FDA warns against fake online H1N1 remedy claims

WASHINGTON, Oct 16 (Reuters) - The U.S. government this week warned against the online marketing of unlicensed health remedies claiming to protect against H1N1 swine flu infection, including fake "Tamiflu" pills from India.
 The Food and Drug Administration reported on Thursday that it had purchased and analyzed several products represented on the Internet as Tamiflu, Roche Holding AG's brand name version of the antiviral drug oseltamivir.
 One order, which arrived in an unmarked envelope from India, consisted of unlabeled white pills that contained talc and the common pain reliever acetaminophen, the FDA said. Others contained various amounts of oseltamivir but were not approved for use in the United States.
 In one action, the FDA and the Federal Trade Commission ordered well-known author and doctor Andrew Weil to stop marketing his Immune Support Formula to protect against the H1N1 flu virus.
 "Claims that a dietary supplement can prevent, treat or cure human infection with the H1N1 virus must be supported by well-controlled human clinical studies," the regulatory agencies said in a warning letter to Weil.
 Officials at Weil's Phoenix, Arizona-based headquarters were not immediately available for comment.
 "Products that are offered for sale online with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated," FDA Commissioner Dr. Margaret Hamburg said in a statement.
 Swine flu, which emerged in March, spread quickly around the world, and was declared a pandemic in June, poses a serious health threat because most people lack immunity to it.
 But U.S. health officials say the most effective protection against infection is vaccination and the federal government hopes to offer as many as 250 million vaccine doses to the public by the end of the year.
 The government has ordered vaccine from five companies -- Sanofi-Aventis SA, CSL Ltd, Novartis AG, GlaxoSmithKline and the AstraZeneca unit MedImmune.
 Once someone is already infected, oseltamivir and another antiviral drug called zanamivir -- an inhaled medicine produced as Relenza by GlaxoSmithKline Plc can help relieve the severity of disease.
 Widespread and unnecessary use threatens to make the H1N1 virus resistant to the antivirals, which would render them ineffective as medicine for people with severe flu cases.
 Health officials have already reported H1N1 resistance to Tamiflu. (Reporting by David Morgan)

New flu can kill fast, researchers agree

WASHINGTON, Oct 16 (Reuters) - The new H1N1 flu is "strikingly different" from seasonal influenza, killing much younger people than ordinary flu and often killing them very fast, World Health Organization officials said on Friday.
 A review of studies done during the seven months the virus has been circulating shows it is usually mild, but can cause unusual and severe symptoms in an unlucky few, according to a WHO-sponsored meeting in Washington this week.
 "Participants who have managed such cases agreed that the clinical picture in severe cases is strikingly different from the disease pattern seen during epidemics of seasonal influenza," WHO's Dr. Nikki Shindo told the meeting.
 Swine flu was declared a pandemic in June and has been circulating globally. WHO stopped trying to count cases, as there are nowhere near enough tests to formally diagnose everyone who gets sick.
 Separately on Friday, Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said 86 U.S. children had died of swine flu, most in the 5- to 17-year old age group that normally escapes serious bouts with flu.
 "In severe cases, patients generally begin to deteriorate around three to five days after symptom onset. Deterioration is rapid, with many patients progressing to respiratory failure within 24 hours, requiring immediate admission to an intensive care unit," Shindo said.
 While most such patients need to be put on ventilators right away, some are not helped by this treatment, Shindo noted.
 In some places, she said, emergency rooms have been overwhelmed with patients, many requiring critical care.
 The good news is that quick treatment with the antiviral drugs oseltamivir, made by Roche AG under the brand name Tamiflu, and zanamivir, made by GlaxoSmithKline as Relenza, helps a great deal, she said.
 Usually influenza is a disease of the upper respiratory tract, affecting the nose and throat. But H1N1 goes deeper, into the lungs.
 "This virus really likes the lower respiratory tract. That means this virus is very likely to cause viral pneumonia compared to seasonal influenza," Shindo told a news conference.
 Among the doctors speaking to the WHO meeting was Dr. Anand Kumar of St. Boniface Hospital in Winnipeg, Manitoba, who reported swine flu's effects in the Journal of the American Medical Association this week.
 "At one point, 50 percent of the available ICU (intensive care unit) beds in the entire city were filled with H1N1 patients," Kumar said in a telephone interview. "We basically maxed out our capacity."
 Shindo said WHO was struggling to understand what the risk factors are for a serious bout with swine flu.
 "Although the exact role of obesity is poorly understood at present, obesity and especially morbid obesity have been present in a large portion of severe and fatal cases," Shindo said. "Obesity has not been recognized as a risk factor in either past pandemics or seasonal influenza." (With additional reporting by Julie Steenhuysen in Chicago; Editing by Doina Chiacu)

Obama declares swine flu a national emergency

WASHINGTON, Oct 24 (Reuters) - U.S. President Barack Obama has declared 2009 H1N1 swine flu a national emergency, the White House said on Saturday.
The declaration will make it easier for U.S. medical facilities to handle a surge in flu patients by allowing the waiver of some requirements of Medicare, Medicaid and other federal health insurance programs as needed, the White House said in a statement.
The U.S. Centers for Disease Control and Prevention said on Friday that swine flu has become widespread in 46 of the 50 U.S. states, a level comparable to the peak of ordinary flu seasons but far earlier and with more waves of infection expected.
Obama signed the statement on Friday night.
The White House statement said the declaration was intended to prepare the country in case of "a rapid increase in illness that may overburden health care resources." It was similar to disaster declarations issued before hurricanes hit coastal areas.
"It's important to note that this is a proactive measure -- not a response to a new development," an administration official said.
"H1N1 is moving rapidly, as expected. By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly," he said.
Seasonal flu normally peaks sometime between late November and early March and kills about 36,000 Americans in an average year.
Swine flu has hit young adults and children the hardest, while seasonal flu normally is more dangerous for people over age 65.
H1N1, declared a public health emergency earlier in the year, has killed more than 1,000 people in the United States and put more than 20,000 in the hospital since it emerged earlier this year, the CDC said. But health officials are quick to note that the actual number of cases cannot be measured.
The new declaration clears the way for waivers of federal requirements that, for example, could prevent hospitals from establishing off-site, alternate care facilities that could help them deal with emergency department demands, the White House said.
The Health and Human Services Department is trying to deliver vaccines against H1N1 but says production is falling short of projections because companies are having trouble making them.
HHS has also moved to make available stockpiles of antiviral drugs oseltamivir, made by Roche AG under the brand name Tamiflu, and zanamivir, an inhaled drug made by GlaxoSmithKline under the brand name Relenza.
On Friday the U.S. Food and Drug Administration issued an emergency use authorization for an experimental new drug called peramivir, made by Biocryst Pharmaceuticals Inc and licensed to Shionogi & Co Ltd.
  The authorization allows the intravenous drug to be used in hospitalized patients who cannot take pills or inhale Relenza or when Tamiflu or Relenza do not seem to be helping. (Additional reporting by Maggie Fox, editing by Eric Beech and Mohammad Zargham)

GlaxoSmithKline third quarter profit up 11 percent

LONDON — GlaxoSmithKline PLC, the world's second largest drug maker by revenue, forecast a big boost from its swine flu vaccines before the end of the year as it reported an 11 percent rise in third quarter earnings on Wednesday.
 London-based Glaxo posted net profit of 1.44 billion pounds ($2.35 billion) for the three months to Sept. 30, compared to 1.29 billion pounds a year earlier, helped by strong sales of its flu drug Relenza and gains in its consumer healthcare division.
 Revenue rose 15 percent to 6.76 billion pounds, underpinned by surging sales in emerging markets.
 Total sales lifted 3 percent, marking the first growth in two years, as the company made progress in breaking its reliance on the "white pill western market" by diversifying its business across geographical and product markets.
 "This is the quarter that shows a build in momentum at GlaxoSmithKline," said Chief Executive Andrew Witty.
 Glaxo's shares, however, dropped 0.9 percent to 1,245 pence after the overall earnings for the quarter just missed consensus forecasts of around 1.47 billion pounds.
 The company, which has been hit by rising competition from generic versions of its previously patented drugs, is expected to receive an earnings windfall from products dashed out in response to the H1N1 flu virus.
 Witty said that a market consensus forecast that Glaxo will make around 1 billion pounds in sales of H1N1 vaccines in the fourth quarter "is pretty accurate."
 "In the fourth quarter, I expect further improvement including significant sales generated from our influenza products," Witty told reporters on a conference call immediately after the results were released.
 Glaxo has reported orders for 440 million doses of its H1N1 vaccine Pandemrix, which began shipments last month.
 Witty said that more orders had been taken since that update, without providing details. The company has also donated 50 million doses to the World Health Organisation.
 "We continue to have government express an interest and signing contracts with us and we anticipate that will continue for some time to come, although the lion's share is probably passed," he said.
 Sales of Relenza reached 182 million pounds over the quarter.
 Relenza is competing with Roche Holding AG's Tamiflu, sales of which grew more than eight-fold in the third quarter to 994 million francs. The Swiss company expects full-year sales of the drug to reach 2.7 billion francs.
 The demand for the influenza drugs comes as Glaxo repositions itself in the pharmaceutical sector, moving to replace falling sales of older drugs facing generic competition through acquisitions and other diversifying deals to boost its businesses in emerging markets and consumer healthcare.
 Glaxo, which also sells the Ribena range of soft drinks, reported solid earnings in its other divisions, with consumer healthcare sales up 8 percent, against estimated global market growth of just 1.5 percent. Sales in emerging markets jumped 25 percent.
 Witty added that he was happy with progress in the company's U.S. market where management has been overhauled to cope with the rise in generic competition. The coming year would remain "challenging" in that market, he said.

Swine flu fears on rise after numerous deaths

The Health Ministry is trying to identify the deadly virus that has killed at least 30 people in western Ukraine so far.
 An unknown virus is afflicting thousands in western Ukraine, according to health authorities who say at least 30 people have died this month alone from the mysterious ailment. The death toll is expected to grow higher soon.
 As of Oct. 29, Ukraine’s Health Ministry had not yet determined whether the recent deaths are related to the global outbreak of the H1N1 "swine flu" virus, but they admitted to sending more than 1,200 doses of Tamiflu, the antiviral drug used to treat H1N1, to western Ukraine.
 Thus far, there have been only two confirmed cases of swine flu in Ukraine, according to health officials, who have expressed confidence that the country is ready to combat the virus should an outbreak occur. But fears about the possible onset of a swine flu pandemic in Ukraine increased on Oct. 27 after media reported that a man from Zakarpattya Oblast had died of swine flu complications. The diagnosis has not been confirmed.
 “Ukraine’s Health Ministry has convened an emergency team to identify the virus and identify measures to prevent it from spreading,” Health Minister Vasyl Knyazevych said on Oct. 29 during a cabinet meeting.
 “Specialists on the team are working around the clock and we are confident that we will be able to identify the cause [of the deaths] on Monday or Tuesday next week and announce preventative measures,” Knyazevych said.
 “Some 10 people have perished in Ternopil Oblast, and several in the Lviv and Ivano-Frankivsk oblasts,” Deputy Health Minister Oleksandr Bilovol said a day earlier during a press conference in Kyiv. He added that all victims were less than 45 years of age.
 “The individuals died of viral pneumonia, the cause of which we have not yet determined,” said Bilovol, adding that health officials are awaiting the results of laboratory tests. “According to our data, the number of deaths due to viral pneumonia is a little higher than last year.”
 More than 6,000 people in Ukraine died of pneumonia in 2008, according to Health Ministry statistics, with 400 fatalities registered in the Ternopil, Lviv and Ivano-Frankivsk oblasts.
 Bilovol said during the press conference that 34 individuals of the 160 patients currently afflicted are in critical condition. He said that most of the people who died waited too long — one week — before seeking medical assistance.
 Health officials say they will need several days to determine whether the cases are, indeed, swine flu. In neighboring Russia, meanwhile, the H1N1 virus is definitely making the rounds. Since June, about 1,300 cases of H1N1 have been registered in Russia by health officials, who have urged people not to panic.
 “Two women are believed to have died of the influenza A/H1N1 virus,” a spokesman for eastern Siberia’s Chita region said on Oct. 27, adding that official confirmation of the causes of death would only be available in 21 days.
 As of Oct. 29, the number of patients in the region diagnosed with swine flu grew to 251, according to Natalya Zhdanova, deputy governor of Chita region. She said seven patients were critically ill.
 Ukraine has set up a laboratory that can test for the H1N1 virus and more test kits are planned to be purchased. Ukraine’s strategy has been to contain the H1N1 virus and impede its spread among the population by surveillance in airports and train stations.
 The H1N1 virus is not usually deadly, but spreads more quickly than usual flu because it’s a new virus against which people have not yet built immunity.
 According to the World Health Organization, 2 percent of patients sick with H1N1 come to hospitals with complications. People with lung and heart conditions, diabetes, obesity, pregnant women, elderly and very young children are in the high-risk groups.
 U.S. President Barack Obama on Oct. 25 declared a national emergency as the estimated number of swine flu cases topped one million. During a visit to Ukraine weeks ago, U.S. health officials urged their Ukrainian counterparts to boost preparations for combating a possible H1N1 epidemic, warning that it’s only a matter of time before the country would be hit. Experts have also expressed concern about the ability of Ukraine’s dilapidated and under-financed health system to contain a serious outbreak.

Governor: Lviv region needs 15,000 packs of Tamiflu

Lviv region needs an additional 15,000 packs of Tamiflu, a medication used to treat and prevent flu. 
Regional Governor Mykola Kmit made the comment at a council chaired by Prime Minister Yulia Tymoshenko in Ternopil on Friday, the press service of Lviv Regional State Administration reported.
Kmit said earlier that the region has 2,500 packs of Tamiflu.
He also said that the region requires UAH 40 million to buy the necessary medicines.
The press service said that regional drugstores had sold nearly all of the necessary medications so far.
  A total of 234 people diagnosed with flu and another 110 people diagnosed with pneumonia have been hospitalized in the region, while 19 people are in intensive care units, the press service said.

Ukraine, Poland reach agreement on medicine deliveries

Ukraine and Poland have reached agreement on delivery of a large consignment of medicines to Ukraine as humanitarian assistance in combating the influenza epidemic in Ukraine.
This is stated on President Viktor Yuschenko's official Internet website.
According to the statement, Yuschenko discussed the influenza epidemic in Ukraine with Poland's President Lech Kaczynski on telephone.
Kaczynski raised the issue of providing humanitarian assistance to Ukraine, particularly the western regions of the country.
Yuschenko and Kaczynski agreed that Poland will deliver a large consignment of medicines, including Tamiflu, and 1 million flu masks to Ukraine.
Kaczynski will personally transfer 300 kits for testing for the A(H1N1) influenza virus from Poland's presidential hospital.
Kaczynski also promised to assist Ukraine by providing mobile diagnostic centers.
As Ukrainian News earlier reported, the Foreign Affairs Ministry has requested that the European Commission and NATO provide humanitarian assistance to Ukraine in connection with the A(H1N1) influenza epidemic.
  The Health Ministry has declared an epidemic of the A(H1N1) influenza in Ukraine.