British Medical Journal critized for promoting drug cocktail ignoring risks

Mon, 14 Jul 2003

The push toward adopting a radical cholesterol lowering strategy, including the use of statin drugs was given a shot in the arm when the British Medical Journal (BMJ) published an article– endorsed by its editor–promoting the concept of multiple drugs, packaged as a “polypill”, for preventing heart attacks–in the June 27 issue.. See: http://bmj.com/cgi/content/abstract/326/7404/1419

Why, one wonders did the BMJ endorse this radical, multiple drug strategy that would require prescribing multiple drugs–including statins–for everyone over the age of 55? Doctors have frowned on such prescribing strategies because they invite unintended consequences such as unidentified drug-induced side effects. The strategy, if implemented, would be entirely experimental–a vast unregulated human experiment, much like the hormone replacement debacle. It too was touted with certitude (until recently) as a preventive measure against cardiovascular disease.

It’s easy to see this as another drug marketing scheme to increase profits for the pharmaceutical industry–but it is doctors not drug companies that hold the key (i.e. their license to prescribe). It is less clear how this strategy can be scientifically justified: Inasmuch as the components of the “polypill”–in particular statins–pose severe adverse side effects, and everyone over the age of 55 is not at risk of heart attacks. Therefore, doctors should be held accountable if they chose to prescribe recklessly.

Numerous responders to the BMJ article and editorial were not duped. The following excerpts are from the responses to BMJ:

Barry Goves, an independent researcher wrote: “I have read some rubbish in my time, but this just about takes the biscuit. Let’s take this to its logical conclusion and put every drug known to medical science in the water supply. That way we will prevent and cure every disease Man is subject to. And we can all live happily ever after. Diseases will be abolished overnight; doctors will all be redundant; the NHS will no longer need vast sums of money, and we will all be, not only healthier, but wealthier. Or, of course, we could cut mortality by 100% by preventing the most important “risk factor” of them all – being born.”
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Edie Vos quipped: “Maybe, Editor Smith’s editorial idea is a good one: adding red wine in a pub would raise HDL-cholesterol. Let me propose that jogging from pub to pub would add another HDL raising exercise component while avoiding the danger of driving on heart-healthy alcohol, but not that of liver toxicity and addiction for some.”
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Dr. John S Ashcroft, a General Practitioner, did a cost analysis arriving at a cost of 60 British pounds a year per person. (At the current exchange rate of 1 British pound = $1.63, the “polypill” would cost about $97.80. But given that the cost of drugs in the US is more than double that elsewhere, the cost on the US for every person over the age of 55 would be $195.60 a year.
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Nicholas Regush, editor, RedFlagsWeekly.com wrote:

This has got to be one the most egregious presentations that I have ever come across in all my years as a health reporter, both in the print world and at ABC News in New York. That the authors actually appear to have the support of the editor of the British Medical Journal is truly amazing – and dangerous. All these so-called health professionals actually have convinced themselves that if you put six different drugs together, they will all add up to one big cure of sorts. This is not only junk science at its worst, but reveals the sloppy intellectual processes going on these days in medical science, in focusing attention on such complex issues (and controversial ones, I might add) surrounding cardiovascular disease.

Furthermore, to assume that each and every one of these drugs used for different strategic purposes in the battle against heart disease is, for one thing, the best approach in providing treatment for heart trouble, and then to assume that you can batch them, on the basis of what they appear to be doing on their own, is Fool’s Gold. Can we please have some real science conducted, preferably research that deals with safety and efficacy before we become enchanted with a polypill idea? Any serious discussion about incorporating a variety of theories about cardiovascular disease into one product package, which is what this entire issue amounts to, reveals a total disregard for scientific principles and for the human condition, which is far more complex than these authors seem to think.”
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Richard Fiddoan Green pointed out that a meta-analysis raised concern about statins which, “whilst not specific for statins per se there was a trend (p=0.06)towards an increase in suicides, accidents, and trauma in a meta-analysis of the effects of cholesterol reduction on mortality from all causes (1)).”

“Anytime one treats an effect rather than a cause there is a risk of unintended consequences, such as an increase in suicides, accidents and trauma. Until the primary cause or causes of all diseases is defined, and that could be closer to reality than commonly supposed, the sooner doctors will stop flying by the seat of our pants as they have done since antiquity.

I would not bet on this issue being the most important issue of the BMJ in decades unless the Polypill has been proposed with the specific intent of provoking a legal confrontation with the drug industry. It is not the drug companies that are at fault. It is us, the doctors.

1. Cholesterol reduction and non-illness mortality: meta-analysis of randomised clinical trials Matthew F Muldoon, Stephen B Manuck, Aaron B Mendelsohn, Jay R Kaplan, and Steven H Belle BMJ 2001; 322: 11-15.

See Letters to BMJ at: http://bmj.com/cgi/eletters/326/7404/1419#33751
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A column on RedFlagsWeekly disects the polypill proposal further. By Dr. Peter H. Langsjoen, a cardiologist and biochemist with a clinical practice in Tyler, Texas offers an alternative, equally absurd prevention proposal:

“At its core, the proposal, in effect, implies that risk factors are causative. If that’s the case, why don’t we do some novel prevention work. For example, since a deep ear lobe crease is a risk factor for coronary artery disease, why not cut off our ear lobes after the age of 55, or for that matter, why not start snipping them off at birth? After all, the sooner the intervention, the better, and the small inconvenience is certainly worth the millions of lives and billions of dollars that might be saved.” See: http://www.redflagsweekly.com/extra/2003_jul12.html
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An excerpt from a forthcoming book by Duane Graveline MD MPH, Former USAF flight surgeon, Former NASA astronaut, Retired family doctor, tells of his harrowing experience after taking Lipitor–namely amnesia. He notes that the risks associated with statins and their propensity to cause memory lapses poses particular risks for pilots, flight crews, commercial truck and bus drivers, and heavy equipment operators and operators of dangerous tools. The list is limited only by one’s imagination.

“This potential problem of statin drug associated memory dysfunction while flying is further confounded by the reality that amnesia is but the tip of the iceberg of the many other forms of memory lapses that occur far more commonly. An increased tendency for disorientation, confusion and forgetfulness can be easy to miss in many individuals, for a certain degree of this is in the nature of all of us.” See: http://www.spacedoc.net/Statins_flyer.html
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Dr. Langsjoen observes: “If we are gullible enough to believe that we are all somehow diseased after age 55, and that in order to save ourselves, we must swallow this toxic garbage pill, with blind confidence in the pharmaceutical/medical industry, then perhaps there is more than a little of the lemming in us all. Maybe in some mysterious way humans need to run off a cliff from time to time.”

To this observer it is refreshing to see a rising tide of doubters!