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REACH, “atherothrombosis”, and the marketing of Plavix

Posted by Colin Rose on June 23, 2007

An example of a “free” paper in a prominent medical journal reporting a study funded by industry.

Let’s examine what is behind this beneficence.

Disney World

The REACH type subject

REACH is an an acronym for REduction of Atherothrombosis for Continued Health. The term “atherothrombosis” was concocted by “industry” to market Plavix and has now infiltrated into the literature. This is a classic example of marketers inventing a disease for which their drug is the cure. The first and most lucrative was the invention of the disease,”dyslipidemia”, to market statins.

The web site,, is funded by sanofi-aventis and Bristol-Myers Squibb who sell Plavix. Dr. Bhatt, an author of REACH, is prominent on the site. Here is a quote from the site by a Dr. Cannon:
Atherothrombosis vs atherosclerosis: Different diseases?

The patients were divided into those who had had a prior event versus those who had not. Interestingly, the patients who’d had a prior event each had about a 20% reduction in death, MI, stroke over the subsequent 2 ½ years in this otherwise pretty stable outpatient population. On the other hand, there was no benefit whatsoever in those who had coronary disease without a prior MI, or cerebrovasculardisease without prior stroke. So, in thinking about this, the question comes up: ‘Does this mean that the patients with a prior event are different?’ They’ve had a thrombotic event as part of their course of vascular disease. The question popped into my head: ‘Would this mean, potentially, that atherothrombosis might be a different disease than atherosclerosis?’

If we circle back to thinking clinically, there are a lot of patients we see who are 80 years old who finally come in with evidence of angina and have diffuse atherosclerotic disease, but who have never had an MI or stroke; then there are other patients who come in at age 40 with a large anterior MI and just one atherosclerotic lesion on their cath. Those would seem to be two extremes: the atherosclerotic patient (the 80-year-old with diffuse disease) and the atherothrombotic patient (the person who comes in with an acute event). And, the difference in the benefit of dual antiplatelet therapy for the atherothrombotic patient makes perfect sense: you’re treating a thrombotic disease with an antithrombotic agent. This may give us insight into subcategorizing a little bit the disease process itself and targeting long-term therapies.

Readers should be made aware of the disclosure of Dr. McDermott, the editorialist:
Financial Disclosures: Dr McDermott reports that she has received honoraria from Bristol-Myers Squibb, Sanofi-Aventis, NicOx, and Otsuka Pharmaceutical, has served as a consultant for Hutchinson Technology, and is currently receiving support from research grants from the National Heart, Lung, and Blood Institute.
Why couldn’t JAMA find an editorialist with no connection to “industry”, particularly the company funding the study which was editorialized?

If you wonder why this is a “free” publication just look at the disclosures and funding:
Financial Disclosures: Dr Bhatt reports that he has received honoraria for consulting on scientific advisory boards from AstraZeneca, Bristol-Myers Squibb, Centocor, Eisai, Eli Lilly, GlaxoSmithKline, Millennium, Otsuka, Paringenix, PDL, Sanofi-Aventis, Schering Plough, The Medicines Company; honoraria for lectures from Bristol-Myers Squibb, Sanofi-Aventis, and The Medicines Company; and provided expert testimony regarding clopidogrel (the compensation was donated to a nonprofit organization). Dr Röther reports that he has received honoraria from Bristol-Myers Squibb and Sanofi-Aventis. Dr Steg reports that he has received honoraria from Bristol-Myers Squibb and Sanofi-Aventis and has received research grants from Sanofi-Aventis. Dr Steg reports having served as a member of the speakers’ bureau for Boehringer Ingelheim, Servier, GlaxoSmithKline, Merck, Sharp & Dohme, and Nycomed and also on a consultant ad board for AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Sharp & Dohme, Sanofi-Aventis, Servier, and Takeda. Dr Ohman reports that he has received research grants from Berlex, Sanofi-Aventis, Schering-Plough, Eli Lilly, Bristol-Myers Squibb, and Millennium. Dr Ohman reports that he has stock ownership in Medtronic, Savacor, and Response Biomedical and is a consultant for Invoise, Response Biomedical, Savacor, and Liposcience. Dr Hirsch reports that he has received research grants from Bristol-Myers Squibb and Sanofi-Aventis; honoraria from Sanofi-Aventis; and speaker’s bureau fees for Sanofi-Aventis. Dr Wilson reports that he has received a grant from Sanofi-Aventis. None of the other authors reported disclosures.

Funding/Support: The REACH Registry is sponsored by Sanofi-Aventis, Bristol-Myers Squibb, and the Waksman Foundation (Tokyo, Japan), who assisted with the design and conduct of the study and data collection.

Call me paranoid but I have a suspicion that the conclusion of the next paper from REACH will be that “dual anti-platelet” therapy (read ASA and Plavix) is underused. Thus the “reduction” in REACH.

But the sponsors may have shot themselves in their feet. The REACH data shows that in Japan the use of statins is about two-thirds and hypertensives one-half of the world average but Japanese all-cause mortality is 40% less than the world average. Also the Japanese used about the same “dual anti-platelet therapy” as the world average. So, total mortality has no relation to drug use of all types. This glaring paradox is nowhere mentioned in the paper or the editorial and I doubt most readers will look at the data themselves.

In the final analysis, what is the point in studying atherosclerosis in a population in which 80% are overweight or obese, 44% are diabetic, 82% are hypertensive and 16% are smoking? The causes of their atherosclerosis are obvious, food and/or tobacco addictions as we have known for many years.

If sanofi-aventis and Bristol-Myers Squibb really want to reduce “atherothrombosis” and improve health they should fund programs for fighting these addictions instead of doing more surveys to try to justify more drug sales. From their own data it is clear that drugs do not increase life expectancy.

Posted in atherosclerosis, coronary artery disease, diet, professionalism, Uncategorized | Tagged: , , , , , , , , , , , , , , , , , , | Leave a Comment »

ILLUSTRATE illustrates the futility of measuring and treating blood “cholesterol”

Posted by Colin Rose on March 31, 2007

Intravascular ultrasound is a sensitive method for measuring the size of atherosclerotic plaques in the arterial wall. When testing a drug to see if it will have an effect on plaque volume, this technique is the gold standard.

ILLUSTRATE set out to show that adding torcetrapib, a drug that increases HDL, the “good” cholesterol, to Lipitor, that decreases, LDL, “bad” cholesterol would reverse plaque or at least stop its progression.

Here are the baseline characteristics of the subjects. Note that the average BMI was 30. Overweight is defined as a BMI over 25 and obesity over 30. So, all of them were overweight or obese. 20% were diabetic, most likely Type 2, related to obesity, and 75% were hypertensive. 18% smoked. All of those factors are risk factors for atherosclerosis related to lifestyle. Therefore, unless one intends to first completely eliminate these lifestyle risk factors, it was unethical to even conceive such a trial particularly since it is proven that atherosclerosis can be reversed by lifestyle change alone. The trialists probably rationalized that atherosclerosis, like pneumonia, must be treatable by drugs and Pfizer, who funded the trial, has a slogan, “Working for a Healthier World” it is ethical to do such a trial. Besides the money helps to keep one’s IVUS lab going and one is promoting the notion that the technique will some day lead to the cure for atherosclerosis.


Legal Addictions

The typical ILLUSTRATE patient

Here are the reported results. What was not mentioned in the abstract above is that plaque actually INCREASED in both the the Lipitor only group and the Lipitor plus torcetrapib group. Now, before actually starting the trial, the subjects were given enough Lipitor to adhere to the guidelines written by doctors paid by Pfizer and other statin dealers. So, following the guidelines for blood cholesterol lowering with Lipitor does not slow progression of plaque. The obsession with blood cholesterol is completely futile.


The conclusions of the authors shows their blinkered view of atherosclerosis. While Dr. Nissen donates his personal drug money to charity (how much is paid to run his IVUS lab, if any, is not stated), all the other authors have major financial connections to drug dealers. Revkin, Shear and Duggan are employees of Pfizer and own stock. Naturally this group would ignore non-drug methods for reversing atherosclerosis

We have known how to reverse the atherosclerotic process very easily since the revolutionary work of Dean Ornish the final report of which was published in 1998. No drugs are necessary, only a change in lifestyle which was not seriously attempted in this study. There is even no reference to Ornish’s work in the paper, a major oversight of the reviewers. So, why don’t the IVUS groups do a study of plaque volume after significant lifestyle change? Who would fund it? If Pfizer is really “Working for a Healthier World” and not just making a profit, Pfizer should be funding an IVUS lifestyle trial.

Posted in atherosclerosis, cholesterol, coronary artery disease, professionalism, statins | Tagged: , , , , , , , , , , , , , , , , , , , , , | Leave a Comment »

COURAGE demolishes the myth of the “widow maker” and the “time bomb” but does not use optimal medical therapy

Posted by Colin Rose on March 26, 2007

For 30 years since the development of a balloon-tipped catheter to dilate coronary arteries, now known as PCI (percutaneous coronary intervention), it has been revealed truth from “experts”, most of whom paid their mortgages by doing PCI’s, that all significant coronary narrowings should be dilated to prevent a heart attack. In spite of overwhelming evidence that heart attacks are caused by rupture or early, unstable, non-obstructive plaques, most cardiologists still believe that heart attacks (sudden complete blockage of a coronary artery) occur at the site of the largest plaques. Patients are shown angiograms and told they have a “widow maker” or are “sitting on a time bomb”. I refused to do angioplasties until there was some proof for this superficial but very lucrative theory. Again, it turns out I was right. Even in patients with major narrowings and symptoms, PCI does not prolong life or prevent heart attacks. Chronic symptoms were slightly more improved in the PCI group but most medically-treated patients had symptom improvement just with pills.


Legal Addictions

The COURAGE type subject

All cardiologists give lip service to the necessity for lifestyle change as the ultimate cure for atherosclerosis, but in this study there was no attempt at lifestyle change. Most patients were overweight or obese, gained weight over the five year study. 20% smoked and did not stop. While the authors claim to using “optimal” medical therapy, they did not even try significantly changing lifestyle, the obvious cause of the patients’ atherosclerosis. No doubt even better results that could have been obtained with just lifestyle change, without pills or PCI, as Dean Ornish showed many years ago.

If you want an explanation for why, except for a feeble attempt to raise HDL by exercise, NO attempt was made to change lifestyle meaningfully before using statins or PCI you need look no further than the source of funding and the disclosure statements of the authors. Those who recieve substantial income from drug dealers are not keen on proving that cost-free lifestyle change alone will do the same or better than expensive drugs.




Now, why has it taken 30 years to finally prove the futility of PCI in patients with stable or stabilized coronary disease? Unlike new drugs, there are no rules and no government agency mandating that surgical procedures have to undergo clinical trials before being done on the general population. Any surgeon can develop some operation that seems superfically rational and he and his colleagues can do many thousands of those operations, costing millions or billions of dollars and risking many lives until someone gets around to actually testing it to see if the outcome is really as advertised.

Doctors profess to want to practice “evidence-based medicine” but when change negatively affects bank accounts habits change very slowly if at all. Angioplasty in stable CAD can always be rationalized by the classic, “my patient is different than those in the controlled trial”. We can predict that angioplasties in patients with stable CAD will not decline significantly until most of those trained in the procedure have retired. The system could save a lot of money by giving each of them $one million and a house in Mexico to retire to.

Posted in angioplasty, atherosclerosis, coronary artery disease, diet, drugs, professionalism, statins | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment »