VentMedic Posted October 30, 2009 Posted October 30, 2009 This should prove to be an interesting and controversial flu season. It should also present arguments for other medications and devices that haven't been approved by the FDA. Emergency Use Authorization of Peramivir IV http://www.cdc.gov/h1n1flu/eua/peramivir.htm PERAMIVIR is experimental because it is still being studied. It is not approved by FDA for use in the United States. There is limited information known about the safety and effectiveness of using PERAMIVIR to treat people in the hospital with 2009 H1N1 flu. There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have the 2009 H1N1 virus. The Canadians are watching this also: http://chealth.canoe.ca/channel_health_news_details.asp?channel_id=131&relation_id=1883&news_channel_id=131&news_id=29303 http://ca.news.yahoo.com/s/capress/091023/national/flu_new_drug While the emergency use authorization only covers the United States, Toronto-based infectious disease expert Dr. Allison McGeer said the drug will likely be available to Canadian physicians too, if the company has adequate supplies. She said Health Canada has a good emergency release system for compassionate use of drugs not available in Canada. "In order to get compassionate release anything, the company and Health Canada have to agree that it's a reasonable thing to do," said McGeer, who is head of infection control at Mount Sinai Hospital. "And my guess is that in real situations where somebody cannot for some reason take an oral (flu) drug, that the company and Health Canada will agree to that.... It will depend on availability of supply." Newspaper story: CDC Makes Unapproved H1N1 Drug Available The unapproved antiviral that saved a teen's life is now more widely available in emergencies. http://www.emsresponder.com/features/article.jsp?id=10893&siteSection=24 Oct. 29--He was a healthy teenager from another country, visiting friends and relatives in Minnesota, when he got sick. Then really sick. In early September, he wound up at Hennepin County Medical Center in Minneapolis, near death with complications from H1N1 flu. But his doctors there were able to get their hands on an experimental antiviral drug that saved his life. A month after he was admitted, the teenager walked out of the hospital and was able to go home to his own country. The 17-year-old boy, who has not been identified, was among the first H1N1 patients in the United States to get the new drug, Peramivir. On Friday, the U.S.Centers for Disease Control and Prevention (CDC) took the unusual step of making the unapproved drug available to hospitals across the country for emergency use in just such cases. Peramivir is similar to other antivirals, such as Tamiflu. What makes it unique is that it can be given intravenously. Other, similar drugs have to be swallowed or inhaled with an inhaler, and are widely used both in and out of hospitals. When patients are near death or in organ failure like the 17-year-old at HCMC, an intravenous drug is the only option, said the boy's doctor, Dr. Stacine Maroushek, a pediatric infectious-disease specialist at the medical center. "I don't think he could have been any closer to death without dying," Maroushek said. He had severe bleeding in his digestive track, almost every organ had failed, and he was on a ventilator to help him breathe. Doctors could not have gotten any other antiviral into his system, she said. But Maroushek was familiar with an experimental drug made by a small company called BioCryst of Birmingham, Ala. She had to get permission from the U.S. Food and Drug Administration to use the drug in the boy's case. That meant she had to fill out numerous forms, get permission, then contact the company, which sent it to her. "We were able to get it within 24 hours," she said. "After he was on the medicine for a day and a half or two days, he started turning around." Like all antivirals, the drug works by suppressing the growth of the virus in the body, allowing the immune system to fight off the infection. Since early September, the drug has been available on what's known as a "compassionate use" basis around the country for hospitalized patients with severe H1N1 infections. Maroushek said the teenager at HCMC was the third person and the first pediatric patient in the country to receive it. That doesn't mean, however, that it will always work. The same drug reportedly was given without success to Michael Milbrath, the Waseca hospital executive who died Saturday of complications from H1N1. On Friday, his family said on his CaringBridge website that Milbrath, 54, had received "the new experimental drug" at Immanuel St. Joseph's hospital in Mankato. Milbrath had been hospitalized Oct. 14 in intensive care with complications of the flu, according to the CaringBridge site. As his condition worsened, doctors received permission on Oct. 22 to use Peramivir, and the drug was flown in from the East Coast overnight, the family reported. He received the drug Friday, but died the following day. His funeral will be held today in Waseca. A spokesman for the medical center declined to comment on Milbrath's treatment, citing patient confidentiality laws. Under the new emergency-use designation, doctors can get Peramivir directly from the CDC in Atlanta, Maroushek said. It is designated for patients who have run out of other options, either because other treatments failed or they can't use other antiviral medications. Doctors must report any side effects or complications to the federal government. The company, BioCryst, said last week that it has donated 1,200 courses of the drug to the federal government for use during the flu pandemic. It also said it is producing 130,000 more and is prepared to make additional doses, if necessary. The company is conducting a formal clinical trial in 400 patients nationwide that is expected to be completed by April 2011. 1
tniuqs Posted October 30, 2009 Posted October 30, 2009 Firstly great link thanks Vent, just FYI we now have an RRT dependent on a ventilator in Calgary this minute (no vaccine available) pity, the newest release is now shortages in vaccine the demand here is huge ... so for those doubters in the crowd looks like your in the minority and may be too late ... OK so EBM anyone heard of just one death from either type inoculation .. I AM ALL EARS ! So the history of the development of drugs/medicine Banting and Best a perfect example (ants in dogs urine with pancreas removed resulted in development of Insulin) by just good observational skills one of the most familiar is ventolin/albutrol used initially to slow premature labour a women that just "happened" to be asthmatic and suddenly improved (yes a sidebar) Could it be that sometimes the mother of invention is necessity, we see this every day in ICUs as when your down to multi system failures anything is worth a go, for those bothering to read these posts if you havent been there consider yourself DAMN lucky. My son now 18 informed me hes not getting the vaccine cause drug companies are just making money .... the 18 year old mentality OMG, I wish he could read this excerpt: But neither Roche, which makes Tamiflu, nor GlaxoSmithKline, which makes Relenza, have been willing to bring intravenous formulations of their drugs through the expensive regulatory approvals process.Testing the drugs in ways that meet the standards of drug regulators has proven to be a challenge and the market for IV flu drugs would not be large or lucrative during regular flu seasons. Lurarative ... hmm thanks Roche,GlaxoSmithKline, looks like someone is ! I think with this announcement by CDC they are running scared !!!! The demographic at risk of increased mortality morbidity has taken us off guard, young healthy vigorous children and in under 48 hours from minor symptoms to death. Please click on the MAP LINKS listed on the WHO site and please remember that many countries do not have the capability to report accurately due to health care funding, and the stats are not this weeks snapshot either, so lets look at the bigger picture. http://www.who.int/csr/disease/swineflu/updates/en/index.html Make NOTE of this link if you dare: The qualitative indicators monitor: the global geographic spread of influenza, trends in acute respiratory diseases, the intensity of respiratory disease activity, and the impact of the pandemic on health-care services. Pandemic (H1N1) 2009 - update 71 Weekly update World Health Organization As of 17 October 2009, worldwide there have been more than 414,000 laboratory confirmed cases of pandemic influenza H1N1 2009 and nearly 5000 deaths reported to WHO. As many countries have stopped counting individual cases, particularly of milder illness, the case count is significantly lower than the actually number of cases that have occurred. WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of data. New Activity: Mongolia, Rwanda, and Sao Tome and Principe have reported pandemic influenza cases for the first time this week. Iceland, Sudan, and Trinidad and Tobago reported their first fatal cases. Situation update: In general, influenza activity in the northern hemisphere is much the same as in the last week, though respiratory disease activity continues to spread and increase in intensity. In North America, the U.S.A. is still reporting nationwide rates of Influenza-Like Illness (ILI) well above baseline rates with high rates of pandemic H1N1 2009 virus detections in clinical laboratory specimens (29% of all specimens tested are positive for influenza A and all of those subtyped are pandemic H1N1 2009 virus. Canada reports increases in ILI rates for the fourth straight week but the highest level of activity is in the western province of British Columbia. Mexico still reports active transmission in some areas of the country. Although influenza activity is low in most countries in Europe, in Belgium, Israel, the Netherlands, Norway, and parts of the United Kingdom consultation ILI/ARI rates are above baseline levels. Similarly the number of influenza virus detections relatively high, which may indicate the early start of an influenza season. Rates of respiratory illness in Eastern Europe and Northern Asia are increasing but are not yet at levels normally seen in an influenza season (baseline levels are not defined in many countries of the area). Of note, the proportion of cases in Asia that are related to seasonal influenza A(H3N2) continue to decline globally as the proportion related to pandemic H1N1 2009 virus increases. Currently, only East Asia is reporting any significant numbers of influenza A(H3N2) isolates.In tropical areas of the world, rates of illness are generally declining, with a few exceptions. Cuba, Colombia, and El Salvador are reporting increases in the tropical region of the Americas. In tropical Asia, of the countries that are reporting this week, all report decreases in respiratory disease activity.The temperate region of the southern hemisphere has no significant pandemic related activity in the past week. Weekly update (Virological surveillance data) *Countries in temperate regions are defined as those north of the Tropic of Cancer or south of the Tropic of Capricorn, while countries in tropical regions are defined as those between these two latitudes. Qualitative indicators (Week 29 to Week 41: 5 October - 11 October 2009) The qualitative indicators monitor: the global geographic spread of influenza, trends in acute respiratory diseases, the intensity of respiratory disease activity, and the impact of the pandemic on health-care services. Human infection with pandemic (H1N1) 2009 virus: updated interim WHO guidance on global surveillance A description of WHO pandemic monitoring and surveillance objectives and methods can be found in the updated interim WHO guidance for the surveillance of human infection with pandemic (H1N1) virus. The maps below display information on the qualitative indicators reported. Information is available for approximately 60 countries each week. Implementation of this monitoring system is ongoing and completeness of reporting is expected to increase over time. List of definitions of qualitative indicators Geographic spread of influenza activity Map timeline Trend of respiratory diseases activity compared to the previous week Map timeline Intensity of acute respiratory diseases in the population Map timeline Impact on health care services Map timeline Laboratory-confirmed cases of pandemic (H1N1) 2009 as officially reported to WHO by States Parties to the IHR (2005) as of 18 October 2009 Map of affected countries and deaths The countries and overseas territories/communities that have newly reported their first pandemic (H1N1) 2009 confirmed cases since the last web update (No.70): Mongolia, Rwanda and Sao Tome and Principe. The countries and overseas territories/communities that have newly reported their first deaths among pandemic (H1N1) 2009 confirmed cases since the last web update (No 70): Iceland, Sudan and Trinidad and Tobago. Ok so the other side of the controversy ... this H1N1 is just normal stuff its nothing just a cold yea people die so whatever EH .... NOW the question must be asked: ARE WE PREPARED FOR THE NEXT SPANISH TYPE FLU ? that killed 50 million, these stats are screaming at us all. cheers 1
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