A German district attorney has fined a doctor who participated in a bogus study showing chocolate helps weight loss, designed to illustrate how shady science can make the news, arguing it was unethical to ask people to participate unknowingly in such a scam.
As soon as the study was published, critics raised questions over whether it was appropriate to include volunteers in a bogus clinical trial, which included giving blood. Recently, a German district attorney for professional conduct of physicians ruled that it was not.
In an anonymized version of a decision from the district attorney – who investigates on possible violations of the physicians’ professional law – he fined the doctor who participated in a bogus study about the health benefits of chocolate 500 Euros for not obtaining proper consent from the people who volunteered to participate, and for not involving an ethics committee.
In 2015, German journalists Diana Löbl and Peter Onneken, along with science journalist John Bohannon and physician Gunter Frank, decided to conduct a deliberately false scientific study including 16 subjects who – for three weeks – either followed their standard diet, a low-carb diet, or a low-carb diet with an additional 1.5 oz of dark chocolate. For the TV documentary, for which the journalists wore a doctor’s coat and recorded a controversial trailer, all subjects weighed themselves and had their blood drawn by Frank at the beginning and end of the study.
However, neither were the subjects informed about the real purpose of the study, nor was it submitted to an ethics committee.
Last year, the president of the German Working Group of Medical Ethics Committees, Joerg Hasford, told “Meta” magazine that he doubted whether real subjects needed to be included in the study, given also the unnecessary risk by drawing the blood. Since Hasford saw possible violations of the professional law by the involved doctor, he contacted the bodies that conduct such investigations. The district attorney of the “Bezirksberufsgericht Nordbaden” (“Court of Professional Conduct in the District of Nordbaden”) in the city of Karlsruhe, the professional court for physicians, started an investigation on suspicion that no ethics approval was obtained and that blood was drawn without adequate informed consent.
The case against Gunter Frank was filed as under reference number KA 50/15; later the prosecutor sent us the decision on case KA 50/15, in an anonymized version.
It in detail describes the concept of the fake study and the following media coup, cites the Facebook post used for recruiting the subjects, and describes the explanations of the doctor.
The district attorney has similar power as a public prosecutor of a public court. According to the document (which we translated using One Hour Translation), the physician indicated that he took the blood samples not primarily for data analysis, but to exclude pre-existing diseases:
While typical care was provided, this process was carried out – with patients in his practice – with no written information about the possible risks of blood collection.
According to the decision, the consent was ineffective since the physician wasn’t totally truthful with participants:
…the point of the “study” was not about the possible suitability of chocolate as a diet enhancement, but about the gullibility of certain media and the public with regards to supposedly scientific study results. The accused concealed this fact [from] the participants of the study, which is why the consent is to be regarded as ineffective.
…the project should not be recognized as a research project within the meaning of the provision, because no serious quest was intended for scientific (medical) knowledge. However… the study participants were deliberately uninformed that the project was not about using scientific methods for determining if dark chocolate had a slimming effect.
According to the decision, if such a project were related to actual research it would need to be approved by an ethics committee. Since the subjects and the public were made to believe it was a research project to a certain degree, and the patients gave blood, an ethics committee would have to approve it, the district attorney concluded. Hence, the doctor violated the professional code.
According to his verdict, the defendant acknowledged the external facts. He clarified that he had very benevolent intentions:
This entire situation has sensitized him in a profound way. In the future, he will seek approval from the chamber when [asked by] third parties for participation. Investigative journalism should never go so far that the self-determination rights of patients are affected. He fully acknowledges that every patient has a right to self-determination and that they must know what kind of treatment they are subjecting themselves to.
According to the order, the physician – who was under legal counselling – agreed with the verdict and fine.
Frank declined to comment on the verdict.
We asked Löbl and Onneken for their reaction to the verdict; they wrote in a joint statement that they do not share the impression that Frank conceded violations of the professional code, but did not elaborate further.
John Bohannon told us:
It’s great to see that the German bureaucracy is working, and even better that the process did not result in an overreaction.
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