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Posted on March 8th, 2013, by

A current trend in the pharmaceutical industry is the development of chiral agents. In 1983, accounted for 3% of drugs currently reaching 70% of new drugs. Chirality can influence the biological properties of molecules. Hence, many drugs of racemic mixtures can be compared to their own active enantiomers. Enantiomers are compounds that have the same sequence of atoms, but differ in their three-dimensional structure, have a mirror image. They are classified into left-handed and right-handed (R or S). The atom that allows for mirror structures called chiral center and is usually a carbon atom. Enantiomers have identical chemical properties except that rotate the plane of polarized light in opposite directions. However, the stereo-selectivity makes a chiral agent may have better affinity with a receptor or enzyme, according to Pharmaceutical Industry- a one stop resource (2011).

The stereo-selectivity can have significant consequences on the therapeutic effect or toxicity of a drug. This has led to new drugs with better effects on the tolerability, pharmacokinetics, pharmacodynamics and drug interactions of children on the metabolism and bioavailability. In recent years, the impact of these techniques has been remarkable in the class of drugs acting on the central nervous system, leading to the development of new antidepressants (escitalopram), psychostimulants (dexmethylphenidate; armodafinil) and hypnotics (eszopiclone).

Economic importance: the industry as a business
Currently, the pharmaceutical industry globally is growing vigorously. Revenues for the sector during 2004 were 550 billion dollars, 7% higher than those recorded in 2003. Sales in the U.S. totaled $ 235,400 million, implying a growth rate of 8.3% over the previous year. The United States accounts for 46% of world pharmaceutical market.

From 2008 is imminent expiration of some patents that reported more revenue to the industry. Because of this, have increased budgets for research and development areas, especially in the most powerful corporations in the sector. They are played almost the entire market for new drugs, a growing trend of concentration in supply.

Drugs are not any other good, but a necessary element to maintain the health of citizens. And here begins the conflict of interest, since on the one hand there is the pharmaceutical industry’s right to obtain benefits that provide incentives for further research, while on the other side is the right to health, which should be given every humans.

The arguments used to justify the increase in drug prices say the new techniques, making more complicated molecules and the use of increasingly expensive equipment have greatly increased costs. These difficulties are increased by the pressure to reduce prices in the sector, given the concern of governments for the aging population, the problem of patents and access to medicines and the consequent increase in health expenditure, accounting an increasing share of state budgets.

Critique
However, critics argue that the industry actually manufacturing costs have declined significantly, due to the use of appliances and more efficient industrial processes, and automation of many stages of production, thereby reducing labor. Moreover, the workforce has been reduced dramatically after the mega mergers of major pharmaceutical companies that have occurred in the 90’s, which have generated a wave of layoffs on the order of tens of thousands of employees, according to Pharmaceutical Industry (2011).

In fact, the largest generator of costs in the pharmaceutical industry today is not the manufacture of medicines, nor investment in research and development, but the costs of marketing of their products, millionaires include outlays for market research, competitor analysis, positioning strategies, patent extension, distribution, promotion, advertising and sales of its products as well as administrative expenses necessary to maintain multinational structures, which include wages paid astronomical their top executives.

According to critics of the pharmaceutical industry, high prices are not directly related to investment in research but, rather, with the gains from the sale of drugs. Some of these concepts were developed by Marcia Angell, former editor in chief of the scientific journal New England Journal of Medicine for over 20 years. Their complaints have generated a response from the Association of Pharmaceutical Research and Manufacturers of America (Pharmaceutical Research and Manufacturers of America, or PhRMA), as a document available online.

Alternative approaches
Alternative approaches show the reality of a market in which the industry promotes research and commercialization of new therapeutic products. However, less than one fourth of the drugs that come into the market are innovative. When these developments are reviewed by committees of independent experts, using standard operating procedures that ensure transparency and reproducibility of the scientific assessment of comparative effectiveness, safety, dosage, and economy, it appears that most of these new drugs are only to replace the economic space to allow other companies with patents expiring or already expired, so it will be much business as they were. Thus, we see about 90% of new drugs used in primary care do not represent a therapeutic improvement over other medications on the market, with efficacy and safety knowledge and great user experience.

This new therapeutic substitution represents an unsustainable increase in health spending for the economy of many countries, having to divert huge amounts of the national budget could be earmarked for improvements in their health system performance that gives its citizens or just the development of its economy and standard of living. Most of the increase in expenditure on health systems in rich countries is due to the substitution of new therapeutic drugs known.

Government agencies are supposed to exercise control function of this economic sector for the benefit of the citizens are very high percentages financed by the industry (the U.S. FDA by 75% and the European Agency for the Evaluation of Medicinal Products in 80% are an example), depending, as is the case of Europe the Directorate General of Industry and of Health. From all this it follows that there is a conflict between the industry generates wealth (otherwise it’s like then redistributed) and the damage that citizens should take for it. In 2002, just when the patent expired in hormone replacement therapy (HRT) patches for menopausal women with symptoms, it was recognized that not only protect against heart attack or Alzheimer’s disease, but actually increase their risk, such as breast cancer. It is estimated that the UK may have caused 20,000 extra cases of breast cancer. In Spain may have produced some 16,000 additional cases of breast cancer, 6,000 of 8,000 of stroke and pulmonary embolism, in exchange for reducing the number of cases of colorectal cancer in 6000, and the femoral neck fracture in 2500. As dementia, increased incidence doubled among users of HRT compared with nonusers, according to Pharmaceutical Industry (2011).

A review of knowledge about these risks shows that in 1974 it was known that estrogen increases the risk of myocardial infarction, stroke and endometrial cancer, and in 1978 already suggested that also increase the risk of breast cancer. As this example there are unfortunately others, calling into question the reality of a research often not independent or free from conflict of interest, which is sometimes based on studies with methodological design “unorthodox” from the point scientific, or that clearly benefit the new drug. Research is not performed with the type of patients after the drug is intended, as in many cases of women or children, in which up to 90% of cases is not done. The latter led the European Commission to give a warning to the industry continent, according to Pharmaceutical Business Review (2011).

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