Cleveland Clinic Contradicts Nissen Over Vytorin?
13 CommentsBy Ed Silverman // January 30th, 2008 // 4:47 pm
The infamous cardiologist helped cause a ruckus two weeks ago after the Vytorin study results were released by saying the expensive cholesterol med should only be used as a last resort. Nissen made his widely publicized remarks after the trial found Vytorin offered no statistical difference in reducing arterial plaque in the carotid artery in a small group of high-risk patients, even though Vytorin lowered LDL cholesterol more than Zocor (which along with Zetia forms the Vytorin combo therapy).
As a result, a huge national debate has since ensued over the benefit of Vytorin and, by extension, cholesterol meds, since the Vytorin trial - known as Enhance - yielded nothing about reducing heart attacks, strokes or death. And so, prescriptions for Vytorin and Zetia have plummeted and, along with them, Merck and Schering-Plough’s stock prices.
Not surprisingly, Wall Street analysts have labeled the sell-off an overreaction. Now, though, Tim Anderson of Sanford Bernstein points out an irony in an investor note today - two days after Nissen made his remarks, the Cleveland Clinic Foundation, which employs Nissen, issued a statement urging patients to continue taking Vytorin or Zetia without first checking with their doctors.
“The prestigious Cleveland Clinic,” he writes, has come out to “politely defend Vytorin and Zetia and implicitly support that lowering LDL cholesterol levels remains an important therapeutic goal. The steep irony here, of course, is that the Cleveland Clinic employs Dr. Steve Nissen. Dr. Nissen’s scathing interpretation of the Enhance results that were released on Jan. 14 were widely captured by the media. Many industry and academic contacts claim Dr. Nissen’s comments almost single handedly put Vytorin and Zetia where they now are, which is in a state of disarray.”
Then, shortly after issuing his note, Anderson writes Pharmalot to say that the Cleveland Clinic called to tell him the institution isn’t actually defending Vytorin or Zetia. “I told them that, in my opinion, the message seemed to run counter to what the chair of their cardiovascular division has said about Vytorin and Zetia, which is what I found interesting. I’m just trying to call it as I see it.” We agree with his interpretation. So we’ve asked a Cleveland Clinic spokesperson to explain this tightrope walk. When we hear something meaningful, we will update you.
UPDATE: A Cleveland Clinic spokesman writes Pharmalot to say Anderson’s note is “misleading and factually incorrect. The Cleveland Clinic has not taken any position on Zetia and Vytorin…(and that Nissen) fully supports communicating to patients that they should consult with their physician before taking any action related to their medications.”
Alfred
Gary Taubs Op-ed in the sunday NY Times did a great job in expressing that the science itself is the question and that before judging Vytorin, look at the whole promise behind the category of drugs…it was simple and brilliant. And why not the same uproar about the suppressed anti-depressant data? This just goes to show the Media is as irresponsible — actually more — than Big Pharma.
BDM
Ed,
To me, this appears to be a major case of over interpretation by both parties. Dr. Nissen, who is quite out-spoken, seems to have over-interpreted the ENHANCE results. The statements he made were his own medical opinions, not dogma and not the collective opinion of the entire Cleveland Clinic. The Cleveland Clinic statement, which is on their patient website, advises patients NOT TO STOP their medication without checking with their doctors, leaving the decision as to what needs to be done for the patient in the hands of the doctor. Their lawyers may have pushed for this clarification because they were concerned that patients who needed the drug may stop the drug based on news stories rather than physician advice.
On the other hand, Mr. Anderson appears to have over-interpreted the statement on the Clinic’s website, by interpreting that the Clinic disagreed with Dr. Nissen. However, the Clinic seems to be simply clarifying to patients what they should do if they are concerned about their prescription regimen. Keep taking it and contact your personal physician for advice. Do not let the news stories impact your adherance to therapy. This is common sense and the Clinic is providing a service to the public.
Bottom line, the ENHANCE results failed to indicate any beneficial effect regarding the progression of atherosclerosis with Vytorin (ezetimibe + simvastatin) compared with Zocor (simvastatin alone). Therefore, the addition of ezetimibe, which further lowered LDL-C, did not have any benefit on the rate of progression of atherosclerosis in the carotid arteries. However, this result doesn’t mean that physicians and patients should not use the drugs for cholesterol reduction. It simply means that the study was a failure and we will have to wait for 2011-2012 to have any additional information regarding the efficacy of Zetia and Vytorin for the treatment of atherosclerotic cardiovascualr disease.
BAC
Alfred,
I disagree that the media is more irresponsible than Big Pharma. In contrast, the media loves a dirty story full of corruption and intrigue. Unfortunately, Big Pharma offers more of that in 2008 than any of us within the industry would like to admit. Gone are the days when the pharmaceutical industry truly cared about patients more than money. When the scientists and physicians were in charge, their motives were more genuine. Now that the MBAs are in charge, nothing is genuine. it’s all about the money. How much the company can make as well as how much the executives can make. It’s a really dirty business.
Lisa Van S
Ed,
Somerset Medical Center’s, Chief of Cardiology, sent a letter to the Editor, his comments can be found on the Opinion Page of the Courier News. I found it to be an interesting read.
Lisa Van S
ED,
Courier News: Investigate Further before heeding Study
Steven Georgeson
Chief of Cardiology
Somerset Medical Center
http://www.c-n.com/apps/pbcs.dll/article?AID=/20080130/OPINION02/801300323/1010
Ed Silverman
Hi Folks,
A couple of quick points. I understand that Steve Nissen may have spoken as an individual, and I agree the Clinic has every right to express an institutional viewpoint. Moreover, I’m not saying Nissen was right or wrong, or making a judgement about the Clinic’s advice.
But there was a disconnect - the statement stops way short of the conclusion Nissen propagated. Despite its protests about its position on the meds, the Clinic doesn’t say the meds should be used only as a last resort. So I used a question mark in the headline to suggest a contradiction may exist.
Beyond that, this topic is open for discussion, so I’m glad you’ve all shown up.
cheers
ed
BP Watch
Lisa,
What’s the web site for the newspaper? If not known, could you summarize?
Thanks,
BP Watch
BP Watch
I read the Letter to the Editor. It provides good sound advice to patients who take the drugs. DO NOT STOP them and consult with your personal physician. He/She is the one to advise you regarding your individual health, not the news media or an opinion leader.
Ed Silverman
Hi BP Watch,
Please don’t misunderstand me. I agree that everyone should speak with a physician before making a decision or taking a next step. My last comment referred to what the Clinic didn’t say in its statement.
Hope this helps,
ed
Lisa Van S
BP Watch,
Thought it was best to provide a link, and allow the Dr’s words speak for themselves. On another note, My Mother, and Mother-in-law rcvd excellent Cardiac Care at Somerset Medical Center!!
truthman
I have no comment to make on the article.. Apart from maybe.. Don’t dis the doctor Nissen….
but seriously…
What inspires me about sites such as pharmalot and (of course the wonderful Dr Rost and his blog) is the reflection of the tides and how they are turning….
With the advent of the unexpected and fantastic internet revolution , Big Pharma can no longer dupe the public, Its propaganda will always be dissolved and disected by someone (somewhere) who has the balls and humanistic integrity to disect the truth from the fallacy…
No one expected the internet and the worldwideweb to become the empowering and revolutionary force which it has bceome today..
And Like a modern day Oracle, people turn to the Net as a source of truth,..
Everyone “googles” information, people have become their own researchers…
The corporate agenda can’t compete on the internet..
And stuff can’t be hidden…
We can bypass mainstream media…
Bad shit can’t hide in this age…
I love it.. :)
Chris
truthman - I agree with a lot of what you say but easy access to a keyboard, no editorial oversight nor any particular credentials to be communicating with the entire world doesn’t mean what we are fed is all accurate. There’s a place in Hde Park in London, called Speaker’s Corner. Anybody can bring their ownm soapbox, steps whatever, and get up and speak. There are some very lucid speakers and there are some fruitcakes. It doesn’t mean any of them are right, so I think we need to be more discerning when we read opinions, exclusives, revelations on the internet and not take them at face value.
And Ed, this is Chris the first - not sure how the other Chris got to use the same name. We occasionally differ in opinion (not that many read what I post anyway) but I suppose the readers are all pretty discerning themselves.
Cheers
Truthman
agree with a lot of what you say but easy access to a keyboard, no editorial oversight nor any particular credentials to be communicating with the entire world doesn’t mean what we are fed is all accurate.
Well thats exactly the point i was making…
For far too long corporations could spin and market whatever way they liked..
But with the internet , people can do their own research and possibly discover that the reality is far different than what is advertised…
The internet has brought more balance, and more voices can be heard, which in my opinion can only be a good thing…