Are we a terminally ill nation?

There are occasions when those afflicted with terminal diseases (e.g. certain forms of cancer and AIDS) are offered the option of being administered with experimental drugs. The desperate, i.e. those with no other choice, generally agree.  These are in reality clinical trials, typically couched as exercises in the larger interests of humankind.  While there is no doubt a positive aspect to such procedures in the development of cures to debilitating diseases, the seeming generosity tends to be marred by the profit motives of the primary movers.

Dr. Panduka Karunanayaka in an article titled ‘The banal face of medical research’ in these pages, details a ‘chain’ where scientists and professionals engrossed in the tasks they set themselves consciously or unconsciously serve the interests of those who command the chain.  He explains: 

‘A new Science Discourse is brought forth to legitimise the chain in our eyes; it appropriates the language of science, but serves the interests of commerce andfeeds upon our consumerism. We mistake the commodities – which is the form in which knowledge is packaged and delivered to us – for the science.’

In an earlier article, ‘Clinical trials: Cart before horse?’ (The Nation, December 25, 2011), Dr. Karunanayake comments on legislation under consideration with respect to clinical trials.  Many have warned that a bill proposed tolegalise or streamline the legal mechanisms of clinical  trials would reduce Sri Lankan patients to guinea pigs for drug testing.  Critics have pointed out flaws in the make-up of ‘regulatory committees’ and ‘expert panels’ while Dr. Palitha Maheepala, Additional  Secretary to the Health Ministry has claimed that the bill was drafted in consultation with experts and would be made available for public scrutiny.  The Government Medical Officers Association claims to be in the dark. 

Interestingly, the Department of Health and Human Services of the USA had admitted that clinical trials conducted in foreign countries for drugs intended for use in that country had increased by over 2000%over the past 20 years and that 80% of allocations for the registration of new drugs submitted to the US Food and Drug Administration were based on data from clinical trials conducted overseas.
The question arises, ‘why don’t US citizens offer themselves up for clinical trials to develop drugs that in the end are marketed as life-savers for US citizens?’  Since these companies are businesses, the answer must lie in costs and benefits.  Research subjects in countries like Sri Lanka could be ‘cheaper’.  On the other hand, it could be that US citizens are better acquainted with patient rights and reasonable compensationin view of potential risk, all issues that may not be understood or appreciatedby a population to which the language of clinical trials is patently foreign. 
The relevant authorities no doubt have taken into account the rupees and cents (or Dollars and Euros) of the matter, who stands to profit, the benefits that may or may not accrue to Sri Lankan patients and if they do at what cost.  In a world where pharmaceutical companies are known to be aggressive and doctors easily lured by the benefits of the particularities of prescription, however, caution makes a lot of sense.

As important is the fact that there are questions about the integrity, strength and independence of relevant ethics committees in Sri Lanka and their capacity to appraise proposals and monitor trials.  That the Ethics Committee of the Kelaniya Medical Faculty was scandalously dissolved and its replacement hurriedly given the green light to a clinial trial that the previous committee had not approved, suggests that interests other than science and healing are operating behind the scenes. 

Even though death rarely waits on us it is still better in the long run to exercise circumspection when it comes to this kind of legislation.  While the Government has the option of applying the ‘Urgent’ clause and hurry the bill through Parliament, such a move would naturally raise serious questions. Given the far reaching consequences for the ordinary citizens of this country and especially its most vulnerable segments, the more prudent measure would be to open the door to a comprehensive review of the relevant articles by the general public, including the broader intellectual community.  It is advisable that if the Government decides to table the bill, it will not use the minimalist option of a two week period for appraisal and objection subsequent to gazetting. 

It is also advisable that the Government actively encourages and uses its extensive media sway to educate the general public about all aspects pertaining to clinical trials.  This is imperative because an ill-informed or ignorant citizenry would be easy prey for drug companies that disguise profit-motive as scientific need.

The bottom line is that for all ‘globalisation’ we’ve received and suffered from,we are yet to become a ‘terminally ill’ nation. We are nation of human beings and not guinea pigs, let us remind ourselves.

[The Nation editorial of January 22, 2012]