U.S. pharmaceutical companies have moved their operations overseas in the past decade, testing their drugs on poor people in such lands as Russia, China, Brazil and Romania. It is a $30 billion business, and today around 105 countries are allowing such large corporations as Merck and AstraZeneca to conduct clinical trials on their soil.
One country that has experienced a boom like no other in this industry is India, with its widely spoken English, an established medical infrastructure and welcoming attitudes towards foreign industry. Most importantly, these pharmaceutical companies are exploiting the country’s vast number of illiterate and poor people who are willing to become guinea pigs.
Zeina Awad, a reporter for Al Jazeera’s “Fault Lines” program, traveled to India to investigate clinical research being conducted there. She explored what role the United States regulatory agencies are playing in overseeing the clinical trials, and whether the testing complies with international ethical standards.
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Her report, “Outsourced: Clinical Trials Overseas,” aired on Al Jazeera English recently.
New America Media Health Editor Viji Sundaram interviewed Awad about what she found.
Viji Sundaram: Your report seems to suggest that a combination of poverty and inadequate public health care is what drives many Indians to enroll in clinical drug trials as guinea pigs. Do they actually know what they are getting into?
Zeina Awad: The growth of the clinical-trial industry in India needs to be seen within the social and economic context of the country. According to the United Nations, 40 percent of people in India are illiterate. The gap between rich and poor continues to grow. Many risk not knowing whether the treatment their doctor is prescribing is [a proven] treatment or a part of a clinical trial. That aside, it’s also important to remember that in certain societies – and India is one of them – doctors are respected to the point of being revered. Their word is rarely questioned, so the likelihood of a person questioning their doctor about specific treatments is low.
Economics plays a role in a person’s decision-making. We met a young man in the impoverished community of Dharavi (Asia’s largest slum) in Mumbai, who told us that he enrolls in clinical trials as a way to make a living because he makes more money that way then when he works as a laborer. He also told us that he has many friends who do the same. Most of them don’t tell their families because there is some shame associated with doing this.
Sundaram: You report that some U.S. pharmaceutical companies chose patients for their tests at a hospital in Bhopal that was built as a memorial to the 1984 victims of the Union Carbide gas leak. Satinath Sarangi, the activist who is working to get justice for the survivors and one of the people you interviewed, said that 100 Bhopal survivors in six trials enabled the hospital to earn a whopping $220,000. How long were trials allowed to go on there?
Awad: Yes, it is ironic — and sad. The hospital in Bhopal was built by Union Carbide as part of their compensation for the victims of the 1984 gas-leak disaster. But after the scandal about drug testing on the gas leak survivors broke last year, the government took over and banned all testing.
The drug trials ran from 2004 until 2008. The complete lack of empathy of both the doctors we secretly recorded stood out to me. In addition to what one of them says in our film, he also told us he believes the reason why his hospital has been singled out was because others were “jealous” of the hospital’s performance. Some of the pharmaceutical companies and CROs [Clinical Research Organizations] who ran the trials refused to speak to us. Meanwhile, people who are almost always poor and often illiterate fell by the wayside.
Sundaram: Explain the nexus that seems to exist between CROs and hospitals. How do these CROs pick the hospitals where they want to test drugs? Did your investigation reveal any particular doctors who benefited from this testing?
Awad: CROs are profit-driven companies that specialize in running clinical trials. Their clients are hospitals and pharmaceutical companies. CROs and the Association of Clinical Research Organizations, (the body that represents a number of CROs,) say that hospitals are chosen based on their performance, resources, professionalism and whether or not they have the technology necessary for clinical trials.
Sundaram: One family you interviewed in Andhra Pradesh lost two daughters after they were vaccinated with Merck’s Gardasil, one of the vaccines that is used in the United States to prevent contracting the Human Papillomavirus, which causes genital warts and cervical cancer. A few other girls also died after they were vaccinated with Gardasil. Were there any health care professionals you interviewed, who said they believed that the deaths were or could be related to Gardasil? Is any action going to be taken against the principal of that school, who gave consent to the CRO to vaccinate his students? How many students in all were vaccinated with Gardasil?
Awad: There is no evidence linking Gardasil vaccine to the deaths. There was also no adequate follow up with the girls’ families, and with no follow up there is no way of knowing what went wrong. The government did issue a report in which it concluded that none of the girls died from the vaccine.
We looked at the girls who were vaccinated while they were at school in India’s tribal region. It was the school’s headmaster, and not the families of the girls, who gave consent for the girls to participate in the vaccination program. The headmaster is no longer working at that school, and he has not been prosecuted. In fact, the government’s investigation found that there is no one party responsible for any wrongdoing, and therefore no one was to be prosecuted.
Sundaram: But why would Merck want to test a drug that has been already approved by the U.S. Food and Drug Administration on more people in another country?
Awad: PATH (a nonprofit whose stated goal is to improve global health and well-being) wanted to see which of two vaccines, Merck’s Gardasil and GlaxoSmithKline’s Ceravix, yielded better results within certain populations. PATH says it wanted to get large volumes of the better-performing vaccine at a lower affordable price to a number of countries, including India. PATH was not testing Gardasil for FDA approval or for a U.S. market.
Sundaram: Did you ask Merck if they had to pay fines to families of women vaccinated with Gardasil in any part of the world?
Awad: Merck did not want to clarify to “Fault Lines” the terms under which it provided PATH with the medication. We did not ask them if they had to pay fines in other parts of the world, but we did not come across a case where they paid out.
Sundaram: When did the U.S. Department of Justice (DOJ) begin its industry-wide corruption investigation into overseas clinical trials? Were you able to find out if any Indian officials had been bribed to allow the clinical trials to be done there?
Awad: The U.S. Department of Justice launched its investigation in the summer of 2010. In India, many health workers (doctors, nurses, etcetera) and health officials work for state-run hospitals and government agencies, which makes them government employees. Bribing them to advance business interests violates U.S. antibribery laws.
During the course of our reporting, one doctor told us when the camera was not rolling that he taken his family to the United States on trips funded by the CRO and pharma companies. Another doctor said – on the record – that he witnessed how pharmaceutical companies have offered some of his colleagues kickbacks and all-expenses paid trips to the U.S. and other Western countries. The DOJ is investigating whether such perks are being used to advance business interests.
Sundaram: Dr. Sidney Wolfe, health research director with the U.S.-based nonprofit, Public Citizen, told you that ethical oversight of clinical trials in foreign lands is less than it is in the United States, which makes it easy for CROs to exploit the poor and illiterate. You interviewed families in India on whom clinical trials were conducted, who told you they were illiterate and didn’t know what they were signing. Is there an oversight agency in India to ensure that those who sign consent forms know what they are signing?
Awad: In India, as in other countries in the world, clinical trials are supposed to be conducted following internationally agreed upon norms and ethics. These include informed consent, follow-up care and the practice of testing drugs on populations that stand to benefit from any breakthrough results.
During our research and reporting, we found evidence that all three have not always been properly adhered to. Also, by law, every hospital that runs a clinical trial is supposed to have an independent committee that oversees the trial. We heard anecdotal accounts that that does not always happen. In some cases, the people running the clinical trials have their own friends and family members sit on the independent committees.