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THIS HOUSE WOULD GRANT THOSE DIAGNOSED WITH TERMINAL ILLNESSES CURATE THIS DEBATE
THE RIGHT TO ACCESS TREATMENTS THAT HAVE NOT COMPLETED CLINICAL If you are an academic or highly
knowledgeable about a particular
TESTING debate could you give an hour or
two a month to curate a debate?
Clinical trials1,2 have four phases, which proceed sequentially. Not all drugs make it to the end of the
process (if a drug ‘fails’ a phase 1 trial, there is little point in running it through phase 2!). Find out more
Preclinical trials: These happen in a lab, and whilst they almost invariably involve testing on animals, do
not involve human testing. The purpose of these trials is to establish whether the drug is safe and effective.
Phase 1 trials:
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The purpose of phase 1 trials is to discover possible side-effects, establish efficacy in humans and calculate
what dosage is needed.
Idebate needs editors from around
These trials are the first to involve humans, and so involve a degree of risk. To minimise this, researchers the world to check, moderate and
test on small groups (normally giving progressively greater doses to successive groups) using small doses. create content for debatabase and
Sometimes healthy volunteers are used in these trials, and other times people who are very ill are recruited the site more generally. Editors
(e.g. the trial of a new cancer drug). Whether healthy or unwell volunteers are used depends on factors like
are vital in making the site run
whether the treatment involves a level of risk unacceptable to the healthy (e.g. a new form of chemotherapy
smoothly and ensuring that
would normally be trialled in an advanced cancer patient, because the level of risk and severity of expected
side-effects are not acceptable to those who have nothing to gain. Further relevant factors include whether debates are as informative as
or not the treatment is feasible in a healthy volunteer. possible.
Phase 2 trials test the treatment on larger groups of people with the relevant illness. The purpose is to find
out more about the efficacy of the drug (including which specific thing it treats best, e.g. a new form of
chemotherapy might work better on some forms of cancer than others) and more about side-effects.
These trials are tested against a placebo (e.g. an identical pill that doesn’t contain any medication). That is, AUTHOR
those recruited into the trial will be split into two groups, one of which receives the medicine, the other of
which receives a placebo. These are normally conducted under ‘double blind’ conditions: whilst everyone Amanda Moorghen
involved knows that there is the possibility of receiving a placebo, neither the patient nor the doctor giving
the pill knows who is receiving what (obviously who gets what is nevertheless recorded). The purpose of
this is to find out whether the effect the treatment has is due to the drug, or whether it’s just due to the
expectation of getting better (placebo effect). Like 0 Share
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Phase 3 trials:
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The purpose of phase 3 trials is to determine whether or not the new drug/treatment is better than the best
currently available treatment.
Because this is a difficult thing to test, and may involve the measurement of small differences between
treatments, a large sample size is needed (many people must be tested on). For example, if we were testing
a new drug for cancer (let’s call it Newafex) we would get a big group of people, give half of them Newafex,
and the other half would receive the best current treatement (whatever drug they would have had if
RELATED DEBATES
Newafex didn’t exist; let’s call it Oldafex). Then we look at remission rates (the percentage of people who
get a bit better) and compare. This house would allow the
production of generic drugs
A new drug is unlikely to get a license if it is not more effective than other drugs, although there are
exceptions (if, for example, the side-effects are less severe, or variety is needed).
This house believes that the
Phase 4 trials: press should be able to
publish allegations about
These occur after a drug has been granted a licence (and is allowed to be prescribed by doctors). Their
private lives without consent
purpose is to determine the long term risks and benefits of the treatment, and monitor its performance
when used more widely. These go on for many years (and severe long term side-effects are rare), and it
would consequently be impractical to perform this sort of long term testing before licensing This house believes that
animals have rights.
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Patients who may benefit from a treatment that is being trialled can be referred to that trial by their This House would explore the
doctors; the company trialling the drug will have criteria that that patient must meet in order to qualify for universe
the trail and it is ultimately at their discretion, not the doctor’s, whether someone is accepted.
Healthy volunteers participating in phase 1 trials tend to be recruited through adverts, and are normally paid This House believes science is
well for their participation. a threat to humanity
Some countries do already allow the provision of unapproved drugs that are still going through trials on
compassionate grounds through programs such as Expanded Access to Investigational Drugs for Treatment This house would deny
Use (United States), Special Access Program (Canada), and Temporary Authorisation for Use (France).3 smokers access to state
healthcare.
1 ‘Clinical trials and medical research – Phases of trials’, NHS Choices, 5 September 2011,
http://www.nhs.uk/Conditions/Clinical-trials/Pages/Phasesoftrials.aspx
This House supports the death
2 ‘Phase 1, 2, 3 and 4 trials’, Cancer Research UK, 6 September 2012, penalty
http://cancerhelp.cancerresearchuk.org/trials/types-of-trials/phase-1-2-3-and-4-trials
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discuss this DISCUSSIONS
TH regrets the
commercialization of sports
POINTS FOR POINTS AGAINST
Should Parenting Classes be
Disastrous impact on medical trials compulsory...
DEBATE..SHOULD
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improve this
POINT COUNTERPOINT
If these drugs are made available, you risk Doctors are trained in the presentation of
giving many people false hope in the last news to their patients. This includes the
days of their lives. People, particularly when delivery of bad news, and the dispelling of
in desperate situations, tend to overestimate media-myths. Patients with terminal illnesses
a treatment’s efficacy. are often well-informed about their disease,
and (in particular those with chronic
Given that these treatments are still
conditions) often gain a good understanding of
undergoing the trial process, it is possible
the possibilities of future treatments.
that they are ineffective, or have side-effects
that outweigh any benefits. The risk that they may all get carried away on
a wave of false hope is, consequently,
Thus, to allow such drugs and treatments to minimal. Patients in this circumstance are
be handed out during the testing process, more than capable of reaching, in conjunction
there is a great risk of giving people false with their physician, an informed decision
hope. This is especially the case given the regarding experimental drugs, and make a
compromised role of the physician in this choice accordingly. The moderate risk of
scenario: ordinarily, if a patient wants an
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experimental drug, they can have a someone making an error in no way outweighs
discussion with their physician that stresses the chance of giving someone some more time
the ‘in trial’ nature of the drug, and thus the with their family.
uncertainty of it working. Subsequent
experiences (the inconveniences of trials; Countries that already allow access to
filling in forms and receiving expenses) treatments that have not completed trials do
reinforce the idea that these drugs were not just allow the doctor to simply proscribe
experimental, and that the bulk of the benefit the drug as with any other. Rather the doctor
from the trial accrues for future patients. will need to apply for access to the drug.1 In
addition the drugs company will also have to
Consequently, in that scenario it is easier for
give its approval.2 As a result it is unlikely that
the physician to help the patient to come to
the patient will consider this the same way as
terms with the end of life; to deal with this
they do normal drugs.
and to realise that any trial drugs give only a
slim chance of improvement. In the scenario 1 ‘Special Access Programme – Drugs’,
Health
envisaged by this proposition, experimental
Canada, 15 August 2005, http://www.hc-
drugs can be acquired as easily as licensed
sc.gc.ca/dhp-mps/acces/drugs-
ones, and therefore there is no longer that
drogues/sapfs_pasfd_2002-eng.php
clear distinction for the patient between
‘doing all you can’ in the ordinary sense, 2 ‘Compassionate Use of Unapproved
(trying every treatment that is known to be
Investigational Product’, Pfizer,
effective) and trying ‘one more
http://www.pfizer.com/research/research_clini
(experimental) drug’.
cal_trials/compassionate_use_policy.jsp
Therefore, the patient is less likely to be able
to come to terms with their own condition, improve this
and therefore less likely to be able to deal
with the emotional trauma inflicted not only
upon them, but on close family and loved
ones.
improve this
This policy enhances the role of drug reps and advertising, at the cost of
evidence-based medicine
POINT COUNTERPOINT
By allowing anyone who is critically ill to use Drugs that are still undergoing clinical trials do
experimental drugs you enhance the already not have a complete void of information about
dubious role of drug company reps: especially them. Presumably this policy covers drugs that
in the USA, (where doctors do not operate have completed at least some testing in
under the NHS guidance found in the UK), humans (say, phase one of the trials), and
there is already a problem of patterns of therefore at least some information would be
prescription being altered by the techniques available on which doctors and patients could
of drug reps, rather than by evidence1. base their decisions.
Where drugs are for sale before they have
Further, it is implausible to suggest that
completed testing, there is even less evidence
doctors are entirely under the sway of
available, and therefore less ability for
advertisers: whilst drug reps under the status
physicians to contest the claims of either reps
quo have some influence in getting a doctor to
or their own patients (who may have heard of
use one drug rather than another, this is in
the drug during their own research). Hence
instances where there is little to choose
you magnify the problem of potentially
between those products, and (importantly!)
ineffective of even harmful prescription.
both are licensed, safe and effective. They
1 Harris, Gwyn, ‘Pharmaceutical would clearly not be so reckless as to blindly
representatives do influence physician follow a drugs rep and prescribe an untested
behaviour’, Family Practice, Vol.26 2009, product to their patient.
pp.169-70,
http://fampra.oxfordjournals.org/content/26/ improve this
3/169.full
improve this
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VOTING RESULTS
BIBLIOGRAPHY
‘Phase 1, 2, 3 and 4 trials’, Cancer Research UK, 6 September 2012,
http://cancerhelp.cancerresearchuk.org/trials/types-of-trials/phase-1-2-3-and-4-trials
DiMasi, Joseph A. et al., ‘The price of innovation: new estimates of drug development costs’, Journal of Health
Economics, Vol.22, 2003, pp.151-185,
http://moglen.law.columbia.edu/twiki/pub/LawNetSoc/BahradSokhansanjFirstPaper/22JHealthEcon151_drug_de
velopment_costs_2003.pdf
Harris, Gwyn, ‘Pharmaceutical representatives do influence physician behaviour’, Family Practice, Vol.26 2009,
pp.169-70, http://fampra.oxfordjournals.org/content/26/3/169.full
Jenkins, John, ‘Considerations for Clinical Trial Designs’, U.S. Food and Drug Administration,
https://rarediseases.info.nih.gov/files/Jenkins.pdf
‘Clinical trials and medical research – Phases of trials’, NHS Choices, 5 September 2011,
http://www.nhs.uk/Conditions/Clinical-trials/Pages/Phasesoftrials.aspx
Roy, Avik S. A., ‘Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials’, Project FDA Report, No. 5,
April 2012, http://www.manhattan-institute.org/html/fda_05.htm
Schüklenk, Udo, and Lowry, Christopher, ‘Terminal illness and access to Phase 1 experimental agents, surgeries
and devices: reviewing the ethical arguments’, British Medical Bulletin, Vol.89, 2009, pp.7-22,
http://bmb.oxfordjournals.org/content/89/1/7.full.pdf?keytype=ref&ijkey=Ip64J5FUXThKvP0
Wilson, Fred, "John Stuart Mill", in Edward N. Zalta (ed.), The Stanford Encyclopedia of Philosophy (Spring 2012
Edition), http://plato.stanford.edu/archives/spr2012/entries/mill/
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