Adriana Petryna. When experiments travel: clinical trials and the global search for human subjects.Princeton, NJ: Princeton University Press; 2009. 258 pp

The words "randomised controlled trials" have taken on new meaning for me. In When experiments travel, Adriana Petryna reveals the experimental machinery manipulated by the globalising clinical trial industry in the quest for blockbuster drugs. She chronicles interviews of people who are not so much heroes or villains but ordinary actors engaged in a partly dirty business across national boundaries.

In this anthropological account, Petryna explores how the research industry has mastered the science of "evidence making", which includes configuring to which countries to offshore clinical trials, teasing out the loopholes of existing regulatory frameworks and seeking out "foolproof, treatment-naïve, steroid-naïve, statin-naïve" clinical trial populations in the most ailing healthcare systems.

Through her interviews of clinical trial industry players in Eastern Europe and Latin America, the author weaves an intricate web of issues involved in the politics of pharmaceutical globalisation. She reveals a paucity of accountability, oversight and transparency. She expresses concern over "commodified patients" and exploitation of the vulnerable, raising questions about the scientific integrity of research, wondering whether ethics is simply "workable documents on paper".

The author describes how the epidemic of cardiovascular diseases in Poland in the 1980s and 1990s was the pull factor leading to a "gold rush" of drug and surgery trials in cardiac care in that country. According to the director of a global contract research organisation (CRO), Poland among other Eastern European countries was used as a "rescue country" where failed projects of me-too drugs were often dumped. Salvage research and floating "garbage trial" protocols to low-income countries began to be seen as a profitable form of rescue for pharmaceutical companies. The author flags concerns about the aftermath of these trials which leads to the worsening of health inequities, complicated by the lack of post trial access to treatment.

While in Brazil, healthcare is the duty of the state. Pharmaceutical access is a cornerstone of healthcare coverage providing for all kinds of medicines – whether they are on the country’s essential drug list, part of specialised programmes or even in experimental stages not yet approved for marketing. This "pharmaceuticalisation" – a term coined by medical anthropologist Joao Beihl – paved the way for a strained health system offering too much. The irony is obvious; "you might be out of work and hungry but you could still claim your free anti-anxiety pill" at the local health post, writes Petryna. In Brazil’s context of poverty, people die mostly of infectious diseases while the consumption of drugs for lifestyle diseases soars. The apparent disconnect between clinical experimentation and local health needs is starkly evident. "We have no idea what their value is for our patients. All we know is that many of the new drugs can’t kill, but we don’t know if they can save" explains Dr Andry Costa, a cardiologist and researcher. She goes on to explain the exploitation of Brazilian real-life patients who are much sicker than the ideal patients in clinical trials and in these scenarios biased data is an inherent flaw. They use human subjects not only to generate drug value through R&D, but they also turn them into vociferous consumers of treatment via the state, creating a dangerous "public health trial".

A running theme through the book is that of cold blooded research at the hands of CROs, the data generating enterprises working on behalf of sponsor companies. They care most about getting the data, ensuring their "integrity," "engineering out" the possibility of adverse events by including a "randomised" (read "highly edited" and cautiously selected) patient population and making data from international sites portable and usable within the US drug approval process. In the unsettling words of a CRO professional, "I don’t see patients, I see data." The benefit of this lop-sided approach, he claims, is that while data are transferred out of the country, a lot of clinical investment comes back in.

Providing context, Petryna highlights a notable event for the clinical trials research industry: the International Conference of Harmonization’s Good Clinical Practice (ICH-GCP) guidelines. Their main aim was to make clinical data from international sites transferable and acceptable to regulatory authorities in the US, Western Europe and Japan. They also served to undercut the regulatory significance of the 2000 revision of Helsinki Declaration regarding placebo-controlled trials. The Helsinki Declaration requires a new drug to be tested against the best or standard treatment for a particular indication. ICH-GCP on the other hand allows placebo-controlled trials. The experimental drug can be tested against "equivalent medication", not necessarily standard or best treatment, but whatever was locally available and accepted by local review boards – which could be no treatment, or a placebo. This ethical variability allowed pharmaceutical companies to bypass ethics in the developing world. Placebos also happen to reduce trial costs and provide better evidence.

Though India’s clinical trial scenario receives nothing more than a few passing references, one can’t help but draw parallels and wonder about the fate of pharmaceutical research in this country. How is India going to respond in the wake of being dubiously hailed as the "global clinical trials hub"? With the inflow of clinical trials investments, will the Drugs Controller General of India beef up regulatory mechanisms? Or will clinical trials become a part of healthcare delivery for disadvantaged groups? At present, one can only guess.