CBEL Report Volume 4, Issue 2

Akihito Imai

LetterAdvertisement and Legal Liability for Falsifying Data

Akihito Imai（Aoyama Gakuin University）

The manipulation of data in clinical trials of the bloodpressure drug, Diovan, is a major medical scandal. Stud-and critiqued by experts in the same field to confirm thereliability of the contents.

ies using the data were published in several journals, but

Furthermore, one of the judges, Atsushi Yamaguchi,

were later retracted. On the one hand, articles were usedshared his opinion that, if the writing, submission andfor advertising campaigns for Diovan until they began

publication were to be subject to such regulations, it

to be viewed with suspicion, and were then retracted.

could have chilling effects on academic activities.3

On the other hand, Japan’s pharmaceutical law prohibits

Therefore, such regulations are also inappropriate in

the advertising, description or circulation of false state-consideration of academic freedom.

ments regarding pharmaceuticals. The Japanese subsid-

However, this decision is problematic, and the court

iary of Novartis and its former director were accused ofshould have passed a harsher judgement in this case.

falsifying the data to highlight the benefits of Diovan.1

First, given that Diovan is a prescription medication, theBased on the background of this case, the main issue ofcourt must have considered that the journal articles dothe trial was whether articles published in journals usingexert advertising effects. By the court’s definition, thethe falsified data should be considered false advertising.

problem is beyond the scope of advertising because theIn June 2021, Japan’s Supreme Court upheld themain readers are experts and not unspecified or large

Lower Court’s ruling that the subsidiary and the former

numbers of people. This definition raises problems

director were not guilty.2 In relation to pharmaceutical

where prescription medications are concerned. With re-law, the court defined an advertisement as an act of in-gard to over-the-counter medications, it is important toforming unspecified or large numbers of people to en-

consider whether advertisements exert their effects on

courage them to purchase the medication that is adver-

numerous people, especially potential users, as can betised. The court concluded that the articles using falsi-

understood in court’s definition. However, advertise-fied data did not fulfil the definition because the main

ments for prescription medications, as in this case, doreaders of the articles were experts, such as researchers

not require such pervasive effects. That is, if advertise-and doctors.3

ments exert their effects on doctors who then prescribe

Interestingly, the court described the peer review sys-

them for patients, it is sufficient to encourage them totem as highly reliable. Publishing the results of studies

purchase the medication. In this sense, the court used anin academic journals is naturally expected to be verified

excessively narrow definition of an advertisement.

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Advertisement and Legal Liability for Falsifying Data

Second, the peer review system is a fundamental part

CBEL Report Volume 4, Issue 2

Acknowledgementof academia, but it is imperfect. Here, it is important toThis work was supported by JSPS KAKENHI Grant

consider peer review before publication (pre-peer re-Number JP20J10491.

view) and after publication (post-peer review) separately. The court focused on post-peer review, as verifi-References

cation and criticism after publication are mentioned. In1.

over valsartan data. Lancet 2014; 383: 2111.

some cases, however, it is too late for verification andcritique by other experts because products have already

McCurry J. Former Novartis employee arrested

2.

Japan's top court upholds not-guilty ruling overbeen sold and may even have resulted in health prob-Novartis data. Jiji press, June 29, 2021.

lems. Therefore, excessive trust in post-peer review ishttps://sp.m.jiji.com/english/show/13243 (accesseddangerous to public health. In addition, pre-peer review

August 8, 2021)

cannot prevent the use of falsified data because it as-3.

Supreme Court. The case of violation of pharma-sumes the authors’ integrity. Reviewers are not obliged

ceutical law (in Japanese). June 28, 2021.

to verify whether the data have been falsified. Even if

https://www.courts.go.jp/app/files/hanrei_jp/456/0

this should be the case, it is not always possible to detect

90456_hanrei.pdf (accessed August 8, 2021)

such falsification of data.
Third, a classification system for regulations is nec-Received 8 August 2021

essary. The judge, Yamaguchi, raised concerns over theFinal version accepted 28 October 2021

possible chilling effects on academic activities andmade the decision that no steps should be taken in thiscase. Clearly, this is feasible, but it is also possible forregulations to be tailored to avoid such chilling effects
whilst punishing undesirable actors in academia. Here,intentionality is important, and should not be confusedwith carelessness or negligence, which may occur but is
not always legally liable. The court could have made it
clearer when and under what conditions legal liability
would be imposed whilst avoiding negative effects on
academic freedom.
In conclusion, the court should have ruled that the useof falsified data in the journal article represented illegal
advertisement in this case. By not doing so, the judgement leaves room for future undesirable false advertisement of prescription medications.
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