Drug companies have a duty to continue treatmentBMJ 1997; 314 doi: https://doi.org/10.1136/bmj.314.7084.889 (Published 22 March 1997) Cite this as: BMJ 1997;314:889
- a National Centre in HIV Epidemiology and Clinical Research University of New South Wales Sydney NSW 2010 Australia
- Correspondence to: Professor Cooper
There is growing interest from the pharmaceutical industry to sponsor clinical research and development in the developing nations of the world. This expansion is a direct response to the critical need for companies to reduce their development times, thus extending the time over which a product might make a financial return on investment. In supporting such research and development, industry plays an important role in developing further the healthcare systems of selected countries. Research supports the development of infrastructure and enhances the training and experience of healthcare professionals. In return, data that define the potential clinical value of new treatments are generated.
This reciprocity is threatened by problems such as the ethical dilemma identified by Professor Cleaton-Jones. The continued provision of study treatment to participants of a trial, as deemed necessary by the treating clinician, after the trial has ended is clearly a complex issue. Resolution will require the productive interaction between various different groups with diverse interests. The basis for such discussions is often obscured by the emotive nature of the disease. It is vital to further progress that a framework is established within which specific detail can be resolved. It is equally imperative that clinical research continues in countries of the developing world. This is particularly important for diseases such as HIV infection and AIDS, where even modest benefits in relatively small numbers of people may have a substantial impact on affected communities.
Where there is enthusiasm for clinical research and use of experimental treatments there should be few hurdles to prevent doctors and their patients from making informed decisions that are relevant to their circumstances. Virtually all nations have guidelines or regulations describing the ethical requirements of conducting clinical research in human subjects. It is important that such national autonomy is preserved and nurtured. Central to every set of guidelines is the obligation of adherence to the Declaration of Helsinki, particularly the sections relating to conduct of medical research in humans.1 The Helsinki declaration is appended to almost all industry sponsored protocols as a binding framework for conducting clinical trials.
More importantly, regulatory authorities around the world (including the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products) require that submissions made to them in support of a licensing application are composed of data from clinical studies that fulfil the requirements of the Helsinki declaration. Two sections from the declaration are relevant to the issue identified by Cleaton-Jones:
In any medical study, every patient–including those of a control group, if any–should be assured of the best possible diagnostic and therapeutic methods (section II, para 3).
In the treatment of the sick person, the doctor must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, re-establishing health or alleviating suffering (section II, para 1).
In our view, these explicit statements demand the continued provision of antiretroviral therapy. This should be, at a minimum, to the standard of care identified by the protocol. In studies of antiretroviral therapy for HIV infection, clinical judgment can be supported with great accuracy by measurement of plasma HIV load and CD4 cell counts. Any industrial sponsor that does not make substantial efforts to satisfy these requirements in countries where there is restricted access to established treatments should recognise that its studies might be regarded as unethical. As such, any data generated from the studies would be unusable in support of a licensing application. This represents a greater ethical dilemma since the research would have no utilitarian value.
Companies that go to countries in the developing world in order to have access to large numbers of HIV infected people who have never been treated must be under an obligation to conduct the study as they would in countries of the developed world. Clinical research in countries of the developing world must not be seen solely as a cost saving mechanism. Clearly, there will be a financial penalty to companies that provide continued access to treatment for the participants of trials, and this will be amplified if drugs from other companies must be purchased. However, companies that make this relatively small investment may be rewarded through the generation of data that increases their product's market lifetime by reducing development times.
The National Centre in HIV Epidemiology and Clinical Research is supported by the Australian National Council on AIDS through the Commonwealth AIDS Research Grants Committee.