A criminal probe into the manipulation of clinical data on the effectiveness of a high blood pressure treatment drug marketed by Novartis Pharma K.K. has failed to reveal the full picture of the scandal.
The Tokyo District Public Prosecutors Office has indicted an employee of the firm and the company itself on the charge of exaggerated advertising — using false data to promote the drug as more effective than similar products sold by rival drug makers. But the social responsibility of not only universities but also doctors involved in the clinical research in question have yet to be clarified.
The Japanese sales arm of the Swiss-based pharmaceutical giant Novartis provided about ¥1.1 billion in donations to five universities that engaged in clinical research on the drug Diovan in the 2000s.
In July 2013, Kyoto Prefectural University of Medicine and Jikei University School of Medicine said they found that data in their research had been manipulated. It also came to light that the Novartis employee, who quit the firm in May 2013, had taken part in the clinical research at the five universities while hiding his employment by the firm. Novartis used the papers based on the research results to promote Diovan.
The investigation only dealt with papers resulting from the clinical research at Kyoto Prefectural University of Medicine and failed to delve into papers produced by doctors at the other four universities.
None of the doctors who led the clinical research — many of them professors at their respective institutions — were indicted even though they published papers advantageous to Novartis in international medical journals. After the scandal surfaced, many of the papers were withdrawn.
The doctors bear grave responsibility for the scandal, which needs to be publicly clarified. Some of them resigned from the universities after the internal probes by the institutions were concluded. But none have come forward and publicly spoken about the manipulation of clinical research data.
It is known that the Novartis employee was involved in the analysis of the clinical data. But the prosecution’s investigation ended without finding an answer to the question of who manipulated the data.
The probe has also failed to expose how Novartis was involved as an organization. The employee’s job was not related to advertising. One wonders how he could successfully carry out a campaign utilizing exaggerated advertisement, which is prohibited by the Pharmaceutical Affairs Law.
These and many other questions remain unresolved despite the investigation. The biggest problem with the probe is that it has failed to shed light on the collusive relationship between the drug maker and the researchers at the university hospitals.
Suspicions over clinical research on drugs do not end with the Diovan case. It also came to light that Takeda Pharmaceutical Co., Japan’s largest drugmaker, used inappropriate data for advertising its own high blood pressure treatment drug. It was also found that Novartis employees were involved in planning clinical research at the University of Tokyo Hospital on Novartis’ leukemia drug, and in collecting and analyzing clinical data on patients who were given the drug.
A similar suspicion has been raised concerning clinical research conducted at the same university hospital on an Alzheimer’s disease drug also marketed by Novartis.
Clinical research plays an important role in scientifically proving the efficacy and safety of drugs. This is indispensable in providing the most appropriate treatment for patients. Manipulation of research data affects a large number of people. Drug makers’ involvement in clinical research, financially or otherwise, can and sometimes does distort research results.
Universities need to establish a system that will shield clinical research from the influence of pharmaceutical companies. For their part, individual doctors must renew their resolve to uphold medical ethics.