Deaths from prescription medications each year exceed deaths from car accidents.
ABS data shows that prescription medications take over 1,500 lives annually and the number continues to climb year on year.
Prescribed Deaths - Life in the Killing Zone is a lived experience report on the Australian healthcare system, that details multiple systemic issues and how they are costing lives every day.
Award-winning ABC journalist Lorna Knowles has presented key parts of the research on the ABC 7.30 Report and in online stories in 2021.
The report exposes how lethal risks and side effects have been illegally witheld from PBS medication warnings given to Australians by pharmaceutical companies since 1999.
The TGA has also been exposed as facilitating this practice, by refusing to review and approve the warnings.
The Prescribed Deaths report details how the exact risks not disclosed in the consumer warnings are directly linked to the majority of Australia’s prescription medication hospitalisations and deaths since 1999. The cause and effect are unequivocal.
By providing PBS support for these medications and endorsing the medication warnings, the Australian Government funds the cause of death for hundreds of Australians each year, without warning them of this very risk.
Isaac Samuel Reis (1997 - 2019)
Isaac Samuel Reis aged 14
On the 18th of August 2019, Isaac Samuel Reis died after taking medications prescribed to him by his GP and psychiatrist and dispensed by his usual pharmacists. Benzodiazepines, opioids, codeine, antidepressants, antipsychotics and gabapentinoids are the leading drugs found in accidental drug deaths each year in Australia.
Isaac was prescribed drugs from each of these lethal prescription medication classes, all at the same time, they combined to end his life at the age of 22. Not one health care professional warned Isaac of the risk of death, nor was there any information on these lethal risks in the medication warnings from the TGA.
In 2019 the Queensland Coroner ruled the cause of death was the combination of these medications, exacerbated by his health conditions (known to his doctors and pharmacist). Isaac’s death was not deemed intentional, he took the medications as instructed, and he did not take any alcohol or illegal substances.
Isaac died because he followed the advice of his doctors, pharmacists and the TGA.
His death is currently being investigated by the Queensland Coroners Court. To prescribe and dispense these medications without warning Isaac and his carers (his parents) of the risk of death is indescribably abhorrent. Tragically, that is what happened, and his family deserve answers and accountability. Isaac’s story is featured on the 7.30 report in May 2021.
On the day of the story AHPRA released their findings into the investigation of the prescribing of Isaac’s GP, Dr Kamalaruban Ratnam. The Medical Board of Australia found that the way that Dr Ratnam practises the profession is unsatisfactory. They have imposed a number of conditions on his registration that includes undergoing training on the prescribing of opiates and benzodiazepines, the management of patients seeking or requiring high levels of pain medication, and effective patient medical record keeping.
This information is available by using the search engine for Dr Kamalaruban Ratnam on the AHPRA website or a PDF of the page can be downloaded here.
Consumer Medicine Information (CMI) - deadly failures
The Consumer Medicine Information (CMI) is the Australian Government endorsed warning document that lists the serious risks and potential adverse effects of taking a relevant medication, as well as any dangerous side effects it has when combined with other medications and alcohol. Millions of Australians each day place their lives in the hands of the information in these documents.
Pharmaceutical companies including Pfizer, have illegally excluded deadly side effects from Australian CMIs, for over 20 years, yet these risks are present in the comparable US consumer warnings for the same medications made by the same companies.
What are the risks not included in the CMIs?
With the assistance of doctors from Harvard and Yale universities, the Prescribed Deaths report details how side effects relating to death, coma, respiratory depression, addiction, overdose, abuse, withdrawal symptoms, dependence and pregnancy have been deliberately withheld from Australians. It has been happening since CMIs began in 1999 and continues today unchallenged by the TGA.
Australian Human Rights Commission
In February 2021 the TGA replied to a complaint lodged by the Australian Human Rights Commission on behalf of Patrick O’Connor. In this reply the TGA has admitted that the entire content of each CMI is left solely up to the pharmaceutical companies. They have complete discretion as to what risks and side effects they include and what they leave out.
The TGA has also admitted that they have no process to read, review or approve each CMI. They do not regulate them on an ongoing basis, and they do not take action against the pharmaceutical companies for any regulation breaches.
TGA regulations state all lethal side effects must be included in a CMI, in easy to read language. However the Prescribed Death report shows that these warnings have not been included in thousands of CMIs and the TGA has never taken any action to investigate, fine or regulate the pharmaceutical companies.
What is worse is that the TGA’s position is not known to the Australian public, in fact, the CMIs are stored on the TGA website and App, which tragically misleads people into thinking the TGA has reviewed the CMIs for accuracy and that they are approved documents.
The Australian Government endorses the CMI as the information source for accurate medication safety and side effects, including prescription medication interactions. The law of informed consent means that a person has a right to be informed of all the risks and benefits of a medication. Australians rely on CMIs to detail all of the known risks.
Patrick O’Connor – Author Prescribed Deaths
Based on the information they receive, they will choose to proceed with taking the medication, fully aware of the risks. For the consent to be valid, it has to be informed. This includes when multiple medications are prescribed. Informed consent is also required again, anytime a new medication is added or a dose changed.
Simply put, vulnerable people cannot consent to risks they have never been told, nor follow mediation safety advice if it has not been provided. The failure of the TGA and the Department of Health to uphold this legal right has resulted in the deaths of thousands of vulnerable people. It must end with this report.
“The greatest dangers exist when multiple medications are prescribed at the same time. For example, patients taking Benzodiazepines like Valium and Opioids like Endone together have a 15-fold increase in the risk of death compared to patients taking neither medicine.”
- Babalonis and Walsh, International Association for the Study of Pain
… these are all very dangerous drugs, reading these Australian warnings, I am very disturbed that patients haven’t been warned upfront, they haven’t been warned adequately, and they haven’t been warned enough.”
Dr Lori Calabrese, US psychiatrist and medication expert
Specific medication risks and warnings
The TGA MedSearch app enables Australians to view both the CMI and the PI on an Australian Government Department of Health app. The PI (product information) is written by the pharmacuetical companies for healthcare professionals, research shows that these documents do include all the lethal warnings.
Users can compare the risks provided in the PI that are not included in the CMI.
ScriptWise is dedicated to increasing awareness and understanding about the harms associated with prescription medication use.
The ScriptWise awareness online toolkits include resources on prescription benzodiazepines, opioids and the combined use.
“… people with mental illness typically live between 10 and 32 years less than the general population.”
The Royal Australian and New Zealand College of Psychiatrists (RANZCP)
About this report
Prescribed Deaths – Life in the Killing Zone offers a detailed, holistic and wide-ranging assessment of the Australian mental health care sector. The report contains honest opinions and critical examinations of the end-to-end treatment experience for those living with severe mental illness. These conclusions are backed by multiple research references from reputable sources.
The research and findings provide an integration of lived experience, detailed investigations, expert opinions, and matters of public health concern.
The author of this report, Patrick O’Connor, has been an advocate for reform in mental illness support services over many years. As a person with lived experience of the issues facing millions of Australians, public interest is at the forefront of the author’s intent.
All statements made in the report are presented as critical examinations of the topic. There is no malice intended and the strength of language used in the report is designed to maximise the education and awareness of critical safety failures, with the goal to warn other Australians.
By investigating government policy and legislation, the report provides a link between systemic healthcare failures and the legal implications of these failures. The author provides these assessments as a complaint to multiple organisations with the responsibility to uphold these legal standards.
The author has no conflicts to disclose at the time of publication. The preparation of the entire report and all travel and associated costs have been funded by the author. No government or third‑party funds or donations have been received nor requested. Further to this, donations post‑release will not be accepted.
The author would also like to strongly note that the report has not been produced for commercial benefit. The report is available electronically at no cost. Access is not limited and provided on an ongoing full access commitment. The only cost you may incur is if you choose to purchase a hard copy through a publication organisation.
Any potential litigation or claims for compensation by people with lived experience against organisations assessed in this report will have no financial interest to the author or any entity the author is associated with. This is a lived experience report, provided for free for the primary purpose of bringing urgent attention to physical risks that Australians are exposed to every day, without warning.
All interviewees provided their time and opinion at no cost. They neither requested nor were offered any remuneration for their services. Their personal disclosures can be obtained from their organisational websites.
All recorded interviews were undertaken whilst asking questions for the sole purpose of obtaining medication safety information. No information was requested that did not relate directly to the topics examined in this report. Any information that has not been included relates to personal information that does not meet the purpose of the report and would breach the commitment to confidentiality.
Prior to the publication of this report, the author has on multiple occasions provided, or attempted to provide, the information in this report to organisations including the National Mental Health Commission (NMHC), Australian Government Department of Treasury, Australian Government Department of Health, Beyond Blue, Orygen/Headspace, and the Black Dog Institute. Feedback has been provided to individual pharmacies around Australia on multiple occasions, with no evidence of changed dispensing practices. The universal lack of any interest in understanding the information provided or offered to these organisations has necessitated the publication of this report. While the author attempted to warn numerous parties in the Australian healthcare system, he failed to obtain any engagement from these parties.
Further reports are in production and are expected to be published after a period of public feedback following the release of this report. Any modifications to this report will be included in the document available on this website.