Microsoft word - agoa talk 2.doc

AGOA Conference, Workshop on Health Infrastructure.
January 2003
I work for a health NGO based in South Africa and given what I am going to be saying, I think it is important to point out that we do not receive any funding from the pharmaceutical industry, nor from the chemicals or insecticides industry. I would like to talk about some of the exiting developments that are taking place between the private sector and public sector in the protection of public health and development of new drugs. I will also talk about some entirely private initiatives that do not have any input from the public sector. I happen to believe (and I feel with good reason) that in many cases, the private sector is far better in public health projects than governments and so I would like to discuss some of the bureaucratic and legal impediments to private sector involvement in healthcare. I have been researching and writing about malaria and malaria control for some time and so will spend a good deal of time talking about malaria. I do this with good reason. The WHO estimates that there are between 300 and 500 million cases of malaria every year in Africa, with more than 1 million deaths, mostly children under the age of 5. There are two exciting and entirely private initiatives to control malaria in Africa. The first is funded by Mozal, the state of the art aluminium smelter in southern Mozambique. This smelter was a huge investment $1.2 bn initially plus a further $800 m built in an area of appalling poverty and deprivation and where the malaria parasite prevalence rates were around 90%. (Compared to about 40% prevalence in KwaZulu Natal Province of South Africa and 3% in Swaziland). Malaria was resulting in high incidence of morbidity and mortality among the construction workers and then subsequently the smelter workers. Mozal engaged Foray Consultants who are (as far as I know) the only entirely private vector control company in the world. With a vector control programme using insecticides and insecticide treated bed nets and larviciding as well as providing proper treatment & education. Mozal recognised that they simply couldn’t control malaria in their area alone and so they funded the extension of the malaria control initiative undertaken by the governments of South Africa, Swaziland and Mozambique. This has ensured that almost the entire area from Matola (near Maputo) to the border of South Africa and Swaziland is now well protected from malaria. The result has been a 40% reduction in parasite prevalence rates which is a great achievement and it looks as though these efforts will continue and will improve. Another great example of private control of malaria is in Zambia on the copper belt. Konkola Copper Mines operates in Chingola and Chililabombwe and were recently privatised. While nationalised, malaria control activities broke down and there was little or no malaria control in the region since the 1980s. During the 1970s, when there was some malaria control, the incidence of malaria was around 20 per 1000 population. This however had risen to 158 per 1000 by 2000. The newly privatised mine undertook malaria control activities, under a plan formulated by Dr. Brian Sharp from the Medical Research Council in South Africa. This programme was based mostly on vector control using indoor residual spraying protecting around 280 000 people. The insecticides used are DDT and synthetic pyrethroids and I will discuss the issue of DDT a little later if I have time. The results of this programme have been extraordinary – The programme began in 2000 and you can see that in 2001 there was a 50% decrease in malaria cases and in 2002 there was a further 50% reduction. These are two extraordinary efforts that are not only saving lives, but creating an environment in which business can be done and wealth created. I would like to briefly discuss a great public private partnership in drug development – the Medicines for Malaria Initiative. This is a partnership between among others the Gates Foundations, the WHO, the Exxon Mobil Foundation, the British Aid Agency, DFID and the International Federation of Pharmaceutical Manufacturers Association. In addition, the private sector involvement has come from GlaxoSmithKline, Bristol Myers Squibb, Bayer, Roche, Jacobus Pharmaceuticals and Korea’s SP Pharma. All of these companies have contributed financially, but more importantly have devoted technical expertise and infrastructure to the effort. The upshot of this is that MMV is now managing the largest portfolio of anti-malarial drugs in history. Research is taking place to bring new artemesinin combination therapies (I’ll talk more about these in a second) and is improving existing drugs and conducting research into entirely new compounds to attack the various different stages of the parasite’s life cycle. It is likely to be between 3 and 4 years before new drugs are available. The projected costs of MMV are around $25m for next year, however the value of the investment is double this as much of the contribution from the private sector has come in the form of expertise and laboratory facilities rather than cash. Another important private sector commitment to developing malarial drugs has come from Novartis. This Swiss based company has produced the first single dose artemesisin based combination therapy. Artemesinin is currently the most effective anti-malarial drug based upon the Quishoa the ancient Chinese herbal remedy. Coartem is a combination of artemesinin and lumefantrine and is highly effective at treating malaria, and is particularly useful in areas where there is resistance to Chloroquine or Sulphadoxine Pyramithamine. The artemesinin is produced in China and unfortunately the extraction process is complex and expensive, hence the efforts underway to develop a synthetic version of artemesinin. South Africa has introduced Coartem as its first line treatment in areas where there is drug resistance and has secured very favourable pricing for this drug. Novartis is selling the drug at cost to African countries via the WHO and I was delighted to hear recently that Zambia has now decided to use Coartem as its first line treatment. Even though Coartem is being provided at cost, it is a great deal more expensive than Fansidar (which in many areas was the first line treatment). I think that it is important to be reminded however that Coartem works, where Fansidar fails and so one has to take into account the costs of the failed treatment, repeated doses and the economic costs of a population being unproductive and sick because of a lack of effective drugs. Despite the fact that it is more expensive however, it is important to put these drug costs in perspective. If we assume that South Africa’s Limpopo Province were to give Coartem to all its malaria cases (which it wouldn’t as it is only used in the case of resistance) the total cost of the drugs would only amount to 1.35% of the total malaria control costs. Anyway, these are two very important initiatives where research based drug companies are committing enormous resources to combating poverty diseases. I think the other speakers may touch on some of the other private sector initiatives in disease control, so I won’t dwell on this. I should mention however that there are initiatives to combat a number of poverty diseases from almost all of the large research based drug companies. These initiatives are estimated to have been worth almost $2bn over the last 4 years. I have mentioned how successfully indoor residual spraying has been in controlling malaria and saving lives in Southern Africa. There are a number of companies that are involved in the development of insecticides for vector control and in supporting public health programmes. Avima, the South African company that supplies among other products DDT provides enormous support and training to a number of the malaria control programmes in Southern Africa. Bayer is also very involved in providing support, education and training to these programmes. Sasol (another South African company) is doing some innovative research in developing new insecticides and repellents. I also recently heard of a public private partnership to develop mosquito repellent materials for emergency situations. This aims to provide insecticide treated tarpaulins, blankets and other materials to refugees and other displaced people in Africa. The major market however for insecticides is agriculture and so public health normally has to take whatever is developed for farmers. I should note that the precautionary principle which is feted by so many people, acts as a significant disincentive to industry to develop new insecticides. The unscientific nature of the precautionary principle along with the discretionary powers given to regulators is certainly not going to help to bring much needed new insecticides to the market. It would be remiss of me to mention the use of insecticides and indoor residual spraying (IRS) without commenting on donor agency policies on this topic. Despite the fact that DDT is being used to save lives so successfully in so many places, no OECD donor agency will fund its use. In fact they will not even fund IRS with any insecticide, preferring to fund what is politically correct – ITNs and bio-environmental control. I think it is high time that donor agencies sat down and thought about what they doing in Africa. If they are here to implement politically correct policies that are designed to keep environmentalists in Northern countries happy, then at least admit this. If they are here to save lives and encourage development, then they should fund what works and not what looks pretty for their glossy brochures. I want to spend a minute or two just mentioning some of the obstacles private involvement in healthcare. Top of my list is the bureaucracy that authorises new drugs. In South Africa, a drug that is registered for use in the US, Europe and Japan can take between 2 to 3 years to be registered. The system is slow, inefficient, unresponsive and there are a catalogue of horror stories that I have heard from drug developers about the bureaucracy. I was driven to despair recently when I sat through a presentation by the head of the Namibian MCC. She explained how all the drugs that were registered prior to 1990 in Namibia were now no longer registered and she required all documentation for the re-registration. Namibia obtained its independence in 1990 and so they decided to turn the clock back and start a fresh from then. This kind of bureaucracy is expensive, time consuming and frustrating and sends a message to the developers of drugs that Government is only interested in building bureaucratic empires on the back of their innovation. It is those in need of medicines that pay for this with higher drug prices and lengthy delays before the drugs are available. This is a sort of gruesome experiment that the various bureaucracies are conducting on the people of Africa and it has to be stopped. There are a number of other legal and bureaucratic obstacles, but I will only dwell on 1 other. In Kenya and Tanzania, most people get essential drugs not from clinics or hospitals, but from general traders, small shops and kiosks. The reason is that the public sector has failed utterly to respond to the demand for drugs, while the private sector has responded effectively. Yet this trade is illegal and these shop owners have to be secretive about their trade. This is madness. Because it is illegal, shop owners cannot receive training on storing or dispensing drugs and find it difficult to improve their service. They also cannot advertise, compete effectively and improve their service. One last point – can someone please explain to me why governments are imposing import duties and taxes on drugs that are being sold to poor countries at cost or at huge discounts. You cannot convince me that a government is serious about increasing drug access when it slaps on taxes to low cost drugs. This is destructive madness. If African countries want to attract a greater share of drug development, Rob Ridley from the WHO is of the opinion that intellectual property protection is the most important institution that should be in place. There is an interesting example in India. I have spent quite a bit of time there recently and it is an extraordinary country. It estimated that it has between 10 and 20 million cases of malaria every year and there are over 22 000 drug companies in India. Not one of these companies has contributed a single cent to the MMV. The reason given by Dr. Venugopal from the MMV in India is that these companies cannot protect their IPR and so are unwilling to even begin research. IPR is important in drug development and the evidence is increasingly clear that it plays little or no role in blocking access to drugs in Africa. The barriers to drug access are poverty, a lack of health infrastructure, a lack of political will, stigmatisation etc. It is my opinion that all the discussion surrounding TRIPS, drug patents and access to drugs is a huge red herring. It is directing attention away from the real barriers to drug access and is allowing Pascal Lamy and the Europeans to drag their feet on reducing agricultural barriers to trade. If we are concerned with increasing drug access, we need to create wealth and the best way to do this is to allow Africa to sell more goods abroad. In conclusion. The reason that there were reductions in infectious diseases in Europe came about from improved sanitation, better water supplies, better nutrition and housing. Basically these came about from increased wealth. If we want to improve health in Africa, we need to increase wealth and the best way to do this is to increase economic freedom, and to trade more. We want trade not aid and so I am really encouraged by the benefits that can come from AGOA. I think that we should be cooperating more with research based drug companies, rather than fighting them at every turn. I want them to see profitable commercial opportunities in Africa, not just a charity case. NGOs can play an important role here in working with both the public and private sector. We need to challenge donors so that they fund what works and what is appropriate and not what is politically correct. We need widespread reforms to the bureaucracies in Africa (and I have to say in Europe and the US) so that we can reduce drug prices. I strongly believe that the best public private partnership is found where the government does as little as possible, removes, destructive laws and regulations and allows the private sector to flourish and do what it does best. Thanks


Microsoft word - medical history form revised.doc

10. Hormone Replacement Medication History Please identify all the products you have used How Often? (e.g. # times Pharmacist’s Comments Estrogens (e.g. Premarin®, C.E.S. ®, Topical Estrogens (e.g. Estrogel®, Vagifem, Estraderm®, Vivelle, Climara®, Estradot®, Premarin® Vag Cream, Tri-est) Progestins (e.g. Provera®, MPA, Progesterones (e.g. Prometriu


aDivision of Toxicology, Albert Einstein Medical Center, 5501 Old York Road,bThomas Jefferson University Hospital, Philadelphia, PA 19141, USAcChildren’s Hospital of Philadelphia, Philadelphia, PA 19141, USAdPhiladelphia Poison Control Center, Philadelphia, PA 19141, USAThe term salicylate refers to any of a group of chemicals that are derivedfrom salicylic acid. The best known is acet

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