Apparently, the editors of the NEJM read my blog (even though they stop short of calling for a BOYCOTT):
"...it seems prudent to encourage patients whose LDL cholesterol levels remain elevated despite treatment with an optimal dose of a statin to redouble their efforts at dietary control and regular exercise. Niacin, fibrates, and resins should be considered when diet, exercise, and a statin have failed to achieve the target, with ezetimibe reserved for patients who cannot tolerate these agents."
Sound familiar?
The full editorial can be seen here: http://content.nejm.org/cgi/content/full/NEJMe0801842
along with a number of other early-release articles on the subject.
The ENHANCE data are also published online (http://content.nejm.org/cgi/content/full/NEJMoa0800742
and there's really nothing new to report. We have known the results for several months now. What is new is doctors' nascent realization that they have been misled and bamboozled by the drug reps, Big Pharma, and their own long-standing, almost religious faith in surrogate endpoints (see post below). It's like you have to go through the stages of grief (Kubler-Ross) before you give up on your long-cherished notions of reality (denial, anger, bargaining, then, finally, acceptance). Amazingly, the ACC, whose statement just months ago appeared to be intended to allay patients' and doctors' concerns about Zetia, has done a apparent 180 on the drug: "Go back to Statins" is now their sanctimonious advice: http://acc08.acc.org/SSN/Documents/ACC%20D3LR.pdf
I was briefly at the ACC meeting yesterday (although I did not pay the $900 fee to attend the sessions). The Big Pharma marketing presence was nauseating. A Lipitor-emblazoned bag was given to each attendee. A Lipitor laynard was used to hold your $900 ID badge. Busses throughout the city were emblazoned with Vytorin and Lipitor advertisements among others. Banners covered numerous floors of the facades of city buildings. The "exhibition hall," a veritable orgy of marketing madness, was jam-packed with the most aesthetically pleasing and best-dressed salespersons with their catchy displays and gimmicks. (Did you know that abnormal "vascular reactivity" is a heretofore unknown "risk factor"? And that with a little $20,000 device that they can sell you (which you can probably bill for), you can detect said abnormal vascular reactivity.) The distinction between science, reality, and marketing is blurred imperceptibly if it exists at all. Physicians from all over the world greedily scramble for free pens, bags, and umbrellas (as if they cannot afford such trinkets on their own - or was it the $900 entrance fee that squeezed their pocketbooks?) They can be seen throughout the convention center with armloads of Big Pharma propaganda packages: flashlights, laser pointers, free orange juice and the like.
I just wonder: How much money does the ACC receive from these companies (for this Big Pharma Bonanza and for other "activities")? If my guess is in the right ballpark, I don't have to wonder why the ACC hedged in its statement when the ENHANCE data were released in January. I think I might have an idea.
Showing posts with label zetia. Show all posts
Showing posts with label zetia. Show all posts
Monday, March 31, 2008
Wednesday, March 26, 2008
Torcetrapib, Ezetimibe, and Surrogate Endpoints: A Cautionary Tale
In today's JAMA, (http://jama.ama-assn.org/cgi/content/extract/299/12/1474 ), Drs. Psaty and Lumley echo many of the points on this blog over the last six months about ezetimibe and torcetrapib (see posts below.) While they stop short of calling for a boycott of ezetimibe, and their perspective on torcetrapib is tempered by Pfizer's early conduct of a trial with hard outcomes as endpoints, their commentary underscores the dangers inherent in the long-standing practice of almost unquestioningly accepting the validy of "established" surrogate endpoints. The time to re-examine the validity of surrogate endpoints such as glycemic control, LDL, HDL, and blood pressure is now. Agents to treat these maladies are abundant and widely accessible, so potential delays in discovery and approval of new agents is no longer a suitable argument for a "fast track" approval process for new agents. We have seen time and again that such "fast tracks" are nothing more than expressways to profit for Big Pharma.
Psaty and Lumley's chronology of the studies of ezitimibe and their timing are themselves timely and should refocus needed scrutiny on the role of pharmaceutical companies as the stewards of scientific data and discovery.
Psaty and Lumley's chronology of the studies of ezitimibe and their timing are themselves timely and should refocus needed scrutiny on the role of pharmaceutical companies as the stewards of scientific data and discovery.
Wednesday, January 16, 2008
Is the American College of Cardiology (ACC) Complicit with Big Pharma (Merck and Shering-Plough)?
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:
http://www.acc.org/enhance.htm
which states:
"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.
"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:
http://www.acc.org/enhance.htm
which states:
"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.
Friday, December 21, 2007
Patients and Physicians should BOYCOTT Zetia and Vytorin: Forcing MRK and SGP to come clean with the data
You wouldn't believe it - or would you? The NYT reports today that SGP has data from a number of - go figure - unpublished studies that may contain important data about increased [and previously undisclosed] risks of liver toxicity with Zetia and Vytorin: http://www.nytimes.com/2007/12/21/business/21drug.html Unproven benefits, undisclosed risks? If I were a patient, I would want to be taken off this drug and be put on atorvastatin or simvastatin or a similar agent. If teh medical community would get on board and take patients off of this unproven and perhaps risky drug, that might at least force the companies to come clean with their data.
In fact, I'm astonished at the medical community's reluctance to challenge the status quo which is represented by widespread use of drugs such as this and Avandia, for which there is no proof of efficacy save for surrogate endpoints, and for which there is evidence of harm. These drugs are not good bets unless alternatives do not exist, and of course they do. I am astonished in my pulmonary clinic to see many patients referred for dyspnea, with a history of heart disease and/or cardiomyopathy who remain on Avandia. Apparently, protean dyspnea is not a sufficient wake-up call to change the diabetes management of a patient who is receiving an agent of unproven efficacy and which is known to cause fluid retention and CHF. This just goes to show how effective pharmaceutical marketing campaigns are, how out-of-control things have become, and how non-normative physicians' approach to the data are.
The profit motive impels them forward. The evidence does not support the agents proffered. Evidence of harm is available. Alternatives exist. Why aren't physicians taking patients off drugs such as vioxx, avandia, zetia, and vytorin, and using alternative agents until the confusion is resolved?
In fact, I'm astonished at the medical community's reluctance to challenge the status quo which is represented by widespread use of drugs such as this and Avandia, for which there is no proof of efficacy save for surrogate endpoints, and for which there is evidence of harm. These drugs are not good bets unless alternatives do not exist, and of course they do. I am astonished in my pulmonary clinic to see many patients referred for dyspnea, with a history of heart disease and/or cardiomyopathy who remain on Avandia. Apparently, protean dyspnea is not a sufficient wake-up call to change the diabetes management of a patient who is receiving an agent of unproven efficacy and which is known to cause fluid retention and CHF. This just goes to show how effective pharmaceutical marketing campaigns are, how out-of-control things have become, and how non-normative physicians' approach to the data are.
The profit motive impels them forward. The evidence does not support the agents proffered. Evidence of harm is available. Alternatives exist. Why aren't physicians taking patients off drugs such as vioxx, avandia, zetia, and vytorin, and using alternative agents until the confusion is resolved?
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