Who Is Addressing the Availability, Safety & Efficacy of our Medications?

I watched all three presidential debates this summer with health care being a time-consuming topic for all. Universal health care and Medicare-for-All, with or without an option for private insurance, were debated and discussed at length.

At the same time NBC Nightly News presented a story documenting that all our antibiotics come from production in China. With globalization policies, which promote moving production to lower cost overseas factories, there is no longer any production of antibiotics in the USA. A former member of the Joint Chief of Staffs, citing the current trade conflicts and China’s aggressive military stance in the Pacific, considers this a security issue. I have heard not one question or comment on this topic in the debates?

This week, once again, the blood pressure medicines losartan and valsartan were recalled because they contained potential carcinogens. These generics were produced in India, Asia and Israel. These same drugs have been recalled multiple times in the last few years for similar problems.

Due to reduction in funding for FDA inspections, many of these foreign plants have not been inspected for years. We can add recalls of generics to drug shortages. We suffered a shortage of intravenous fluids for hydration because the primary production site in Puerto Rico was destroyed in a hurricane. We had shortages of morphine and its derivatives for treatment of orthopedic trauma and post-surgical pain. They substituted foreign-produced short acting fentanyl. I saw pediatric ER physicians unable to administer the most effective treatments for sickle cell crisis in children because it required the use of a narcotic drip to offset the dramatic pain the treatments induce as they stop the crisis.

Then there are the psychiatric patients on antidepressant generics who are paying hundreds of dollars per month for products that wear off in 16 hours rather than 24 as the brand product did. Their symptoms creep back in allowing them to tell time based on the reduced efficacy of these products. By law, generics are required to provide 80% of the “bioavailability” of the brand product but what does that mean and who is testing?

This all began when the Reagan Administration closed the FDA research lab. Prior to that, all new products were sent to that lab for approval prior to being released in America. On their watch, a pharmaceutical product never had to be recalled. Big Pharma complained they took too long as did some consumer groups. This resulted in the defunding and closing of the lab. Products are now outsourced to private reference labs and their reports are sent to the FDA for review. The frequent drug recalls contrast to the success of promoting safety when the FDA did it themselves.

Isn’t it time for the health care debate, especially the presidential debates, to discuss the safety, efficacy, supply and cost of pharmaceutical products? I am all for bringing production home to the USA, restoring the FDA funding for the reopening of their lab as an impartial test site and putting the cost of repeatedly testing the generics for efficacy even after approval and release on the backs of Big Pharma. Let’s see these topics introduced to the health care debate too.

Sodium Chloride Salt Substitution Works in a Community Trial

At a meeting of the European Society of Cardiology, J. Jaime Miranda, M.D. PhD, of the University of Peruan Cayetano Heredia in Lima, Peru reported that substituting artificial salt substitute potassium chloride for table salt lowered the blood pressure of participants, reduced the number of new cases of hypertension and ultimately reduced stroke and heart disease mortality

For this study, researchers enlisted the assistance of six semi-rural agricultural fishing villages in the Tumbes region of Peru. All adults 18 and older were approached and over 91% of the 2,605 potential enrollees agreed to participate. Patients with chronic kidney disease, known heart disease or digoxin use were excluded because of the use of potassium and potential cumulative effects of this element.

The study area and residents historically have very little high blood pressure. In Peru, 140 systolic blood pressure and 90 diastolic blood pressure are considered the upper limits of normal.

The researchers replaced the sodium chloride used in food preparation with potassium chloride salt distributing it free to all families, shops, restaurants and bakeries over a three-year period. The results revealed a very small reduction in systolic blood pressure which still reduced the risk of stroke by 10% and ischemic heart disease by 7 %. The drop in blood pressure was more definitive in the 18% having hypertension at the time they entered the study and those 60 years of age or older.

This study raised the possibility of researchers approaching food manufacturers around the world to substitute potassium chloride artificial salt for sodium chloride as a means of lowering blood pressure and its stroke, cardiac, renal and vascular complications. It reinforced the suggestions to stop adding sodium chloride salt at the table or in food preparation if you wish to keep your blood pressure under control.

Antibiotic Use – Independent of Physician Prescribing

A recent article in the Annals of Internal Medicine looked at individuals who took antibiotics without them being prescribed by physicians at a visit.  The authors looked at 31 published studies between January 2000 and March 2019.  The medications came from family and friends, online distribution sites, drugs prescribed for their animals by their veterinary doctors and those stored after a previous indicated use.   When asked about it, and the reasons why these patients took these medications, the main factors cited were lack of health insurance or lack of healthcare access, cost of physician visits or medications, long waiting times in clinics, embarrassment for needing antibiotics, lack of transportation and/or easy availability of antibiotics  from other sources.

We are currently going through an antibiotic resistance crisis in the world.  Most of the fault lays with agricultural industry feeding livestock tons of antibiotics to fatten them up. Patterns of resistance develop on the farms and are passed species to species.

To remedy this, the US agriculture industry, especially in chicken production, has cut back drastically on this process.  At the same time, we are requesting physicians to work with infectious disease doctors in stewardship programs to reduce their use of ineffective antibiotics and to prescribe with precision when these medications are needed.  It works. Studies are beginning to show the benefits of these programs.

Despite this, the pressure from patients to be given something when they pay for, and invest in, a medical evaluation for an infection is overwhelming. In the setting of telemedicine, as well as walk-in and urgent care centers, reviews and patient satisfaction survey results are tied to whether the patient was given an antibiotic whether it was indicated or not.

As bacteria become resistant to common and inexpensive antibiotics, pharmaceutical manufacturers are not being incentivized to produce newer more efficacious medications.  At the same time, older useful antibiotics which do not generate much of a profit are not even being ordered and stored by chain pharmacies that lose money each time the older generics are prescribed.

To begin solving this problem, an improvement of our health literacy is required. Education in schools and in public health announcements, both in print and social media, need to realistically address the issue. This education will not replace the need for access to health care and health, but it is a beginning to make individuals understand how, when and why these “miraculous” medications can and should be used.

Heartburn, Indigestion & Protein Pump Inhibitors

I have seen multiple adult patients with intractable heartburn, reflux, indigestion and chest pressure all related to food and digestive enzymes kicking back up the esophagus from the stomach through a lax group of muscles known as the lower esophageal sphincter.  All these patients receive a fiber optic upper endoscopy (EGD) at some point and are observed and biopsied to eliminate the possibility of ulcers, cancer, gastric polyps, esophageal cancer, potential esophageal cancer and Helicobacter Pylori bacteria as the cause.

They are all treated with weight control suggestions, avoiding a host of foods, most of which are quite healthy from a cardiovascular standpoint plus limits on alcohol, elimination of tobacco and other indulgences of adults. We ask these patients to wear loose clothing at the waistline, avoid reclining for three hours after eating and take a host of medicines including proton pump inhibitors (PPI) such as Nexium, Protonix, Prilosec.  Drugs like Tagamet, Zantac (H2 Receptor Blockers), Tums, Rolaids are far less effective.

In recent years, numerous articles have appeared in medical journals stating that protein pump inhibitors, when taken regularly, can predispose to increased and early death, pneumonia and dementia.  A large review article from a prominent GI group in Boston, and published in the New England Journal of Medicine, tried to eloquently refute these claims but the doubt about long term safety lingers buoyed by numerous lay periodicals and online internet sites sensationalizing the down sides of these medicines.

To allay the patients fears, doctors and patients work together to try and stop the PPIs and substitute the older standbys like Tagamet and Zantac but they just don’t provide the symptom relief that the PPI’s do. Patient’s face the dilemma of taking the medicine that works best and incurring the potential risks or suffering.

In a recent edition of the journal Gastroenterology, Paul Moayyedi, MB ChB, PhD from McMaster University in Canada followed 17,000 patients for three years with half the group taking PPI’s. Those taking a PPI (Protonix) for three years had no more illness or adverse effects than those taking a placebo.  L. Cohen, MD, a reviewer at Mount Sinai School of Medicine in NY, concluded that the study provided strong evidence of the safety of PPIs for patients taking the drug for three consecutive years.

The controversy will continue. I am sure next week someone will produce data revealing some additional horrible consequences of taking these medications to relieve heartburn. It will ultimately come down to individual decisions about quality of life versus potential risks because the lifestyle changes necessary to control this problem are difficult for human beings to sustain over a long period of time.