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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.
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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: Find out more

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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Getting on to a clinical trial:

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

3 ‘Compassionate Use of Unapproved Investigational Product’, Pfizer,

http://www.pfizer.com/research/research_clinical_trials/compassionate_use_policy.jsp

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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

POINT COUNTERPOINT PARENTING CLASSES BE

COMPULSORY?
We need medical trials. It is important to First, this may well be overridden by the
have large groups of recruits, which can often individual rights of present patients (see
be very difficult: a problem with the speed at proposition arguments).
which new treatments for rare diseases is the start a discussion
rate of recruitment (and therefore the length Second, the greater time taken to recruit is
one that may be offset by greater numbers:
of time taken to complete the trial)1.
whilst the trial will be of a lower quality (no
If you pass this motion, trials will face large control group, etc.) there will nevertheless be
problems with recruitment, an area where a greater number of people willing to take the
drug (people who wouldn’t have wanted to be
RELATED TAGS:
there are already sometimes shortages2: if
part of a trial, but are willing to try the new Healthcare Pharmaceuticals
people can get access to the drug without a)
treatment). Consequently, it may well be Research and development Ethics
the possibility of being placed in the placebo
possible to compensate for the other problems Healthcare Science General Health
arm or b) inconveniences of being part of a
with the trial. Further, alternative trialling Philosophy Science
trial, there is a reduced chance of them
models can be employed, for example using
choosing to enter the trial.
patients who choose not to take the drug as
Consequently, the sample size in trials will be the control group. Whilst you lose the benefit
decreased. This will have a couple of here of having a double-blind trial (as under
outcomes: the status quo), you gain in terms of the
benefits to current patients.
First trials will take a longer time to be
completed as a result of fewer volunteers and
improve this
this is bad for patients currently taking the
new drug as well as for future patients. This
is because it will take longer to determine the
safety of the drug meaning if it is dangerous
those taking the drug will be taking it for
longer before the danger is fully appreciated
and if safe then the drug will have taken
longer to get to the market than it could
have. The longer the trials take to complete,
the more people are forced to decide whether
to take the drug in the absence of reliable
information. This means that, at such a
stressful time, people are effectively forced to
gamble the quality of their remaining years
with the hope of gaining a few more (new
drugs are unlikely to be ‘miracle cures’.

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Rather, they are likely to extend life by driving

the disease into remission).

It is important to remember that, at this

stage, it has yet to be determined whether
new drugs are more effective than old ones,
and second, that the sorts of drugs used to
treat terminal illnesses tend to come with
substantial side effects. As a consequence, if
many people are using a new treatment
before trialling has been completed, they may
be using something that is not effective and
has side-effects that significantly impact the
quality of the last years of their life.

Finally, the longer trials are delayed, the

greater the chance that future trials will be
biased by media hype ad speculation. It is
both easy and profitable for media outlets to
exaggerate early successes of a drug with
claims and headlines such as “wonder drug”.

This is problematic because of the tendency

towards confirmation bias on the part of
researchers: the greater their expectation of
a positive result, the more likely they are to
alter data to receive that result. Note that this
is not as a result of deliberate fraud or
deception, but rather, the result of any
number of small decisions that, cumulatively,
create a large result.

1 Jenkins, John, ‘Considerations for Clinical

Trial Designs’, U.S. Food and Drug
Administration,
https://rarediseases.info.nih.gov/files/Jenkins.
pdf

2 ‘Volunteer for research at

UNClinicalStudies.org’, University of Michigan
Comprehensive Cancer Center,
http://www.cancer.med.umich.edu/living/clini
cal-trials.html

improve this

This gives people false hope

POINT
If these drugs are made available, you risk
giving many people false hope in the last
days of their lives. People, particularly when
in desperate situations, tend to overestimate
a treatment’s efficacy.
Given that these treatments are still
undergoing the trial process, it is possible
that they are ineffective, or have side-effects
that outweigh any benefits.
Thus, to allow such drugs and treatments to
be handed out during the testing process,
there is a great risk of giving people false
hope. This is especially the case given the
compromised role of the physician in this
scenario: ordinarily, if a patient wants an
COUNTERPOINT
Doctors are trained in the presentation of
news to their patients. This includes the
delivery of bad news, and the dispelling of
media-myths. Patients with terminal illnesses
are often well-informed about their disease,
and (in particular those with chronic
conditions) often gain a good understanding of
the possibilities of future treatments.
The risk that they may all get carried away on
a wave of false hope is, consequently,
minimal. Patients in this circumstance are
more than capable of reaching, in conjunction
with their physician, an informed decision
regarding experimental drugs, and make a
choice accordingly. The moderate risk of

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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
By allowing anyone who is critically ill to use
experimental drugs you enhance the already
dubious role of drug company reps: especially
in the USA, (where doctors do not operate
under the NHS guidance found in the UK),
there is already a problem of patterns of
prescription being altered by the techniques
of drug reps, rather than by evidence1.
Where drugs are for sale before they have
completed testing, there is even less evidence
available, and therefore less ability for
physicians to contest the claims of either reps
or their own patients (who may have heard of
the drug during their own research). Hence
you magnify the problem of potentially
ineffective of even harmful prescription.
1 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
COUNTERPOINT
Drugs that are still undergoing clinical trials do
not have a complete void of information about
them. Presumably this policy covers drugs that
have completed at least some testing in
humans (say, phase one of the trials), and
therefore at least some information would be
available on which doctors and patients could
base their decisions.
Further, it is implausible to suggest that
doctors are entirely under the sway of
advertisers: whilst drug reps under the status
quo have some influence in getting a doctor to
use one drug rather than another, this is in
instances where there is little to choose
between those products, and (importantly!)
both are licensed, safe and effective. They
would clearly not be so reckless as to blindly
follow a drugs rep and prescribe an untested
product to their patient.
improve this

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

‘Special Access Programme – Drugs’, Health Canada, 15 August 2005, http://www.hc-sc.gc.ca/dhp-

mps/acces/drugs-drogues/sapfs_pasfd_2002-eng.php

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

‘Compassionate Use of Unapproved Investigational Product’, Pfizer,

http://www.pfizer.com/research/research_clinical_trials/compassionate_use_policy.jsp

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

‘Volunteer for research at UNClinicalStudies.org’, University of Michigan Comprehensive Cancer Center,

http://www.cancer.med.umich.edu/living/clinical-trials.html

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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