Testing Drugs on the Developing World

By Stephanie Kelly

For people struggling to put food on the table and a roof over their heads, "voluntary" participation in clinical trials is a slippery slope. While disclosure of new data from pharmaceutical companies is a good first step, questions remain.

RTXX3P615.png
Claudia Daut/Reuters

The purpose of clinical trials is to find out if the newest wonder drug is all that wonderful, and what kind of side effects we humans might expect. It worked on animals, but will this drug kill people, and/or turn them green? Every warning you see on a label is there because a test subject -- or 50 of them, or 500 of them -- have suffered that side effect.

These clinical trials for new medications take place all over the world, but developing countries often serve as cost effective locations. 

Medicine and Machine special report
The evolution of health technology. See full coverage

In 2008, the Center for Research on Multinational Corporations released a document full of examples of the detrimental effects of unethical clinical testing that went on the 1990s and throughout the 2000s in the developing world. The report included the case of clinical trials in Uganda between 1997 and 2003, when women taking the anti-transmission drug Nevirapine experienced thousands of serious adverse effects (SAEs). These symptoms went unreported and testing was allowed to continue, resulting in the (also unreported) deaths of 14 women. In Hyperabad, India in 2003, eight test subjects died during the testing of the anti-clotting drug Streptokinase. The worst part, though, was that the subjects did not even know that they were part of a trial. 

These two cases are just a couple out of numerous in the report, which is only one of numerous reports of unethical clinical testing on the world's least privileged people.

Until now, pharmaceutical companies themselves have acted under cloak and dagger, not telling us just how many test subjects have suffered ill effects, so that we can stop a headache, or  have better sex, or sleep more soundly. 

In that sense, we stand to gain huge knowledge from GlaxoSmithKline's recent commitment to publish clinical study reports from the last 20 years, a move the company is claiming will further transparency, aid future research, and protect patients from misinformation. But what do the numbers hide?

Clinical study reports describe every aspect of the clinical trial for a new drug, including the number of participants, methodology, analysis, and conclusions. While releasing this data is a huge step in the intensely competitive and all too secretive pharmaceutical industry, it is researchers, health care practitioners, and patients who stand to gain. What about the 1 or 50 or 500 test subjects in rural Uganda or the slums of India who the numbers are describing? 

"But what about those participants whose health did improve? And either way, these test subjects volunteered for these programs, freedom over your own body etc, etc." I hear you shouting at your screen. True, there is a chance that test subjects stand to see their health improve. But when people sign up to participate in drug trials, they are signing up for a casual game of Russian roulette with their health; the stakes are high. 

Not only that, but drug trials do not last forever. Once the period of allotted time for testing ends, the researchers can pack up and head back to headquarters. What if the illness being cured involves lifelong treatment, such as for HIV/AIDS patients? Indeed, what if the treatment being tested requires interrupting testing, just to see what happens? 

This is what happened in the case of anti-retroviral methodology research in Uganda, Zimbabwe, and the Cote d'Ivoire cited in the SOMO document. The research, sponsored by a multitude of pharmaceutical research firms including GSK, caused uproar as patients were separated into two groups -- one group to get continuous anti-retroviral treatment, one to get interrupted treatment with the same drug. Needless to say, not taking necessary anti-retrovirals took a lethal toll on participants and some died in the process. While we now know that interrupting anti-retroviral therapy for 12 weeks at a time is a bad idea, participants had to die for this discovery to be made.

So this is where the argument about "free" will comes in. These same participants died because they volunteered to take part in the study, right? Choice is a tricky concept in developing countries where people and their families are struggling to put food on the table and a roof over their heads. To what extent do you have a choice about participating when you see an opportunity to feed your starving family, or assist your extended family, or get treatment for a terminal disease you could never hope to pay for by conventional means? This problem has been documented again and again, particularly in India, where women are under pressure from their families to participate in trials which carry a greater return than many other potential occupations for women. With these kinds of life or death pressures, the idea that it is a choice gets fuzzy. It gets even more complicated when you consider language barriers. 

That is, assuming that the researchers go to the trouble of translating consent documents. One of the most commonly cited ethical qualms with clinical trials tends to be misinformation. While sometimes it is a case of "lost in translation," there are even more dubious cases of misrepresentation at work. In Kano, Nigeria Pfizer tested a new drug called trovafloxacin on children infected with meningitis without informing their parents; five died in treatment. While this case dates back to 1996, deceptive research practice is still alive and well. 

Just last year, the BBC reported on patients from India's lowest caste being placed in drug trials without their informed consent. For a deeply divided country, being of the lowest caste and given medical treatment is an honor, one not to be questioned. The power of the white coat, the elevated role of the doctor throughout the world as a demi-God who has the power to save lives, is one that is being taken advantage of in India where doctors enroll their trusting and often uneducated patients in risky drug trials, at a profit of course. These trials led to 438 deaths in 2011 alone. This kind of misinformation will not show up in the data released by GSK.

RECOMMENDED

Why Are So Many People Still Suffering From Leprosy?

While ethics boards exist  to investigate and expose the ethical misconduct at play in clinical research in the developing world, accountability is difficult as many research endeavors involve pharmaceutical research firms teaming up to carry out trials. This makes it difficult to pin down the perpetrator for any kind of retribution. Even if the finger of blame could be pointed at one firm, whose finger would it be? For wronged research subjects in African villages or Indian slums, retribution seems unattainable. Reporting the wrongdoings of a multinational company to your local police station in the depths of Uganda doesn't achieve a whole lot. Even when it is possible, monetary compensation would be a pittance relative to the money being made by the world's largest pharmaceutical companies. 

These things considered, the win-win of pharmaceutical firms targeting developing countries looks more like a zero-sum game. 

This article available online at:

http://www.theatlantic.com/health/archive/2013/02/testing-drugs-on-the-developing-world/273329/