The
controversial Vytorin trial released by Merck and Schering-Plough yesterday was quickly interpreted by Cleveland Clinic cardiology star Steve Nissen (pictured left) as a reason to use the drug as a last resort (he said the same thing about Zetia, which along with Zocor, is contained in Vytorin). His remarks apparently contributed to a sell-off in Merck and Schering-Plough stock, prompting Wall Street wags to call his reaction an overreaction.This evening, the American College of Cardiology released a statement saying the same thing - prescribers and patients should think twice before switching off either med. This is a slap in the face for Nissen, who stirred controversy last year with his meta-analysis of Glaxo's Avandia diabetes pill. Moreover, "this is a major win for Schering-Plough and Merck," writes Tim Anderson, an analyst at Sanford Bernstein, in an e-mail. Here is a portion of the statement...
"According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. There should no be reason for patients to panic. The difference in IMT changes between the simvastatin (Zocor) group and the Vytorin group was 0.006 mm vs. 0.011 mm.
Health care professionals should speak to their concerned patients using this drug. The ACC is also releasing a public statement explaining that this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering strategy is preferred (statin alone vs. statin plus ezetimibe, or Zetia).
Here's what Nissen had to say on CBS News...
Please keep reading for the rest of the ACC statement...
Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin."
Hat tip to ">Pharmagossip for the clip
5 Comments
Who wrote the ACC statement? They mysteriously left their names off! Why? Because they're probably in the back pockets of Schering-Plough and merck and the FAVOR was called in. The authors should reveal themselves and their financial ties to the companies. The ACC should reveal how much it basks in the money of the companies. The AHA should do the same thing. The truth is that these organizations derive millions of dollars in money from the Big Pharma companies. Lock, stock and barrel - bought and paid for hired guns!
I'll give you 10:1 odds that prominent members of the Duke and Harvard academic research organizations that take home hundreds of millions from these companies had their hands in the mix. They're all warm and fuzzy with the comercial arms of both companies.
Nissen is controversial, but he's not that far off. Statins have proven their value over and over and over again, while ezetimibe has not proven anything except that it does lower cholesterol. Trouble is, we don't know what else it does or doesn't do.
I say it's investigation time and Congress should pursue the issue. Who knew what when and who was calling the shots? Chances are it goes all the way up to the top management of both companies and the bottom line is they blew it for money. They should ahve come clean long ago, when they knew they're were issues with the trial. This was probably within a few months of the completion of the study. They had to know that the data was messed up and the study was unlikely to show anything. Why sit on it for 18 months. Becasue they made about $7.5 billion in that time and that will pay a lot of fines. they'll still laugh all the way to the bank and the executives will get off free. That's the way Big Pharma works.
Whytorin - why take it? Why prescribe it? Why pay for it???
Nissen is a doc that likes to make news. In certain circles he's very well respected, but he certainly does enjoy being at the forefront of the commentary on hot issues. Good advice regarding any comment he makes on a hot topic: just notch everything he says back by a step or so. This, of course, is the same thing we all have to do with press releases from manufacturers, so it should be no new task. Wall Street might not be on to this yet, but the sell-off wasn't huge (MRK down 2.7% on Tuesday), and the stock will likely rebound.
As a general rule of thumb, however, why would any physician use Vytorin as a first-line therapy in a general patient population? If you want to be aggressive, you can do so with statins. If patients can't tolerate statins, you can use Zetia. With the data out on Lipitor, Zocor, etc, why start with this combo?
Without a doubt, these statements form the ACC have been bought and paid for. Let's see the books of the ACC and the two companies involved. Hopefully Congress will! What they find will no doubt continue to shock and amaze.
I personally know that Schering-Plough is in a huge panic because every conference room has been filled with suits holding endless meetings for the past several days. They can't figure out what to do next. Their whole 'turnaround" is in jeopardy. If Congress looks, it will be over.
I am glad and relieved to see Nissen's comments. So few people in medicine are immune to the druggies dollars.
I am homozygous for sitosterolimia and participated in some of the studies of zetia, including before and after Calcium scans. I have not heard the results of the trials I was in. I know that my scan was slightly worse after taking zetia, but thought that it might just be an aberation.