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35-475: Most of the documents on DIDA were made public as a result of lawsuits against pharmaceutical companies Parke-Davis , Warner-Lambert , Pfizer , Merck & Co. , Wyeth and Abbott Labs , among others. DIDA was founded in 2005 with the support of a gift by Thomas Greene, the attorney for David Franklin , whistleblower in United States ex rel. Franklin v. Parke-Davis, the case from which the first documents in

70-506: A Drug Fiend and The Confessions of Aleister Crowley , stopped by Parke-Davis in Detroit, where, according to Crowley, the cooperation was complete. "[They] were kind enough to interest themselves in my researches in Anhalonium lewinii (peyote) and made me some special preparations on the lines indicated by my experience which proved greatly superior to previous preparations." Parke-Davis also

105-529: A secondary course of treatment for epilepsy , to be used only when the first medication had not brought the epileptic seizures entirely under control. Warner-Lambert executives found the potential revenue in that indication was too low, and decided to promote Neurontin for additional indications, for which the drug was not approved by the FDA and for which there was little to no evidence, including migraines , bipolar disorder and attention-deficit disorder . Members of

140-719: A supervisor that his career would be threatened or ended if he continued to raise objections, and this is what finally prompted him to quit and hire a Boston attorney, Thomas M. Greene. In August 1996, Franklin and attorney Thomas Greene filed a qui tam complaint in the United States District Court for the District of Massachusetts in Boston under the False Claims Act , a federal statute which permits private citizen-whistleblowers (also known as "relators") to sue on behalf of

175-435: A third partner in 1867. Parke was a businessman looking for business opportunities and Davis, an ambitious man with skills in sales. Duffield withdrew in 1869 because of poor health and an interest in practicing medicine. The partnership adopted the name Parke, Davis or Parke-Davis in 1871, and was formally incorporated as Parke, Davis & Company in 1875. In 1871, the company sent expeditions to Central and South America and

210-436: A variety of sources including: Parke-Davis 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. Parke, Davis and Company

245-517: Is a National Historic Landmark ; the surrounding Parke-Davis and Company Pharmaceutical Company Plant is on the National Register of Historic Places . In 1912, Parke-Davis pharmacist Wilbur Scoville developed the "Scoville Organoleptic Test" - now standardized as the Scoville scale - to measure the "spiciness" or "heat" of various chili peppers. The production facility on Parkdale Road in what

280-543: 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 (Warner-Lambert was subsequently acquired by Pfizer in 2000). 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

315-540: The Federal Food, Drug, and Cosmetic Act , resulting in a $ 240 million criminal fine. Civil damages under the False Claims Act were paid out to the federal government in the amount of $ 83.6 million, and damages paid out to the states totaled $ 106.4 million. Relator David Franklin was awarded one of the highest shares ever under the False Claims Act, 29.5% of the settlement, in recognition of his important role in exposing

350-504: 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. After four months of employment at Parke-Davis, Franklin became disillusioned by what he believed to be the company's illegal marketing practices in connection with sales of the drug Neurontin . In December 1993, the Food and Drug Administration (FDA) had approved Neurontin as

385-465: The Department of Justice decided if it would intervene and take over the case, which it had the right to do under the False Claims Act . In 1999, the government declined, and the case moved forward. The defendants sought to have the complaint dismissed, arguing that the causal link between any representations made by Parke-Davis sales representatives and reimbursements for off-label Neurontin prescriptions

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420-407: The False Claims Act using this case as a precedent. Subsequent research reported that the wrongful promotion of the drug was planned by integrating it into Continuing medical education , supporting consultants and members of medical advisory boards to recommend the use to institutions, and paying people to write about the drug in any positive context including in academic literature , letters to

455-490: The Parke-Davis sales team, including medical liaisons like Franklin, were hired to conduct this marketing. Franklin also alleged that physicians and other health care providers were paid illegal kickbacks as a quid pro quo for prescribing Neurontin, including expensive meals, stays at luxury resorts, and cash payments and that Parke-Davis hired ad agencies and marketing firms to produce articles about gabapentin describing

490-535: The West Indies in search of medicinal plants. The company produced an herbal laxative drug Cascara found from Native Americans in the Pacific Northwest. It was once the world's largest pharmaceutical company and is credited with building the first modern pharmaceutical laboratory and developing the first systematic methods of performing clinical trials of new medications. The Parke-Davis Research Laboratory

525-522: The application on its own. In partnership with the Japanese firm Daiichi Sankyo Co. and the British firm Glaxo Wellcome , Parke-Davis developed and marketed the anti-diabetic drug Rezulin ( troglitazone ) in the late 1990s. The drug was withdrawn in 2000 because of liver toxicity. Parke-Davis developed the first bacterial vaccine , and the company was thus known as a pioneer in the field of vaccinology . It

560-532: The archive originated. Researchers as well as students, journalists, and the general public, use the archive to investigate the ways pharmaceutical companies market their products. The UCSF_Library created this digital archive in an attempt to facilitate further research into the drug industry's practice of establishing close links with the medical community which has been shown to influence scientific research, drug approval, prescription practices, and ultimately, consumer health. DIDA contains: Documents come from

595-452: The criminalization of cocaine , the drug was sold by Parke-Davis in various forms, including cigarettes, powder, and even a cocaine mixture that could be injected directly into the user’s veins with the included needle. The company promised that its cocaine products would "supply the place of food, make the coward brave, the silent eloquent and ... render the sufferer insensitive to pain." In October 1915, Aleister Crowley , author of Diary of

630-586: The depicted scene and its place in history. Launched in 1957, the series was developed in cooperation with the Institute for the History of Pharmacy at the University of Wisconsin. Druggists were encouraged to display the artwork in their stores. Thom also did a comparable series on the history of medicine. In the case of Franklin v. Parke-Davis (2002), the company was accused of illegal marketing practices, including

665-476: The drug's emerging uses and recruited physicians and paid them to sign their names to the ghost written articles as authors. According to Franklin, a case report stating that Neurontin had made a child's attention deficit disorder worse, and his supervisor's dismissal of the report, was a key factor in his decision to leave Parke-Davis in July 1996 after only four months of employment. He also reported being told by

700-631: The exclusive contract to produce the vaccine for field trials but in February 1954 the National Foundation for the Prevention of Polio reneged on the contract and opened vaccine production to other companies as well. Parke-Davis commissioned Detroit illustrator Robert Thom to produce 40 illustrations for the series, “A History of Pharmacy in Pictures.” Each print came with a history article that explained

735-638: The federal government for fraud involving federal money. Franklin's suit proposed a novel theory, that Warner-Lambert had perpetrated a fraud against the federal government by causing doctors and patients to submit claims for reimbursement to Medicaid that Medicaid should not pay for, since by law, Medicaid only pays for treatments that are either approved by the FDA, or are otherwise "medically accepted" (as evidenced, for instance, by being included in an approved list of drugs and their uses ). The suit also alleged that Warner-Lambert had broken federal kickback laws. The suit remained sealed for three years while

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770-523: The first cancer vaccine, which was developed by William Coley to treat osteosarcoma. Additionally, the company entered into a distribution agreement with the Inoculation Department of St Mary's (London) and distributed a number of vaccines for infectious diseases and even acne and cancer. Another of the company's products developed by Takamine was a pure form of adrenaline. The compound was patented in 1900 and trademarked as "Adrenalin." Because of

805-521: The first time that drug companies could be held liable under the False Claims Act for off-label promotion of pharmaceutical products. On May 13, 2004, the Department of Justice announced that it had reached an agreement with Warner-Lambert and Pfizer. Warner-Lambert agreed to pay $ 430 million to resolve criminal and civil liability related to the off-label promotion of Neurontin , and also agreed to plead guilty to two felony counts of misbranding drugs under

840-479: The illicit marketing scheme. Pfizer agreed to institute a corporate compliance program as part of the settlement. Also as part of the settlement the Consumer & Prescriber Grant Program was established to fund public programs to raise awareness of problems with pharmaceutical advertising. Since the settlement in 2004, whistleblowers and the federal government have prosecuted numerous off-label promotion cases under

875-408: The lawsuit. Judge Saris found that, if it could be proven that the off-label marketing of Neurontin caused doctors to prescribe the drug and submit prescriptions to Medicaid, then the company would indeed be liable under the False Claims Act. In addition, Judge Saris found that the submission of false Medicaid claims was a foreseeable result of Warner-Lambert's marketing scheme. The case established for

910-615: The promotion of off-label uses of its anticonvulsant medication Neurontin . The drug had only been approved for use in patients with epilepsy , but in 2001 over 80% of its $ 1.8 billion in sales were for indications unapproved by the United States Food and Drug Administration . In 2004, Pfizer "admitted that Parke-Davis aggressively marketed Neurontin by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal ", and consented to $ 430 million in penalties although it claimed

945-411: The similarity of this name to "Adrenaline," the use of the alternative name "epinephrine" for generics was mandated in the United States and is used to this day. Parke-Davis filed a lawsuit against H. K. Mulford Company alleging infringement of its Adrenalin patents. The ruling in favor of Parke-Davis by Judge Learned Hand is considered crucial to modern patent law. Like Bayer with heroin ; before

980-539: The violations originated in 1996, well before Pfizer's acquisition of Warner–Lambert. As announced on January 22, 2007, Pfizer closed its research facilities in Ann Arbor, Michigan. One of Parke-Davis' early products was an amylase isolated from Aspergillus oryzae by Dr. Jōkichi Takamine . The enzyme was originally intended for use in distilleries but was more successfully marketed as "Taka-diastase" for dyspepsia . Also, Parke-Davis distributed Coley's toxins ,

1015-444: Was a blockbuster product before the discovery of its association with aplastic anemia . Other products popularized by the company included anti-infectives and brands of combined oral contraceptive pills . Franklin v. Parke-Davis Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis , a division of Warner-Lambert Company, and eventually against Pfizer (which bought Warner-Lambert in 2000) under

1050-469: Was also among the five firms contracted to manufacture the original Salk killed-virus vaccine . A combination of the DPT and polio vaccines, called Quadrigen, was developed in 1954 and approved in 1959. Quadrigen was later removed from the market in 1968 after a series of lawsuits pertaining to adverse effects in vaccinated children. Parke-Davis also produced the broad-spectrum antibiotic chloramphenicol , which

1085-466: 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

Drug Industry Documents Archive - Misplaced Pages Continue

1120-558: Was founded in Detroit , Michigan by Dr. Samuel P. Duffield, a physician and pharmacist. In 1860, Dr. Duffield owned a small drugstore at the corner of Gratiot and Woodward Avenues. Dr. Duffield made a variety of pharmaceutical preparations, including Hoffman’s anodyne and mercurial ointment, but was overwhelmed by the operations of the business. Dr. Duffield and Hervey Coke Parke formed a partnership in October 1866, with George S. Davis becoming

1155-409: Was the original manufacturer and patent holder of phencyclidine (PCP) which is currently listed as a Schedule II drug in the United States. It also developed Ketalar ( ketamine hydrochloride), a general anesthetic and dissociative drug, in 1962. Parke-Davis marketed the first widely available epilepsy treatment, Dilantin , which was approved in 1939, although it discovered neither the compound nor

1190-482: Was then Avon Township, Michigan (site now in Rochester, Michigan ) was also a landmark in that vicinity and is now used by PAR Pharmaceuticals. In the 1950s, Parke-Davis employed Jonas Salk as a consultant on vaccine adjuvants. Parke-Davis was also involved in manufacturing the polio vaccine. It took Salk much effort to convince Parke-Davis to follow his production protocols exactly. For about six months Parke-Davis had

1225-449: Was too remote. Furthermore, Warner-Lambert argued that Franklin could only prove the pharmaceutical company's liability by showing that Parke-Davis sales liaisons made fraudulent misrepresentations about the drug, as opposed to merely engaging in truthful off-label promotion. In an opinion handed down on August 22, 2003, District Judge Patti B. Saris agreed with David Franklin, denying Warner Lambert's summary judgment motion to dismiss

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