON, Nov 20 (Reuters) - British health officials are investigating the likely person-to-person spread of a drug-resistant strain of swine flu, the Health Protection Agency said on Friday.
There have been nine confirmed cases of an H1N1 variant among patients on a ward in a hospital in Wales, it said, five of which are known to be resistant to oseltamivir -- the generic name of Roche AG's antiviral drug Tamiflu.
The cases occurred in people with a serious underlying health condition that is known to cause Tamiflu resistance in flu cases, the HPA added.

"Although further epidemiological investigation is underway, it would seem likely that transmission of oseltamivir-resistant H1N1 virus has taken place," it said in a statement.
The HPA said the swine flu variant remained sensitive to alternative antiviral drug Relenza, made by GlaxoSmithKline , and that patients were responding well to it.
"At present we believe the risk to the general healthy population is low," it said.
The World Health Organisation has reported 57 cases of Tamiflu resistance worldwide. There have not yet been any confirmed cases of person-to-person transmission, although a possible case in the United States is under investigation.
The British government launched a national pandemic flu service in July to allow people to get a diagnosis and prescription online or over the phone without visiting a doctor.
It said on Friday it was taking the development of a Tamiflu-resistant strain seriously but it would continue to offer the antiviral to all patients.
"Our strategy to offer anti-virals to all patients with swine flu is the right one, to help prevent complications and reduce the severity of the illness," the Department of Health said in a statement.
The H1N1 virus has so far killed 214 people in the United Kingdom.
A nationwide vaccination programme began last month, initially targeting those considered high risk, such as pregnant women and front-line healthcare workers.
Norwegian health authorities have discovered a potentially significant mutation of H1N1 that they said could be responsible for causing the most severe symptoms among those infected but that they do not believe has any implication for the effect of flu vaccines or antiviral drugs.

(Reporting by Kylie MacLellan; editing by Philippa Fletcher) Keywords: FLU BRITAIN/STRAIN (kylie.maclellan@thomsonreuters.com; +44 207 542 0401)

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OTTAWA, Nov 20 (Reuters) - Enough H1N1 flu vaccine for almost half of Canada's population will have been shipped out by the end of the next week, Health Minister Leona Aglukkaq said on Friday.
Huge lines had formed when vaccinations for the H1N1 swine flu started more than three weeks ago. But by the end of this week more than 10 million doses will have been shipped out and more than 15 million by the end of next week, she told Parliament.
GlaxoSmithKline Plc has a contract to supply 50.4 million doses to Canada, which has a population of more than 33 million. Health officials said several days ago that more than 20 percent of the population had been vaccinated.

(Reporting by Randall Palmer; editing by Rob Wilson) Keywords: FLU/CANADA (randall.palmer@thomsonreuters.com; +1-613-235-6745; Reuters Messaging: randall.palmer.reuters.com@reuters.net)

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OSLO, Nov 20 (Reuters) - Norwegian health authorities said on Friday they have discovered a potentially significant mutation in the H1N1 influenza strain that could be responsible for causing the severest symptoms among those infected.
"The mutation could be affecting the virus' ability to go deeper into the respiratory system, thus causing more serious illness," the Norwegian Institute of Public Health said in a statement.
Authorities added they had no reason to believe the mutation had any implication for the effect of flu vaccines or antiviral drugs made by groups such as Roche, GlaxoSmithKline , Novartis or AstraZeneca.
H1N1, a mixture of swine, bird and human viruses, has killed more than 7,000 people globally.
In Norway the mutation was found in the bodies of two people killed by the virus and of one person made seriously ill.
The two people infected by the mutated virus were among the first fatalities from the H1N1 pandemic in Norway, the institute said.
It was unclear whether the mutated virus was transmitted among humans, the health authorities said.
"Based on what we know so far, it doesn't seem like the mutated virus is circulating in the population, but rather that spontaneous changes have happened in the three patients," director Geir Stene Larsen at the public health institute said in the statement.
In some later fatalities linked to H1N1 that were studied, the same mutation was not found. It had found other mutations in some other cases, but the mutations found in two of the first fatalities and one seriously ill patient had been of "particular interest", it said.
Norway has seen relatively more fatalities in the flu pandemic compared to the size of the population versus other European countries, with 23 confirmed deaths.
Public health authorities have said this could be due to the country being hit early in the pandemic's northern hemisphere winter wave, before a mass vaccination programme got underway.

"Nevertheless, it is important to study if there's still something about the Norwegian fatalities that separate us from other countries, and that make us learn something that strengthens our treatment of the seriously ill," director Bjorn-Inge Larsen at the Norwegian Directorate of Health said.

(Reporting by Richard Solem; Editing by Matthew Jones) Keywords: FLU NORWAY/ (richard.solem@thomsonreuters.com; +47 22 93 69 71; Reuters Messaging: richard.solem.reuters.com@reuters.net)

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By Susan Heavey

WASHINGTON, Nov 20 (Reuters) - It's not just spending on U.S. healthcare that's hitting record levels. Drugmakers, insurers and industry groups are on track to spend an all-time high of more than $500 million this year to influence Congress' revamp of the U.S. healthcare system.
Lobbyists for the healthcare sector will likely smash previous spending records by tens of millions of dollars this year as Democratic lawmakers attempt to reshape the industry by expanding coverage and shaving costs.
"If current trends continue, the health sector is likely to spend more than a half-billion dollars on lobbying in 2009," said The New England Journal of Medicine's Dr. Robert Steinbrook.
As Congress makes a final push for a bill to overhaul the $2.5 trillion healthcare system that fuels one-sixth of the U.S. economy, health companies and industry groups both for and against various proposals are trying to shape the outcome.
The Senate is headed for a test vote on Saturday that will determine if it can proceed to three weeks of floor debate followed by a final vote on an $849 billion, 10-year bill. The House of Representatives has already approved its $1 trillion version of healthcare reform.
Differences between the two bills would have to be reconciled in a potentially long negotiation process, and lobbyists have been jockeying for time with members of Congress and their staff.
Lawmakers, especially Democratic Senators up for re-election next year, have also seen a flood of campaign donations from hospitals, devicemakers and others with billions at stake.

$400 MILLION IN NINE MONTHS
The healthcare sector, which spent $486 million on lobbying in 2008, spent nearly $400 million through September of this year, according to the non-profit group Center for Responsive Politics.
For drugmakers, always among the top spenders in Washington, reform could mean higher sales because more Americans will have insurance coverage to pay for medications. Drug companies such as Pfizer Inc, Merck & Co Inc and others spent a combined $237 million on lobbying last year, an amount they nearly surpassed in the first three quarters of 2009.
"They're on pace to obliterate their totals ... due to health reform undoubtedly," said Dave Levinthal, a spokesman for Center for Responsive Politics.
So is the Pharmaceutical Research and Manufacturers of America. The powerful group, which represents big drugmakers, is on track to spend more than $30 million this year, Levinthal said.
"It should come as no surprise to anyone that we stepped up our efforts this year," said Ken Johnson, senior vice president of the group which backs most of the Democrats' measures and cemented a $80 billion, 10-year deal of rebates and discounts to help pay for it.
"We have a lot at stake right now. We're talking about fundamentally changing our healthcare system," Johnson said.
Insurers such as UnitedHealth Group Inc and WellPoint Inc ramped up spending to oppose Democrats' plan to create a public insurance option that could rival private plans.
"In all cases, these would be record annual expenditures," said the New England Journal of Medicine's Steinbrook.

Like many other U.S. industries, the healthcare sector has generally favored Republican candidates in doling out political campaign cash in recent years.
But that trend changed in the 2008 election that ushered Democrat Barack Obama in the White House with his party controlling the House and the Senate.
The industry gave 54 percent of its political contributions to Democrats in the 2008 cycle, up from 37 percent just two years earlier, according to data from the Center for Responsive Politics. For the cycle under way ahead of next year's mid-term elections, 59 percent has gone to Democrats.
"They're trying to influence the people who have the power," said Josh Israel, a campaign finance expert at the nonprofit investigative group The Center for Public Integrity.
In the Senate, political contributions are piling up behind a number of Democrats, especially those facing tough 2010 election fights such as Majority Leader Harry Reid of Nevada and Democrat Blanche Lincoln of Arkansas.
Reid has received $615,675 this year ahead of next November's vote, according Federal Election Commission data collected by the Center for Responsive Politics. Lincoln, one of a handful of conservative Democrats who hold crucial votes in the healthcare debate, has taken in $474,950 so far.
And even though the House has already passed its reform bill, healthcare companies are likely to keep up the pressure given House Democrats' slim 220-215 victory on the measure. Every House member is also up for re-election next year.
"The people who have an opinion on either side of this are still going to be pressing the House either way," said Israel. "There's going to be some sort of give-and-take."

(Editing by Mohammad Zargham) Keywords: USA HEALTHCARE/LOBBYING (sheavey@thomsonreuters.com; +1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net)

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By Maggie Fox, Health and Science Editor

WASHINGTON, Nov 20 (Reuters) - As U.S. health officials struggle to vaccinate tens of millions of Americans against the pandemic of swine flu, some are looking regretfully at one easy way to instantly double or triple the number of doses available -- by using an immune booster called an adjuvant.
These additives, often as simple as an oil and water mixture, broaden the body's response to a vaccine, reducing the amount of active ingredient called antigen needed.
They are widely used in European flu vaccines as well as in Canada. But not in the United States -- even though the federal government has spent nearly $700 million buying them.
The reason -- people might not trust them.
"If we really do want pregnant women to trust this vaccine or even parents, we have to think about what is acceptable to them," Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said in an interview.
"We have so much vaccine hesitancy in this country," agreed Jeff Levi of the non-profit Trust For America's Health. "To add ... a new element could well have undermined the efficacy of this campaign," Levi told a hearing this week before a Congressional subcommittee.
This frustrates the World Health Organization, which says the global capacity to make influenza vaccines is about 3 billion doses a year -- not enough to cover the population of 6.8 billion people. WHO has hoped rich countries would donate leftover H1N1 vaccine to others.
The U.S. Health and Human Services Department was ready to try adjuvants had the pandemic been worse. H1N1 swine flu has infected an estimated 22 million Americans and killed 3,900, but it so far does not appear to be any deadlier than seasonal influenza.
The worry is that it is affecting younger adults and children instead of the elderly usually targeted by flu, and has the potential to mutate into something more deadly.
"If things had been worse and this would have been a more severe pandemic, we may well have needed to go that way anyway," Levi said.

Instead, the United States has stuck with what CDC director Dr. Thomas Frieden has repeatedly called the "tried and true" approach -- the same formulation used in seasonal flu vaccines. Five companies have contracts -- Sanofi-Aventis, CSL , Novartis, AstraZeneca unit MedImmune and GlaxoSmithKline.
Polls show that only about half of Americans plan to be vaccinated against H1N1. Of those who do not, about half say they worry about safety.
Even so, long lines have formed as people try to get the 50 million or so swine flu doses that have rolled out of factories. Drug companies have struggled with an unpredictable virus that does not grow well in eggs, as well as changes to U.S. orders that slowed down packaging.
Studies suggest the supply that is out now could have been tripled.
In September, GlaxoSmithKline found a single shot of its H1N1 vaccine protected 98 percent of volunteers, using an adjuvant and just 5.25 micrograms of antigen. A standard dose without adjuvant takes 15 micrograms of antigen.
Vaccine makers urged Congress this week to help federal agencies find ways to approve the use of adjuvants, and to assure skeptical Americans about their safety.
Dr. Vas Narasimhan, president of Novartis Vaccines USA, noted adjuvants had been licensed for use in Europe for 10 years and tested in 200,000 people.

"Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," Narasimhan told a hearing this week.
He said they may protect better than standard vaccines against viruses that have drifted a little -- the single biggest reason that flu vaccines must be re-formulated every year.

They may also eventually help require less vaccination. "Adjuvanted vaccines have been shown to more broadly prime patients' immune response (up to seven years later), requiring fewer vaccinations to the newly circulating strain," he said.
The National Institute of Allergy and Infectious Diseases is intrigued. Last month it awarded $60 million to researchers and companies to develop new adjuvants.
(Editing by Philip Barbara) Keywords: FLU/VACCINES USA

(Maggie.Fox@ThomsonReuters.com; Washington bureau newsroom 202-898-8492)

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LONDON, Nov 20 (Reuters) - In a change of tack, Europe's drugs watchdog said on Friday that giving a single dose of GlaxoSmithKline's Pandemrix or Novartis's Focetria swine flu vaccines would suffice for most people. The European Medicines Agency (EMEA) had previously said two doses were preferable, although many governments have already been pushing ahead with single-shot immunisation programmes for adults.
"For both vaccines, a single dose may be used in adults aged between 18 and 60 years and in children and adolescents, from the age of nine years for Focetria and from 10 years for Pandemrix," the EMEA said in its latest statement following a monthly meeting of experts.
Focetria and Pandemrix can be also been given at the same time as seasonal flu vaccines, it added. The updated position follows a review of the latest clinical data.
In the case of Baxter International's Celvapan, however, the agency said that the data were still being assessed.

(Reporting by Ben Hirschler; Editing by Greg Mahlich) Keywords: FLU/VACCINES EUROPE (ben.hirschler@thomsonreuters.com; Tel: +44 20 7542 5082; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; www.twitter.com/reutersBenHir)

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LONDON, Nov 20 (Reuters) - European corporate credit default swap spreads were slightly tighter on Friday, as European equities rebounded after a three-day losing run.
By 1050 GMT, the investment-grade Markit iTraxx Europe index was at 84.75 basis points, according to data from Markit, 0.75 basis points tighter versus late on Thursday.
The Markit iTraxx Crossover index, made up of 50 mostly "junk"-rated credits, was at 528.06 basis points, 0.94 basis points tighter.
In a week that has seen more companies buying back short-dated bonds and issuing new longer-dated securities to improve their debt maturity profile, Gary Jenkins, an analyst at Evolution Securities, highlighted other possible contenders in a note.
From looking at company debt profiles he suggested BMW , Deutsche Telekom, Daimler, GlaxoSmithKline, Proctor & Gamble, Siemens , Total and Volkswagen might be in the frame, although he stressed more work was needed to identify potential names.
The International Swaps and Derivatives Association (ISDA) said late on Thursday a credit committee had ruled that a bankruptcy credit event had occurred that would trigger settlement of CDS for Hellas Telecommunications (Luxembourg) II , the Greek telecoms operator.
The company did not make an interest payment at the end of a 30-day grace period following the Oct. 15 due date.
The date and terms of the auction will be published in due course, said ISDA.
(Reporting by Claire Milhench; Editing by David Holmes) All Eurobond news Debt news New debt issues Investment-grade bonds High-yield bonds Asset-backed securities Credit derivatives news Credit ratings news Top fixed income news Top credit news Other market reports: Euro government debt report U.S. Treasury market report U.S. corporate bond report European stock market report UK stock market report Wall Street report Guides: For two-year Schatz yield, double click on For the 10-year Bund yield, double click on For euro swap rates, double click on For average IG corporate spread over govt bonds For prices or rates, double click on: For credit ratings, double click on: For credit derivatives, double click on For top corporate bond issuers, double click on Keywords: MARKETS BONDS EUROCORP

(claire.milhench@thomsonreuters.com; +44 (0)20 7542 3571; Reuters Messaging claire.milhench.thomsonreuters.com@reuters.net)

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By Lisa Richwine

SILVER SPRING, Md., Nov 19 (Reuters) - Pfizer Inc and Boehringer Ingelheim won support on Thursday for a proposed new claim for a blockbuster medicine that treats a deadly lung disease. A Food and Drug Administration advisory panel, in an 11-1 vote, said Boehringer presented "substantial and convincing evidence" that Spiriva HandiHaler reduced flare-ups of chronic obstructive pulmonary disease (COPD).
The inhaled medicine already is approved for treating COPD but the companies want to specifically promote it for reducing exacerbations, a claim held by GlaxoSmithKline's rival drug Advair.

Spiriva is considered the gold standard for treating COPD, or "smoker's lung," commonly caused by cigarette smoke and other harmful fumes and characterized by a persistent obstruction of airflow in the lungs which results in breathlessness. Two Boehringer studies "showed unequivocal evidence of benefit," said panel member Daren Knoell, an associate professor at Ohio State University's College of Pharmacy.
The FDA usually follows panel recommendations. Winning approval for the new claim could help the company boost sales of the drug, which hit 2.07 billion Euros ($3 billion) globally in 2008.
The FDA advisers also said current data were adequate to address concerns about strokes and heart problems, an issue raised in a medical journal report last year. A team of researchers reported in September 2008 that Spiriva raised the risk of heart attack, stroke and death from heart disease. Boehringer strongly disagreed with the finding.
Members of the FDA panel said there were limitations in the journal study and that other evidence provided reassurance about the drug's safety.
Dr. Mark Brantly, the panel chairman and a pulmonary specialist at the University of Florida, said he felt the overall data "is compelling that there is no increased cardiovascular risk."
The panel voted 11-1 that data were sufficient on the stroke issue, and 11-0 with one abstention that cardiovascular risk data were adequate.
Boehringer said it was pleased the panel supported the claim for reducing disease flare-ups.

"Exacerbations in COPD patients may lead to disability, premature death and increased healthcare costs," Dr. Christopher Corsico, a Boehringer vice president, said in a statement.
Shares of Pfizer, the world's largest drugmaker and Boehringer's marketing partner for Spiriva, fell 8 cents to close at $18.11 on the New York Stock Exchange.

(Reporting by Lisa Richwine; Editing by Carol Bishopric) Keywords: PFIZER SPIRIVA/ (Reuters Messaging: lisa.richwine.reuters.com@reuters.net +1 202 310 5691)

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SILVER SPRING, Md., Nov 19 (Reuters) - Pfizer Inc and Boehringer Ingelheim won support on Thursday for a proposed new claim for a blockbuster lung medicine. A Food and Drug Administration advisory panel, in an 11-1 vote, said Boehringer presented "substantial and convincing evidence" that Spiriva reduced flare-ups of chronic obstructive pulmonary disease (COPD).
The inhaled medicine already is approved for treating COPD but the companies want to specifically promote the drug for reducing flare-ups, a claim held by GlaxoSmithKline's rival Advair.
The FDA committee also said current data were adequate to address potential concerns about strokes and heart-related problems, an issue raised in a medical journal report last year. Boehringer said overall data do not support a connection between the drug and an increased risk of those problems.
Pfizer shares were down 12 cents at $18.07 in afternoon trading on the New York Stock Exchange.

(Reporting by Lisa Richwine; Editing by Carol Bishopric) Keywords: PFIZER SPIRIVA/ (Reuters Messaging: lisa.richwine.reuters.com@reuters.net +1 202 310 5691)

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By Robin Pomeroy

LONDON, Nov 19 (Reuters) - Britain will expand its H1N1 flu vaccination programme to all children between 6 months and 5-years-old, some 2.7 million people, the government's health chief said on Thursday.
Although infection rates of swine flu are dropping and worst-case forecasts have been sharply revised down, Chief Medical Officer Liam Donaldson said young children were still at significant risk.
"Whilst we are seeing these relatively high numbers of people, particularly children, in hospital and intensive care, I think we are not taking so much interest in the overall trend, we are more interested in continuing to fight the disease," Donaldson told a news conference.
He declined to say if the virus was now definitively in decline. "I think it's just really too early to say," he said. New cases of swine flu in England continue to decline, with 53,000 recorded last week, down from 64,000 the week before.
But cases of children under 5 being hospitalised due to H1N1 have spiked in recent weeks, above July levels when infections last peaked. A total of 214 people have died of the virus in the United Kingdom.
With the decision to vaccinate even healthy children, more than 12 million people in Britain are now eligible. Many European countries have begun vaccinating against H1N1, usually targeting at-risk categories first.

A first phase of the vaccination programme, launched last month, targeted pregnant women, front-line healthcare workers, and other people considered "high-risk".
But a survey this week in doctors' magazine Pulse showed a majority of them had declined to take the virus, possibly due to scepticism over the severity of the pandemic.
Donaldson, whose own survey showed 73 percent of parents would vaccinate their children, dismissed that report.
"If the readers of Pulse, general practitioners, had done a study of that sort and submitted it to a reputable medical journal it wouldn't have been published. It was a very small scale poll of GPs," he said.

GlaxoSmithKline Plc, AstraZeneca Plc, Novartis and Sanofi-Aventis are among about 25 manufacturers producing H1N1 vaccine around the world.

(For full Reuters coverage of H1N1 double click on)

(Editing by Matthew Jones) Keywords: FLU BRITAIN/ (robin.pomeroy@reuters.com; Reuters Messaging: brobin.pomeroy.reuters.com@reuters.net)

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By Stephanie Nebehay

GENEVA, Nov 19 (Reuters) - The World Health Organisation said on Thursday the H1N1 vaccine had been cleared of blame for 41 deaths which health authorities worldwide had investigated after suspicions they might have been caused by the inoculation.
The U.N. agency reaffirmed that the pandemic vaccine is as safe as the seasonal flu vaccine used for more than 60 years. It also voiced concern that some pregnant women and others at risk were shunning it because of a fear of side-effects.
"No new safety issue has been identified from reports issued to date ... Reporting so far reconfirms that the pandemic flu vaccine is as safe as the seasonal flu vaccine," Marie-Paule Kieny, WHO's top vaccine expert, told a telephone conference.
Governments have so far reported that 65 million vaccine doses have been administered against H1N1, known as swine flu, in 16 countries, but the true figure is probably higher since immunisation campaigns are under way in 40 countries, she said.
Side-effects commonly reported include swelling and redness or pain at the injection site, although some had fever or headache, and all symptoms usually disappear after 48 hours.
A "small number of deaths" had been reported, she said, and a WHO spokeswoman later put the figure at 41 in six countries.
"Although some investigations are still ongoing, the results of the completed investigations reported to WHO have ruled out that the pandemic vaccine is the cause of death," Kieny said.
Authorities in China -- where 11 million people have been vaccinated -- have reported 2 deaths following inoculation and 15 cases of severe side effects, the WHO said in a statement.
"Thorough investigation of these deaths, including a review of autopsy results, determined that underlying medical conditions were the cause of death and not the vaccine," it said of China.
Fewer than a dozen suspected cases of Guillain-Barre syndrome had been reported following pandemic vaccination, she said. "Only a few of this Guillain-Barre may be linked to the pandemic vaccine .... and patients have recovered," she added.

"NO SIGNIFICANT DIFFERENCE"

GlaxoSmithKline Plc, AstraZeneca Plc, Novartis and Sanofi-Aventis are among about 25 manufacturers producing H1N1 vaccine using different techniques.
"No significant difference in the safety profile between different types of vaccine has been detected," Kieny said.

She denounced conspiracy theories about vaccines circulating on the Internet, saying they were causing "artificial worries".
"We have to reiterate that the vaccines are safe, that the disease in certain people can be severe and can be cause of death," she said.
The H1N1 virus is known to have killed 6,250 people worldwide since emerging in North America last April, according to the WHO.
A survey of doctors showed on Wednesday that more than half of Britons being offered vaccination against H1N1 were turning it down because they feared side-effects or believed the virus was too mild to bother about.
"It is worrying indeed that certain groups don't seem to be coming readily to be vaccinated. But we hope that the data ... on the safety of these vaccines will dissipate the worries that a population might have and will help convince them that the vaccine is safe and vaccination will protect them against this disease which can be severe," Kieny said.

(For full WHO statement go to http://link.reuters.com/zuv52g )

(Additional reporting by Jonathan Lynn; Editing by Sam Cage and Andrew Roche) Keywords: FLU/WHO (jonathan.lynn@reuters.com; +41 22 733 3831; Reuters Messaging: jonathan.lynn.reuters.com@reuters.net )

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By Stephanie Nebehay

GENEVA, Nov 19 (Reuters) - About 40 people have died after being inoculated against H1N1 pandemic flu, but investigations so far show the fatalities were not caused by the vaccine, the World Health Organisation said on Thursday.
The U.N. agency reaffirmed that the pandemic vaccine was safe and voiced concern that some pregnant women and others at risk were shunning it because of a fear of side effects.
"No new safety issue has been identified from reports issued to date ... Reporting so far reconfirms that the pandemic flu vaccine is as safe as the seasonal flu vaccine," Marie-Paule Kieny, WHO's top vaccine expert, told a telephone conference.
Governments have so far reported that 65 million vaccine doses have been administered against H1N1, known as swine flu, in 16 countries, but the true figure is probably higher since immunisation campaigns are under way in 40 countries, she said.
Side effects commonly reported include swelling and redness or pain at the injection site, although some had fever or headache, and all symptoms usually disappear after 48 hours.
A "small number of deaths" had been reported, she said, and a WHO spokeswoman later put the figure at 41 in six countries.
"Although some investigations are still ongoing, the results of the completed investigations reported to WHO have ruled out that the pandemic vaccine is the cause of death," Kieny said.

Fewer than a dozen suspected cases of Guillain-Barre syndrome have been reported following pandemic vaccination, she said. "Only a few of this Guillain-Barre may be linked to the pandemic vaccine....and patients have recovered," she added.
The rare neurological condition was linked to a 1976 U.S. swine flu vaccination campaign. Although no case of Guillain-Barre syndrome was ever linked to the vaccine, a belief that the vaccine was worse than the illness remains widespread.

"NO SIGNIFICANT DIFFERENCE"

GlaxoSmithKline Plc, AstraZeneca Plc, Novartis and Sanofi-Aventis are among about 25 manufacturers producing H1N1 vaccine using different techniques.
"No significant difference in the safety profile between different types of vaccine has been detected," Kieny said.

She denounced conspiracy theories about vaccines circulating on the Internet, saying they were causing "artificial worries".
"We have to reiterate that the vaccines are safe, that the disease in certain people can be severe and can be cause of death," she said.
Novartis said on Tuesday a U.S. clinical study suggested just half a dose of its H1N1 vaccine might be enough to generate a protective immune response.
Kieny said the WHO was aware of reports from other drug makers that half a dose was effective, but cautioned that the studies usually involved limited numbers of people.
"It may well be the case that a smaller quantity of vaccine may be protective, but it is really up to national regulators to define what is the best regimen for immunisation in their countries," she said. "Currently, we think that one dose of a licensed vaccine is what should be used in adults at least."
A survey of doctors showed on Wednesday that more than half of Britons being offered vaccination against H1N1 were turning it down because they feared side effects or believed the virus was too mild to bother.
"It is worrying indeed that certain groups don't seem to be coming readily to be vaccinated. But we hope that the data ... on the safety of these vaccines will dissipate the worries that a population might have and will help convince them that the vaccine is safe and vaccination will protect them against this disease which can be severe," Kieny said.

(Additional reporting by Jonathan Lynn; Editing by Sam Cage and Andrew Dobbie) Keywords: FLU/WHO (jonathan.lynn@reuters.com; +41 22 733 3831; Reuters Messaging: jonathan.lynn.reuters.com@reuters.net )

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BRUSSELS, Nov 19 (Reuters) - EU regulators will ask drug companies for details of deals with makers of generic medicines as part of a crackdown on firms suspected of blocking cheaper treatments, a European Commission official said on Thursday.
European Union Competition Commissioner Neelie Kroes said in her July report into the sector that delays in bringing generic drugs to the market had cost consumers and healthcare providers billions of euros.
Last month, a U.S. Senate panel voted to bar drugmakers from paying generic companies to delay bringing their cheaper medicines to market. A branded medicine can lose up to 80 percent of its revenues once generics go on sale.
"We will ask companies to give a copy of patent settlements between July 2008 to December 2009," Dominik Schnichels, the head of the Commission's pharma taskforce, told an industry conference on Thursday.
"We will not take the view per se that patent settlements are probably illegal but we would look closely at the justification the company gives for the settlement. We will look at the merits of the case," he said.

The European Commission last month raided several drugmakers, including France's Sanofi-Aventis, on suspicion they had violated rules against restrictive business practices and abuse of a dominant position.
It is also investigating privately owned French drugmaker Servier and a number of firms that make generic drugs to see whether they have blocked medicines from entering the market.
Pharmaceutical companies argue the deals are an effective way to resolve costly litigation and often result in generics coming to market before patents expire.
(Reporting by Foo Yun Chee, editing by Dale Hudson) Keywords: EU/PHARMACEUTICALS Keywords: EU/PHARMACEUTICALS=2

(foo.yunchee@thomsonreuters.com; tel +32 2 287 6844; Reuters Messaging: foo.yunchee.reuters.com@reuters.net)

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BRUSSELS, Nov 19 (Reuters) - EU regulators will ask drug companies for details of deals with makers of generic medicines as part of a crackdown on firms suspected of blocking cheaper treatments, a European Commission official said on Thursday.
European Union Competition Commissioner Neelie Kroes said in her July report into the sector that delays in bringing generic drugs to the market had cost consumers and healthcare providers billions of euros.
Last month, a U.S. Senate panel voted to bar drugmakers from paying generic companies to delay bringing their cheaper medicines to market. A branded medicine can lose up to 80 percent of its revenues once generics go on sale.
"We will ask companies to give a copy of patent settlements between July 2008 to December 2009," Dominik Schnichels, the head of the Commission's pharma taskforce, told an industry conference on Thursday.
"We will not take the view per se that patent settlements are probably illegal but we would look closely at the justification the company gives for the settlement. We will look at the merits of the case," he said.

The European Commission last month raided several drugmakers, including France's Sanofi-Aventis, on suspicion they had violated rules against restrictive business practices and abuse of a dominant position.
It is also investigating privately owned French drugmaker Servier and a number of firms that make generic drugs to see whether they have blocked medicines from entering the market.
Pharmaceutical companies argue the deals are an effective way to resolve costly litigation and often result in generics coming to market before patents expire.

(Reporting by Foo Yun Chee, editing by Dale Hudson) Keywords: EU/PHARMACEUTICALS (foo.yunchee@thomsonreuters.com; tel +32 2 287 6844; Reuters Messaging: foo.yunchee.reuters.com@reuters.net)

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By Susan Heavey

WASHINGTON, Nov 18 (Reuters) - Democrats in the U.S. Congress are seeking government investigations into recent price increases of brand-name prescription drugs, as lawmakers finalize an overhaul of the healthcare system.
Lawmakers are concerned the companies are trying to reap gains ahead of reforms aimed at lowering drug prices and forcing drugmakers to partly fund changes that aim to boost the number of Americans covered by health insurance.
"I want to know if there's a back-door move underway by the drugmakers to recover some of the concessions they've promised for healthcare reform," said Senator Bill Nelson, who represents many older Americans in the state of Florida.
Nelson on Wednesday asked the Department of Health and Human Services' inspector general to investigate the issue.
Leaders of the House of Representatives Ways and Means and Energy and Commerce committees said in a letter to the Government Accountability Office (GAO) that they would probably seek another analysis of price trends after the health overhaul measures are implemented.
The House letter was sent late on Tuesday after the nation's top lobbying group for the elderly, the American Association of Retired Persons, earlier this week criticized an estimated 9 percent increase in prices for some of the most-widely used medicines.

Pharmaceutical Research and Manufacturers of America (PhRMA), which represents brand-name drugmakers, said the hearings were inspired by "the misleading use of statistics and sensationalized media reports" and that prescription drug price increases were in line with medical inflation.
"Clearly, AARP has been trying to muddy the waters -- for its own political gain -- as we enter the homestretch of the healthcare reform debate," said a statement by PhRMA Senior Vice President Ken Johnson.

"Companies make price adjustments independently as the result of market forces, which include everything from patent expirations to the huge, sunk R&D costs which typically exceed $1 billion for a single medicine, as well as the ability of powerful purchasers to obtain large savings, benefiting patients." Charles Rangel and Henry Waxman, the chairmen of the House Ways and Means Committee and the House Energy and Commerce Committee respectively, wrote that drugmakers "may be artificially raising prices for certain pharmaceutical products in expectation of new reforms."
"Any price gouging is unacceptable, but anticipatory price gouging is especially offensive," their letter said.
Lawmakers asked the nonpartisan GAO to compare drug price increases against the Consumer Price Index and to analyze which specific drugs accounted for the biggest price changes.
The report will give Congress a "benchmark of drug manufacturer pricing activity just prior to passage" of a Democratic-written healthcare reform bill, the lawmakers said.
The House lawmakers also asked the GAO to prepare a proposal to continually monitor drug prices for Congress.
Industry analysts have largely expected Pfizer Inc, Merck & Co Inc and other manufacturers to boost prices of top-selling medicines that are nearing the end of their patent protection, triggering cheaper generic alternatives.
The so-called "patent cliff" is likely to cost top drugmakers billions of dollars in sales through 2016.
Drugmakers have largely backed Democrats' plan to overhaul the U.S. healthcare system, making a deal with some senators and the White House to provide $80 billion in savings and rebates over 10 years.
The House has already passed its bill and takes a harder line on drugmakers through additional rebates and other changes.

(Reporting by Susan Heavey; Editing by Lisa Von Ahn, Derek Caney and Tim Dobbyn) Keywords: HEALTHCARE/PRICES (sheavey@thomsonreuters.com; +1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net)

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WASHINGTON, Nov 18 (Reuters) - A U.S. Senate healthcare reform bill of more than 2,000 pages long was released Wednesday evening by Democratic leaders and included the following provisions:
* Would impose a 5 percent tax on elective cosmetic surgery procedures to raise an estimated $5 billion in new revenue to help pay for reforms.
* Would end the Federal Coordinating Council on Comparative Effectiveness that was created in 2009 stimulus spending law to assess the benefits and costs of certain medical treatments.
* Would create user fees to pay for the Food and Drug Administration to review generic biologic drugs.
* Would have Congress authorize a "biosimilar" user fee program to be launched in October 2012.

* The Senate bill was posted at: http://democrats.senate.gov/reform/patient-protection-affordable-care-act.pdf (Reporting by Susan Heavey and Julie Vorman; Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com)

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