David Franklin (scientist)
David Franklin[1] | |
|---|---|
| Born | 1961 (age 62–63) |
| 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 |
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[3] and several other pharmaceutical companies totalling more than $7 billion.[4] Civil cases also followed Franklin v. Parke-Davis in which insurance providers sued Pfizer for fraud. Franklin testified before the jury which found Pfizer guilty of fraud and violation of the federal Racketeer Influenced and Corrupt Organizations Act (RICO) and awarded more than $142 million to the Kaiser Foundation Health Plan.[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.
Franklin v. Parke-Davis case
Franklin's suit, filed under the False Claims Act,[9] claimed that Parke-Davis (since acquired by Pfizer) had used fraudulent scientific evidence[9] supported by "tens of thousands of payments" to doctors for "consultations" and "studies" to encourage them to prescribe the drug 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.[10] 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.[11]
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.[9]
Franklin v. Parke-Davis opened a unique window into pharmaceutical industry practices through UCSF's archiving[12] and study[13] 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
- ^ a b Chitose Suzuki, USAToday/AP, Photo: Dr. David P. Franklin at Pfizer guilty plea press conference (5/12/2004)
- ^ a b 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.
- ^ Rockoff J., Kendall B. "Pfizer to Plead Guilty To Improper Marketing".
{{cite journal}}: Cite journal requires|journal=(help) - ^ Evans D. "Pfizer Broke the Law by Promoting Drugs for Unapproved Uses".
{{cite journal}}: Cite journal requires|journal=(help) - ^ Voris B, Lawrence J. "Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud".
{{cite journal}}: Cite journal requires|journal=(help) - ^ Feeley J. "Pfizer Settles Neurontin Suit Over Minister's Death".
{{cite journal}}: Cite journal requires|journal=(help) - ^ Feeley J., Lawrence J. "Pfizer Agrees to First Neurontin Lawsuit Settlement".
{{cite journal}}: Cite journal requires|journal=(help) - ^ Google Books, Books citing David Franklin and Neurontin
{{citation}}:|author=has generic name (help) - ^ a b c 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.
- ^ Mack A (2003). "Examination of the evidence for off-label use of gabapentin" (PDF). J Manag Care Pharm. 9 (6): 559–68. PMID 14664664.
- ^ FD&C Act 21 USC §331, Federal Food, Drug, and Cosmetics Act Sec. 301 Prohibited acts
{{citation}}: CS1 maint: numeric names: authors list (link) - ^ Drug Industry Document Archive
- ^ Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents -- Steinman et al. 145 (4): 284 -- Annals of Internal Medicine
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