The Helsinki Declaration and Off-Label Drug Use

The Helsinki Declaration, primarily aimed at clinical research and trials involving human subjects, also offers guidelines for the use of unproven treatments in clinical practice. These guidelines help doctors provide potential treatment opportunities ethically when no other effective options are known.

Specifically, the Declaration includes guidance on individual medical actions, particularly in its section on "unproven interventions." It states that, in the absence of standard interventions or after these have been exhausted, doctors may use unproven interventions with the informed consent of the patient or their legal representative, provided these measures are likely to save life, restore health, or alleviate suffering. This is based on the professional judgment of the doctor and usually under the advice of experts.

This part of the Declaration reflects a comprehensive consideration of medical ethics, extending beyond the scope of clinical trials to everyday medical practice. This helps ensure the protection of patient rights while also promoting the exploration and use of new treatments by doctors under ethical principles.

SpaceX has disrupted traditional rocket launch models by successfully developing reusable rockets, significantly reducing costs and increasing the scale of spacecraft launches. Similarly, while traditional cancer treatment models are hard to break, we can choose uncommon but potentially more suitable treatments for cancer patients' long-term goals within the existing medical system. For example, unproven interventions represent a chance to break away from traditional cancer treatment models using individual initiative. When a patient feels that existing cancer treatments are ineffective, they should also have the capability to explore unproven interventions. In large hospitals, various factors, especially professional risks, make it difficult for doctors to adopt unproven interventions; however, in smaller hospitals, there may be more opportunities to implement such treatments.

The most common form of unproven intervention is likely the off-label use of drugs. In the current medical system, completely unproven interventions are rare. In reality, some small hospitals openly specialize in off-label treatments for cancer patients. For instance, in China, a renowned professor named Baofa established three small hospitals named Baofa Hospitals in Shandong and Beijing, which openly promote a cancer treatment method involving intratumoral injection of chemotherapy drugs, attracting thousands of treatment cases from multiple countries. Intratumoral injection of chemotherapy drugs is an interesting idea to reduce the systemic side effects of chemotherapy drugs without sacrificing their inhibitory rate. Additionally, the resistance to chemotherapy drugs and the sustainability of intratumoral injections are good treatment ideas, and the convenience has significantly improved with medical technology advancements. The biggest challenge with intratumoral injection of chemotherapy drugs is how to keep the drugs in the tumor long enough to maximize their cytotoxic effects on cancer cells. According to Baofa Hospitals, they use a slow-release technology to affect the action of chemotherapy drugs.

In the United States, similar small hospitals are dedicated to an off-label use of anticancer drugs. Williams Cancer Institute, with three cancer centers in Mexico and the United States, uses a combination therapy of tumor ablation and intratumoral injection of immunotherapy drugs to treat cancer patients. Previously, immunotherapy drugs like PD-1 needed to be administered intravenously, which would distribute throughout the body. However, by combining tumor ablation technology with direct injection of immunotherapy drugs into the tumor, it is said to enhance the effect of the immunotherapy drugs. Tumor ablation releases antigens, and combined with immunotherapy drugs, it can increase the inhibition rate while reducing costs, as PD-1 drugs are particularly expensive and their systemic use could be wasteful.

Based on our cancer model, the off-label treatment approaches of these two hospitals maximize the long-term effects of existing cancer drugs, aligning well with our first principles. There might be many other small hospitals adopting various unproven interventions, and with today's advanced information, cancer patients who have learned our first principles of cancer treatment can easily discover such new therapies.

Just as in selecting the best therapy methods in the NCCN guidelines, under the protection of the Helsinki Declaration, cancer patients can incorporate these off-label treatment methods into their options. Using a five-factor scoring method, all options are evaluated together, and the cancer treatment plan with the highest weighted average score is selected. If the final choice is an off-label treatment method, one must first reject the original doctor and proceed alone to a small private hospital for treatment. Since visiting a private small hospital might not be covered by insurance, this factor needs to be incorporated into the five-factor evaluation method and may require reassessment. For example, in the United States, the cost of cancer treatment not covered by medical insurance could reach as high as $100,000. Conversely, if choosing to undergo off-label drug treatment at a hospital in China, the expense might be only $10,000.

Today, my intratumoral chlorine dioxide injection therapy is offered as an alternative treatment in Germany, Mexico, Brazil, and the Philippines, which aligns appropriately with the Declaration of Helsinki. This is because the top priority for cancer patients is the rapid reduction of tumors, especially with minimal side effects. Currently, only my therapy can meet the patients' goal of quickly shrinking tumors.