In the US, research with embryonic stem cells is well established. In Germany however, this is a sensitive issue. Should Germany also allow embryo research in the interest of medical progress?
In type 1 diabetics, the insulin-producing cells of the pancreas are destroyed by autoimmune processes. The disease can therefore only be controlled with lifelong strict blood sugar control and insulin therapy – a cure does not yet exist. Lisa Hepner, who has been suffering from type 1 diabetes for 30 years, does not give up hope. In an interview with DocCheck News, the Los Angeles filmmaker says: “I'm not only optimistic but I think it can happen in 5 years!”
Hepner has spent nearly 10 years following an experimental study by biotech company ViaCyte, which is working on developing an artificial pancreas. The idea is to replace the destroyed beta cells of the pancreas with stem cell-derived cells. In the meantime, ViaCyte has been taken over by Vertex Pharmaceuticals, which is developing a similar therapy and has already made significant progress. With her documentary “The Human Trial”, she wants to “show the public what it takes to push medical innovation forward; to viscerally capture what it’s like to live with type 1 diabetes and show why it needs to be cured, and to honor clinical trial participants who put themselves on the line to be first.”
From a German perspective, the film is also interesting because it deals with a highly controversial topic: The therapy investigated in the study uses stem cells from discarded embryos created through in vitro fertilisation (IVF) – a topic that has always been controversial in this country. In fact, Germany has one of the strictest laws in Europe regarding the handling of embryos.
The Embryo Protection Act (ESchG) of 1990 prohibits any research on or use of human embryos – with the sole exception of inducing a pregnancy in the context of artificial insemination. The law also applies to so-called surplus embryos that were created in an IVF procedure but are no longer needed. These embryos must be destroyed and may also not be donated for research, as is the case in many other countries (such as Great Britain, Belgium or Switzerland). The law also prohibits obtaining stem cells from human embryos for research purposes.
Before 2002, however, it was unclear whether researchers working in Germany were generally not allowed to conduct research with embryonic stem cells – even if the cells for this purpose came from abroad. It was not until 2002 that the Stem Cell Act (StZG) was passed to clear up this ambiguity: since then, research with embryonic stem cells has been permitted in Germany under the strictest conditions – but only if the embryonic stem cell lines were imported from abroad and were created before 2007.
However, many research associations in Germany are critical of the fact that scientists are not allowed to use donated embryos. “Research on early embryos in vitro, [...] which were created for reproductive purposes but are no longer used for that purpose, should be allowed in accordance with international standards”, reads a joint statement by the National Academy of Sciences Leopoldina and the Union of the German Academies of Sciences and Humanities from 2021, for example.
Many scientific questions about embryonic development, disease development, reproductive medicine or applications of stem cells for regenerative and personalized therapies can only be answered through research with early human embryos, the statement reads. Scientists working in Germany have so far been able to contribute little to the clarification of these questions. Although there is also the alternative possibility of working with induced pluripotent stem cells (iPS cells), embryonic stem cells are still considered the gold standard for medical research.
The discussion about embryo research is essentially about the age-old question: at what point is a human being a human being who may be granted human dignity and the right to live? The Catholic moral theologian Prof. Kerstin Schlögl-Flierl, who has also been a member of the German Ethics Council since 2020, says: life begins with the fusion of egg and sperm cell. In her view, the early human embryo already has human dignity and a right to live. That is why embryos should not be regarded as research objects. “The embryos’ worthiness of protection comes before freedom of research”, said Schlögl-Flierl at a panel discussion on embryo research in Germany.
Prof. Horst Dreier, lawyer and legal philosopher and former member of the German Ethics Council, on the other hand, says: “A blastocyst is not yet an indivisible life and thus not an individual”, he explained. As a species-specific but not yet individual life, it cannot yet be accorded human dignity in the days before nidation, which must be protected.
The experimental therapy against type 1 diabetes, which Lisa Hepner accompanied on film, was also only possible with the help of donated embryos. She has no ethical concerns about this: “You have to remember that these human embryos are five-day blastocysts – a cluster of microscopic cells that were donated to science by patients who had finished their IVF treatment”. She herself had donated her leftover embryos to science. That’s how much she believes in it, Hepner says. “Using hESC [human embryonic stem cells] is not destroying life. On the contrary, it is giving life to tens of millions of people who are struggling and dying from disease every day. [...] The science actually honors and celebrates life.”
The filmmaker herself lived in Germany as a child and was “admiring Germany for its medical advances and overall progressive politics”, she says. “So I was very surprised to learn that human embryonic stem cell research is banned.” While the intent behind the laws is noble – given the historical context of the Third Reich – the same safety and ethical standards apply to this research as to traditional areas of medical science, Hepner says. “I hope these laws are overturned soon – not only for the researchers who work tirelessly and mostly anonymously in the labs, but also for the patients who desperately want a better life.”
What's your take on the issue? Write it in the comments!
The film can now be watched in Germany (and in Europe) on Amazon, iTunes and Vimeo on Demand. Here is the trailer.
Image source: Erik Mclean, Unsplash
