The “Right To Try”
Segment #427
The thing here is that the consumer thinks they can feel secure knowing he or she has a final shot with the Right to Try Act, which really is just a con job. Why .. because your drug, protocols, or procedures must first qualify for inclusion on an approved list. How do you qualify.?. You must have completed a Phase 1 trial which is funded by the FDA or BIg Pharm. Oh by the way half the FDA’s budget comes from usage fees from Big Pharm. So what does this mean? It means its not happening in the US. Often you must travel internationally for treatments performed successfully all over the world that are banned here by our corrupt government and pharmaceutical industry. You think your doctor is going to buck this system or follow the dictated standard of care knowing it could potentially result in a less than optimum outcome to include death. They are going with the system. Spare me the virtue signaling.
The Right to Try Act (federal law passed in 2018) allows terminally ill patients to access investigational drugs outside of clinical trials without FDA approval, but only under specific conditions. Ivermectin for pancreatic cancer does not qualify under this law — and here’s why:
✅ Right to Try Law: Key Criteria
A drug must:
Have completed a Phase I clinical trial
Be under active development for FDA approval
Not be approved for any other use in treating the same condition
Be unavailable through clinical trials (i.e., the patient is ineligible)
❌ Why Ivermectin for Pancreatic Cancer Does Not Qualify:
No Phase I Trial for Pancreatic Cancer Use
– Ivermectin has not completed a Phase I clinical trial specifically for pancreatic cancer, a required threshold under the Right to Try Act.Not Under Active FDA Review for This Use
– Ivermectin is not being developed or submitted to the FDA for use in treating pancreatic cancer, which is also required.Approved for Other Uses (but not for cancer)
– While ivermectin is approved for parasitic infections, that does not disqualify it—but its lack of cancer-specific trial progress does.
But There is Data and more in the works
Ivermectin and gemcitabine combination treatment induces apoptosis of pancreatic cancer cells via mitochondrial dysfunction
https://pubmed.ncbi.nlm.nih.gov/36091811/
🔬 Preclinical Studies on Ivermectin for Pancreatic Cancer
1. Ivermectin Combined with Gemcitabine
A 2022 study published in Frontiers in Pharmacology examined the effects of combining ivermectin with gemcitabine on pancreatic cancer cells. The combination:
Inhibited cell proliferation by inducing G1 phase cell cycle arrest.
Promoted apoptosis through mitochondrial dysfunction and increased reactive oxygen species (ROS) production.
Suppressed tumor growth more effectively than gemcitabine alone in mouse models.American Holistic Health Association+2PubMed+2IIAR Journals+2
These findings suggest that ivermectin may enhance the efficacy of gemcitabine in treating pancreatic cancer.
2. Ivermectin Combined with Recombinant Methioninase (rMETase)
Another study investigated the combination of ivermectin with rMETase, an enzyme that depletes methionine, an amino acid essential for cancer cell growth. The study demonstrated that this combination:
Synergistically inhibited the growth of pancreatic cancer cells.
Induced apoptosis more effectively than either agent alone.
This suggests that ivermectin may also enhance the anticancer effects of other therapeutic agents.
🧪 Contrast: Investigational Cancer Drugs That Would Qualify
Examples of drugs that meet Right to Try criteria include experimental immunotherapies or targeted therapies that have:
Passed Phase I trials for specific cancers
Are in Phase II/III development
Are not yet FDA approved for that cancer
⚖️ Bottom Line
You cannot invoke Right to Try for ivermectin in pancreatic cancer because there is no investigational pathway or Phase I trial for that indication. It remains preclinical and off-label, which is outside the law’s scope.
Would you like to explore FDA Expanded Access (compassionate use) or trials involving ivermectin-like compounds?
Lobbying pressure: Big Pharma spent over $377 million lobbying Congress in 2023.
Pharmaceutical and Biotech Companies
Private sector entities, including pharmaceutical and biotech companies, fund a substantial portion of Phase 1 trials. A study found that 40% of clinical studies were funded by private companies . These companies often sponsor trials to test new drugs or expand indications for existing ones.
Who Funds Clinical Trials?
By Michael Greenwood, M.Sc.Reviewed by Emily Henderson, B.Sc.
Introduction
Reporting clinical trial funding
Bias introduced from funding
References
Funding for clinical trials comes from a wide variety of sources, including government, private investors, charities, universities, and other research institutions, though the vast majority generally originates from the pharmaceutical company with the greatest financial stake in the completion of the trial, allowing them to produce and market products for which they own the intellectual property.
Government funding is allocated by research councils and other informed bodies that make educated decisions about where funding would be best applied in the face of current medical issues, often with a highly specific scope or at the whim of political forces. This type of funding is more commonly encountered in the early stages of clinical trials, allowing universities and other research institutions to investigate potential new therapeutic leads. Similarly, research funding from charities more often focuses on novel and emerging treatment strategies that have the potential to revolutionize clinical practice, allowing market forces to then secure further investment for those that produce promising results.
Image Credit: Den Rise/Shutterstock.com
Reporting clinical trial funding
Ideally, all clinical trials should list any funding sources within the report generated, including a breakdown of how the money was spent and the role of each funder in the design, implementation, and authorship. Most governments host health organizations responsible for tracking and overseeing clinical trials, and as a part of clinical trial registration, all funders must be reported in detail. However, several journal papers and other scientific outputs may be produced from a single clinical trial with differing reporting requirements, often obscuring the funding source.
In a meta-study by Hakoum et al. (2017), the reporting of funding sources within 200 clinical trials was assessed. The group found that most clinical studies are funded by just one source, though they ranged as high as 12 independent contributors. 58% of studies were funded by the government, and 40% by private companies, with around a quarter receiving funding from claimed not-for-profit organizations. However, upon further investigation, around half of these non-profit organizations were linked in some way to profit-driven corporations, around half of which again were not reported in the published study.
Only around half of the studies assessed identified the detailed roles of any funders within the study, which mostly consisted of assisting in study design (42%), data analysis (41%), data collection (27%), and manuscript authorship (32%). Interestingly, multivariable regression analysis suggests that those clinical trials with rigorous reporting of funding were more likely to publish in journals with higher impact factors and be affiliated with institutions from high-income countries, though this is likely also related to the influence of higher minimum journal requirements and the larger scale of studies possible given more funding.
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Image Credit: whiteMocca/Shutterstock.com
Bias introduced from funding
The finding that half of the non-profit organizations funding clinical trials are actually supported by private companies is likely significantly underestimated, with only around a third of peer-reviewed journals requiring complete disclosure of funding sources and allocation. This is concerning regarding the clear conflict of interest that could result in manipulated or hidden scientific data, obvious examples being the heavy investment of tobacco and fast food industries into researching the adverse health effects of their products. Such funders should be as far removed as possible from the design, implementation, and analysis of clinical trials to ensure that trials are carried out without bias and should not be the only responsible party in the decision to publish.
Even when these factors are minimized as best as possible, funding from a particular source tends to favor the desired outcome of the funding organization regardless. Another 2017 meta-analysis of over 8,000 trials found a risk ratio of 1.27 for producing favorable drug efficacy results and of 1.34 for overall favorable conclusions when a pharmaceutical company primarily funded the trial as compared to any other funder, despite pharmaceutical companies actually often going to greater efforts than other funders to implement blind processes meant to prevent bias. Therefore, the principle issue in bias generated by the source of funding does not necessarily originate from scientific methodological concerns but from systemic bias starting in the initial planning stages, where only studies likely to produce good results are put forward, and ending with the decision only to promote the publication of favorable material.
Pharmaceutical companies often design the clinical trial and then sub-contract laboratories and independent researchers to collect and analyze the data, the latter of which should then go on to publish independently. In many cases, however, pharmaceutical companies tightly control subsequent publication according to pre-set publication plans implemented based on the data expected from the trial, and, arguably, independent researchers are used as a screen to maintain the illusion of independent research.
Anonymous surveys of corruption within the clinical sciences present worrying statistics regarding the number of respondents reporting first-hand knowledge of scientific fraud, as high as 50-92% amongst some of the groups surveyed. Importantly, a third of USA respondents reported having engaged in at least one of ten questionable behaviors previously, 16% of which had changed the design, methodology, or results of a study at the wishes of the funding source.
The FDA's budget comprises both federal appropriations and industry-paid user fees. These user fees are collected under various legislative acts, such as the Prescription Drug User Fee Act (PDUFA), to support the agency's review of medical products.Wikipedia+2U.S. Food and Drug Administration+2Reuters+2WIRED+2Wikipedia+2Reuters+2
Overall FDA Budget: Approximately 45% of the FDA's total budget is funded by industry user fees, with the remaining 55% coming from federal appropriations. UConn Today+2U.S. Food and Drug Administration+2Wikipedia+2
Drug Division Specifics: Within the FDA's Center for Drug Evaluation and Research (CDER), which oversees human drug approvals, 65% of the funding for regulatory activities is derived from industry user fees. UConn Today
This funding model has raised concerns about potential conflicts of interest, as the agency relies significantly on the industries it regulates. Critics argue that this dependence may influence the FDA's decision-making processes.