Drug Trials – The Dark Side

BBC Reporter Paul Kenyon - speaking to patients outside an Indian hospital

BBC Reporter Paul Kenyon – speaking to patients outside an Indian hospital

A documentary in BBC2’s This World strand, Drug Trials: The Dark Side investigated the murky world of clinical trials carried our in the developing world. Reporter Paul Kenyon travels to India in an attempt to uncover the actions of some of the world’s biggest drug companies. Through a series of interviews with both doctors and patients, it reveals some discrepancies with regards to clinical trial protocol. This raises five main ethical issues:

  • Patient recruitment onto drug trials
  • Informed consent
  • The trust between a doctor and their patient
  • The methodology implemented during a drug trial
  • The cost and accessibility of drugs in the developing world

Dr Vijay Kumar, Neeman Medical International

Dr Vijay Kumar, Neeman Medical International

India’s population is almost 1 in 6 of the entire world, and thus represents a huge population of potential patients on whom to trial new drugs. Recruitment of volunteers for clinical trials has become a boom industry in India, “We can recruit a third more patients, in a third less time and we can save at least a third of the cost”, states Dr Vijay Kumar, Neeman Medical International (01:05:00 – 00:03:00).  Dr Kumar continues to explain that in Western countries such as the USA and Canada, successful helathcare systems mean it is hard to recruit suitable patients onto drug trials. Drug companies value “treatment naive” or “clean” patients that have never previously received any medications. Poverty and reduced access to healthcare in India means that patients of this type are relatively abundant. Indeed, the process of recruitment itself raises interesting ethical questions:

  • Should vulnerable patients who suffer because of social and economic circumstances be recruited onto a drug trial?
  • Are these vulnerable patients susceptible to exploitation? What safeguards should be in place to protect such people?

The theme of vulnerability extends throughout the documentary. Patients have to provide ‘informed consent’ to being put onto a drug trial. This is to safeguard the patient’s autonomy and protect them from harm. There are a series of issues to consider when discussing informed consent:

  • Does the patient have the capacity and competence to truly understand the purpose of the proposed research?
  • Has all information being disclosed to the patient; why the patient is being asked to take part in the drug trial and what are the realistic potential harms and benefits of being on the drug trial?
  • Has the patient being able to consent to being on the drug trial voluntarily without coercion and pressure from other bodies?

Sections between 00:02:54 – 00:21:36 and 00:47:22 – 00:52:37 are useful for raising these issues. They investigate what happened when an American cancer drug was tested on humans for the first time. The documentary tracks down one of the surviving patients from the trial, which involved M4N, a derivative of an ancient herbal remedy called Chaparral. Researchers suggested that despite this chemical being dangerous it would help inhibit the growth of cancerous cells if it was injected directly into them. The trial bypassed the normal procedure for treating cancer by surgically remove the tumour cells prior to radiotherapy or chemotherapy, and went directly to injection of M4N into the patients’ tumours. In addition, the trial also side-stepped the usual requirment to test a new drug another on two mammal species, such as rats and dogs, to observe its affects before giving it to humans; here only minimal animal testing had taken place. Interviews with the patient and his family revealed that not all the information was fully disclosed to the patient and false claims were made about the trial:

  • The patient was told “The injection was part of the treatment, they didn’t mention it was an experiment”. The patient was told that the cancer would never recur.
  • The consent form said that the patient understands the side effects, “But how could they, when the scientists didn’t” Paul Kenyon.

The documentary continues to reveal further improper conduct in patients recruitment. A patient’s desire to be cured from their disease leaves them vulnerable to try anything on offer. In addition, if the patient is unaware that they will be included in a drug trial they are more likely to enrol.

The section 00:21:38 – 00:32:05 discusses how extreme poverty in India leaves patients unable to buy the drugs they need and thus leaves them with the choice between no drugs or an experimental drug provided free in a clinical trial.  The issue of informed consent is again evident here, and in particular exploitaiton of the very strong trust there is in India between a doctor and their patient. The documentary observes a patient going through the informed consent procedure with his doctor. It immediately becomes apparent that despite the doctor’s best attempt, it is doubtful that the patient fully understands that he has consented to being involved in a clinical trial. It seems from the evidence presented in the documentary that the patient’s ability to fully consent to being on the drug trial is blurred by:

  • their desire to be cured of their disease
  • little or no access to full and proper health care
  • the blind trust between a patient and a doctor
Dr Vikram Patel

Dr Vikram Patel

In a further development, the documentary investigates a drug trial which was published in The British Journal of Psychiatry (00:32:12 – 00:47:22). This follows the concerns of Dr Vikram Patel, London School of Hygiene and Tropical Medicine and a member of the editorial board of the journal. Having read the research he became increasingly worried with the methodology of this particular trial of a psychiatric drug.

An American drug company withheld medication from patients with serious psychiatric illness. Without beneficial treatment, the patients became increasingly vulnerable, and they are thus exposed to possible further suffering.

One of the patients involved, who suffers from Bipolar mania, speaks to the documentary. He had been on the same medication for many years, but these were withdrawn prior to the start of the trial, to allow for a ‘wash-out’ period. This reduces the chances of any of his previous medications interacting with the experimental new drug.

The patients on the trial were separated into two groups: One was given the experimental treatment Risperdal, the other group were given a placebo. This effectively leaves some patients without any form of treatment during the trial and raises ethical issues such as:

  • Is a placebo a justified deception?
  • Does the placebo increase the risk of possible suffering for patients and the friends and family who care for them?

Again in this example it is revealed that much of the information presented to the patient was unclear.

  • The patient was wrongly promised that the new drug would cure them
  • The patient was not fully aware they were involved in a drug trial
  • The patient was told that the old drugs were discontinued and that a new drug had been introduced

This lack of transparency suggests that wrongful actions are taking place. Patients who already find themselves in unfortunate circumstances with their illness, suffer further because of the ambitions of drug companies which neglect ethical guidelines.

Paul Kenyon speaking to a patient

Paul Kenyon speaking to a patient

The documentary concludes by discussing the issues that surround the high cost of new drugs in the developing world (00:47:22 – 00:52:37). For example, after the Risperdal drug  trial, patients were only provided with 12 weeks of medication and thereafter would be responsible for purchasing it from the pharmacist, despite being priced 1500% higher than the Indian equivalent. Drug companies believe that the continued supply of the new drugs is the responsibility of the national government. However many argue that drug companies owe a particular duty of care to the patients that directly helped them with the trial.

One of the central ethical issues that surrounds this topic is best summarised by Dr Vijay Kumar, Neeman Medical International (00:55:20 – 00:55;39) , “A clinical trial is not an end in itself, it a means to an end. Ultimately the beneficiary is the patient of tomorrow. As a physician seeing a patient today, I am treating a patient of today. But when I am involved in a clinical trial I am looking after the benefits of the patients of tomorrow”. In other words, the patients of tomorrow reap the greatest benefit from a clinical trial, which may actually compromise the rights of patients today.

Possible questions for discussion:

  1. Whose rights are more important, patients of today or patients of tomorrow?
  2. Should drug companies be prevented from carrying out clinical trials in the developing world? Give two arguments to support your view.
  3. How does each of these groups of people benefit from a clinical trial; the patient, the doctors, the wider society, the drug companies.
  4. Is it right that drug companies can charge high prices for drugs they developed? Suggest two reasons in support of high prices, and two against.
  5. Is the use of placebos ethical? What might be an alternative to compare against the new medicine?

The ethics of clinical trials/drug trials can be found across the UK curriculum.
GCSE: Examination boards – AQA, Edexcel and OCR
A level: Examination boards – Edexcel.

This World: Drug Trials – The dark side (60 minutes) was first broadcast 27th April 2006, on BBC2, at 21:00, TRILT Identifier 005912F8.

Update 4th April 2015: For users at subscribing institutions, the programme is now available within Box of Broadcasts

6 Responses to Drug Trials – The Dark Side

  1. David Willis says:

    A recent newspaper article in ‘The Times’ newspaper (Wednesday 20th August 2008), reports on further ethical issues surrounding clinical trials in India. http://www.timesonline.co.uk/tol/news/world/asia/article4568717.ece

  2. Simon says:

    wow.. very usefull information, that I was looking for, Thanks.

  3. Rinku Dahiya says:

    1. According to me rights for patients today as well as tomorrow is important because if we do clinical trial today on these patients, then only we can come along with future drugs of tomorrow where the patients of tomorrow will get benefit, but things to remember is to have transparency between investigator and patients so that autonomy is there for today’s patient.
    2. No companies should not be prevented with doing Clinical trial in developing countries as scope for clinical research is more in developing countries then developed world.
    (a) Availability of variety of patients and ability to understand the scope of trial,provided should be explained properly by the investigators in the layman language or the language spoken by patient can reduce ethical issues. The investigator should understand the research involved in clinical trial and accordingly can give sufficient time and value to conduct clinical trial.
    (b)Country like India where English is not a problem for clinical team as well as for pool of patients. Only the thing is the investigator should provide sufficient time to review the patient before recruitment. Should analyse patients for clinical research and then recruit him/ her in study.

    3.Each of these goups get benefited from clinical trial.
    The patient gets benefit when the drug comes into market for that particular indication for which clinical trial was going on and he was the subject.So not only the patient of today but patients of tomorrow are also getting benefit. Patients of today who are in trial are benefitted when they are followed by the investigators for longer time due to Protocol requirements which might not be true for all routine patients.
    The Doctors who are doing the trial are benefitted by getting the data on trial and the various aspects of drug which is not yet launched in market. So when it is released he becomes pioneer of that drug. Also he can publish his data once he gets permission from sponsor.
    The wider society is benefitted by getting new drug.
    The drug company gets recobnition and revenues.

  4. […] longer post about this episode is available on the sister site […]

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