Serious Novartis Scandal Causes Japan To Mull Penalties for False Data

Serious Novartis Scandal Causes Japan To Mull Penalties for False Data

August 6th, 2013 // 12:53 pm @

Latest FDA and cGMP Compliance News

After the big scandal regarding research for the blood pressure drug Diovan, the government in Japan is thinking about new laws to more tightly regulate clinical trials. The penalties for not preserving and submitting the records to the Japanese government would include a good number of fines, having the trials stopped and the drug approvals could be pulled back.

The Health, Labor and Welfare Ministry is going to set up a committee to look into details of the cases where data was faked. The debate on the proposed law, called the Pharmaceutical Affairs Law, is thought to start this week. There are ethical rules set up in Japan, but there is not a strict law that regulates clinical studies, so the researchers in the case were not subjected to any punishment.

What has caused the proposal was the big controversy over the Diovan drug, which caused a great deal of embarrassment for Novartis and a top university in Japan. Hiroaki Matsubara, who was a top researcher and was the top investigator in several of the trials, resigned his role from Kyoto Prefectrual University of Medicine  earlier this year. School officials later admitted that some of the underlying data was indeed manipulated and faked.

Matsubare was a co author of papers from 2008-12 and this included the Kyoto Heart Study, which was first published in the periodical called the European Medical Journal four years ago. It made the claim that Diovan cut the risk of heart attack and stroke. Novartis then used this information in its ads. This helped Diovan to become a big seller in Asia and sales increased to $6 billion around the world, before generics came out.

Some other papers have also been retracted and the firm admitted that two workers were involved in clinical trials that should not have been. These workers were involved in clinical trials that were supposed to be independent. The conflicts were not talked about, and Novartis claimed that there was not any evidence that data was manipulated.

Novartis stated thta there were not any rules in the country to regulate conflicts of interest in doctor-led clinical studies. The employees and their bosses did not have enough understanding about employees being involved in drug companies and in such clinical research. Now those guidelines have been put in place.

Subscribe Now

Featured Partner