Below are some of our videos explaining the potential dangers of Actemra, and especially the connection to heart failure, stroke, pancreatitis, lung disease, and gastrointestinal perforations (holes and tears).
To learn more about the types of injuries that have been linked to this medication, and the legal claims that have been filed, click Actemra.
Actemra: Big Pharma’s Latest Big Lie
Mike Papantonio: Rheumatoid arthritis is a chronic disease affecting more than 1.3 million Americans and as much as 1% of the worldwide population. The specific cause of rheumatoid arthritis is not known, and there is no known cure for the disease. Rheumatoid arthritis is one of the most common autoimmune disorders and the symptoms are triggered when a person’s antibodies attack the synovial joint fluid, causing chronic inflammation.
Actemra is an immunosuppressive medication used to treat the symptoms of moderate to severe rheumatoid arthritis. The medication was first approved by the FDA in 2010. The drug has been marketed to doctors as not increasing the risk of heart failure, stroke and lung disease, which competing drug makers admit, rheumatoid arthritis medication usually does. The problem is that Actemra absolutely does carry this risk, and the manufacturer seriously misled the FDA and doctors in order to sell its drug.
According to the medical journalism organization STAT, patients taking Actemra are 50% more likely to suffer a heart attack or stroke than patients using Enbrel, a competing drug. In fact, STAT analyzed more than half a million reports of adverse events during treatment with rheumatoid arthritis drugs, and found evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high – or even higher – for patients treated with Actemra than they were for patients treated with competing drugs. In other words, they out-in-out lied to the FDA and medical doctors about Actemra dangers.
The failure of Actemra to carry a proper warning has led doctors to overly prescribe this medication to individuals who are susceptible to heart and lung injuries, and has led doctors to fail to monitor these patients more closely for potential harm.
Drug makers Roche and Genentech, the manufacturers of Actemra, are now facing thousands of potential lawsuits. Plaintiff attorneys claims that Roche and Genentech failed to properly test Actemra before placing it on the market; They failed to warn doctors and patients that the medication was just as likely to cause serious injuries as competing drugs; They concealed evidence of the dangers of the drug from the government and public; And the drug makers misrepresented the safety of the medication in its marketing material and publications. Pretty much a grand slam of fraud.
Patients have a right to be able to make informed choices about what medications they take. But when you have drug companies that hide the real dangers of their drugs from doctors, it becomes impossible for consumers to make an informed choice. And make no mistake – that is exactly what Big Pharma wants, because the second people start questioning the safety of a drug, the profits for those big drug companies begin to fall.
Joining me to talk about this is attorney and doctor, John Restaino. John, let’s start by talking about the condition itself, rheumatoid arthritis. This disease affects millions of people across the planet, yet it still has a bit of mystery as to how and when it’s gonna strike somebody that you might know. Is that kind of a quick take on it?
John Restaino: It is in fact. It does affect predominantly women. It’s been estimated that approximately 1% to 3% of women in the United States are affected with this disease. As has been mentioned, there’s no known cause. It’s in the class of rheumatic diseases and it’s a form of autoimmune disease, meaning it’s where the immune system of the body actually turns on the body itself, instead of attacking bacteria or virus or exogenous agents. It actually attacks the tissue within the joints of the body itself.
Mike Papantonio: Well there’s some good medications out there, but part of big pharma right now, it seems like they’re trying to capitalize on a problem. And really, they’re doing it with a drug like Actemra. The only way I can look at these facts is to say they … You’ve got a company that’s totally misrepresented the truth about the drug that they were selling to millions of people all over the globe. What’s your take?
John Restaino: Well, that’s apparently so. The evidence is coming out now to showing that the risks of these very serious adverse events associated with the drug is at least equal to other members of the class of drugs that are used, the DMARDS, or Disease Modifying Anti Rheumatic Drugs. The other members of the class are recognized as carrying specific risks, including cardiovascular events, such as heart attack and stroke, and a form of heart failure. Included in that is a very serious condition that affects the pancreas, inflammation of the pancreas, or pancreatitis. What has been analyzed now are the reports to the FDA’s adverse event database. The reports being sent in by physicians and patients are showing that these serious adverse events with these other drugs are also being seen with this drug, and even at higher levels.
Mike Papantonio: John, how does a company just get away with lying about its clinicals? I mean, that’s what happened here. We had a company that said, ‘Look, we’re different. We know that rheumatoid arthritis treatments carry risks, but we’re different because ours doesn’t.’ How does a company just get away with that? In the case of Actemra, the company seemed to downplay the risk. They did that, but they also told physicians that the risks were decreased with Actemra. Isn’t that what they represented to the American public?
John Restaino: Exactly. Looking at their clinical trials, which were relatively short in duration, so if we’re going to start getting adverse events with a particular drug, then you want to be able to see drugs that are powered enough to find these. Meaning, there are enough people in this study and that the studies are conducted for a long enough period of time. First of all, it’s important to recognize that rheumatoid arthritis carries with it an inherent increased risk of cardiovascular events. Now, the manufacturer may say, ‘Aha.’ In this particular case, an individual with a heart attack of a stroke, it might be due to the rheumatoid arthritis, but when they’re taking a medication that increases that risk, that’s putting that person at, obviously, an even higher risk of it.
It’s well known and it’s reported from the clinical trials, that Actemra increases the blood levels of all of the cholesterols in our body, meaning the low density lipoprotein, known as bad cholesterol, and total cholesterol levels. It’s well known that cholesterol levels and elevated LDLs are associated with heart attack and stroke-
Mike Papantonio: John, I don’t want to get too much in the weeds here. Let me stick to what people need to know. And that is the FDA-
John Restaino: Okay.
Mike Papantonio: The FDA hears this message from the manufacturer. That is that gee whiz everything’s okay. Now the FDA knows that they weren’t told the truth. What does the FDA do now to correct the problem? Is there any kind of publication campaign? Are they getting the television? Are they trying to correct this big lie that’s out there? What’s happening?
John Restaino: Well, there’s not much happening. The FDA has required the manufacturer to conduct post marketing approval studies, meaning phase four studies. But that’s something that many times is not done and can take many years to conduct. In the meantime, there has not been a safety alert sent out to physicians. They’re not being told to evaluate the patients for any of the signs and symptoms of these cardiovascular events that we’re seeing with the other drugs. The FDA, once again, is falling down on the job.
Mike Papantonio: Well, I mean you bring up the point. There are things that can be done once a product is put on the market, you can then say, ‘Okay, well we have to do some things now to correct our screw up to begin with.’ When this is another major mess up by the FDA where they’re not doing their job. There’s no other way to put it. They could have looked at the clinicals. They could have seen that the clinicals were gamed. They could have seen if they were missing. They could have seen if they were extensive enough. There were a lot of things they could have done. They could have looked at the power aspect of the studies that were done. Here. They now mess up again. The FDA messes up again. And they have ways to correct it. They can send out alert letters, as you point out. They can start a public service kind of campaign. What other things can they do, John?
John Restaino: They have many things available to them. As you just mentioned, the public service campaign can be important. Every patient has a right to know of the serious effects associated with the drugs that they’re taking. These adverse events that are being recognized with Actemra are inherent in the entire class and the other drugs are warning of. The FDA should be sending, as we mentioned, a safety alert to the doctors, so when doctors are putting the patients on this drug, they’re now monitoring them for the early signs and symptoms of cardiovascular disease, interstitial lung disease and pancreatitis. All of which have been found to be increased when taking this drug.
Mike Papantonio: Okay, now. Look, you’re sitting here both as a medical doctor and as an attorney. Wearing both of those hats, what is happening with the drug industry in general to where we, it’s almost weekly, where we do a story just like this to where we find out they just haven’t told the truth? A drug manufacturer has again lied to consumers. Consumers have died because the company has lied. FDA has dropped the ball because the company has lied. What is this trend that we’re seeing? In about 30 seconds or so, what’s your take on this trend?
John Restaino: Big pharma is going to continue to do this because of the monetary advantages for as long as they can. We can go back to Vioxx. I the clinical trials of Vioxx, they knew there was an increased risk of cardiovascular disease. They hid it from the FDA until it came out in the public as more and more people took these drugs. It’s exactly what we’re seeing with Actemra right now. The reports to the FDA itself is showing a markedly increased risk.
Mike Papantonio: Yeah. It seems to be what we have to live with. I tell everybody, unless a drug has been on the market for more than 10 years, why would you take a risk with a drug? John, thanks for joining me.
Actemra's Failure to Warn of Serious Side Effects Leads to Thousands of Potential Lawsuits
Farron Cousins: It's estimated that about 1.5 million Americans suffer from rheumatoid arthritis and with such a large population suffering from a disease, it's no wonder that big pharma has stepped up and offers a variety of different treatments, some more dangerous than the others. And one of the things that we are learning now is that one popular rheumatoid arthritis drug, actemra, is actually causing some very severe side effects that the company knew about allegedly but failed to warn consumers. For more on the dangers of actemra, I am joined by attorney Kim Adams, Kim has handled countless lawsuits against some of the biggest pharmaceutical companies in this country.
So Kim, with actemra, I mean we are talking about rheumatoid arthritis medication here and as far as we know so far, all rheumatoid arthritis drugs typically come with a myriad of side effects that, you know, quite dangerous. So with actemra, what are we seeing specifically?
Kim Adams: I think specifically, we are seeing some of the same adverse reactions as we see with some of the other rheumatoid arthritis drugs, heart attacks, strokes, acute pancreatitis and interstitial fibrosis. So the danger with actemra is that it might be having high or higher adverse event reports as with the class of drugs that treat this severely debilitating condition.
But doctors and consumers are being misled because there are absolutely no warnings on the actemra label and I think that's the concern that we're seeing right now with this drug.
Farron Cousins: Absolutely. And see, that's one of the things that I always like to explain to people about lawsuits, it's not that a product came out and it caused horrible things and so we just sue, sue, sue. It's when the company understands it and fails to warn consumers. Now we've had plenty of products like some of these other rheumatoid arthritis drugs, they come out and they say it can help with this disease, it can help with this condition but be warned, it's been linked to these things.
Actemra just forgot, conveniently, that second step of putting that warning on the label, telling doctors about this and that's when you're gonna always run into liability problems with a company when they say "Well, it does these things but let's not put that on the box, let's maybe not tell the FDA, maybe tell the FDA and see if they're okay with us putting this box out that doesn't have a warning." And that's kind of what we're seeing in this situation with actemra.
Kim Adams: Right, so essentially this is Roche's fifth largest selling medication and that's often a criticism of our drug safety evaluation, right. I think that some of the evaluators at the FDA may have been aware, have seen signals of these issues. The problem is, it may not have been significant enough for them to feel like they needed to force a label change. We're stuck in a world of being innovative to cure these conditions and also giving the public the right to make a choice.
If you don't put anything on those labels when you know it should be, our mode in this country is ask questions later. Let's get it to the market which in some instances might be beneficial, but for something where there's other markets and there's other drugs in this class, you either want the drug company to take a little bit more time or warn now and if you want to remove that warning later, great but right now, if you've got a signal, let a person make the appropriate decision and let them make an informed decision. That's why we do our job.
Farron Cousins: And there's been a lot of, I guess, medical pharmaceuticals I should say in the same kind of category when there is plenty of other competitors on the market that do carry a warning or might actually just be safer, not cause these side effects but because of that rush to market, that quest for profit, a pharmaceutical company will come out, blood thinners are a great example, market it as safer even though it is not and then with the case of actemra, it could be as high or higher instances of heart attack and strokes and other deadly potentially side effects.
That's what we're seeing again here. The FDA basically fell down on the job here. I mean they still as far as I've seen from the current reading are not making them put this warning on yet and so as you pointed out with the informed decision making, we still can't necessarily have that when we have the regulatory agencies and the pharmaceutical companies not doing their job which is the first step of telling doctors "This is a great medication but ..." It's the but that they're not doing.
Kim Adams: That's correct. And honestly, it is the manufacturer's duty to monitor this drug and in fact, with actemra specifically, some of the researchers may have had a little bit of concern about pushing it through but they pushed it through based on and on the condition that Roche would continue to study this drug long-term.
We can get into all the financial interest that might go into a drug company funding the studies that it has committed all these dollars to to market but outside of that, there is no protocol of the FDA necessarily to follow up on these studies and these adverse events that happen. And so, yes, we want them to act but Lord only knows how long it's going to take them to act, how many people will die. You know, 50% of the population, it's estimated, potentially can die from an acute pancreatitis attack. So this is not a condition where maybe someone, their fingernails stop growing. I'm just throwing out examples. This is death caused by these drugs, actemra specifically.
You know, they looked at, as you mentioned when we opened, I think 13,000 of the adverse event reports that they review, 1,000, 1,100 of those were death cases. Unfortunately, there is not enough information in the form that you fill out that says "This happened after this drug" for the FDA or anyone else to make those, it's up to the drug companies to get in and investigate those and unfortunately, I just don't think that happens.
Farron Cousins: So at this point, hundreds of potentially, 1,100 people died while taking this medication, there are other alternatives, they might carry the same risks but at least with those, the drug company tried to, I guess, cover themselves by saying "Listen, it might help your rheumatoid arthritis, you might get a heart attack or stroke. Those are risk benefits that you, the patient, needs to weigh out, we've given you what you need." Actemra, Roche, has essentially failed to do that and that's why we're starting to see this story take hold right now.
Kim Adams: I think so and unfortunately, I think that it might ... you know, it's been akin to the vioxx situation, I know none of this is gonna be the exact same deal but in vioxx it took a time period before "Oh my goodness, these early clinical preliminary information didn't show us what we found out years later." Actemra was showing the same situations, I forget which doctor it was but a couple of doctors that were on the FDA panel saw the increased elevations in triglycerides, in lipids and things that do contribute to a heart attack that you're not gonna have necessarily immediately. It might be a time tense sort of issue but the problem is, how much time?
Farron Cousins: Right. And Roche could easily do the right thing, go ahead and at least stick some kind of warning on there but they continue to refuse to. Kim Adams, appreciate your work on everything you do to keep consumers safe.
Kim Adams: Thank you.
Farron Cousins: And thank you very much for talking with us today.
Kim Adams: Thank you.