Fwd: Pfizer-Neurontin Trial Testimony--snake oil list

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ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountability http://www.ahrp.org  FYIIn 2004, Pfizer settled an illegal Neurontin marketing case with the U.S.Justice Department for $430 million.  The original whistleblower complaintwas filed by David Franklin, a microbiologist  who had worked forWarner-Lambert (the original manufacturer of Neurontin)  under the FalseClaims Act. The settlement did not address harm to patients prescribedNeurontin.There are currently 1,200 lawsuits awaiting trial that were filed byindividuals who claim to have been harmed by Neurontin, a drug approved asan adjunctive treatment for epilepsy which was widely prescribed forunapproved, off-label uses. The first case to go to trial, Bulger v Pfizer,involves the suicide of Susan Bulger. The case is being tried in FederalDistrict Court in Massachusetts.Bloomberg News reports (below) that David Franklin testified:"I was trained from day one to market the drug illegally...My job was topromote Neurontin and motivate doctors to experiment on patients. Afterbeing hired as a medical liaison, I was selling drugs. The uses promotedwere from the "snake-oil list" of 13 medical conditions."Franklin testified that Warner-Lambert officials used a variety of tacticsto persuade doctors to prescribe Neurontin for unapproved uses. "They provided the company's sales force with a list of ailments that wouldbenefit from Neurontin use, including restless leg syndrome, migraineheadaches and withdrawal symptoms from drug and alcohol abuse." He notedthat the FDA hadn't approved the drug for any of those illnesses at thetime.Mark Lanier, the lawyer representing the Bulger family, told jurors thatWarner-Lambert executives began the off-label marketing campaign totransform Neurontin into a "blockbuster" medicine generating $1 billion inannual sales. The company estimated that selling it solely as an epilepsydrug would generate only about $50 million in sales."The company made a conscious decision to do something illegal -- marketingthis drug off-label." Indeed, illegal, off-label marketing has become "the norm and practice" ofthe pharmaceutical industry: Clinically insignificant, toxic drugs becomeblockbuster sellers. That's because industry spends the most money aggressively marketing theworst drugs--drugs of dubious benefit which pose life-threatening risks.For example,Merck: Fosamax,VioxxPfizer: Neurontin, Bextra, Zoloft, Chantix, GeodonGlaxoSmithKline: Paxil, AvandiaLilly: Oraflex, Prozac, Cymbalta, ZyprexaJanssen (J & J): Prepulsid, RisperdalAstraZeneca: SeroquelWyeth: Prempro, Redux (Fen-Phen)See:http://www.ahrp.org/cms/images/stories/articles/evidencepropagandawcsj2009.pdf Contact: Vera Hassner Sharavveracare212-595-8974http://www.bloomberg.com/apps/news?pid=20601202 & sid=al5DwPlZ_z4I BLOOMBERG NEWSPfizer Unit Marketed Drug Illegally, Ex-Employee Says (Update2) By Jef Feeley and Margaret Cronin FiskJuly 28 (Bloomberg) -- Pfizer Inc.'s Warner-Lambert unit created a list of13 ailments that its epilepsy medicine Neurontin could treat as part of itspromotion of the drug for unapproved uses, a former employee testified. "I was trained from day one" to market the drug illegally, David Franklintestified. Franklin, who worked as a medical liaison at the Parke-Davisdivision of Warner-Lambert, said he encouraged doctors to prescribeNeurontin for uses beyond those approved by the U.S. Food and DrugAdministration. "My job was to promote Neurontin and motivate doctors to experiment" onpatients, he said today in federal court in Boston. After being hired as amedical liaison, "I was selling drugs," he said. The uses promoted were fromthe "snake-oil list" of 13 medical conditions, said Franklin, amicrobiologist. Franklin was the first witness in the trial over claims by the family ofSusan Bulger, 39, who hanged herself after taking the drug. Bulger's familyclaims Pfizer promoted Neurontin for unapproved uses and failed to warn itcould increase the risk of suicide until forced to do so by the government.Bulger started taking the drug in 1999. The trial of the suit, the first of about 1,200 over Neurontin to go totrial, is expected to last three weeks. Pfizer fell 59 cents, or 3.6 percent, to $16.03 at 4:15 p.m. in New YorkStock Exchange composite trading. Pfizer shares have fallen 9.5 percent sofar this year. Whistleblower Suit Franklin filed a federal whistleblower complaint in 1997 alleging thecompany illegally marketed the drug for attention deficit disorder, pain andother unapproved uses. The suit resulted in a $430 million settlement byWarner-Lambert with the U.S. Justice Department in 2004. Franklin, who worked at Warner Lambert for four months in 1995 beforeresigning over the company's off-label marketing practices, received about$25 million as his share under the federal False Claims Act, the governmentsaid at the time. Warner-Lambert officials used a variety of tactics to persuade doctors toprescribe Neurontin for unapproved uses, Franklin told jurors. They provided the company's sales force with a list of ailments that wouldbenefit from Neurontin use, including restless leg syndrome, migraineheadaches and withdrawal symptoms from drug and alcohol abuse, Franklinsaid. The FDA hadn't approved the drug for any of those illnesses at thetime, he added. Suicide Warning The U.S. Food and Drug Administration in December required all makers ofepilepsy drugs, including Neurontin, to add a suicide-risk warning to theirlabels. Neurontin didn't cause Bulger's suicide, and her doctors didn't prescribethe drug because of off-label marketing, Pfizer's lawyer said in hisopening. "There's no reliable evidence that Neurontin causes suicide or makesdepression worse," said lawyer William Ohlemeyer. Pfizer's lawyer also pointed out the off-label marketing practices coveredby the Warner-Lambert settlement with the government occurred before the NewYork-based drugmaker's 1999 purchase of its rival. Mark Lanier, a lawyer representing Bulger's family, told jurors thatWarner-Lambert executives began the off-label marketing campaign totransform Neurontin into a "blockbuster" medicine generating $1 billion inannual sales. The company estimated that selling it solely as an epilepsydrug would generate only about $50 million in sales, he added. 'Conscious Decision' "The company made a conscious decision to do something illegal -- marketingthis drug off-label," Lanier said today in his opening statements. Bulger's family, of Peabody, Massachusetts, sued Pfizer and Warner Lambertin August 2007, more than three years after Bulger's husband and 4-year-olddaughter found her body in their basement. Ronald Bulger said he gave hiswife four Neurontin pills an hour before she killed herself. Ohlemeyer noted in his opening statement that Bulger had made at least sixother suicide attempts during her lifetime and had battled drug addictionand depression. The case is Bulger v. Pfizer Inc., 1:07-CV-11426, U.S. District Court,District of Massachusetts (Boston). The suit is part of In Re NeurontinMarketing, Sales Practices and Products Liability Litigation, MDL 1629. To contact the reporters on this story: Jef Feeley in Wilmington, Delaware,at jfeeley; Margaret Cronin Fisk in Southfield, Michigan, atmcfisk. Last Updated: July 28, 2009 16:36 EDT FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. _____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. 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