The trend has gone largely unnoticed by the public at large. Yet more and more clinical studies are being conducted by the pharmaceutical industry in developing, and rapidly-developing countries. The objective of the studies is to test medication for effectiveness and side effects. But non-governmental organizations (NGOs) claim that when conducting tests in the developing countries, drug companies do not abide by the same ethical rules they would follow at home. As a result, participants in clinical trials conducted in developing countries are being abused, critics claim.
Exact figures for just how widespread the phenomenon is worldwide are not available. But as a report by the European Medicines Agency (EMA) reveals, between 2005 and 2009 some 26% of clinical studies submitted to the European Union for approval were conducted in Asia, Latin America, Africa, Middle East and Russia. That doesn't include the 10 new EU member states in Eastern Europe, which make up another 10%. Popular spots for clinical trials are: Brazil, India, China and South Africa – the so-called BRICS countries – and Poland.
The NGOs claim that the pharmaceutical industry is taking advantage of the weak position of people in developing and rapidly-developing countries. For many, signing up to be part of a trial is often the only way to get medication, says Annelies den Boer of Wemos, a Dutch NGO. And because the authorities in those countries don't tend to monitor the trials, participants are insufficiently protected from abuse.
"If a patient suffers from side effects, the companies often deny any connection of those effects with the medication," den Boer says. The burden of proof lies with the trial participant, not the pharmaceutical company. ‘"Proving anything, for participants like this, is exceptionally difficult.''
NGOs like Wemos further reproach the drug companies for breaking treatment off as soon as the clinical trial is completed. The Declaration of Helsinki, a set of ethical principles governing medical research on human beings to which the world's top 10 pharmaceutical companies, recommends the opposite – that treatment continues. This is a clear example, den Boer says, of how the companies often do not abide by the declaration's principles. Working with journalists, Wemos has cited numerous cases of patients who did not continue to receive medication after clinical trials were over.
Who's watching the watchdogs?
A further dimension to the problem is a generally insufficient monitoring over whether the drug companies follow ethical guidelines. Ethical commissions in each country are responsible for this, but they themselves operate with little oversight by local authorities, says den Boer. And although EMA does conduct checks to ensure that approval is not given in Europe for medication that has been unethically tested, the controls are very lax, she adds.
The matter did come up in the EU Parliament in 2009, with the result that the EMA is due to come up with a tighter set of controls by the end of 2011. Review of ethical guidelines has also come on in Switzerland. Patrick Durisch of the Erklärung von Bern (EvB), which describes itself as an independent organization devoted to aid development policy, says he doubts that Swissmedic, which grants licenses for pharmaceutical products in Switzerland, has the capacity to ascertain whether or not ethical guidelines are followed during clinical trials.
However, Verena Henkel, deputy head of Swissmedic's clinical review section, says the organization is well aware of increasing globalization and the consequences of it. The problem challenges all licensing agencies, worldwide, she says, adding that increased international cooperation was important. Henkel says that Swissmedic examines "all documents submitted by the pharmaceutical companies'' and abides not only by international rules such as Good Clinical Practice but also the Declaration of Helsinki.
Henkel says that Swissmedic asks the following questions for each case under review: Before being accepted for a clinical study, were patients fully briefed? Did they agree to participate and sign a document to that effect? Was the corresponding local ethics committee an independent body, and did it approve the study? Did the concept and implementation of the study take ethical guidelines and current science into account?
If there are any doubts, Swissmedic follows up with the company concerned and consults with relevant other authorities, Henkel says. If doubts remain, approval of the medication would not be granted.
There are a number of factors underlying the movement of clinical trials to developing and emerging countries. For the drug companies, the primary concern is cost. According to U.S. research, the cost per participant is about half in China or India as it would be in Europe or the United States. This holds particularly true for the major studies that have to be conducted once the clinical development of a medication has been completed.
Due to increased demands on the part of approving authorities, studies must be carried out on larger numbers of trial participants. For example, one Roche trial for cholesterol medication involved 15,600 patients. But another reason for moving trials to developing countries is access: lucrative markets in Asia and Latin America play an increasing role in sales. Chances of getting the necessary approval to sell a drug in a country are better when trials are conducted in the country. Time concerns also play a role: there are fewer administrative hurdles to clear in Asia and South America, so less time is spent prepping the trial, meaning it can get underway faster.
Finally, people in developing countries are more willing to participate in such studies because it is often the only way to get treatment. These poorer participants also come with a built-in extra advantage for the drug companies: they are much less likely to be on medication for any other condition either, which makes the trial easier and more accurate.
Read the original article in German.
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