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.
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, http://www.atherothrombosis.org, 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.