Could a scientific paper ever be considered an advertisement?
That was the question posed to a Tokyo court, in a criminal case where prosecutors argued — at the behest of Japan’s ministry of health — that a peer-reviewed paper containing faked data should be considered “fraudulent or exaggerated advertising” under that country’s laws.
In that case, however, the argument didn’t work. In March, the court decided that a fraudulent paper was not false advertising, allowing a pharmaceutical researcher at a Novartis subsidiary to escape jail time. The decision also cleared Novartis of charges and helped the company avoid a ¥4 million ($35,373 USD) fine.
According to an article in The Japan Times, the presiding judge Yasuo Tsujikawa said:
Posting the articles on the journal represented the announcement of research results, so it’s difficult to say that this was a measure to stimulate consumers’ desire to purchase the drug.
Could a similar case ever be brought in other countries? According to Ann Walsh, a lawyer who used to work at the U.S. Food and Drug Administration but now works in private practice, a similar case might even succeed in the U.S., especially if the paper were used as promotional material:
[U.S.] courts have said that any written material distributed with a product is material that is subject to labeling laws.
(In the U.S., drug and medical device labeling laws govern information directed at health care professionals, while advertisements can also be directed at consumers.)
At issue was work by Nobuo Shirahashi, an ex-Novartis employee, who was accused of submitting faked data to a study of the company’s blood pressure drug Diovan (valsartan). The trial did not focus on the scientific fraud; rather, it considered whether or not Shirahashi could be charged with a criminal violation of Japan’s drug advertising laws. In fact, The Japan Times reported that Tsujikawa acknowledged Shirahashi had manipulated data.
In 2014, Novartis’ Japanese subsidiary acknowledged that it had cited the bogus Diovan research papers as part of Japanese advertising campaigns 700 times since 2006.
Here’s how that research got tainted, per The Japan Times:
Shirahashi took part in a research project at the Kyoto Prefectural University of Medicine as a clinical test data analyst. He supplied the research team with manipulated data concerning patients who were not given the drug.
In 2011, the team eventually published in a medical journal a research paper showing those who were administered the drug suffered strokes at a lower rate than those who were not given the drug.
We aren’t sure which paper the case revolved around, but one 2011 paper about the use of Diovan (valsartan) in Japanese patients was corrected in 2013 to show Shirahashi worked for Novartis, then retracted in 2014 over issues with the data and conflict of interest. “Effects of valsartan and amlodipine on home blood pressure and cardiovascular events in Japanese hypertensive patients: a subanalysis of the VART” has been cited five times, according to Clarivate Analytics’ Web of Science, formerly part of Thomson Reuters.
In total, Shirahashi was a collaborator on no less than three Diovan-related papers that have since been retracted, although data manipulation was not cited as the reason for any of those retractions. The second paper, “Effects of valsartan and amlodipine on cardiorenal protection in Japanese hypertensive patients: the Valsartan Amlodipine Randomized Trial,” published in Hypertension Research in the fall of 2010, was retracted in 2016. He was also listed as a collaborator for a retracted 2007 The Lancet paper on the Jikei heart study.
If U.S. prosecutors were to attempt a similar false advertising case, whether or not the company had circulated the paper as promotional material would be an immensely important fact, Walsh told us:
The critical part to implicate the company is that it has to be doing something — either they knew about the falsity of the data or they were proactively disseminating it. The company needs to have some sort of involvement. If there isn’t that, I think a case would be difficult to bring.
A “willful blindness” to the fraud could also put the company in jeopardy, she said.
In the case of off-label studies for already approved prescription drugs, attorney Joel Androphy, of Berg & Androphy, told us that successfully prosecuting a criminal case was unlikely. Not only would the prosecution have to prove the data were falsified, but also that the study had been done to solicit business; however, if someone died after taking a drug off-label, or if the FDA were willing to support the prosecution, a criminal case could become more likely, he said.
Both lawyers noted that civil charges could also be brought, either by a federal agency or another entity such as a competitor.
The Japanese prosecutors are reportedly planning to appeal the decision.
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