More than meets the eye
UNETHICAL collusion between the pharmaceutical industry and healthcare professionals has been the subject of some debate. Such a relationship is rapidly eroding the ethics and professionalism of academic medicine and research at the global level.
It is well known that in Pakistan physicians, many among them professors and heads of medical associations, haggle with pharmaceutical companies for money to organise academic conferences in expensive hotels.
Without a second thought we ingest food paid for by industry, drink from bottles ringed with drug advertisements and gobble up fruit adorned with stickers announcing company names. In return, as there is no such thing as a free lunch, we prescribe specified medicines and appliances claiming — contrary to established fact — that accepting favours from drug companies does not influence prescribing habits.
The industry festoons our lecture halls with banners advertising products on the same stage as that used by academic to deliver talks. Medical conferences conclude with company CEOs honoured with shields inscribed with the conference logo for the millions they poured into our coffers, while universities garland medical students with gold medals tagged with company logos.
Industry and physicians have become comfortable bedfellows.
But pharmaceuticals are making inroads into medicine through other insidious means too. One is by funding research on human subjects, an activity that largely passes under the radar and has led to little public debate.
The Global Forum for Health Research reported a ‘10/90 Gap’ signifying that less than 10 per cent of billions of dollars spent on health research are devoted to health problems accounting for 90 per cent of the global disease burden, most of which is borne by poor nations least likely to benefit from this research. Currently, almost 78 per cent of clinical trials from US take place outside that country; of these, the majority is sponsored by pharmaceuticals which control the agenda for research.
The industry is turning to contract research organisations (CROs), small agencies and multinational corporations, to accelerate the recruitment of human subjects for drug trials. Human subject research is being privatised, a business run on industrial management principles of ‘efficiency’, to expedite trials and increase industry profits.
In a one-window operation, CROs manage all aspects of clinical trials from developing protocols and obtaining ethics approval from for-profit review boards to recruiting subjects through incentives to physicians and hospitals, as well as data analysis. Profit-driven research on human subjects is a vastly different universe from one understanding research as necessary but morally perilous and requiring strong safeguards against the potential of exploiting the study subjects.
Progressive regulation of human subject research in industrialised countries is driving the industry to outsource clinical drug trials to developing countries with large pools of impoverished, uneducated people — ‘ready to recruit’, vulnerable populations that are too poor to afford medications, unaware of their rights and have little recourse against exploitation by researchers.
Pakistan fits this bill. Our physicians and hospitals are increasingly willing to become industry partners, follow industry protocols, and collect industry data by using their patients. The absence of institutional ethics oversight — or worse, ethics committees willing to rubber stamp approval for research proposals deemed lucrative for their institutions (and the government) — permit research to run roughshod over public welfare. The refrain of ‘do more research in Pakistan’ and the push for training researchers sans ethics regularly bypass the axiom that unethical research is bad science.
Another particularly egregious development is the increasing financial support of multinationals for bioethics centres, staff and programmes. Carl Elliot of the Centre for Bioethics, University of Minnesota, who follows this phenomenon in the US, reports a $100,000 grant established by a leading drug manufacturer for a Fellowship in Bioethics, meant to allow researchers to explore “conflicts of interest”.
The irony of this is inescapable if one recalls that not too long ago this company was involved in a deadly drug research scandal involving Nigerian children with meningitis and, according to Elliot, made to pay the largest criminal fine in 2009.
This year, another two more pharmaceuticals are to fund a “crash course in bioethics” in China which will include “meetings” with “pharma folks … expats who work for large drugmakers”. The University of Pennsylvania faculty member that is organising this course admits that he has worked “in big pharma for many years” with the key objective to “develop academic-industry collaborations”. One of the companies was cited last year for interfering in the approval of generic alternatives to its blood-thinning drug.
It has become the in thing in Pakistan to organise bioethics workshops, and include a lecture or two on ethics in medical conferences. That done, we collect our certificates and go home. But there is hope. It is visible in public debates and discussions within the medical community regarding industry-physician dealings and a growing sense that enough is enough.
The Karachi Bioethics Group made the first move to develop guidelines for ethical pharma-physician interactions and many of its members are introducing these recommendations within their institutions. Changing entrenched practices, particularly those that line pockets, can be slow but it is not an impossible task if a critical mass of professionals is evolved who are willing to take a stand against dishonest practices.
The crux of the matter remains that industry must increase profits for shareholders and physicians must protect the interest and welfare of patients above all else. As physicians, we take a moral oath when entering our profession; members of the industry do not.
The writer is the chairperson of the Centre of Biomedical Ethics and Culture at the Sindh Institute of Urology and Transplantation.