Thursday, July 4, 2024

Beyond Polyvagal Theory: Addressing the Missteps in Pharmaceutical Interventions

As a pathomechanism, chronic fight-or-flight (sympathetic dominance) inhibits the rest and repair process by reducing white blood cell activity, which is essential for laying down new tissue. High circulating stress hormones cause oxidative stress, creating a more acidic environment that shifts tissue composition towards more bone-like qualities. An ECM that is too acidic leaches bone tissue (Ca++) to maintain a neutral pH, leading to bone loss (early osteoporosis). And once primitive reflexes are reactivated, the impulses from the vagus nerve are blocked through the brainstem. Once spasticity develops in the cervical spine, we become yang dominant (sympathetic) and functionally hypoxic.

Overlooking the systemic effects of chronic fight-or-flight becomes more problematic once medication is introduced. Without an understanding of the effects of chronic sympathetic dominance and underlying physiology, the use of drugs in western medicine to effect symptom relief causes unanticipated severe side effects, some times years later. Unbeknownst to many patients, the pathomechanisms of many diseases are poorly understood! For this reason, pharmaceuticals that are widely used have been proven to be deleterious years later. The pharmaceutical industry is not required to publish negative drug results in the PDR for at least five years, and many side effects are dismissed as anecdotal or imaginary.

This approach is evident in the traditional advice for osteoporosis, for example, which typically includes weight-bearing exercise to reduce bone loss, along with medications like Fosamax prescribed to inhibit microfibroclast activity. However, without considering the effects of chronic sympathetic dominance and the need for more elastic tissue generation, body tissue continues to become more brittle. Stretching is ineffective if the ECM is too acidic for proper elastin formation, or if the patient has reactive primitive reflexes and the sympathetic charge in the ANS is too high.  Over time, even the elastic properties of bones are lost.

 Fosamax, for instance, has been linked to serious side effects such as osteonecrosis of the jaw, where the bone tissue actually dies. Additionally, long-term use of Fosamax is associated with atypical femur fractures, where the bone becomes excessively brittle and prone to fractures with minimal trauma. These fractures result from the loss of elastin in the bone and demineralization, a paradoxical effect given that Fosamax was intended to prevent bone loss.[1]

The lack of understanding has even more insidious implications once a drug loses its patent and becomes available without a prescription. Over-the-counterdrugs are marketed directly to consumers, making them widely available without patients understanding the risks and many times without communicating their use to their doctor. Seniors who take acid blockers known as proton-pump inhibitors (PPIs), for example, have an increased risk of developing respiratory infections. A meta-analysis found that individuals on outpatient PPI therapy had a significantly higher incidence of community-acquired pneumonia. This increased risk is due, in part, to a decrease in stomach acidity, which is the body’s first line of defense against infection. The widespread use of PPIs in the senior population almost certainly contributed to the high transmissibility of COVID-19 among seniors. Furthermore, long-term PPI use is contraindicated in individuals treated for Helicobacter pylori, due to a significantly higher risk of developing gastric cancer (Cheung et al., 2018; AAFP, 2022).  The American Geriatrics Society's Beers Criteria highlight that prolonged PPI use is inappropriate for patients over 65, recommending treatment duration not exceed eight weeks unless the benefits clearly outweigh the risks (FDA, SpringerLink, JHBSPH, USC Schaeffer).  PPIs permanently damage the ability of the stomach to manufacture adequate stomach acid, and digestive enzymes, leading to slow, chronic malabsorption, further aggravating dyspepsia.  What is more staggering is that we discussed the damage from this class of drugs in a herbal pharmacology class over 22 years ago, and the general public is still blissfully unaware of their dangers.  If it is available over the counter, it must be safe.

If we consider that chronic sympathetic dominance reduces metabolic function in the gastric area and delays transit time, the issue is not excessive stomach acid but rather reduced metabolic innervation, rather not enough! By contrast, the naturopathic community has successfully used digestive enzymes and dietary modification to address these issues for years.  Clinical trials have shown that digestive enzymes significantly improve digestive health and reduce gastrointestinal distress without the adverse effects associated with many pharmaceuticals. This lack of comprehensive research on natural treatment is due, at least in part, due to the fact that almost all drug development is grant-funded by pharmaceutical companies. When there is a profit motive to sell a drug, there is little incentive to demonstrate how a natural practice or product could be more beneficial. Consequently, the potential of digestive enzymes and safer natural methods like acupuncture remain underutilized in clinical settings. (Digestive Enzyme Blend in Satiety and Indigestion and Digestive Health - Clinical Trials Registry, 2021).

Another common medication that poses significant risk is acetaminophen (Tylenol), for which toxicologists have been sounding the alarm since I was an undergraduate at UC Davis.  The therapeutic dose of acetaminophen is alarmingly close to its toxic level, which can lead to serious liver damage. Many consumers are unaware that mixed formulations of pharmaceutical drugs often contain acetaminophen, increasing the risk of accidental overdose. Sympathetic dominance inhibits digestion and the detoxification of medications, leading to slower detox and higher levels of harmful chemicals.  This is particularly concerning as about 1,600 cases of acute liver failure occur annually in the U.S. due to acetaminophen overuse, with around 500 fatalities each year. Therefore, it is essential for patients to be well-informed about the contents of their medications and to communicate their use in primary care to avoid unintentional overdoses.

Addressing Misinformation and Regulation in Nutraceuticals

Ancillary providers have long bemoaned the lack of education in Western medicine regarding supplements and herbs, and there is widespread misinformation on both sides regarding their use.  The pharmaceutical industry has a substantial influence on medical education which reduces the motivation to investigate a natural product or method when a marketable pill can be developed instead. Physicians often lack training in this area and several colleagues have privately admitted tome that they do not feel adequately trained to provide guidance on their safe use.  Opponents of the industry have persistently tried to restrict nutraceuticals through prescription (to limit competition with pharmaceutical drugs), even attempting to ban the sale of over-the-counter vitamins or limit them to prescriptions.

Simultaneously, we must address the fact that the nutraceutical industry is highly unregulated and needs reform, particularly in terms of manufacturing standards and unregulated claims. The internet further adds to the confusion, with many clients relying on Amazon reviews for self-medicating.  Rather than self-diagnosing, I have long advocated that patients who want to explore supplements and herbs do so with a trained ancillary provider such as a naturopath or acupuncturist trained in Functional Medicine.  The body has to process nutraceuticals through the same pathways as medication, and when its wrong, its wrong.  

Despite these challenges, many products and modalities in alternative medicine have proven invaluable in providing safe symptomatic relief without causing harm, often more effectively than conventional pharmaceuticals.  While critics argue for stringent regulation and overhaul of the nutraceutical industry, alternative medicine undeniably plays a crucial role in healthcare, offering safer options for many patients.  Dozens of my patients have successfully resolved clinically documented kidney neuropathy with acupuncture, supplements, and dietary change only to have their efforts dismissed by primary care as errors in the original diagnosis.  Admittedly, while there needs to be more education in Western medicine about the use of alternative medicine, diet and supplements, it behooves healthcare providers to stop denigrating these methods since their patients use them anyway. And given the rampant sympathetic dominance in our physician population, they may wish to consider the potential benefits of these supportive practices for their own healing. 

Unfortunately, fear of litigation and greed also discourage the validation of alternative medicine. If shame impedes creativity and innovation, as noted sociologist BrenĂ© Brown suggests, then fear of litigation and greed stifle it. Fear of litigation prevents the scientific community from considering practices that show benefit, and a profit motive in the medical system further discourages exploration and validation of these methods. 

This issue was particularly pronounced during the COVID-19 pandemic, where calls for “trust the science” did not address the ethical, medical and political concerns in a for-profit medical system.  When a policy advisor who mandates a vaccine schedule is also a shareholder in the company researching and marketing the drug, it creates a conflict of interest that is difficult to ignore. This situation, coupled with politics and social media, has led to widespread distrust among the public regarding all scientific information, and a paralyzing level of uncertainty about where to turn for answers. 

Public doubt of medical information results in poor compliance with medical guidelines and skepticism towards health recommendations that do work, ultimately undermining the entire healthcare system. Patients are less likely to follow prescribed treatments, adhere to vaccination schedules, or engage in preventive health measures that are effective. In their confusion, patients feel compelled to turn to the internet, a source of information with no oversight whatsoever, for their health concerns.

The misinformation on the internet is particularly time-consuming for healthcare providers.   A surgeon with whom I worked for many years reflected this with admitted irony when he gave me a Christmas mug one year that read, "Don't confuse your Google search with my medical degree." Half our time with patients is spent talking them out of a diagnosis they gave themselves online. (Real quote:  "You don't have pleurisy; you have a rib out and would benefit from a chiropractic adjustment.") Thanks to direct marketing of drugs to consumers, they also demand medication for conditions they don’t have, and overscheduled, understaffed primary care providers don't have the time for a thorough evaluation.  When a patient declares his gout has returned, it can be easier to simply prescribe his prior medication without a differential diagnosis. (Telemedicine has made this more problematic).  Patients who self-prescribe and self-medicate may also overlook natural approaches that include modifications to diet and exercise. Your self-diagnosis, while fascinating, is usually inaccurate.  

The erosion of trust in scientific information has deeper implications when we consider the urgent issue of climate change.  A profit motive stands firmly behind much of the misinformation and suppression of science regarding the role impact of human activity as the primary cause.  This has led to significant policy reversals in the U.S., gutting the ability of agencies to enforce science-based regulations, and rolling back regulations that have been in place for decades.   If we are to "trust the science," it has to be made public without regard to profit. (2) 

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[1] Fosamax (alendronate) has not been officially recalled but has faced significant scrutiny and numerous lawsuits due to these severe side effects. The FDA has issued warnings about these risks, and there have been multiple multidistrict litigations (MDLs) against Merck, the manufacturer of Fosamax, regarding these adverse effects. Despite these issues, Fosamax remains on the market and is still prescribed, though doctors are advised to monitor patients closely for these potential side effects (Drugwatch.com, Very well Health, Johns Hopkins Arthritis Center).

(2) The Day the Earth Changed is a fantastic documentary that illustrates the impact that the lockdown had on the planet, giving it a much needed rest.  It dramatically illustrates the beneficial impact that restricting human activity has on the environment. 

https://youtu.be/XswV_yqPq28?si=AuLmLqqBAeb3GxLX

References:

 American Academy of Family Physicians (AAFP). Proton Pump Inhibitor Use Associated With an Increased Risk of Gastric Cancer. Am Fam Physician. 2022.

 Cheung KS, Chan EW, Wong AYS, Chen L, Wong ICK, Leung WK. Long-term proton pump inhibitors and risk of gastric cancer development after treatment for Helicobacter pylori: a population-based study. Gut. 2018.

Chevalier, G., Mori, K., Oschman, J. L., & Brown, R. (2013). The effect of earthing (grounding) on human physiology. European Biology and Bioelectromagnetics, 39, 24-36.


Chevalier, G., Sinatra, S. T., Oschman, J. L., Delany, R. M. (2012). Earthing (grounding) the human body reduces blood viscosity—a major factor in cardiovascular disease. Journal of Alternative and Complementary Medicine, 19(2), 102-110.

Digestive Enzyme Blend in Satiety and Indigestion and Digestive Health - Clinical Trials Registry. (2021). Retrieved from ICH GCP: ICH GCP

Oschman, J. L., Chevalier, G., & Brown, R. (2015). The effects of grounding (earthing) on inflammation, the immune response, wound healing, and prevention and treatment of chronic inflammatory and autoimmune diseases. Journal of Inflammation Research, 8, 83-96.

Sinatra, S. T., Oschman, J. L., Chevalier, G., Sinatra, D. R. (2011). Grounding the human body during yoga exercise with a grounded yoga mat reduces blood viscosity. Journal of Alternative and Complementary Medicine, 17(4), 301-308.

 Stecco, C. (2014). Functional Atlas of the Human Fascial System. Elsevier Health Sciences.

 US Pharmacist. Deprescribing Proton Pump Inhibitors in Older Adults. 2023.

 


 

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