Here is a letter Schering Plough's Ken Banta sent on Friday to Matt Herper, Associate Editor at Forbes demanding corrections and apologies for this story that ran in the magazine about the ENHANCE study, Schering-Plough, and CEO Fred Hassan.
Matt,
Thanks for discussing the articles on Schering-Plough and our CEO that ran today in Forbes.
From our call this morning, you know how disturbed we are about some inaccuracies and unfair portrayals in the piece -- and I appreciate after talking with you that many of these were the result of editing decisions that you did not control.
These wrongly damage our company reputation and the reputation of our CEO.
They also misinform your readers on medical matters, many of whom are surely taking cholesterol medications and could be frightened into bad decisions.
I know you were on the FDA call this afternoon. I think what those experts had to say was an eloquent and authoritative answer to a lot of the criticisms and tonalities in the Forbes story.
I assume you will get the transcript of that FDA discussion and can compare what those experts said point by point with what your story said.
In brief I heard unequivocally - Lower LDL IS better, -it is not at all uncommon for a complex trial to take a long time to read out, -it is not uncommon or wrong for there to be contemplation of an endpoint change or an actual change in endpoint before a trial is unblinded,
-that there are lots of reasons to question the validity of imaging studies given the contradictory results of these studies with statins which have a proven cardiovascular outcomes benefit,
-that it is outcomes studies that matter and that is why IMPROVE-IT is the study that will matter.
Let me summarize the main concerns that we feel should be redressed immediately in online form and as corrections and amplifications in the next print issue.
Starting with the second paragraph and throughout the piece, the story wrongly states or implies that the Enhance trial and its handling were the sole responsibility of our CEO Fred Hassan (as in 'Then he botched the handling of a study…') when in fact this trial and every aspect of its handling are the joint responsibility of Merck and its CEO and Schering-Plough through their joint venture, including the funding and supervision and 'handling' of the Enhance study. Nowhere in the story is the joint-venture relationship properly stated. It is my understanding that language clarifying this that may have been in a previous draft of the story was deleted by editors. This needs a correction and an amplification.
Your story says the study raises doubts about Zetia's effectiveness. The study does not raise doubts about Zetia's effectiveness. Your story is incorrect and misleading and as the FDA panel stated the effectiveness of Zetia and Vytorin in lowering LDL cholesterol is demonstrated. What the study is inconclusive on is effect on thickness of the arterial wall -- which may have no correlation to cardiovascular events. This needs a correction.
' The excuses are thin. Either..or" There was not an either or. There were many, many possible reasons why the study did not happen on the anticipated time frame. Read the FDA transcript for details. This needs a correction.
"..case reveals the ugly reality of the pharma business…" This paragraph is unsupported by anything in the article and is not even supported by the casual references to other drugs mentioned. I.E. Zetia and Vytorin are based on new high innovation and Detrol was also a breakthrough new molecule, and so is Sugammadex featured in the sidebar story. I can only assume it was not written by you -- but it did appear in this article and it hurts us. This needs a correction and amplification as an editing error or misstatement.
"Now this delayed study shows that even pharma's Mr. Fix-It can't run a straightforward operation." This is incorrect and unfair -- as the FDA commentary reflects there is no reason to believe the time it took to report topline findings was out of line and it is accusing our CEO of running deliberately deceptive organization. This is unacceptable and it needs a correction and an apology.
Matt, those are the specific points. More broadly I would also say that I was surprised by the tone of some of this piece that again, seemed out of character with your usually careful and balanced tone. There is a cavalier and dismissive tone to many of the sentences and paragraphs that is inappropriate, and I think you can understand why Fred Hassan would be personally disturbed by this treatment of comments that he made to you in good faith.
Matt, I would also appreciate knowing whom to contact on this at the editorial level.
Your response and that of your editors meantime to these points and the actions Forbes will take to correct and improve and apologize will be appreciated.
Sincerely
Ken Banta
Strategic Affairs
Schering-Plough Corporation
Insider's view: Wow! Looks like a nerve was touched.
Let's just contemplate on what Schering Plough would have been saying about ENHANCE had the result been positive for Vytorin.
Insider guesses there could be documents and meeting notes inside S-P and Merck that might help us with that thought!
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