Staphylococcus toxoid vaccine treatment

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Hi, do you have links or copies of these trials? This is the first I've heard of this.

 

All the studies and trials on the Staphypan® Staphylococcus toxoid vaccine treatment for ME/CFS are to be found in this post on the thread about the vaccine. The thread is long, but I created an index to the most important posts (the posts relevant to buying and trying the Russian Staphylococcus toxoid vaccine).

I discovered a possible replacement for the discontinued Staphypan vaccine: namely a Staphylococcus toxoid vaccine made in Russia, and which can be bought online quite cheaply. I tried this Russian Staphylococcus vaccine myself, and went into near remission for around 2 weeks, but then for some reason the vaccine unfortunately stopped working for me.

However, it's quite possible that this Russian vaccine may work for other patients, because it contains the same Staphylococcus alpha toxoid ingredient that was found in the original Staphypan. This ingredient has known immune boosting effects against coxsackievirus B, one of the most common viruses linked to ME/CFS.

I was hoping that at least 10 or so ME/CFS patients would be enthusiastic about trying the Russian vaccine as an experiment, so that we could work out whether it does work as well as the original, but almost nobody seemed interested in testing it.

 

Wasn't mercury toxicity an issue too? The formulation used mercury and it would be too expensive to change the ingredients, given low sales in generally.

 

That is what what I also heard initially; but Janssen Pharmaceuticals did not mention anything about mercury to me, only the fact that their Staphypan® vaccine was a very old product which used "artisanal" techniques in its manufacture that could not be updated to comply with the new GMP rules. So I am guessing it would have required starting from scratch, and developing a new manufacturing process to create a new Staphylococcus vaccine (which I guess would not be guaranteed to work like the original for ME/CFS, as the ingredients might be different).

I would not have thought that mercury is a GMP issue, as this is still used in some vaccines, and the current Russian Staphylococcus vaccine contains mercury.

The sad thing is that Prof Gottfries' larger clinical trial was published in 2002, and then Staphypan was discontinued just 3 years later — probably not enough time for uptake of this treatment to occur globally (it was a popular ME/CFS treatment in Sweden, but I believe not really known about further afield). If this ME/CFS treatment had taken off globally, perhaps the higher sales might have prompted Janssen to consider developing a new replacement vaccine.

 

Isn't the issue not that mercury in a one-time vaccination is safe, but rather that taking repeated injections (as the treatment regime seems to suggest) might make that a problem? Presumably, regular injections may need different ingredients?

 

I would not have thought so, because I believe you get more mercury into your bloodstream from eating a can of tuna than you do from a vaccine.

 

You may be right.

 

So what's the consensus on this treatment? Is it worth continuing to study?

It feels like there must have been an unpublished negative study if it didn't go anywhere (beyond the issues of manufacturing, that is).

 

There was no negative study that I am aware of. The team in Sweden campaigned hard to persuade the pharmaceutical company that made the Staphypan vaccine (Berna Biotech) to try to find a way to continue manufacturing it, because the health of so many ME/CFS patient's was at stake, but the company still went ahead and discontinued production in 2005.

I am in contact with two medical professionals in Sweden, including the discoverer of this ME/CFS treatment Prof Gottfries, who both had ME/CFS, but found they could return to full time work as a result of Staphypan (they stockpiled a lifetime's supply before its was discontinued, but obviously for new patients there is now no vaccine available). They both tell me that it is crazy that a safe, cheap and effective treatment was discovered, but nobody does anything about making it available to ME/CFS patients.

If anyone has any ideas about how to get pharmaceutical companies interested in investigating this treatment, and developing a replacement, please post.

 

The most efficient route would probably be to purchase the recipe, start a company and get investors/funding onboard to develop, market and sell it directly. Which would still probably take 10 years, but could be done if the right pitch and numbers could be put together. You would have to be fairly certain it really works for it to be worth that amount of work. The recipe price is probably the biggest obstacle, I have no idea what it would be but I imagine probably very high.

 

The manufacturing recipe is probably propriety knowledge of Janssen pharmaceuticals, but the actual ingredients of Staphypan are known, as Prof Gottfries's team conducted a study analyzing Staphypan.

So any pharmaceutical company who wanted to develop a replacement vaccine already has this head start. You would probably want to figure out exactly which ingredients have benefits for ME/CFS, and then base the new vaccine on those. Because these ingredients are already known to be safe when injected into humans, I imagine it would be relatively cheap and straightforward to develop a replacement vaccine, in the order of $millions, rather than the typical half a $billion cost to develop and test a new drug from scratch.

 

Have you sent this to Ron?

 

No, perhaps I should. Although I think it's more a pharmaceutical company whose interest we need to engage, as this is more or less a ready-made treatment, that just needs to be manufactured.

 

If it was purely a financial decision, perhaps it was because they knew it would be many years (10ish?) before research validated Staphypan for ME and then more years before govts approved it through their drug approval systems. That's a long time to wait for access to the ME market.

Sounds like a product ripe for the black market for faster access and at an affordable price. How hard would it be to get the ingredients and make a batch in my garage?

 

There was some confusion initially because on the Phoenix Rising Staphylococcus thread we started using the wrong weaker version of the Russian Staphylococcus alpha toxoid vaccine, when we should have been using the stronger ("adsorbed") version.

I had no response from the weaker vaccine, even after 6 months, but got very positive results from the stronger vaccine within about 3 weeks of starting in — a night and day improvement that was blatantly obvious — but for some reason the improvements did not last for more than 2 or 3 weeks, even though I continued to take the vaccine.

Another person (Tinnybell) reported good results (can't remember which vaccine version he tried), and a third person (CaptainA) trying the stronger vaccine for 6 months reported he only got beneficial effects that lasted for 24 to 48 hours after each injection but then wore off (but his ME/CFS started somewhat unusually from a neck injury, rather than the more usuals viral onset, so I wonder if he may be in a different disease subset). There was also a Russian guy (hvac14400) who reported positive results, but he did not come across as reliable observer.

Quite a few people did show interest, and I'd explain all the details to them on the thread or by PM, but most did not actually go on to try the vaccine.

This stronger ("adsorbed") version of the vaccine is sold here.

I don't know, but you can get lots of background info on the story of the Staphypan Staphylococcus vaccine treatment from Professor Carl-Gerhard Gottfries five video interviews on YouTube, the first video here. Cort also did an article on Gottfries and his vaccine treatment. And his studies on the vaccine treatment are listed in this post.

Long story short: he discovered by serendipity in around 1961 that the Staphypan vaccine was effective for his own ME/CFS which he developed during the Asian flu (H2N2) viral pandemic in 1957 and 1958 in Sweden. He was hit with ME/CFS right at the very beginning of his medical career as a psychiatrist, but used the vaccine to treat himself, and this allowed him to go back to work. He also started using the vaccine to treat ME/CFS patients referred to his psychiatric unit. As a psychiatrist, Gottfries's investigation of the ME/CFS patients he saw indicated to him that they did not have any psychiatric illness, but a physical disease, and he found the vaccine an effective treatment, right way back then in the 1960s.

Unfortunately his boss at the psychiatric unit did not like all these ME/CFS patients coming to the clinic, and asked Gottfries to stop seeing these patients. So he unfortunately had to stop treating ME/CFS, but kept taking the vaccine himself. Then decades later as he approached retirement, he felt that he should do some research on this vaccine, and so in the 1990s I believe he set up up an ME/CFS clinic (the Gottfries clinic) in Sweden with the purpose of treating patients with the vaccine as well as conducting research on the vaccine — research which included two double-blinded clinical trials. Then in 2005 Berna Biotech withdrew the vaccine, in spite of heavy protests from Prof Gottfries's team.

Yes possibly. Staphypan vaccine was being prescribed to ME/CFS / fibromyalgia patients in Gottfries's clinic Sweden under an agreement with the Swedish medical authorities, but that was only a small group. Had the vaccine become known for example in the US in the 1990s, where doctors have more clinical freedom to prescribe treatments, I am sure it would have had a rapid take-up there, and then things might have been different.

 

It was more me thinking that he's a person determined enough to do the work of testing it. And he seems to be creating new tech for diagnosing ME, so he might be able to convince a pharmaceutical company to take a look at it.

 

It may be.

 

I remember discussing this treatment on the other forum and not being impressed. I have re-read the 2002 paper and see why I had concerns. Perhaps the most relevant sentence is:

All the patients had a local reaction at the site of the injection but to preserve blindness, the severity of these reactions was not rated.

If all patients had reactions worth mentioning I think we can be fairly sure that blinding was lost. Reactions to coloured water will have been trivial and purely due to repeated needle-sticks. (Another worrying thing is that injections were given subcutaneously in the gluteal region. This is not an accepted practice for immunisation. The subcutaneous space is relatively immunologically inert and is usually accessed for things like insulin in the front of the abdomen and thigh. The gluteal region is preferred for intramuscular injection. Immunisations are either give intradermally (very superficial into the dermis itself in the arm) or intramuscularly. It sounds as if patients receiving vaccine had noticeable reactions both in terms of local soreness (maybe even skin redness if the injection was not fully subcutaneous) and in particular headache which would indicate a systemic immune response.

The claim that reactions were not rated to preserve blindness rings alarm bells. If the nurse giving injections rated reactions that would not affect blinding, as long as the log was blinded from the outcome assessors. But failure to rate reactions is the best way to avoid gathering evidence of failure of blinding. If people make mistakes like this they are going to make all the other usual mistakes that lead to bias.

The abstract of the paper leaves one with the conclusion that there is good evidence for efficacy of the treatment if, and only if, we can be confident that blinding was secure. We cannot be confident so there is no meaningful result.

I think one needs to consider the scenario of a private clinic with staff being asked by the boss to undertake a trial of the treatment producing a major income flow. If patients can reasonably easily guess whether they are on treatment or dummy then it does not take much for staff to work that out. The primary outcome was a staff assessment as far as I can see. That is even worse than a subjective patient assessment in this sort of context.

So, like the PACE authors, this group has wasted time producing a result we cannot make any real sense of.

Is it worth continuing to study? The hypothesis given in the 2002 paper does not amount to anything much. The idea of prodding the immune system with a microbial protein is not specific enough for anyone trying to identify an active ingredient to set up any model test systems. Continual administration of a foreign protein that causes local reactions and headaches is not attractive. And listening to Gottfries I doubt that any professional immunologist or pharmaceutical company is going to take it seriously.