Lawsuit Alleges Pfizer Marketed Lipitor Too Broadly

In what may become a national class-action lawsuit, a New Jersey union welfare fund alleged that Pfizer marketed its blockbuster cholesterol-lowering drug, Lipitor (atorvastatin), to patients who did not need it. The suit charges that the company tried to expand the market for Lipitor by convincing doctors to prescribe it for patients whose cholesterol count was lower than what is specified in the prescription guidelines on the drug label. The lawsuit does not claim that patients were harmed.  The aggrieved parties are insurance companies and drug benefit plans -- like the New Jersey union -- that paid for off-label prescriptions that, the suit claims, might not have been written if Pfizer had marketed the drug legally.

The suit relies on the federal Racketeer Influenced and Corrupt Organizations Act (RICO) to build a national class of defrauded third-party payers. In case the RICO class fails, the plaintiffs’ lawyers are filing additional state lawsuits.

We talked about the lawsuit with Geoffrey Jarvis, a partner at Grant and Eisenhofer, P.A., the plaintiffs’ attorneys, and with Bryant Haskins, a Pfizer spokesman.

PharmExec Direct:

What is it that you are accusing Pfizer of doing, and who are you accusing Pfizer of harming?

Geoffrey Jarvis, partner at Grant and Eisenhofer:

What we are claiming that Pfizer has done. Let’s back up a minute.

This is about the low-risk people. Those that have less than a 10 percent chance of contracting coronary heart disease in the next five years. For that group of people, according to the drug label, unless their cholesterol is above 160, statin drug therapy is not recommended. You are not supposed to use it. You are supposed to use therapeutic lifestyle changes.

The NCEP [National Cholesterol Education Panel] report says that there are two reasons for this. First, the benefits for people with low risk of heart disease and relatively low cholesterol -- under 160 -- are not that great. And there are, of course, risks associated with using statin drugs -- liver complications, for instance. I don’t think they are very common, but they exist.  And second, the course of the drug is very expensive -- $1500 or $1800 a year, or whatever it is. And it’s a lifetime commitment. So the trade-off the government has made is that for this group of people, based on the medical and other evidence available at this time, they don’t believe that statins are worth it. Those guidelines are on the label.

Where does it say on the label that there is a lifetime commitment?

It doesn’t say that. But when you start a statin drug, it only works if you use it forever. Once you stop using it, then you don’t get the benefit of the lower cholesterol to the extent you have risk for heart disease.

Okay, that’s the background. Now give me the brass tacks of what you accuse Pfizer of doing.

We claim that Pfizer is -- through marketing programs to doctors-- trying to get physicians to prescribe this drug to people who are at low risk of heart disease and whose cholesterol level is below 160. There are about 15 million people in that group. Basically, they are trying to expand the market of the drug to people who really ought to not be on it.

And who is harmed by that?

The people who are paying for it: your insurance company. Insurance companies traditionally do not check if a patient meets the guidelines. If a doctor prescribes Lipitor, the companies don’t check to see the person’s cholesterol. Is it really above 160? Do they really have a greater than 10 percent risk? The system isn’t set up to have that kind of Big Brother aspect to it.

And Pfizer is taking advantage of the that fact companies will pay for whatever is on the formulary for the label indication of the drug.

But aren’t we underestimating the knowledge and critical-thinking capacities of doctors? If somebody comes and tells me to write a story that I think is a dumb story, I don’t write it. In fact, PR people do that all day long, and I ignore them. Don’t doctors do the same thing when companies come and tell them to prescribe a drug for somebody it’s not indicated for?

They may. But doctors might not be as familiar as they could be with balancing all the factors: risk, benefit, and cost. For the doctors’ perspective, it’s probably about risk of liver disease versus any benefit at all from the drug. But the ATP III guidelines go one step further. [ATP III guidelines are found in the third report of the Adult Treatment Panel, developed by the National Cholesterol Education Panel, which is a panel of the National Heart, Lung, and Blood Institute.] They go to the cost side. Well the doctor ain’t paying for it. And in 99 percent of the cases the patient ain’t paying for it. So the cost-benefit side doesn’t play a role in the doctor’s thinking. The drug company, we claim, is trying to talk doctors into prescribing it for people who it’s not indicated for, but the real burden falls on somebody else entirely.

But really, isn’t some of this up to the doctor? Can’t he say, maybe Lipitor is a good idea for you, even if it’s off label?

Yes. The complaint makes that clear. You can prescribe an FDA-approved drug for any purpose whatsoever. But does that mean that somebody else has to pay for it? Here, the concern is what kind of system we want to have to maintain the doctor’s discretion. Should people, to get their Lipitor prescription, have to turn in all of their medical records to the insurance company to get it approved? We don’t want that system. But we would like, at least as a prophylactic measure, to prevent the drug companies from advertising the drug to the physicians. To prevent them from trying to get doctors to prescribe it to people who it’s not appropriate for.

You call this RICO, Racketeering Influenced and Corrupt Organizations Act, if I remember right?

That’s basically a way of pleading a nationwide fraud. It’s just a way to build a nationwide class of people. Fraud is a common-law claim in the United States. There is no national fraud law; every state has its own. In the event that a court claims that it’s not RICO, we’ve also set up state complaints. We filed in New Jersey, you saw that, and we are going to file complaints in other states to take advantage of their state laws. 

So you’re not calling Pfizer a bunch of racketeers.

We’re not calling them the Mafia, no.

Tell me a little more about what you call Pfizer’s scheme to promote the off-label use of Lipitor.

They would make presentations to doctors and try to take the focus off the guidelines set up in NCEP III or ATP III and promote what they call the get-to-goal message. That was their mantra. The goal for everyone, even the patients who are low risk, was cholesterol of 130. So what they suggested was that if you’re above 130, you should get to goal. But that’s not what the guidelines call for. They say that if you are above 160, and it’s called for, then we try to treat you to make sure you are at 130. What Pfizer is trying to do is promote this get-to-goal message for everybody. They want to cloud the message that if you are above 160 you take it, and if you are below 160 you don’t.

What evidence stands out for you?

Not indicative of the marketing they did, but of the overall scheme: When they are speaking to investors and they talk about the size of the Lipitor market, they include the people who are in the 130-to-160 category –- the low risk people who clearly should not be part of the market. But their slides of how they put the market together include those people among patients who ought to be taking Lipitor. It shows the corporate goal. It shows that they did have an overall plan to include the people who were low risk and had cholesterol between 130 and 160 in the market.

What do you think this cost your clients?

It’s hard to say. Nationally, we think this is a multibillion-dollar-a-year problem. Our clients have some percentage of that. They’ve all paid for a substantial number of Lipitor prescriptions. I’m not at liberty to tell you what their prescription payments are. It’s not an insignificant amount. We talked about what we think the percentages are. But we didn’t put it in the complaint on purpose. We don’t want to go out with a number we aren’t sure of.

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PharmExec Direct:

What do you think of the lawsuit?

Bryant Haskins, Pfizer spokesman:

Our lawyers are looking at it. We can’t comment on specific points. We take very seriously our responsibility to provide appropriate information to physicians and patients and to comply with all federal laws and regulations regarding the promotion of our medicines. But based on the information that we have, we believe there is absolutely no merit to the claims that the suit makes regarding the promotion of Lipitor.

They basically say in a nutshell that you are promoting the use of Lipitor for cholesterol levels that are below those specified in the label, which is taken from the ATP III guidelines [Third report of the Adult Treatment Panel, developed by the National Cholesterol Education Panel, which is a panel of the National Heart, Lung, and Blood Institute].

Well I think the ATP III are guidelines. And we always recommend that patients consult with their doctors and determine what is the best approach for them to take regarding any of our drugs, and particularly for Lipitor for cholesterol reduction. That’s a decision to be made between them and their doctors. Are they claiming that the doctor has no position as far as prescribing medicine to patients?

No. Quite the opposite, I think. They are saying that you are trying to influence doctors to prescribe at levels lower than the label recommends.

They’re basically saying that Pfizer goes out and hires a lot of consultants and invites doctors to fancy meetings in nice hotels, where the company tells them to prescribe Lipitor when patient’s cholesterol levels are lower than specified in the ATP III guidelines on the label.

Our position has always been that patients should consult with their doctors to determine the appropriate treatment for them as individuals.

But they would say, fine, instead of influencing patients you decided to influence doctors.

They’re not giving much credit to the doctors, are they?

No, they’re not. But that’s what they’re saying. I think I owe it to both sides to ask the question. Pfizer recognizes that the doctor-patient relationship is a very powerful one, and that doctors influence their patients. So Pfizer sets out this big elaborate -- the attorneys call it a scheme -- to influence doctors. And you do spend a lot of money influencing doctors. They’re your customers, right?

Yes. But that doesn’t mean we’re influencing them unduly. And I can’t get into addressing specific allegations of this lawsuit. Other than to say that we would strongly disagree with many, if not most or all, of the points that they make in the lawsuit. But beyond that, we’re not going to get into talking point by point. We never do that with litigation that’s in progress.

I’m grateful that you talked about it as much as you did.