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The Legal Drug Dealer Podcast

Getting Pharmacy as a profession Closer to The Patient

March 31 2020

#17 Why New Vaccines Take so Long to be available for us
And a little bit about my book.

With Marilena Grittani, RPh

We all need an explanation of why a vaccine for the corona virus is not available yet!

So, on this episode I will give you all the details

  • Where vaccines come from
  • How are vaccines made
  • How regulates the making of vaccines and why
  • How long does it take for a vaccine to be available for the general public
  • Why we should be happy that vaccines take a long time to be available

Also, I will tell you about the book I am writing and how you can help me to get it done!

I hope you enjoy episode #17

Vaccines are really important to prevent epidemic diseases

"Most of the legislators that write pharmacy laws, are 99% of the time not even aware of what a pharmacist does. They think the same way that the general population thinks, which is we just count pills put in a bottle and that's it."

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" So as I said, Whoever said that the vaccine is going to be here in a few weeks, is not only lying but it's also an ignorant about the process and, how potentially harmful this vaccination could be. "

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Episode Transcripts

Marilena Grittani, RPh  0:05  

Hola, and welcome to The Legal drug dealer podcast.

Marilena Grittani, RPh  0:07  

Marilena Grittani. Here. I am a registered pharmacist, and also your host. Thank you for listening to this new episode. This is episode number 17. And we are going to be talking about why new vaccines take so long, for us to be able to get them and, a little bit about a new book that I’m writing.

Marilena Grittani, RPh  0:27  

So I will start talking about my book. Actually, it’s a book project, I have not started actually writing itself because I am still in the research process. So, basically what I decided to do was to write a book that would illustrate or explain or show or give details to whoever want to learn how the pharmacy industry works in the US specifically how retail hospital and what is called specialty pharmacy; pharmacy works in the US.

Marilena Grittani, RPh  1:02  

I have a ton of information that I could provide myself. But I realized that it’s not just what I think. My idea is not to teach anybody about what my thoughts are. What I want to do is to be the platform that you can listen to, at least 100 voices, specifically experts on this area. Which in our case is pharmacy. 

Marilena Grittani, RPh  1:29  

So I decided to interview one on one 100 pharmacists from all over the US to ask them questions about what they thought about pharmacy before they started, why did they start working in pharmacy and stuff that are going to illustrate the why the situation of pharmacy as an industry is these days the way that it is.

Marilena Grittani, RPh  1:54  

I think that most of the stuff that is happening is because we pharmacist are very shy. Not me, you have noticed that, but most of us are. And we try to keep our stuff to ourselves. So, we don’t go out. We’re shy. We like to be in our pharmacy, that doesn’t have any windows that is mostly in the dungeon, or I like to call them the dungeon because we didn’t have any Windows is the way that it should be because of contamination. And we have a very secluded because we have control drugs, and it needs to be like that in hospital. 

Marilena Grittani, RPh  2:30  

Or we are in our retail pharmacy and we’re just so busy that we don’t have time to interact and to have conversations with our customers or patients. So this is why most people don’t know what’s going on with our industry. But the other reason is because people take us for granted. I believe. People don’t know what’s going on. And I don’t blame you, number one because we are service for you, whether it’s at a hospital or a specialty pharmacy or retail pharmacy, you are so tired and so sick, or feeling so bad or after a surgery that the last thing that you want to know is, hey, how is it going? How are you doing? I just want my medicine, I want to go, whether it’s for you, or if it’s for your kids because they’ve been screaming with ear pain or an infection or what have you. So it is a tough situation for our profession.

Marilena Grittani, RPh  3:27  

And I believe that with a book that is going to be short and concise and is going to have the opinion of 100 of us altogether. And to give you an idea of what’s going on. I think it will be a great way for us to have our voice out. And because I know people are, shy pharmacists are very shy. I have decided to do one on one interviews so they don’t have to be in a group. They don’t have to answer a bunch of questions. That’s not what I want. I want to know their opinions and I wanted to tabulate them for you and give them to you in a nutshell, so you will understand what are thoughts. 

Marilena Grittani, RPh  4:04  

The other intention of this book would be to give it to those legislators that are in charge of the laws that regulate our profession. I don’t know if you guys know but I talk about it in the first two, three episodes of this podcast because episode two, three and four of the law that is involved with pharmacy. Pharmacy is highly regulated, not only because we work with prescription drugs that are controlled, that can cause you know, addiction and all this kind of stuff, but also because we are in healthcare, and the safety and efficacy of the products that we sell, are key for the population of our countries. So we are very much regulated.

Marilena Grittani, RPh  4:49  

Most people do not know that and don’t understand the whys and how it works. But if you want to know a little bit more, I will post this episode links on the show notes on Thelegaldrugdealer.com/17. There you will find the links that I mentioned on this episode and then you will see the episodes that I talk about the law in detail. So you will understand what I’m talking about.

Marilena Grittani, RPh  5:16  

So the legislators that write this law are 99% of the time not even aware of what a pharmacist does. They think the same way that the general population thinks, which is we just count pills put in a bottle and that’s it. And that is not the reason why we went to school in the past 20 plus years, we have changed our profession based on the needs and the necessities of our patients and our colleagues and the other healthcare members that needed our support because we are the drug expert. They needed extra work to be done from our part for them so they can give the best result to their patient which at the end of the day, there are patients as well. So Since 2002, I believe it is pharmacy became a doctored profession. So we have to go through four years of pharmacy school including one year of clinical rotations for that we need to go to pre pharmacy college. And it’s a lot of studies and a lot of information. But most of the legislators that and what we cannot do I don’t know about that. Part of my intention with this book is to kind of give one of my books to each one of the ones that are working on those committees and say, Hey, I know you don’t get it because you might be a broadcaster, or you might be a engineer or you might be a gardener, which is perfectly fine. But I need you to understand what we do and what we need and where we are and what is our dream and what is it that we’re capable to do for the community. So you will decide if we have enough preparation and enough studies or if we need to change something. So we will be able to perform at the top of our scope, which is what we’ve been begging for years.

Marilena Grittani, RPh  7:09  

And I know this is repetitive, but it meant a lot to me. Most physical therapists and dietitians and speech pathologists, they practice at the top of their scope because they’re recognized as experts in the areas that they work on. They also have doctorate degrees, so please respect your doctors, PTs, or OTs or speech pathologist, but the same way that they are authorized to have their independent practices and they get to support the medical team and also they can build directly insurances or Medicare and Medicaid. We are asking to do the same. We have proven ourselves that we can prevent patients to go back to the hospital after discharge, or even after ER visit. We have proven ourselves that we can help people manage their chronic diseases regulated medications and adjusting them to the point that they feel more comfortable and they’re more compliant. And a ton more things that we pharmacists can do that I know you guys have learned with me in our first 16 episodes. So that is mainly the reason why I’m writing this book and it means a lot to me to get it done.

Marilena Grittani, RPh  8:18  

The problem is I have not finished it because I just don’t have enough pharmacists to give me their opinions. So if you happen to be a pharmacist, and you would like to give me your opinion, that is 100% anonymous. I just want to know where did you go to school? Where did you go to school? Where do you work? What type of setting do you work? What are you expecting from our career? What would you like pharmacy profession to go to? What don’t you like? How do you think we can fix it? That is mainly the questions that I’m going to ask and I would not again mentioned your name at all. And if you are not a pharmacist, but you know a pharmacist that is like me that likes to voice her or his opinion, please tell them to send me an email to comment@thelegaldrugdealer.com, so I can reach out to them.

Marilena Grittani, RPh  9:12  

And then I will set up an interview, we will talk and then I would just write down the information and then put it in my book, I need at least 50 more. I’m not even close to 50 yet, but at least I need 50 more, I’m hoping that the 50 that I can get in the near month and a half can help me get the other 15 that I need. So again, if you’re a pharmacist or you know a pharmacist, whether it’s practicing or not, or if it’s in retail, hospital, specialty, whatever areas of pharmacy, you work, I want to know your opinion. I want to have a spread out opinion of the pharmacist or can in the US at this moment, or the ones that worked in the past and still have a view about the future of our profession. So if you do, please again, send me an email to comments@thelegaldrugdealer.com again comments@thelegaldrugdealer.com. 

Marilena Grittani, RPh  10:06  

That email was created for my listeners to write me any comments that they have, like, Hey, I don’t think the subject was good, or Hey, that was awesome. Thank you so much for that. But I’m using it as well for you guys to get in touch with me to get you interviewed one on one with me so I can finish my book. So I hope that I get a bunch of emails on my inbox tomorrow after this episode airs. So thank you so much for listening and helping me with that.

Marilena Grittani, RPh  10:37  

Now, without further ado, let’s just start talking about vaccines.

Marilena Grittani, RPh  10:42  

Let’s start talking about what is a vaccine and what do they do?

Marilena Grittani, RPh  10:48  

Well, a vaccine is a way that our body gets help to fight against foreign stuff, in this case, bacteria or viruses that might come inside of us, and cause harm. So, vaccinations are kind of a heads-up to the immune system to tell them, Hey, this is a guy that might come over and cause a lot of harm. So if you find him, this is what you need to do. This is the process. These are the steps, this is how we do it, this are the cells that need to be involved, and this is how we’re going to kill it. And then it will be easier and faster for you to get rid of it. So basically, it’s like, our immune system is like an army that is guarding our body from anything foreign that can cause any damage. And vaccines are this strategy that we need to follow to fight this foreign viruses or bacteria that are coming in to cause potentially big harm. Now, I know that you heard about the rule that you cannot get a vaccine if you’re sick if you have a cold or if you have any kind of fever or disease. And that is because if you do your immune system is pretty busy. And then have time to be learning a new trick or a new strategy to get rid of the viruses they’re basically fighting one right now. So that would not pay much attention to what the vaccine is saying about the project to fight this new potential harm. Now when you get your vaccination when you’re perfectly healthy, your immune system is ready to say okay, what are you bringing me and then the vaccine has the actual virus or the actual virus bacteria attenuated which means that is not at full capacity, which translates to it is kind of weak. So it’s easier for the immune system that is constantly monitoring if we get any potential harms whenever the immune system find this say, Okay, this is something new, let’s see what it , let’s see  how we can work against it, this figure something out, and once we do, then we will have a whole strategy of how to get rid of this, if it comes back. Actually, there’s some cells that We’ll be assigned exclusively to be the ones that go and talk about who these bacterial o viruses are how to get rid of them, which cells are in charge, which cells have to work. And then the immune system will work together, super quickly to get rid of this potential harm.

Marilena Grittani, RPh  13:16  

This is how vaccines work is actually a heads up to the immune system that says, hey, this is what it would be, but it’s going to be 20 times stronger. But now you know what it is you know how to react, you know how to kill it, and it will be easier for us to do it. That is the reason why sometimes we get a little tiny teeny teeny bit of disease,when you get the vaccination. Because your immune system might not be as perky or as ready to learn,how to attack it, it might be distracted with something else that you don’t have symptoms of, and then he doesn’t have a quick reaction. The other reason is that your immune system might not be at the top of its health so it might be suppressed and then you will not be able to fight the decision, the way that others would, even when it’s attenuated in a form of a vaccination.

Marilena Grittani, RPh  14:05  

So when people say you are injecting me that the virus why are you thinking that I’m going to allow that to happen? And the answer should be well, because that way now that you’re healthy, you know what to do, you know how to find it, and you know, that you have time to get a strategy ready for whenever they actually says come over. That is the reason why; not everybody understands it. I get that. But that is the why and this is the How.

Marilena Grittani, RPh  14:30  

Why fever? Why when you get a vaccine, mostly your baby, you get fever, and why it get the area inflamed and why did you get into area a little bit of redness and warmth? Well, all that means that the immune system is working really, really hard to say, Hey, this is new. We don’t know this thing. Let’s attack it. All the cells that are vigilant to find something, new or harmful or set the alarm so everybody else that is part of the immune system will come over and say, what is it, let’s just figure it out. And it’s just attack it to get it out of our system. And whenever they get into that phase, they, when they get together and start studying the stuff, they generate temperature, that’s why we have fever. And then they get, they need like a highway to get there super fast. So that’s why we have a lot of blood flow there. And that’s why it’s red, and it’s warm, and it gets a little inflamed and swollen because there’s a lot of cells that are normally not there, trying to encapsulate this stranger or this potential harm, so it doesn’t go further and it doesn’t spread.

Marilena Grittani, RPh  15:39  

So, basically, that’s what happened at the point of injection, which is where the needle goes, do you get a little inflammation and it’s red and it hurt. And then if you touch it, it will be warm, warmer than the rest of your skin, and then the patient might have a little fever. So that’s why the pediatrician will tell you give the baby a little bit of acetaminophen,if the baby gets fever. Because it’s normal fever is one way that the immune system says something is wrong. Let’s just get acting really quick. I just want the full body to understand that something bad is happening and, everybody needs to be alarmed. That is why when you get a virus normally you start with fever.

Marilena Grittani, RPh  16:17  

Okay, now that we know how vaccines work and why do we get these side effects or this redness or pain or inflammation? We need to understand why vaccines takes so long to make and, why is it so slow for us to get them when we have something as bad as coronavirus that is killing a bunch of people and we cannot get a vaccine like now.

Marilena Grittani, RPh  16:41  

Well, let me start saying that it will be very responsible from any entity to say let’s just vaccinate everybody with something that we came up with, yesterday. Because there’s not enough proof that it will work for everybody, that it will not harm anybody. So we need to make sure absolutely sure that is the best case scenario, and the possible negative effects that it will have will be so small that it will be worth it to give it a try for the rest of the population, with something as spread as a vaccine.

Marilena Grittani, RPh  17:15  

This is precisely the reason why the FDA or the Food and Drug Administration, came up with this process that has a bunch of phases and a bunch of time, and studies and requirements that are necessary for a product, whether it’s a vaccine or medication to go through and, to prove that works and is efficient and it doesn’t cause harm, and it doesn’t cause any side effects that may or could kill people. So then they get it approved for it to be for it to be used by anybody and everybody.

Marilena Grittani, RPh  17:49  

Because this process is rather boring. I’m going to try to shorten it as much as I can with the minimum information that you need to know, so you will understand what it is. 

Marilena Grittani, RPh  17:59  

The first thing thing is that you came up with something you have already something that you investigated enough to say: Okay, I have something I want you guys to allow me to start the process. So it’s not that you start with nothing; you start with already ahead of the game investigations and research of something that you think that might help with whatever circumstances, which in this case is a vaccine for a virus, for example.

Marilena Grittani, RPh  18:27  

So in the case of the corona virus, it started in China and, scientists in China started to study the virus, while doctors were treating patients. The idea was to understand how the virus work, how it reproduces, how long does it last in a table or in a desk or in the air, so they will understand how it spreads.And the best and most important part is how to kill it.

Marilena Grittani, RPh  18:53  

So all of this research occurred in China in a specific case of coronavirus, started in November. When they learned about this virus; then all that information was published and that other researchers or other scientists took that information and kept working with that. So,they came up with a “vaccine”, which is a tentative chemical or product that might be a vaccination. So they said, Okay, I have this that I think it might work. I already tried a bunch of rats and I think it will work. So basically, they’ve they buy those white rats that are for the lab…

Marilena Grittani, RPh  19:30  

And I’m sorry about animal lovers. I am an animal lover too. But it’s either that this rats are born to do that to save humanity, or we use humans for that and, a bunch of us could die. So it’s not a better choice. It is what it is, unfortunately, anyways… 

Marilena Grittani, RPh  19:48  

So they inject this vaccines to rats, and they see if it works, they start finding out if the vaccine will have any effect on this animals to prevent having the disease so basically, they get a bunch of healthy rats and they put the vaccine on. And then after a certain period of time, whether it’s a day, a week, a month, six months a year, they start getting the animal or the rat in contact with the virus. So they get contaminated. And then they observe how the vaccine works. And they see if the rat and end up dying, if the immune system of the animal is able to use the vaccine information to fight the virus faster and then survive, and how long would it take for you to work? that data, all those results are presented with the application to the FDA and, they say this is what we found out this is what we did. We think that this could be applied to humans, please let us start studying.

Marilena Grittani, RPh  20:47  

And that is what is part of the IND or investigational new drug application, which is the first phase for the FDA to allow this kind of investigation to happen. So then they get all the data, they review everything they have experts, in their staff to find out if all what they did were correct if the data is believable and is something that work, and then they said: okay, after a certain time month, sometimes they say, okay, it’s okay, you can continue to with phase one.

Marilena Grittani, RPh  21:22  

This is when the drug that was investigated in rats and the doses that were ideally found on the results of studies on rats, starts to be tested on healthy humans. The first phase is to make sure that is not going to harm humans. Of course, they have their rules. They know if it’s a proportion that they figure it out, and then they start trying and they go with low dose to the highest dose that they think it could be given to have the best results.

Marilena Grittani, RPh  21:55  

Then these people that started as healthy humans, get studied for a long period of time, sometimes it’s six months, sometimes it’s two years depending of the product. And they want to see what are the results on these people, as harm potentially caused by this drug that they got inoculated or injected on them. So then they review if they had fever, if they had nausea, if they have any issues with their kidneys, with their brain, with their heart with everything, so they get completely studied, in a depth that you wouldn’t ever get normally a doctor, because they want to make sure that whatever they gave them that tentative vaccine is not going to harm them.

Marilena Grittani, RPh  22:39  

These people have to continue coming back to be studied by the research team. So that’s why sometimes when you see on the paper, hey, we’re looking for people to research this new drug. They pay you for that and they don’t pay you because they think you’re nice or because your time is valuable. They pay you because they can harm you really bad because it could be a high dose. It could be something doesn’t work in humans, but it works in rats. Or it could be something that is so low in dose that it’s not going to do anything to you, but then it’s not going to protect you against the virus in this case is a vaccine either. So those are the risks that people that are participating in a research are open to deal with.

Marilena Grittani, RPh  23:20  

And then the results come after, at least after six months to a year. So we are sure that whatever doses or amount of drug that we gave have a bandwidth that we can decide, okay, this is a low dose, this is a high dose. So based on that, the results that they get, they put that all in paper and they presented to the FDA and they say we have completed phase one, and here you have our results.

Marilena Grittani, RPh  23:47  

Once they present that to the FDA, then they have a team that reviews all those results and make sure that every single step that they follow, was as the protocol demands and they didn’t have any mistakes and all the results are going to happen again, if they try themselves; it’s not something that they made up. And that is completely safe. They take their time to make sure that all that review is is done thorough. So that again takes a couple of months, maybe more to make sure that that phase is approved.

Marilena Grittani, RPh  24:22  

So these days when we heard that there is a vaccine investigation in the US that some healthy humans started to get doses. That is what it was, that was the beginning of it. So we still need months and months of following up of these people just to determine if it’s safe for humans to use. And if they don’t get sick, if they don’t get the disease, if they don’t get any harm in any other part parts of their body. And that takes time. As I said it could be month it could be a year so that is the phace that we are today at the end of March. 2020, we’re talking about the investigation of a vaccine for COVID-19.

Marilena Grittani, RPh  25:07  

 So once that face is ready, as I said, they’re presented to the FDA, then they have a bunch of researchers that will review it, and then make sure that everything that they said that they did is correct. That is believable, that the statistics are correct, that there is no flaws, there’s not errors, there’s no mistakes, and there is not enough information to make them afraid or doubt that the product will  harm people.

Marilena Grittani, RPh  25:35  

So once that phase is completed, and the investigation team and the FDA team decide that yes is safe enough, we can try with other people now, because we try with this few dozens of people and it’s okay so far, then the FDA say okay, you can go to phase number two, which is the phace that you start giving the dose to figure out how much product, how much concentration of product, Do you need to determine the dose that is effective but not harmful. And then if it works, so that phase starts that next, in this case, this phase is for hundreds of healthy humans that are, because it’s a vaccine, open to get inoculated with the virus to see after whatever length of time they determine that the vaccine is going to start working to see how the results are in terms of efficacy or to see if it works.

Marilena Grittani, RPh  26:34  

So basically, the people that volunteered the beginning the dozens of people who volunteered to see if it didn’t harm them, they can say, Okay, I’m okay with you putting the virus on me, to see if the vaccine worked. They could say no, or they need more volunteers. In this case, this is hundreds of people at the beginning and phase one was dozens of people in this case when they’re trying to see if it works. We’re talking about hundreds of people, they determine the number of people based on the product and the FDA has their rules and they have to follow. But it will depend again on the product.

Marilena Grittani, RPh  27:10  

In this case, it might be 200 might be 500, might be 1000. I don’t really know how many they’re going to request whenever they get to phase two. But that’s what needs to happen. 

Marilena Grittani, RPh  27:19  

Within this phace. They also determine how many doses the patient would need for them to have full immunity. I don’t know if you recall, but there are certain vaccines that you have, given your children that needed more than one dose, or if we think about Hepatitis B, which is a vaccine that we all healthcare people must take, requires three doses. The first dose is given on day one, the second dose on day 30, and the third those six months later, after the first dose.

Marilena Grittani, RPh  27:49  

So that’s the way that during this phase or phase two of the investigational product they determined that needed to be given so the patient is for sure going to be protected against that particular disease or virus or bacteria, if the patient somehow gets it. So that’s part of this phase as well.

Marilena Grittani, RPh  28:12  

Once phase two is completed, they do all the documentation, they prepare all their files, and they write everything the way that the FDA requires it. Then they present it to the FDA and they say, phase number two is completed. This is our information. This is our data, please review it. And then they,have a bunch of scientists, doctors, physicians, PhDs, people super smart an super trained on this particular area. to make sure that every single detail of this information that the company that is investigating this vaccine did, so they make sure people are truly safe. And secondly, that they were immune or they were able to battle the virus or the bacteria easier, than if they didn’t have the vaccine, and then is the control studies where they show people that never had the vaccine versus people that did, and the time that they got, the symptoms that they got, how sick they got, how many died, if any did; all this details is presented in the second phase. So once that is reviewed, and it takes quite a bit of time as well for a bunch of scientists to study this independently, and then they get together and they discuss it and, then they say, Okay, this is all perfect.

Marilena Grittani, RPh  29:29  

Or they say, Listen, you have a mistake here. This is what we think this is was not done, right? You need to go back and do it. Again! 

Marilena Grittani, RPh  29:36  

That could happen at any phase of this process. Because if the FDA believe that something is wrong, there is some mistake, there is something that they didn’t consider or if there is something that they deliberately left out, because they wanted the drug to be approved. They will stop it, and make them go back and do it again because main purpose of the FDA is to protect us All. Yes, the virus in this case the corona virus is a threat to humanity. But if we start giving “vaccines” that instead of helping or preventing the virus to be that bad on us that is going to kill us. Actually, the medication harms or kills us… What’s the point? or the FDA in this case makes sure that nobody is going to be harmed in a high scale with this product before it gets approved.

Marilena Grittani, RPh  30:31  

That is their responsibility, and they are very, very picky with it. That is why when you say a product was approved by the FDA, you know, it’s safe to take anybody that says the FDA got this approved, you can close your eyes and take it, because the chances that you’re going to get harmed are very, very small. They’re very, very picky, as I said, as they should, because it will be very responsible that you’re trying to get rid of a virus but then you die because, this thing harms your heart and then you have a heart attack and you die, you die the next day… That is very irresponsible

Marilena Grittani, RPh  31:06  

Once the FDA approves this phase, which is phase two, then is the third phase stage: which is when people that are sick or are in high risk of getting this disease or virus or whatever it is that we’re studying, get a sample of this drug.

Marilena Grittani, RPh  31:24  

Basically they say okay, you are in high risk, get this, like healthcare providers like doctors, nurses, X-ray people, PT people, pharmacist, CNAs… Everybody that is in touch with a patient that could potentially get the disease, are the first ones that are going to get this vaccine because they’re not only considered high risk, but also they are very much needed to treat the people that are sick. So those are the main goal at the beginning, to treat those that are in highest risk, and are technically healthy and start seem results and then they get studied.

Marilena Grittani, RPh  32:04  

They say, well, we gave it to this many thousands of people. And these are the results that we got. We got some people that got a little bit of fever, we got people that got aches, but then after the third day, they were fine. And they were exposed to the disease. Of course, they all use protective personnel equipment, they were protected, but still they did not get the disease. So once they get that, that they consider success, and then it’s the second part of this third phase, were they start to give it to those that are not healthy.

Marilena Grittani, RPh  32:33  

For example, in the case of coronavirus. We know that people that have asked my people that have congestive obstructive pulmonary disease or COPD, as well as, those that are immunosuppressed as well as those that have high risk of getting this disease, hypertension and diabetes at the same time. The doctors will evaluate who could get them and then they give it to these people and then seed results based on that in this phace. We treat thousands of patients. They all know that this is a research, this is a clinical trial, that might not work, that might harm them. But because they’re in high risk, and it’s been studied in other people and have shown good results, they take the risk and they sign to try the drug. And then we do this, as I said on thousands of people. 

Marilena Grittani, RPh  33:22  

Once phase three has enough data that will be required by the FDA try this product on and the results are completed, they finished this phase and they presented to the FDA for review, again. Again, the FDA has a team that is highly trained to review this face of the project and then they determine if all the data that they presented was believable that it was reliable, they didn’t make any mistakes that there is no bias. 

Marilena Grittani, RPh  33:50  

There’s no intention to get it approved so they can make a bunch of money when it’s not safe for the patients that would get them so that is part of the responsibility for the FDA, team to review this.

Marilena Grittani, RPh  34:01  

So that’s why they cannot take this lightly. That’s why they take their time because they will potentially be responsible for millions of lives. So they take their time to review this the way that it needs to be reviewed. So they are absolutely sure that he would not harm people.

Marilena Grittani, RPh  34:18  

And again, if they think that something is wrong, or something is not a suspected or is too many people that was harmed based on this phase, then they will say no, this is not approved, you need to go back and redo it, because Do you need to change something because this is not working! This is too many people that doubt too many people that got sick have too many people that got affected in their brains, their heart, had heart attacks or strokes or what have you.

Marilena Grittani, RPh  34:42  

And then it’s not worth it to risk so many millions of people lives with something that might or might not give the results. Or simply the drug was not effective enough that the vaccine was not good against the virus. So this is the face that is very, very important and it takes a very Long time, not only to go through the studies, but also to make sure that it was done correctly, so we don’t harm people.

Marilena Grittani, RPh  35:08  

In the best case scenario. Everybody that was doing the research to find the vaccine for in this case coronavirus, or COVID-19 disease. If everything went right, everything was perfect. The studies were done properly. Everybody was careful and nobody got harm and, there was very little side effects and, they were no dead caused by the vaccination, and everybody was protected against the virus once they injected to the patient and they were exposed to the virus, then and only then is when the FDA: say now you can sell it to millions of people you have permission to do so.

Marilena Grittani, RPh  35:51  

Now, this is the face that, we really would know what would happen. Because before as I said the phase one was only for dozens of healthy people that didn’t have anything to do with the disease, then it was for a few hundred that got exposed to the virus after they got the vaccine. And then, we got it for thousands of people that were high risk, and they got the vaccine, we got results from them. But then when we start selling it, it goes to millions and millions of people all over the world, once it is a vaccine.

Marilena Grittani, RPh  36:23  

So this is the time that we truly will see what would happen. There is cases that I personally have seen it with drugs that go to the market and then after a year or two that the product has been sold, they recovered. The FDA say no, it’s causing cancer is causing heart attacks is causing too many issues. So it’s not worth it, to use it for what is supposed to be doing because it causes too much harm. And then just take them out of the market and, guess what is needed like a vaccine. In this case, they need to start again; whether it’s from phase two or phase three, but they need to restart because they’re going to take it out of the market, it is not responsible to sell it because there’s too many people being harmed. 

Marilena Grittani, RPh  37:01  

So whenever anybody, I do not care who says that I don’t care if it’s the most powerful men of the world, the most powerful female in the world that says, I said that they need to get the vaccine quickly and they’re going to do it. That person isn’t ignorant. That person does not know that this is the process at any product, mostly in the US. And I know that in Europe, they have their own entities that work with this, but they believe in each other. So, if it’s approved by the group in Europe, the FDA will do it faster, like fast track, but they still will review it. There is no way that it can be rushed, taking in consideration the potential harm, that this could have for millions and millions of people.

Marilena Grittani, RPh  37:43  

So as I said, Whoever said that the vaccine is going to be here in a few weeks, is not only lying but it’s also an ignorant about the process and, how potentially harmful this vaccination could be. Please be aware of that and trust me… I’m not trying to be political here, because that is not my place. And I’m ignorant about politicians and politics. All what I know is the area that I’m an expert on the area that I have studied for over 31 years, since I started pharmacy school. And I want you to know, what I know. 

Marilena Grittani, RPh  38:19  

Of course, I’m not telling you what you need to think. I’m giving you the fact and you can backtrack me and you can go to the FDA webpage, and read every single detail that I have said to you today, of course, it’s going to be in a different lingo. And it’s going to be a little bit harder for you to get, because I’m giving you very easy words for you to understand and digest. But you are welcome to go check the fda.gov website and, then verify that everything that I’ve said is true. 

Marilena Grittani, RPh  38:48  

Because I am not against anybody. I’m not pro-anybody, politically speaking only on the side of my patients and, what is responsible in healthcare. So, just to finish This long conversation about vaccines. The vaccine for COVID-19 will NOT be available in the market until June 2021 or so. Or maybe way later. 

Marilena Grittani, RPh  39:18  

There’s ways for this to go a little bit faster because, it has all the resources in the whole world for people to get it done fast. But it does not mean that they have to bypass any of the steps that needs to happen to make sure, that this is safe. Because if the FDA approves it, and a bunch of people get harm or die, this is mayhem. So no, it’s not gonna happen.

Marilena Grittani, RPh  39:41  

So, again, we need to be mindful of this. We need to be careful with it and we need to make sure that what is exactly what is going to happen is the information that we manage and we wait.

Marilena Grittani, RPh  39:54  

I wanted to say this because I have colleagues that are pharmacist that get phone calls, every that people are calling and saying, Hey, did you get the vaccine for COVID-19 Already? Did you receive it already? And they don’t have the time to explain what I explained in this past 25 minutes to you. They only say no, not yet. That’s the answer, not yet. But, they’re not yet is going to take at least 12-14 more months for it to come out. So, again, we’re not ready for a vaccine, to have a new vaccine. It takes a lot of time, but it is absolutely credible and very trustworthy, once the FDA approves it.

Marilena Grittani, RPh  40:38  

So, the day that the FDA says we have approved this vaccine for COVID-19 I will take it without a problem. But if for some reason somebody rushes that process, and it’s less than a year and we have a vaccine, I would think about it two or three times. Because I will not get myself harm with something that I don’t really know what it is, when I don’t have high risk for the disease. Number one, I’m not working directly with patients these days. And number two, I am not in high risk. I’m not diabetic, I don’t have high blood pressure and don’t have any lung diseases. My theory: I do not smoke or vape. So I don’t have any risks. I will make sure a bunch of people get it first. If that’s the way that it gets approved faster before I use it. 

Marilena Grittani, RPh  41:32  

Now, if it takes a year, year and a half for the vaccine to be approved, and I can read all the data that they have at the FDA for me to make sure that this is safe for me and my patient, then and only then I will recommend for you to have them and I will tell my family and my husband and myself to use it and, my kids before that I won’t.

Marilena Grittani, RPh  41:52  

So that is the information that I had for you about vaccines. Again, this is fact this is information that I got from the FDA web page, this is the information that I learned since the beginning, because this process, over 20 years old, I believe so there is a lot of information that only pharmacists and people that work in this area of health of healthcare knows. So that’s why I wanted to communicate it to you. That’s why I wanted to educate you about this.

Marilena Grittani, RPh  42:20  

You are free to make your own decisions. You are a human being and you’re independent, and you get to choose, what to do. But this is my two cents about what is it, How is it and you can double check me. 

Marilena Grittani, RPh  42:33  

If you have any questions. So if I made a mistake with whatever I said, please send them to me to comment@thelegaldrugdealer.com again, comments@thelegaldrugdealer.com,  and I’d be happy to fix them. I’ll be happy to correct myself or to answer any questions that you might have.

Marilena Grittani, RPh  42:51  

So, that’s it for this episode. Thank you so much for listening. Please subscribe to the podcast. Give us a review and if you have a question send them to me at comments at the legal drug dealer calm, and I will respond them to you directly, or I will include it in one of my future episodes. Also please visit thelegaldrugdealer.com look around and see what I have there for you. And follow us on Instagram and join our private Facebook group community. And please subscribe to our mailing lists so you will not miss a detail.

Marilena Grittani, RPh  43:23  

Next week I will be talking to you about bladder pain or interstitial cystitis with my friend Lisa king that is also a pharmacist that is an expert in this area. And she actually called it: ditched bladder pain. So let’s just ditch it and get rid of it. So with this I’m done. So I hope that you listen to my episode number 18 next week with Lisa King about bladder pain.

Marilena Grittani, RPh  43:51  

So with this I’m done. But before I go on, just in case no one has told you today I wanted to take a minute to remind you of, how awesome you are. How lucky are those that have you in their lives.

Marilena Grittani, RPh  44:03  

 Thank you for being the awesome you that you are!

Marilena Grittani, RPh  44:06  

Have a wonderful rest of your day.

Marilena Grittani, RPh  44:08  

This is Marilena Grittani, The Legal Drug Dealer.

Marilena Grittani, RPh  44:11  

Bye for now.

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