Food and Drug Administration
The registrar of medicines, Mandisa Hela, admitted to MPs yesterday that the Medicines Control Council could not cope with its workload, and was in dire need of an overhaul.
FDA is weighing, for over-the-counter purchase and home use, a saliva-swab test that is 99% accurate.
Attempting to treat millions of HIV patients in developing countries is a noble goal that humanitarian organizations will probably eventually achieve. Currently, however, the World Health Organization (WHO) and the Clinton Foundation are making costly errors concerning the number of treated patients and the price of drugs. These inaccuracies encourage the belief that more widespread treatment is possible. This in turn leads to unsustainable programs. Moreover, the organizations' imprecise numbers for treatment and drug pricing are encouraging the use of low-quality, insufficiently tested drugs to fight HIV. This will result in misery for those not sustained by treatment and exacerbate drug resistance problems for all who are HIV positive.
Johannesburg - Generic antiretrovirals are not likely to have any short-term impact on prices, the Treatment Action Campaign's legal representative said on Tuesday.
Anti-retrovirals (ARVs) could cost South Africans as little as about R100 a month and local manufacturing of generics could start as early as next month, it was announced on Tuesday.
WASHINGTON -- The government's research on using an AIDS drug to protect African babies was so flawed that health officials had to use blood tests after the fact to confirm patients got the medicine. Ultimately, they had to acknowledge the study broke federal patient protection rules.
DRUG manufacturer Aspen Pharmacare has got the nod from the US government to produce and supply generic HIV/Aids drugs, news that could see the SA firm receive millions of dollars in funding.
CLOSING DATE: 14th September 2009
Enhancing Childrens HIV Outcomes (ECHO) purpose is to save and enhance the lives of children and adolescents infected and affected by HIV and AIDS.
For a payment of R150 Albertina Shakoane will provide five litres of her mauve-coloured tea she claims will cure AIDS. She makes the infusion from a small leafy plant, which her father pointed out to her when she was growing up in Cullinan, describing it as a medicinal Jack of all trades. Shakoane says she has 20 customers, and as news spreads in her community, demand is growing. Shakoane's treatments are illegal. The World Health Organisation estimates that 80% of people living in Africa use traditional medicines. At present 70% of South Africans consult the more than 200000 traditional healers in the country. The African traditional medicines market is unregulated, leaving consumers vulnerable to unsubstantiated claims and potentially lethal remedies. There are countless concoctions on the market that have absolutely no therapeutic benefit. Diluted Jeyes Fluid, industrial solvents and battery acid are just some of the dubious ingredients commonly found in fake traditional medicines.The ever-increasing numbers of people infected with HIV, few of whom have access to antiretroviral medicines, are contributing to the demand for traditional medicines. Traditional remedies, which have evolved amongst indigenous communities in SA over thousands of years of careful use and observation, hold hope of new treatments and perhaps even cures for diseases. The problem is sifting through the claims, and deciding which remedies to subject to scientific scrutiny with the limited resources available to conduct clinical trials, says Gilbert Matsabisa, head of the Medical Research Council's Indigenous Knowledge Systems health unit. An initiative launched at the weekend by the health department may help efforts to find the effective traditional remedies. The National Reference Centre for African Traditional Medicines is a virtual institution that will be jointly managed by the Medical Research Council and the Council for Scientific and Industrial Research (CSIR). It plans to establish a network of experts and facilities, and a database that captures information on traditional remedies and encourages people who bring cures to track the progress of research into their products. We expect samples to come in from a wide range of sources, from plants that are widely used to those that are not. We will prioritise (claims) based on their usage and national priorities, says Vinesh Maharaj, business manager for bio-prospecting at the CSIR's Biochemtek division. (Source: Tamar Kahn: Business Day, 3 September 2003)
The World Health Organization on Wednesday will present its case for US approval of a malaria drug that may save the lives of patients around the world who now lack access to emergency treatment. The WHO is seeking US Food and Drug Administration approval for a rectal formulation of artesunate, which may help people who are too far from a hospital or clinic to get injectable drugs, and who are too sick to take oral medications. We saw a public health need....If we could develop a drug that would substitute for an injectable, this would reduce the mortality that often arises, WHO researcher Dr. Melba Gomes said in an interview. No company appeared to be wanting to do this, Dr. Gomes added. There is not a great deal of money to be made from malaria drug development. The WHO is in talks with a small Danish company that may produce the rectal formulation, Dr. Gomes said. Clearance from the FDA and other regulators known for high standards would make it easier to win approval for the drug in developing nations, Dr. Gomes said. The WHO aims to work initially on making the drug available in a handful of countries where disease prevalence is highest.