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Old 27th May 2010, 05:23 PM   #1
Rolfe
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Wakefield and the colostrum nostrum

I’m thinking this is an aspect of the Wakefield situation that has been underexplored. Do the parents who idolise Wakefield know what he was really planning to inject into their children - and may actually be injecting?

Colostrum is the first milk produced by most mammalian species and contains the antibodies that provide passive maternal immunity to the newborn. The human placenta is very unusual in being permeable to macromolecules such as antibodies, with the result that the human infant is born with its passive immunity safely on board. Antibodies in human milk fulfil a fairly minor role and breast-feeding is not essential to the acquisition of maternal antibodies. (This has its downside in that maternal anti-foetal antibodies will affect the foetus in utero while in most animals the danger does not present until after birth.)

In non-human mammals the placenta is impermeable to antibody molecules and the neonate is born with no passive immunity. This has to be acquired within the first hours of life by consuming the mother’s colostrum, specially-secreted milk that is extremely high in immunoglobulins. To this end, the gut mucosa of the neonate is permeable to these molecules, which are absorbed intact. This permeability begins to decline quite sharply after about eight hours, and has vanished entirely by two days of age - by which time the mother is secreting ordinary milk.

Wakefield’s notorious patent application for a “measles vaccine”, which was also in some miraculous way a treatment for MMR-induced autism, was for a product derived from goat colostrum. Brian Deer has made available images of the entire text of two versions of the relevant patent applications.

http://briandeer.com/wakefield/vaccine-patent.htm
http://briandeer.com/mmr/1998-vaccine-patent.pdf

The product is described by Wakefield as “transfer factor”, and in his usual confident manner he has pontificated about the “extensive scientific literature, demonstrating safety and efficacy of TF in different diseases” and the number of experts he consulted on this subject. However, this literature seems conspicuous by its absence and this is not a product with a scientific pedigree. The Wikipedia article on transfer factor doesn’t mention colostrum, merely describing a component of cell mediated immunity, and states in relation to therapeutic uses, “the United States Food and Drug Administration regulates transfer factors as a dietary supplement and has issued a warning notice to a website selling transfer factors that they have not been proven to be effective or safe in the treatment of any condition, nor have there been any biological licenses or New Drug Applications produced for the substance.”

Deer’s treatment of this aspect acknowledges that the approach is quackery, but otherwise majors on the evidence contained in the patent application literature of Wakefield’s plans (even from before the controversial paper was published) to carry out a standardised testing protocol on the 12 children described, and to profit from the discrediting of the MMR by offering his product not only as a treatment for “vaccine-induced autism” but as a measles vaccine in its own right. However, closer examination of the nature of the product and its production is very instructive, and might be rather disturbing for any parent already concerned about what is being injected into their children’s bodies.

I am not an immunologist, but the basic biology of transfer factor as a component of CMI appears to be uncontentious enough. Nevertheless, virtually all the returns for a google search on “transfer factor” are quack sites. Exactly where colostrum comes into it, I’m not certain. However, this seems to be Wakefield’s (and woo in general’s) preferred method for manufacturing the stuff.

I am a vet, and I have to say that my knowledge of colostrum is confined to its immunoglobulin content. Standard veterinary teaching does not acknowledge that colostrum intake provides any active immunity, whether humoral or CMI. I have been unable to find any mainstream information on this subject online apart from an isolated 1977 paper describing T-lymphocytes in human colostrum. Any link combining transfer factor and colostrum appears to be woo.

Wakefield’s patent application’s description of the production of his transfer factor product makes startling reading.

First he describes the injecting of mice with “live or killed virus or an antigen derived from such a measles virus”. The mice are presumably killed and their lymphocytes harvested. A filtrate of these lymphocytes is then added to “an immunologically virgin human lymphoblastoid cell line”. The source of this cell line is not specified, however this seems to resonate with his guru Hugh Fudenberg’s statement to Deer that he was curing autistic children with a preparation derived from his own bone marrow.

Then, “one cell is serially expanded 10-fold with killed measles virus and interleukin-2, to a billion cells. Measles virus-specific TF preparations are made from this expanded cell population.” Following some description of a purification process, the recipe then introduces the goats.

“The ability of TF to stimulate further TF production, and the cross-species reactivity of TF are subsequently exploited in order to produce large quantities of concentrated TF at low cost. This is achieved by injecting the TF preparation into pregnant goats 3 times prior to delivery. Colostrums are collected for the first 3 days post-delivery and TF preparations were made from these by micropore filtration.”

So, we have measles virus and mice. Then we have the mice lymphocytes and a human cell line. Then more measles virus, for some reason. Then goats, and the final product coming from the colostrum of the nanny-goat. The route of administration described in the patent application is oral, but intramuscular injection is also referred to. There is description of reactions of human patients to this preparation, but absolutely no hint of any of the normal drug testing procedures that would have to be undertaken for any product to be licensed as a safe and effective therapeutic agent. Really, read the original text. It’s a classic example of junk science.

Just how happy should concerned parents be to have something like this injected into their children? Mice? Human bone marrow? Goat’s milk? Measles virus involved in the production process? Absolutely no background literature supporting the process, and no evidence of any safety or efficacy testing?

Just this year, something else has emerged that should put a whole new perspective on the use of animal colostrum as a therapeutic agent. A new, fatal syndrome, bovine neonatal pancytopenia, has recently been identified in young calves. The cause of this is as yet unknown, but suspicions currently centre on toxic properties of the colostrum of cows which have themselves been vaccinated. The syndrome has not been recognised in goats, nevertheless the wisdom of consuming colostrum or a colostrum-derived product from any animal has to be questioned - especially an animal that has been subjected to an unorthodox vaccination procedure.

A further area of concern is the welfare of the goats used in the production. In order to harvest colostrum, the newborn kids must be prevented from sucking. This will necessitate someone observing the animals constantly so that the neonates can be whisked away before they have got to their feet. (If anyone has devised a mechanical system for ensuring that a newborn kid can’t get to its mother’s udder even if parturition is unobserved, I really, really, don’t want to hear about it.) Kids would have to be fed artificial colostrum for the three days described in the patent, before they could be allowed to nurse. Maybe. Or would there simply be so many unwanted kids, these would be shot at birth?

Where is all this being done? How many goats are involved? What are the welfare standards? Did any of this animal experimentation (for that is what it is) have a proper Home Office licence, if it was done in Britain? Where might one find answers to these questions?

It would be perfectly possible to do this with acceptable welfare standards as a small cottage industry, with just a few animals. However, Wakefield clearly envisaged mass production of a product intended to supersede the MMR he was trying to discredit. How many litres of colostrum a day would the new industry require? Just how was this to be achieved? How many barns full of battery goats would be needed to supply this market? How many unwanted kids would be shot?

I wonder how many of Wakefield’s disciples have any idea about the production of this stuff he wants to give to their children. Do you think we should tell them?

Rolfe.
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Old 27th May 2010, 05:47 PM   #2
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It is fascinating, no?
So many questions, so few answers or attempts at explanation.

Here is what the GMC had to say about the affair:
Quote:
On 2 February 1998 you [Wakefield] submitted an application to the Ethics Committee seeking approval for a trial which involved studying the effect of "transfer factor" in children with autistic enteropathy, naming you as the Principal Scientific investigator and Professor Walker Smith as a Principal Clinical investigator. The application was referenced as Project 22-98. You admitted that around the same time, you were involved in a proposal to set up a company called Immunospecifics Biotechnologies Ltd to specialise in the production, formulation and sale of Transfer Factor. You have also admitted that the proposed CEO of the company was the father of Child 10 and you wrote to this effect to the finance officer of the Royal Free Hospital School of Medicine on 26 February 1998. A proposal drafted by the father of Child 10 was submitted to the Royal Free in March 1998 seeking funding for a clinical trial of Transfer Factor in the treatment of IBD and pervasive developmental disorder and for research into using Transfer Factor as an alternative measles-specific vaccine. You were to be the Research Director and the father of Child1 0 was to be the Managing Director. It was proposed that the equity would be shared between a number of parties including the Managing Director and yourself.

Between July and November 1998 you and Professor Walker-Smith undertook research into the safety of Transfer Factor and Project 22-98 was approved by the Ethics Committee on 16 December 1998.

The Panel found that you inappropriately caused Child 10 to be administered Transfer Factor for experimental reasons without causing to be recorded in his medical notes the fact of, or dose of, the prescription and without causing the child's GP to be informed that it had been prescribed. The Panel is aware that you and Professor Walker-Smith had written to the Dispensary Manager to inform her that "we are prepared to take full responsibility for the outcome of this treatment." You did not have the requisite paediatric qualifications and your actions were contrary to the clinical interests of Child 10 and an abuse of your position of trust as a medical practitioner.
Is there any more information than this?
Does Brian Deer have the dirt on this? He was at all the GMC hearings.

Then there is your question about the production line.
How Wakers could dare make an untested experimental vaccine filled with chemical toxins and evil animal contaminants to inject into helpless, innocent babies is quite beyond me. The antivaxers will quite rightly be calling for his head. Offit and rotavirus vaccine have nothing on this one, believe me.
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Old 27th May 2010, 05:54 PM   #3
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Hmmmm. I'd just skimmed over that part. There is some mention of safety testing, but no mention of methodologies, or any results or publications.

The legal implications of such a preparation for human administration are one thing. The licensing reqirements for this animal experimentation are another. I'd dearly love to know what was going on here.

You can collect animal colostrum to your heart's content and sell it if you like, so long as hygiene standards are met. So far as I know. But injecting a preparation of mouse lymphocyte extract, measles virus and human lymphoblasts into pregnant goats definitely needs Home Office approval as far as I know.

I wonder if anyone ever investigated that aspect? I don't think Brian Deer thought about this as such. His point about the patent applications is that it shows Wakefield had the experiments on the children planned out in advance (hence the invasive procedures weren't done purely on clinical indications), and that he planned to market the goat colostrum as a substitute measles vaccine, not just a treatment.

This is all so bizarre, I think the half of it has not been plumbed. Note that Wakefield was way down the rabbit hole on this one as early as 1996, before the Lancet paper was published.

Rolfe.
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Old 27th May 2010, 06:53 PM   #4
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Rolfe, hat tip to you and I can say that this aspect has not been examined such as you have done. I think it is well worth pursuing with Brian Deer as he has the resources to obtain information to (hopefully) fill in the gaps. Oh, and great thread title.

Quote:
The antivaxers will quite rightly be calling for his head. Offit and rotavirus vaccine have nothing on this one, believe me.
DeeTee, they know about this, have known about this and don't care one jot. The man can do no wrong in their eyes and he was developing an 'autism treatment' after all.

Este
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Old 27th May 2010, 11:52 PM   #5
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The concept of the patent makes no sense to me. The procedure takes T cells from mice and then the culture supernatant from that is used to expand human T cells along with measles virus and a factor harvested from that culture to then inject into goats which will make an antibody to that factor; that antibody should be in the colostrum. I think that would make anti-cytokine antibodies in the goat. I think most scientists would have identified what the transfer factor was first.

Rolfe, I don't think it would be unusual for someone at the Royal Free to hold a Home Office Licence to do the animal work (mice and goats).
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Old 28th May 2010, 12:47 AM   #6
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Thanks Rolfe - even as a layman, I found that absolutely fascinating.

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Old 28th May 2010, 01:25 AM   #7
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Originally Posted by Estellea View Post
DeeTee, they know about this, have known about this and don't care one jot. The man can do no wrong in their eyes and he was developing an 'autism treatment' after all.
Este
Yes I know.
I was trying to be facetious when I said they would now be calling for his head on a platter. As you say they will turn a blind eye to every excess this man has committed.
He could skewer tiny babies to infuse a mix of cobra venom, organophosphates, botulin toxin and plutonium; he could leave them all permanently damaged, but because he has done it in the name of autism the parents would still hail him as their hero and saviour.
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Old 28th May 2010, 01:27 AM   #8
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If I have time I will email Brian Deer to ask if he knows more details about this, or you could Rolfe. I think this needs pursuing really but am short of time to do it all...
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Old 28th May 2010, 01:34 AM   #9
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Originally Posted by Estellea View Post
DeeTee, they know about this, have known about this and don't care one jot. The man can do no wrong in their eyes and he was developing an 'autism treatment' after all.

I'm not sure how far that goes. These are people who pontificate like mad about the wicked ingredients they think are in ordinary vaccines. I'm not clear that they've even thought about the production of or ingredients in Wakefield's product.

If would be simplicity itself to monster these production methods in just the same way, and to imply that the product countained mouse lymphocytes and human bone marrow and measles virus (even though it doesn't) in just the same way the antivaxers claim normal vaccines have aborted foetuses and suchlike in them (even though they don't).

Rolfe.
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Old 28th May 2010, 02:00 AM   #10
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Originally Posted by Rolfe View Post
I'm not sure how far that goes. These are people who pontificate like mad about the wicked ingredients they think are in ordinary vaccines. I'm not clear that they've even thought about the production of or ingredients in Wakefield's product.

If would be simplicity itself to monster these production methods in just the same way, and to imply that the product countained mouse lymphocytes and human bone marrow and measles virus (even though it doesn't) in just the same way the antivaxers claim normal vaccines have aborted foetuses and suchlike in them (even though they don't).

Rolfe.
What would be funny to do would be a fake website against the production of this new "product". Go round the silly woo sites, mother.com etc giving awareness then doing a "reveal" a few weeks later.

Sadly I could make a web site for toffee!
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Old 28th May 2010, 02:46 AM   #11
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Do it! I'd happily troll said forums on your behalf
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Old 28th May 2010, 02:50 AM   #12
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Originally Posted by bit_pattern View Post
Do it! I'd happily troll said forums on your behalf
Oops, typo there - meant I couldn't make a web site, I can barely turn this thing on!
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Old 28th May 2010, 05:05 AM   #13
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Originally Posted by Capsid View Post
The concept of the patent makes no sense to me. The procedure takes T cells from mice and then the culture supernatant from that is used to expand human T cells along with measles virus and a factor harvested from that culture to then inject into goats which will make an antibody to that factor; that antibody should be in the colostrum. I think that would make anti-cytokine antibodies in the goat. I think most scientists would have identified what the transfer factor was first.

Thanks. I was hoping you'd show up to comment on that. I've been trying to figure out more about "transfer factor", and I'm developing a very strong suspicion it doesn't actually exist.

Wakefield refers to the work of a guy called Lawrence who seems to have described this substance in the late 1940s, and I've found a few references trickling on through to a book chapter dated 1970, but really only relating to Lawrence. I can't see any indication that Lawrence's interpretation of his findings (something about a dialysed leucocyte extract being able to transfer a specific delayed hypersensitivity reaction to a previously negative individual) was ever accepted by mainstream immunology, never mind verified.

The wiki article on transfer factor is short and seems more concerned with countering woo than actualy describing the molecule. The talk page is also instructive, and contains no real evidence that they're talking about a currently-recognised component of the immune system. There is a diagram purporting to show the role of "transfer factors" in CMI, but I've have a scout round mainstream articles on CMI (this is a good one I think), and none of them contains the word "transfer", which is instructive. I haven't read these in detail, but I can see nothing about any antigen-specific factor which can transfer CMI from one individual to another.

I'm coming to the conclusion that this substance may be something proposed by Lawrence 60 years ago to explain some results he was getting, with was in fact a misinterpretation of his findings, and which simply doesn't exist. It could be some sort of cytokine, but I think it's more likely to be fantasy. The references to it dating from 1990 on all seem to be woo-related. I would welcome any further information anyone has about it.

Wakefield himself seems fairly hazy about what the molecule actually is.

Quote:
Generally, human, mouse and bovine TF are small molecules of approximately 3500 to 6000 daltons. TF is heat labile but cold stable; biological activity remains unimpaired after several years of storage at -20oC to -70oC. Most studies of the effects of enzymes on the antigen-specific biological activity of TF indicate that it is composed of RNA bases attached to small peptides of at least 8 amino acids. [....]

My first comment is CITATION??!! I don't think he knows what it is he's producing, handling or measuring. He doesn't even seem sure it's antigen-specific. ("If as seems likely each TF is antigen specific, then individual TFs may differ structurally....") I have not been able to find any literature supporting these claims, though of course I could be missing it at the moment.

So what is he actually producing?

He starts with the lymphocytes of mice immunised with measles antigen. No description of how he harvests the lymphocytes or how pure the preparation is. The only manipulation done on this is fragmentation by freeze/thawing, and micropore filtration. This presumably excludes macromolecules but the size of the molecules included isn't specifically stated.

This crude extract is then added to the "immunologically virgin human lymphoblastoid cell line". What it does to that is unclear, but he only takes one cell from that, which is "serially expanded 10-fold with killed measles virus and interleukin-2, to a billion cells", then "measles virus-specific TF preparations are made from this expanded cell population."

So he's got rid of the mouse cells but now has human lymphoblasts, apparently with added measles virus and interleukin-2. He seems to be lysing these cells and then simply using dialysis and other procedures to separate off everything with a molecular weight between 1,800 and 12,000 daltons. This would exclude viruses and immunoglobulins, but would still include a hell of a lot of stuff. Maybe Capsid can suggest what.

This is what he's injecting into the pregnant goats. He seems to be asserting that the goat's colostrum secretion will simply "amplify" the injected transfer factor, but this is nonsense, and entirely baseless. Colostrum doesn't work like that and I have no idea where anyone got the idea it does. Actually, he's vaccinating the goats with his crude 1,800 to 12,000 dalton preparation of human lymphoblasts, measles virus and interleukin-2. The goats would be expected, if anything, to mount an immune response against these molecules. The immunoglobulins resulting from this would them appear in the colostrum along with the immunoglobulins against everything else the goats happen to be immune to, to be passed on to the kid.

However, he then treats the colostrum by microfiltration to exclude everything above 12,500 daltons. This would suggest there are no immunoglobulins in the final preparation. What the hell is there? God alone knows, frankly. I would doubt it would be significantly different from a similar fraction of any random goat colostrum, from an animal that didn't have the immunisation with the lymphoblast preparation.

It's complete, utter and absolute junk science, and he provides no support at all for any of the massive assumptions he's making all the way through.

And as I said, we very much suspect there's something highly toxic to bone marrow stem cells appearing in the colostrum of some cows at present, and this seems to be related to prior vaccination of the cows. While this may be a toxic immunoglobulin, we don't know what molecular weight the toxic component is. If you asked me right now to consume colostrum from any ruminant that had been vaccinated against human bone marrow stem cells (lymphoblasts), frankly I'd run screaming.

Originally Posted by Capsid View Post
Rolfe, I don't think it would be unusual for someone at the Royal Free to hold a Home Office Licence to do the animal work (mice and goats).

Mice, certainly. I could well imagine that part being done at the Royal Free, but I'd still like to know who, and how the project was presented to the animal experimentation ethics committees. Goats, I'm less sure about. That's a whole other ball game from laboratory mice, requiring a lot more in the way of specialised facilities, never mind ethical justification. The procedure is obviously woo. I'm struggling to believe that somewhere in the Royal Free they were keeping pregnant goats, delivering the kids, disposing of the kids, and collecting the colostrum for three days, without someone wondering what the hell was happening. The Named Veterinary Surgeon for a start.

Possibly this did happen, and the natural instinct of animal house personnel to keep their mouths shut about what goes on behind closed doors kept it all quiet. I'd dearly love to know exactly how it was done though.

Rolfe.
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Old 28th May 2010, 05:47 AM   #14
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Originally Posted by Deetee View Post
If I have time I will email Brian Deer to ask if he knows more details about this, or you could Rolfe. I think this needs pursuing really but am short of time to do it all...

I emailed Ben Goldacre last night to point him to this thread. (I had thought about starting it on the Bad Science forum, but then I thought it might get more serious comment here.)

You have a point about Brian Deer. He may still want to pursue the Wakefield story, especially if the scumbag is appealling the GMC ruling. What's actually in "transfer factor" is actually a fairly straightforward quackbusting exercise, but how it is/was produced and whether any laws were broken in so doing is something probably only Deer would be in a position to find out.

It appears that Hugh Fudenberg, Wakefield's associate, was using the straight human lymphoblast preparation to treat autistic children (a preparation made from his own bone marrow, rolled out three molecules thick!). Sounds icky, to put it mildly. I'm not at all sure I'd be happy to put pills made from Fudenberg's bone marrow in my mouth, never mind inject the stuff.

Wakefield's preparation, though, seems to be something completely different. He represents the procedure of innoculating the goats with the lymphoblast preparation and then harvesting the colostrum as simple amplification. However, it's no such thing. He's gone from utilising a microfiltrate of human lymphoblasts to a microfiltrate of goat colostrum, and it's likely the only thing the two preparations have in common is that the molecules are less than 12,500 daltons.

For all I've expressed alarm about the colostrum, I think I'd rather consume that than the lymphoblasts!

Maybe someone should email Brian Deer to suggest he looks at this thread? I know about goats and colostrum, somewhat, but I'm no immunologist. I suspect the enormity of what Wakefield was up to is such that no immunologist has really got down to looking at the details of what he was promoting as a "measles vaccine" or an autism cure.

Someone really needs to show these patent applications, and the associated literature on "transfer factor", to an interested immunologist.

Rolfe.
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Old 28th May 2010, 06:05 AM   #15
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Originally Posted by bit_pattern View Post
Do it! I'd happily troll said forums on your behalf

Trolling a few antivax forums was something I had in mind, actually. However, there are two approaches.

If one simply takes the line that the preparation is just an ultrafiltrate of goat colostrum, which is likely to contain nothing of any immunological benefit and nothing of what was actually injected into the goats (which is likely to be true), it's a bit like debating homoeopaths. Your medicine has nothing in it! Oh yes it has, look at the great benefits I see from it! Goat milk as such is likely to be viewed as fairly innocuous, and about all you could really do would be some scaremongering along the lines I was indicating regarding the neonatal pancytopenia and bone marrow toxicity seen in cow colostrum.

On the other hand one could monster the preparation by going on about the things it's made from - tissues from dead mice, and measles virus, and human bone marrow. Of course there's none of that in the goat milk, but then there's no aborted human foetus or chick embryo or whatever in normal vaccines either, even though they may be made using cells ultimately derived from such sources.

I'm not sure if Wakefield is actually treating children with this stuff in the USA but I strongly suspect he is. However, even on the basis of "this is what this man wanted to inject into your children", it's something I doubt the antivaxers have considered.

Rolfe.
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Old 28th May 2010, 06:26 AM   #16
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Originally Posted by Deetee View Post
Yes I know.
I was trying to be facetious when I said they would now be calling for his head on a platter. As you say they will turn a blind eye to every excess this man has committed.
He could skewer tiny babies to infuse a mix of cobra venom, organophosphates, botulin toxin and plutonium; he could leave them all permanently damaged, but because he has done it in the name of autism the parents would still hail him as their hero and saviour.
My apologies, I missed the sarcasm.

Originally Posted by Rolfe View Post
I'm not sure how far that goes. These are people who pontificate like mad about the wicked ingredients they think are in ordinary vaccines. I'm not clear that they've even thought about the production of or ingredients in Wakefield's product.

If would be simplicity itself to monster these production methods in just the same way, and to imply that the product countained mouse lymphocytes and human bone marrow and measles virus (even though it doesn't) in just the same way the antivaxers claim normal vaccines have aborted foetuses and suchlike in them (even though they don't).

Rolfe.
Rolfe, here in the States, there are 'practitioners' that have awarded themselves expertise in treating autism with 'biomedical' means. They are known as Defeat Autism Now! (DAN!) doctors. They are a not-so-quaint export to the UK and possibly AU/NZ. If you aren't familiar with them, it is mind-boggling what they will 'treat' autism with, what parents will subject their children to and what medical boards allow them to get away with.

For example, there are a couple of quacks you may of heard of, the Geiers. They are a father-son snake-oil merchant pair that are 'treating' autism with Lupron, amongst many things, it is a chemical castration drug. Chelation and HBOT are widely used. One chelation drug has been developed for treating industrial mining sludge but the inventor is marketing it as a supplement for autism and parents are using it on their children!

Good move to contact Ben Goldacre although I would hazard a guess that Brian Deer would be interested in this but only if it is something that Wakers may still be pursuing.

Este
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Old 28th May 2010, 06:40 AM   #17
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Rolfe, have you seen any of these?
http://www.ncbi.nlm.nih.gov/pubmed/11098887
http://www.ncbi.nlm.nih.gov/pubmed/8993773
http://www.ncbi.nlm.nih.gov/pubmed/6100889

I have 2 of the 3 (on order for one) but haven't read them thoroughly yet.

Este
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Old 28th May 2010, 07:18 AM   #18
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Rolfe, the process is not antigen specific despite it appearing so. It's just bizarre. I don't know where to start, it doesn't follow our current understanding of immunology. The papers Estellea quotes appear to be talking about transfer factors but they are not mainstream science now. I think they are called cytokines now and they are not made by expanding cells and injecting goats with filtrates.

It is possible that the goats were held at a farm for the specific use of immunisations. Although I do know of some that were held on the top floor of a London hospital too. The wording on the licence may be sufficiently vague to allow for immunisations and collection of colostrum. A home office licence was less ethically rigorous in the 1980s.
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Old 28th May 2010, 08:15 AM   #19
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I have to say, this is an interesting take on the issue. We (the anti-Wakefield, vaccine science advocates, among whom I am only a cheerleader) have focused so much on the failings of his "autistic intercolitis" claims and the research misconduct, that other aspects of his "science" have been ignored.

However, I do not agree with your comments about the yuckiness of the components of his supposed vaccine. I realize that it exposes the anti-vaxxers, with their nonsense about aborted fetal tissue and whatnot, but there is no legitimate basis for those objections, and none for this, either. Let's stick with the real issues, of how this supposed vaccine is inconsistent with facts of immunology, and other real scientific failings, as opposed to emotional appeals like "he's using his own bone marrow."
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Old 28th May 2010, 08:38 AM   #20
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Originally Posted by Capsid View Post
Rolfe, the process is not antigen specific despite it appearing so. It's just bizarre. I don't know where to start, it doesn't follow our current understanding of immunology. The papers Estellea quotes appear to be talking about transfer factors but they are not mainstream science now. I think they are called cytokines now and they are not made by expanding cells and injecting goats with filtrates.

It is possible that the goats were held at a farm for the specific use of immunisations. Although I do know of some that were held on the top floor of a London hospital too. The wording on the licence may be sufficiently vague to allow for immunisations and collection of colostrum. A home office licence was less ethically rigorous in the 1980s.

The Home Office licences changed in 1986. I remember, because I held one before then, and gave it up when the more rigorous standards came in because I wasn't doing any active research then anyway. It seems to me that the Wakefield work must have been done after the 1986 Act came into force.

I know there are hospital basements where weird things happen. I'd love to know exactly how this one worked though, and especially what happened to the kids. (The caprine kids I mean.)

Wakefield never refers to "cytokines" anywhere. The term "transfer factor" seems specifically to relate to some sort of (probably cytokine-like) agent which can transfer some aspects of specific immunity from one individual to another. I don't believe there is such an agent.

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Old 28th May 2010, 08:41 AM   #21
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Originally Posted by Estellea View Post
Rolfe, have you seen any of these?
http://www.ncbi.nlm.nih.gov/pubmed/11098887
http://www.ncbi.nlm.nih.gov/pubmed/8993773
http://www.ncbi.nlm.nih.gov/pubmed/6100889

I have 2 of the 3 (on order for one) but haven't read them thoroughly yet.

Este

Woo vanity publishing, by the look of these journals. The author of the second link is Fudenberg, Wakefield's collaborator, the person who was using his own bone marrow to treat autistic children.

This is all I could find relating to transfer factor. Quack promotions. There's no actual immunology relating to the term at all.

Rolfe.
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Old 28th May 2010, 09:23 AM   #22
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Originally Posted by Rolfe View Post
Woo vanity publishing, by the look of these journals. The author of the second link is Fudenberg, Wakefield's collaborator, the person who was using his own bone marrow to treat autistic children.

This is all I could find relating to transfer factor. Quack promotions. There's no actual immunology relating to the term at all.

Rolfe.
Right, the term transfer factor is not a term I recognise either (being an immunologist).
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Old 28th May 2010, 09:27 AM   #23
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It's fairly mindboggling that Wakefield seems to indicate in the patent application that he isn't certain these nebulous "transfer factors" are antigen-specific, and yet it's the assumption of that very specificity that underpins the entire house of cards.

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Old 28th May 2010, 09:42 AM   #24
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Originally Posted by Rolfe View Post
Trolling a few antivax forums was something I had in mind, actually. However, there are two approaches.

If one simply takes the line that the preparation is just an ultrafiltrate of goat colostrum, which is likely to contain nothing of any immunological benefit and nothing of what was actually injected into the goats (which is likely to be true), it's a bit like debating homoeopaths. Your medicine has nothing in it! Oh yes it has, look at the great benefits I see from it! Goat milk as such is likely to be viewed as fairly innocuous, and about all you could really do would be some scaremongering along the lines I was indicating regarding the neonatal pancytopenia and bone marrow toxicity seen in cow colostrum.

On the other hand one could monster the preparation by going on about the things it's made from - tissues from dead mice, and measles virus, and human bone marrow. Of course there's none of that in the goat milk, but then there's no aborted human foetus or chick embryo or whatever in normal vaccines either, even though they may be made using cells ultimately derived from such sources.

I'm not sure if Wakefield is actually treating children with this stuff in the USA but I strongly suspect he is. However, even on the basis of "this is what this man wanted to inject into your children", it's something I doubt the antivaxers have considered.

Rolfe.
Maybe you could take quotes from the patent application and put it on some autism webs without attributing it to Wakefield till after the explosion of indignation that's bound to occur.

Last edited by tsig; 28th May 2010 at 09:44 AM.
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Old 28th May 2010, 09:45 AM   #25
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Originally Posted by Capsid View Post
Rolfe, I don't think it would be unusual for someone at the Royal Free to hold a Home Office Licence to do the animal work (mice and goats).

I was forgetting that the Royal Free actually knew at least some of what Wakefield was up to, and apparently because it smelled money, was apparently happy to go along with this. I don't imagine any of the people who supported him at that point had any idea the science behind what he was claiming was so wacky.

http://briandeer.com/wakefield/falk-pharma.htm

It also appears that Wakefield was putting the Royal Free on the patent applications as well as his own name, though the Dean seems later to have said he didn't know about this. They gave up any claim to the patents when they realised how quacky it all was, at about the time Wakefield left. I'm getting the impression that at the same time the admin and finance people were loving him for his patents and potential money-making ideas, and the clinical people were expressing concerns about the ethics of what was going on.

The letters in that link do suggest the Royal Free was explicitly supporting the "transfer factor" proposals at the outset, though as I said I imagine the finance people involved had no idea it was quackery. So maybe the animal house and so on were all on board with the mice and even the goats. I'd still like to know, though.

I'd especially like to know what happened to the kids, because if they were killed at birth to allow the nannys' colostrum to be harvested, this is something the public would not be at all happy about.

Also, Wakefield left the Royal Free in about 2003. He may have been using stored product after that, if he was using it, and any further production taking place in the USA. I'd still like to know!

Rolfe.
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Old 28th May 2010, 10:09 AM   #26
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Capsid, I was looking a bit further into the relationship between transfer factor and cytokines, and it's a bit hazy. Cytokines are, I believe, peptides, proteins or glycoproteins. The peculiarity of Wakefield's description of transfer factor is that he talks about "RNA bases attached to small peptides". I don't know what that would make this, but as far as I know, cytokines don't have nucleic acids in them, do they?

My suspicion is that in the 1940s and 1950s, Lawrence was transferring cytokines (not identified or named then, as far as I know) between individuals, and wrongly assumed he had identified something antigen-specific. He believed he had found a way to transfer CMI between individuals and so apparently confer active CMI immunity to the second individual without actually exposing him to the antigen.

Am I right in saying that cytokines are however not antien-specific, therefore the idea that transferring cytokines from one individual to another would not confer CMI to a particular antigen on the second individual? So the whole idea is completely wrong?

As I said, I suspect Lawrence had noted some non-specific effect of transferring cytokines, and interpreted in wrongly. It seems as if he himself was regarded as a bit of a maverick even at that time, and nobody appears to have followed up on his research. It all petered out in the 1960s I think.

Then if looks as if it was rediscovered by quacks in the 1990s, possibly Fudenberg himself, though I haven't looked into that, and Wakefield has become attached to the people promoting the idea.

I can just imagine the conversations at the Royal Free when someone actually looked into the details of what was on these patent applications, and got the real immunologists to comment. I'd like to have been a fly on the wall. No wonder they washed their hands of the patents, as well as Wakefield.

So, if "transfer factor" is anything, it's cytokines. A crude extract, inevitably containing an awful lot of different molecules. Wakefield never seems to have attempted to isolate his alleged active ingredient. If the preparation also contains RNA fragments, that might explain his description of it as contaiing both RNA bases and peptides.

What do we know about cytokines?

Correct, what went wrong with that drug trial disaster was a "cytokine storm" caused by the antibodies that were injected into the volunteers. Again, that's a very different situation to what Wakefield was doing, but would the parents of autistic children be pleased to learn that the "transfer factor" Wakefield is giving is likely to be composed of the same cellular regulators as were responsible for that incident?

Capsid, do you have any thoughts on this?

Rolfe.
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Old 28th May 2010, 10:13 AM   #27
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Rolfe, I found this. They are the umbrella organisation for DAN!s and it appears as though they are using it. I also found this on Thoughful House's site. They are careful about what they say but that was Waker's home in the U.S. until recently and they appear as though they, at the very least, endorse it. These fools are still using secretin for crying out loud.

Este
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Old 28th May 2010, 10:15 AM   #28
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I dropped BD an email.
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Old 28th May 2010, 10:23 AM   #29
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Again and again, I come across press claims that Wakefield had patented a "single measles vaccine". No, he really hadn't. Whatever "transfer factor" is (crude preparation including a mix of cytokines?), it's not a vaccine. It doesn't deliver an antigen for the immune system to recognise.

When Deer accused Wakefield of having such a patent, Wakefield angrily denied this, claiming that transfer factor was a treatment for autism, not a vaccine. This is undoubtedly technically correct. However, Deer is also correct where it matters, in that the patent applications themselves refer to the product as "a combined vaccine/therapeutic agent which is not only most probably safer to administer to children and others by way of vaccination/immunisation, but which can also be used to treat IBD [....]" Similar statements appear several times throughout the application. Even though it wasn't a vaccine, he was intending to market it as a vaccine.

Nevertheless, the persistent description of this product by the media as a "single measles vaccine" seems to have obscured the sheer depths of the quackery involved. It portrays Wakefield as some sort of genuine hot-shot immunologist who could actually develop a vaccine and (implicitly) get it through the product regulation process.

Er, no.

Rolfe.
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Old 28th May 2010, 10:47 AM   #30
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Originally Posted by Rolfe View Post
Capsid, I was looking a bit further into the relationship between transfer factor and cytokines, and it's a bit hazy. Cytokines are, I believe, peptides, proteins or glycoproteins. The peculiarity of Wakefield's description of transfer factor is that he talks about "RNA bases attached to small peptides". I don't know what that would make this, but as far as I know, cytokines don't have nucleic acids in them, do they?
Correct.

Originally Posted by Rolfe View Post
My suspicion is that in the 1940s and 1950s, Lawrence was transferring cytokines (not identified or named then, as far as I know) between individuals, and wrongly assumed he had identified something antigen-specific. He believed he had found a way to transfer CMI between individuals and so apparently confer active CMI immunity to the second individual without actually exposing him to the antigen.
. you will get an effect by injecting cytokines into someone such as lymphoproliferation which could be confused for an immune response but it won't be antigen specific.

Originally Posted by Rolfe View Post
Am I right in saying that cytokines are however not antien-specific, therefore the idea that transferring cytokines from one individual to another would not confer CMI to a particular antigen on the second individual? So the whole idea is completely wrong?
Correct. The only way to transfer antigen specific CMI is to transfer the lymphocytes but that doesn't work because a graft vs host reaction results unless the cells are completely matched for their MHC.

Originally Posted by Rolfe View Post
As I said, I suspect Lawrence had noted some non-specific effect of transferring cytokines, and interpreted in wrongly. It seems as if he himself was regarded as a bit of a maverick even at that time, and nobody appears to have followed up on his research. It all petered out in the 1960s I think.

Then if looks as if it was rediscovered by quacks in the 1990s, possibly Fudenberg himself, though I haven't looked into that, and Wakefield has become attached to the people promoting the idea.

I can just imagine the conversations at the Royal Free when someone actually looked into the details of what was on these patent applications, and got the real immunologists to comment. I'd like to have been a fly on the wall. No wonder they washed their hands of the patents, as well as Wakefield.

So, if "transfer factor" is anything, it's cytokines. A crude extract, inevitably containing an awful lot of different molecules. Wakefield never seems to have attempted to isolate his alleged active ingredient. If the preparation also contains RNA fragments, that might explain his description of it as contaiing both RNA bases and peptides.
Maybe they did some crude analysis of the culture supernatant and found nucleic acid in it, which if course they would have done.

Originally Posted by Rolfe View Post

What do we know about cytokines?

Correct, what went wrong with that drug trial disaster was a "cytokine storm" caused by the antibodies that were injected into the volunteers. Again, that's a very different situation to what Wakefield was doing, but would the parents of autistic children be pleased to learn that the "transfer factor" Wakefield is giving is likely to be composed of the same cellular regulators as were responsible for that incident?

Capsid, do you have any thoughts on this?

Rolfe.
I think you have summed it up pretty well. The cytokine storm of the TGN trial works by a very specific method. I can't say it's different from what Wakefield filed a patent on as I don't think any method or mode of action was determined by Wakefield anyway.
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Old 28th May 2010, 04:37 PM   #31
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I've emailed Brian Deer myself, as he's said (on the BMJ rabid responses) that he doesn't agree it's time to forget Wakefield.

I predict Wakefield intends to go to ground for a little to let the hue and cry die down (he surely has enough money to be going along with, what about that 2 million house he was selling), then to continue practising as a SCAM practitioner, still pushing the colostrum nostrum. In America of course, where such things are easier, and a long way from the GMC, Channel 4 and the Sunday Times.

Rolfe.
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Old 28th May 2010, 04:43 PM   #32
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I heard from a conspiracy theorist that no, we haven't heard the last from him, because now he's finally free to preach his gospel without having to abide by Big Pharma rules.

As if he ever did.
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Old 28th May 2010, 06:39 PM   #33
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Originally Posted by Rolfe View Post
I was forgetting that the Royal Free actually knew at least some of what Wakefield was up to, and apparently because it smelled money, was apparently happy to go along with this. I don't imagine any of the people who supported him at that point had any idea the science behind what he was claiming was so wacky.

http://briandeer.com/wakefield/falk-pharma.htm

It also appears that Wakefield was putting the Royal Free on the patent applications as well as his own name, though the Dean seems later to have said he didn't know about this. They gave up any claim to the patents when they realised how quacky it all was, at about the time Wakefield left. I'm getting the impression that at the same time the admin and finance people were loving him for his patents and potential money-making ideas, and the clinical people were expressing concerns about the ethics of what was going on.

The letters in that link do suggest the Royal Free was explicitly supporting the "transfer factor" proposals at the outset, though as I said I imagine the finance people involved had no idea it was quackery. So maybe the animal house and so on were all on board with the mice and even the goats. I'd still like to know, though.

I'd especially like to know what happened to the kids, because if they were killed at birth to allow the nannys' colostrum to be harvested, this is something the public would not be at all happy about.

Also, Wakefield left the Royal Free in about 2003. He may have been using stored product after that, if he was using it, and any further production taking place in the USA. I'd still like to know!

Rolfe.
Maybe he didn't use any colostrum at all.
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Old 29th May 2010, 05:54 AM   #34
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Originally Posted by tsig View Post
Maybe he didn't use any colostrum at all.

I just had a short but quite fascinating email from Brian Deer, and yes, he did use colostrum. Mr. Deer appears to be well up to speed on all these issues, and says he even knows "the man who paid for the goats".

I think Brian Deer knows most of what we've been speculating about. It's an area I'm very very interested in, but I'm not sure if he's going to do a feature about it or not.

Rolfe.
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Old 29th May 2010, 08:14 AM   #35
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Originally Posted by Rolfe View Post
As I said, I suspect Lawrence had noted some non-specific effect of transferring cytokines, and interpreted in wrongly. It seems as if he himself was regarded as a bit of a maverick even at that time, and nobody appears to have followed up on his research. It all petered out in the 1960s I think.
I remember hearing about transfer factors in immunology classes in the mid to late 1960s. It was presented as "if it worked as described, it could be useful, but no one has been able to make it work except the guy who claimed discovery."

Quote:
Then if looks as if it was rediscovered by quacks in the 1990s, possibly Fudenberg himself, though I haven't looked into that, and Wakefield has become attached to the people promoting the idea..
I don't think the idea was completely forgotten - the idea that drinking colustrum from cows will help humans is still floating around, and has been since it was discovered that colustrum contained immune globulins.

ADDING: The notion got its start after "cellular transfer of delayed hypersensitivity in guinea pigs" was discovered. Make one guinea pig hypersensitive to something, transfer some cells, and the recipient will acquire delayed hypersensitivity. This is an accepted, repeatable phenomenom, and you can even make it happen with no cells. But guinea pigs are not humans.

Dr. William Smith Tillett - a medical big gun in the 30s and 40s, encouraged Lawrence to begin his career by determining whether this sort of cellular transfer could be accomplished in man using viable white blood cells.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC416355/ (My professors!)

http://www.ncbi.nlm.nih.gov/pubmed/13233344 (Lawrence, making something work in humans)

Note that this is a direct transfer - a long way from the convoluted process described by Wakers of immunizing mice, harvesting lymphocytes, running it through cell cultures, then into pregnant goats, and extracting who knows what from the colustrum.

Last edited by TsuDhoNimh; 29th May 2010 at 09:00 AM. Reason: Adding info
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Old 29th May 2010, 09:05 AM   #36
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Originally Posted by TsuDhoNimh View Post
I remember hearing about transfer factors in immunology classes in the mid to late 1960s. It was presented as "if it worked as described, it could be useful, but no one has been able to make it work except the guy who claimed discovery."

That seems to fit with all the rest!

Originally Posted by TsuDhoNimh View Post
I don't think the idea was completely forgotten - the idea that drinking colustrum from cows will help humans is still floating around, and has been since it was discovered that colustrum contained immune globulins.

But that's a non-sequitur. As far as I know, Lawrence didn't say anything about colostrum. He was working with filtration fractions of lymphocytes. Colostrum doesn't transmit CMI - as you say, it transmits immunoglobulins.

Of course, immunoglobulins are useless to anyone except a neonate of the appropriate species less than a couple of days old (at most). Only at that stage of life is the intestine able to absorb the immunoglobulins intact and functional. If you miss that window, you can feed the calf all the colostrum you like, it will do no good. The proteins will merely be digested.

It's amazing the silly ideas some people get. The idea that bovine colostrum could be at all beneficial to humans is silly. The idea that caprine colostrum will contain a peptide that will confer immunity to measles if you inject the goat with a fraction of a lymphocyte preparation that has been exposed to the measles virus is insane to the nth degree.

Rolfe.
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Old 29th May 2010, 09:12 AM   #37
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Can I say bizarre again?
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Old 29th May 2010, 11:33 AM   #38
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From what I've managed to compute in my tired addled brain is that colostrum won't cause the immune system to build up any permanent immunity anyways, since it needs to react to actual antigens anyhow (hence real vaccines work, and we know why). So, this whole complicated process using this methodology to come up with colostrum to inject is completely useless to even meddle with?
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Old 29th May 2010, 12:04 PM   #39
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Not all parents of autistic children think highly of Mr. Wakefield, some of us think of him as "The Bastard Wakefield". He's done far more harm than any fraction of good from his B.S. research. He does need his head served up on a platter.
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Old 31st May 2010, 02:02 AM   #40
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Well, you've got his head, platter and all. Though he seems quite unrepentant, and will probably still manage to net more money from all this than you or I could dream of in our entire careers.

I think what amazes me about the colostrum thing is the window it opens into Wakefield's thought processes. Here is someone in a research post in a teaching hospital, and yet he goes to a lot of trouble to take out patents on something which is complete, 24-carat nonsense. It's difficult to overstate the silliness of the entire concept. Commentators have tended to state that he had a patent on "a competeing single measles vaccine", because that clearly illustrates the conflict of interest involved. But of course it was no such thing.

How could anyone with even the most rudimentary knowledge on immunology and pharmacology imagine that pills made out of goat's milk with no defined active ingredient could become an accepted treatment for anything, or an alternative even to a single measles vaccine? It was going nowhere, and it was always going nowhere.

Pace the surgeons on here, but this is something I see in a lot of surgeons. Perhaps it's a side-effect of the degree of self-confidence needed to take patients apart on the operating table and put them back together again. They come to imagine they know everything about everything, and can pontificate just as authoritively on biochemistry or molecular biolody or immunology as they can on their own subject. Even when they know approximately bugger-all about it.

The patent applications are very badly-written as far as I can see. The Lancet trial is covered in just about as much detail as it is in the actual paper, but important things such as what transfer factor actually is and how you produce it are glossed over. It's pretty much Walter Mitty. It's just weird to see it from someone with an FRCS, rather than someone like ShareCures.

Rolfe.
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