Glossary of terms used in Pharmacovigilance:

Glossary of terms used in Pharmacovigilance:

 

    Absolute risk:

 

Risk in a population of exposed persons; the probability of an event affecting members of a

particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence) or at a given time (prevalence). Also see Attributable risk and Relative risk.

 

Adverse Event (AE):

 

Any untoward medical occurrence that may present during treatment with a pharmaceutical

product but which does not necessarily have a causal relationship with this treatment.

 

  Also see Adverse reaction and Side Effect.

 

Synonym: Adverse experience

 

Adverse (Drug) Reaction (ADR):

 

A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. (WHO, 1972). An adverse drug reaction, contrary to an adverse event, is characterized by the suspicion of a causal relationship between the drug and the

occurrence, i.e. judged as being at least possibly  related to treatment by the reporting or a

reviewing health professional.

 In the EU Directive 2010/84,

which will become applicable in July 2012

 

An adverse reaction is defined as: A response to a medicinal product which is noxious and unintended.

 

Allopathy:

 

Non-traditional, western scientific therapy, usually using synthesised ingredients, but may also contain a purified active ingredient extracted from a plant or other natural source; usually in opposition to the disease.

 

Also see Homeopathy.

 

Association:

 

Events associated in time but not necessarily linked as cause and effect.

 

Attributable risk:

 

Difference between the risk in an exposed population (absolute risk) and the risk in an

unexposed population (reference risk). Also referred to as Excess risk. Attributable risk is the result of an absolute comparison between outcome frequency measurements, such as incidence.

 

Benefit:

 

An estimated gain for an individual or a population.

 

Also see Effectiveness/Risk.

 

Benefit - risk analysis:

 

Examination of the favourable (beneficial) and unfavourable results of undertaking a specific course of action. (While this phrase is still commonly used, the more logical pairings of benefit-harm and effectiveness-risk are slowly replacing it).

 

Biological products:

 

Medical products prepared from biological material of human, animal or microbiologic origin (such as blood products, vaccines, insulin).

 

Causal relationship:

 

A relationship between one phenomenon or event (A) and another (B) in which A precedes and causes B. In pharmacovigilance; a medicine  causing an adverse reaction.

 

Synonym: Causality

 

Causality assessment:

 

The evaluation of the likelihood that a medicine was the causative agent of an observed adverse reaction. Causality assessment is usually made according established algorithms.

 

Caveat document:

 

The formal advisory warning accompanying data release from the WHO Global ICSR Database: it specifies the conditions and reservations applying to interpretations and use of the data.

CemFlow:

 

Software developed by UMC for collection and analysis of data in Cohort Event Monitoring.

 

Also see Cohort Event Monitoring.

 

Clinical trial:

 

A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the objective of ascertaining their efficacy and safety.

 

Cohort Event Monitoring:

 

Cohort Event Monitoring (CEM) is a prospective, observational study of events that

occur during the use of medicines, for intensified follow-up of selected medicinal products phase. Patients are monitored from the time they begin treatment, and for a defined period of time.

 See also Prescription Event Monitoring.

Compliance:

 

Faithful adherence by the patient to the prescriber’s instructions.

 

 

 

Control group:

 

The comparison group in drug-trials not being given the studied drug.

 

Critical terms:

 

Some of the terms in WHO-ART are marked as‘Critical Terms’. These terms either refer to or might be indicative of serious disease states, and warrant special attention, because of their possible association with the risk of serious illness which may lead to more decisive action than reports on other terms.

Also see Serious adverse event or reaction.

 

Data mining:

 

A general term for computerised extraction of potentially interesting patterns from large data sets, often based on statistical algorithms. A related term with essentially the same meaning is ‘pattern discovery’. In pharmacovigilance, the commonest application of data mining is so called disproportionality analysis, for example using the Information component (IC).

 See also Disproportionality analysis, Information component,

Omega.

 

Dechallenge:

 

The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of adverse effects may be observed.

 

Disproportionality analysis:

 

Screening of ICSR databases for reporting rates which are higher than expected. For drug-ADR pairs, common measures of disproportionality are the Proportional Reporting Ratio (PRR), the Reporting Odds Ratio (ROR), The Information Component (IC), and the Empirical Bayes Geometrical Mean (EBGM). There are also disproportionality measures for drug-drug-ADR triplets, such as Omega (Ω).

 

 See also Information component, Omega.

 

Effectiveness/risk:

 

The balance between the rate of effectiveness of a medicine versus the risk of harm is a quantitative assessment of the merit of a medicine used in routine clinical practice. Comparative information between therapies is most useful. This is more useful than the efficacy and hazard predictions from pre-marketing information that is limited and based on selected subjects.

 

Efficacy:

 

The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard).

See also Absolute risk, Reference risk, Attributable risk and Relative risk.

 

Epidemiology:

 

The science concerned with the study of the factors determining and influencing the frequency and distribution of disease, injury and other health-related events and their causes in a defined human population for the purpose of establishing programs to prevent and control their development and spread (Dorland’s Illustrated Medical Dictionary).

 Also see Pharmacoepidemiology.

 

Essential medicines:

 

Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.

 

EudraVigilance:

 

The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products

authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.

Excipients:

 

All materials included to make a pharmaceutical formulation (e.g. a tablet) except the active drug substance(s).

Formulary:

 

A listing of medicinal drugs with their uses, methods of administration, available dose forms, side effects, etc, sometimes including their formulas and methods of preparation.

 

Frequency of ADRs:

 

In giving an estimate of the frequency of ADRs the following standard categories are

recommended:

Very common* > 10%

Common (frequent) >1% and <10%

Uncommon (infrequent) >0.1% and < 1%

Rare >0.01% and <0.1%

Very rare* <0.01%

* Optional categories

 

Generic (multisource product):

 

The term ‘generic product’ has somewhat different meanings in different jurisdictions. Generic products may be marketed either under the non-proprietary approved name or under a new brand (proprietary) name. They are usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after the expiry of patent or other exclusivity rights.

Harm:

 

The nature and extent of actual damage that could be caused by a drug. Not to be confused with risk.

 

Herbal medicine:

 

Includes herbs, herbal materials, herbal preparations and finished herbal products.

 

 

Homeopathy:

 

Homeopathy is a therapeutic system which works on the principle that ‘like treats like’. An illness is treated with a medicine which could produce similar symptoms in a healthy person. The active ingredients are given in highly diluted form to avoid toxicity. Homeopathic remedies are virtually 100% safe.

Also see Allopathy.

 

Information component (IC):

 

The Information component (IC) measures the disproportionality in the reporting of a drug- ADR pair in an ICSR database, relative to the reporting expected based on the overall reporting of the drug and the ADR. Positive IC values indicate higher reporting than expected. The IC has also been implemented on electronic health records, to detect interesting temporal relationships between drug prescriptions and medical events.

 

Incidence:

 

Number of new cases of an outcome which develop over a defined time period in a defined population at risk.

 

Individual Case Safety Report (ICSR):

 

A report that contains ‘information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient…’.

(Volume 9 of the Rules Governing Medicinal Products for Human and Veterinary Use in the European Union).

 

MedDRA:

 

MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO

Adverse Reactions Terminology, is now mapped to MedDRA.

 

 

Medical error:

 

“An unintended act (either of omission or commission) or one that does not achieve its intended outcomes.”

Leape, Lucien. Error in Medicine. Journal of the

American Medical Association 272(23):1851-57

(Dec. 21, 1994).

Member countries:

 

Countries which comply with the criteria for, and have joined the WHO Programme for International Drug Monitoring.

 

 

National pharmacovigilance centres:

 

Organisations recognised by governments to represent their country in the WHO Programme (usually the drug regulatory agency). A single, governmentally recognized centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety.

 

Odds:

 

Probability of an occurrence p divided by the probability of its non-ocurrence (1 - p).

 

Odds ratio:

 

Ratio of the Odds in a given population and the odds in another population.

 

Omega (Ω):

 

            A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases, designed to highlight potential signals of drugdrug interactions. Just like the more established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between the observed and expected number of reports. A positive Ω indicates higher reporting than expected.

 

OTC (Over The Counter) medicine:

 

            Medicinal product available to the public without prescription.

 

PaniFlow:

 

            Software developed by UMC for collection and analysis of data in relation to vaccinations in  pandemic situation.

 

Periodic Safety Update Report

(PSUR):

           

            A systematic review of the global safety data which became available to the manufacturer of a marketed drug during a specific time period. Produced in an internationally agreed format.

 

Pharmacoepidemiology:

 

            Study of the use and effects of drugs in large populations.

 

so see Epidemiology.

 

Pharmacology:

           

            Study of the uses, effects and modes of action of drugs.

 

Pharmacovigilance:

 

            The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem.

 

Phocomelia:

 

            Characteristic deformity caused by exposure to thalidomide in the womb, also very rarely occurring spontaneously. Meaning: limbs like a seal.

 

Phytotherapy:

 

            Western-style, scientific treatment using plant extracts or materials.

 

 

 

 

Placebo:

 

            An inactive substance (often called a sugar pill) given to a group being studied to compare results with the effects of the active drug.

 

Polypharmacy:

 

            The concomitant use of more than one drug, sometimes prescribed by different practitioners.

 

Post-marketing:

 

            The stage when a drug is generally available on the market.

 

Predisposing factors:

 

            Any aspect of the patient’s history (other than the drug) which might explain reported adverse events (genetic factors, diet, alcohol consumption, disease history, polypharmacy or

use of herbal medicines, for example).

 

Pre-marketing:

 

            The stage before a drug is available for prescription or sale to the public.

 

Prescription Event Monitoring (PEM):

 

            System created to monitor adverse drug events in a population. Prescribers are requested to report all events, regardless of whether they are suspected adverse events, for identified patients receiving a specified drug. Also more accurately named Cohort Event Monitoring.

 

Prescription Only Medicine (POM):

 

            Medicinal product available to the public only on prescription.

 

Prevalence:

 

            Number of existing cases of an outcome in a defined population at a given point in time.

 

 

Prophylaxis:

 

            Prevention or protection.

 

Rational drug use:

 

            An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance with the best understanding of their appropriateness for the indication and the particular patient, and of their benefit, harm effectiveness and risk.

 

Rechallenge:

 

            The point at which a drug is again given to a patient after its previous withdrawal  also see dechallenge.

 

Record linkage:

 

            Method of assembling information contained in two or more records, eg in different sets of medical charts, and in vital records such as birth and death certificates. This makes it possible to relate significant health events that are remote from one another in time and place.

 

Reference risk:

 

            Risk in a population of unexposed persons; also called baseline risk. Reference risk can be measured over time (incidence) or at a given time (prevalence). The unexposed population refers to a reference population, as closely comparable to the exposed population as possible, apart from the exposure.

 

Regulatory authority:

 

            The legal authority in any country with the responsibility of regulating all matters relating to drugs.

 

Relative risk:

 

            Ratio of the risk in an exposed population (absolute risk) and the risk in an unexposed

population (reference risk). Relative risk is the result of a relative comparison between outcome frequency measurements, e.g. incidences.

 

Risk:

         

          The probability of harm being caused; the probability (chance, odds) of an occurrence.

 

Serious Adverse Event or Reaction:

 

            A serious adverse event or reaction is any untoward medical occurrence that at any dose:

 

·         Results in death

·         Requires inpatient hospitalisation or

·         Prolongation of existing hospitalisation

·         Results in persistent or significant

·         Disability/incapacity

·         Is life-threatening

            To ensure no confusion or misunderstanding of the difference between the terms ‘serious’ and ‘severe’, the following note of clarification is provided:

            The term ‘severe’ is not synonymous with serious. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event (as in mild, moderate or severe); the event itself, however, may be of relatively minor medical significance (such as severe headache). Seriousness (not severity) which is based on patient/event outcome or action criteria serves as guide for defining regulatory reporting obligations.

 

Side effect:

 

            Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the pharmacological properties of the drug.

 

Signal:

           

            Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually

more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. The publication of a signal usually implies the need for some kind of review or action.

 

(SPC):

 

            A regulatory document attached to the marketing authorization which forms the basis of the product information made available to prescribers and patients.

 

Spontaneous reporting:

 

            System whereby case reports of adverse drug events are voluntarily submitted from health professionals and pharmaceutical manufacturers to the national regulatory authority.

 

Also see ICSR.

 

Thalidomide:

 

            Drug prescribed in the 1950s as a mild sleeping pill and remedy for morning-sickness for pregnant women. Led to serious birth defects and the start of modern pharmacovigilance.

Returning to favour in treatment of serious diseases such as cancer and leprosy.

 

Traditional medicines:

 

            Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or

treatment of physical and mental illness.

 

 Also see Allopathic medicine.

 

Unexpected adverse reaction:

 

            An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from characteristics of the drug.

 

 

 

VigiBase:

 

            The name of the WHO Global ICSR Database.

 

VigiFlow:

 

            VigiFlow is a complete ICSR management system created and maintained by the UMC. It is web-based and built to adhere to the ICH-E2B standard. It can be used as the national database for countries in the WHO Programme as it incorporates tools for report analysis, and facilitates sending reports to VigiBase.

 

Vigimed:

 

            Sharepoint based conferencing facility, exclusive to member countries of the WHO Programme for International Drug Monitoring for fast communication of topical pharmacovigilance issues.

 

VigiMine:

 

            A statistical tool within VigiSearch with vast statistical material calculated for all Drug-ADR pairs (combinations) available in VigiBase. The main features include the disproportionality measure (IC value) stratified in different ways and useful filter capabilities.

 

VigiSearch:

 

            A search service for accessing ICSRs stored in the VigiBase database offered by the UMC to national pharmacovigilance centres and other third-party inquirers.

 

WHO-ART:

 

            Terminology for coding clinical information in relation to drug therapy. WHO-ART is

maintained by UMC.

 

                                            

 

 

 

 

 

 

 

WHO Drug Dictionary (WHO DD):

 

            The WHO Drug Dictionary is an international classification of drugs providing proprietary and on-proprietary names of medicinal products used in different countries, together with all active ingredients.

 

Misdiagnosing 1 Million Kids With ADHD

Being The Youngest In Kindergarten is Misdiagnosing 1 Million Kids With ADHD
 

Two studies published suggest there could be something wrong with the way ADHD is diagnosed in young children in the US, one found that nearly 1 million kids are potentially misdiagnosed just because they are the youngest in their kindergarten year, with the youngest in class twice as likely to be on stimulant medication, while the other study confirmed that whether children were born just before or just after the kindergarten cutoff date significantly affected their chances of being diagnosed with ADHD.



Papers on both studies by US researchers are published in theJournal of Health Economics .

In the first paper, Dr Todd Elder, assistant professor of economics at Michigan State University, looked at a sample of nearly 12,000 children from the Early Childhood Longitudinal Study Kindergarten Cohort, which is funded by the National Center for Education Statistics. He analysed the difference in ADHD diagnosis and medication rates between the youngest and the oldest children in a kindergarten grade.

He found that the youngest children were significantly more likely to be diagnosed with ADHD and to be prescribed behavior-modifying stimulants such as Ritalin than their older classmates. He told the press that the "smoking gun" was that the diagnoses depended on the children's age relative to classmates and the teacher's perceptions of whether they had symptoms.

Elder said:

"If a child is behaving poorly, if he's inattentive, if he can't sit still, it may simply be because he's 5 and the other kids are 6."

"There's a big difference between a 5-year-old and a 6-year-old, and teachers and medical practitioners need to take that into account when evaluating whether children have ADHD," he urged.

Elder said medicating such children inappropriately was a cause for concern not just because of the effect of long term stimulant use on their health but also because it costs a lot of money: he estimated about 320 to 500 million US dollars is being wasted on unnecessary medication of young children for ADHD, of which 80 to 90 million is funded by Medicaid.

From his analysis, Elder found that the youngest kindergarten kids were 60 per cent more likely to be diagnosed with ADHD than the oldest in the same grade, and also, by the time those groups reached the fifth and eighth grades, the youngest were more than twice as likely to be on prescription stimulants.

Elder estimated that overall in the US, the misdiagnosis rate is about 1 in 5, that is around 900,000 of the 4.5 million children currently diagnosed with ADHD have been misdiagnosed.

Like the researchers in the second study, Elder used kindergarten eligibility cutoff dates to distinguish between the youngest and the oldest kids in a grade. While this date differs among states in the US, the most commonly used one is that used by 15 states to rule that kids must be 5 years old on or before 1st September to be eligible for kindergarten.

He found the same definitive pattern both in the case of individual states and when he compared across states.

Michigan for example has a cutoff date of 1st December for kindergarten attendance. Elder found higher rates of diagnosed ADHD among Michigan kids born on 1st December than born on 2nd December. Those born on the 1st December would have been the youngest in their grade, while those born on the 2nd, just one day later, because of the cutoff date, would have enrolled a year later and therefore been among the oldest in their grade.

Elder remarked that even though these kids were only born a day apart, they were assessed differently because they were being compared with classmates of a different age set.

Looking across states, Elder gave the example of Illinois and Michigan. In Illinois, where the cutoff date for kindergarten is 1st September, August-born kids were more likely to have been diagnosed with ADHD than Michigan kids born in August of the same year.

Elder's study defined a diagnosis of ADHD as including evidence of multiple symptoms, including inattention and hyperactivity sustained for six months or more observed in two settings, for instance the home and school, before the age of seven.

Although a mental health professional performs the diagnosis, the opinions of teachers often influence whether a child is sent for evaluation in the first place, said Elder.

"Many ADHD diagnoses may be driven by teachers' perceptions of poor behavior among the youngest children in a kindergarten classroom," said Elder, but the "symptoms" that teachers perceive may "merely reflect emotional or intellectual immaturity among the youngest students".

ADHD is the most commonly diagnosed behavioral disorder for kids in the United States, and currently there are no neurological markers for ADHD (such as a blood test for example). Experts disagree on how common it is, hotting up public debate about whether it is under- or over-diagnosed, said Elder.

In the second paper, researchers at North Carolina (NC) State University, Notre Dame and the University of Minnesota drew very similar conclusions to those of Elder's study.

Co-author Dr Melinda Morrill, a research assistant professor of economics at NC State, told the press that:

"The question we asked was whether children who are relatively young compared to their classroom peers were more likely to be diagnosed with ADHD."

Morrill and colleagues looked at kids born just before the kindergarten eligibility cutoff date and those born shortly after and found large discrepancies in rates of ADHD diagnosis and treatment based on small differences in birth dates.

For the study they analyzed data from two national health surveys and a national database of private health insurance claims. The data covered several periods between 1996 and 2006.

They found that kids who were "relatively old-for-grade", that is those born just after the kindergarten cutoff date, were 25 per cent less likely to have received a diagnosis for ADHD than their the "relatively young-for-grade" peers, that is kids born just before the cutoff date.

As their premise was that children born a few days apart should have the same underlying risk of developing ADHD, finding a significant discrepancy based on small differences in age suggests the problem is inappropriate diagnosis, concluded the researchers.

"This indicates that there are children who are diagnosed (or not) because of something other than underlying biological or medical reasons," said Morrill.

"We believe that younger children may be mistakenly diagnosed as having ADHD, when in fact they are simply less mature," she added, drawing the same conclusion as Elder in the first study.

However, she wished to stress that their study is "not downplaying the existence or significance of ADHD in children".

"What our research shows is that similar students have significantly different diagnosis rates depending on when their birthday falls in relation to the school year," she pointed out.

"The importance of relative standards in ADHD diagnoses: Evidence based on exact birth dates." 
Todd E. Elder
Journal of Health Economics ,


"Measuring Inappropriate Medical Diagnosis and Treatment in Survey Data: The Case of ADHD among School-Age Children." 
William N. Evans, Melinda S. Morrill, Stephen T. Parente
Journal of Health Economics

 

Reporting the adverse drug reactions - vision disorders

REPORTING ADVERSE DRUG

REACTIONS

 

Definitions of Terms and Criteria for their Use

 

Vision Disorders

 

Introduction

 

The eye is a highly developed sense organ in which minimal impairment

can produce a substantial effect upon function. The field is difficult with

regard to ADR reporting, for many non-specific terms have to be used if

special methods of investigation are not available.

 

The following descriptors are unsatisfactory as clinical or ADR reporting

terms, and further development of this terminology is necessary.

 

Terms

 

Cataract

 

Cataracts may result from a number of processes and are mainly agerelated.

Cataract is responsible for about 35 per cent of cases of visual impairment and is one of the largest single causes of blindness world-wide. Cataracts usually progress slowly, but are frequently only detected when they reach a certain extent. Thus, even a ‘‘sudden appearance’’ could result from a pre-existing condition. Care should be taken in evaluating apparent association between these lesions and drug therapy. Symptoms may include glare, blurred vision, altered colour perception, change of

refraction, and monocular diplopia.

 

Definition

 

A cataract is a congenital or acquired lack of clarity of the lens.

Basic requirements for use of the term

Demonstration of lack of lens clarity, normally by ophthalmoscopy with

dilation of the pupil. For confirmation, characterization and localization

of a cataract, slit-lamp examination of the lens is usually required.

 

Keratitis

 

The term keratitis without qualification is undesirable in ADR reporting.

 

Keratitis may be caused by many factors, including physical exposure of

the cornea; bacterial, viral or fungal infection; toxic agents or foreignbodies; and local exposure of the eye to drugs or the concentration of drugs

in the lachrymal fluid. lt may be associated with decreased corneal

sensitivity.

 

Definition

 

The non-specific term keratitis is used to describe a wide variety of lesions

of the cornea.

 

Basic requirements for use of the term

 

The demonstration of corneal appearances satisfying the definition.

Specific terms describing the pathological nature of the lesion are to be

preferred.

 

 

Retinal disorder

 

Many retinal disorders, especially those of the macula, lead to visual

impairment, which may ultimately be irreversible. Drugs have been

implicated in a wide variety of retinal lesions. Macular lesions may include

degeneration, oedema, and pigmentary changes. Other retinal lesions may

include detachment, vascular disorders (e.g., hypertensive, diabetic, and

other forms of retinopathy) inflammation, haemorrhage, deposits,

degeneration, and pigmentary changes. An exact diagnosis should be

established whenever possible.

 

Definition

 

All abnormalities of the retina are included in the term retinal disorder.

Basic requirements for use of the term

Fundoscopy, usually with dilation of the pupil, is necessary.

 

Vision abnormal

 

The term vision abnormal is non-specific and therefore undesirable inADR

reporting. If the use of the term is unavoidable, then careful follow-up or

referral should be considered in order to establish a definitive diagnosis.

 

Definition

 

Vision abnormal is a change, usually a deterioration, in visual function or

perception.

 

Basic requirements for use of the term

 

A report of vision abnormal should lead to the establishment and reporting

of a specific diagnosis.

 

Vaccines reducing our immunity

9 Ways Vaccines Are Reducing Our Immunity 

1) Vaccines contain many chemicals and heavy metals, like mercury and aluminum, which are in-themselves immuno-suppressing. Mercury actually causes changes in the lymphocyte activity and decreases lymphocyte viability.

2) Vaccines contain foreign tissues and foreign DNA/RNA which act to suppress the immune system via graft-vs-host rejection phenomena.

3) Vaccines alter our t-cell helper/suppressor ratios ... just like those seen with AIDS. This ratio is a key indicator of a proper functioning immune system.

4) Vaccines alter the metabolic activity of PMNs and reduce their chemotaxic abilities. PMNs are our body’s defenses against pathogenic bacteria and viruses.

5) Vaccines suppress our immunity merely buy over-taxing our immune system with foreign material, heavy metals, pathogens and viruses. The heavy metals slow down our immune system, while the viruses set up shop to grow and divide. It is like being chained and handcuffed before swimming.

6) Vaccines clog our lymphatic system and lymph nodes with large protein molecules which have not been adequately broken down by our digestive processes, since vaccines by pass digestion with injections. This is why vaccines are linked to allergies, because they contain large proteins which as circulating immune complexes (CICs) or "klinkers" which cause our body to become allergic.

7) Vaccines deplete our body of vital immune-enhancing nutrients, like vitamin C, A and zinc, which are needed for a strong immune system. It is nutrients like these that primes our immune system, feeds the white blood cells and macrophages and allows them to function optimally.

8) Vaccines are neurotoxic and slow the level of nervous transmission, and communications to the brain and other tissues. Now we know that some lymphocytes communicate directly with the brain through a complex set of neurotransmitters. Altering these factors will also depress our immunity.

9) Vaccines suppress cellular immunity which occurs when vaccines are injected. Adjuvants include oil emulsions, mineral compounds (which may contain the heavy metal aluminum), bacterial products and liposomes (which allow delayed release of substances). The side effects of adjuvants themselves include hyperactivity of B cells leading to pathologic levels of antibody production, as well as allergic reaction to the adjuvants themselves.

Old age simple ways to defeat

Sometimes friends come to me with what they call “symptoms of old age.” But often they’re not symptoms at all. They’re side effects.

Here’s what I mean: Prescription drugs cause side effects that look a lot like “aging.”

Research shows some drugs cause major cellular damage. They attack the mitochondria, the tiny energy generators in each cell of your body.

Why is that important?

Damage to the mitochondria is related to many diseases we think of as occurring in the elderly. Alzheimer’s, Parkinson’s, coronary artery disease … even strokes and diabetes.

One of the reasons these synthetic, man-made molecules cause aging is that mitochondrial damage shortens telomeres.

Telomere shortening causes cells to go into repair mode to fix the shortened DNA. All that repair activity going on while your body tries to fix your DNA and damaged mitochondria generates a lot of free radicals. They cause oxidation, which can shorten telomeres more. And the cycle continues.

You can trace mitochondrial damage back to statins, pain medications like acetaminophen, and a long list of psychoactive drugs. These cross the blood–brain barrier and can age brain cells.

1) Other drugs directly shorten telomeres. Especially chemotherapy drugs. They also slow down the activity of telomerase, the enzyme that repairs telomeres.

2) Most doctors wouldn’t think to blame premature as a side effect of medical drugs. They are taught that becoming older and more feeble is normal. They might even prescribe another drug to treat your new “symptoms.”

How can you protect yourself?

Here are a few of the drugs that age your body the most, and what you can do as an alternative:

1) Corticosteroids: Worse than arthritis pain. Some of my least favorite drugs are corticosteroids, like the hydrocortisone cream your doctor might prescribe. This is a family of anti-inflammatory medicines many doctors use to treat arthritis, asthma or a skin rash.

These drugs turn off your body’s natural repair and rejuvenation mechanisms, causing you to age more quickly. Fortunately, there are alternatives.

For Asthma: Try daily breathing exercises, massage therapy, and omega-3 fatty acids.

For Arthritis: Guggul and meadowsweet relieve osteoarthritis. Guggul is a Southeast Asian remedy which studies showed to be highly effective in reducing the symptoms of osteoarthritis.3 Meadowsweet is a great example of why no matter how many times we think we’re smarter than nature, nature is better.

Meadowsweet stores its active anti-inflammatories as inactive compounds. So when you ingest them, they go past your stomach intact. Then your liver safely converts them into the healing inflammation-dousing compounds that really work.

For Eczema or Skin Rash: My patients report great results with vitamin D oil while others prefer chamomile oil. Both are very effective.

2) Beta blockers: Shortcut to old age. Lopressor, Tenormin, Inderal, Corgard, or Normodyne and other beta-blockers age your heart more than almost any other drug. And in a recent study people who received beta blockers after having surgery that wasn’t even heart-related were at higher risk of dying or having a stroke.4

Here’s what you need instead:

CoQ10: This is my go-to supplement for my heart patients. It is the most important heart nutrient. Half of my patients have their blood pressure return to normal with CoQ10 alone. And it cures congestive heart failure.

Garlic: This herb not only reduces triglycerides, which protects your heart, but it can also significantly reduce diastolic blood pressure.6
Hawthorn: This is the heart tonic of the ancients and it really works to relax the blood vessels.

3) Bisphosphonates: Perfect way to create old brittle bones. The bone drugs like Fosamax, Actonel and Reclast work by poisoning the cells that remove old bone. This disrupts natural bone remodeling so you get bones that are denser, but have weaker cells. If you take these drugs, your bones get more brittle and more prone to fracture, not stronger.

Before you take a bone drug, consider these natural alternatives that will harden your bones:

Natural D: The D3 form of vitamin D is the hormone that directs bone building in your body. Vitamin D also increases telomerase, the enzyme that lengthens telomeres.7 Get 5,000 IU a day, preferably from direct sunlight.

Vitamin K2: This forgotten vitamin aids with your bones’ absorption of calcium to help make them stronger. The other benefit of vitamin K2 is that it rescues damaged mitochondria and cures mitochondrial dysfunction.8 This helps prevent telomere shortening. You can find K2 in a variety of different foods including egg yolks, organ meat, and organic milk. I recommend 90 mcg a day if you supplement.