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February 7, 2010 -- 11:10pm EST Herbal Supplements vs. Heart Drugs: Controversy
Re-ignited
The JACC article details the significant amounts of money ($34.4 billion) expended annually in the U.S. on Complementary and Alternative Medicine (CAM). The authors calculate over $5 billion is spent out-of-pocket on herbal supplements alone. Yes, that's $5 billion -- the total worldwide market for drug-eluting stents -- perhaps executives at Medtronic or Boston Scientific might be thinking, "maybe we're in the wrong business". In any case, the JACC paper details a number of herbs, natural substances and preparations that have an impact on the cardiovascular system -- from helping lower high blood pressure by dilating arteries, to increased antiplatelet effects to keep blood from clotting. These all sound like useful and good qualities. But, as the authors point out, problems may occur, as in "too much of a good thing". The CAM forces are unhappy with what they claim is the implication that herbal and natural supplements are unsafe. But I think this misses the major point of the paper. Quite the opposite, the paper details the ways in which herbal supplements are powerful medicines. If, for example, you have had a stent implanted and are on dual antiplatelet therapy (aspirin and clopidogrel) to keep from developing dangerous blood clots in the stent, you may think it would be a good idea to also take Ginkgo for "cardiovascular health" to keep the blood even more slippery. Yet Ginkgo intensifies the antiplatelet drugs to the point where bleeding complications may arise and may cause internal hematoma or hemorrhage. So it's not that ginkgo is unsafe -- it's that it has a very definite effect. And so with other supplements that affect the cardiovascular system. Some covered in the JACC article are: St. John's wort, motherwort, ginseng, garlic, grapefruit juice, hawthorn, saw palmetto, danshen, echinacea, tetrandrine, aconite, yohimbine, gynura, licorice, and black cohosh. The important point of this paper is that patients and physicians should be talking to each other about alternative supplements, and making sure they are taken into account when drawing up a medical management plan -- to ensure there are no interactions or unwanted enhanced effects. To rebut the implication that physicians currently do not query patients about herbal supplements, CRN has published the results of a survey, showing that, in fact, patients and cardiologists DO discuss them to a high degree. I wonder if that is really the norm and would welcome comments. « permalink » « send comment » « back to top »
February 5, 2010 -- 8:40pm EST Patent Spending But no such hyperbole for this week's stent news. Instead, on Monday, Boston Scientific announced (rather quietly) that, rather than go to jury trial later this month on patent disputes with Johnson & Johnson / Cordis that date back to 2003, they've decided to just settle everything -- for a mere $1.725 billion! Consider that this price tag is the same quantum as Toyota's hit, and consider that, as the Wall Street Journal points out, not only is this amount almost double J&J's total 2009 sales of drug-eluting stents, it may eclipse Boston's as well. So one might wonder why, other than a few scattered articles in the business press, there's been so little publicity regarding this major concession. After all, these disputes have been in the courts for years, and many millions already have been spent on lawyers' fees, etc. One can only assume that Boston Scientific foresaw a worse outcome from a jury trial and so, decided on the option of settlement. Perhaps the company saw the futility of trying to challenge the original stent patents of Palmaz and Gray, patents that time and again have been upheld. But a worse outcome than $1.725 billion?
Ray Elliott, Boston's new CEO, stated that the company settled to "mitigate risk" and to resolve "major litigation without exposing Boston Scientific to the uncertainties of a jury trial and a potential damages award that was impossible to predict." But the price tag is very high and a stock analyst, quoted in Tuesday's WSJ, opined, "We think most investors will be surprised and concerned," by the new deal. As for Dr. Palmaz, he will no doubt be relieved at being able to spend February and March elsewhere. « permalink » « send comment » « back to top »
November 25, 2009 -- 6:15pm EST Fractional Flow Reserve (FFR) Recognized
in Guidelines, Not So Much In Reimbursement So FAME and the value of Fractional Flow Reserve (FFR) have now found their way into the official PCI guidelines. Last week, the ACC/AHA/SCAI issued their first Focused Updates -- a way of responding more quickly to recent and important clinical and research information (guidelines normally are only issued every two to three years) -- and FFR was included as "useful to determine whether PCI of a specific coronary lesion is warranted." The two manufacturers of FFR catheters, Volcano and St. Jude, feel that functional measurement (FM) is going to be a rapidly growing field. With the upgrade in the Focused Guidelines this may be so. But, as usual, reimbursement is lagging behind. Interventional cardiologists may see the scientific evidence that FFR improves outcomes but, if there isn't sufficient reimbursement for its use, they will be less inclined to use it. Augusto Pichard, MD of Washington Hospital Center told me he doesn't have this problem because he did an analysis of how much money was saved by using this technology and his hospital "got it". And, as William F. Fearon, MD of Stanford University Medical Center observed, "Use of FFR technology represents a rare opportunity in medicine in which an innovative product not only improves clinical outcomes but also saves money." Lower costs and a third less heart attacks and deaths. FFR should be in every cath lab, right? Yet currently penetration of this technology in the U.S. is only 5%. Comments? « permalink » « send comment » « back to top »
November 17, 2009 -- 11:30pm EST PPIs and Plavix -- Confusion Reigns Supreme In the past a number of observational studies (namely from Medco and the Veterans Administration) have shown that patients who take PPIs and Plavix experience an increased risk of adverse events, such as heart attacks. However, other studies have shown no clinical effect. In fact it was only a short while ago that a panel of cardiologists, commented during this year's TCT meeting on the COGENT trial (COGENT examined the clinical results of taking Plavix with PPIs). The panel exclaimed quite pointedly that the COGENT study, a randomized clinical trial (not a retrospective observational study) was THE study that revealed the truth -- and that truth was that there was NO increase in adverse clinical events when PPIs were taken with Plavix. They even did a Colbert-like "wag of the finger" to the medical news outlets that published inflammatory headlines about the non-existent danger. So it was a bit of a shock to these and other cardiologists assembled at the American Heart Association Annual Scientific Sessions in Orlando to read today's warning from the FDA:
This warning also mentioned other drugs to be avoided when taking clopidogrel, such as esomeprazole (Nexium), cimetidine (Tagamet) and so on. In addition, yet another observational study about PPIs and Plavix was presented yesterday at the AHA meeting. This retrospective study, which looked at patient records from Mt. Sinai in New York, showed an increase in adverse events. These two provided a double whammy to the results of the COGENT trial.
The difference between a randomized clinical trial (RCT) and a retrospective observational study is an important one here in understanding the different results. An RCT is a carefully-designed scientific test of a hypothesis -- patients are randomized to two different treatments in a way that negates differences in ages, states of health, and other "confounding" data. An observational study looks at patient data that already exists. Attempts can be made to normalize the patient groups for comparison's sake, but the results are not necessarily accurate when measuring two treatments, for example. This is why the FDA normally requires that an RCT be done before a new treatment is approved. Observational studies, however, can point to possible problems, or can generate hypotheses for future randomized scientific trials. They can show associations, but not necessarily prove cause and effect. This is, in effect, what happened with PPIs and Plavix, and why the COGENT trial was done: to answer the questions raised by the early observational studies. Dr. Chet Rihal, director of the catheterization lab at Mayo Clinic put it another way (as quoted in HealthDay):
Indeed, one explanation for these different results is that patients who are having gastric distress and require Prilosec may be sicker or older patients, thus skewing the results of any observational study against the group taking PPIs -- they may have worse outcomes because they started off sicker or older -- and the worse outcomes are not "caused" by the PPIs. As for the FDA warning, which involves a label change to the drug clopidogrel, Dr. Cannon noted to me that it was more carefully worded, and did not claim that PPIs caused more adverse events, only that PPIs have been shown to reduce the antiplatelet effect, something that was shown in a small study last year, titled OCLA (Omeprazole CLopidogrel Aspirin) -- a study conducted by Dr. Deepak L. Bhatt, Cannon's colleague at Brigham and Women's in Boston. Dr. Cannon continues:
So should you stop taking your Prilosec or Nexium with your clopidogrel? Most doctors say no -- in fact suddenly stopping either medication could cause serious problems. However, you should call or see your cardiologist and ask him or her about these studies. Meanwhile the FDA has placed this issue on the agenda for the November meeting of its Drug Safety Oversight Board and HealthDay reports that new AHA/ACC recommendations on the use of PPIs with Plavix will be announced tomorrow (Wednesday) during the American Heart meeting. « permalink » « send comment » « back to top »
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An
article, that should be of special concern to stent and angioplasty
patients, appears in the current Journal of the American College
of Cardiology (JACC). This "state-of-the-art paper" from
the Mayo Clinic, titled "
Julio
Palmaz, inventor of the original stent design, told me recently that,
if you wanted to be an inventor, you'd better be prepared to spend
a lot of time in court. Over the past two decades, Palmaz spent years
sitting in courtrooms all over the world. In fact, he sold his patents
to J&J in 1998 partly to eliminate the suspicion of personal
gain when he testified on behalf of his invention. As he told the New
York Times in 
When
I heard Dr. Nico Pijls first present data from the FAME study
during a press conference at the 2008 TCT, I was struck by the
similarity of the concept to what Andreas Gruentzig, inventor
of coronary angioplasty, was doing in the early days of balloons:
measuring intra-arterial pressures to discern what exactly was
going on inside the coronaries during these procedures. I brought
this up with Dr. Pijls and he agreed. I've detailed this whole
thread back in my January post titled, 
Patients
taking Plavix (a.k.a. clopidogrel) -- and that would be all stent
patients -- sometimes experience a side effect of gastric upset,
heartburn or even bleeding. So they are given a Proton Pump Inhibitor
(PPI) with a brand name of Prilosec, Nexium, Prevacid or Protonix
to alleviate these symptoms.
So
earlier today I asked Dr. Christopher Cannon about this new study
(two months ago he stated in no uncertain terms that the COGENT study
proved that there was no increased risk for patients when taking
Plavix and PPIs). Dr. Cannon is the senior investigator of the Thrombolysis
in Myocardial Infarction (TIMI) Study Group, and has led some of
the most well-known practice-changing guidelines in the treatment
of heart disease He replied: