Marketing to patients

More recently, a group in England led by a structural biologist compiled a list of marketed medicines that came from SBDD [133]. These are labeled SBDD in Table 1.2. It can be seen that there is only a little overlap between the two compilations (CADD and SBDD). It can also be seen that the number of pharmaceuticals from SBDD is very impressive. Computer-based technologies are clearly making a difference in helping bring new medicines to patients. 

It is evident that numerous conditions exist that separate the elderly from young adults. Moreover, some of these conditions have a substantial impact on the use of drug-delivery systems by elderly patients. With the ever-increasing proportion of elderly patients in our population, it is surprising that relatively few special products are marketed to accommodate the needs of these patients in terms of drug-delivery design. 

Pre-approval safety and efficacy clinical studies involved product administration to 2500 adults with either type-1 or -2 diabetes. The primary efficacy parameter measured was glycaemic control (as measured by the reduction from baseline in haemoglobin Ale). Hypoglycaemia was the most commonly reported adverse effect. Trials also showed a greater decline in pulmonary function in the Exubera group, and product should not be administered to patients with underlying lung disease, or to smokers. Exubera was developed by Nektar Inc. and is marketed under licence by Pfizer. 

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

This debate is particularly pertinent as some of these first generation biopharmaceuticals produced by rDNA technology are coming off-patent, as shown in Table 10.3, and the generics industry aims to tap into this market, while at the same time regulatory authorities are under pressure to work toward making drugs more affordable to patients. 

The common objective of all pharmaceutical companies is to discover, develop and market safe and effective medicines that will bring benefits to patients and consumers and result in profitable returns to the company. In this process it is important that, at all stages in the life cycle of a pharmaceutical product, the needs and interests... 

The LA had 35 days to respond to the notification to proceed with a clinical trial but could in exceptional circumstances require a further 28 days to consider the notification, if the CTX was refused, the applicant could apply for a CTC, in which case complete data had to be filed, if the CTC application was refused the statutory appeal procedures came into play if the applicant company wished to avail itself of this provision. These appeal procedures were identical with those applying to marketing applications. The CTX scheme proved highly successful in encouraging inward investment into research in the United Kingdom, in a sample of 42 companies, an increase in research investment of 10% or more was attributed to the scheme by 23 of them. its implementation was criticised by consumer groups and its effect was carefully monitored every 6 months to ensure that no added risk to patients had been introduced. 

There is ample support for the notion that innovation rates are greater when market forces are allowed to operate. However, a prerequisite for a competitive market to function is adequate consumer knowledge. In this market for pharmaceutical products, physicians function as agents for their patients (Sloan and Hsieh, Chapter 1). But even physicians may have dif-hculty in gauging the value of specific drugs in absolute terms and relative to their cost. The rapid pace of technological change in this sector has led... 

Conventional evaluation of new medical technologies such as pharmaceutical products includes consideration of efficacy, effectiveness, and safety. The methodology for such analyses is well developed, and studies of safety and efficacy often are required prior to drug marketing. Health care researchers from a variety of disciplines have developed new techniques for the evaluation of the economic effects of clinical care and new medical technologies. Clinicians, pharmacists, economists, epidemiologists, operations researchers, and others have contributed to the field of clinical economics , an evolving discipline dedicated to the study of how different approaches to patient care and treatment influence the resources consumed in clinical medicine. 

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