THE TRAP CREATED BY THE DESIRE FOR HEALTH AND THE CAPITALISM OF THE PHARMACEUTICAL INDUSTRY – Morenike Folayan

Morenike Folayan
New HIV Vaccine and Microbicide Advocacy Society
The 2017 Bioethics Forum has come and gone leaving a lot of thoughts for the 35 participants at the conference. The second edition of the bioethics conference was a two days meeting held at the Rockview (Royale) Hotel on the 13th and 14th of December 2017. The theme was ‘participation in research and research demand: striking the balance.’ In attendance were speakers and participants from the United States, Australia, Ghana, Senegal, Guinea and Nigeria.
The opening plenary speaker, Kris Peterson, highlighted how the economic meltdown in the United States made pharmaceutical industries turn to the Wall Street for financialisation of the pharmaceutical industry during the great depression. This in-effect meant that pharmaceuticals had to grow markets to enable them make the huge profits they need to pay back loans. One of the ways they have had to grow that market is to outsource significant number of their research to low and low-middle income countries where the costs of production of drugs are cheaper. The out-sourcing process also implies a significant fragmentation of the entire pharmaceutical enterprise in ways that makes the regulation of the entire industry practically impossible and unmanageable.
Another strategic approach is the development of alternative use of the same drug molecule or/and increase in marketing of drugs for prophylaxis and chronic illnesses. These forms of drugs have sustained long term demands thus are able to sustain the pharmaceutical markets for long. For this reason, there is an increase in the support of clinical trials by the pharmaceutical industry to identify disease risk and continue to lower the thresholds for these diseases. This in turn expands the market for these pharmaceuticals.

A recent event made the reality of this process titled ‘the economies of health through the lens of  the pharmaceutical industry by the forum organizers indeed a huge reality. The American Heart Association, American College of Cardiology and nine other organizations produced a new guideline lowering the threshold for treating hypertension with lifestyle changes and medication. Treatment is now recommended at 130/80 mmHg as oppose to 140/90 mmHg in January 2017. The implication of this is that 46% of the US adult population will now be considered hypertensive under the new guideline as opposed to 32% under the old guideline.
For the HIV prevention world, the renewed use of tenofovir based regimen for HIV prevention in addition to its continued use for HIV treatment was an all time booster for the pharmaceutical industry called Gilead. The medicalisation of the HIV prevention field continues to widen the prospect for pharmaceutical industries to invest in the field, make huge profits. While the field needs the investment of the pharmaceutical industries to help increase the HIV prevention armamentarium, it is equally important for HIV prevention advocates to keep an eye on the evolution of the pharmaceutical industries in this space so that the capitalism drive of the industry does not unwittingly drive advocates and activists to promote clinical trials that continue to drive down the HIV prevention thresholds.
The huge number of people chronically living with HIV infection that will continue to need first and second line drugs, salvage therapy is enough huge market for the pharmaceuticals. Medicalisation of HIV prevention is now expanding that space for the industry. We need to be watchful and ensure that the collective push of advocates for increased investment of pharmaceutical industries in the HIV prevention space does not end up getting we community members out-priced in our search to expand the armamentarium for HIV prevention. There is a need to strike a moral and ethical balance in this process.

PARTICIPATION IN RESEARCH AND RESEARCH DEMANDS: STRIKING THE BALANCE – Morenike Folayan

The 2017 Bioethics Forum that held at the Rockview (Royale) Hotel in Abuja on the 13th and 14th of December left an indelible mark in the memories of most of the 35 participants. Many key issues that will inform the practice of research were highlighted at the conference.
One of the highlights was the recognition that for research, the law regulates the minimum standard of practice. The standards are raised through the research ethical codes. Adherence to the high standards of research ethical codes can lead to research outcomes that can lead to the review of laws.
Second, vulnerability should not be a reason for unethical exclusion of research participants. Research protocols should be reviewed to ensure that the vulnerability of study participants is not exploited. The prospect for exploitation should however not be a reason to exclude any vulnerable population from research participation. Rather, ethics committees should put safe guard measures in place to prevent such exploitation. It is important to generate research derived evidence about vulnerable populations so as have needed information to plan for their health access.
Ironically, legal liabilities may restrict the respect for the principle of justice when designing and implementing research, leading to unjust exclusion. Researchers and ethics committee members need to strike a balance between the law and ethical practices when reviewing research protocols and when implementing research in the field.
Third, there was a huge debate on the choice between the universality of the standard of care packages for research and adherence to local standard of care for research. The debate remained unresolved though the majority of participants advocated for the universality of the standard of care for research.
Fourth, all communities are organized with recognized political leaders and mechanisms for communicating. The lack of visibility of the community does not imply they do not exist. In every community, there are persons educated and literates to engage with during with designing and implementing research protocols. Look for representatives of communities targeted in any research protocols; and engage educated community representatives during research protocol development and implementation. Community members best understand mechanism for communicating with one another. This is needed to be able to effectively engage with any community. Community engagement needs to be strategically planned and funded. A media engagement plan should be developed as part of any community engagement plan.
Fifth, health research design should not only have a public health approach but should also have a human right focus. The two should be inseparable.
Sixth, research is essential but not an emergency. Take time to do the right thing.
Finally, all research designs need to respect diversities. This implies that all community based research should be encouraged to include social scientists as part of their research team members. Ethics committee members were encouraged to screen for this during the review of community based research protocols. Targeted committee head should also give letter of permission for the research; and the letter should be submitted along with the research protocol at the time of application for ethics clearance.

COLLATERAL DAMAGES IN RESEARCH: THE NEED FOR STRATEGIC RISK AND BENEFIT ANALYSIS

Very often, researchers and ethics committees are stocked with thinking about the welfare of the study participants. Participants at the 2017 Bioethics conference that held on the 13th and 14th of December 2017 at Rockview Hotel Abuja encouraged researchers and ethics committee members to think beyond the study participants and prevent possible ‘collateral damages’ that can also results through affectation of research participants’ spouse, family and community. Bioethics thinking has to stretch beyond the only the study participants especially for communal societies like that found in Nigeria. Study participants are part of a community. As much as possible, researches should be designed in a way that ensures it is a win-win situation for all direct and remotely affected parties.

RESEARCH, COMMUNITY AND ETHICS COMMITTEE NEED ONGOING SCIENCE LITERACY

Participants at the 2017 Bioethics conference that held on the 13th and 14th of December 2017 at Rockview Hotel Abuja identified the need for researchers, community members and ethics committee members to have ongoing science literacy to be able to contribute meaningfully to the research process. How do we promote ongoing research literacy for all members of the ethics committee? How do we ensure that researchers also continue to build their competency around research and ethics literacy? Is there a need to remunerate ethics committee members for their services?

COMMUNITY VOICES ARE POWERFUL

During the 2017 Bioethics conference that held on the 13th and 14th of December 2017 at Rockview Hotel Abuja, contributions from the audience raised a critically important point. They noted that community voices can change ethical and legal standards. It is therefore not appropriate to push on communities, ‘a’ considered ethical and legal standard. It is important that standards for a research are defined through consultation with community members rather than being legal about the application of rules and standards for the conduct of a research.