Anthrax Vaccine-- posts by Meryl Nass, M.D.: Legal immunity set for swine flu vaccine makers: What are the implications?

AP Medical Writer Mike Stobbe got a swine flu vaccine scoop--yet the news is four weeks old. It turns out that DHHS Secretary Sibelius has not only given immunity to the makers of Tamiflu and Relenza for injuries stemming from their use against swine flu. She also granted immunity to future swine flu vaccines and "any associated adjuvants," which was published in the June 25, 2009 Federal Register. Here is the start of his story:

The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed...

However, the compensation issue is more difficult than portrayed by Stobbe. The special vaccine court to which Stobbe refers applies only to specially designated vaccines, excludes most adult vaccines, and swine flu is not a designated vaccine for which compensation can be paid.

The 2006 Public Readiness and Emergency Preparedness Act (PREPA) allows the DHHS Secretary to invoke almost complete immunity from liability for manufacturers of vaccines and drugs used to combat a declared public health emergency. PREPA removes the right to a jury trial for persons injured by a covered vaccine, unless a plaintiff can provide clear evidence of willful misconduct that resulted in death or serious physical injury, and gets permission to sue from the DHHS Secretary. There has been no government funding of its potential compensation mechanism, to date. Furthermore, a PREPA declaration explicitly shields "government program planners" who arranged for the liability waiver.


Pharmaceutical companies making swine flu vaccine today may have demanded immunity from liability before agreeing to begin a crash program to manufacture H1N1 vaccine for the government. According to a 1978 report by the National Academy of Sciences, something similar happened with the 1976 swine flu program:

... all manufacturers made plain that they would not insure themselves, not even temporarily. Instead they put off plans to bottle their vaccine; pending legislation they would keep the stuff in bulk. Each week’s delay in moving from bulk to bottles assured at least as much delay in starting inoculations. Thus ended hopes of immunizing anybody in July or even August...

Behind Merrell’s firmness, there almost certainly was fear of the intentions of the casualty insurers. In May it was no secret that at least some major firms wanted to steer clear of swine vaccine. As early as April 8 Merck had been warned by its primary insurer that coverage for swine vaccine was “considered” not “feasible … at virtually any price.” So Merck's President had written Mathews and everyone else in sight.

Merrell, then about to switch insurers (for unrelated reasons) is reported to have been told by its new one something of the same sort at about the same time. We do not know precisely what was made of this, where in Merrell’s management. We do know that the issue was reviewed again, in June, by the insurer with the same result, a “no.” But we assume that Merrell’s counsel knew in May what the insurer had already warned in April. However that may be, it shortly would turn out that all insurers saw the swine flu program much alike: not for them.

Here is the problem: once the PREP Act is invoked to shield manufacturers from liability, the pharmaceutical firms have no financial incentive to make the safest product, and have a negative incentive to test it for safety. As long as they do not deliberately harm consumers of the product, they will not be liable for damages.


Are you following this argument closely? In order to avoid having prior knowledge of possible harm to users of the product, for which they could be found liable, it is in the manufacturers' best interest to know as little as possible about adverse reactions caused by their product.


Thus manufacturers can be expected to perform minimal testing, as they have been incentivized by PREPA to avoid learning of potential harms related to their product. The rush to manufacture and administer new vaccines serves two purposes: it provides an excuse to avoid adequate testing, as well as providing rapid vaccine availability. For example, see this Bloomberg article, "Glaxo to Limit Tests of Flu Vaccine, Citing Urgency."


On the other hand, France, which has ordered vaccines from Sanofi, Glaxo and Novartis AG, sees no reason at this point to ask vaccine makers to shorten or skip clinical trials, Health Minister Roselyne Bachelot-Narquin said at a news conference.


It is worthwhile to go back and consider the reason for passing PREPA in 2006: fear of an avian flu pandemic, in the event the avian flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate. Faced with such a potentially devastating disease, it perhaps made sense to create legislation to permit rapid deployment of drugs and vaccines without adequate testing, and issue a liability shield for those involved in the process.


But the H1N1 flu has only caused 353 US deaths (as of July 31),though CDC estimated over one million Americans had been infected (as of June 30). Instead of 70%, H1N1's death rate is under 0.03%. Therefore, this virus in no way justifies the risks the population is being asked to take: receiving vaccines, and perhaps experimental adjuvants, which their manufacturers have been encouraged not to test, with no prospect of compensation for illness or death that might result.

Please read the last paragraph at the bottom.

posts by Meryl Nass, M.D.: Doctors may refuse swine flu vaccine/Guardian

According to the Guardian,

"Several studies suggest up to 60% of GPs would oppose being immunised because they are concerned the safety trials will be rushed..

The biggest reason given by those who said they would not have it was concern that the safety trials would not be adequate: 71.3% said they were "concerned that the vaccine has not yet been through sufficient trials to guarantee safety". Half – 50.4% – said they "believe that swine flu is too mild to justify taking the vaccine"...

The Department of Health played down the results, saying that the small number of responders could not accurately be said to reflect the opinions of all GPs..."


A US News article of Aug 21 claimed,
"Early results for this first trial among adults have found the vaccine to be safe with no serious side effects,"
said Tony Fauci.

Yet the reportage is misleading. Since none of the US trials have so far used novel adjuvants, they fail to provide any information about the safety of MF59 or ASO3-adjuvanted vaccines. For example:

Another trial, also involving adults, is looking to determine the best timing for giving the vaccine for seasonal flu as well as the new H1N1 swine virus vaccine. A third trial that began a few days ago is testing the vaccine in children 6 months to 17 years old, Fauci said. Dosing information from this trial is expected in September and October, he said.

Trials are also planned involving pregnant women; they are scheduled to start in mid-September.

Finally, there will be a trial testing so-called adjuvants, which are additions to the vaccine to make it more effective. This trial is set to launch in mid- to late September, Fauci said.


I hate to keep beating a dead horse but this information needs to get out.

BioMed Central | Full text | Restorative effect of endurance exercise on behavioral deficits in the chronic mouse model of Parkinson's disease with severe neurodegeneration

The importance of exercise on the brain is extremely important. Movement of the joints and muscles fire receptors that stimulate the neurons in the brain. With out the movement you can and will see many different health problems arise.This is one of the main reasons how chiropractic,massage therapy and exercise helps people stay healthy.

Health Care Reform

-----Original Message-----
From:
Sent: Thu, Aug 20, 2009 10:29 am
Subject: Health Care Reform

This is important.

This letter is from a physician, you know, one of those evil doctors who are only in it for the money. Doctors have been vilified and demonized for decades. Those who do so want to be paid as much as the highest paid doctor, but do not want to work as hard. Read this letter. It hits the mark on government run healthcare.


READ THIS !!!!

Subject: Health Care by Atlanta Physician

This letter is from Dr. Zane Pollard.  He is operates at Children'sHealth
Care of Atlanta.   Google him, he has a very impressive CV.

Friends:

I have been sitting quietly on the sidelines watching all of this national
debate on healthcare. It is time for me to bring some clarity to the table
and, as your friend, by explaining many of the problems from the aspect of a
doctor. First off the government has involved very few of us physicians in
the healthcare debate.  While the American Medical Association has come out
in favor of the plan, it is vital to remember that the AMA only represents
17% of the American physician workforce.

I have taken care of Medicaid patients for 35 years while representing the
only pediatric ophthalmology group left in Atlanta, Georgia that accepts
Medicaid.  Why is this?  For example, in the past 6 months I have cared for
three young children on Medicaid who had corneal ulcers. This is a
potentially blinding situation because if the cornea perforates from the
infection, almost surely blindness will occur.  In all three cases the
antibiotic needed for the eradication of the infection was not on the
 approved Medicaid list.  Each time I was told to fax Medicaid for the
approval forms which I did. Within 48 hours the form came back to me who was
mailed in immediately via fax and I was told that I would have my answer in
10 days. Of course by then each child would have been blind in the eye. Each
time the request came back denied.  All three times I personally provided
the antibiotic for each patient which was not on the Medicaid approved list.
Get the point-rationing of care.

Over the past 35 years I have cared for over 1000 children born with
congenital cataracts. In older children and in adults the vision is
rehabilitated with an intraocular lens. In newborns we use contact lenses
which are very expensive. It takes Medicaid over one year to approve a
contact lens, post cataract surgery. By that time a successful anatomical
operation is wasted, as the child will be close to blind from a lack of
focusing for so long a period of time. Again extreme rationing.

Solution - I have a foundation here in Atlanta supported 100% by private
funds which supplies all of these contact lenses for my Medicaid and illegal
immigrants children for free.  Again waiting for the government would be
disastrous.

Last week I had a lady bring her child to me.  They are Americans but live
in Sweden as the father has a job with a big corporation. The child had the
onset of double vision 3 months ago and has been unable to function normally
because of this. They are people of means but are waiting 8 months to see
the ophthalmologist in Sweden. Then if the child needed surgery they would
be put on a 6 month waiting list. She called me and I saw her that day. It
turned out that the child had accommodative
esotropia (crossing of the eyes, treated with glasses that correct for
farsightedness) and responded to glasses within 4 days, no surgery was
needed.  Again rationing of care.

Last month I operated on a 70 year old lady with double vision present for 3
years. She responded quite nicely to her surgery and now is symptom free. I
also operated on a 69 year old judge with vertical double vision.  His
surgery went very well and now he is happy as a lark.

I have  been told - but of course  there is no healthcare bill that has been
passed yet - that  these  2 people because of their age would have been
denied  surgery and just told to wear a patch over one eye to alleviate the
symptoms of double vision.  Obviously cheaper than surgery.

I spent two years in the US Navy during the Viet Nam war and was well
treated by the military.  There was tremendous rationing of care and we were
told specifically what things the military personnel and their dependents
could have and which things they could not have.  While in Viet Nam, my wife
Nancy got sick and got essentially no care at the Naval Hospital in Oakland,
California. She went home and went to her family's private internist in
Beverly Hills.  While it was expensive, she received an  immediate work up.
Again rationing of care.

For those of you who are over 65, this bill in its present form might be
lethal for you. People in England over 59 cannot receive stents for their
coronary arteries. The government wants to mimic the British plan. For those
of you younger, it will still mean restriction of the care that you and your
children receive.

While 99% of physicians went into medicine because of the love of medicine
and the challenge of helping our fellow man, economics are still important.
My rent goes up 2% each year and the salaries of my employees go up 2% each
year. Twenty years ago ophthalmologists were paid $1800  for a cataract
surgery and today $500. This is a 73% decrease in our fees.  I do not know
of many jobs in America that have seen this lowering of fees.

But there is more to the story than just the lower fees. When I came to
Atlanta there was a well known ophthalmologist who charged $2500 for
cataract surgery as he felt the was the best. He had a terrific
reputation and in fact I had my mother's bilateral cataracts operated on by
him with a wonderful result. She is now 94 and has 20/20 vision in both
eyes. People would pay his $2500 fee.  However the government came in and
said that any doctor that  does  Medicare  work can not  accept  more than
the going rate  (now  $500)  or  he or she would be  severely fined. This
put an end to his charging $2500.  The government said it was illegal to
accept more than the government allowed rate.

What I am driving at is that those of you well off will not be able to go to
the head of the line under this new healthcare plan just because you have
money as no physician will be willing to go against the law to treat you.

I am a pediatric ophthalmologist and  trained  for  10 years  post college
to become a pediatric ophthalmologist (add  two years  of my service in the
Navy and that comes  to 12 years).  A neurosurgeon spends 14 years Post
College and if he or she has to do the military that would be 16 years. I am
not entitled to make what a neurosurgeon makes but the new plan calls for
all physicians to make the same amount of payment. I assure you that medical
students will not go into neurosurgery and we will have a tremendous
shortage of neurosurgeons. Already the top neurosurgeon at my  hospital who
is in good health and only 52 years old has just quit because he can't stand
working with the government anymore. Forty-nine percent of children under
the age of 16 in the state of Georgia are on Medicaid so he felt he just
could not stand working with the bureaucracy anymore.

We are being lied to about the uninsured.  They are getting care. I operate
on at least 2 illegal immigrants each month who pay me nothing and the
children's hospital at which I operate charges them nothing also.
This is true not only on Atlanta, but of every community in America. The
bottom line is that I urge all of you to contact your congresswomen and
congressmen and senators to defeat this bill.  I promise you that
you will not like rationing of your own health.

Furthermore, how can you trust a physician that works under these conditions
knowing that he is controlled by the state?  I certainly could not trust any
doctor that would work under these draconian conditions. One last thing,
with this new healthcare plan there will be a  tremendous shortage of
physicians.  It has been estimated that
approximately 5% of the current physician work force will quit under this
new system.  Also it is estimated that another 5% shortage will occur
because of decreased men and women wanting to go into medicine.  At
The present time the US government has mandated gender equity in admissions
to medical schools.  That means that for the past 15 years that somewhere
between 49% and 51% of each entering class are females. This is true
of private schools also, because all private schools receive federal
funding.

The average career of a woman in medicine now is only 8-10 years and the
average work week for a female in medicine is only 3-4 days.  I have now
trained 35 fellows in pediatric ophthalmology.  Hands down the best was  a
female that I trained  4 years  ago - she  was head and  heels above all
others I have trained.  She now practices only 3 days a week.

 Zane Pollard, MD

Health Care Reform

-----Original Message-----

Sent: Thu, Aug 20, 2009 10:29 am
Subject: Health Care Reform

This is important.

This letter is from a physician, you know, one of those evil doctors who are only in it for the money. Doctors have been vilified and demonized for decades. Those who do so want to be paid as much as the highest paid doctor, but do not want to work as hard. Read this letter. It hits the mark on government run healthcare.


READ THIS !!!!

Subject: Health Care by Atlanta Physician

This letter is from Dr. Zane Pollard.  He is operates at Children'sHealth
Care of Atlanta.   Google him, he has a very impressive CV.

Friends:

I have been sitting quietly on the sidelines watching all of this national
debate on healthcare. It is time for me to bring some clarity to the table
and, as your friend, by explaining many of the problems from the aspect of a
doctor. First off the government has involved very few of us physicians in
the healthcare debate.  While the American Medical Association has come out
in favor of the plan, it is vital to remember that the AMA only represents
17% of the American physician workforce.

I have taken care of Medicaid patients for 35 years while representing the
only pediatric ophthalmology group left in Atlanta, Georgia that accepts
Medicaid.  Why is this?  For example, in the past 6 months I have cared for
three young children on Medicaid who had corneal ulcers. This is a
potentially blinding situation because if the cornea perforates from the
infection, almost surely blindness will occur.  In all three cases the
antibiotic needed for the eradication of the infection was not on the
 approved Medicaid list.  Each time I was told to fax Medicaid for the
approval forms which I did. Within 48 hours the form came back to me who was
mailed in immediately via fax and I was told that I would have my answer in
10 days. Of course by then each child would have been blind in the eye. Each
time the request came back denied.  All three times I personally provided
the antibiotic for each patient which was not on the Medicaid approved list.
Get the point-rationing of care.

Over the past 35 years I have cared for over 1000 children born with
congenital cataracts. In older children and in adults the vision is
rehabilitated with an intraocular lens. In newborns we use contact lenses
which are very expensive. It takes Medicaid over one year to approve a
contact lens, post cataract surgery. By that time a successful anatomical
operation is wasted, as the child will be close to blind from a lack of
focusing for so long a period of time. Again extreme rationing.

Solution - I have a foundation here in Atlanta supported 100% by private
funds which supplies all of these contact lenses for my Medicaid and illegal
immigrants children for free.  Again waiting for the government would be
disastrous.

Last week I had a lady bring her child to me.  They are Americans but live
in Sweden as the father has a job with a big corporation. The child had the
onset of double vision 3 months ago and has been unable to function normally
because of this. They are people of means but are waiting 8 months to see
the ophthalmologist in Sweden. Then if the child needed surgery they would
be put on a 6 month waiting list. She called me and I saw her that day. It
turned out that the child had accommodative
esotropia (crossing of the eyes, treated with glasses that correct for
farsightedness) and responded to glasses within 4 days, no surgery was
needed.  Again rationing of care.

Last month I operated on a 70 year old lady with double vision present for 3
years. She responded quite nicely to her surgery and now is symptom free. I
also operated on a 69 year old judge with vertical double vision.  His
surgery went very well and now he is happy as a lark.

I have  been told - but of course  there is no healthcare bill that has been
passed yet - that  these  2 people because of their age would have been
denied  surgery and just told to wear a patch over one eye to alleviate the
symptoms of double vision.  Obviously cheaper than surgery.

I spent two years in the US Navy during the Viet Nam war and was well
treated by the military.  There was tremendous rationing of care and we were
told specifically what things the military personnel and their dependents
could have and which things they could not have.  While in Viet Nam, my wife
Nancy got sick and got essentially no care at the Naval Hospital in Oakland,
California. She went home and went to her family's private internist in
Beverly Hills.  While it was expensive, she received an  immediate work up.
Again rationing of care.

For those of you who are over 65, this bill in its present form might be
lethal for you. People in England over 59 cannot receive stents for their
coronary arteries. The government wants to mimic the British plan. For those
of you younger, it will still mean restriction of the care that you and your
children receive.

While 99% of physicians went into medicine because of the love of medicine
and the challenge of helping our fellow man, economics are still important.
My rent goes up 2% each year and the salaries of my employees go up 2% each
year. Twenty years ago ophthalmologists were paid $1800  for a cataract
surgery and today $500. This is a 73% decrease in our fees.  I do not know
of many jobs in America that have seen this lowering of fees.

But there is more to the story than just the lower fees. When I came to
Atlanta there was a well known ophthalmologist who charged $2500 for
cataract surgery as he felt the was the best. He had a terrific
reputation and in fact I had my mother's bilateral cataracts operated on by
him with a wonderful result. She is now 94 and has 20/20 vision in both
eyes. People would pay his $2500 fee.  However the government came in and
said that any doctor that  does  Medicare  work can not  accept  more than
the going rate  (now  $500)  or  he or she would be  severely fined. This
put an end to his charging $2500.  The government said it was illegal to
accept more than the government allowed rate.

What I am driving at is that those of you well off will not be able to go to
the head of the line under this new healthcare plan just because you have
money as no physician will be willing to go against the law to treat you.

I am a pediatric ophthalmologist and  trained  for  10 years  post college
to become a pediatric ophthalmologist (add  two years  of my service in the
Navy and that comes  to 12 years).  A neurosurgeon spends 14 years Post
College and if he or she has to do the military that would be 16 years. I am
not entitled to make what a neurosurgeon makes but the new plan calls for
all physicians to make the same amount of payment. I assure you that medical
students will not go into neurosurgery and we will have a tremendous
shortage of neurosurgeons. Already the top neurosurgeon at my  hospital who
is in good health and only 52 years old has just quit because he can't stand
working with the government anymore. Forty-nine percent of children under
the age of 16 in the state of Georgia are on Medicaid so he felt he just
could not stand working with the bureaucracy anymore.

We are being lied to about the uninsured.  They are getting care. I operate
on at least 2 illegal immigrants each month who pay me nothing and the
children's hospital at which I operate charges them nothing also.
This is true not only on Atlanta, but of every community in America. The
bottom line is that I urge all of you to contact your congresswomen and
congressmen and senators to defeat this bill.  I promise you that
you will not like rationing of your own health.

Furthermore, how can you trust a physician that works under these conditions
knowing that he is controlled by the state?  I certainly could not trust any
doctor that would work under these draconian conditions. One last thing,
with this new healthcare plan there will be a  tremendous shortage of
physicians.  It has been estimated that
approximately 5% of the current physician work force will quit under this
new system.  Also it is estimated that another 5% shortage will occur
because of decreased men and women wanting to go into medicine.  At
The present time the US government has mandated gender equity in admissions
to medical schools.  That means that for the past 15 years that somewhere
between 49% and 51% of each entering class are females. This is true
of private schools also, because all private schools receive federal
funding.

The average career of a woman in medicine now is only 8-10 years and the
average work week for a female in medicine is only 3-4 days.  I have now
trained 35 fellows in pediatric ophthalmology.  Hands down the best was  a
female that I trained  4 years  ago - she  was head and  heels above all
others I have trained.  She now practices only 3 days a week.

 Zane Pollard, MD

BioMed Central | Full text | Paraquat induces oxidative stress, neuronal loss in substantia nigra region And parkinsonism in adult rats: Neuroprotection and amelioration of symptoms by water-soluble formulation of Coenzyme Q10

Open Access

Highly Access

Paraquat induces oxidative stress, neuronal loss in substantia nigra region and Parkinsonism in adult rats: Neuroprotection and amelioration of symptoms by water-soluble formulation of Coenzyme Q10 Somayajulu-Niţu, Mallika Sandhu, Jagdeep K Cohen, Jerome Sikorska, Marianna Sridhar, TS Matei, Anca Borowy-Borowski, Henryk Pandey, Siyaram info:doi/10.1186/1471-2202-10-88 info:pmid/19635141 BMC Neuroscience 2009, 10:88 2009-07-27 BMC Neuroscience 2009-07-27 10 1 Research article 88 -->Research article

Paraquat induces oxidative stress, neuronal loss in substantia nigra region and Parkinsonism in adult rats: Neuroprotection and amelioration of symptoms by water-soluble formulation of Coenzyme Q10

Mallika Somayajulu-Niţu1 email

, Jagdeep K Sandhu3 email

, Jerome Cohen2 email

, Marianna Sikorska3 email

, TS Sridhar1,4 email

, Anca Matei2 email

, Henryk Borowy-Borowski3 email

and Siyaram Pandey1 email

1Chemistry & Biochemistry, University of Windsor, Windsor, ON, Canada

2Psychology, University of Windsor, Windsor, ON, Canada

3Institute for Biological Sciences, National Research Council Canada, Ottawa, ON, Canada

4St John's Research Institute, Bangalore, India

author email corresponding author email

BMC Neuroscience 2009, 10:88doi:10.1186/1471-2202-10-88

The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1471-2202/10/88

Received: 7 March 2009
Accepted: 27 July 2009
Published: 27 July 2009

© 2009 Somayajulu-Niţu et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

This is a great neuroscience article on the dangers of pesticides and the importance of taking water soluble CoQ10. Go to the discussions and conclusion parts to get the meat of the paper.