Welcome to this month’s Comp Medical News recap. An unexpected rise in the U.S. death rate, personalized medicine through genetic testing, and synthetic drugs are your headlines for July 2016.
First, medical technology – genetics and experimental treatments – gain regulatory traction:
Genetic Testing Could Improve Care and Lower Costs
Up to 70 percent of patients show partial or no response to commonly prescribed drugs, which can lead to non-adherence to a treatment regimen. The estimated annual financial burden due to nonadherence in the U.S. is about $300 billion. Further, the Centers for Disease Control and Prevention (CDC), estimate that drug adverse reactions cost the U.S. health care system approximately $3.5 billion annually. New research is coming close to making genetic testing for drug effectiveness a reality, with groups like the Clinical Pharmacogenetics Implementation Consortium (CPIC) identifying genetic factors that play into prescribing decisions for opioid and antipsychotic medication.
Read more about the effort via Workers’ Compensation 360 here.
FDA Eases Access to Experimental Drugs for Terminal Patients
The FDA has reduced an obstacle from its compassionate use policy, streamlining paperwork that physicians must submit in order to obtain experimental drugs for patients with life-threatening illnesses. Doctors will now file an application for FDA approval that contains eleven questions, less than half of the number on the older form. Further, as NPR reports, the new form is simpler because it was designed for individual patients, replacing an all-purpose format that had been used by doctors acting on behalf of individuals or groups of patients. However, doctors still must first obtain a letter of authorization from the drug’s manufacturer and the FDA cannot compel drugmakers to grant permission, which is just one of several major obstacles for terminally ill patients seeking entrance into clinical trials.
Read more from NPR and Kaiser Health News here.
Next, the national opioid crisis influences policy and research as frightening statistics continue to roll in:
U.S. Death Rate Increases for the First Time in a Decade
Experts were surprised at recent government statistics that found that the death rate rose in 2015 for the first time since 2005; drug abuse was named as a major factor. The national death rate increased to 729.5 deaths per 100,000 people in 2015, up from 723.2 in 2014, according to the National Center for Health Statistics. According to a New York Times report on the data, this is one of the few times in the past 25 years that the rate has increased. A bad flu season pushed it up in 2005, and AIDS and the flu contributed to a sharp increase in 1993. In 1999, there was a minor increase.
Chronic disease kills more Americans than anything else, so analysts identify small changes in those stats as most likely to affect the whole. Heart disease death rates, long in decline, were basically flat in 2015, which meant that increases in drug overdose death (especially among whites) became much more significant at a rate of 15.2 per 100,000. Deaths related to Alzheimer’s and by suicide also edged up.
Read more here.
DEA: Synthetic Drugs Like Fentanyl Pose an “Unprecedented” Threat
The DEA identified designer drugs, especially counterfeit painkillers like fentanyl (similar to that which killed Prince) as enemy number one in the fight against drug abuse. In the face of an opioid crisis that shows no signs of abating, DEA Chief Chuck Rosenberg told a U.S. Senate committee that the agency is “playing catch up” and needs funding to discover and enforce drugs as they become synthesized and enter the market. More than 11 million people illegally consume prescription painkillers for non-medical purposes each year, and overdoses are likely to increase as fentanyl is introduced to that market. Michael Botticelli, President Obama’s drug czar, echoed Rosenberg and stated that the administration supports legislation that would broaden prosecutors’ ability to cite sales strategies as evidence when prosecuting synthetic drug manufacturers, especially manufacturers who claim their drugs are not intended for human consumption but clearly market them as such.
Read more via Reuters here.
Obama Administration Reduces Barriers to Medication Assisted Treatment for Opioid Addiction
Health and Human Services Secretary Sylvia Burwell announced new rules today (July 6th, 2016) to loosen restrictions on doctors who treat people addicted to heroin and opioid painkillers with the medication buprenorphine, commonly known as medication assisted treatment. Doctors who are licensed to prescribe the drug, which is sold mostly under the brand name Suboxone, will be allowed to treat as many as 275 patients a year – almost triple the current limit of 100. HHS estimated that as many 70,000 more people may have access to the drug as a result of the change.
Read further coverage via NPR here.
Lastly, a group of doctors has a new idea to treat medical guidelines more like legal opinions:
Should Medical Guidelines Include Dissenting Opinions?
Pieter Cohen, MD, of Harvard Medical School; Michael Hochman, MD, of AltaMed Health System in Los Angeles; and Rachael Bedard, MD, palliative care fellow at the Mount Sinai Hospital in New York produce “Updates in Slow Medicine” about the latest research in medical care. In this editorial, the trio argue that dissent could be a positive addition to medical guidelines and, rather than undermine their authority, help doctors participate in “shared decision making.”
Read the piece via MedPage Today here.
Image Credit: Illicit fentanyl seized by Calgary Police via VICE