Below are some of our videos explaining the potential dangers of Invokana, and especially the connection to kidney failure, heart attacks, and ketoacidosis. To learn more about the types of injuries that have been linked to this medication, and the legal claims that have been filed, click Invokana.
Popular Diabetes Medication Linked to Kidney Failure
Papantonio: According to latest data from the Centers for Disease Control, more than 29-million Americans suffer from diabetes, and nearly one of four people with the disease aren’t even aware that they have it. Even worse, as many as 86-million Americans currently suffer from pre-diabetes, and if preemptive measures aren’t taken they too will be diagnosed with full blown diabetes in a matter of years. With so many people suffering from both type one and type two diabetes, Big Pharma saw an opportunity to make a huge profit. In the rush to cash in on the diabetic epidemic they cut corners. They created a product that’s causing as much harm, if not more, than the actual disease itself. That product is called Invokana.
Invokana was developed by Janssen, an offshoot of Johnson & Johnson. Unlike other diabetes medications that are designed to help the body produce more insulin to metabolize sugar, Invokana actually forces the body to filter sugar out of the blood by the kidneys and then the sugar is expelled as waste. As a result of that the body loses carbohydrates that it needs to function. The kidneys become overworked and could eventually shut down, and the body goes into a form of survivor mode where it begins to break down body fat to compensate the loss of that sugar. The condition is known as Ketoacidosis. It’s deadly.
Diabetic Ketoacidosis occurs when the body begins to break itself down for energy, and it creates a dangerously high level of acid in the bloodstream. This condition is extremely painful and the patient can end up losing control over their bodily functions, their kidneys could shut down completely and they can die.
On May 15th, 2015 the FDA warned consumers about the increased risk of Ketoacidosis from Invokana, so Janssen was put on notice that their medication was extremely dangerous for patients. This wasn’t the first time the FDA had expressed concerns over Invokana. The drug was approved in 2013, and it was only approved by the FDA by a margin of one vote. Members of the approval committee were concerned about the safety of the drug, but they voted eight to seven to put it on the market anyway. Janssen wasn’t about to let their cash cow go away. After all, the drug was pulling in more than one-billion dollars a year for the company.
They tried to use Ketoacidosis in their favor telling doctors that patients might even lose weight if they take the drug. In other words, they told patients that this disease was good news, really. They didn’t bother to tell doctors that the weight loss was due to the fact that patients’ body would begin metabolizing itself in a horrendous way. All Janssen saw were big profits, and those dollar signs always trump the warning signs.
Joining me now to talk about Invokana’s story is Tim O’Brien, the first attorney in the United States to file a lawsuit on behalf of Invokana victims. Tim, start by telling us how Invokana is different from other forms of diabetes treatments. What’s odd about this one?
O’Brien: What’s odd about this is if you look at a patient who has received no treatment at all, has full blown diabetes, is in a diabetic crisis mode, that’s what this drug mimics. Most diabetes type two drugs actually metabolize, that is use the body’s own insulin to actually eat up, to digest the sugar. This one doesn’t. As a result, the patient who takes the Invokana is put into a crisis mode. If I were a diabetic and I received no medication and I was undiagnosed, my kidneys would pee out the blood sugar. That’s exactly what this drug is designed to do, is to use an emergency mechanism, a mechanism which is only designed to be used for a few months and then you’re going to go into a bad situation, rather than actually use the carbohydrates as an energy source. Instead, because the carbohydrates cannot be used as an energy source, the body has to cannibalize itself. Not only does it eat its own fat, it eats muscle.
Papantonio: Okay, Tim, let me make a point. First of all the manufacturer knew that these were problems before it went to the market. That’s something we probably can agree on. They knew it was a problem. The FDA knew it was a problem on this marginal vote, but the FDA lets it go anyway. They understand that this is a whole new concept on how to treat diabetes. What is your take on why the FDA again just let things go because the pharmaceutical industry wanted them to? What’s your take on that?
O’Brien: I think it’s all part of PDUFA, which is Prescription Drug User Fee Amendment Act. Way back several years ago you recall that the pharmaceutical companies had to start writing prescriptions, that is actually writing checks to have their drugs approved. Now the FDA regards the pharmaceutical companies as its client. They have to get drugs to market within a certain time, otherwise the FDA is punished. Here you have Janssen trying to create “the better rat trap” when there have been for 30, 40, 50 years very effective type two diabetes medications. They pressured the FDA to release this onto the market even with this information in hand.
Papantonio: Tim, this is another one of those situations where the pharmaceutical industry invents this medication. They have to find a way to market it. This medication is not even necessary. Can we agree on that, that a person out there taking this doesn’t even need it because there are all types of alternatives? Did I state that right or is there another angle to that?
O’Brien: Oh, no. Absolutely, there are so many different types of medications out there for type two diabetic patients. They could go on Metformin, they could go on Glucophage, things have which been tried and true for decades. The pharmaceutical industry, because this is the largest group, this type two diabetic group is the largest pill taking market out there, the pharmaceutical industry is not going to stop trying to invent the better rat trap. Instead of using things like it has normally done, which is metabolize the sugar, now they’ve run out of the metabolic options and are going into the emergency mode of action options such as the Invokana mechanism.
Papantonio: Tim, when you filed this lawsuit there were certain things that you knew about the physiology of all this that certainly the company had to know. When the kidneys are forced to go into this emergency mode and they jettison sugar from the body, what happens to the organs? The kidneys are among some of the most fragile organs in the body. What happens when this occurs?
O’Brien: Two things. Number one is this is the only type of drug that is by design organized mechanically so that large amounts of blood sugar actually enter the kidneys. It goes into tubules in the kidneys, which are very, very delicate tubes which are meant to filter normal waste, not this amount of sugar. The second thing is in order to flush all that sugar from the body, the body has to dehydrate. It actually extracts water from the cells in order to create the urine to create the strain through which all of this excess sugar can be evacuated. Two things happen. Number one, a large amount of sugar is entering a very fragile organ. Number two, the kidneys start shutting down on an acute basis because they start getting dehydrated. They lack the medium, that is the water, to get the actual sugar out of the body.
Papantonio: Okay. Let me back up now. Again, the FDA was aware of that when this product was put on the market. They understood what could happen to the organ systems. The manufacturers certainly understood. Nevertheless, the FDA by a margin of one vote says, “Yeah, we’re going to take the risk.” Now on top of that, tell us the story about the manufacturer, Janssen, going in and telling the public, “Gee, it’s a good thing. It’s a good thing that your body is wasting away because you’re going to lose weight.” Tell us how ugly that kind of argument was weighed. I mean, how do you get anything more bizarre than that? It’s a disease.
O’Brien: It is the most damnable thing. Here you got an emergency mechanism, literally cannibalizing yourself, eating your own muscle, eating your own fat because it’s not converting carbohydrates to energy. In a totally off label maneuver Janssen says, “You know what, you may lose weight”, as if this is a good thing. You may lose weight because the body is metabolizing itself, it is cannibalizing itself. The FDA knew this would happen. This is a tried and true symptom of diabetic Ketoacidosis when you have unexplained weight loss, and that’s exactly what it was resulting. The body metabolizes itself and so you lose both muscle mass and fat. As a result, they are claiming it has an unintended benefit of taking the drug.
Papantonio: This disease process that’s caused by Invokana, the drug company sees that they have to put a positive spin on it, when they should be pulling the drug from the market. Again, it’s not a necessary drug. There are many things that you can treat diabetes with. They take this negative, they have the facts, then they have their marketers turn that negative on its head and tell people, “This is great, you’re going to lose weight. Oh, by the way it might kill you.” Has there been any repercussions at all from the Justice Department or anybody in regard to that kind of representation to the public?
O’Brien: No. There has been no DOJ action at all. However, obviously the private attorney’s general, people like you and me who represent folks who’ve been injured by the wrongdoing of companies such as Janssen, we have formed a multi district litigation in the district of New Jersey to bring justice to these folks and actually reveal to the world the sheer fallacy of this mechanism, this bad design drug. It’s my prediction, Mike, that within three to four years this drug is going to be boxed up through a black box warning that’s going to render it a nullity. Right now, Janssen is riding the blockbuster status that it has got and it’s making almost two-billion dollars a year on it.
Papantonio: Okay. Again, Tim, we see that the drug industry trumps safety because they’re making billions of dollars a year and nothing has changed here at all. Thanks for joining us. We’ll keep up with this story. I think it has just begun actually as I listen to you talk.
Diabetes Drug Invokana: The Treatment Might Be Worse than the Disease
Farron: David, Invokana, a blockbuster diabetes type two drug, we're finding out now it has a lot of negative side effects, as often happens with some of these blockbuster drugs. Before we get into those, real quick, just give us an overview of what Invokana is specifically used for as far as the diagnosis and things of that nature.
David: This is another Johnson and Johnson product which has become incredibly popular. They've put a lot of money behind it. It is a drug to deal with the control of diabetes, which of course is a condition that millions of people have. Diabetes has a lot to do with the acid levels in a particular patient, and this is an inhibitor of some of those issues and has helped to control the diabetes issues, but what we're seeing is again, with real safety concerns with Johnson and Johnson being raised, and very serious concerns and a lot of very serious adverse side effects for these patients, where it appears that Johnson and Johnson has not properly tested this blockbuster drug before bringing it to market, and putting millions and millions of dollars behind their advertising instead of more clinical trials prior to pushing it out nationwide.
Farron: What's really interesting is that Invokana commercials are very common on television, obviously because type two diabetes is becoming more and more common these days. In these commercials, as we've often seen, they show the happy people. Once they're on the medication, they're living their lives. They're out there having fun. They're barbecuing. They're exercising. Then, in the real professional speak, they start giving all these, ‘Invokana may cause yadda, yadda, yadda, yadda.’
That's what they do. There is a difference. The side effects are spoken at a high school grade level. The benefits of the drugs are always spoken at a grade school level. Study after study has shown that this is the way that these drugs are marketed.
When we're talking about a drug like Invokana, we're looking at something that is causing kidney failure, heart attacks, ketoacidosis, and this is a drug that is meant to help excrete blood sugar from the bloodstream through the kidneys. Those were just the first side effects we knew of. Now we're starting to see things where people are losing limbs as a result of taking this medication?
David: Yeah, that's right. That's the latest FDA advisory that's come out, is that there are a number of cases of amputation. Of course, diabetes patients can be prone to risk for amputation and loss of limb, loss of toes. A lot of times that's where it starts, so if you have a serious diabetes condition, you have to always be cognizant of that, but the information that's coming out in this recent clinical trial test, which the FDA has issued an advisory about and said that they're going to be checking into further, is that the Invokana drug is greatly increasing the propensity for these types of amputations.
First, this is how the pattern for a lot of these drugs unfortunately has played out. Information keeps on seeping out about some of the concerns here, first starting with heart attacks, stroke, bone fracture, and things like that. Last year, those were the advisories that were coming out, and now more recently the amputation risk. The issue is that with a lot of these drugs there are side effects, of course, but the issue is whether the manufacturer, in this case Johnson and Johnson, have properly warned about the potential side effects so that the physician and the patient can make an educated decision about whether or not the drug's pros outweigh the potential cons and the risk.
Johnson and Johnson has not properly warned of these risks, which now are only coming out after the fact, and that is really the disconcerting thing. Johnson and Johnson, who we think of it as such a household product and the baby to baby shower and talcum powder, which we're learning a lot about cervical cancer there unfortunately, but it's a household name. Obviously, with the systemic problems at Johnson and Johnson, it certainly appears that advertising and profit is a primary motive here, perhaps over patient safety.
Farron: You pointed out something very interesting there, and I want to expand on that just a little bit. That's the fact that it's not that the drug, or any drugs, cause side effects. Even ibuprofen and Tylenol can cause side effects. A lot of it has to do with the risk benefit analysis, the side effect of it versus what it does, but the most important thing, and this is where lawsuits come from, is what did the company know, did they hide it, did they properly deliver this information to physicians and patients. It's when there is a cover-up, or when they did not disclose, that they face liability. It's not just because their product isn't doing everything it says. It's because they knew it wouldn't, and they hid the dangers. I think that's something that the public needs to understand. People don't just get sued for no reason. It's because there was a cover-up, because there was no warning.
David: That's correct. The warnings, and we see the fine print and so forth, but you wonder how much consumers really understand, as you say with the TV commercials, or you look in the weekly periodicals and things, and you've got all this fine print which of course goes over everyone's head. A lot of it is education of the physicians as well. Instead, Johnson and Johnson is paying tens of millions of dollars in marketing the products for medical consultants, literally wining and dining a lot of physicians to the tune of a couple of million dollars in food and beverage expenditures for this particular drug, and so they're glossing over a lot of these issues. Either they knew of the problems and they haven't given proper warnings, or they didn't do sufficient medical and clinical trials to determine what the side effects were.
If a black box warning goes on a particular drug, studies have shown that the prescriptions of that drug may go down by about 40%. That's what these manufacturers don't want, and so they're making an oftentimes ... Unfortunately, they're making calculated decisions about whether it's better to avoid the black box warning and take their chances on the liability side, and deal with the lawsuits that come as a result of the various injuries, amputation, stroke, heart attack, or death, versus having their drug, which they are talking about on their quarterly Wall Street conference calls, that this is great, ‘We're getting great market share in this huge patient population for diabetes.’
That is the issue. Is the black box warnings appropriate warnings to the patients? The patients need that. Johnson and Johnson is a very sophisticated company. They need to be putting out all of the information that they have about these drugs so patients can make informed decisions.
Farron: As we've seen too many times, it always comes down to profits over patients, and that's why people like you, the trial lawyers, Mike Papantonio, Howard and Michael Burg, all a part of this show, that's why you guys are out there doing what you do every day, to help protect American consumers. We appreciate your work both in the courtroom and on this show, so David, thank you very much for talking with us today.
David: Thank you, Farron. It's my pleasure.
Diabetes Drug Invokana Creates Even Worse Problems Than It Solves
Mike: In Screwed News, last night we told you about the potentially disturbing connection between Johnson & Johnson's brand of baby powder in ovarian cancer. It turns out that baby powder isn't the only Johnson & Johnson product under fire for dangerous side effects. Invokana, a blood sugar drug made by Johnson & Johnson's subdivision Janssen Pharmaceuticals, has been connected to cardiovascular problems and kidney failure and now a recent court case in Minnesota's threatening to blow the whole thing wide open, I hope. With me now for more on this is consumer attorney Travis Lepicier.
Travis, welcome. I know you've been at this case now for a couple of years. Tell us what exactly Invokana is and what's it used to treat and what are the problems that we're finding with this drug?
Travis: Sure, Invokana is a medication that's in a new class of diabetes treatments called SGLT2 inhibitors. The drugs are prescribed to Type 2 Diabetes patients with the intent of lowering their blood sugar. The drugs do that by preventing the patient from metastasizing the sugar that they consumer and instead the person will excrete the metabolized sugar through their urine and it passes through their system without ever being used as energy. As you said, Johnson & Johnson and Janssen are the manufacturer and the seller of this drug. Here in the U.S., the drug has been absolutely a huge boon for these companies to the tune of a billion dollars in annual sales in 2015 alone.
Mike: As you started looking at this case, first of all, the things that you found was a cardiac arrest, a heart failure, kidney failure, ketoacidosis which also can be fatal, but Travis, isn't this another situation where the FDA simply takes whatever the industry says, whatever the drug manufacturer says, they take their word for it? People think the FDA does their individual studies. The FDA does no studies. Xarelto for example, I know you're one of the lawyers involved with that. On Xarelto now we're finding that the Duke studies that the FDA used might have been completely way, way out of kilter. It might have been on purpose. This is another one that got by. It's a drug that nobody needs because they're plenty of drugs that do the same thing. How does this happen time after time Travis?
Travis: I think it's even worse than just taking the company's word for it. Here, especially with the cardiovascular issues, the FDA was aware that there was an increase, or there's indications of increased risk of stroke and heart attack with Invokana, yet they still passed it through the advisory committee by an eight to seven vote, so it just got through by one vote. They were aware that the cardiovascular events were a problem so they told Janssen to go back and complete their trials. In effect, the FDA's rubber-stamped using consumers as guinea pigs for Janssen while they complete their trial and determine whether or not heart attacks and strokes are a concern for Invokana. The initial trial numbers indicate that they are a problem.
Mike: Travis, do you find in this practice that most people believe, they honestly have a real believe, that the FDA actually studies these drugs? You know that's not accurate. I know that's not accurate but most people actually believe that the FDA has done studies on this themselves. Nothing's further from the truth, is it?
Travis: Absolutely. I think the common person on the street expects the FDA to rigorously vet these drugs when they're coming up for approval and the reality is, they don't do that at all. It's much more of a rubber-stamp and these drugs are put on the market and the American people are used as guinea pigs to determine whether or not they're actually safe.
Mike: It all seems to flow from the top. For example, this committee that you talked about. The committee is political isn't it? I mean this committee that reviews this is totally political. There are plants that come directly from the pharmaceutical industry. Sometimes they come directly form the company. Nobody asks questions about them being planted on this committee. It's just a matter of following the money, isn't it?
Travis: Absolutely. All you have to do is look at Obama's recent nomination to head the FDA. That person has been taking money from big pharma for years now and he's now being nominated to lead the FDA by the president of our country so it's a pretty scary situation.
Mike: Travis, this administration knows that. It's very clear that you had Bernie Sanders out there on the stump saying that this guy is an abomination, and he is, but neither the less Obama appoints him anyway because the political impact that comes from the pharmaceutical industry's so strong. But with this Invokana product, this is a dangerous product. The company making it, Janssen, they call it their "cash cow." It's making so much money they call it their "cash cow." People are being hospitalized. They're dying of heart attack. They're dying of kidney failure and the FDA sits there fat, dumb, and happy. Did I get that right?
Travis: Yeah. I think that's absolutely right. I think it's really important that people understand one of the reasons this drug is so successful is because Janssen and Johnson & Johnson are out there greasing the doctors. The doctors are the ones prescribing these drugs to the patients and we know that they have spent almost 30 million dollars since the drug has been on the market paying doctors in various forms to be selling these drugs.
Mike: Explain that. People can't even fathom that a doctor is being paid to prescribe medicine. Explain how that works.
Travis: Sure. It comes in many forms. There is often compensation for menial tasks in the form of just a check to the doctor for performing a speech somewhere at a seminar. There's often prestigious seminar speaking spots that they're offered. There's vacations. There's fancy dinners. There's all kinds of perks and benefits, as well as just cash, that these doctors are given in an effort to get them to prescribe the drug that the manufacturers want them to prescribe.
Mike: Basically it's pay to play. Doctors know they have their hand out, "Give me money and I will prescribe your new cash cow." The doctor at the same time ... Tell me if I'm wrong. The doctor at the same time has many other alternatives that have been on the market for a long time. They don't have to take chances. There's nothing they have to do to take a chance here but they take the chance anyway to make money. It's the old greed thing at work. We never believe that our doctor would do that but they're doing it every day, aren't they?
Travis: It appears so. It seems like greed is trumping safety. It's a really sad state of affairs but when it comes to Invokana and many prescription drugs that you see that cause injuries, that's typically what you're seeing.
Mike: Approximately how many cases have been filed ... In less than a minute talk about this. About how many cases have been filed in this case Travis?
Travis: There's a couple handful of cases that have been filed around the country. There's both state court and federal court litigation that's going on. We're really getting ramped up for discovery against these defendants. These are corporate behemoths and it's going to take a lot to take them down on this drug. We feel confident that at the end of the day this drug is causing these injuries ketoacidosis, kidney failure and the heart attack and stroke as well. We think the litigation will go well. It's very on in the process but it will go well.
Mike: Travis, thank you for joining us. Keep up the work on this case. If you don't do it, obviously nobody else is going to take care of this problem.
Diabetes Drug Invokana Linked to Ketoacidosis and Potential Kidney and Heart Failure
Papantonio: A blockbuster diabetes drug called Invokana has pulled in hundreds of millions of dollars for big pharma, but the FDA recently announced that the treatment is causing even more problems with diabetics, but the FDA are the people who allowed that to happen. Joining me now to explain what’s happening is Tim O’Brien. Tim, a dysfunctional FDA has allowed it to happen again. It seems like every week we’re talking about a new blockbuster drug that’s killing people by the blockbuster thousands. Invokana is no different.
O’Brien: Yeah, it is the caboose on the type 2 diabetes drug train that the FDA just keeps shuttling down the track. When you look at the history of what the FDA has done with these type 2 diabetes drugs, you got Avandia, that had heart attacks and strokes. You have Actos, bladder cancer. You have Byetta, pancreatitis and pancreatic cancer. Rezulin, you remember that one, liver failure. Now with Invokana, the latest in the type 2 catastrophe out of the FDA, there’s kidney failure and a condition known as diabetic ketoacidosis, a bad condition that can take your life.
Papantonio: Tim, you and I tried the Rezulin case out in Texas, the test case, God, I don’t know how many years ago. It seems like such a long time ago. We hit them for $48 million out there. The reason … When the jury came back and we talked to the jury about it, the jury was absolutely shocked that the company had not only covered documents up, had covered bad labs up, they had actually manipulated and changed the numbers on the lab tests. This is something we’re starting to see in all of the major pharmaceutical blockbuster litigation these days. I don’t care what it is. If it’s Xarelto we see the same thing. I know we’re going to see the same thing with Invokana. What’s your take?
O’Brien: It’s part of the dysfunction of the FDA. It’s a calculus that these drug companies engage in, and that is once you get past the approval process and you’ve got your billion dollar juggernaut going, it takes a lot of momentum, it takes a lot of public outcry, and it takes some activity from the FDA to either make a change or label or take the drug off the market. This calculus is all about let’s get it out there. Get the drug out there. Get it up to blockbuster status, over a billion dollars a year, and Invokana is already there. After 2 years on the market, it’s already over a billion dollars a year, and “When they come and make us do something, well, we’ve been out of the market, and we’ve made our several billions of dollars.”
Papantonio: How bad is it as far as shutting down people’s kidneys?
O’Brien: What the Institute of Safe Medicine Practice has revealed is there’s a several hundred percent more likelihood with Invokana versus other type 2 diabetes drugs outside of the class of you going through acute or chronic kidney failure. The problem is the way this drug works is rather than chew up or metabolize the sugar like all of the other type 2 diabetes drugs or classes are supposed to do, it doesn’t. It puts the body into an emergency excretion mechanism where the drug instead of actually using the sugar just urinates it out. The urination process is actually a mechanistic process. It’s an emergency mechanism, and so this drug, Invokana, is the only type of diabetes drug, this class is the only type 2 diabetes drug class that lets, by design, high blood sugar go into a very, very fragile organ, and that’s the kidney.
Papantonio: Okay, so same kinds of questions. Here they are. First of all, the company doesn’t really care that the FDA probably may or may not fine them, that they might be fined for this kind of conduct. Even if we prove our case, the FDA will come in and maybe slap them on the hand with a fine. The people who made the decisions about this, let me just predict, we’re going to find that they absolutely knew about the risks. They had marketing get involved. Marketing took the lead on everything, and marketing just told the scientists basically, “Go piss off. We’re going to do what we want to do.” Isn’t that basically what we see on every one of these blockbuster drugs?
O’Brien: It’s almost like a playbook. You got it exactly right. Here’s the thing about Invokana. We’ve been talking about kidney failure and we’ve been talking about that which the FDA finally caught onto, and that’s this condition known as ketoacidosis, but actually, Pap, this drug almost didn’t get out of committee, and here’s something that’s flying under the radar right now. When the ad comm, when these experts on the Advisory Committee actually looked at the clinical trial, they discovered in the very first month of the clinical trial for Invokana, when you looked at the people who were on Invokana versus the placebo group, in the Invokana group there were thirteen people who had had either a heart attack or stroke, and in the placebo group, it was one.
It almost didn’t get in the market. There was a majority vote that the investigators were concerned with this cardiovascular risk profile, and the FDA and Janssen’s negotiated a compromise where Janssen’s would continue to study, all the way into 2017 on the back of this billion dollar drug and really using folks as guinea pigs, the cardiovascular risk profile of Invokana. We won’t know what happens with respect to a heart attack and stroke warning until the very earliest the summer of 2017.
Papantonio: Why is this just second rate, third world kind of a regulatory review, why has that become just okay with the FDA, that, “Hey, this is what we are. We are a Banana Republic kind of review organization”? Why has that happened, that we have Invokana, that we have Xarelto, that we have Actos, that we have Rezulin, that we have Yaz? Product after product. Why has that become okay with the FDA?
O’Brien: It is a two word answer, Pap, a two word answer that summarizes how and why the FDA has gotten so lazy, and it’s called surrogate markers. What the FDA does now, it no longer looks at, is this drug really helping you not have a heart attack, really helping you not go into kidney failure, really helping you stay out of the hospital? Instead it looks at a surrogate marker, so it doesn’t even examine over a long term period, what is the benefit in terms of preventing heart attack? What is the benefit of preventing blindness or preventing kidney failure? Instead it looks at a test, one test, the hemoglobin A1c, and as long as those numbers are correct, the way the FDA thinks they should be, then they rely upon that.
They lie under that umbrella and say, “Well, the surrogate markers are good. Therefore we’re going to assume that all of these other downstream effects that we don’t want to have happen to people won’t happen to people because the surrogate markers are good.” Expert, after expert, after expert who knows anything about pharmaceutical trials knows that surrogate markers are number one, misleading, and number 2, what you’re really trying to do is prevent things of clinical consequence like heart attacks, like strokes, like diabetic ketoacidosis. These clinical trials, the FDA lets them go on without measuring, without really demanding a result in the clinical outcomes.
Papantonio: When you add to that the fact that it’s big money for the people working in the FDA because they go out and they go to work for the very companies who’ve they’ve given permission to, they go to work for the very people they’re supposed to be regulating, and the reverse of it is true. The drug industry puts their plants inside the FDA. It is totally dysfunctional. Tim, make sure you bring these people down. Tim O’Brien, thank you for joining me.
O’Brien: Thank you, Pap.