by NexDev | June 24, 2016 | Uncategorized
On June 22, 2016, the French Health Minister, Marisol Touraine announced the launch of the program “Genomic Medical Plan”, which consists in investing 670 million euros in 5 years to equip France with 12 platforms of high speed gene sequencing (to analyze DNA). A report entitled “Genomic Medicine in France, 2025” was submitted to the Government the same day. Sequencing of the genome consists in the complete analysis of the genes which compose DNA, allowing the diagnosis of some diseases, evaluating certain predispositions to some illnesses (predictive medicine) or even to adjust certain treatments. This plan is designed to improve the diagnosis of rare diseases, but also “common diseases” such as diabetes, obesity, and cardiovascular and neurodegenerative diseases like Alzheimer’s, for example. The goal is to establish genome clinics throughout France and to organize a national branch of genomic medicine.
To partake in the “revolution of personalized medicine”, the Minister specified that “we need to know each individual’s genome, in order to adapt medicine to the human capital of each person”.
This plan necessitates having access to thousands of numerical data (« big data ») on the population’s health. The conditions for access to this data and to their use constitute considerable ethical stakes, especially in the field of the right to privacy, and it has already been planned to consult with the National Ethics Consulting committee (CCNE) who published their Advice n°124 in January 2016 entitled:“ Ethical reflection on the evolution of genetic tests related to very high speed human DNA sequencing”.
by NexDev | June 24, 2016 | Uncategorized
On June 5, 2016 the French National Medical Academy published an informational bulletin entitled: “parity in healthcare: scientific research and medicine can no longer ignore biological differences between sexes”.
The Academy esteems that « men and women are biologically different and are not the same when faced with disease, and they should each be taken into account and treated differently”.
The bulletin states that “several European countries have already adapted their scientific research and their therapeutic strategies in function of this, whereas France continues to ignore these recommendations under the pretext of parity”. And thus, “the priority given to gender on the realities of sex, risks creating yet another injustice, therefore it’s the doctors’ and scientists’ responsibility to realize this in order to alert others and act appropriately.”
Nonetheless, “it is known that differences related to sex in fact determine the prevalence, the age when numerous diseases appear, their severity, their evolution, the metabolism, and the response to medication or diet, and behavior”.
According to Claudine Junien, a geneticist and member of the Medical Academy, “We try to erase the differences to reach equality, whereas one needs to take it into account in medical practice but also in medical prevention”.
However, sex is initially and uniquely determined in a biological manner. The genetic differences occur very early during the course of embryonic development.
The geneticist specifies that “parity is not always reached in biomedical research”, research and experiments are performed on individuals of masculine sex. The result is that “women have 1.5 to 2 times more secondary accidents linked to medication than men.” Taking these differences into account would contribute to making advances in medical prevention and practice.
According to cardiologist Vera Regitz-Zagrosek “women suffer from cardiovascular diseases which are different from men, but the diagnosis and treatment are not adapted”. This lack of differentiation of the sexes can sometimes lead to a delay in care-taking of approximately 30 minutes, which could be fatal in the case of a severe myocardial infarct for example.
On the basis of these findings, the French National Academy of Medicine has recommended proceeding to a complete revision of the “principles established from fundamental and clinical research including medical practices in everyday life situations trying to distinguish between the biological differences related to sex and to social constraints related to gender”. Basically they “recommend changing from undifferentiated medicine to sex-determined medicine” whether it be in training, prevention, practice or in research. This differentiation in medicine should be “thought of as an advance in health for women and for men”.
These recommendations from the Academy of Medecine arrive at a time when France has lagged behind. Germany has taken these differences into account for several years, and specific recommendations were published in Germany and on a European level, for example concerning coronary diseases.
For further information:
_ “Medecine denies differences between the sexes… and (wrongly) makes males the standard” (April 2013) by Peggy Sartre, author of “The Sex of Diseases”.
by NexDev | June 24, 2016 | Uncategorized
On May 31, 2016, the Committee for Legal Affairs at the European Parliament presented a draft motion proposing that robots be considered as “electronic people”. The text concerns robots capable of “making autonomous decisions in an intelligent manner” or of “interacting in an independent manner with third parties”.
For Luxembourger European Member Mady Delvaux, rapporteur of this text: “Humanity is at the dawn of an era where robots, intelligent algorithms, androids, and other forms of more and more sophisticated artificial intelligence, appear to be on the verge of setting off a new industrial revolution”.
From a legal point of view, everyone is accountable and responsible for his own actions as long as he is competent. But in the case of a robot, who would be responsible for its acts? Would it be the manufacturer, the designer of the algorithms, the seller or the owner? If we consider that the artificial intelligence of the robot exceeds the capacities of a human being, can we impute the responsibilities of its acts to the manufacturers?
According to the European report, these autonomous robots have partial responsibility. The Delvaux report notes, “The more autonomous a robot is, the less it can be considered as a simple tool controlled by another actor. (…) It’s time to adopt new rules allowing us to impute the action or inaction to the machine (totally or partially).”
Therefore, the European Parliament could propose “the creation of a legal entity specific for robots, so that at least the most sophisticated and autonomous robots be established as having the status of electronic persons with specific rights and obligations, including that of making amends to any damage inflicted on a third party.”
According to this project, the more advanced robots would need liability insurance policies with the companies in order to frame their social interactions and to manage any possible damages.
Additionally, these robots would have to be labeled so the owner could be easily identified. “The robot must be recognizable: it must have a registration number, a name, and funds to cover their liability, somewhat like a moral person. Because if the robot causes damage, there has to be a way to have recourse against it”, explains Alain Bensoussan, lawyer at the Appeals Court in Paris and legal expert in technology, especially information technology.
This resolution project recommends the institution of a “European Agency for Robots and Artificial Intelligence” to administer all of this.
by NexDev | June 23, 2016 | News
During its annual convention in Belfast on June 21, 2016, the British Medical Association (BMA) reaffirmed its opposition to assisted suicide.
The BMA is the professional association and the official union for medical doctors and students in the United Kingdom.
A motion was submitted for vote which aimed to call into question the BMA’s position on assisted suicide. Motion 80 stated that the BMA should adopt a neutral position on assisted suicide. It was rejected by two thirds of the delegates.
The advocates of assisted suicide pushed for this debate, whereas Parliament had rejected a bill on medical aid in dying in 2015. They reproached the BMA for not discussing the issue. However, the BMA had already addressed the issue on several occasions, and has not changed its position.
There have been recent precedents in Canada and in California, where the doctor’s associations have adopted a position of “neutrality” some time before the legalization of assisted suicide.
by NexDev | June 23, 2016 | Uncategorized
In France, several establishments are considering the ethical questions raised by the use of the genetic editing technique, CRISPR-Cas9.
In the journal « Science et Santé » (Science and Health) in June 2016 edited by INSERM (Inserm : French public organization dedicated to biological , medical and public health research), three specialists give their opinion from scientific, ethical and regulatory viewpoints
Jean-Claude Ameisen, President of the National Ethics Consulting Committee (« CCNE”), shares his personal comments. He states “the possible applications of the CRISPR-Cas9 technique pose ethical problems”, especially for genetic therapy which led to international discussions and to the Oviedo Convention. “It appears necessary to have a moratorium on this type of treatment, at least for security reasons”, he feels, but that “research should be encouraged”.
According to molecular biologist, Carine Giovannangeli[i], « it is a genuine technological and scientific revolution which should lead to enormous progress in our comprehension of biological mechanisms of basic life sciences, genetic therapy and biotechnology. To avoid abuse, it is indispensable to ensure compliance of current health and safety procedures. In addition, the technique is not infallible; it should not be used to transmit modifications to human descendants. In her opinion, “research should include a variety of systems, not excluding germ cells”.
Agnès Saint-Raymond, Director of the Program Design Board for the European Medicines Agency, “the trials performed in China and the United States against HIV and beta-thalassemia demonstrate incomplete mastery of the technique, even if research is advancing quickly”. She explains that “in Europe, some countries such as the United Kingdom or Belgium, authorize the creation of embryos for research purposes and did not sign the Oviedo Convention. The Francis Crick Institute in London has just begun genetic research on fertility and embryo implantation.” Among the countries forbidding the modification of germ cells, some, such as France, carry out research on embryos without having parental projects pending. The European Commission is therefore reticent to finance all genetic research on embryos while there are such substantial differences. But the train has already left the station: the debate is no longer whether a moratorium is needed for this promising technique. Good standard practices and evaluation of reports on safety and efficacy should be the criteria for any authorization. Ethical questions should be enlightening rather than coercive. For some parents transmitting a genetic disease to their off-spring is a very heavy burden. Wouldn’t there be a medical interest to avoid this by intervening on germ cells? In an uncertain context, modifying the species seems to be very adventurous, but the debate is not only for doctors: the entire public should be able to participate!”
Tugdual Derville, Alliance VITA’s General Delegate and supporter of the Stop GM Baby petition, comments on these opinions:
« We have noted that numerous specialists agree on the severity of risks related to genetically modifying the human embryo or gametes. Nevertheless, they are remarkably timid when it comes to guidelines for embryo research. However, such research represents the first step towards sliding quickly towards eugenic and trans-humanist practices.
We need to be rational: if these techniques are perfected, and demonstrate that in the future these modified embryos are viable, one will want to see GM babies born. They will be life-long guinea pigs of the technique that manufactured them. France should be at the ethical forefront, as it currently is on an international level when it defends the non-commodification of the human body and its products. Ethical guidelines for research on embryos and gametes should be addressed in a concerted international action, where our country can be a leader.”
For further information
Op-ed article « Humble faced with the embryo » by Tugdual Derville
