Comments on: Schering-Plough CEO Implies Vytorin Critic Is Biased

By: Orlando

Orlando — Wed, 09 Apr 2008 05:17:08 +0000

It is apparent to me (a medical professional) that most of the comments I have read have come from people ignorant of cardiovascular issues and complete knowledge of all the data on statins and other lipid lowering agents. Just reducing LDL is not the issue and not what “good doctors” strive for. The evidence (if you knew it) shows that it is not just about hitting a magic number that prevents heart attacks and strokes - rather it is what agent you use to achieve that goal!
As Dr Krumholz stated in his presentation, we have evidence of agents that lower LDL significantly such as HRT and torceptrapib. But these agents also carry a significant risk of death! As physicians, we need first to use agents that yes, lower LDL but that have “PROOF” from large scale clinical trials that they can prevent heart attack and stroke! And that those agents can do this safely! Statins are used by millions of people worldwide with few side effects and serious consequences.And every statin I have seen brought to market has had evidence of reduction in risk of CV events and regression of plaque data within three years of it coming to market. Zetia has been on the market for “6 YEARS”! So we as physicians are supposed to blindly use an unproven product and one that could potentially do HARM to our patients because S-P and Merck say so?
I believe that we have saved many lives by using statins as first line agents. And the ACC panel did not tell us not to use Zetia, but to reserve it as a last resort, or for those patients who are truly statin intolerant. I applaud Dr Krumholz and the ACC panel because their ultimate goal is to do what is best for the patients! For those who condemn him for his comments; first, educate yourself fully in the disease state/treatments before you make ignorant comments, and second, it is not about the money or the stock or the conspiracies - it is the health and safety of you, the patient, that forces us to research and collect as much data as possible about the agents prescribed to you.
Does it make myself and other physicians angry when S-P and Merck hide that data from us for 18 months? You BET IT DOES!

By: Interested Watcher

Interested Watcher — Sat, 05 Apr 2008 03:30:56 +0000

Patients should be concern with the fact that some doctors will follow Dr. Krumholz’s recommendations. Let’s see, why don’t we put patients back on a statin only plan…jack up the dose and see what happens. I think they’ve done that and it didn’t work.

I believe that shareholders of MRK and SGP should point their class actions law suits at Dr. Krumholz for his drastic misrepresentation, brash tone and over aggressive show boating actions during Sunday’s presentation. He has not only put patients in danger but has also lead to the destruction of Billions of dollars in value in both MRK and SGP.

By: Ethicist

Ethicist — Fri, 04 Apr 2008 01:08:26 +0000

Question for Dr. Krumholz

You describe yourself as having an impeccable reputation. Did you not think it important to disclose at the time of the ACC panel that you have been paid more than $10,000 to serve on an advisory board at United Health Care which has spent millions of dollars on Vytorin and Zetia?

By: Doc

Doc — Thu, 03 Apr 2008 22:12:28 +0000

Ed & Chris,
Yes it helps. I actually think Hassan has done a great job of turning the corp around, shame its gotten to this, but I still say he needs to look in the mirror more on this one.

By: Conn

Conn — Thu, 03 Apr 2008 18:13:45 +0000

The big thing that Dr. Krumholz doesn’t address is that many, many patients have had good outcomes in reducing LDL with Vytorin. How does he explain how thousands of patients who have had their LDL reduced at much higher rates after they were switched a statin to Vytorin. It is not luck, there has to be some clinical benefit with the addition of Zetia. To say as he implied that Zetia might be a placebo effect seems to me to carry some sort of vendetta since the medical science does not support that in clinical practice.

The other thing that he doesn’t address is that to get the clinical benefit of using a statin like Lipitor to get the benefit of reducing heart attacks was a small study. To get this effect you have to go to the highest dose of these statin drugs which many people cannot tolerate. Personally I have known many people who could not tolerate statins at all even in the lowest dose. One person in particular told me he had the worst muscle soreness he had ever had and it felt like he had the flu and ending up losing over 10 pounds before he discontinued the statin. To scare people aware from a potential product is medically imprudent in my eyes.

By: MVP

MVP — Thu, 03 Apr 2008 16:53:31 +0000

Hi Dr. Krumholz,

I am currently using 10/40 Vytorin and one of the reasons my Cardiologist prescribed this medication is that he felt it had a better profile in terms of its effect on the liver. He showed me data which suggested that the combination with the lower statin dose had a similar or even better LDL lowering profile than higher doses of simvastatin or etorvastatin alone. Since (as far as I can tell) no statin has been proven to reduce plaque using imaging studies should we be judging Vytorin so harshly? I’ve also read that the outcome study for Lipitor which claims a 34% reduction of heart attacks was really the difference of 1 case (3 heart attacks on Placebo and 2 on Lipitor)? So, the ultimate question should be, has the frequency of heart attacks been significantly reduced since LDL lowering agents have become available? If that is true then it seems that any drug which does this and exhibits an improved safety profile should be considered an advancement and should not be held to a higher standard than any other LDL lowering agent.

By: Health Blog : Vytorin Postgame: Dueling Opinions

Health Blog : Vytorin Postgame: Dueling Opinions — Thu, 03 Apr 2008 15:32:43 +0000

[...] Krumholz posted a comment to a blog post that highlighted Hassan’s comments, and emailed the blog Pharmalot with this [...]

By: Ed Silverman

Ed Silverman — Thu, 03 Apr 2008 02:58:35 +0000

Hi Doc,

Well, yes, it’s his job to defend his product and company - assuming the defense is sound, which is being widely debated right now. That’s what I wrote earlier and I deliberately added that caveat. That’s not the same thing as agreeing with his position.

If his position isn’t sound - if his drug and data weren’t ‘timely, honest, free of bias and ethically promoted with full disclosure,’ as you noted - then he should suffer the consequences. Does this help?

Regards
ed

By: Chris

Chris — Thu, 03 Apr 2008 02:18:46 +0000

Doc,
As you say SPG is a company ie a business. That means the CEO has responsibility to employees, patients, healthcare professionals and investors. I think what he’s doing is responding to just those groups and I understand he’ll have his chance to rebut the claims of insider trading later. Your final point doesn’t account for the realities of the market, which in turn affect shareholders, many of whom are employees: if SPG believes it is already complying with the other items on your list (I don’t know but assume it does) he must deal with that first because as thie week’s events have shown, the America stock market is hugely volatile, brittle and hyper-sensitive to whiffs of bad news, let alone what followed ACC. So yes, he’s doing his job.

By: Doc

Doc — Thu, 03 Apr 2008 02:08:42 +0000

To Chris and Ed,
Hassan is just doing his job defending the company and drug???? I thought that SGP was a pharma company? I would hope that his first job was to assure that his drugs and data are timely, honest, free of bias and ethically promoted with full disclosure. Then he might need to assure that his exec team isn’t trading on inside info, which disadvantages all other stockholders. THEN, he can defend his company and drug.