The world of biotechnology and pharmaceuticals is complex, and the line between right and wrong is not always clear-cut. In this essay, I will analyze the ethical and financial implications of targeted medicine and large-scale medicine and argue that targeted medicine is more ethical and financially viable. Additionally, I will discuss the science behind these treatments to provide a well-rounded perspective on the topic.
Specific targeted treatments usually present a favorable risk-benefit ratio, where the benefits outweigh the potential side effects and toxicity. This is because the treatment is targeted toward individuals who are already suffering from a specific disease and have a high likelihood of developing severe consequences without treatment. In the case of a severe disease, even a substantial risk of toxicity could be acceptable if the treatment can cure a debilitating or potentially fatal disease. However, when it comes to treatments for large populations, such as vaccines, we must consider the potential risks and side effects in a different manner entirely. This is because the intervention is not targeted toward individuals who are already suffering from a specific disease, but rather toward a population that may not necessarily even need the intervention. In the case of most mass treatments, almost any toxicity would be unjustifiable as there was nothing wrong with the individuals from the beginning, nor is there is any certainty that anything will ever be wrong with them.
In my studies, I came across several ground-breaking drugs such as Eylea, developed by Regeneron. It works by reducing the natural effect of Vascular Epithelial Growth Factor (VEGF) in the macula of the eye. VEGF is responsible for angiogenesis – the formation of blood vessels as well as cell growth. Too much VEGF in cases such as Age-related Macular Degeneration (AMD) can cause overgrowth and lead to blindness. The mechanism of action of Eylea is straightforward and easily understandable for those with limited medical knowledge. Researchers conjugated an Immunoglobulin G to a laboratory-produced VEGF receptor that has a higher affinity for VEGF than naïve receptors located in the blood vessels of the macula of the eye.(1) Essentially this drug Eylea steals extra VEGF which results in less endothelial growth.
I came across an intriguing clinical case that sparked my interest in another promising drug. Von-Hippel Lindau’s disease is indicated by abnormal tumors, one of the most common of which is a Wilms tumor in the kidneys. This is because of a simple point mutation that occurs in a hypoxia-inducible factor gene resulting in the overproduction of hypoxia-inducible factor. Belzutifan, made by Merck, whose structure is shown below binds to hypoxia-inducible factor and inhibits its tumor activity.(2) This is a recent drug that was FDA approved in August of 2021.(3)
It’s crucial to consider the limitations and potential side effects of these drugs, as with all drugs. Belzutifan and Eylea come with potential side effects, such as unusual bleeding or bruising with Belzutifan and vision problems and sudden numbness with Eylea.(4)(5) Most drugs need to be metabolized by the kidney or cytochrome P enzymes in the liver, and may not be suitable for people with renal or liver failure. These drugs can cause other toxicities as well in the heart or the brain. In fact, these drugs could even result in death. However, when considering the potential serious consequences of these drugs, one must consider the threat of cancer from untreated von Hippel Lindau’s disease and Age-related Macular Degeneration, the threat of blindness from AMD, and the dread such serious illnesses cause to family members. Even with potential severe side effects, the risk-benefit ratio comes out in favor of administering the drugs.
Let us contrast the previous examples, with an example of a mass population medicine – the Gardasil vaccine. According to the manufacturer’s website, Gardasil “can help protect your child from certain types of HPV-related cancers that may affect them later in life.“(6) Gardasil is injected into healthy young girls, at an age when the vast majority are not sexually active, to protect them against a disease strain they may never encounter, and which if they did, would not necessarily cause them any harm. Despite its rather popular intended purpose (protecting women from cancer), Gardasil has faced legal challenges from Miller & Zois and has been subject to controversial lobbying efforts in Congress to make it mandatory for school-aged girls. (7)(8) Criticisms have been made towards the Gardasil vaccine for its misleading trial results, improper placebos, and reported cases of infertility, neurological disorders, and increased susceptibility to other HPV-related cervical carcinomas. The vaccine actually makes it more likely to develop cervical carcinoma from HPV strains that the vaccine does not protect against. It is also worth noting that not all cervical carcinomas arise from HPV. To understand the issue more deeply, it is recommended to review the presentation by Robert F. Kennedy Jr. on the Gardasil vaccine, which provides a detailed analysis of clinical trials and peer-reviewed research. The information provided is of medical school-level complexity and should be widely known among pediatricians in the United States. (9)
Clearly, any rational risk-benefit analysis would conclude that it is unacceptable to inject millions of school-aged girls with this drug. Any potential adverse reactions would easily outweigh the very modest potential benefits.
Economics plays a role in the discussion of targeted versus mass population medicine. Pharmaceutical companies often voice the concern that without a mass market for a particular drug, it is not economically viable to invest in research. There are ways to provide, in a socially responsible manner, targeted drugs for smaller markets and sustain acceptable levels of corporate profitability. An example is the Orphan Drug Act passed in the United States in 1983. This Act provides incentives for companies to develop and market drugs for rare diseases, defined as those that affect fewer than 200,000 people in the US. (10) The Orphan Drug Act provides financial incentives such as tax credits, user fee waivers, and market exclusivity to pharmaceutical companies that develop drugs for rare diseases. Eylea and Belzutifan are both orphan drugs. (11)(12)
The National Organization for Rare Disorders (NORD) estimates that there are approximately 7,000 rare diseases affecting more than 400 million people worldwide.(13) Clearly, there are many diseases that need treatment, including many that are debilitating or even terminal. Further, potential treatments for these diseases would advance medical knowledge and capabilities, leading to advances in combatting other diseases.
An example of a needed Orphan Drug with much potential is the case of Beckwith-Wiedemann syndrome (BWS). All humans have the H19 gene located on Chromosome 11 which is responsible for regulating insulin-like growth factor 2. As is the case of every pair of chromosomes, one is obtained from the mother and the other is obtained from the father. In a normal, non-cancerous state H19 from the maternal allele is silenced and active in the paternal allele. In BWS, there is often a mutation in the CTCF binding site on the maternal allele of the H19 gene. This results in the loss of CTCF-mediated silencing of the maternal allele and leads to the overexpression of the IGF2 gene.(14) Here is a diagram of Chromosome 11 and related genes under normal conditions.
What is needed is the development of a drug, by a pharmaceutical company, that would suppress the maternal allele and prevent tumor formation. While this is not a common type of cancer, its successful treatment would be a substantial advancement in medicine and can be financially viable because of the Orphan Drug Act. As a targeted medical treatment, it would be worthwhile even if it came with the risk of serious side effects.
It is not necessary to force unneeded medical interventions on mass populations to make money.
Targeted medicine is a powerful tool in the fight against disease, offering hope for individuals suffering from conditions with severe consequences. The precision of these treatments allows for a favorable risk-benefit ratio, even when the treatments have potential severe side effects. The benefits usually outweigh the potential side effects and toxicity when compared to the fatal and/or debilitating conditions which the patients are already suffering from. The development of targeted medications is a testament to the ingenuity of biotechnology, utilizing cutting-edge science to create life-saving solutions for those in need.
On the other hand, mass population medicine, such as vaccines, raises ethical and practical questions as it intervenes in the lives of perfectly healthy individuals who may not necessarily need the intervention. The potential risks and side effects, which can be life-altering, must be carefully considered, as any toxicity caused by a mass treatment, such as a vaccine, would be unjustifiable as there was nothing wrong with the individuals from the beginning.
Targeted medicine brings people hope in the fight against disease, offering new possibilities for individuals suffering from life-threatening (sometimes rare) conditions to recover their health. Mass population medicine often results in the opposite situation – making perfectly healthy people ill, perhaps even fatally.
Vasily Maltsev is an Orthodox Christian and highly educated in the field of biomedical sciences. He has an undergraduate degree from University of Central Florida and a Master’s in Medical Sciences from Lake Erie College of Osteopathic Medicine. His interests include understanding the mechanisms behind drug development and the impact they have on patients. Vasily seeks to share his insights and knowledge with readers and engage in dialogue about the important issues facing the industry today. The COVID19 Pandemic sparked his interest in exploring the dark side of the industry, including such topics as medical malpractice and medical tyranny. His goal is to gain a deeper understanding of both the positive and negative aspects pharmaceutical science.
- https://eyewiki.aao.org/Aflibercept#:~:text=retinal%20vein%20occlusion.-,Mechanism%20of%20Action,affinity%20than%20its%20natural%20receptors.
- https://www.cancer.gov/news-events/cancer-currents-blog/2021/fda-belzutifan-vhl-tumors#:~:text=Belzutifan%20Approved%20to%20Treat%20Tumors%20Linked%20to%20Inherited%20Disorder%20VHL,-Subscribe&text=In%20people%20with%20VHL%20disease,inhibits%20HIF’s%20tumor%2Dpromoting%20activity.
- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-cancers-associated-von-hippel-lindau-disease
- https://www.mayoclinic.org/drugs-supplements/belzutifan-oral-route/side-effects/drg-20520339
- https://www.rxlist.com/eylea-side-effects-drug-center.htm
- https://www.gardasil9.com/adolescent/should-your-child-get-hpv-vaccine/
- https://www.millerandzois.com/products-liability/gardasil/
- https://www.prnewswire.com/news-releases/judge-appoints-four-lawyers-to-lead-gardasil-mdl-multidistrict-litigation-301647703.html
- https://childrenshealthdefense.org/news/rfk-jr-video-and-facts-about-gardasil/
- https://oig.hhs.gov/oei/reports/oei-09-00-00380.pdf
- https://investor.regeneron.com/news-releases/news-release-details/regeneron-receives-six-months-us-pediatric-exclusivity-eylear#:~:text=EYLEA%20was%20granted%20orphan%20drug,FDA%20and%20other%20regulatory%20authorities.
- https://adisinsight.springer.com/drugs/800048395#:~:text=In%20February%202022%2C%20the%20Therapeutic,Goods%20Administration%2C%20June%202022).
- Source: National Organization for Rare Disorders (NORD). “Rare Disease Statistics.” https://rarediseases.org/rare-disease-statistics/
- https://www.nature.com/articles/ejhg2011166
I don’t see what this article has to do with Orthodoxy and I’m surprised it was posted here. I also disagree with the writer’s claims against the Gardasil vaccine, and his references do not support his claims. The presence of lawsuits means nothing -it’s their outcome that matters – and, let’s face it – few countries are as medically litigious as the US.
The Gardasil vaccine has been in use since 2006. The medical profession has 17 years of experience with it. it is a highly effective and safe recombinant vaccine (same technology as the Hepatitis B vaccine which saved my life when I stuck myself with a contaminated needle) and I have been administering Gardasil-9 for years to both boys, girls, men and women, and none of my patients have ever had a vaccine injury from this vaccine. It is the only vaccine that protects people from cancer – cervical, anal, vaginal, vulvar, penile, oral and throat cancers, as well as venereal warts in these areas, that are caused by the various strains of the sexually transmitted HPV – Human Papilloma Virus.
About 80% of the population is infected with at least one strain or another of HPV. There are over 100 different kinds of HPV strains and the Gardasil-9 vaccine protects against the worst of these – 7 cancer causing strains and 2 venereal wart causing strains. These particular strains cause 90% of all HPV related cancers and the Gardasil-9 vaccine protects against all of these 90%, which is as close to 100% as anyone can get.
The more sexual partners a person has, the more strains of HPV they can get, and the greater the risk for developing cancer and venereal warts. If the vaccine is taken before the onset of any sexual activity, it is virtually 100% protective. This is why children are vaccinated so they can be protected before they start to be sexually active, which, I regret to say, is usually around the age of 12 years these days.
I disagree with the writer that vaccination is inappropriate for healthy populations. He wants to wait until a person gets the disease before it’s treated. He does not believe in prevention?! Vaccination does not treat, but it can prevent a lot of disease. It is a lot easier preventing cancer than treating it, and as for Hepatitis B, it can kill you and there is no cure for that disease – only prevention. I know two people who died of Hep B. One was a surgeon who refused to be vaccinated and another was a young girl who had a one night stand with a guy that was an asymptomatic carrier. And, If we had not developed a vaccine against small pox, we might ALL be dead by now. Smallpox killed more than 300 million people since 900 alone, but no one dies of small pox anymore, thanks to the small pox vaccine.
Don’t underestimate the importance of traditional, sound, well researched vaccines which have stood the test of time!
With all due respect, please see Dissolving Illusions by Suzanne Humphries, M.D., for a historically based refutation of pretty much everything you have posted in your comment.
Dear CSJ,
Thank you for suggesting the book “Dissolving Illusion” by Suzanne Humphries M.D. This is not a book I have read, so for the benefit of whoever may be reading these comments, I have copied and pasted an on-line description of the book here:
“Not too long ago, lethal infections were feared in the Western world. Since that time, many countries have undergone a transformation from disease cesspools to much safer, healthier habitats. Starting in the mid-1800s, there was a steady drop in deaths from all infectious diseases, decreasing to relatively minor levels by the early 1900s. The history of that transformation involves famine, poverty, filth, lost cures, eugenicist doctrine, individual freedoms versus state might, protests and arrests over vaccine refusal, and much more.Today, we are told that medical interventions increased our lifespan and single-handedly prevented masses of deaths. But is this really true?Dissolving Illusions details facts and figures from long-overlooked medical journals, books, newspapers, and other sources. Using myth-shattering graphs, this book shows that vaccines, antibiotics, and other medical interventions are not responsible for the increase in lifespan and the decline in mortality from infectious diseases. If the medical profession could systematically misinterpret and ignore key historical information, the question must be asked, “What else is ignored and misinterpreted today?”Perhaps the best reason to know our history is so that the worst parts are never repeated.”
There is no doubt that improved work & living conditions, personal and public hygiene, education and so on have contributed significantly to the reduction of transmissible disease, but this does not mean than antibiotics and vaccines did not also play a pivotal role. The description above claims that the “transformation of societies” played the only significant role in better health, which started becoming apparent in the early 1900’s.
This does not address those societies or countries which still suffer tremendous famine and poverty, war, and child labour to name a few, Despite their problems, people in these countries have benefited from organizations such as Doctors Without Borders, where volunteers risk life and limb to bring life saving antibiotics, anti-parasitics and vaccines to the victims. Food and clean water isn’t all they need.
Small Pox vaccine was first used in humans in 1880, which could explain some of the better outcomes by 1900, which Humphries only contributes to better living conditions. Before the advent of antibiotics, Iodine was all they had for wounded soldiers in WWI, which also helped save many from death by sepsis. It is so easy to poo-poo antibiotics when they are so plentiful now-a-days that as soon as your child has a sore throat you can get a prescription for Penicillin. Thanks to that antibiotic, the world has seen a sharp decline in rheumatic fever & heart disease, Syphilis and bacterial meningitis to name a few.
Did you know that small pox vaccination was not first developed in the West but in the far East? Small pox changed the course of history until the West found out what the East was doing to combat it. Please watch the fascinating history of small pox here: https://youtu.be/eWT2mWf0ULY – 28 minutes. It will blow your mind. Vaccination of small pox did not begin with big pharma because they stood to gain millions. I will not spoil how it began. You have to watch the video.
I understand how and why many people are disillusioned with vaccines and modern medicine because of the recent pandemic, and I know there is corruption to spare; but let’s not judge – and God forbid cancel – all of the medical milestones of the past based on the present. Let’s not dismiss good antibiotics and legitimate vaccines because we are disappointed in the latest ones.
In her book, I’m sure Dr. Humphries provides some good history and data, However, I doubt very much she gives the big global picture. I have not yet read it, but I have read similar books, and I can almost predict what she says in hers. Nevertheless, you have piqued my interest, and i have added it to my bucket list, but I still stand by our traditional antibiotics and vaccines.
https://youtu.be/eWT2mWf0ULY – 28 minutes