Marketing Of New Drugs Research Articles

Beneficios de la investigación médica para la sociedad

Medical research can benefit society in many ways and through a multiplicity of inter-connected pathways. Some of these pathways involve the commercial sector directly, through the invention, trial and marketing of new drugs, vaccines, medical devices and equipment, which can improve patient diagnosis and treatment. These inventions are usually protected by patents. Biomedical patents often cite scientific articles, usually basic research rather than clinical observations. However, disease prevention may provide greater returns, and is typically accomplished through public health measures (e.g., vaccination, health services, provision of clean water) and wiser lifestyle choices by the population (e.g., not smoking, taking more exercise, practising safe sex, and eating a healthy diet). The reduction of environmental pollution has also played a major role in the increase in life expectancy. All these measures are ideally informed by sound research, and are brought about by government policy and influenced by public opinion. The latter is strongly affected by the mass media, which play an increasing role in connecting readers, listeners and viewers with medical research enterprise. Hopes of a cure for a disease are frequently offered, but commentators usually warn that much more research is needed first. New bibliometric techniques allow some of these interconnected pathways to be traced and analyzed, mainly through news stories or other documents citing research articles. For example, clinical guidelines rely on scientific evidence, including clinical trials, and even government policy documents sometimes cite research findings, although not often enough. Thus the socioeconomic effect of biomedical research can be evaluated in new ways that may provide a fairer view of its utility and impact than do conventional methods of citation analysis.

Lifestyle drugs in India: Are we ready for them?

‘Lifestyle has moved from being an indicator of the overall well being of an individual to a cause of disease and now, “lifestyle” has itself become an object of medical attention’. Alcohol has been used enormously as one of the oldest ‘lifestyle’ drugs, and currently sildenafil citrate (Viagra), the drug of choice for erectile dysfunction, exemplifies a turning point in the era of modern lifestyle drugs. The compound has transformed the lifestyle of millions and greatly increased the revenue of many pharmaceutical companies. With the Indian economy growing rapidly at the annual rate of 89%,2 we have witnessed a new era of drug discovery and development coupled with an enormous increase in the marketing of new drugs. This has certainly made us vulnerable to issues related to lifestyle drugs. There is a need to study the concept and impact of these drugs on Indian society, particularly as the topic has already been discussed in other developed nations. ,4, 5, 6

A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development

Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an evidence-based review of acute toxicity studies and assessed the value of the data generated. Preclinical and clinical information was shared on 74 compounds. The analysis indicated acute toxicity data was not used to (i) terminate drugs from development (ii) support dose selection for repeat dose studies in animals or (iii) to set doses in the first clinical trials in humans. The conclusion of the working group is that acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe.

Increasing Costs of Urinary Incontinence Among Female Medicare Beneficiaries

We measured the financial burden of urinary incontinence in the United States from 1992 to 1998 among women 65 years old or older. We analyzed Medicare claims for 1992, 1995 and 1998 and estimated spending on the treatment of urinary incontinence. Total costs were stratified by type of service (inpatient, outpatient and emergency department). Costs of urinary incontinence among older women nearly doubled between 1992 and 1998 in nominal dollars, from $128 million to $234 million, primarily due to increases in physician office visits and ambulatory surgery. The cost of inpatient services increased only slightly during the period. The increase in total spending was due almost exclusively to the increase in the number of women treated for incontinence. After adjusting for inflation, per capita treatment costs decreased about 15% during the study. This shift from inpatient to outpatient care likely reflects the general shift of surgical procedures to the outpatient setting, as well as the advent of new minimally invasive incontinence procedures. In addition, increased awareness of incontinence and the marketing of new drugs for its treatment, specifically anticholinergic medication for overactive bladder symptoms, may have increased the number of office visits. While claims based Medicare expenditures are substantial, they do not include the costs of pads or medications and, therefore, underestimate the true financial burden of incontinence on the aging community.

Economic and Developmental Considerations for Pharmacogenomic Technology

The pharmaceutical industry's core business is the innovation, development and marketing of new drugs. Pharmacogenetic (PG) testing and technology has the potential to increase a drug's value in many ways. A critical issue for the industry is whether products in development should be teamed with genetic tests that could segment the total population into responders and non-responders. In this paper we use a cost-effectiveness framework to model the strategic decision-making considerations by pharmaceutical manufacturers as they relate to drug development and the new technology of PG (the science of using genetic markers to predict drug response). In a simple, static, one-period model we consider three drug development strategies: a drug is exclusively developed and marketed to patients with a particular genetic marker; no distinguishing among patients based on the expression of a genetic marker is made (traditional approach); and a strategy whereby a drug is marketed to patients both with and without the genetic marker but there is price discrimination between the two subpopulations. We developed three main principles: revenues under a strategy targeting only the responder subpopulation will never generate more revenue than that which could have been obtained under a traditional approach; total revenues under a targeted PG strategy will be less than that under a traditional approach but higher than a naive [corrected] view would believe them to be; and a traditional [corrected] approach will earn the same total revenues as a price discrimination strategy, assuming no intermarket arbitrage. While these principles relate to the singular (and quite narrow) consideration of drug revenues, they may nevertheless partially explain why PG is not being used as widely as was predicted several years ago when the technology first became available, especially in terms of pharmaceutical manufacturer-developed tests.

Once-daily antiretroviral therapy: Spanish Consensus Statement

Administration of antiretroviral therapy (ART) once daily is creating extraordinary interest among the members of the scientific community and also among those who receive the therapy. However, in clinical practice, some doubts remain about its use. This document examines the characteristics and possibilities of treatment administered once daily. Consensus of 248 Spanish experts in the field. Once-daily dosing is considered an added value which could favour adherence and, therefore, efficacy, as well as the quality of life of certain patients, however, the objective of adequate adherence in the long term is often difficult to achieve regardless of the treatment used. In theory, any patient can receive once-daily therapy, although some patients could particularly benefit from it, e.g. those with unfavourable social or personal circumstances, including drug users, patients whose treatment must be supervised, patients receiving multiple medications, or those who need rescue therapy after multiple treatment failures. At present, it is possible to design once-daily ART using some of the combinations of drugs considered as first-choice in national and international recommendations for antiretroviral therapy, but the options are still limited. The marketing of new drugs with this characteristic could allow us to increase the number and types of patient who can benefit from once-daily regimens, including those patients who need rescue therapy. Once-daily ART is a good alternative to regimens administered several times each day when a potent combination of active drugs is available.

Is therapeutic innovation responsible for the increase in drug expenditure?

Two years running, the drug consumption neither relates to the same pharmaceuticals nor those bought in the same proportions. The result of this is that the consumption structure changes and involves usually an increase in the average price of a drug, even without any rising of individual prices. This evolution is conventionally explained by marketing of new drugs for which therapeutic contribution involves higher prices. This article aims to demonstrate that such a approach is insufficient to explain what is called a structural effect. On the one hand, demographic and socio-cultural factors must be taken in account because they have a long-term influence on the level and on the composition of the drug demand. On the other hand, the drastic transformation of any markets, stirred up by a few drugs, cannot be understood if we only consider innovation and quality. As they come up to a latent demand, which could not be fulfilled before, new drugs create a "need effect", the results of which may be very strong on the consumption structure, as shown by some examples. To apprehend accurately the "structure effect", supply and demand have to be taken into account. Using the French example, which can easily be transposed to most Western economies, this article presents all the short-term and long-term factors which contribute to the development of the structural effect, and gives its value.

DRUGMAKERS PLAY IN CONTRACT FIELD

THE BUSINESS OF CUSTOM PHARmaceutical chemical manufacturing has come into its own in recent years because many pharmaceutical companies are focusing their efforts on the research, development, and marketing of new drugs, leaving the unglamorous step of production to third-party chemical firms happy to do the job. Yet a handful of drug companies are bucking the trend. Not only do these firms continue to manufacture the bulk of their own products, they are successfully competing in the $8 billion-per-year contract manufacturing arena against the growing number of pure play chemical companies that want a slice of what for them is a high-margin market. Merck KGaA, Aventis, Pharmacia, Boehringer Ingelheim, Abbott Laboratories, Schering AG, and a few other drug-makers are active participants in the contract manufacturing market. Through an emphasis on quality manufacturing and regulatory expertise, they manage to overcome the perception that they are high-priced providers out merely to fill unused capacity i...

Drug prescription in Italy.

Drug use in Italy in the period 1983-1991 has been analysed. The twenty most used substances accounted for about 20% of the sold packages. The effect of marketing of new drugs is worth noting: new and more expensive drugs are preferred even when effective, safe and less expensive alternatives are available. Prescribers have to face a highly dynamic pharmaceutical market in which 30% of substances (among the 300 most sold) changes every five years. Other than a more rational formulary, independent information and continuing education have to be considered as tools to improve a more rational prescribing.

Drug utilization data in benefit analysis of drugs.

The usefulness of drug utilization data from the medical point of view is closely related to possibilities for benefit analysis of drug treatment. In drug regulatory work this analysis may be facilitated by more recent evaluations in connection with reviews when granting marketing of new drugs. The general difficulties in benefit analysis have been especially noticed following observations on international differences in the utilization of certain groups of drugs. These difficulties are discussed and the importance of new attempts taken to assess the benefit of the treatment is emphasized.

Stereochemistry, a basis for sophisticated nonsense in pharmacokinetics and clinical pharmacology.

The significance of stereochemistry in therapeutic action is outlined and elucidated. Often only one isomer is therapeutically active, but this does not mean that the other is really inactive. It may very well contribute to the side-effects. The therapeutically non-active isomer in a racemate should be regarded as an impurity (50% or more). It is emphasized how in clinical pharmacology, and particularly in pharmacokinetics, neglect of stereoselectivity in action leads to the performance of expensive "highly sophisticated scientific nonsense". This also holds true in the development and marketing of new drugs as exemplified by various "pseudo-hybrid" drugs now reaching the clinic.

Therapeutic implications of the drug lag.

The American lag with respect to Britain in the introduction of new therapeutic drugs over the past decade was analyzed to determine whether, in therapeutic terms, Britain has gained or lost from adopting the more permissive policy. The therapeutic impact of a new drug on the whole community is difficult to assess, mainly because there are few methods or data available for measuring benefit. On the evidence currently available, Britain probably did not lose appreciably from the introduction of ineffective drugs, nor from the fact that a greater number of new drugs were made available. The main deleterious effect was that Britain suffered more tOXicity due to new drugs than did the United States, as could have been anticipated from the fact that mare new drugs were marketed there. However, considering the size of the total burden of drug tOXicity, the portion due to new drugs was extremely small, and would in any case be at least partially offset by the adverse effects of older alternative drugs had the latter been used instead. Conversely, Britain experienced clearly discernible gains by introducing useful new drugs, either sooner than the United States or exclusively. On balance, Britain appears to have gained in comparison from its more permissive policy toward the marketing of new drugs coupled with a more rigorous program of postmarketing surveillance. Wider issues raised by this study include the desirability of further intensifying postmarketing surveillance, particularly in the case of new drugs; the conflict between the presently conceived public health role of a regulatory agency and the desire of a physician to choose optimal therapy for particular patients; the therapeutic and social implications of the control of drug utilization as distinct from marketing; and the significance of the latter controls for the future of medicine.

Marketing of New Drugs

DEAR SIR: I would like to compliment you on your very thorough and thought-provoking analysis of the drug industry (CE Aug. 17, page 114). It is the best report of this type I have seen for some time. I am glad to know that some of the figures I have compiled on new product introduction in recent years have been of use to you. I agree with you that the drug industry can be expected to do well. The savings that are accumulating through the nonmarketing of products which later turned out to be a loss are considerable and will continue to contribute to the profit of many manufacturers. But there was no doubt an excess of expenditure for promotional purposes in recent years and the industry is gradually reducing this because the sales department cannot ask for the marketing of as many new products has it did in the past. On ...