In a single paper Mirowsi, Phillip and Van Horn address a wide variety of the issues we have been talking about in this course. They are specifically concerned with Contract Research Organizations (CRO’s) as an exemplar of the modern paradigm of science as a commercialized interest. They identify five characteristics of CRO’s which indicate the manipulations and consequences which come about as a result of this focus: treatment of human subjects, control of disclosure, subjection of research tools to commercialization, redefinition of authorship, and the re-engineering of the goals of research.
The author’s begin the paper by setting out the various historical contingencies which allowed for the biopharmaceutical industry to become the dominant focal point of scientific commercialization. Most centrally was the industry’s shift away from the FDA; a result of their expense and inefficiency, ‘As the demands imposed upon pharmaceutical development have become more elaborate, they also came to be regarded as excessively onerous (510).’ The authors note that even with the FDA itself 12% of the budget is now accounted for by fees paid by pharmaceutical companies who wish to speed up the process. In the economic sphere, if a service is proving unsatisfactory moves will be made to fill the gap and this is exactly what happened with the CRO’s. Consequently the authors claim that rather than have a basis in scientific progress, ‘the bottom line for CRO’s…is the facilitation of the approval process for new drugs for the pharmaceutical industry. (532)’ Hence there is an underlying commitment to speed, cost-cutting and pro-industry results. Other factors for the rise of CRO’s are highlighted including the ability to terminate unpromising trials and the ability to carry out trials overseas where it is easier to achieve the desired outcome.
The authors then look too quash the notion that the rise of CRO’s is simply a consequence of the capitalist marketplace and as such has no footing in bias or morality. They note that CRO’s ‘divert attention from the actual means through which the promised cost savings could be realized…information on the conduct of CRO research has become even more inaccessible…[and] pharmaceutical executives rank ‘cost saving’ as relatively low on the scale of importance. (513)’ Next the paper moves onto the Institutional Review Boards (the bioethicists who deal with testing on human subjects) and draws a distinction between local and independent IRBs. Local IRBs are attached to an institution whereas independent IRBs are more like bioethicists for hire. Independent IRBs benefit CRO’s because once more they are far more favorable to their employer and process applications incredibly fast.
We are then faced with the familiar dialogue on conflict of interest, gift giving and funding, the author’s summarize the issue as, ‘Individually small but cumulatively decisive ways for the data to be biased in a ‘positive’ direction.’ The author’s complete the paper by noting that the strong bonds formed between consumerist market place capitalism and CRO’s have ultimately led to a stalling in scientific progress, because the pharmaceutical industries are more interested in making drugs which are similar to ones which have previously been successful rather than discovering new drugs.
Adriana Petryna goes into a little more detailed concerning the outsourcing of clinical trials to other (less developed) countries, in particular Poland. This offshoring occurs mainly during Phase III trials immediately preceding the release of the drug onto the Western markets. The issue is of particular complexity because we find ourselves caught in a conflict between the ethical concern of patients and access to care. Clinical trials have become ‘a normal part of health-care delivery…they have become integral to public health and quality of care in these contexts. (22)’ Petryna also notes the broad scope of the involvement of CRO’s; patient recruitment, site management and organization and data capture are just a few of the tasks taken on by the CRO’s. The main focus of the article is on the negligence of human subject protection on the part of the trial organizers, and the inconsistencies between standards of care in the West and in these underdeveloped nations. Of increasing concern is the economic related practice of ‘expected failure’.
First, Petryna clarifies the reasons for the need to carry out the clinical trials outside of the countries that will mainly be benefiting from the results. The sheer number of trials has increased significantly over the past decade and the regulations in the U.S require an increasingly large number of patients in the trials in order to ensure accuracy of results. The consequences of market competition mean several companies are competing to deliver the ‘best’ version of a drug and the increasing number of new chemical entities available to be researched is also driving up the number of studies. These phenomena are also coupled with a shrinking pool of human subjects in the West. The main reasons for this is that Westerners are already aware of the inherent dangers of clinical trials, and most importantly most Westerners are already taking several drugs which does not allow for scientifically sound research. The author terms this scenario as ‘treatment naiveté’; meaning that these populations have not been diagnosed or treated for particular conditions in the past, and know little information about them, and so there is less variability in the results.
Petryna’s research reveals a striking number of admissions on the part of individual involved in CRO’s concerning the practices which are regularly played out. She writes, ‘There is now bias-induction in both the recruitment of epidemiologically convenient populations and in protocol design.’ Not only can the trials be designed to negate the presence of side effects; but also when comparing one drug with another the rival’s drugs can be proven to produce more side –effects though techniques like doubling the dosage.
Granting the potential health benefits which do come about as a result of these trials , it seems clear to the author that there is an element of exploitation taking place in pursuing test subjects who have little or no access to legal infrastructures in the case that things go wrong. She also notes a legally condoned double standard with regards the ethics of research as illustrated in the case of AZT, she questions whether it is evidence of ethical imperialism or ethical relativism. She also addresses other ethical issues such as whether we have a duty, or a debt, to continue treatment once the trial is over. Ultimately she states, ‘In this find-and-fix approach, safety problems are detected after the fact and this makes everybody anxious. (33)’