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'Big pharma' and clinical trials

Carton of Retrovir, AZT, England, 1992-1993

Carton of Retrovir, AZT, England, 1992-1993

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Pharmaceutical companies spend large sums on developing new drugs. These must be tested on humans to ensure they are safe and effective. Testing drug safety must be balanced with the risks to participants in clinical trials.

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Guidelines were introduced to regulate clinical trials on humans. These were the Nuremberg Code, developed after the Second World War; the 1966 Helsinki Declaration; and the 1974 establishment of the US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research.

These guidelines protect participants in clinical trials. They require voluntary agreement and let participants withdraw at any time. They also ensure people running the trials are accountable.

Informed consent

Informed consent is the most important issue in human trials. Participants must be told of the clinical trial’s aims and risks before taking part.

Competing pharmaceutical companies run most trials, so money is a big issue in developing new drugs. Many trials are run in developing countries, where test subjects are cheap and easy to find. It is questionable whether these often illiterate and poor patients give truly informed consent.

Critics claim many of these people, who might need the money or treatment offered for taking part, cannot give truly informed consent. They may not understand fully the risks of the trials they participate in. Treatment may stop when the trials end, leaving patients unable to afford drugs they helped develop.

Patients or profits?

Patients sometimes fight pharmaceutical companies. When new AIDS drugs were trialled in the United States in 1986, it was clear which patients were given the drugs rather than a placebo. The positive effect on those receiving the drug caused patient advocacy groups to speak out. ACT UP argued it was unethical to give some patients fake drugs and let them possibly die when the drug clearly worked. They believed the benefits of the new drugs outweighed potential dangers to patients. ‘Buying clubs’ also bought leftover drugs from deceased patients. This bypassed the pharmaceutical company and doctors’ control. It helped poorer patients get around the high cost of the new drugs.

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Generic drugs are identical copies of drugs still under patent. Since 2001 they have made a huge difference to many patients in the developing world, especially those living with HIV/AIDS. These drugs are mainly produced in India, and are much cheaper than the patented versions. There is resistance from pharmaceutical companies. However, in 2001 the South African government authorised the import and manufacture of generic drugs. Brazil, Thailand and several African nations also produce significant quantities of generic drugs locally.

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Bibliography

J S Hawkins (ed.), Exploitation and developing countries: the ethics of clinical research (Princeton: Princeton University Press, 2008)

H Lune, Urban Action Networks: HIV / AIDS and Community Organizing in New York City (Lanham: Rowman & Littlefield, 2007)

E J Emanuel (ed.), Ethical and regulatory aspects of clinical research (Baltimore: Johns Hopkins University Press, 2003)

S M Chambré, Fighting for our lives: New York’s AIDS community and the politics of disease (New Brunswick: Rutgers University Press, 2006)

A Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton: Princeton University Press, 2009)

J A Fisher, Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (New Brunswick: Rutgers University Press, 2009)

J Abraham, Science, Politics and the Pharmaceutical Industry: Controversy and bias in drug regulation (London: UCL press, 1995)

Glossary:

Aids

Acquired Immune Deficiency Syndrome (AIDS) is a disease caused by infections resulting from a weakened immune system due to the HIV virus. It leads to failure of the immune system and is usually fatal. It is spread through direct contact with bodily fluids.

Patent

Grants made by a government to an inventor, assuring the inventor the sole right to make, use, and sell the invention for a certain period of time.

Hiv

Human Immunodeficiency Virus (HIV) is a virus that weakens vital cells in the immune system, and leads to AIDS. There are two strands: HIV-1, which leads to immunity suppression; and HIV-2, which is not as potent and is only common in West Africa. HIV is spread through direct contact with bodily fluids.