Criminal complaint filed against Novartis Pharma KK over the Diovan Incident
2013-11-01
On November 1st 2013, Medwatcher Japan filed a criminal complaint with the Tokyo District Public Prosecutors Office against Novartis Pharma KK, accusing the firm of violating the Pharmaceutical Affairs Law and the Unfair Competition Prevention Act.
<Extracts>
The accused is believed to have violated the Pharmaceutical Affairs Law Article 90 item 2, Article 85 item 4 and Article 66 Paragraph 1 on exaggerated advertising and the Unfair Competition Prevention Act Article 22 Paragraph 1 and Article 21 Paragraph 2 Item 5 on unfair competition.
A criminal complaint has been filed requesting that the accused be severely punished after thorough investigations have been conducted. (Article 239 Paragraph 1 of the Code of Criminal Procedure).
<Facts>
The accused, Novartis Pharma KK, is a manufacturing company that produces and sells Diovan (generic name Valsartan), an antihypertensive. However, the accused has manipulated data in a research paper that is part of the KYOTO HEART Study, clinical research by the Kyoto Prefectural University of Medicine comparing the effects of Diovan and other existing antihypertensives. The research paper concluded that compared to other antihypertensives Diovan is able to control cardiovascular events such as strokes and angina. Although this conclusion was not true and correct....
1. In the Nikkei Medical published in January 2011, the accused stated that
(1) "The test objects in both studies were different; the JIKEI HEART Study referred to high blood pressure caused by cardiovascular conditions such as coronary artery disease and heart failure and the KYOTO HEART Study referred to high-risk high blood pressure and the relative risks of the primary end point (a mix of cardiovascular death and cardiac events: hospital stays resulting from stroke, TIA, myocardial infarction, heart failure and angina) had decreased significantly in both studies." (Accompanying material 1, Page 151, Horiuchi)
(2) "In both tests, relative risks against strokes and angina decreased significantly in the Valsartan group, didn't they?" (Accompanying material 1, Page 151, Mitsuyama)
2. In Issue 3 of Hypertension Navigator published by Medical Review in June 2011,
(1) "The KYOTO HEART Study shows that Valsartan significantly reduces cardiovascular events in Japanese people." (Accompanying material 2, Pages 299 - 300, Komuro)
(2) "(In the KYOTO HEART Study) primary evaluation criteria(cerebral, cardio and renal events) on the whole decreased significantly (P<0.0001) by 45% in the Valsartan group. Looking at the breakdown, like the JIKEI HEART Study, the KYOTO HEART Study also states that angina has declined significantly in the Valsartan group (relative risk reduction ratio 49%: P=0.01058). CT and MRI scans are underway as part of the KYOTO HEART Study to search for the stroke lesion but like the JIKEI HEART Study this has declined significantly in the Valsartan group (relative risk decline ratio 45% P=0.01488)." (Accompanying material 2, Pages 300-301, Kumagai).
...the accused submitted articles containing dialogue among doctors on the results of a KYOTO HEART Study research paper and therefore advertised, described or distributed false or exaggerated articles on the therapeutic effects of Diovan.
As noted above, this is an example of a falsification that makes people misunderstand details on the advertising and quality of the product, by submitting articles containing dialogue among doctors who quoted the results of the KYOTO HEART Study research paper.
<Meaning of the criminal complaint>
The actions of the accused, including the use of unfair clinical trials on Diovan and their results for advertising purposes, invade the human rights of research participants who took part believing the trials were fair. They also violate the human rights of all patients and doctors who used Diovan believing in the advertisement that cardiovascular events would be better suppressed compared to other antihypertensives. This is a serious incident that shakes confidence in Japan's clinical trials.
Because of this there is now an urgent need to thoroughly verify the facts and draw up preventive measures. Each university that conducted the clinical trials set up inquiry panels, reports were released and the Ministry of Health, Labor and Welfare drew up an investigative commission on the clinical research of antihypertensives, releasing its interim guidelines on October 8th 2013 (Accompanying material 7).
However, all the above are voluntary with no legal force and the facts are still not sufficiently clarified.
For example, it's unclear who manipulated essential data from the clinical trials, when and for what reason. Shirahashi, an employee of the accused, is strongly suspected of being involved but the accused strongly asserts that "there is no evidence of this and no sign that employees were instructed to manipulate data." However, this conflicts with the statement which universities make which state that "researchers didn't have sufficient knowledge and experience of statistical analysis and data management," "it's suspected that the data was manipulated in some way before the final analyzed version was produced and there is material evidence that Shirahashi analyzed the data."
It is also completely unknown to what extent the accused was systematically involved in planning the clinical trials, who made decisions on using the trial results for advertising and at that point to what extent the accused knew the details of the trials and their credibility. In this kind of situation, preventing another recurrence of an incident likesuch as this will be hardly possible for a while.
As is the case here, advertisements that pretend to supply academic information such as medical research or articles on dialogue among doctors areis used widely. However, this is possible because of an unhealthy relationship among industry and academia. This complaint concerns illegal advertising involving fraudulent acts in clinical trials conducted against such a relationship. It has raised issues not just about advertising medicine but also about the relationship between industries and universities and how clinical trials should be conducted.
According to the accused, there are an estimated 495 uses of related theses and materials for promotional purposes. This complaint has been filed in the hope that it will provide clues to the truth surrounding the Diovan Incident through detailed investigations into violations of the Pharmaceutical Affairs Law and the Unfair Competition Prevention Act and that by making people's responsibilities clear, the ways in which medicine is sold in Japan will improve and the public will have a guaranteed right to receive appropriate medical care.
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