This is a good article on combating opioid misuse.
Now read this: Pharmacies are dispensing 245M opioid prescriptions every year! This begs one question: Since there are better totally reversible alternatives with no or little side effects such as medical devices, why are we considering opioids for therapy at all?
The excuse: Medical devices are expensive. No, not any more. There are very low cost, fully programmable platforms one can adopt for any indication and go.
We all need to do our part to combat opioid misuse.
Researchers at King’s College London in the UK have recently looked at tDCS (transcranial direct current stimulation) as a potential approach to improve cognition in patients with schizophrenia. The results are promising.
A new study is recruiting participants. The study aims to provide non-Invasive therapies for people with spinal cord injury. Click here to read more.
Obesity and related illnesses claim more than 400,000 lives and account for $150 billion in annual spending on health care in the U.S. alone.
Currently, the only effective, long-term therapy is surgery, such as gastric bypass or gastric banding, which can carry serious risks.
The procedure to implant a gastric electrical stimulators however, are less invasive and offer a simple solution: These can be used to slow the pace at which food empties from the stomach, thereby creating a sensation of fullness and reducing the amount of food consumed.
Obesity is a major worldwide health problem. In the United States, about one-third of the population is obese and more than 15 million patients face such serious health risks from morbid obesity that they need treatment.
Electrical neurostimulation may be the solution many patients have been awaiting globally as a low risk and reversible alternative to dangerous surgical options.
Nature uses fractals everywhere. For instance, bronchial trees transfer oxygen to the bloodstream, trees absorb sunlight, and coastlines to disperse wave energy very efficiently by their natural fractal geometries. Learning from the nature, novel fractal electrode designs' large surface areas increase their capacity to hold electrical charge, which in turn generate larger electric fields than their non-fractal counterparts.
According to a recent research, fractal electrode designs outperform Euclidean geometries and may improve patient outcomes in neuronal stimulation.
FDA voted 22 to 1 in finding that a Company's New Drug Application for abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time!
The committees also voted 19 to 4 that the Company has not demonstrated that the medication has properties that can be expected to deter abuse by the intravenous route of administration and 23 to 0 that there are not sufficient data for the medication to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration.
One major reason why neuromodulation devices aren't more widely used is because legacy products are still expensive, costing anywhere from several hundred dollars to tens of thousands of dollars. Insurance covers the cost of some therapies, but not all. Naturally, it is also easy for insurance companies to hide behind the National Coverage Determination (NCD) for Electrical Nerve Stimulators.
Today, there are invasive or non-invasive medical devices that promise to fight pain without opioids and the cost of these devices are coming down rapidly. Further, full-featured, fully-programmable platforms accelerate medical research without having to invest top dollars and time to develop purpose-built hardware.
With tens of thousands of people dying every year and with lower cost of modern devices, it is time to say "enough is enough" to opioid addiction. We must stop thinking of pain control as just being about opioid medications.
Statistics from the Centers for Disease Control and Prevention (CDC) show that 33,000 people died in 2015 as a result of an opioid overdose. The report indicates that more than half of these casualties were due to prescription painkillers. The mortality rate is expected to keep climbing, as there are more than 2 million citizens hooked on these medications.
FDA finally says it is updating its policy on opioids, since 90 percent of the 200 million opioids prescribed in this country are for short-acting medications, like oxycodone and hydrocodone.
So, what exactly is being done?
Food and Drug Administration (FDA) has announced a plan that will force more painkiller producers to provide training for the health care community. Is it enough? It is better than nothing…
However, the National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7), Section B, paragraph 2 still reads: “The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain”.
Over the last decade medical device technologies have advanced significantly, with smaller, safer, and lower cost devices. It is now possible to measure nerve signals for closed loop therapy modalities. Devices with IoMT (Internet of Medical Things) capabilities allow doctors to reach out to their patients anywhere, anytime for personalized care.
So, in addition to educating the heath care community, why are we not abolishing the archaic guidance NCD 160.7 as the highest priority and make medical devices as our first line of defense for pain management?
The Medical Device Single Audit Program (MDSAP) is an international initiative designed to harmonize regulatory efforts globally.
From January 2014 to December 2016, FDA and international partners participated in an MDSAP pilot program. In June 2017 a report was generated summarizing the outcomes of prospective proof-of-concept criteria established to confirm the viability of the Medical Device Single Audit Program. Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot has demonstrated the viability of MDSAP.
In the United States:
FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. It will reduce the number of inspections by the agency, improve the efficiency, and consistency of audits across the industry.
On January 1, 2019, Canada will require companies selling Class II, III and IV (Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC, and class IV generally corresponds to Class III, ECD) medical devices and IVDs to have a MDSAP certificate to maintain their Medical Device Licenses. MDSAP will replace the current Canadian Medical Device Conformity Assessment System (CMDCAS) as a way to demonstrate quality management system compliance to ISO 13485 and the Canadian Medical Devices Regulations (CMDR).
According to a 7.5 year study by Dr. Simon Thomson et al., satisfaction with SCS was high with 92% of patients stating that they would have it all done again for the same result. Further, 96.4% of patients would have wanted SCS as a treatment option earlier!
So, why do we still resort to opioids?
Lone Star NeuroMODULATION
LSN is targeting unmet clinical needs by creating disruptive device platforms that offer promising solutions for lowering costs, realizing higher returns and effectively addressing more therapeutic indications if adopted for medical applications.