Following reports of alleged drug testing on unknowing patients in communist East Germany, pharmaceutical firms are in the spotlight. The industry is accused of exploiting people for testing in poorer countries.
"Many people in India live in extreme poverty and rarely have access to medical care due to an inadequate state healthcare system," said Christian Wagner-Ahlfs, a chemist with BUKO, an organization that investigates pharmaceutical companies' activities in poorer countries. "They would have to pay for medical care themselves and they just don't have the money," he added.
Wagner-Ahlfs accuses companies of exploiting the desperate situation of these people.
"It's of course very tempting when they are given the option of receiving medical care as part of a clinical study," he said.
"Many trials are unnecessary since drugs are developed where it's already clear that they will not advance the treatment," says Wagner-Ahlfs
The pharmaceutical lobby rejects such accusations, but cannot completely rule out exceptions among local research institutes commissioned to do the studies. In highly populous countries like India and China, it's easier to find subjects with the relevant illnesses. The participants, of course, must agree to the trial beforehand, said the Association of Research-Based Pharmaceutical Companies (VFA).
"Pharmaceutical companies can even help to make improvements to the healthcare system by equipping hospitals and other medical institutes with modern technology and personnel," said VFA's Rolf Hömke.
Guidelines for medical tests
Medication that is supposed to help people must be tested on people - something that researchers agree on. A drug must undergo a long development process before it even gets to clinical trials on human subjects. And for that phase of clinical tests on people, there are clear regulations. The World Medical Association (WMA), to which medical organizations from more than 100 countries belong, established precise rules under which new drugs can be tested.
Patients must be thoroughly informed about the study, participation is voluntary and subjects are permitted to quit the trials at any time and without giving reason. Subjects must confirm their participation by signing an "informed consent form."
In addition, it must be determined how and in what form a patient will continue to receive medical attention once the study is over, said WMA Secretary General Otmar Kloiber. "That can be particularly important with chronic illnesses. People cannot be viewed as guinea pigs and then abandoned once the trial is over," he added.
Fewer studies, more supervision
German drug maker Boehringer-Ingelheim is currently conducting 125 clinical trials in 72 countries, according to the company. More than 70,000 people are participating in the studies. Other companies likely have similar figures.
Yet, "many trials are unnecessary since drugs are developed where it's already clear that they will not advance the treatment," said Wagner-Ahlfs. Many drugs being tested differ only negligibly in their composition from medication already on the market. "They are only developed to ensure new patent protection and reap higher profits," he noted.
In addition, subjects in clinical trials in poorer countries offer up their health for the development of a drug, but cannot afford the medication later once it ends up on the free market. "That's a major ethical issue," said chemist Wagner-Ahlfs.
No "outsourcing" of studies
The charge that pharmaceutical companies outsource the majority of their trials to Africa or Asia for financial reasons is something the Association of Research-Based Pharmaceutical Companies rejects. According to one US statistic, pharmaceutical companies last year initiated 2,590 studies in the United States, 715 in Germany, and Great Britain, Canada and France each had 500. In China and India, on the other hand, there were less than 200.
To ensure that criteria for medical testing is as uniform as possible around the world, state regulatory agencies in the United States, Europe and Japan have established the guideline for "Good Clinical Practice" that developed out of the WMA's "Declaration of Helsinki" first adopted in 1964. It outlines ethical principles for medical research involving human subjects.
Major pharmaceutical companies have pledged to respect these guidelines, and it is in their interest to do so because they can only submit a new drug for approval by regulatory agencies if they can prove they have fulfilled these standards.