Polypill
Encyclopedia
A polypill is a medication that is a combination drug of multiple active ingredient
s, and that is aimed to be consumed widespread in the population, even currently healthy ones, as a means of preventive medicine
. It usually contains four or more active ingredients, with the intention of reducing the number of tablet
s or capsules (generally orally administered
) that need to be taken, which in turn may facilitate handling and administration of the drug. The dosages are usually relatively low compared to what is administered to people already having disease or significant risk factor
s.
Furthermore, polypills usually refers to formulations of multiple ingredients specifically aimed at prevention of cardiovascular disease
, but this usage of the term is blurred out as it is used for other (yet related) conditions as well, such as diabetes.
) on June 28, 2003, Wald and Law postulated that by using a combination of well known, cheap medications in one pill (the "Polypill") would be a particularly effective treatment against cardiovascular disease. They presented a statistical model
which suggested widespread use of the polypill could reduce mortality due to heart disease
and stroke
s by up to 80%. The treatment is potentially cheap, with few side effects (in perhaps 10-15% of recipients) and the research was based on data from many trials relating to the individual components.
The concepts they present are based on these principles: reducing blood pressure
, cholesterol
and taking a low dose of aspirin
to help prevent heart disease
and stroke
.(In the interim, however, there is concern that the use of aspirin in a healthy population causes more harm than good.) Tests of the Wald and Law polypill have been recommended in 2005. Additionally, "polypills" are currently available in India.
Any GP can currently prescribe all the components of the polypill separately for her/his patients. The ingredients of the polypill are off patent
. Since this would make the polypill quite cheap (some estimates on the BMJ rapid responses were less than 70 pounds per year), there is little financial incentive for pharmaceutical companies to pay the high costs of a clinical trial. (Naturally, however, large insurers, or national healthcare systems
, may have considerable financial incentive to pay for such trials).
Cardiologists in Spain (Sanz and Fuster, 2009) are currently developing a polypill for secondary cardiovascular prevention. This project is being done in collaboration with Ferrer-Internacional, which is a Spanish pharmaceutical company based in Barcelona with
experience in the development and launching of international projects.These authors believe that this polypill delivered at a low price could improve adherence to treatment, reduce the cost and make treatment affordable in low-income countries. Furthermore, they preview that success in this area of prevention could lead to the development of polypills for several other diseases, such as diabetes and stroke.
in 2002.
In a 2003 article in the BMJ
, Wald and Law coined the term "polypill" and proposed the concept of combining six medications that have been used for decades to treat cardiovascular disease
and providing this to all people with cardiovascular disease and those in Western countries aged 55 years or more. They combined the numerical results from several meta-analyses
of the individual effects of these medications to produce an estimate of the overall combined effect on morbidity and mortality
.
Articles using similar methods have proposed other sorts of polypills, including one for diabetes (and potentially for pre-diabetes).
During a 12-week treatment period, 400 of the study participants were given Polycap. The remainder were divided into eight groups of 200 who were given either individual components or groups of them.[1] Three of the groups of 200 received only aspirin, simvastatin or thiazide respectively; Three groups received two of the three blood pressure medications; Another received all three blood pressure medications, while the last received all three combined with aspirin.
The individuals who were given Polycap saw their blood pressure drop from six to seven points for both their systolic and diastolic levels. These reductions in blood pressure could cut the risk of heart disease by 62% and of stroke by 48% based on the results of other studies that showed risk reductions from cutting blood pressure levels. The combined pill was almost as effective as the individual pills with no increase in side effects.
Currently, individual cardiovascular risk can be calculated based on the 50-year (and still going) longitudinal study on the population of Framingham, Massachusetts
(the Framingham Heart Study
). The polypill takes a population-based approach to management. The concept of "normal" and treatment thresholds becomes less relevant when taking a population-based approach to disease control. Traditionally, the approach has been to treat only if certain risk thresholds have been reached.
Paradoxically, even though an individual may not reach these traditional thresholds, benefit will still accrue by further reductions in blood pressure, cholesterol etc. This is because there is a sliding scale of risk; the concept of abnormal on one side of the line corresponding to high risk and requiring treatment, and normal on the other side, being low risk requiring no treatment is now under scrutiny.
Doctors will be treating population risk rather than individual risk factor thresholds as is current mainstream practice. So, if everyone was given the “Polypill” the average blood pressure and cholesterol levels within the population would fall, thus reducing overall population risk.
The "polypill" would contain 3 blood pressure medications at low dose:
This is combined with
Folic acid has been shown to reduce the level of homocysteine in the blood which is another risk factor for heart disease.
Further research is being planned and coordinated after an international forum recently discussed the concept of the “Polypill”.
Diabetes also contributes substantially to cardiovascular risk. Unfortunately, some
of the ingredients in Wald and Law's original polypill may not be advisable for patients
with diabetes (for example : beta-blockers - which can lead to weight gain, and
thiazide diuretics). The polypill for diabetes includes :
Many people who are overweight are diabetic without knowing it. Many additional people
have prediabetes
and may benefit from active intervention. Overall, people who
have diabetes or prediabetes, high cholesterol and /or high blood pressure and are overweight
are considered to have metabolic syndrome
X, and may benefit substantially from the Diabetes polypill.
Perhaps, as the polypill strategy becomes widely adopted, people over 55 with a "normal"
body mass index
or waist circumference will take the Wald and Law polypill, and the obese or
substantially overweight will take the Diabetes / Syndrome X polypill.
More importantly, the human cost of these chronic diseases can be substantially reduced. When a person has a stroke, it can ruin his or her quality of life. It also places a major burden on careers. Kidney failure and dialysis
(common in end-stage diabetics) is also devastating.
it may threaten some experts and specialists who might stand to lose financially
(although no doubt most of these experts would be delighted by the human benefits,
and would probably endorse it - despite any personal financial hardship that this might
cause them).
The polypill, being a simple "off-the-rack" default treatment, also reduces the
sense of control and exercise of expertise that comes from prescribing individually
tailored medication regimens. Unfortunately, individually tailored approaches may be
more expensive and difficult and time consuming to access.
It is held that, if a person stops smoking, exercises 30 minutes or so per day and eats a healthy diet, over time his or her risk of cardiovascular disease can be significantly lessened.
Many people are resistant to this regimen, finding it too difficult, unpleasant,
invasive and inconvenient to adhere to, and therefore are unable to achieve and
sustain these benefits.
Furthermore, there is increasing evidence that even among individuals with healthy
lifestyles, some medications, like statins, can even further reduce one's
cardiovascular risk.
The benefits from reminding people of the benefits of lifestyle modifications and encouraging them to pursue them are generally agreed, but proponents of polypills argue that this does not justify delay of potentially highly
beneficial medications like the polypill. In practice, many people above 55 will probably not observe sufficient lifestyle modifications to improve their health, and will benefit from medications such as those
contained in the polypill.
Excessive insistence on the lifestyle modification approach implies
that "sinners" (those who are unable or unwilling to dramatically alter their lifestyle
and habits) should expect to suffer for their non-compliance. This may be objected to on grounds of freedom of action, in using legal means to punish financially, or through the withdrawal of medical services, non-compliance with a prescribed regimen.
While individuals who prefer to observe a lifestyle modification approach should
be encouraged to do so, the alternative of effective medical treatment may be beneficial to non-compliers. Cardiovascular disease and diabetes may be asymptomatic until substantial irreversible damage has occurred. This makes a dogmatic "lifestyle modification" approach alone undesirable because it may deter vulnerable individuals from seeking prophylactic diagnosis and treatment.
Some of the more original contributions in this regard have take the form of satire.
One such facetious article proposes that consumption of a mixture of many different healthy food types, mainly a Mediterranean diet and Red Wine will have similar benefits as the Polypill. The authors have referred to this as the polymeal
. The BMJ even ran a Polymeal contest inviting people to come up with a meal using the 6 ingredients.
Active ingredient
An active ingredient is the substance of a pharmaceutical drug or a pharmaceutical ingredient and bulk active in medicine; in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient...
s, and that is aimed to be consumed widespread in the population, even currently healthy ones, as a means of preventive medicine
Preventive medicine
Preventive medicine or preventive care refers to measures taken to prevent diseases, rather than curing them or treating their symptoms...
. It usually contains four or more active ingredients, with the intention of reducing the number of tablet
Tablet
A tablet is a pharmaceutical dosage form. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose...
s or capsules (generally orally administered
Oral administration
Oral administration is a route of administration where a substance is taken through the mouth.-Terminology:Per os is an adverbial phrase meaning literally from Latin "by mouth" or "by way of the mouth." The expression is used in medicine to describe a treatment that is taken orally. The...
) that need to be taken, which in turn may facilitate handling and administration of the drug. The dosages are usually relatively low compared to what is administered to people already having disease or significant risk factor
Risk factor
In epidemiology, a risk factor is a variable associated with an increased risk of disease or infection. Sometimes, determinant is also used, being a variable associated with either increased or decreased risk.-Correlation vs causation:...
s.
Furthermore, polypills usually refers to formulations of multiple ingredients specifically aimed at prevention of cardiovascular disease
Cardiovascular disease
Heart disease or cardiovascular disease are the class of diseases that involve the heart or blood vessels . While the term technically refers to any disease that affects the cardiovascular system , it is usually used to refer to those related to atherosclerosis...
, but this usage of the term is blurred out as it is used for other (yet related) conditions as well, such as diabetes.
Cardiovascular polypill
In their paper A strategy to reduce cardiovascular disease by more than 80% (published in the British Medical JournalBritish Medical Journal
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
) on June 28, 2003, Wald and Law postulated that by using a combination of well known, cheap medications in one pill (the "Polypill") would be a particularly effective treatment against cardiovascular disease. They presented a statistical model
Statistical model
A statistical model is a formalization of relationships between variables in the form of mathematical equations. A statistical model describes how one or more random variables are related to one or more random variables. The model is statistical as the variables are not deterministically but...
which suggested widespread use of the polypill could reduce mortality due to heart disease
Heart disease
Heart disease, cardiac disease or cardiopathy is an umbrella term for a variety of diseases affecting the heart. , it is the leading cause of death in the United States, England, Canada and Wales, accounting for 25.4% of the total deaths in the United States.-Types:-Coronary heart disease:Coronary...
and stroke
Stroke
A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...
s by up to 80%. The treatment is potentially cheap, with few side effects (in perhaps 10-15% of recipients) and the research was based on data from many trials relating to the individual components.
The concepts they present are based on these principles: reducing blood pressure
Blood pressure
Blood pressure is the pressure exerted by circulating blood upon the walls of blood vessels, and is one of the principal vital signs. When used without further specification, "blood pressure" usually refers to the arterial pressure of the systemic circulation. During each heartbeat, BP varies...
, cholesterol
Cholesterol
Cholesterol is a complex isoprenoid. Specifically, it is a waxy steroid of fat that is produced in the liver or intestines. It is used to produce hormones and cell membranes and is transported in the blood plasma of all mammals. It is an essential structural component of mammalian cell membranes...
and taking a low dose of aspirin
Aspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
to help prevent heart disease
Heart disease
Heart disease, cardiac disease or cardiopathy is an umbrella term for a variety of diseases affecting the heart. , it is the leading cause of death in the United States, England, Canada and Wales, accounting for 25.4% of the total deaths in the United States.-Types:-Coronary heart disease:Coronary...
and stroke
Stroke
A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...
.(In the interim, however, there is concern that the use of aspirin in a healthy population causes more harm than good.) Tests of the Wald and Law polypill have been recommended in 2005. Additionally, "polypills" are currently available in India.
Any GP can currently prescribe all the components of the polypill separately for her/his patients. The ingredients of the polypill are off patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
. Since this would make the polypill quite cheap (some estimates on the BMJ rapid responses were less than 70 pounds per year), there is little financial incentive for pharmaceutical companies to pay the high costs of a clinical trial. (Naturally, however, large insurers, or national healthcare systems
Publicly-funded health care
Publicly funded health care is a form of health care financing designed to meet the cost of all or most health care needs from a publicly managed fund. Usually this is under some form of democratic accountability, the right of access to which are set down in rules applying to the whole population...
, may have considerable financial incentive to pay for such trials).
Cardiologists in Spain (Sanz and Fuster, 2009) are currently developing a polypill for secondary cardiovascular prevention. This project is being done in collaboration with Ferrer-Internacional, which is a Spanish pharmaceutical company based in Barcelona with
experience in the development and launching of international projects.These authors believe that this polypill delivered at a low price could improve adherence to treatment, reduce the cost and make treatment affordable in low-income countries. Furthermore, they preview that success in this area of prevention could lead to the development of polypills for several other diseases, such as diabetes and stroke.
Origin
The broad concept of a polypill for cardiovascular disease has existed for decades, with early proponents coining the term "aspolol" i.e. a combination of aspirin and atenolol. Fixed dose combinations are common in other clinical areas, such as tuberculosis and HIV/AIDS. The Wellcome Trust and World Health Organisation convened a meeting to discuss the concept in 2001, but did not progress it at that time. The concept was mentioned by Dr. Salim Yusuf in an editorial in The LancetThe Lancet
The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's best known, oldest, and most respected general medical journals...
in 2002.
In a 2003 article in the BMJ
BMJ
BMJ is a partially open-access peer-reviewed medical journal. Originally called the British Medical Journal, the title was officially shortened to BMJ in 1988. The journal is published by the BMJ Group, a wholly owned subsidiary of the British Medical Association...
, Wald and Law coined the term "polypill" and proposed the concept of combining six medications that have been used for decades to treat cardiovascular disease
Cardiovascular disease
Heart disease or cardiovascular disease are the class of diseases that involve the heart or blood vessels . While the term technically refers to any disease that affects the cardiovascular system , it is usually used to refer to those related to atherosclerosis...
and providing this to all people with cardiovascular disease and those in Western countries aged 55 years or more. They combined the numerical results from several meta-analyses
Meta-analysis
In statistics, a meta-analysis combines the results of several studies that address a set of related research hypotheses. In its simplest form, this is normally by identification of a common measure of effect size, for which a weighted average might be the output of a meta-analyses. Here the...
of the individual effects of these medications to produce an estimate of the overall combined effect on morbidity and mortality
Death
Death is the permanent termination of the biological functions that sustain a living organism. Phenomena which commonly bring about death include old age, predation, malnutrition, disease, and accidents or trauma resulting in terminal injury....
.
Articles using similar methods have proposed other sorts of polypills, including one for diabetes (and potentially for pre-diabetes).
The Indian Polycap Study
A study called The Indian Polycap Study (TIPS) was sponsored by Cadila Pharmaceuticals Limited and led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College in Bangalore, India. The results of the randomized, controlled, double-blind study, reported in March 2009 at an American College of Cardiology conference and published online by The Lancet, documented the outcome of 2,000 individuals with an average age of 54 given the medication, all of whom had at least one heart disease risk factor: diabetes, hypercholesterolemia, hypertension, obesity or smoking.During a 12-week treatment period, 400 of the study participants were given Polycap. The remainder were divided into eight groups of 200 who were given either individual components or groups of them.[1] Three of the groups of 200 received only aspirin, simvastatin or thiazide respectively; Three groups received two of the three blood pressure medications; Another received all three blood pressure medications, while the last received all three combined with aspirin.
The individuals who were given Polycap saw their blood pressure drop from six to seven points for both their systolic and diastolic levels. These reductions in blood pressure could cut the risk of heart disease by 62% and of stroke by 48% based on the results of other studies that showed risk reductions from cutting blood pressure levels. The combined pill was almost as effective as the individual pills with no increase in side effects.
Treatment of population risk
Wald and Law has taken the novel perspective that everyone over the age of 55 should take a pill containing medications to manage these issues irrespective of individual risk factor levels. The idea is that most people in Western Countries are at high overall risk, and the lowering risk factor levels will benefit all. Central to this is the realisation that risk factors are continuously associated with risk, and the dichotomies of, for example, "hypertension" and "no hypertension" have no scientific basis. Basically, the polypill could be used as a default medication for all people over 55 (or for others with comparable risks).Currently, individual cardiovascular risk can be calculated based on the 50-year (and still going) longitudinal study on the population of Framingham, Massachusetts
Framingham, Massachusetts
Framingham is a New England town in Middlesex County, Massachusetts, United States. The population was 68,318 as of the United States 2010 Census. -History:...
(the Framingham Heart Study
Framingham Heart Study
The Framingham Heart Study is a long-term, ongoing cardiovascular study on residents of the town of Framingham, Massachusetts. The study began in 1948 with 5,209 adult subjects from Framingham, and is now on its third generation of participants...
). The polypill takes a population-based approach to management. The concept of "normal" and treatment thresholds becomes less relevant when taking a population-based approach to disease control. Traditionally, the approach has been to treat only if certain risk thresholds have been reached.
Paradoxically, even though an individual may not reach these traditional thresholds, benefit will still accrue by further reductions in blood pressure, cholesterol etc. This is because there is a sliding scale of risk; the concept of abnormal on one side of the line corresponding to high risk and requiring treatment, and normal on the other side, being low risk requiring no treatment is now under scrutiny.
Doctors will be treating population risk rather than individual risk factor thresholds as is current mainstream practice. So, if everyone was given the “Polypill” the average blood pressure and cholesterol levels within the population would fall, thus reducing overall population risk.
The "polypill" would contain 3 blood pressure medications at low dose:
- a diureticDiureticA diuretic provides a means of forced diuresis which elevates the rate of urination. There are several categories of diuretics. All diuretics increase the excretion of water from bodies, although each class does so in a distinct way.- Medical uses :...
, such as hydrochlorothiazideHydrochlorothiazideHydrochlorothiazide, abbreviated HCTZ, HCT, or HZT, is a first-line diuretic drug of the thiazide class that acts by inhibiting the kidneys' ability to retain water. This reduces the volume of the blood, decreasing blood return to the heart and thus cardiac output and, by other mechanisms, is...
, - a beta-blocker such as atenolol,
- an ACE inhibitorACE inhibitorACE inhibitors or angiotensin-converting enzyme inhibitors are a group of drugs used primarily for the treatment of hypertension and congestive heart failure...
such as lisinoprilLisinoprilLisinopril is a drug of the angiotensin-converting enzyme inhibitor class that is primarily used in treatment of hypertension, congestive heart failure, and heart attacks and also in preventing renal and retinal complications of diabetes. Its indications, contraindications and side effects are as...
.
This is combined with
- a statinStatinStatins are a class of drugs used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol in the liver. Increased cholesterol levels have been associated with cardiovascular diseases, and statins are therefore used in the...
such as simvastatinSimvastatinSimvastatin is a hypolipidemic drug used to control elevated cholesterol, or hypercholesterolemia. Simvastatin is a member of the statin class of pharmaceuticals, is a synthetic derivate of a fermentation product of Aspergillus terreus.-Medical uses:The primary uses of simvastatin is for the... - aspirinAspirinAspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
at a dose of 75 mg - folic acidFolic acidFolic acid and folate , as well as pteroyl-L-glutamic acid, pteroyl-L-glutamate, and pteroylmonoglutamic acid are forms of the water-soluble vitamin B9...
Folic acid has been shown to reduce the level of homocysteine in the blood which is another risk factor for heart disease.
Further research is being planned and coordinated after an international forum recently discussed the concept of the “Polypill”.
Polypill for diabetes and Syndrome X
Diabetes - particularly Type II diabetes is a major cause of morbidity and mortality.Diabetes also contributes substantially to cardiovascular risk. Unfortunately, some
of the ingredients in Wald and Law's original polypill may not be advisable for patients
with diabetes (for example : beta-blockers - which can lead to weight gain, and
thiazide diuretics). The polypill for diabetes includes :
- A StatinStatinStatins are a class of drugs used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol in the liver. Increased cholesterol levels have been associated with cardiovascular diseases, and statins are therefore used in the...
. To reduce LDL cholesterol and they also have recently been shown to have anti-inflammatoryAnti-inflammatoryAnti-inflammatory refers to the property of a substance or treatment that reduces inflammation. Anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system....
properties. - An ACE inhibitorACE inhibitorACE inhibitors or angiotensin-converting enzyme inhibitors are a group of drugs used primarily for the treatment of hypertension and congestive heart failure...
(for blood pressure control AND to protect the kidneys). - AspirinAspirinAspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
(antiplateletPlateletPlatelets, or thrombocytes , are small,irregularly shaped clear cell fragments , 2–3 µm in diameter, which are derived from fragmentation of precursor megakaryocytes. The average lifespan of a platelet is normally just 5 to 9 days...
and anti-inflammatory properties), and - MetforminMetforminMetformin is an oral antidiabetic drug in the biguanide class. It is the first-line drug of choice for the treatment of type 2 diabetes, in particular, in overweight and obese people and those with normal kidney function. Its use in gestational diabetes has been limited by safety concerns...
- an excellent medication for diabetes that is also associated with weight loss.
Many people who are overweight are diabetic without knowing it. Many additional people
have prediabetes
Prediabetes
Prediabetes is the state in which some but not all of the diagnostic criteria for diabetes are met. It is often described as the “gray area” between normal blood sugar and diabetic levels. While in this range, patients are at risk for not only developing type 2 diabetes, but also for cardiovascular...
and may benefit from active intervention. Overall, people who
have diabetes or prediabetes, high cholesterol and /or high blood pressure and are overweight
are considered to have metabolic syndrome
Metabolic syndrome
Metabolic syndrome is a combination of medical disorders that, when occurring together, increase the risk of developing cardiovascular disease and diabetes. It affects one in five people in the United States and prevalence increases with age...
X, and may benefit substantially from the Diabetes polypill.
Perhaps, as the polypill strategy becomes widely adopted, people over 55 with a "normal"
body mass index
Body mass index
The body mass index , or Quetelet index, is a heuristic proxy for human body fat based on an individual's weight and height. BMI does not actually measure the percentage of body fat. It was invented between 1830 and 1850 by the Belgian polymath Adolphe Quetelet during the course of developing...
or waist circumference will take the Wald and Law polypill, and the obese or
substantially overweight will take the Diabetes / Syndrome X polypill.
Cost effectiveness
Wald and Law's analysis predicts major cost savings and productivity gains can be from a polypill approach. Similarly, the Diabetes / Syndrome X polypill is estimated to save hundreds of billions of dollars.More importantly, the human cost of these chronic diseases can be substantially reduced. When a person has a stroke, it can ruin his or her quality of life. It also places a major burden on careers. Kidney failure and dialysis
Dialysis
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure...
(common in end-stage diabetics) is also devastating.
Medical expertise and simplicity of treatment
If a polypill strategy works for a large percentage of the patient population,it may threaten some experts and specialists who might stand to lose financially
(although no doubt most of these experts would be delighted by the human benefits,
and would probably endorse it - despite any personal financial hardship that this might
cause them).
The polypill, being a simple "off-the-rack" default treatment, also reduces the
sense of control and exercise of expertise that comes from prescribing individually
tailored medication regimens. Unfortunately, individually tailored approaches may be
more expensive and difficult and time consuming to access.
Lifestyle Modification and "punishing the sinners"
There is a large cohort of health professionals that advocate lifestyle modification.It is held that, if a person stops smoking, exercises 30 minutes or so per day and eats a healthy diet, over time his or her risk of cardiovascular disease can be significantly lessened.
Many people are resistant to this regimen, finding it too difficult, unpleasant,
invasive and inconvenient to adhere to, and therefore are unable to achieve and
sustain these benefits.
Furthermore, there is increasing evidence that even among individuals with healthy
lifestyles, some medications, like statins, can even further reduce one's
cardiovascular risk.
The benefits from reminding people of the benefits of lifestyle modifications and encouraging them to pursue them are generally agreed, but proponents of polypills argue that this does not justify delay of potentially highly
beneficial medications like the polypill. In practice, many people above 55 will probably not observe sufficient lifestyle modifications to improve their health, and will benefit from medications such as those
contained in the polypill.
Excessive insistence on the lifestyle modification approach implies
that "sinners" (those who are unable or unwilling to dramatically alter their lifestyle
and habits) should expect to suffer for their non-compliance. This may be objected to on grounds of freedom of action, in using legal means to punish financially, or through the withdrawal of medical services, non-compliance with a prescribed regimen.
While individuals who prefer to observe a lifestyle modification approach should
be encouraged to do so, the alternative of effective medical treatment may be beneficial to non-compliers. Cardiovascular disease and diabetes may be asymptomatic until substantial irreversible damage has occurred. This makes a dogmatic "lifestyle modification" approach alone undesirable because it may deter vulnerable individuals from seeking prophylactic diagnosis and treatment.
Satire
Wald and Law's approach has generated substantial controversy and criticism.Some of the more original contributions in this regard have take the form of satire.
One such facetious article proposes that consumption of a mixture of many different healthy food types, mainly a Mediterranean diet and Red Wine will have similar benefits as the Polypill. The authors have referred to this as the polymeal
Polymeal
The Polymeal is a diet-based approach to combatting heart disease, proposed in December 2004 by Oscar Franco, a Colombian public health scientist at the University Medical Centre in Rotterdam, Netherlands. Franco and his colleagues suggest the "Polymeal" as a natural alternative to the "Polypill",...
. The BMJ even ran a Polymeal contest inviting people to come up with a meal using the 6 ingredients.