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Limitation of medical research in German law.

In Germany, pharmaceutical trials and the testing of medical devices is regulated by statute. Any other kind of medical experimentation is handled according to the Declaration of Helsinki. Medical experimentation has to be reviewed by an ethics committee before the start and there has to be an elaborate research protocol, which provides for the protection of the experimental subject. In case of an accident, there is compulsory accident insurance as far as pharmaceutical trials and the testing of medical devices are concerned. The third party accident insurance just covers material loss, there is no provision paying and suffering. The sum paid by the insurance company is set off against damages for negligence. There is no strict liability for medical experimentation, but the German courts are expected to set very high standards for medical care in experimentation. The data protection and medical confidentiality have been lessened because of the European law that requires the experimental subject to give his consent to the inspection of the data or the file and if he takes part in the experimentation, that his data and some of his cells might be with the pharmaceutical company forever. In general, the German law seems to be adequate to the protection of experimental subjects.

Biomedical Research↗
PubMed2005

Ethics and policy perspectives on personalized medicine in the post-genomic era.

The completion of the human genome project and the accompanying biotechnological revolution hold great promise for the creation of pharmaceutical agents to combat not only previously incurable diseases, but also those for which therapeutics exist, yet they either cause severe adverse effects or exhibit no benefit in subsets of the population. In many instances variation in therapy response can be attributed to genetic differences, more particularly single nucleotide polymorphism (SNPs). Detection of the genetic differences which affect drug response, commonly referred to as pharmacogenomics, may result in further classification of diseases, and consequently, the development of 'personalized' therapies. While of potential great benefit, the widespread use of pharmacogenomic data poses social, ethical, and economic risks that need to be addressed by regulatory agencies such as the Food and Drug Administration (FDA). This paper explores some of the common problems associated with the use of pharmacogenomic data including validation of the data, patient confidentiality, social stratification, economic risks faced by pharmaceutical and insurance companies, and offers suggestions for regulatory procedures to ensure the appropriate use of the data in drug development and clinical trials.

Alzheimer Disease↗
PubMed1997

[Knowledge of good clinical practice among Danish physicians. A questionnaire study among hospital-employed physicians in the Copenhagen area].

To investigate knowledge of current requirements concerning clinical research among researching physicians, and to compare this knowledge among physicians in different research areas, a survey based on twenty-two questions was sent to 1000 hospital physicians in the Copenhagen area. Forty six percent and three hundred and four of these were used for further analysis. Eighty-two percent of the physicians replied that they had knowledge of GCP, nevertheless only 24% were able to recognize the meaning of the terms "monitor", "investigator" and "SOP". When asked about six different fictitious situations concerning making reports to an Ethical Review Board, only 33% replied correctly to all reporting situations. A frequent distinction was seen between physicians who respectively had or had not co-operated with the pharmaceutical industry for trials of medicinal products during the past three years.

Clinical Trials as Topic↗
PubMed1985

[Legal and ethical aspects of drug therapy].

Legally speaking, the administration of drugs for diagnostic and therapeutic purposes is, in fact, bodily injury which enjoys exemption from punishment only when it is justified and the patient has given his consent. In daily practice the application of relatively low-risk diagnostic drops ought to represent a part of the commission which the patient gives the ophthalmologist in seeking out his practice. The risk involved in diagnostically and therapeutically administered drugs must be reasonably related to the possible advantage to be gained. Therefore, a brief explanation to the patient and the securing of his consent are surely appropriate before the use of a mydriatic in cases with a dangerously narrow chamber angle. Rational therapy with drugs depends on knowledge of their effects. In our specialty this is by no means the case with all drugs. However, there are problems in verifying their efficacy. Personal, practical experience often leads to false conclusions and to perpetuation of the same mistakes. From retrospective studies we can only arrive at reliable conclusions in the case of obvious, gross effects; not even exploratory data analysis provides sure knowledge; at best it established hypotheses. Therefore, the most important means of testing drugs is the prospective controlled study with random distribution of patients into a control group and groups given the test substance. With the help of statistical methods, this leads from ignorance to secure knowledge. Members of the legal profession have expressed their misgivings about randomized studies, partially because they are not familiar with the state of our ignorance and the difficulties involved in testing pharmaceuticals.(ABSTRACT TRUNCATED AT 250 WORDS)

Diagnostic Uses of Chemicals↗
PubMed2004

Multiple sclerosis in its European matrix: some aspects of history, mechanisms and treatment.

Susceptibility to multiple sclerosis is influenced by several genes which are relatively common in populations of European origin. Their precise identification is currently being intensively investigated. The pathophysiology of the main clinical features is better understood. Relapse results from abnormalities of conduction to which both demyelination and inflammation contribute. At the membrane level, remission depends on the formation of new sodium channels which restore conduction even in persistently demyelinated axons. Remyelination presumably contributes and synaptic reorganisation may also do so. Axonal degeneration contributes to irrecoverable deficit and progression of disability. These observations suggest new therapeutic strategies. The management of multiple sclerosis needs to be improved. Progress requires an ethically based partnership between patients, whose needs are paramount, the research and caring communities and the pharmaceutical industry.

Europe↗