whitenight639
01-05-2009, 08:47 PM
jumping on the pig flue thing I thought I'd give people an overview of tamiflu that had been prescribed to over 200 children in devon already and looks like they'll be prescribing it alot more to anyone that been in contact with someone infected with H1N1.
ok some excerts from wikipedia;
After following WHO protocols in treating 41 victims of the H5N1 bird flu virus (19% of the worldwide cases of bird flu reported to date), Nguyen Tuong Van (http://en.wikipedia.org/w/index.php?title=Nguyen_Tuong_Van_MD&action=edit&redlink=1), MD, who runs the intensive care unit of the Center for Tropical Diseases in Hanoi, Vietnam concluded that Tamiflu, the drug most widely stockpiled around the world to combat a potential bird flu pandemic, is "useless".[5] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-4) According to this article, the WHO confirmed Van's experience stating that Tamiflu has not been "widely successful in human patients", but speculated the drug has not been administered until late in the disease in many Asian countries.
The standard recommended dose incompletely suppresses viral replication in at least some patients with H5N1 (http://en.wikipedia.org/wiki/H5N1) avian influenza (http://en.wikipedia.org/wiki/Avian_influenza), increasing the risk of viral resistance and rendering therapy less effective.[6] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-de_jong_2005-5) Accordingly, it has been suggested that higher doses and longer durations of therapy should be used for treatment of patients with the H5N1 virus.[6] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-de_jong_2005-5)[7] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-ward_et_al_2005-6)
Clinical trials for an increased dosage were set to begin by May 2007. All avian influenza cases in Indonesia, Thailand, and Vietnam will be inducted into the trial. The trial will also include 100 cases of severe seasonal influenza from each of those countries, plus the United States. Half of cases will receive the current standard dosage, and half will receive a double dosage, but for the standard length of time.[8] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-7)[9] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-8)
Chokephaibulkit et al. recommend the use of oseltamivir for children with avian influenza, based on experience with one patient
Oseltamivir is marketed by Roche under the trade name Tamiflu, as capsules (containing oseltamivir phosphate 98.5 mg equivalent to oseltamivir 75 mg) and as a powder for oral suspension (oseltamivir phosphate equivalent to oseltamivir 12 mg/mL).
Adverse effects
Common adverse drug reactions (http://en.wikipedia.org/wiki/Adverse_drug_reaction) (ADRs) associated with oseltamivir therapy include: nausea, vomiting, diarrhea, abdominal pain, and headache. Rare ADRs include: hepatitis (http://en.wikipedia.org/wiki/Hepatitis) and elevated liver (http://en.wikipedia.org/wiki/Liver) enzymes (http://en.wikipedia.org/wiki/Enzyme), rash, allergic reactions including anaphylaxis (http://en.wikipedia.org/wiki/Anaphylaxis), and Stevens-Johnson syndrome (http://en.wikipedia.org/wiki/Stevens-Johnson_syndrome).[4] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-rossi_2006-3)
Various other ADRs have been reported in postmarketing surveillance including: toxic epidermal necrolysis (http://en.wikipedia.org/wiki/Toxic_epidermal_necrolysis), cardiac arrhythmia (http://en.wikipedia.org/wiki/Cardiac_arrhythmia), seizure, confusion, aggravation of diabetes, and haemorrhagic (http://en.wikipedia.org/wiki/Hemorrhage) colitis (http://en.wikipedia.org/wiki/Colitis)
Neurological effects
There are concerns that oseltamivir may cause dangerous psychological, neuropsychiatric (http://en.wikipedia.org/wiki/Neuropsychiatric) side effects including self harm (http://en.wikipedia.org/wiki/Self_harm) in some users. These dangerous side effects occur more commonly in children than in adults.[13] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-12) This stems from cases in Japan, where the drug is most heavily prescribed. Concern has focused on teenagers, but problems have also been reported in children and adults.[citation needed (http://en.wikipedia.org/wiki/Wikipedia:Citation_needed)]
In March 2007, Japan's Health Ministry warned that oseltamivir should not be given to those aged 10 to 19.[14] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-13) The Ministry had previously decided, in May 2004, to change the literature accompanying oseltamivir to include neurological (http://en.wikipedia.org/wiki/Neurological) and psychological (http://en.wikipedia.org/wiki/Psychological) disorders as possible adverse effects, including: impaired consciousness, abnormal behavior, and hallucinations (http://en.wikipedia.org/wiki/Hallucination).[citation needed (http://en.wikipedia.org/wiki/Wikipedia:Citation_needed)]
According to Japan's Health Ministry, between 2004 and March 2007, fifteen people aged 10 to 19 have been injured or killed by jumps or fallen from buildings after taking oseltamivir, and one 17-year-old died after he jumped in front of a truck.[15] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-14)[16] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-15) A renewed investigation of the Japanese data was completed in April 2007. It found that 128 patients had been reported to behave abnormally after taking oseltamivir since 2001. Forty-three of them were under 10 years old, 57 patients were aged 10 to 19, and 28 patients were aged 20 or over. Eight people, including five teens and three adults, had died from these actions.[17] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-16)[18] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-17)[19] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-18)
In October 2006, Shumpei Yokota, a professor of pediatrics at Yokahama City University, released the results of research involving around 2,800 children which found no difference in the behavior between those who took oseltamivir and those who did not. A media source notes that Chugai Pharmaceutical Co. (http://en.wikipedia.org/wiki/Chugai_Pharmaceutical_Co.) (which produces Tamiflu in Japan) gave Yokota's department 10 million yen (US$85,000) over five years.[20] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-19)[21] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-20)
To determine whether to lift the 2007 ban, a research team from the Japanese Health, Labour and Welfare Ministry studied 10,000 children under the age of 18 who had been diagnosed with influenza since 2006. The study was finalised in April 2009. Taking into account all degrees of abnormal behaviour, including minor behavioural problems such as incoherent speech, the study found that children who took Tamiflu were 54 per cent more likely to exhibit abnormal behaviour than those who did not take the drug. When the team limited its analysis to children who had displayed serious abnormal behaviour that led to injury or death, it found those who had taken Tamiflu were 25 per cent more likely to behave unusually.[22] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-21)
In November 2006, the United States Food and Drug Administration (http://en.wikipedia.org/wiki/Food_and_Drug_Administration) (FDA) amended the warning label to include the possible side effects of delirium (http://en.wikipedia.org/wiki/Delirium), hallucinations, or other related behavior.[23] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-22) This went further than the FDA's previous pronouncement, from a year before, that there was insufficient evidence to claim a causal link between oseltamivir use and the deaths of 12 Japanese children (only two were from neurological problems, although more have died since then).[24] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-23) The change to a more cautionary stance was attributed to 103 new reports that the FDA received of delirium, hallucinations and other unusual psychiatric behavior, mostly involving Japanese patients, received between August 29, 2005 and July 6, 2006. This was an increase from the 126 similar cases logged between the drug's approval in 1999 and August 2005.[25] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-24)
Resistance
As with other antivirals, resistance (http://en.wikipedia.org/wiki/Antibiotic_resistance) to the agent was expected with widespread use of oseltamivir, though the emergence of resistant viruses was expected to be less frequent than with amantadine (http://en.wikipedia.org/wiki/Amantadine) or rimantadine (http://en.wikipedia.org/wiki/Rimantadine). The resistance rate reported during clinical trials up to July 2004 was 0.33% in adults, 4.0% in children, and 1.26% overall. Mutations conferring resistance are single amino acid (http://en.wikipedia.org/wiki/Amino_acid) residue substitutions in the neuraminidase (http://en.wikipedia.org/wiki/Neuraminidase) enzyme.[7] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-ward_et_al_2005-6)
Mutant (http://en.wikipedia.org/wiki/Mutant) H3N2 (http://en.wikipedia.org/wiki/H3N2) influenza A virus isolates resistant to oseltamivir were found in 18% of a group of 50 Japanese children treated with oseltamivir.[30] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-kiso_et_al_2004-29) This rate was similar to another study where resistant isolates of H1N1 (http://en.wikipedia.org/wiki/H1N1) influenza virus were found in 16.3% of another cohort of Japanese children.[7] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-ward_et_al_2005-6) Several explanations were proposed by the authors of the studies for the higher-than-expected resistance rate detected. First, children typically have a longer infection period, giving a longer time for resistance to develop. Second, Kiso et al. claim to have used more rigorous detection techniques than previous studies.[30] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-kiso_et_al_2004-29)
U.S. Government policy and oseltamivir
In November 2005, U.S. President George W. Bush requested that Congress fund US$7.1 billion in emergency spending for flu pandemic preparedness (the Senate had already passed an US$8.1 billion bill).[54] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-53) Bush's plan included US$1.4 billion for government purchases of antiviral drugs.[55] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-54)
now the Roche group are massive but here are the first quater reports from the half owned (51.5%) japanese pharma manufacturer chugai-pharmaceutical co. ltd.
Name of Company:
Chugai Pharmaceutical Co., Ltd. April 24, 2009
Stock Listing: Tokyo
Security Code No.: 4519
(URL http://www.chugai-pharm.co.jp/english)
Representative: Mr. Osamu Nagayama, President and CEO, Chairman of the Board of Directors
Contact: Mr. Mamoru Togashi, General Manager of Corporate Communications and IR Department
Phone: +81-(0) 3-3273-0881
Date of Submission of Marketable Securities Filings: May 13, 2009
Date on which Dividend Payments to Commence:
―
1. Consolidated Operating Results for the First Quarter of FY 2009 (January 1, 2009
–March 31, 2009)
1st quarter of FY 2009 (Jan.-Mar.) ¥94,690 million ― ¥17,531 million ― ¥22,797 million
1st quarter of FY 2008 (Jan.-Mar.) ¥66,160 million (27.4) ¥10,060 million (50.6)¥10,231
1st quarter of FY 2009 (Jan.-Mar.) ¥13,767 million ― ¥25.27 ¥25.27
1st quarter of FY 2008 (Jan.-Mar.) ¥ 6,698 million (49.6) ¥12.30 ¥12.29
so thats over double the profit this quater compared to same quater 2008.
source: http://www.chugai-pharm.co.jp/pdf/financial/090424eFinancialStatements.pdf
Heres a document sent to GP's warning of related phycological effects of tamiflu:
http://www.fda.gov/medwatch/safety/2008/Tamiflu_DHCP.pdf
ok some excerts from wikipedia;
After following WHO protocols in treating 41 victims of the H5N1 bird flu virus (19% of the worldwide cases of bird flu reported to date), Nguyen Tuong Van (http://en.wikipedia.org/w/index.php?title=Nguyen_Tuong_Van_MD&action=edit&redlink=1), MD, who runs the intensive care unit of the Center for Tropical Diseases in Hanoi, Vietnam concluded that Tamiflu, the drug most widely stockpiled around the world to combat a potential bird flu pandemic, is "useless".[5] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-4) According to this article, the WHO confirmed Van's experience stating that Tamiflu has not been "widely successful in human patients", but speculated the drug has not been administered until late in the disease in many Asian countries.
The standard recommended dose incompletely suppresses viral replication in at least some patients with H5N1 (http://en.wikipedia.org/wiki/H5N1) avian influenza (http://en.wikipedia.org/wiki/Avian_influenza), increasing the risk of viral resistance and rendering therapy less effective.[6] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-de_jong_2005-5) Accordingly, it has been suggested that higher doses and longer durations of therapy should be used for treatment of patients with the H5N1 virus.[6] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-de_jong_2005-5)[7] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-ward_et_al_2005-6)
Clinical trials for an increased dosage were set to begin by May 2007. All avian influenza cases in Indonesia, Thailand, and Vietnam will be inducted into the trial. The trial will also include 100 cases of severe seasonal influenza from each of those countries, plus the United States. Half of cases will receive the current standard dosage, and half will receive a double dosage, but for the standard length of time.[8] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-7)[9] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-8)
Chokephaibulkit et al. recommend the use of oseltamivir for children with avian influenza, based on experience with one patient
Oseltamivir is marketed by Roche under the trade name Tamiflu, as capsules (containing oseltamivir phosphate 98.5 mg equivalent to oseltamivir 75 mg) and as a powder for oral suspension (oseltamivir phosphate equivalent to oseltamivir 12 mg/mL).
Adverse effects
Common adverse drug reactions (http://en.wikipedia.org/wiki/Adverse_drug_reaction) (ADRs) associated with oseltamivir therapy include: nausea, vomiting, diarrhea, abdominal pain, and headache. Rare ADRs include: hepatitis (http://en.wikipedia.org/wiki/Hepatitis) and elevated liver (http://en.wikipedia.org/wiki/Liver) enzymes (http://en.wikipedia.org/wiki/Enzyme), rash, allergic reactions including anaphylaxis (http://en.wikipedia.org/wiki/Anaphylaxis), and Stevens-Johnson syndrome (http://en.wikipedia.org/wiki/Stevens-Johnson_syndrome).[4] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-rossi_2006-3)
Various other ADRs have been reported in postmarketing surveillance including: toxic epidermal necrolysis (http://en.wikipedia.org/wiki/Toxic_epidermal_necrolysis), cardiac arrhythmia (http://en.wikipedia.org/wiki/Cardiac_arrhythmia), seizure, confusion, aggravation of diabetes, and haemorrhagic (http://en.wikipedia.org/wiki/Hemorrhage) colitis (http://en.wikipedia.org/wiki/Colitis)
Neurological effects
There are concerns that oseltamivir may cause dangerous psychological, neuropsychiatric (http://en.wikipedia.org/wiki/Neuropsychiatric) side effects including self harm (http://en.wikipedia.org/wiki/Self_harm) in some users. These dangerous side effects occur more commonly in children than in adults.[13] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-12) This stems from cases in Japan, where the drug is most heavily prescribed. Concern has focused on teenagers, but problems have also been reported in children and adults.[citation needed (http://en.wikipedia.org/wiki/Wikipedia:Citation_needed)]
In March 2007, Japan's Health Ministry warned that oseltamivir should not be given to those aged 10 to 19.[14] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-13) The Ministry had previously decided, in May 2004, to change the literature accompanying oseltamivir to include neurological (http://en.wikipedia.org/wiki/Neurological) and psychological (http://en.wikipedia.org/wiki/Psychological) disorders as possible adverse effects, including: impaired consciousness, abnormal behavior, and hallucinations (http://en.wikipedia.org/wiki/Hallucination).[citation needed (http://en.wikipedia.org/wiki/Wikipedia:Citation_needed)]
According to Japan's Health Ministry, between 2004 and March 2007, fifteen people aged 10 to 19 have been injured or killed by jumps or fallen from buildings after taking oseltamivir, and one 17-year-old died after he jumped in front of a truck.[15] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-14)[16] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-15) A renewed investigation of the Japanese data was completed in April 2007. It found that 128 patients had been reported to behave abnormally after taking oseltamivir since 2001. Forty-three of them were under 10 years old, 57 patients were aged 10 to 19, and 28 patients were aged 20 or over. Eight people, including five teens and three adults, had died from these actions.[17] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-16)[18] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-17)[19] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-18)
In October 2006, Shumpei Yokota, a professor of pediatrics at Yokahama City University, released the results of research involving around 2,800 children which found no difference in the behavior between those who took oseltamivir and those who did not. A media source notes that Chugai Pharmaceutical Co. (http://en.wikipedia.org/wiki/Chugai_Pharmaceutical_Co.) (which produces Tamiflu in Japan) gave Yokota's department 10 million yen (US$85,000) over five years.[20] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-19)[21] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-20)
To determine whether to lift the 2007 ban, a research team from the Japanese Health, Labour and Welfare Ministry studied 10,000 children under the age of 18 who had been diagnosed with influenza since 2006. The study was finalised in April 2009. Taking into account all degrees of abnormal behaviour, including minor behavioural problems such as incoherent speech, the study found that children who took Tamiflu were 54 per cent more likely to exhibit abnormal behaviour than those who did not take the drug. When the team limited its analysis to children who had displayed serious abnormal behaviour that led to injury or death, it found those who had taken Tamiflu were 25 per cent more likely to behave unusually.[22] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-21)
In November 2006, the United States Food and Drug Administration (http://en.wikipedia.org/wiki/Food_and_Drug_Administration) (FDA) amended the warning label to include the possible side effects of delirium (http://en.wikipedia.org/wiki/Delirium), hallucinations, or other related behavior.[23] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-22) This went further than the FDA's previous pronouncement, from a year before, that there was insufficient evidence to claim a causal link between oseltamivir use and the deaths of 12 Japanese children (only two were from neurological problems, although more have died since then).[24] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-23) The change to a more cautionary stance was attributed to 103 new reports that the FDA received of delirium, hallucinations and other unusual psychiatric behavior, mostly involving Japanese patients, received between August 29, 2005 and July 6, 2006. This was an increase from the 126 similar cases logged between the drug's approval in 1999 and August 2005.[25] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-24)
Resistance
As with other antivirals, resistance (http://en.wikipedia.org/wiki/Antibiotic_resistance) to the agent was expected with widespread use of oseltamivir, though the emergence of resistant viruses was expected to be less frequent than with amantadine (http://en.wikipedia.org/wiki/Amantadine) or rimantadine (http://en.wikipedia.org/wiki/Rimantadine). The resistance rate reported during clinical trials up to July 2004 was 0.33% in adults, 4.0% in children, and 1.26% overall. Mutations conferring resistance are single amino acid (http://en.wikipedia.org/wiki/Amino_acid) residue substitutions in the neuraminidase (http://en.wikipedia.org/wiki/Neuraminidase) enzyme.[7] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-ward_et_al_2005-6)
Mutant (http://en.wikipedia.org/wiki/Mutant) H3N2 (http://en.wikipedia.org/wiki/H3N2) influenza A virus isolates resistant to oseltamivir were found in 18% of a group of 50 Japanese children treated with oseltamivir.[30] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-kiso_et_al_2004-29) This rate was similar to another study where resistant isolates of H1N1 (http://en.wikipedia.org/wiki/H1N1) influenza virus were found in 16.3% of another cohort of Japanese children.[7] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-ward_et_al_2005-6) Several explanations were proposed by the authors of the studies for the higher-than-expected resistance rate detected. First, children typically have a longer infection period, giving a longer time for resistance to develop. Second, Kiso et al. claim to have used more rigorous detection techniques than previous studies.[30] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-kiso_et_al_2004-29)
U.S. Government policy and oseltamivir
In November 2005, U.S. President George W. Bush requested that Congress fund US$7.1 billion in emergency spending for flu pandemic preparedness (the Senate had already passed an US$8.1 billion bill).[54] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-53) Bush's plan included US$1.4 billion for government purchases of antiviral drugs.[55] (http://en.wikipedia.org/wiki/Oseltamivir#cite_note-54)
now the Roche group are massive but here are the first quater reports from the half owned (51.5%) japanese pharma manufacturer chugai-pharmaceutical co. ltd.
Name of Company:
Chugai Pharmaceutical Co., Ltd. April 24, 2009
Stock Listing: Tokyo
Security Code No.: 4519
(URL http://www.chugai-pharm.co.jp/english)
Representative: Mr. Osamu Nagayama, President and CEO, Chairman of the Board of Directors
Contact: Mr. Mamoru Togashi, General Manager of Corporate Communications and IR Department
Phone: +81-(0) 3-3273-0881
Date of Submission of Marketable Securities Filings: May 13, 2009
Date on which Dividend Payments to Commence:
―
1. Consolidated Operating Results for the First Quarter of FY 2009 (January 1, 2009
–March 31, 2009)
1st quarter of FY 2009 (Jan.-Mar.) ¥94,690 million ― ¥17,531 million ― ¥22,797 million
1st quarter of FY 2008 (Jan.-Mar.) ¥66,160 million (27.4) ¥10,060 million (50.6)¥10,231
1st quarter of FY 2009 (Jan.-Mar.) ¥13,767 million ― ¥25.27 ¥25.27
1st quarter of FY 2008 (Jan.-Mar.) ¥ 6,698 million (49.6) ¥12.30 ¥12.29
so thats over double the profit this quater compared to same quater 2008.
source: http://www.chugai-pharm.co.jp/pdf/financial/090424eFinancialStatements.pdf
Heres a document sent to GP's warning of related phycological effects of tamiflu:
http://www.fda.gov/medwatch/safety/2008/Tamiflu_DHCP.pdf