CONVERTING MILLIONS OF HEALTHY PEOPLE INTO PERPETUAL PATIENTS

[Guest guest]

http://www.redflagsweekly.com/rosch/2003_jul21.html

 

 

PAUL ROSCH, MD

 

July 21, 2003

 

CONVERTING MILLIONS OF HEALTHY PEOPLE INTO PERPETUAL PATIENTS

 

By Paul J. Rosch, MD, F.A.C.P.

THE AMERICAN INSTITUTE OF STRESS

 

Paul Rosch, MD, FACP, is clinical professor of medicine and psychiatry at New

York Medical College and is President of the American Institute of Stress, and

Honorary Vice-President of the International Stress Management Association.

 

This column will also appear in a future edition of the Health and Stress

monthly newsletter of the American Institute of Stress

 

Forget about the alchemist's magical " Elixir of Life " and Ponce De Leon's

" Fountain of Youth " . These fantasies have recently been replaced by a

combination pill concocted not by some " kook " , but two distinguished scientists,

Nicholas Wald, Professor and Head of the Wolfson Institute of Preventive

Medicine in London and Malcolm Wald, a Professor at the University of London and

University of Auckland in New Zealand. These researchers believe they can

prevent almost nine out of ten heart attacks as well as four out of five strokes

in anyone with cardiovascular disease and everyone age 55 and older. All you

need to do is to take their powerful Polypill daily.

 

So what's in this latest magic bullet? A statin to lower LDL, three different

antihypertensive drugs (a beta blocker, diuretic and ACE inhibitor), aspirin to

reduce clotting tendencies and folic acid to prevent high homocysteine levels.

There is no vitamin C or vitamin E, omega-3 fatty acids, Coenzyme Q10 or other

ingredients that have also been shown to reduce heart disease. There are no

dietary restrictions or recommendations nor any apparent need to exercise more

or stop smoking.

 

The Polypill was introduced with much fanfare in a lead article entitled " A

strategy to reduce heart disease by more than 80% " . It appeared in the June 28

issue of the British Medical Journal accompanied by two enthusiastic editorials.

Richard Smith, the editor, started out by stating that this was possibly the

most important issue of the journal in the last 50 years. He suggested that

everyone save their copy since it would likely become a collector's item. A

guest editorial by Anthony Rogers, co-director of the Clinical Trials Research

Unit, University of Auckland was not quite as gushy. However, it also seemed to

endorse the authors' claim that the Polypill would have " a greater impact on the

prevention of disease in the Western world than any other known intervention " !

Not surprisingly, the professors filed a patent application for their

formulation and a trademark application for the name Polypill over three years

ago

 

Their contention is that one in three people over the age of 54 could look

forward to an additional 11 or 12 years of life free from cardiovascular disease

by taking a daily Polypill. All the ingredients are readily available and not

protected by patent so the price of the pill would be minimal, especially when

purchased in huge quantities. There is apparently little concern about safety

because of the relatively low dosages of the various drugs, which apparently

does not reduce their effectiveness.

 

These conclusions seem somewhat premature, if not preposterous, for several

reasons. The first is that no studies have ever been done with the Polypill

since it does not exist. It is not clear if this will be manufactured as a

tablet, capsule containing powder or gelcap, and the various different fillers

required or formulation of the covering may not be compatible with all the

constituents. Proximity to meals and time of day of administration may influence

efficacy. Simvastatin and beta blockers are more effective when given in the

evening, but a thiazide diuretic taken at the same time could significantly

interfere with a good night's sleep. Some of the ingredients have significant

side effects or are relatively contraindicated in common conditions like

diabetes and asthma. In addition, desired responses may be suppressed and/or

unwanted actions augmented when certain of these drugs are taken simultaneously.

 

The claims for efficacy and safety of the Polypill are based solely on

meta-analyses and statistical evaluations of more than 750 clinical trials

involving some 400,000 participants. Many of these study groups involved

individuals with evidence of or at increased risk for coronary heart disease and

hypertension. Extrapolation of such results to populations with no increased

risk for cardiovascular disease other than having reached the age of 55 seems

unwarranted and potentially dangerous. They hardly justify converting millions

of healthy people into perpetual patients, some of whom may well develop

complaints like chronic cough and bleeding tendencies. The promises that 88% of

heart attacks and 80% of strokes will be prevented are based on statistics that

reflect relative risk reduction, which is very different than absolute risk

reduction. This is a great example of Harry Truman's advice, " If you can't

convince them, confuse them " .

 

For example, your doctor tells you that there is a new blockbuster statin drug

with no side effects and if you take it every day for the next five years it

will significantly " reduce your risk " of heart attack. How likely is it that you

would take the drug based on the following clinical studies?

 

1. Over five years, patients taking this drug had 34% fewer heart attacks

compared to controls who took a placebo. (Sounds pretty convincing)

2. Over five years only 2.7% of patients taking this drug had a heart attack

compared to 4.1% taking a placebo. (Also not too bad)

3. If seventy-one people take this drug every day for five years it will prevent

one of them from having a heart attack. However, there is no guarantee that you

will be that person. (These odds are not very attractive)

 

All these scenarios are accurate and are based on the same data but the

statistics have been presented in very different ways. To avoid becoming

confused, it is essential for you to be able to distinguish between relative

risk reduction, absolute risk reduction and number-needed-to-treat.

 

Scenario 1: 4.1% taking the placebo had heart attacks; compared to only 2.7% for

those taking the drug, a 34% Relative Risk Reduction of 34%.

 

Scenario 2: When you compare the percentage of the 4.1% in the placebo group who

had heart attacks with the 2.7% of statin-takers who had heart attacks, the

Absolute Risk Reduction is only 1.4%!

 

Scenario 3: How many people need to take the drug to prevent just one heart

attack? Your doctor would have to treat 71 people just like you for five years

to prevent one of them from having a heart attack but there is no way of knowing

who this will be. This is called the Number Needed To Treat and would probably

not persuade many healthy patients to take this pill for the rest of their life.

 

Statin manufacturers are able to persuade physicians to prescribe their products

by citing Relative Risk Reduction statistics and these are also featured in

direct advertising to consumers, who may not be aware of their true

significance. The fact is that none of the primary prevention statin trials have

demonstrated a decrease in overall mortality rates and most show no significant

decrease in the incidence of heart attacks or strokes. The Polypill proponents

have done the same thing. Many will interpret their claims to mean that taking a

pill every day for the rest of their lives will reduce the likelihood of having

a heart attack by 88 per cent and lower their chances for stroke by 80 per cent.

If the meta-analyses statistics were reported instead as Absolute Risk Reduction

percentages and Number Needed To Treat, quite a different picture would be

painted. According to a rapid response posted on the BMJ web site by two British

physicians entitled " Patients Before Populations " ,

 

" We are duty bound to inform our healthy 55-year-old that if he or she takes the

Polypill for the next 10 years there will be less than 1% chance per year of

benefit and a 6% overall chance of side effects, some of which (e.g. aspirin

related GI haemorrhage) may be life threatening. Furthermore if the Polypill is

successful, our patient’s chance of dying from cancer, trauma and degenerative

brain disease will increase pari passu with the effectiveness of the Polypill,

as sadly even on the Polypill, mortality will remain stubbornly around the 100%

mark. "

 

Not mentioned were the possible adverse effects of statin induced Coenzyme Q10

depletion, beta blocker fatigue and impotence, etc. The selection of three

antihypertensive drugs at " half standard doses " shotgun approach is based on the

erroneous premise that most patients will eventually require three or more

medications to achieve satisfactory blood pressure control. It also assumes that

this particular combination will provide a satisfactory synergistic effect while

significantly reducing individual side effects. Calcium channel blockers were

apparently excluded to keep costs down but they can also conflict with

thiazides. However, beta blockers may deplete levels of Co Q10 and potentiate

other adverse statin side effects like fatigue. There could be additional

complications from unanticipated interactions between the constituents of this

crazy concoction.

 

Extrapolating the results from epidemiologic studies of large populations to

treat individual patients is dangerous, especially when based on meta-analyses

of groups that may not be relevant. This approach also ignores comorbidity

problems due to other conditions that may affect metabolism and excretion or

require conflicting medications. A good example of this is the current confusion

about treating elevated blood pressure, which is also usually a trial and error

buckshot approach. A bullet will do the trick, since 60% of all hypertensive

patients can be controlled on one medication permanently by renin profiling to

determine whether the problem is salt (volume) related or due to activation of

the renin-angiotensin-aldosterone system. As will be explained in a subsequent

article, this testing is now readily available. Until then it would be wise to

heed the " Patients Before Populations " advice of other Polypill critics.

 

 

 

 

 

 

 

 

 

@

 

Alternative Medicine/Health-Vitamins, Herbs, Aminos, etc.

 

To , e-mail to:

alternative_medicine_forum-

 

Or, go to our group site at:

alternative_medicine_forum

 

 

 

SBC DSL - Now only $29.95 per month!