amanet-trust.org

[FabriceBoyom]

Some few remarks are to be made before we can argue about ethical issues!
1. I do not see the background of this allegation.
2. Scientists need to gather a convincing load of evidence that their compound has efficiency against HIV.
3. Moving from in vitro/in vivo testing to clinical trials is a very long way to go. And each step needs careful management and interprettation of data.
On another hand, this is simply a jok! because NO ETHICAL RULE was observed during the whole process. THIS IS AN EXAMPLE OF WHAT SHOULD NOT BE DONE!!
Fabrice Boyom

[kabongo]

1.a) Trangression of the research protocol
b) Trangression of MCC and NIMR opinion
c) Firm (international pharmaceutatical companies) in competition can't involve the debat
2. We agreed with the MCC, the NIMR and critics because they use ethical decisions
_________________
kamitalu

[Seth]

[color=blue]Virodene Trial was a joke. If these people who call themselves VPH are really scientists and some of them are Medical Doctors, they should re-think their decision to be medical researchers because they probably do not deserve to be.

Somehow corruption steered by excessive ambition and greed may have contributed to this. We should all watch how we conduct our research since we need to make sure we protect the rights, safety and dignity of research participants as well as generating credible data. We should always bear in mind that conducting ethical research is right becoming a committed religious person. Knowing what you are supposed to do is one thing while actually doing it is another. Greed, excessive ambition or drive to succeed and excel always compromise the latter i.e. practicing what you preach. Let us all beware! [/color]
_________________
LET'S JOIN HANDS AND FIGHT OUR WAY THROUGH AS ONE. TOGETHER WE'LL GET THERE!!!
Misago Seth
National Institute for Medical Research (NIMR) Tanga Centre
Amani Biomedical Research Laboratory (AMBRELA)
P.O.Box 5004
Tanga, Tanzania

[fsaguti]

Ethical Issue
1. To the Pharmaceutical company(sponsor), should have been its responsibility in the first place to make sure that the trial is fund to carry on when got the Ethical clearance from MCC and NIMR.

2. To the PIs( researchers), its all clear without Ethical clearance then you study in unacceptable in anyway. by passing NIMR and MCC concerns that was ethically unacceptabe.

Its bad to see in this study, even after by passing NIMR they were able to lobby the armed forces. but, it's strange to see this because even in the army there scientists who knows the demand of ethical clearance( how was this possible when NIMR said NO!)

scientific rythm of the trial, there was no control that involves in this trial-that is over role the use of the trial finding to generalizable for human use of these antiretrival at anytime.

2.School of thoughts

Justice. only part of the people were involved in this study and there were even no control on this trial. so the principle of Juctice was over roled.

Benefience Non malebeneficence. althought beneficials of the study were not clear but the side effects were so bad compared to the benefits. Just considering that, this study was not acceptable.

[Aida Nakawunde]

1. No ethical and scientific clearance was obtained, politicians should not interfere with scientific research, No approval from regulatroy agencies was sought, the methodology used was poor, the validity of the science was inadequate and questionable

2. I agree with the critics raised because the scientist seemed to be in a hurry ie all the ethical and scientific clearances were by passed and the military patients must have not consented appearing to be vulnerable thus underlooking the principle of justice.
_________________
n aida

[zinyama-gutsire]

1) This study has raised several ethical issues outlined below:

•Study was conducted without a control arm was a flaw in the scientific design of the study since the effectiveness or weakness of the drug was difficult to evaluate.
the study was not peer –reviewed
•the risks to the participants outweighed the benefits and this is highly unethical.. The benefits of conducting a clinical should far be far more than the risks.
•study by passed the ethical and scientific review process makes it absolutely unethical in several aspects;
•The study violated the principle of autonomy which stresses the right of individuals to freely make decision to participate or withdraw from a research. For example, the fact that the study was not reviewed we do not know if they used an inform concern form to recruit participants. How was the 64 subjects recruited in the military hospital? This will suggest that the subjects were forced to participate in the research especially as the study was rejected.
• Participation by military personnel maybe was not voluntary, in violation of the rights of all human beings to consent or refuse to participate in research. This was unethical and is against the Nuremberg code
• This study also violated the principle of Beneficence which states that the advantages must outweigh the disadvantages. The experimental drug virodene is known to be toxic and the scientists went ahead administer it in humans with no proven preclinical tests on animals.

(2) I support the critics of virodene because there is every indication that the efficacy of the drug is questionable. We have seen that the clinical trial of the drug has been marked by several irregularities and unethical malpractices. While the pharmaceutical companies may have a point, market interest may not have a place when it comes to dealing with human lives. It is clear that the drug trial did not respects and follow establish scientific research procedures in conducting their studies.

The supporters of the virodene study have a point when they say large international pharmaceutical companies are responsible for the wide-spread condemnation of virodene as a potential drug for HIV/AIDS treatment because they want to safeguard sale of their drugs. The researchers of virodene should have followed the right and proper channels for their drug to finally get approval for use in humans. But then they employed short cuts.
_________________
Rutendo Zinyama-Gutsire (MSc, MpH)
Medical Research Council of Zimbabwe
Research Oversight Department
CY 573 causeway
Harare
Zimbabwe

[Resign]

1. There is no mention of the consent process in the recruitment of the army personnel to take part in the study. Sometimes army personnel may enter into studies just because the superiors have given a nod to the study without looking at the facts and making an informed decision themselves. In this case however, that information has not been supplied.
2. It was a great error for any Tanzanian Defense Forces to ignore the recommendations of the country’s regulatory body, in this case NIMR. They should have objectively analyzed the reasons why NIMR rejected the study in the first place. Going ahead with approving the study in the army probably prejudiced the participants putting them at risk
3. Political interference should never be allowed in research as this poses ethical problems
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[Resign]

1. There is no mention of the consent process in the recruitment of the army personnel to take part in the study. Sometimes army personnel may enter into studies just because the superiors have given a nod to the study without looking at the facts and making an informed decision themselves. In this case however, that information has not been supplied.
2. It was a great error for any Tanzanian Defense Forces to ignore the recommendations of the country’s regulatory body, in this case NIMR. They should have objectively analyzed the reasons why NIMR rejected the study in the first place. Going ahead with approving the study in the army probably prejudiced the participants putting them at risk
3. Political interference should never be allowed in research as this poses ethical problems
_________________
Resign Gunda
Medical Research Council of Zimbabwe (MRCZ)
Harare
Zimbabwe
gundazr@yahoo.co.uk
+263-912-876825

[makamche]

Dear Dr Aceme,
1) Autonomy: the study is done in the military camp, soldiers can be consider as vulnerable people as they are bound to obey orders from their superiors.
2) Beneficience was violated. Though knowing that DMF had side effects on human being which could outweigh potential benefit the scientists went ahead to conduct their study.
3) Non-maleficence was violated as the conduct the study without any control arm, this implies that participant was unnecessarily exposed to harm.
4) The conduct of the study without any ethical approval shows that the study was not ethically sound and these scientists had many things to hide.
5) Justice was violated. Though the NIMR refuse approving the study, some individual went ahead to conduct the study on their own benefit and never care about the well being of participant. In short, the study was conducted without some scientific justification nor ethical approval exposing participant to unnecessary harm.

I am agree with those who said that there is insufficient preliminary evidence derived from properly designed studied that show that virodene has the potential to treat or cure HIV/AIDS because they did not show us the result of clinical trials that prove that HIV disease can be treated or cured.
_________________
Dr Marie Florence Makamche épse Dzukam
Ph.D Molecular Virology
CANTAM, CIRCB
P.O. Box: 3077
Yaounde, Cameroon
Mobil: 74 61 36 44

[jessegitaka]

Dr.Aceme,

1, The Virodene saga raises the following ethical issues:
a) The scientific merit of the research was not established properly, with no control arm, the design is wanting. As a medicinal product, it would have been important to have it undergo graduated testing to as well be ascertained as safe, via pre clinical and then clinical evaluation.
b) The scientists declined to have peer review and ethical approvals, and alternatively decided to go the political way and this definitely washes down the credibility of the whole process of their research.
c) The ethical principles of beneficence, non malfeasance, and justice were trampled on. With serious side effects known in humans with no benefits established, the scale was tilted to make the chemical not to be used in humans.
2, I agree with the critics of the Virodene scientists, these scientists clearly failed to adhere to accepted ethical standards, and declined to have their product undergo the necessary scientific scrutiny. By so doing, they exposed participants to harm and even worse took the political route to cover up their work.

[Elizabeth Ochola]

Dr Nyika,

The ethical issues in this context are:
The first clinical trial of the drug was conducted in 7 participants without a control arm(a control shoould have been used)

The trial was later conducted at Lugalo millitary Hospital without approval from NIMR which is an ethical board(IRB/ERC approval is required)

Political interference allegedly facilitated the clinical trial without sound scientific justification or ethical approval(politics should be sepated from peoples well being)

There was insufficient preliminary evidence derived from previous studies to show that virodene can treat/cure HIV/AIDs( positive sufficient preliminary studies are important in clinical trials)

International drug companies allegedly condemned virodene for HIV/AIDS treatment so as protect their profitable market for existing ARVs which in this context wasnt true because the drug already had known side effects

2. I support the NIMR for refusing to grant ethical approval for the trial, the drug companies for refusing to adopt virodene after knowing that it has known side effects

DMF which is a component of virodenehas known side effects.
_________________
Elizabeth Ochola
NTD
Schistosomiasis Project
Kisumu,
Kenya

[sithembile Ruzario]

1)What ethical issues does this case study raise? List them and give your views on each one of them.

a) The study design was poor. How do you find the effectiveness of a drug without a control arm? This is poor science and poor science is unethical
b) The study with seven participants was not peer reviewed. This is unethical. Any study needs to be peer reviewed for the safety of the participants.
c) Non-maleficience. This was violated. The participants were exposed to harm. The risks were more than the benefits so the research was not supposed to be carried out. The scientists needed more animal tests before going on to human beings. There was no sufficient evidence to show that the drug was safe on human beings
d) Ethical review process. The researchers did not follow the normal ethical and scientific review process, instead they jumped the gun straight to the cabinet, and this is unheard of. I am surprised that the cabinet requested for scientific evidence instead of demanding ethical approval from an ethics committee
e) The clinical trial was not approved by the drug regulatory authority. This is unethical. All drugs need to be registered before they are administered to patients as a safety measure. A clinical trial also needs review and approval by the drug authority.
f) Vulnerable populations. Soldiers are considered vulnerable populations and need extra protection, this research was not supposed to take place in a military hospital because the consent process in questionable. The scientists obviously approached the head of military to gain entrance into that hospital. The moment a senior gives permission, the juniors are supposed to agree even if they do not want.

2. Which school of thought do you agree with and why.

I do not agree that large pharmaceutical companies are to blame for condemnation of virodene. Those who think that virodene is effective against HIV have to prove it through proper scientific and ethical channels than to point fingers at the pharmaceutical companies
_________________
Sithembile Ruzario
Medical Research Council of Zimbabwe
Research Training and Monitoring Officer
sithembileruzario@yahoo.co.uk

[Abdulai Ali Martha]

I think that several ethical principles have been broken.
First of all, autonomy this allows individual to freely make their own choice
Beneficence and Non-maleficence: Maximizing benefits and minimizing risks because the DMF in the virodene is said to be harmful than beneficial.
With the desperation of the VPH scientist am tempted to think that the safety and wellbeing the study participants was not an issue at all because they seem to have forgotten that bad ethics is bad science. It appears they were interested in their results and nothing else mattered. If they had the wellbeing of their participants at heart they will rather work on the reason for disapproval rather than moving to Tanzania where the NIMR disapproved their work too.
Why will they go to the cabinet when the appropriate office is still in place? We have condemned Pfizer severally at different forums but VPH is right here in Africa. If we make the mistake of politicizing research we will be going back in age.
2. I do not at all agree with critics, they should rather ask if all ethical procedures have been followed. If things are done in the right way then the issue of “sabotage” can duly be raised.

[sahmed]

Ethical issues raised in this cas study
There was no any peer review in this study -so even some potential harm could be detected and some modificational changes /suggestion could be given.Peer review is one of the important issue in Research and must be emphasized.
There was no any control arm in this study so its difficult to say the Virodene was beneficial.
Study lack Scientific validity in South Africa,thus disapproval by Medicine Control Council (no need for that study at the first place.)
Conducting the study in Tz without approval from NIMR that was unethical and then manipulating and do it in military ,its so bad and we dont know who were participants may be even prisoner were exploited(Proper procedure were not followed).
There was political interference in conducting the study thus why it was presented in the parliamentary and managed to come to TZ and by pass the law-So bad to participants.
No any animal study was conducted and then toxic IP was given to human beeing(They did harm).
Benefits must outweigh harm when introducing the new product and all procedure need to be followed and research need to have scientific validity(it was lacked).

[Kwame Kesse Adjei]

1.Ethical Issues
•This case raises a lot of ethical issues with the first being how the trial was eventually conducted without ethical approval from an established Ethical Review Board and a Science baord. It is true that policy makers are needed in the implementation of the findings made by a health research institution but I believe in this case the government/policy makers over stepped their borders by bypassing the ethics board and science boards. What makes this more interesting is that they bypassed their own ethics committee as well as that of Tanzania.
•I’v heard about some trials which were conducted without control arms, but in a trial like this which sought to determine the efficacy of a new drug, am still baffled as to how the trial was conducted without a control arm. This raises a lot of ethical questions for me because there is nothing to show how efficacious or otherwise the drug in question (Virodene) is.
•Since the trial bypassed the approved boards, there were no justifications as to why a small sample size was used, how the randomization was done etc. This means that the trial did not follow the rules and regulations required for the conduct of a trial. On top of that, it eventually took place in a military place and we all know the amount of superiority commanders have over their troops. For all we know, the participants did not take part in the trial on their own free will.
•Again, if what the critics said was true and that the component of virodene,DMF has shown serious effects, then the trial went against a basic principle of ethics, non- malficience – “above all/first do no harm”.
•Finally, I believe this trial is examples of how some sponsors and PI’s who have direct links with policymakers can wrongly take advantage of this to undertake research whilst bypassing the right authorities in charge of conducting trials. In the above case, the science was bad and once the science is bad, the ethics will definetly be bad.

2. I agree with the critics, after all if the South African scientists had gone through the right procedures and sought ethical approval for the trial to take place, nobody would have doubted their authenticity. Instead, by taking the measures they took, it looked as though they had their own selfish motives which had nothing to do with the well being of their participants and the society as a whole.