Unproven medical devices and cancer therapy: big claims but no evidence
Department of Radiation Oncology, Peter MacCallum Cancer
Centre, Melbourne, Australia
The scientific method is an affront to the advocates of
the irrational, magical or pseudo-scientific belief systems that characterise
�alternative� or �complementary� therapies such as homeopathy, craniosacral therapy
and ear candling, to name but a few of the less credible varieties.
Practitioners of these so-called therapies are unable to provide any verifiable
explanations as to how these might work but they nevertheless claim that they
can restore or improve health with their natural and gentle healing methods.
Some practitioners claim that they can cure or control cancer and they are
often sought out by desperate patients or their families. Unfortunately, no
consistent bodies of high-quality evidence exist to show that their therapies
or methods work as claimed or are better than the placebo effect. In fact, the
claimed benefits of alternative medicines are most often described in glowing
testimonials and advertisements rather than in scientific papers. Despite the
fact that many alternative or complementary therapies are claimed to embody
ancient wisdom, there is a surprising lack of well-conducted research, carried
out to see if these therapies actually work. When rigorous testing is done, the
benefits of alternative therapies are swiftly reduced to the placebo effect. If
a treatment has a sound scientific basis and is proven to work reproducibly,
then it is not alternative medicine � it is just medicine.
Many herbal medicines are effective because they contain
pharmacologically active substances derived from plants. For example, St John�s
Wort has been shown to be helpful for some patients with depression. Unlike
modern pharmaceuticals, herbal medicines vary in their strength from batch to
batch because they may contain unpredictable amounts of the active substance
that produces the therapeutic effect. Herbal medicines may also contain other
substances that are toxic or antagonistic to the effects of the therapeutic
components of the plant. Many modern medicines were first isolated from plants
used in herbal medicine, but are now produced by the pharmaceutical industry in
pure form, in metered doses and uncontaminated by other molecules. However, in
societies where modern medicine is unavailable or available only to the rich, a
consultation with a herbalist or other non-medical practitioner may be the only
source of healthcare.
It is easy to understand why alternative and complementary
therapies flourish when no other help can be found. However, such therapies are
also popular in prosperous countries with relatively well-educated populations.
When conventional cancer treatments have failed to cure, patients will try any
method that seems plausible and fits in with their world view. Despite the lack
of scientific evidence, many people find the philosophies and magical belief
systems underlying many alternative medicines to be very attractive.
Practitioners offer hope when all seems lost. Modern medicine can seem
impersonal, rushed and blind to the needs of the individual. Alternative
practitioners can more offer time and empathy than is usually available from
conventional practitioners. Some parts of society harbour a significant amount
of hostility to the �pharmaceutical industry� and the �medical establishment�. There
is suspicion that the benefits of natural healing systems are being concealed
to keep profits up. New Age beliefs and dissatisfaction with conventional
medicine can make patients easy prey for unscrupulous providers of dubious
alternative therapies. Patients may receive advice that is frankly dangerous.
Many homeopathists in the UK are opponents of vaccination and some have even
promoted homeopathic treatment (sugar pills) instead of antimalarial
prophylaxis; advice that will kill people travelling unprotected to endemic
There is no doubt that many alternative practitioners
actually believe that their therapies work. In recent years there have been
efforts of varying sincerity to test some of these therapies. Unfortunately,
the bulk of scientific studies of alternative or complementary medicines have
been poorly-designed and poorly-controlled, and are published in journals with
less-than-rigorous peer review. As the more prominent alternative therapies
such as acupuncture and homeopathy are tested in ever more rigorous and
well-designed trials, their apparent benefits progressively disappear. A prime
example of this occurred in a recent study that compared acupuncture with sham
acupuncture and standard therapy in the management of 1162 patients with back
pain . Interestingly, both groups of patients treated with either �real acupuncture� (using needles placed on correct traditional Chinese acupuncture points) or sham acupuncture (using superficial needling at non-acupuncture points) did about twice as well as patients given the standard therapy of drugs, physical therapy and exercise. So, does acupuncture work? Unfortunately not in this study! The results for �real� and �sham� acupuncture were not significantly different. Needle placement on acupuncture points was not necessary. This study suggests that a consultation that involves placing needles under the skin and a belief that this is part of an ancient system of medicine is enough to invoke a very powerful placebo effect in very many people. Five large meta-analyses have investigated the evidence for homeopathy. All have had the same result: after excluding methodologically inadequate trials and accounting for publication bias, homoeopathy produced no statistically significant benefits over placebo .
Alternative and complementary approaches to treatment may
involve the use of unproven �medical devices�; pieces of �technology� that are
claimed to have diagnostic or therapeutic properties. One of the simplest and
most ridiculous is the so-called traditional Hopi Indian ear candling. This is
a method that involves placing a lighted hollow candle in the ear to remove
wax. Some practitioners have also claimed that it can �draw toxins� from the
body. Vanessa Charles, public relations officer for the Hopi Tribal Council,
has stated that ear candling "is not and has never been a practice
conducted by the Hopi tribe or the Hopi people�. The method is not only of
doubtful provenance, but is ineffective and has led to injuries. Professor of
Complementary Medicine at Universities of Exeter and Plymouth, Edzard Ernst has
published critically of ear candles: �There are no data to suggest that it is
effective for any condition. Furthermore, ear candles have been associated with
ear injuries. The inescapable conclusion is that ear candles do more harm than
good. Their use should be discouraged� .
Why am I discussing alternative medicines at such length
in an article about unproven medical devices used in cancer therapies?
Unfortunately, too many patients are being offered useless treatments for
cancer that use unproven medical devices, or misuse real medical devices.
Claims made for these medical devices are the same sorts of claims made for
older and better established forms of alternative medicine. The same sorts of
justifications and similar poor-quality evidence are used to impress patients
(or victims, as I prefer to call them). The practitioners often have better
pseudoscientific jargon than most alternative practitioners, and they also have
an impressive-looking machine of some sort. In some cases, the practitioners even
have medical degrees. Some of these therapies are clear cases of medical fraud,
others are just plain old-fashioned quackery, and perhaps others represent a
sincere failure of judgement or even a delusion on behalf of the therapist. The
claims made for these devices are often false, distorted, or at best,
unsupported by evidence. Many victims suffer financial losses, bad health
outcomes or both. The most tragic cases are those in which patients with
potentially curable cancers forsake proven therapies for quackery.
The same types of advertising are used as for other
alternative therapies, especially on the Internet where regulation ranges from
lax to non-existent. Advertising emphasises anecdotes and testimonials but
never quotes the most relevant type of research: the controlled clinical trial.
However, unlike many other types of alternative medicine, the claims for these
medical devices are dressed up with plausible-sounding bits of scientific
jargon. The therapist may say that this treatment will �help the immune system
fight cancer� or that it will �starve the cancer of the glucose it needs to survive�.
The therapist may use a device that will �scan your body� or �analyse� your
blood or a hair sample and detect critical nutritional deficiencies or
imbalances that you need to correct to survive your cancer. The therapist will
claim to have special knowledge that is not accepted by the established medical
profession. Conventional cancer medicine is determined to �slash, burn and
poison cancers� they say, instead of adopting a gentle and more reliable
method, with the unproven medical device at its centre. The patients may be
assured that conventional medical specialists are aware of the fantastic
scientific advances enshrined in the unproven medical advice but are determined
not to accept this knowledge for fear of losing their livelihoods. On the other
hand, the medical world may be too stupid to appreciate the genius of the
therapist. The patient may be assured that the huge international efforts
involved in the study of difficult sciences such as molecular biology,
immunology pharmacology, radiation biology, etc, is a shameful waste (perhaps
even a deliberate waste) when the problem of cancer can be reduced to a few
simple concepts that the average person can grasp. Ideas such as �working with
your body rather than against it to fight the cancer�, �sorting out your
lifestyle� and �taking responsibility for your own illness� make the patient
think of the therapist as a concerned individual offering a real alternative to
the nasty treatments provided by conventional cancer specialists. A holistic
approach and �empowerment of the patient� should, of course, be part of good
quality cancer care from any source. The difference is that truth should be the
basis of any treatment approach, and the truth is in short supply when these
unproven medical devices are promoted.
For these devices or methods, no proper clinical trials
are done or discussed. No phase I trials to assess toxicity, no phase II trials
to assess efficacy and no phase III trials to compare with standard therapies.
There is no ethics committee approval and patients are not asked to sign a
consent form stating that they are enrolled in a trial of an investigational
therapy. However, they may be asked to sign a waiver to �cover� the person
treating them, acknowledging that the therapy is not accepted by the medical
establishment. This, they are assured, does not mean that the treatment does
not work, �it is just a legal requirement to satisfy the regulators�. The
practitioner may adopt the wry smile of an embattled innovator struggling with
the uncaring forces of government regulation. The therapist may claim to be
conducting research, but there is no ethics approval and the results of
well-conducted clinical trials are not published in respected journals.
Then there is the money. No matter how simple the
treatment seems, it will be expensive. It may seem tailored to the amount that
the person seems likely to be able to afford. Special discounts may be offered
to those with less money, or a cheaper �but just as effective� form of the
therapy may unexpectedly become available for those with financial problems.
Often treatment with the unproven medical device is just one of a menu of
treatments available at an alternative cancer treatment centre. One may also
find homeopathy, iridology, naturopathy, orthomolecular medicine and other
mutually contradictory members of the complementary and alternative medicine
The types of unproven therapies used to treat cancer
patients with �medical devices� vary considerably. Usually they are completely
without evidence other than anecdotes. The types of devices include so-called
�energy machines� that can supposedly cure cancer and eliminate AIDS by
transmitting electromagnetic waves through the body. The �Rife� machine has
been claimed to be effective against cancer by causing
"differentiation" of cancer cells into normal cells by eliminating
microorganisms that caused the cancer. There is no evidence to support this
therapy but it is widely available. Some therapists use a box called a �magnetic
pulser� and claim that it can shrink cancers. In the UK, a practitioner was
found guilty under the trades descriptions act after using an �IFAS High
Frequency Therapy� machine to treat cancer. Other methods are more subtle and
represent a misuse of existing and proven therapeutic technologies. For example
the practitioner may offer whole body hyperthermia to a patient, using a
microwave machine that is unable to induce whole body hyperthermia to a
temperature that is effective for killing cancer cells. The practitioner may
offer local hyperthermia with a machine that is incapable of heating the
patient�s deep-seated tumour to an effective temperature. The patient may be
offered photodynamic therapy for a deep-seated tumour, when the therapist knows
very well that the laser beam used in the therapy is unable to penetrate deeply
enough into tissue to treat the tumour effectively.
Regulation in this area is lax in many countries.
Governments do not like to be seen to be limiting patient choice. There are,
however, occasional comprehensive reviews of unproven therapies by scientific
bodies. In 2005 the Australian National Medical and Health Research Council
reviewed a form of �microwave therapy� delivered with so-called �glucose
blockers� and found that there was no high-quality published scientific
evidence which showed superior benefits in terms of therapeutic effectiveness
for the treatment of cancer with microwave (or UHF) cancer therapy when
combined with radiotherapy or �glucose blockers� . Despite these findings,
the therapy remains available.
This is a tragic problem and I must confess that sometimes
it makes my blood boil. I have seen patients who have wasted large sums of
money that they or their families could ill-afford. Some patients have listened
to the advice of quacks and refused conventional treatment for cancer at a time
when they could have been cured. Instead they have accepted useless treatment
in which a �medical� device was used or misused. Others have suffered
needlessly with severe symptoms that could have been readily relieved with
conventional anti-cancer therapies. These devices are unfortunately just part
of the spectrum of alternative and complementary medicine, dressed up in a coat
of pseudoscience, giving the impression to a person with a limited
understanding of science that they represent an exciting advance being held
back by the corrupt medical establishment. Some of the practitioners of this
form of fraud are clearly heartless predators. Members of the medical
profession who deliberately practise fraud should be de-registered. Those who
recklessly endanger life and cause suffering to vulnerable patients and their
families for profit deserve even more serious penalties. Those of us who use
evidence-based medicine in the treatment of cancer need to be alert to the size
of this problem. We need to offer patients good advice and we should warn them
of the dangers that they may face when, all too understandably, they seek
opinions from purveyors of unproven therapies. We should empower them with
information so that when confronted by an alternative practitioner they will
ask, �show me the evidence that what you say is true�.
Haake M, Muller HH, Schade-Brittinger C et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med 2007; 167(17):1892-8.
Goldacre B. Benefits and risks of homoeopathy. Lancet 2007; 370(9600):1672-3.
Ernst E. Ear candles: a triumph of ignorance over science. J Laryngol Otol 2004; 118(1):1-2.
National Health and Medical Research Council. Review of the use of Microwave Therapy for the Treatment of Patients with Cancer [Online]. 2005; Available at http://www.nhmrc.gov.au/publications/categories/microwave.htm.
|Received 13 May 2008; accepted 14 May 2008
Correspondence: Department of Radiation Oncology, Peter MacCallum Cancer Centre, St. Andrew�s Place, East Melbourne, VIC 3002, Australia. Tel.: +613 9656 1111; Fax: +613 9656 1424; E-mail: email@example.com (Michael P. Mac Manus).
Please cite as: Mac Manus MP,
Unproven medical devices and cancer therapy: big claims but no evidence, Biomed Imaging Interv J 2008; 4(3):e25