The Nobel Prize winner and the unethical autism trial

Luc Montagnier is a winner of the Nobel Prize for Medicine in 2008 for his discovery of HIV, the virus that causes AIDS.  Since then his achievements have been more ignoble; he has asserted that nutrition can be used to clear the body of HIV on camera in an interview for a film denying the link between HIV & AIDS and has patented a machine that he claims is capable of detecting radio waves from the DNA of pathogenic bacteria.  This latter invention turns out to have been identical to a machine created by discredited scientist Jacques Benveniste, who believed it could be used to transmit homeopathy down telephone wires.  Montagnier has even claimed that this machine can be used to detect the presence of HIV derived DNA in tissue samples, including in red blood cells, which do not have any DNA.  Montagnier is clearly sincere in these nonsensical beliefs as he presented this research at a meeting of fellow Nobel Prize winners, to incredulous muttering and a minima of polite applause – damning criticism considering the audience.

Now Montagnier is preparing a research project that combines these eccentricities and adds to them extraordinary ethical breaches.

In conjunction with the Autism Treatment Trust (ATT) and the Autism Research Institute (ARI), both of whom support unorthodox and sometimes dangerous treatments for autism, the following research proposal has been advertised:

We are finally in a position to run some very exciting investigations/interventions with the support of Professor Montagnier, Nobel Prize winner for Medicine (for the discovery of HIV) and Dr. C. Skorupka a DAN! practitioner from Paris and long time friend. The project proposes to look at potential bacterial and viral chronic infections in autism. Prof Montagnier is of the view that some abnormalities in autism as well as in a whole range of neurological conditions, such as chronic fatigue and multiple sclerosis may be caused by potential infective agents. These would be difficult to the immune system to track down and would affect cell function thereby contributing to the development of the pathologies. He has developed a new technique that detects, by resonance, the genetic material of these potential infective agents. Additionally, using a very sensitive PCR assay, he can screen for a range of gram positive and gram negative bacteria as well as mycoplasma and borrelia (Lyme disease). He can also look at viruses (PCR assays under development). We are not alone in believing that this approach can help develop our understanding of the causes of autism and enable it to be treated more effectively. The proposed treatment combines a succession of antibiotics with basic biomedical supplements and probiotics. These antibiotics block cell division rather than kill bacteria, thereby avoiding potential side effects. Unfortunately, at the moment, there is no funding available to cover the costs of this project, but we are hoping to use the data collected to help us obtain funding for future research.

We offer your child the opportunity to be part of this project and to access to the Montagnier Infection Screen protocol. There will be medical follow up from Dr. Skorupka. The details of the project are outlined below. The total cost per child is likely to be around £1800, spread over a six-month period (details below). The antibiotic treatment is not included and may cost some £30- £60 a month, depending of the particular antibiotic selected. Every two months each child’s progress will be reviewed by Dr. Skorupka and Dr. Amet at ATT with interim progress reviews carried out by phone.

The project involves 2 blood tests, one at the start and the other after 6 months of treatment. Also integral to the project are a standardised behavioural evaluation (ADOS) and Vineland Test, both at the start and at the end of the project. If you are interested in participating in this project please contact us as soon as possible. We intend to commence testing on the 14th and 15th of September. We will be able to accommodate 12 children at first, but will consider including additional participants if demand is high. Please note that there is absolutely no obligation to continue with the full proposed treatment if your child clearly does not benefit from it, but we recommend at least 3 months of treatment in order for you to evaluate of potential benefits, and of course the treatment will depend on the laboratory findings and clinical evaluation of each child.

Aims of the project:

1- Investigate the possibility that some cases of autism are associated with a range of bacterial infections, based on laboratory testing and clinical examination conducted by Dr. C. Skorupka in Edinburgh.

2- Assess the ASD children for the presence of nanobacteria following Prof Luc Montagnier’s protocol of investigations. The protocol would require a blood draw conducted at the clinic with the help of our nurse. The blood normally has to be centrifugated immediately and the supernatant extracted, then frozen to -80C and shipped on carboice to France.

3- Evaluate the efficacy of antibiotic intervention as well as behavioural evaluations (ATEC and ADOS). This would involve meeting with Dr Skopurpka and Dr. Amet every 2 months and reviewing progress over the phone in the interim month.

4- Report outcomes.

Montagnier believes that his resonance machine can detect the distinguish the DNA of pathogenic bacteria and viruses.  There is no evidence, other than a non-peer reviewed paper Montagnier self published in a journal he edits, that this is possible.  This paper makes  most extraordinary claims that remain unreplicated – a basic requirement for research to be considered worth responding too, much less accepted.  Therefore it would be unwise to consider it real, and mistaken to use it as a basis for a treatment protocol.

However parts of the protocol are rational from basic scientific point of view.  PCR assays can be used to detect bacterial and viral DNA present at low levels and it may be the case that antibiotics that block cell division in bacteria have reduced side effects, if the side effects are caused by the toxic byproducts of bacteria dying.  Arresting their growth would theoretically allow various immune mechanisms to act with greater efficiency.  Unfortunately there is no evidence that bacterial or viral infections have a part to play in the causes of autism.  It is not good practice to base a research protocol on assumptions that are inconsistent with observations.

Perhaps the most fatal flaw is that there appears to be no control group.  There is no means of determining whether this treatment, nonsensical as it may be, has caused changes in a treatment group compared to control.  By design it cannot produce meaningful data.

The most disturbing part of this protocol is not it’s flawed premise, disregard of existing data, the use of implausible technology or even the lack of a control group but that it will cost £1800, plus an additional £180 – £360 for participants.  This suggests an extraordinary disregard for ethics, to charge parents of autistic children, desperate for succesful intervention, large sums of a money to participate in a useless trial  is ethically questionable at best.  This leads to the question, was ethical permission sought for this trial?

Most research trials involving humans are passed through an ethical review process, and in some cases this is a statutory requirement, as the MHRA make clear:

Clinical trials in the UK are regulated by The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) as amended. These regulations implement Directive 2001/20/EC (‘The Clinical Trials Directive’).  According to the Clinical Trials Directive, clinical trials of medicinal products in human subjects requires authorisation by the competent authority (MHRA in the UK) and a favourable opinion by an ethics committee. This authorisation is granted in the form of a clinical trial authorisation (CTA).

The criteria for coming under the authority of the MHRA are laid out in this document below.

This research may need MHRA oversight with respect to the answers to  A.1, B.1, C.1, D.1 & E.1-5.  It is a study involving human patients investigating the use of medical products aimed at treating disease to determine their effects in a non-standard manner.  There is no indication that this research has been approved by the MHRA and attempts to contact the Autism Treatment Trust have been unsuccessful.  If this research should have been overseen by the MHRA and has not then there will be a clear breach of legislation.  This trial, and those who run it, will be breaking  the law.

Luc Montagnier’s eccentricities have led him to a situation where vulnerable people will be exploited and the possibility that criminal acts will be committed.

This is the inevitable end point of quackery.  Staunch believers in unorthodox medical treatments and theories inevitably run foul of acceptable ethics, whether it’s homeopaths in Tanzania or  Nobel Prize winners in Paris.  It doesn’t matter how respectable the person or how prestigious their prize, quackery corrupts the mind and corrodes the reputation.  Their belief in the fundamental correctness of their thinking eventually leads them to actions where the norms of ethics and the rule of law are secondary considerations or no consideration at all.  This is why quackery should be challenged and those who associate with it discouraged.

 

Update

Anthony Cox has also blogged this and has made enquiries to the MHRA.