Why Am I Concerned about Safety of Swine Flu Vaccines? by Meryl Nass MD

[Guest guest]

of course I think that nothing is worth the risk as I know

vaccines do NOT give immunity

Sheri

Why

Am I Concerned about Safety of Swine Flu Vaccines? My

friend Mark Crispin has urged me to be more specific about why I

am concerned about the safety of swine flu vaccines in the US. In a

nutshell:

1. Newness

I am always concerned about new drugs and vaccines. A

former FDA Commissioner, Dr. Jane Henney, once said she did not use drugs

during the first year they were on the market, and advised others to

likewise avoid them. The reason is that many drugs and vaccines

have caused serious side effects that were not picked up, or not

considered enough of a concern, during initial clinical trials.

Rotashield vaccine is a good example: intussusception

(causing bowel obstruction) did occur but was overlooked in prelicensure

trials

because

it was judged unrelated to the vaccine, and a million babies

received the vaccine before it was taken off the market in 1999.

Rotashield caused 22 times the expected rate of

intussusception in infants, causing much more harm than good... but was

marketed for nearly a year.

Pre-licensure trials typically involve about 1,000 subjects for short

periods of time.

2. The currently available evidence is thin and inadequately

collected

There are few published studies of swine flu vaccine. The

Greenberg et al. study from Australia (Response after one dose of a

monovalent influenza A H1N1 2009 vaccine--preliminary report; NEJM 2009;

epub Sept. 10) is a relatively high quality study. How was vaccine

safety evaluated? By using a diary card for 7 days

post-vaccination. The 240 subjects returned on day 21 for a blood

draw, and presumably some data were collected then, but it is not clear

from the published report what safety information was obtained after 7

days. Local symptoms like a sore arm were reported by 46% of

subjects, and systemic symptoms such as headache, muscle aches or malaise

were reported by 45%. Subjects were healthy adults aged

18-64.

The authors stated, " No deaths, serious adverse events or adverse

events of special interest were reported. " The investigators

did specifically query subjects about several neurologic and immunologic

events, including Guillain Barre Syndrome. However, it is unclear

how actively other adverse events were sought, if at all, after the

initial seven days post-vaccination.

The authors acknowledge that, " The full safety profile of the

H1N1 vaccine has not yet been elucidated. Population-based

postlicensure surveillance will be required for all H1N1 vaccines,

especially to assess rare outcomes, such as the Guillain-Barre

Syndrome. " And they point out that they studied a population

of healthy adults, and " trials need to be conducted in other

populations that may have different responses to the vaccine, such as the

elderly, children, and those with impaired immunity. "

What further concerns me are the later side effects that will not be

collected, or not attributed to the vaccine due to lack of

" biological plausibility. " Since there do not exist

reliable scientific criteria for assigning causality to vaccine adverse

events, those the vaccine causes are likely to be dismissed as

coincidental. Compounding this problem, the brief periods of active

surveillance are insufficient to identify later reactions. When it

takes 10-14 days to achieve peak antibody levels, a week of active

surveillance for side effects is clearly inadequate.

3. The Liability Waiver... blanket immunity in the absence of

willful misconduct

As I've noted previously,

swine

flu vaccine

manufacturers can only be sued for damages if they are guilty of

willful misconduct. As long as they don't know about safety

problems, they cannot be held liable for them. This thoughtless

language in the

Public Readiness and Emergency Preparedness Act, which regulates pandemic

vaccines, may induce manufacturers to perform minimal safety testing

in order to avoid potential liability. Don't you think corporate

attorneys have so advised their clients?

4. When the program isn't transparent, the result is lack of

trust.

I expect the government, which is supplying free swine flu vaccines,

to advise recipients honestly about them. Live flu vaccines have

very low efficacy in adults, compared to injected subunit vaccines.

How attractive would a nasal vaccine that was only 29% effective at

preventing influenza be to you, when the injected vaccine had 72%

efficacy? Yet this is what

Monto et al. recently reported in the NEJM about last year's seasonal

vaccine. It makes you wonder why live flu vaccines are even licensed for

adults. And how good are they in children? Better--but the

data are limited.

Some hospitals are refusing live nasal vaccines for employees.

That is wise: they are concerned the live viruses could be

transmissible to patients, especially those with impaired immunity.

They should also be concerned about efficacy of live nasal vaccine. Why

didn't government tell the public about these concerns? Why didn’t

government tell the public it issued a liability waiver to the

manufacturers?

Schools offering these vaccines don't seem to be aware of potential

problems such as vaccine virus transmission to immune-compromised

students.

5. Benefit and risk should be compared

Yes, there are serious swine flu illnesses and deaths in a young,

healthy population. But how frequent are they? How good is

the vaccine at protecting against them? The very best flu vaccines

are about 70% protective against catching the disease, which is the

measure you are interested in. Most studies measure the rise in

antibody levels, which may not reflect actual protection.

During 4 weeks in September there were

182 confirmed influenza

deaths in the US. Though not a small number, it is not a big number

either compared to seasonal flu. Admittedly incomplete, WHO has

reports of just 4100 deaths worldwide since the pandemic began.

There have been 60 deaths in US

children related to swine flu since the pandemic began.

Cities (like Boston and New York) that had a lot of swine flu cases in

the spring are having few now, suggesting a large enough number of

people (perhaps 50% or more to induce this effect) had subclinical

infections, generating herd immunity. It is likely many will be

vaccinated who are already immune. In the

Australian trial 31.7% of vaccine recipients had antibodies against

swine flu before they were vaccinated, even though they had no symptoms

of disease. The effect of preexisting antibody spuriously raises

vaccine efficacy statistics in some trials, and reduces the need for

vaccine.

If you have a neuromuscular disorder or lung disorder, you are at higher

risk of a serious outcome from flu. Thus your benefit from

vaccination is greater.

Vaccination was once intended for only the most serious illnesses.

Doctors knew some children would develop encephalopathies (brain

injuries) as a result of vaccination, but the risk was worth the

benefit. Over time, and as the profits from vaccines have risen,

" mission-creep " has led to increasing numbers of vaccines for

less serious illness, even moving vaccine development into areas of

non-infectious diseases like cancer. During this process,

appreciation of vaccine risks got marginalized.

The benefit of vaccination should be balanced against the risk, but as

yet we don't know the risk. I do my best to balance the known and

potential risks and benefits as I advise people regarding vaccination,

and I hope readers of this blog do also. Vaccination shouldn't be a

“one size fits all” intervention.

Posted by Meryl Nass, M.D. at

1:14 AM 0 comments

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start October 28 & 29

[Guest guest]

of course I think that nothing is worth the risk as I know

vaccines do NOT give immunity

Sheri

Why

Am I Concerned about Safety of Swine Flu Vaccines? My

friend Mark Crispin has urged me to be more specific about why I

am concerned about the safety of swine flu vaccines in the US. In a

nutshell:

1. Newness

I am always concerned about new drugs and vaccines. A

former FDA Commissioner, Dr. Jane Henney, once said she did not use drugs

during the first year they were on the market, and advised others to

likewise avoid them. The reason is that many drugs and vaccines

have caused serious side effects that were not picked up, or not

considered enough of a concern, during initial clinical trials.

Rotashield vaccine is a good example: intussusception

(causing bowel obstruction) did occur but was overlooked in prelicensure

trials

because

it was judged unrelated to the vaccine, and a million babies

received the vaccine before it was taken off the market in 1999.

Rotashield caused 22 times the expected rate of

intussusception in infants, causing much more harm than good... but was

marketed for nearly a year.

Pre-licensure trials typically involve about 1,000 subjects for short

periods of time.

2. The currently available evidence is thin and inadequately

collected

There are few published studies of swine flu vaccine. The

Greenberg et al. study from Australia (Response after one dose of a

monovalent influenza A H1N1 2009 vaccine--preliminary report; NEJM 2009;

epub Sept. 10) is a relatively high quality study. How was vaccine

safety evaluated? By using a diary card for 7 days

post-vaccination. The 240 subjects returned on day 21 for a blood

draw, and presumably some data were collected then, but it is not clear

from the published report what safety information was obtained after 7

days. Local symptoms like a sore arm were reported by 46% of

subjects, and systemic symptoms such as headache, muscle aches or malaise

were reported by 45%. Subjects were healthy adults aged

18-64.

The authors stated, " No deaths, serious adverse events or adverse

events of special interest were reported. " The investigators

did specifically query subjects about several neurologic and immunologic

events, including Guillain Barre Syndrome. However, it is unclear

how actively other adverse events were sought, if at all, after the

initial seven days post-vaccination.

The authors acknowledge that, " The full safety profile of the

H1N1 vaccine has not yet been elucidated. Population-based

postlicensure surveillance will be required for all H1N1 vaccines,

especially to assess rare outcomes, such as the Guillain-Barre

Syndrome. " And they point out that they studied a population

of healthy adults, and " trials need to be conducted in other

populations that may have different responses to the vaccine, such as the

elderly, children, and those with impaired immunity. "

What further concerns me are the later side effects that will not be

collected, or not attributed to the vaccine due to lack of

" biological plausibility. " Since there do not exist

reliable scientific criteria for assigning causality to vaccine adverse

events, those the vaccine causes are likely to be dismissed as

coincidental. Compounding this problem, the brief periods of active

surveillance are insufficient to identify later reactions. When it

takes 10-14 days to achieve peak antibody levels, a week of active

surveillance for side effects is clearly inadequate.

3. The Liability Waiver... blanket immunity in the absence of

willful misconduct

As I've noted previously,

swine

flu vaccine

manufacturers can only be sued for damages if they are guilty of

willful misconduct. As long as they don't know about safety

problems, they cannot be held liable for them. This thoughtless

language in the

Public Readiness and Emergency Preparedness Act, which regulates pandemic

vaccines, may induce manufacturers to perform minimal safety testing

in order to avoid potential liability. Don't you think corporate

attorneys have so advised their clients?

4. When the program isn't transparent, the result is lack of

trust.

I expect the government, which is supplying free swine flu vaccines,

to advise recipients honestly about them. Live flu vaccines have

very low efficacy in adults, compared to injected subunit vaccines.

How attractive would a nasal vaccine that was only 29% effective at

preventing influenza be to you, when the injected vaccine had 72%

efficacy? Yet this is what

Monto et al. recently reported in the NEJM about last year's seasonal

vaccine. It makes you wonder why live flu vaccines are even licensed for

adults. And how good are they in children? Better--but the

data are limited.

Some hospitals are refusing live nasal vaccines for employees.

That is wise: they are concerned the live viruses could be

transmissible to patients, especially those with impaired immunity.

They should also be concerned about efficacy of live nasal vaccine. Why

didn't government tell the public about these concerns? Why didn’t

government tell the public it issued a liability waiver to the

manufacturers?

Schools offering these vaccines don't seem to be aware of potential

problems such as vaccine virus transmission to immune-compromised

students.

5. Benefit and risk should be compared

Yes, there are serious swine flu illnesses and deaths in a young,

healthy population. But how frequent are they? How good is

the vaccine at protecting against them? The very best flu vaccines

are about 70% protective against catching the disease, which is the

measure you are interested in. Most studies measure the rise in

antibody levels, which may not reflect actual protection.

During 4 weeks in September there were

182 confirmed influenza

deaths in the US. Though not a small number, it is not a big number

either compared to seasonal flu. Admittedly incomplete, WHO has

reports of just 4100 deaths worldwide since the pandemic began.

There have been 60 deaths in US

children related to swine flu since the pandemic began.

Cities (like Boston and New York) that had a lot of swine flu cases in

the spring are having few now, suggesting a large enough number of

people (perhaps 50% or more to induce this effect) had subclinical

infections, generating herd immunity. It is likely many will be

vaccinated who are already immune. In the

Australian trial 31.7% of vaccine recipients had antibodies against

swine flu before they were vaccinated, even though they had no symptoms

of disease. The effect of preexisting antibody spuriously raises

vaccine efficacy statistics in some trials, and reduces the need for

vaccine.

If you have a neuromuscular disorder or lung disorder, you are at higher

risk of a serious outcome from flu. Thus your benefit from

vaccination is greater.

Vaccination was once intended for only the most serious illnesses.

Doctors knew some children would develop encephalopathies (brain

injuries) as a result of vaccination, but the risk was worth the

benefit. Over time, and as the profits from vaccines have risen,

" mission-creep " has led to increasing numbers of vaccines for

less serious illness, even moving vaccine development into areas of

non-infectious diseases like cancer. During this process,

appreciation of vaccine risks got marginalized.

The benefit of vaccination should be balanced against the risk, but as

yet we don't know the risk. I do my best to balance the known and

potential risks and benefits as I advise people regarding vaccination,

and I hope readers of this blog do also. Vaccination shouldn't be a

“one size fits all” intervention.

Posted by Meryl Nass, M.D. at

1:14 AM 0 comments

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://www.wellwithin1.com/vaccine.htm

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start October 28 & 29