Murder By Medicine 1 - Dr. Jennifer Daniels - 03-28-2013

Doctor Jennifer Daniels: 107,000 Americans die every year from improperly prescribed medications

Doctor Jennifer Daniels: Hello. My name is Doctor Jennifer Daniels, and I am a formerly licensed, board certified family practice physician trained in the United States. And this video is dedicated to the 107,000 Americans every year who die in the hospitals at the hands of competent physicians, prescribing medications as they are intended, according to protocol and instructions. Now, this has been talked about and talked about by many really, famous, studious people who put a tremendous amount of effort into documenting this effect. This has appeared in the Journal of the American Medical association and many credible journals. But sometimes a problem is so big, a problem is so huge that in order to understand it, you actually have to take one small, little piece of it, like the facets of a geodesic dome. Once you understand the configuration of one facet, then the whole construction of the dome becomes easier to comprehend. And I believe the problem, or the issue of 107,000 people every year dying at the hands of competent physicians from properly prescribed medications is one such problem. Did you know that from time to time, your physician, in fact, every physician in the United States, receives mail from pharmaceutical companies, letting them know about new developments concerning certain drugs. And these drugs let your doctor know what to do and how to safely prescribe medications for your benefit. And I think if we look at this mail, we're going to learn a whole lot. So let's open the mail. Even though I no longer practice medicine, I do still get these letters. So this is a letter that I got in the mail. Important drug warning. Now, in the old days, this box was. This box was a black box warning. Now it's red. And so this is an important letter says, drug warning. So we're going to open it. And there's a lot of stuff in this, mail. first of all, there's a personal letter to the doctor, important drug warning. And it says, dear doctor, there's some new information I'm summarizing for you. New information about this drug. in this case, it's orlistat, but it could be any drug, and it tells you contraindications, reasons why maybe you might not want to use it. Warnings and precautions and adverse reactions, and a little bit of background about what the FDA is requiring. Okay, nothing unusual there. So we have important information. That's good. And then we have a summary of important information about xenocol. Now, this summary, of important information is written just in case the doctor doesn't have time to read the other things in the letter. Now, this is an important piece of, summary. So the doctor has to read this as she reads nothing else. And basically it says that this particular drug, we'll call it orlistat. That's a generic name because again, this could be any drug. Doctors get letters like this all the time. And so it should not be used in patients who have male absorption, who are pregnant, who have gallstones, and who are allergic to the drug. Okay, warnings and precautions. This can decrease the absorption of certain other drugs. Patients should be encouraged to take a multivitamin supplement. Rare cases of severe liver injury, blah, blah, blah, resulting in death have occurred. Patients may develop increased levels of urinary oxalate stone, things forming urinary stones, and renal insufficiency. That's a big word for needing dialysis. So we could die from liver failure or need dialysis for kidney disease and substantial weight loss. That means if this drug works and really does help you lose weight, you could get gallstones. And that the doctor have to check for other reasons for obesity before I prescribe orlistat. And also, a patient should be advised to adhere to dietary guidelines, namely eating a diet which is less than 30% fat. Now, when they do that, of course, xenochel works better. Well, if you adhere to a diet that's less than 30% fat and you're eating a diet 50% fat, if you reduce the fat in your diet, you're going to lose weight anyway, even if you don't take a particular aid. But that is beside the point. So, summary here is there's some pretty hefty side effects here and warnings, namely death and dialysis.

We also have in this envelope, package insert. Now, uh, what do you need to know about this

Okay, now we have more in this envelope, a lot of stuff in this envelope. We also have in this envelope, package insert. It's big. Now, what do you need to know about this? First of all, I want you to notice the print. It's very, very small. This appears to be ten, maybe even eight point type. And the paper it's written on is so thin, I don't know if you can appreciate it, but you actually can see the type from the other side bleeding through as you try to read it. So it's very small. And the type that you're reading is overshadowed by the type which is on the other side. This is very difficult to read, and I want you to see how big this piece of paper is. Okay. And this is two sides, small print, average, busy doctor. I don't think he's going to read all of it, and I don't think the orlistat folks do either of this. While we have a special summary. However, there's a lot of very important, information here. Namely, we have recent, changes, highlights of prescribing information. We have indications, reasons why you might want to use a drug. We have doses and re strength, contraindications, warnings, adverse precautions, drug interactions, use in particular populations, and overdose description, clinical pharmacology and clinical studies, and how to storage this thing, and also special information on how to counsel the patient. And I think it's probably going to be pretty important. I'm looking forward to that section because I already know this patient could end up on dialysis or even dead if I prescribe, or when I prescribe this drug. So let's take a look and see what we've got here.

One thing that's really touted in medicine is placebo controlled clinical trials

So first, let's take a look at the full prescribing information. And that starts over here. Full prescribing information. And as we take a look at this, one thing that's really touted in medicine is placebo controlled clinical trials. And we see here that this manufacturer is very responsible, and they did use a placebo controlled clinical trial. However, their subjects are all teenagers. And the people who take weight loss medicines are generally people between the age of 40 and 60, and they're generally female. And we don't know anything about the gender of these teenagers. However, drug manufacturers have been known to use all male teenage subjects to test weight loss drugs. In this case, we do know it was all teenagers. Now, another thing is just very, very curious about this placebo controlled trial is we have a comparison as to what happened with the drug and with placebo in the first year, and what happened with drug and placebo in the second year. What we see is the exact identical side effects were experienced. But in the placebo group, the side effects were slightly less. So there was never a side effect that appeared in the placebo group that was not in the experimental group, and there was never a side effect that appeared in the experimental group that was not in the placebo group. So the footprint of the placebo and the footprint of the drug appear to be identical. This is another dirty little secret that most people don't know. Placebo is usually not a sugar pill. Yep, that's right. Placebo can be anything. And, drug companies have successfully argued that they can't use a glass of water or a sugar pill for placebo, because then the people who are not taking the placebo or people who are taking the placebo would know it because they wouldn't have any side effects. So in this case, we can see, because the footprint of placebo is identical to the footprint, the side effect footprint of the drug. There's a possibility, I can't say, because I wasn't there a possibility that the placebo is actually a lower dose of the actual drug being studied. What does this mean? This means that when you test a drug and a drug has certain side effects, you compare those side effects to placebo, presuming that the side effects you observe with placebo would be the same side effects of anyone walking down the street with no drug exposure at all. And as we can see, this is obviously not the case. So whatever placebo they're using is not biologically neutral. We can see that because the side effect profile of the placebo is the same as the side effect profile of the drug being tested. So that's already a bit of a concern. Red, flag, if you will. Now, so we've got through that. We've figured out our, adverse reactions and side effects as compared to placebo. And now we're going to take a look at, drug interactions. Okay. We don't need to look at those because there really aren't very many. But now let's take a look at the side effects. It seems that my patient can expect to get oily spotting. 26% of my patients, should I prescribe this drug, are going to get oily spotting, and they're going to pass gas and get discharged from their rectum, and they're going to have to go to the bathroom really, really quick, and sometimes they're not going to make it. That's called fecal incontinence. So they can expect to have embarrassing, events with their pants full of you know what in 7% of cases. So that's going to happen now, just in case. So this is basically a summary of this side. So in case my eyes haven't gotten all blurry by now or I haven't lost my attention, let's turn to the other side. Here's where it gets really, really interesting. This is a graph. And take a look at this graph. Very interesting. I'm going to show it here. Right there. Okay. You can see all those dots kind of look like a triangle. And you could have easily have drawn a line going up and over, but they decided to draw a line going up and over, suggesting that the higher the dose of the drug, the more effective the drug is. Now, again, this is very, very small print. So unless you have your magnifying glass, you wouldn't notice on the x axis here that the dosage usually prescribed is 360 milligrams a day. Well, 360 milligrams brings you all the way out to here. So, in other words, here on out is the benefit you would get from increasing your dose. So you can see it's a flat line. There is no benefit in increasing the dose of this drug. Not only that, if you say all the drugs at or above this line showed patient benefit, maximum patient benefit was actually seen at a dose lower than the recommended dose. Again, it would take a doctor a, pretty much a fair amount of time. And if I were a doctor in an office, I would already have a line waiting outside while I'm reading this package insert. So, that's one piece of information. Now, this is another piece of information. Again, pictures are really telephonic words. So, this draft here shows what happens when you take a, placebo, how much weight loss you get, and the drug in question. And this is initially after a couple months. But on the other hand, if you look over here at the other end of the graph, after four years, you notice this is in kilograms. So I have to convert, right? So, at the end of a four year test period, in exchange for risking death through the liver failure, kidney dialysis, gallstones, and soiling my pants with an orange or brown discharge, I'm going to lose an additional six pounds than had I never taken the medication at all. So, for a six pound weight loss, I'm risking death. Not me, the patient. I would just be the prescribing doctor. So, it's the patient taking, all the risks here. So, now, in the end, they have a little summary section here on, patient counseling. Now, this tells the doctor, now, don't forget, this is what you need to tell the patient. This is your special patient counseling information, and these are information for patients. So, how to take the drug, medicines, to take with it commonly observed adverse, events like, boiling your pants, potential risks and benefits, and dosing instructions. Doesn't mention death or dialysis at all. No mention whatever of death or dialysis to apparently frequent enough side effects that they had to be put in the package insert. And, the FDA demanded they be mailed out. Now, this is what the patient gets. I don't know if you can appreciate this, but this is much, much bigger type. This is orlistat. Much bigger type. And this is all the information that the patient gets about the drug. No place is it mentioned the possibility of death or the possibility of dialysis. And what it says to the patient, in summary, is this patient information leaflet summarizes the most important important information about orlistat. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about xenocol that is written for health professionals. But can the patient really do that? Truth of the matter is, I only have one copy of this package insert. I could give it to the first lucky patient that comes along, but they didn't give me a whole pile of these. And since this is not an eight and a half by eleven page, and because one side bleeds through to the other, it's very labor intensive to copy it. And if I did copy it, the copy probably would not be legible. So actually, I'm really not in a position to give the patient a copy of the package insert. Now, what does this accomplish? Why would a company mail such a mailing?

The package insert tells the doctor what information he should be sharing with patients

Well, first of all, there's a net effect. One, the patient remains uninformed. The patient is not told the medicine is deadly. The doctor is not instructed to tell the patient that the medication is deadly. In fact, the implication is that he's not supposed to tell us, the patient, because on, the package insert, they tell the doctor exactly what he should be sharing with the patient, and the risk of death. And dialysis is not on that list. And when I was in medical school, we were often told that sharing this information with the patients was not appropriate because patients would not know how to handle this kind of information. So distributing information in this manner leaves the patient in the dark, leaves, the patient coming to the doctor's office in response to commercials demanding this drug, and sales of this drug or any other drug marketed in this manner would continue to soar. Now, why inform the doctor at all if the intent is that the patient never know and the doctor never inform him? Well, when a patient does die and the patient and the family, the survivors decide, you know, I think it might have been that drug, then they have legal recourse to sue the doctor for satisfaction because the doctor was informed. The drug company is no longer legally liable because they informed the doctor. And so this is the doctor's failure to give informed consent, which is actually, if you look up the malpractice law, this is, there is such an offense, and it becomes a doctor oversight for not sharing the information, not a drug company oversight for concealing the hazard. And there were very famous arthritis drugs in the past where the drug company did not inform the doctors of the hazard. And so patients, en masse had access to the drug companies, in terms of financial liability. And so this type of notification process. Leaves the drug companies off the hook. Leaves the doctor basically holding the bag. If, he follows his protocols and does as he's instructed and as he's told. And this is how 107,000 Americans die every year from properly prescribed medication.