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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.

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NOVARTIS

Switzerland’s Novartis to help make Pfizer-BioNTech Covid vaccine

Swiss pharmaceuticals giant Novartis said Friday it had signed an initial agreement to help produce the Pfizer-BioNTech vaccine against Covid-19, as countries scramble to boost supplies.

Switzerland's Novartis to help make Pfizer-BioNTech Covid vaccine
Novartis will help manufacture Pfizer vaccine. Photo by AFP.

The rare act of cooperation — in an industry usually marked by cut-throat competition — comes after French pharma group Sanofi announced earlier this week that it would also team up with rivals Pfizer and BioNTech to help produce 125 million doses of their jab.

The two-dose vaccine, which is based on mRNA technology, has been shown to be around 95 percent effective and has been approved for use by the World Health Organization and in some 50 countries.

But it is in limited supply as nations around the world race to immunise their populations against the coronavirus, which has killed nearly 2.2 million people in just over a year.

Novartis said in a statement that it would use its sterilised manufacturing facilities at its site in Stein, Switzerland to help produce the Pfizer-BioNTech jabs.

Under the agreement, the company said it would “take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world”.

Once a final agreement is reached, Novartis said it expected to begin production in the second quarter of the year, with initial shipment of finished product expected in the third quarter.

Steffen Lang, Head of Novartis Technical Operations, stressed that the company was “committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world”.

“We expect this to be the first of a number of such agreements,” he said in the statement.

Novartis said it was already in “advanced discussions” with a number of other companies about with other production tasks, including of mRNA, therapeutic protein and raw material production for Covid vaccines and therapeutics. 

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