Guest guest Posted December 9, 2003 Report Share Posted December 9, 2003 The Public Citizen exposé: http://www.citizen.org/ELETTER/ARTICLES/neurontin.htm The SF Chronicle exposé + CLASS ACTION SUIT DOCTORS DON'T WANT YOU TO KNOW ABOUT: Bernadette Tansey, Chronicle Staff Writer Sunday, November 23, 2003 ©2003 San Francisco Chronicle | Feedback URL: sfgate.com/article.cgi?file==/c/a/2003/11/23/BUG5D37C851.DTL An uprising is under way in California among patients and consumer groups who think drug firms have been pushing their products too hard while government regulators are taking the consequences too lightly. Convinced that the Food and Drug Administration won't curb aggressive marketing that can hurt patients and hike medical costs, the insurgent citizen movement is using a controversial state consumer law to challenge manufacturers. In civil suits against a range of drug and biotech companies including Botox maker Allergan Inc. and drug giant Pfizer, private citizens are turning to California's courtrooms to change the ground rules for the industry. The emerging consumer strategy, which bypasses FDA prerogatives, alarms drug and biotechnology firms. In the most organized and far-reaching effort, a Boston consumer coalition that blames drug firms for soaring health care costs is bringing its fight to California. The nationwide group, Prescription Access Litigation, is challenging company practices ranging from drug advertising to doctors' freebies. PAL, an initiative of the watchdog group Community Catalyst, says the FDA lacks the resources to rein in aggressive marketing that can inflate the nation's prescription drug bill. " To the extent they do any enforcement, companies take it as a cost of doing business,'' said Renee Hodin, PAL's associate director. The coalition is seeking heavy financial judgments from firms accused of exaggerating drug benefits, touting products for unproven uses or paying doctors to drum up expensive prescriptions. The companies deny wrongdoing, while industry officials warn that the lawsuits raise a nightmare scenario of state court judges in 58 counties setting their own rules for practices usually overseen by the FDA. Pfizer the major target Citizen actions under the state consumer law have hit a number of firms in and out of California. But the biggest target is New York's Pfizer Inc., the world's largest drug company. Pfizer is the defendant in two actions sponsored by PAL, which has member groups in 34 states, including California. In the suits against Pfizer, PAL is seeking sweeping refunds to California purchasers of two prescription drugs with combined sales close to $2 billion. The consumer groups claim Pfizer subsidiaries improperly promoted the drugs, Neurontin and Bextra, for uses not approved by the FDA. Pfizer maintains the actions by PAL are pre-empted by federal drug laws. " The relief it seeks would frustrate Congress' intent to have the FDA determine the 'truth' about the safety and efficacy of drugs,'' Pfizer attorneys argued in a brief in the Bextra suit. Far from being a tiny David confronting a drug industry Goliath, PAL has teamed up with an ally closer to Pfizer's size in the world of litigation -- the Seattle law firm Hagens Berman, a class-action practice that represented 13 states in landmark litigation against the tobacco industry. Managing partner Steve Berman said the firm chose to file the Pfizer suits in California for two reasons. " It has, next to New York, the largest market share (in prescription drug sales) of any one state,'' Berman said. " We feel a victory in California would have a very big impact on company practices.'' Reason No. 2: California has one of the toughest consumer laws in the nation. The Unfair Competition Law is a tool used by state prosecutors to combat anti-competitive or corrupt business dealings. It also allows private citizens or groups to file suit in the name of the public. When these suits succeed, judges can order a halt to unfair business practices. They can also order firms to forfeit some of the money they made while those practices occurred -- penalties that can be far higher than fines imposed by regulatory agencies. Trial attorneys, consumer groups and many prosecutors see the law as a bulwark against violations too numerous to be pursued by the state attorney general or county district attorneys. Industry groups say attorneys abuse the law by filing frivolous suits to reap quick settlements, not to protect consumers. Industry attorneys worry The law can put firms in great jeopardy, forcing many to settle rather than take a risk on a judge's ruling, industry lawyers say. " The standards are so broad, and not necessarily completely defined, that there is a tremendous risk of liability,'' said Vanessa Wells, an attorney with Heller Ehrman White & McAuliffe. If judges uphold suits like PAL's, California courts could become a separate arena, independent of the FDA, that could strongly influence drug industry practices nationwide. PAL's suits against Pfizer revolve around an issue that has long been a point of conflict between the drug industry and the FDA itself: off-label promotion. Once the FDA approves a drug for sale as a safe and effective remedy for one disease, doctors are free to prescribe it for other conditions not listed on the FDA label if they conclude a patient will benefit. But in general, the FDA forbids firms from actively advertising off-label uses. The agency wants companies to prove that drugs work in other diseases by conducting more clinical trials. Off-label drugs have sometimes been linked to patient injuries and deaths. The PAL-sponsored lawsuits claim that Pfizer caused a different kind of harm through off-label promotion: inflating health care costs. Costly off-label uses Repeating the allegations of a whistle-blower, PAL claims Pfizer and its Parke-Davis unit deliberately bypassed FDA rules and touted their epilepsy drug Neurontin for an array of other off-label conditions such as migraine headaches, attention deficit disorder and bipolar disorder. The suit alleges that Neurontin grew into a $1.3 billion blockbuster, with up to 90 percent of that coming from off-label sales, according to some estimates. The whistle-blower, former Parke-Davis employee David Franklin, claims the company boosted such sales by giving doctors thousands of dollars to promote off-label uses at medical meetings, by paying other doctors to attend such meetings in luxurious settings and by sponsoring flawed research studies. Pfizer spokeswoman Mariann Caprino said many of the allegations concerning Neurontin cover a period before Pfizer acquired Parke-Davis. " It's a long-standing and very well-known Pfizer policy that we have not and do not promote our medicines for uses for which they have not been FDA-approved,'' Caprino said. The FDA has warned that some Neurontin marketing materials violated agency rules. But FDA spokesman Brad Stone said he could not comment on whether the FDA asked prosecutors to take further enforcement actions. Government prosecutors are looking into Franklin's charges and might seek payback for the millions of dollars that public insurance plans like Medicaid have spent on Neurontin. But it's the potentially larger outlays by private patients that PAL is going after in California. A second PAL-backed suit accuses Pfizer and its subsidiary, Pharmacia, of promoting the arthritis drug Bextra for an off-label use, a charge Pfizer denies. Pfizer seeks dismissal Pfizer insists that both suits should be thrown out of court because they trespass on the FDA's jurisdiction over drug promotion. Some California judges have agreed that federal law pre-empts such state court actions, but other judges have not. The FDA generally does not weigh in on such disputes, and the question remains open, legal experts say. Consumer advocates say the FDA is now slower to sanction aggressive drug promotion. Critics also point to a new rule that forbids FDA staff from warning companies of alleged marketing violations without the approval of FDA Chief Counsel Daniel Troy, formerly a prominent drug industry lawyer. Nancy Ostrove, an FDA risk communication manager, said the agency's enforcement program has not been deterred by a lack of resources. She said the review by Troy's office lends force to the FDA's warnings because violators know FDA lawyers have already agreed that serious penalties could follow if the violations persist. " We're trying to get the industry to understand we're serious about the actions we undertake,'' Ostrove said. To seek court penalties under California's Unfair Competition Law, consumer advocates need not prove that any patient was harmed by a drug, only that its promotion amounted to an unfair business practice. Hagens Berman attorney Tom Sobol said aggressive marketing of unproven drugs hurts everyone. " There ends up being a widespread harm of increased (drug) utilization and increased cost that ends up being borne by everybody,'' Sobol said. As Hagens Berman handles pre-trial skirmishes in the Pfizer suits, the firm has already settled one suit against a Florida drug firm for $12 million and has filed another state consumer action against a Georgia company. Berman, the firm's managing partner, said he is considering three or four more suits against drug firms under the California law. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 10, 2003 Report Share Posted December 10, 2003 Thank you. This is not the article I am trying to find. The article was about how the tested this drug. The drug trials were faked by the company. I am not good and finding things with search engines or on my puter. lol Does anyone remember the article about the faking of the trials on this drug? om , donna <donnajor@e...> wrote: > The Public Citizen exposé: > http://www.citizen.org/ELETTER/ARTICLES/neurontin.htm > > The SF Chronicle exposé + CLASS ACTION SUIT DOCTORS DON'T WANT YOU TO KNOW > ABOUT: > > Bernadette Tansey, Chronicle Staff Writer > Sunday, November 23, 2003 > ©2003 San Francisco Chronicle | Feedback > > > URL: sfgate.com/article.cgi?file==/c/a/2003/11/23/BUG5D37C851.DTL > > > An uprising is under way in California among patients and consumer groups > who think drug firms have been pushing their products too hard while > government regulators are taking the consequences too lightly. > > Convinced that the Food and Drug Administration won't curb aggressive > marketing that can hurt patients and hike medical costs, the insurgent > citizen movement is using a controversial state consumer law to challenge > manufacturers. In civil suits against a range of drug and biotech companies > including Botox maker Allergan Inc. and drug giant Pfizer, private citizens > are turning to California's courtrooms to change the ground rules for the > industry. > > The emerging consumer strategy, which bypasses FDA prerogatives, alarms > drug and biotechnology firms. In the most organized and far- reaching effort, > a Boston consumer coalition that blames drug firms for soaring health care > costs is bringing its fight to California. The nationwide group, > Prescription Access Litigation, is challenging company practices ranging > from drug advertising to doctors' freebies. > > PAL, an initiative of the watchdog group Community Catalyst, says the FDA > lacks the resources to rein in aggressive marketing that can inflate the > nation's prescription drug bill. > > " To the extent they do any enforcement, companies take it as a cost of > doing business,'' said Renee Hodin, PAL's associate director. > > The coalition is seeking heavy financial judgments from firms accused of > exaggerating drug benefits, touting products for unproven uses or paying > doctors to drum up expensive prescriptions. > > The companies deny wrongdoing, while industry officials warn that the > lawsuits raise a nightmare scenario of state court judges in 58 counties > setting their own rules for practices usually overseen by the FDA. > > Pfizer the major target > > Citizen actions under the state consumer law have hit a number of firms > in and out of California. But the biggest target is New York's Pfizer Inc., > the world's largest drug company. Pfizer is the defendant in two actions > sponsored by PAL, which has member groups in 34 states, including > California. > > In the suits against Pfizer, PAL is seeking sweeping refunds to > California purchasers of two prescription drugs with combined sales close to > $2 billion. The consumer groups claim Pfizer subsidiaries improperly > promoted the drugs, Neurontin and Bextra, for uses not approved by the FDA. > > Pfizer maintains the actions by PAL are pre-empted by federal drug laws. > " The relief it seeks would frustrate Congress' intent to have the FDA > determine the 'truth' about the safety and efficacy of drugs,'' Pfizer > attorneys argued in a brief in the Bextra suit. > > Far from being a tiny David confronting a drug industry Goliath, PAL has > teamed up with an ally closer to Pfizer's size in the world of litigation -- > the Seattle law firm Hagens Berman, a class-action practice that represented > 13 states in landmark litigation against the tobacco industry. > > Managing partner Steve Berman said the firm chose to file the Pfizer > suits in California for two reasons. > > " It has, next to New York, the largest market share (in prescription drug > sales) of any one state,'' Berman said. " We feel a victory in California > would have a very big impact on company practices.'' > > Reason No. 2: California has one of the toughest consumer laws in the > nation. > > The Unfair Competition Law is a tool used by state prosecutors to combat > anti-competitive or corrupt business dealings. It also allows private > citizens or groups to file suit in the name of the public. When these suits > succeed, judges can order a halt to unfair business practices. They can also > order firms to forfeit some of the money they made while those practices > occurred -- > > penalties that can be far higher than fines imposed by regulatory > agencies. > > Trial attorneys, consumer groups and many prosecutors see the law as a > bulwark against violations too numerous to be pursued by the state attorney > general or county district attorneys. Industry groups say attorneys abuse > the law by filing frivolous suits to reap quick settlements, not to protect > consumers. > > Industry attorneys worry > > The law can put firms in great jeopardy, forcing many to settle rather > than take a risk on a judge's ruling, industry lawyers say. > > " The standards are so broad, and not necessarily completely defined, that > there is a tremendous risk of liability,'' said Vanessa Wells, an attorney > with Heller Ehrman White & McAuliffe. > > If judges uphold suits like PAL's, California courts could become a > separate arena, independent of the FDA, that could strongly influence drug > industry practices nationwide. > > PAL's suits against Pfizer revolve around an issue that has long been a > point of conflict between the drug industry and the FDA itself: off- label > promotion. Once the FDA approves a drug for sale as a safe and effective > remedy for one disease, doctors are free to prescribe it for other > conditions not listed on the FDA label if they conclude a patient will > benefit. > > But in general, the FDA forbids firms from actively advertising off-label > uses. The agency wants companies to prove that drugs work in other diseases > by conducting more clinical trials. Off-label drugs have sometimes been > linked to patient injuries and deaths. > > The PAL-sponsored lawsuits claim that Pfizer caused a different kind of > harm through off-label promotion: inflating health care costs. > > Costly off-label uses > > Repeating the allegations of a whistle-blower, PAL claims Pfizer and its > Parke-Davis unit deliberately bypassed FDA rules and touted their epilepsy > drug Neurontin for an array of other off-label conditions such as migraine > headaches, attention deficit disorder and bipolar disorder. > > The suit alleges that Neurontin grew into a $1.3 billion blockbuster, > with up to 90 percent of that coming from off-label sales, according to some > estimates. > > The whistle-blower, former Parke-Davis employee David Franklin, claims > the company boosted such sales by giving doctors thousands of dollars to > promote off-label uses at medical meetings, by paying other doctors to > attend such meetings in luxurious settings and by sponsoring flawed research > studies. > > Pfizer spokeswoman Mariann Caprino said many of the allegations > concerning Neurontin cover a period before Pfizer acquired Parke- Davis. > " It's a long-standing and very well-known Pfizer policy that we have not and > do not promote our medicines for uses for which they have not been > FDA-approved,'' Caprino said. > > The FDA has warned that some Neurontin marketing materials violated > agency rules. But FDA spokesman Brad Stone said he could not comment on > whether the FDA asked prosecutors to take further enforcement actions. > > Government prosecutors are looking into Franklin's charges and might seek > payback for the millions of dollars that public insurance plans like > Medicaid have spent on Neurontin. But it's the potentially larger outlays by > private patients that PAL is going after in California. > > A second PAL-backed suit accuses Pfizer and its subsidiary, Pharmacia, of > promoting the arthritis drug Bextra for an off-label use, a charge Pfizer > denies. > > Pfizer seeks dismissal > > Pfizer insists that both suits should be thrown out of court because they > trespass on the FDA's jurisdiction over drug promotion. Some California > judges have agreed that federal law pre-empts such state court actions, but > other judges have not. The FDA generally does not weigh in on such disputes, > and the question remains open, legal experts say. > > Consumer advocates say the FDA is now slower to sanction aggressive drug > promotion. Critics also point to a new rule that forbids FDA staff from > warning companies of alleged marketing violations without the approval of > FDA Chief Counsel Daniel Troy, formerly a prominent drug industry lawyer. > > Nancy Ostrove, an FDA risk communication manager, said the agency's > enforcement program has not been deterred by a lack of resources. She said > the review by Troy's office lends force to the FDA's warnings because > violators know FDA lawyers have already agreed that serious penalties could > follow if the violations persist. > > " We're trying to get the industry to understand we're serious about the > actions we undertake,'' Ostrove said. > > To seek court penalties under California's Unfair Competition Law, > consumer advocates need not prove that any patient was harmed by a drug, > only that its promotion amounted to an unfair business practice. > > Hagens Berman attorney Tom Sobol said aggressive marketing of unproven > drugs hurts everyone. > > " There ends up being a widespread harm of increased (drug) utilization > and increased cost that ends up being borne by everybody,'' Sobol said. > > As Hagens Berman handles pre-trial skirmishes in the Pfizer suits, the > firm has already settled one suit against a Florida drug firm for $12 > million and has filed another state consumer action against a Georgia > company. > > Berman, the firm's managing partner, said he is considering three or four > more suits against drug firms under the California law. 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