By Farron Cousins
November 5th, 2012 1:00pm
Advances in pharmaceuticals have helped save countless lives across the globe. But when you drill down to the heart of a pharmaceutical company, the desire to make a quick profit will always trump the desire to save a life. As a result, the media is constantly filled with stories about dangers and defective drugs that make it to the market that leave people horribly sick, or worse, dead. Mike Papantonio of Ring of Fire recently spoke with investigative journalist Martha Rosenberg about a few of most egregious examples of pharmaceutical company negligence, and the following is a transcript of that interview:
Mike: Martha, there are never any surprises where it comes to the pharmaceutical industry giving us another drug that’s causing us some kind of health issues if not death, and there’s never any surprise when they make $3 or 4 billion a year doing that. Fosamax, just another story … I mean, I hate to say it, but it really is just another one of those pharmaceutical, Merck, Pfizer type stories.
Martha: You’re right. There is an element of repetition in all of these, which is they hit and run like a bad stock or a bad movie. They make their money real quickly, and then when the truth comes out, they’ve made their money.
Mike: Yeah, what we found is that–early on, of course, we’ve handled every major pharmaceutical case in the country–I’ve always seen the pattern. The pattern is the company coming in, deciding, doing like what they call a five-year projection. That is to say, can we keep it out there for five years, and if we do, how much can we make in that five years, and if we make $4 billion, can we get away with settling the entire thing for $2 billion? They come out $2 billion ahead.
It’s almost the same analysis that we saw with Ford Pinto, where they figured out we can cause this many deaths by exploding gas tanks, and it’s only going to cost X number of dollars; therefore, let’s keep it out there. The Fosamax story really is that story, I’ve got to tell you. Go ahead and tell me what you have learned about the Fosamax story, and let’s share notes.
Martha: Okay, surely, and by the way, you’re absolutely right. They build the settlements right into the profits seen. I’ve been writing about Fosamax, which was the first bisphosphonate since about 02/06, and there was a just a progression of dangerous side effects that surfaced that Merck did not disclose. The first, of course, was esophageal irritation where you have to sit upright, and you couldn’t have food or water for 60 minutes after taking the drug. That was not known when the drug was approved, so they had to add that warning after it was already being taken. Then, after that you had, of course, the osteonecrosis of the jaw, and some of the dentists and oral surgeons who were seeing this were just furious because they really doubted that Merck didn’t know, and now many of these dentists and oral surgeons won’t even work on women, some men, but mostly women.
Mike: Let me back up just a minute. Even with the reflux, this esophagitis, the issue really came down to there’s something called scar-based cancer. When you have an ulcerative process taking place in the esophagus, what ends up happening is that you create scar tissue. That scar tissue has the propensity to develop into a different very unique kind of cancer, and so that was another problem, and that was something that they didn’t talk about. That was something they didn’t warn about. The jawbone tissue issue was certainly something they didn’t say anything about until doctors started saying, “Hey, there’s a problem here.” The necrotic condition that you’re describing … describe how bad it really was. I mean, it was severe.
Martha: Well, it is, and you know, too, Mike, it’s still going on. We like to say it’s in the past tense because we’re aware of it. It’s still … basically, because the jaw tissues renew at a faster pace than other parts of the body, it’s more susceptible to the suppression of the bone renewal that these drugs cause, and consequently, if you need renewal in a socket where a tooth might have been pulled, it won’t happen, and instead, that area goes necrotic and it dies. What I read from some of the journals and the dentists and oral surgeons taking is that it was disfiguring. It was almost impossible to treat. In some cases, women had to be trached. It was major, major …
Mike: Probably what you didn’t see, Martha, that we saw was the actual documents where they talk about “How do we make this go away? How do we cover this up? How do we make it look less of an impact than it actually is?” It’s one thing when you start actually looking at the documents, the email, and the interoffice correspondence where they’re saying, “This is a problem. We know the oral surgeons are upset. We know that the doctors and the dentists are upset. What do we do to make them feel more comfortable?” That’s the ugliest part of that.
Martha: It’s just criminal, and I’m sure you’ve seen incredible documents on that. I did see a CME that these Merck-funded doctors conducted, continuing medical education in which they actually were telling clinicians that the real source of this osteonecrosis of the jaw was bad oral hygiene. In other words, the women weren’t flossing.
Mike: Yes, it’s their fault.
Martha: Unbelievable. Just nasty.
Mike: You mentioned something that I think is very important. Again, we’re talking about Fosamax, which is given to women in homes of strengthening their bones, but what happened was you had Merck actually create this dread, this hysteria that “My God, if you don’t take this, your bones are going to crumble.” What they did–and you have it in your article, and I’ve seen the documents first hand–where they actually went around to doctors’ offices, and they put in what they called bone scan machines. They put in ten … actually, it’s even more than that, but around 10,000 bone scan machines where they actually put them in the medical offices to try to promote this drug. Tell us about that.
Martha: They invented–they being Big Pharma–invented the term osteopenia, which really meant nothing more than “You’re at risk of osteoporosis,” which anybody could be at risk of it. Then, as you say, they hired a research company–and this is according to a good source–who planted these machines in doctors’ offices. Then they promoted … the women would be told, “Well, you’re at risk” or “You’re wrist is thinning” or whatever it is. Just this year, there was an article in the New England Journal of Medicine that said only 10 percent of women benefit from these scans.
Mike: Right.
Martha: The scans were huge scams that helped sell the bone drugs.
Mike: Yes, you say scans. It’s actually scam is what it really was. It was a scam, and we … it was one thing if we were just seeing this with one company, but you look through all the companies where, for example, you had YAZ, which was a product that … I took the depositions over in Europe, and the story was the same thing. “Let’s create hysteria. Let’s create a disease. Let’s create something that scares the hell out of everybody, and then sell our product.” At the same time they’re doing that, the typical MO is not to disclose the clinical data that shows there really is no risk. I mean, the risk is one-tenth of what they actually say it is, and the dangers of taking the drug–the risk/benefits analysis–is so slanted against the drug that if the public knew it there’s no way they would take the drug. That’s very, very typical, and I saw that with Fosamax just as you’ve pointed out.
Martha: You’re absolutely right, and the final irony after the cancer that you referred to and the irregular heart beat and the intractable pain … the final irony is that these drugs actually cause the immediate fractures that they were marketed to prevent.
Mike: Yes. Your book, by the way, is an important book because people have a hard time believing that corporate America will take a look at people’s health and say, “To hell with the health. We’re going to make billions of dollars, and we’re going to do it on a five-year projection because we know–”. Here’s the statistic: if the drug is approved and it gets onto the market, they know they can fight off, no matter the problem is, statistically if you look at the history on this, they can fight off the problem for anywhere between five to ten years. Now, we’re finding that … they’re saying this is to prevent your bones from fracturing. This is to prevent you developing weak bones as you get older. Now, we’re finding that it’s actually promoting fractures of the femur. That people can simply be … we have cases where people are walking, just everyday walking, and the femur fractures.
Martha: For no reason, absolutely.
Mike: No reason. Talk about that a little bit.
Martha: This is the most outrageous part. This is the shameless part in my opinion. Now, as early as 2004, the New England Journal of Medicine and another medical journal had doctors theorize that this would happen. They said, “If you can’t suppress bone turnover and not create a desiccated bone that’s likely to snap,” so it’s not like Merck wouldn’t have known because even clinicians knew this. The idea is that the very concept of the drug is ill-conceived because it keeps the bone from renewing, and consequently it’s brittle, and then it snaps. That’s, of course, how they tried to sell the drugs, was telling women that when you least expect it one of your bones will snap. It was a fear campaign, and last summer, they finally had two FDA advisory committees that sat down and looked at this, and all they came up with was, “Maybe we should limit how long women are on these.”
Mike: First of all the advisory committees–and this is another MO, method of operation–you stack the advisory committee with people who have worked in the industry some time directly for the company. The last advisory that took place, for example, on YAZ, was completely stacked with industry hacks.
Martha: Right, I heard that. Right.
Mike: We knew what was going to happen before it ever happened, and sure enough, it happened. Just as a quick review here, you have a company that creates … they create hysteria. They say, “You’ve got to have something because your bones are crumbling.” Then they create the bone measurement institute where it’s part of the scam. They put 10,000 scan machines in doctors’ offices. They then start saying that women are having what they call jaw necrosis, and that’s awful. That’s where the entire jaw basically disintegrates and has to be replaced by artificial jaw. We’ve seen cases of cancer, the 23 incidents of Fosamax cancer, esophageal cancer, eight deaths, 27 incidents of cancer in Europe directly related to the drug. Now, we find out that the very thing it’s supposed to be doing is strengthening the femur, and in fact, it’s causing the femur to snap. The FDA and advisory committees are so in bed with the drug industry that they’ve taken no action, and nobody has gone to jail for not telling truth, you see.
Martha: You’re exactly right, no CEOs, and nor has … the reason I wrote the article is Merck is launching a new bone drug on the heels of this … nor has Merck been prevented from doing this again. There’s not only no penalties; there’s a green light to continue. There was a quote in Reuters from one of the top Merck executives, and he said their new drug may be a viable alternative for patients who want benefits beyond what they received from bisphosphonate.
Mike: Yes, the benefit of having a necrotic jaw. The benefit of having your femur snap. The benefit of cancer. You see, this goes on Martha. You’ve been doing this a long time. You’ve been writing about pharmaceuticals a long time. You can’t tell me a story where a pharmaceutical CEO and his pals have gone to prison for fraud, for lying to doctors, for lying to the medical community, for phonying up clinical records, for hiring biostitutes to write just completely fantasy stories about their drug. Nobody’s gone to jail for it, and until somebody goes to jail, this will continue because it’s too profitable. You make $3 billion and you pay one billion in settlement. You still make a pretty good profit there.
Martha: You’re right. Nobody’s gone to jail. None of the companies have even been removed from Medicaid and Medicare pipelines and revenue, nor has anyone looked at why this was approved so quickly by FDA that all these side effects came out after people were using them.
Mike: We know, don’t we? I mean, you and I know why it was approved quickly, and that is because the FDA is simply an extension of the pharmaceutical industry. It’s a swinging door where you say … somebody’s with the FDA, they say, “Help us here. By the way, how would you like to work for Merck when you get through with this job?”
Martha: Exactly, exactly.
Mike: “How would you like to work for Merck?”
Martha: Exactly.
Mike: Some college professor: “How would you like to write this article making it look like Fosamax is a great product? How would you like to make a cool $500,000 for writing the article.”
Martha: I know.
Mike: We see it all the time. We saw it with YAZ with off-label where they were selling the product completely for purposes it never should have been sold for. The company knew what they were doing. They knew it was illegal. They were operating under what they call a corporate integrity agreement where people should have gone to prison for not complying with it, and nobody went to prison. I don’t know how else to stop it, Martha, other than tell people, “You simply don’t use a drug unless it’s been on the market ten years.” I don’t know what else to say?
Martha: Right. That’s what a lot of people say. Don’t use anything that you’ve seen advertised on TV. There’s another irony for women, because I do see sexism and ageism in this marketing. Like the hormone replacement therapy, it was marketed kind of, “You don’t want to be old and ugly,” was kind of the real message. The irony was that all these women ended up with mastectomies. With these bone drugs, they end up disfigured in the jaw through wanting to not be old and fractured. It’s like a double whammy against women.
Mike: They even have a term for it. It’s called learned helplessness, and it’s not a very flattering term, but it is to say that you have people in the market that would rather look good at all costs because that’s what they’ve learned their entire life. It’s better to be pretty than healthy.
Martha: It’s just a sad … but as you say, nobody’s gone to jail. The shameless part is it just continues. There’s so much money flooded into this, and then there’s another irony about the osteoporosis, which is that some of the asthma drugs and some of the SSRI antidepressants, and certainly the GERD meds actually cause the osteoporosis to a certain extent. Actually, Big Pharma is causing it’s own problem in some of those cases.
Mike: I mean, the truth is, Big Pharma … look at the money they’re putting into this election. They understand. I think last presidential cycle, when you added up all the money, the money they had put in was somewhere in the neighborhood of $400 million. They get their way. The argument is always, “We’re helping people.” No, they’re not helping people. They’re on what they call a short-term big profit plan. That is where a CEO used to a run a company like Merck for 20 years. Now the CEO comes in for five years, extracts everything he can from the company to make high bonuses, high profits, big golden parachute, leaves the company, and so there is no sustainability to any credibility here. That quick profit short term, is killing the drug companies. I don’t know what else to say. Somebody asked me, “Do you take a drug before ten years.” I used to say, “Don’t take it before five years.” I say now ten years because there’s always an alternative. There’s always an alternative. That’s what people have got to learn.
Martha: I agree with you, and I also caution people when they hear about a new so-called disease to be skeptical because it’s not from the Center for Disease Control; it’s from Big Pharma.
Mike: Yeah, ADHD is a great example. My God, if you watch the history of ADHD, you would think that … you have adults that, hell, they can’t read a full page without losing concentration, and then you give them a drug. It’s our fault. It’s Americans’ fault. It’s our fault as much as it is the drug company because we let them do it.
Martha: It’s gotten a lot worse since the direct-to-consumer advertising, because that was my background was advertising, and it works.
Mike: Yes, it absolutely does. We can be led around by the nose, and it’s just so easy for them to do it, and that’s what we see here.
Farron Cousins is the executive editor of The Trial Lawyer Magazine, a contributing writer at DeSmogBlog.com, and the producer of Ring of Fire Radio. Follow him on Twitter @farronbalanced.
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