Tamiflu and Influenza

Highly pathogenic Avian influenza

he world would have never thought that beautiful and innocuous creatures like poultry birds could pose a major health threat to humans. The unthinkable has already happened in certain countries of Asia, Africa and Europe. The poultry birds like chickens and even ducks have been found affected by highly pathogenic avian flu.

Technically called the H5N1 virus, it normally affects the birds and has a very high mortality rate amongst the birds. Though the possibility of human transmission of this virus is extremely low, yet there have been more than 100 confirmed cases of human infection with avian influenza viruses since 1997. Now there are genuine fears that the current outbreak of bird flu can transform itself into the deadly influenza pandemic.

The last century was witness to 3 influenza pandemics that killed millions of people worldwide. The experts have predicted huge monetary and human losses if and when another influenza pandemic was to strike the green planet.

Bird flu prevention is the major thrust of health experts the world over. The poultry workers who are most prone to bird flu are advised not to come in direct contact with the secretal and faecal matter of birds. They must also wash their hands with soap as and when the contact is suspected. However, most national governments have tried to identify the infected area and culled all the birds in that region to effectively arrest the spread of the disease.

Tamiflu (oseltamivir) is the only known effective drug for bird flu treatment in humans (though there are some unconfirmed claims about Relenza as an effective drug against avian flu doing the rounds). No vaccination has yet been developed to prevent the onset of disease among humans. The governments worldwide have stockpiled Tamiflu to tackle the bird flu. But if ever a Tamiflu-resistant strain developed in humans, in all probability we would witness the first influenza pandemic of this century. Till then, it is prudent to buy Tamiflu for bird flu treatment.

Bird flu fears in Cairo prompt frantic run on bottled water

Of all the panicky ways that people worldwide have tried to seek protection from bird flu, perhaps the strangest took root among Egyptians last week. Via e-mail messages and through mouth-to-ear advice dispensed on crowded city streets, word went out: Don't drink the water.

Farmers -- and that includes rooftop poultry breeders, a Cairo fixture -- had begun to dump stricken, dead chickens into the Nile River, the source of drinking water for millions of Egyptians, newspapers and satellite television reported. Suddenly, taps were turned off and consumers rushed to stores to purchase bottled water.

"I never saw anything like it," said Emad Abu Fouad, a grocer in the Bab al-Zuweila district. "People bought whole cases."

No matter that the government assured everyone that purification chemicals in public water supplies would kill the H5N1 virus that infects birds and, scientists fear, could mutate into a form that is easily transmitted among humans.

On Saturday, Abu Fouad put up a paper sign at his shop: No Water, it read. "My supplier says he can't get more until Monday," he said.

Egypt is not the only country whose populace reacted with alarm during bird flu's recent thrust out of Asia. In Western Europe, poultry sales plummeted as soon as the disease was found in migrating fowl. But in Egypt, there is a reservoir of mistrust of official information that leads to an especially irrational response.

"There is little transparency in our society, and whatever information is given is likely to be false. It will take a long time for people to believe the government," Magdi Mehanna, a journalist, wrote in the independent al-Masry al-Yom newspaper.

No humans have come down with the flu, Egyptian officials say, but as in other countries where the virus arrived in birds, the spread of H5N1 immediately depressed the chicken market.

In Egypt, 750,000 people are employed in large-scale poultry breeding. Layoffs are approaching 30 percent, industry officials say, as sales plummet. About 800 million chickens are consumed annually in Egypt, and the entire industry is losing $1.7 million a day, the government-owned Al-Akhbar newspaper reported.

Bird Flu Detected in Italy and Greece

Bird Flu has reached Western Europe, with Italy and Greece announcing Saturday they had detected the H5N1 strain of the virus in dead swans.

The announcement that the disease was detected in five swans in southern Italy came a day after the opening of the Winter Games in Turin, several hundred miles to the north. Italian officials said the virus had only affected wild birds and posed no immediate risk to people.

The European Union said the deadly strain, which has infected at least 166 people and killed 88, most in Asia, also had been confirmed in swans in Bulgaria.

No human infections were reported in the three countries, but the outbreak raised concerns that the spread of the disease could increase chances for it to mutate into a form easily transmissible among humans, who generally catch the disease from domestic poultry.

"It's a relatively safe situation for human health; less so for animal health," Italian Health Minister Francesco Storace said.

Also Saturday, authorities in Nigeria said they were investigating whether the deadly strain, which was discovered in the country last week, had spread to humans after at least two children were reported ill.

The U.N.'s chief bird flu expert said the spread of bird flu, which has been ravaging poultry stocks across Asia since 2003, increased the chance that the virus would mutate into a form transmitted between humans and set off a pandemic. Most human deaths from the disease so far have been linked to contact with infected birds.

"We have got bird flu now in India, central Asia, eastern Europe, and west Africa," Dr. David Nabarro said, before the Greek and Italian announcements. "Compared with eight months ago, this is a major extension of the avian influenza epidemic."

Experts said they were reassured by the fact that the virus has been detected in wild birds in Western Europe instead of on farms.

"The risk to humans is less if the disease is in wildlife than if it is in poultry," said Juan Lubroth, a senior animal health officer at the Rome-based U.N. Food and Agriculture Organization. Bird Flu News

Roche says now shipping Tamiflu to all markets

Swiss drug maker Roche Holding AG said on Tuesday it had lifted restrictions on shipments of influenza drug Tamiflu that were put in place to prevent hoarding by consumers worried about bird flu.

Roche said it was now shipping the oral drug to all markets to fight the seasonal flu widespread in several U.S. states.

The company said it previously was distributing Tamiflu only to U.S. cities where a high incidence of influenza was being reported.

Roche said it boosted shipments after seeing an increase in flu reports in the United States and a Centers for Disease Control and Prevention advisory to doctors to avoid using two older flu drugs this season.

"We are prepared to meet seasonal demand for Tamiflu, including any increase stemming from CDC's recent announcement," George Abercrombie, president and chief executive of Roche unit Hoffmann-La Roche Inc., said in a statement.

Roche in Tamiflu pact with generic makers

US senator Charles Schumer said on Thursday that Tamiflu maker Roche Pharmaceuticals had reached agreements with two US generic drugmakers, Teva Pharmaceuticals and Mylan Laboratories, as well as 13 other drug producers.

The agreements are meant to allow more production of the drug, known generically as oseltamivir, in case of an avian flu pandemic, Schumer, a New York Democrat, said in a statement.

Roche has allowed Schumer to make similar announcements in the past, in part because Schumer has been pressing the company to allow generic makers to license the pill to help prepare for an influenza pandemic. A spokesman for Roche said the company did not have an announcement to make yet.

�Roche is in advanced discussions with potential partners that can help enhance its supply chain and add capacity for certain specialized steps in the manufacturing of Tamiflu,� Terence Hurley said in am e-mail.

�Teva Pharmaceuticals and Mylan Laboratories are among these potential partners. Roche is moving ahead as planned with the third-party discussions and is planning an update on the current status soon.�

Tamiflu is one of four drugs known to work against influenza. It does not cure the virus but can reduce the severity of infection and in some cases prevent infection.

Tracking Down Tamiflu

It may seem hard to believe, but this cold snap is actually good news for KELOLAND health officials. That's because people don't tend to venture out much in weather like this. And that should slow the spread of this year's flu.

That's especially important because officials here aren't as well-armed against the flu as they'd like to be. You see, bird flu fears are putting the bite on supplies of medication that some of us may need to fight the regular flu.

If a pandemic flu hits, health officials say, they'll need millions of doses of the antiviral drug Tamiflu to battle the bug. But fears of not having enough to go around are already putting restrictions on those who need it now. Bill Ladwig, vice president of pharmaceutical services for Lewis Drug Stores, explains, "We actually have to call the wholesaler and you have to do an override to get the product."

Meaning pharmacists have to prove there's an outbreak of Influenza B going around in an area, before they can get the order to go through. Ladwig says, "I think once you've established that, and the CDC recognizes that it's in your state, then they may release the product. But they want to make sure that they get the product to the people who truly need it."

Because despite federal officials' insistence that the likelihood of a bird flu pandemic is extremely small, plenty of people are hoarding Tamiflu just in case they need it. U.S. Drug stores have already filled more than 422,000 prescriptions since mid-August. More than four times the amount of Tamiflu sold in all of last year. Ladwig continues, "They won't ship it to you unless you call and specifically ask for the product. If they have any, right now they're out of stock."

And the clock is already ticking on influenza B. Ladwig says, "Generally, we have in the past seen it in December. Right before the Christmas break period you get a couple of outbreaks. You never really know, but when it hits, it hits hard."

Just how hard could determine just how tough it will be for flu sufferers to find relief. Ladwig explains, "It's just in the long haul, when we get to two weeks of an outbreak, three weeks of an outbreak, then you may need to go to an allocation process to find the product."

Kenya opts for Tamiflu in case of bird flu outbreak

Kenya last week said that it would stock at least 2,000 doses of the avian flu treatment, Tamiflu, even as samples from seven dead birds found at a migratory corridor in the Rift Valley tested negative for the deadly virus.

The announcement of Kenya's intention to buy Tamiflu, which was made by the director of medical services James Nyikal, came as the Nairobi office of international pharmaceutical company Roche confirmed that it had made an offer to sell the active pharmaceutical ingredient of the medicine to the government in powder form at a subsidised price to prepare for any outbreak of the deadly flu.

According to Roche's regional manager, Dr Anthony Wanyoike, stocking of the powder form of Tamiflu will enable the Ministry of Health to make thousands of treatments available at short notice and low cost in the event of an outbreak.Currently, Dr Wanyoike said, one full treatment course with Tamiflu in capsule form costs about Ksh2,500 ($34), which is beyond the ministry's capability in case of an epidemic.

"The key intervention in case of an outbreak would be for the government to have a cheap, easily available form of Tamiflu, and the powder form is ideal," Dr Wanyoike told The EastAfrican. "We have already made an offer to the ministry of health, and we are expecting a positive reply in due course."

Due to high global demand however, Dr Wanyoike added, the earliest Kenya can receive a consignment of the powder Tamiflu is July 2006. Guidelines issued by the World Health Organisation (WHO) say that countries at risk of an outbreak of avian flu, which is caused by the H5NI virus, should ideally stock medicines to cover between 15 and 20 per cent of the population.

Roche's Nairobi office filed registration documents for Tamiflu with the Ministry of Health Pharmacy and Poisons Board last month, and the drug is expected to be registered in the next few weeks. According to Dr Wanyoike, distribution of the medicine to retail outlets will be limited to registered pharmacies according to the supply situation, following widespread hoarding in the West.

"The important thing is that there is currently no reason for the public to panic, because the avian flu has not yet reached the country and we have some stock to deal with a limited outbreak," Dr Wanyoike said. "We have also ordered another consignment which should be coming into the country in the next three or four weeks."

Kenya has set up a high-level taskforce bringing together experts from the National Museums, the Kenya Medical Research Institute (Kemri), and the Ministries of Health and Livestock to co-ordinate the response to any outbreak. Last week, the taskforce announced that tests on seven migratory birds found dead near Kericho in the Rift Valley had shown them to be free of the H5N1 virus.

The overuse of Tamiflu in treating avian flu

Tamiflu -- generic name oseltamivir -- has been promoted too far to be used in avian flu because it is neither proven nor significantly effective even in the treatment of common flu. In influenza Type A and B (common flu) the efficacy in clinical studies is manifested as an improvement of one day (FDA website -- updated on Nov. 17, 2005 -- states one to one-and-a-half days) in the recovery-time of influenza that normally heals within a week. A one-day improvement should be considered an insignificant result in a clinical trial.

Moreover, in the U.S. most flu is that of Type A. Such results, measured by days of recovery for a sickness that lasts normally a week, should be classified as "modestly effective" at the most to justify marketing of the product. Adverse reactions are not yet completely known.

On the current FDA website, adverse event reports from Japan in children documented "primarily unusual neurologic and psychiatric events such as delirium, hallucinations, confusion, abnormal behavior, convulsions and encephalitis... 12 deaths in pediatric patients were documented since Tamiflu's approval".

The FDA is currently investigating these reported events, all of them from Japan. Although adverse events are different from (established) adverse reactions, this phenomenon should not be taken for granted, since this is not the first time that Japan has produced such reports on other drugs that have later been proven to be true.

Against avian flu Tamiflu has never been studied before, while avian flu is quite a different disease than ordinary flu that occurs in countries with a cold climate nearer the Antarctic. Influenza in tropical climates, such as Indonesia, is again not the same as the cold winter flu in the above countries.

Preparing for influenza and major health threats

Why did the Commission draw up a new EU influenza preparedness plan?

There have been many developments since the Commission published its last influenza preparedness plan in March 2004. Firstly, the WHO updated its definitions of pandemic phases in 2005, placing more emphasis on pre-pandemic phases e.g. when threats exist in animal viruses or when a new human virus emerges but does not spread efficiently. The WHO recommendations for pandemic preparedness are based on these defined phases, and therefore, this needed to be factored in to any EU preparedness planning. Secondly, the European Centre for Disease Prevention and Control (ECDC) became operational in May 2005, and its central role in preparing for a pandemic needed to be clearly defined in the overall EU plan. Finally, it is necessary to continually review and revise national preparedness plans in light of new information and latest disease situations in order for them to be properly effective. The progression of avian influenza from South East Asia over the past few months, and global concern at the possible the emergence of a new pandemic-causing virus, have made it all the more pertinent that the EU reviews its plan to prepare for and deal with a pandemic.

What are the WHO pandemic phases and EU pandemic alert levels?

The WHO, in its recommendations on pandemic influenza, defines 6 different phases of a pandemic, ranging from Phase 1 (no new influenza virus subtypes detected) to Phase 6 (full-scale global pandemic). Phases reflect the cycle of a pandemic, i.e. inter-pandemic, pandemic alert, pandemic and post-pandemic period. The WHO advice on action to be taken is tailored to each of these phases. The EU has based its pandemic planning to a large extent on the WHO recommendations. However, in its preparedness plan, the Commission has introduced EU alert levels, which relate more directly to the situation in the EU, rather than the global situation encompassed in the WHO phases. For example, WHO pandemic phase 6 could be announced if the disease became widespread in Asia, but may not yet have reached Europe. The EU alert levels (levels 1-4) would occur within a WHO Phase 6 pandemic, and the alert level would rise depending on how widespread and virulent the virus was in the EU.

China confirms second bird flu death

China said on Wednesday that a 35-year-old woman farmer had died of bird flu, its second confirmed fatality from the virus.

The Xinhua news agency, quoting the Health Ministry, said the woman had developed fever and pneumonia-like symptoms on Nov. 11 after contact with sick and dead poultry in the eastern Anhui province. She died on Nov. 22.

Xinhua said tests by China�s Centre for Disease Control and Prevention had proved positive for the deadly H5N1 strain of avian influenza.

The health ministry has reported the new confirmed case to the World Health Organisation (WHO). It has also informed the authorities in Hong Kong, Macau and other countries.

H5N1 has killed 67 people in Asia since 2003, and both the World Bank and Asian Development Bank have warned of the huge economic costs of a human pandemic should the virus mutate into a form that can spread easily among people.