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Human immunodeﬁciency virus infection/ acquired immunodeﬁciency syndrome (HIV/AIDS) is a public health issue worldwide because of its high prevalence, its pathogenic character, its mortality, and its morbidity. AIDS is a particular disease which entirely affects the infected person: his/her physical appearance, mental, morale, close relatives, and all his/her social relations. Because of the moral issue related to the disease, stigmatization and discrimination can occur in the society regarding HIV-positive individuals. In addition, many ethical problems arise, not only for the prevention of HIV/AIDS, its screening, and its medical care but also for the pharmaco-clinical research and the production and commercialization of antiretroviral drugs.
According to the 2013 estimates of the United Nations Organization in charge of AIDS (UNAIDS), 35 million people lived with HIV/AIDS in the world; 2.1 million new infections were recorded and 1.5 million deaths were reported. Since the start of the epidemic, around 78 million people have become infected with HIV and 39 million people have died of AIDS-related illnesses (UNAIDS 2014).
From 1981 up to date, AIDS has caused more than 17.8 million orphans (UNAIDS 2013) and has made several million widows who are languishing in misery (Simpore et al. 2011). It is true that plague has terrorized and destroyed many men and women during the past centuries and the Ebola virus is terrifying and challenging humankind currently. However, in living memory, no pathogenic infectious agent, by its aggressiveness, violence, and virulence, has ever stirred in humankind so much physical suffering as well as moral misery and deaths among young people as HIV.
With the appearance of this new pathology, called “the disease of the century” which destroys preferably people in age of childbearing, very often, an unspeakable and unimaginable paradox arises: grandparents rediscover themselves, with bitterness and sorrow, as fathers and mothers of their grandchildren who have become orphans.
HIV is a retrovirus that infects man and leads, in more or less long term, to AIDS. It can also make the organism more vulnerable for its host, through some coinfections, associating with other pathogenic agents such as the hepatitis B (HBV) and the hepatitis C (HCV) viruses, Mycobacterium tuberculosis, the human papillomavirus (HPV), the human herpesvirus 8 (HHV-8),
Treponema pallidum, and so on. Although there are now some antiretroviral therapies (ART) against HIV, consequently permitting to delay its appearance and reduce both its mortality and morbidity, to this date, there is no vaccine or medicine capable of eradicating it. Consequently, without an appropriate prevention, entire generations of young people, in the prime of life, will surely disappear from many poor areas of the world which are highly HIV endemic.
In order to develop the AIDS topic, ﬁrstly the history of AIDS and its biomedical aspects will be discussed, followed by the deﬁnition and etiopathology of HIV/AIDS. Lastly, the bioethical issues of AIDS today will be discussed according to the following points: ethics of condom use, health and anthropologic imperatives, issue related to patents, TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreements, research ﬁnancial cost, and lifelong care for HIV-infected individuals.
History Of HIV/AIDS And Its Biomedical Aspects
According to the polymerase chain reaction (PCR) tests carried out in 1981 on preserved samples, the ﬁrst infections by HIV dated back to the year 1950, long before the appearance of the infection in the United States (Watson et al. 1994). Thus, the history of HIV/AIDS unfolds in the following steps:
1980: in Los Angeles, three (3) homosexual patients presenting clinical signs of weight loss, fever, mycosis, mouth candidiasis, and pneumonia as well as an abnormal rate of blood cell CD4 lymphocytes were detected and treated.
1981: the bulletin MMWR (Morbidity and Mortality Weekly Report) reported ﬁve cases of a rare pathology, lung pneumocystosis (CDC
1981), which mostly occur in immune-depressed patients; on July 3, 1981, the New York Times published an article reporting 41 other patients presenting a Kaposi’s sarcoma. At the same time, similar cases were detected in Europe (Simpore 2012).
1982: CDC named this new pathology “AIDS,” “acquired immunodeﬁciency syndrome” (CDC 1982).
January 3, 1983: the team led by Professor Luc Montagnier in France discovered the lymphadenopathy-associated virus (LAV) (Barre-Sinoussi et al. 1983). In September of the same year, Luc Montagnier patented a test “ELISA” (enzyme-linked immunosorbent assay) capable of showing the presence of anti-LAV antibodies.
1984: Professor Robert Gallo from the United States discovered the human T-cell lymphotropic virus type III (HTLV-III) and immediately asked an international patent for the “anti-HTLV-III antibodies test” (Connor
1987). These discoveries and those patents provoked heated debates since Montagnier and Gallo both claimed the paternity of the discovery of this retrovirus. The reconciliation between these two famous researchers only occurred in early 2000.
1985: two important events took place: the commercialization of the ﬁrst diagnostic tests and the introduction of the ﬁrst clinical trials.
1986: the international committee of virus taxonomy adopted the name HIV instead of LAV and HLTV-III. In that same year, Luc Montagnier and his team discovered a second type of virus that they named HIV-2.
1987: the ﬁrst molecule against HIV/AIDS was discovered: the azidothymidine (AZT), an inhibitor of the reverse transcriptase.
From 1990 to 1995: a move was made from monotherapy to dual therapy: zidovudine + saquinavir.
1996: it was the beginning of the triple therapy with the new protocol: highly active antiretroviral therapy (HAART).
2008: the international scientiﬁc community clariﬁed the paternity of the discovery of HIV and awarded the Nobel Prize of Medicine to Professors Luc Montagnier and Françoise Barré-Sinoussi.
From 2008 to date: the history of HIV and AIDS goes on with the discoveries of new subtypes of HIV, new circulating recombinant forms (CRF), new strains resistant to ARVs, new medicines and vaccines under experiments, new challenges to take up such as the sanctuarization of the provirus integrated in memory cells, and HIV reservoirs.
Modes Of Infection
There are three main routes of transmission of HIV:
- Transmission through sexual contact
- Parenteral infection through infected human biological ﬂuids such as blood, breast milk, male seminal liquid, amniotic liquid, female cervical secretions, etc.
- Vertical transmission from mother to child through placenta or during childbirth (Simpore et al. 2007)
The infection process is quite complex since it requires several elements in the host (CD4 receptors, CCR5 or CXCR4 coreceptors) and many steps (the recognition and ﬁxation of the virus on the cluster of differentiation antigen 4 (CD4) receptors and the C-C chemokine receptor type 5 (CCR5) or CXCR4 coreceptors of the lymphocyte T4, the membrane to membrane fusion, the injection of the virus genome in the cytoplasm of the host cell, the reverse transcription of the viral RNA into double strand DNA, the proviral DNA integration, the transcription of the RNAm of the integrated provirus, the assembling of the viral proteins, and the budding of the virus and its diffusion in new cells of the host).
Diagnosis Of The HIV/AIDS Infection
There are two types of methods: direct and indirect methods. The direct methods try to isolate the virus itself from lymphocytes: looking for the protein 24 (p24) antigenemia and ampliﬁcation and identiﬁcation of the viral DNA by PCR. The indirect methods do not target the virus directly, but the detection of anti-HIV antibodies produced by the human organism in contact with the viral antigen. The most common and used methods are the ELISA test and the Western blot.
It must be speciﬁed that there are two types of tests to reveal if someone is HIV-positive: the screening tests – these tests are very sensitive. It is very rare to get false-negative results, but this test lacks speciﬁcity. This means that every positive result must be conﬁrmed by a very speciﬁc test known as “conﬁrmation test.” Conﬁrmation tests – the conﬁrmation test resorts to a more sophisticated technique performed in a laboratory, whose interpretation is validated by the World Health Organization (WHO). Its result can be positive, negative, or undetermined. If the test is undetermined, a period of 2–4 weeks must be observed before making new sampling for testing purposes. This period is the “window period” since there are not yet enough antibodies to be detected unless the PCR test is used.
In the absence of antiretroviral treatment, the majority of the HIV-infected persons will evolve toward AIDS, the ultimate stage of the disease. Nowadays, many types of antiretroviral drugs are available for the treatment of patients infected by the HIV. These monotherapy, dual therapy, and triple therapy and even cocktail therapies have truly proved their undeniable therapeutic efﬁciency. Nevertheless, all the patients cannot beneﬁt from these multi-therapies for many reasons:
- There are important side effects to the treatment for many patients.
- For some patients, HIV mutant strains also become resistant to these multi-therapies.
- The treatments are heavy and difﬁcult to stand, and some patients cannot comply to them all their lives.
- The prices of these ARVs still remain very high for patients of developing countries.
Nowadays, gene therapy made its ﬁrst move in the clinical services for the treatment of some hereditary genetic pathologies and some cancers. HIV, which causes AIDS, is a virus that has a great variability and a very important genetic diversity that impedes the research for efﬁcient vaccines and medicines. However, gene therapy which is in development will allow in a close future to act on targeted molecules, some of which cannot be reached, to date, by classical medicines. In this perspective, some target cells that could be “transduced” ex vivo with genes of interest are probably lymphocyte T CD4+, macrophagic monocytes, and dendritic cells derived from hematopoietic stem cells (HSCs). In that sense, genetic engineering will be able to develop new strategies to combat HIV through intracellular immunization, selective destruction of infected cells, secretion of inhibiting proteins, genetic pharmaceutical modulation, and genetic immunotherapy. But all of this requires, ﬁrst, a sound knowledge of a whole series of mechanisms: HIV vital molecular mechanism, its viral pathogenic mechanisms, innate and acquired immunologic response mechanism against HIV, differing progression mechanisms of the disease according to individuals, and ﬁnally mechanisms for reservoir destruction which are virus sanctuaries. Undoubtedly, these types of fundamental research will contribute to redeﬁne new therapeutic and prophylactic strategies.
Worldwide, the number of HIV/AIDS-infected people went from 34 million in 2011 to 35.3 in 2012 (UNAIDS 2012, 2013). The number of new cases of infection was estimated in 2012 to be 2.3 million (UNAIDS 2013); the number of deaths were 1.6 million (UNAIDS 2013) and there were 16.6 million orphans in 2009 (UNAIDS 2010). Without prevention, the HIV/AIDS pandemic would spread exponentially in the world through sexual, vertical, and parenteral transmissions.
Prevention presumes the upstream inhibition of the three main transmission routes of HIV:
- Fidelity, abstinence, and sexual hygiene can signiﬁcantly limit HIV transmission by sexual contact.
- In addition, it is to be noticed that a good biomedical practice would also limit not only nosocomial infections in our care units but above all the parenteral infections through human biologic ﬂuids during deliveries and from breastfeeding.
- At the world level, programs of mother-to-child transmission prevention of HIV (MTCT) through administration of ARVs have shown their efﬁciency. With prevention, less than 1 % of women transmit the virus to their children.
HIV/AIDS Definition And Etiopathology
Nowadays, all the scientists agreed to deﬁne acquired immunodeﬁciency syndrome as being a sexually transmitted affection, caused by the human immunodeﬁciency virus. For methodological reason, biomedical researchers have well characterized and deﬁned the HIV structure, its genetic variability, and the etiopathogenesis of the disease generated and have determined the different phases or classes of AIDS stage.
The human immunodeﬁciency virus is a retrovirus having 0.1 mm diameter, from the Lentiviridae subgroup which has a two RNA-molecule genome (ribonucleic acid). HIV is a virus which has an important genetic variability.
HIV Definition AND Etiopathogenesis
AIDS derived from HIV-1 is characterized mainly by a slow and progressive diminution of lymphocytes T CD4+ circulating in the organism infected by the virus. The lymphocytes T are with the lymphocytes B, the monocyte-macrophages, the killer cells NK (natural killer), the cytotoxic T lymphocytes (CTL), and the granulocytes, the main actors of the immune system. As every infection, the HIV-1 progression in the organism depends on the interaction between the virus and the host. AIDS corresponds to the symptomatic phase of the HIV infection that comprises three main phases.
The Primary Infection
An acute pseudo-mononucleosidic syndrome appears in certain persons 2–6 weeks after the HIV infection. This syndrome is characterized by the appearance of fever, articulatory pain, myalgia, diarrhea and a maculopapular rash.
The Asymptomatic Phase
This phase is characterized by a visible absence of clinical manifestation during several years in the LTNP (long-term nonprogressors: slow progressors) and 2–3 years for fast progressors. In the absence of any treatment, this latent period can last 8–10 years and even more. Human beings are born equal in right and dignity, but they are not born equal for HIV infection. People having mutated coreceptors such as CCR5D32 resist to HIV infection, while individuals having HLA-B*57 alleles develop AIDS more slowly.
The Symptomatic Phase Of AIDS
The symptomatic phase of AIDS is characterized by a very serious immune depression (<200 CD4/mm3) and the appearance of opportunistic germs: tuberculosis, esophagus or airway candidiasis, extra pulmonary cryptococcosis, Pneumocystis carinii pneumonia (PCP), atypical mycobacterial infections, tumors (Kaposi’s sarcoma,), and neurologic manifestations (cerebral lymphoma).
To assess the progression of the HIV infection, based on the clinical manifestation and the biological anomaly, the WHO and the CDC (Centers for Disease Control) propose, respectively, clinical phases (1, 2, 3, and 4) and categories (A, B, C, and D). It is necessary to specify that the CDC classiﬁcation is hierarchical and historical. According to this hierarchy, once a patient has reached a category and if the clinical signs disappear, he/she stays in this category. For example, a patient categorized B will not be able to go back to category A, even though the clinical signs have disappeared.
As it appears from what has just been said, the objective of ﬁnding a sound vaccine or treatment against HIV still seems away. And, in this anxious search, only efﬁcient cultural, biomedical, ethical, and bioethical options can permit humankind to engage, collectively and in solidarity, a new type of struggle to safeguard and protect our human community through adopting a responsible human behavior (Simpore 2012).
HIV And AIDS Bioethical Issues Today
HIV Prevention Ethics
HIV does not need a particular passport with a speciﬁc visa to go from one country to the other, nor to circulate from one continent to the other. In a globalized world, the AIDS virus ﬂourishes and becomes a free citizen of the world. The only way to stop it is prevention.
Plural Bioethical Vision Of AIDS Prevention
The ethical appreciation of an action is not always easy since the elements to take into account are so numerous that we do not always know where to start. So there are different ways to conceive the ethics and to advise people, according to the principles one follows and his/her own judgment. In a variety of bioethical conceptions and visions, it appears clearly that the practice and respect of ethical standards would depend more on the philosophical, anthropological conception of the person observing and interpreting the facts. There are mainly three trends: the liberal trend, the pragmatic and utilitarian trend, and the persona list trend.
The Liberal Trend Viewpoint
The ultimate reference value for this trend is freedom. In this perspective, everything that is freely desired and freely accepted and does not affect other people’s freedom is allowed. This trend draws its origin from the French Revolution, Popper’s subjectivism, Jean-Paul Sartre’s existentialism, and Marcuse’s liberalism. For the supporters of this current, moral judgment is subjective; there is no objective truth because ethics is not a positive science. In this sense, as far as HIV/AIDS epidemic is concerned, this viewpoint opposes all the restrictions to individual freedom. The prevention in this perspective aims mainly at informing people of hygienic prescriptions formulated by health facilities: diminish the number of partners, avoid high-risk partners, and always use a condom.
The Pragmatic And Utilitarian Trend Viewpoint
What is essential and of reference in this current is what is “useful.” The utilitarian trend gets its inspiration from Hume’s, Hobbes’s, and Locke’s philosophy and Auguste Comte’s positivism and neopositivism. The in-depth criterion of this philosophy is utilitarianism, on the basis of the principle of cost/beneﬁt, and its aim is to promote social, even economic, well-being. The neo-utilitarians get their inspiration from Bentham and Stuart Mill and their thought is summarized in their precepts: “Optimize pleasure, minimize pain, and increase the sphere of personal liberty for the highest number of people.” In this utilitarian perspective, society desires, on one hand, that the spread of AIDS be controlled and, on the other hand, considers that individuals are not capable of restricting themselves to avoid “high-risk” behavior and then proposes “safe sex.”
The Personalist Trend Viewpoint
The advocates of this current defend that the ultimate reference is the human being who is considered as a whole, with his freedom, his responsibility, his social value, and his relationships with others. As for AIDS prevention, the commitment of this viewpoint is to put the focus not on a short-term efﬁciency of one or the other method, but on the impact that each method will have on the individual and his growth in humanity. That is why, in the personalist perspective, the aim will not be only to avoid HIV infection but to adopt a lifestyle to prevent the infection.
So, for the personalist model, the central and fundamental value in the AIDS phenomenology is the human being: a “psychosomatic being.” Prevention, screening, medical care, pharmaco-clinical experiments, health works, psychological assistance, and social services are developed for the suffering body (Simpore 2012).
Prevention Of Mother-To-Child Transmission Of HIV (PMTCT)
The prevention of the mother-to-child HIV trans-mission is a prevention program which is even more complex than the one implemented in the population in general. Indeed, the PMTCT implies not only the duos husband-wife and mother-child but also a multidisciplinary medical staff (physicians, pharmacists, biologists, midwives, nurses, psychologists, etc.) and requires a laboratory facility for PCR tests.
The PMTCT process comprises mainly ﬁve steps: (i) voluntary counseling and testing (VCT) which is a pretest counseling, (ii) the screening test itself, (iii) a posttest counseling, (iv) taking care of the HIV-positive pregnant woman through HAART, and (v) a clinical monitoring and an ARV prophylaxis for the children born from infected mothers. In all these steps, there are many bioethical challenges such as the ethics of pregnant women screening, issue of the free and informed consent, professional secrecy, conﬁdentiality, stigmatization, discrimination, ARV prevention with its risks of side effects, the induced resistance, etc.
Ethics Of HIV Screening
The Issue Of HIV Screening
When the epidemics of cholera, plague, meningitis, and Ebola occur, the health authorities put in quarantine the infected individuals to prevent them from contaminating the rest of the population. So, in isolating and taking care of the infected individuals, the transmission chain of the pathogenic agent is broken (isolating room for Ebola, sanitarium for tuberculosis, etc.). In these circumstances, nobody speaks of stigmatization or discrimination for individuals infected by Ebola or cholera. However, the HIV epidemics as all the other epidemics pose to health authorities a dilemma, a conﬂict between, on one hand, the necessity to protect the population health in general and, on the other hand, the necessity to protect people as free individuals having rights (Conseil pontiﬁcal pour la famille 1989). So there is inside the society an opposition, a confrontation between safeguarding individual freedom and the necessities of the public good in terms of HIV infection. In the case of HIV infection, the contamination prevention through screening of infected people and their isolation are not acceptable for all the members of the civil society. In fact, potentially contaminating individuals are often asymptomatic and so, in good health, working, having income, and facing their families’ economic expenses. In addition, today, an obligatory screening for HIV during recruitment or on entry of every patient in health units is not acceptable. These infected individuals will be immediately stigmatized and discriminated and consequently will not be able to live in peace nor ﬁnd a job. However, the screening is mandatory for the following cases: blood, organ, and sperm donation. For the reasons mentioned earlier, the HIV tests are still, to date, only voluntary and cannot, in any case, be imposed. Nobody can be submitted to an HIV screening test without giving his free and informed consent.
Necessity For HIV Screening In Public Health
During epidemic eruptions, the health authorities have the duty to carry out, here and there, epidemiological surveys in order to deﬁne the epidemic proﬁle, its origin, virulence, and spreading modes and, in the case of AIDS, determine the contagious persons, HIV “reservoirs.”
In addition to the need for the public health authorities to know the HIV infection mechanism, the screening is done for the beneﬁt of the individuals. Indeed, the persons diagnosed as HIV-positive can beneﬁt from antiretroviral treatments (ART), whereas those who are found HIV-negative can seek then to keep their negative status forever. In that sense, it would be good to promote HIV screening for couples preparing for marriage or for pregnant women to avoid mother-to-child transmission.
Free And Informed Consent And HIV Screening For Pregnant Women
The free and informed consent is the corner stone, the standard for the ethical conformity of the HIV test for pregnant women. The principle of the free and informed consent and the organization of voluntary HIV screening for pregnant women aim at permitting the empowerment of the potential patient, her care, and medical treatment. Clearly, at the Bangkok conference, in 2004, UNAIDS and WHO announced a major change in the HIV screening policy. For them, the “voluntary counseling and testing (VCT),” symbol and mainstay of the liberal paradigm for the struggle against the epidemics, was becoming subject of debates on the way to make VCT access more universal. From then on, for UNAIDS and WHO, the “scaling-up” of the access to treatment in countries where the majority does not know their status, each contact with the health system should be a systematic access to HIV screening. In this sense, according to WHO, any patient seen in medical consultation, in a country with high prevalence where antiretroviral treatments are available, must systematically undergo an HIV test. This new strategy of systematic promotion is known as “opt-out” in the sense that the patient remains free to refuse, but no longer “opt-in” since he is no longer the one asking for it (Baisley et al. 2012).
Taking into account this new vision of the WHO and expecting all pregnant women to be compulsorily screened for HIV, during the prenatal visits, could in some cases lead us to an ethical loss of control in practicing tests without free and informed consent or without patients knowing it. In the cases where the tests are done without the patient approval, it will be later difﬁcult to implement the ARV prevention.
Ethics Of HIV Screening: Medical Secrecy And Care
Every human being has the right to respect of his dignity, private life, and what is conﬁdential to him/ her. Here is the ethical principle of the respect for the human being – “privacy.” So this principle obliges physicians and all the health professionals, without exception, not to reveal anything concerning the patient’s health in relation with his intimate and private life, except if the latter gives his consent to reveal it. In this regard, every violation of professional secrecy, of this conﬁdentiality, by a physician, can be object to proceedings and court sentence for violation of medical conﬁdentiality. However, it must be speciﬁed that for AIDS, medical secrecy is required but it is not absolute. It is limited by the personal interest of the patient, other people, and population’s well-being.
If, for example, a pilot of a big plane as the Boeing 747 has an epileptic episode, and despite the advice of his medical doctor he does not want to stop piloting, this physician despite the medical conﬁdentiality has the right and duty to denounce his patient.
In the AIDS domain, if, for example, a person is HIV-positive and does not want to tell his serology to the spouse despite the multiple advice of his medical doctor, what is to be done? The physician must press the person to reveal his status to the spouse. If the patient refuses to reveal his serology, the medical doctor’s hands will be tied facing this dilemma. Must he break the conﬁdentiality to save the life of the spouse or must he keep the latter ignorant of the status and condemn her/him to be infected? According to Elio Sgreccia (2006), the physician can give up professional conﬁdentiality and inform the authority if the attitude of the AIDS patient seems dangerous for those around him/her.
However, for Sgreccia, to break this medical secrecy, there are speciﬁc conditions:
- The need to disclose medical secrecy stems from the need to protect the right of the equal or the superior’s fundamental right to privacy.
- The medical doctor has done everything to convince the patient of the need to reveal the secret.
- There is no other way to protect the health of the person whose life is in danger.
- The physician takes every necessary precautions.
- The medical doctor should provide psychological assistance to the individual to be informed.
- The revelation should not be more than what is necessary.
- The recipient of revelation should be the uninformed spouse or partner.
So the most frequent obligation mentioned in favor of giving up conﬁdentiality is the one of “assistance to a person in danger.” The guilty silence of the medical doctor might be interpreted as complicity. The principle to be followed in this case takes into account the hierarchy of values. So human life which is not negotiable has precedence over the right to privacy. And when maintaining professional conﬁdentiality endangers someone’s life, this conﬁdentiality law becomes null and, as a result, should no longer bind anyone.
Ethics, Research, And Clinical Trials
Biomedical research is an absolute necessity related to the emergence of new diseases, epidemics, development of resistance to antibiotics, and the persistence of non-curable pathologies such as AIDS. The subject of the biomedical research can then be deﬁned as seeking to improve diagnostic, therapeutic, and prophylactic methods and the understanding of the etiology and the pathogenesis of diseases (Rouëssé 2003). Medical science, as it is constituted since antiquity, has always aimed at efﬁciency rather than philosophical and rhetoric speeches. The practitioner performs actions which are beneﬁcial to the patient and provides him/her few words. What was fundamental for Hippocratic medicine and is still very relevant today is this motto: “primum non nocere” which means “ﬁrst, do no harm.” This indicates, on one hand, a respect for the physical integrity of the patient and, on the other hand, the search for his recovery using new treatment methods.
It is then the duty of researchers and the moral obligation of scientists to carry out appropriate clinical experiments on animals and humans so that biomedical science can make progress (Sgreccia 1999).
This being said, the ethics applying to the biomedical research or pharmaco-clinical experiment applies to the clinical and biological research on HIV. The ethical standards which resulted from the Nuremberg Code and the Helsinki Declaration are its key elements and foundations. Any research on HIV or on AIDS implying human beings must take into account these ﬁve essential ethical principles: (i) respect of human dignity, (ii) beneﬁcent character, (iii) non-harmfulness, (iv) autonomy, and (v) justice. In addition, the researcher who carries out pharmaco-clinical investigations on HIV-positive patients should, ﬁrst of all, have the authorization of a committee on ethics in charge of health research. The researcher will engage not only in applying the correct norms in clinical practices (BPC) and correct norms in laboratory practices but also engage in respecting conﬁdentiality and medical secrecy, once the free and informed consent of HIV-infected patients is obtained.
Issue Of ARV Production And Commercialization
Currently, more than 40 million people worldwide are infected by AIDS. Despite the international mobilization, in 2012, 9.7 million people underwent an antiretroviral treatment in low and intermediary-income countries, which amounts to 61 % of people entitled to it, according to the 2010
HIV guidelines of the World Health Organization (WHO). But according to the 2013 guidelines, only 34 % got covered of the 28.6 million people entitled to the treatment in 2013 (UNAIDS 2013). To develop the access to AIDS medicines in developing countries and in order for every country to implement a national program for access to treatment, it is necessary to beneﬁt from low-cost ARVs.
The Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a text annexed to the Agreement Establishing the World Trade Organization (WTO). The TRIPS Agreement is intended to integrate intellectual property (copyright, trademark or trade name, and patent) to the WTO system. This agreement applies the principles of the trading system to intellectual property. However, today, this agreement is subject to several controversies, among which are the prohibition to “developing countries” to manufacture generic drugs against AIDS at an affordable cost to their people and biological patents.
In short, according to some very critical current ideas, this agreement appears as an instrument of protectionism for the promotion of industrial monopolies on technologies, seeds, genes, and medicines.
“Man is a cure for man,” says the popular wisdom. For ARVs to reach every part of the world, more solidarity will have to be fostered among human beings. The World Trade Organization (WTO) through the TRIPS Agreement, the WHO, pharmaceutical ﬁrms, laboratories, political authorities, and researchers should work in collaboration and synergy.
We discussed the historical and biomedical aspects and bioethical issues of HIV/AIDS. Faced with an epidemiological scale of 40 million people infected worldwide, facing the biomedical and ethical challenges of drug development and effective vaccines against HIV, we focused on the different types of prevention. In fact, biologically and strategically, to date, HIV has defeated Homo sapiens since it has bafﬂed his immune defense system and resists to antiretroviral drugs.
Since the last 30 years, man encountered a major violent adversary, HIV, a retrovirus with neither scruples nor wisdom, infecting blindly and without discrimination its victims: man or woman, newborn or elderly, rich or poor, nonbeliever or man of God. But sooner or later, culturally, thanks to science and modern biotechnology, man will overcome AIDS. So, as the plowman was telling his children in La Fontaine’s tales, the searchers for drugs and vaccines against HIV, before reaching victory over this pathogenic retrovirus, should undoubtedly “dig, search, turn over, leaving no place where a hand does not pass again and again.” It is at this cost and with the invaluable assistance of international organizations, the United Nations, and countries that the researchers will be able to overcome AIDS forever! Armed with this hope, we dare believe that future generations will not face HIV and as a result will only talk about it as a past event and will only study HIV in their history books and encyclopedia. Yes, “AIDS, we will overcome it”!
- Baisley, K., Doyle, A., Changalucha, J., Maganja, K., Watson-Jones, D., Hayes, R., & Newell, M. (2012). Uptake of voluntary counselling and testing among young people participating in an HIV prevention trial: Comparison of Opt-Out and Opt-In strategies. PloS One, 7, E42108.
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