SHARE
COPY LINK

DRUGS

Novartis under fire over false Japanese drug data

Test data on a widely used blood pressure drug from Swiss pharmaceutical giant Novartis was very likely fabricated and falsified, Japan's health minister says.

Novartis under fire over false Japanese drug data
Photo: Novartis

Norihisa Tamura on Friday characterized as "extremely regrettable" an incident in which an employee of the world's number two drug maker had hidden his affiliation during a medical study into the effects of Valsartan.

A study at Kyoto Prefectural University of Medicine concluded that the drug, developed to treat high blood pressure, could also help to prevent strokes and angina.

But the university said on Thursday that incomplete clinical data had been used to support this finding and that had patients' records been used in their entirety, the study would have had a different conclusion.

While Valsartan was effective in controlling high blood pressure, the university said the medication did not necessarily have any effect on strokes or angina.

Novartis sells the drug under the name "Diovan" in Japan, where it is one of the most commonly prescribed drugs on the market.

It is licensed for use in more than 100 countries.

The firm used the study to market its drug, playing up its supposed additional benefits.

Tamura said the case "highly suggests fabrication and falsification of data" and he would be establishing a special committee to work out how to prevent this in future studies and to review ethical guidelines.

The study was led by professor Hiroaki Matsubara, and included among its researchers an un-named Novartis employee, who was identified as an adjunct lecturer at Osaka City University.

Matsubara resigned his post at the university in February after scientific journals pulled his papers citing inconsistent data and as the school launched a probe.

The Novartis worker, who has already left the firm, has refused to cooperate with the university's investigation.

In a statement issued on Friday, Novartis maintained that the university was unable to conclude that there was intentional wrong-doing.

The Basel-based company said the inconsistencies might be unintentional errors, not the "manipulation" suggested by the university.

The Novartis researcher was also involved in Diovan research at Tokyo Jikei University, Chiba University, Nagoya University and the Shiga University of Medical Science, Kyodo News said.

These universities have said they will also conduct investigations to see if there were any problems.

Member comments

Log in here to leave a comment.
Become a Member to leave a comment.

DRUGS

Germany should make cannabis available at pharmacies not ‘coffee shops’, says FDP boss

Germany's possible new government could well relax the country's strict cannabis laws. But FDP leader Christian Lindner says he doesn't want to go down the Netherlands route.

A demonstrator smokes a joint at the pro-cannabis Hanfparade in Berlin in August 2021.
A demonstrator smokes a joint at the pro-cannabis Hanfparade in Berlin in August 2021. Photo: picture alliance/dpa | Annette Riedl

The Social Democrats (SPD), Greens and the pro-business Free Democrats (FDP) are set to engage in coalition talks in a bid to become the next German government.  And the future of cannabis will likely be one of the topics to be thrashed out.

In drug policy, the three parties are not too far apart in their positions. So it’s possible that the drug could be decriminalised.

However, nothing is set in stone and the parties still haven’t come to a common line on the question of where and to what extent cannabis could be accessed. 

The leader of the Liberal FDP, Christian Lindner, has now come out in favour of allowing cannabis products such as hashish to be sold in a controlled manner. 

Consumers should be allowed “to purchase a quantity for their own use, for example, in a pharmacy after health education,” Lindner told a live broadcast on German daily Bild on Sunday.

Lindner said he was sceptical about the sale in “coffee shops” according to the Dutch model. “I am in favour of controlled distribution, and therefore health education must be able to take place,” he said.

READ MORE: Patients in Germany still face hurdles accessing medical marijuana

People in the Netherlands can access cannabis products in coffee shops under the country’s tolerant drugs policy. However coffee shops have to follow certain strict conditions. For instance they are not allowed to sell large quantities to an individual. 

Lindner said his main aims were about “crime and health prevention” and not with “legalising a right to intoxication”.

It’s not clear if Lindner advocates for prescription-only cannabis for medical use, or an over-the-counter model. 

The FDP previously said that they they are in favour of the creation of licensed shops. Their manifesto highlights the health benefits, tax windfalls and reallocation of police resources that legalisation would create.

The Green party also want licensed shops, as well as a whole new approach to drug control starting with the controlled legalisation of marijuana. The Greens state that “strict youth and user protection” would be the centre point of their legislation and hope to “pull the rug from under the black market”.

The SPD also want a reform of Germany’s prohibition stance – but are more cautious than the smaller parties on the legalisation aspect. They would like to initially set up pilot projects. 

READ ALSO: Why Germany could be on the brink of legalising cannabis

Controversial topic

So far, the sale of cannabis is officially banned in Germany. Possession of cannabis is also currently illegal across the entire country. Those caught carrying the substance can face anything from a fine to five years in jail.

However, the justice system generally looks away if you are caught carry small quantities for personal use unless you have a previous conviction.

The definition of personal use differs from state to state, with Berlin having the most liberal rules and Bavaria the tightest.

It is estimated that around four million people regularly use cannabis in Germany.

Representatives of police unions in Germany have warned against legalisation. They argue that cannabis is an often trivialised drug that can lead to considerable health problems and social conflicts, especially among young people.

Oliver Malchow, from the GdP police union, said that “it doesn’t make any sense to legalise another dangerous drug on top of alcohol”.

The current Ministry of Health also continues to oppose the legalisation of cannabis, a spokesperson for Minister Jens Spahn (CDU) made clear. Cannabis is a dangerous substance and therefore legalisation is not advisable, the spokesman said. 

SHOW COMMENTS