Before a new drug can be released onto the market it has to be tested on people in order to assess its efficacy and safety. During the clinical trial phase, which comprises four stages, the drug is tested on people.
2. What does informed consent mean?
Informed consent is a legal condition whereby a person can be said to have given consent based upon a clear appreciation and understanding of the facts, implications and future consequences of participating in a clinical trial.
3. What does treatment-naive mean?
Treatment-naive refers to someone never having used (similar) drugs. Test subjects in developing countries have less frequently (already) been exposed to (similar) medicines, and this can improve the reliability of the test results of a clinical trial.
4. What is a Contract Research Organization?
Clinical drug trial supervision in developing countries is often outsourced to a Contract Research Organization (CRO); this can save the pharmaceutical company money, for instance on staffing costs. However, the contracting pharmaceutical firm remains ultimately responsible for the methods employed.
5. Why do pharmaceutical companies increasingly shift their clinical drug trials to developing countries?
Doing clinical trials in developing countries is cheaper. The amount of cost saving differs per country, and a range of estimates can be found in literature;
Regulatory constraints in developing countries are either less stringent or less actively policed. Research protocols can therefore be approved more easily, trials can be carried out more quickly, and drugs can be brought to market more quickly;
It is easier to find test subjects in developing countries, because participation in a trial is often the only treatment option, or because it offers the chance to make some money. Many developing countries have large populations, which makes it easier to find patients suffering from a given disease, even if this disease is comparatively rare;
Test subjects in developing countries have less frequently already been exposed to similar medicines, and this can improve the reliability of the test results.
Other reasons are:
Governments of developing countries are interested in the economic benefits of allowing clinical trials to be carried out in their countries;
Fewer and fewer people in Western countries appear to be prepared to take part in clinical trials.
6. What developing countries are particularly popular for conducting clinical trials?
Recent studies find that China tops the list of the most preferred locations, with India in second place and Russia a close third (source: SOMO, 2008).
7. Can you give concrete figures on how many clinical trials take place in developing countries?
It is impossible to state with any certainty how much of their clinical trials pharmaceutical companies currently carry out in developing countries. The reason that these figures are uncertain is that there exists no universal, compulsory registration system for these trials; nor is there any centralized, recognized, supervisory body. It is therefore impossible to know how many trials are taking place, where they are being held, or what methods are being used. Although a number of pharmaceutical companies do post information on the internet, they are not formally obliged to publish it at all.
8. What kind of people participate in clinical trials in developing countries?
Dr Amar Jesani is a medical doctor from India with expertise in medical ethics and human rights. In a recent interview, he says that trial participants generally are poor, vulnerable and illiterate people. Apart from that, Dr Jesani says, they are desperate. They have either terminal diseases or they have no way of getting good health care. So the most vulnerable people of society are being used for clinical trials.
9. What legislation is relevant when conducting clinical drug trials?
10. What exactly is your problem with clinical trials in developing countries?
We closely follow the activities of the pharmaceutical industry in carrying out clinical drug trials in developing countries. Research (see e.g. Resources) has shown that the industry has not been unstintingly assiduous in adhering to the international codes and guidelines that apply. An increasing number of news media around the world is reporting on the abuses surrounding clinical drug trials in developing countries and organizations in Asia and Latin America confirm that ethical violations take place.
11. So you are against clinical drug trials in developing countries?
No, we’re not. We recognize that there are health, economic, knowledge and infrastructure related benefits and that for some conditions occurring only in developing countries, clinical trials are necessary. We also hear from our contacts that in some countries the situation has improved since foreign companies are sponsoring the trials. We do, however, point out that there are risks involved when carrying out clinical drug trials on the inhabitants of developing countries and we put forward concrete proposals for their improved protection.
12. What are common ethical violations?
Trial subjects not being well informed in advance about the nature of the trial and the risks involved;
Trial subjects not being guaranteed continuing treatment when the trial has ended;
Failure to have the ethical aspects of the research proposal approved by a local ethical review committee prior to the start of the trial;
The experimental drug being tested against a placebo instead of the current proven intervention;
Failure to ensure that the population involved in the trial benefits from the results of the research.
13. Are we talking about incidents or a structural problem?
The lack of transparency in clinical trials means that it is impossible to say whether the existing problems are structural in nature, but we are of the opinion that the problem is more than incidental and are engaged in ongoing research to substantiate this claim. Even though we cannot be certain of the amount of unethical clinical trials, the conditions under which clinical trials are being carried out in developing countries – including malfunctioning medical ethical review committees, lack of oversight and weak health systems – make it impossible to safeguard the rights of trial subjects.
14. Some say that ethics cannot be transplanted from one culture to another. Trials that are not acceptable here, may be acceptable elsewhere. What do you think?
The ethical guidelines that have been formulated to protect the rights of trial subjects apply worldwide. Western nations must not allow ethical regulations to be violated in developing countries where government supervision is often lacking and there is a high risk of ethical regulations being flouted with impunity.
15. Some say that participating in clinical trials is better than having no access to drugs at all. What do you think?
We have asked this question to Dr Amar Jesani from India. He says: ‘Out of the hundreds of thousands suffering from a particular disease, your trial participants may run into a few hundred, at the most. So you are providing benefit to only a few. The real benefit for the hundreds of thousands who are suffering from that disease will come only after the drug is found to be good enough and is made available to the entire community of that patient. But that doesn’t happen because of intellectual property rights. The costs are kept to such a high extent that these people don’t get the drug.’
16. People in developing countries have so many problems. Is the issue of unethical testing a priority?
The number of people taking part in clinical trials in developing countries is growing rapidly. The problem is that developing countries lack the infrastructure and manpower required to enforce legislation, technical standards and ethical guidelines. So now is the time to act.
17. Have you spoken with people who have participated in unethical clinical trials?
18. Are there any 'good' pharmaceutical companies?
We have not rated pharmaceutical companies based on their ethical performance. This is difficult to do because there is little information available about where companies carry out their trials and how they do it.
19. What is an ethical review committee?
Ethical review committees, also called ethics committees or research ethics committees, are established to examine all research protocols involving human subjects to ensure that they follow ethical principles. It is their job to ensure that test subjects are not exploited and that the trials are carried out in accordance with the regulations. The Declaration of Helsinki says: ‘The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No change to the protocol may be made without consideration and approval by the committee.’
20. How are the ethical review committees in developing countries functioning?
Research has shown that ethics committees in developing countries are frequently unable to adequately perform their work (see e.g. A Bitter Pill, p. 16). There are examples where trials had not been subjected to prior ethical assessment, ethics committees did not follow the prescribed guidelines, or possible conflicts of interest could not be ruled out.
21. Who sees to the functioning of ethics committees in developing countries?
Ideally this is done by the governments of the countries in which the trials are being carried out, but in practice this is seldom the case, either because these governments are ill-equipped to undertake such activities or because they do not possess the relevant information.
22. Why do you call on registration authorities in richer nations to conduct stricter ethical checks?
To ensure that unethically tested medicines do not reach the market, and that pharmaceutical companies do not earn large sums of money despite having violated the regulations, it is necessary that other bodies, for instance the European Union (EU), perform stringent checks of their own. As a purchaser of drugs tested in developing countries, the EU has a clear responsibility towards the test subjects on which these drugs have been tested.
23. What progress have you made so far?
We have attracted a great deal of attention from politicians, policy-makers, media and medical associations. For example, the Standing Committee of European Doctors (CPME), a Brussels-based organization which provides a collaborative framework for national doctors' organizations, spoke out against unethical drug trials in developing countries. Members of the European Parliament submitted questions to the European Commission about the issue of unethical drug testing. For a more detailed update, click here.
24. What do you want to achieve with the Call for Ethical Clinical Trials in Developing Countries?
We are concerned that politicians are closing their eyes to reality and are unwilling to consider concrete recommendations to improve the current situation. Therefore, we have joined forces with organizations from India, Latin America and Europe, and with scientists, experts and opinion makers, to work towards the Call for Ethical Clinical Trials in Developing Countries and improve the position of trial subjects in developing countries.
25. How can I help?
Sign the Call for Ethical Clinical Trials in Developing Countries;
Become an ambassador for the Call for Ethical Clinical Trials in Developing Countries by inviting others to sign;
Post a banner on your website (available in English and Dutch);
Report cases of unethical clinical trials to us (go to Contact);
Raise attention about the issue of unethical testing in developing countries among politicians, policy makers and the media in your country;
Make a donation to support Wemos’ work on ethical clinical trials. Please earmark your donation as “FairDrugs.org”.
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26. Who paid for this site?
This web site was built with funds from Wemos. You can find more information about Wemos’ financiers here.