David Franklin (scientist)

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David Franklin [1]
Born1961 (age 61–62)
Rhode Island, United States
Citizenship United States of America
Alma mater University of Rhode Island (doctoral)
Harvard Medical School (Post-doctoral)
Known forPrecedent 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 advisorsBarbara 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

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.

Related Research Articles

<span class="mw-page-title-main">False Claims Act</span> United States federal law

The False Claims Act (FCA) is an American federal law that imposes liability on persons and companies who defraud governmental programs. It is the federal government's primary litigation tool in combating fraud against the government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government. This is informally called "whistleblowing", especially when the relator is employed by the organization accused in the suit. Persons filing actions under the Act stand to receive a portion of any recovered damages.

<span class="mw-page-title-main">Pfizer</span> American multinational pharmaceutical and biotechnology corporation

<span class="mw-page-title-main">Gabapentin</span> Anticonvulsant medication

Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. It is commonly used medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain. It is moderately effective: about 30–40% of those given gabapentin for diabetic neuropathy or postherpetic neuralgia have a meaningful benefit.

<span class="mw-page-title-main">Valdecoxib</span> Nonsteroidal anti-inflammatory drug

Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995.

Many countries have measures in place to limit advertising by pharmaceutical companies.

<span class="mw-page-title-main">Parke-Davis</span> Pfizer subsidiary

Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although Parke, Davis & Co. is no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history. In 1970 Parke-Davis was acquired by Warner-Lambert, which in turn was acquired by Pfizer in 2000.

In common law, a writ of qui tam is a writ through which private individuals who assist a prosecution can receive for themselves all or part of the damages or financial penalties recovered by the government as a result of the prosecution. Its name is an abbreviation of the Latin phrase qui tam pro domino rege quam pro se ipso in hac parte sequitur, meaning "[he] who sues in this matter for the king as well as for himself."

<span class="mw-page-title-main">Off-label use</span> Use of pharmaceuticals for conditions different from that for which they were approved

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

<span class="mw-page-title-main">Peter Rost (doctor)</span>

Peter Rost is an American former drug marketing executive who is most known for taking public stances critical of the pharmaceutical industry as an "insider" and whistleblower. He sued his last two pharmaceutical employers, Wyeth and Pfizer, the latter of which fired him in 2005. At Wyeth, he uncovered tax evasion practices, and after informing senior company executives, was transferred from Sweden to a post in New Jersey. Rost sued the company, saying that the transfer was a retaliatory demotion, though the company said it was a promotion. Rost settled with Wyeth for an undisclosed amount in 2003. At Pfizer, Rost filed a qui tam suit disclosing off-label marketing of Genotropin at Pharmacia prior to its purchase by Pfizer. The U.S. Department of Justice declined to join in Rost's suit as the marketing violations had already been disclosed to the Department by Pfizer. Rost was eventually fired by Pfizer, and sued for wrongful dismissal, but this lawsuit was summarily dismissed by the court based on evidence that Pfizer had decided to fire Rost prior to discovery of his whistleblowing activities. Since then, Rost has worked outside the pharmaceutical industry, as a public speaker, blogger, writer, and litigation consultant.

The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture. Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. Organizational ethics are best demonstrated through acts of fairness, compassion, integrity, honor, and responsibility.

The Drug Industry Documents Archive (DIDA) is a digital archive of pharmaceutical industry documents created and maintained by the University of California, San Francisco, Library and Center for Knowledge Management. DIDA is a part of the larger UCSF Industry Documents Library which includes the Truth Tobacco Industry Documents. The archive contains documents about pharmaceutical industry clinical trials, publication of study results, pricing, marketing, relations with physicians and drug company involvement in continuing medical education.

Pharmaceutical fraud involves activities that result in false claims to insurers or programs such as Medicare in the United States or equivalent state programs for financial gain to a pharmaceutical company. There are several different schemes used to defraud the health care system which are particular to the pharmaceutical industry. These include: Good Manufacturing Practice (GMP) Violations, Off Label Marketing, Best Price Fraud, CME Fraud, Medicaid Price Reporting, and Manufactured Compound Drugs. Examples of fraud cases include the GlaxoSmithKline $3 billion settlement, Pfizer $2.3 billion settlement, and Merck $650 million settlement. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).

<i>Franklin v. Parke-Davis</i>

Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer under the qui tam provisions of the False Claims Act. The suit was commenced by David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert. In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for prescriptions that were not reimbursable, triggering False Claims Act liability. The case was also significant in exposing the degree to which publication bias impacts the randomized controlled studies conducted by pharmaceutical companies to test the efficacy of their products. Ultimately, the parties reached a settlement agreement of $430 million to resolve all civil claims and criminal charges stemming from the qui tam complaint. At the time of the settlement in May 2004, it represented one of the largest False Claims Act recoveries against a pharmaceutical company in U.S. history, and was the first off-label promotion settlement under the False Claims Act.

<span class="mw-page-title-main">Reuben Guttman</span>

Reuben A. Guttman, born 1959 in New York City, is an American attorney and a founding Partner of Guttman, Buschner & Brooks PLLC ("GBB"), a DC-based plaintiffs' firm His practice involves complex litigation and class actions. He has served as counsel in some of the largest recoveries under the False Claims Act. The International Business Times has called Guttman "one of the world's most prominent whistleblower attorneys," and he has been recognized as a Washingtonian Top Lawyer by Washingtonian Magazine.

The STEPS trial was a clinical trial sponsored by Parke-Davis to evaluate the anticonvulsant Neurontin. It is notable for being a seeding trial to promote that drug and for contributing to the drug companies loss in the court case Franklin v. Parke-Davis.

Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after Franklin v. Parke-Davis, in which a court ruled off-label marketing a violation of the False Claims Act.

The Consumer & Prescriber Grant Program was a grant program established with fines paid by Pfizer in the Franklin v. Parke-Davis trial for False Claims Act violations relating to off-label use of gabapentin.

References

  1. 1 2 Chitose Suzuki, USAToday/AP, "Photo: Dr. David P. Franklin at Pfizer guilty plea press conference (5/12/2004)", USA Today
  2. 1 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 {{citation}}: |author= has generic name (help)
  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? Archived 2016-03-04 at the Wayback Machine 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. 1 2 3 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
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