David Franklin (scientist)

David Franklin[1] is an American microbiologist and former fellow of Harvard Medical School who while employed by Parke-Davis filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (gabapentin) for off-label uses.[2] Franklin's suit, filed on behalf of the citizens of the United States under the qui tam provisions of US federal and state law, uncovered illegal pharmaceutical industry practices and created new legal precedent that resulted in a cascade of criminal convictions and civil and criminal penalties against Pfizer and several other pharmaceutical companies totalling more than $7 billion.[3] Civil cases also followed Franklin v. Parke-Davis. Insurance companies, led by Kaiser Permanente, sued Pfizer for fraud and violation of the federal Racketeer Influenced and Corrupt Organizations Act;[4] the Kaiser case settled in April 2014 after Pfizer's appeal at the US Supreme Court was rejected.[5] Franklin v. Pfizer also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin.[6][7] Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions.[8] The settlement was the first off-label promotion settlement under the False Claims Act.[9][10]^:194

David Franklin[1]
Born	1961 (age 59–60) Rhode Island, United States
Citizenship	United States of America
Alma mater	University of Rhode Island (doctoral) Harvard Medical School (Post-doctoral)
Known for	Precedent setting stance against pharmaceutical industry fraud
Awards	Dana-Farber Cancer Institute Abraham Fellowship in Pediatric Oncology National Research Service Award
Scientific career
Fields	Biotechnology/Entrepreneurship Evidence-based medicine Dempster–Shafer theory Decision theory Complex adaptive system
Institutions	BSX IDXX Parke-Davis
Doctoral advisor	Paul Cohen
Other academic advisors	Barbara Bierer Jamie Ferreira
Influences	T. M. Scanlon Thomas Nagel Jay Wright Forrester

Franklin v. Parke-Davis case

Franklin's suit, filed under the False Claims Act,[11] claimed that Parke-Davis (since acquired by Pfizer) had used fraudulent scientific evidence[11] supported by "tens of thousands of payments" to doctors for "consultations" and "studies" to encourage them to prescribe the drug Neurontin for conditions including migraine, bipolar disorder and attention deficit disorder, even though it was approved for use only as adjunctive treatment in patients with partial seizures and postherpetic neuralgia.[12] Prescribing a drug for such off-label use was not itself illegal, but promoting such use was prohibited by the U.S. Food and Drug Administration[2] and federal law.[13]

The case revealed that the company marketed the drug for these illnesses while withholding evidence that the drug was not effective for these illnesses. After initially denying wrongdoing, Pfizer pleaded guilty on 13 May 2004 to criminal violation of the Federal Food, Drug, and Cosmetic Act and paid a criminal fine of $240 million and $152m to state and federal healthcare programmes. Under the False Claims Act, Dr Franklin received $24.6m as part of the settlement agreement.[11]

Franklin v. Parke-Davis opened a unique window into pharmaceutical industry practices through UCSF's archiving[14] and study[15] of documents obtained by Franklin’s attorney Thomas Greene. The case was unique in a number of ways: it was the largest settlement obtained for U.S. taxpayers in a case not joined by the Department of Justice, it established a new standard of accountability for pharmaceutical industry marketing practices, it broadened the use of the False Claims Act to include fraudulent marketing claims (not just financial fraud) as criminal violations of federal and state law, it revealed the involvement, complicity and active participation in fraud by many renowned physicians, and it demonstrated that the medical literature which is the foundation for medical practice (particularly off-label prescribing by physicians) has been deeply adulterated by the pharmaceutical industry and its paid clinical consultants.

References

1. Chitose Suzuki, USAToday/AP, "Photo: Dr. David P. Franklin at Pfizer guilty plea press conference (5/12/2004)", USA Today
2. Lenzer J (2003-03-22). "Whistleblower charges drug company with deceptive practices". BMJ. 326 (7390): 620. doi:10.1136/bmj.326.7390.620. PMC 1125531. PMID 12649230.
3. David Evans for Bloomberg News. November 9, 2009. Pfizer Broke the Law by Promoting Drugs for Unapproved Uses
4. Bob Van Voris and Janelle Lawrence for Bloomberg News. March 26, 2010 Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud
5. Kira Lerner for Law360. April 17, 2014 Pfizer, Kaiser End Neurontin Off-Label Suit With Fee Deal
6. Jef Feeley J for Bloomberg News. May 17, 2010 Pfizer Settles Neurontin Suit Over Minister's Death
7. Jef Feeley and Janelle Lawrence for Bloomberg News. April 2, 2010 Pfizer Agrees to First Settlement of a Neurontin-Related Suicide Lawsuit
8. Google Books, Books citing David Franklin and Neurontin
9. Joseph JN, et al. Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where Are We Going? Journal of Health & Life Sciences Law 2(2):73-108. January 2009
10. David S. Torborg The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation 26 J.L. & Health 181 (2013
11. Lenzer J (2004-05-22). "Pfizer pleads guilty, but drug sales continue to soar". BMJ. 328 (7450): 1217. doi:10.1136/bmj.328.7450.1217. PMC 416587. PMID 15155480.
12. Mack A (2003). "Examination of the evidence for off-label use of gabapentin" (PDF). J Manag Care Pharm. 9 (6): 559–68. doi:10.18553/jmcp.2003.9.6.559. PMID 14664664. Archived from the original (PDF) on 2010-09-17. Retrieved 2009-03-18.
13. FD&C Act 21 USC §331, Federal Food, Drug, and Cosmetics Act Sec. 301 Prohibited acts
14. Drug Industry Document Archive
15. Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents -- Steinman et al. 145 (4): 284 -- Annals of Internal Medicine