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Biomedical subjects

C Hervé

Publications and source records attributed to C Hervé.

At least 19 recordsLinked to original sources

[Evaluation of the risk of abortion abuse resulting from the two-week legal delay in France].

OBJECTIVE: The legal delay for abortion in France has recently been prolonged from 10 (12 weeks of amenorrhea) to 12 weeks (14 weeks of amenorrhea). With the progress in sonography, certain foetuses may exhibit malformations during the first trimester. Diagnosis of foetal gender at 12 weeks of amenorrhea is sometimes possible. We studied the possibility that the prolonged legal delay before abortion might incite women to abort, simply on sonographic criteria. METHODS: Our enquiry was conducted in March 2001 in the department of Obstetrics and Gynaecology of the Jean Verdier hospital in Bondy. Two questionnaires were drawn-up by the Medical Ethics Laboratory of the Necker Hospital in Paris and were distributed to 128 women and 24 nurses. RESULTS: Recourse to abortion was high if laparoschisis or the absence of a hand was revealed, low in the case of opacity of the neck, and almost inexistent in the case of unwanted gender, in a female population with less than one child. CONCLUSION: A national consensus on foetal abnormalities to be searched for, and not to be searched for (Number of fingers? Upper lip?...) and the eventual detection of the gender during sonography of the 1st trimester is urgent in view of the technological progress made. Clear and reassuring information is essential when confronted with foetal abnormalities and must lead to complete and precise antenatal diagnosis (caryotyping, sonographic control 2 or 3 weeks later).

Abortion, Legal↗

[Clinical study and prevalence of fetal alcohol syndrome in medico-social institutions of the Reunion Island].

BACKGROUND: Fetal alcohol syndrome (FAS) is a major problem in the Reunion Island and the Public Health Authorities decided to determine its prevalence in their medico-social centers on 31 December 1996. MATERIAL AND METHODS: A questionnaire was established to identify affected patients in the 20 medico-social centers in charge of 1320 children. Eighty-eight children were selected and 87 could be analyzed. RESULTS: Sixty-four of 87 (76.3%) were FAS and 23 of 87 (23.7%) had closely alcohol-related diseases. The prevalence was between 7.1 and 14.1% and lower than expected from available data. CONCLUSION: The study allowed to precise the social and familial factors predisposing to alcohol addiction during pregnancy. A TV prevention message will be broadcasted after this study.

Adolescent↗

[Living donors for transplantation and bioethics laws. Survey with French transplantation professionals].

OBJECTIVES: Renewed interest in living donor transplantation in France led us to survey French transplanters to determine their opinion concerning this technique and the ethical issues involved. Their concerns and suggestions about current legislation were examined. METHODS: An anonymous questionnaire was sent to physicians working in the different kidney, liver and lung transplantation units operating in France. RESULTS: French transplanters expressed a wide range of opinions concerning living donor transplantation and possible broadening of the current regulations. Sixty-two percent of the transplanters had a positive opinion on living donor transplantation compared with 22% who expressed a negative opinion. For 23% of the transplanters, it is preferable to transplant with a living donor graft compared with 64% who preferred cadaveric grafts. A living donor transplantation program is under study in 65% of the units. There is some debate concerning the legitimate nature of the emergency donation situation for spouses. About one-half of the transplanters were in favor of controlled extension of potential donors to second degree relatives and to the recipient's spouse or living partner. CONCLUSION: There is no real consensus among French transplanters concerning living donor transplantation due to the complexity of the ethical issues involved. Their opinions reflect medical tradition with background marked by autonomy and paternalism. This leads to a wide range of opinions concerning current bioethics legislation and the usefulness of more flexible laws.

Bioethics↗

[Tubal sterilization in mentally handicapped women].

ETHICAL ISSUES: When performed for contraception purposes, tubular sterilization for mentally handicapped women poses important ethical issues, including patient's rights, body integrity, and the notion of informed consent. French law guarantees the respect and safety of all patients, but in everyday practice, patient's rights must be upheld by family and healthcare workers searching for the most adapted solutions for each individual situation. PROPOSITIONS: We present here our proposals for everyday practice. Our conclusions are based on an analysis of the notion of handicap as defined by the WHO and on the observed sexual activities of this type of patient. In this context, informed consent involves a number of subjective factors pointing out the difficulty encountered in providing dear comprehensible information. Finally we discuss the ethical issue of tubular sterilization which many consider to be a masked form of eugenism.

Ethics, Medical↗

[Access to care, access to rights, and health education: stakes of the global management fo patients].

Together with primary care physicians, the public health clinic of the Max Fourestier Hospital (Nanterre, France) initiated a pilot experience within the framework of its access to health care network (ADES). In addition to full access to traditional health care, patients who agree to participate in this unique network benefit from a medical and social risk screening and prevention program. This program is proposed to all patients who, by definition, have one or more medical or social risk factors. At each visit, targeted history taking and the physical exam can lead to individualized propositions for a global approach to screening and prevention, whatever the initial reason for consulting. In addition, patients who require permanent care benefit from the dose link between the medical care and social care teams. Over the last year, this experience has involved 3430 consultations in a polyvalent clinic that has provided global care including health education and screening for health risks. Our analysis of the medical and ethical issues involved points out the importance of a global approach to health care.

Ethics, Medical↗

[The risks of unrestricted application of the principle of precaution in medicine. The need to keep in mind the findings of medical ethics in the development of health care rights].

The principle of precaution, a fundamental, essentially legalistic, rule underpinning health care legislation in France, basically arose from environmental protection policies. This principle became the topic of a good deal of well-publicized debate following the decree concerning HIV contamination rendered in 1993 by the Conseil d'Etat, the supreme jurisdiction on legislative matters in France. This translation of a fundamental principle from one domain to another is not devoid of significance and could have an unexpected impact on the nature and meaning of health care itself. When applied to medicine, the principle of precaution must be confronted with the notion of risk, inherent in all acts of health care. This risk certainly implies patients' rights and informed consent to medical care, but also, in a reasonable search for an acceptable balance between risk and benefit, the freedom of biomedical research from overly-restrictive regulations. Consequently, in accordance with an ethical approach to medical care, legislative and judicial bodies must take into consideration the practical reality of medicine in order to integrate the scientific, economic, social, and psychological aspects of everyday medical practice into health care laws and regulations. Once faced with the reality of health care, the principle of precaution could appear contradictory to the fundamental principles of medicine. Indeed, every physician, every health care worker, makes daily evidence-based decisions that are never devoid of risk. Unrestricted application of the principle of precaution to a growing number of public domains, including medicine, as advocated by a large number of opinion leaders, could lead to an inextricable situation, in total contradiction with the goal of health care itself. In order to develop new truly ethical and adapted health care regulations, we must break down the barriers confining judges and legal representatives to a purely legalistic vision of health care and equally confining physicians to a purely scientific vision of their mission.

Defensive Medicine↗

[Knowledge of flap complications in finger pulp surgery and patient education--ethical implications].

INTRODUCTION: The two highest French courts have recently decided that not to fully inform a patient constitutes negligence, and that doctors should be able to prove that the information has been given. The medical community is now debating as to how to protect physicians without harming the doctor-patient relationship. Following this study we put forward the hypothesis that although information might not be available to surgeons nevertheless this should not prevent them taking the ethical steps necessary to redress the situation. METHODS: We conducted a telephone interview to discover what surgeons knew about the complications of finger flaps used for the reconstruction of pulp defects. Four flaps were studied: the VY flap described by Atasoy, the island finger flap known as Ventataswami's, the reverse island flap and the thenar flap. Surgeons were asked to give the percentage of necrosis, infection, sensory disturbances, digital stiffness and exclusion, as well as the time off work, the time of healing and the sensory discrimination of the flap. The results obtained were compared to those obtained by a literature review. RESULTS: Twenty one qualified hand surgeons answered the questionnaire. Many answers were absent or only fragmentary when sought in the literature. Where complication rates were available, there was a huge variation among series. A large variety of answers was also found in our study. The direct island flap was the best known flap. Complications of the reverse island flap and the thenar flap were overestimated in the group interviewed. DISCUSSION: There is no true answer, either in the literature or from the study group. There is a gulf between the jurists' demand and the possibilities of knowledge by surgeons. We are still waiting for clinical studies that will answer the questions asked by patients regarding the complications of surgery. However, even if absolute knowledge is not available, it is the ethical duty of surgeons to give the patient information that is as close as possible as the "truth", and that will be helpful to them.

Adult↗

Evaluation, selection, and follow-up of live kidney donors: a review of current practice in French renal transplant centres.

BACKGROUND: A resurgence of interest in the concept of live-donor renal transplantation has prompted a closer look at methods of live donor evaluation, selection, and follow-up. The aim of this study was to describe these methods in all 46 French renal transplant centres. METHODS: Questionnaires were sent to all chief renal physicians. RESULTS: The survey was completed by 78% of centres, which accounted for 95% of all live-donor renal transplants carried out in France in 1995 and 1996. There was a substantial variation in all three steps of live-donor management. For example, we observed variations in the screening for specific short- or long-term risk factors (especially cardiovascular or thrombotic risk factors and diabetes). In addition the exclusion criteria differed, especially the cut-off age for donation, which ranged from 45 to 75 years. The composition of teams evaluating and selecting potential donors and the role of the potential donors in the decision-making process varied greatly among centres. Finally, we observed less variation in the methods of donor follow-up. CONCLUSIONS: The current survey revealed a marked disparity in the management of live donors in France. It raises the question of whether these practices should be codified into a set of guidelines for live-donor transplantation.

Adult↗

French intensivists do not apply American recommendations regarding decisions to forgo life-sustaining therapy.

OBJECTIVE: Recommendations for making and implementing decisions to forgo life-sustaining therapy in intensive care units have been developed in the United States, but the extent that they are realized in practice has yet to be measured. DESIGN: Prospective, multicenter, 4-wk study. For each patient with an implemented decision to forgo life-sustaining therapy, the deliberation and decision implementation procedures were recorded. SETTING: French intensive care units. PATIENTS: All consecutive patients admitted to 26 French intensive care units. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 1,009 patients admitted, 208 died in the intensive care unit. A decision to forgo life-sustaining therapy was implemented in 105 patients. The number of supportive treatments forgone was 2.3 +/- 1.7 per patient. Decisions to forgo sustaining therapy were preceded by 3.5 +/- 2.5 deliberation sessions. Proxies were informed of the deliberations in 62 (59.1%) cases but participated in only 18 (17.1%) decisions. The patient's perception of his or her quality of life was rarely evaluated (11.5%), and only rarely did the decision involve evaluating the patient's wishes (7.6%), the patient's religious values (7.6%), or the cost of treatment (7.6%). Factors most frequently evaluated were medical team advice (95.3%), predicted reversibility of acute disease (90.5%), underlying disease severity (83.9%), and the patient's quality of life as evaluated by caregivers (80.1%). CONCLUSIONS: A decision to withhold or withdraw life-sustaining therapy was implemented for half the patients who died in the French intensive care units studied. In many cases, the decision was taken without regard for one or more factors identified as relevant in U.S. guidelines.

Adult↗

First evidence of lysogeny in Propionibacterium freudenreichii subsp. shermanii.

Dairy propionic acid bacteria, particularly the species Propionibacterium freudenreichii, play a major role in the ripening of Swiss type cheese. Isometric and filamentous bacteriophages infecting P. freudenreichii have previously been isolated from cheese. In order to determine the origin of these bacteriophages, lysogeny of P. freudenreichii was determined by isometric bacteriophage type analysis. The genomic DNA of 76 strains were hybridized with the DNA of nine bacteriophages isolated from Swiss type cheeses, and the DNA of 25 strains exhibited strong hybridization. Three of these strains released bacteriophage particules following UV irradiation (254 nm) or treatment with low concentrations of mitomycin C. A prophage-cured derivative of P. freudenreichii was readily isolated and subsequently relysogenized. Lysogeny was therefore formally demonstrated in P. freudenreichii.

Bacteriophages↗

Ethical acceptability, health policy and foods biotechnology based foods: is there a third way between the precaution principle and an overly enthusiastic dissemination of GMO?

The demand for consumer safety with regard to the food-processing industry is becoming, legitimately, more and more urgent. If ingested drugs can carry deleterious effects that exceed the beneficial effect that the research was initially undertaken for, then the same can only be the case for foods that stem from the same new biotechnologies, zero risk being non existent. There are two conflicting viewpoints about the possible risks linked to genetically modified organisms: a posteriori protection (based on vigilance once the product is on the market) and an a priori protection (at present usually supported by the precaution principle). We suggest a third way, which ensures consumer safety, but doesn't hinder scientific progress. Just as there are regulations for the protection of human subjects in biomedical research and regulations for the use of drugs after they are marketed, so should such regulations be introduced in the domains of food production that use biotechnologies. We therefore suggest that the scientific community and the food-processing industry develop evaluation protocols for new foods like the ones that exist for drugs. We thus offer thirteen regulations, based on the Helsinki declaration, in order to establish these protocols. These proposals, applied to food-processing research, would enable the industry to return confidence to consumers and thus avoid the random blocking of scientific progress, which is a source of health for the greater population.

Bioethics↗

Bio-libraries and DNA storage: assessment of patient perception of information.

BACKGROUND: Since the creation of places where DNA is stored, a number of questions appear about protecting the individual, confidentiality and the validity of the proposed consent to storage. This study, originating in France, analyzes and assesses the impact of the information given by the clinician to the patient regarding having his DNA stored. How does the patient receive the information? What is left of it? Is he informed enough to sign a "well-informed" consent? METHODS: A questionnaire issued to 170 patients in the same department was used to assess: (1) their knowledge of genetics, (2) their knowledge of DNA storage, (3) their perception of the consent. FINDINGS: A third of the patients answered, 20% of whom understood the objectives of a genetic test. None of the patients contacted was aware that he had samples stored in a DNA bank, that genetic analyses had been undertaken or remembered that he had signed a consent (which indeed exists). INTERPRETATION: The idea of a "well-informed" consent belongs to the criteria defining the validity of a cure and research agreement. Yet, its validity is doubted as soon as the information it implies is not understandable by the patients. Indeed, can the individual be considered autonomous, in the philosophical sense, in a well-informed decision making if the information given to the patient has not been well understood?

Cardiovascular Diseases↗

Ethical assessment of clinical research publications.

The ethical quality of research could be improved in four ways: increasing the expertise of research committees, encouraging the popularization of research in ethics, delivering medical training in ethics, and improving the a posteriori control of editorial committees. With regard to the last point, we propose ethical guidelines that may be used as a screening device for publication. Scientific publications have a duty to contribute to the diffusion and application of ethical principles. But too often pieces of research published in these journals do not adequately demonstrate their ethical reflections and chosen ethical procedures. Only scientific procedures are extensively discussed. We think it is essential to develop an assessment of the ethical value of research that is featured in journals, in the same way that the methodological value is assessed. This paper reports what motivated our group to create an ethical scheme, how we developed this scheme and what was our process of validation. In the same way that today a study can be refused publication for methodological inadequacies, in the future publication could more likely be refused for ethical shortcomings.

Ethics↗

[Development of bioethics. Analysis of practices in 20 hospital departments].

OBJECTIVE: In order to analyze the constitution and management of DNA banks and the limitations on procedures currently used in France, we conducted a study in a sample of French hospital units. A DNA bank was defined as any facility where individual samples of DNA, irrespective of the form, are stored for ongoing or future gene studies. The aim of this work was to focus attention on the need for in-depth thought on the ethical issues involved in storing and using DNA as part of everyday clinical practice and research and to provide elements for a debate on the interest and limitations of the French bioethics laws whose revision is currently being considered. METHODS: A questionnaire was sent to the heads of departments in two university hospitals. Five areas were retained for evaluation: the nature and degree of DNA storage activities, procedures followed for reporting the DNA bank, procedures used to protect confidentiality, information given to patients and procedures used for informed consent, and finally, internal rules governing the bank's operation. The answers to the questionnaires were analyzed anonymously. RESULTS: Among 20 hospital units collecting DNA samples, 70% also stored other samples (DNA, blood, tissue, cell lines) including a large proportion of tissue samples. These samples were collected for purposes of fundamental research and clinical practice. The number of samples stored was quite variable, ranging from a few dozen samples to more than 40,000. Only 55% of the units had reported the facility to a control body, in compliance with current law. Seventy percent maintained computerized data bases but only 50% used an anonymous code. Seventy-five percent obtained written consent but patients were not always informed of the site of the storage or the transfer of their DNA. In addition, the validity of the consent over time, the duration of storage and the types of studies that could be conducted on the DNA were poorly detailed. Internal rules governing the bank's activities were not implemented by most of the units (65%). CONCLUSION: The responses to our questionnaire survey show that there is currently a gap between everyday practice and regulatory procedures concerning DNA banks in France. Further analysis of current practices would appear to be necessary so professionals could become more aware of the human and social issues involved with the use of DNA banks. These data on everyday practices should be made available to health care workers, public officials and law makers in order to promote ethical practices that, as has been observed, are not dictated solely by legislation which often lags behind everyday activities. All those involved in the management of DNA banks must be aware of their responsibilities in protecting patients' rights within the framework of a system based on information, consent, and over-the-board trustworthiness regularly submitted to short and long term assessments. A correct response to ethical issues is the only means of developing a real process of social interaction which cannot be achieved by revision of the bioethics laws alone.

Confidentiality↗

Stearoyl-CoA desaturase 1 coding sequences and antisense RNA affect lipid secretion in transfected chicken LMH hepatoma cells.

Hepatic stearoyl CoA desaturase (SCD) activity in chickens from a fat line is higher than that of chickens from a lean line and correlates with plasma triacylglycerol concentrations. Furthermore, in these lines, the hepatic SCD1 mRNA level is positively correlated with the adipose tissue weight. To analyze the contribution of the SCD1 gene in the regulation of adiposity in the early stages of triacylglycerol secretion, SCD1 coding sequence and antisense RNA expression vectors were transfected in LMH cells. After selection, these cells were analyzed with regard to SCD1 expression and lipid secretion. The amounts of secreted triacylglycerols and phospholipids were shown to be higher in LMH cells transfected with the SCD1 gene, but reduced in those transfected with the SCD1 antisense sequences when compared to cells transfected with the vector alone (without SCD1 sequences). These results provide direct evidence that the expression of the SCD1 gene plays a major role in the triacylglycerol and phospholipid secretion process.

Animals↗

[Controversies over the surgical placebo: legal issues and the ethical debate].

The debate on controlled surgery trials has had some rather "sensational" repercussions, enlivening the placebo issue. In France, there is a consensus on the ethical conditions necessary for proper protection of individual persons. This consensus has taken on a legal form with the promulgation of the Huriet law. For this reason, all studies and research protocols in medicine and surgery are examined by ethics committees (CCPPRB) who assess the inclusion conditions within the framework of biomedical research and in compliance with the concept that individual participants must be give proper protection. These committees are faced with increasingly complex situations, particularly concerning the pertinence of information give to the participant and the modalities of consent. In France, standard measures were established after a parliamentary debate issuing from a wider public debate. The issue has become a social transaction between biomedical research professionals and the society in general. The international debate over the surgery placebo is an interesting illustration of how mediation institutions, working along the principles of ethical committees, play a key role in social awareness of the ethical issues involved before an innovating practice is initiated. But how legitimate are sensational pieces published in the media, which as is clearly demonstrated with the debate over the surgical placebo, are almost always individual points of view? Shouldn't the debate take into account the contributions of ethical committees which integrate representatives of the social community as well as the importance of a legal framework for individual protection as proposed by the French law? Shouldn't personal points of view be counterbalanced by regularly expressed ethical committee opinions formed after appropriate ethics-oriented discussion going beyond the simple question of "should we do it", a question often dismissed by extreme theoretical arguments that leave unanswered the practical question of "how should we do it"?

Controlled Clinical Trials as Topic↗

[Piercing: health education or medicalization?].

In Europe, the piercing mode has naturally been associated with specific complications raising an important public health problem. The debate on the role physicians should play requires a careful analysis of the ethical issues involved. Specifically, should the piercing be done in a medical setting? This question is raised because, when performed under ideal conditions, the act of piercing requires a certain degree of medical competency: history taking, asepsia, technical procedure (hemostasis), anesthesia.... However, mandatory medicalization would not, in our opinion, appear to be desirable since we are dealing with a social rite which lies outside the domain of specific medical care. Nevertheless, although we do not advocate systematic medicalization, we do believe that medicine should play a role, in terms of public health, in this emerging practice. We discuss the modalities of a health education dialogue which could be established with professional practicing piercing.

Cosmetic Techniques↗