JIM LEHRER: The world’s largest drugmaker agreed to pay a record $2.3 billion in civil and criminal penalties. After a four-year investigation, the government said Pfizer illegally promoted four prescription drugs, including the painkiller Bextra.
Assistant Attorney Gen. Tony West spoke at a news conference this morning.
TONY WEST: Once a drug is approved for an intended use, it may not be marketed or promoted for so-called off-label uses, that is, a use that is not specified in the application and approved by the FDA.
Now, in this case, Pfizer asked the FDA if it could promote the sale of Bextra, an anti-inflammatory drug, for certain other uses and in doses higher than the approved maximum. The FDA, citing safety concerns, said no. But Pfizer marketed Bextra for those unapproved uses anyway.
When off-label marketing like this occurs, patients’ health and lives are put at risk, and those who cause that risk must be held accountable.
JIM LEHRER: Ray Suarez takes the story from there.
RAY SUAREZ: Here to tell us more about the case and the record fine Pfizer agreed to is Scott Hensley, the health correspondent for National Public Radio’s Health Blog.
And, Scott, let’s start with some more details on what the government said Pfizer did and what the company ultimately pled guilty to.
SCOTT HENSLEY: Sure.
Pfizer, as the intro said, was taking drugs that had approved by the FDA for one thing and trying to induce doctors, according to the government, to use them for other things. A physician is free to prescribe a medicine for any use that he or she sees fit. And the problem was that Pfizer was trying to get doctors to do this in a systematic way.
RAY SUAREZ: Now, for instance, let’s take Bextra, the now-withdrawn pain drug.
SCOTT HENSLEY: Right.
RAY SUAREZ: If you saw commercials on television — and many drugs are widely advertised on TV now — companies wouldn’t suggest off-label uses on TV or radio or in print ads.
SCOTT HENSLEY: Right.
RAY SUAREZ: How did they go about marketing it…
SCOTT HENSLEY: Right.
RAY SUAREZ: … toward off-label use?
Drug advertised as an alternative
SCOTT HENSLEY: Well, for Bextra, for instance, I myself was at some medical meetings where Bextra was being shown as an alternative to the -- Pfizer's other painkilling drug Celebrex, and it was implied as being stronger than Celebrex and available for use in treating acute pain.
But that wasn't the case, according to the evidence. And, in fact, the FDA had not approved it for regular old pain treatment. It was for osteoarthriti, rheumatoid arthritis, and menstrual pain.
One of the other areas where Pfizer allegedly was getting into trouble was promoting the drug for use in treating pain after surgery. And, in fact, there were clinical studies that showed there were risks, cardiovascular risks, heart -- heart risks for patients getting Bextra after surgery. And that's why the FDA didn't approve it for that use.
RAY SUAREZ: So, here the company is being asked to pay a multibillion-dollar fine. Are doctors are in any jeopardy for prescribing these same off-label uses?
SCOTT HENSLEY: Right.
The question came up today at the news conference whether the government had looked at the doctors and was going to do something about them. And they really said that the focus was on the company and its behavior.
Some of the things that did come out about the doctors were, Pfizer enlisted physicians to help sell to other physicians. They paid some doctors to be consultants for the company and to come to meetings and hatch strategies on how, in fact, the company could get other doctors to use the drug for these things that the FDA had not approved.
RAY SUAREZ: But don't doctors give people drugs for off-label uses all the time?
SCOTT HENSLEY: Sure. It's common.
Cancer drugs, for instance, are often approved on data for a particular indication, and then studies are done, and patients are in dire straits. And physicians say, we think this could help you, and it's worth a try.
What is different here is a concerted method -- a concerted effort by a company to get physicians to do it, rather than doctors coming to those conclusions on their own.
Fourth agreement for Pfizer
RAY SUAREZ: How was $2.3 billion arrived at as an amount for a fine against the company?
SCOTT HENSLEY: Yes.
RAY SUAREZ: And where does the money go?
SCOTT HENSLEY: It's a great question, both parts.
I think part of the reason that the fine was so big was described in the news conference today. This is the fourth agreement between Pfizer and the federal government to do a better job on marketing and to comply with the law when it comes to health -- health fraud provisions.
And, so, the feds, I think, were saying, look, you have had your chances. This is a big one. We want to make sure that people really take notice at Pfizer and throughout the industry that we mean business.
RAY SUAREZ: So, they were already in trouble for doing something similar earlier?
SCOTT HENSLEY: Yes, they had -- there were various agreements.
One, the next biggest one, a few years back involved an epilepsy and pain drug called Neurontin that had supposedly been sold for off-label uses, many of the similar kinds of practices.
And the U.S. -- acting U.S. attorney in Boston was involved in that case, and mentioned today that he was very frustrated to learn that, after the company -- that, while the company had been negotiating with him on how to do a better job related to that case, these things were happening in another part of the company.
Whistleblowers to get millions
RAY SUAREZ: And the fine, where does the money go?
SCOTT HENSLEY: Some of it will go to whistle-blowers. About $100 million is going to go to a half-dozen or so people who told the government, hey, we know about this stuff, Pfizer employees.
And they brought forward evidence that was really crucial to the government's investigation and that really got things rolling. Some of it will go back to Medicare and Medicaid, which are the main federal programs that were financially hurt by this misrepresentation, money spent on things that it shouldn't have been spent on. And some, I believe, goes to the Treasury.
RAY SUAREZ: And this is, what, a warning to other drug companies, too, the size of this fine?
SCOTT HENSLEY: Absolutely. I think it's the biggest by a long shot. The next closest was an agreement that Eli Lilly engaged in with the government earlier this year for about $1.4 billion, similar kinds of allegations around the marketing of a drug called Zyprexa, an antipsychotic medicine, that also had some side effects issues.
RAY SUAREZ: Now, in the original charging documents, in Pfizer's plea, in anything that comes from the government, has there been any indication that anybody was hurt, made ill, injured in any way by off-label use of these drugs?
SCOTT HENSLEY: Right. It's a good question.
And, again, it came up today. And the government said their focus had not been on looking for the individual patient harms, but instead looking at the practices and marketing approach of the company, and doing something about that.
I mean, there were certainly risks. The -- the Bextra medicine, which is the focus of this action, was withdrawn from the market four years ago, because the FDA concluded that the risk profile, even for the approved uses, not even including the ones that we're talking about here, were not outweighed by the risks of some very serious skin reactions and also the cardiovascular profile.
RAY SUAREZ: Scott Hensley from NPR, thanks a lot.
SCOTT HENSLEY: My pleasure.