– From a patient perspective, it is of course encouraging that a usage which has been made an exception for decades now will be accepted, Johanna Hök, pharmacist, PhD and I C researcher comments on the decision by the Swedish Medical Products Agency (MPA) to approve mistletoe preparations for injection.
The approval of the mistletoe preparations Iscador and Helixor by the MPA refers to the indication “Herbal medicines used in individualized palliative cancer care as an adjunct to conventional therapy.”
The preparations became available in 1982 for Swedish patients in accordance with the then legislation on herbal preparations for injection by decision of the National Board of Health and Welfare, a law that was repealed in 1993. Following that, up until 2014, the preparations have had temporary marketing permits with the support of drug regulation.
1000 publications on Medline
In information to caregivers, the MPA writes that approval is based on well established medicinal use within the EU and more than 1000 publications on Medline since 1950.
The MPA bases its assessment mainly on a Cochrane review from 2008 and eight subsequently published clinical studies. The Agency writes: “The available bibliographic data on symptom relief and/ or improved quality of life in a broad sense are consistent and positive, but anti-tumoral effects have not been demonstrated.”
In a press release, the MPA says that there is support for the approved use in order to achieve symptom relief and that ” These effects are expected to be proportional to the side effects of treatment .”
Not Approved for Cancer
In particular, the MPA notes that “no effect on cancerous tumors has been established , and preparations are not approved for that use.”
In the information targeted at caregivers, MPA further points out that no interaction studies have been performed with Iscador.
MPA advises against concomitant use of immunomodulators (excluding chemotherapy) because of the possible influence of mistletoe extract on the immune system. For the same reasons, Iscador should not be used in patients with autoimmune disease, in which a worsening of the disease can not be ruled out. Iscador should not be used by children and young people under 18, pregnant or nursing women or by women of childbearing potential not using contraception.
The approval has upset some doctors, who in some media have criticized the decision for lending credibility/legitimacy to a treatment they regard as less than evidence-based, for any indication.
Quality of life and symptom relief
Johanna Hök, a PhD chemist and researcher at the IC and the Karolinska Institutet says it is important to remember what the approval is for.
– It’s about quality of life and symptom remission in some patients, nothing else, In the scientific literature, there is support for such use in certain patient groups, although more research is also needed. It is important to remember that the approval of any drug is based on an analysis of the risk-benefit balance.
The usage for improved quality of life she sees both as potentially problematic and as a unique opportunity. Quality of life is a broad concept measured by validated instruments. As the indication states that the drugs should be used for ”individualized palliative cancer care”, this puts a lot of responsibility on the attending physician, who may have no knowledge or previous experience of the preparation.
No treatment recommendation
Johanna Hök:
– It is important to note that the MPA also emphasizes that approval is never a treatment recommendation, and that it is important that the prescriber has knowledge of the preparation, as is true in any case of drug prescribing. Use of these drugs, as well as of drugs in general, should always be based on the Swedish Council on Health Technology Assessment´s three pillars of evidence-based care, which are evidence for different measures, healthcare resources, the caretakers and, last but not least, patient needs and preferences.
– The opportunity that comes with approval, says Hök, is that the health care system now will have an additional tool to meet patients’ needs for improved quality of life, something both the profession and patients have been asking for.
Mistletoe therapy will certainly not be indicated for everyone, but for those patients requiring such treatment, they can now make use of approved drugs prescribed by qualified personnel, familiar with these preparations, something she believes will increase patient safety.
Opportunities to follow up
The MPA will monitor the prescribing of the mistletoe preparations. Johanna Hök, emphasizes that approval status offers improved possibilities to control the usage.
– Patients have previously been completely at the mercy of their own usage, but when a drug is approved, there are better chances of monitoring side effects and learning more about their use. This is something that Swedish cancer patients have been using for a long time to some extent. To sweep it under the rug may possibly pose risks in terms of for example interactions with conventional cancer drugs.
A recent German study specifically warns against this. It is known that 40-70 percent of cancer patients use complementary or alternative (CAM). The survey study interviewed 299 alternative therapists about their use of CAM in cancer.
David Finer
MPA. Press Release March 11, 2014. Mistletoe preparations for injection approved for palliative cancer care (in Swedish).
Koehl B et al. Survey of German Non-Medical Practitioners Regarding Complementary and Alternative Medicine in Oncology. Oncol Res Treat. 2014, 37 (1-2):49 – 53.
Tags: ADR, adverse-drug reactions, anthroposophical integrative care, anthroposophy, autoimmune disease, cancer, Cochrane, contraception, David Finer, evidence, Helixor, herbals, immunomodulator, individualized care, Iscador, Johanna Hök, mistletoe, National Board of Health and Welfare, palliative care, patient-centered, quality of life, side effects, Swedish Medical Products Agency
