Japanese prosecutors laid charges against the local unit of Swiss pharmaceutical company Novartis. The scandal claims that falsified data was used to exaggerate the benefits of a popular blood-pressure drug.
The drug studies suggested that Valsartan, sold under the brand name Diovan in Japan, could help prevent strokes and angina, in addition to its recognized benefits in battling blood pressure.
What Is Valsartan?
Valsartan is used to treat high blood pressure and heart failure. It has also been prescribed after heart attacks which may reduce deaths in patients who developed congestive heart failure after a heart attack.
Valsartan side effects include
- Shortness of breath, with even mild exertion
- Urinating less than usual or not at all
- Weakness, confusion, increased thirst , loss of appetite
- Fainting feeling
Less serious side effects include:
- Headache, dizziness, feeling tired
- Flu symptoms
- Cold symptoms
- Blurred vision; or
- Mild itching, skin rash
What Data Was Manipulated?
Prosecutors indicted former employee, Nobuo Shirhashi, 63, alleging he manipulated the data in clinical studies that were later used in marketing the drug, Valsartan.
The firm used data from those studies to market its drug, playing up its supposed additional benefits.
Novartis’ Japan unit has also been involved in another scandal over allegations or not properly disclosing the possible side effects of leukemia treatments.
Was Novartis Charged?
Under the country’s pharmaceutical law, anyone found guilty of exaggerating advertising can face up to two years in prison or a fine of as much as two million yen.
Dual chargers were laid by the Tokyo District Public Prosecutor’s Office, which allege that Novartis bore responsibility for Shirahashi’s actions.
The unit said in a statement on its website, “We take the arrest of our former employee and the indictment of our company very seriously.”
“We deeply apologize to patients, their families and medical workers as well as Japanese people for causing these concerns and troubles,” it added.