The US government spends billions every year to finance scientific research and yet a country like America has an epidemic of heart diseases, diabetes, depression, anxiety disorders and environmental diseases which is impressive if compared to underdeveloped countries. Photo credit: Geo Martinez Why, after so many years of huge research investments, aren't we closer to eliminating these diseases? And why do you think pharmaceutical companies and conventional medicine have such a strong bias against any alternative approach that doesn\’t involve the assumption of pharmaceutical products that have often been proved harmful? Gary Null, a popular member of the Nutrition Institute of America, has produced a shocking video documentary that explores the relationships that exist between lawmakers, lobbyists, medical schools and …

A recent report by BBC has brought to the light the existence of an infamous clinical trial business that is spreading in the developing countries. Such business involves thousands of unaware patients that get drawn into experimenting new drugs without their explicit consent, sometimes under the wrong impression that those trial medications are the official ones.

Photo credit: shapiso

Most of the pharmaceutical companies that are involved in the spreading of such activities are private and their policies are not always clearly revealed to the institutions that are supposed to regulate their behavior. According to the same BBC research, India is the country in which illegal clinical trials are more frequent due to its economic and social conditions.

However, BBC journalist Brian Deer found out that dishonest clinical trials have been carried out also in London. Covering the story of six British volunteers who accepted to experiment new drugs without being adequately informed about the consequences of their act, Brian Deer describes the devastating side effects that influenced the lives of these individuals.

According to international law, giving informed consent to be part of an experiment is a fundamental requirement of all clinical trials. This law goes all the way back to the Nuremberg Code, which is a set of principles for human experimentation compiled during the Nuremberg trials at the end of World War II.

But what is a clinical trial and how can it become an illegal activity?

What is a clinical trial

Clinical trials refer to the process by which medicines are developed. Before a drug is tested on humans, it would have to go through laboratory and animal testing. There are then three stages of drug testing on humans – and any such trials have to be approved by ethics committee.

• Phase one: this stage tests safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects.
• Phase two: in this stage the drug is given to people who have the condition to see if it does indeed help them.
• Phase three: during this phase large scale studies are performed, usually involving tens or thousands of people.

Participants are often randomly allocated to either get the drug or a placebo. In most cases neither the scientists nor the patients know who has got the real drug, so that the results cannot be skewed by expectations.

Once a drug has been through all these stages of testing – which can take up to 10 years – it will be considered for licensing. But even then, pharmaceutical companies must keep carrying out research to ensure a drug is still safe and effective.

The drug trials business in developing countries

It is estimated that 20-30% of global clinical trial activities are being conducted in developing countries. The reason that the business of clinical trials has grown so rapidly, is that it provides the pharmaceutical industry with the necessary underpinning for obtaining a license to market drugs.

The drug industry is increasingly moving to developing countries where companies are enrolling uninformed, non-consenting people who have few life choices. As a developing country, India has a targeted population for drug testing. Almost all the top names in the pharmaceutical world have started setting up clinical trail facilities in major Indian cities, especially Hydearbad and Ahmedabad. Global consultancy McKinsey & Co estimates that by 2010, major pharmaceutical companies would spend around $1-1.5 billion just on drug trials in that country.

Recent investigations by BBC have in fact brought to light the scandalous abuse of patients in Indian hospitals on behalf of major pharmaceutical companies for drug trial purposes. Such experimentations are conducted either without the consent of the patients or with no detailed information being given to these people.

Six years ago, an experimental drug from the US called M4N was injected into cancer patients in India without being properly tested on animals first. Dr V. Narayan Bhattathiri, told the BBC:

“I can only say that what they did is something unbelievable or incomprehensible. I couldn’t find any example of such a thing being done, maybe in the last 50 years or so. Maybe something similar could have happened in say concentration camps.”

This behavior would explain pretty well the abnormal recruitment rates for clinical trials available in India and the strong presence of pharmaceutical companies in that country. There are at least three reasons why India is the most targeted location for clinical trials:

1. Indian patients are often untreated, reducing the number of confounding factors in study of medications.
2. Paying indian enrollees in clinical trials is very convenient: a tiny payment – by US standards – could amount to three months’ wages or more. Incentive payments to physicians for enrolling research subjects are also amplified greatly by the exchange rate.
3. The use of complicated medical language while illustrating the risks of such drug trials to people who are often completely uneducated is certainly one of the reasons that make this process go on smoothly.

“Most of the patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them” said Dr Shashank Joshi.

During the testing of an anti-psychotic drug developed by Johnson & Johnson at a psychiatric hospital in Gujurat, some patients reported they were told they had to take new “American” tablets because old drugs were discontinued and were no longer available in the pharmacies.

A British scandal: the drug trial that went wrong

Dishonest clinical trials are not only an issue of developing countries. During 2006, six British men under 40, had volunteered to take part in a trial of an anti-inflammatory drug, called TGN1412, to treat conditions such as rheumatoid arthritis and leukemia being tested at an independent research unit based at Northwick Park Hospital in London.

The responsible for recruiting volunteers was Parexel, a company that offers a range of services to assist the pharmaceutical, biotech, and medical device industries in bringing new products to market.

During and after the trial period, all six volunteers have experienced serious side effects, with the result that some of them have reported permanent damages to their immune system. One of the volunteers, Ryan Wilson, has developed a blockage of blood vessels of some body parts, such as his toes and fingertips.

In this video (1 hr) BBC reporter Brian Deer tells the story of Ryan Wilson and all the six British drug trials volunteers, trying to figure out what really happened

A spokesman for the German company TeGenero, whose drug was being tested on the six men, said the results were “completely unexpected” and did not reflect the results they obtained from initial laboratory studies.

The six British volunteers had expected to gain at least £ 2.000 by participating in the drug trials based on the impression that such trials are completely safe due to the approval on behalf of the British government, which claims that patients are always told about the risks. Nonetheless, clinical trial patients may mistakenly believe they would be compensated for accidental harm because of badly worded contracts that they are requested to sign.

University of London Professor Desmond Laurence pointed out the unlawful use of doublespeak in the patient recruitment process, telling the British Medical Journal that injury pay-out decisions were at the trial sponsor’s discretion. In his letter to the BMJ, he cited the wording of the government-agreed statement: “[The sponsor] will pay compensation for [non-negligent harm]. Any payment would be without legal commitment.”

The trial sponsor of course may always pay ex-gratia compensation, if it cares to. But if it does not, then the cost of compensation for non-negligent harm falls up on the injured patients themselves. Professor Laurence acknowledged that if it was spelt out clearly to people they were not entitled to compensation the numbers volunteering for trials might drop.

Conclusions

The extent of Western-sponsored drugs experimentation in developing countries is unclear. The laws that protect commercial confidentiality allow companies to keep clinical trials secret. Even the ethics committee estabilished by the government are often sworn to regard such clinical trials as “company business” – in both the West and the developing world.

Amnesty International reports say that the human rights of patients are supposed to be protected by the Declaration of Helsinki, which, in the 1960s supplemented the Nuremberg Code as the main point of reference for medical care standards.

The Declaration of Helsinki sets norms that are internationally recognized: It forbids coercion and states that consent must be “formally documented and witnessed.” But if the principles set out in Helsinki are high, critics say that practice is often plagued by poor government oversight and poorly implemented procedures for retrieving consent.

Read more

• A bitter pill: exporting drug trials to the developing world (on Amnesty International Magazine)
• Clinical trials: why India is irresistible (on Rediff)
• Drug trials outsourced to India (on BBC News)
• Clinical Trials: open house on drug trials in India (on InfoChange India)
• Clinical Trials: some questionable drug trials (on InfoChange India)
• Letter of Professor Desmond Laurence to the British Medical Journal on clinical trials (on British Medical Journal)
• The unlawful use of doublespeak in the patient recruitment process (on Applied Clinical Trials)

Photo credits

Doctor and nurse: Rick Lord
Injection: BBC