David Franklin (pharmacy)
Encyclopedia
Dr David Franklin is a 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. 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. Civil cases also followed Franklin v. Pfizer 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. Franklin v. Pfizer also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin. Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions.
, claimed that Parke-Davis (since acquired by Pfizer
) had used fraudulent scientific evidence 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 seizure
s and postherpetic neuralgia. 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 and federal law.
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.
Franklin v. Pfizer opened a unique window into pharmaceutical industry practices through UCSF's
archiving and study 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.
Microbiologist
A microbiologist is a scientist who works in the field of microbiology. Microbiologists study organisms called microbes. Microbes can take the form of bacteria, viruses, fungi, and protists...
and former fellow of Harvard Medical School
Harvard Medical School
Harvard Medical School is the graduate medical school of Harvard University. It is located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts....
who while employed by Parke-Davis
Parke-Davis
Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history.- History :...
filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (gabapentin
Gabapentin
Gabapentin is a pharmaceutical drug, specifically a GABA analogue. It was originally developed for the treatment of epilepsy, and currently is also used to relieve neuropathic pain...
) for off-label uses. Franklin's suit, filed on behalf of the citizens of the United States under the qui tam
Qui tam
In common law, a writ of qui tam is a writ whereby a private individual who assists a prosecution can receive all or part of any penalty imposed...
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. Civil cases also followed Franklin v. Pfizer 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
Racketeer Influenced and Corrupt Organizations Act
The Racketeer Influenced and Corrupt Organizations Act, commonly referred to as the RICO Act or simply RICO, is a United States federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization...
(RICO) and awarded more than $142 million to the Kaiser Foundation Health Plan. Franklin v. Pfizer also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin. Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions.
Franklin v. Pfizer case
Franklin's suit, filed under the False Claims ActFalse Claims Act
The False Claims Act is an American federal law that imposes liability on persons and companies who defraud governmental programs. The law includes a "qui tam" provision that allows people who are not affiliated with the government to file actions on behalf of the government...
, claimed that Parke-Davis (since acquired by Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
) had used fraudulent scientific evidence supported by "tens of thousands of payments" to doctors for "consultations" and "studies" to encourage them to prescribe the drug for conditions including migraine
Migraine
Migraine is a chronic neurological disorder characterized by moderate to severe headaches, and nausea...
, bipolar disorder
Bipolar disorder
Bipolar disorder or bipolar affective disorder, historically known as manic–depressive disorder, is a psychiatric diagnosis that describes a category of mood disorders defined by the presence of one or more episodes of abnormally elevated energy levels, cognition, and mood with or without one or...
and attention deficit disorder
Adult attention-deficit disorder
Adult attention deficit hyperactivity disorder is the common term used to describe the neuropsychiatric condition attention-deficit hyperactivity disorder when it is present in adults. Up to 60% of children diagnosed with ADHD in early childhood continue to demonstrate notable ADHD symptoms as...
, even though it was approved for use only as adjunctive treatment in patients with partial seizure
Seizure
An epileptic seizure, occasionally referred to as a fit, is defined as a transient symptom of "abnormal excessive or synchronous neuronal activity in the brain". The outward effect can be as dramatic as a wild thrashing movement or as mild as a brief loss of awareness...
s and postherpetic neuralgia. Prescribing a drug for such off-label use
Off-label use
Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration...
was not itself illegal, but promoting such use was prohibited by the U.S. Food and Drug Administration and federal law.
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
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
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.
Franklin v. Pfizer opened a unique window into pharmaceutical industry practices through UCSF's
University of California, San Francisco
The University of California, San Francisco is one of the world's leading centers of health sciences research, patient care, and education. UCSF's medical, pharmacy, dentistry, nursing, and graduate schools are among the top health science professional schools in the world...
archiving and study 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.