Yes, the avian flu is scary. How many people have died from it now? 62, mostly people who handle poultry? So, just when people were beginning to think that no one could hope to gain financially from this possible "pandemic" as we are constantly reminded, along comes news that one of America's favorite patriots, Defense Secretary Donald Rumsfeld, is becoming a very very rich man. As ex-chairman of (and current stockholder in) Gilead Sciences , the California biotech company that owns the rights to Tamiflu, Rumsfeld has become $1 million richer in the past 6 months.

But really, this shouldn't erode our trust in everything the government tells us about vaccines. Especially when they tell us it's in our interest to shield drug manufacturers from lawsuits brought on by damages their vaccines cause to people who have been forced to take them. And, even more obvious, all records should be closed to the public - after all, who needs evidence when no harm is being done, right? Just have faith, people!

Rumsfeld to Profit from Avian Flu Vaccine
By Nelson D. Schwartz
Fortune

Monday 31 October 2005

Defense Secretary, ex-chairman of flu treatment rights holder, sees portfolio value growing.

New York - The prospect of a bird flu outbreak may be panicking people around the globe, but it's proving to be very good news for Defense Secretary Donald Rumsfeld and other politically connected investors in Gilead Sciences, the California biotech company that owns the rights to Tamiflu, the influenza remedy that's now the most-sought after drug in the world.

Rumsfeld served as Gilead Research's chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.

The forms don't reveal the exact number of shares Rumsfeld owns, but in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead's stock from $35 to $47. That's made the Pentagon chief, already one of the wealthiest members of the Bush cabinet, at least $1 million richer.

Rumsfeld isn't the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead's board, has sold more than $7 million worth of Gilead since the beginning of 2005.

Another board member is the wife of former California Gov. Pete Wilson.

"I don't know of any biotech company that's so politically well-connected," says analyst Andrew McDonald of Think Equity Partners in San Francisco.

What's more, the federal government is emerging as one of the world's biggest customers for Tamiflu. In July, the Pentagon ordered $58 million worth of the treatment for US troops around the world, and Congress is considering a multi-billion dollar purchase. Roche expects 2005 sales for Tamiflu to be about $1 billion, compared with $258 million in 2004.

Rumsfeld recused himself from any decisions involving Gilead when he left Gilead and became Secretary of Defense in early 2001. And late last month, notes a senior Pentagon official, Rumsfeld went even further and had the Pentagon's general counsel issue additional instructions outlining what he could and could not be involved in if there were an avian flu pandemic and the Pentagon had to respond.

As the flu issue heated up early this year, according to the Pentagon official, Rumsfeld considered unloading his entire Gilead stake and sought the advice of the Department of Justice, the SEC and the federal Office of Government Ethics.

Those agencies didn't offer an opinion so Rumsfeld consulted a private securities lawyer, who advised him that it was safer to hold on to the stock and be quite public about his recusal rather than sell and run the risk of being accused of trading on insider information, something Rumsfeld doesn't believe he possesses. So he's keeping his shares for the time being.

www.washingtonpost.com
 
 
 NOTES FROM HILARY: The article on website has graphs that
 wont copy over to this post - might wanna check it out. Also, this
 article is written by Physician researchers who teach courses on how
 to effectively analyze research results & studies. And, here are some
 key pieces of data from this article:
 
 For people younger than 65 (including children), the chance of a flu-related
 death is much smaller -- about one in 100,000.
 

Of course, the flu shot may have benefits besides reducing the chance of death. Many may get flu shots simply to avoid getting sick. The Cochrane Collaboration identified more than 20 randomized trials addressing this question. The overall chance of developing "clinical" flu (we'll explain in a minute) was 19 percent in those chosen, again by chance, to receive the recommended flu vaccine vs. 23 percent in the control groups.

The careful reader may notice that these percentages are substantially higher than those reported for the elderly. (See "How Well Does the Vaccine Work in the Elderly?") This is because clinical flu is defined as a set of non-specific symptoms including fever, cough and muscle aches -- symptoms shared by many non-flu illnesses like the common cold. These non-flu illnesses may be especially common in younger adults because of their exposure to other people, particularly children. To try to isolate the effect of the vaccine, scientists sometimes use laboratory tests to confirm the activity of flu virus in the blood. Using this measure, the chance of flu in the vaccine group is 2 percent vs. 7 percent in the control group.

Happy reading!

----------------------------------
 
 http://tinyurl.com/ddjxk

 A Shot of Fear
 Flu Death Risk Often Exaggerated; So Is Benefit of Vaccine
 By Steven Woloshin, Lisa M. Schwartz and H. Gilbert Welch
 Special to The Washington Post
 Tuesday, October 25, 2005
 

Medical research often becomes news. But sometimes the news is made to
 appear more definitive and dramatic than the research warrants. This
 series dissects health news to highlight some common study
 interpretation problems we see as physician-researchers and show how
 the research community, medical journals and the media can do better.
 
 For years, the public health community has used fear as one strategy
 to promote the flu vaccine. A vaccination poster distributed by the
 U.S. Centers for Disease Control and Prevention (CDC), for example,
 emphasizes that "36,000 Americans die of flu-related illnesses each
 year," implying that the vaccine could prevent many of these deaths.
 
 When it became aware of the vaccine shortage last October, the federal
 government changed course and tried to reassure Americans that going
 without a shot was no big deal. "We all need to take a deep breath.
 This is not an emergency," CDC director Julie Gerberding advised the
 public.
 
 Instead of urging vaccination for everyone age 50 and older, as they
 had been doing, government officials recommended shots only for people
 65 and older, and those in selected high risk groups. The public's
 response was predictable: People were upset and confused. Our local
 television news played a story in which a pharmacist was called "a
 murderer" when his vaccine supply ran out. Ironically, the crisis
 mentality led some to engage in behaviors that probably increased
 their risk. Frail elderly people, some with oxygen tanks, stood in
 long lines in the cold, waiting for the vaccine. Others crowded
 clinics and doctors' offices, increasing their chance of exposure to
 flu and other infectious agents.
 
 With uncertainties about this year's vaccine supply, the CDC again
 recommended that highest-risk people get priority for flu shots, at
 least until late October. But last year's flu season may have left
 people confused about essential points: Just how risky is the flu? And
 just how effective is the vaccine? The answers to these questions may
 surprise readers.
 
 How Risky Is the Flu?
 
 First, a caveat: The risk calculations we analyze here describe
 typical flu seasons only. We don't consider here what the picture
 would be in the event of a deadly flu pandemic -- a worldwide outbreak
 of a new, highly virulent flu strain, the potential for which has
 recently drawn considerable media attention. No one really knows how
 likely such an outbreak is, but the risk profile would certainly
 change. A pandemic is a fundamentally different situation: The risk of
 death would be substantially higher, and untested strategies
 (including new treatments, quarantine and a new vaccine) would need to
 be implemented rapidly.
 
 We deal here with what is known about typical flu seasons, based on
 data that form the basis for the federal government's flu-risk figures.
 
 By choosing to highlight the annual number of flu deaths, the CDC
 employed an attention-grabbing tactic often used by public health and
 disease advocacy groups. It's a tactic readers should be inoculated
 against if they want a clear picture of the risks they face. (See
 "Research Basics: Understanding How Big a Risk Is," right.)
 
 In fact, it is very difficult to know how many people die from any
 given disease because there is often much uncertainty in determining
 the cause of death. This is particularly true for the flu. That's
 because it shares symptoms with so many other diseases, and because
 people most likely to die a flu-related death are also at high risk
 for many other causes of death.
 
 Flu deaths are probably undercounted because doctors do not routinely
 test for the flu, and because some deaths that should be attributed to
 the flu are given other diagnoses. For example, someone who dies from
 a heart attack because they are debilitated by the flu might not get
 counted as a flu death. Some overcounting of flu deaths also occurs:
 Clearly not all winter pneumonia deaths are caused by the flu.
 
 According to the CDC, 90 percent of flu-related deaths occur among
 people age 65 years and older. Based on this information and the age
 distribution of the population, the chance of a flu-related death for
 people in that age group is about one in 1,000. Another way of saying
 this is that the chance of not dying from flu for those 65 and older
 is about 999 out of 1,000. (For context, the chance of a flu-related
 death is slightly lower than the chance of dying from a fall or other
 accident.)
 
 For people younger than 65 (including children), the chance of a
 flu-related death is much smaller -- about one in 100,000. Of course,
 adults and children might be concerned about flu-related problems
 besides death, such as being hospitalized or just suffering with
 unpleasant symptoms (typically three to seven days of fever, muscle
 aches, headache, weakness, dry cough and runny nose). As you might
 guess, counting the number of flu-related hospitalizations or the
 number of people experiencing symptoms from the flu is even more
 difficult than counting flu deaths.
 How Good Is the Vaccine?
 
 Getting a shot does not guarantee you will not get sick from the flu
 or die from it. Recently, the Cochrane Collaboration, an international
 group that evaluates the evidence for various medical interventions,
 reviewed the medical literature on the effectiveness of the flu
 vaccine in preventing death.
 
 Unfortunately, the evidence on how well the vaccine works to prevent
 death in the elderly is limited. Few of the existing studies are
 randomized trials -- considered the gold standard for medical
 evidence. Instead, most data are from observational studies -- studies
 in which scientists simply count up outcomes (here, the number of
 deaths that occur among people who did or did not get the vaccine).
 
 But drawing conclusions about cause and effect from such observations
 is fraught with problems.
 
 For example, a 2003 study published in the New England Journal of
 Medicine observed that the flu vaccine was associated with a 50
 percent reduction in the overall death rate (that is, death from heart
 disease, stroke, cancer and all other causes combined). To attribute
 an effect of this magnitude solely to the flu vaccine is ludicrous:
 Flu-related deaths make up less than 2 percent of all deaths. If the
 claim were accurate, the vaccine's power would dwarf that of any other
 medical intervention. There is, however, a much more likely
 explanation: People who choose to get a flu shot are much healthier --
 and therefore already at much lower risk of death -- than people who
 do not.
 
 Only five randomized trials have examined the effectiveness of the flu
 vaccine. In these studies, patients were randomly assigned -- a
 selection technique equivalent to the flip of a coin -- to get either
 a flu vaccine or a placebo injection. But none of these studies looked
 at whether the vaccine prevents death. Instead, the scientists
 measured who developed a flu-like illness. For a summary of the
 findings of these studies, see "How Well Does the Vaccine Work in the
 Elderly?" below.
 
 In the absence of good randomized trial data, it is still possible to
 gauge the effectiveness of vaccination by looking at time trends in
 flu vaccine rates compared with flu-related deaths in the elderly. As
 more people get vaccinated, you would expect the flu-related death
 rate to decline -- if the vaccine is effective. But, as the graph
 below, titled "A Windening Gap," shows, despite a dramatic increase in
 vaccination among the elderly, deaths from the flu and pneumonia have
 hardly budged. (The calculations have taken into account the aging of
 the population.)
 
 For younger adults, flu-related death is so rare that it has not been
 reliably studied: Doing so would require a trial of millions of people.
 
 Of course, the flu shot may have benefits besides reducing the chance
 of death. Many may get flu shots simply to avoid getting sick. The
 Cochrane Collaboration identified more than 20 randomized trials
 addressing this question. The overall chance of developing "clinical"
 flu (we'll explain in a minute) was 19 percent in those chosen, again
 by chance, to receive the recommended flu vaccine vs. 23 percent in
 the control groups.
 
 The careful reader may notice that these percentages are substantially
 higher than those reported for the elderly. (See "How Well Does the
 Vaccine Work in the Elderly?") This is because clinical flu is defined
 as a set of non-specific symptoms including fever, cough and muscle
 aches -- symptoms shared by many non-flu illnesses like the common
 cold. These non-flu illnesses may be especially common in younger
 adults because of their exposure to other people, particularly
 children. To try to isolate the effect of the vaccine, scientists
 sometimes use laboratory tests to confirm the activity of flu virus in
 the blood. Using this measure, the chance of flu in the vaccine group
 is 2 percent vs. 7 percent in the control group.
 
 Studies have also measured another outcome: how vaccination affects
 days lost from work. On average, there are about 0.16 fewer days lost
 from work per person vaccinated. Another way of saying this is that
 about 5 percent of those vaccinated avoid missing about three days of
 work because of the flu. (That is, 0.16 days divided by the 5 percent
 who benefited from vaccination equals 3.2 days.) The other 95 percent
 vaccinated got no benefit.
 Take-Home Messages
 
 To promote vaccine use, many in the public health community have
 overstated the risk of flu-related death and the effectiveness of the
 vaccine in preventing it. While the flu vaccine may have some
 important benefit (less flu-related illness), we really do not know
 whether it reduces the risk of death. For younger individuals -- for
 whom the chance of flu-related death is extremely small -- any
 death-protection benefit can only be very modest (and it is unlikely
 we will ever reliably know whether it even exists). However, we do
 know that the vaccine reduces the risk of being sick and time lost
 from work. But because the effect is small, individuals will have to
 judge for themselves whether it's worth the bother.
 
 We are not suggesting that Americans forgo flu vaccines. We simply
 want to help people make informed decisions.
 
 For many people, getting the vaccine is a reasonable choice. And many
 may reasonably choose not to get it. (Consequently, the use of flu
 vaccination rates by Medicare and others to measure health care
 quality probably does not make sense.)
 
 Regardless, public health officials should not exaggerate risks or
 benefits to promote vaccination. Exaggeration carries a price: Not
 only do some people get scared and engage in behaviors that increase
 their risk (like waiting in a crowded clinic for a flu shot). They may
 also grow cynical and end up ignoring health messages that really matter.
 
 Steven Woloshin, Lisa Schwartz and Gilbert Welch are
 physician-researchers in the VA Outcomes Group in White River
 Junction, Vt., and faculty members at the Dartmouth Medical School.
 They conduct regular seminars on how to interpret medical studies.
 (Seehttp://www.vaoutcomes.org.) The views expressed do not necessarily
 represent the views of the Department of Veterans Affairs or the
 United States Government.
 
 To respond to this article, send e-mail to health@washpost.com.
 © 2005 The Washington Post Company

Is anyone worried yet? The most critical piece of info from this article: 

"This proposed legislation will strip Americans of the 
right to a trial by jury if they are harmed by either an experimental or 
licensed drug or vaccine they are forced by the government to take 
whenever federal health officials declare a public health emergency."

MOUNTAIN VIEWS: BIRD FLU SCAM TO COST US PLENTY
By John Hanchette
Niagara Falls Reporter 
http://www.niagarafallsreporter.com/hanchette178.html 
Oct. 25 2005

OLEAN -- The current U.S. Congress has many qualities that are not 
endearing, but one of the worst is its addiction to hidden agendas.
Case in 
point: 

In the middle of last week, one short day after the bill had been 
introduced, the powerful Senate Health, Education, Labor and Pensions 
Committee -- by a quick, simple voice vote of the full panel -- passed 
something called the "Biodefense and Pandemic Vaccine and Drug
Development 
Act of 2005." 

It will probably hit the Senate floor this week for a full vote of that 
august chamber (and may have already done so by the time you read 
this). A similar companion bill is expected to be introduced in the
House of 
Representatives before week's end. The lobbying lubrication needed in 
that conservative chamber to ram it through passage will be even less 
than in the Senate. 

The Senate proposal (S.1873) -- authored and filed by North Carolina 
Republican senator Richard Burr, an obedient favorite of the current Bush 
administration -- sounds innocent and altruistic enough, right? 

It would establish an efficient-sounding Biomedical Advanced Research 
and Development Agency (BARDA) to speed up and "provide incentives and 
protections" for the "domestic manufacture of medical countermeasures" 
-- vaccines and drugs -- that would help stop pandemic or epidemic 
sickness within the United States. 

Burr said in introducing the bill that it will simply give the 
Cabinet-level Department of Health and Human Services (HH the
"additional 
authority and resources to partner with the private sector to rapidly 
develop drugs and vaccines." 

So, who could be against such a lofty goal? Well, I could, for one. 
This bill is a slavering wolverine masquerading as a furry little lab
rat. 

First of all, whenever you -- as consumers, taxpayers and citizens -- 
hear any federal government source saying it wants "to partner with the 
private sector," you should grab your wallet with both hands and hold 
on tight. In this case, you should also take your children into your 
arms. I'm not the only one who's noticed the danger in this proposal. 

Barbara Loe Fisher, president of the National Vaccine Information 
Center (NVIC) -- a private, non-governmental advocacy group pushing for 
safer vaccines -- calls the Senate bill "a drug company stockholder's
dream 
and a consumer's worst nightmare." 

It is, simply put, a legislative genuflection to Big Pharma -- the 
steamroller-powerful drug-making sector of the economy. The
pharmaceutical 
mega-firms contribute millions to the coffers of congressional members, 
but if this is signed into law, they potentially could save billions. 

That's because this proposed legislation will strip Americans of the 
right to a trial by jury if they are harmed by either an experimental or 
licensed drug or vaccine they are forced by the government to take 
whenever federal health officials declare a public health emergency. 

This bill gives the HHS secretary the sole authority to decide if a 
drug manufacturer violated laws that mandate drug safety, and it bans any 
citizen from challenging the HHS head's decision in the civil court 
system. Big Pharma has been pushing for protection like this for several 
years. In this millennium, the angst and sense of loss following 9/11 
was manipulated to produce similar legislative efforts designed to 
protect drug and vaccine makers even if they manufactured products
that were 
not properly tested, nor clinically proven safe. 

"This proposed legislation," said NVIC's Fisher, "like the power and 
money grab by federal health officials and industry in the Homeland 
Security Act of 2002 and the Project Bioshield Act of 2004, is an 
unconstitutional attempt by some in Congress to give a taxpayer-funded
handout to 
pharmaceutical companies for drugs and vaccines." 

Further, Fisher points out, the government, under this bill, "could 
force all citizens to use these drugs and vaccines while absolving 
everyone connected from any responsibility for injuries and deaths which 
occur" in their wake. 

Sen. Burr is himself the chairman of the Senate Subcommittee on 
Bioterrorism and Public Health Preparedness. In his bill, BARDA -- the
new R 
and D agency mentioned above -- would be established as the single point 
of authority in the federal system for the advanced research and 
development of vaccines and drugs in response to bioterrorism and
outbreaks 
of natural disease. 

And BARDA would operate in secret. 

The agency would be exempt from the Freedom of Information Act and from 
the Federal Advisory Committee Act, which requires public public 
transparency -- making it almost certain that no evidence of injuries or 
deaths caused by drugs and vaccines labeled as "countermeasures" to 
bioterrorism or new disease epidemics would ever become public. The
bill would 
not only provide Big Pharma impenetrable cover, it would exempt lots of 
federal cost oversight requirements, and would forbid government 
purchases of generic versions of such new drugs or vaccines, a current 
practice that saves taxpayers millions of dollars. 

The Burr bill means, notes vaccine safety advocate Fisher, "that if an 
American is injured by an experimental flu or anthrax vaccine he or she 
is mandated to take, that citizen will be banned from exercising the 
constitutional right to a jury trial even if it is revealed that the 
vaccine maker engaged in criminal fraud and negligence in the manufacture 
of the vaccine." 

Burr himself has acknowledged that "liability exposure" is one of the 
factors that has left drug firms "reluctant to invest" in biodefense and 
influenza countermeasures. 

The timing of the new attempt at congressional protection for Big 
Pharma -- the Burr bill -- is exquisite. 

The wording "natural outbreaks" of disease and "pandemics" mentioned by 
Sen. Burr in his call for support of the bill are designed to make 
citizens and fellow senators alike think of one thing -- avian flu. 

This new biological "threat" is increasingly on the minds of Americans 
and is reaching near-panic level in terms of public perception. 

David Daigle, a spokesman for the federal Centers for Disease Control 
and Prevention, said the CDC has been experiencing an incredible average 
of 447,000 hits a day on its bird flu information Web site. He pegged 
the Internet traffic level "insane." 

Americans are avalanching health officials, newspapers, TV stations, 
their doctors and other public information sources with anxious questions 
about keeping bird-feeders in their back yards, whether they can eat 
turkey this Thanksgiving, and whether they should report sightings of 
dead birds along the roadside. (You can, you can, you don't have 
to.)Worried patients are asking their doctors for Tamiflu, designed to
treat 
ordinary human flu -- not bird flu. 

And guess the number of Americans who have died of avian flu already? 
Zero. 

How many human cases of the bird flu have been reported in the United 
States? Zero. 

That's right, none. The bird flu, which originated in South Korea more 
than two years ago, rarely spreads from birds to humans, and hasn't 
even been shown to affect poultry yet in this country. Only 120 or so 
humans have ever come down with this rare viral strain of influenza --
H5N1 
-- and all of them in Asia. Most of the 60 deaths so far -- 43 -- have 
occurred in Vietnam. Thailand has the next largest number of deaths, 
13. 

The disease in birds is just now reaching eastern Europe through avian 
migration. Turkey, Romania, and European Russia have cataloged the 
dangerous strain. 

The virus might be an eventual threat to the flocks of poultry farmers 
here, but many scientists seem to think H5N1 influenza won't sicken or 
kill humans on a mass basis unless its mutating properties change 
dramatically. 

Can Senate Democrats stop the passage of Burr's bill? Not bloody 
likely. 

Several Democrats in that chamber have criticized the Burr bill, but 
mostly from the perspective that it would do little to provide any 
response to an avian flu outbreak. 

"I hope that people don't think this is going to solve the problem of 
the possible avian flu pandemic that is on our doorstep," warned Sen. 
Tom Harkin, an Iowa Democrat. 

This legislation is obviously fast-tracked. Senate Majority Leader Bill 
Frist, the Tennessee Republican, is a co-sponsor, as is Senate Budget 
Committee Chairman Judd Gregg, a Republican from New Hampshire. 

They obviously don't care that if signed into law, this proposal would 
eliminate both legal and regulatory safeguards, applied to vaccines and 
drugs, that need strengthening, not weakening or elimination. They 
obviously don't care if children or adults harmed by vaccines and drugs 
will have to forfeit their right to present a case in front of a jury
in a 
civil court of law. 

Don't think this never happens. The Food and Drug Administration is 
legally responsible at present for regulating Big Pharma, and for
ensuring 
that vaccines and drugs released to the public are safe and effective. 
Drug companies marketing pain-killer and anti-depressants that have 
injured thousands are being held accountable in civil courts all the
time. 
And the FDA has come under intense criticism for keeping information 
from the American public about drug dangers. 

For almost two decades, vaccine makers have already been protected from 
most liability in civil courts through the National Childhood Vaccine 
Injury Act of 1986 and a concurrent compensation program that offers 
victims an alternative to civil courts. That program has already awarded 
almost $2 billion to injured victims of mandated vaccines -- yet 
two-thirds of the plaintiffs are turned away from such compensation
through 
vigorous defense of the manufacturers by Justice Department lawyers. 

"The drug companies and doctors got all the liability protection they 
needed in 1986," says Fisher of the NVIC, "but they are greedy and want 
more." 

She continues: "It's a sad day for this nation when Congress is 
frightened and bullied into allowing one profit-making industry to
destroy the 
Seventh Amendment to the Constitution guaranteeing citizens their day 
in court in front of a jury of their peers." 

Amen to that. 

efficacy was found to be 38.1% ... and slightly higher 41.6%

Other sources report even lower success rates.

15 percent of those vaccinated developed flu-like symptoms and 17 percent of those not vaccinated developed similar symptoms.

That's a barely perceptible benefit of ~2% from getting vaccinated.