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Australian Journal of Pharmacy : April 2005
osteoarthritis ...health professionals—and patients—are being kept in the dark Indeed, in the statement released by the TGA, Professor Martin Tattersall, chair of the Australian Drug Evaluation Commit- tee (ADEC), confirms that the Committee reviewed evidence of six drugs in the COX-2 inhibitor family, but that ‘the exact size of the risk and the exact duration of therapy associated with increased risk are still unknown’. health professionals—and patients—are being kept in the dark. ‘It’s a mess, isn’t it? It’s very difficult for all parties—patients, pharmacists, GPs and specialists,’ he said. ‘These comments are apparently based on some published information and some commercial in confidence information, which we cannot see. I don’t see why we shouldn’t be able to see it. We have no idea what informa- tion was submitted, so on face value it is difficult to know why the TGA has taken this step.’ Professor Bertouch queries why such tough measures have been announced when there is such limited published evi- dence to back it up. ‘There are three long-term studies on celecoxib, but no long-term studies about meloxicam and cardiovascular risk.’ After looking at the results of a recent study published (16 February 2005) in the New England Journal of Medicine (Solomon et al: 2005, page 352), Professor Bertouch agreed with the conclusion that ‘the risk is low versus placebo—2.3 per cent of patients taking of 400mg celecoxib and one per cent of patients taking placebo. That’s a very small percentage difference, and it was a pretty sick group of patients—40 per cent had hypertension and 30 per cent were taking aspirin. These were not patients who had arthri- tis of any kind.’ Two other studies did not show any dif- ference between 400mg of celecoxib and the comparator drug. This uncertainty led the ADEC Com- mittee to recommend that COX-2 inhibitors ‘should be prescribed only when other treatments cannot be tolerated or have caused serious adverse effects’. Dr John McEwen, principal medical adviser of the TGA, states that the review of COX-2 inhibitors ‘clearly indicated’ the increased risk of heart attacks and strokes ‘with high doses of these drugs’. He con- cedes that ‘unfortunately this recom- mended dose reduction may result in some patients with arthritis having increased symptoms’. Professor Bertouch believes the TGA is being ‘extremely conservative’ and should provide more explanation and evidence for their decision to restrict the use of COX-2 inhibitors. ‘It’s certainly true that 800mg a day may have an increased risk of cardiovas- cular side effects, but why the TGA is say- ing the same about 200, 300 or 400mg is unexplained,’ he said. Lack of review transparency Professor Bertouch believes this apparent lack of transparency about the review and the consequent advice, which contradicts other studies, is not acceptable, but health professionals are obliged to acknowledge the TGA’s statements. ‘It’s understandable that doctors and pharmacists could be confused about what to recommend. So how do pharma- cists navigate through it all? ‘If a patient has a history of cardiovas- cular risk factors and they’re being pre- scribed celecoxib or meloxicam, it would be prudent to advise that they go to their GP to talk about it. If they take antihyper- tensives, aspirin, diuretics, if they have diabetes or smoke—it’s hard to know which of these are the most important, but 254 ? THE AUSTRALIAN JOURNAL OF PHARMACY VOL.86 APRIL 2005 all cardiovascular risk factors be consid- ered. For patients who do not have car- diovascular risk factors, it would seem rea- sonable to continue taking up to 400mg of celecoxib and 15mg of meloxicam,’ he said. The supply of both celecoxib and meloxicam is subsidised by the Pharma- ceutical Benefits Scheme (PBS). In terms of cost to the Government, historically these agents in this category have been very expensive, but in the last two or three years, as Professor Bertouch observes, the amount of budget money spent on this class of agent has been falling. Celebrex was very costly initially because it was the first of the coxib class and was in the mar- ket on its own. There had been extensive publicity about the GIT side effects of the traditional NSAIDs and patients and doc- tors wanted a safer alternative. ‘But the message that these products were safer for the gastrointestinal tract seems to have been forgotten. So what do we do about that? Either we go back to a traditional NSAID and add a proton pump inhibitor or we prescribe regular parac- etamol or other analgesics and explore other methods of pain management such as physiotherapy, hydrotherapy, acu- puncture, and glucosamine supplements,’ Professor Bertouch said. ‘This may be helpful for those with osteoarthritis or mild inflammatory con- ditions, but may not work for patients with chronic inflammatory painful dis- eases like rheumatoid arthritis who are likely to have tried all these agents years ago when they first came onto the mar- ket,’ he said. As Professor Bertouch emphasises, the case concerning celecoxib and meloxicam is not isolated and reflects the larger issue of the non-transparency of the nation’s medicines watchdog. ‘This highlights a major problem of our current system. When pharmaceutical companies submit information to the Government, nobody can see it, except the Committee. And if a company has a study with negative findings, they don’t have to publish it. Where does that leave the rest of us?’ ¦