Striking a nerve

Striking a nerve

Since the Avandia controversy first became public Diabetic Investor has looked at the controversy from a very simple viewpoint – What good will come from this. We chose not to argue about the merits of meta-analysis or whether or not GlaxoSmithKline (NYSE:GSK) acted inappropriately, rather we decided to look at this whole mess through the eyes of a patient with diabetes. Given that most patients are not scientists or biostatisticians and most do not read medical journals or follow the results of drug trails, we thought most patients want a simple answer to a simple question- Are the medications we take safe and will they help me manage my diabetes? Or put even more simply have the lives of patients with diabetes improved since the Avandia controversy started?

Over the past few days Diabetic Investor has noted the latest casualty of the Avandia controversy was Bydureon. As everyone knows the FDA has asked Amylin (NASDAQ:AMLN), Alkermes (NASDAQ:ALKS) and Lilly (NYSE:LLY) to conduct yet another study as they are concerned over a possible cardiovascular issue. Although none of the extensive data already compiled by Amylin shows Bydureon to have any serious cardiovascular issues nor have we seen any cardiovascular issues with patients taking Byetta, Amylin’s twice-daily GLP-1 which is used by over a million patients, the ultra conservative FDA who’s afraid of their own shadow, asked the company to conduct another study.

When this news became public Diabetic Investor reached out to several respected diabetes researchers for their view of what the FDA had done. Not one could understand why the FDA asked for this and all were shocked Bydureon was not approved. The general consensus, even from companies who compete with Amylin, was Amylin got screwed by an over cautious FDA.

While writing about this issue we noted that Dr. Nissen, who’s now famous meta-analysis, was the first domino to fall in the Avandia controversy was partially responsible for the FDA’s decision. It seems that Dr. Nissen doesn’t think very highly of Diabetic Investor. Thanks to a subscriber who violated the Diabetic Investor copyright, Dr. Nissen has read what we have written and has taken issue with our characterization that he is a self-promoting publicity seeking physician who has put his point of view over what’s in the best interest of the patient with diabetes.

Over the past few days Dr. Nissen and Diabetic Investor have had series of email exchanges and we thought it might enlighten our subscribers to see the feelings of this noted cardiologist.

Below is the complete series of exchanges which includes our responses:

Round One

Your note about the FDA rejection of long acting exenatide was extremely offensive.

Your attempt to blame me for the failure of FDA to approve Bydureon is absolutely laughable and makes you look like a blithering fool.

I wish I had the ability to influence FDA decisions, but the Agency makes up its own mind.

In the future, you might consider thinking before opening your mouth.


Thanks for the note and I did think long and hard before I wrote – let’s be honest about how things have turned out since you initially performed your now famous meta-analysis – ask yourself this simple question – has anything good come from it? I am not trying to be condescending however as a patients with diabetes who understands the real world of diabetes management I would say the answer is NO – I do not believe for a second that you could have envisioned the series of events which have transpired since the Avandia controversy began – and I do believe your heart (excuse the expression) was in the right place – however the reality of the situation largely due to the Avandia controversy is the FDA has become ultra conservative and is preventing excellent drugs like Bydureon from reaching the market –  I am sorry you took offense to what I wrote but the last time I looked this is America where are allowed to express our opinions – I have seen many of your interviews and you seem to take issue with anyone who disagrees with your views – and please do not insult me by saying your opinion does not carry weight at the FDA – you and I know this is not the case- and finally I did not blame you personally for the FDA’s decisions but the controversy you started did contribute to it – happy to talk with you at anytime in the future


Round Two

Dear David,

You have allowed your passion to cloud your sense of reality. The Avandia debacle finally focused the medical community on the need for diabetes drugs that improve clinical outcomes, not just blood sugar.

The offensive comments relate to your suggestion that I am an media-seeking self promoter. You are dead wrong. Taking on a corrupt pharmaceutical company like GSK doesn’t win you many friends, but it was necessary.

The real villain dere is GSK. They concealed data and aggressively marketed a drug they knew was harmful. They published a fraudulent clinical trial (RECORD). Any blame for the FDA’s current approach rests more with GSK that independent scientists.

Questioning my motives is perfectly within your rights, but it makes you look angry, irrational, desperate and vindictive. Leave that persona for the tea party crazies.


Steve –

As far as the final result of the Avandia controversy I believe the jury has not yet rendered the final verdict. Yes the medical community is more focused however it is still open to debate whether they are focusing on the right issues.

You seem to be a little sensitive about your relationships with the media – frankly I don’t have a problem with your use of the media as long as it promotes public debate, as I stated before there is nothing wrong with expressing an opinion – however I believe there have been times when you stepped over the line of promoting public debate and sought to defend your position and attack your critics – believe me I have been called much worse than a blithering idiot and honestly it’s doesn’t bother me one bit and is many respects is actually a little funny

And you are right I am very angry but not at you rather the whole mess we’re in today. At a time when diabetes is growing at epidemic rates and costing our economy billions of dollars the FDA is taking away weapons that could be used to fight diabetes and preventing new weapons from reaching patients with diabetes – the drug approval process has slowed to a crawl – and the regulatory path is filled with uncertainty – it is disingenuous to say that you did not play a role in this – you promoted public debate and stood by your conclusions – however it seems to me that you have a real problem if anyone questions your conclusions or methods for promoting your point of view – I believe you are very educated man but I must admit I am a little disappointed in the tone of your emails – this is not personal – helping the millions of patients with diabetes is more important than any one person – as a respected physician I would think you would be aware of that

I am sorry if my writings have upset you, that was not my intention – I write what I believe to be true and express my opinions accordingly – as they old saying goes sticks and stones may break my bones but names will never hurt me – I look forward to a continued dialogue

All the best,


Round Three

You just don’t get it. You note consisted of an ad hominem attack, not a scientific argument. This will be my last e-mail

Since Steve seems a little miffed and no longer seeks an exchange of emails Diabetic Investor thought we would give our final response here. Given that there is a subscriber out there violating our copyright we figured Dr. Nissen would receive it.


You are correct I not giving a scientific argument as I am not a scientist, physician or researcher. I am patient with diabetes who cares about one thing and one thing only; helping other patients with diabetes. Thankfully I have access to some of the best and brightest minds in diabetes and rely on their knowledge and expertise when explaining the science.

I also will take issue that you are using a scientific argument as meta-analysis is not science, it’s math. When your meta-analysis was first leaked to the media, I reached out to several statisticians as I am not very good at math and wanted to understand the rational used with meta-analysis. Basically what I learned was the results of a meta-analysis can vary widely depending on which data sets are incorporated into the meta-analysis. Or as Mark Twain said, “There are lies, damn lies and there are statistics.”

I also find your characterization of Glaxo as a villain interesting. While I do believe GSK acted inappropriately, and they are paying a very heavy price for their behavior, there are several respected scientist who believe your meta-analysis was flawed as well. And I strongly disagree that FDA’s actions came as result of what GSK did.

In my opinion the FDA is a broken agency who has strayed from their mission. The agency is supposed to use scientific evidence when making their decisions but this is no longer the case. Having attended several FDA panel meetings and seeing the agency in action, it’s obvious that science has little to do with their recent string of decisions. The reality is the FDA is an agency griped by fear and this is not in the best interest of patients.

While I am sure there are others who also believe I am a blithering idiot, perhaps you have friends who work at Roche, this seems to me to be a hypocritical statement and a personal attack. The same type of personal attack you accuse me of doing. And for the record I do not practice witchcraft and I can name several Supreme Court decisions so I do not believe I am qualified to be a member of the tea party.

As I stated from the start I view this whole situation from a very simple perspective- Has any good come from it? While I have enjoyed our dialogue I do not believe you have answered this question in the affirmative. I truly hope you continue your efforts as I believe public debate to be a cornerstone of our great democracy. America is a great country for several reasons but one I truly admire is we are allowed to freely express our views. I am sorry if you took offense to what I wrote, I really wasn’t attacking you personally rather like many writers I was making a point.

I look forward to continued discussions in the future.

All the best,