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The release of written opinions on the Diovan Data-Manipulation Scandal


On September 11th 2013, Medwatcher Japan released some written opinions on the Diovan Data-Manipulation Scandal

Diovan (generic name Valsartan) is an antihypertensive manufactured and sold by Novartis Pharma K.K.

Since 2002, the Jikei University School of Medicine, Chiba University, Shiga University of Medical Science, Kyoto Prefectural University of Medicine and Nagoya University have been carrying out large-scale clinical research or so-called investigator-initiated trials comparing the effects of Diovan and other existing antihypertensives. The results of these trials revealed that the effects of Diovan on preventing complications such as strokes were better than existing antihypertensives and Diovan became a huge hit with annual sales of over 100 billion US dollars.

However, it soon became apparent that data in the research article was unnatural and in 2012 Japanese and European academic journals retracted articles on tests conducted by Kyoto Prefectural University of Medicine. It then became clear that the responsible person for 5 statistical analyses during the trials was an employee of Novartis Pharma K.K. Investigations up to now have revealed that data on the conclusion of the trials carried out at Kyoto Prefectural University of Medicine and the Jikei University School of Medicine were manipulated to show Diovan in a good light. The investigations are continuing.

It has also become clear that the research laboratories headed by the principal researchers in the 5 universities that conducted the trials had received large financial donations from Novartis Pharma K.K.

Below is an outline of our written opinions concerning the roles that related institutions should take in clarifying the problems brought about by this scandal and preventing a recurrence.

◆Clarify the problems about the scandal
1 Bringing the matter to light
(1) The 5 universities that conducted the clinical trials must conduct continued investigations by checking their data against those of medical records, talking to those involved and thoroughly examining any related records. They must also verify the appropriateness of the trial results and make clear how Novartis Pharma K.K. and its former employee were involved, as well as the relationship between any financial donations and the costs of the trials.

(2) Principal researchers in each clinical trial should not just fully cooperate in the investigations of related institutions but also publicly explain the facts on their own responsibilities.

(3) Details of a report released by Novatis Pharma KK on July 29th 2013 are extremely insufficient so the company should immediately disclose more detailed results of its investigation into this matter. Meanwhile the Minister of Health, Labor and Welfare should order Novratis Pharma K.K. a report on this scandal and make the contents public.

(4) The Ministry of Health, Labor and Welfare's investigative commission on the clinical research of antihypertensives should get to the bottom of the matter as much as it can. This includes interviewing those concerned and requesting the submission of objective materials on issues such as a conflict of opinion between Novartis Pharma K.K. and the universities involved as well as other important facts. It should also aim to make the investigation process and outcomes as transparent as possible.

(5) Both Houses of Representatives and Councilors should hold intensive deliberations on the scandal, investigate the facts by summoning witnesses and make clear what kind of laws could be established to prevent a recurrence.

2 Related academic institutions as well as the media that promoted Diovan should validate the roles played by themselves and medical specialists from the institutions in promoting the drug. Also they should make the problems surrounding this scandal clear and announce measures they will take to prevent a recurrence, which process includes investigating medical specialists who were involved in promotion any possible conflict of interest.

3 The government should conduct a fact-finding investigation into company involvement in investigator-initiated clinical trials held up to now in Japan.

◆ Preventive measures
1 Preventing the recurrence of unfair practice
(1) Today discussions are underway into revising the Ethical Guidelines for Clinical Studies. On this occasion, these guidelines should be given legal force and legal regulations drawn up to guarantee trust in all forms of clinical research.

(2) A system needs to be established to investigate any possible unfair practice in medical research while investigative bodies must be given appropriate authority. Each research institution also needs to come up with internal laws on disciplinary action for wrongdoers and if anyone with a medical or pharmaceutical license commits any unfair practice, appropriate administrative steps (warnings, order of suspension or license revocation) should be taken.

(3) Companies that gain a profit through unfair research on medicine and medical equipment should put any such profit (the equivalent of costs covered by patients ) into a public fund due to be established. Any money put towards health insurance should be returned to health insurance associations and the required legal grounds for that must be established.

2 Addressing conflict of interest
(1) Funding for clinical trials should be offered in line with systems such as contract research that makes the purpose of the funding clear. Any donation that simply aims to fund clinical trials must be prohibited.

(2) The Japan Pharmaceutical Manufacturers Association must immediately implement the Transparency Guideline for the Relation between Corporate Activities and Medical Institutions. The Japan Medical Association needs to do the same and legislating the guidelines should also be looked into.

(3) All universities and research institutions need to disclose information on accepting donations from pharmaceutical companies and the fees received by researchers and staff who give lectures by using methods such as websites.

(4) As well as increasing government financial support for clinical research, a public fund for such research needs to be set up by studying systems used abroad.

 The Diovan Data-Manipulation Scandal has once again shown that a conflict of interest can be a threat to the fairness of research. Japan's Medical Associations and administrations should admit that they have had underestimated the potential risk of conflict of interest that industry-university collaborations include. They must now take thorough steps to ensure this does not happen again.