Thursday, July 30, 2009

Novartis: We have done no testing for the carcinogenicity of MF59

At the 12/2008 FDA-NIH meeting on how to study novel adjuvants, Novartis scientist (Novartis owns the MF59 adjuvant) Dr. Novicki made the following statement:
"Carcinogenicity--we have done no testing for the carcinogenicity of MF59 adjuvant or any of our preventive vaccines. We haven't done it and we don't plan to." (See page 391.)
And if that wasn't reckless enough, DHHS Secretary Sebelius has since given Novartis a liability waiver through the PREP Act for injuries their swine flu vaccines and adjuvants may cause, as long as Novartis lacks prior knowledge of the products' dangers.

Are you wondering what else they may not be testing for?


AR said...


Thanks for answering my question.

In answer to yours: Yes, I wonder what effects other than carcinogenicity could be caused by MF59 and other squalene adjuvants, such as immune up-regulation, or chronic cytokine production.

Squalene is used in some skin lotions. What effects does squalene cause when introduced to the body via absorption through the skin?

Meryl Nass, M.D. said...

I suggest you read the FDA-NIH (NIAID) meeting of Dec. 2-3, 2008 that I have linked to; it contains a host of questions about the safety profile of MF59 and other novel adjuvants (those not used in routine vaccines).

The scientists and regulators are clearly concerned.

The issue imo is that certain individuals or groups will have much more dramatic reactions to these adjuvants than the rest of the population, and the effects may not develop within the one year time fram within which adverse reactions will be sought.

People claim that the effects of squalene are different when injected than when ingested or applied to the skin. This is a sensible assumption but I have not seen proof of it.

We do eat squalene, and we manufacture squalene as part of normal human biosynthesis, and it is used in lipsticks and many other personal care products. As best I know, those uses have not led to harm.

Meryl Nass, M.D. said...


A quote from Dr. Schodel (p 19):

"We are mostly concentrating on the acute responses, and the tests are mostly concentrating on what happens in the acute phase reactions, and [but the acute reactions] they are really not an
issue; ... Are there any tests that could be used in preclinical work that would actually help us grapple with the much more difficult to answer questions in the clinic, such as, for example, this suspicion that there might be autoimmune responses generated. That could have negative consequences, which you can't test in the clinic, because they are too infrequent."

It should be obvious that a number of scientists feel the jury is still out on the safety of MF59 and other novel adjuvants.

AR said...

Dr. Nass,

Thanks for your replies. As a lay person (albeit with an undergraduate degree in biology) I found this article at Mercola most helpful in describing the potential effects of squalene injection.

Squalene: The Swine Flu Vaccine's Dirty Little Secret

I would rather take my chances with the flu than with squalene, seeing as I already have some GWS symptoms, as I reported in a comment here, last year.

I was not in a vaccine trial. I had requested the injections at a local walk-in clinic. Perhaps I was deceived, and received some other vaccine. I apologize for not following up with this reply to your question before. My reply got 'poofed' into the ether when I tried to publish the comment, not a good excuse.

About 8 years ago I got a tetanus shot, with no ill after-effects. So, aluminium phosphate or aluminium potassium sulphate adjuvants are tolerated better than squalene.

While I've got your you know if it is true that farmers don't need regular tetanus boosters due to likely chronic occupational exposure to tetanus? If that is true, then I won't feel it necessary to seek out another tetanus booster, since I get rusty, dirty cuts and splinters in my garden every summer.

Meryl Nass, M.D. said...

If you had a serious adverse reaction to a vaccine, you should only get vaccines in future when absolutely necessary.

Tetanus requires an anaerobic environment for growth, and is more likely to become a problem in an abscess. So that would necessitate a shot.


daedalus2u said...

Oh come on, squalene is a natural metabolic intermediate. Sebum contains ~12% squalene. Every cell in your body can make squalene as an intermediate in cholesterol synthesis.

Just about every hydrophobic oil-like substance will work as an adjuvant (including vitamin E and vitamin E acetate) and can cause autoimmune sensitization.

Autoimmune sensitization is likely not due to specific ingredients, but rather to the generic interaction of the immune system with antigens. It is likely due to regulation of the immune system, not what the immune system is exposed to.