amanet-trust.org

[Dr. James Chipeta]

1. The scenario of the antimalaria treatment policy change in Tanzania is typical of nearly all the developing nations as they are mainly and often driven by donor nations than accurate policy reasoning. If the donor nation say, ‘Do not put this money we are giving you there yet’. They do just that regardless of the prevailing circumstances. Also developing nations such as Tanzania rather work more often in a 'fire fighting mode'. 'Solve the current crisis than the crisis of tomorrow'. So in case of the above scenario it was prudent for Tanzania to put aside change from CQ as I quess they had more pressing issues then. It is all ‘poverty’ driven rather than research or evidence driven.
2. It is the responsibility of both the researcher and the community where research has been conducted.
3. For research evidence to be promptly and appropriately translated into action, there should be prompt and stead dissemination of the results into clear terms/recommendations to the community involved. The researcher and the community should be involved all the way in a steady partnership.

[goadjei]

the assumption that, "the delay in policy change for at least half a decade may have delayed alleviation of disease or even deaths….." may be supported by the fact that timely policy change to replace an ineffective therapy in a disease with high morbidity and mortality cost could alleviate part of the burden, but sustainability of the policy can be greatly enhanced by consensus and the overall implementation success of the policy can also be enhanced if all stakeholders are brought on board. It is certainly important to have had the sort of broad consensus. On the other hand, because there is no need to “re-invent the wheel” and it could be argued that it may have been sufficient to decide on a new policy based on the evidence from elsewhere. but it is also important to ensure that even that sort of evidence is tailored to the local ituation.

[mworozi]

Case study 3
It is true that policy change from one drug to another requires careful planning, consensus building and review of the available research findings at local, regional and international levels if any. Thus this can take a long time depending on the national capacity financially and technically. However, for a disease which is the major cause of morbidity and mortality in a country, this should not take too long. Thus the delay by the Tanzania government to change the anti malarial policy for at least half a decade can not be justified especially since there was enough evidence from neighboring countries that chloroquine resistance was high. Although we are not given the mortality and morbidity characteristics for malaria in Tanzania during this period, the delay was not justified given the information that was available from the neighboring countries. After all WHO had recommended such a change in 1990 based on credible evidence.

The responsibility to ensure that health research findings translate into information that benefits the people participating in the research lies with the researchers, research sponsors/ pharmaceutical industries, research institutions, ethics committees and relevant government departments particularly the ministries of health, and development partners to ensure that research findings are disseminated, discussed and translated into policy.

It was unfortunate that the Tanzanian population which contributed to the highlighting the seriousness if CQ resistance and the need to change to SP as the first line treatment for malaria were not among the first populations to benefit from the change of policy. . This is a usual requirement for such studies. First of all, the delay appears to have been partly due the government bureaucracy.
To address this anomaly the researchers, sponsors/ pharmaceutical companies, ethical committees and policy makers should ensure that this is clearly stated and agreed upon before the study is implemented.

[FabriceBoyom]

1.
Firstly, the fact that after about two decades, the effective CQ dose to teat semi-immune individuals had risen from 2.5 mg/kg to 25 mg/kg should have been enough to start suspecting resistance and envisaging a change in antimalaria drug policy.
Secondly, follow up surveys undertaken throughout Tanzania during the 1980s confirmed wide-spread CQ resistance.
Thirdly, WHO in the mid-1990s recommended change in first line drug policy if resistance to CQ reached 25%.
Fourthly, competent entities had already concluded from clinical studies on the need for drug policy change.
I should conclude saying that although enough time and data are necessary for efficient decision-taking; the case in Tanzania lasted too long.
2.
In light of CIOMS guideline 10 and its commentary, the approach in Tanzania was unethical in that. There was a complete mix-up where media and parliament intervened. The Ministry of Health or any relevant entity should take the responsibility of translating biomedical research findings into direct intervention among those who really need it.
3.
This situation highlights the bureaucracy that sometimes involves bodies with irrelevant background in policy-making and decision-taking. Such biomedical studies should be straight to the point, so that people needing health assistance can benefit.

[offianan]

1/ Research have to respond to the health needs of the people. Effecting policy change is a process which requires active participation of many stakeholders. Introduction of SP as first line was supposed to be supported by all stakeholders regarding evidence of change.
In this case study, the evidence of change had long been provided but the issue of sustainability and acceptability of the change took a long time.
Change in a national policy need financial resources and we know developing countries are poor and health is not a priority for many governments in these countries.
Of course it is easy to formulate policies from research findings but it is very costly to implement the research findings.

2/ All the stakeholders in particular the ministry of health are responsible for ensuring that health research findings translate into intervention that benefit people.
The blame of the delay should be placed firstly on the Tanzanian Ministry of health, who in spite of the numerous and credible data only informed the parliament in 2001, which led to the approval of the change.
The work of researcher is to generate information and implementation is the work of policy makers.

3/ We note always a gap between health research and policy formulation.
The Tanzanian populations were not among the first populations to benefit from a change of policy based on the data collected. It’s important that health research findings should be communicated to policy maker. The goal of all, policy makers and health researchers is to work towards the welfare of the participants under investigation and the population in generally.
It is the responsibility of ethics committee to ensure that the community is protected in this direction.

Offianan Andre Toure
Malariology department
Institut Pasteur of Ivory Coast

[kabongo]

1. a)argument pro :authority should seek for a agreement between depositories and financial means.
b)If this way of acting will take us much time, by considering ethical opinion we will avoid it because of Africa emergency reality to protect poeple life
2. In Dem Rep of Congo, the population Health depends on the gouvernent but other actors have an i,portant influence in this procces ; donors, searchers, ...
3) to create a system that will help in having things done; Ethical National Commitee in cooperation with authorities but don't forget that Africa has more than political or economical problem
_________________
kamitalu

[fsaguti]

In this case, although it’s not clear stated which year exactly (mid of 1990s? is it 1995!) WHO put forward the need to the changes of CQ regime to sp when failure is 25%, as Tanzania as a nation might have counted WHO as a source of alert in this matter to declared changes of CQ to SP in 2001.

Thinking as nation, (TZ) had to collect the data to see for sure whether they have passed that unacceptable level (25%) nationally (fact, there might have been other countries at that time which had failure below unacceptable 25 % level at that time). This part, might be the source of delay to this case, because if there were enough storage data already concerning CQ resistance in TZ, then they could not need to spend more time to collect more informations from stakeholders.

Apart from that they had to conduct the clinical trials for the alternative antimalaria drug SP to be sure of the safety and efficacy of the drug (SP) and see whether is cost effective to her citizens. Although, SP might have been already gone clinical trials on other part of the world enough to be accepted , but I think this was necessary to be conducted once again in TZ before applied as first line antimalaria treatment as saying” even the best proven prophylactic , must undergoes a series of research to check its consistency, safety and efficacy etc”.
Due, to the facts above it was necessary to take time to make right decision especially safety of citizens, although it might have been delayed but to there was political and scientific logic on delay to the changes declared in 2001.

However, delay might have cost and might have been the first time for a nation to face the challenge, there should have been better strategies to make sure there is unnecessarily delay next time, my concern is how do other countries were able to make it so fast and what were strategies toward to the shift of one drug regime to another?

[Constance Agwang]

1. It was necessary for the ministry of health and the NMCP to first collect all data necessary to justify the change of CQ, so that money and other resources could not be wasted changing the drug when actually CQ was still effective enough. On the other hand this delay must have cost the country a lot more in terms of mortality and morbidity among the vulnerable groups, which is a major cause of absenteeism from school and work, which in the long run affects the economy. The delay also could have given the country more time to actually put into place a system that could directly monitor control of malaria which is a positive move. The delay was also necessary to sensitize the public on why CQ had to be phased out.
2. Researchers, health workers, policy makers and the government, all have the responsibility of ensuring that the research findings are actually translated into benefits for the communities. That means there must be a means of information transfer between these groups, such that after findings have been done, the information is passed on to the policy makers who will then translate this into policy formulations and the health workers do the implementation, it’s a collective role.
3. This issue of discrepancies can be addressed by ensuring that all the stakeholders serve the interest of the communities. The government should also be involved in these interventions, because many times without political will, no funding goes to such activities.
_________________
Constance Agwang
Med Biotech Laaboraories
P.O Box 9364
Kampala, Uganda
Mobile: 256-77-257791

[zinyama-gutsire]

1. The unfortunate delay arose because maybe because of unnecessary bureaucracy on the part of government officials and those in the national malaria control programme. They did not act with the speed that was necessary in responding to the malaria drug resistance problem. They had all the evidence from the researches carried out that there was a problem. It is true that it takes time to formulate or even change one treatment policy to another, but in this case this took unethical too long and a lot of people received ineffective treatment or even died.
2.
2. Sponsors, investigators and ethical committees have shared responsibility to ensure that health research findings translate into intervention that benefit people. The ethical committees especially must insists on a well laid road map by the researchers and sponsors that will lead to the translation of findings into benefits before approval is granted

3. Researcher and the policy makers should be brought together to advocate for implementation of beneficial policies. Public demand and political will should also play a major role in policy making for the benefit of the well being of the people.
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[Resign]

Every major health policy change needs to be well thought out and there is need for wide consultation in that regard. Inevitably, this will take time. While this is a disadvantage to the population in need of that intervention, there is not much that can be done to circumvent that situation. I therefore understand why it took long for the Tanzanian authorities to introduce SP. However, I agree with the the contributor who suggested that perhaps there is need for TZ to find out how other countries managed to switch faster SP.
The other point that was raised in this case study is cost effectiveness of SP compared to CQ. Here I think even if SP was more costly, the fact is CQ was now found to be resistant and it was paramount for a new drug to be introduced anywhere even if it’s more costly. In my opinion, The only issue that was critical here was efficacy and safety studies on the new drug
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Resign]

I think that it is the role of regulating authorities to make sure that the protection of vulnerable groups is ensured. Being minors and vulnerable does not take away the right of the children to give assent to research. One of the ethical issues here is that there is no mention of ascent by the children themselves. There is need for constant monitoring of research involving vulnerable groups. What this case shows me is perhaps a lack of monitoring of on-going research. Had that been done, I am sure these loopholes would have been unearthed in good time
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Tekwu]

1. I think, it is not usually easy to change a heath policy in a short period of time because enough budget need to be allocated, people need to be educated, data about the new drug need to be generated and guidelines developed. I think the delay in the policy change was necessary and justified by the above mentioned reasons.
In the other hand the delay could have an impact on the economy, would increase self medication probably leading to resistance to Sulfadoxine-pyremethamine (SP) before its official introduction. Its early introduction might have reduced morbidity and mortality rate.

2. It is the responsibility of the sponsors, researchers (investigators), the Ministry of Health, the Health care workers to ensure that all health research findings translate into interventions that benefit the people

3. Discrepancies in the relationship between health research and policy formulation can be addressed from different line of actions. For instance, Ministry of Health shall identify research priority and could mobilize resources to answer the identified research questions. Thus, all series of research findings which are very urgent for the policy formulation could be communicated to the community as early as possible.

[Elizabeth Ochola]

Dear Dr. Nyika,
The pros of the case was that consensus was built across the board even though it might have taken long, but the stakeholders were in agreement at long last to implement the policy.
The cons was deaths of hundreds of thousands of children due to delayed policy change and budgetary allocations which could have been prevented by rapid policy implementation

2.that is quite true because it targets the risk/benefit ratio
All the stakeholders who are invoved in the research from the top most to the bottom most

3. Health benefit of a population should always come first and policy implementation should be done at the fastest rate possible among the various stakeholders i.e the government and the health officials
_________________
Elizabeth Ochola
NTD
Schistosomiasis Project
Kisumu,
Kenya

[makamche]

Dear Dr Aceme,
1) the change in drug policy in a country is an action that involves so many stakeholders. In most situation we could have enough data to justify a change from one drug to another but we have to be sure of the sustainability of such a decision. I think this was what happened in Tanzania. They had to evaluate the feasibility of such an action before taking decisions.
On the other hand, research data is meant for analyses. After analyses these results have to be disseminated so that appropriate decisions can be made. If data are collected and stored in drawers, we would have wasted resources and time which is contrary to good ethical practice. Participants would have been exploited and the principles of beneficence and justice would have been violated given that the end point of every research is to bring a solution to observed problems in the study community as well as other communities.
2) the stakeholders, local authorities, community heads and researchers. I think there should be a consortium were these people meet to decide on how to disseminate research data.
3) The Tanzanian population was exploited and the principles beneficence and justice were violated. As earlier said a consortium have to be created where stakeholders can sit and discuss on what to do with data from research studies so that participants can benefit from the study in which they participate.
_________________
Dr Marie Florence Makamche épse Dzukam
Ph.D Molecular Virology
CANTAM, CIRCB
P.O. Box: 3077
Yaounde, Cameroon
Mobil: 74 61 36 44

[psoipei]

1. In my view, I think it was prudent for the various stake holders to build consensus before changing policy from CQ to SP but on the flip, taking half a decade to consider changing policy even with availability of supportive data was some kind of negligence on the government side.

2. I think it is the government responsibility to enforce policies proposed by the Ministry of Health to ensure that health research findings translate into interventions that benefit people, particularly those who participated. I think governments through Ministries of Health should put systems in place to ensure that health policies are implemented in a timely manner to prevent damage from unnecessary delays.


3. The discrepancies can be address by all stakeholders coming together to prioritize formulation and implementation of policies bearing in mind that the health status of its population comes first.

Thanks
PS