OR WAIT 15 SECS
Kevin Gopal is Pharmaceutical Executive's international correspondent, covering pharma and regulatory issues around the word. He is also a political columnist for North West Business Insider, one of the UK's leading regional business magazines. He started his career as a journalist at SiYu, the UK's Chinese community magazine, before joining the PE staff.
GSK in Hot Water
Geneva-The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) has upheld a complaint against GlaxoSmithKline that one of its executives made inappropriate claims about Paxil (paroxetine). Charles Medawar of Social Audit-an activist charity that examines inappropriate use of medicines-filed the allegation in August 2000.
Medawar claims that a GSK executive's comments in the program, "A Painful Withdrawal," screened in the United States, contravenes sections of the IFPMA code of pharmaceutical marketing practices. The executive said, "What we have seen in terms of the anecdotal reports [of withdrawal from Paxil] is that it happens very rarely." A voiceover added that withdrawal or discontinuation syndrome "occurs in only two out of every 1,000 patients who are discontinued appropriately. Even then, the symptoms are mild and short-lived."
Medawar says scientific evidence does not support those claims, which were repeated in promotional material. So far, the company has made no response to his requests for information about the statements.
Because GSK is headquartered in the United Kingdom, the complaint was referred to the Prescription Medicines Code of Practice Authority (PMCPA), which initially found in favor of the company. But on appeal, IFPMA overturned the decision and ruled that GSK had contravened sections 1.3 and 1.7 of the code, covering scientific evidence and communication to the public, respectively.
The appeal board says, although GSK did not positively promote Paxil in the program, the employee's defense of the product was itself a form of promotion and therefore section 1.3 of the code applied. Notes to section 1.3 state: "Companies should deal objectively with requests for information made in good faith and should provide data appropriate to the source of the enquiry."
It further noted the difference between the executive's claims that withdrawal symptoms happened "very rarely" and US product information describing them as "rare." Thus the board concluded that there had been a further breach of section 1.3, as well as a breach of section 1.7, because the claims were made directly to the public. A public reprimand is the only consequence.
Last December, the company changed the medicine's US labeling when it was approved for post-traumatic stress disorder. The new labeling states that there have been reports of adverse events, "which may have no causal relationship to the drug," including dizziness, agitation, and anxiety. The company now recommends tapering off the dose of the medicine rather than abrupt withdrawal.
Meanwhile, a powerful UK parliamentary committee is considering summoning the company to explain comments attributed to its R&D head, Tachi Yamada, who reportedly said GSK might sell parts of its research operation to boost productivity. At the time of the merger between Glaxo Wellcome and SmithKlineBeecham, Sir Richard Sykes, then GW executive chairman, claimed that scale was a critical factor in the merger.
Dr. Ian Gibson, Labour chairman of the Commons Science and Technology Select Committee, says the company misled Parliament members about the merger's rationale and announced that he would summon senior executives before the committee. He says Yamada's comments open up questions about what the merger promised and what it really delivered and adds, "I always smelt a rat about what they were really up to."