More on the "Right To Try" in Australia and Albanese's MAD Bill of Censorship

And the regulators who prevent you accessing life saving natural and naturally derived and repurposed medicines.

More on the "Right To Try" in Australia and Albanese's MAD Bill of Censorship

The concept of the "Right to Try" has gained traction globally as a framework allowing patients with terminal illnesses or debilitating conditions to access unapproved treatments. This movement is driven by the belief that individuals should have the autonomy to make choices about their health care, especially when conventional treatments have failed. In Australia, the dialogue surrounding the "Right to Try" has been rekindled amid discussions about legislative reforms and patient rights.

Australia's approach to the "Right to Try" has evolved, with advocates urging for more flexibility in accessing experimental therapies. The Therapeutic Goods Administration (TGA) has made a few strides toward improving access to unapproved medications, primarily through its Special Access Scheme. This allows practitioners to request access to unregistered therapeutic goods for patients in need.

However, the framework remains complex and often discouraging for patients seeking alternative treatment options. I argue that the current regulatory environment can be overly restrictive, preventing timely access to potentially life-saving treatments. This is particularly poignant for patients battling aggressive cancers or rare diseases, where standard therapies may not suffice.

Efforts to broaden access are further complicated by concerns over safety and efficacy. While the "Right to Try" advocates for patient autonomy, it also raises questions about the ethical implications of allowing access to treatments that lack rigorous clinical validation. Proponents emphasize the need for a balanced approach that protects patients while providing them with options when faced with dire circumstances.

Albanese's MAD Bill of Censorship

In parallel with discussions about the "Right to Try," the Albanese government has introduced the ‘Media Accountability and Diversity (MAD) Bill’. This legislation aims to enhance accountability among media organizations and promote diversity in the media landscape. However, critics I label it a censorship bill. It will stifle dissenting voices and restrict free expression to the point of that of a totalitarian state.

The MAD Bill proposes mechanisms that will lead to stricter regulation of media content and will empower authorities to monitor and control information dissemination. This has raised alarms among civil liberties groups and free speech advocates, who argue that the legislation could infringe upon journalistic independence and the public's right to access diverse viewpoints.

The introduction of this bill has sparked a fierce debate within Australia about the balance between media regulation and freedom of speech. While the government argues that the bill is necessary to combat misinformation and hold media entities accountable, detractors worry that it could lead to an environment where dissenting opinions are silenced. We in the medical profession were shut down during covid, unable to offer proven treatments and forced to comply with supporting the toxic vaccines. Without the freedom to speak, we will live in a state of fear and that eventually becomes a state of totalitarianism.

I say NO to Albanese’s attempts to control Freedom of Speech. This Bill should never have been thought of; not in an open democracy. Those who support it should go and live in North Korea, China, Iran or Russia, where they will own nothing but be happy because they also won’t have to think. So here we go with our Right To Try………..

The Use of Repurposed Medicines

The Use of Repurposed Medicines in the Context of "The Right to Try" in Australia

In addition to alternative, complementary, integrative, and nutritional medicines, the concept of "The Right to Try" in Australia also applies to repurposed medicines—drugs originally developed and approved for one condition but found to have potential benefits for treating other diseases. For seriously ill or terminally ill patients, the use of repurposed drugs represents a valuable treatment option, especially when conventional therapies have failed. This approach is gaining momentum in medical research and practice as scientists and clinicians identify new applications for existing drugs with established safety profiles.

Repurposing medicines adds another layer to the broader debate about patient rights, medical innovation, and regulatory oversight.

Repurposed medicines offer healthcare practitioners an additional option when traditional therapies have failed. Since these drugs have already been approved for use in other conditions, their safety profiles are generally well-understood, making them a potentially safer and faster alternative compared to experimental drugs that are still in clinical trials. For example, drugs like metformin, originally developed for diabetes, have shown promise in cancer treatment, while certain anti-inflammatory medications have been explored for their potential in treating Alzheimer's disease.

For practitioners, the ethical challenge lies in balancing hope with scientific evidence. The use of repurposed medicines often rests on preliminary data, off-label usage, or anecdotal reports, which may not have undergone the rigorous testing required for full approval for a new indication. Nonetheless, seriously or terminally ill patients may view these treatments as offering hope where conventional medicine offers none.

The ethical principle of beneficence—acting in the patient’s best interests—could support the use of repurposed medicines if there is reasonable evidence suggesting that the treatment may help improve quality of life or survival. However, the ethical principle of non-maleficence (do no harm) remains a concern, particularly when robust clinical trials are lacking. Healthcare practitioners must ensure that patients are fully informed of the risks, benefits, and uncertainties surrounding the use of repurposed drugs.

The moral tension between offering hope and adhering to evidence-based medicine becomes acute in these scenarios. While repurposed drugs offer potential, their use without conclusive evidence can challenge the healthcare provider's responsibility to base decisions on sound medical data.

Medical Regulators and the Challenge of Repurposed Medicines

For regulators like the Therapeutic Goods Administration (TGA) in Australia, the use of repurposed medicines represents both an opportunity and a challenge. Regulatory bodies have a duty to ensure that all medicines used in healthcare meet stringent standards of efficacy, safety, and quality. However, in the case of repurposed drugs, the regulatory framework can be less clear, especially when these medicines are being prescribed for off-label uses that have not yet been fully investigated in clinical trials.

One of the ethical dilemmas faced by regulators is balancing the need for rigorous scientific validation against the urgency of providing options for terminally ill patients. Denying access to repurposed medicines based on the absence of large-scale clinical trials can be seen as overly restrictive, particularly when patients have no other viable options. In contrast, allowing widespread off-label use without sufficient training and experience could expose patients to ineffective or harmful treatments, undermining public trust in the health system.

Regulatory allowances for compassionate use and expanded access could help navigate this ethical landscape. By allowing the use of repurposed drugs under the right conditions such as doctor training, regulators can respect patient autonomy and offer hope, while still maintaining safeguards to ensure that patients are not exposed to undue harm. The TGA has mechanisms in place for doctors to prescribe unapproved or off-label medicines, including those that are repurposed, under the Special Access Scheme. However, the approval process is often slow, and the availability of these medicines can be limited, particularly in the case of novel treatments for rare diseases or late-stage conditions. Most repurposed medicines in use by integrative doctors in Australia are readily available.

From a societal perspective, the use of repurposed medicines raises important questions about the balance between innovation and public health. Many people believe that seriously ill and terminally ill patients should be given the right to try any treatment that might offer them a chance at recovery or improved quality of life, even if the evidence is not yet conclusive. This belief is grounded in the moral principle of autonomy—the right of individuals to make decisions about their own healthcare.

At the same time, society has a vested interest in ensuring that treatments are both safe and effective. The widespread use of repurposed medicines without sufficient oversight could lead to unintended consequences, such as drug shortages, misuse, or the diversion of resources away from more promising treatments. Moreover, allowing repurposed medicines to be prescribed based on anecdotal or preliminary evidence can undermine the integrity of evidence-based medicine, potentially eroding public trust in healthcare systems.

Repurposed medicines have the potential to offer significant benefits to society as a whole. By using existing drugs for new indications, healthcare systems can save time and resources that would otherwise be spent on developing entirely new treatments. This can be particularly valuable in the context of rare diseases or conditions with limited treatment options. Furthermore, repurposing drugs that are already widely available and affordable can help reduce healthcare costs and increase access to treatments for vulnerable populations.

The inclusion of repurposed medicines in the broader debate on "The Right to Try" in Australia brings additional ethical complexity. For healthcare practitioners, repurposed drugs offer hope for patients with limited options but raise concerns about the sufficiency of evidence. Medical regulators face the challenge of balancing patient access to innovative treatments with the need to uphold rigorous standards of safety and efficacy. Society, meanwhile, must weigh the moral imperative to offer hope and dignity to terminally ill patients against the potential risks of widespread, unregulated use of repurposed medicines.

Ultimately, the ethical use of repurposed medicines requires a nuanced approach that respects patient autonomy while ensuring that treatments are grounded in sound scientific evidence. The path forward involves strengthening regulatory frameworks for compassionate use, promoting ethical healthcare practices, and fostering a societal commitment to innovation, compassion, and patient safety.

References

1. Therapeutic Goods Administration (TGA). "Accessing Unapproved Therapeutic Goods." Australian Government, Department of Health, 2021https://www.tga.gov.au/accessing-unapproved-therapeutic-goods

2. Pushpakom, Sudeep, et al. "Drug Repurposing: Progress, Challenges and Recommendations." Nature Reviews Drug Discovery, vol. 18, no. 1, 2019, pp. 41–58.

https://www.nature.com/articles/nrd.2018.168

3. Breckenridge, Andrew, and James C. Aronson* "Unapproved and Off-Label Uses of Drugs: Principles for Ethical Use." BMJ, 2020.

  https://www.bmj.com/content/371/bmj.m4221

4. Croghan, Caitlin, et al. "Repurposing Medicines in Oncology: The Ethical and Clinical Implications." The Lancet Oncology, 2022.

   https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00345-6/fulltext

5. Emanuel, Ezekiel J. "Compassionate Use of Experimental and Repurposed Drugs. New England Journal of Medicine, vol. 379, no. 25, 2018, pp. 2463–2466.

https://www.nejm.org/doi/full/10.1056/NEJMp1812981

The Role of Nutraceuticals and Herbal Medicines

The Role of Nutraceuticals and Herbal Medicines in "The Right to Try" in Australia

In the context of "The Right to Try," nutraceuticals (such as vitamins, minerals, amino acids, essential fatty acids, and trace elements) and herbal medicines represent another vital treatment option for seriously ill and terminally ill patients. While these substances are often considered part of complementary and alternative medicine, they have attracted increasing scientific attention due to their potential therapeutic benefits. Nutraceuticals and herbal medicines offer patients a non-invasive and natural approach to improve their prognosis, manage symptoms, or enhance their quality of life and death, especially when conventional therapies are limited.

Healthcare Practitioners and Nutraceuticals: Balancing Tradition and Science

For healthcare practitioners, nutraceuticals and herbal medicines pose a complex ethical challenge. While these therapies have been used for centuries in various traditional medicine systems, modern Western medicine places a strong emphasis on evidence-based practice, which requires treatments to undergo rigorous clinical trials before being recommended to patients. This creates a tension between the scientific community’s demand for proof and the patient’s right to try therapies that have not yet been fully validated.

Many nutraceuticals, such as omega-3 fatty acids, vitamin D, magnesium, and coenzyme Q10, have been shown to have beneficial effects in chronic illnesses, including cardiovascular disease, cancer, and neurodegenerative disorders. Likewise, certain herbal medicines, such as curcumin (from turmeric), milk thistle, and ginseng, have demonstrated anti-inflammatory, antioxidant, and immune-modulating properties. However, the evidence supporting their use in terminal illness is often incomplete, and their therapeutic effects may vary widely depending on factors such as dosage, bioavailability, and individual patient characteristics.

For healthcare practitioners, the ethical principle of ‘autonomy’—respecting the patient's right to make full, free and informed decisions about their care—is crucial in this context. Patients facing terminal illnesses may choose to explore nutraceuticals and herbal medicines as part of their treatment strategy, even if the evidence is not fully conclusive. From the practitioner’s perspective, supporting these decisions ethically requires transparency about the potential benefits and limitations of these therapies, as well as clear communication about the lack of robust clinical evidence in some cases.

At the same time, the principle of ‘non-maleficence’ (doing no harm) remains paramount. Many nutraceuticals and herbal medicines are generally considered safe when used appropriately, but interactions with other medications or underlying health conditions could pose risks. Healthcare providers must carefully assess the safety profile of any nutraceutical or herbal medicine before recommending its use to ensure that the potential for harm is minimised.

Medical Regulators and Nutraceuticals: Striking a Balance Between Safety and Innovation

Medical regulators, such as the Therapeutic Goods Administration (TGA) in Australia, play a critical role in overseeing the safety and efficacy of all health products, including nutraceuticals and herbal medicines. Unlike conventional pharmaceuticals, which are subject to stringent clinical trials and approval processes, nutraceuticals and herbal remedies are often classified as complementary medicines. This classification allows them to be sold over-the-counter with fewer regulatory hurdles, but it also means that they may not undergo the same level of scientific scrutiny as prescription drugs.

One of the ethical challenges for regulators is finding the right balance between ensuring patient safety and allowing access to alternative therapies. While nutraceuticals and herbal medicines are generally viewed as low-risk, they are not without potential complications, especially when used in high doses or in combination with other treatments. For example, some herbal medicines, such as St. John’s Wort, can interfere with the metabolism of conventional drugs, leading to reduced efficacy or increased toxicity.

The TGA has mechanisms in place to regulate complementary medicines, ensuring that products meet safety standards and are appropriately labeled. However, the level of scientific evidence required for these products is often lower than that for conventional medicines, which raises ethical concerns about whether patients are fully informed of the limitations of these therapies. For terminally ill patients, the desire to try any treatment that offers hope may outweigh concerns about scientific validation, but regulators have a moral obligation to protect patients from misleading claims or unsafe products.

One possible solution is for regulators to create a specific framework for the use of nutraceuticals and herbal medicines in seriously ill or terminally ill patients, similar to compassionate use programs for experimental drugs. This would allow patients to access these treatments under the supervision of healthcare providers while ensuring that safety and efficacy are carefully monitored.

Societal Perspectives on Nutraceuticals and Herbal Medicines

Societal attitudes toward nutraceuticals and herbal medicines are generally positive, with many people viewing these therapies as natural and therefore safer alternatives to conventional drugs. In Australia, a significant portion of the population regularly uses supplements and herbal remedies, either as part of a wellness regimen or to manage specific health conditions. This cultural acceptance of alternative therapies supports the argument that terminally ill patients should have the right to try these treatments, particularly when conventional options have been exhausted.

From an ethical perspective, society’s support for the use of nutraceuticals and herbal medicines in seriously ill patients is rooted in the principles of ‘autonomy’ and ‘compassion’. People generally believe that patients facing the end of life should have the freedom to explore all available options to improve their quality of life, even if those options are not fully validated by scientific research. This belief aligns with the moral imperative to respect individual choice and to offer hope in the face of terminal illness.

However, there are also concerns about the commercialisation of nutraceuticals and herbal medicines, particularly when companies make exaggerated or unproven claims about their efficacy. Vulnerable patients may be susceptible to marketing tactics that promise miraculous cures, leading them to spend significant amounts of money on treatments that may have little or no benefit. This raises ethical questions about the role of consumer protection in the nutraceuticals industry and whether stricter regulations are needed to prevent the exploitation of seriously ill patients.

To address these concerns, society may need to advocate for stronger oversight of the marketing and labelling of nutraceuticals and herbal medicines, ensuring that patients are not misled by unfounded claims. At the same time, there should be greater support for research into the potential therapeutic benefits of these substances, so that patients can make informed decisions based on reliable evidence.

Expanding "The Right to Try" to Include Nutraceuticals and Herbal Medicines

Expanding the "Right to Try" framework in Australia to explicitly include nutraceuticals and herbal medicines would recognise the growing interest in these therapies and provide a formal mechanism for their use in seriously ill and terminally ill patients. Such an expansion would require the development of guidelines to ensure that patients receive appropriate counselling and oversight from healthcare providers when using these treatments.

Healthcare practitioners could play a key role in helping patients navigate the often-confusing landscape of alternative therapies, providing evidence-based advice on the potential risks and benefits of nutraceuticals and herbal medicines. This would also involve educating patients about possible interactions with conventional treatments and ensuring that their use of alternative therapies is integrated into a comprehensive care plan.

For medical regulators, expanding "The Right to Try" to include nutraceuticals and herbal medicines would involve creating a regulatory pathway that allows for compassionate use while maintaining safety standards. This could include post-market surveillance to monitor adverse effects and real-world data collection to evaluate the effectiveness of these treatments in seriously ill patients.

Nutraceuticals and herbal medicines offer an important, if sometimes controversial, option for seriously ill and terminally ill patients under the "Right to Try" framework. While these therapies may not have the same level of scientific validation as conventional drugs, they represent a potentially low-risk and accessible option for improving quality of life and symptom management in patients facing terminal illness.

Healthcare practitioners, medical regulators, and society all have a role to play in ensuring that nutraceuticals and herbal medicines are used responsibly and ethically. By promoting transparency, patient education, and research into the therapeutic potential of these substances, Australia can create a healthcare system that respects patient autonomy while upholding safety and evidence-based practice.

Expanding "The Right to Try" to include nutraceuticals and herbal medicines would recognise the evolving landscape of healthcare and offer terminally ill patients more options to manage their condition. With proper regulatory oversight and ethical guidance, these treatments can become a valuable part of compassionate end-of-life care.

1. Therapeutic Goods Administration (TGA). "Regulation of Complementary Medicines in Australia." Australian Government, Department of Health, 2022.

   https://www.tga.gov.au/regulation-complementary-medicines-australia

2. Sarris, Jerome, et al. "Nutraceuticals in Psychiatry: A Review of Evidence and Recommendations.” The Lancet Psychiatry, vol. 3, no. 4, 2016, pp. 398-412.

https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(16)00024-0/fulltext

3. Gulati, Om P. "Nutraceuticals: Emerging Trends in Regulation and Research." Current Pharmaceutical Biotechnology, vol. 17, no. 4, 2016, pp. 303-310.

   https://www.eurekaselect.com/141642/article

4. Barnes, Joanne, et al. "Herbal Medicines: Beneficial or Risky?" *Pharmacology & Therapeutics*, vol. 139, no. 2, 2013, pp. 222-228.

   https://www.sciencedirect.com/science/article/abs/pii/S0163725813000675

5. Heger, Matthias, et al. "Challenges and Advances in the Use of Herbal Medicines for Cancer." *Frontiers in Pharmacology*, vol. 10, 2019.

   https://www.frontiersin.org/articles/10.3389/fphar.2019.00592/full

Ian Brighthope