Bioethics in the research of drugs and interests of pharmaceutical industries

2013/11/01 Calvo Hernáez, Begoña - Farmazian eta Farmazia Teknologian katedradunaFarmazia Faktultatea. EHU | Sánchez Vitores, Cristina - Farmazia eta Farmazia Teknologiako LaborategiaFarmazia Fakultatea. EHU Iturria: Elhuyar aldizkaria

• Industria
• Etika
• Farmakologia

The impact of the pharmaceutical industry on healthcare spending is increasing. The Ministry of Health has recently accused the pharmaceutical industry of applying an overprice to new treatments. For example, the director of the Directorate General for Pharmacy and Health Products indicates that some new drugs approved in Europe for the treatment of cancer are marketed at a "very high price", taking into account that in some cases they offer "almost inappreciable improvements" with respect to previous treatments.

It is not necessary to be an expert in the field to realize that research and development of drugs are subject to stresses imposed by the industry. Tensions generate great ethical dilemmas that not only affect the system economy, but, unfortunately, also affect patients.

If these dilemmas seem disturbing to our society, we should analyze what is the situation in impoverished countries, where, in many cases, the increase in the price of drugs implies that they are inaccessible to the majority of the citizens of those countries.

Pharmaceutical industry: profits and investments

The pharmaceutical industry is one of the most profitable sectors in the world and has achieved, above all, limiting its interests. In other words, it has fostered research into the diseases of developed countries, leaving aside the diseases of non-profitable peoples, rather, the diseases of developing peoples.

The pharmaceutical industry not only solves health problems, but one of its most notable interests is the search for solutions for “cost-effective” problems. Thus arises an ethical dilemma. The industry has to achieve improvements in health, but to obtain benefits it has to invest in profitable areas, which in many cases means to flee poorer territories. The pharmaceutical industry, like any company, is a for-profit organization that aims at the field of health. Specifically, these are companies dedicated to the research, development, production and marketing of therapeutic and diagnostic products. Of course, the investments made by the pharmaceutical industry must generate benefits that allow progress in the research and development of new drugs. This is one of the reasons why, unfortunately, there are still so-called forgotten diseases. They are diseases that range from Malaria to Buruli's ulcer and cause more than 35,000 deaths every day. This type of disease occurs mainly in underdeveloped countries, without treatment or with inadequate treatments for toxicity, administrative problems or resistance.

In general, the pharmaceutical industry cannot investigate diseases without recovering much of the investment. But, how much does the pharmaceutical industry invest in the investigation of new drugs? Normally, the industry dedicates 15-19% of its profits to research, while the biggest investment is made in product marketing. Proof of this are the data obtained from the sales of the 10 large multinational pharmaceutical companies. In recent years, the profits achieved with sales (17%) were higher than the amount used in research and development (14%), while marketing and marketing costs were much higher (up to 35%). From this data it is concluded that the costs of research and development are only a small part of the budgets of pharmaceutical companies compared to those used in marketing and administration. Therefore, justifying the high price of drugs with the need to recover money to invest in research is just an excuse.

Sectors of interest for the pharmaceutical industry

Advertising new drugs is a key factor for success. One of the objectives of the industry is to shorten the time of introduction of pharmacological innovations in general medicine. The ethical dilemma that arises before this situation, however, is not the result of a greater or lesser generation of wealth, but the main factors of the dilemma are how it is achieved, what resources are used, and how the benefits obtained are distributed or used. The strategies used by the pharmaceutical industry to deal with the existing competition in the pharmaceutical market would be included in it. In many cases, pharmaceutical companies protect their brands and forget that their main interest should be health. To this we must add that in recent years marketing and research expenses have grown without increasing the number of new drugs. This aggravates competition among the industries of the sector, so it is starting to overcome in some circumstances the line that separates legal and not legal, even ethics and not ethics.

Advertising resources

Advertising is the most used medium by pharmaceutical laboratories to increase their profits and increase their name. The promotion of products mainly seeks to increase short-term sales. Pharmaceutical companies are increasingly targeting pharmaceutical marketing and using more and more resources to do so, as the pharmaceutical industry can invest more than a third of its benefits in promoting its products.

To keep pharmaceutical advertising under control throughout Europe, the Code of Good Practices for Drug Promotion was established. It contains the rules of promotion, as well as all the information and trade activities carried out by the pharmaceutical company, in order to promote the medical prescription, the dispensation of medicines, the sale and consumption of medicines. The European Federation of Pharmaceutical Associations and Industries (EFPIA) approved this code to ensure that the information provided by the drug industry was correct, accurate and objective and to be able to make reasonable decisions regarding its use.

The pharmaceutical industry uses different means for the promotion, among which are advertisements in medical publications, postal advertising, traditional medical visit, meetings on scientific information of new drugs (congresses) and promotion of scientific meetings. Sometimes anti-ethical practices are used. For example, direct payment to health professionals for each prescribed drug, advertising campaigns of certain diseases and illegal commercial practices to deal with competition between companies.

Once this reality is known, it is fair to think that the information provided by pharmaceutical laboratories significantly influences the perceptions and opinions of physicians when prescribing. If not, pharmaceutical companies would not invest so much resources in these practices.

Strategies to increase sales

In some cases it has been reported that the pharmaceutical industry has tried to 'produce' some disease to improve the market, that is, it has 'medicalized' the normal processes of life and has become a medical problem. A case of new pathologies driven from industry was "female sexual dysfunction." Several pharmaceutical companies organized a meeting of specialists funded to publicize this 'pathology'. This manipulation of medical criteria, according to commercial interests, was denounced in the British Medical Journal. In many cases, it's about seducing people to come to the doctor when they have small or unrecognized symptoms. That is, the production of medicines for healthy people and, therefore, the sale of them around the world is the way of acting of these companies. In other cases, the invention or promotion of diseases has not been the only objective; for example, they have dared to lower the limits of cholesterol or blood pressure so that more people are considered sick.

Another example of the strategies used by pharmaceutical companies is the commercialization of new products, although in reality there are no therapeutic advantages compared to older drugs. Known as me-too drugs ('imitation drugs'), 77% of the new drugs that were marketed in the United States at the beginning of this century were me-too drugs. It is called me-too drug to modify the smallest part of a molecule of an existing drug for its commercialization as a new drug. The laboratories use the me-too drug marketing strategy to lengthen the patent of an endangered drug. In this way they manage to delay the expiration of the patent of the drug and avoid the commercialization of the generic version, thus achieving a greater benefit. In fact, many new drugs are only medications as usual, but, as current legislation allows, they manage to market despite having no differences with those existing in the market. Examples of me-too medications can be found in many therapeutic groups, such as cholesterol-lowering agents, antidepressants, or high-voltage antidepressants.

However, it must be taken into account that the pharmaceutical industry plays a fundamental role in the promotion of health and, in addition, it is logical to think about taking advantage of those who have invested in research, as well as other companies. If there is no minimum income, expansion would remain, and there would be no benefit for further research and development of new drugs.

Assessment of good practices

All companies must act ethically taking into account the consequences of their behaviors. It is increasingly valued the efforts of pharmaceutical companies to facilitate the criterion of essential drugs around the world, as well as the effort made by these companies in the research of forgotten disease treatments.

Thus, the Access to Medicine Foundation has compiled a list of pharmaceutical laboratories that have begun to collaborate in these situations. The aim of this idea is to draw the attention of other companies to participate in the initiative. On the other hand, the Foundation is responsible for informing governments, researchers and non-governmental organizations about the pharmaceutical industries, to facilitate the search for suitable partners and, in the same vein, to extend the possibility of medicines to everyone.

The right to essential medicines is a problem that confuses us all, so interagency collaboration is important. Although pharmaceutical laboratories are the main agents in this field, they are not the only ones responsible.

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