*The Science of Precision Medicine
*According to YourGeneTest.org Pharmacogenomics (PGx) gene testing for drug interaction, provides precise and accurate clinical support for the safe and effective management of medications and genetic metabolic factors. Knowing a patient’s genotype helps a prescriber design patient drug therapy to mitigate clinical risk factors and improve therapeutic outcomes. YourGeneTest.org goes on to say that, Prescribing medications and treatment without the benefit of patient PGx genetic data adds unnecessary risk and reduced efficacy to clinical care and treatments.
Most content originally published in the May, 2017, Vol 42, No 5 Medical Liability Monitor “Pharmacogenomics – Metric of Clinical Accuracy”
The national epidemic of overdosing and deaths due to illicit and prescription drugs are the leading cause of accidental death in the United States, according to the Centers for Disease Control (CDC). Adverse Drug Reactions(ADR's) are generally considered to be the number four cause of death in the United States. President Trump recently convened a committee to study the devastating effects of clinical overdosing and prescription drug abuse. According to the National Practitioner Data Base (NPDB) over 55% of paid malpractice claims were based on errors in diagnosis, medications and treatments.
Senator John McCain, is leading the charge to stop over-medication of veterans with the proposed Veteran Over-medication Prevention Act. The VA is in the spotlight because veterans have a higher rate of overdosing deaths than the national average. Many VA facilities are considered “candy factories” that systematically over prescribe medications. Sen McCain is proposing a pathology review of all deceased veterans treated in VA facility over the last 5 years in order to obtain more accurate data on the cause of death.
The Jason Simcakoski Memorial Opioid Safety Act, was inspired by the death of a 35 year old Marine, Jason Simacakoski. He passed away in a VA medical center from a fatal combination of drugs administered to him at the VA facility. The purpose of the JSMOSA, is to strengthen dosing guidelines as the VA is slowly transitioning away from “internal cocktail committees” and the “one size fits all” drug company dosing guidelines. It’s perplexing, in spite of the scientific evidence, that most doctors still utilize traditional methods to prescribe medications and dosages without their patient’s genetic information.
According to the Center for Disease Control, opioid deaths are increasing due to the availability and access of dangerous narcotic drugs. Some states located in the Southeastern parts of the United States carry an opioid per citizen ratio of 1.4 prescriptions for each citizen. Many of these controlled substances are illegally resold on the street – with health insurers and government programs paying the bill. Hospitalization can lead to even more opportunity for addiction, as many get “hooked” on prescription pain killers while undergoing treatment. Approximately 80% of Heroin addicts started on prescription drug medications.
The reaction of the pharmaceutical drug industry and medical providers to Pharmacogenomics has been cold for good reason – a staggering 4.51 billion retail prescriptions were sold in the United States in all of 2016 – 2017 estimates are in the 4.62 billion range. Many doctors receive significant sums of compensation from drug companies according to Time magazine. Time cited one survey in 2014, stating that Dr. Stephen S. Burkhart, an orthopedic surgeon practicing in San Antonio, TX, received $7,356,276 in direct compensation from drug companies. The actual amount of overall compensation derived by doctors from pharmaceutical interests can be difficult to complex anti-kickback provisions and laws – but it believed to be in excess of $12 billion annually.
In 2014, a lawsuit filed on behalf of the state of Hawaii alleged that Bristol-Myers Squibb and Sanofi-Aventis deceptively marketed and unfairly labeled Plavix since its launch by failing to alert consumers that the drug has "a diminished or no effect on approximately 30 percent of the [Hawaiian] population because they metabolize the drug poorly due to their genetic traits or poly-pharmacy – which refers to multiple drugs that affect the body's ability to metabolize Plavix."
It has been predicted that similar lawsuits will be directed towards Drug Companies and Providers omitting genetic clinical data as PGx becomes more mainstream with mounting evidence of its clinical usefulness. Indeed, as evidenced by the recent lawsuit on behalf of 1800 former NFL players against the National Football League and their team doctors – that team physicians knowing and willingly over-medicated players with powerful painkillers and anti-inflammatory medications. In fact, every doctor deposed so far has admitted at least one violation of the Controlled Substances Act. PGx testing could play a significant role in future efforts on behalf of the NFL to protect players against abusive medical practices.
Even The FDA now has Pharmacogenetics data in their package inserts for over 120 drugs of which 30 accounts for 738 million of the most commonly prescribed. Several of the published FDA recommendations are meant to be followed prior to first dosing. One example of out of many FDA specified drugs is Aripiprazole. The FDA warning from the drug label states: “the Aripiprazole dose in PM [poor metabolizer] patients should initially be reduced to one-half (50%) of the usual dose.” Prescribing this medication without knowledge of the patient’s genetic modifiers can be both reckless and negligent.
Consider the challenges facing Psychotropic Medications. According to the American Journal of Managed Care – the sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, demonstrated that the rate of response to an initial antidepressant was 49.6%, which regressed with increased treatment. Annual medical costs for patients non-responsive to treatments were nearly $10,000 more than those for those in a reasonable metabolic response range. Patients suffering from ineffective treatments also faced higher rates of suicide ideation and suicide attempts – and higher severe adverse events and side effects. Genotyping can significantly reduce treatment costs and shorten hospital stays according to Basic & Clinical Pharmacology & Toxicology.
The benefits of precision medicine and genetic testing in support of preventative health have not escaped large underwriters in the healthcare industry that serve veterans and active military. According to the 2nd issue of the 2017 of the Humana Tricare publication “Health Matters”, PGx testing is being expanded for Women’s early detection health, targeting BRCA1 and BRCA2 for breast cancer screenings. Other tests available are cervical cancer screening (HPV) which has the potential to replace the more expensive and invasive Pap Smear. Many of these exams are being administered within a “covered” Prenatal or health promotion and disease prevention exam at no cost to the patient.
Other Tricare approved PGx panels are: Addiction, ADHD, Cardiovascular, Cystic Fibrosis, Mental Health, Pain Management, PTSD and Thrombotic Risk. This wide arsenal of genetic panels and PGx testing resources will assist the VA and large entities such as Humana, UnitedHealthcare and Health Net, battle the rising costs of unnecessary and ineffective medical treatments for Veterans.
It’s perplexing, in spite of the scientific evidence, that most doctors adhere to traditional methods to prescribe medications and dosages without considering the patient’s genetic information. In an effort to battle the escalating costs and danger of ineffective and negligent medical practices, patients and providers searching for solutions may soon discover that Pharmacogenomics is the path to the metric of precision science and clinical accuracy.
At the end of the day, healthcare is personal. So perhaps one should ask, do I continue to continue to trust the old clinical methods of uncertainty and disclaimers or rely on the cutting edge science of precision medicine and knowledge?
This article is sponsored by: YourGeneTest.org educational website for doctors and patients. YourGeneTest.org says that “Only by knowing the comprehensive genetic profile of the patient can providers be relatively confident that the patient’s risk of adverse and potentially critical interactions between medications be minimized”. Different genes regulate how fast or slow various drugs are metabolized. Some people metabolize certain types of drugs very quickly and some people very slowly, which can cause problems with side effects and toxicity. In other words, knowing the genetic code of a patient functions as an “owner’s manual” that a doctor can use to prescribe safe and effective medications the first time without trial and error. For more information on how to request PGx testing for patients and medical providers, go to: YourGeneTest.org
This article is composed by:
Dr. Charles Sailey, MD, Medical Director of Molecular Testing Laboratories, Board Certified in both Clinical Pathology and Molecular Genetic Pathology. He also holds dual Master of Science degrees in Cell Biology and Biotechnology. Dr. Sailey may be contacted at: CSailey@MolecularTestingLabs.com
David Yates, Director of Business Operations for 3D Healthcare, Consultant for Clinical Integration and Management of Genetic and Toxicology Testing resources. He holds a Bachelor of Business Administration in Entrepreneurial Studies and Marketing from Baylor University. David Yates may be contacted at: David@3DHealth-care.com
In Search of the Elusive Underwriting Metric of Clinical Accuracy