They call it the Nobel disease.
Linus Pauling is the prototypical example. A brilliant chemist who won two Nobel Prizes, one for chemistry and the Nobel Peace Prize, in his later years Pauling became convinced that high dose vitamin C was a highly effective treatment for cancer and the common cold and, expanding upon that, came to believe in the quackery that is orthomolecular medicine. As a result, Pauling’s reputation was tainted for all time, and he became known more for his crankery than his successes. Since his death, Pauling’s successors have continued to chase his dream with minimal success because even massive doses of vitamin C have little or no effect on cancer and may even interfere with some chemotherapy regimens.
Unfortunately, Pauling is not alone in becoming a crank. For example, there’s Louis Ignarro, who won the Nobel Prize in Medicine for discovering nitric oxide signaling pathways. Unfortunately, Ignarro didn’t even wait until his later years to descend into the swamp of dubious science. Four years ago I saw Ignarro give an ostensibly scientific talk at a surgical meeting, a talk whose second half was dominated by a discussion of arginine supplementation as a heart disease cure-all and the selling of his book entitled NO More Heart Disease: How Nitric Oxide Can Prevent–Even Reverse–Heart Disease and Strokes. I later found out that Ignarro was a paid shill for HerbaLife. I still remember how betrayed I felt as his talk progressed and wondered if the meeting organizers felt a similar sense of betrayal or whether they were too in awe of the Nobel aura to notice. Then there was Nikolaas Tinbergen, whose adoption of the “refrigerator mother” hypothesis as the cause of autism in his Nobel lecture led Prometheus to quip that Tinbergen’s Nobel acceptance speech represented a “nearly unbeatable record for shortest time between receiving the Nobel Prize and saying something really stupid about a field in which the recipient had little experience.”
Now it looks as though there’s another Nobel crank out there, and he’s an autism crank now. This time around, the Nobel Laureate who’s descending into pseudoscience is French virologist Luc Montagnier, who shared the Nobel Prize for his discovery of the human immunodeficiency with Harald zur Hausen, who discovered the link between the human papilloma virus and cervical cancer. First, earlier this summer, Montagnier appeared to endorse homeopathy:
French virologist Luc Montagnier stunned his colleagues at a prestigious international conference when he presented a new method for detecting viral infections that bore close parallels to the basic tenets of homeopathy.
Although fellow Nobel prize winners — who view homeopathy as quackery — were left openly shaking their heads, Montagnier’s comments were rapidly embraced by homeopaths eager for greater credibility.
Montagnier told the conference last week that solutions containing the DNA of pathogenic bacteria and viruses, including HIV, “could emit low frequency radio waves” that induced surrounding water molecules to become arranged into “nanostructures”. These water molecules, he said, could also emit radio waves
He suggested water could retain such properties even after the original solutions were massively diluted, to the point where the original DNA had effectively vanished. In this way, he suggested, water could retain the “memory” of substances with which it had been in contact — and doctors could use the emissions to detect disease.
Montagnier may not beat Tinbergen’s record for shortest time to descend into pseudoscience after winning the Nobel Prize, but he’s definitely in contention. He only won the Nobel Prize in 2008, and it only took him two years to endorse homepathy-like concepts. He’s also made a name for himself, such as it is, by appearing in the HIV/AIDS denialist film House of Numbers stating that HIV can be cleared naturally through nutrition and supplements:
Meanwhile, patented a device to detect these fantastical radiowaves allegedly emitted by bacterial and viral DNA in water. This he did after publishing a paper in a journal that for which himelf is the editor after a mere three days between submission and acceptance, which prompted Le Canard Noir to nominate him for an Ignobel Prize last year. From there it only took Montagnier a few months more to turn his eye to applying that “knowledge” to autism, as I discovered from Gimpy, Anthony Cox. Unfortunately, the pseudoscience that Montagnier appears to have embraced with respect to autism is combined with a highly unethical study in a manner that would put Andrew Wakefield to shame.
The trial is sponsored by the Autism Treatment Trust (ATT) and the Autism Research Institute (ARI), both institutions that are–shall we say?–not exactly known for their scientific rigor. Apparently Montagnier has teamed up with a Dr. Corinne Skorupka, who is a DAN! practitioner from France, and a Dr. Lorene Amet, who is described as a neuroscientist but is a PhD and not an MD (i.e., not a clinician). The study that, together, the Nobel Prize winner and the woo-meisters propose is described thusly:
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.
Before I discuss the “study” itself, let me just say one thing here. Whenever you see an “investigator” charge patients to undergo an experimental protocol, be very very wary. Be very, very afraid. In general, with very few exceptions, reputable medical researchers do not charge patients to undergo experimental protocols; their studies are funded with grants from the government, private foundations, or pharmaceutical companies. Yet here we have Montagnier and colleagues charging the parents of autistic children:
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 Â£1800, spread over a six-month period (details below). The antibiotic treatment is not included and may cost some Â£30- Â£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.
Perhaps even worse than that, check out how badly designed this experimental protocol is. Its specific aims are described thusly:
- 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.
- 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.
- 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.
- Report outcomes.
Montagnier intends to enroll 12 children into this study.
How is this study unethical? Let me count the ways. First, as I mentioned, it charges the patient for an experimental protocol. More importantly, it tests a hypothesis that is implausible from a biological standpoint. Still, it’s not so implausible that bacterial or viral infection might cause or contribute to autism that it reaches homeopathy-level implausible. However, the hypothesis that infections cause autism doesn’t reach the level of plausibility where it can be considered ethical to subject human subjects to a regimen based on it. One reason is that there are no convincing preclinical data that support the idea that bacterial or viral infections either cause or contribute to autism. Quite the opposite, in fact. Of course, where scientists note that there is no relationship between specific infections and autism, no doubt Montagnier would claim that any old bacterial infection will do. After all, his magic device, at least according to him, detects any bacterial or viral DNA, even after it’s been diluted to nonexistence and the water filtered so that no DNA could be left behind.
But it gets even worse than that.
Based on an unsupported hypothesis that bacterial infections cause autism, Montagnier will be subjecting autistic children to blood draws and treatment with antibiotics. The former will cause unnecessary pain and suffering, and the latter has the potential to cause the complications that can occur due to long term antibiotic use over several months. These include antibiotic-induced diarrhea and even C. difficile colitis, as well as a variety of other problems that can be caused when normal bacterial flora are killed off with antibiotics. Since there is no reason to suspect that these children have any sort of clinical infection that needs treatment, giving them antibiotics for several months is all risk, no potential benefit.
But it gets even worse than that.
The study proposed is poorly designed even for a pilot study. There is no control group, for one thing; so any results observed will be nigh meaningless. After all, there will only be 12 children; any improvements observed will not be even the least bit generalizable because we won’t know whether they were due to random variation or any treatment intervention. Moreover, because the selection criteria for the study are not specified, there is no way of knowing how much selection bias might be operative there. I realize that this is only a pilot study, but come on! Even pilot studies are designed to provide some meaningful data that can be used to justify further clinical trials.
What I want to know is how quacks like this can get away with doing such unethical clinical trials. In the U.S., we have Mark and David Geier, who created an Institutional Review Board at their own “research institute” with cronies. The likely reason they could get away with it was because their research wasn’t federally funded and thus they could skirt the Common Rule, which applies only to federally-funded research or research being used to support an application for FDA approval, although many states require any human subjects research carried within their borders to adhere to the Common Rule regardless of funding source. I’m not sufficiently familiar with the U.K. to know exactly how its ethical oversight of human subjects research works, but fortunately Gimpy is there to explain. Given that this trial proposes to use medicinal compounts (antibiotics), it clearly requires oversight from an ethics board. Clinical trials are regulated by the Medicines and Health Care products Regulatory Agency (MHRA), which enforces regulations that dictate that clinical trials of medicinal products in human subjects requires authorization by the MHRA and authorization by an ethics committee much like IRBs in the United States. Not only is there no indication that this trial has obtained the necessary approvals from the MHRA and an applicable ethics committee. In other words, it’s bad science and bad ethics, all rolled into one.
It rather reminds me of Andrew Wakefield, actually.
I’ve wondered how some Nobel Laureates, after having achieved so much at science, proving themselves at the highest levels by making fundamental contributions to our understanding of science that rate the highest honors, somehow end up embracing dubious science (Ignarro) or even outright pseudoscience (Pauling or Montagnier). Does the fame go to their head? Do they come to think themselves so much more creative than other scientists that their fantastical ideas become plausible to them? Does winning the Nobel Prize lead some scientists to think that the genius they showed in their own area of expertise that allowed them to win such an exalted prize also applies to other areas of science outside their area of expertise? Who knows? What I do know is that Montagnier has become the latest Nobel Laureate to go woo.