TAC Electronic Newsletter
23 March 2005
Yesterday the Indian Lower House of Parliament approved a new bill that will make it more difficult to access affordable generics..Please fax, phone, email or mail the Indian embassy or consulate in your area asking the Indian Upper House of Parliament not to pass the bill in its current format.
South African details of the Indian Consulate are:
Consulate General of India, 1 Eton Road, Parktown,2193, P.O. Box 6805, Johannesburg 2000,SOUTH AFRICA
Tel:+27-11-4828484/5/6/7/8/9 (RECEPTION & PABX) Fax:27-11-4828492/4824648 Email:firstname.lastname@example.org
South African Medical Association condemns Matthias Rath.
Southern African HIV Clinicians Society condemns Matthias Rath.
The Beginning of the End of Affordable Generics
Press Release Issued by the Affordable Medicines and Treatment Campaign, Medecins Sans Frontieres, Lawyers Collective HIV/AIDS Unit, Alternative Law Forum
Delhi, India, 22nd March 2005, 8:45 p.m.
Under a new Bill approved today, India will start granting product patents for medicines – something they have not done since 1970 - without the necessary procedures in place to safeguard against wholesale hiking of medicine prices. India amended its 1970 Patent Act in order to be compliant with the requirements of the World Trade Organisation.
A key safeguard to assure availability of affordable medicines is the procedure of compulsory licenses – government grants patents but allows generic companies to make their versions of the patented medicines against a payment of a royalty to the patent holder. However, in the Bill that passed the Lower House (Lok Sabha) today procedures are still extremely complex and there is no control on levels of royalties to be paid, which will lead to endless litigation and delays.
The new Bill "grandfathers" products that are already on the market by allowing for automatic right to produce. The generic companies in such cases will pay royalties to be set by the government to the patent holder. International norms for royalties are in the range of 3-4%. This new law however does not set a fixed royalty rate. In South Africa, GlaxoSmithKline attempted to charge 40% royalty until activists and the courts intervened.
The worst-case scenario for people living with life-threatening diseases has been averted, but only in the short-term.
People who rely on low-cost medicines will have to wait three years before a generic company can even make an application for a right to produce the drug. Whereas people in wealthy countries will have access to new medicines immediately when they are proved safe and effective, people in poor countries will have to wait years.
In addition, with this Bill the government has crippled the critical right of the members of the public to oppose patent applications on medicines, the so-called "pre-grant opposition". It is has been rendered ineffective because the essential information on which to base the opposition will be withheld from the public.
The Bill will go before the Upper House (Rajya Sabha) for a final vote. It is expected that the Upper House will approve the Bill in its current form.
Contacts: Leena Menghaney +91 98 11365412, Daniel Berman +33 677535317
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Statements by South African Medical Association on Matthias Rath
SAMA NOTES RESURGENCE OF UNFOUNDED THERAPIES FOR HIV/AIDS
DATE: MARCH 2, 2005
EMBARGO: NONE, IMMEDIATE RELEASE
The South African Medical Association (SAMA) notes with concern the resurgence of unfounded claims of alternative therapies for the treatment of HIV/AIDS as well as fallacious information contained in newspaper advertisements in recent weeks.
Most notable, the Dr Rath Foundation has advertised in national publications where they selectively quote from scientific papers and distort the information. In addition, they attack civil society organisations such as the Treatment Action Campaign and undermine the authority of statutory organisations such as the Advertising Standards Authority of South Africa. This reprehensible behaviour is despicable considering the enormous human cost of the HIV pandemic in South Africa.
Claims are also made with respect to the role of nutrition in the management of HIV/AIDS. Nutrition in conjunction with effective antiretroviral (ARV) therapy is vital in the long-term treatment of HIV infection. Any claim that purports that nutrition alone can deal with HIV/AIDS is untrue and suggestions that patients stop their treatment in favour of natural therapies is irresponsible.
Other claims with respect to the exorbitant costs and toxicity of drugs like AZT and Nevirapine is a further example of misinformation. The costs of ARVs have become considerably more affordable and the issues of toxicity and adverse effects are well researched and understood by the medical profession.
SAMA calls on clear thinking people as well as the Government to reject the misinformation of these organisations and join together in tackling HIV/AIDS based on sound scientific reason.
Issued by the Corporate Communication Unit of the South African Medical Association
Editorial Enquiries: Dr Mark Sonderup 083 626 1909
Enquiries: Corporate Communication, Magda Naudé Tel: 012 481 2042 / 082 452 5878 or Tracy Sage 012 481 2052/082 450 4332
THE SOUTH AFRICAN MEDICAL ASSOCIATION
Volume: 13 Number: 4
11 March 2005
Association comments on unfounded therapies for HIV/AIDS
The South African Medical Association (SAMA) is concerned about the resurgence of alternative therapies for the treatment of HIV/AIDS that have appeared in newspaper advertisements in recent weeks.
In a media statement, SAMA criticised the Dr Rath Foundation for advertising in national publications where they selectively quote from scientific papers and distort the information.
'This reprehensible behaviour is despicable considering the enormous human cost of the HIV pandemic in South Africa,' said Prof Denise White, vice-chairperson of SAMA.
In the advertisements patients were advised to discontinue their antiretroviral (ARV) treatment for various nutritional programmes, claiming these programmes brought better results. Prof White added that nutrition in conjunction with ARVs is vital in the long-term treatment of HIV infection. 'Any claim that purports that nutrition alone can deal with HIV/AIDS is untrue and suggestions that patients stop their treatment in favour of natural therapies is irresponsible,' she said. SAMA urged government to reject the misinformation of such organisations and to tackle HIV/AIDS based on sound scientific reason.
[END OF SAMA STATEMENTS ON RATH -BACK TO CONTENTS]
Statement by the Southern African HIV Clinicans Society on Matthias Rath
In a double-page spread advertisement which appeared in national newspapers including the Sowetan on 26 November 2004, the Dr Rath Health Foundation claimed that the Advertising Standards Authority (ASASA) was attempting to ban and discredit natural health in direct opposition to medical and biological science.
To the Society’s knowledge the ASASA do not have the authority to ban ‘natural health’ nor are they attempting to do so. Neither are they intent on discrediting ‘natural health’. They are a consumer body which take-up complaints with regard to perceived untrue, exaggerated and/or misleading claims made in advertisements used in the South African media.
The ASASA upholds the national Code of Advertising Practice in an attempt to prevent the South African consumer from being duped by unethical advertising practices into buying products which do not deliver promised benefits. The Code is intended to ensure that advertisers do not breach, amongst others, the following Clauses related to: honesty, substantiation, misleading claims, puffery, hyperbole, expert opinion, statistics and scientific information, headlines, disparagement, comparative advertising, safety, and advertising for over-the-counter-medicines. Their major responsibility is to the consumer and another is to protect companies competing with one another in the same market, with similar products.
The complaint lodged by the Treatment Action Campaign (TAC) and another, regarding the above-mentioned advertisement, resulted in the ASA ruling that most of the information appearing in the advertisement was insufficiently substantiated and should therefore be withdrawn. It also upheld Clause 6.1. which disallows advertising that directly or indirectly attacks, discredits and/or disparages other products (in this case, zidovudine - AZT).
In the 11 March edition of the Sowetan, the Dr Rath Health Foundation together with the Traditional Healers Organization of South Africa, and the South African National Civic Organization (SANCO) placed another double-page spread advertisement with the headline banner: ‘There is no place for the ASASA in Democratic South Africa’. It has the by-line: ‘The drug industry-funded Advertising Standards Authority (ASASA) is trying to keep life-saving health information from the people of South Africa’. In fact, there is a tax on all media advertising which supports the existence of this body. Using Dr Rath’s logic it could therefore be claimed that Dr Rath’s Foundation is part-funding the ASASA by placing such large (DPS) advertisements in costly high-readership daily newspapers.
With regard to the most recent advertisement, there could be a complaint from some quarter about the efficacy of ‘treating’ Aids with multivitamins. The internationally accepted classification of drugs used for the treatment of HIV/Aids is the ‘antiretroviral’ group of drugs which, when used in combination, decrease the viral load which in turn positively impacts on the CD4+ cell count. In HIV-positive patients, the HI-virus slowly, over a period of about 10 years (in most infected people) destroys the body’s natural store of CD4+ cells.
Dr Rath may not be aware of the Southern African HIV Clinicians Society’s* published Pre-ART guidelines, compiled and written by a sub-committee of South Africa’s most distinguished HIV/Aids experts. These guidelines give due attention to the use of nutritional and other supplementation (e.g. vitamins) prior to the administration of antiretroviral treatment (ART) which is usually reserved for 6-7 years post-HIV-infection i.e. when the immune system has been so badly damaged that the infected-person’s white blood cells (T-helper) or CD4+ cells have decreased in number to less than 200. CD4+ cells are used by the body to destroy invading foreign pathogenic organisms and therefore to fight off potential disease. When CD4+ cells fall below 200, HIV-infected persons begin to suffer from various diseases (called opportunistic infections or OIs) which are serious and may ultimately lead to death if untreated e.g. co-infection with tuberculosis, Cryptococcal pneumonia, Cryptococcal meningitis etc.
Dr Rath’s Foundation and colleagues may also face accusations of misleading consumers due to the claims regarding AZT being, "extremely toxic and kill people. They damage the immune system thereby worsening immune deficiency. This is why many people taking AZT get sick with tuberculosis and other infectious diseases." AZT is one of the most widely used and researched antiretroviral drugs used world-wide in the treatment of HV/Aids.
There is an overwhelming amount of research on the adverse effects and toxicities of ARVs generated by world-renowned and highly respected researchers and clinicians. Many of these studies have been conducted in countries which produce their own antiretroviral drugs at very low prices e.g. Brazil, South America, and none have found that the side effects of ARVs outweigh their benefits. ARVs are prescribed for a serious viral infection which eventually leads to death and they are given with the objective of lengthening lives, sometimes by up to 17 to 20 years, and markedly decreasing the occurrence of opportunistic infections. This, in turn, decreases expensive (often lengthy) hospital admissions and costly drugs to treat OIs (which are often far more expensive that ARVs).
Lengthening of life with a good quality (QOL) is of extreme importance for all people but especially so for adults who are parents, as it lengthens their productive years in the workforce and allows them to care for and educate their children until they are old enough to live productive lives themselves. Widespread use of ART therefore decreases the number of orphans being cared for by poor and aging grandparents, or roaming the streets in despair, being used by paedophiles and criminal elements, adding to the enormous pool of sexually abused children and petty and other criminals.
Dr Rath says in his more recent advertisement, that the TAC and "their financial backers: the Rockefeller Foundation support the pharmaceutical cartel" and that as a result South Africans pay the price with "Aids and their lives". It continues to say that, "….the pharmaceutical industry’s business in our country (SA) depends on the continuation of the Aids epidemic."
The DMI research data produced by a highly respected research house tracks all classes of pharmaceutical preparations from pharmaceutical companies/warehouses to pharmacies and, amongst other things, calculates the percentage of the pharmaceutical Rand for which the classes of drugs are responsible. The ARV’s are responsible for only a very small percentage of the total pharmaceutical market. Much larger markets are: antidepressants, antibiotics, anti-inflammatory drugs, antihypertensives etc. We believe therefore, that the above statement is incorrectly informed.
Of related interest is that at a recent briefing to the National Assembly’s Science and Technology Committee, by the Medical Research Council’s (MRC) Interim President, Professor Anthony Mbewu, he was reported in the Star 16 March 2005, to have said that cardiovascular disease accounts for 25% of the disease burden of South Africa and costs the country about R4-billion a year more than it did a decade ago. He said that the figure was now likely to be nearer R10-billion - in the same region of HIV/Aids. He was talking about ‘cost to the country’ which to date has mostly been for hospitalization for treatment of HIV-infected people with OIs, and terminal care. Only recently has the National ARV Rollout begun. In time the costs of ARV will be included into "cost to the country". Interestingly, in Brazil the cost to the country diminished when ART was introduced as OIs diminished along with the related drug treatment and hospitalization costs.
Some indisputable facts in support of the provision of widespread use of ART for HIV/Aids in appropriate individuals (CD4+ count of 200 or less – SA DoH recommendations) in developing countries have come not from a doctor or a pharmaceutical manufacturer but from a respected international economist.
Last week, in an article published in Time (14 March 2005) Dr Jeffrey D. Sachs, an economist and Director of the United Nations (UN) gave some compelling reasons why the world’s challenge in developing countries is not to overcome laziness and corruption but rather to take on the solvable problems of geographic isolation, natural hazards and poor health including the ravages of AIDS. He listed vigorous prevention and treatment of endemic diseases together with clean water and productive soil as the absolute minimum in dealing with the vicious cycle of extreme poverty.
Dr Sachs is author of The End of Poverty and spends his life going round the world promoting the UN’s Millennium Development goals. He is special adviser to Kofi Annan and head of Columbia University’s Earth Institute. Dr Sachs says that extreme poverty, with all of its ‘killers’, could be ended by 2025 if good ‘clinical economics’ were employed. He says that there are similarities between good development economics and good clinical medicine.
He reports that one-sixth of humanity (1.1 billion people worldwide) live in extreme poverty or ‘poverty that kills’ which is defined as an income of less than $1 a day. More than 8 million people around the world die each year because they are too poor to stay alive.
Dr Sachs says that they die due to:
and a lack of:
drugs (including antiretrovirals)
functional health systems
antimalarial bed nets
safe drinking water
good (productive) soil
The Society would sincerely request that the Dr Rath Health Foundation, the Traditional Healers Organization of South Africa and SANCO cease to add to the confusion that already abounds in the arena of HIV/Aids pre-ART and ART- treatment in southern Africa. Ultimately it ends in more deaths of HIV-infected South Africans as, when they fail to take ARVs, or take ARVs incorrectly, they suffer from fatal opportunistic diseases and may develop resistant organisms. Patients may also be tempted to take ARVs with other (non-researched) substances which may interact with them, causing toxic side effects.
It is most important for all South Africans to speak with one voice on this issue, in line with the world’s leading medical researchers, HIV/Aids clinical and virology specialists, and "medical" economists, in order to make any impact on prevailing death rates from HIV/Aids.
We would like to point out that ARVs are:
much more affordable than they used to be (more so than many other treatments for diseases such as cardio-vascular disease, diabetes, high blood pressure, antidepressants, anti-cancer drugs etc
allow people to lead productive lives for a longer period of time
allow parents more time to input into the lives of their children
allow young people to qualify and obtain employment in order pay off university loans to educational institutions and banks, pay taxes and buy houses and goods (all of which impact positively on the economy)
allow more people to receive and pay for services
allow employers to employ HIV-positive skilled workers for an extended period of time
do have side effects like all ingested substances, but the serious ones are rare if patients are managed by experienced clinicians
benefit the economy in the short, medium and long-term.
In the Star on 16 March 2005, Sheena Adams reported that the burden of Aids and an alarming increase in the rate of heart disease could result in a decline in the economy. Gross domestic product could decline by between 0,3% to 0,6% in the next 10 years. She warned that government incomes might also decline as tax revenues fell.
*The Society is a registered South African Medical Association (SAMA) Special Interest Group (SIG) for doctors with a special interest in HIV/Aids. It is a Public Benefit Organisation with over 8 600 members (mostly doctors) and produces the specialist quarterly publication, Southern African Journal of HIV Medicine. Website:www.sahivclinicianssociety.org. The Society has to date trained more than 6 000 doctors in the correct use of ARV’s through a recognized, registered HIV Management Course.
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