COMMENT: Another Tamiflu competitor is trying to elbow its way into the money trough. Peramivir, a neuraminadase inhibitor, failed trials in 2005 for oral use of the drug. But the September, 2005 issue of Medical technology Stock Letter, it was shown that "a single intramuscular (IM) injection of peramivir was comparable to, or better than, five days of oral treatment with Tamiflu in preventing death from the avian flu virus." The current study, which used the drug in an IV format, called the drud "safe." It would be interesting to read the entire study to see what side effects were present that were not considered "serious."
September 29, 2006: High doses of new bird flu drug safe in U.S. study. "We demonstrated that you can go to very high levels of peramivir in humans," Dr. Charles Bugg, Chairman and Chief Executive Officer of BioCryst, said in a telephone interview. "We did escalating doses — starting at a low dose and showing it's safe and going until we have a dose way, way above what we think it takes to inhibit the virus. We can go to very high levels," Bugg added. They gave more than 60 healthy volunteers intravenous peramivir each day for up to 10 days in doses ranging from about 30 mg to 600 mg. All doses were well tolerated with no serious adverse effects, researchers independent of the company told a meeting in San Francisco of the American Society for Microbiology. ____________________________________
COMMENT: This has been known for more than a year....that once Tamiflu is used more widely, resistance would begin. I documented this problems in FOWL! long before this report!
September 28, 2006: WHO: Deadly Bird Flu Virus Mutating. "We know from surveillance studies and from hospital clinical studies that resistance to the two primary anti-viral drugs, the Tamiflu and Amantadine drugs, have already occurred," Perdue said. ____________________________________
COMMENT: Indonesia has been convinced to poison it population (humans and birds)....and Rumsfeld wins again.....
September 7, 2006: Indonesia to produce millions of tamiflu to combat bird flu. Indonesia will produce 5 million tablets of tamiflu this year and conduct a massive vaccination of poultry to combat avian influenza, senior officials said here Tuesday. Two local companies, the Kimia Farma and the Indo Farma have registered to take part in the production, said Director General of Pharmacy Services of the Indonesian Health Ministry Richard Panjaitan. "Five million capsules of tamiflu will be produced before December this year," said Panjaitan. However, he said that the materials for the capsules would still be imported from other countries. Earlier, Indonesia has imported 5 million tamiflu from India and 2 million from Switzerland, he said. ____________________________________
COMMENT: Looks like Rumsfeld will continue to rake in the millions as this drug gains approval for treatment of bird flu.
August 14, 2006: Czechs successfuly devlop anti-bird flu drug -(no link available) Czech scientists from the Organic Chemistry and Biochemistry Institute of the Academy of Sciences successfully work on the development of a medicine against bird flu, the daily Mlada fronta Dnes (MfD) reports. In mid-July, representatives of the Czech Organic Chemistry and Biochemistry Institute and Gilead Sciences signed a cooperation agreement on the basis of which a new academic research centre will be established. The U.S. company will subsidy it with an annual $1.1 million. In another agreement, Gilead Services pledged to finance selected patents.
Gilead Sciences is dealing with research, development and distribution of innovative medicines. It also focuses on the treatment of patients suffering from fatal diseases in various parts of he world. The list of Gilead's medicines includes the Tamiflu antiviral medicine to be applied against bird flu symptoms
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COMMENT: If this therapy is approved, sounds like it could blow Tamiflu out of the market interms of an effective treatment
August 9, 2006: United Press International - Health Business - Gene delivery adds to bird-flu arsenal?U.S. biotech firm BioDelivery Sciences International said Wednesday its Bioral gene-delivery system cuts flu virus levels in mice 200-fold. In the mouse model, a single intranasal dose of encochleated siRNA administered four hours after influenza exposure appeared to cut the viral load in the lung by 200 times, BDSI said. The company said it also tested in the rodent model an intravenous version of the technology, noting that the encochleated siRNA was approximately 25 times more effective in reducing the virus using intravenous delivery, compared to "naked" or non-encochleated siRNA. The siRNA technology works by triggering a cellular response that destroys molecules that produce virus proteins within the cell, preventing the virus from replicating and causing disease, BDSI said. ____________________________________
COMMENT: Good grief. Too bad the medication won't help them.
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The World Health Organization put the maker of the global stockpile of the anti-bird flu drug Tamiflu on alert for the first time after human-to-human transmission was suspected in Indonesia, officials said Saturday. The organization said that a precautionary 9,500 treatment doses, along with protective gear, were flown into Indonesia on Friday, but the shipment was not expected to be followed by further movement of the drug.
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COMMENT: This is creepy! Why was this announced? and why now?
Mike Leavitt, US Health and Human Services Secretary, says US stocks of Tamiflu are being sent to a safe location in some unnamed Asian country. He said this move is to help the first line of defense in case a flu pandemic breaks out. Many wonder why this sudden move was announced. Why is the country unnamed? Mike Leavitt said the Tamiflu stocks that are being moved from the USA to Asia would belong to the USA - America would control its deployment. We are told the shipment will arrive at the Asian country later this week. We don't know how many Tamiflu doses were sent.
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COMMENT: The H5N1 virus is barely susceptible to Tamiflu and taking it can lead to "mutant" viruses that the FDA is concerned may be more aggressive than the initial (H5N1) virus. Neither amantadine nor rimantadine have EVER been shown to have any effective against H5N1. One more way to sell ineffective drugs--with side effects---to an unsuspecting public. And these drugs may be completely protected from liability.....
May 18, 2006: IOL: WHO backs dual antiviral therapy for bird flu Geneva - Bird flu patients should receive Tamiflu as a frontline treatment, but doctors may also consider combining it with an older class of effective flu drugs, the World Health Organisation (WHO) said on Friday. The experts said amantadine and rimantadine - in an older class of drugs known as M2 inhibitors which are cheaper - may be used alongside the newer drugs in certain cases. ____________________________________
COMMENT: Tamiflu is barely effective--if at all--against H5N1. It can cause formation of mutant viruses that can be more serious than the original influenza virus. Children can have psychiatric side effects. Its apparent bad taste may be the least important reason to not take it!
May 14, 2006: U.S. Newswire : Releases : "UPDATED: Tamiflu's Achilles Heel: Taste Test by..." Due to taste, children, who are the major carrier/transmitter of the typical flu, are likely to be less than 50 percent compliant with the pediatric version of this medication. Not only will children refuse the medication, but not finishing the entire drug regimen as prescribed could result in persistent symptoms, uncured disorders, and the evolution of drug-resistant strains. ____________________________________
COMMENT: No surprise....the FDA has been very concerned about Tamiflu actually CAUSING the pandemic once it is in widespread use....for complete information, see the chapter, "The Scam of Tamiflu" in my new book, FOWL! Bird Flu: It's Not What You Think
April 22, 2006 - Mutated flu strain said contagious - The Asahi Shimbun - A strain of the type B influenza virus resistant to Tamiflu is now believed capable of human-to-human infections, researchers reported Friday. "One researcher said the apparent human-to-human spread could prompt a review of the use of Tamiflu, the government's main weapon in the battle against influenza outbreaks." ____________________________________
April 4...Daily Times - Site Edition Donald Rumsfeld makes $5m from bird flu drug. US Secretary of Defense Donald Rumsfeld has made more than $5 million from selling shares in the biotechnology firtm that discovered and developed Tamiflu, the drug being bought in massive amounts by governments to treat a possible human pandemic of bird flu, reports British newspaper the Independent. ____________________________________
March 30, 2006: U.S. clears Glaxo drug for preventing influenza - Mar. 29, 2006 WASHINGTON (Reuters) - GlaxoSmithKline Plc's prescription flu treatment Relenza has won U.S. approval for preventing influenza in adults and children ages 5 and older, regulators said Wednesday. The inhaled drug already is sold for treating the flu in adults and children. ____________________________________
U.S. orders additional 2.2 million Relenza doses
The U.S. government has ordered another 2.2 million doses of GlaxoSmithKline's Relenza bird flu drug, according to Biota Holdings Ltd., which licenses the antiviral to GSK. Earlier this month, the U.S. ordered 1.75 million courses to increase its stockpile of antiviral drugs as part of a strategy to have enough drugs to treat 25% of Americans. The Age (Melbourne, Australia) (free registration) (3/23)
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February 1, 2006 - Roche 2005: Record Sales and Operating Profit - Roche via www.pharmalive.com - "Pharmaceutical sales advance 25%, four times the global market growth rate - Sales of anticancer drugs up 42% to 11 billion Swiss francs, further strengthening Roche'™s market leadership in oncology -Tamiflu production expanded significantly to meet huge need for pandemic readiness supplies - Positive results from phase III clinical trials in rheumatoid arthritis and breast, lung and pancreatic cancers ____________________________________
COMMENT: There is a reason that so many deaths have been in Vietnam. Answer in by book, FOWL!
respective numbers in the country since December 2003 to 93 and 42.
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Comment: this is the IV form of Tamiflu....I've been wondering when they would put this on the front burner.
trials in early 2006 in collaboration with the National Institutes of Health.
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December 22, 2005: CTV.ca | Experts warn against personal Tamiflu stockpile People who have been building up a personal stockpile of the flu drug Tamiflu should stop, or they risk becoming a "walking mutated virus bomb," warns a Toronto infectious disease expert...Bird flu may not become the strain that causes a pandemic. For another, taking Tamiflu in a way not recommended by doctors could create a risk to others. ____________________________________
December 22, 2005: TAMIFLU PROPHYLAXIS EXTENDED TO CHILDREN Roche announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) extending the prophylaxis (prevention) indication for TamifluÒ (oseltamivir phosphate) to include children ages one through 12.
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COMMENT: The vast majority who contract the flu--even the very young and the very old--recover from it uneventfully. Tamiflu is being reported to cause more and more deaths from side effects. BEWARE!
December 16--CattleNetwork.com Japan - Two Deaths May Be Linked To Tamiflu. TOKYO (AP)--The deaths of two Japanese might be linked to the antiviral drug Tamiflu - used to treat flu victims, including those with bird flu - the country's Health Ministry said Friday. A man in his fifties died from toxic epidermal necrosis in 2005, while another in his eighties died from kidney failure in 2004, both after taking the drug, ministry spokesman Shinichi Watanabe said. ____________________________________
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December. 4, 2005: Doctor says bird flu drug is "useless" - Sunday Times - Times Online A VIETNAMESE doctor who has treated dozens of victims of avian flu claims the drug being stockpiled around the world to combat a pandemic is 'useless' against the virus. ____________________________________
November 28, 2005 - BioCryst Files for Peramivir Testing - AP via Forbes - The company said that peramivir, an influenza neuraminidase inhibitor, has been shown to be active in fighting a wide variety of flu viruses including the H5N1 strain of bird flu." ____________________________________
November 8, 2005 - Major banks prepare for potential bird flu threat - Reuters - "Major international banks based in the City of London a regearing up to cope with a potential avian flu epidemic, including preparing contingency plans and looking at buying supplies of anti-flu drugs such as Tamiflu." ____________________________________
COMMENT: The Tamiflu studies for pediatric approval only contained 1000 kids; some of the smaller studies were as few as 10. Only 760 kids got full doses of Tamiflu. "Remains an open question" is an understatement.
November 7, 2005 - Treating kids during flu outbreak cost-effective - Reuters Health - "Oseltamivir (Tamiflu) and amantadine (Symmetrel, Endantadine) are the only two antivirals currently licensed for treatment of influenza in children younger than 7 years. Whether the benefits of therapy outweigh the costs and potential adverse effects remains an open question." ____________________________________
October 27, 2005 - Feature-US doctors struggle with demand for bird flu drug- Reuters AlertNet - "The calls have been pouring in to Dr. Howard Bennett's pediatrics office in Washington -- parents wanting prescriptions of Tamiflu to protect themselves and their children in case avian flu becomes a human pandemic." ____________________________________
October 27, 2005 - GSK takes steps to meet demand of avian flu treatment - The Independent, UK - "GlaxoSmithKline is to signal that it is willing to licence production of its avian flu treatment Relenza to outside manufacturers in order to ensure sufficient supplies to tackle a pandemic and to pre-empt calls that the company be stripped of patent rights on the drug." ____________________________________
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October 18, 2005 - Avian flu fear flies out window in face of daily woes - Boston Herald - "Even as Americans are visiting the CDC's avian flu information Web page at a rate of 447,000 hits a day, and blasting the Bush administration for ordering Tamiflu rather on the late side. ____________________________________
COMMENT: The virus morphed months ago and has been developing resistance to Tamiflu. .
October 15, 2005: Bird Flu Virus That Is Drug-Resistant Is Found in Vietnamese Girl A strain of H5N1 bird flu virus found in an infected Vietnamese girl is resistant to the drug being stockpiled by more than a dozen countries, including the United States, as a defense against a possible global pandemic, researchers reported yesterday. The new finding, while not unexpected, raises the possibility that oseltamivir, sold as Tamiflu, might be less useful than anticipated. ____________________________________