amanet-trust.org

[fsaguti]

1. ITNs/LLINs have without doubt proved their worth. Who should provide them after their trial: to the control group/community; neighbouring communities; far off communities, etc.  How long, and how soon should they be provided?

In the phase of eliminating malaria, policy makers( government and other stake holder) should be up front on providing these ITNs/LLINs to the community,

2. It has taken almost 30 years to scale up ITNs/LLINs for public health use. Investments by the private sector were very late. Would the process take as long if the product was for a rich man’s market? Explain.

I do not think that private sectors were very late to invest on ITNs/LLINs because it targets the poor and not the rich man. What I see in my perspective is there were no intensive awareness on the matter that could let private sectors to have early alert.

[nkechianunobi]

CASE STUDY 10
1) The sponsor though negotiation with the relevant representatives of the host countries, the participants community, neighboring communities, scientific, advocacy, NGO groups, and the private sector. It should be provide as soon as the trial findings are published and policy formed.

2) No, investment would have been directed towards it, if it was for the benefit of the rich or the developed nations. This is because of the availability of resources, the great emphasis and attention paid to health, as well as the strict adherence to the ethical principles of research in their setting.

3) The principle of beneficence and justice was abrogated. The informed consent process which should have emphasized that the rural dwellers and their participants would first benefit from the product of the trial did not do that, hence the poor rural dwellers were merely research tools for the benefit of the rich urban settlers, thus negating the principle of respect for their persons and justice.
4) a. No; the African ethics committee should negotiate with the sponsors of the research in malaria involving ITNS/LLINS.

b. Yes; the researchers should incorporate ITNS/LLINS into other interventions they tend to study since the efficacy of the ITNS/LLINS are already proven otherwise it would amount to using them as placebo in the presence of an existing proven intervention. The universal coverage of persons at risk should not be compromised in any way.

c) No; appropriate blinding and statistical design, random selection of subjects from planning to implementation will avert complication during interpretation.

5) a. Yes; the lonely NMCP is right since the polythene LLINS has passed the phase 111 trial and is therefore ready for public health use while the polyester LLINS has only interim approval of phase 11 trials, thus not ready for public health use.

b. No; they should not. The country’s’ standard of care can be augmented by donor; otherwise it would amount to intimidation and exploitation.

c. No; they should maintain their stand, the donors if they are really interested in reducing the morbidity and mortality should augment the effort of the one NMCP.

6) Why should the LLINS with interim approval be allowed wide spread use?
If the disease burden were in the developed countries, will a product with phase 11 interim approval be allowed wide spread public use?
Is it because the developers of the LLINS with phase 11 interim approval are Europeans?
The Japanese LLINS surpassed that of the European countries in terms of quality, durability, effectiveness, has passed phase 111 trial is ready for public health use, is cheap and is guaranteed.
Whereas the Japanese LLINS cost $5 , lasts for 5-7 years, that of the Europeans cost $3, lasts for 2-3 years.
Why is it not then preferred to the European counterpart?
Why has WHO not stopped the wide use of the LLINS with phase interim approval? A Case of double standard?
Is the ethical principle of beneficence and justice upheld in this case?

[TONA LUTETE GASTON]

Case 10
• Basically it must be the governments that should provide LLNTs to the population. They need to choose the best ones in terms of efficacy and safety. But as our nations are poor, we depend on NGOs and multilateral agencies that provide them. But it’s important to make an effort to have them provided by the African governments. The LLNTs should be available as soon as the studies about their efficacy and safety are published and the policy about thrir use well defined.
• Obviously it would have taken less time. Pharmaceutical firms want to earn money from the work they do. It’s “normal” for them to do the work that can produce money like providing interventions to rich people. Sometimes they are compelled to do something for the poor but this takes much time; too much time. This doesn’t seem fair to me. Making the health and welfare of people depending on the money they have is not in the “justice” field.
• This has to do with the principle of justice, it’s a justice issue. Te population to whom the intervention is given is not the one that undertook the studies for making the intervention available. Efforts should be made to take care of the rural population first.
• Taking in account the principle of beneficence, this seems to me a good idea; But I think, effort s should be made to provide them to the population without expecting it from clinical studies. This means that the population will not be protected when there isn’t any clinical trial ongoing.
• This is a highly ethical question. Interim approval and full approval are not the same. Everyone should choose the LLNTs with the most complete data i.e the one that has completed the phase III. My opinion is that the NMCP that chose the LLNTs with full approval is fully right. The issue here is again the poverty of our countries that interfere with full applications of laws and directives. We depend on others money and we are obliges to follow their choices. We need to make our own choices, based on reliable and accurate data.
• Donors should not dictate standards for countries. The country should establish its own standards based on reliable scientific data. But this is always a big issue. In real life we have to deal with other realities and case in one of them. I don’t think the NMCP should give up. This is a kind of blackmail that I don’t agree with. We have to save lives but not by losing the right to do what seems good to us.
• Ethical issues: Phase II versus phase III product. The product with the best complete data should be chosen. This is about beneficens.
TONA Lutete gaston
Clinical Pharmacology and Pharmacovigilance unit
University of Kinshasa


University of Kinshasa

[marthazewdie]

ITNs/LLINs should be provided to the control group and community by the researchers and sponsors of the research project which demonstrated their efficacy and who is going to profit from the final product. This is provision of justice to the participants who cannot otherwise afford the product. This is a point that should have been addressed by the researchers, community, and local ethics committee at the beginning of the study. According to the agreement and based on their generosity, the sponsor and researcher can also provide ITNs/LLINs to the neighbouring communities and far off communities as well; or at least provide them at a reduced cost. Otherwise, it is the responsibility of the ministry of health and international aid organizations to find means of providing the nets to their communities. The communities should be provided as soon as the product is ready for use.

The time it took to scale up the use of ITNs/LLINs for public health use might have been faster if there was a high demand in the market simply because investors would be interested and money can be a factor in delay in research output. However, as it is indicated in this case study, there were findings and implementations all along the way and 30 years is the time taken to improve the product to its final state. Some of these improvements could not be foreseen without trials in the field which takes time.

The research trials were undertaken in rural areas and therefore these communities should benefit from the product. They should be given the product free of charge. Otherwise, the ethical principle of justice is abrogated. However, the advertisement targeting the urban and well to do communities is not necessarily an indication that this ethical principle is abrogated. It could simply be that people who can afford to buy it should while at the same time people in rural areas who cannot afford it should be provided free of charge.

The African ethics review committees should demand or at least strongly recommend for the researchers and the sponsor to provide the nets. The sponsors are definitely going to benefit from the product so there should be no reason why they do not provide it to the participants.

Malaria researchers should make sure that the nets are compared to the new nets to be tested and if the new product is a drug, it should be compared to the currently available and effective drugs. Placebos should not be accepted be it for nets or drugs.

If there is a best available product and it can be afforded, then the NMCP has the right to demand it. However, in the absence of this product or inability to provide it, the other WHO recommended products should not be discredited and they should be used for the benefit of the communities. Their efficacy has been proven and it has been shown to cause no harm so with the right precautions, these products can be used.

Donors should not dictate the standard of care for a country. It should be the local communities that should demand the best standard of care and the donors should provide the care that would be provided if the study was conducted in their own country.

If the product is provided free of charge to benefit the communities and there is no alternative, the one NMCP country should indeed accept the offer and help the people of the community. But if this is a trial to be conducted in the community, then the sponsor should provide the product asked to be granted permission to do the study.

Martha Zewdie
Armauer Hansen Research Institute
Addis Ababa, Ethiopia

[nkwesch]

I believe the ITNs/LLINs should be provided to the control group by the study team. This could be considered as an immediate benefit of research. But this should be provided to the neighbouring & far off communities by the program / Government. As far as the moment of supply is concerned , it should be as soon as possible.
Of course the process will not be so long in a case of a rich country.
Depriving rural areas of Mosquito nets which has served for the research, is abrogating the principle of distributive justice. They have not benefited from the product of research for which they contributed.
I don`t think it will be fair to demand provision of ITNs/ILLNs from researchers. it is not their duty to supply these assets to the communities but the state which is in charge of the health of the entire nation.

[Asfawesen G/Yohannes Wold]

1. ITNs/LLINs have without doubt proved their worth. Who should provide them after their trial: to the control group/community; neighbouring communities; far off communities, etc.  How long, and how soon should they be provided?

The communities who participated in the research to prove the effectiveness of ITNs/LLINs should be supplied by the sponsor of the study. This an ethical obligation. How the community members can be preferentially benefited from the product should be discussed from the outset of the study. At least, the company should give the net for free or sell out at a lower price to the community , possibly to the country at large. Issues related to the duration or initiation of distribution can be settled by negotiation. The responsibility for distributing the nets to the neighboring and far off communities rests on the government.


2. It has taken almost 30 years to scale up ITNs/LLINs for public health use. Investments by the private sector were very late. Would the process take as long if the product was for a rich man’s market? Explain.

The effectiveness of bed nets have been known as early as the 20th century. Ronald Ross, the prominent malariologist had witnessed this by stating that his scrupulous use of bed nets had protected him from malaria while living in India and making several expeditions to malaria endemic areas. When the developed world become free of malaria it is evident that producing bed net could not be attractive investment for the pharmaceuticals. The same holds true in the development of drugs for many of the diseases in tropics which we name them neglected diseases. With the global commitment on MDGs, however, Billions of dollars and have started to be mobilized to control poverty related disease like malaria. Seeing the billions of dollars mobilized for malaria control and prevention then the pharmaceuticals and private sectors have started to engage themselves in developing these cost effective materials which have a fair money return.




3. The R&D of ITNs/LLINs was almost exclusively undertaken in rural areas. Yet their marketing e.g on TV, targets urban and well to do communities. Explain what ethical principle is abrogated.

While the malaria burden is in the rural areas and where the utilization of nets are expected to have the maximum benefit for the rural population, the social marketing targets the urban population which are affected less by malaria (comparativey). This can appear unjust, but one has to take in to account the ITN/LLIN distribution policy of each country. People in malaria endemic area and vulnerable groups are usually offered the net for free and those who can afforded and living in non priority area may get access to the net through a subsidized cost-sharing scheme.



4. Many African heads of state and government adopted the Abuja declaration in 2000 whereby they agreed to make ITNs/LLINs readily available, and therefore a standard of care in malaria control.


• Should African ethics review committees therefore demand provision of ITNs/LLINs from all malaria researchers coming to study their communities?

ITN/LLINs are malaria prevention tools. I think those researchers dealing with malaria research particularly prevention related issues should be advised to help their study participants have access to these nets. This will be much helpful to the participants instead of multivitamins or antihelmenths.

• Should malaria researchers particularly entomologists make sure that ITNs/LLINs are compared to whatever new interventions they intend to test, since doing otherwise would amount to providing a mere placebo? Wouldn’t incorporation of LLINs into studies complicate study interpretation? Discuss.

The value of ITN/LLINs in prevention of morbidity and mortality of malaria is influenced by the malaria epidemiology and behavior of the users. I am not aware about the comparison of the effects different types of malaria prevention tools. When doing research on malaria prevention using new tools it may be considered unethical to strip of the participants from ITN/LLINS to see the effects of the tool understudy ( because its effectiveness is unknown). I do not know if it will be possible to measure the added effect of the new tool to ITN/LLINs ( but it may have a negative effect too). Other option is introducing the new tool who do not have already an access to bed nets.
_________________
Asfawesen G/Yohannes Woldegiorgis
Armauer Hansen Research Institute
Addis Ababa
Ethiopia

[justinchileshe]

The sponsor has a responsibility to carter for the control/community where the trial is conducted and if they are generous they also provide for the neighbouring as well as the far off communities. They can provide just after the trial as a start up nd other coorperating partners can otherwise provide for the far off and neighbouring communities.
It wouldn’t have taken this long for sure if it was a rich man’s market because investors would have been fighting to grab the market share. Again some governments care much about their citizenry and public health so they could have moved faster considering their economies are much stronger but it wouldn’t have taken a short time per se because the efficacy trials take some time to achieve results.
The principle of equity, fairness and justice require that research be undertaken in response to the needs of a particular are or country and that once it yield positive results the communities must be cared for in a manner that is fair regardless of their status. In the rural parts most people are under the authority of traditional leaders who have so much authority such that if research is brought in their communities and the tradional leaders say yes it would be difficult for the population to say no therefore they will not give consent as in the way a person in the urban area would.

African Ethics committees should demand provision of these nets from all researchers coming to study their communities because that should be the ethical thing to do and for researchers to use placebo, it is unethical because benefits of using the nets are known and denying the community that benefit is not right.
_________________
Justin Chileshe, TDRC, Ndola, Zambia

[Roger TINE]

It's sponsors role to provide LLIN to the control group; it has to maintain untill the use of LLIN can became a policy. National Malaria Control programm (NMCP) is suppose to provide them for the communities who need it once their use is consider as policy. Effort made by NMCP represents gorvements efforts against malaria.
Scaling up malaria control strategies is a complex phenomen with lot of considerations. Gorvements, NGOs, private sector mainly has to work together in order to achieve these objective.

[Constance Agwang]

1. The NMCP should be responsible for providing these nets to the communities and this should be done sooner than later and it should be a policy to supply nets t the communities.
2. The process would not take as long because these companies are after making money. If they had ready market, it would not have taken so long.
3. I think the principle abrogated here is that of Justice, because the people who actually take part in the research studies are not benefiting from the positive findings.
4. I think researchers should be encouraged to have LLNs when going for research work, so that the people can be willing to take part in the study, just as an incentive and yet with so much help in protecting the people from malaria infection.
5. I think they should not be compared, but whatever interventions that are brought into use should be used in addition to the LLNs.
6. The question becomes an ethical issue because all humans have the right to what is best. So not providing the best means of protection is denying the communities their human right. Donors should not dictate on what the country care but should prioritize the country’s needs. Well the donors have the money and since what they are offering is also good enough, then the NMCP should just give in so as to save the innocent lives. Its a tough decision because it means compromising quality.
7. From the table it can be seen that the polyethylene is more durable that the polyester and also cost effective compared to the polyester. Donors prefer the polyester because it’s a European product and they want to promote their own companies.
_________________
Constance Agwang
Med Biotech Laaboraories
P.O Box 9364
Kampala, Uganda
Mobile: 256-77-257791

[cwasunna]

1. This responsibility rests with investigators, sponsors and research regulatory authorities.

2. LLTNs are typically used in resource-poor settings and therefore private companies would be reluctant to pursue an invetment in items whose cost would have to be further subsidized.

3. This is a case of competing interest resulting in the disregard of the risk/ benefit calculus.

4. Ethics guidelines dictates that any new intervention must be compared existing known effective procedures, if available. If there does not exit any, there is need for scientific and/or medical justification. Use/Non-use of LLINs can be used as a measure of exposure in some form of studies. The concern would be in instituting an effective monitoring and evaluation mechanism process of monitoring correct use of the LLTN .


5. The standards of care for a country is typically guided by its principles which may not be in line with internationally accepted procedures. However, this differences should not be exploited. The safety, rights nd wellfare of the population is supreme!

6. There should be clear policies on proceurement and use of LLTNs. all stakeholders must be involved in the decision making process. Ethics is not just a set of rule!

[aboss25]

The NMCPs should provide the nets in collaboration with the Ministry of Health. It should be provided within the shortest possible time.

It is possible for the process to take as long though it might take a little shorter time than 30 years because interested stakeholders would make money readily available to speed up the process. But it is important to note that the nets would have to be tried and tested over a long period of time before it can be certified for use. Therefore there is a possibility that it might take this long.

It is ethically sound for research outcomes to first of all benefit communities in which the research was conducted. In the case of ITNs/LLINs, the research was conducted in rural Africa where TV is scarce, therefore marketing of ITNs/LLINs should be made to target rural communities where malaria is more common than on TV which targets urban communities.

Well, demanding ITNs/LLINs from all malaria researchers would go a long way to help control malaria but this may also discourage most researchers from malaria research since they may find it as an additional cost. I think it should not be made compulsory, after all research on malaria would not only benefit the researcher but the world at large.

It is a good idea to compare interventions therefore incorporation of LLINs into studies even if it would complicate study interpretation should be managed.

If WHOPES is the recognized body to approve LLINs for public use then without its full approval of the polyester LLINs it is quite unethical to be used. But with cost benefit analysis, some NMCPs may want to use it since it has interim approval after all.

Never! Donors should not be allowed to dictate the standard of care. The standard of care policy should be based on research and prevailing conditions of a particular country.

The one NMCP has a point in its decision i.e the fact that the polyester nets have only interim approval so that if they could find other means of generating funds to purchase their own WHOPES fully approved nets then that would be fine. Otherwise they may have to give in to the donors demands in order to “save innocent lives”. The one NMCP has a strong point that we must recognize, thus as much as they want to save innocent lives, they want to avoid possible public health issues in future that these polyester nets may bring since they have not gone through phase III trial.

From the table it is evident that donor preference is being influenced by the cost per net. Otherwise when we take into consideration the various criteria it is clear that the polythene nets outweigh the polyester nets in terms of duration of insecticidal activity, WHOPES phase approval, insecticide application and durability.
Although the polyester nets are not fully approved they are cheap and hence donors would opt for that in the name of cost benefit analysis without taking into consideration the possibility of future public health effects.
I believe the policy to procure polyester nets by the majority NMCPs has been influenced by donors. Until NMCPs in collaboration with the Ministries of Health are able to find other means of generating funds for such procurements, policies would always be influenced by donors.
_________________
N.A.Kotey

[naah tabala felicite]

normally, the benefits of a research is for the control group/community, but for perennity of this action, the state should be more involved in this action. implementation in the community of all decisions taken should necessite the full action of the state. this will imply that, state budget is involved not only sponsors. interegional action should take care of the neigbouring communities.

considering the fact that LLINs have only interim WHOPES approval meaning it hasn't fulfilled all laid out procedures for its approval for public health use this raising ethical problems. another ethical issues arising here is faireness in distribution of benefits of which many communities are victimes
state implementation of this ITNs /LLO's should be a regalian routine for the possible eradication of malaria