Combination Therapy Might Be Better Choice Than Nevirapine Alone To Prevent Vertical HIV Transmission, Researchers Say
Antiretroviral drug combination therapy might be more effective in preventing mother-to-child HIV transmission and less likely to foster drug resistance among pregnant women than single-dose nevirapine, according to data presented this week at the... 12th Conference on Retroviruses and Opportunistic Infections in Boston, the Washington Post reports.
The Medicines Control Council (MCC) has declared a generic version of antiretroviral (ARV) Duovir undesirable and ordered a recall, the manufacturer confirmed on Thursday.
There is an urgent need for local suppliers of anti-retrovirals (ARVs), according to people living with HIV/Aids, pharmacies and manufacturer GlaxoSmithKline. This was highlighted by shortages this week in the supply of ARVs to South Africa. Despite the government's decision to roll out the provision of ARVs, a lack of planning has meant temporary shortages - and could presage future crises if problems are not dealt with. This week, GlaxoSmithKline lost two batches of 300mg Retrovir (AZT) in transit. The pharmaceutical company's spokesperson, Vicki Ehrich, described the loss as a rare short-term hitch, but concurred that an alternative local supplier would be helpful. GlaxoSmithKline, she said, had done its bit by granting a voluntary licence to generic drug manufacturer Aspen Pharmacare for the manufacture and sale of three anti-retrovirals - Epivir (3TC), Retrovir and Combivir - in 2001. Aspen Pharmacare is, however, still awaiting approval from the Medicines Control Council (MCC) to manufacture the drugs. A pharmacist who did not want to be named said her pharmacy was having trouble estimating the demand for the ARVs every month. Aspen's Philip, also citing the ever-increasing infection rate in South Africa, underlined the need to nurture a domestic pharmaceutical industry. It does help to have the medicines available locally. Such a factory would also be at the MCC's doorstep to inspect and monitor quality control. But Treatment Action Campaign spokesperson Mark Heywood attributed the current shortage to the incompetence of pharmacies and suppliers: You can always plan for emergencies. He said local drug manufacturers could be part of a back-up plan should imported supplies fall short. (Source: Jaspreet Kindra, Mail and Guardian, Johannesburg ,12 December 2003 )
The reduction will drop the price of Combivir, an HIV/Aids treatment recommended by the World Health Organisation, to 90 cents a day in 63 developing countries, including South Africa. The pharmaceutical company announced it would also reduce the price of Epivir, commonly known at 3TC and Retrovir, also known as AZT, by 45% and 38% respectively. TAC spokesperson Nathan Geffen said the price reduction was not being made available to pharmacies which was where most patients obtained their medication. Only about a 1 000 people get their medication through the public health system. Most people get their medication in the private sector. Geffen said the only way of keeping prices substantially low was through generic competition. He said GlaxoSmithKline also needed to clarify if it was going to lower the price of Lamibudine. Combivir is made up of AZT and Lamibudine. He said while Glaxo's action was insufficient, the positive side was that the drugs were being offered to employers who were treating their workers who were not part of medical aid plans. Jean-Pierre Garnier, Glaxo's chief executive, emphasised yesterday that this was not its first price cut. Glaxo has said it has trebled sales from two million people treated to six million in the 63 poorest countries between 2001 and 2002. Sales had not increased much since the last price cut, but manufacturing processes had improved. (Source: Sapa, Guardian Newspapers Limited 2003, Sapa,29 April 2003)
US-Based AIDS Healthcare Foundation is planning to file a complaint with the SA Competition Commission against pharmaceutical giant GlaxoSmithKline, in a bid to widen access to AIDS drugs. The attorney representing the foundation in SA, Musa Ntsibande of law firm Strauss Daly, said yesterday that the complaint would argue that Glaxo abused its dominant market position in contravention of the Competition Act, and was engaging in excessive pricing of its drugs to the detriment of the consumer. Glaxo holds the patent for the antiretroviral medicines AZT, Lamivudine (3TC), and a combination of the two (Combivir), which are used to treat HIV-positive patients. Glaxo is opposing a lawsuit brought against it by the foundation in the US, in which the foundation is challenging Glaxo's patent on the drug AZT The foundation's US attorney, Ron Katz, said yesterday that the foundation was challenging Glaxo on the grounds that it had defrauded the US patent office. The foundation was therefore seeking to have the patent declared invalid, he said. The foundation describes itself on its website as the largest specialised provider of HIV medical care in the US. Its presence in SA is confined to a pilot HIV/AIDS treatment project in KwaZulu-Natal, which it established last year in partnership with a local nongovernmental organisation called Netcom SA, to provide antiretroviral medicines. The pilot programme's doctor, Paul Musoke, said that more patients could be treated if the drugs were cheaper.(Source: Tamar Kahn: Business Day, 28 January 2003)
The European Union is taking measures to prevent low cost drugs intended for patients in some of the world's poorest countries from being diverted and resold for huge profits in the West. By clamping down on the illegal trade in reimported drugs that undercuts standard European prices, the EU is hoping to encourage pharmaceutical companies to expand the trend of making medicines available at special rates to the developing world. The initiative comes amid growing evidence that cut price drugs are being diverted onto the European market. Recent investigations by Belgian customs authorities uncovered large quantities of GlaxoSmithKline productsnotably Combivir (zidovudine) Epivir (lamivudine), and Trizivir (abacavir)destined for Africa being sold in the European Union. Under the scheme, which covers both patented and generic products, companies will register with the European Commission the drugs they intend to sell at lower, tiered prices. These would then be stamped with a highly visible special logoa light blue capital E surrounded by 15 gold stars to alert customs that they should be banned from re-entering the union. To qualify for the register, the commission has, for the first time, proposed a definition of low cost, tiered pricing. The drugs must be sold at either the cost of production plus 10% or at a price reflecting 80% off the average ex factory price in member states in the Organisation for Economic Cooperation and Development. Initially, the scheme will only cover medicines for the prevention, the diagnosis, and the treatment of HIV/AIDS, tuberculosis, and malaria and will apply to 49 least developed and 23 other low income countries, mainly in Africa and Asia. Announcing the plan, Pascal Lamy, the EU trade commissioner, said: The EU wants to set an example with a practical means of helping poorer countries struggling with public health crises. Vaccines and contraceptives have long been available at affordable prices now developed countries need to make an effort with other medicines. He added that the initiative was a concrete example of the trade liberalisation commitment made during last year's negotiations in Doha, Qatar, and was just one element of a broader poverty reduction and health programme for the developing world. The commission is confident that the governments in EU states will approve the plan before the end of the year, and it is hoping that other major pharmaceutical producing countries, notably the United States, will follow its example. However, it also acknowledges that to a large extent the success of the scheme will depend on the vigilance of customs authorities. Source: BMJ 2002;325:1058,9 November 2002 .
WASHINGTON Nearly $18 million worth of reduced-price HIV drugs intended for impoverished Africans have been intercepted by profiteers and shipped back to Europe to be sold at marked-up prices, according to a current investigation. As a result of the scheme, nearly a quarter of the supply of the anti-retroviral drug Combivir that was intended for African patients has not reached them in the last year, said the drug's manufacturer, GlaxoSmithKline. Instead, it and two other Glaxo HIV drugs were sold in Germany, the Netherlands, Britain and Switzerland by European wholesalers that now are under investigation. Glaxo used air-freight companies to transport the medicine to Africa. On the ground, according to the documents and Glaxo executives, the shipments were moved from one company that handles customs clearances on imports to another, and then to an air-freight service employed by the profiteers and flown to Europe. Delivered to wholesalers there, the drugs made their way into the regular chain of commerce. Because the drugs were identical to European versions, the pharmacists who bought them could innocently have thought they were their usual orders, Salet said. After agitation by AIDS activists to improve access to treatment in developing countries, Glaxo discounted Combivir, which costs between $4 and $6 a pill in Western Europe, to 80 cents a pill in sub-Saharan Africa. The diverted medicines were intended for use in Congo Republic, Senegal, Ivory Coast, Togo and Guinea-Bissau, according to European sources. The scheme involving Glaxo's products has been going on since at least July 2001 but was undetected by the drugmaker and European regulators until this July, when customs inspectors in Belgium noticed irregularities in a shipment sent from Senegal. Glaxo estimates that 28 shipments of Combivir, Epivir and Trizivir were diverted, totaling close to 3 million doses. Those shipments, worth $18 million retail, moved from the five African countries through Paris and Brussels, then into Antwerp, the Belgian city where inspectors noticed discrepancies in July. None of Glaxo's discount customers complained that they had not received their products, a lapse that might be explained by inventory problems or delays between shipping and billing. The Washington Post Friday, October 4, 2002
The Treatment Action Campaign' (TAC) and the Congress of SA Trade Unions (Cosatu) launched a new broadside in their campaign to widen access to affordable AIDS drugs, lodging a complaint of excessive pricing with the Competition Commission against multinational drug companies GlaxoSmithKline and Boehringer Ingelheim. If the Competition Commission refers the case to the Competition Tribunal, it will open up the possibility of the companies being ordered - under provisions in the Competition Act - to reduce the prices of AIDS drugs in the private sector.They could also be forced to pay a penalty of up to 10% of their annual turnover in SA and face damages claims from individuals. The complaint alleges that the local and international operations of the companies have engaged in excessive pricing of antiretroviral medicines, used to delay the onset of AIDS. It also alleges that the pricing practice is detrimental to the consumer because it is directly responsible for premature, predictable and avoidable deaths of people living with HIV/AIDS. Geffen said the commission would consider a price to be excessive if it was higher than one reasonably related to the economic value of the product. Three of the drugs in question are manufactured by Glaxo AZT (Retrovir), Lamivudine (3TC) and the two in combination (Combivir). Boehringer is being challenged over the price of Nevirapine, which it manufactures under the brand name Viramune. Antiretroviral medicines are currently available only in the private sector because government policy limits provision of the drugs in state facilities to victims of sexual assault and medical personnel injured at work. Boehringer SA MD Kevin McKenna said yesterday he rejected completely allegations that the company had abused its dominant market position to charge excessive prices. The SA price of Viramune was about 20% of that in developed countries. Glaxo's director for corporate affairs, Vicki Ehrich, said a preliminary assessment of the complaint led the company to believe that it was unjustified We reject the allegations of excessive pricing. Glaxo's pricing in the private sector in SA was among the lowest in the world. The price of Combivir, for example, was 80% lower than the world average, she said. She also pointed out that Glaxo had offered its AIDS drugs at preferential prices to governments in the developing world, including SA, and they had not taken up the offer. Nine complainants have joined TAC and Cosatu in the case. (Source: Business Day, 20 September 2002)
Prices of AIDS drugs set to drop: Voluntary licence granted to local firm to manufacture antiretroviral AZT and 3TC
Prices for AIDS drugs will become more affordable with the announcement this weekend of two initiatives aimed at cutting the cost of the most frequently prescribed antiretrovirals. Multinational pharmaceutical company GlaxoSmithKline (GSK) said yesterday it was granting a voluntary licence to local firm Aspen Pharmacare to produce AZT and 3TC - as well as the combination pill Combivir exclusively for the public sector. The deal also obliges Aspen to pay 30% of the net sale price to non-governmental organisations dealing with HIV/AIDS. At the same time Cipla-Medpro, the local associate of Indian pharmaceutical manufacturer Cipla, has submitted a complaint to the Competition Commission alleging that GSK and Boehringer Ingelheim abused their patents. Cipla manufactures Nevirapine, an antiretroviral drug that helps to prevent the mother-to-child transmission of HIV. Cipla-Medpro CEO Jerome Smith said late last night that the complaint might now have to include Aspen Pharmacare. The only real market in SA for antiretroviral drugs has been in the private sector as government has consistently refused to provide the life-prolonging drugs to public sector patients who could not afford them. GSK has kept the lucrative - albeit small - market that includes medical aid schemes and larger buyers, like mining or manufacturing companies like Ford or DaimlerChrysler. The Cipla action is groundbreaking and challenges the way the patents have been used by both companies to keep drug prices high. Cipla has chosen to challenge the patents through the commission initially, but it will use the Patents Acts if necessary. Cipla's complaint says that the patents and licence-holders qualify as a dominant firm in terms of the Competition Act, and claims that they have abused that dominance. James Love, director of the Washington-based consumer project on technology, believes that GSK needs to be challenged further on its drug policy for the private sector, and says that the competition which the Cipla action will bring, will see prices lowered further. (Source: Business Day, 8 October 2001)
None of the rape survivors given antiretroviral drugs by Sunninghill Hospital has become HIV-positive, according to Dr Adrienne Wulfsohn, who heads the Sandton hospital's accident and emergency unit. Sexual-assault survivors who come to Sunninghill's Albertina Sisulu Rape Crisis Centre within 72 hours of being attacked are offered a three-day course of the antiretroviral drug Combivir if they consent to an HIV test and test negative. They are then advised to buy their own Combivir (a combination of AZT and 3TC) for a further 28 days at a cost of R900. Despite the poverty of many patients - most of whom are from Alexandra, Diepsloot and Zevenfontein - it's amazing how many of them manage to raise the money, said Wulfsohn. The crisis centre treats about 50 women and children free of charge each month as part of the Netcare group's service to communities, Wulfsohn pointed out. The cost of fully treating a sexual-assault case is about R8 500. The Netcare clinics in Gauteng offering this service pro bono cost the group about R2,3-million last year, said Wulfsohn. The Medicines Control Council has not approved Combivir for use after sexual assault, so the patients have to sign a consent form which explains that they might still get HIV. (Source: Health-E, 3 July 2001)