Tamiflu Cited in 2 Teen Deaths_Global Plan for Influenza Action_Lancet

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Mon, 14 Nov 2005 20:57:58 -0500

Tamiflu Cited in 2 Teen Deaths_Global Plan for Influenza

Action_Lancet

 

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

 

www.ahrp.org <http://www.ahrp.org/>

 

 

 

FYI

 

 

 

Japanese newspapers report that two teenage boys-one 14 the other

17-died after taking one dose of the antiviral drug, Tamiflu, the drug

being stockpiled in the event that the Avian flu crosses from birds to

humans. The boys became disoriented " exhibited abnormal behavior that

led to their deaths. " According to reports, neither had exhibited any

psychological abnormalities before taking the drug. The Japanese

Ministry of Health requires disclosure of adverse side effects:

 

" the literature accompanying the drug a list of side effects such as

impaired consciousness, abnormal behavior and hallucinations and has

called doctors' attention to the possible side effects...there were 64

cases of psychological disorders linked to the drug between fiscal

2000 and 2004. "

 

 

 

 

 

An article in The Lancet surveyed experts around the globe about what

steps are needed to avert or prepare for a flu pandemic. The report

notes that " escalation in political rhetoric about avian influenza has

led all countries to recognise the importance of the five essential

action strategies put forward by WHO [World Health Organization] to

reduce the risk of a pandemic. These are: reducing human exposure;

intensifying capacity for rapid containment; strengthening early

warning systems; rapid investigation of cases and clusters; and

building general capacity for health. "

 

 

 

The consensus for dealing with this global problem emphasizes the need

for a coordinated global plan of action requiring ready

communication-which is believed to be the key to successful management

of a pandemic.

 

 

 

Samuel Jutzi, Director of the Division of Animal Production and

Health, emphasizes that avian flu remains a disease of birds: " and

this fact buys the international community some valuable time. " " The

way to stop avian influenza in its tracks is rapid containment of

outbreaks by widespread culling of birds in infected areas. "

 

 

 

Jutzi believes that too much emphasis has been given to the

stockpiling of antiviral drugs while the battle against bird flu in

animals remains under-funded. For example, he says, FAO and WHO

together have just 40 veterinarians. Jutzi asserts that addressing

this issue is " the only way by which the likelihood of the H5N1 virus

acquiring human-to-human transmissibility can be influenced " .

 

 

 

Everyone agrees that: " The costs of panic to nations are magnified by

misinformation and loss of trust among the public. Governments need to

establish credibility and trust from the start. "

 

Instead, US officials who lack credibility and public trust are using

public anxiety about the potential flu pandemic and bioterrorism as an

opportunity for submerging medical research on infectious diseases and

biological-weapons in deep freeze. Senator Richard Burr's proposed

legislation-S. 1873 (Biomedical Advanced Research and Development

Agency, BARDA)-that would preclude public oversight and accountability.

 

The model for this legislation is the military forced anthrax vaccine

debacle, a model grounded in tainted science, the disregard for

medicine's foremost principle, " First, do no harm, " which gave way to

contractual deals between government and vaccine / drug manufacturers.

Drug and vaccine manufacturers stand to gain huge profits from

government stockpiling of drugs and vaccines -whether these have

undergone adequate safety tests or not, whether evidence of their

effectiveness is credible.

 

 

 

If passed into law, S. 1873 would spell the end of the American

democratic process and preclude the following FDA public advisory

committee hearing from taking place:

 

Flu Vaccine Manufacturing Shift:

Will influenza vaccine production go to the dogs?

 

Nov. 16-17: FDA's Vaccines & Related Biological Products Advisory

Committee will discuss whether canine kidney cells may be used for the

manufacture of inactivated influenza vaccines.

 

a.. How safe are cells from the tumorigenic canine cell lines with

regard to cancer risk from residual cell DNA and unrecognized

oncogenic viruses?

b.. Will Solvay and Chiron be given the green light for continuing

their clinical development of influenza vaccines using Madin Darby

canine kidney cells?

CBER - Nov 16 -17 (Wed-Thur) 8:30 a.m.

 

Holiday Inn Select - Bethesda, MD

 

8120 Wisconsin Ave

 

A curtain of secrecy around contentious public health policies will

only generate mistrust and further alienate the public from

government. If enacted, Sen. Burr's legislation would effectively

strip Americans of the right to say no to an experimental or

unlicensed drug or vaccine. [see analysis by Dr. Karen Effrem to be

posted on the AHRP website.]

 

 

 

Contact: Vera Hassner Sharav

 

212-595-8974

 

veracare

 

 

 

http://www.boston.com/news/world/asia/articles/2005/11/14/chugai_says_two_deaths\

_have_possible_tamiflu_link/

 

Chugai says two deaths have possible Tamiflu link

 

November 14, 2005

 

TOKYO (Reuters) - Japan's Chugai Pharmaceutical Co. said on Monday it

has reported to the government that two teenage boys exhibited

abnormal behavior that led to their deaths after taking the anti-flu

drug Tamiflu, made by Chugai's Swiss parent Roche Holding AG.

 

The comments come in response to weekend news reports that Japan's

health ministry is investigating the deaths of two teenage boys who

died in accidents linked to odd behavior shortly after taking the

drug. Health ministry officials were not available for comment.

 

Shares in Chugai were down 3.1 percent at 2,630 yen on Monday

afternoon, compared with a 1.3 percent fall in the Tokyo Stock

Exchange's pharmaceutical sector subindex. Tamiflu, considered one of

the best defences against bird flu in humans, might help slow the

spread of a much-feared pandemic should the H5N1 flu virus become able

to spread from person to person.

 

The Mainichi newspaper and Kyodo News agency reported on Saturday that

a 17-year-old high school student jumped in front of a truck in

February last year shortly after taking the medicine, while a junior

high school student is believed to have fallen from the ninth floor of

his apartment building this February.

 

 

 

 

 

" We reported these cases to the health ministry as a link between the

deaths and the drug could not be ruled out, " a Chugai spokesman said.

The reports were made separately after each incident, he said. He said

Chugai has included in the literature accompanying the drug a list of

side effects such as impaired consciousness, abnormal behavior and

hallucinations and has called doctors' attention to the possible side

effects.

 

Kyodo said the ministry is considering issuing a fresh warning about

the side effects, following its decision to increase stockpiles of the

drug amid growing fears about a possible pandemic.The Pharmaceuticals

and Medical Devices Agency said there were 64 cases of psychological

disorders linked to the drug between fiscal 2000 and 2004, according

to Kyodo.

 

Chugai launched Tamiflu in Japan in 2001. During the last flu season

it shipped the drug to more than 10 million people.

 

The Japanese government is planning to boost its target stockpile of

Tamiflu to 250 million capsules, up 70 percent from its previous

target, to cover treatment for 25 million people.

 

© Copyright 2005 The New York Times Company

 

________________________________

 

 

 

<http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673605676799.pdf>

 

The Lancet 2005; 366:1684-1685

 

 

 

Nations set out a global plan for influenza action

 

Hannah Brown

 

 

 

A pandemic of human influenza is coming. That was the warning last

week from WHO Director-General Lee Jong-wook, who called for an urgent

global consensus on how to combat avian influenza. Reporting from

Geneva, Hannah Brown finds out if the world is up to the challenge.

 

 

 

Warning of the " incalculable human misery " that will inevitably

accompany the next influenza pandemic, WHO Director-General Lee

Jong-wook opened the international meeting on avian and pandemic human

influenza in Geneva last week with a single request: that delegates

should use the 3-day meeting to build a global consensus on what

should be done to halt the relentless spread of avian influenza. The

hope is that action now will delay, or perhaps even avert, a global

crisis.

 

 

 

During the past few months, the threat of a human pandemic of

influenza has catapulted the issue of global preparedness into a

political priority in almost all nations. Since the end of August,

there have been high-level meetings in Paris, New York, Washington,

DC, and Ottawa, to forge links between national representatives at the

highest echelons of government and across the political spectrum.

 

 

 

Lee told delegates on Monday that now, for the first time, there is " a

truly global awareness of the importance of pandemic preparedness and

the role of international cooperation in responding to the pandemic

threat " . Without international cooperation, he warned, no nation can

consider itself safe.

 

 

 

Encouragingly, on the big issues at least, consensus on what needs to

be done has not been difficult to achieve. The escalation in political

rhetoric about avian influenza has led all countries to recognise the

importance of the five essential action strategies put forward by WHO

to reduce the risk of a pandemic. These are: reducing human exposure;

intensifying capacity for rapid containment; strengthening early

warning systems; rapid investigation of cases and clusters; and

building general capacity for health. But implementation of these

policies is far from easy.

 

 

 

Cultural change

 

 

 

Reducing human exposure requires education about handling poultry and

a fundamental change in cultural attitudes towards human-animal

interactions and husbandry in many parts of the world. In some African

countries, people sleep in the same places as poultry. In southeast

Asia, " wet markets " , where live poultry are traded and slaughtered on

the spot, pose a risk of human transmission. And in central Asia and

eastern Europe, hunting of wild birds may have played a major part in

the spread of avian influenza.

 

 

 

Countries such as Vietnam and China have begun to tackle these

problems with new laws limiting poultry rearing and live trade. And

the Ukraine, whose new laws came into force on Nov 11, is among

several nations to issue restrictions on hunting. But all these

governments fear that local authorities will not abide by the

regulations, thus limiting their effectiveness. UN Secretary-General

Kofi Annan has said that the threat of avian influenza may make it

necessary for humanity to fundamentally review its ways of close

co-habitation with animals.

 

 

 

The second point in WHO's urgent action list-rapid containment of the

first human cases-requires stockpiles of antiviral drugs that can be

quickly distributed to infected individuals and people living nearby.

But according to Margaret Chan, Representative of the Director-General

of WHO for Pandemic Influenza, current stockpiles are not sufficient

in even the richest countries. And the existence of just two drugs to

use against H5N1 infection, according to Dennis Carroll, Director of

USAID's Avian and Pandemic Preparedness and Response Unit, makes us

especially vulnerable. " We need an urgent increase in antiviral drug

production and availability " , he says.

 

 

 

Representatives of several low-income countries speaking in Geneva

last week expressed concerns about the lack of action to promote

equitable distribution of drug stockpiles and vaccines in the event of

a pandemic. Many countries are too poor to buy drug stockpiles and

have no capacity for manufacturing vaccine or generic versions of

drugs. India challenged the international meeting delegates to resolve

this problem; whether they did so remains to be seen.

 

 

 

Common to all the main preparedness strategies is the problem of

coordination across government departments, and between governments

and international organisations. Shigeru Omi, WHO Regional Director

for the Western Pacific, says there remains little communication

between agriculture and health sectors in most of the countries

affected by avian influenza. This issue is not easily solved. In

Indonesia, for instance, where several people have died from H5N1

infection this year, while avian influenza has been spreading in the

country, pro-democracy changes in government have boosted

decentralisation. And, since two of the key areas of devolved power

are health and agriculture, this change has made national-level

coordination for preparedness planning difficult. Resolving this

problem will take months of negotiations about where state and local

responsibilities lie.

 

 

 

Worrisome though these issues are, Samuel Jutzi, Director of the

Division of Animal Production and Health at FAO, emphasises that avian

influenza remains a disease of birds-and this fact buys the

international community some valuable time. Jutzi believes that too

much emphasis has been given to the stockpiling of antiviral drugs

while the battle against bird flu in animals remains under-funded. For

example, he says, FAO and WHO together have just 40 veterinarians.

Jutzi asserts that addressing this issue is " the only way by which the

likelihood of the H5N1 virus acquiring human-to-human transmissibility

can be influenced " .

 

 

 

The way to stop avian influenza in its tracks is rapid containment of

outbreaks by widespread culling of birds in infected areas. But this

strategy has a huge impact on the poorest people in affected

countries, who often depend on poultry for their livelihoods. Farmers

may also resist culling unless there is an appropriate level of

compensation. " Too little and farmers will not have sufficient

incentive to report disease in their animals; too much and the money

will be an incentive to deliberately infect their flocks " , says Milan

Brahmbhatt, World Bank Lead Economist for East Asia and Pacific Region.

 

 

 

WHO's Omi, however, is confident that a coordinated, concerted effort

to solve these problems will work. " I firmly believe it is not

impossible to avert or at least delay the outbreak of a human

pandemic " , he says.

 

 

 

 

Testing and action

 

 

 

So how prepared are we? 6 months ago, less than 50 countries had

preparedness plans for pandemic influenza. Now, over 60% have at least

some sort of plan in place. FAO, WHO, and OIE (the International

Organisation for Animal Health) have helped achieve this mark by

providing clear guidance and offering technical support while

countries are working to build up surveillance infrastructure. But,

says WHO's pandemic influenza representative Chan, some plans are

little more than single sheets of paper. What is needed now is testing

and action. " A plan is a plan. Until you test it and use it you will

not know the gaps " , she says.

 

 

 

Countries affected by outbreaks of H5 influenza in animals and human

beings

 

 

 

There is a mild optimism among international health experts about the

likely success of a global response. The experience of countries that

have already battled human and animal cases has refined preparedness

plans and improved recommended actions. However, according to David

Nabarro, Senior UN System Coordinator, Avian and Human Influenza, if a

pandemic occurs this winter, the world will certainly not be able to

cope. " The more I find out about the potential impact of a pandemic

and about the general preparedness of the world to deal with it, the

more concerned I am " , he says. And the fact remains that we know very

little about H5N1. " Neither our knowledge or our tools are currently

adequate " , adds USAID's Carroll.

 

 

 

Worryingly, this immediate gap remains unaddressed. While preparedness

planning focuses on the long-term goals of boosting capacity for

surveillance and response, the issues that would become immediate

priorities for individual nations in the event of a pandemic-drug and

vaccine distribution, civil unrest, and economic disruption-are

virtually untouched. Nabarro says these issues will feature in his

discussions with humanitarian agencies over the coming months.

 

 

 

World Bank economist Brahmbhatt believes that the most immediate

problems caused by a pandemic will probably arise not from death or

sickness, but from uncoordinated efforts of individuals to avoid

infection, as happened with SARS. Communication is the key to

mitigating this type of crisis. Governments must have effective

mechanisms for communicating with the public, to make sure they

understand the real risk. They must talk with other countries and

international organisations to share information necessary for disease

control. And they must communicate within themselves to ensure

preparedness plans can be effectively acted upon.

 

 

 

The costs of panic to nations are magnified by misinformation and loss

of trust among the public, warns Brahmbhatt. " Governments need to

establish credibility and trust from the start. "

 

 

 

2005 Elsevier Limited <http://www.elsevier.com> . All

rights reserved.