In this episode, I introduce a podcast refresh. Ethically Sourced is moving to its own show entitled, “Curbside Ethics”. This is a noun as well as a verb.
Additionally, I discuss the revolutionary, new medication for Alzheimer’s Disease that was recently approved by the FDA, “aducanumab”. This medication brings into question multiple ethical issues. There are concerns about the research that developed the risk, benefits and side effect profiles. Additionally there is a question of resources as the medication is extremely expensive and may have a profound effect on Medicare funding.
Thank-you for following along during these exciting times. Stay tuned for your opportunity to subscribe to “Curbside Ethics.”
Transcription:
Hello, i’m Dr Steven Bradley and a cesil is and clinical medical episode. I am the host of the black doctor’s podcast, i’m also the host of the podcast, formally known as ethically sourced. That’s right after six months, i’m actually going to make some changes in the new name for the podcast is going to be curbside ethics. We’re going to go ahead and split. This show out from a backdoors. Podcast have entirely new host and server for the program. Thank you so much for following us this long and please continue to follow us as we make this transition this week on. Curbside ethics were looking at some of the ethics involved in this new medication. It just hit the market. If you didn’t know, there’s been a revolution in the world of all cymer disease and after about a twenty year period, with no innovations or no significant innovations that food and drag administration just to prove this new azymes medication, it’s called aghel. The generic game is i ad kinney map and it was developed by a company named biogen. The estimated yearly price tag for this medications about fifty six thousand dollars. There was a lot of concern with the approval of this medication. There’s concerns about the effectiveness of this drug. Some of the side effects some of the research that went in to bring this drug to market and serious concerns for the patients and for the people that are ultimately going to pay for this medication, regiment, all timer disease. It affects about six million americans and a lot of them. It is an older patient population, so people that are over sixty five years of age in our eligible for medicare. So hence the the significant cost concerns essentially there’s talks of this draining the coffers of medicare or at least putting a significant financial strain on medicare funding. It’s hard to know exactly how many medicare beneficiaries will take the medication, but even conservative estimates would lead to a significant increase medicare spending if just one quarter of the current medicare beneficiaries are prescribed agie. This would be about five hundred thousand bit of fisheries. Medicare would pay about a hundred three percent of fifty six thousand dollars in the near term. Total spending for that one year would be almost twenty nine billion dollars paid by medicare and paid by the patient. All this drug that amount far exceeds a spinning of any other drug as covered under betica part. Be your party, so definitely a significant concern about the financial impact and the ethical issues that were raised over the food and drug administration and their decision to approve as medication. So there were several trials that biogen sponsored i’ll, try to kind of summarize what went down and how it happened. Back in two thousand and sixteen on the cover of nature magazine, there was in a headline that read targeting amali, so amelot is a protein and it makes up these plates that are found in patients with all samers disease and are bought to contribute to the decline and memory and kind of dive abilities. So this medication this is ponakonta. Anybody that has been developed, is going to target and fight the development of these plaques biogene. The company launched to clinical trials to study the effects of this new medication. The food and drug administration actually allowed biogen do skip a crucial step in the drug development. They skipped the face to trial, which is where you learn and confirm the study to assure that the final stage of of testing is completely accurate. The face to results you can learn how to dose a drug, appropriate level and amount to achieve the right balance of safety and benefits, and this is incredibly important for the development of that occasion. So, by skipping face to the pace three trials didn’t have as much information going into them as they should have. They didn’t have good information about the effective doses of the medication as they worked on a rolling participants in these trials. Biogen, the company continue to learn more about dosing and they actually had to change the instructions and how they were dosing medication. Some patients that had a certain genetic mutation were more susceptible to side effects and complications, toke medication, as opposed to others, as they were continuing to crunch this information. This data, the interim data analysis, was determined to be futile essentially, and the word is tossed around a different circles. So in medical ethics, there is futility of care that needs to be better described and broken down when it comes to typically comes down to not offering additional medication during event just to prolong life. However, in this part, you’re seeing a merger of the business side of medicine, or actually i ave medicine, the industry that the pharmacy industry and for them futility kind of means, this is no longer cost effective, they’ve sunk, some cost into research development, but as they get data back to these clinical trials, they’re saying hey, this doesn’t really work and the low tinted success means we’re going to lose a lot of money on this. Companies will defend this concept, as this is a part of their business research and their economics every day that you’re working on these clinical trials, the companies paying money they’re using time. So if it’s not going to work out, it doesn’t look promising they’ll cut their losses and move on to the next drug. Unfortunately, especially when you’re looking at science, when you stop these trials early due to various reasons- usually u sapotille. If it shows that the medication or nimesio works fantastically well or if there’s terrible terrible side effects, you can stop those trials and those are due to patient safety and outcomes. If you stop these trials due to kind of the financial risk, benefit, you’re left with some incomplete data sets, and this can really have a negative impact on the research for these medications. Skipping that phase to and then performing is futility. Analysis led to a series of other events which affected the development of bringing this drug to market in two thousand and nineteen. In march, o thousand nineteen by i announced that, due to this futility analysis, they were going to shut down these clinical trials. There was a commensurate dropped in the price of biogen stock and, of course, this drug i do canny map was finished, then, all of a sudden it came back on the market or it came back into a talk of researchers and laboratories and the three months between when they stopped the datasets for futility, analysis and the announcement of the result. They received additional data which they were able to put back into this data set. They kind of crunch the numbers massage and if you will in after about seven months after they said they were going to stop pursuing this medication, they change their mind in the stock prices, shot right back up, essentially what they ended up doing was taking some of the information that they had now. Typically, when you have these products that are considered futile, you can abandon that data, but what they did was take. That data add some additional data that they had from continuing the trial and you’re able to get a much different result that made the risk benefit profile, much nicer, and they were able to present that date to the food and drug administration. At a meeting in november, the advisory committee reviewed the application and honestly they all voted overwhelmingly. There was more people on this committee that advised against a provins medication that approved then a then boned to approve is medication. What some of the studies found- and they knew this going into it- was at an increase dose of this mocolane body could increase the risk of some patients to have baseen candela in the brain, which was seen using a specific type of imaging study. So they had the data that this was a complication that could occur with higher doses. However, with a new day to they were able to add, they re wile to contrive kind of a result that was more minimal for the food and drug administration to end up approving it sobbed to it the top to thirty five percent of patients actually see in his complication and studying the new day that they present it in november, the committee voted against recommending approval. The boat was one yes for approval, eight nose and two uncertain recording. Accordingly, the fda should have taken this bo consideration. We decided whether or not to prove the drug, whoever they still decided to move for with a provens medication. Again now the brought overview of his concern is you have a company in s clinicians? We have to decide what do we do with the information that we currently have based upon the research? I don’t have all the data in front of me to determine fully whether it was connected ethically there’s other people that should be keeping on on that. To be honest, but take the information that we have and look at the risk benefit profile. Are the patients that we’re seeing an increased race for complications is had effects? Would we or should we restart, or should we start this medication for our patient population? Is this an appropriate use of resources? All those are questions that will come into play. The patients are going to come into the office because they will get in some direct o a super marketing, especially with this new incredible advance. Quite a quote: in the field of all syme’s treatment and as positions, we have to be aware of the issues around in these new medications. So what are your thoughts when it comes down to drug development and the ethical nature of of doing so? You er anything else on this medication. What are you? What would you do for the patient sitting in front of you? Thank you so much for joining us on this episode of curb side ethics tune in next week for another episode, where we seem to ve tools to make equitable and ethical decisions for the regarding the health of your patients and mater stephen. Rather your host to day next week