I am reminded of the surgical attending at Johns Hopkins who (perhaps apocryphally) would scream at the intern in the morning when a patient had done poorly overnight:
"Whose side are you on, the patient or the disease?!"
And I ask the ACC, "Whose side are you on? Patients' or Big Pharma's"?!
Their main web page now links to this statement:
"The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone."
Is it really a "major clinical decision" to stop Zetia/Vytorin and take a statin or niacin until the very efficacy of Vytorin and Zetia is sorted out?
I'd say that the ACC and its members need to reconsider the rather major decision they made to support the use of this drug based on surrogate end-points. As with torcetrapib, they're going to have to learn the hard way to take their lashings.
The statement goes on to say:
"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."
Well, that sounds reasonable, but do you really thing that the majority of patients on Zetia or Vytorin are on it because they failed a reasonable attempt to use a high-dose statin? We all know that after it hits the market, a drug is generally prescribed willy-nilly rather than carefully and rationally in selected patient groups. The ACC should know this. Hence my suspicion of complicity.
It bothers me how entrenched the use of these drugs becomes and how hard it is to remove patients from them. This is a serious status quo bias that I have commented upon before. Few physicians would start a patient on Avandia now, but the ones who are already on it get left on it. The same is true, it appears, with Vytorin, and the ACC is contributing to the status quo bias!
The mandate for physicians and the FDA is to prescribe only SAFE and EFFECTIVE therapies. The burden of scientific proof is on the drug companies who are driven by profit to promote these drugs. It is up to physicians to stand between patients' health and the companies' profits and prescribe only drugs that have met the burden of proof. And Vytorin and Zetia have not. Boycott them until the proof is in. Use alternative agents in the meantime.
This is discussion forum for physicians, researchers, and other healthcare professionals interested in the epistemology of medical knowledge, the limitations of the evidence, how clinical trials evidence is generated, disseminated, and incorporated into clinical practice, how the evidence should optimally be incorporated into practice, and what the value of the evidence is to science, individual patients, and society.
Wednesday, January 16, 2008
Is the American College of Cardiology (ACC) Complicit with Big Pharma (Merck and Shering-Plough)?
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Nice Blog Site, for full disclosure I've worked in the biotechnology industry for many years, not on the clinical side but on the drug discovery side.ReplyDelete
Almost all clinical studies are initiated from the marketing side (especially post market approval), if the study has a slick name, you should be worried. It's been designed to succeed.
From an industry view, and I've been there, if an "act of god" happens and you don't get what you want out of the study, it's usually blamed on "bad" science","poor experimental design", "underpowered", "poor patient selection, i.e overly narrow population, too sick etc".
The conclusion of the marketing... I mean clinical experiment never is the drug sucks for this indication.
It's pass out more purple koolaid to the reps and keep selling.
By the way, thats why they are so good at selling the product, they truly believe in it.
Bottom Line-if Vytorin and Zetia can't ENHANCE peoples health in the most biased of clinical studies, the drug is probably of very little value.
Keep Up the Good Work.
agree totally with Dr Scott on changing from a product that possibly worsens atherosclerosis to othersReplyDelete
(Niacin & Questran), which in combo with a statin have been successful in achieving aggresive lipid control. I as an FP in Northwest Ga. plan to do this and I know of another FP in Rome Georgia already taking my office scribe's mother off of zetia this week. Good rational Blog- We need more
I remain undecided as to how to think about ezetimbe, but my bias toward the drug remains slightly positive.ReplyDelete
On the one hand, we have seen from the ENHANCE trial that ezetemibe had no impact on a surrogate endpoint (carotid IMT) that, while not fully validated, has at least been correlated with cardiovascular (CV) outcomes in prior studies.
On the ohter hand, lowering LDL has been shown to result in CV benefits regardless of mechanism by which LDL levels are brought down (HMG coA reductase inhibition, diet, or bile acid sequestration [as with cholestyramine]).
I believe that certain paradigms are well-enough established as to be cornerstomes of current medical practice. Lowering LDL is one of these. Controlling blood pressure and avoiding smoking are two others.
The results of the ENHANCE trial clearly give me pause, but I am not ready to cite these results as the reason to abandon my aceptance of lowering LDL as a valid goal. A single, 750 patient (relatively small) trial is not sufficient to cause me to disregard all other evidence that lower LDL is better.
For me, clinically, I may be inclined to push doses of statins further before turning to ezetemibe. Having said that, there have been enough different mechanisms of LDL lowering that have resulted in improvements in cardiovascular outcomes that I will use Zetia in high-risk patients in whom LDL levels remain elevated. I will maintain this practive even in the absence of a definitive outcomes trial.
I am comforted by the evidence that Zetia appears safe. I believe that, in prescribing ezetemibe, at worst, I am lowering LDL without conferring a health benefit [though I am leaving the economic consequences of using Zetia out of this equation].
Ultimately, my choice of whether to use Zetia seems to be a little easier of late, as my patients have shown a reticence about taking this drug, now that it has been impugned by the "Wall Street Journal of Medicine." I do think that we, as clinicians, should not allow the media to let headlines sway our rational judgment. They need to sell newspapers. We need to trat patients.
On a slightly different note, as a scientist, I will look forward to the results of the outcomes trial (IMPROVE-IT) with great interest. We have yet to answer the question of whether the benefits of lower LDL are partially dependend on the mechansim by which levels are lowered. Understanding the impact of Zetia has tremendous scientific import.
On that last point, I am actually pleased that marketing efforts drive a willingness for new medicines to be adopted. It is unfortunate that some medicines will ultimately found to have too little benefit to justify their use. Still, the scientific advances that we (as humans) make, even if the advances are driven by a desire to generate profits, make this a more interesting world and a world in which more options ultimately become available to combat disease.
There are new questions aboute ezetemibe following the results of the ENHANCE trial. However, to completely write-off this drug as useless would be as short-sighted a conclusion as to insist that the drug provides an outcomes benefit in the absence of supportive data. The jury is still out on this one. But I am pleased that court is in session.
Dr Michael Bernard
This is by far the most intelligent thing I've read on this blog thus far. I have to say that I agree with Dr Bernard.ReplyDelete
Citing "medical evidence" from the New York TImes--not your first offense--hardly qualifies as hard science.
I certainly do not believe that you, Dr Aberegg, are the end-all-be-all for determining what drug(s) should be boycotted or endorsed. Science is neither black nor white--there are several grey areas that go unexplained as well as interpreted differently from person to person. You should also be aware that certain therapies and drugs that work for one patient may not work for the next.
Your blog is a joke and it sucks. It leads me to believe that you are a pompous, self-righteous jerk who would not dare admit he was every wrong. Likewise, your need to inflate your ego by criticizing others and "tooting your own horn" is tiresome and annoying. You are the kind of doctor we should be leery and afraid of--someone who thinks he is better and smarter than all the rest. You, Dr Aberegg would be incapable of writing a semi-intelligent blog if it weren't for your thesaurus.
Hopefully we can stay focused on the data and their public health consequences and avoid vitriol, acrimony, and ad hominem attacks on this blog.ReplyDelete
(I consulted my thesaurs for that sentence.)
All guests are always welcome to express their diverse opinions, however.
I would like to point out to everyone who thinks that the NYT and the WSJ are unsubstantial sources of evidence that MRK and SGP can now and always could have had their data tried in the court of peer-reviewed medical evidence rather than in that liberal rag the NYT and that conservative rag the WSJ. But they didn't. They stalled and obfuscated, because every month of unimpeded Vytorin and Zetia sales is hundreds of millions of dollars.ReplyDelete
And that has been the point of many/most of the posts here on the topic - that greater transparency is due consumers of these medications (patients and docs). There should also be consequences for failures to "come clean" with the data. And, when you appear that you have somehting to hide, that lends creedence to conspiracy theorists and doubters.
Take home message: if you don't the NYT and the WSJ and me and others to run with your incomplete data, publish/release them in a timely, transparent, honest fashion.
Quite. We are not discussing scientific evidence. We are discussing likely scientific misconduct and possible scientific fraud (however redefined). We have been placed in a position where discussing the intricacies of science is not even within the realms of possibility - there is no science.ReplyDelete
Those discussing it are the WSJ, NYT, Forbes and scientific blogs - and good on them. Our medical journals have simply failed.
I agree that an ethical boycott of products would be an ethical step. We sell our wares under the banner of science, and when science is not allowed to operate, we are doomed (and so is this industry) if we repeatedly react with silence.
Maybe the name of this blog should be changed then. If the medical journals are worthless to us...then why do "doctors" like Aberegg publish in them? I find these comments contradictory.ReplyDelete
I don't get why you would rather harangue the public about Vytorin, Zetia, etc. instead of conducting your own study.ReplyDelete
Conduct my own study of what? A proprietary agent owned by MRK and SGP? And who, praytell, would fund that study?ReplyDelete
I do conduct my own research which related to biases in physicians' evaluation of evidence from clinical trials.
This blog hranagues the drug companies and educates the public, and I am very satisfied with that arrangement. Any member of the public who feels harangued is welcome to never visit the blog again.
Thank you for your comments!
He's said it with his own mouth, he RESEARCHES bias in doctor's evaluation of presented medical (non)evidence. He is NOT a cardiothoracic surgeon, nor is he a cardiologist. Let's try to keep that in mind and maybe Dr. Scott can use this a gentle reminder.ReplyDelete
He's also stated that he uses his blog to educate the public--another funny. I"ve also noticed that your blog postings closely mimicks others, days after they've posted. Which therefore leads to the speculation that you're a blowhard-wannabe.
Here's your take home message: there's a lot more UNBIASED medical information and reporting of said information out there than what this guy has to offer.
And thank you for the offer, I shall never visit this blog again.
Dr. H. Kee
Ad hominem attacks undermine the credibility of the attacker, Mr. Kee.ReplyDelete
I appreciate your passion about important issues in medicine.
We all have a lot to learn, and if we remain motivated, we will continue to approach the truth.
"Ad hominem attacks undermine the credibility of the attacker" didn't you say something similar to that in a previous post--substitute the word "anonymous" for "ad hominem attacks" ? I believe you did.ReplyDelete
Either way, it's not true.