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The downside of medical trials in developing nations

by Pieternel Gruppen

07-03-2008

Almost everyone who lives in the West uses medicines from time to time; be it paracetamol to soothe a headache or something stronger to combat heart disease or diabetes. But how often do people think about how all those pills and powders are tested as they stand in line for to have their prescriptions dealt with at a dispensing chemist?

There is, in fact, an increasing trend among pharmaceutical companies to test their new drugs and medications on people living in the world's developing nations, and this isn't always handled in the most ethically responsible manner.

These days, almost 40 percent of all medical tests carried out across the globe take place using human 'guinea pigs' in developing countries. In some cases, that yields a cost reduction of almost 50 percent.

New drugs are increasingly tested in the developing worldBut besides the cost factor, the relevant rules and regulations in these countries are frequently less strict than in the West, or there's simply a more relaxed regime in terms of monitoring compliance with those rules.

On top of all that, it's generally easier in these countries to find people who are willing to let themselves be used as guinea pigs, as Leontien Laterveer of the Wemos development organisation explains:

"In these countries taking part in a trial is often the only way to get your hands on medicine. In a country like India, for example, there are also a great many people, so there's simply a large chance of finding patients with a specific type of ailment, even one that's rare. Added to this is the fact that these guinea pigs have had less exposure to other medicines, so the results [of the trials] are more reliable."

Popular locations
Russia, China and India are popular locations for clinical trials. The healthcare systems there are well developed, whereas Africa, where healthcare provision is generally at a much lower level of development, is less popular with pharmaceutical companies.

It's been estimated that in 2010 alone, around two million people will be taking part in some or other clinical trial. The government of India has even relaxed the law to make it easier for pharmaceutical companies to conduct trials. Dr Chandra Mohan Gulhati, editor of India's MIMS medical journal in New Delhi, says doctors can make a lot of money by providing patients for clinical research.

"Huge sums of money are made by hospitals, especially private ones, from clinical trials. And investigators are prepared to compromise their professional ethics for what we call the three 'F's: fame, funds and foreign travel."

Pressure on patients 
Doctors may exert pressure on their patients because they get a bonus for each person they refer for a trial. Patients in developing nations can be susceptible to this kind of pressure because the doctor-patient relationship is often more hierarchical than in the West.

In some cases, people simply can't read the information they're offered, or it's written in a language which they don't understand.

But even in cases where full information is provided, there are many things that can go wrong. For example, once a trial is over the pharmaceutical companies are required in principle to go one supplying the participants with the medicine free of charge if they are benefiting from using it. This is something which also doesn't happen all the time.

In other cases, patients never get any medication because they take part in a placebo trial. In richer nations such as the Netherlands this kind of research, in which one of the two trial groups doesn't receive the medicine in question, is often prohibited, but it's normal practice in India says Dr Gulhati:

"We know an example of a drug that was given to one part of the group, the other group got placebo. You can't do that for severely psychiatric patients, because they can commit suicide. In this case, one patient did."


Leontien Laterveer says the pharmaceutical companies argue in their defence that they have to do these placebo trials because otherwise they can't get their medicines registered in Europe. Because of this, Wemos believes the European Union has a serious responsibility, as the 'consumer', towards people in developing nations who are used for trials. It argues that the EU needs to put pressure on the pharmaceutical companies to make their clinical trials public and transparent so that everyone in future who goes to get their prescription from the chemist can see whether their medicine has been ethically tested.

* RNW translation (tpf)

 

Tags: development, Medicines, MIMS, placebo, Wemos

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Reaction(s):


jasmin, 05-03-2009 - India

No medicine is safe, not evn the innocuous looking paracetamol. Overdosing of paracetamol can cause liver problems. So never take medicines, more than, than presrcibed by the doctor and do read the pamphlet of the drug for dosage and side-effects. And consult a doctor for over-dosing.


S Jain, 07-03-2008 - India

"even ultrasound equipment has been tested as a trial demonstration, before being released for sale" Victor, are you suggesting the companies release untested product in the market and then test it on people? I hope you are not. I think we need realize clinical trials for what they are, and that is necessary evils. These are necessary in order to protect large number of lives and hopefully save even larger number of lives.


Victor Romero, 07-03-2008 - Mexico

In Mexico, the clinical trials are made specially in the government hospitals, one of the 3 F´s... "funds" are received by the chief of an specific department, i.e Cardiology department, and patients are coerced in a subtle way to comply with the drug trial protocol. Of course, pharmaceutical companies only give to the patient the “trial drug”. And it is not only the ¨trial drugs¨, even ultrasound equipment has been tested as a trial demonstration, before being released for sale. (The equipment is being manufactured in India!)


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