Μετὰ τὸ φετεινὸ τεράστιο σκάνδαλο κατὰ τῆς ἀντικαπνιστικῆς μαφίας, μὲ τὴν καταδίκη τριῶν …«εἰδικῶν-ἀντικαπνιστῶν ἀκτιβιστῶν»σὲ ὐψηλὲς θέσεις στὶς ΗΠΑ, ποὺ πιάστηκαν νὰ εἶναι στὸ μισθολόγιο τῶν μεγαλοφαρμακευτικῶν Pfizer καὶ Glaxo, καὶ μετὰ τὴν ἀφαίρεση τῶν τριῶν σημαντικοτέρων ἐκθέσεων ἀπὸ τὸ Surgeon General, στὶς ὁποῖες ἐβασίσθη ἡ καπνοαπαγόρευση καὶ ποὺ οἱ τρεῖς διεφθαρμένοι ἁπατεῶνες εἶχαν κατασκευάσει, κατ’ ἐντολὴν τῶν μεγαλοφαρμαεκευτικῶν, ἄλλο ἕνα κτύπημα ἦρθε γιὰ τὴν Pfizer:
τὸ δηλητήριο ποὺ εἶχε μαρκετάρει σᾶν δῆθεν «χάπι γιὰ κόψιμο τοῦ καπνίσματος» (καὶ ποὺ εἶχε λαδώσει γιὰ νὰ παρέχεται δωρεὰν ἀπὸ ὁρισμένα συστήματα δημόσιας ὑγείας σὲ ἀνυποψίαστους ἀνθρώπους) ἀπεδείχθη ἄκρως βλαβερό, προεκάλεσε σοβαρότατες νευροψυχολογικὲς διαταραχὲς καὶ αὐτοκτονίες (=δολοφονίες) καὶ μετὰ ἀπὸ 2.900 ἀγωγὲς ἐναντίον του ἡ Pfixer πλήρωσε κάπου 300 ἐκατομμύρια δολλάρια στοὺς πληγέντες.
Αὐτὰ γιὰ τὴν ἀντικαπνιστικὴ ἀπάτη. Ἕνα διαρκὲς ἔγκλημα.
Alabama federal judge: Time to end nationwide litigation against Pfizer anti-smoking drug Chantix
FLORENCE, Alabama – All of the nearly 2,900 lawsuits claiming pharmaceutical giant Pfizer Inc.’s smoking cessation drug Chantix triggered suicidal thoughts and other psychological problems in patients have been settled – for about $300 million – so the nationwide litigation should now be dismissed, a federal judge in Alabama ruled Monday.
Despite the end to those lawsuits, Pfizer next week will continue its fight with the U.S. Food and Drug Administration for a less severe warning label for Chantix.
U.S. District Court Judge Inge Johnson on Monday held the final status conference in the litigation at the federal courthouse in Florence. Johnson had been appointed by United States Judicial Panel on Multidistrict Litigation in late 2009 to preside over all the Chantix cases being filed in the United States.
Johnson, in her order issued today, stated that she has now dismissed all the claims that were settled and she recommends the MDL panel terminate the litigation. If any future lawsuits are filed, Johnson writes, she would “welcome the transfer of any such action to this court for further proceedings, given the court’s experience with these claims.”
The judge noted the size of the 5-year litigation in her order. She wrote that with the assistance of counsel for both sides, “the court oversaw extensive discovery, including the production of over 22 million pages of documents, dozens of depositions, and voluminous written discovery.”
Johnson also stated she coordinated the litigation with related cases in New York state court “to reduce costs and duplication of discovery and to promote the consistent determination of similar issues among these proceedings. “
“The court adjudicated a number of dispositive motions, including Daubert motions with respect to whether the use of Chantix can cause serious neuropsychiatric events and whether the current Chantix label is adequate as a matter of law,” the judge ruled.
Several bellwether – or test – cases were selected for trials before Johnson. But none of the trials happened before Pfizer reached a settlement that ultimately covered all the cases.
According to a Pfizer financial report, as of April 2013 the company had settled, or entered into definitive agreements or agreements-in- principle to settle, virtually all of the known Chantix claims in the U.S., including actions pending in the MDL and in state courts. The settlements at that time included charges to the company’s ledger sheet of $288 million in 2012 and another $11 million in the first quarter of 2013.
Kristian Rasmussen, a partner with the Birmingham law firm of Cory, Watson, Crowder, & DeGaris and a lead attorney on the Plaintiffs Steering Committee for the litigation, said Judge Johnson deserves most of the credit. “It is remarkable for a judge presiding over a case of this magnitude to have managed it to a satisfactory conclusion for both sides in such a short amount of time,” he said.
The first hearing was in January 2010 and Monday was the final hearing. Rasmussen said that, “unfortunately many multidistrict litigations drag on much longer than this.”
While the lawsuits are now in the rear view mirror for Pfizer, the company is fighting to get the U.S. Food and Drug Administration to ease up on the “black box” warning on Chantix – a label added in 2009 to warn of potential serious side effects.
The Wall Street Journal recently reported that the FDA in September updated the warnings and precautions section on Chantix to include information about some new studies that show the drug’s psychological effects, including suicide, isn’t as bad as once thought.
Next week – Oct. 16 – Pfizer officials go before a joint meeting of the FDA’s Psychopharmacologic Drugs Advisory committee and its Drug Safety and Risk Management Advisory committee to present its studies in the hopes of getting the black box warning removed altogether.
Lack of label warnings on Chantix was a key issue in the lawsuits. The black box warning was added in 2009.
“I cannot comment on any of Pfizer’s actions regarding Chantix,” Rasmussen said. “I do believe that it would be a mistake if the FDA takes action that minimizes the current warning in the drug label. However, I would defer to the experts and evidence.”
According to a statement issued by Pfizer on Monday afternoon, the new scientific evidence being presented next week “includes our analyses of the placebo controlled Chantix clinical trials conducted by Pfizer, and published or publicly available independently conducted large observational studies comparing Chantix to other smoking cessation medications.”
“The recent label update and the upcoming Advisory Committee meeting both serve as a step forward in the process of accurately communicating the clinical and observational data in the label in relation to the post-marketing reports of serious (neuropsychiatric) events that are reflected in the Boxed Warning, which was added to the Chantix label in 2009,” according to the company.
Pfizer states that each year in the U.S., 480,000 people die from smoking and that the health benefits of smoking cessation are “substantial and immediate.”
“Chantix is a highly effective aid to smoking cessation treatment that has been shown to help adults quit smoking and increase their chances of staying abstinent for as long as one year compared to placebo,” according to the Pfizer statement.
More than 10 million smokers in the U.S. have been prescribed Chantix, according to the Pfizer statement.
Updated at 5:50 p.m. Oct. 6, 2014 with comments from Pfizer. Updated at 11:30 p.m. to correct that the FDA changed the warnings and precautions section in September and definition of NPS.