Clinical trials

The list of side effects on the packaging of prescription drugs can give you the chills, but who actually reads them? We trust the chemist who sells them, the doctor who prescribes them, the laboratory that tests them and the regulatory instance that authorises their sale. The drugs have of course been tested in many phases but they aren’t necessarily safe or effective.

Pre-clinical animal trials

Whilst part of pharmaceutical research & development is carried out thanks to High Throughput Screening (HTS) and in-vitro studies, animals are used in pre-clinical trials prior to human testing.

Laboratories are legally obliged to perform tests on two categories of species: Rodents & non-rodents.

These observations reveal problems of acute toxicity, organ damage, side effects from the dosage, metabolic disorders, pharmacokinetic carcinogenicity, mutagenicity and teratogenicity for these animals.

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In the event of a medical catastrophe, the laboratories can plausibly deny responsibility by using positive animal test results as evidence.

This does not prevent huge compensation payments to the victims of side effects.1

Given the genetic, metabolic, immune, hormonal, physiological and behavioral differences that exist between species, animals do not develop the same diseases and do not respond to chemicals in the same way that humans do (see "Scientific reasons").
It must be taken into account that a chemical may be toxic for humans in the long term and, furthermore, that ‘cocktails’ of chemicals are not tested on animals.2

 

Human clinical trials

Having been tested on animals, a new drug is tested on as few as 500 to 5000 people prior to being launched onto the market.3

Phase I: the first human results.
This phase consists in evaluating volunteer patient’s tolerance to a drug and the absence of undesirable side effects on the men being studied. 20 to 50 volunteers are used at this stage. Generally speaking, non smoker, medium weight & height Caucasian males are used.

This isn’t a random choice:

  • Caucasian males suffer fewer side effects than any other ethnic group (asian, sub-saharan African, etc).
  • Men react less than women.

Phase II
This phase is designed to determine the drug’s optimal dose to control side effects in genuine patients. It requires 150-350 ill patients who could benefit from the new drug.

Phase III
Trials on 250 to 4000 more varied groups of patients to determine the safety and effectiveness of drugs in the short term.

Phase IV
Post market release studies.
This provides information on rarer side effects or complications that arise in the long term.

A plethora of Guinea pigs

Throughout Human history humans have been used in official and secret experiments. Some were volunteers, whilst others have been misled or forced.
Today, to reduce costs and have more control over their studies, some major laboratories perform clinical trials in countries where the legislation is more flexible and where guinea pigs are paid less and poorly informed about the inherent risks.
Jean-Philippe Chippaux wrote a highly evocative article on ‘southern countries’ in Le Monde Diplomatique.4

Just like African countries, India has recently become the main destination for therapeutic testing by Western pharmaceutical laboratories. In summer 2008, The Times of India revealed that 49 babies had died following clinical testing. That same summer, Argentina was in the press after the death of 12 babies that had been used to test experimental vaccines.5

Prescription drugs rejected during clinical trials

Animal models
According to the Food and Drug Administration (FDA), around 92% of drugs that are successfully tested on animals are then rejected during clinical trials on humans. The substance is revealed to be ineffective or too dangerous to be commercialised.

Do you know many businesses where an 8% success rate is acceptable?

If a drug is successful in clinical trials and is released onto the market it has a 50% probability of being withdrawn or relabelled following newly discovered side effects.6

All clinical trial results are the intellectual property of the laboratory which is behind the trial and it can decide whether or not to publish them in the medical press. Both the medical researchers and test subjects are signatories to a non-disclosure agreement. Unfortunately, the publication of purely positive results doesn’t improve drug safety.

Virtually all drugs successful in animal trials, fail human clinical trials due to ineffectiveness or toxicity, although the undesirable side effects human guinea pigs suffer are rarely made public.

Due to its severity, the TGN 1412 tragedy made headlines and raised serious doubts over the use of model organisms in the development and testing of medicines destined for human consumption.
In March 2006, six young men came extremely close to death whilst participating in the trials of a new drug: The monoclonal antibody TGN 1412.

Within an hour of the drugs injection the volunteers complained of headaches, excessive perspiration and burning sensations.
In the hours that followed, the already serious side effects intensified and included vomiting and loss of consciousness. One of the young men’s heads became so swollen, it was the same width as his chest, that he thought it was going to explode. Another volunteer’s neck tripled in size.

All of them were moved to an intensive care unit and two of them had to be put into an artificially induced coma.
Later, a volunteer had 3 fingers and all of his toes amputated due to gangrene.

All six men suffer from organ failures and will most likely develop cancer according to Professor Richard Powell of Nottingham University.
He said this drug which was designed to treat auto immune disorders such as multiple sclerosis and leukaemia is actually promoting cancer and auto immune disorders in these six men.7

Pre-clinical tests on rats, rabbits and monkeys had concluded that the drug was safe for humans. The monkeys (cynomolgus macaques) had even received a dose 500 times greater than that administered to the volunteers.

So, who are the real guinea pigs?

Human beings are unofficially the pharmaceutical, chemical and agribusiness industries’ true guinea pigs. As no other species can truly be a model organism for another, it is only during clinical trials and/or commercialisation of a product that we really discover its full side effects.
 

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This Work, Clinical Trials (except pictures by Fotolia), [translated by Juan Dates], by Coalition Anti Vivisection France is licensed under a Creative Commons Attribution-ShareAlike license.