Very Interesting Indeed
Diabetic Investor has confirmed that Dr. Steven Nissen is a member of the steering committee which is overseeing the Victoza cardiovascular studies. According to a press release issued back in May by Novo Nordisk (NYSE:NVO), “The trial named LEADER™ (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) aims to assess and confirm the cardiovascular safety of the company’s new once-daily human GLP-1 analog Victoza®. The trial satisfies the new FDA guideline for type 2 diabetes treatments.”
Diabetic Investor has no problem with Dr. Nissen’s involvement with this committee and it’s understandable that Novo would want the input of a noted cardiologist. What concerns Diabetic Investor is why Dr. Nissen did not disclose this fact during our email exchanges.
According to people familiar with this committee Dr. Nissen is a “very engaged and well informed” member of the committee. Again this is not all that surprising as Dr. Nissen is not just a noted cardiologist; he has become a key figure in the diabetes community.
Contrary to his assertions, it is also well known that Dr. Nissen is very well connected to the FDA.
Before everyone ventures down the conspiracy path, it could well be that Dr. Nissen did not think to mention his role in this committee as it was not relevant to our discussions. But for those who do wish to venture down this path, his involvement with this committee does pose some interesting possibilities.
Consider that of all the companies that stand to lose the most from Bydureon being delayed its Novo Nordisk. After interviewing several Novo sales reps Diabetic Investor fully understood just how worried the company was. The story from each rep was nearly identical, physicians like Victoza but they loved Bydureon and couldn’t wait for it to get here. The simple line was- once-daily trumps twice-daily but once-weekly trumps once daily.
Novo was already smarting that Victoza itself found the approval process difficult and was also delayed before finally being approved. At the time many, including Diabetic Investor, believed that Novo’s window of opportunity to establish Victoza in the marketplace was a short one. Well now it doesn’t look like they have to worry about that and they have plenty of time to build the Victoza market. Strange how these things work out isn’t it?
To be clear here Diabetic Investor is not accusing Dr. Nissen of doing anything improper or illegal. Nor do we have any direct knowledge that he has communicated any information to the FDA. However what we do know is that he is involved with this committee and he chose not to disclose that fact. In the current environment where transparency is the new buzz word in Washington D.C., Diabetic Investor finds this omission notable. As Aldous Huxley noted; “Facts do not cease to exist because they are ignored.”
