Drug giant accused of false claims - Whistleblower alleges illegal encouragement of off-label use

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Drug giant accused of false claims

Whistleblower alleges illegal encouragement of off-label use
Scientist David Franklin says he became part of a broad mission at pharmaceutical company Warner-Lambert to deceive, even entice doctors to prescribe drugs to patients whether it was scientifically justified or not.

NBC NEWS


July 11 — The questions began with the confession of an insider at one of the nation’s largest pharmaceutical firms. He says his former company deliberately distorted information about one of its drugs, possibly putting lives at risk, and costing patients and taxpayers millions of dollars. “Dateline” went looking for some answers and has the results of a year-long investigation into what may be one of the biggest medical deceptions in history. NBC’s John Hockenberry reports.

DAVID FRANKLIN: “I was trained to deceive, to lie to doctors.”
John Hockenberry: “So these doctors were completely misled?”
Franklin: “Absolutely.”
Who would train and then pay someone to mislead doctors? Scientist David Franklin says pharmaceutical company Warner-Lambert paid him to do that back in 1996.
Franklin: “It was my responsibility to leverage the trust that physicians had with pharmaceutical companies to corrupt the relationship between the physician and the patient.”
John Hockenberry: “Your job was to find trust, and exploit it, to produce more sales for Warner-Lambert.”
Franklin: “Absolutely.”
Since he was a little boy growing up in Rhode Island, Franklin says, he wanted to be a scientist. But he wanted to use that science to help people, doing medical research to cure disease. So Franklin got his Ph.D. in biology at the University of Rhode Island and from there became a researcher at the prestigious Dana Farber Cancer Institute. After more than three years as a researcher, Franklin wanted to get out of the lab. He found a job at Parke-Davis, a division of Warner-Lambert. He would be a medical liaison, using his scientific expertise to explain the scientific merits of drugs to doctors.
Franklin: “The medical liaison was supposed to be fair and balanced, where the physician could trust what the medical liaison was telling them.”
Hockenberry: “So, doctors wouldn’t necessarily see you as a company guy, as much as they would see you as a scientist. As as a medical doctor, like them in a way.”
Franklin: “Exactly. A person whose primary responsibility is to care of the patients, making sure that the doctor, to enable the doctor to practice the best possible medicine that science would allow at this point in time.”
Hockenberry: “So, a doctor needs more drugs for their practice. They call the salesman. But if they have questions about the medical use of that drug, they call you.”
Franklin: “Exactly.”
But almost immediately, Franklin says, he became little more than a salesman. The job he thought would be about caring for people turned out to be little more than caring for the company’s bottom line. With his Ph.D. and the title of doctor, Franklin says he became part of a broad mission to deceive, even entice doctors to prescribe drugs to patients whether it was scientifically justified or not.
Franklin: “It was a matter of leveraging, corrupting, if you would, perverting the science, to greatly increase sales and profitability.”
This corporate whistleblower, telling his story to “Dateline” in his first broadcast interview, has rocked the pharmaceutical industry to its core. Pieced together with confidential documents and taped voicemails, you’ll see a portrait of sales over science.

But mostly this is the story of how David Franklin helped one little drug become a star: Gabapentin, one of the drugs Franklin was responsible for, which goes by the brand name Neurontin. Neurontin is a useful and generally safe drug. The Food and Drug Administration approved it in 1993, but for only one use — to help control epileptic seizures and only if taken in conjunction with another drug.
But Franklin says he soon learned that Warner-Lambert had plans for Neurontin, the little epilepsy drug, a plan to go directly to doctors and get them to prescribe Neurontin for all kinds of uses the FDA hadn’t approved, called “off-label” uses.
Hockenberry: “Warner-Lambert basically told you, ‘The FDA says, scientifically, Neurontin treats epilepsy. But we can convince doctors. And here’s how you’ll do it, to use Neurontin for a dozen other things.”
Franklin: “Absolutely. This was holding their hands and pushing them into to using Neurontin off-label.”
And according to Franklin, the list of off-label uses was long, everything from attention deficit disorder to alcohol and drug withdrawal.
Now, off-label uses are nothing new. Doctors have been observing surprising new uses for drugs throughout history. Some of their discoveries become medical breakthroughs. One of the best-known examples is aspirin, once thought only good for pain, was found by doctors to increase blood circulation and prevent heart attacks.
Hockenberry: “So it’s legal for doctors to say, ‘You know what? I think this drug that is approved for your ear might be good for your throat.’”
Franklin: “Not only is it legal, but it’s good medical practice.”
But what is not legal is for a drug company to promote such unapproved, off-label uses or to exaggerate or report unproven breakthroughs to doctors as a way to get them to prescribe their drugs. Assistant U.S. Attorney Jim Sheehan, one of the country’s leading prosecutors of health care fraud, says such regulation exists because off-label use can be unsafe.
Sheehan: “Every prescription drug is an inherently dangerous product with the potential to kill people as well as cure them. That’s why we have very strict regulation, that’s why we have rules about what marketing and promotion they can do. That’s why we have rules about what they can produce and how they produce it.”
Franklin says the rules went out the window from the moment he arrived on the job. For instance, he was told not simply to wait for doctors to ask him for his scientific opinions, but to instead target doctors and convince them to prescribe Neurontin, even though he knew that there was no FDA approval for its off-label uses.
Franklin says he was actually “cold calling” doctors, showing up like a salesman unannounced, and he found one thing about him opened a lot of doors.
Franklin: “If I were to show up at a doctor’s office and say, ‘Dr. Franklin is here to speak to Dr. Smith,’ Dr. Smith is much more likely to respond, as opposed to his receptionist calling him in his office, and saying, ‘The Warner-Lambert sales rep is here to talk to you.’”
Franklin didn’t say that he wasn’t a medical doctor. Simply having the title of doctor, the Ph.D. he was so proud of, was all that mattered, Franklin says, and Dr. Franklin, it turns out, wore lots of hats, depending on whom he was visiting.
Hockenberry: “So, you could have had a Ph.D. in economics or metallurgy, and it would have been just as fine?”
Franklin: “As long as it granted me the title of Dr. Franklin.”
Hockenberry: “What were you told to tell doctors about your background?”
Franklin: “We actually trained the sales representatives to introduce me as an expert in cardiovascular medicine.”
Hockenberry: “Were you?”
Franklin: “Absolutely not. My Ph.D. was in microbiology. At 9 in the morning I was an expert in cardiovascular medicine. At 10 when we walked across the street to a neurologist office, I was an expert in neurology.”

And once inside, Franklin would make his pitch to the doctor. As I played the doctor’s part — he showed me what he would say about Neurontin.
Franklin: “We’re really being inundated with information from across the country with physicians that are seeing a profound improvement in patients with bipolar disease ... so we would suggest that you titrate the patient up to 4,800 milligrams — you will see marked improvement in their symptoms.”
Hockenberry: “So your suggestion to me is triple the dose and I might see some positive results.”
Franklin: “Absolutely. It’s not a matter of might. You will see an improvement.”
He’s a scientist who couldn’t sound more certain. But is there any scientific validity to what he is saying about, for instance, bipolar disorder?
Franklin: “None at all. And in fact, much of it is a fabrication. It is simply untrue.”
Hockenberry: “Was there any data that really supported the claims you were making?”
Franklin: “Not at all.”
At best the claims were based on promising anecdotal and untested preliminary information that Franklin says was, promoted to doctors vigorously, directly and illegally.
Franklin: “Not only is it illegal, it’s downright immoral. It doesn’t just hurt the medical community, it has the potential of hurting patients.”
But as you’ll see, there was nothing potential about the money to be made through these tactics. The billions to come were real ... as real as the patients whose stories are just beginning to emerge. Was their health compromised in a scientifically invalid campaign to raise sales of Neurontin?

A PATIENT’S PERSPECTIVE
By the late spring of 1996, Franklin understood fully what he was doing in supplying misleading information to doctors about the drug Neurontin. What he didn’t know, he says, was the effect on real patients. It’s a knot in his stomach that’s still there today.
Franklin: “There hasn’t been a day in six years that I haven’t thought about this and wrestled with my involvement in it.”
Long after David Franklin began to have his first reservations about his job, 54-year-old Regina Adams got her own education about off-label uses of Neurontin.
Adams: “My whole life was turned upside down, and I almost lost my life because of it.”
Adams has bipolar disorder.
Hockenberry: “When were you first diagnosed with a condition that might require ongoing use of pharmaceutical drugs?”
Adams: “About 11 years ago.”
Hockenberry: “And the symptoms you were exhibiting were?”
Adams: “Mania, mostly mania. Because I had just lost touch with reality.”
Bipolar disorder occurs when the brain constantly cycles between mania and depression. Those who suffer from it can experience uncontrollable highs and lows.
Before she found a reliable treatment the disease played havoc with Adams’ life. She divorced and was in and out of hospitals. Doctors finally found a therapy that seemed to work, a drug called Depakote, FDA-approved for bipolar disorder.
Adams: “That worked really well, worked for my head. But the side effect was weight gain.”
Hockenberry: “Weight gain?”
Adams: “I gained 100 pounds.”
Adams wanted the benefits of Depakote without all the weight, so she asked her doctor for a different drug. The doctor recommended Neurontin At first Adams felt better and lost weight, but soon after things started to come apart.
Adams: “I became more and more out of control. My whole personally — I’m very a sweet, nice person. And I got hostile.”
Hockenberry: “Had you ever behaved like this before?”
Adams: “No. No. My ex-boyfriend said he had never seen me, when I was manic, act like this.”
Adams went back to her doctor for help.
Adams: “She just kept increasing the Neurontin. I didn’t want to go any higher. I didn’t want to get harmed from it.”
Hockenberry: “And your doctor’s response was, Increase the dosage.’”
Adams: “Mm-hm.”

Was there a risk? Adams’ dosage was tripled. Neurontin is known to have few if any side effects, one of its big selling points. But Neurontin was now Adams’ only treatment for bipolar disorder, which was very risky because Neurontin, it turns out, does essentially nothing for bipolar disorder — and that’s a scientific fact.
Dr. Gary Sachs: “Neurontin’s a drug that has been studied under double-blind conditions twice. And in neither case did it prove to have any efficacy at all.”
Hockenberry: “In neither case?”
Sachs: “In neither case.”
Dr. Gary Sachs runs the Bipolar Treatment Center at Massachusetts General Hospital.
Hockenberry: “So, based on the science, someone with bipolar who’s only taking Neurontin is essentially untreated.”
Sachs: “I think that’s a fair assumption.”
And for a bipolar patient like Adams, being untreated can be life-threatening. On Neurontin, Adams’ manic behavior became uncontrollable. She says she tried to kill herself. She ended up in the hospital.
Hockenberry: “If your doctor gives you something, your assumption is that it works, and that somebody’s shown that it works, right?”
Adams: “Right.”
Hockenberry: “In the case of Neurontin, was any of that true?”
Adams: “Not for me.”
We tried to talk to Adams’ doctor at Meridian Behavioral Healthcare in Gainesville, Fla. — and Adams said she had no problem allowing us see her medical records. But the company refused our request, issuing only a statement from her doctor acknowledging that Adams was treated with Neurontin but that the drug was discontinued when she “experienced a manic episode.”
Adams is back on her old medication and doing fine.
Hockenberry: “What do you have to say to the drug company that might have been very interested in doctors’ prescribing their medication?”
Adams: “I think that they’re greedy, and they just are after money. And they don’t really care about the person who takes the medicine, obviously.”
David Franklin says he was surprised how easy it was for him to get doctors to switch to Neurontin or to raise dosages.
Hockenberry: “And would they do it?”
Franklin: “It’s remarkable the high percentage of physicians that would do this.”
Hockenberry: “How did you feel?”
Franklin: “I would leave a physician’s office in pain. There was no other way of describing it. This is — I was in — a combination of embarrassed by what I had just done, felt responsibility to the patient, to the doctor and the patient, that I had just misled this individual. And that some third party that wasn’t even in the room, some patient, may actually be impacted by it.”
Parke-Davis’ own internal documents obtained by “Dateline” show the company couldn’t have been more excited about: “new indications for Neurontin,” especially for people like Adams with bipolar disorder: “Bipolar disorders offer the greatest expected return on investment ... as much as $55 million.”
Even though the 1995 memo later states “there is no pre-clinical evidence of efficacy in bipolar disorders.” In other words, no real scientific evidence that it would work. Franklin says the company’s enthusiasm about off-label prescriptions translated into real pressure on the job — pressure, he says, to sell.
Franklin: “I was pressured to fill the gap that the sales team, the actual sales representatives weren’t filling. That the sales representatives weren’t as effective as medical liaisons. And that we had to, I think the quote was, to take the ball and run with it.”
And Franklin let “Dateline” experience this sales pressure just as he did, through this recorded voicemail from his boss.

“You know there’s a Neurontin push that’s supposed to be on.... So what we need to do is focus on Neurontin, when we get out there - we want to kick some ass on Neurontin - we want to sell Neurontin on pain all right? And monotherapy...I don’t know if you guys are embarrassed, but I’m embarrassed with where we are with Neurontin.”

Franklin saved this voicemail because he could barely believe what his boss was saying: sell Neurontin expressly for uses not approved by the FDA. Franklin was frightened. What he was being asked to do, he believed, was illegal. So he began to tape more conversations and messages from company officials. Here’s a quote from a senior Warner-Lambert executive on a conference call:

“I want you out there every day selling Neurontin... holding their hand, whispering in their ear — Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything.... I don’t want to see a single patient coming off Neurontin before they’ve been up to at least 4,800 milligrams a day.”

And then he said this:

“I don’t want to hear that safety crap either.... It’s a great drug”

We showed Assistant U.S. Attorney Jim Sheehan that colorful quote.
Sheehan: “It would seem to me that’s a pretty clear advocacy for off-label use by the company. And therefore a violation of the FDA’s rules.”
Hockenberry: “You know, I don’t know if I’d use the word advocacy. I might use, like, threat.”
Sheehan: “When I look at this, Neurontin not for pain, not an on-label use, Neurontin for bipolar, not approved, no application for that either. Neurontin for everything, well, that’s pretty obvious.”
And company sales people got to make this pitch right in the inner sanctum of doctors’ offices. Franklin would tell doctors they could get paid to let company sales reps go over patient medical records and to actually be there in the examining room while patients were being treated.
Franklin: “If you are willing to allow a sales representative to spend a day with you as you see patients, we’ll compensate you for that. We’ll pay you for it.”
This is a voicemail Franklin recorded, in which a salesman boasts about his success after a day spent with a doctor and his patients:

“The doctor would review the chart of each patient with me in a one-on-one fashion. Then we would go meet the patient, the patient would be examined. I saw the actual prescription generated in front of me... that was certainly nice. I certainly felt that me being there, I had some influence on that medical decision.”

Medical decisions that were very good business. From its introduction in 1993, Neurontin the little epilepsy drug, has rocketed to the top of the sales charts. Today it’s a more than $2 billion drug, outselling even blockbuster Viagra, and more than three-quarters of Neurontin’s sales, by the parent company’s own estimate, are from off-label uses.
But Franklin was having serious doubts about the safety of off-label use, about his job and about what kind of legal trouble he might be in. He would not make it through his first year at Parke-Davis. In the summer of 1996, he decided he’d had enough.

GOING PUBLIC
By the early summer of 1996, after four months working as a medical liaison for Warner-Lambert, David Franklin began to realize it was time to get out. He believed what he was doing was wrong and feared what would happen if he stayed.
Franklin: “I knew that in the period of time that I had been there, my own personal behavior was illegal, that I had done things that were simply illegal.”
His biggest worry was that he was aiding and abetting a medical fraud. The scientist who reluctantly became a salesman now wondered if he had what it took to blow the whistle on a drug company worth billions.
Franklin: ”“Either I needed to own up to this now and put it behind me, or at some point in the future, this could come back, and I’d find myself on the wrong side of this investigation. I did believe, when I left, that they were so aggressively ramping this up, that at some point, someone would expose what was going on there. And therefore, I would find myself in the equally, or even more difficult, position of trying to explain why I ignored an obvious illegal and immoral activity within the company.”
So on July 29, he drove to a co-worker’s home, dropped off his office keys and company car and turned his back on Parke-Davis for good. Next stop? Greene and Hoffman attorneys at law.
Franklin: “I showed up to their office saying, I’ve— I’m in trouble. And I need some help out of this.”
Franklin filed a lawsuit against Warner-Lambert and its Parke-Davis division charging the company with violations of the U.S. False Claims Act. He says he was not motivated by the fact that he stands to be in line for a percentage of the damages if the company loses or if it settles out of court.
Tom Greene: “We had no idea the extent of the Neurontin prescriptions, how successful this program had been.”
Tom Greene is David Franklin’s attorney. He has spent the last seven years amassing Warner-Lambert and Parke-Davis documents going back to 1994. He shared many of them with “Dateline” — they fill more than 160 boxes, memos and reports that prove, Greene says, that David Franklin was merely a cog in a grand marketing strategy to deliberately and illegally encourage off-label use.
Greene: “There are countless documents that support what he says and go far beyond his story and bring the level of knowledge of this illegal marketing program to the highest levels of the company.”
For example, one memo shows that plans for marketing Neurontin for at least one off-label use were sent to top executives, including Anthony Wild, the president of Parke-Davis’ pharmaceutical division, and Lodewijk de Vink, president of parent company Warner-Lambert. Neither responded to our request for comment.
Other Parke-Davis documents, like one from 1997, show that there were teams inside the company not merely pushing the envelope on acceptable marketing practices but deliberately advocating going around the expensive FDA approval process, because the patent life of the drug was so short.
The “recommendation” is that Parke-Davis “not file” an application with the FDA but instead take the message straight to the doctors.
It was a full-court press. While sales reps and medical liaisons like David Franklin supplied company information in doctors’ offices, documents show company messages being planted aggressively in the scientific literature. Doctors simply trying to stay educated about new drugs would find themselves inundated with research, paid for by the company and made to look like independent scientific papers.
Greene: “They wanted to disseminate knowledge of these off-label uses throughout the medical literature. They hired outside companies to write articles about off-label uses so that the message about off-label use of Neurontin could be planted in the medical literature around the country, and indeed around the world.”
Here’s one example of how what Parke-Davis called its “publication strategy” worked: A company called Medical Education Systems of Philadelphia (MES) was hired by Parke-Davis to put together a series of articles on off-label uses of Neurontin. MES would contact doctors hand-picked by Parke-Davis to author the articles. But in some cases, it appears that articles were essentially ghostwritten by MES, and the doctor’s name added later. As one MES status report notes: “MES draft completed — we just need an author.”
And what did the doctors get for becoming authors of papers they sometimes didn’t write? Fees of up to one thousand dollars a pop.
Sheehan: “You are attempting to create a false impression, and you are making false representations, and you’re doing it for money. I just don’t see how that approach can be supported or can be viewed as appropriate.”
Hockenberry: “You know, it’s always been my impression that the finding of an author precedes the actual writing of the paper.”
Sheehan: “One would hope that’s what would happen.”
Papers were just the beginning. Franklin says there was lots of money to go around.
Hockenberry: “Did you pay doctors?”
Franklin: “I personally did not pay physicians. What my responsibility was, was to let physicians know that there was money available to them.”
In fact the documents show there were all kinds of ingenious ways for doctors to get paid for an education in the use of Neurontin. For instance, “honoraria” are fees paid to doctors to hear information or a presentation about Neurontin. Parke-Davis records show that these scientific presentations occurred in some unscientific places: “Bus to Yankee Stadium,” “World Yacht Cruise” and “Braves Stadium.”
Doctors were also recruited for teleconferences, seminars and trips to places like Jupiter Beach, Fla., perhaps better known for golf than for research.
Paying physicians like this, giving them drug company money to listen to information about the products they prescribe, may be legal and common practice in the industry, but to critics like Dr. Arnold Relman, professor emeritus at Harvard and former editor of the New England Journal of Medicine, it’s a conflict of interest — especially in the case of Neurontin.
Relman: “What you have is an unproven drug being widely used for difficult problems by doctors who are given a powerful economic incentive to do it, spurred on by a company that’s wildly aggressive in its marketing.”
After seven years of legal motions and countermotions, Franklin’s lawsuit is now being scrutinized by the U.S. government and all 50 states to see if government medical programs like Medicaid may have been defrauded into spending millions on improper off-label prescriptions.
And in fact, in recently filed court papers, the Justice Department said that Franklin’s case “has presented evidence of an illegal off-label marketing scheme that is rife with false statements and fraudulent conduct all of which had one intended purpose and result — increasing sales ...”
Three years ago, Pfizer bought Warner-Lambert and Parke-Davis, so now the biggest drug company in the world is the defendant in one of the highest-profile cases in the history of the industry. Pfizer officials would not speak on camera but did provide this statement: “...the events to which you referred are alleged to have occurred well before — in some cases years before — Pfizer acquired Warner-Lambert. Pfizer completed the acquisition of Warner-Lambert in June 2000. It is long-standing policy that Pfizer has not and does not promote its products outside their FDA-approved labeling.... We are unable to comment further because of the pending litigation...”
But it’s litigation that will mean little to Regina Adams, who says she will always believe that her experience with bipolar disorder and the drug Neurontin almost ruined her life.
Adams: “Now that I look back, and that I know what I know now, I wouldn’t have ever taken the drug. I want everybody to know that’s taking this drug the truth about it.”
Last year the FDA approved the use of Neurontin in the treatment of post herpetic neuralgia, severe nerve pain, in addition to epilepsy. It is still widely prescribed for pain and a variety of other unapproved uses, some of which have been studied and endorsed by scientists and approved for use in other countries.
And as for whistleblower Franklin, he may have escaped legal liability for what he did during his four months with Parke-Davis, but he hasn’t escaped his own conscience. He admits he should have known from the start that he was heading down the wrong path.
Franklin: “Actually interviewing for this position, I was asked about giving examples of where I had to bend the rules in the past and how I handled that and how comfortable was I working in gray areas.”
This case could end up clarifying some of those gray areas and end up costing defendant Pfizer millions of dollars. And there’s one more thing. Because his lawsuit is filed under the federal False Claims Act, as a whistleblower Franklin stands to get a piece of any monetary damages, up to 30 percent, which could add up to millions. So the four-month job in sales that caused so much agony for this scientist, ironically, might in the end have set him up for life.
Hockenberry: “But even after you get a settlement, if you do, or a judgment if you do, or the case just completely goes away if it does, there are patients out there who took drugs based on decisions doctors made relying on your judgment.”
Franklin: “Right.”
Hockenberry: “They could be hurt because of that.”
Franklin: “They may have been hurt. And that’s something that I wrestle with.”
Hockenberry: “What’s to wrestle with? If they’re hurting, it’s because of you.”
Franklin: “It’s because of me. There hasn’t been a day in six years that I haven’t thought about this and wrestled with my involvement in it and the guilt I feel associated with it, and the sense that I need to correct it.”

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