MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Cancer

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Would it not be nice to have a world where everything is positive? No negative findings ever! A dream! No, it’s not a dream; it is reality, albeit a reality that exists mostly in the narrow realm of alternative medicine research. Quite a while ago, we have demonstrated that journals of alternative medicine never publish negative results. Meanwhile, my colleagues investigating acupuncture, homeopathy, chiropractic etc. seem to have perfected their strategy of avoiding the embarrassment of a negative finding.

Since several years, researchers in this field have adopted a study-design which is virtually sure to generate nothing but positive results. It is being employed widely by enthusiasts of placebo-therapies, and it is easy to understand why: it allows them to conduct seemingly rigorous trials which can impress decision-makers and invariably suggests even the most useless treatment to work wonders.

One of the latest examples of this type of approach is a trial where acupuncture was tested as a treatment of cancer-related fatigue. Most cancer patients suffer from this symptom which can seriously reduce their quality of life. Unfortunately there is little conventional oncologists can do about it, and therefore alternative practitioners have a field-day claiming that their interventions are effective. It goes without saying that desperate cancer victims fall for this.

In this new study, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”.

Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care. Finally, most commentators felt, research has identified an effective therapy for this debilitating symptom which affects so many of the most desperate patients. Few people seemed to realise that this trial tells us next to nothing about what effects acupuncture really has on cancer-related fatigue.

In order to understand my concern, we need to look at the trial-design a little closer. Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual, and the former is therefore moer than likely to produce a better result. This will be true, even if acupuncture is no more than a placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

I can be fairly confident that this is more than a theory because, some time ago, we analysed all acupuncture studies with such an “A+B versus B” design. Our hypothesis was that none of these trials would generate a negative result. I probably do not need to tell you that our hypothesis was confirmed by the findings of our analysis. Theory and fact are in perfect harmony.

You might say that the above-mentioned acupuncture trial does still provide important information. Its authors certainly think so and firmly conclude that “acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life”. Authors of similarly designed trials will most likely arrive at similar conclusions. But, if they are true, they must be important!

Are they true? Such studies appear to be rigorous – e.g. they are randomised – and thus can fool a lot of people, but they do not allow conclusions about cause and effect; in other words, they fail to show that the therapy in question has led to the observed result.

Acupuncture might be utterly ineffective as a treatment of cancer-related fatigue, and the observed outcome might be due to the extra care, to a placebo-response or to other non-specific effects. And this is much more than a theoretical concern: rolling out acupuncture across all oncology centres at high cost to us all might be entirely the wrong solution. Providing good care and warm sympathy could be much more effective as well as less expensive. Adopting acupuncture on a grand scale would also stop us looking for a treatment that is truly effective beyond a placebo – and that surely would not be in the best interest of the patient.

I have seen far too many of those bogus studies to have much patience left. They do not represent an honest test of anything, simply because we know their result even before the trial has started. They are not science but thinly disguised promotion. They are not just a waste of money, they are dangerous – because they produce misleading results – and they are thus also unethical.

Guest Post by Louise Lubetkin

A study published last week in the New England Journal of Medicine (NEJM) has brought to light some stark differences in the way that physicians and their patients see the role of chemotherapy in the management of advanced (i.e., metastatic) cancer.

Physicians who treat patients with advanced cancer know only too well that while chemotherapy can sometimes be helpful in easing symptoms, and may temporarily slow tumor growth, it cannot reverse or permanently cure the disease.  In other words, when chemotherapy is given to patients with advanced cancer it is always given with palliative rather than curative intent.  However, this is a distinction that a sizeable majority of cancer patients apparently do not fully understand.

In the NEJM-study, which involved 1193 patients with advanced lung or colorectal cancer, only 20-30 percent of patients reported understanding that chemotherapy was not at all likely to cure their cancer. The remainder, a full 81 percent of patients with colorectal cancer and 69 percent of patients with lung cancer, continued to believe, even when told otherwise, that chemotherapy did indeed offer them a significant chance of cure.

The study raises important questions concerning possible lack of informed consent: would patients still accept chemotherapy if they knew that it stood no chance of curing them? The authors cite a study which revealed that patients  – especially younger patients – would opt for chemotherapy if it offered even a 1 percent chance of cure, but would be considerably less willing to accept the same treatment if it offered only a significant increase in life expectancy. In the light of this, the authors write, “…an argument can be made that patients without a sustained understanding that chemotherapy cannot cure their cancer have not met the standard for true ongoing informed consent to their treatment.”

Because of the searching nature of the questions raised by the NEJM-study, and its potential ethical ramifications, it seems destined to be picked up by advocates of alternative medicine and used as a cudgel against standard medicine. To promoters of alt med, oncology represents a cynical institutionalized conspiracy to obstruct the use of purported “natural” cures, and chemotherapy is simply a license to poison patients in pursuit of profit. Take, for example this fevered headline and article from the Natural News website : “Chemo ‘benefits’ wildly over-hyped by oncologists; cancer patients actually believe they will be ‘cured’ by poison.”

“…chemotherapy is nothing but a sham “treatment” that puts cancer patients through needless pain and suffering while making the cancer industry rich,” continues the Natural News article.

“And perhaps the most disturbing part about this now-normalized form of medical quackery is that oncologists typically fail to disclose to their patients the fact that chemotherapy does not even cure cancer, which gives them false hope.”

(Which incidentally is pretty rich, coming from a website which carries, on the same page as this article, an ad which reads “How to CURE almost any cancer at home for $5.15 a day.”)

In fact, as more than one study has previously demonstrated, the majority of oncologists do indeed try their best to convey the incurable nature of metastatic cancer, and do mention the limited aims of chemotherapy in this setting. However, patients themselves are not always psychologically receptive, and are not always immediately able to confront the bleak truth. Neither, understandably, are physicians always eager to dwell on the negative aspects of the situation during “bad news” consultations. While two thirds of doctors tell patients at their initial visit that they have an incurable disease, only about a third explicitly state the prognosis. And even when prognosis is explained, more than one third of patients simply refuse to believe that treatment is unable to cure them (see Smith TJ, Dow LA, Virago EA, et al., here).

Moreover, patients’ initial reaction to the news that their cancer has recurred, or has metastasized, is typically “What can be done?” rather than “When will I die?”  Similarly, physicians – who, contrary to the calumnies of alt med conspiracy-mongers, are just as human as the rest of us, and just as averse to being the bearer of awful news – are apt quickly to follow their patients’ lead away from the hopelessness and finality of the situation and towards a practical discussion of treatment options, a realm in which they feel far more at home.

Significantly, the NEJM-study found that the very physicians who most explicitly drummed home the message that chemotherapy would not cure advanced cancer were consistently given the lowest marks for empathy and communication skills by their patients.  Conversely, those physicians who projected a more optimistic view of chemotherapy were perceived as better communicators.

In an era of greater measurement and accountability in health care,” the study concludes,  “we need to recognize that oncologists who communicate honestly with their patients, a marker of high quality of care, may be at risk for lower patient ratings.”

In an accompanying NEJM editorial titled “Talking with Patients about Dying” (unfortunately it’s behind a paywall but you can read a summary here), Thomas J. Smith, MD, and Dan L. Longo, MD, provide a trenchant commentary on this important subject.

Chemotherapy near the end of life is still common, does not improve survival, and is one preventable reason why 25 percent of all Medicare funds are spent in the last year of life. Patients need truthful information in order to make good choices. If patients are offered truthful information – repeatedly – on what is going to happen to them, they can choose wisely. Most people want to live as long as they can, with a good quality of life, and then transition to a peaceful death outside the hospital. We have the tools to help patients make these difficult decisions. We just need the gumption and incentives to use them.”

As these uncompromisingly candid editorialists point out, chemotherapy is a crude and ineffective treatment for advanced cancer. But to claim, as do many proponents of alternative approaches to cancer, that palliative chemotherapy represents a highly lucrative business built on the deliberate deception of dying patients, is a clear-cut case of the pot calling the kettle black.

When advocates of alternative cancer therapies have subjected their own highly profitable nostrums to the same kind of scientific scrutiny and honest, unsparing self-criticism as the NEJM researchers and editorialists, and when they produce evidence that their remedies and regimens, their coffee enemas and latter-day reincarnations of laetrile offer greater efficacy, whether palliative or curative, than chemotherapy, then, and only then, will they will have earned the right to criticize rational medicine for its shortcomings.

Cancer patients are understandably desperate to try every treatment that promises a cure. They often turn to the Internet where they find thousands of “alternative” cancer cures being sold often for exorbitant cost. One of them is Ukrain.

Ukrain is based on two natural substances: alkaloids from the Greater Celandine and Thiotepa. It was developed by Dr Wassil Nowicky who allegedly cured his brother’s testicular cancer with his invention. Despite its high cost of about £50 per injection, Ukrain has become popular in the UK and elsewhere.

Ukrain has its name from the fact that the brothers Nowicky originate from the Ukraine, where also much of the research on this drug was conducted. When I say much, I should stress that I use this word in relative terms. In the realm of “alternative” cancer cures, we often find no clinical studies at all. For Ukrain, however, the situation is refreshingly different; there are a number of trials, and the question is, what do they really tell us?

In 2005, we decided to review all the clinical studies which had tested the efficacy of Ukrain. Somewhat to our surprise, we found 7 randomised clinical trials. Even more surprising, we thought, was the fact that all of them reported baffling cure rates. So, were we excited to have identified a cure for even the most incurable cancers? The short answer to this question is NO.

All of the trials were methodologically weak; but, as this is not uncommon in the area of alternative medicine, it did not irritate us all that much. Far more remarkable was the fact that these studies seemed to be odd in several other ways.

Their results seemed too good to be true; all but one trial came from the Ukraine where research governance might have been less than adequate. The authors of the studies seemed to overlap and often included Nowicky himself. They were published in only two different journals of little impact. The only non-Ukrainian trial came from Germany and was not much better: its lead author happened to be the editor of the journal where it was published; more importantly, the paper lacked crucial methodological details, which rendered the findings difficult to interpret, and the trial had a tiny sample size.

Collectively, these circumstances were enough for us to be very cautious. Consequently, we stated that “numerous caveats prevent a positive conclusion”.

Despite our caution, this article became much cited, and cancer centres around the world began to wonder whether they should take Ukrain more seriously; many integrative cancer clinics even started using the drug in their clinical routine. Dr Nowicky, who meanwhile had established his base in Vienna from where he marketed his drug, must have been delighted.

Soon, numerous websites sprang up praising Ukrain: “It is the first medicament in the world that accumulates in the cores of cancer cells very quickly after administration and kills only cancer cells while leaving healthy cells undamaged. Its inventor and patent holder Dr Wassil Nowicky was nominated for the Nobel Prize for this medicament in 2005…”  .

Somehow, I doubt this thing with the Nobel Prize. What I do not question for a minute, however, is this press release by the Austrian police: since January, the Viennese police have been investigating Dr Nowicky. During a “major raid” on 4 September 2012, he and his accomplices were arrested under the suspicion of commercial fraud. Nowicky was accused of illegally producing and selling the unlicensed drug Ukrain. The financial damage was estimated to be in the region of 5 million Euros.

I fear, however, that the damage done on desperate cancer patients across the world might be much greater. Generally speaking, “alternative” cancer cures are not just a menace, they are a contradiction in terms: there is no such a thing and there will never be one. If tomorrow this or that alternative remedy shows some promise as a cancer cure, it will be investigated by mainstream oncology with some urgency; and if the findings turn out to be positive, the eventual result would be a new cancer treatment. To assume that oncologists might ignore a promising treatment simply because it originates from the realm of alternative medicine is idiotic and supposes that oncologists are mean bastards who do not care about their patients – and this, of course, is an accusation which one might rather direct towards the irresponsible purveyors of “alternative” cancer cures.

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