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CLINATEC: THAT DISCREET CLINIC WHERE NANOS ARE IMPLANTED IN THE BRAIN

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CLINATEC: THAT DISCREET CLINIC WHERE NANOS ARE IMPLANTED IN THE BRAIN.
By Agnès Rousseaux
24 October, 2012
 
Translated from French by Rudy Andria.
 
A research center of a new kind is about to lead its first experiments. Nanotechnology implants in the brain, neuro-stimulation, “regenerative medicine”, and even technologies which are able to change the behaviour: such will be the research conducted on volunteer patients at Grenoble Clinatec . Some opacity surrounds the project, which is the result of an alliance between the nuclear industry and a “start-up” of nanotechnology and neurosurgeons. How will this research be carried out? How will their business and industrial applications be controlled? “Basta!” has conducted the survey.
 
It is an “experimental clinic” where they test electronic devices implanted in the brain. Called “Clinatec,” this neuro-clinic controlled by the Grenoble CEA or Commissariat à l’Energie Atomique (Atomic Energy Commission), is working on applications of nanotechnology in the field of neuroscience, in particular on neurodegenerative diseases, such as Parkinson’s.But it is difficult to know what is really going on: a certain opacity surrounds the activities. Its being located outside the hospital site on a CEA ground with a few buildings subject to secret defence makes it a unique case in France.

At Clinatec, talks are on brain-machine interface, deep neuro-stimulation,and nano-implants in the skull. These novel medical devices will be tested in the next few months on patients. This alliance between nuclear industry, that of nanotechnology and neuroscience researchers bodes ill for the necessary democratic control which should guide the use of these dangerous sciences , at the very least, futuristic , b
ecause nanotechnology is not without many problems (please see our articles on the issue). Would they, by any chance, be trying to very discreetly invent at Clinatec the future bionic man bristling with electrodes and monitored by sensors?
 
Brain implants against nervous breakdown or obesity.
 
The common point of these studies are the development of medical devices implanted in the human body, like this kit of electrical stimulation of the brain which helps to mitigate the effects of Parkinson’s disease. A kind of brain pacemaker. More than 40,000 patients worldwide have already been “implanted”,after a technique developed by Professor Alim-Louis Benabid, one of the designers of the Clinatec Project. The goal today is to develop less invasive techniques of reduced size, thanks to micro and nanotechnologies. Another example: neuroprosthesis to enable quadriplegic patients to control a robotic arm through electrodes implanted in the skull or move through a motorized exoskeleton.
 
Clinatec is the result of a partnership between CEA, Grenoble University Hospital (CHU) and Inserm. The project is led by Jean Therme, Director of the Grenoble CEA [1] and neurosurgeon Alim-Louis Benabid [2], who is currently a CEA scientific advisor. Clinatec is an extension of the work of the neurosurgeon on deep brain stimulation and Parkinson’s disease. But the research field is widening: epilepsy, mental disorders, obsessive compulsive disorder (OCD) … Clinatec Director François Berger, Medical Professor [3], raises the possibility of treating obesity or anorexiaby neuro-stimulation [4] and maybe nervous depression in the near future.
 
These new research fields, with technologies whose consequences are difficult to control, do not seem to unduly disturb the government. The Regional Health Agency (ARS) granted a license to open Clinatec in 2010 . After an inspection visit on April 16, 2012, a decree authorizes the activity center as a “biomedical research place dedicated to the applications of micro- and nanotechnology to medicine.” A very vague definition. But it doesn’t matter, the research can start. Will they be conducted with the same opacity surrounding the project development from the outset? 
 

Geneviève Fioraso, Clinatec Minister.

The building of Clinatec was launched in 2008 with a “restricted procedure”: as a statutory body classified “defense secret” it is not subject to the Procurement Code. Secrecy cult is strongly criticized by its detractors. Why carry out clinic research outside a hospital? What is Clinatec’s status? Does it have an ethics committee? Whom is its “Management Board” which includes François Berger and Alim-Louis Benabid to be composed of?

We did not wish to talk about the project as long as we did not have the permission (from ARS, ed), says François Berger, who is being interviewed by “Basta!”. We are just beginning to communicate. We also decided not to make a science-fiction communication, but keep a low profile about what we do at Clinatec.” After opacity, time for transparency ?

Clinatec Project is strongly supported by the city of Grenoble. Its mayor, Socialist Michel Destot is a strong supporter. Nothing surprising: he used to be a former CEA engineer, and also led a start-up born in the lap of CEA itself. As a mayor, he has been presiding over Grenoble CHU or University Hospital Center since 1995, another Clinatec key actor. Professor Alim-Louis Benabid was on his list in the last local elections. This researcher also chaired the support committee of Geneviève Fioraso, then Assistant to the City of Grenoble, in the recent legislative elections.

Clinatec, the dream of nuclear engineers.

Geneviève Fioraso, the current Minister of Higher Education Research, responsible for “innovation” in the campaign team of François Hollande, is another Clinatec key player. The joint enterprise she chairs, SEM Minatec Enterprise, is housing Clinatec in its activity area. Her partner, Stéphane Siebert, is Deputy Director of Grenoble CEA. Destot, Fioraso, Siebert means CEA is within the City Hall, Fioraso in the Higher Education means CEA is within the Ministry” , declares Grenoble ecologist Raymond Avrillier in his analysis.

CEA Director makes us run around, but we do cope” says Geneviève Fioraso [5], about Jean Therme. As the Director of Grenoble CEA, he is the designer of Clinatec. A “dream” started on June 2, 2006 in his office in the presence of Alain Bugat, General Armament Engineer [6], then CEA Deputy Head and of Bernard Bigot, then High Commissioner to Atomic Energy and now vice-chairman of Areva Supervisory Board and CEA Deputy Head [7]. Will this dream cherished by the men of the nuclear industry, both civil and military, turn into a nightmare for democracy?

Trade secret or top defense secret?
 
 With influential local officials, the CEA and the innovation argument it is no surprise that the project gets funded by a plan-contract between the state and local authorities. Over 20 million euros are provided by the state and local officials [8]. Grenoble municipality contributes to the tune of 2,2 million euros. Without being given information nor permission from the City Council, the environmentalistelected representatives, who published a complete file on Clinatec, protested in 2009.. Despite their repeated requests and a favourable opinion from the Commission for the Access to Administrative Documents (CADA), these officials said they had received, after two years of inquiries, only one document from the state. Reason: trade secret or defence secret.
Three years later, the researchers could begin operations. But before launching the clinical tests, they must be given another green light by the National Agency for Medicinal and Health Products Safety (ANSM), and have a Committee for the Protection of the Persons (CPP), as required by the biomedical research law. Problem: at ANSM and CPP in the Rhône – Alps region, nobody has seen the request for permission. “Normal“, replies the representative for the research pole at the Grenoble Teaching Hospital (CHU),”there is no clinical research project in progress” .
 
First patients in February 2013.
 
Research would be at “projects of projects” stage,” but not yet at “research protocols” or clinical tests stage. Is a date envisaged for the patients’ reception? “No schedule has been fixed yet,” says the Teaching Hospital (CHU) Head. Obviously, questions are not welcome. “Clinatec’s inauguration date is the best kept secret in Grenoble,” quipped Grenoble-based “Pièces et Mains d’Oeuvre” Collective, which is strongly opposed to the project (please read our interview).
 
According to the order of the Regional Health Agency in April 2012, biomedical research, however, must be conducted within the year, otherwise the permission becomes null and void. The place is operational, confirm the CHU authorities and “hospital projects could switch to this site.” For example? A “machine setting on healthy volunteers” … The first non-therapeutic research protocol is scheduled for mid-November, confirms François Berger to Basta!. Fifty people or so are already working at Clinatec, says its director. The first surgical procedures on patients are scheduled for February-March 2013. Permissions remain to be granted.
 
Surgical unit of the future.
 
Engineers and physicians will therefore be together in the same 6 000 m2 secure building [9], which isn’t a hospital establishment. They will have a common mission i.e putting nanos in the head of guineapigs-patients. They will benefit from substancial means: research labs, pre-clinical experimental zones, surgical units and even animal facilities to provide guinea pigs – rats, piglets and primates – before starting the tests on human beings.
 
These individuals will stay in a “futuristic surgical ward where physicians and technologists will cooperate, and six in-patient wards. To enable physicians and engineers to understand each other, “the engineers have to be present in the surgical unit until the end”, François Berger pleads. Innovations “will be tested on voluntary patients, who will have giveń their informed consent” first́, stated Clinatec, which addedthat “Clinatec’s medical and surgical activities appertain to researchers and surgeons from research organisations like Inserm or from Teaching Hospitals (CHU)”, and not to the CEA. Patients will appreciate that.
 

“Knowledge transfer to industry”.

Performing research, including on human beings, with risky technologies is one thing. Commercialising applications for industry is another. Does this frontier between clinical tests and industrial applications exist at Clinatec? The centre is a “hotel for projects, opento academic and industrial collaboration”. Facilities can be rented for both public and private research purposes. Clinatec is referred to as a place allowing “knowledge and know-how transfer to industry ” [10] and is introduced as an exemplary public-private partnership . By placing all the necessary competences in the same place, projects’ promoters hope “to speed up the process of technology transfer to the patient” via thepharmaceutical or medical industry.

Even long before setting down to work, economic markets already seem assured. The Laboratory of Electronics and Information Technologies (Leti) of Grenoble CEA, which Clinatec depends on, is particularly keen on close cooperation with the private sector. Its slogan? “Innovation at the service of industry”. Its objective? Strive “to reinforce the competitiveness of its [365] industrial partners“. Leti prides itself on being one of the most prolific research institutes in the world, in technological start-ups. Clinatec’s geographic closeness with the firms on the site – Siemens, Philips, Thales, Bio-Mérieux, Becton Dickinson or Sanofi Aventis – is definitely an asset to speed up the transfer of these nano-medical innovations!

Which business opportunities?

A U.S. company, Medtronic, already sells “deep neurological brain stimulation kits” for people with Parkinson’s disease. A system which is the result of Professor Alim-Louis Benabid’s research work. The firm, nicknamed “the Microsoft of medical implants,” according to PMO, achieved a 16.2 billion dollar turnover in 2012, probably thanks to the new version of its neurological stimulator [11].

With this implant, patients can improve their speech or mobility ability, but one has to make sure not to get the wrong program, because the stimulation of the “speech” function can hinder mobility and vice versa [12]!
This technology is still high risk: if poorly implemented, it can cause coma or death of the patient.

From the treatment of Parkinson’s to “regenerative medicine.”

The definition of new avenues for future medicine involves a new culture of research,” says Clinatec’s presentation file . We hope to go well beyond those early uses. Researchers will mainly work on neurostimulation, on the localized administration of drugs through the pumps placed in the body, for example, or the functional substitution of machines replacing over failed functions . They could also concentrate on magnetic stimulation, to fight against depression.

We are venturing here far beyond the treatment of the uncontrolled movements of Parkinson’s disease. The question is to stimulate with electrodes the reward brain circuitry, as shown by experiments in Germany for the treatment of severe depression. In Grenoble, “regarding this issue, we’re only at a theoretical research stage, not at clinical tests stage yet ,” points out François Berger. Will we soon have brain implants to erase our bad memories, stimulate our joviality or change our perception of the world?

In 2008, the Center’s director reported another possible application i.e. the use of implants for “regenerative medicine“. Neurostimulation would start before the onset of symptoms, to slow down the degenerative process. “It should then come much earlier, perhaps be pre-clinical, in the event we have biomarkers, which would not fail to cause ethical problems [13],” admits François Berger … Imagine electrodes implanted in the brain at birth, electrodes which will speed up to prevent aging.

“You can change someone’s personality.”

The fact of having some device implants that will treat the disease before it appears, can also be an advantage, even if it is somewhat amazing ” François Berger argued before the Parliament. “It is true that one of the goals of nanomedicine is to not have to repair. (…) Through nanomedicine, we will provide a new border between the normal and the pathological. We will have to be extremely careful. These are decisions of the firms, “warns Clinatec Director[14].

What does his colleague Alim-Louis Benabid think? “With electrodes and brain implants, you can change someone’s personality, from abnormal to normal. We can put people from a suicidal state to jolly one. Should we then conclude that we can manipulate people and get them to work in quick time? Certainly, but they are already made to work in quick time through other different means», Benabib allegedly declared in January. [15] For the Union of psychiatry, there’s no doubt: “The creation of Clinatec is clearly a step furthermore in a techno-scientist escape forward , with no other purpose than controlling populations, by reducing the human being to a mere brain, a mere behaviour, a mere utility, and a mere docility.»

What about the precautionary principle?
 

Clinatec embodies a “new culture of research” with unprecedented implications for the human being, and which in addition aims at “accelerating” the transfer of these technologies to industry. These twofold objectives are far from being consistent with the precautionary principle. “The clinician that I am can however, only sound the alarm to the precautionary principle. Too much regulation kills therapeutic innovation, “said François Berger at a hearing by the Parliamentary Office for the Evaluation of Scientific and Technological Choices. “Obviously, people are scared,” pointed out the researcher, who was thankful to the conference organization for giving researchers “the opportunity to educate citizens” on the issue.

Letting people believe that we would impose a totalitarian “nanoworld” on the population without a preliminary debate, is not only misleading manipulation, but also a form of well known political paranoia, based on the conspiracy theory, the hatred of the elites (sic), of the elected officials, and other authorities“, cried out Grenoble Mayor, Michel Destot, at the inauguration of Minatec in 2006. “There is much talk of the precautionary principle for rather dark domains for us and where scientists cannot have their say or takea position. The application of this principle, in my view, leads to inaction and immobilism, which does not seem to be the best choice for me”, stated the official, who seemed to prefer CEA action and voluntarism which are undeniable in nuclear matters. Any philosophical and ethical questionning would be tantamount to fearful inertia.
 
 
Chips in the brain.
 
Implanting electrodes in the brain is not without danger: “Poor location of the electrode may also cause laughter or, on the contrary, states of sadness,” advanced François Berger [16]. And the technique is not quite sure: Researchers from the computer company McAfee have discovered a way of diverting an insulin pump installed in the body of a patient. They could inject a shot the equivalent of 45 days’ treatment in one go… Others have shown the ability to remotely reprogram an implanted defibrillator. Computer bugs in these medical devices are not uncommon [17].

A hacker had allegedly found a way to hack remote pacemakers and cause fatal electric shocks by rewriting the computer code … Imagine the impact on the brain! Medtronic, a leading manufacturer of neurological pacemakers advised to avoid security gates at airports, and warned that the neurostimulator can turn on or off when close to small permanent magnets, such as speakers or refrigerator doors.

High tech version of electroshock?

Will the nano-miniaturization of these devices make them safer? Or on the contrary more uncontrollable? In the race for nanotechnology [18], such projects as Clinatec are presented as symbols of French excellence. Current medicine, based on anatomy and symptoms, is stepping to regenerative nano medicine, so what does it have in store for us ? Where is the boundary between medicine and human “enhancement”,transhumanists’ fond topic? How far can you dive into the brain?

And is it to be wished to treat symptoms rather than the environmental factors of neurodegenerative diseases? Neurostimulation “corrects the symptoms and not the disease. In other words, as recognized by Benabid himself, electrodesdo not cure. “When applied to mental suffering, they become only the high-tech version of electroshock”, claims Pièces et Main d’Oeuvre Collective. “No matter what the cause of depression, addiction, food disorder, and OCD, just send the correct frequency and say no more!”

Society Choices.
 
If these techniques help make the life of Parkinson’s patients easier, the risks of abuse are no less considerable. Neuroprosthetics linking human and machine has been around for some decades. But “miniaturization due to nanotechnology is promising unprecedented qualitative leap,” stated PMO (Pièces et Main d’Oeuvre). The use of nanotechnology is already envisaged for “aggressive purposes, whether military or consumeristpointed out the National Consultative Ethics Committee in 2007.Investing without societal reflection, without any awareness of human dignity, with some sort of innocence, in an environment and medicine that would a priori produce well-being and health thanks to nanotechnology, would paradoxically lead to the banishment of man himself.”
 
Concerns which Clinatec promoters do not seem to share. Each year in France 60,000 people receive a pacemaker for their heart failure, according to the Clinatec presentation file, and “many more people have hearing aids and glasses which are very much widespread in our societies “. Why then worry about one more “medical device” ? Glasses with nanoelectrodes in the brain!, there would be only one step, suggested Clinatec proponents. A step we have crossed, without any debate.
Agnès Rousseaux

@AgnesRousseaux sur twitter

A lire aussi :
- Nanotechnologies : tous cobayes de la nano-bouffe ?
- Nanotechnologies : « Eviter que l’histoire de l’amiante ne se répète »
- Le débat national sur les nanotechnologies fait naufrage
- « Avec les nanotechnologies, nous entrons dans une société de contrainte, totalitaire »
- Face aux nanotechnologies, l’Afsset appelle à « agir sans attendre »

Résumé du fonctionnement de Clinatec (dossier de présentation du CEA) :

Notes

[1] Les deux objectifs majeurs du CEA sont : « devenir le premier organisme européen de recherche technologique et garantir la pérennité de la dissuasion nucléaire », rappelle le dossier de présentation de Clinatec

[2] Alim Benabid est professeur émérite de l’Université Joseph Fourier, il a été Chef du service de neurochirurgie au CHU Grenoble de 1989 à 2004 et Directeur de l’Unité INSERM U318 de 1988 à 2007, membre de l’Académie des Sciences et de l’Académie de Médecine.

[3] François Berger, Institut des neurosciences de Grenoble, équipe nano médecine et cerveau (INSERM- CEA)

[4] Audition devant l’Office parlementaire d’évaluation des choix scientifiques et technologiques du 7/11/06

[5] Source : Les Échos, 21/10/2008.

[6] Membre du conseil d’administration de DCNS, EDF et Cogema.

[7] Source : Le mensuel, journal interne du CEA, n°150, mai 2011, cité par PMO

[8] Une partie du financement est également apporté par la Fondation philanthropique Edmond J. Safra.

[9] Voir les détails donnés par l’architecte

[10] Notamment lors de colloques organisés sous égide de Nicolas Sarkozy et de Roselyne Bachelot, ministre de la Santé, en 2009 et 2010

[11] « Avec batteries sans fil rechargeables à travers la peau par induction (comme les brosses à dents électriques) », explique un site suisse sur la maladie de Parkinson. Ce dispositif est remboursé par la Sécurité sociale.

[12] « Les patients chez lesquels la stimulation permet une amélioration de la mobilité mais limite également la faculté de la parole peuvent passer, selon la situation, d’un programme “mettant l’accent sur le langage” (par exemple téléphoner, discuter) à un programme “mettant l’accent sur le mouvement” (par exemple marcher, écrire) » Source : Parkinson.ch.

[13] Source : Office parlementaire d’évaluation des choix scientifiques et technologiques, Exploration du cerveau, Neurosciences : Avancées scientifiques, enjeux éthiques, Compte-rendu de l’audition publique du 26 mars 2008

[14] Audition devant l’Office parlementaire d’évaluation des choix scientifiques et technologiques, 7/11/06.

[15] Lors d’une présentation publique à Saint-Ismier, le 17 janvier 2012, propos rapportés par PMO

[16] Pour Luc Mallet, Psychiatre, chercheur au centre de recherche de l’Institut du Cerveau et de la Moelle épinière (ICM), les observations sur les erreurs d’implantation ont montré, de façon décisive, la possibilité d’agir sur des comportements, des affects, des cognitions, en modulant de façon très précise de toutes petites zones au coeur du cerveau, les « ganglions de la base », alors que jusqu’à présent, on mettait en avant le rôle de ces petites structures dans la motricité. « La stimulation de zones très précises, par exemple, dans une petite zone qui s’appelle « noyau sous-thalamique », qui est toute petite (à l’échelle des millimètres), peut induire un état d’excitation et d’euphorie. » Source par le Sénat, le 29 juin 2011

[17] L’Organisation américaine de l’alimentation et des médicaments (FDA) s’est penchée sur le cas des pompes à perfusion qui auraient causé près de 20 000 blessures graves et plus de 700 morts entre 2005 et 2009, à cause d’erreurs de logiciels. Source

Written by rudy2

November 11, 2012 at 09:34

One Response

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