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
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