Innovative Pharmaceuticals Save Lives; But Costs Are Excessive; and the Effectiveness of Natural Remedies are Underestimated

By Cesar Collado

Continuing from last week’s article on the “2018 FDA Changes in Guidance” (HERE), I wanted to share how these two different types of medical remedies can complement each other.  Because we live in a market-driven system, drug companies will continue to pursue innovation for diseases where they can get a return on their investment sufficient for their shareholders.

The goal of the consumer is usually to maintain their health and manage diseases in a manner that they can afford without bankruptcy.  Thus, I’d like to address the pharmaceutical business model for a better understanding of the drug company’s role in healthcare and to clarify the value of natural remedies, especially in disease prevention, which is not necessarily part of the pharmaceutical company’s deliverables.  In most cases, for a pharmaceutical to make it to market, the drug must show a statistically significant improvement on specific endpoints over placebo or the standard of care.  When this is understood, the new, “vague” FDA Guidance on Homeopathic medicines and natural remedies is even more perplexing and potentially damaging to US citizens who want to play a more increasingly focused role in driving their own healthcare solutions.

For those who are not familiar with my background, I spent over two decades in the pharmaceutical industry with a heavy emphasis in drug discovery, R&D Strategy, and new market analysis.  Thus, I am very familiar with the intricate process of getting drugs to market and on the product life cycle.  Over the past 8 years, I have come to learn to appreciate the need for homeopathic medicines and natural remedies as precursors or adjuncts to aid in controlling disease, while limiting the need for overly expensive pharmaceuticals.

Big Pharma, Biotech, and Generic Medicines Evolution

It is important to note that pharmaceuticals account for only 14% of healthcare expenditures and account for 14% of health care costs today.1.  That is up from the 3-5% of expenditures it accounted for in the 90s.  Therefore, today’s high cost of pharmaceuticals is only a part in the astronomical rise in the costs of healthcare. Unfortunately, because pharmaceutical costs are easily calculated and compared, they inaccurately remain the “poster child” of rising healthcare costs.

25 years ago, branded pharmaceuticals accounted for approximately 33% of medicines prescribed. Pharma focused on many disease states but payed special attention to the disease states which impact the larger populations.  Diseases like diabetes, cardiovascular disease, osteoarthritis, infections requiring antibiotics, depression, GI disorders, and others dominated their offerings.  Branded medications were priced higher than generic medications in the marketplace but were not unreasonable.  In my experience, we often referred to surrogate daily expenses, such as the price of a pack of cigarettes, at that time as metrics for affordability.  To contrast pharmaceutical pricing concerns, the generic pharmaceutical market was highly fragmented and price competitive demonstrating a striking cost difference, often less than $10.  In addition, at that time, generic quality and equivalence was often questionable and often maintained patient loyalty to use of branded pharmaceuticals.

During the mid 1990s, technology development and innovation across almost all scientific disciplines advanced dramatically rendering past drug discovery and development methods obsolete.  The advent of sequencing the human genome and material advances in physics (detection), chemistry, biology, and computer technology created newer, more accurate, means to understanding disease biology and chemistry.  The accuracy and developments of newer methods to scan, test, capture data, diagnostics (analyze biological activity) and validate accurate information on what is happening in the body made drug discovery and development faster and more precise.

But like many technologies, the pharmaceutical innovations could be relatively, but not necessarily valuable until another technology enabled the processing or understanding. (For example, consider the pencil’s popularity growth after the eraser was introduced).  Because of the complexity of drug discovery and development, innovations across multiple disciplines have taken decades to perfect at tremendous costs.  Today, the average cost to develop drugs is an astronomical $2.6 Billion.  This includes all of the drug failures in the process. Pharmaceutical companies relentlessly pursue game-changing therapies for treatment to cure many unmet medical needs. The current successful advances made in healing cancer, while limiting painfully toxic chemotherapeutics, is balanced by the lack of success in drugs to treat diseases such as Alzheimer’s where 99.6% of all drug candidates failed over the last 15 years.2.  The current $259 billion cost of Alzheimer’s care in the U.S. will reach an “unsupportable” $1 trillion annually by 2050, according to the Alzheimer’s Association.2.

Regardless of empirical data of the efficacy of natural remedies that can be dated back thousands of years, it remains obvious that the FDA requiring traditional clinical trials and testing is not viable for the much smaller companies to afford $100 M or more to seek approval, not accounting for failures. This leaves the potential future interpretation of the FDA guidance incredibly risky for producers of homeopathic, natural remedies, and nutraceuticals.

The Drug Industry Today  

Fast forward to today, the drug industry has evolved significantly. Today, 90% of all medications prescribed are generics.3.  Companies focus the vast majority of resources on severe diseases of unmet medical needs.  These diseases affect a much smaller part of the population, and drugs are priced astronomically, to offset the costs of developing the drug, accounting for all failures, and satisfying shareholder return.

Generic companies have, however, increased their prices closer to the original brand name prices.  Their investment, while not as high as Pharma, has increasingly become litigation to battle patents and exclusivity of branded products.  This increases prices for everyone as Pharma defends their brand prices.

The vast majority of diseases where natural remedies are currently utilized do not fall in the areas of research pharmaceutical companies are focused on. This makes the FDA guidance even more perplexing.

I cannot fully understand or support the unreasonable pricing of pharmaceuticals today nor the rationale for excessive price increases.  I only know that prices fall well out of reach for most consumers. Treatment today for any disease remains costly, even with generics and insurance.  The entire system seems to be grossly inefficient with the addition of many “middle men” in the form of pharmacy benefit managers (PBMs) profiting handsomely in the process. The US healthcare system is broken, and legislation successes and failures have yet to materially improve healthcare for the common person.

Consumers Take Control of their Health and Look for Alternatives

Because of the healthcare system today, many people rely on themselves and have turned to natural remedies to address their healthcare needs.  While these natural remedies do not replace traditional medical intervention for these diseases, the process of either researching their disease and seeking help from integrative or holistic healthcare professionals has its advantages. Patients often learn to seek the underlying cause of their disease, rather than just to medicate its symptoms. This is a “blind spot” for the current medical pharmaceutical marketplace.

Patients who seek natural remedies often combine natural remedies with proper diet, lifestyle changes, and nutritional supplementation aimed at addressing the cause of their ailment.  The result can often positively alter their body’s ability to better deal with the disease. Better nutrition and behaviors can prevent, improve their condition, and delay onset or severity of disease.  Thus, their outcome not only prevents future healthcare costs, but also improved their quality of life.

It is no secret that losing weight can sometimes eliminate chronic diseases where medication would have been required.  If a patient loses weight through a combination of diet and exercise, the requirements for anti-diabetics, anti-hypertensives, cholesterol medicines, etc. goes away.  Ironically, pharmaceutical companies have sought treatments for obesity for decades focusing on various strategies involving the brain, metabolic pathways, and GI absorption, rather than by pushing that patients actually alter or address their lifestyles.  In the end, the few medications that made it to market have had limited efficacy, significant side effects and drug interactions and STILL required exercise and diet to gain very limited efficacy.  In addition, patients often could not maintain their weight loss. Perhaps diet and exercise remain today’s best medical solution.

For example, chronic inflammation or inflammatory diseases account for the largest pharmaceutical expenses and costly medications.  Today’s processed and high-palatable food diet remains one of the most critical causes of chronic inflammation.  The top-selling biologic treatments for chronic inflammatory autoimmune diseases (rheumatoid arthritis, Crohn’s disease, psoriasis, etc.) accounted for 47.4 Billion in 2017 sales.4.  To put that into perspective, the price of Humira (No. 1), an anti-inflammatory drug dispensed in an injectable pen, has risen from about $19,000 a year in 2012, to more than $38,000 today, per patient, after rebates, according to SSR Health, a research firm. That’s an increase of 100 percent.5.

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While these medicines help manage symptoms, many people can benefit from natural remedies. These include lifestyle changes (stretching, exercise, hot and cold treatment, rest, and stress avoidance), diet changes (anti-inflammatory), and supplements (Fish oil, Indian frankincense, Turmeric and probiotics).6.Eliminating gluten, dairy, high fructose corn syrup, soy foods, and industrial seed oils and replacing them with vegetables, fruits, lean meats, and good fats can effectively eliminate the specific cause of the disease as well. The costs of these changes are also negligible when compared to the costs of the drugs to alleviate just the symptoms.

Practicing Safety with Natural Remedies

The top reason for the FDA intervening in the homeopathic medicine and natural remedy market was the increase in use of homeopathic medicines. Sales increased to approximately $3B.  While this pales in comparison to pharmaceutical sales, it is hard to believe that the powerful Pharmaceutical lobby was not complicit in pushing this response.  Pharmaceutical lobby spending in 2018 to date accounted for $216 M, primarily focused on pricing.  Of that, $40,000 was spent by the Natural Remedy Association.6. The FDA is increasingly beholden to Pharma Companies.  In 2017, pharma paid 75 percent — or $905 million — of the agency’s scientific review budgets for branded and generic drugs, compared to 27 percent in 1993.7.

I am not totally blind to risks of homeopathic remedy use. There remain several legitimate concerns for safety with natural remedies and supplements:

  • Only a portion of natural remedies have the long history of empirical data regarding efficacy that dates back to ancient Chinese, African, and Indian medicine where these remedies remain in practice today.
  • Because they are known to be bioactive, they have the potential to interfere with the metabolism and efficacy of traditional medicines. For this reason, patients should always inform their physicians of ALL of the OTC supplements they are taking.
  • Well-known brands or physician recommended brand are the best alternatives as there are wide discrepancies between levels of quality and ingredients in products.
  • Some offer a new mechanism of action or unrealistic benefits without scientific evidence to support the usage. 

Chronic Sinusitis

Chronic sinusitis is one disease where expensive pharmaceuticals have not yet penetrated.  However, the first experimental drug to demonstrate efficacy in chronic sinusitis is in mid-stage trials.  Expect this to follow pricing of current biological treatments for chronic diseases. The first migraine pharmaceuticals are priced at approximately $6,000 per year with limited efficacy.

Chronic sinusitis, however, is an inflammatory disease where the environment plays a critical role in both the inflammation and the body’s ability to heal. Dr. Dennis’s body and environmental protocols to decrease exposure to mold and mycotoxins is extremely effective.

  • Twice-a-day rinsing with CitriDrops Dietary Supplement in a nasal rinse system will remove the mold spores residing and reproducing in your sinuses. When the mold is eliminated before it can get into the body, the cycle of inflammation is cut off.
  • EC3 Mold Spray or fogging with EC3 Mold Concentrate and the EC3 SANI+TIZER Foggerwill help decrease the fungal air load in your home and furnishings. This increase the health of your home; thus, your health improves as a result.
  • EC3 Laundry Additive will remove mold from your clothing and linens. This addresses potential cross contamination of mold, again, eliminated the cause or source of inflammation and illness.
  • Sinus Defense will aid your body’s immune system in identifying and tagging antigens so your body’s natural T Cells can identify and kill them immediately. Adding BetaMax 500 (Beta-glucan) to Sinus Defense will increase macrophage production to clear out the debris from the killed antigens in your body.
  • CellTropin provides support for your pituitary function which helps to mitigate hormonal dysfunction and support cellular regeneration. This addresses the causes of chronic fatigue.

 

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