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Big Pharma vs Australian Pharmaceutical Benefits Scheme
- Tom Hughes (12 November 2004)
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Health and adequate education
- Carlos Cuello (12 November 2004)
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Poor Patients Deserve More Science and Less Advocacy
- Carol C. Adelman, Jeremiah Norris, Senior Fellow, Center for Science in Policy, Hudson Institute (25 November 2004)
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Patients need access to drugs not meddling from US conservative groups
- Stuart Rennie (3 December 2004)
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Tom Hughes, Physician Australia
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You know when a strategy is highly effective when the pharmaceutical industry tries to shut it down - it is the ultimate validation. Australia's Pharmaceutical Benefits Scheme limits state subsidy to drugs which are proven to have clinical benefits, and makes class drugs fight out between themselves on price. The [US-based] pharmaceutical companies specifically targetted the PBS in the recent Free Trade Agreement with Australia, and succeeded in having it crippled with a committee of paid shills. This was not because Australia was an important market per se, but that other countries were looking at the success of the PBS in controlling costs, and wondering about following suit. As a consultant about to return to the UK, I would welcome the introduction of a similar system, as I believe it would work well, and would be NICE with teeth. I don't believe the Australian public fully understand how effective it is, but they get extremely good value for money. Competing interests: None declared |
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Carlos Cuello, Professor of Paediatrics. Tecnologico de Monterrey, School of Medicine Av. Morones Prieto 3000 pte 64710 Monterrey, Mexico
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Sir: The article by Hogerzeil [1] reminds us the importance of sharing information between low income and developing nations. Any country with an appropriate health care system can have some control over which medications are given to certain patients with certain conditions (like AIDS or tuberculosis). A problem often encountered in middle income countries (specially in Latin America) is the “unseen expenditure” within families secondary to the culture of self-medication; or even worse, inadequate prescription of drugs for the wrong illness by physicians. Taking an example, the misuse of antibiotics in my country reached 70% to 80% of patients with a viral upper respiratory infection [2], without mentioning the use of over-the-counter drugs and how a patient can easily found medications without prescription. People often do not understand why you are not prescribing antibiotics for a cold or diarrhoea; they prefer the “magic” cure found with a local healer or a pharmacist, an action that sometimes leads to an increase in complications and higher costs. Among the components of a national medicine policy potentially relevant for developed countries mentioned in this article, public education should be emphasized, as any effort would be useless without it. An evidence based health care should be shared with patients and families, a more regulated system on the prescription of drugs should be established in countries where they are not regulated, and more crucially, a strong medical culture should be provided in low and middle income countries. The complexity of this type of intervention would require the support of the pharmaceutical industry, governments, private foundations, and international organizations. [3] 1.- Hogerzeil HV. The concept of essential medicines: lessons for rich countries. BMJ 2004;329: 1169-72.[Free Full Text] 2.- Peláez-Ballestas I, Hernández-Garduño A, Arredondo-García JL, et al. Use of antibiotics in upper respiratory infections on patients under 16 years old in private ambulatory medicine. Salud Publica Mex 2003;45:159 -164. 3.- Homedes N, Ugalde A. Improving the use of pharmaceuticals through patient and community level interventions. Soc Sci Med. 2001;52(1):99-134. Competing interests: None declared |
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Carol C. Adelman, Director, Center for Science in Policy Hudson Institute, 1015 18th Street NW, Suite 300, Washington DC 20036, Jeremiah Norris, Senior Fellow, Center for Science in Policy, Hudson Institute
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Mr. Hans Hogerzeil of WHO/Geneva contends that the WHO selects essential medicines within a therapeutic class “on the basis of comparative efficacy, safety and cost”. His reference text, Essential Medicines, WHO Model List (revised April 2003), is at variance with that contention. WHO’s drug of choice to treat 3 million by 2005 is the triple dose combination ARV from India. In the April listing, WHO states: “The Committee strongly recommends the use of three-or four drug combinations ... The use of fixed dose preparations for these combinations is also recommended, with assured pharmaceutical quality and interchangeability with the single products”. The regulatory test to judge whether a drug is interchangeable is the presence of an originator product. Since none of the patent holders for the three separate originator ARVs has produced an equivalent combination product, there is no comparator drug. Thus, an analysis of efficacy, safety and cost has scant scientific merit. If the WHO system was working as well as Mr. Hogerzeil claims, then why have ARV products that were on the WHO pre-qualified list, been taken off, long after they have been in use throughout the developing world? Of the two Indian companies pre-qualified to supply combination drugs, one had its product de-listed from the WHO list on August 4, 2004 for lack of proof of bioequivalence with the originator product. The other company is under a restriction from the Indian licensing authority to make “no reference that the Government has approved the drug.” In November 2004 two Indian companies voluntarily withdrew their entire portfolio of AIDS drugs from the WHO system. Of the 12 ARVs on the Essential Medicines list, five either have been withdrawn by various manufacturers or de- listed by WHO. Of the remaining, four are manufactured only by originator companies. The lesson here is that poor countries have followed the example of rich countries and voluntarily withdrawn their products—even though the agency which pre-qualified them failed to take remedial action. Competing interests: None declared |
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Stuart Rennie, Research Assistant Professor in Bioethics University of North Carolina-Chapel Hill
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As of November 30th, the WHO has reinstated two antiretrovirals manufactured by Cipla Ltd., India onto its list of pre-qualified medicines. This is as it should be: whenever there are serious doubts about the safety or efficacy of a generic antiretroviral, it should be tested as soon as possible, and if it passes muster, reinstated as soon as possible. Delisting has has very serious consequences for patients and health systems in resource-poor countries, so the reasons for delisting must be substantial. It must be based on warranted concerns about bioequivalence. Unfortunately, this has not always been the case in the past, where drugs have been delisted on the basis of minor administrative errors or through obscene political pressures from pharmaceutical companies and conservative groups in the US (such as the Hudson Institute). Generics have proven themselves effective where it matters: with actual patients in low-income countries. Survival rates of AIDS patients in South Africa on generics are comparable to those of European patients on patented drugs. The WHO is correct in stimulating low-income countries to build capacity in manufacturing their own generic ARVs. Why should AIDS patients have to forgo generics and wait until they and their government can afford patented drugs? The lesson is that the WHO should stay the course – the ethical course – and promote the manufacture and use of generic drugs for resource -poor countries, and ignore those who have something other than the interests of AIDS patients in mind. Competing interests: None declared |
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