To the Honorable President and Members of the Senate in Parliament Assembled
Your Petitioners ask the Senate
The petition of the undersigned shows:
- The World Health Organization has identified that unsafe medicines are a major worldwide issue and has announced Medication Without Harm is their current major patient safety initiative.
- Numerous American, British and Australian studies repeatedly show unsafe medicines to be amongst the top 4 causes of death and disability.
- Current Australian prescribing guidelines adopt a “one size fits all” model and assume that a person takes one medicine.
- Current practices do not consider how an individual person will respond to the medicine before prescribing them. The only way to consider the individual is through pharmacogenomic testing.
- The branch of medicine that predicts an individual’s response to a medicine is called pharmacogenomics.
- An individual’s genes (and particularly four key genes – CYP2D6, CYP2C19, CYP2C9, and CYP3A4) determine how an individual will respond to medicines.
- These four genes process approximately 80% of all medicines.
- They are highly variable between people including specific ethnic groups. Therefore drug response varies significantly.
- Around 10% of Caucasians are at severe risk of hospitalization, death, and disability if given the "average" dose of certain medicines. 40% need a higher or lower dose to get the desired effects.
- In other ethnic groups including Asian, Pacific Islanders, and Africans, the risk is significantly higher. Approximately 70% (rather than 10%) are at risk if given the "average" dose. The pharmacogenomic makeup of descendants of aboriginal persons is currently subject to a detailed study.
- Pharmacogenomic testing enables a doctor to know before prescribing medicine how that person is likely to respond to them and to take the guesswork out of the selection of the medicine and dose.
- Pharmacogenomics has a life-long application, applies to all medicines a person will take over their lifetime, and does not predict any other aspect of a patient’s health.
- The implementation of pharmacogenomics in Australia lags behind the science and world’s best practice.
- The central tenant of the ethical practice of medicine is to do no harm.
- We consider it to be unethical to prescribe certain medicines without pharmacogenomic testing as to do so exposes the person to a high risk of avoidable harm.
- A key platform of the Australian Government’s long-term reform is "Precision Medicine”. Precision medicine focuses on disease prevention and early intervention, particularly through pre-medication.
- Whilst this initiative will consider pharmacogenomics it does not meet the consumer’s needs for safe medicines as it fails to address all the medicines a person may take over their life.
- For example, in June 2018, the Therapeutic Goods Administration issued a warning, that a significant number of medications cause severe adverse reactions including suicide. These medications are not linked to disease processes, including anti-depressants, attention deficit hyperactivity disorder medications, seasonal allergy medicines, smoking cessation medicines, and acne medicines.
- Furthermore, we should be implementing pharmacogenomic science now. There are actionable recommendations for pharmacogenomics now that will not be altered by precision medicine, and precision medicine still carries considerable scientific and ethical challenges.
- Continuing to delaying the implementation of pharmacogenomics even further puts lives at risk whilst waiting for the science around precision medicine to catch up. It puts the science of medicine before the safety of people.
- Australian's are dying and becoming disabled whilst waiting for the precision medicine science to catch up.
- First, do no harm. Then implement precision medicine. Our lives matter.
Your petitioners ask that:
- Pharmacogenomic testing is subsidized by Medicare to remove the barriers of access so that individuals can protect themselves and their families from avoidable iatrogenic harm.
The National Health and Medical Research Council conduct a review, independent of entrenched political interests, of:
- The International Guidelines and Recommendations of the Pharmacogenetic Working Group of the Royal Dutch Association for the Advancement of Pharmacy (DPWG) and the Clinical Pharmacogenetics Implementation Consortium (CPIC),
- The American Food and Drug Administration’s black box warnings and pharmacogenomic labeling inclusions, and
- Provide detailed recommendations to implement these into the Australian prescribing and regulatory system, without delay, and independent of precision medicine.
- The Medical Research Future Fund prioritize funding and research to improve gaps (if any) in knowledge identified by The National Health and Medical Research Council Review.
- NPS MedicineWise prioritizes a health professional and consumer awareness campaign on pharmacogenomics.