Last modified on 24 February 2014, at 14:14

Professionalism/David Franklin, Parke-Davis, and Neurontin

IntroEdit

Whistleblowing

Parke-Davis developed the drug Neurontin, or generically gabapentin. The Federal Food and Drug Administration approved this drug in 1993 to treat epilepsy patients and in 2002 to treat neuralgia patients. [1] However, these two uses did not have a large market. Therefore, Parke-Davis began an illegal marketing campaign, advertising the drug for treatment of bipolar disorder, migraines, and headaches in the 1990s.

Per FDA regulations, it is legal for doctors to prescribe a drug for an unapproved use, but it is not legal for drug companies to market the drug for these unapproved uses.[2] In 2004, Pfizer, the parent company of Parke-Davis, was found guilty for promoting and marketing Neurontin for unapproved uses.

This chapter first introduces Neurontin and Parke-Davis and then examines the whistleblower of this illegal marketing campaign, Dr. David Franklin. This analysis allows the reader to understand both the context and motivation surrounding the whistleblower in both a positive and negative light.

Parke-DavisEdit

Parke-Davis, America's first pharmaceutical producer, was founded in 1866. At one time it was the largest drug maker in the US. Parke-Davis introduced the first methodical clinical trials and was a leader in the industry. In 1970, Parke-Davis was acquired by Warner-Lambert, which later merged with Pfizer in 2000 to form the world's highest valued pharmaceutical company.[3]

Original Parke-Davis plant in Detroit, 1891.

The phrase on the Parke-Davis logo, "Medicamenta Vera," translates to 'True Medicine.' Conflictingly, the tactics executives from Parke-Davis pursued in the late 1990s were far from truthful. Most notably, Parke-Davis began a huge marketing campaign to persuade doctors to prescribe Neurontin for unapproved uses- despite the fact that it is illegal for pharmaceutical companies to encourage, or even suggest, this practice. In the year 2000, a staggering 78% of Neurontin prescriptions were for off-label uses.[4]

Other illegal activities included paying doctors to:

  • Pose as authors for journal articles on unapproved Neurontin uses
  • Attend resort dinners and weekend retreats where they were encouraged to prescribe the drug
  • Speak about its benefits
  • Include their Neurontin patients in clinical trials.[5] [6]

In May 2004, Pfizer pleaded guilty to violating FDA regulations, resulting in a $430 million settlement. It is interesting to note that, when this was settled, Pfizer tried to make the distinction between itself and Parke Davis - noting how the acquisition occurred well after the illegal activity began and how the activities under investigation did not involve any Pfizer employees.[7][8] Interestingly enough, since then, Pfizer has been involved in another $2.3 billion settlement for the illegal marketing of drugs.[9]

David Franklin - A 'Good Guy' PerspectiveEdit

The key, and only, whistleblower for this case is David Franklin. Franklin grew up aspiring to be a scientist and to cure disease. He graduated from the University of Rhode Island as a doctoral microbiologist. He went on to become research fellow at Harvard, and then to work at the Dana-Farber Cancer Institute. From there he was accepted as a medical liason at Parke-Davis in April of 1996. [10] As a medical liaison, Franklin's job was to be the intermediary expert on prescription drugs between doctors and the pharmaceutical company. Liaisons are supposed to be objective, third-party advisers to doctors, without carrying a 'company man' label. Typically, medical liaisons are strictly forbidden by their employers to discuss off-label uses with their clients.[4]

It was my responsibility to leverage the trust that physicians had with pharmaceutical companies to corrupt the relationship between the physician and the patient.

— Franklin's words on marketing tactics[10]

At the time Franklin joined Parke-Davis, company executives were frustrated with the limited sales potential of Neurontin due to the few FDA-approved uses. So top staff initiated an illegal marketing plan to sell the drug for a plethora of off-label uses.[4] This was not just in isolated cases, rather, this was an extensive training campaign for company liasons. They worked closely with doctors to win their trust, and then promoted Neurontin prescriptions for unapproved uses. As Franklin puts it in a Dateline NBC interview, "I was trained to deceive, to lie to doctors."[10] Essentially, the Parke-Davis medical liaison converted from an objective adviser to a salesman with ulterior motives.

After only a few weeks at Parke-Davis, Franklin began to doubt these practices. He was told by executives that 'if he talked publicly about the company's marketing he would be made a scapegoat and be described as a rogue employee in a company that played by the rules.'[4] Franklin also recorded a voicemail left by his boss, shown below.

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…

— Voicemail from Franklin's boss[10]

This pressure placed on employees by the Parke-Davis hierarchy was presumably suffocating. Intimidation became a key tactic for executives. Similar to 'teachers' in the Milgram Experiment, liaisons felt they had no choice but to follow orders to sell Neurontin to doctors for all possible uses. Liasons for Neurontin were told that if they were not comfortable with their tactics, then they should leave. So on 29 July, only four months later, Franklin dropped his company car and office keys at a co-worker's house and never returned.[10]

From there, he decided to file an eight year long lawsuit with Greene and Hoffman attorneys at law. During these years Franklin had no job, no income to support his family, and no company friends to turn to. As one journalist puts it, “the microbiologist ended up blackballed in the pharmaceutical industry and had to endure an emotionally and financially draining odyssey as a whistle-blower.”[11] He had to endure this stress, all because he was the only one who felt morally obligated to do the right thing, to turn in his own employer. When the case was finally settled in May of 2004, Pfizer paid the second largest criminal fine in a healthcare fraud case of $430 million.[7]

David Franklin - Questionable Motivations as a WhistleblowerEdit

It is easy to paint the picture of a whistleblower - someone who has come forward, spoken up, and put themselves in a precarious situation to protect others and do what is morally just. However, not all whistleblowers are motivated by purely ethical reasons. In the case of David Franklin, we must consider if the same is true. First, we will acknowledge whether or not David Franklin was trying to protect himself by coming forward. Second, we will discuss whether this whistleblower was swayed by the power of a financial incentive.

Protecting himself

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.

— Franklin's words on going public[10]

In an interview with Dateline, Franklin states that if he had not come forward, he would be "on the wrong side of this investigation” [10]. This suggests that Franklin was, at least in part, trying to protect himself. Assuming this is true, we must ask if he should have voiced his concerns sooner, especially when "He admits he should have known from the start that he was heading down the wrong path" [10] Furthermore, the New York Times reports that “Dr. David P. Franklin decided within weeks of accepting a job with the drug maker Warner-Lambert that he had become a crucial component in an apparent corporate plan to illegally market an epilepsy drug called Neurontin.” [4]After this realization, he waited four months before resigning and filing a law suit. [10]. How long do you wait before you turn someone in? is it better to report it and withdraw yourself or play along to gather evidence to build a strong case? After all, lives were at risk. Are you building a stronger case to simply make yourself look like more of a hero in the public eye/protect yourself and get a larger reward or to actually prove malicious actions?

Rewards

Ultimately, Franklin filed his case under the terms of the US False Claims Act. As a result of the settlement, Franklin came away with 26.6 million dollars. It is clear that with this settlement, Franklin is set for life. As a USA Today report puts it, “Thursday's settlement gives him even more personal satisfaction — not to mention enough money that he could walk away and retire.” [11]. Even MSNBC acknowledges the irony: "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" [10]

Franklin's interview suggests he was not in it for the money - "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" [10]. Nevertheless, taking a skeptical approach to this scenario results in an interesting ethical analysis. Thus, we must ask: what if the idea of this money tipped the ethical scale for Franklin? did knowing of the potential reward encourage Franklin to come forward?

He states that his next stop after leaving Parke Davis was a law firm, but it is possible that during this four month period Franklin had done his research and learned about the potential rewards before coming forward. A quick search reveals that there are a number of resources - law firms and websites alike - which educate viewers about becoming a pharmaceutical whistle blower.

Franklin would have gathered that building a strong case and filing under the False Claims Act would be the best way to proceed to ensure a large reward. This act allows private citizens to sue on behalf of the government and get a portion of awards in cases where firms defraud the government. Persons filing under the Act stand to receive anywhere from 15 to 25 percent of any recovered damages. The law was on his side. In fact, the reward itself is known as a writ of qui tam, originating from the latin phrase “qui tam pro domino rege quam pro se ipso in hac parte sequitur.” Translated, the phrase means "who brings the action for the king as well as for himself." [12] As the translation shows, Franklin could have been motivated not only for the good of the people ('the king') but also for selfish reasons ('for himself'). Can a financial incentive encourage people to come forward who might otherwise remain silent? How much of an incentive is appropriate?

Related CasesEdit

Douglas Durand and TAP PharmaceuticalEdit

The case of David Franklin and Pfizer is not unique. There have been several other cases in which whistleblowers received a great deal of money from the US False Claims Act. The settlement of Douglas Durand and TAP Pharmaceuticals is one such instance. Durand worked for TAP Pharmaceuticals for over 15 months, serving as a vice president of the company. As Vice President of Sales, Durand found that the company was defrauding the government's Medicare program and also encouraging Urologists to "cheat" or "game" the Medicare system by falsely billing for product purchased at discount or even on free samples. Durand tried to change the system at TAP but his efforts were resisted by senior management. Before resigning, he collected information, secured an attorney, and cooperated with the government under the US False Claims Act. For his whistleblowing, Durand received 78 million dollars. [13]

VioxxEdit

While it has been debated whether the whistleblowers blew the whistle for their own gain or because the right thing to do, does it really matter? For example, Merck, a large pharmaceutical company, covered up negative information about an arthritis pain killer, Vioxx, that potentially increased patients' risk of a heart attack. As a result, thousands of people may have been put at risk of heart disease. One challenge in this case was the fact that most patients with arthritis are older and by virtue of their age, have an increased risk of heart disease. This brings up the question of whether it is okay to do the right thing for the wrong reasons.

Concluding ThoughtsEdit

While some people blow the whistle to prevent deaths and fraud, not everybody has such high moral value incentives. Some people are driven wholly or partly by monetary gain or feel the need to protect themselves. While it cannot be known what David Franklin's incentives were, it might be asked: Does knowing someone has alternate motives for doing the right thing change your perspective on them? Does it even matter?

However, because of the increased incentives, there have certainly been an increased number of people wrongly reported fraud cases under the United States False Claims Act. [14] This slows down the legal system. With the judicial branch having to navigate which cases are legitimate and which ones are angry ex-employees, companies continue their illegal practices. Therefore it should be better understood the impact that the United States False Claims Act has on reporting efforts and whether this impact is negative or positive.

ReferencesEdit

  1. Neurontin FDA Insert, Neurontin Drug Insert
  2. David C. Radley; Stan N. Finkelstein; Randall S. Stafford (2006). "Off-label Prescribing Among Office-Based Physicians". Archives of Internal Medicine 166 (9): 1021–1026. doi:10.1001/archinte.166.9.1021. PMID 16682577. http://archinte.ama-assn.org/cgi/content/full/166/9/1021. 
  3. Pfizer Website, Warner-Lambert: A History
  4. a b c d e New York Times, "Doctor Explains Why He Blew the Whistle"
  5. New York Times,"Whistle-Blower Says Marketers Broke the Rules To Push a Drug"
  6. Annals of Internal Medicine, "Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents"
  7. a b San Francisco Chronicle, "Huge penalty in drug fraud"
  8. British Medical Journal, "Whistleblower charges drug company with deceptive practices"
  9. Washington Post, "In Settlement, A Warning To Drugmakers"
  10. a b c d e f g h i j k Dateline NBC, "Drug giant accused of false claims"
  11. a b USA Today, "$26.6M won't change me, whistle-blower says"
  12. Legal Dictionary, Qui Tam Actions
  13. Durand Case , "Doug Durand's risky documentation of fraud at drugmaker TAP is prompting wider probes"
  14. Burden of US False Claims Act, "Whistle Blowing: An Economical Analysis of the False Claims Act"