The pursuit of new medical treatments often hinges on the balance between the efficacy of the drug and the adverse effects it causes. A key part of that balance is deciding on recommended dosing for a given treatment.
Opioids provide an excellent example of the challenge in maintaining that balance and the risks of non-ideal dosing. 20% of patients experiencing pain are prescribed opioids even though the recommended dose of the drugs will cause 50-80% of patients to experience some serious adverse effects. OxyContin’s standard dose was discovered to wear off early for many leading some users to take dangerously high amounts.
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Alon Ironi Alon Ironi is the CEO and co-founder of Theranica Bio-Electronics, a bio-medical technology company developing advanced electroceuticals like Nerivio for migraine and other pain disorders. He received a Master’s of Science in Electrical Engineering from Santa Clara University, and a Bachelor’s of Science in Electrical Engineering from Technion – Israel Institute of Technology.
The problem with dosing is well known in the medical community. For instance, some doctors have advocated using much lower doses than recommended on product monographs in non-severe situations. Similarly, for cancer treatments, high dosing levels are being challenged as advanced treatments like immunotherapy gain popularity.
Problems exist on the other end of the spectrum as well. Nonsteroidal Anti-inflammatory Drugs NSAID’s are a common over-the-counter pain treatment and a 2018 study found that 15% of people took dangerously high amounts to reduce their pain. One explanation for the overuse was the lack of sufficient pain relief provided by the recommended dose. Taken in large quantities, the drugs can cause serious stomach issues.
A major reason for these dosing issues is that decisions are made on a statistical basis for large sample patient populations. The variability of these populations, including differences in height, weight, and ethnic background, make it unlikely that recommended doses will be ideal for everyone. Fortunately, as medicine is opening to non-pharmaceutical options, personalization is becoming easier. As a result, a new paradigm for dosing is emerging.
Personalized Medicine
Personalized medicine, a medical approach that optimizes both response and safety for individual patients, provides an alternative model to dosing that considers individual patient needs. For instance, 5% of the population do not get pain relief from codeine while others have it stay in the body too long due to their genetics. The ability to identify a patient’s genetics can help doctors make dosing decisions.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Unfortunately, genetics-based personalized medicine is costly and complicated for various reasons such as increased training and adapting electronic health records. An alternative approach is to allow patients to try different doses in cooperation with their physicians to discover the ideal balance. With pharmaceuticals though, this can mean delaying an effective treatment or exposing patients to adverse reactions and drug interactions.
Personalization Through Devices
One solution that is gaining popularity is to turn to non-pharmaceutical medical devices when possible. These devices allow for a far greater range of safe treatment options that a patient can adjust even during a single treatment. For example, several medical devices using electrical neuromodulation have been developed to treat pain, spinal injuries, epilepsy, migraine, and other conditions. The devices stimulate nerves through electrical pulses delivered at different intensities to treat the given problem. Essentially, these intensities are the doses, but because they are not interacting with the body as pharmaceuticals do, they allow for a wider range of treatment options.
More than just a new technological solution, the possibility presented by these and similar medical devices is significant. User-controlled customization of the intensity of each treatment will both engage users and create a far higher chance of finding an ideal dose for each patient. Chronic pain patients, who may be more reliant on frequent use of pharmaceuticals, could especially benefit as they are most susceptible to having to limit dosing even if it makes the therapy less successful.
Back to the NSAID issue mentioned above, it is very easy for patients to take a third Advil pill for pain relief without sensing the danger of overdosing. With devices delivering electronic stimulation, the feeling of intensity is an immediate sensational signal that places a natural limit on the “dose”, without any serious long-term negative effects. Patients can trust that they can take a high yet tolerable “dose” safely. If their issue is still not solved, they can go back to their doctor to try different treatments.
Conclusion
Personalizing dosing is the future of treatment development. Allowing for individual patients to select their ideal dose will improve outcomes and reduce adverse events. Some aspects of personalization, such as seamlessly incorporating a patient’s genetics into dosing decisions, is still too costly to apply widely. However, we can create new treatments that give patients more control and safe choices, such as those provided by medical devices.
Pain’s ubiquity and its ability to be treated through medical devices make it a perfect target for this new approach. As with any new paradigm though, we need to educate patients and medical professionals about this new possibility. Furthermore, we need to lower costs and improve insurance processes to make sure that they are available to everyone.
If we do so, we will not only support patients (or customize treatment), but we will also improve outcomes and save money by avoiding adverse events.
Photo: Olena Agapova, Getty Images
Alon Ironi is the CEO and co-founder of Theranica Bio-Electronics, a bio-medical technology company developing advanced electroceuticals like Nerivio for migraine and other pain disorders. He received a Master’s of Science in Electrical Engineering from Santa Clara University, and a Bachelor’s of Science in Electrical Engineering from Technion – Israel Institute of Technology.
