Episode 8
Denying acknowledgment of adverse drug reactions and lack of FAERS reporting
In the first of three mini-episodes, Heather and Lee recap lessons learned from previous guests Dr. David Healy and Dr. Charles Bennett, and look ahead to forthcoming episodes with Andrew Marriott and Dr. Beatrice Golomb.
TRANSCRIPT
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Heather: OK, so, Lee, we haven’t been able to chat lately but I wanted to make sure that we caught up on a few things. So we’ve had quite a few podcasts posted, have a few more coming up that are almost ready to go to post on the Know Risks site.
It was really striking to me — and I want to get your feedback on it too — but a theme that’s come up, even with some of the experts in the field that we’ve had on, has been this idea of just the acknowledgement after you have an adverse effect from a specific drug. I just thought that was really, really, you know, important. I knew that from the struggle my family went through, more so the struggle my son went through, trying to get health providers to acknowledge it. Unfortunately for me, that didn’t become evident until after his death, and just looking at the records and it being noted over and over again. Just kind of thought we would share some thoughts about that.
And I know you went through that too with Charlie.
Lee: Yeah, I agree. I think that the acknowledgment is a big problem, but more importantly, even once it’s acknowledged, I didn’t know for the longest time — and I had to do quite a bit of digging — where to report it, because if people aren’t reporting these symptoms or side effects, then there’s no record. It’s that reporting that actually will hopefully create change. I mean, that’s what the process is supposed to be, the adverse drug reactions reported to, say, like the FDA or in, you know, my scenario would have been Health Canada. I think people don’t know to do that, they’re not informed to do that and, most often, it’s my understanding that none of the physicians that we were dealing with actually reported it.
Heather: Yeah, it’s kind of like a circular issue here because I don’t think the duty to report should be on the patient. Certainly, if it’s a minor adverse drug reaction and they’re able to, yes, there should be more awareness on how to do that, but really, the responsibility for reporting should be on the health provider. And the health provider — if a health provider won’t even acknowledge that the harm is connected to the drug and won’t acknowledge the patient’s complaints and, you know, if you have a patient proffering this, “I really believe everything, to me, correlates with this drug,” I mean, how do you — it’s just so tough. That’s why I know for — in the United States with the FDA the adverse event reporting through FAERS, and then there’s also a separate one for vaccines, but, you know, there’s some projections by academics that it’s for every one report, there’s 10 more. There’s other opinions in the field that it’s much, much higher than that. So I don’t even know how you extrapolate that. It’s just such a real issue.
Lee: Yeah, and my fear is it’s only going to get worse because now with what — everything that’s been going on in the last couple years, you know, with doctors that are speaking out about side effects, you know, to do with some of the stuff with COVID, and then being, you know, kind of like chastised or, you know, reprimanded for those kinds of things. People are going to be scared to report on any — any — side effects to do with any medication. It’s only going to get worse.
Heather: Yeah. If it doesn’t fit the mainstream kind of messaging, it will be difficult. I think there’s even been some laws passed in the States where — if you should divert from that, the mainstream medical opinion — whatever that might be; we don’t even know who comes up with that, I don’t think — but that there’s, you know, a lot of censoring of that, which is just — it just makes it so difficult to have any type of reliable reporting system. And we heard from David Healy, the way the random control trials are set up for these drugs, we’re not getting a reliable risk-benefit analysis from that because it’s looking at the benefit; it’s looking at showing the drug benefits some, you know, certain ailment. And what gets lost in that is any type of harm that might be cause to get to that benefit.
Lee: Yeah. I mean, I think too — I think we — you know, you just sort of said the onus should be on the medical professional, but, you know, similar to what we’re sort of advocating, as far as being your own expert, I really truly believe that people have to take these adverse reactions into their own hands and be the ones to figure out how to do this reporting. We should probably potentially just post on here or on our website the steps to take to report an adverse drug reaction, because I think the onus is going to have to be on each individual or there will be no record and then, as a result, it will be very difficult to get dangerous drugs off the market without any kind of reporting.
Heather: It just seems so unfair because you have consumers, patients; they’re given a drug; they’re not made aware of any type of risk-benefit analysis. And I do promote — that’s, you know, why we’re doing this — promote being your own expert. But you know, my goodness, for people who are harmed by a drug and then they’re left to try to navigate and, in many cases, they’re suffering horribly, like our children were, and there parents are trying to deal with it — you know, in your situation, in terms of reporting, Charlie was a minor — and dealing with, you know, this devastation that’s created by these adverse effects. It just does not seem — it doesn’t seem right. (Laughs.) And I think that’s what really frustrates me. And piled on top of that is a whole system — I mean, David Healy talked about the system from the top down — you know, industry, the pharmaceutical industry, the health care industry being violent. And that’s — you know, this is just another way because we’re not even — we can’t even rely on the information that we’re giving from our regulatory agencies, you know? And of course, I’m referring to here in the United States, but it’s just so frustrating, and, you know, I know it hasn’t been posted yet but it’s coming up soon, Dr. Beatrice Golomb saying — you know, brilliant, brilliant doctor, brilliant researcher. She has manuscripts that talk about some of these adverse effects that can’t even find homes in journals, so then there’s this whole system blocking the peer review process that gets you to the level where you have some type of, you know, validity in regards to looking into these adverse effects and how they happen and what’s causing them. So there is just this real concerted effort, it appears from everything we’ve learned so far, to really bury, you know, this information, which is frightening. And I do — I mean, I think one of the ways to expose that is, you know, what we’re trying to do through telling these stories and talking to, you know, different people who this has affected or who have worked in this field. But it is quite an uphill battle and it is quite a challenge.
Lee: Yeah. I think that we have to sort of encourage people to sort of not give up hope, try and use — you know, obviously the systems in place are not perfect; they’re all that we have now. And, you know, you and so many others that spoke at the FDA, and I know it was the same with the European Medical Association meeting that they had in I think it was like 2019 — you know, those did make — at least for the fluoroquinolones and the prescribing guidelines and black box warnings. So, you know, everything — there’s always a perfect,but I think that people do need to at least do the reporting for now, because it’s just the one thing that can be done, and if we could encourage people to at least do that with their side effects. You don’t need — I guess the one point is you don’t need a doctor’s validation of what you think has happened. You can report it and then it will go on record and it will hopefully be one of the numbers that, if there’s enough, will create that change.
Heather: Yeah. And I think we need to do that here. You’re absolutely right; we should get that up on the website so those people who are following us or who tune in can — really just stress the importance of that to make sure it happens. We could do our part in that. (Laughs.) Right?
Lee: Yeah. Every little bit counts.
Heather: Perfect. Well, we’ve got some great podcasts coming up and I hope you’ll join us to hear — tune in and hear some of them. And please, if you have a story to tell, reach out to our website. We have a place where you can get in touch with us and it would be wonderful if you could do that and we could share some more of the stories out there of some others who have gone through some of the issues that Lee and I have.