The Neon Roberts case highlights the shortcomings of conventional cancer treatments and the bias against fair testing of the alternatives
The recent controversy over the most effective treatment for Neon Roberts-the seven-year-old with a brain tumour whose mother tried to prevent him having surgery and radiotherapy-has highlighted the myths and half-truths concerning alternative cancer therapies.
Conventional medicine maintains that no alternative to chemotherapy, surgery or radiotherapy has ever been proven to work, and patients who delay treatment in favour of an alternative are endangering their lives and reducing their chances of survival. High Court judge Mr Justice Bodey, who was hearing Neon’s case, agreed and in his summing up commented: “I find it difficult to see that doctors would withhold alternative treatment that would improve survival.”
Neon’s mother Sally had challenged the use of surgery and radiotherapy, and had put forward a range of possible alternative therapies that she said were safer and equally effective. Her main concern was the use of radiotherapy, and she cited studies that suggested the treatment could reduce a child’s IQ level by as much as 16 points, putting an average child with a 100 score at the level of ‘dull normal’ and just one point away from mental retardation.
Instead, Mrs Roberts proposed seven possible alternative cancer treatments, including light therapy, boron neutron-capture therapy and immunotherapy, where the protective powers of the immune system are activated to fight cancer cells. However, the hospital trust treating Neon dismissed the therapies as “experimental and unproven” and entering “uncharted waters”.
It’s an argument that is often cited by oncologists, and it implies that the conventional cancer treatments of chemotherapy, radiotherapy and surgery have been subjected to rigorous testing and have been proven to be highly successful, whereas alternatives have never been properly tested and the inadequate trials that have been carried out show they don’t work.
The truth is far more complicated-and disturbing-than this position suggests as issues of ethics, money, professional standing, data-massaging, sleight of hand and downright fraud all play a part in blurring the information we’re given about cancer treatments.
Conventional therapies
Implicit in the condemnation of alternative cancer therapies is the assumption that conventional treatments are effective. Although there have been many trials involving conventional medicine’s three main cancer therapies, few have met the ‘gold standard’ of a double-blind placebo-controlled study, where the treatment or drug is tested against a placebo or dummy drug or procedure over a period of time. This is because medical ethics do not allow the withholding of treatment to a cancer patient.
However, without this sort of comparative trial, the studies rarely answer such basic questions as: Would the patient have done better on a different therapy? What would have happened if the patient hadn’t had the treatment? Did the treatment actually extend the life of the patient?
Chemotherapy
This is medicine’s major answer to cancer. Cytotoxic drugs are either given exclusively or as a follow-up to surgery or radiotherapy, in which case they are called ‘adjuvant treatment’. The aim is either to cure (or put into remission) cancer, or at least alleviate the worst symptoms if a cure is not possible.
Many cytotoxic drugs are used in chemotherapy, including newer agents such as taxanes and anthracyclines, but overall the oncologist often talks about a 50 per cent success rate. In other words, you have a 50-50 chance of living a further five years or longer after chemotherapy. This sounds like an attractive option to a patient who may otherwise be seeing his life expectancy in terms of months rather than years.
But chemotherapy’s real success rate is far, far lower than half: in fact, it hovers around the 2 per cent mark-the cancer patient has a 2 per cent chance of living a further five years or longer if he has chemotherapy.
So how can the two figures be so wildly different? It’s all to do with the way the data are massaged and interpreted. Researchers like to put the best face on study results-often because the trial sponsor happens to be the manufacturer of the drug being tested-and one useful sleight-of-hand trick is to show the results in terms of relative risk rather than absolute risk.
Let’s say you have osteoporosis, the brittle-bone disease. Your condition may be at a stage where your risk of suffering a fracture is 4 per cent, but a drug can reduce that risk to 2 per cent. There are two ways of expressing the same thing: as a relative risk, the drug has a 50 per cent rate of effectiveness-it’s reduced your risk from 4 to 2-and that sounds attractive, but in absolute terms its effectiveness is just 2 per cent.
For years, researchers have been presenting the effectiveness of chemotherapy in terms of relative risk, and oncologists have revealed in surveys that this has had a significant effect on the way they have expressed the drugs’ effectiveness to the patient. This has also influenced the media and the way it reports on cancer treatments.
The alarming discrepancy between relative and absolute risk was uncovered a few years ago by some of Australia’s leading oncologists, some of whom influence the country’s medical policies. They even cherry-picked the very best clinical trials, choosing only those showing that chemotherapy had led to a “statistically significant” increase in five-year survival.
Despite this, the researchers found that chemotherapy’s contribution to the five-year survival was only 2.3 per cent in Australia and 2.1 per cent in the US in terms of absolute risk. Similar levels were likely to be seen in every developed country, the researchers said.1
Although the gulf between absolute and relative risk was the major cause of the difference in effectiveness claims, the Australian researchers discovered that the studies had also massaged the data for patient survival rates. Although the only measures that matter are meaningful prolongation of life and improved quality of life, researchers had often fudged the survival rates by using vague terms such as “progression-free survival” instead, with no indication of how long the cancer remained in remission. This meant that a patient whose cancer had been “progression-free” for just a matter of months was reported as a success.
In general, chemotherapy can help to alleviate the worst symptoms and it can be very effective in some rare cancers, but it’s far from being the life-saver against the major cancers that medicine claims, say the researchers.
Radiotherapy
The good news is that radiotherapy kills cancer cells. It can shrink tumours and alleviate the worst symptoms. It’s also useful as an adjuvant therapy in the follow-up after surgery. The bad news is that it kills healthy cells too and, despite the claims of its strongest advocates, there is scant evidence to suggest that radiotherapy actually cures cancer.
Essentially, radiotherapy is the use of high-energy radiation to kill cancer cells by damaging their DNA, which stops them from dividing and spreading. The radiation can either come from an external device, or radioactive material can be placed in the body close to the site of the cancer in a form of treatment known as ‘brachytherapy’, or ‘internal radiation therapy’.
For any good that it does, however, radiotherapy also seems to do an equivalent amount of harm. One study of 470,000 cancer patients found that 27 per cent hadn’t died of the cancer, but from the conventional treatment. In many cases chemotherapy and radiotherapy had fatally damaged the heart and respiratory system.2
And radiotherapy appears to reverse the good work achieved by chemotherapy in women with breast cancer. One study found that the number of lives saved by chemother
apy was matched by the number of deaths caused by the radiotherapy.3
The concerns of Neon’s mother are also well founded. Studies support her fears that radiotherapy given to children with brain tumours affects their cognitive development and IQ (intelligence quotient). An analysis of 29 studies concluded that the children’s verbal and performance IQ levels, and their intellectual functioning and attentiveness, were “seriously impaired”. Children who had both chemotherapy and radiotherapy and longer times since diagnosis were reported to have even lower IQ scores.4
Surgery
An operation to cut away the tumour is medicine’s oldest intervention and has been in regular use since the 16th century. Although it is the least harmful of the conventional treatments-and can even be a life-saver-it can also aggravate the problem. Surgery is also limited to the less malignant tumours.
Although an operation can ease the worst symptoms of cancer, it doesn’t appear to prolong life, a fact that was established back in 1844 in a study that is still the most comprehensive ever undertaken. Dr Leroy d’Etoilles of Paris, France, studied the case histories of 2,781 cancer patients over a 30-year period who had undergone either surgery or caustics-the chemotherapy of the day-or had done nothing.
The average survival after surgery was one year and five months-similar to today’s rates-although in absolute terms, caustics and surgery prolonged life by only two months in men and six months in women. However, those who survived the first two years after diagnosis and did not receive either treatment had the best survival rates by around 50 per cent.5
This uncomfortable fact has been amplified more recently by researchers who have observed prostate cancer patients who had either submitted to localized surgery or a radical prostatectomy, or did nothing. They discovered that those who underwent surgery didn’t live any longer than those who did nothing. Absolute differences between the three groups-which involved a total of 731 men with an average age of 67 years-were less than 3 per cent, say researchers in the PIVOT (Prostate Cancer Intervention versus Observation Trial) study group.6
Any alternatives?
Poor as the conventional therapies may be, they are the only approaches that have any evidence that they might help, according to the doctors who testified at Sally Roberts’ High Court hearing.
Researcher Andrew Vickers at the Memorial Sloan-Kettering Cancer Center in New York put it more emphatically. Alternatives aren’t just unproven-they’re disproven, he says.7
Vickers’ statement suggests there have been numerous trials that have demonstrated that alternative treatments have been thoroughly tested, but found wanting. But this isn’t the case, as America’s National Cancer Institute (NCI), which researches various cancer therapies, confirms. There are several reasons for this, it says.
The first is probably the main reason: a lack of funding. Pharmaceutical companies almost exclusively pay for medical research, and there aren’t enough institutes or interested individuals prepared to foot the enormous bill for a full-blown study into alternative therapies.
The second reason is that very few academics would be prepared to undertake the research anyway.
Worried about their own prestige and standing, few would want to be associated with what might be viewed as some maverick therapy.
The third reason is a Catch-22: if doctors and researchers don’t really believe that an alternative therapy is effective, should they ethically be using it in favour of a conventional treatment they believe might work better?
Evidence, evidence
Despite these impediments, many alternative therapies have more evidence than the sceptics claim, although it may not be to the rigorous standards of a proper clinical trial. Yet the fact that the data from studies of conventional therapies are widely manipulated seems never to be raised as a concern by the critics of alternative therapies.
Over the years, many alternatives to conventional therapies have been tried, and some have garnered many hundreds of case reports describing successful outcomes. These include high-dose intravenous vitamin C, hydrogen-peroxide treatment, bovine cartilage treatment, Essiac, Coley’s toxins and Hoxsey therapy. The following are five such therapies and their supportive evidence.
u Gerson therapy. This is one of the most promising therapies. It’s a natural treatment that activates the body’s own healing system through an organic vegetarian diet that also includes raw juices, coffee enemas and supplements.
Although there have been no controlled studies published in a peer-reviewed scientific journal, there have been numerous trials of the therapy on its own or comparing it with no intervention. In one such trial, 18 patients with colorectal cancer and 38 with breast cancer were divided into those who used the therapy after surgery and those who didn’t. Both groups also carried on with any conventional treatment they were receiving.
Three of the nine patients in the Gerson diet group increased their survival time after surgery up to 28.6 months compared with 16.2 months in the non-diet group.8
In another study carried out by the Gerson Research Organization in San Diego, California, 153 patients with stage I to IV melanoma skin cancer were assessed; all 14 patients with stage I or II were disease-free 17 years after the Gerson treatment, while 70 per cent of patients with stage III melanoma were still alive five years later compared with averages of between 27 per cent and 42 per cent in the general population. Most impressively, 39 per cent of patients with stage IV, or end-stage, cancer were still alive five years later, whereas the average at that stage is just 6 per cent for people receiving conventional treatment.9
Antineoplastons
More than 60 clinical trials have been carried out with this alternative therapy pioneered by Dr Stanislaw Burzynski, who works out of a clinic in Houston, Texas. The therapy uses synthetic chemicals called ‘antineoplastons’-mostly made up of peptides and amino acids-to help the body fight cancer.
According to Burzynski, antineoplastons are part of the body’s “natural biochemical defence system” that acts independently of the immune system and protects the body against diseases such as cancer. This means that, according to the theory, cancer patients are depleted in antineoplastons, and the therapy involves a course of injections or tablets of antineoplastons, taken from human blood and urine, to restore their levels. People who want the therapy can do so only as a participant in one of Burzynski’s clinical trials, which are restricted to cancer sufferers whose tumours continue to grow despite conventional treatment.
Burzynski claims to have successfully treated more than 8,000 people with cancer, but detractors say his trials have never been successfully repeated by doctors not associated with his clinic.
Nonetheless, results have been impressive, including one trial of 21 patients, of whom four had a “complete tumour response”-indicating that the tumour had shrunk and completely disappeared-while four had partial tumour responses (the tumours had shrunk by more than half); in six participants who were still taking the treatment, their cancer continued to regress but had not yet reached the stage of complete remission at the time of the report.10
In another trial of 14 men with prostate cancer, 13 of whom had tumours at stage IV, two achieved complete remission and three had partial remission, while the cancer had stabilized in seven of the participants and progressed in two cases.
All of the men were still alive two years after the trial had come to an end.11
Coenzyme Q10
There are impressive case reports and a few clinical trials showing the effectiveness of coenzyme Q10 in reversing cancer, although
a full controlled study has never been undertaken. In one case report, three women with breast cancer were given 390 mg of coenzyme Q10 a day-the usual dose is around 90 mg-and after five years, one showed complete remission of a tumour in the liver that had spread from the breast (and no signs of tumour elsewhere), another had complete regression of tumour that had spread throughout the chest cavity and the third had no signs of any tumour or metastases (spreading).12
The compound has also been used successfully as a complementary therapy alongside chemotherapy. In one study, 32 women with breast cancer were followed for 18 months, during which time they took antioxidant supplements and 90 mg/day of coenzyme Q10. All of the women were alive at the end of the trial, although four deaths had been anticipated, and six showed signs of partial remission.
All of the women also reported using fewer painkillers, a good quality of life and no weight loss.13
Hyperthermia
(see Don’t tell the president, below). This alternative-which exposes cancer to high temperatures-is beginning to attract interest from researchers. One study involved 105 rectal cancer patients, 61 of whom had heat therapy after receiving conventional cancer care. They were given as many as four one-hour sessions, and the target temperature was 40.5 degrees C (104.9 degrees F). Overall the positive response rate-defined as having no spread of the cancer while showing some signs of tumour shrinkage-was three times greater with the heat therapy than in those who only had the conventional treatment.
This study underscores the success of hyperthermia, which has also been seen in the treatment of soft-tissue sarcoma and late-stage cervical cancer.14
u Avemar. This liquid solution made up of fermented wheat-germ extract-which is mixed with water-has been the subject of around 30 peer-reviewed studies so far. It’s mainly been used as an adjuvant treatment with chemotherapy or radiotherapy, and patients have generally fared better with it than without it.
In one study of melanoma skin cancer patients who had been treated with chemotherapy, those who were also given Avemar survived for nearly 59 months on average compared with the chemotherapy-only group, who survived on average for around 30 months.15
Who cares?
Despite the constant complaints that alternative cancer therapies don’t have any evidence, there are plenty of people like Sally Roberts who are looking for alternatives to standard medical treatment.
One survey of 394 breast cancer survivors found that 51 per cent were using some kind of alternative medicine. Around 80 per cent of these survivors were taking vitamins or other dietary supplements, mainly to make their everyday activities easier and to improve their immune system and emotional well-being.
Although the most popular source of information about alternatives was family and friends, around 25 per cent said their doctor had told them about these treatments-so perhaps doctors aren’t quite so convinced about the standard cancer treatments after all.16
References
1. Clin Oncol [R Coll Radiol], 2004; 16: 549-60
2. J Natl Cancer Inst, 1993; 85: 979-87
3. J Clin Oncol, 1994; 12: 447-53
4. Dev Med Child Neurol, 2012; doi: 10.1111/dmcn.12020
5. Walshe WH. The Anatomy, Physiology, Pathology and Treatment of Cancer. Boston, MA: William D. Ticknor & Co, 1844
6. N Engl J Med, 2012; 367: 203-13
7. CA Cancer J Clin, 2004; 54: 110-8
8. Aktuel Ernahrungsmed, 1990; 2: 72-8
9. Altern Ther Health Med, 1995; 1: 29-37
10. Physiol Chem Phys, 1977; 9: 485-500
11. Drugs Exp Clin Res, 1990; 16: 361-9
12. Biochem Biophys Res Commun, 1995; 212: 172-7
13. Mol Aspects Med, 1994; 15 Suppl: s231-40
14. Int J Hyperthermia, 2012; 28: 707-14
15. Cancer Biother Radiopharm, 2008; 23: 477-82
16. Asian Pac J Cancer Prev, 2012; 13: 4081-6
The scandal of the Gonzalez study
Even when an alternative therapy is recognized as having some possible merit and a large chunk of money is released to research it, it can still fall foul of spin, mismanagement, data manipulation and even worse.
Dr Nicholas Gonzalez found this out to his cost after America’s National Cancer Institute agreed to stump up $1.4 million to test his pancreatic enzyme therapy against a new chemotherapy protocol for people with inoperable pancreatic cancer.
Dr Gonzalez has been practising nutrition-enzyme therapy-based on the findings of his university colleague Dr Donald Kelley-from his New York clinic since the late 1980s. Kelley was desperate to have his therapy independently tested, but he died without seeing it happen, and Gonzalez has held similar hopes. In 1998 the dreams of Kelley and Gonzalez seemed to have come true when the NCI announced it would fund a clinical controlled study, led by Dr John Chabot from Columbia University, that would test the enzyme therapy against a new triple-agent chemotherapy regime known as ‘GTX’.
Then without warning, Dr Chabot wrote an article for the Journal of Clinical Oncology announcing that
GTX was more effective than the enzyme therapy.
On the face of it, his evaluation-albeit published without Gonzalez’s knowledge-was right: patients given GTX did fare better than those on the enzyme therapy. However, what was not revealed was that Chabot had recruited very sick patients into the ‘enzyme group’ and most of them were either too ill or unable to commit to following the therapy’s regime.
An independent review by a division of the National Institutes of Health of Chabot’s methods revealed that he had admitted 42 out of 62 patients into the study inappropriately. The US Food and Drug Administration (FDA) agreed and posted on its website a statement that Chabot had failed to perform informed consent properly, failed to follow the investigation plan, and kept inadequate and inaccurate records.
Later, Gonzalez discovered that Chabot was one of the pioneers and advocates of GTX, the treatment his therapy was being tested against.
So from the outset the cards had been stacked against enzyme therapy, as Dr Gonzalez now acknowledges.
“Scientists and physicians were biased from the onset and couldn’t entertain the possibility that my ‘odd’ nutritional treatment could have any value in the treatment of advanced cancer. This bias led to the study’s ultimate failure and a need to prove my therapy worthless. In retrospect, I believe that so great was the bias of those assigned to supervise the project that a legitimate scientific outcome seems to have been impossible.”
Don’t tell the President
Almost every step taken by the President of the United States is covered by the press, whether it’s signing a treaty or just walking the dog. So it’s strange that when President Ronald Reagan’s cancer was successfully treated with an alternative therapy, the press remained remarkably quiet about it.
Reagan was treated by renowned cancer ‘maverick’ Dr Hans Nieper in the 1970s with hyperthermia, where cancer cells are exposed to very high temperatures. The treatment was successful and Reagan went on to live another 15 years.
It wasn’t the only time the press was silent about Nieper and alternative therapies. At the time, Nieper was working at the Memorial Sloan-Kettering Cancer Center in New York City, where he was seen by such esteemed colleagues as Robert Good, Lloyd Old and Lewis Thomas as one of the sharpest of minds.
He was an early advocate of laetrile, or amygdalin, a form of vitamin B17 that’s found in apricot pits. Today the treatment is not only discredited, it is also banned in some countries, but back in 1974, Sloan-Kettering researchers were starting to see positive results when laetrile was being used on laboratory mice. One of the leading researchers there even sent his own mother to Hanover, where Nieper treated her cancer with laetrile.
Eventually, Sloan-Kettering’s official line was that laet
rile was a sham and a rip-off, preying on desperate people, although the lead researcher never went along with that condemnation. Dr Kanematsu Sugiura said: “I write what I see. Laetrile is a good palliative drug.”
Meanwhile, Nieper had moved on to other therapies, developing the cancer-fighting compounds known as the ureyl-, nicotinyl- and para-aminobenzoic mandelonitriles and, more recently, iridoids derived from Australian meat ants.
But Nieper never saw his work properly tested, let alone accepted. Whenever the press did report on him, it was to label him a charlatan and a fraud. And of course his successes, such as with President Reagan, were never talked about at all.
Dr Nieper died in 1998.
Spinning out the truth
Everyone knows that the side-effects of chemotherapy can be every bit as bad as the cancer it’s treating. But it seems they are even worse than doctors tell us.
Researchers have investigated studies into the side-effects of chemotherapy drugs and found an alarmingly high degree of fraud, where the drugs’ dangerous effects have been downplayed or even ignored.
Researchers at the University of Toronto analyzed 164 studies into chemotherapy and uncovered a high degree of ‘spin’ that could mislead oncologists and the public. Two-thirds of the papers downplayed the adverse effects of the drugs, and this was especially apparent in studies that found the treatment was effective. So in these trials, the true risk/benefit picture was distorted; had the true side-effects been reported, the benefits may have been less attractive.
The research team also discovered a high degree of spin when it came to studying chemotherapy. Every study has a ‘primary end-point’-in other words, what is the main purpose of the study? It could be to discover how long the patient lives after treatment or how effective a new treatment is compared with an older treatment.
The Canadian researchers discovered, however, that the primary end-point was often missed-the study was unable to prove what it had set out to do-and so researchers concentrated on a ‘secondary end-point’ instead, often an interesting but less compelling conclusion.
This suggests that researchers are frequently unable to prove the effectiveness of chemotherapy drugs and mask their disappointing findings by instead focusing on a secondary issue. In fact, 33 per cent of the studies they analyzed could be considered positive trials for chemotherapy’s effectiveness when in reality they were nothing of the sort.1
Reference
1. Ann Oncol, 2013; doi: 10.1093/annonc/mds636
Close to the bone
Twenty years ago, bone marrow transplantation (BMT)-or stem cell transplantation as it’s known today-was the great new hope for cancer treatment. Breast and ovarian cancers were targeted as ideal for the new therapy; with BMT, oncologists could use extremely high doses of chemotherapy and replace the bone marrow that would normally be suppressed by the drugs.
The cancer industry swung into action, and oncologists in the US were forcing the insurance companies into paying the $450,000 cost for each procedure, while the media was hailing it as the great cancer breakthrough.
All it needed was proof.
Unfortunately, the first four studies found there was no improvement in patients given BMT over those receiving standard chemotherapy. Then suddenly, the study everyone was waiting for was published in the Journal of Clinical Oncology, one of the world’s most prestigious cancer journals. South African researchers reported that BMT had achieved a “complete response rate” of 51 per cent compared with just 4 per cent using standard-dose chemotherapy.
The result was so much better than any of the four earlier studies that some researchers started to get suspicious. But such was the desire to believe the good news that the National Cancer Institute refused to support any independent evaluation of the South African study, and the journal also would not retract the article. The authors also refused to reveal their data to other researchers.
The magazine changed its tune six years later when it was finally presented with overwhelming evidence that the study was fraudulent. In a summary of the whole affair a year later, the British Medical Journal concluded that objectivity and a lack of bias are not at the heart of cancer therapy and research.1
Reference
1. BMJ, 2002; 324: 1088-92
Bryan Hubbard
WDDTY vol 23 no 11
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