The Skinny on Weight Loss Injectables: A Deep Dive into Benefits, Risks, and Legal Battles

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[00:01:00] Hello and welcome to the Ask Nurse Alice podcast. The show where all things health and wellness take center stage. I'm your host, Alice Benjamin, clinical nurse specialists and family nurse practitioner in my mantra is, I like to talk to people before they become my patients.

[00:01:20] In on today's show, we're going to take a deeper dive into a topic that has been making headlines and stirring conversations across the globe, across health and wellness communities.

[00:01:32] And that is a topic of weight loss injectables. We're going to explore how they work, the benefits, the side effects, the growing concerns for their safety and what has led to the rising number of lawsuits.

[00:01:46] So let's start from the beginning, shall we weight loss injectables, often known as GLP1 receptor agonists. These have been hailed as a revolutionary approach to managing obesity.

[00:01:56] They work by mimicking the actions of hormones that target areas of the brain involved in appetite regulation, which can lead to decreased hunger and consequently weight loss.

[00:02:07] But as with any medication, there are definitely potential side effects. Now these can range from minor side effects including nausea, vomiting, diarrhea, minor intermittent, right?

[00:02:19] To those that are more severe and more constant, nausea, vomiting, diarrhea, pancreas, hiatus, gastroparesis, kidney problems, so many other GI side effects.

[00:02:30] And recently, there's been an uptick in the discussion about the long term safety of these drugs, sparking not only debates but lawsuits. Originally, ozemic was not designed to be an anti obesity drug. Instead, semi-glutide, which is the active ingredient of it, when it was developed, it was intended as a diabetes therapy.

[00:02:50] So when ozemic became available to the public in 2017, it was approved by the FDA for the use as a drug to control diabetes. Less than a year later, after ozemic was released, researchers at the University of Leeds discovered that the drug could also be used to treat obesity. They were discovering weight loss in the people who were using it.

[00:03:10] So just a few years later in 2021, the FDA approved Wagovii, which is also a semi-glutide. And that was approved for long term weight management and adults who have at least one other weight-related condition.

[00:03:23] Now when we talk about ozemic and we talk about wagovii, these are the same medications with the same active ingredient semi-glutide. The only difference is ozemic is one particular dose, same strength.

[00:03:36] And wagovii, think of the W for weight, has an increased dose of the semi-glutide. So that's the difference between the drugs. Now, the drug quickly became a popular option for weight management in the United States and around the world. However, less than a year later, the FDA's adverse event reporting system had already received 10,000 adverse event reports about semi-glutide variants.

[00:04:02] Now when we talk about the FDA's adverse event reporting system, it's very important for people to understand that this is a reporting system that is available for all medications. And many, if not all medications receive reports about adverse effects or side effects.

[00:04:20] That's for a reason we want to hear. The FDA wants to hear if you have any concerns or feel like you're having any symptoms that could possibly be related to the drugs. And the reason being is that this information is tracked and trended, and it's evaluated by the FDA as well as pharmaceutical companies.

[00:04:37] That way, if trends are noted, a particular adverse effect is noted with the particular medication. Swift intervention can be made based on the data that it's collected. So it's important that people communicate this information not only with your healthcare provider but also in this reporting system.

[00:04:54] So you can imagine that you're going to have some reporting with any type of drug, right? Now when you take something like these weight loss injectables and then you see the volume of people who are taking these medications.

[00:05:07] If we're going to proportionately look at the percentages of people that report, it sounds like a large volume of people when you just refer to a number, when really we should be referring to this as percentages.

[00:05:19] So it sounds like there was an overwhelming response of adverse events reported and that may be proportionate to the number of people who are using that.

[00:05:29] Just something for consideration, but despite the large quantity of adverse event reports semi-glutide continued to be a popular weight management option for another two years.

[00:05:40] That is until on the scene came tricepatide, that's the active ingredient, or at least one of them for the medications, monjaro and zepbound.

[00:05:50] Monjaro for diabetes, zepbound is that for weight loss. Now before we dive deeper, let's take a quick break to hear from our sponsors.

[00:05:59] So now we're back where we were talking waggoli, a zepbic, zepbound and monjaro weight loss injectables.

[00:06:06] And the recent surge in lawsuits against the manufacturers, Novonardis and Eli Lilly, they are on the hook for these weight loss injectables and the many adverse effects that people are suing for.

[00:06:19] So to get back to the kind of the history lesson we were going through, walk up through kind of the historic parts of these injectables.

[00:06:26] Around 2021, mainstream news outlets started reporting on the alleged side effects of ozepic and the first lawsuits were shortly after that and then became public information.

[00:06:37] Now patients have reported experiencing severe side effects in these lawsuits. These patients were saying that at the time of prescription, they were not fully made aware of the potential or risks for severe adverse effects.

[00:06:52] Now that's scary. As a health care provider myself, before I start anyone on any medications and I'll take an all discusses weight loss injectables as well.

[00:07:00] Because I prescribed these and I've renewed these orders. It is extremely, extremely important that you make an appointment with your health care provider and have a discussion.

[00:07:11] Now if you want to do this by a virtual visit, that's fine. But you still got to be screened to screen with a provider.

[00:07:17] They have to see you, they have to talk to you and it's going to be very important.

[00:07:20] I prefer an in-person visit but because we need to do a physical, we need to talk to you about your medical history, family history, lifestyle, medication drawn and the other medical conditions you may have.

[00:07:36] Screen you to ask if you see your R-Canadied or not candidate for this as well.

[00:07:42] There's some baseline laboratory tests that need to be done to make sure that everything is squared away and it's safe to prescribe this medication.

[00:07:51] And then also as part of that face-to-face visit, I want to talk to you about what your plans are.

[00:07:57] I know that the plan is to lose some weight but what else are we doing? Because this should be something in addition to.

[00:08:03] So I want to talk to you about diet and exercise. Now I get it. There are some people who are limited with physical activity because of musculoskeletal issues, maybe they have arthritis, they have some other type of muscle joint disorder, perhaps there's a problem with balance, agility, flexibility, makes it very difficult to exercise.

[00:08:25] So I get that. Also eating, what are you eating? How are we managing the food intake? Are we eating the foods we should eat? Are we curving those that we should no longer eat?

[00:08:36] And how are we going to manage your eating patterns while you're on this medication?

[00:08:42] And then also let's talk about it when you start to lose weight. This is not just a oh I lost weight now I can eat more type of thing and do we need a nutritional consult?

[00:08:51] Because maybe there's some added value in connecting you with a nutritionist to talk about healthy food options. Listen, it's not a beneath us to want to talk to a nutritionist.

[00:09:00] I know it's like oh I'm 40 or I'm 50 and I know what I'm eating. Well sometimes we need a little reminders. We need some help and some creativity with trying to find foods that are healthy, nutritious and things that we're going to like as we're on a weight loss journey plan.

[00:09:14] Also let's talk about how you're managing your mental health. Are we managing it? Depression, anxiety, stress, PTSD, being codependent there are definitely things that we need to talk about that we need to support you with and equip you with a plan and support group in an opportunity to discuss how you're feeling, how you're managing these things.

[00:09:37] Maybe you are an emotional eater maybe you just went through a breakup and you're just sad and that's why you're eating more foods and that's why you gained weight. Now you're here wanting to lose weight when really it's really a mindset piece that we need to help you with if we can help the mindset we can help with you with your eating habits so there are other things that we need to look at so I definitely offer a mental health consult and then also sleep how are you sleeping? How's it going?

[00:10:01] We got to make sure you're sleeping well because hopefully you're exercising and you're getting tired. Also if you're having mental health, mental wellness matters that can be influencing your sleep and what happens when you sleep is that it regulates to your hormones, great little and leptin and those are very important when it comes to managing your weight.

[00:10:22] Those are responsible for satiety helping you to feel satisfied and then also managing the munchies. We want to manage those things when your sleep is dysregulated, those hormones are dysregulated and therefore those things that we talked about will be dysregulated.

[00:10:38] You won't feel full and you'll always have the munchies so we want to fix that and make sure you're getting enough sleep.

[00:10:43] And then we also know that sleep is very important for the immune system and as you're going through this entire process it's important that you might feel a little bit stressed initially as you're making these changes because I'm feeling comfortable.

[00:10:56] Right, you're doing something different, you're doing something new. It might feel hard, you might feel like oh my gosh, it's never going to get better.

[00:11:03] And so you're struggling with these things and we want to make sure that your immune system is as boosted as much as it could be during this process and sleep helps with that a lot.

[00:11:11] And feeling rest and restored, and just feeling your best, we want you to feel your best on this entire journey.

[00:11:17] So we're going to look at all of those things, diet, exercise, mental health, nutrition, get your nutritionist, talk about your sleep in addition to weight loss injectables.

[00:11:27] But also at that visit, when I'm talking to you and doing an assessment to make sure you're the right candidate for this medication.

[00:11:34] We're also going to talk about the pros and the cons of this medication.

[00:11:38] Listen, the benefits were like, ooh, I saw so and so taken and they lost a lot of weight.

[00:11:43] We know the research shows that it helps to lose weight absolutely.

[00:11:46] Now what are the cons? What are the risks? You may experience some of there's some expected side effects, right?

[00:11:53] The nausea, the vomiting, diarrhea, low abdominal pain, abdominal cramps.

[00:11:57] Minor intermittent shouldn't be anything that significantly impacts, negatively impacts your quality of life.

[00:12:03] But you might experience these things because this is what the drug is supposed to do.

[00:12:06] It's supposed to make you feel more full by slowing things down when things slow down.

[00:12:09] They sit in the stomach for a little bit longer so you might have these uncomfortable GI feelings, expected, minor.

[00:12:15] Still, please let me know because I want to keep my pulse on this.

[00:12:18] So if it's happening more and more and more what may seem to be excessive, we need to reevaluate.

[00:12:23] Should you continue taking the drug or perhaps if you've been able to level up on the drug and go a higher dose, maybe we need to come back down.

[00:12:30] Something that we need to talk about and monitor.

[00:12:33] Now also here are some very dangerous adverse effects.

[00:12:38] And if these happen, notify me right away or go to the emergency room but go seek help.

[00:12:43] Severe abdominal pain. I mean you're bent over.

[00:12:47] I mean it feels like you're just being stabbed, right? The pain is unbearable.

[00:12:51] Constant non-stop nausea, vomiting, diarrhea.

[00:12:55] Like you can't hold any food down like you can't even hold any nutrition down.

[00:13:00] Or it's just coming up either up to the mouth or out through the butt.

[00:13:04] Something like that we have to know you're going to need to be seen.

[00:13:07] We need to get fluids on board. We need to help control this.

[00:13:10] We need to identify what's going on and some of those might be related to gastroparesis or it could be an ilius.

[00:13:17] Things that are very life, could be life threatening and dangerous.

[00:13:20] We need to talk about those things.

[00:13:22] And some of the allegations in these lawsuits that people were saying that they were not made aware of the side effects or adverse effects at the time of prescription.

[00:13:32] This is why it's so, so, so important that whenever under any medication, prescription medication,

[00:13:38] you are under the supervision of a provider whether a physician, a PA, a nurse practitioner, somebody.

[00:13:45] Somebody's got to be watching you because if you're a modification we're going to have that in-depth meeting before you start.

[00:13:51] I'm going to connect with you once a month because the dosing is for once a week, for four weeks, right?

[00:13:58] As with how are things going, how are you feeling in an adjuvant?

[00:14:01] I'm going to run through the whole list in case you forget I'll hopefully going to prompt you.

[00:14:04] Things are going well, okay, well let's continue this dose at where it is.

[00:14:08] Let's get your body used to this.

[00:14:10] We don't need to just jump to a higher dose every one month.

[00:14:13] Let's start slow and go slow so it's something that your body can adjust to, something that your body's okay with.

[00:14:19] And then also by the way you should still be doing the diet, the exercise of therapy and the sleep and all the other things we talked about.

[00:14:24] So there should be some weight loss.

[00:14:26] Also at that one month interval, I'm going to ask you about your symptoms, I'm going to ask how things are going.

[00:14:31] I'm going to ask you about your diet and nutrition, exercise, how often you're exercising.

[00:14:34] And I'm going to ask you how much weight have we lost, right?

[00:14:38] It should not be just the medications responsible for the weight loss but the conglomerate of activities and things that we're doing to make this weight loss.

[00:14:46] And if we're not making the weight loss, let's reassess where are we?

[00:14:49] What's going on?

[00:14:50] Diet, exercise, mental health, not getting the sleep.

[00:14:52] What's going on that we can look at because it shouldn't just be the weight loss injectables as if that's the only thing that we can control or change.

[00:14:59] We can help manage and control and change some of the other things as well.

[00:15:04] So again patients are reporting not being aware of these severe side effects at the time of prescription.

[00:15:10] So these legal actions bring to light questions about the duty of pharmaceutical companies to ensure their products are safe and that the information about them is transparent and cohesive.

[00:15:20] Now let's talk about that.

[00:15:22] So what are the pharmaceutical companies responsible with patient education and making this information is where?

[00:15:28] I will say this and I know, don't nobody like to read the fine print, the prints too small, too much words on the page.

[00:15:34] I get overwhelmed with there's lots of paint words on pages so FYI find prints,

[00:15:38] a lot of big words, but it's there.

[00:15:41] It's there y'all, I promise you it's there.

[00:15:43] The information about side effects and adverse effects about the medication is there.

[00:15:48] It's on the package in turn, it's there.

[00:15:50] When you start the medication and talk to your healthcare provider, it should be there.

[00:15:54] When you go pick up the medication and they said, do you want to consult with the pharmacist?

[00:15:58] Pharmacist should be there.

[00:15:59] So there are opportunities to talk to licensed healthcare professionals.

[00:16:04] There is written material that is available to you now, whether you read it, I don't know.

[00:16:08] Whether you're having an in-depth conversation with your healthcare provider, I don't know.

[00:16:12] Whether you are having the pharmacist consult when you go pick up your medications, I don't know, but it's there.

[00:16:18] And if I can be honest and transparent because I love y'all, I really, really do.

[00:16:22] But I would be doing you a disservice if I didn't say this.

[00:16:27] Some of y'all don't want to talk to me.

[00:16:29] You just want the prescription.

[00:16:30] It is what it is.

[00:16:32] I've had patients come to me and tell me they want to lose weight and tell me exactly what medication they want,

[00:16:39] what dose they want to start at and where they want to pick up the pharmacy.

[00:16:42] Am I response to them through the medical system?

[00:16:45] Please schedule a patient for an appointment to discuss weight loss injectables and plan for weight loss.

[00:16:51] Yeah, that's what you don't get from me.

[00:16:53] If you've not been on this medication and you want to start this medication, that's what you don't get from me.

[00:16:56] But some of y'all decline the appointments.

[00:16:59] Why do I need an appointment?

[00:17:00] I want to start this medication.

[00:17:02] Ma'am, sir, we need to do a physical.

[00:17:04] We need to do a baseline.

[00:17:05] Why?

[00:17:06] Because I need to see you to make sure that's the safe and appropriate.

[00:17:09] I need to talk to you about lifestyle.

[00:17:11] We need to redo some labs to make sure that this is safe.

[00:17:13] This is a medication.

[00:17:14] It is an injectable.

[00:17:16] It does act on hormones.

[00:17:18] There are, you know, contraindication to this medication.

[00:17:22] I'm going through this game and I'm having to justify and drag people for their appointment.

[00:17:28] And I love you, but I'm a drag you into the appointment or you're going to find somebody else to prescribe it.

[00:17:32] It's not because I'm an asshole.

[00:17:34] It's because I love you and it's because I will not do any harm to you.

[00:17:39] And even though you might take it and be fine, but I don't know that.

[00:17:43] At that point, 0.05 percent, that might be you.

[00:17:46] And that might be the time I prescribe it.

[00:17:48] And that's just not going to happen.

[00:17:50] Your goal is to lose weight and be healthy, and I'm going to see it to it that you get there.

[00:17:55] But that's not by skipping anything here.

[00:17:58] And besides if you read the manufacturer's insert and said this medication must be given under the supervision of a healthcare provider.

[00:18:04] I can't supervise you through texts or through a message.

[00:18:07] And I haven't even seen you.

[00:18:08] You haven't even done any labs and you want this medication.

[00:18:11] I'm sorry, that's just not going to happen.

[00:18:13] So not an asshole.

[00:18:15] I'm just telling you that a healthcare provider who really cares about you is going to ask you these things.

[00:18:21] Now, I get it.

[00:18:22] Let's say you've done a physical in the last six months, maybe nine months.

[00:18:25] Some might even go be okay with the year.

[00:18:27] But you've had some type of lab done.

[00:18:30] No glaring issues since your last visit.

[00:18:34] Okay, that might be enough.

[00:18:36] But if you're someone who I've seen you in two, three, four years, you've only come in only coming when you have COVID or an earache or an eye infection.

[00:18:48] You only come in when there's problematic things and I don't have a good baseline annual wellness visit for you in recent labs.

[00:18:55] I'm not prescribing it to you.

[00:18:57] Point period blank poo.

[00:18:59] It is what it is.

[00:19:00] And it's just for your safety.

[00:19:02] And what kind of that would be negligent of me as a provider to do so.

[00:19:06] I know you're living a very busy life.

[00:19:08] You got things to do, but I can't be a part of that because your busy living life, life is life.

[00:19:14] I prescribed this medication and life is life.

[00:19:16] And you start to experience some of these side effects and you don't come and see me.

[00:19:19] I don't know what your baseline is.

[00:19:21] I don't know if this is, you've always had this or this is new or this is really bad.

[00:19:25] Life will be unliving.

[00:19:26] It's what's going to happen in that.

[00:19:28] I just can't be a part of that.

[00:19:30] And what's interesting about these losses now, I'm not an attorney.

[00:19:35] I've not read the briefs.

[00:19:37] I've only read in summary of what some of the complaints are and the biggest complaint was people were saying that they were not made aware of the severe side effects and adverse effects of these medication upon prescription.

[00:19:50] I get that.

[00:19:51] But see the patient that I just was describing to you earlier had a patient that came in and wanted the medic or excuse me.

[00:19:57] This particular patient, she was on the medication.

[00:19:59] She been on it for a while.

[00:20:01] I can't say for a while, maybe three months.

[00:20:03] And she'd wanted to go up in her dose and I was asking her questions.

[00:20:07] She didn't want, she was offered an appointment, didn't want to come in.

[00:20:09] So I thought, well let me ask her some questions because her baseline labs were okay.

[00:20:13] Everything seemed okay so far.

[00:20:15] But I need to know things can change, right?

[00:20:17] So I'm asking her any nausea vomiting, diarrhea with this.

[00:20:21] Oh, I have a look, I have some nausea in this and that will happen.

[00:20:24] I'm nauseous most of the day.

[00:20:26] That's what she said.

[00:20:27] A little bit of vomiting and I've had episodes of diarrhea.

[00:20:31] Well, that doesn't sound very well.

[00:20:34] I mean, how much are you eating or drinking?

[00:20:37] She sounded like she wasn't eating much.

[00:20:39] She's very dehydrated.

[00:20:40] She said she felt weak.

[00:20:41] Well, I don't know that I can continue to give you this medication without being imbaguated.

[00:20:44] And then she just said, just give me the anti-naudio medication and some anti-dioria medication.

[00:20:49] And I'll be fine.

[00:20:51] I don't need to be eating anyway.

[00:20:52] This is good for me because this is how I'm going to lose weight.

[00:20:54] That is not the healthy way to lose weight.

[00:20:56] So basically, it sounds like she was having some GI symptoms wanted me to give her some medications

[00:21:02] to mask them, right?

[00:21:04] If she's having vomiting and she's having diarrhea, then I give her anti-bomiting nausea medication

[00:21:10] so she won't experience that.

[00:21:11] And I give her anti-dioria medication and she doesn't experience that.

[00:21:14] How are she going to know what's happening in our body?

[00:21:17] Usually those are, when we experience those things, that is our body talking to us.

[00:21:22] Hello, something's wrong.

[00:21:23] I don't like this.

[00:21:24] That's your body talking and your body talking loudly.

[00:21:28] She just said, just give me the Zofrin and the anti-dioria medication and I'll be fine.

[00:21:32] And then I can go up on her dose.

[00:21:33] So absolutely not that did not happen.

[00:21:35] I actually referred her to the physician, my supervisor physician, to evaluate her

[00:21:41] because she didn't want to come in for an appointment.

[00:21:43] She didn't want to do a video visit and she was very demanding of what she wanted and wasn't

[00:21:49] answering my questions.

[00:21:50] So I referred her to the supervising physician to manage and handle that.

[00:21:54] And I hope he was able to bring the patient in to have a discussion and figure out what's going on with her.

[00:21:59] But I personally did not believe she was a candidate and that's another thing.

[00:22:02] Y'all are going to get so mad at me.

[00:22:03] But if I didn't care about you as a healthcare provider, I'll just keep providing you.

[00:22:07] Keep prescribing you the medication and then boom, you're going to end up in the emergency room

[00:22:11] or pancreatitis.

[00:22:12] You need your gall bladder is going to be having to take it out because I didn't intervene.

[00:22:17] And that just cannot be.

[00:22:19] That is not how that's going to work.

[00:22:22] Because with ozampic, this can lead to some very dangerous conditions like gastroperesis.

[00:22:28] Gastroperesis is a chronic condition where the nerves and muscles in the stomach wall

[00:22:33] are severely weakened and this weakening in the wall makes it difficult for the stomach

[00:22:38] to move food along for its called parasalysis.

[00:22:41] It makes it difficult for that to happen.

[00:22:43] So food is not able to transfer from the stomach to the small intestine.

[00:22:48] And the results of gastroperesis can include intestinal blockages or obstruction.

[00:22:53] And this is what often leads to the chronic nausea and diarrhea.

[00:22:58] And furthermore, gastroperesis cannot be cured.

[00:23:01] Okay guys, there is no cure for it.

[00:23:03] Once you have it, you have it.

[00:23:04] And it can only be managed medically with my other medications or surgically.

[00:23:09] And so this means that anyone who develops this condition can be potentially facing a lifetime

[00:23:14] of medical intervention.

[00:23:16] So for all I know that lady in that example who just wanted me to give her the anti-nauja

[00:23:20] and anti-diagonal medication, she could have been developing gastroperesis

[00:23:23] and we would have been masking it for a while until something really, really bad happened.

[00:23:28] Her bowel is going to perforate it.

[00:23:30] Like so many bad things can happen.

[00:23:33] Her, I mean I don't even want to go into it but end up septic, all kinds of things.

[00:23:37] So gastroperesis is one of the severe adverse effects that is some of the reasons

[00:23:42] why some of the people are filing for in these lawsuits.

[00:23:46] I think I talked earlier about the possible connection of suicidal ideation.

[00:23:51] Now the European Medicine Agency which is currently reviewing data suggests

[00:23:55] that there may be a connection between semi-glutide and suicidal ideation.

[00:24:00] And the agency has received at least 150 reports of people suffering suicidal thoughts

[00:24:05] while on those impact but in the US what goby is required to carry a warning about the suicidal behavior.

[00:24:12] And however, this warning is required for all chronic weight loss medications in the United States

[00:24:18] and although semi-glutide might reflect a higher risk than other weight loss medications.

[00:24:25] But so far there haven't been any lawsuits based on that particular allegation.

[00:24:29] Something else that can happen while an adverse effect while on these injectables are in gallbladder disease.

[00:24:35] So instead is published by the Journal of the American Medical Association.

[00:24:39] Researchers found a link between drugs like ozempic and wangovie

[00:24:43] and it's been associated with an increased risk of bladder disease.

[00:24:48] And so far, you know, lawsuits have not been filed against nervous or the Eli Lilly on this

[00:24:55] but patients who have used these drugs have been diagnosed with gallbladder disease

[00:25:00] and so they may potentially file in the future.

[00:25:02] Now what are the pharmaceutical companies saying?

[00:25:06] Well, nervous has released a public statement attesting to the safety of its products

[00:25:12] including semi-glutide variants and as part of the statement, the company has acknowledged

[00:25:17] that gastrointestinal side effects can occur with a drug use but it is not downplayed their severity.

[00:25:26] According to Norvernordist, the side effects are mild to moderate and of a short duration.

[00:25:31] Additionally, the manufacturer emphasizes that these effects are listed on the warning labels of the drugs.

[00:25:38] Now this likely represents the main defense of Norvernordist and what they'll say against these ozempic lawsuits.

[00:25:44] The company will publicly claim that the users were warned of the potential effects before taking the drug

[00:25:49] and that the drugs should be used only in the supervision of a healthcare professional

[00:25:55] and then if you're in the supervision of a healthcare professional and a good one I should say,

[00:25:59] these side effects should be monitored, certain labs should be monitored,

[00:26:03] you should be advised and treated with certain conditions before it gets this far.

[00:26:08] Okay, now if you're someone who has not been doing that and you're part of the lawsuit I can imagine

[00:26:13] and although I hate to see it because I don't want to see anyone harmed but they basically can turn around and say,

[00:26:18] well you were taking the drug and weren't taking it as prescribed.

[00:26:23] You were not under following the supervision or recommendations of your healthcare provider.

[00:26:28] You weren't going in and being monitored properly for your labs and other things

[00:26:33] and the information is there. It's on the insert and you should have talked to your healthcare provider

[00:26:37] and you could have talked to the pharmacist. Now I'll tell you this, as a healthcare provider

[00:26:42] even myself reading the package insert is not an easy thing but I have to

[00:26:48] and it's probably a little bit easier for me because I am a healthcare provider

[00:26:51] so I can't imagine what it's like reading that as a consumer

[00:26:55] but on the website there are videos and other material for health consumers

[00:27:01] to learn more about the medication and again talk to your healthcare provider,

[00:27:04] talk to the pharmacist when you go pick up the medications is our other means

[00:27:09] to help support the patient and make them more knowledgeable about the medication that they are taking.

[00:27:14] Now side note because we know there's a shortage of these medications

[00:27:18] semi-glute tide in the shortage of these medications has been made

[00:27:23] the generic compounding versions of this are available at compounding pharmacies.

[00:27:29] The FDA has made it very clear semi-glute tide variants that are made

[00:27:34] at compounding pharmacies are not FDA approved because they cannot monitor, maintain

[00:27:40] or manage the quality of the medications and the way which they're made.

[00:27:45] It might have too little of an active ingredient, it might have too much of an active ingredient

[00:27:49] it might be contaminated, there might be other materials or buffers in the medication

[00:27:54] the FDA cannot guarantee that so therefore they are not FDA approved.

[00:27:58] That's not to say that semi-glute tide medications are bad from compounding pharmacies

[00:28:03] I'm just saying that they're not FDA approved because of those things

[00:28:06] because of the shortage however these are options.

[00:28:09] Other countries their compounding pharmacies are fine but they also have a more surveillance

[00:28:13] than they do here in the United States so it's almost like you know

[00:28:17] and then there are other certifications that these compounding pharmacies have

[00:28:20] so it's not like they're bad or they're not good.

[00:28:23] They actually are very useful for other unique medications that need to be made

[00:28:27] for you know, they need to flavor certain medications or very unique medications

[00:28:32] that have short shelf lives and they're made real time

[00:28:35] they're good for other medications semi-glute tide can be made there

[00:28:39] but in this particular case the FDA has been very clear these are not FDA approved

[00:28:44] so if you are someone who maybe maybe you're in this lawsuit

[00:28:47] you start taking the ozemic and then said oh shoot that's too expensive

[00:28:52] I can't afford that let me go to this compounding pharmacy now I'm going to take the semi-glute tide there

[00:28:56] not saying that compounding pharmacies should not be responsible for the medications

[00:29:01] that would be something you take up with them but you couldn't sue the manufacturers of

[00:29:05] Wango v or ozemic or anything like that for medications you were taking a compounding pharmacy

[00:29:10] because those are not the same thing.

[00:29:12] I know it's a lot but listen I got to keep it real with you

[00:29:16] I have to keep it 100 with you because listen when I have a patient appointment

[00:29:20] I get to talk to people for I'm really only talking about 15 minutes right

[00:29:24] for follow appointments a little bit longer for your new patient

[00:29:27] or a little bit longer if you're very very sick

[00:29:29] it never feels like it's enough time

[00:29:31] it never feels like it's enough time to talk to patients about all the things they need to know

[00:29:35] and we'll need to know about their condition their medication their treatment

[00:29:40] they're follow up it just never feels like enough time

[00:29:43] because many of you know I lost my father in emergency room to a massive heart attack

[00:29:47] to an underserved hospital

[00:29:49] I can only imagine how the providers were short with my father and didn't explain things

[00:29:54] listen call me batman if you want to but it's like I have dedicated my life's work

[00:30:00] to help improve the experience and the outcomes of other people

[00:30:05] so they don't get short changed by their healthcare provider

[00:30:08] and they get the information that they truly in dearly need

[00:30:12] there's wonderful healthcare providers out there that will talk to you

[00:30:16] that will message you that will do video visits with you

[00:30:21] that do classes all that are available by a phone

[00:30:24] just ask just ask now your healthcare provider should make the time to talk to you

[00:30:29] but in the event they overlook something or in the event that you forget something

[00:30:33] it's a two way street please ask please say something

[00:30:36] if you're going to be prescribed a new medications please ask okay now listen

[00:30:39] I know that this is going to help me with xy and z

[00:30:42] but I want you to also tell me what could go wrong

[00:30:44] what could go bad

[00:30:45] what are the side effects

[00:30:46] what are the adverse effects

[00:30:47] I need to know those things so they happen I can tell you

[00:30:50] those are I mean obviously we don't want things happen to us

[00:30:52] and we're not necessarily talking about the fruition

[00:30:54] you as a patient you as a patient's support person the husband

[00:30:59] the wife the mom the dad whatever you are

[00:31:02] you want to know these things

[00:31:03] you it's whether to know them and not need them

[00:31:06] and rather than need them and not know them okay

[00:31:09] we don't want to get into a pinch like that this also raises question

[00:31:13] what are the roles and responsibilities of the patient

[00:31:16] the provider and the pharmaceutical company

[00:31:18] so we'll get more to that once we hear from a word from our sponsor

[00:31:22] okay so now we're back so let's talk about it the roles of healthcare providers

[00:31:26] pharmaceutical companies and also us patients you know

[00:31:30] it's critical to ensure the safe and effective use of medications

[00:31:34] and everyone has a very important role to play in this

[00:31:37] so we're not playing the blame game and pointing the finger at this person

[00:31:40] that person because at the end of the day

[00:31:42] at the end of the day all that really matters is that you as a health consumer

[00:31:46] are happy and healthy and getting the care that you need

[00:31:49] that's what's most important and that's what we should all strive for

[00:31:52] but you can't expect for the pharmacy pharmaceutical companies

[00:31:55] and the healthcare provider to carry your weight

[00:31:57] ooh yes I said it

[00:31:59] that means that you as a health consumer you have

[00:32:01] responsibilities as well

[00:32:03] there are things that you're supposed to do listen

[00:32:06] and I know we're talking about pharmaceutical companies

[00:32:08] but just think of any medication that's wrong

[00:32:10] whether it's for your diabetes

[00:32:12] whether it's for blood pressure

[00:32:14] whether it's an antibiotic for a urinary tract infection

[00:32:18] you have a responsibility to take the medication

[00:32:22] take it as prescribed for the most part

[00:32:25] eat healthy drink plenty of water

[00:32:28] report any signs and symptoms

[00:32:30] if you're not feeling well

[00:32:32] to contact us and let us know

[00:32:34] if something changes

[00:32:36] if you're having any rashes to let us know

[00:32:38] like we can't do anything if we don't know

[00:32:41] I understand that you got to work all day

[00:32:43] you got to pick up the kids from school

[00:32:45] you got church function

[00:32:47] and then you gotta do something for your mom

[00:32:49] and your dad and your busy busy busy

[00:32:51] but at one point when are you going to stop

[00:32:53] and put yourself first?

[00:32:55] I can't help you if you can't first help yourself

[00:32:57] and so I've seen it where patients have foregone

[00:33:00] their appointments because oh I gotta do this

[00:33:02] and I gotta do this and I just don't have time

[00:33:04] you don't have time now

[00:33:05] but I promise you when you really really don't feel good

[00:33:08] even if you say you don't have the time

[00:33:10] God himself is gonna come down

[00:33:12] and be so sick, so weak

[00:33:14] so can't even move, can't eat drink nothing

[00:33:17] that you're gonna, he's gonna physically stop you

[00:33:20] and then you're really not gonna have time

[00:33:22] to do anything else

[00:33:23] but just sit there and be sick

[00:33:24] we don't want to wait to that

[00:33:26] we don't want to wait to that

[00:33:27] and that's probably very extreme

[00:33:28] and I don't know if I said that right

[00:33:29] so I hope I didn't offend anyone

[00:33:30] but I'm just saying

[00:33:31] you have to stop

[00:33:33] and take action to take care of yourself

[00:33:35] you as the health consumer

[00:33:37] have a responsibility

[00:33:38] to be honest and transparent

[00:33:40] about what you're experiencing

[00:33:42] talk to us about what you're taking

[00:33:44] talk to us about what you're doing

[00:33:46] what you're not doing

[00:33:47] and don't feel ashamed in embarrassed

[00:33:49] like oh well the doctor told me

[00:33:51] that I needed to eat this

[00:33:52] and I need to exercise this

[00:33:53] and I didn't do it

[00:33:54] but I'm gonna say I did it anyways

[00:33:55] don't do that either

[00:33:56] because then we're gonna look at you

[00:33:58] like this is the progress

[00:33:59] and we're doing all these things

[00:34:00] my goodness

[00:34:01] like we're in a tough first situation

[00:34:03] then I thought so let's just be honest

[00:34:04] let's just be honest

[00:34:05] we can't make any progress

[00:34:06] unless we're honest

[00:34:07] okay now I will also

[00:34:09] say this as a health consumer

[00:34:11] it's also in your responsibility

[00:34:13] if I say something and you don't understand it

[00:34:15] it's confusing or you forget

[00:34:17] please ask me

[00:34:19] please ask me please don't be like

[00:34:21] well I'm just taking this medication

[00:34:22] because the nurse practitioner prescribed it

[00:34:24] please don't do that

[00:34:25] I mean I want you to take your medicine

[00:34:26] but I also want you to understand

[00:34:27] why you're taking your medication

[00:34:29] and talk to me and hold me accountable

[00:34:31] because you're gonna say

[00:34:32] well you know why are you prescribing me

[00:34:34] this blood pressure medications

[00:34:35] especially when I already take this

[00:34:37] thisness because you know what

[00:34:39] hopefully this is in the case

[00:34:40] but it might be the case like

[00:34:41] oh my gosh

[00:34:42] I didn't know you're on that medication

[00:34:43] let me just continue this

[00:34:45] and we've just clarified to miscommunication

[00:34:47] or I might say to you like

[00:34:49] well Mr. Jones

[00:34:50] you know we've taken this

[00:34:51] you've taken these blood pressure medications

[00:34:52] but they've not been as helpful

[00:34:54] so research shows

[00:34:55] if we add this third one

[00:34:56] we should have better blood pressure control

[00:34:58] you got to talk to me about

[00:35:00] what your symptoms are

[00:35:01] right?

[00:35:02] And yes this episode is

[00:35:03] about the way the doctor was injectable

[00:35:04] I was just using the blood pressure medications

[00:35:06] as an example to showcase

[00:35:08] what your responsibility is as a patient

[00:35:10] Now if I talk about

[00:35:11] what are the responsibilities of health care providers

[00:35:14] you know this goes for doctors nurses

[00:35:16] nurse practitioners pharmacists

[00:35:18] we play a direct role in patient care

[00:35:20] I mean from accurately diagnosing

[00:35:22] health conditions and prescribing

[00:35:23] the appropriate medications

[00:35:24] based on your specific health status

[00:35:26] history and needs

[00:35:28] we need to be providing you

[00:35:29] the proper patient

[00:35:31] information and education

[00:35:32] so you know about the medications

[00:35:34] the correct dosing

[00:35:35] when you're supposed to take it

[00:35:36] how you're supposed to take it

[00:35:37] the side effects

[00:35:38] if it interacts with other drugs or foods

[00:35:40] follow up

[00:35:41] we got a regularly monitor

[00:35:42] your response to these medications

[00:35:44] including the effectiveness

[00:35:45] and any adverse reactions

[00:35:46] and adjusting the treatment plan is necessary

[00:35:49] and reporting any severe

[00:35:51] adverse reactions

[00:35:52] like if you're having these

[00:35:53] adverse effects

[00:35:54] and yes you come and tell me

[00:35:55] I have a duty to make sure that the FDA

[00:35:57] gets this track and trended

[00:35:59] in their database too

[00:36:00] because you may not be the only one

[00:36:01] and then there's some ethical

[00:36:03] concerns so I need to make sure I'm

[00:36:04] acting in your best interests

[00:36:05] including considering the cost

[00:36:07] benefit ratio of the medications

[00:36:09] and also your ability to afford

[00:36:11] and adhere to the treatment plan

[00:36:13] like it makes no sense for me

[00:36:15] if you have a medical condition

[00:36:17] and I prescribe you a medication

[00:36:18] that I know you can't afford

[00:36:19] because I know you're not going to take it

[00:36:20] I need to keep that in mind

[00:36:22] and look for a treatment option

[00:36:23] that is within means

[00:36:25] and is attainable to you

[00:36:27] okay because I need to make sure

[00:36:28] that you're treated

[00:36:29] now when we talk about pharmaceutical companies

[00:36:31] like what is their responsibility

[00:36:33] well they're responsible for the development

[00:36:35] testing and marketing of medications

[00:36:37] and so there's research and development

[00:36:39] so they got to conduct rigorous clinical trials

[00:36:41] to assess for the safety

[00:36:43] and efficacy of medications

[00:36:45] and this includes identifying potential

[00:36:47] side effects, interaction, and contraindication

[00:36:49] so when we think about the way

[00:36:51] lots of injectables

[00:36:53] this is the information that they have put

[00:36:55] in their patient pamphlet

[00:36:57] and they have a lot of information

[00:36:59] set by governing bodies

[00:37:01] which is why medications

[00:37:03] how they get FDA approved

[00:37:05] they need to make sure that they get this approval

[00:37:07] before marketing the drug

[00:37:09] they need to provide information

[00:37:11] comprehensive, accurate

[00:37:13] and accessible information about the medications

[00:37:15] including the indications

[00:37:17] and the dosages

[00:37:19] and potential side effects

[00:37:21] in any safety warnings

[00:37:23] that must be available

[00:37:25] and continuously monitoring the safety

[00:37:27] and effectiveness of medications

[00:37:29] after they've been released into the market

[00:37:31] so this involves tracking

[00:37:33] and trending the adverse reactions

[00:37:35] remember I told you about that

[00:37:37] the FDA tracking system

[00:37:39] and then also updating the drug labeling

[00:37:41] as new information becomes available

[00:37:43] they need to be prompt

[00:37:45] when reporting safety concerns

[00:37:47] and adverse effects through the post marketing surveillance

[00:37:49] and they also need to provide

[00:37:51] educational resources and training

[00:37:53] and health care providers to ensure

[00:37:55] that we are prescribing it properly

[00:37:57] and ensuring that we are well informed

[00:37:59] when prescribing the medications

[00:38:01] so these are things that all need

[00:38:03] to be considered

[00:38:05] and currently the losses that have been filed

[00:38:07] concerning the side effects of ozemic

[00:38:09] are related to

[00:38:11] the lack of knowledge

[00:38:13] or information

[00:38:15] upon starting the medication

[00:38:17] so it sounds like there's some conversations

[00:38:19] that maybe weren't happening

[00:38:21] and I don't even want to say they weren't happening

[00:38:23] they didn't happen in a way that was

[00:38:25] understandable for the person in front of them

[00:38:29] so that's a word we use health literacy

[00:38:31] I just would like to use living room language

[00:38:33] it's great level language

[00:38:35] I need to make sure that you understand

[00:38:37] the words that are coming out of my mouth

[00:38:39] right

[00:38:41] but no really that you understand it

[00:38:43] and the way I know that you're going to understand

[00:38:45] is if you can say back to me

[00:38:47] so if I'm going to explain to you a medication

[00:38:49] switch roles here

[00:38:51] I want you to educate me

[00:38:53] so I just told you about the medication

[00:38:55] why you're taking it

[00:38:57] you tell me now

[00:38:59] what is the medication and why are you taking it

[00:39:01] and how the person is saying back to you

[00:39:03] okay so that's how we're going to assess

[00:39:05] that between the provider and the patient

[00:39:07] that the patient really understands it

[00:39:09] and so you as a patient

[00:39:11] as a health consumer listening to this

[00:39:13] I need to make sure that you really understand

[00:39:15] and if you don't it's okay

[00:39:17] let me give you a pamphlet

[00:39:19] let's find you a YouTube video

[00:39:21] something but I need to make sure you understand it

[00:39:23] because my duty is to work with you

[00:39:25] to help you to achieve your health goals

[00:39:27] the way in which we achieve those

[00:39:29] I can provide you options

[00:39:31] but at the end of the day

[00:39:33] it's ultimately your decision

[00:39:35] so if I explain to you that this medication

[00:39:37] helps with A, B and C

[00:39:39] but it cares a risk factors

[00:39:41] ZD and F

[00:39:43] if you are okay with that

[00:39:45] you feel based on your value system

[00:39:47] that the benefits outweigh the risks

[00:39:49] then I can't do anything but respect it

[00:39:51] you can ask me what my opinions were like

[00:39:53] well doc what are your recommendations

[00:39:55] I'll provide you my recommendations

[00:39:57] but I will also have to be mindful

[00:39:59] and respectful of what your decisions are

[00:40:01] okay so at the end of the day

[00:40:03] that's how that really works

[00:40:05] the patient has autonomy here

[00:40:07] the patient is the one that's going to choose

[00:40:09] and you are the patient

[00:40:11] you are the health consumer

[00:40:13] I'm merely a vessel to help guide you

[00:40:15] in your journey

[00:40:17] with some science and a license

[00:40:19] but to help you and to do so safely

[00:40:21] and I feel like something is not safe

[00:40:23] I'm going to say it in fact

[00:40:25] and even though you may want to do it

[00:40:27] if I really feel like it's not safe

[00:40:29] I might say you know what Mr. Jones

[00:40:31] I hear you

[00:40:33] and I just in good faith

[00:40:35] cannot prescribe that medication

[00:40:37] considering X, Y and Z

[00:40:39] I'm so sorry I'd like to refer you

[00:40:41] to making with another health care provider

[00:40:43] they may have insight that I don't have

[00:40:45] which they may feel more safely

[00:40:47] or have more experience

[00:40:49] in prescribing this medication

[00:40:51] in this situation

[00:40:53] I'm okay to say it

[00:40:55] now you're going to get mad at me

[00:40:57] if I tell you know

[00:40:59] I'm not prescribing something or this and that

[00:41:01] but just know I'm doing it out of love

[00:41:03] I'm doing it because I care about you

[00:41:05] and I want to do the right thing

[00:41:07] swear on my father

[00:41:09] never ever ever be me

[00:41:11] so I'm going to be the health care provider

[00:41:13] that you want on your team

[00:41:15] I'm nurse Alice

[00:41:17] I love talking to people before they become my patients

[00:41:19] I want to thank you so much

[00:41:21] for listening and yes baby

[00:41:23] I am back with the podcast

[00:41:25] talking about all things health and wellness

[00:41:27] as they take center stage

[00:41:29] and giving you that dose of TLC

[00:41:31] that you need to hear

[00:41:33] yes might be a little unconventional

[00:41:35] I'm going to spill some tea

[00:41:37] I know what the streets are saying

[00:41:39] I know what y'all are saying

[00:41:41] and so I'm here to help you

[00:41:43] before the insult, before the injury

[00:41:45] before the trauma

[00:41:47] before you become my patient

[00:41:49] I want to thank you so much for listening

[00:41:51] please make sure to visit asknersalst.com

[00:41:53] I have a wonderful website

[00:41:55] full of articles, blogs, information

[00:41:57] I have amazing health library

[00:41:59] where you can go for

[00:42:01] videos, tools, screening tools

[00:42:03] just an amazing amount of information

[00:42:05] any medical health condition from five

[00:42:07] boys to newborn babies

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[00:42:15] and then also with the podcast

[00:42:17] whatever podcast platform you're listening to

[00:42:19] I would kindly ask if you can like, share, subscribe

[00:42:23] leave a rating

[00:42:25] all of those things to help raise awareness

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[00:42:35] so people like yourself can hear

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[00:42:39] and get the information that they do

[00:42:41] because I really want to help as many people as I can

[00:42:43] with the podcast

[00:42:45] again you are tuning in to asknersalst.com

[00:42:47] I am your host Alice Benjamin

[00:42:49] listen, I do this every week

[00:42:51] tune in

[00:42:53] and I want to thank you so much for listening

[00:42:55] so until next time

[00:42:57] please make good choices

[00:42:59] be kind to one another

[00:43:01] music