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Exaggerated or all-embracing. No special merit was implied. As this was a comparative advertisement mentioning type 2 diabetes and insulin, the group of patients in question should be clear to the health professional. COMMENTS FROM SANOFI-AVENTIS Sanofi-Aventis referred to a recent newsletter from the Medicines and Healthcare products Regulatory Agency MHRA ; No.148 March April 2005 ; , which it considered succinctly summed up its position: `Where secondary endpoint data are being used to promote a product, primary endpoint data and the limitations [emphasis added] of the data must be included too.' `Presenting selected data may exaggerate the benefits of the product and be considered to be in breach of the legislation. We have taken action to correct misleading advertising on the basis of weak comparisons and to ensure that advertising contains information that is sufficiently complete to allow the data to be set in context so that the significance of the findings can be evaluated.' `Care should be taken to present all relevant data to ensure that fair and balanced comparisons can be made, so that any conclusions derived from the advertisement lead to rational prescribing of a product.' Sanofi-Aventis noted that the INITIATE study had been subject to much discussion in the UK and the US. Indeed, in the same edition of the journal, an editorial Davidson 2005 ; compared this to another study Janka et al 2005 ; . This month, two letters to the editor Mikhail et al 2005 and Janka 2005 ; had commented on the comparison of these studies. For each of Clause 7.3 and 7.10, Sanofi-Aventis requested that the Appeal Board considered two points: the limitations of the INITIATE study with respect to methodology target population, concomitant medication and dose schedule ; and its impact on results and the emerging clinical and scientific opinion in the context of other available data. Sanofi-Aventis noted that the target population of the INITIATE study was insulin nave patients with type 2 diabetes. As type 2 diabetes was a progressive chronic illness, this group of patients had very different insulin requirements in those type 2 diabetics who had been on insulin for many years. Sanofi-Aventis alleged that concomitant medication was not addressed in the advertisement at issue and it remained unclear that this subgroup were not taking TZDs. The most important limitations and sources of bias in the study were: the design and implementation of dose titrations and schedules and the population to which the improvement occurred. The importance of fasting blood glucose FBG ; targets related to optimising basal insulin dose ie the highest dose without hypoglycaemia. The definition of `without hypoglycaemia' varied according to individual protocols, but was generally accepted as documented significant hypoglycaemia blood glucose 72mg dL, for example, aldara flat warts.
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The aim of the consensus guidelines is to optimize the use of TDM of psychotropic drugs, including mainly antidepressants, antipsychotics, and opioid substituents, and to recommend when TDM and genotyping phenotyping procedures may help to improve pharmacotherapy. Therefore, the indications for TDM, taking into account the different classes of drugs, had to be defined, the most relevant reports of the literature had to be selected, especially also with regard to reference values of plasma concentrations therapeutic windows ; and steady-state drug concentrations at clinically relevant doses. There was also a general need for recommendations regarding the practice of TDM in the clinical context and in the laboratory and alendronate.
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The important thing to remember in this category is that by the time pharmaceuticals appear on the market, they reflect naming trends that might have been popular three to five years earlier. The Latinate "A" ending continues to be very consumer-friendly and popular, as reflected in the top 3 names in this category Aldara, Inspra, and Lunesta. For the sleep aid Lunesta a soothing, calming name that suggests the moon makes a great deal of sense. But for Aldara, and Inspra, which are prescribed for more serious indications genital warts and heart failure respectively ; , the drug companies could have chosen a name that sounds more efficacious or hard-hitting. The popularity of names like Aldara, Inspra, and Lunesta reflects the rise in direct-toconsumer advertising. These names are non-threatening, which makes it easier to talk to consumers about serious conditions. It also makes it easier for consumers to go to their physicians and request a prescription. And if your bottle of Aodara accidentally falls out of your purse, the name sounds so innocuous and friendly that it's not going to cause any embarrassment. Factive, on the other hand, is a very strong name. Factive is an antibiotic, most commonly prescribed for pneumonia or bronchitis, so it's important to telegraph effectiveness with the name. Factive does just that, but is still friendly enough that it doesn't sound like a drug that wreaks havoc on your system. We were surprised to see Abilify score so low, as this goes against the trend that real words or names that are close to real words ; are preferred by consumers. Perhaps the association with "ability" is a little too obvious and people expect their pharmaceutical names to be more coined and scientific-looking.
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