FDA Expands Indication of Antiviral Therapy to Include Post-Exposure Influenza Prevention
November 23, 2020 09:45pm
Dr Sarath Malepati discusses the benefits of the 5-day immune support pack in combating antibiotic overuse.
Antibiotic resistance has become a worldwide problem rooted in the overuse of antibiotics. Over the past 70 years, these antimicrobial agents have helped to successfully treat patients with infectious diseases, but improper and overuse of these drugs has allowed bacteria to become resistant. Each year, approximately 2 million individuals in the United States are infected with bacteria that is resistant to antibiotics, according to the CDC. Of these, at least 23,000 individuals die each year as a direct result of their infections.
In an effort to curb the overuse of antibiotics—–particularly in upper respiratory infections––and combat the emerging superbugs, Sarath Malepati, MD, creator of theEZC Pak, spoke withContemporary Clinicin an exclusive interview regarding the benefits of the formulated tapered immune support pack and its benefits in managing viral infections.
CC: Could you explain what the EZC Pak is?
Dr Malepati: EZC Pak is an echinacea, zinc, and vitamin C immune support pack that’s physician formulated and is positioned and marketed against inappropriate antibiotic prescriptions for upper respiratory infections.
CC: What prompted you to create the EZC Pak?
Dr Malepati:I'm a general surgeon, and I used to be a faculty member at Georgetown University Medical School in Washington, DC. While there, I was also health care policy researcher at the National Institute for Health Care Management. I deal with a lot of complex infections—infections that either require quite a bit of care in terms of wound management or infections that increasingly have become a larger part of my practice, which are multidrug resistant infections or infections that can’t be treated with conventional medications orantibioticsand ultimately require surgical intervention.
One of the infections I deal is calledC. difforClostridium difficile. When I was in medical school, they said you may see 1 or 2 cases of end-stageC. diffover the course of your career. As I entered into practice, I probably see end-stageC. diffor what they refer to as toxic megacolon, somewhere between 5 and 10 times a year. It’s stunning that this has occurred.C. diffis actually a normal bacteria in your gut; however, when we take antibiotics for whatever reason, the antibiotics don’t kill selectively in those particular areas. If you have a sinus infection or an ear infection and you take an antibiotic for it, it doesn’t just kill the bacteria in your sinus passages or in your ear canal; it will also kill other bacteria. Those bacteria get killed in other parts of your body, like your gut, and soC. diff, which is normally kept in check by other bacteria, ends up proliferating. Nowadays, the strains ofC. diffhave gotten so aggressive and so virulent, that more and more people are ending up in the operating room as a result of taking an antibiotic for another issue.
I was looking at this problem withC. diff, and I was finding that, when I looked at the CDC data, my personal experiences in my practice were actually similar to the experiences that other people were having around the country, nationally.C. diffwas on the rise, and the number of people who are dying fromC. diffhas risen at a very alarming rate. I started to look at what the problem is here: why are we writing so many antibiotics that are resulting in people getting these weird infections? And it wasn’t justC. diff; it was other infections like MRSA and things of this sort that I deal with.
So it was really just globally looking at why are we having these issues of antibiotic resistance and why are the number of infections that we’re seeing nowadays not amenable to conventional antibiotic treatment. I started looking at where this problem was occurring, and it was interesting to me to find that upper respiratory infections—–which are the most common infections in people––are one of the areas of greatest inappropriate antibiotic use. I came across a study, [which showed that] over 80% of upper respiratory infections are viruses, which means they can’t be treated with an antibiotic. Antibiotics only treat bacterial infections. Yet when you look at the data, we write in the US over roughly 260 million antibiotic prescriptions a year just in the outpatient setting alone; and of those, 260 million prescriptions are for a population of America that is only 310 million, we’re writing over 8 antibiotic prescriptions for every 10 Americans. And that’s just in the outpatient setting.
WebMD did a study in 2014 that looked at asking doctors of their antibiotic prescribing patterns, and in that study, 95% of providers in the US admitted to writing antibiotics when unclear of the necessity. The number one cited reason for writing antibiotics that are unclear of the necessity was patient expectation.
Looking at that in terms of what I was dealing with in the hospital and seeing where the different buckets are, where these inappropriate antibiotic prescriptions were happening, in the case of upper respiratory infections primarily in the primary care clinics, urgent care settings, and emergency rooms, this was a huge area of inappropriate practice, a huge area of inappropriate health care expenditure that was actually resulting in new diseases. Either drug resistant infections or other superbug infections, such asC. diff, were what I was dealing with.
We need more clinical tools or tools for when patients come in demanding antibiotics that they don’t need. We need more tangible tools to deal with this problematic interaction, and we need more education materials. And so that was kind of the birth of EZC Pak—designing a tangible tool that empowers clinicians while also educating patients on the difference between a virus and a bacteria, when an antibiotic may be clinically indicated and when it’s not, what the consequences are of takingantibiotics that are not indicated, and the value of immune support when you get these types of illnesses.
CC: How does the EZC Pak work?
Dr Malepati: EZC Pak is a physician-formulated immune support pack composed of echinacea, zinc, vitamin C, and it’s based on the best available clinical data in the management of upper respiratory infections, colds, and flus. Each of these components has different properties that help nutritionally support a patient’s immune system when they get one of these types of illnesses.
While there were many products in the market place, many of the products that I was looking for were products that, in a sense, were basically sugar pills. They may have a trace amount of a certain mineral or a trace amount of a certain herb, but the quality of the ingredients was not particularly good, and it wasn’t based on what we actually knew in the larger data sets in terms of what is actually effective for a cold or flu.
Echinacea is an immunostimulant, and it helps increase or enhance T cell activity; zinc is widely prevalent across different functions of our body, especially in the immune system; and vitamin C also has a certain role to play in supporting our immune systems healthy function. Vitamin C also has an antihistamine effect as well, so it’s a common reason why patients take vitamin C when they get colds and flus. But vitamin C, one of the things symptomatically patients do have is an improvement in their congestion and they take vitamin C as a result of this antihistamine effect.
CC: What suggests do you have on how clinicians can present the treatment to patients who insist on receiving a course of antibiotics?
Dr Malepati: Say to the patient, “At this time, I don’t think the infection warrants an antibiotic, but I do think that you could receive benefit from taking an immune support pack to help support your immune system and clear the infection.” Then provide them with the EZC Pak.
The EZC Pak is a 5-day tapered dose pack. Patients can follow the instructions as directed on the pack, and a majority will get better within that 5-day window. The idea here is that by having that 5-day pack, it provides a critical safety valve for the provider as well as the patient. If [a patient has] spiking fevers or they're getting clinically worse while taking EZC Pak—–and are in fact taking it correctly, as well as resting and hydrating to help support their immune systems clearance of the infection––then they can either ask the patient to come back in 5 days or to give them a call to return for a repeat evaluation. It’s really providing a directed manner in which a clinician can deal with a very problematic interaction.
CC: Why are physicians overprescribing antibiotics?
Dr Malepati: Why are we writing so many antibiotic prescriptions? Why are so many doctors admitting to this known practice? When you look at it, they actually write more antibiotic prescriptions as the day progresses because as they get more and more demands, they get what Jeff Linder at Brigham, calls “decision fatigue.”
As the day wares on and more prescribers are being asked for specific antibiotics that are not indicated, they just end up writing more and more antibiotics because they just get tired. I was at a meeting recently, and a family doctor came to me and told me that she stopped going to work during the flu season this year because she was just so tired of patient requests for antibiotics for viral illnesses.
The EZC Pak creates a tool that takes interaction that is often awkward and problematic and provides an empowering solution. There’s a provider pad that comes with the EZC Pak that provides patients with further instructions that they can take home. There’s also some patient handouts and educational materials that help teach the patient the difference between a virus and bacteria, and some of the impacts that they’re having by taking an antibiotic that they don’t need on a global level.
CC: Where is the EZC Pak available?
Dr Malepati: Primarily in medical offices and independent pharmacies. We launched in the domestic market this past year. Earlier in the year, we won the National Cold & Cough Buyer’s Choice Award, and we’re growing at a pretty fast rate. Primarily our biggest areas of growth have been in the Northeast, which will continue through this Fall, and then we’ll be launching in some regional food drug chains as well.
CC: Are there any available data supporting the efficacy of the EZC Pak?
Dr Malepati: Those can be found at ezcpak.com/data. Some of the highlights include a 77% symptom resolution within 2 days [and] 94% within 3 days. To give you some comparison, the average cold typically lasts somewhere between 3 and 5 days, and the typical flu lasts 7 days or more. So we have shown a reduction in the duration of symptoms as well as a significant reduction in the number of antibiotic prescriptions written. In patients who did not meet criteria for an antibiotic in the initial presentation, we reduced antibiotic prescriptions to less than 5%, with an over 90% patient satisfaction rating.
Some of the concerns clinicians may have is whether the patient be satisfied if they get the [EZC Pak] when they ask for an antibiotic. At least in what we’re finding, the answer seems to be a pretty resounding yes. Patients wantsomething, and that’s why they’re coming—they want to feel better. And that was also kind of reinforced by some of the things that came out of the WebMD study. Patients said they figured the antibiotic would make them feel better—that theycould get back to work faster. They didn’t know that there were really any consequences to taking an antibiotic that they didn’t need.
CC: What do you want patients and clinicians to know?
Dr Malepati: We're a national partner of the CDC's “Get Smart About Antibiotics” initiative. We really went through and worked on looking at the data clearly. While there can be a lot of generic products, as I mentioned, [many] of those products were [ultimately] sugar pills and I didn't feel personally comfortable recommending them. So the product is really designed to deal with the psychosocial, economic, and cultural factors that contribute to inappropriate antibiotic prescribing and use. We're continuing to move forward in helping to reduce the inappropriate use of antibiotics.
For more information on the EZC Pak, please clickhere.