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{{Infobox scientist |
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| name = David Franklin<ref name="franklin_photo">{{citation |author=Chitose Suzuki, USAToday/AP |title=Photo: Dr. David P. Franklin at Pfizer guilty plea press conference (5/12/2004)|url=http://images.usatoday.com/money/_photos/2004/05/14/franklin.jpg | work=USA Today}}</ref> |
| name = David Franklin<ref name="franklin_photo">{{citation |author=Chitose Suzuki, USAToday/AP |title=Photo: Dr. David P. Franklin at Pfizer guilty plea press conference (5/12/2004)|url=http://images.usatoday.com/money/_photos/2004/05/14/franklin.jpg | work=USA Today}}</ref> |
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| birth_date = {{birth year and age|1961}} |
| birth_date = {{birth year and age|1961}} |
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| birth_place = [[Rhode Island]], [[United States]] |
| birth_place = [[Rhode Island]], [[United States]] |
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| residence = [[Hopkinton, Massachusetts]] |
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| citizenship = [[United States of America]] |
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| nationality = |
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| fields = [[Biotechnology]]/[[Entrepreneurship]]<br>[[Evidence-based medicine]]<br>[[Dempster–Shafer theory]]<br>[[Decision theory]]<br>[[Complex adaptive system]] |
| fields = [[Biotechnology]]/[[Entrepreneurship]]<br>[[Evidence-based medicine]]<br>[[Dempster–Shafer theory]]<br>[[Decision theory]]<br>[[Complex adaptive system]] |
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| workplaces = [[Boston Scientific Corporation|BSX]]<br>[[IDEXX Laboratories|IDXX]]<br>[[Parke-Davis]] |
| workplaces = [[Boston Scientific Corporation|BSX]]<br>[[IDEXX Laboratories|IDXX]]<br>[[Parke-Davis]] |
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| academic_advisors = Barbara Bierer<br>Jamie Ferreira |
| academic_advisors = Barbara Bierer<br>Jamie Ferreira |
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| doctoral_students = |
| doctoral_students = |
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| influences = [[T. M. Scanlon]]<br>[[Thomas Nagel]]<br>[[Jay Wright Forrester]] |
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| known_for = Precedent setting stance against pharmaceutical industry fraud |
| known_for = Precedent setting stance against pharmaceutical industry fraud |
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| awards = [[ |
| awards = [[Dana–Farber Cancer Institute]] Abraham Fellowship in Pediatric Oncology <br>[[National Research Service Award]] |
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''' David Franklin'''<ref name="franklin_photo" /> 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.<ref name="BMJ_20030322">{{cite journal |author=Lenzer J |title=Whistleblower charges drug company with deceptive practices |journal=BMJ |volume=326 |issue=7390 |pages=620 |date=2003-03-22 |pmid=12649230 |pmc=1125531 |doi=10.1136/bmj.326.7390.620 |
''' David Franklin'''<ref name="franklin_photo" /> 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.<ref name="BMJ_20030322">{{cite journal |author=Lenzer J |title=Whistleblower charges drug company with deceptive practices |journal=BMJ |volume=326 |issue=7390 |pages=620 |date=2003-03-22 |pmid=12649230 |pmc=1125531 |doi=10.1136/bmj.326.7390.620 }}</ref> 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.<ref name="BLB_20090909">David Evans for Bloomberg News. November 9, 2009. [https://www.bloomberg.com/apps/news?pid=newsarchive&sid=a4yV1nYxCGoA Pfizer Broke the Law by Promoting Drugs for Unapproved Uses]</ref> 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]];<ref>Bob Van Voris and Janelle Lawrence for Bloomberg News. March 26, 2010 [https://www.bloomberg.com/apps/news?pid=email_en&sid=a_9aVylZQGjU Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud]</ref> the Kaiser case settled in April 2014 after Pfizer's appeal at the US Supreme Court was rejected.<ref>Kira Lerner for Law360. April 17, 2014 [http://www.law360.com/articles/528848/pfizer-kaiser-end-neurontin-off-label-suit-with-fee-deal Pfizer, Kaiser End Neurontin Off-Label Suit With Fee Deal]</ref> ''Franklin v. Pfizer'' also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin.<ref>Jef Feeley J for Bloomberg News. May 17, 2010 [https://www.bloomberg.com/news/2010-05-17/pfizer-settles-neurontin-epilepsy-drug-suit-over-retired-minister-s-death.html Pfizer Settles Neurontin Suit Over Minister's Death]</ref><ref>Jef Feeley and Janelle Lawrence for Bloomberg News. April 2, 2010 [https://www.bloomberg.com/news/2010-04-02/pfizer-agrees-to-first-settlement-of-a-neurontin-related-suicide-lawsuit.html Pfizer Agrees to First Settlement of a Neurontin-Related Suicide Lawsuit]</ref> Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions.<ref>{{citation |author=Google Books |title=Books citing David Franklin and Neurontin |url=https://www.google.com/search?q=neurontin+David+Franklin}}</ref> The settlement was the [[List of off-label promotion pharmaceutical settlements|first off-label promotion settlement under the False Claims Act]].<ref name=Joseph>Joseph JN, et al. [http://www.postschell.com/site/files/415.pdf Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where Are We Going?] {{Webarchive|url=https://web.archive.org/web/20160304221444/http://www.postschell.com/site/files/415.pdf |date=2016-03-04 }} Journal of Health & Life Sciences Law 2(2):73-108. January 2009</ref><ref name=Torberg>David S. Torborg [http://engagedscholarship.csuohio.edu/cgi/viewcontent.cgi?article=1340&context=jlh The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation] 26 J.L. & Health 181 (2013</ref>{{rp|194}} |
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==''Franklin v. Parke-Davis'' case== |
==''Franklin v. Parke-Davis'' case== |
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{{Main|Franklin v. Parke-Davis}} |
{{Main|Franklin v. Parke-Davis}} |
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Franklin's suit, filed under the [[False Claims Act]],<ref name="BMJ_20040522">{{cite journal |author=Lenzer J |title=Pfizer pleads guilty, but drug sales continue to soar |journal=BMJ |volume=328 |issue=7450 |pages=1217 |date=2004-05-22 |pmid=15155480 |pmc=416587 |doi=10.1136/bmj.328.7450.1217 |
Franklin's suit, filed under the [[False Claims Act]],<ref name="BMJ_20040522">{{cite journal |author=Lenzer J |title=Pfizer pleads guilty, but drug sales continue to soar |journal=BMJ |volume=328 |issue=7450 |pages=1217 |date=2004-05-22 |pmid=15155480 |pmc=416587 |doi=10.1136/bmj.328.7450.1217 }}</ref> claimed that Parke-Davis (since acquired by [[Pfizer]]) had used fraudulent scientific evidence<ref name="BMJ_20040522"/> 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 [[Adult attention-deficit disorder|attention deficit disorder]], even though it was approved for use only as adjunctive treatment in patients with partial [[seizure]]s and postherpetic neuralgia.<ref>{{cite journal |author=Mack A |title=Examination of the evidence for off-label use of gabapentin |journal=J Manag Care Pharm |volume=9 |issue=6 |pages=559–68 |year=2003 |pmid=14664664 |doi=10.18553/jmcp.2003.9.6.559 |pmc=10437292 |url=http://www.amcp.org/data/jmcp/Contemporary%20Subject-559-568.pdf |access-date=2009-03-18 |archive-url=https://web.archive.org/web/20100917222044/http://amcp.org/data/jmcp/Contemporary%20Subject-559-568.pdf |archive-date=2010-09-17 |url-status=dead }}</ref> 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]]<ref name="BMJ_20030322" /> and federal law.<ref>{{citation |author=FD&C Act 21 USC §331 |title=Federal Food, Drug, and Cosmetics Act Sec. 301 Prohibited acts |url=https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIIIProhibitedActsandPenalties/ucm086300.htm}}</ref> |
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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.<ref name="BMJ_20040522" /> |
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.<ref name="BMJ_20040522" /> |
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''Franklin v. Parke-Davis'' opened a unique window into pharmaceutical industry practices through [[University of California, San Francisco|UCSF's]] archiving<ref>[http://dida.library.ucsf.edu Drug Industry Document Archive]</ref> and study<ref>[http://www.annals.org/cgi/content/full/145/4/284 Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents -- Steinman et al. 145 (4): 284 -- Annals of Internal Medicine]</ref> of documents obtained by |
''Franklin v. Parke-Davis'' opened a unique window into pharmaceutical industry practices through [[University of California, San Francisco|UCSF's]] archiving<ref>[http://dida.library.ucsf.edu Drug Industry Document Archive]</ref> and study<ref>[http://www.annals.org/cgi/content/full/145/4/284 Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents -- Steinman et al. 145 (4): 284 -- Annals of Internal Medicine]</ref> 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. |
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== References == |
== References == |
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[[Category:American microbiologists]] |
[[Category:American microbiologists]] |
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[[Category:1961 births]] |
[[Category:1961 births]] |
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[[Category:Scientists from Rhode Island]] |
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[[Category:Harvard Medical School people]] |
[[Category:Harvard Medical School people]] |
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[[Category:People from Hopkinton, Massachusetts]] |
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Latest revision as of 03:35, 18 June 2024
David Franklin[1] | |
|---|---|
| Born | 1961 (age 62–63) |
| 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 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
Franklin v. Parke-Davis case
[edit]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
[edit]- ^ a b Chitose Suzuki, USAToday/AP, "Photo: Dr. David P. Franklin at Pfizer guilty plea press conference (5/12/2004)", USA Today
- ^ 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.
- ^ David Evans for Bloomberg News. November 9, 2009. Pfizer Broke the Law by Promoting Drugs for Unapproved Uses
- ^ Bob Van Voris and Janelle Lawrence for Bloomberg News. March 26, 2010 Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud
- ^ Kira Lerner for Law360. April 17, 2014 Pfizer, Kaiser End Neurontin Off-Label Suit With Fee Deal
- ^ Jef Feeley J for Bloomberg News. May 17, 2010 Pfizer Settles Neurontin Suit Over Minister's Death
- ^ Jef Feeley and Janelle Lawrence for Bloomberg News. April 2, 2010 Pfizer Agrees to First Settlement of a Neurontin-Related Suicide Lawsuit
- ^ Google Books, Books citing David Franklin and Neurontin
{{citation}}:|author=has generic name (help) - ^ 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? Archived 2016-03-04 at the Wayback Machine Journal of Health & Life Sciences Law 2(2):73-108. January 2009
- ^ David S. Torborg The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation 26 J.L. & Health 181 (2013
- ^ 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. doi:10.18553/jmcp.2003.9.6.559. PMC 10437292. PMID 14664664. Archived from the original (PDF) on 2010-09-17. Retrieved 2009-03-18.
- ^ 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
