Tuesday, March 31, 2009

What do Doctors Tell Parents About Vaccination?

I'm wondering what doctors tell the parents in their practice who are going to vaccinate their children. Do they talk about side effects? Do they explain about the Vaccine Adverse Events Reporting System (VAERS) and that they should report any kind of side effect? Do they talk about contraindications to vaccination--allergies, immunocompromised kids, illness?

Do they ask that parents keep their kids at home for the length of time that the live vaccines in them will be shedding? Do they explain what that means? For all the fervor a while ago with the actress Amanda Peet calling non-vaccinating parents parasites, do doctors tell parents that the live viruses injected into their kids will be excreted through feces, saliva, and nasal secretions for weeks at a time? Do they tell them to stay away from babies, or the elderly in their concern for their weakened systems which may not be able to fight off exposure to live viruses? Do they tell them that vaccines are not 100% effective and that they shouldn't risk exposing people to the live vaccine? Do they explain how negligent that is or how irresponsible or selfish?


I know doctors tell people that vaccines are well tested, but do they tell them that they're not tested for carcinogenic or mutagenic potential or potential to impair fertility? Not that they've been found safe, rather that they're not even tested for that possibility? Do they tell them that Merck and other vaccine manufacturers aren't even looking? You can see that if you read Merck's package insert for MMR II (mumps, measles and rubella vaccine)


That's kind of amazing to me in light of SV40. I guess if you don't look, you don't find. Maybe that's enough of a scientific standard for some, but it seems a little bit shoddy to me.

Do doctors share the package inserts, as they're instructed to do in the package inserts?

Here's some information about the live nature of viruses in some vaccines. There's also some good information in the comments section. Which raises another question for me, has your doctor talked to you about nutrition for you or your kids?

Maybe your doctor should...


Secondary Transmission: The short and sweet about live virus vaccine shedding.

February 24, 2008 by generic
Filed under: Parents' Pages, Vaccine/Disease Analysis

shedding.<span class=jpg">

A child gets vaccinated and is from that moment on protected from the vaccine virus, correct? We all realize that vaccines are not 100% failproof, but is that the only concern?

If it only were that simple. The fact is that once a child is injected with a live virus vaccine (and let’s assume that this child is immune as a result of it) there are still other things to consider which most parents do not know about and most pediatricians fail to warn about - which is shedding!

Shedding is when the live virus that is injected via vaccine, moves through the human body and comes back out in the feces, droplets from the nose, or saliva from the mouth. Anyone who takes care of the child could potentially contract the disease for some time after that child has received certain live vaccines. This was a huge problem with the oral polio vaccine, and was one of the reasons why it was taken off the market in the US.

The OPV is still used in developing counties.

Secondary transmission happens fairly often with some of the live virus vaccines. Influenza, varicella, and Oral Polio Vaccine (OPV) are the most common. On the other hand it may happen very seldom or not ever with the measles and mumps vaccine viruses.

Here are the vaccines that shed or have been known to result in secondary transmission:

Measles Vaccine - Although secondary transmission of the vaccine virus has never been documented, measles virus RNA has been detected in the urine of the vaccinees as early as 1 day or as late as 14 days after vaccination. (1)

In France, measles virus was isolated in a throat swab of a recently vaccinated child 4 days after fever onset. The virus was then further genetically characterised as a vaccine-type virus. (2)

Rubella Vaccine - Excretion of small amounts of live attenuated rubella virus from the nose and throat has occurred in the majority of susceptible individuals 7-28 days after vaccination. Transmission of the vaccine virus via breast milk has been documented. (3)

Chicken Pox Vaccine - Vaccine-strain chickenpox has been found replicating in the lung (4) and documented as transmtting via zoster (shingles sores) (5) as well as “classic” chickenpox (6) rash post-vaccination.

Oral Polio Vaccine (OPV) - In areas of the world where OPV is still used, children who have been vaccinated with it pass the virus into the water supply through the oral/feces route. Other children who then play in or drink that water pick up the vaccine viruses, which can pass from person to person and spark new outbreaks of polio. (7)

FluMist Vaccine - The mist contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients.

Transmission of a vaccine virus from a FluMist recipient to a contact was documented in a pre-licensing trial. The contact had a mild symptomatic Type B virus infection confirmed as a FluMist vaccine virus. (8)

Rotavirus Vaccine (RotaTeq) - There is a possibility that one strain of rotavirus which is presently circulating may be an “escaped” vaccine strain, from an old Finnish rotavirus vaccine. (9)

Following are excerpts from the discussion by the FDA Advisory Committee on RotaTeq vaccine shedding: (10)

Page 50:

The latest shedding that we saw was 15 days from dose one.

We had no subjects that shed after dose two, and only one subject shed after dose three. He shed four days from dose three.

Page 51:

A: The quantities were low, similar to what we saw in phase 2 studies, as well.

We also had two placebo recipients that shed, and of course, this raised a red flag for us.

B: Could this have been transmission of vaccine virus from vaccine recipients to placebo recipients?

A: We did a very thorough investigation looking for opportunities for a vaccine transmission to occur and did not find anything. These children were not siblings of a vaccine recipient. They didn’t attend day care with vaccine recipients. They didn’t have a common caretaker with the vaccine recipient, and in the office and clinic in which they were vaccinated, they were not exposed to vaccine recipients.

So going on then to summarize general safety, Rotateq was well tolerated….

Page 70:
Question and answer section -

Then with respect to the possibilities of how these children ended up with vaccine strains in their stool, we really could not find the answer for that. We even went so far as to look and see like on the day that that child was in the clinic, were other children getting vaccine, you know, right before or after them?

And that was not the case. So it has been a puzzle, and we don’t have an answer as to why these children had vaccine strains in their stool.

(One has to ask: Could the reason have been that someone mixed up the placebo with the actual vaccine vials and consequently some kids of the control group got the real vaccine?)

Source:
(1) Detection of Measles RNA
(2) Detection of measles vaccine in the throat of a vaccinated child.
(3) MMR II
(4) Vaccine Oka Varicella-Zoster Virus
(5) Chickenpox Attributable to a Vaccine Virus
(6) Genetic Profile of an Oka Varicella Vaccine Virus
(7) Polio Outbreak in Nigeria
(8) Flumist
(9) Human and Bovine Serotype G8 Rotaviruses
(10) Products Advisory Committee

Comments

2 Comments on Secondary Transmission: The short and sweet about live virus vaccine shedding.

  1. jules on Mon, 25th Feb 2008 10:18 am
  2. I believe the titer test(blood test) for Measles can also tell if it was the vaccine-type Measles or wild Measles. Someone feel free to correct me if I am wrong:)

    Some people never develop an immunity-vaccinated or not. That is why some people get chicken pox more than once, or some women get repeated Rubella vaccines and still show no immunity. Reinfection is also always ‘possible’ if vaccine or natural immunity wears off over time due to NOT being exposed which helps keep immunity level up.

  3. Marconi on Mon, 25th Feb 2008 10:45 pm
  4. The titre blood test cannot differentiate between vaccine-type measles or wild measles. In order to do that, the virus would have to be typed with a test called Polymerase Chain Reaction, and the “bar code” compared with the reference viruses for either the vaccine virus, or the wild virus. Furthermore, the vaccine virus varies slightly with every new attenuation, so each batch of vaccine might show a slight genetic variation from each other.

    To say some people never develop immunity, vaccinated or not is very simplistic. If you mean, some people never show antibodies on a titre test, that too is very simplistic. The current titre test offered to parents is a crude measure. Using other tests such as ELISA, antibodies can be picked up, which the standard titre test does not.

    It is “normal” for some people to develop antibodies, for antibotides to subside over time, and for a titre test years later to show no antibodies. However, if you vaccinated those people, or blood tested them before and after a known exposure and subclinical infection during with the person shows no signs of infection, the immediate rise in detectable antibodies over a period of days is a specific curve which shows an anamnestic response. What that means is that the person actually did have immunity, but it was “memory” immunity. Just because a person doesn’t have “detectable” immunity according to a titre test, doesn’t mean they have lost their immunity.

    What it means is that immunologists have not yet devised a method for detecting permanent “memory” immunity.

    Virology texts are also interesting, in that they point out that many children who don’t have antibodies cope very well with diseases like measles. The reason for that is that the key to survival of a first exposure to disease in any person, isn’t antibodies anyway. When you first come in contact with any disease, how well you survive that is due to your “cellular” immune system, which does utilise IgA, and IgM at some point if you have a normal immune system. But most textbooks, even older ones by ‘greats’ like McFarlane Burnett, describe in great detail, children who have no antibodies, who cruise through measles and polio. The rate of paralytic polio in normal children (using the most virulent strain as a reference point) is one case of paralysis, per 100 children with mild symptoms. The historical rate of paralysis in children with no antibodies is 6 per 100. So while children with no antibodies are 6 times more likely to get paralytic polio, the cellular immune system of those children guarantees that 94 out of 100 of them will not.

    Yes, some children with no antibodies will get sick and die. But not all of them will.

    The key to fighting an infection for the first time, in everyone, normal or not, is a well functioning cellular immunity is nutrition, nutrition, and nutrition. A person can have a normal immune system, but if they have malnutrition or bad nutrition, their immune system will not work properly, and they can die regardless. Anyone working in Africa can tell you that. The connection between nutrition, infection and immunity has been, and is very strong in the medical literature.

    A huge amount of “immunity” is based on the integrity of the gastro-intestinal system, and the person’s nutritional status. Antibodies are essential the net at the bottom of the cliff, which while vital, isn’t the most important factors.

    Using Tetanus as an example, were antibodies the most important part of the immune system with regard to protection against tetanus, then the human beings on the earth would never have got past the first generation. Even in the western world, civilians had no access to a tetanus vaccine until around 1960 (at least in the country in which I live). You just have to look at your own family tree to realise that your great great grandparents probably died of other things rather than tetanus during childhood.

    So the use of antibodies as a measuring rod of “immunity” is not only a very crude measure, it’s inaccurate. But it’s a very useful “weapon” with which to create fear.


    Note: I didn't bold or enlarge the font in the first two paragraphs on purpose. I don't really mean to be yelling with my post up there. I'm just trying to talk and I can't correct it, darn it. Sorry about the bold and the large... that's a soap opera, right?

Monday, March 30, 2009

A Blog by Any Other Name...

My kids have blogs!! What was just an offhand suggestion that maybe they would like to create their own blogs, has become a viral popping up of all sorts of blogs throughout our homeschooling group--lots of the kids now have blogs, with more being created every day!

My son and daughter now have their own e-mail addresses, the better to create their own autonomous blogs where they can download pictures and polls and movies and funny stories about their family. And, by the way, where they can write and read and share in meaningful ways with their friends and family.

With all of this creativity expressed by my kids, they have been using up a lot of computer time--I'm not getting any! OK, I'm still getting some, but it is far less than I had.

I'm sure that screen time is damaging to them--right? I'm sure I should be limiting it far more so that I can have my screen time--right? Isn't there a study somewhere to support the idea that the unbridled, shared creativity of kids is a bad, bad thing?

Really, what good can possibly come from this? I ask you...

Thursday, March 26, 2009

Squirrel Nut Zippers

My husband and I went into Chicago for a rare date night--my parents watched the kids and had a good time--and we saw the Squirrel Nut Zippers perform at the House of Blues.

This group is so tight and play live pretty much the same way as they have recorded their CDs.

I liked their choices in grouping songs. They played Bad Businessman followed by Hell. I think there's some editorial comment in the lineup choice.

Bad Businessman lyrics:

There's a man going around town
Spreading lies
Hes the bad businessman
Does his business while he can
He just does his business bad.

Hes a clown
Gonna get bounced around
If he dont keep his business underground
Hes a player
And everytime he deals a round
Its just a bad hand
What a bad man.
Beware of what he sells
Surely go straight to hell.
Taint no bottom in that wishing well.


That's timely.

Hell lyrics:

In the afterlife
You could be headed for the serious strife
Now you make the scene all day
But tomorrow therell be hell to pay

People listen attentively
I mean about future calamity
I used to think the idea was obsolete
Until I heard the old man stamping his feet.

This is a place where eternally
Fire is applied to the body
Teeth are extruded and bones are ground
Then baked into cakes which are passed around.

Beauty, talent, fame, money, refinement
Top skill and brain
But all the things you try to hide
Will be revealed on the other side.

Now the d and the a and the m
And the n and the a
And the t and the i-o-n
Lose your face, lose your name
Then get fitted for a suit of flame

I'll share a live youtube video of them in New York last year playing Bad Businessman and then you can watch an MTV video of them doing Hell.

Let these songs serve as a warning to all of you Bad Businessmen out there...



Tuesday, March 24, 2009

Wicked Cool--Eagle Cam!

The Norfolk Va. Botanical Garden has a camera trained on a bald eagle's nest. A few eggs have hatched within the last few days.

You can get updates about it all on a blog and see clips and photos there as well.

Wicked cool.

Monday, March 23, 2009

DoulaMomma Wins!

Not only was DoulaMomma the only one to enter the Homeschooling Quiz contest, she happened to get it all right. You win DoulaMomma!

If you leave a private message to me in my guestbook with your address, I will send you some Mexican candy.

Congratulations to you. To the victor go the spoils--you get them all!

Let's review the quiz and see DoulaMomma's answers:

1) I asked how many homeschoolers currently in U.S.

DoulaMomma's answer--

estimated number of homeschoolers in 2008 in the US: 1,273,089

Close enough. I've heard around 1.5 million and some sources say that it's closer to 2 million. I'm not going to quibble.

2) I listed all sorts of famous people and asked what they have in common.

DoulaMomma's answer--

They are famous people who were homeschooled?

Bingo. They were all homeschooled. Alan Alda? Who knew?

3) I wrote up a huge list of very competitive and prestigious colleges and universities and asked what they all have in common.

DoulaMomma's answer--

Universities that admit homeschoolers?

Yes. Not only do they admit homeschoolers but some, notably Stanford, court homeschoolers and actively recruit them.

I think it's fun to note that DoulaMomma said she herself had been homeschooled until 4th grade. We should put her on the list of famous homeschoolers.

If you haven't visited DoulaMomma's blog, please go check it out. She has all sorts of interesting articles about pregnancy and birth and how doulas support a normal, healthy birth. What a noble job she has. She also writes about her own kids, including an essay she recently wrote about the time her son caught her throwing his art work into the recycling bin, and she has links to interesting blogs.

Thanks for entering the quiz DoulaMomma. Congratulations again.

Sunday, March 22, 2009

A Riddle...




I have a riddle for you.

What do you get when you excitedly pick out four artichokes from Trader Joe's (because your kids have never tried them, but have heard about them), trim and steam them and serve them with melted butter?

Do you give up? All right, I'll tell you. You get four artichokes all for you because no one even wants to try them.

Yes, thank you, they were delicious (over a few days) and the non-foodies, whom I adore and love with all my being, don't know what they were missing.

Saturday, March 21, 2009

Flock of Seagulls, Because I want to be Light

And now for something completely different...

Well, I didn't really appreciate these guys back in the day. I didn't appreciate pop music pretending to be Rock. It's only now, as a seasoned, mature adult with a more sophisticated and nuanced understanding of the world that I can fully appreciate Flock of Seagulls.

Imagine the 80's: Reagan in office, frills on women's blouses or little bow ties, women wearing their high-top aerobic shoes over their pantyhose as they run to catch the train into the city for their yuppie jobs, shoulder pads, jocks joyfully wearing pink Izod polos, men wearing blazers with the sleeves pushed up to their elbows to look casual, big crazy permed mall hair or bizarre asymmetrical haircuts, car phones, ATMs introduced at banks, people striving to get their first beemer, AIDS starting to hit the gay community hard, therefore ignored by rest of society, Iran/Contra scandal, revolutionary new foods--salsa, croissants, pita bread, sun dried tomatoes.

It is into this milieu that the Flock of Seagulls landed. Dig their music--also check out the production values in their video. Suh-weet.





Friday, March 20, 2009

Oh No Love You're Not Alone

You're not.  You're not alone.  We may not all realize it all of the time, but we are connected and none of us is alone.

Let's rock out to Bowie as he sings about it.


Thursday, March 19, 2009

And Speaking of Reading--A Confession...

OK.  That last post wasn't really very light reading.  But, I do think it's important reading.  I think it gives an inside view as to how the scientific community speaks to one another about problems in medicine and research and vaccine production, hidden away from the public's eyes. It was very candid, wasn't it?

Not light reading, but illuminating.

This post, however, is not about that post.  This is its own post and is not dependent on some old-timer post.  This is new blood.   This is one of the smartest and brightest.

No it's not.  Joking!  There's actually no pressure on this post.   It can just be without judgment--at least no judgment from me.  It may be judged harshly by others, but that's between the post and those people--not really my business.

Here is this post:

I must confess.  I just read the first part of The Hobbit and skimmed the rest,  because--this is difficult, but I will just let it gush out in one agonized admission--I HATED it!

I know!!   How is that possible?!

I don't know what to tell you, but I couldn't care less about poor Bilbo Baggin's adventures.   I didn't care when he was stuck in the mountain.  Couldn't care less.  I didn't care when he was in the forest and there were spiders everywhere--I had faith that he'd get out of it somehow.   But, I was not worried or concerned.

I knew his compatriots would fare OK too--even the big one who had to do things by himself.

I never read about the dragon--I assume they managed it--right?

I just blithely, and without a twinge of regret or guilt in my conscience, carelessly skimmed to the end and read that Bilbo got back home and they were impudently selling all of his stuff! But, even then I didn't care...

I felt great sympathy for when Bilbo was hungry--which was a lot of the time.  But then they'd be a guest to someone and eat some roasted haunch and drink up water or mead or ale.

I liked the character of Bilbo Baggins.  I hated the story of The Hobbit.   

There, I said it.  Do with it what you will.  As I said, it's between the post and you--leave me out of it.

P.S.  If you must know, I also hated the first Batman movie, the musical Chicago, feathered hair in the late 70's and early 80's, The Bridges of Madison County...

Go ahead, chew on that!

Tuesday, March 17, 2009

Who's up for Some Light Reading? Adventitious Agents in Vaccines

Occasionally, I check out the Vaccines forum at Mothering.com. There are all sorts of varying points of view, but more importantly there are great links to government sites where you can read things that aren't generally written for the public--in other words, they're not dumbed down, or written to scare people into compliance with certain public health agendas. They are minutes from meetings, or information compiled for doctors (the CDC Pink Book for example).

You can read the source material yourself and see what you can glean from it all.

I came across this link in a woman's signature at the bottom of her post. It is a set of meeting minutes from the fda.gov site from a workshop for government agencies dealing with infected animal tissues which are used to grow diseases which are then harvested and used to make vaccines. Whew--did you get that? Monkey kidneys, the sides of calves, eggs have all been used to grow diseases. This workshop speaks to contaminants (adventitious agents) in the cells of monkey kidneys, the sides of calves and eggs that inadvertently get mixed into the vaccines themselves.

A well known contaminant is SV40. It was a monkey virus that was in polio vaccine for years and years before anyone realized it was in there. It has shown up in various cancerous tumors even now. Millions of people were exposed to this monkey virus through vaccination.

This workshop speaks to trying to control these kinds of contaminants.

Let's read some together, shall we? I'll have the minutes in blue so you can differentiate between what they said and what I will say. After you read this post, you might want to go and check out the original minutes from the meeting for yourself.

Welcome:

              U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES


PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

INTERNATIONAL ASSOCIATION FOR BIOLOGICALS


NATIONAL INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES

NATIONAL VACCINE PROGRAM OFFICE

WORLD HEALTH ORGANIZATION


+ + + + +

EVOLVING SCIENTIFIC AND REGULATORY PERSPECTIVES ON
CELL SUBSTRATES FOR VACCINE DEVELOPMENT

+ + + + +


WORKSHOP

+ + + +

Friday,
10 September 1999


A Dr. Phil Minor was introduced to open up the meeting and to give an overview of the issues involving cell substrates in vaccine production.

10                I would like to introduce the first

11 speaker, Dr. Phil Minor, from the National Institute

12 of Biological Standards and Control, who will be


13 giving us an introduction to adventitious agent

14 issues, both reviewing the past and current experience

15 with adventitious agent contamination of biologicals


16 in vaccines.

17 DR. MINOR: Thanks. Thanks very much.

18 Can I have the slide on, please, or do I just press it

19 here?


20 What I am going to do is to review firstly

21 all of biologicals, if you like, from an adventitious

22 agent point of view. So it won't just be vaccines.


23 In particular, I will be talking about the range of

24 source materials that people have used in preparing

25 biologicals. There will be a clear message that comes


5

1 out of that, which is that the more you use well-


2 characterized cells, the better.

3 I will also be talking about the SV40

4 story in some detail, which has been gone through a

5 number of times, but I will be going through it from


6 a particularly regulatory point of view because again,

7 there is a message there which says that if you get it

8 wrong, you will still be working on it 40 years later.




Let's read more.



11 So there are a variety of source materials

12 that you can use if you are preparing biologicals.


13 They are sort of listed here, if you like. There are

14 biological materials which are made from whole

15 animals. That would include things like blood and


16 blood products. I will describe that in a moment. So

17 you can just go to a whole animal and take something

18 out and make your biological from that.

19 You can use your whole animal as a


20 substrate for growth. I will discuss that in the

21 context of things like influenza vaccines and the

22 like.


23 You can grow material on primary cells.

24 This was the main starting point for things like polio

25 vaccines in the early days, where the SV40 issue


6

1 arose. Finally, you can grow materials on well-


2 characterized cell preparation.

3 The further down the list you go on this

4 thing, probably the happier you are from the

5 adventitious agent point of view.


6 This shows some examples of contaminants

7 which have arisen when whole animals have been used as

8 source materials or the origin of the source material.


9 Most of these will be human rather than anything else,

10 but really an awful lot of the serious adventitious

11 agent problems that have arisen have arisen because of

12 materials sourced from whole animals or using pooled


13 preparation.



My take away at this very early point in the presentation is acknowledgment of problems in vaccine production. Carry on.



14                The first one on this list here is CJD,

15 Creutzfeldt Jakob Disease, which was transmitted by


16 growth hormone. The growth hormone was produced from

17 human cadaveric material. A very unpleasant disease.

18 It's almost impossible to detect the agent other than

19 by standing back and waiting for the incubation period


20 to go.

21 In France, there are still a large number

22 of cases coming through as a result of this. It may


23 well be that around 10 percent are recipients of

24 human-derived growth hormone, will actually wind up

25 going down with CJD in France.


Whoa, whoa whoa! Hold on a minute. A disease is passed on to people in France from growth hormone which was derived from producing it in human cadaveric material. "A very unpleasant disease." he said. "Almost impossible to detect the agent other than by standing back and waiting for the incubation period to go." You can't detect it except after the people have it?!? Around 10% of people receiving growth hormone in France will come down with this disease?!

Huh. Sounds a little sloppy. Let's continue.

  
6 Scrapie was first shown to be a

7 transmissible agent by the use of a TBE vaccine, which

8 was grown in the brains of sheep. TBE being tick-


9 borne encephalitis, which then transmitted scrapie to

10 a large number of the sheep that were actually

11 inoculated with it. So again, this is a whole animal

12 source material, if you like, that had quite serious


13 consequences, especially if you were a sheep.


Good one doc, "...especially if you were a sheep." Ha, ha.

Back to humans.


14                Over the last 15 or 20 years or so, one of

15 the best examples of serious or disease-causing


16 transmissions of infectious agents has been through

17 human blood and blood-derived materials, clotting

18 factors in particular. In all of these things, the

19 entire alphabet soup of hepatitis viruses has been


20 transmitted by blood product.

21 In the early days at least, some of these

22 were really regarded as really a hazard, if you like,


23 of being a hemophiliac. So, for example, hepatitis C,

24 in the days when there was a non-A, non-B hepatitis,

25 it was really regarded as an inevitable consequence of


8

1 using factor 8 to treat hemophilia. I am not sure


2 that that is an acceptable way of actually doing

3 things any more. I am sure that hemophiliacs would

4 agree with that. B-19, paravirus B-19 is still

5 transmitted by clotting factors.

Continuing on...


6                Finally, this one down at the bottom here

7 is a classic example of a transmission by a vaccine,

8 if you like, where hepatitis B was transmitted by


9 yellow fever vaccine back in the 1940s. The hepatitis

10 B actually came from the stabilizers of the albumin

11 that was actually put in there to keep it stable.

12 There is a story that Fred McCallum, who


13 is head of the Public Health Service in the United

14 Kingdom tells to the effect that he basically won the

15 war because he prevented Winston Churchill having a


16 yellow fever vaccine when he was going off to talk

17 with Stalin around 1944.

18 So most of the serious consequences really

19 come from whole animal source materials, if you like.


20 You can use whole animals as substrates. I'm using

21 the term "whole animals" in a fairly broad sense.

22 Eggs in the definition of the Animal Regulated Use Act


23 in the United Kingdom count as an animal because they

24 are embryonated.


Yikes. Glad Churchill skipped that vaccine too. Albumin are the egg whites that were in there. Let's continue.

25                For many years, rabies vaccines were


9

1 produced in mouse brain or sheep brain. They have


2 quite serious consequences, but not necessarily

3 associated with adventitial agents. You can get

4 encephalitis as a result of immune responses to the

5 non-invasic protein.

Wait. Wait just a minute. Hold it right there. "You can get encephalitis as a result of immune responses to the non-invasic protein." The protein that's in there can cause encephalitis?! Not some additional contaminant causing it?! (Adventitial agents. Unknown pathogens that are present in the cell lines that are used to produce vaccines and that can become part of the final vaccine.) Your body's natural immune response can bring on the encephalitis?!

I wonder if there are other proteins in other vaccines that can cause this kind of response. Hmmm.

Do they still use mouse brains?

6                The Japanese  encephalitis vaccine, which

7 is used for travelers in the United Kingdom, is still

8 made in mouse brain. So it's not an unusual source of


9 material, if you like. Smallpox for a long time was

10 made on the scarified flanks of calves. Like I said,

11 isn't any more. However, while these things seem

12 really quite primitive, in terms of how you make


13 vaccines nowadays, you still have a number of vaccines

14 that are made in eggs. Yellow fever is the classic

15 example, and influenza.




Reading on...



4                Influenza is an actuated vaccine.  Again,

5 it's not made on SPF eggs, that is, specified


6 pathogen-free eggs. They are avian leukosis free, but

7 they are not free of all the other variety of

8 pathogens that you would choose to screen for measles


9 vaccine production system, for example.

10 So even today then you have to bear in

11 mind that a large amount of vaccine that's made is

12 made on really quite crude materials, from an


13 adventitious agent point of view. It's not a trivial

14 usage. In fact, when you go through and consider what

15 vaccines are actually made on these days, they are


16 quite primitive, if you like, in some respects.



What are SPFs? What's that you say? It means Specified Pathogen Free? So if a vaccine is made from eggs that are not SPF it means that there may be pathogens in there?! "It's not a trivial usage." The doctor said. Meaning, a LOT of vaccines are made on materials where they don't know whether there are any harmful pathogens in there or not... The doctor continued, "In fact, when you go through and consider what vaccines are actually made on these days, they are quite primitive, if you like, in some respects." Huh, ya think?! Yeah, I've got to agree on this one. It sounds like a noxious witches brew. (Not to offend Wiccans. I think they would use some nice herbs or something. Nothing noxious...)

"Oh, but that's crazy." you're thinking. Yep, it is.

Onward to SV40.


24                SV40 is one that I'm going to talk about

25 in some detail in a minute. This was in polio


11

1 vaccines in the 1950s and very early 1960s, probably,


2 a source from rhesus monkey kidney. Polio vaccines

3 are still made on monkey kidney, though they are not

4 usually on rhesus monkey kidney. It would be

5 cynomologous or something like that, for reasons which


6 I'll describe in a moment.

7 Nonetheless, a great deal of vaccine is

8 still made in primary monkey kidney cells. There are


9 reasons for that. There's a deep conservatism I think

10 about changing the vaccine production process if you

11 have a vaccine that works, largely because you are

12 dealing with a prophylactic material rather than a


13 therapeutic material. So you don't want to mess about

14 with anything if it's reasonably safe and effective.


OK. So no one wants to change things that they think are working. Some might argue about the whole "reasonably safe and effective" thing, in light of SV40. Nonetheless, let's hear you explain about SV40 *cough, harmful, cough*--let's hear more about that. But before that, let's hear about some other problems first.

15                I'll mention very briefly the defective


16 retrovirus story in chick embryos. I think Jim

17 Robertson will probably mention this in more detail,

18 but I will mention that just as I go by. Finally

19 recently, the FDA released a talk paper on a


20 preparation of urokinase, which is used in treating

21 the heart. This material was grown from primary

22 cultures made from aborted fetuses. I think it was


23 aborted fetuses or miscarriages, or whatever. There

24 were quite a variety of infectious agents were

25 actually found in this. I believe this one has now


12

1 been suspended.



Ah!! Suspended one because, "There were quite a variety of infectious agents were actually found in this." Great. But, what about the infections that aren't found right away, like SV40? What's your point here?


2                The point is that there are still a large

3 number of materials which are made on really quite

4 basic culture systems, if you like, where adventitious

5 agents are a serious consideration, if you like. So


6 it's not all continuous cell lines versus the rest.

7 I mean there are -- most of the vaccines that are made

8 in the world probably come from other primary cultures


9 or eggs or things of that nature.

"Primary cultures"? Oh you mean animals and animal parts where infectious agents can get mixed in? Wait, I skipped that part. Let's look again:



17                Primary cultures as been described

18 previously around here, are really cultures that are

19 made directly from the animal. So they are not one


20 pass. They are directly from the animal, if you like.

21 Here are a number of examples where agents are

22 actually being found or at least located in these kind


23 of cultures.


And you said that, "most of the vaccines that are made in the world probably come from other primary cultures or eggs or things of that nature." Well, I see why that would be a concern, certainly. Animals and eggs have their own viruses and infections and they just get mixed into the vaccines don't they?

Tell us about SV40.

10                I will now talk about SV40.  I'm sure in

11 this audience there are people who know far more about

12 SV40 than I do. But nonetheless, I'll talk about this


13 from what you might call the regulatory adventitious

14 agent point of view, if you like.

15 So it's a very common polyoma virus of old


16 world monkeys, and particularly rhesus macaques. The

17 difficulty with this was that when the rhesus macaque

18 monkeys are sacrificed and a primary monkey kidney

19 culture is made from him or her, as the case may be,


20 a silent infection is set up. So there is on evidence

21 of infection just by looking at the cultures. In

22 fact, these cultures can throw out as much SV40 as


23 they do polio, when you start infecting it with polio.

24 So you wind up with a culture that's just stiff with

25 adventitious agent which you really don't want.


13

1 It's able to transform non simian cells in


2 vitro, and it can be tumorigenic if you have the right

3 kind of animal that you put it into. Between 55 and

4 62, probably at least a third of all the vaccines that

5 were made on these kind of cultures, because they were


6 pooled and the like, were almost certainly

7 contaminated with SV40. It wasn't a trivial

8 contamination. It was really quite a serious


9 contamination.

10 Because it was mainly an activated polio

11 vaccine, there wouldn't have been that much live SV40

12 in it perhaps. But SV40 is more resistant to formalin


13 than polio is. So almost everybody who received the

14 shot of inactivated polio in the 1950s, which would

15 include me, would have received live SV40 in some form


16 or another.

17 So the concern is really summarized here,

18 which is basically that everybody, I mean this is my

19 own take on it, that everybody -- I mean you can argue


20 that it might not have been sort of everybody, but I

21 think it probably was. But almost everybody who

22 received the full course of polio vaccine between 1955


23 and 1965, also got live SV40 stuck into them. That's

24 millions of people basically.




Wow. That sounds awful. An entire generation exposed to Sv40. I wonder if there was some kind of carcinogenic effect with that additional monkey virus. Was there? Surely vaccine safety standards would have ensured that that was studied for years and years.



25 There were epidemiological studies that


14

1 were done at the time which really didn't cause much


2 concern, but they can all be criticized. Some of the

3 studies were really quite short-term, about two or

4 three years or so, looking to see if there were cancer

5 effects basically, as a result of SV40. It may be


6 that two or three years is not enough to actually find

7 such an effect, if it actually exists.


Such adverse conditions may not show up for years and years afterwards? But, vaccines have no long term studies like that...


16                So while the studies were reassuring, the

17 most reassuring thing was that there was no sudden

18 surge of cancers that you can actually trace back to

19 polio vaccine usage in the United States or in Europe


20 where these things were used in a big way. So it

21 really did seem that in the long term, over about 19

22 to 20 years, there was no real cause for alarm.


OK. So maybe a little monkey virus between friends is no big deal. No problem! Wait, what?


23                However, in 1992, Michaili Carboni and

24 colleagues and others, a number of others, including

25 Janet Butelle down in Texas and the like, identified


15

1 SV40 sequences which were present in a variety of


2 relatively rare tumors. So mysathelia, which is the

3 asbestos tumor, osteosarcomas, pendymonas, actually

4 the young chorioid plexus tumors of children, these

5 sequences do appear to be genuine SV40 sequences.


6 Where they come from is really not quite

7 clear. Part of the argument was that you could get

8 similar types of tumors in experimental animals, like


9 hamsters. I think that is probably the only example

10 where a hamster is cited as a good model for a human

11 being perhaps. But who knows? In fact, this might

12 actually be an argument that this has got nothing to


13 do with it.

14 So the question then arises as to where

15 did the SV40 sequences come from. Of course the


16 classic response really would have been it must have

17 come from the polio vaccine because why not?




Say, I have a question--how did SV40 cancer causing monkey virus show up in kids if the contaminated polio was discovered in the early 60's? How is it effecting kids and giving them cancer? You did change the monkeys to the ones without SV40, right? Let's read.


18                Now SV40 was discovered around 1961 or

19 1962 or thereabouts, 1960 perhaps. Directly it was


20 discouraged. There were precautions put in place to

21 exclude it from polio vaccines, because it was known

22 to be a tumor kind of virus, if you like. These were


23 the kind of things that were put in place. They are

24 listed in WHO requirements from about 1962 onwards.

25 They reached their final fully flowered form, if you


16

1 like, by about 1965. A number of countries certainly


2 had put this in place before that.

3 The first thing you can do is to use

4 seronegative animals as the source of cells. So you

5 can use animals that have no evidence of SV40


6 infection as your source. That really is something

7 which is now very firmly in place, which manufacturers

8 now do.


Good. We're listening. Continue.


9                The second thing is, you remember I said

10 that it was the rhesus macaques with the problems.

11 The problem was that the cell cultures didn't show any

12 sign of having defect, when they were actually


13 infected with SV40. What you can do then is you can

14 use species, such as cynomolgus or pattus monkeys,

15 where the primary monkey kidney culture cell, when


16 infected with SV40, will actually wrinkle up and die

17 on you. So at least you know you have got something

18 nasty and you can throw it away.

19 Finally, you can test your control of


20 production cultures for SV40 by the same kind of

21 procedure. That is why using sesetral cells to see if

22 anything comes through.



Gotcha. Go on.



23                Around the period that this was taking

24 place, wild caught monkeys were being used extensively

25 in vaccine production. Up to a half of the cultures


17

1 would have been thrown away because of adventitious


2 agent contamination, mainly foamy virus, but certainly

3 other things as well. I think that just illustrates

4 the kind of lack of control, if you like, over the

5 source materials that was going on, and the extent to


6 which adventitious agents are really a serious problem

7 in finding monkey kidney cultures or primary cultures

8 in general.





Yeah, I again have to agree with you--it all sounds sloppy and impossible to control. But, I'm not a doctor--what do I know?!



9                An alternative way of doing this is to

10 actually use a validated cell bank. Certainly many

11 manufacturers use MRC5, and Mary of course used vira

12 cells, as we heard last night.


13 Nonetheless, a significant, if indeed not

14 a large proportion of the world's supply of polio

15 vaccine is still made on primary monkey kidney cells,


16 which should really fit this kind of criteria for

17 excluding SV40.

18 One of the questions that then arises is

19 were these precautions good enough? What we did at


20 NIBSC, because we happened to have about 150-odd

21 batches of vaccine archived from the years, was to go

22 back and look at them by PCR. PCR of course is the


23 cat's pajamas. It's really the best technique that

24 anybody ever invented in terms of sensitivity. It's

25 probably about as good as infectivity, at least in our


18

1 hands anyway.


2 But nonetheless, we went back and we

3 looked by PCR at 133 preparations of polio vaccine

4 which had been used in the United Kingdom between 1966

5 and about 1997. What we had done was looked at all


6 batches of vaccine which had been used since 1980, and

7 all of those were free of SV40 sequences. So that

8 gives you some reassurance that these precautions were


9 actually appropriate.

10 In fact, the only preparation which had

11 any SV40 sequence in it at all was a seed virus which

12 was used by a manufacturer for making vaccine from.


13 The amount that was in there was around two logs worth

14 of genome as opposed to seven logs of genomes in a

15 really full-fledged infected preparation. So there


16 wasn't that much in there. The manufacturer had also

17 treated this stuff with toluidine blue, which is

18 supposed to kill of SV40. This was done on the advice

19 of Albert Sabin back in 1960-something or other.


20 But nonetheless, it does seem to me that

21 it's rather a foolish thing to have a seed that's got

22 SV40 sequences in it at all. I think the WHO


23 requirements have now been changed so the seed has to

24 be checked to see if it does have SV40 sequences in

25 it or not.



You think it's foolish for the seed virus to have SV40 in it--even if it's a little, teeny, tiny bit?

Tell us more about the kids and their cancer. If there was no more SV40, how did they get it?

1                This particular seed was not infectious


2 SV40. We did some quite serious studies on it, like

3 transvecting the DNA into cells to see if it would

4 work, infecting monkeys with it to see if we could

5 actually get seroconversion. There was no


6 seroconversion. So there was no infectious virus

7 there that we could actually detect. But nonetheless,

8 the seed did have material in it.


9 If on the other hand you look at materials

10 from around the 1960s or from other parts of the world

11 a little bit later than that, you can pick up SV40

12 sequences quite easily. So the method would have


13 picked it up had it been there.

14 So our conclusion from that was then that

15 really as soon as these kind of precautions were put


16 in place, no SV40 would have been present in all polio

17 vaccines used, at least in the United Kingdom and I

18 would guess in the United States as well, because it's

19 after the same kind of precautions were put in place.


20 So the precautions were adequate. Which means that

21 SV40 exposure of the population through polio vaccines

22 would have stopped around 1962.


23 So what you then have is the problem of

24 the chorioid plexus and appendinoma tumors, which

25 occur in children who are around two years of age or


20

1 maybe less. You have to say well how did they get a


2 hold of the SV40 sequences? One possibility, which is

3 mooted with some enthusiasm is that maybe you are

4 getting passage of SV40 from parents who did receive

5 the SV40 contaminated polio vaccine to their children.





What?! Are you telling me that it's possible that parents who were infected with SV40 in the polio vaccine that they got before the early 60's could be passing it down to their kids?


6    So how this stuff gets around is quite important.

7 One of the things that we have been

8 involved in is doing serological surveys of


9 populations to see who has got SV40 antibodies and who

10 hasn't. It is about a five percent seropositivity by

11 the assay that we're using at least. It seems to peak

12 at around age 10 or thereabouts, and doesn't arise


13 after that.

14 So what you could argue then is that you

15 are seeing vertical transmission from parents down to


16 their children.


Vertical transmission? Where a mother passes on an infection while the baby is in utero? It's continuing to another generation? Cancer causing monkey viruses are being passed from generation to generation?

What other known or unknown infections, viruses or other contaminants will be passed from generation to generation?



2                The point about this long story which I

3 have just been telling you about SV40 is that SV40 was

4 a problem between 1955 and 1962, and it's now 1999,

5 and we still don't really know what was going on.




Yeah, that seems patently obvious...


So


6 if you actually make a mistake, it's really quite

7 serious. It may keep you occupied for the rest of

8 your working life.


9 One last quick thing or two last slides

10 here. One is about reverse transcriptase of vaccines.

11 Dr. Schuepbach will be talking later and Jim Robertson

12 will be talking in a moment about detection of reverse


13 transcriptase in chicken cell grown vaccines, such as

14 flu or yellow fever or measles, mumps, rubella.

15 This appears to be due to the presence of


16 defective non-infectious particles. There are

17 sequences from EAV and ALV both in these things, a

18 ratio of about nine to one as I understand it. It

19 does seem to me that you are not really quite sure


20 what the AV sequence is in there and what ALV sequence

21 is in there. It's probably going to vary from chicken

22 to chicken in so far as these chickens have not been


23 bred. In other words, every egg is a new experiment.

24 You are really not quite sure what you are dealing

25 with in that. I think that is quite an unfortunate


23

1 position to be in. I'm not sure how you control it.



I'm not sure what "reverse transcriptase" is. It doesn't sound good and the doctor explained it's involved with chicken cell grown vaccines: flu, yellow fever, measels, mumps and rubella. As he said, "In other words, every egg is a new experiment. You are really not quite sure what you are dealing with in that. I think that is quite an unfortunate position to be in. I'm not sure how you control it."

It doesn't sound to me like any of these vaccines grown and harvested on living animal tissues or cadaveric tissues is controlled or understood very well. Of course I'm not a doctor, but I just read the words of one--he sounds concerned.

2                Finally, this is my last slide, and this

3 has to do with characterized cells. The issues that

4 I have been dealing with really have been to do with

5 primary cells and primary cell problems where the


6 virus comes in direct from the animal origin. I think

7 there is no doubt in my mind that that's the main

8 source of concern in terms of human health.


9 Nonetheless, there are clearly problems

10 which also arise with characterized cells and the

11 continuous cell lines, in particular. We have some

12 down here.


13 Now the regulatory authorities in the room

14 will be well aware of a large number of other examples

15 of this type which don't actually get published. I


16 think that's not so good. I think this stuff really

17 should be out there in the public literature.


Wow, "...a large number of other examples of this type which don't actually get published." A large number? How big a problem is this? Why don't they get published...

I'm glad to help out. I'm spreading the word here. You can count on me.


That was all the presentation of Dr. Minor. If you look at the index,

 I N D E X


SPEAKER PAGE

Philip Minor, Ph.D. 4

James Robertson, Ph.D. 32

Jorg Schuepbach, M.D. 51


Jens Mayer, Ph.D. 66

Thomas Broker, Ph.D. 78

Neil Cashman, M.D. 102


Panel Discussion 129
Dr. Onions, Chair

John Sedivy, Ph.D. 176

Frits Fallaux, Ph.D. 199


Panel Discussion 212
Dr. Coffin, Chair


you see that it continues on for some time. I didn't read the rest. I'm going to. You might take a look at it too.

This is all public record. Not surprisingly, it is not the kind of thing that's included in the flu vaccine public service announcements I've seen recently. They're not talking about flu vaccines being produced from eggs that may or may not have viruses that may or may not be harmful to humans when injected into their blood streams that may or may not be transmitted vertically to the next generation. It just doesn't come up.

Maybe it should.

Sunday, March 15, 2009

Tendrils, Weeds, Trees and Fences

We visited a working farm in some woods run by the Schaumburg Park District yesterday. The kids played Pooh Sticks at the bridge overlooking some fast moving water. While they mucked about, I took pictures.

Tendrils






Tendrils--Three Different Ways




Weeds







Trees






Fences










Goodbye Farm. See you next time...

Saturday, March 14, 2009

American Pi

Click on Pi and hear a little bit about it...

Do Whales Have Uvulas?

My son asked me this after watching Finding Nemo. He thought it improbable because as he suggested, what would be large enough to choke a whale and therefore necessitate having a uvula to help cause a protective gag reflex? Excellent question, Son.

We googled it: "Do whales have a uvula?"--no, whales do not have uvulas (uvulae?). In fact very few animals do--humans and apes being some who do.

Then we looked up uvula and found that there is no consensus as to the purpose of the uvula. It may not be to elicit a gag reflex. The uvula secretes saliva, so perhaps it helps coat the throat; it is responsible for the formation of some sounds in some languages, so perhaps evolved as our languages did; it closes off the nasopharynx so that you don't constantly blow milk out of your nose. No one knows for sure what it's for.

What is it for??? I really want to know now.

New poll up at the left. Please vote and make your voice heard about this extremely important issue. Thank you.
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