Fred Hassan On Vytorin: ‘I Don’t Have The Answers’
11 CommentsBy Ed Silverman // January 26th, 2008 // 8:30 am
Dealing with a crisis is always challenging for a company. And the Vytorin controversy - some call it a scandal - is engulfing Fred Hassan, the Schering-Plough ceo, who was motoring along quite nicely, having convinced Wall Street that the drugmaker was turning itself around. Now, though, the stock has given up an entire year’s worth of gains as investors, doctors, legislators and regulators try to understand exactly what happened with the Vytorin trial, which measured the cholesterol med against Zocor but found no statistical difference in reducing plaque in the carotid arteries.
The results were delayed nearly two years with scant info about the progress of this bet-the-franchise study. The primary endpoint was briefly changed without the consent of the lead investigator. A so-called independent panel was retained to review the data, although three members had financial ties, which no one knew at first because their names weren’t disclosed. Meanwhile, Vytorin was heavily promoted. And Schering-Plough execs sold lots of stock during all this. In their defense, Schering-Plough and Merck released a chronology yesterday defending their conduct and have run ads defending their meds.
Now, Fred is giving select interviews. But his response to this mess is curious. As he tells Forbes: “I’m quite sure nobody had bad intentions. Why didn’t it happen on time as it should have? I don’t have the answers.” At this point, he needs to know - and say so. That’s what leadership is about. For the moment, one is left to conclude that the drugmakers deliberately delayed releasing negative results - or results that appeared to be negative - or they were clueless about the implications. Neither option inspires confidence. It’s time for Fred to get - and give - some answers.
Matt
For a man who is in the hick of things at Schering-Plough, you would think he would have all the answers by now…
And right “I’m quite sure nobody had bad intentions.” We’re supposed to believe a drug maker doesn’t have bad intentions?
Nathan
Matt,
You just assume that because this guy is from a pharma company that he has bad intentions?
People in the pharmaceutical industry have two (and only two) goals:
1) Improve public health
2) Make money
The problem is that those two goals are often conflicting and frequently cause people to have conflicting interests. There really isn’t a way around it.
This whole thing sortof reminds me of all the congressional investigations into big oil companies’ price gauging in the wake of Katrina. What did all those investigations find? NOTHING. Big corporations supplying essential public services are seemingly always the bad guy.
I’m beginning to think that this web site should change its name from “Pharmalot” to “Vytoralot”. The constant coverage of this issue (and implicit assumption of guilt) is getting very tiring.
Ed Silverman
Hi Nathan,
As I’ve indicated previously, this industry is undergoing enormous change and challenge, and with that comes tension. As a journalist, one part of my job is follow that tension.
The Vytorin flap is the latest example, because it raises various sorts of questions that intrigue a great many people, in and out of the industry. This explains why Vytorin is covered so assiduously elsewhere, not just on Pharmalot, these past two weeks.
And to your last point, I am not implying guilt, but attempting to point out missteps and shortcomings that should be addressed by the drugmakers. Once again, if there is room for improvement, why not discuss it?
Cheers
ed
Dr. Remulac
Ed - continue to report as you have! Open and balanced reporting and discourse is the only way we’ll be able to understand and work-out the issues this industry is facing.
Ken Banta
Ed, I think it is worthwhile dissecting the Forbes story and looking at whether it constitutes good journalism.
We have a lot of respect for Matt Herper but unfortunately his reporting appears to have been subject to a lot of sensationalist and unfair editing. As we know, especially in magazine journalism the end product typically goes through many hands beyond the person who is named in the byline.
Below is the letter I sent to Matt on this — as Dr. Remulac says, “Open and balanced reporting and discourse” is the right approach but “open and balanced” is the key.
Ken
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.
* The study does not raise doubts about Zetia’s effectiveness. This 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
http://blogs.forbes.com/sciencebizblog/2008/01/merck-and-scher.html
Ed Silverman
Hi Ken,
Thanks for the note. For the record, I referred to - and linked to - the Forbes piece because it contained the quote from Fred. And in this instance, I ran only the quote from that piece, with the proper attribution, because I found his remarks interesting. The issues you raise are with the rest of the Forbes article, as I understand it.
And yes, Merck is equally responsible since it is a joint venture. Interestingly, Merck’s ceo, Dick Clark, has been silent - only Peter Kim, Merck’s chief scientist, appears in any statements. Otherwise, Merck’s position is being explained by a spokesman, not someone who is responsible for Merck’s decisions and actions.
This brings me to Fred. Unlike Clark, Fred has made public statements - canned and otherwise - which is in stark contrast to the deafening silence from Merck’s leadership. If there is an issue with open and balanced reporting and discourse, however, take me up on my request to interview Fred. I haven’t heard back from your team about that, but you had the time to post this comment. Let me know. I enjoy good old-fashioned discourse as much as the next guy.
Cheers
ed
Ken Banta
Ed, I was not taking issue with your commentary but with the Forbes article that was so unbalanced. Thanks for your feedback.
Ken
Insider
Hey Ken,
I wonder what you guys would have been saying about ENHANCE had the results been positive for Vytorin.
It might be worth finding out. I’m sure there must have been planning meetings (with minutes/documents etc.) inside SP/Merck.
If not - then why not!?
Let’s hope the ongoing investigations/subpoenas unearth them.
If not - then why not!?
Merck’s silence does hint at (at the very least) a difference in approach. Maybe they have learned somthing from Vioxx after all!?
All the very best.
Jack
Dr. Remulac
Hi Ken - your candor is much appreciated. One question or two that, if you could answer, would go a very long way in the medical community in defending your position:
1. Was there a blinded assessment of ENHANCE IMT results in aggregate (meaning, was there an analysis of all patients pooled together) and if so, who knew and when did that occur?
As you know, it is a common practice to examine surrogate endpoint studies in this manner to see if there are any clear effect signals from baseline to end before formal unblinding.
2. When were the lipid results known and by whom? Clearly, there were no data cleaning issues to be invoked for this simple laboratory endpoint and would have been easily available within a month or 2 after the study ended.
Thank you!
B Martin, MD
Further insight into the delay of the ENHANCE study results can be derived by scouring the sponsors’ provided timeline. Essentially, by my read, it was determined at the time of a data-quality review in 2005 that the ultrasound images used to measure the effectiveness of the drugs were suboptimal (to put it nicely). You can read more of my assessment of the ENHANCE timeline at http://bmartinmd.com/2008/01/enhance-study-basically-the-ul.html, which implies incompetence regarding the gathering of quality ultrasound data, rather than anything particularly sinister.
However, why SP’s CEO wouldn’t have a good, press-worthy spin on the growing PR mess from the ENHANCE trial at present is incomprehensible.
Andrew C..
If Fred Hassan doesn’t have the answers, then who does? Frankly, he should know what’s going on with the most important products in the most imporatnt franchise he has at Schering-Plough. If he doesn’t know, then he needs to find out from his key execs who knew what when so that the whole company doesn’t go down the tubes. Perhaps the final results weren’t available until January 2008, but eveidence that the study was going bad was in by late 2005. Anybody who knows anything about CUS research knows that since the changes are very, very small, the data must be perfectly clean with little variability! Perhaps Ken banta knows! He seems to know everything else about Schering-Plough.
Perhaps Fred wasn’t overtaken by pure greed, but I can’t even use the word perhaps when talking about carrie Smith Cox. I saw where CT is joing NY in the probe. By all rights, every state should join and the federal government should have the hammer.