Primum non nocere or “first, do no harm” is taught to all healthcare providers, so that we might always remember that in our efforts to do something good we also risk doing something bad. Physicians, much like politicians, often feel the need to do something even when it may not be in the best interest of the patient. We don’t always have to reach for the prescription pad…
Adverse reactions and the early role of FDA
According to the US Food and Drug Administration website each year in the US there are about 2 million serious adverse drug reactions and about 100,000 deaths from the normal use of prescription drugs. This is due to a combination of side effects from the drugs, interactions between drugs and medication errors. That makes prescription drugs the 4th leading cause of death in America, after heart disease, cancer and stroke.
In the aftermath of the public health disaster caused by a sleeping pill called thalidomide, which caused birth defects of limbless handicapped children, Congress enacted the 1962 Kefauver-Harris Drug Amendments to the FDA’s mandate. Before marketing a drug, pharmaceutical companies now had to prove not only safety, but also provide substantial evidence of effectiveness for the product’s intended use.
Since that time many positive additions have occurred that promote consumer safety, including requirements for stricter labeling of drugs, with honest, thorough and specific patient package inserts that clearly outline the risks and benefits. Changes in research protocols led to development of Institutional Review Boards that oversee clinical research and help insure the safety of study subjects. Tamper-resistant packaging became mandatory in the 1980s.
The onerous FDA approval
The expanded FDA regulations and requirements for bringing new drugs to market has led to a laborious process in which new drugs now take about a decade of trials to get from invention to market. 95% of new drugs fail to show safety and effectiveness and never make it. By some estimates, pharmaceutical companies spend hundreds of millions of dollars to get FDA approval for a new drug. If they have numerous drugs in the pipeline the estimate gets into the billions for each successful drug brought to market.
Publication bias sets in when companies risk billions to bring a new drug to market. Ironically, the pressure to prove safety and effectiveness leads to the common occurrence in which numerous negative studies are hidden from the public while the few positive studies make it into the medical journals. Cases of scientific fraud, data manipulation, and deception are unfortunately common.
Consider just one example of pharmaceutical trickery coupled with FDA complacency. Remember Vioxx, the arthritis drug made by Merck? According to the British medical journal, The Lancet, the actions of both Merck and the FDA contributed to the nearly 30,000 excess cases of heart attacks and sudden cardiac deaths that resulted from the use of the drug between 1999 and 2003. While Merck sought to cover up the danger of its drug to protect its bottom line, the US government aided the company by approving sale of the drug without conducting any serious investigation into potential harmful consequences of its use.
More frightening, a large randomized trial, publicly identified as a safety study for Vioxx, was designed and carried out specifically to promote the drug to primary-care physicians with the intent of expanding its sales, conclude researchers, on the basis of an analysis of internal company documents. According to the authors, led by Dr Kevin P Hill, their analysis shows that the Assessment of Differences Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness (ADVANTAGE) study was a “seeding” trial, designed to seed the field of potential prescribers with positive Vioxx experiences and enhance their goodwill toward the company even while the FDA’s review of the drug was still under way. Further, they note, the company kept its intended purpose for the trial secret from institutional review boards and participating physicians and patients.
I’m not against prescription medications – quite the contrary as there are numerous prescription drugs that save many lives and do much good. And I heartily support the free-market system in which companies take risk to invent new products. However, our over-reliance on the pharmaceutical model of has created a system in which physicians have become medication-dispensing puppets instead of problem solving healers.
Functional medicine instead
To illustrate how the overuse of medications can lead to more harm that good, while never fixing the original problem, I’ll share a real patient story. John was a 63-year old gentleman who was referred to me by his wife, for evaluation of fatigue. She was thinking he might have low testosterone, which he did, but his health situation was much more interesting and involved 6 medications and 4 doctors.
John had a long, long history of Irritable Bowel Syndrome and Acid Reflux, and he had undergone scopes, CT scans, and blood tests without any relief. His gastroenterologist had him on two medications.
He also had problems with intermittent racing heart and palpitations. A cardiology workup including sonograms and stress tests did not reveal any problems. He was diagnosed with racing heart and placed on a medication to slow the heart rate.
The neurologist saw John for the tingling and pins and needles sensation in his hands and feet. The usual blood tests, MRI and nerve conduction studies did not turn up a cause. John had sensory neuropathy and was on a seizure drug to help manage the symptoms.
Now with all these concerning medical issues and medication side effects John was a bit of a wreck. He was prone to anxiety and insomnia. For this, his family doctor had him taking a sleeping pill and a sedative as needed for panic attacks.
Our functional medicine testing quickly found that John had “leaky gut”, delayed allergies to dairy and wheat, along with adrenal fatigue. With healing the gut, elimination of food allergens and adrenal support all of his symptoms resolved. He now takes no medications.
Consider that most degenerative diseases of aging and the leading causes of death are largely preventable with efforts at improving diet, exercise, sleep and stress management. Many natural supplements have reams of data from rigorous scientific studies that prove safety and effectiveness. According to the American Association of Poison Control Center’s Toxic Exposure Surveillance System, between 1994 & 2004 there were 14 deaths attributed to dietary supplements. The next time someone questions you about the safety of natural therapies hit them with that statistic.
Keep all this in mind the next time we doctors reach for the prescription pad. Ask yourself whether you really need that new medication, what are the side effects, what are the alternatives, and are you just putting a dangerous pharmaceutical bandage on a symptom instead of really getting to the root cause?
Scott Rollins, MD, is Board Certified with the American Board of Family Practice and the American Board of Anti-Aging and Regenerative Medicine. He specializes in bioidentical hormone replacement for men and women, thyroid and adrenal disorders, fibromyalgia and other complex medical conditions. He is founder and medical director of the Integrative Medicine Center of Western Colorado (www.imcwc.com) and Bellezza Laser Aesthetics (www.bellezzalaser.com). Call (970) 245-6911 for an appointment or more information.