Aimspro

A forum to discuss Aimspro (Goat Serum) as a possible therapy for MS

Aimspro

Postby bromley » Mon Apr 11, 2005 8:57 am

Dear all,

Last week I reported that the UK MS Society had called the Aimspro optic neurosis trial results disappointing. The makers Aimspro (Daval International) have written to the UK MS Society.The letter is on their website and is copied below:



Dear Sir

Aimspro

As you know, we act on behalf of Daval International Limited the producers of the above product.

On 6 April 2005 you posted on your website an article headed “Further evidence needed after disappointing Aimspro trial, say neurologists”. The article itself reads:


“The results from the recently completed small study of Aimspro (Goat Serum) in Optic Neuritis (a common symptom or model for MS) were presented at the scientific meeting last week. They make it clear that the main measures used to evaluate its effect were negative. Tertiary outcomes, while not showing a benefit when compared to placebo, showed some interesting results. A spokesman for the MS Society said, ‘we note that this is the first time clinical trial data involving Aimspro has been formally presented to the medical community. In the light of this new information we want to highlight how important it is that research findings are responsibly disseminated and the need for peer reviewed, published research information. Reports in the media can sometimes be limited or exaggerated and may lead to disappointment. The Society awaits publication of the results of this clinical trial”.


The article that you have published is both inaccurate and misleading. This was not the first occasion upon which Aimspro had been presented to the medical community, but in fact the fourth. The trial at Oxford University was not a small study: it was a fully approved double-blinded, independent clinical trial conducted by some of this country’s leading MS experts. The presentation also concluded that Aimspro was a safe medication.

Indeed, the treatment was clearly effective as nine of the eleven patients on the trial have subsequently contacted our clients requesting that they be permitted to continue their treatment with Aimspro.

Our clients have had cause to complain about your disparaging treatment of their product in the past. It is clear that yet again you have chosen to disregard the facts and ignored the actual information that was presented to the Association of British Neurologists.

We require that you now amend the article posted on your website to reflect the actual results of the trial and not the misstated results that you have currently published.

Yours faithfully



My comment - as usual nothing relating to this disease is clear cut. However, when I go for an eye test (I am short sighted +astigmatism)I am put through a series of tests and told at the end what my prescription is. I'm a history graduate who trained as an accountant but surely it cannot be that difficult to design a test. (i) MS sufferer who has ON comes to optician and sight is tested - some grading is given on the level of vision. (ii) Sufferer given Aimspro and day after /week after sight is tested to compare to baseline prior to treatment. Testing might have to take place every month or whatever is deemed appropriate.

What the hell are tertiary outcomes? Surely the important test if for the sufferer to be able to distinguish colours /read the letter board etc. Why did Daval only involve such a small number in the trial? Trials for drugs usually involve hundreds / thousands.

My personal opinion is that this drug has been over-hyped - one UK newspaper in particular has run regular stories about those in wheelchairs being able to walk / blind seeing again. Real biblical stuff. But the proof of the pudding is in the eating - if such dramatic improvements were being seen neurologists / doctors would have seen them. Has anyone on this site used Aimspro? Alan Osmond claimed to have seen benefits when he used it - is he still using it / seeing the benefits?


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Postby SarahLonglands » Mon Apr 11, 2005 2:32 pm

What the hell are tertiary outcomes? Surely the important test if for the sufferer to be able to distinguish colours /read the letter board etc. Why did Daval only involve such a small number in the trial? Trials for drugs usually involve hundreds / thousands.


"Quite!" (courtesy of P.G. Wodehouse)

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??????

Postby treez » Tue Apr 12, 2005 5:12 am

I don't get it Anecdote, am I that niave?

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Postby SarahLonglands » Tue Apr 12, 2005 5:32 am

Oops, sorry, Treez, but it is just something said by a 'distressed duchess' serving fruit in Bellamy's, Piccadilly (London!!) in "the Knightly Quest of Mervyn", one of the tales in The Mulliner Omnibus by P G Wodehouse, and it is actually spelt "Quate!" in imitation of her distressed duchess accent. You certainly aren't naive.

So rather, "What the hell are tertiary outcomes, and what has happened to the primary and secondary ones?"

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outcomes

Postby treez » Tue Apr 12, 2005 6:21 am

You're one step ahead of me.....I didn't have a clue as to what that meant. Had to look it up! Here's what I came up with:

Tertiary \Ter"ti*a*ry\, a. [L. tertiarius containing a third
part, fr. tertius third: cf. F. tertiaire. See Tierce.]
1. Being of the third formation, order, or rank; third; as, a
tertiary use of a word. [1913 Webster]


I guess I'd read into that as "final" outcome.

Primary...secondary.....tertiary.

Perhaps we all sound illiterate?

Perhaps just the questionable use of a seldom used word!

That sounds good to me!

:)


Unfeignedly.........I mean sincerely, :?


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Re: Aimspro

Postby Daunted » Tue Apr 12, 2005 11:28 am

What the hell are tertiary outcomes? Surely the important test if for the sufferer to be able to distinguish colours /read the letter board etc. Why did Daval only involve such a small number in the trial? Trials for drugs usually involve hundreds / thousands.

Bromley


We don't know what measurements were used for primary, secondary, tertiary outcomes. I don't know anything about measurement of visual acuity, myself. Sometimes the measurements (primary, secondary, etc) are designed to measure very different things. Who knows until we see the data?

Small pilot trials like this are common when a drug is new. It doesn't make a lot of sense to do a blinded placebo-controlled trial that is this small, though, since the chances of reaching statistical significance are small, anyway, even with a large drug effect.
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Postby finn » Wed Apr 13, 2005 2:47 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 2:26 pm, edited 1 time in total.
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Fins Post - Unsuccessful HIV-drug candidate in the USA

Postby Nemotoday » Wed Apr 20, 2005 11:29 am

finn wrote:A couple of quick notes:

1. During the past few years the goat serum has been hyped by Gary Davis and Daval International (originally Davis-Daval) as a promising treatment for AIDS (Caprivax) and breast cancer (Anavax). As far as I know, either of those brands exist anymore.

-finn


In another post Fin also stated

"Maybe the worst thing is its controversial history as an unsuccessful HIV-drug candidate in the USA, which could have an effect on the FDA".

I have looked into the second statement and can find no evidence of any HIV /AIDS trial having been undertaken in the USA. It might be helpful if a link supporting the statement might be posted.

It would also be interesting to have a link to the Caprivax and Anavax bits as well.

I would also like to know how it has been determined that we are talking about the same product.

Not having access to the product myself or being able to review its protein combinations, construction or mechanism of action I find these remarkable statements.

I may of course be barking up the wrong tree, but something is not right here.

Perhaps Fin might be good enough to help enlighten me

Regards to all
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Postby SarahLonglands » Wed Apr 20, 2005 2:29 pm

Well, perhaps I can help because Finn has probably gone to bed by now. I don't have the time to look into the USA trial, but try this:

http://www.ms-gateway.de/start.jsp?/resources/treatingms/new_substances/pot_ther/aimspro.jsp

If you don't speak German you can get an understandable translation into English. It dates from 2000, I think. As with many things, first try it on AIDS, then anything else which might be appropriate, then MS! :(

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Postby dignan » Wed Apr 20, 2005 2:44 pm

Aimspro and Caprivax are the same thing. Daval just decided to change the name in 2004.

http://www.proventus.org.uk/aimspro.shtml
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Postby finn » Thu Apr 21, 2005 1:31 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 2:27 pm, edited 1 time in total.
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Postby markchip » Thu Apr 21, 2005 4:40 am

Dear Finn et al,

I thought this thread might benefit from further clarification insofar as information is available…

The "American goat serum" has never been tested in a clinical trial in the USA. After visiting its developer's website one can understand why: "I woke up the next morning, and I knew all this stuff about the AIDS virus that I didn't know before. Did you know a goat can't contract HIV? I saw it in a dream." (Gary Davis, the inventor of the goat serum)

Dr Davis does seem to have been a rather “off the wall” character but despite any interpretations (by him or anyone else) he does seem to have come across something with promise…. Somehow.

Nemotoday wrote:
I would also like to know how it has been determined that we are talking about the same product.

Well, when Caprivax was first brought to our attention healingwell.com warned about it and provided a link to this article about Gary Davis' serum. (It may be worth noting that these links do not always dismiss the product as rubbish necessarily and do contain opinions of individuals who, whilst they might be scientists, did not have much, if any, knowledge of the scientific basis of the product – indeed much of the mechanism of action is only now beginning to be understood) And now that you asked about it, I checked if there is a connection between Gary Davis and Daval International. This is what I found:

After Davis' permission to do a clinical trial with the serum was denied by the FDA, it was given to one AIDS-patient under unclear circumstances. The patient was "cured", and Davis got his share of media coverage. (It was supposed to have been stolen by the patient’s mother who then gave it to her daughter)

In 1999 80 liters of the serum was found in the possession of Steve Migliaccio of Immuno Therapeutic. According to him "Davis had struck a business deal with London investment group Valentine Strategic Investments Limited". The company disputed Migliaccio's statement, but at that time the Managing Director of Valentine was a man named David Shotton. A year later a venture capitalist named David Shotton founded Daval International ltd.

Gary Davis’ failed attempts to get things moving in the States and with the FDA eventually ended up with David Shotton’s involvement and his resolution to try and move things on in the UK, where the environment was less hostile and could be taken forward without Dr Davis (and his “history”) at the helm. One eccentric individual never really stood a chance in the States, no matter how good his early product might have been. There were indeed other “colourful” characters in the picture at this stage, fortunately they have not been allowed to remain and instead Daval has gathered together a highly respectable board of directors and the kind of research team which speaks volumes about whether this is a “quack” idea or a genuinely valid approach.

Circumstantial evidence only, but I rest my case.

-finn


A case founded on circumstantial and incomplete evidence is not that much of a “case” really… As you have said before, this needs more evidence and should be viewed with dispassionate eyes. The problem is that both Daval and many Aimspro patients (myself included) find that the evidence we have witnessed, both first- and second-hand, makes it very hard to be entirely dispassionate! That said, we have supported the principle of independent clinical trials and of scientific rigour.

It becomes very difficult for a small company (especially in a field such as pharmaceuticals) to fund and push forward the right kind of progress when there are very powerful vested interests “wishing” them to fail. It would have been so easy for David Shotton to have sold out and made a killing and then for the purchaser to have put Aimspro on the back burner at least until its current range of competing products had reached the end of their productive (read profitable) lives. But he has not done so. And nor has Daval ever charged any of its informed consent list patients a penny – a fact that has yet to be answered by any of those who have viewed Aimspro as a “scam”.

In recognising the probability that selling out could easily see Aimspro shelved to the detriment of sufferers David Shotton has kept this product safe from predation but has had to undertake the development and progress towards licensing, with all the costs entailed, with minimal assistance from any of the powers-that-be. Developing and getting a new drug to market is a hugely difficult, lengthy and expensive business – no question of that. Daval have done the bulk of this in a much shorter time-span than normal and at (necessarily) much reduced costs precisely because they have not just sat back and done the “standard thing”. Had they done so things would be nowhere near as far advanced as they are and – and this is the key thing here – the potential patients would be years away from being able to receive this treatment.



To sum up – Aimspro does have its origins in the States and with less than pre-eminent individuals(!). It is now being developed in a much more rigorous and scientific manner but it is still subject to very serious “commercial” opposition and precious little assistance. I will continue my advocacy without let up though I do find anonymous, unsubstantiated and factually flawed comments (“Disappointing trial results”) from bodies like the MS Society and outdated references to other scientists statements (“I wouldn’t inject anything from animals myself” – what about insulin or HRT then?) when they patently have zero knowledge of the product to which they are referring to be rather ignorant and definitely annoying.

Regards, Mark
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Postby finn » Thu Apr 21, 2005 5:20 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 2:28 pm, edited 1 time in total.
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Postby Scaggs » Thu Apr 21, 2005 12:29 pm

The efficacy of AIMSPRO was actually broadcast for all live on national TV.

Last month, ITV News in the UK broadcast an item where a Vicar with MS could not lift his right arm at all. 12 minutes after an injection with AIMSPRO, the Vicar had a 12 stone guy hanging off his right arm.

Convincing Finn, I think so!!

True more trials are needed, and this drug might not work for everyone but isnt that like all other MS drugs on the market today?
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Postby markchip » Thu Apr 21, 2005 3:47 pm

Hi Finn,

Jusy a couple of quick (?) points :lol:

I agree that Aimspro's early history is not one that automatically inspires faith... but it has come a long way since then and rejection on those grounds alone seems as naive as accepting Aimspro's worth on just a handful of patients. There are, however, substantially more than a handful, some scientific data albeit in limited quantity and a number of high calibre medics and scientists (none of whom seem to use 10 foot poles!). My biggest beef is with those others who dismiss it without being prepared to look into it and just rely on inaccurate assumptions or the word of someone else (often equally ignorant) who has letters after their name.

It seems bizarre that there is such frequent criticism (often ignorant as stated) of a product that, even if it lives up to half of its promise, stands to be hailed as utterly remarkable. How many other treatments (for MS) do anything more than hold it back to a degree or partially reduce the frequency of episodes? And do they all have a clear safety record? And are they nice and cheap? "At least they have clinical data to back them up????".... One particular product seems somehow to have slipped through the net recently. Clinical data isn't the be-all-and-end-all nor is it the only valid analysis. Anecdotal evidence doesn't have the same cachet and it doesn't bear up as well as clinical data but that does not mean it is worthless or irrelevant. If a high proprortion of a significant number report substantial change then surely that has some merit and deserves some measure of support.

The only valid criticism as far as I can see is the comparative lack of clinical data. Fair enough but I don't see anyone other than Daval being ready to put their hands in their pockets and fund it. Rather than engage in some "Aimspro-bashing" it makes a damned sight more sense for these people to lobby for more assistance so that a promising product is not allowed to wither.

The reason I and others like me campaign on behalf of this treatment is as much about wanting it to become widely available asap as it is also about resisting the detractors and offering some well-deserved support. Their is an unmarked threshold somewhere below which Aimspro could well sink. I don't know where it is and I'm not prepared to find out that Aimspro has just "drowned" when I could have helped it survive and flourish.

For me it's about my wanting it to succeed and giving active support in the meantime (unless I am proven wrong (by hard scientific data!) and not saying "oh that can't be any good 'cos it doesn't have the right pedigree or hasn't followed the normal path". I am not going to sit apatheticly by either - that's just as bad!

Regards, Mark
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