A German court ruled on ‘informed consent’ in so-called alternative medicine (SCAM)

It has been reported that the Dresden Higher Regional Court (OLG) examined the extent to which a doctor must inform his patient, if he/she uses so-called alternative medine (SCAM) that deviates from conventional medicine. To be precise, the case was about a detoxification therapy with so-called chelating agents. A patient had received ‘holistic treatment’ for symptoms of exhaustion with sleep disorders, headaches, concentration problems and general restlessness and became worse and worse during the course of the therapy. Eventually, he sued for compensation for pain and suffering and damages.

Initially, the patient had been treated conservatively with iron supplements. After carrying out ‘provocation test’, the doctor diagnosed a heavy metal load, which he treated with ‘elimination therapy’ in the form of an i.v. “detox therapy” (2-3-dimercaptopropane-1-sulfonate (DMPS)). The patient subsequently became increasingly unwell, leading to hospitalisation and treatment for severe thrombocytopenia with moderate liver damage.

The expert opinion obtained in the first-instance of the ensuing legal proceedings considered the cause of the patient’s complaints to be the administration of an inadmissibly excessive amount of alpha-lipoic acid during ‘detoxification therapy’. It became clear that the doctor had not properly informed the patient about this therapy and its risks.

The court considered that the basic information required under German law had not been provided. This basic information gives the patient a general idea of the severity of the procedure and the impact of the associated burdens on their lifestyle. The obligation to provide information also applies to practitioners who use SCAM. A doctor who offers SCAM must therefore clearly inform the patient that they are deviating from a conventional approach. He/she must also explain why he/she is doing this and what advantages and disadvantages the patient can expect as a result.

Detoxification therapy is indisputably such a SCAM, the costs of which are not covered by the health insurance companies. The patient must therefore not only be informed of the risks and the danger of failure of the procedure, but must also be informed that the planned therapy is not standard medical practice and that the effectiveness of the therapy is unproven.

The patient must be able to weigh up whether they want to take the risks of treatment with regard to the prospects of success in view of their state of health before the procedure. Such information was not provided in the present case. For this reason, the Regional Court awarded damages for pain and suffering amounting to EUR 15,000 for the damage to health suffered.

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On this blog, we have often discussed the problems of informed consent. Informed consent, I have previously stated,  must usually include full information on:

• the diagnosis
• its natural history
• the most effective treatment options available
• the proposed therapy
• its effectiveness
• its risks
• its cost
• a rough treatment plan

Only when this information has been transmitted to and understood by the patient can informed consent be considered complete. I do understand why many SCAM practitioners do not like informed consent – it could stop many from practising: they are frequently unable to provide the required information. Yet, ALL clinicians have a moral, ethical and legal duty to obtain informed consent BEFORE starting a therapy. It is reassuring that the German court agrees.