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Bird Flu - Archives

 
Tamiflu and Relenza
 

Tamiflu Death - A Japanese Family Sues
A Japanese family whose son died after taking Tamiflu are to sue the country's Pharmaceutical and Medical Devices Agency:

The 17-year-old died in February 2004 when he ran out of his home in his bare feet and was run over by a truck about two hours after taking Tamiflu...

The suit comes months after Japanese health authorities ordered doctors not to prescribe Tamiflu...to patients aged 10-19 following dozens of deaths and injuries among teenagers over the past six years.

More than 1,300 people have exhibited neuropsychiatric symptoms since Tamiflu went on sale in Japan in 2001, of whom 71 have died. Twenty-seven, most in their teens, fell from buildings.

Last month the health ministry announced new clinical trials to establish whether the antiviral could cause delirium, delusion and other neuropsychiatric symptoms. The ministry had previously ruled out any link.

July 25th, 2007

 

Relenza a Hit
Aussie company Biota Holdings is seeing windfall profits from its anti-flu drug Relenza, with third-quarter royalties of A$16 million, up from A$7.3 million for the previous quarter:

The figures are based on worldwide sales of $92 million for the third quarter that have promoted Relenza to 14th largest seller in the GlaxoSmithKline product range.

Biota sold manufacturing and marketing rights for Relenza to GSK and is involved in a law suit against the giant over its alleged failure to manufacture the drug in sufficient quantities.

Ben McCaw, an analyst with eG Capital, said increased sales of Relenza were partly because of a World Health Organisation recommendation that nations stockpile enough anti-flu drugs to treat a quarter of their populations.

Australia, the US, France, the Netherlands, Belgium and Czechoslovakia are among countries to have accepted the challenge.

Biota wants Relenza to achieve a 20 per cent stake of these stockpiles. The remaining 80 per cent is held by Tamiflu, manufactured by European chemical giant Roche.

May 7th, 2007

 

Tamiflu and Relenza - Do They Still Work?
Tamiflu and Relenza appear to be losing their effectiveness, as the bird flu virus adapts, according to a Japanese study.

The research suggests that scientists may have to find new ways to combat growing resistance to current flu treatments — and possibly rethink the strategy for preventing a global flu pandemic.
April 19th, 2007

 

Tamiflu Troubles
The Japan Times reports that 128 people, mainly teenagers, have been found acting strangely after taking Tamiflu.

Eight people -- five in their teens and three adults aged up to their 90s -- died in connection with such abnormal behavior, including apparent hallucination-induced suicidal leaps from buildings....

Of the 128 cases, 100 were under age 20, including 43 who were under 10....

One boy under 10 who took the flu medicine subsequently took out a kitchen knife and then tried to jump from a balcony, and a teenage boy suddenly began hopping.


Meanwhile, South Korea will ban most Tamiflu prescriptions to teenagers.
April 5th, 2007

 

Biota Vs GSK - The Battle Gets Hotter
The Australian newspaper reports:

Australian biotech company Biota Holdings could increase its claim for damages against business partner GlaxoSmithKline, alleging it has evidence that reveals GSK concealed a decision to stop marketing the anti-influenza drug Relenza.

...In an amended claim filed yesterday, Biota CEO Peter Cook said a two-year review of almost 300,000 GSK documents showed the company failed to disclose its decision to abandon Relenza.

"Initially our claim was based on a relatively limited number of documents from GSK, maybe 1000 or so," Mr Cook said.

"We now have greater detail that we feel establishes that they concealed their intentions around the product."

Relenza, the world's first broad-spectrum anti-flu drug, was launched in 1999, capturing almost half of the global market for flu medication within a year.

Relenza's main competitor, Tamiflu, was launched by rival pharmaceutical company Roche two months later, but it has since established itself as the market leader, attracting 97 per cent of sales of anti-flu drugs.

Biota's amended claim states there was a strategic shift by GSK away from Relenza, especially after the 2000 merger that combined Glaxo Wellcome and Smith Kline Beecham.

Biota claims GSK failed to disclose its decision to close manufacturing lines and stop promoting the drug, prompting sales to plummet by more than 80 per cent.

March 30th, 2007

 

Tamiflu Warnings - "At Long Last"
Reuters has a good round-up of Japanese opinion on the Health Ministry's warning that Tamiflu should not be given to teenagers:

"At long last they have taken action, but it is extremely slow and half-hearted," Rokuro Hama, a doctor who runs a watchdog group on side effects of drugs, said in a telephone interview.

Hama says there should be similar warnings against the use of Tamiflu for all age groups, because influenza is essentially a minor disease that need not be treated with drugs.

Haruhiko Nokiba, the father of the youth killed in the truck accident, told the Sankei [newspaper]: "The fact that a series of victims has emerged is due to the negligence of the ministry. Just as with previous drug problems, they are dealing with it too late."

The ministry had previously warned that children taking Tamiflu should be supervised and has maintained that warning for younger children, who are seen more at risk of dying from flu. In the new warning it recommends that children aged 10-19 should not be given the drug at all.

March 23rd, 2007

 

Tamiflu - More Deaths in Japan?
The Daily Yomiuri reports:

A second-year middle school boy died after falling from the 11th floor of his condominium building in Sendai on Tuesday, police said. The boy had taken the influenza medication Tamiflu several hours before the fall.

A similar fatal accident occurred on Feb. 16 in Gamagori, Aichi Prefecture, when a middle school girl died after falling from an apartment building after taking Tamiflu.

In light of these two incidents, the Health, Labor and Welfare Ministry announced it will gather information on the side effects of Tamiflu from pharmaceutical companies.

March 3rd, 2007

 

Tamiflu Booms
Roche Holding has reported a 33% jump in 2006 profits, from an 18% rise in sales.

Sales of Tamiflu, which nations around the world have been stockpiling to prepare for a possible flu pandemic, soared 68 percent last year to 2.63 billion francs (US$2.11 billion; euro1.63 billion), largely on government orders.

Since 2004, more than 75 countries have placed orders for pandemic stocks of the drug, which is seen as perhaps the best initial defense should the H5N1 strain of bird flu mutate into a form spread easily among humans.

The company said, however, that it expects Tamiflu sales to drop this year to between 800 million francs and 1.2 billion francs (US$642 million and US$963 million; euro496 million and euro744 million) as a result of competition from generics in the United States.

"Top-line growth and margins came in higher than expected, and that seems to be because of Tamiflu," said Karl-Heinz Koch, a pharmaceutical analyst at the Zurich-based private bank Vontobel.

February 8th, 2007

 

Is Tamiflu Killing Canadians?
Have 10 Canadians died from Tamiflu? That's what some newspapers seem to be reporting. Here's a Digital Journal report, with the headline "Bird flu vaccine leaves 10 Canadians dead", based on a Vancouver Sun story:

Two weeks ago, international warnings were posted of adverse reactions to the medication among children and youth.

Health Canada didn't issue a public update about the flu drug until Wednesday.

Health Canada's bulletin said that since February 2000, 84 Canadians have had adverse reactions after taking the drug, including 10 who died and seven adults who reported "psychiatric adverse events."

This year alone there was 13 reported reactions to the drug including 3 women aged 95, 88 and 81 that died.

Tamiflu is used to treat the flu and combat the H5N1 avian flu virus.

Health Canada spokesman Alastair Sinclair says there is no reason for Canadians to be worried.


But this is what Health Canada said:

As of November 11, 2006, there have been 84 reports of adverse events occurring in Canadian patients using Tamiflu, including 10 which reported a fatal outcome. A causal relationship has not been confirmed in these cases.
December 1st, 2006
 

Tamiflu a Winner for Roche
Business is booming for Roche Holdings, with sales up 19% in the first nine months of 2006:

The figures beat analysts' expectations, but some cautioned that the good sales of Tamiflu, which governments have been stockpiling in case of an influenza pandemic outbreak, masked sluggish growth elsewhere.
October 18th, 2006

Relenza - Safer Than Tamiflu?
Some good news for bird flu drug Relenza. It seems that it's less likely to lead to flu-resistant drug strains that its big rival Tamiflu. That's according to a new study, which was carried out (coincidentally??) by Glaxo (which markets Relenza) and Australia's Commonwealth Science and Industrial Research Organisation (which helped develop it).
August 19th, 2006

 

Tamiflu Vs Relenza - Is It All In The Packaging?
BCP Confidential writes:

I can find no clinical evidence that Tamiflu--one of the two main pharmaceutical weapons against an epidemic or pandemic of Type A influenza--is substantially more effective than its competitor Relenza.

I can find abundant evidence, however, that Switzerland's Roche has much better packaging for Tamiflu, and that it is therefore (a lot) more expensive than GlaxoSmithKline's Relenza. If this isn't a business school case study in the importance of packaging, it surely will be.

July 26th, 2006
 

Another Tamiflu Suicide in Japan?
Tamiflu is widely prescribed in Japan for flu sufferers, and some months back came reports of a series of mystery deaths - including several suicides - from patients who had taken the drug. Now, we have another report:

A junior high school boy plunged to his death on Monday evening after taking the controversial "tamiflu" drug, which has been blamed for producing dangerous side-effects, police said.

At around 5:50 p.m. on Monday, a passer-by found a boy lying face-down in the parking lot of a prefectural apartment complex in the Onaga district of Tomigusuku, local police said. He was rushed to hospital where he was pronounced dead.

The boy has been confirmed to be a 12-year-old, first-year junior high school student living in a sixth-floor condominium in the complex.

His family said the boy took tamiflu at around noon on Monday because he had a high fever. However, after his fever did not decline, he took an anti-febrile drug later in the day.

Some people who have taken tamiflu have shown irregular behavior such as sleep-walking. However, the causal relationship between the drug and such behavior has not been proven.

July 5th, 2006

 

Tijuana Tamiflu

A growing number of Americans are traveling to Tijuana to buy Tamiflu, according to a Biowire report:

"For the past month, we have had an abundant supply of Tamiflu and are selling the FDA-recommended 10-pill dosage for $58, versus about $100 in the United States," said Mario Zamudio, Medicine Store manager.

...."Many people want to have their own supply on hand to treat themselves, their family and their friends if an outbreak occurs," said Elba Orozco, sales manager of Drug Discounters.

"U.S. customers frequently were asking us for Tamiflu, but it was only about a month ago that Roche was able to make supplies available to us," Orozco said.

The Tamiflu available in Tijuana is the same strength and quality of that in the U.S.

The Mexican government keeps drug prices in that country low so more people can afford them. That's why Americans have gone to Mexico for decades to buy prescription drugs at 30 to 80 percent savings, said Gerardo Rosales of Discount Pharmacy.

June 9th, 2006

 

We Want Answers

Medical News Today has questions about Tamiflu:
 

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 defence in case a flu pandemic breaks out.

 

Many wonder why this sudden move was announced. Why is the country unnamed?

 

And about that mystery “cluster” of bird flu cases in a North Sumatra village:

Last week it was announced that 7 members of the same family in
Indonesia were infected with the H5N1 bird flu strain - six of them died. The World Health Organization said it was unlikely that such a large cluster of human infections was due to human-to-human transmission. However, nobody seems to be able to locate the source of infection.

 

If a bunch of people get infected and authorities cannot find any birds as the source, it is not illogical to wonder whether these people may have infected each other. When the WHO says this is unlikely, but cannot offer any other explanation regarding the source of infection, people wonder.
 

They’re good questions. How long will we have to wait for answers? (And check out Recombinomics for a detailed analysis of the Indonesian cluster, and more questions.)
May 23rd, 2006

 

Short-Cut Tamiflu
Professor Elias Corey, who won the Nobel Prize for chemistry in 1990, has devised a quick and easy method of making Tamiflu. You can read all about it at this BBC report.
May 6th, 2006

 

Gumballs – the New Source of Shikimic Acid

Scientists in the US report that the fruit known as gumballs, from the sweetgum tree, contains shikimic acid, the raw ingredient of Tamiflu. The tree grows throughout the US, and is especially common in southern states. Until now, the anise spice plant has been the main source of shikimic acid. Nevertheless, scientists have also developed artificial shikimic acid, and it is expected that this will increasingly be used to make Tamiflu, obviating the need for anise and other natural base materials.

March 31st, 2006

 

42 Tamiflu Deaths in Japan?

Japan’s Mainichi Daily News is reporting that 42 people have died in Japan after using Tamiflu, though in only two cases is a direct causal link apparent.

The Ministry of Health, Labor and Welfare said on Friday that officials had received reports of three new deaths after the victims used Tamiflu. Including the three latest victims, the number of deaths after taking the drug stands at 42 nationwide, as of Jan. 20.

 

Of the 42, 14 were 16 years of age or younger, officials said. Only two cases, men in their 50s and 80s, were causally related to the use of Tamiflu, they added. After questioning experts, the officials suggested that the remaining 40 people's deaths were not particularly related to the drug.

January 28th, 2006

 

Tamiflu – Good Cop, Bad Cop

Two stories today. First, from UPI:

 

In a surprising study researchers have urged against wide usage of the popular Tamiflu and similar antiviral drugs during flu season. The study, published Thursday in the London-based medical journal the Lancet, concluded that the drugs aren't likely to help many patients with flu-like symptoms. The authors also said they found no "credible evidence" that Tamiflu works against bird flu.

 

But then there is this, from the Oxford Press in Ohio:

 

The Centers for Disease Control and Prevention's unexpected recommendation that doctors begin prescribing Tamiflu for everyday influenza could have far-reaching ripple effects, according to pharmaceutical and flu experts.

 

…The CDC said Saturday that physicians should cease prescribing two older drugs, amantadine (Symmetrel) and rimantadine (Flumadine), as protection against the worst side effects of flu because most of the flu now circulating in the country has become resistant and the drugs no longer work. To adequately protect against serious illness or death, physicians should substitute Tamiflu, CDC said.

January 20th, 2006

 

Super-Tamiflu Developed in China

Forbes is reporting a breakthrough in China, with scientists there apparently developing a new, super-Tamiflu. It is a drug that is said to be superior to Tamiflu in treating humans with bird flu, yet costs one-third the price.

 

According to the report:

 

The Chinese drug was developed by a research group at the Academy of Military Medical Sciences, which could not immediately be reached for comment.

'We have completed clinical experiments, and find it is more effective on humans than Tamiflu,' the newspaper [China Daily] quoted Li Song, a leading scientist in the academy's research group, as saying.

No details were given on whether any clinical tests had been conducted on the drug and whether it had been approved for production or sale.

December 28th, 2005

 

Apart from That, It’s Quite Safe

The Free-Market News Network has published what it claims is “an analysis of the potential side-effects from this medicine [Tamiflu], which may make it even less appropriate for consumption.”

 

The list:

 

Aches and pains, allergic reactions (sometimes leading to shock), asthma and aggravation of pre-existing asthma, bronchitis, chest infection, conjunctivitis, dermatitis, diarrhea, difficulty sleeping, dizziness, ear infections and problems, erythema multiforme, headache, hepatitis, indigestion, liver problems, lymphadenopathy, nausea, nose bleed, rash or rashes, runny nose, sinusitis, Stevens Johnson syndrome, symptoms of a cold, tiredness, tummy pain, urticaria, and vomiting.

December 27th, 2005

 

Shikimic Acid from Discarded Christmas Trees

A Canadian company has found a novel use for discarded Christmas trees. It plans to extract shikimic acid – the base ingredient of Tamiflu - from them. According to Biolyse Pharma, “the trees contain shikimic acid in their pine, spruce and fir needles.”

December 26th, 2006

 

Tests to Begin for Tamiflu Rival

A little Alabama biotech firm is “gaining on the front runner” in the race to develop an effective anti-flu treatment, according to a CNN report.

 

The company is BioCryst Pharmaceuticals, and it has just received US Food and Drug Administration approval to start human testing of its new drug, peramivir.

 

According to CNN:

 

Should the tests prove successful the drug could become an alternative to Tamiflu, the medicine currently considered the leading treatment for bird flu. And the effectiveness of that treatment has been called into question this week, with a report in the New England Journal of Medicine that bird flu patients died despite taking Tamiflu.


However, at the same time Business Week is reporting that Sanofi Pasteur of France "is leading the pack in the race to develop a vaccine that could help prevent an avian-flu pandemic."

December 23rd, 2005

 

Sting Operations Target Illegal Tamiflu

The British Financial Times newspaper reports that health regulators around the world have launched a wave of sting operations designed to stop increasing numbers of illegal Tamiflu sales. In many cases, fake Tamiflu – generally sourced from Asia – is involved. In other cases, genuine Tamiflu is being sold, at inflated prices.

 

According to the report:

 

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said on Tuesday it had found nearly 20 websites around the world illegally selling Tamiflu. It had placed orders with several so it could analyse the drugs on offer and begin prosecutions of those involved.

 

…The UK actions mirror similar operations by the US, Sweden and other European nations. All are co-operating with their counterparts in Singapore, South Africa and Australia.

 

The US Customs and Border Protection service said on Tuesday it was continuing to impound regular air freight deliveries to San Francisco of “generic Tamiflu” that had been ordered over the internet by US customers. Since interceptions began one month ago, it had seized 51 shipments.

 

These shipments, along with supplies identified by Austrian and Dutch officials, appear to be from the same source in China. The packets bear Chinese writing and are accompanied by a crude letter from the internet supplier saying that drugs from a generic supplier are being offered because of supply shortages at Roche.

December 21st, 2005

 

First Fake Tamiflu Seized in US

Counterfeit Tamiflu from China has been seized by customs agents in San Francisco.

 

The seizures of 51 packages marked "generic Tamiflu" began Nov. 26 and continued through last week, Roxanne Hercules, spokeswoman for the U.S. Customs and Border Protection agency, said Sunday. "They were actually in containers that stated they were generic Tamiflu, but there is no generic Tamiflu, so that's a pretty big tip off,'' said Hercules.

December 20th, 2005

 

Relenza “Better Than Tamiflu”

The boss of Australian company Biota, which developed the Relenza flu drug, has claimed that it is superior to Tamiflu.

 

"Relenza has not demonstrated the resistance that Tamiflu has and appears to be efficacious in conditions where Tamiflu is not," he said.

December 17th, 2005

 

Japan – More Tamiflu Deaths?

A vague story, appearing on the Japan Today website – and, apparently, nowhere else - and sourced from Kyodo News Service (one of the two big Japanese news agencies), says that two local men have died after taking Tamiflu.

 

The entire story reads:

 

The Ministry of Health, Labor and Welfare said Thursday that two men in their 50s and 80s have died after taking the anti-flu drug Tamiflu either by developing a serious skin disease or by kidney failure.

 

The ministry, however, denied there are "serious concerns" about the safety of Tamiflu at the moment, because the two men had been taking three other medicines such as antibiotics or drugs to treat high blood pressure, which could cause similar symptoms. The number of people aged 17 and above who died after taking Tamiflu stands at 26 since drug importer Chugai Pharmaceutical Co started selling Tamiflu in Japan in February 2001, ministry officials said.

December 16th, 2005

 

Prescribing Tamiflu – What Would You Do?

Randy Cohen has gained renown for his witty, pithy weekly column, The Ethicist, in the New York Times. On Sunday he answered a query from a doctor about prescribing Tamiflu:

 

Like many physicians, I am inundated with requests for Tamiflu, the best hope for combating avian flu should a pandemic occur. Because it is in short supply, I prescribe Tamiflu only to those with an immediate need, not those who want it on hand as a precaution - whether my patients, my family or me. When a close relative requested a prescription, I explained my reluctance, but the relative strongly persisted. I don't want to compromise my ethics or damage family harmony. What should I do? J. B., Philadelphia

 

Here is part of his reply:

 

You should remain firm. Family pressure can be powerful enough to squeeze a lump of coal into a diamond, but it should not be powerful enough to compel you to do for a relative what you would not do for your patients, your spouse, your children or yourself.

December 12th, 2005

 

Bird Flu Round-Up

Tamiflu – a young Vietnamese girl, infected with mild influenza symptoms was given Tamiflu, and subsequently developed a strain of the avian flu virus that was highly resistant to the drug. Sixteen South Korean drugs companies have notified the Korea Pharmaceutical Manufacturers Association that they can produce Tamiflu. Twelve of them have already submitted samples.

 

Vaccines – Michael Fumento provides a most comprehensive round-up of the latest developments.

December 7th, 2005

 

Did Tamiflu Cause This Woman’s Severe Reaction?

Scary. It has just been revealed that a young Florida woman given the anti-flu drug Tamiflu last January developed - 30 minutes later - symptoms similar to those recorded by patients in Japan. Twelve of the Japanese patients later died.

 

The woman, Lianne Esposito (photo) of Cape Coral, was prescribed Tamiflu at an emergency medical clinic to combat flu. Within 30 minutes of taking the first pill she felt her heartbeat racing and she was gasping for breath. She spent the night in hospital. Doctors told her she’d suffered an adverse reaction to Tamiflu, which is currently being touted as the best drug against bird flu.

 

Tamiflu is widely prescribed as an anti-flu medication in Japan – far more than anywhere else - and the past month has seen a series of revelations there about adverse reactions from patients, including two teenage suicides. However, so far both the US Food and Drug Administration and the Japan Pediatric Society have been unable to establish any connection with Tamiflu.


Shares in Tamiflu's producer Roche Holding and in its Japanese partner Chugai Pharmaceutical fell sharply when the Japanese deaths were first reported.
December 5th, 2005

 

“Tamiflu Useless”

An unsettling report from the Sunday Times in the UK:

 

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.

 

Dr Nguyen Tuong Van runs the intensive care unit at the Centre for Tropical Diseases in Hanoi and has treated 41 victims of H5N1. Van followed World Health Organisation (WHO) guidelines and gave her patients Tamiflu, but concluded it had no effect.

 

“We place no importance on using this drug on our patients,” she said. “Tamiflu is really only meant for treating ordinary type A flu. It was not designed to combat H5N1 . . . (Tamiflu) is useless.”

December 5th, 2005

 

Tamiflu Update

Indonesia will start manufacturing Tamiflu in three to five months. Roche, which has production rights for the drug, and Gilead Sciences, which developed it, do not hold an Indonesian patent. It is likely that manufacture will be carried out by two state-owned drugs companies, PT Kimia Farma and PT Indofarma, using raw materials sourced from China, India and South Korea.

 

The Taiwan Intellectual Property Office is likely to authorize local production of Tamiflu, in violation of the rights of Roche and Gilead.

 

Roche chief executive Franz B. Humer has told the New York Times that it will announce in early December which companies will be allowed to start their own Tamiflu production.

November 28th, 2005

 

Star Anise Report

A Reuters reporter visits the Chinese city of Gulong, center of the star anise trade, and writes a fascinating report on the spice that is used to make shikimic acid, the base ingredient of the tamiflu drug.

 

Among his findings:

 

After an unusually small harvest in 2001, prices soared to the highest anyone here had ever seen -- well above current levels. Since then, however, they have declined sharply. Many farmers are making losses, or barely scraping by.

 

"Bird flu may save the star anise farmer," said Wei Xingsong, deputy director of the Guangxi Star Anise Confederation and head of a company in Gulong that sells star anise to exporters. But he says he is not optimistic. "The peasants don't have any enthusiasm at all for star anise," he said. In Gulong, farmers sold most of their crop before the star anise craze hit and prices rose, Wei and others said.

 

"At current market prices, it's hard for us farmers to operate," said Zhou Yongzhuang, 33. Zhou has considered chopping down his 1,000 or so trees and he is not alone. Many others in these verdant hills also are considering getting out of star anise, Wei said. But for now, they have decided to wait and see if prices keep rising.

 

That could be a risky proposition. About a third of the shikimic acid Roche uses is man-made and the firm is said to be seeking ways to expand the amount.

November 26th 2005

 

Success! – Koreans Make Tamiflu; Taiwanese Find New Shikimic Acid Source

Korean news sources are reporting that a local firm, Hanmi Pharmaceutical, has succeeded in producing its own version of Tamiflu. Earlier, 16 Korean drugs companies had responded to a call from the Korean Food and Drug Administration to produce generic Tamiflu samples by December 5th. So far, Hanmi is the only company to have reported success, and it is now in negotiation with Roche about obtaining a licence to begin full production.

 

The Bangkok Post is reporting that Taiwanese scientists have succeeded in extracting shikimic acid – the base material of Tamiflu – from three local plants. Until now, the main natural source of the acid has been the star anise plant, and this is in increasingly short supply, due to soaring demand from Tamiflu’s manufacturer Roche.

November 22nd 2005

 

What’s Happening in Japan?

Suddenly, we keep hearing reports of deaths or strange behavior in Japan from people who have taken Tamiflu. A week ago the Japanese Health Ministry revealed that two teenagers apparently committed suicide after taking Tamiflu. Now come reports of a series of other cases, forcing the US Food and Drug Administration to investigate:

 

An FDA advisory panel Friday said that Tamiflu is safe and apparently unrelated to the deaths of 12 Japanese children who took the drug. The Food and Drug Administration panel did suggest adding warnings about possible serious skin conditions, and said the FDA should review the drug safety profile again in a year. But by a unanimous vote, they said there was no evidence to link the drug to the deaths or to serious psychiatric events in children.

 

The 12 deaths in the past 13 months included one suicide, four cases of sudden death and four heart attacks. Other deaths involved asphyxiation, pneumonia and acute pancreatitis. There have also been 32 cases of psychiatric abnormalities, including delusions, hallucinations and delirium, reported in children who had taken Tamiflu. Thirty-one of the cases involving psychiatric episodes occurred in Japan. Two of the psychiatric cases involved teenagers who jumped from second-floor windows after taking two doses of the drug.

 

"In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail. The level of detail in these reports was highly variable and determining the contribution of Tamiflu to the deaths was difficult," an FDA summary said.

 

According to a report in New Scientist, “a safety committee of the European Medicines Evaluation Agency (EMEA) has also requested information from the drug's manufacturer Roche.” The reports have caused a sharp dip in the share price of Chugai Pharmaceutical, which markets Tamiflu in Japan.

November 19th, 2005

 

Roche and Gilead End Their Dispute

Gilead Sciences, which developed Tamiflu, and Roche Holding, which has the license to produce and market it, have ended a dispute over their contract. Roche will make a $62.5 million retroactive royalty payment to Gilead, which will also gain additional rights over promoting the drug.

November 17th, 2005

 

Up and Down

Shares in bird flu companies Roche Holding and its Japanese partner Chugai Pharmaceutical fell yesterday after reports that Tamiflu – made by Roche – might have caused two Japanese teenage boys to commit suicide. Roche has said there is no clear evidence that the drug was responsible.

 

But shares in Avant Immunotherapeutics soared more than 10% on news that it is developing a bird flu vaccine.

 

Also developing a vaccine is the Russian Flu Research Center, according to the Novosti news agency. It believes it could be ready for commercial production by February or March next year. Just one problem – not enough money.

November 15th, 2005

 

Today’s News Is Not Good

Item 1 – The Japanese health ministry has revealed that two teenage boys who took Tamiflu subsequently exhibited abnormal behavior that led to their deaths. A 17-year-old boy took Tamiflu, then left home in his pajamas and jumped in front of a truck. A 14-year-old boy fell from the ninth floor of his apartment building after taking the drug.

 

In Japan the drug carries a warning of possible impaired consciousness, abnormal behavior, hallucinations, and other psychological and neurological symptoms. The ministry is considering issuing a fresh warning….The Pharmaceuticals and Medical Devices Agency said there were 64 cases of psychological disorders linked to the drug between fiscal 2000 and 2004.

 

Item 2 - The Chinese government says an eighth outbreak of bird flu within a month is creating a "very serious situation" because the virus seems to be spreading.

 

Item 3 - Vietnam's Ho Chi Minh City Pasteur Institute has found that the bird flu virus strain H5N1 in the country has mutated to make it more dangerous.

November 13th, 2005

 

Tamiflu – Difficult or Easy to Make?

An argument that Tamiflu manufacturer Roche Holding has been using, to ward off attempts by rivals to launch their own production of the drug, is that it is extremely difficult to manufacture. As the Wall Street Journal reported:

 

In early October, with world-wide concern about bird flu spreading, the Swiss pharmaceutical company was under mounting pressure to allow other manufacturers to produce the antiviral drug as well. Roche resisted, saying Tamiflu…was too difficult for other companies to manufacture. Roche even pointed to a potentially "explosive" chemical step in the production process and said repeatedly that it would take several years for anyone else to make Tamiflu.

 

But a growing number of countries and companies are claiming they could quickly produce quantities of the drug, if allowed by Roche....continue reading Tamiflu – Difficult or Easy to Make?

November 12th, 2005

 

Tamiflu Update

It wasn’t so long ago that Tamiflu producer Roche Holding was insisting it would not license outside companies to produce the drug. One reason cited was the complexity of production – a 10-stage, one-year process that included extracting shikimic acid from the seeds of the star anise spice, and then converting it into a drug. A Roche spokesperson said it would take other pharmaceuticals companies three years to gain the ability to replicate this process.

 

What a difference a few weeks makes. Now it seems that companies in numerous countries not only plan to launch production, but they believe they can rapidly turn out fairly large quantities of the drug. And it seems they might gain Roche’s permission....continue reading Tamiflu Update - Who’s Going to Produce It?
November 6th, 2005


The Latest

China and Croatia have both confirmed new H5N1 outbreaks, while India investigates. The BBC reports: “Authorities on the French Indian Ocean island of Reunion say three tourists who returned from a trip to Thailand may have contracted bird flu.” The Vietnam News Agency reports that three Vietnamese pharmaceutical companies are to begin producing Tamiflu.

October 27th, 2005

 

Star Anise – Tamiflu’s Vital Ingredient

Star anise, from China and Vietnam, has been known in the West for several centuries as a cooking spice and as an ingredient in anise-flavored liquors like Pernod. Now it has a new use – as the base for Roche’s bird flu drug Tamiflu.

 

In fact, star anise has a long history in Chinese herbal medicines, being used to treat such ailments as colic in babies, stomach aches and indigestion. When brewed as a tea it helps clear breathing passages. In women it has been prescribed to facilitate birth and increase lactation.

 

Unfortunately, the plant takes six years to flower, and it is difficult to cultivate. One estimate is that 10 years would be needed to produce sufficient quantities to treat just 20% of the world’s population....continue reading Star Anise – Tamiflu’s Vital Ingredient.

October 25th, 2005

 

Has Roche Marketed Tamiflu Properly?

Details emerged over the weekend of accusations being leveled against Roche by Gilead Sciences, owner of the Tamiflu patent. Forbes reported:

 

Roche Holding AG has been accused of serious failings in the manufacture of Tamiflu by US biotech firm Gilead Sciences Inc, the owner of the patent on the highly sought after bird flu drug, UK Sunday paper The Observer reported citing court papers filed with the US Securities and Exchanges Commission.

Gilead, which is demanding termination of its licence agreement with Roche because it says that the Swiss drugmaker has failed to market the drug properly, has identified a number of incidents over the past three years which required Roche to issue product recalls, the paper said.

 

Read the entire report for more. This one looks set to run and run.

October 24th, 2005

 

Drugs Latest

One of the developers of Relenza has warned that the world faces “a deadly gap of several years” in finding new drugs to combat a flu pandemic, should the virus develop resistance to Tamiflu and Relenza. Professor Mark von Itzstein said there were no clinical trials in progress of new anti-bird-flu treatments. He said that in his Gold Coast laboratory alone there were three potential drugs that had not been developed due to lack of funding.

 

Meanwhile, Roche has said it will build a new US plant to produce more Tamiflu. And GlaxoSmithKline is to start production of Relenza here in Melbourne. Currently it is made only in France.  

October 19th, 2005

 

Generic Tamiflu

The Taiwanese Department of Health has written to Roche requesting negotiations on the generic production of Tamiflu. Meanwhile, Thailand is apparently going ahead with its own production, without consulting Roche.

October 18th, 2005

 

Thumbs Up for Tamiflu

An Aussie scientist has said Tamiflu will likely be effective against any bird flu that hits Australia.

 

Professor Bill Rawlinson, a virologist from the Prince of Wales Hospital, said there was no need for people to panic that Tamiflu was no longer an effective vaccine….A bird flu outbreak in Australia would be the result of a new strain able to spread from humans to humans, and such a strain was more likely than not to be sensitive to Tamiflu, he said. Australian health officials have stockpiled Tamiflu, as well as a similar drug, Relenza. Professor Rawlinson said any strain of flu resistant to Tamiflu was likely to also be resistant to Relenza. "If bird flu comes to Australia, it is possible that resistance will be a problem - but it is unlikely," he said.

October 17th, 2005

 

Tamiflu Update

First we hear that several companies plan generic versions of Tamiflu. Now we learn that there’s not enough star anise.

 

Production of Tamiflu, made by the Swiss company Roche, is being hampered by a shortage of star anise, a star-shaped fruit grown in China and the source of shikimic acid from which Tamiflu is made in a year-long process. Ninety per cent of the harvest is already used by Roche.

October 16th, 2005

 

The Headline Says It All

Bird Flu Virus That Is Drug-Resistant Is Found in Vietnamese Girl
Washington Post

 

In other drug developments:

 

The Philippine Department of Health has urged local drug manufacturers to try to make their own versions of Tamiflu. “[Health Undersecretary Alex] Padilla said the Bureau of Food and Drugs would issue a certificate of product registration authorizing the sale of a locally produced vaccine in the Philippine market. ‘It’s up to (Roche) to file a complaint.’”

 

Sanofi-Pasteur is to begin clinical trials in (northern) spring 2006 of its vaccine.

Two bloggers, Stephen Gordon and Andrew Sullivan, call for Roche to be forced to allow generic production of Tamiflu. Says Sullivan: "We have no time to waste."

October 15th, 2005

 

Indian Company to Make Generic Tamiflu

Cipla, India’s third-largest drugs manufacturer, says it plans to start producing a generic version of Tamiflu. The company says it has finished reverse engineering the drug, and believes it can have small commercial quantities available as early as January. This is despite claims from Roche, holder of the Tamiflu patent, that it could three years for another company to be able to produce the drug.

October 14th, 2005
 

Roche to Boost Tamiflu Production

Roche has taken steps to boost production of Tamiflu. However,

 

the 12 months it takes to make Tamiflu means governments that have yet to order will have to wait, Swiss pharmaceutical company Roche Holding AG said Wednesday…."We asked governments several years ago to make Tamiflu orders for pandemic purposes well in advance," Roche spokesman Alexander Klauser told The Associated Press. "We explained the procedure to them, how it works and that we had to start production well in advance or we wouldn't be able to produce Tamiflu in the required amounts on time."…Roche said there are 10 complex steps to make Tamiflu and it would be unrealistic to outsource the complete procedure, as outside companies would need up to three years to set up production as well as gain the capacity and know-how.

October 14th, 2005

 

Roche “Won’t Share Patent”

The San Francisco Chronicle reports that Roche Holdings is not prepared to allow generic production of its Tamiflu anti-flu drug. This follows reports that public health officials in several countries are calling for the company to be forced to share the patent with other drug manufacturers, in order to ensure adequate supplies in the event of a major outbreak of bird flu.

 

Although Roche has increased production of Tamiflu eightfold in the past two years, it will take $16 billion and 10 years to make enough of the drug for 20 percent of the world's population, said Klaus Stohr, director of the World Health Organization's Global Influenza Program, in comments to reporters in San Francisco last week.

October 13th, 2005

 

Tamiflu Generic Production Urged

Roche Holdings is reportedly under pressure to allow production of generic versions of its anti-flu drug Tamiflu. The reports say the company believes the drug is so complex that generic maker would struggle to produce significant quantities. This is contradicted by Taiwanese authorities, who believe they could begin manufacture within months of receiving permission.

October 12th, 2005