Just why is ‘pioneering’ cancer treatment so expensive?

A heartstring-tugging appeal in the NZ Herald doesn’t tell the full story.

Jesse Bessant is a little boy from Auckland with a very rare brain tumour. He has a ganglioglioma, a tumour that arises from ganglion cells in the central nervous system. As these tumours are very slow-growing, and with the location of his tumour (close to his brain stem) making surgery very risky, Jesse’s doctors have advised a ‘wait and see’ approach. However, the Bessant family have opted instead to try the Burzynski clinic in Houston, Texas, where Dr Stanislaw Burzynski offers his ‘pioneering’ antineoplastin treatment.

The catch? It’s going to cost the Bessants $375,000 to join one of Dr Burzynski’s clinical trials. The family’s fundraising appeal was covered by the NZ Herald in early March under the headline: “Hope for toddler with rare tumour”.

So what are antineoplastins and why is a clinical trial at the Burzynski clinic so expensive? Let’s start with those ‘pioneering’ antineoplastins. Might they be the next big thing in the treatment of cancer? I’m afraid to say that this is unlikely, as it turns out that Dr Burzynski has been trialling antineoplastins for over 35 years and has never produced strong evidence that his approach actually cures patients or increases their chances of long-term survival.

In fact the results of his trials don’t seem to have been published in the peer-reviewed medical literature and the American Cancer Society has gone so far as to recommend that people don’t spend their money on antineoplastin therapy. Dr Burzynski coined the phrase to describe a group of peptides that he identified first in human blood and then in urine and which he claimed to be “natural, non-toxic compounds that cure cancer”.

It turns out that the peptides can also be made by the body metabolising the drug sodium phenylbutyrate, which is how Dr Burzynski has been administering them for several decades now. Rather alarmingly, each 500 mg tablet of sodium phenylbutyrate contains approximately 62 mg sodium, meaning there is considerable risk of side effects including lethargy, weakness, irritability, seizures, coma and even death.

So if antineoplastins are just the by-product of sodium phenylbutyrate, why are Dr Burzynski’s clinical trials so expensive? After all, patients don’t usually have to pay hundreds of thousands of dollars to join a clinical trial. Sometimes they might even be reimbursed for taking part! It turns out that Dr Burzynski doesn’t just treat patients with his ‘antineoplastins’ anymore. Instead, he seems to be exploiting a very legitimate trend in real cancer therapy, often referred to as personalised medicine. Here patients are tested for particular disease markers which have been shown to respond to specific therapies. Orac, of the Respectful Insolence blog, has described Dr Burzynski’s “Personalized Gene Targeted Cancer Therapy” approach as “throwing everything but the kitchen sink” at the tumours. In fact, Dr Burzynski’s personalised therapy is part of a complaint against him by the Texas Medical Board, which is currently awaiting a hearing date. The complaint describes Dr Burzynski’s treatment of a patient with metastasised breast cancer, which included prescribing sodium phenylbutyrate with another four very expensive immunotherapy agents, none of which are approved for the treatment of breast cancer, and in combination with a chemotherapy agent.

In fact, it also transpires that Dr Burzynski owns the pharmacy that supplies the drugs he prescribes. His pharmacy is also accused of overcharging for drugs. A former patient, Lola Quinlan, has filed a lawsuit, claiming Dr Burzynski swindled her out of nearly $100,000 by using false and misleading tactics, including charging $500 per pill for drugs that could be bought elsewhere for a fraction of that price. And as well as the cost of drugs, there are his consultation fees, listed on one potential patient’s blog as:

  • Review of medical records prior to commencing treatment – $500
  • Initial consultation appointment – $1,000
  • “Genetic Tumor Markers” test – $4,000
  • Monthly treatment fee (with treatment suggested to last 4 to 12 months) – $4,500 – $6,000

All of which might explain why Dr Burzynski lives in a mansion with his initials in gold on the gates! But none of this was covered in the NZ Herald article. Don’t those being asked to donate deserve to know where their money is going? Instead, my emails to the journalist remain unanswered and Letter to the Editor unpublished. And the Bessant family continue to raise funds to send their child to be treated by a man who is accused by the Texas Medical Board of “unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public”. Pioneering? More like profiteering, if you ask me.

Newsfront

Scientologists get government money

A drug awareness programme run by the Church of Scientology has received government funding to spread its views through schools and community groups (Sunday Star Times, 19 February(.

“Drug-free ambassadors” linked to the church have distributed 130,000 drug education booklets around New Zealand, paid for in part by the Department of Internal Affairs’ Community Organisations Grant Scheme. The ambassadors claim at least 18 community groups – including Maori Wardens, one of whom is also an ambassador – and at least seven high schools, endorse and use the materials.

The pamphlets are based on L Ron Hubbard’s ideas on self-improvement through purging oneself of painful experiences.

NZ Drug Foundation executive director Ross Bell called the information flawed pseudo-science which could prove harmful to youth. “This kind of quackery should not be in our schools ” we are talking about young people’s lives,” he said.

Other critics, including former Scientologists, say the drug-free ambassadors are a front group aimed at recruitment which does not openly disclose its ties to the church. The group, which has various aliases, has also come under fire overseas, including in Australia where its links to the government were described as “worrying”.

Scientology New Zealand listed its income for 2010 as $1.2 million. Drug-Free Ambassadors had an income of approximately $6700, of which $6500 was grants.

Green MP Kevin Hague said any funding given to a group that was a front for the church should be stopped. “In the case of someone who is struggling with drugs, they are very vulnerable. So their exploitation by the church for their own ends is despicable.”

Former Skeptic editor dies

Owen McShane, who was editor of the NZ Skeptic from 1994 to 1997, has died, aged 70 (National Business Review, 7 March).

Owen was a longstanding member of the NZ Skeptics and had a regular column in the NBR. He died suddenly at his home in Kaiwaka near Kaipara Harbour, not long after recent heart surgery.

NBR editor Nevil Gibson writes that Owen’s early career encompassed town planning, urban economics and public policy, and he turned to venture capitalism in the 1970s. More recently he established the Centre for Resource Management, a one-man think tank that advocated a laissez-faire approach to environmental and planning issues. Nonetheless he saw himself as an enthusiastic environmentalist, advocating a “gourmet culture” for small land-holders, and putting his ideas into practice on his own property.

Owen wrote and published extensively on a wide range of issues. He was a columnist for Metro from 1983-94 and launched his own magazine, Straight Thinking, in 1994.

He appeared regularly at resource consent hearings after the passing of the Resource Management Act, on which he was a consultant, fighting against what he saw as destructive planning practices such as “smart growth”.

In 1996, he wrote an important report for the Reserve Bank on how planning rules contributed to the high costs of land for residential building – an issue on which the minister for the environment commissioned a further report in 1998.

He was a member of the committee that recommended casinos be established in New Zealand, a member of the Auckland Area Health Board, and was, says Gibson, a sought-after speaker for local and overseas conferences.

Jesus cures cancer?

A Napier church has raised the ire of locals with a billboard stating “Jesus heals cancer” ( NZ Herald, 28 February).

The Equippers Church in Tamatea claims six people have been healed, but Jody and Bevan Condin, whose three-year-old son Toby has leukaemia, said the billboard made their blood boil.

“I was disgusted, I was absolutely disgusted, and I felt quite sick,” said Mrs Condin. “The sign shows no understanding and compassion for people who have journeyed through cancer and lost loved ones.”

Senior minister Lyle Penisula (yes, that’s his real name) said with the exception of one person, he did not believe the sign was causing offence, so saw no reason to remove it.

The sign may, however, have breached the Advertising Standards Authority’s codes ( NZ Herald, 29 February).

The authority said it would take about 25 days to process the complaint. Before that, however, the church modified the sign (NZ Herald, 7 March). It now reads “Jesus heals every sickness and every disease – Matthew 4:23”.

Jody Condin said she felt the replacement was still misleading. She had watched an Equippers church-goer on television explaining his belief the church had helped cure his cancer, but felt he came across as believing his religion had mainly helped him spiritually.

“He’d had surgery and medication so how does he actually know that Jesus healed him?”

Ms Condin has received emails and phone calls from fellow supporters across the country, some of whom had lost loved ones to cancer.

Mr Penisula said religious advertising and freedom of speech were vital components of a democratic society and the measure ‘truth in advertising’ could not and should not apply for faith-based or religious advertising.

Kiwis big believers in homeopathy

Fifty-one percent of New Zealanders believe homeopathy is scientifically proven, but probably have no understanding of what is, according to a UMR study (The Press, 23 January).

Dr Shaun Holt said homeopathy was based on “nonsensical” theories, and could venture into the bizarre, with materials used in preparations that included mobile phone radiation, whale song and dog testes.

The research showed 59 percent of women and 59 percent of people living in rural areas believed homeopathy was scientifically proven. Under 30-year-olds (37 percent) and Asians (35 percent) were less inclined to believe that this was the case.

UMR Research Director Gavin White said it seemed likely many New Zealanders understood the term ‘homeopathy’ to include a much broader range of natural remedies.

Holt agreed with this explanation. “In general people don’t know what it is. They get it confused with naturopathy. It’s not just members of the public it’s doctors as well.”

However, he would fall short of banning homeopathy. He said homeopaths often had long consultations with patients which made them feel good.

Earthquake adds to ‘hypersensitivity’ problem

A Christchurch woman who claims to suffer from something called electromagnetic hypersensitivity has been sleeping out of doors because of repairs in her earthquake-damaged street (The Press, 17 February).

Anne Gastinger has symptoms including migraines and insomnia, which she attributes to electromagnetic waves and allergies to a range of substances, including treated wood. The symptoms worsened in April last year when overhead powerlines were installed because of damage to underground cables.

Her house had been adapted to avoid triggering the allergies and she hoped to relocate it because it was undamaged. However, covenants on new subdivisions and no policy on buying back houses from the Government made that unlikely, she said.

She rarely spoke about the condition because it was not an acknowledged diagnosis in New Zealand, although a Christchurch GP had provided a medical certificate confirming her symptoms.

In an article on the Organic NZ website in 2010, Anne Gastinger wrote that “leading scientists” claim wifi poses potentially serious health hazards, and that children are the most vulnerable in our community. “Opponents of wifi believe that from the moment it is switched on an odourless, invisible, silent, energetic form of air pollution is introduced into our environment.”

Newsfront

Top scientist turns to alternative medicine

Prominent physicist and science commentator Sir Paul Callaghan is resorting to vitamin C megadoses and Chinese medicine to treat his terminal cancer (Dominion Post, 22 September).
Diagnosed in 2008 with aggressive bowel cancer, he has been advised by his oncologist to take a break from chemotherapy to establish the full extent of the cancer’s spread. He is using the time to trial “unproven but interesting” therapies, including traditional Chinese medicine, intravenous vitamin C and “Uncle CC’s famous vegetable juice”.

“Let me be clear. I do not deviate one step from my trust in evidence-based medicine,” Sir Paul said in his blog. However, if there was a potentially effective but unproven drug, “Why would I not try it?” he reasoned. “Am I mad? Probably.”

Victoria University’s Professor Shaun Holt said he could understand terminal cancer patients clutching at straws, but there was no evidence to support vitamin C treatment. It could be harmful, causing kidney problems and interfering with effective treatments such as radiation therapy.

He was concerned Sir Paul’s use of the treatment would further increase the already high number of cancer and leukaemia patients asking for the injections.

GG swears by homeopathy

Another high-profile New Zealander expressing interest in alternative therapies recently was new Governor-General Sir Jerry Mateparae The 56-year-old revealed in an interview (Dominion Post, 2 September( he and his wife Janine, Lady Mateparae shared an interest in homeopathy.
He said he had not taken a sick day since 1998. “We’ve practised a certain way of looking after ourselves which has been very good for me.”

Perhaps he feels it’s part of the job, given his position as the Queen’s representative in New Zealand, and the royal family’s well-known interest in the field.

Blogger John Pagani commented: “Placebos get you quite a long way, but only so far. After that you need actual medicine. If a soldier gets shot up on a battlefield in, say, Afghanistan, he doesn’t want Sir Jerry rubbing arnica cream on the sore bit.”

Divine solution to liquefaction

A Sefton water diviner believes he has the solution to Canterbury’s liquefaction problems (Central South Island Farmer, 7 September).

Dave Penney says he can identify underground water flows by running a crystal over a Google map, followed by on-site investigation. While the article quoted one happy customer, Waimakariri utilities manager Gary Boot was unconvinced by Penney’s proposal that “confluences” of underground flows could be located and drilled, to reduce pressure and stabilise the land. Areas with the worst liquefaction had widespread and very consistent groundwater, Mr Boot said.

“Finding the groundwater is not the challenge. The challenge is how best to treat the land in an affordable manner.”

iPhone trumps psychic

Chilean authorities have used a psychic to help find 17 missing bodies after the crash of a plane near Robinson Crusoe Island killed all 21 people on board (NZ Herald, 6 September).
“Not only are we using all of our technological capabilities, but also all the human and superhuman abilities that may exist,” said Defence Minister Andres Allemand.

He did, however, seek to lower expectations of recovering all the bodies.

The plane’s fuselage was located a few days later, in part using information from a passenger’s iPhone, which transmitted its location shortly before the crash (AVweb, 9 September). Now if only psychics were as smart as iPhones.

Spontaneous Human Combustion in Ireland?

An Irish coroner has ruled a pensioner found dead at home was a case of spontaneous human combustion (NZ Herald, 25 September).

Unsurprisingly, given the history of this phenomenon, 76-year-old Michael Faherty’s charred remains were found on the floor near an open fireplace. Forensic experts concluded the fire was not the cause of the blaze, and that there were no accelerants at the scene. The only damage to the room was a scorched ceiling and floor adjacent to the body.

The case sounds like a classic of its type: an elderly diabetic with presumably limited mobility is found next to an open fire, with his body consumed but his head left unburned. In 1998 scientists on the British TV programme QED (available from the NZ Skeptics video library( showed how this happens, using a pig carcass wrapped in fabric to simulate the victim. An ember spat from the fire catches in clothing and starts to burn; the fire is then fed by fat from the victim (who has already died of a heart attack, or is about to due to the stress of finding himself alight) as it melts and ‘wicks’ into the clothing. The head, lacking a decent supply of fat, remains unscathed, and any sign of heart disease or other pathology is burned away. QED, indeed.

Medium caught cheating

Sally Morgan, who styles herself “Britain’s best-loved psychic” has been caught receiving outside information during one of her shows (The Guardian, 20 September).

Chris French, editor of UK magazine The Skeptic, relates how an audience member named Sue reported on an Irish radio station how she had been impressed by Morgan’s accuracy during the first half of her performance.

“But then something odd happened. Sue was sitting in the back row on the fourth level of the theatre and there was a small room behind her (‘like a projection room’) with a window open. Sue and her companions became aware of a man’s voice and ‘everything that the man was saying, the psychic was saying it 10 seconds later.'”

Other callers to the radio show confirmed Sue’s account.

Sue said she believed the man was feeding information to Morgan via a microphone. The voice would say something like “David, pain in the back, passed quickly”, and a few seconds later Morgan would have the spirit of a David on stage with just those attributes. When a member of staff realised several people were aware of the voice the window was gently closed.

Sue speculated that information had been gathered in the foyer prior to the show by an accomplice engaging audience members in conversation, a technique French says ‘psychics’ use widely, as their marks naturally discuss among themselves who they are hoping to hear from.

The theatre’s general manager claimed the voice came from two theatre staff members. Sally Morgan Enterprises also denied that the medium was being fed information during the show.

French compared the incident to James Randi’s use of a radio scanner to pick up messages sent to faith healer Peter Popoff’s earpiece in 1986, the subject of an entertaining YouTube video clip. Although his exposure led to him declaring bankruptcy the following year, Popoff is back; his ‘ministry’ received US$23 million in 2005. History suggests, says French, that most of Morgan’s followers will continue to adore her and pay the high prices demanded to see her in action, despite this incident.

Ring again

Just one more small piece on Ken Ring then no more, I swear. Despite promises to get out of the earthquake prediction business, he was in Upper Hutt recently declaring Wellington could expect a magnitude 7 quake some time between 2013 and 2016 (Upper Hutt Leader, 5 October).

Of course, predicting earthquakes in Wellington is a bit like predicting drought in the Sahara, and a four-year timeframe is a bit vague, to say the least. He says Wellington gets magnitude 7 quakes every 11 to 13 years (really?) and this period is when the next one is due.

I guess any half-way decent shake in the next eight years or so will be put down as a hit, and if nothing comes along before the end of 2016, who’s going to remember what he said in the Upper Hutt Library in October 2011? How can he lose?

Orthodoxy? – Revisiting the Cartwright Report (Part 2)

NZ Skeptic issues 96, 97 and 98 contained articles presenting different viewpoints on the ‘Unfortunate Experiment’ at National Women’s Hospital and its aftermath. Wellington registered nurse and NZ Skeptics treasurer Michelle Coffey continues the discussion in this web-only special.

When I wrote my original article (NZ Skeptic 97), it was written with the intention that it could stand alone as a more thorough discussion of the findings of the Cartwright Report and later research. This was because there were a number of important issues raised as a result of the report which have been almost lost in the debate, many of them systemic ones. While I’m sure that readers interested enough can source the relevant material and judge for themselves, in Skeptic 98, Linda Bryder has responded and the statements made merit a response to clarify several points. I referenced the Bryder’s book for a complete review of the topic, but did not address it in the original article as while it does deal with aspects of the ‘Unfortunate Experiment’ the book ultimately fails to provide any complete assessment of the matter due to the book omitting to investigate key figures such as McIndoe or dealing with the health care system (in particular it’s politics) as opposed to social movements.

1. “There was no medical certainty about the proportion of cases of CIS…”

None of the references support the contention that there was no medical certainty about the proportion of CIS cases that would advance to invasion, and in any case proportion of cases isn’t the point – it’s whether CIS was considered to be a precursor of invasive cancer. This appears to be the case. In the Cartwright Report1 (p23) a compilation of studies was introduced into evidence giving figures that indicate over time, a significant proportion would progress to invasion.

The 1976 Editorial2 cited is discussing screening and states “The report faces up to the problems which still cause fierce controversy – those of the natural progression and regression of early lesions, the discrepancy between total [CIS] cases and the combined number of number of clinical invasive cases, and the incidence and mortality rates.” The Walden Report3 it is referring to states unequivocally that “The significance of [CIS] as a precursor of invasive disease has been recognised for more than 3 decades. Several series of patients, followed for months or years, have demonstrated progression from [CIS] to invasive disease at rates ranging from 25 to 70%.” The issue of where earlier dysplastic changes fit appears to be where any “controversy” laid rather than the concept of progression from pre-invasive lesion to invasion. The report placed these earlier changes a decade or so prior to invasive disease as a precursor state stating “the concept that progressive degrees of cervical dysplasia are part of the natural history of neoplastic disease of the cervix now seems firm.” This is relevant to developing a screening programme given that there is a window of many years in which the condition could be detected and treated. Ostor4 in his statement “The ultimate fate of patients with CIN is the most controversial issue facing investigators interested in cervical neoplasia.” is discussing similar issues to that discussed in the Walden report which is relevant in terms of assessing the relevance of findings and being able to predict the behaviour of these ‘atypias’. Most studies ended at the point of CIS. Ostor looked at not only progression to invasion but the likelihood of regression, persistence and progression to CIN3 (11% in the case of CIN1) with the conclusion that the probability of invasion increases with severity of dysplasia, but there is potential for regression which reflects on therapy.

One man’s dysplasia is another man’s carcinoma #40;notably without insertions to influence the reader to place a particular meaning on it) is a statement that crops up frequently. One issue is the correlation between cytology and histological confirmation, while this wasn’t perfect it was generally agreed that smears could reliably indicate an existing lesion. Histological confirmation was required, but there could be a lack of agreement between pathologists and laboratories on the histological criteria meaning that the precise differentiation between dysplasia and CIS varied. These uncertainties don’t seem to have impacted on the confidence of pathologists regarding screening for cervical malignancies and grading of a lesion was seen by surgical pathologists as more a statement of probability of progression which had limited applicability in clinical management as noted in Löwy’s history5. The precise definition didn’t matter as much as understanding that it was the same disease that was being managed. This is nothing other than a fairly typical debate as biology and medicine rarely, if ever, give certainties.

1. ” Coffey cites 1958 ” official policy… to show this.”

It’s important to note for clarity that there could be variation in policies in other areas but what is more critical in this case was policy at NWH, the hospital where Green practised which set the standard of care. Policies at NWH evolved over a period of time. In 1955 the formation of a cancer team to which all cases of carcinoma of the cervix were to be referred to for treatment was unanimously supported. Over the next ten years, policies regarding the diagnosis and treatment of CIS and invasive cancer were regularly reviewed. This wasn’t just agreed to at a meeting of “…only nine senior consultants…”the decision was made a formal meeting of the Hospital Medical Committee, with a majority which indicates that the committee was happy with the level of evidence for the policy. The clear majority and evolving policy don’t seem to fit too well with the narrative that there was considerable medical uncertainty and controversy about CIS and its progression.

2. “Professor Barbara Heslop explained this more appropriately…”

Heslop’s6 article is one to which I referred to in writing my article as I found some aspects of it informative. However, it is based in the opinions of the author so it’s unsafe to use this article to make certain statements about Green. Heslop considers that Green was doing research but seeks to place this in context stating “Herb Green aimed to ‘prove’ his hypothesis by carefully observing that dysplasia did not lead to cancer…Unfortunately, the proposed methodology was equally appropriate for showing dysplasia did lead to cancer. Paradoxically, and I am sure unintentionally, he ended up demonstrating…more convincingly than had been done before, the transition of dysplasia to cancer.” It was demonstrable that Green considered his work as a study initiated to test a theory and his 1974 paper said (p65) “This…represents the nearest approach yet to the classical method of deciding such an issue as the change or not of a disease from one state to another – the randomised controlled trial. It has not been randomised and it is not well controlled but it has at least been prospective…”

While Baker may have had the presumption that the therapeutic relationship would predominate, little suggests this happening in the case of Green. Whether he knew about such things as falsifiability, Green set out to prove his ‘dormant cancer’ idea despite indications early on that following such patients was unsafe (such as three cases of invasive disease in patients followed with positive cytology occurring by 1969). If the therapeutic relationship was predominant, those cases should have prompted reconsideration of the hypothesis; instead they were reclassified and removed from the study.

3. The 1966 management protocol was to “extend” conservative treatment…”

What seems to be being said here is that under 35 doesn’t mean that, but that it means older patients can be included as well. It should mean what it says as this was a safeguard intended to protect patients which Green then breached. When aging occurs, physiological changes mean it is more difficult to view areas of abnormality and Green and his colleagues were aware of this and the additional risks. The report (p37) stated “As a woman gets older, the squamocolumnar junction is more likely to lie in the endocervical canal and therefore be invisible to the colposcopist.” This means that it can’t be determined whether lesions extending further are suspicious and it was impossible to get a sample without a cone biopsy. Older women were more likely to have unsuspected invasive carcinoma. The use of words like treat is misleading as the intention was not to extend conservative treatment, but to monitor women with positive cytology to fulfil the aim of the proposal. As an example the proposal stipulated punch biopsies and used the word treat and treated (p 21 “four have been treated by punch biopsy alone.”) however this was regarded as a diagnostic procedure. The only way a punch biopsy could be a ‘treatment’ is if somehow by accident or design, the biopsy managed to obliterate a small lesion.

4. “Coffey presents this as a negative outcome, as if it was unnecessary outcome for the women.”

It was. There is a difference between ongoing monitoring which often can be done at primary care level and repeated attendances at a hospital over many years for multiple tests and interventions. Patient 4M (p44) was first admitted in 1970 with abnormal smears. In between 1970 and 1983 she had 38 appointments and six biopsies (wedge, ring, cone, surface) were performed with two occasions being histologically incomplete. A review of patient notes (p42) showed many women had more than one cone biopsy and in some cases up to six. Testimony showed that doing this more than twice was not considered unless under exceptional circumstances and doing this procedure could have effects such as stenosis or haemorrhage and make later evaluation difficult. Bonham testified that this was a dangerous practice and with the third or fourth conisation, it was probably a greater risk than hysterectomy.

Nothing in medicine is benign, and there are obligations to treat patients ethically. This includes minimising as far as possible unnecessary medical procedures as there are a number of risks entailed every time intervention is made. In a condition as treatable as CIS that could have been simply excised that means that over a period of time many women had a number of procedures that were unnecessary and posed excess risk to them that still left them with positive cytology resulting in risk of progression with its own complications. The associated disruption, pain and discomfort of these multiple interventions shouldn’t be trivialised.

5. Regarding the infant vaginal swabs, a press release by Judge Cartwright’s counsel stated “Mothers were told of the tests.”

Any kind of consent would have sufficed. Judge Cartwright stated (p141) “&#8230 there was no provision made to comply with the fundamental requirement that children are not included in research with the consent of their guardians.” This was not a test but a trial and was non-therapeutic research that held no benefit for the infant. Green quickly realised after 200 babies had undergone the procedure that it was a waste of time and lost interest in the study without communicating this to the nursing staff leading to over 2000 babies being subjected to an unnecessary and potentially harmful vaginal vault smear for the purposes of research without the consent of their parent or guardian.

With randomisation of Green’s 1972 “R series” radiotherapy and hysterectomy trial it is difficult to see that it conformed to international practice. Randomisation is aimed at preventing systematic differences between groups and preventing bias but in this case, the selection criteria were made in advance but there was no allocation of patients prior to anaesthesia, grading and decision on surgical treatment so no concealment. Enrolment could have been influenced by biases such as the need to enrol sufficient patients into the study along with the potential for further bias to be added with the use of coin tossing. The patients were not given any opportunity to consent, and were mislead about the treatment decision. Testimony on p170 states “Dr Green and myself and others discussed this question of informing women in the trial about it when it was initiated in 1972. We decided in the end not to tell patients about the trial. We told them they would be examined under anaesthetic when the most appropriate mode of treatment would be decided and then we would proceed accordingly.”

I can contrast this lack of any kind of consent from the parents or “R series” patients with the oral consent obtained by Sir Liley for his intra-uterine infusions where he sufficiently informed the patient of the possible risks and that the treatment was experimental. His case study published in 19637 states “the patient and her husband were an intelligent couple, and the prognosis for the foetus, the possibility and uncertainty of intrauterine transfusion, and the potential hazards to the mother were fully explained to and discussed with them.” This was not the case with Green and his research projects, as no real attempt was made to provide any kind of informed consent.

6. “Despite writing this, Coffey herself makes it clear that the two groups…had nothing to do with the two groups whose records Green analysed.”

This is an assertion and no reason is given as to why you state this. As such, there is nothing there to counter other than to say they had everything to do with those groups. McIndoe et al8 was retrospective while Green’s research was prospective, which made a difference in how the study was conducted but they were measuring the same thing as Green’s 1974 paper (p65) describes: “This series of 750 cases of in situ cervical cancer, and the following of 96 of them with positive cytology for at least two years…” The McIndoe paper was also a comparison of two groups of women, one with normal follow-up cytology and one without and was the final paper that Green never wrote that completed follow-up on the patients that were the subjects of his study. In my discussion, I highlighted the summary in the paper of patients who were included in the punch biopsy special series and that alone should make it clear the relationship between the “special series” and the study. I’m sure if Green could have asserted the same he would have, but couldn’t. The report didn’t rest on this paper alone but reviewed 1200 patient files and 226 were used as exhibits.

7. “Cartwright accepted this as “accurately reflect[ing] the findings of the 1984 McIndoe paper.”

Except Judge Cartwright did not. This is selective quotation that distorts the statements in the report and falls short of what you would expect from an historian whom you would expect to take care to fairly represent the context and statements in documents. The statement is from Ch4 “Expressions of Concern” where the article is addressed as it was the subject of public comment and had prompted the Hospital Board to request an inquiry. This put the article under scrutiny and criticism by some witnesses. Under the title “Was the magazine article accurate?” It is stated that the manuscript was submitted and editorial changes explained but there were some errors in the article that was finally published. This section states:

1.Significant editorial changes: The matter of accuracy was raised firstly by the authors themselves. In her evidence Sandra Coney drew attention to two editing changes which she considered substantially altered the meaning of sentences in the magazine article.

a. “Twelve of the total number of women had died from invasive cancer as had four, or 0.5%, of the group-one women, and eight, or 6% of the group-two women who had limited or no treatment.”

In the original manuscript the authors had written: “Twelve of the total number of women died from invasive carcinoma. Four (0.5%) of the Group-one women, and eight (6%) of the Group-two women who had limited or no treatment. Thus women in the limited treatment group were twelve times more likely to die as the fully treated group.”

I accept that the unedited material more accurately reflects the findings of the 1984 McIndoe paper. The edited version is not accurate.

It’s clear when looked in context that the statement was sourced from the original manuscript of the article and those words cannot be attributed to Cartwright. Cartwright is accepting that the original manuscript more accurately reflected the findings of the paper and is being misquoted to say something else. It is of note that in Bryder9 p33 that this statement is used to say “Cartwright too suggested differential treatment. In her report she quoted Coney and Bunkle’s statement that: ‘Twelve of the total number of women died from invasive carcinoma… [etc]” Cartwright accepted that this accurately reflected the findings of the 1984 McIndoe paper.” This statement is again used misleading to say something other than what it actually says and is being used inconsistently.

8.“How had they “returned to negative cytology”

McIndoe did not say treatment did not enter the study. The citation in Bryder used to reference this says only “The detailed management of patients is not under consideration in this paper…” The paper looks at the initial management and in some cases more detailed management of patients as Bryder would be aware. Here, it does become evident that there were differences, for instance in group 1 cone biopsies excision was incomplete in 24%, but in group 2, 74% were incomplete with the difference likely to be largely due to management where complete excision is not a necessity. The paper states “…any examination of the natural history of CIS of the cervix must depend on a representative, though incomplete, biopsy specimen on which to base the initial diagnosis. Thereafter, meticulous long-term follow-up of all patients using techniques such as clinical examination, cytology, and colposcopy, and if indicated biopsy, is required.” The paper detailed some limitations, such as small biopsies or possibly trauma eradicating lesions, or inadequate biopsies missing abnormalities. So in answer to that question, it was because initial management in group 1 patients either intentionally or unintentionally was adequate in treating the lesion and restoring them to negative cytology. Of this group only 0.7% had recurrence of CIS. In group 2, follow-up showed continuing positive cytology after initial management either by limited biopsy or incomplete treatment which was ideal for studying the natural history of CIS as set out in the 1966 proposal.

9. “Coffey refers to the 1986 paper…as critical of conservative treatment…”

This paper10 was only briefly mentioned before moving on with discussion of McIndoe et al as there was insufficient space to deal with it in detail. Here long term follow-up of vulvar carcinoma shows that of 31 patients managed by surgical excision, there were 4 recurrences and one developed a vulvar carcinoma 17 years later. 4 women managed only by biopsy progressed to invasion in 2-8 years and one additional patient managed with incomplete excision after a lengthy period of observation progressed to invasion. The paper demonstrated that untreated lesions have significant invasive potential. This approach was an extension of Green’s study of CIS of the cervix, and in this case a biopsy cannot be considered treatment at all. While the authors were advocating conservative treatment this was excision of the lesion not biopsies or incomplete excision.

10.“Would a modern gynaecologist agree with this assessment?”

The relevant sentence is presented as a statement, but it omits a significant portion of the sentence which is “This needs to be explained, as those figures strongly suggest the progression of CIS to invasion when it is and was a totally curable lesion.” Gynaecologists would accept the statement that CIS is a curable lesion which can be readily treated with a variety of local destructive methods with complete removal of the lesion and reversion to negative cytology which then prevents the risk of the lesion progressing. In the quoted statement McIndoe et al is referring to group 1 patients, whose cytology had returned to normal. It states “However, contrary to what would be expected, of the 139 group 1 patients with incomplete excision of the original lesion, only five (3.5%) later developed invasive carcinoma. Thus whether or not the lesion is completely excised does not appear to influence the possibility of invasion occurring subsequently.” In this case it didn’t, the rate of recurrence was unexpectedly small probably due to the initial intervention influencing the condition.

Treatment of a diagnosed lesion is then conflated with cervical cancer at a population level in asking for an explanation of why cervical cancer hasn’t been completely eliminated. In an ideal world this might be possible, but in the real world there are a number of difficulties to be faced in ensuring the entire population at risk is screened and treated if necessary. Green’s conclusion was that screening was not effective, however the conclusion was unjustified. The report discusses this on page 56 and crucially treatment needs to improve the prognosis as if subsequent cases are not adequately treated there is little value in screening in the first place. Also, if screening is done in low risk cases and high risk populations are missed, that means screening will be limited in being able to affect morbidity and mortality. In McIndoe et al, the age-standardised incidence of invasive carcinoma in group 2 was 1141/100,000 compared with 18.2/100,000 in the general population in 1975. This has since dropped considerably.

11. “As stated above, group 1 and group 2 had a similar range of treatments…”

My statements stand on this matter that “this ignores that while many women were treated with various procedures, there was evidence of continuing disease, demonstrating that the intervention was inadequate. This was not followed up, posing a high risk of development of invasive disease.” To prove that CIS is not a premalignant disease necessitated the area is sampled for diagnosis, but done in a way that left the lesion available for further study. In some cases there was no treatment, for instance the punch biopsy series which only used a diagnostic method. The criteria included that “the colpscopically-significant area is large enough not to be completely excised by the diagnostic punch biopsy.” The intention was to leave the lesion as undisturbed as possible. The use of cone biopsy is covered in q 5 and 9 as this could also be diagnostic. Of the hysterectomy series, only 4 out of 25 had the procedure for CIS so the procedure was done but not often specifically for CIS. Either way, women were left with positive cytology which put them at risk.

12. ” The methodology of the 2008 paper has been questioned by Sandercock and Burls…”

I would be embarrassed to cite this letter11 as an example of “questioning”. Every paper is flawed to a degree but this isn’t the right criticism to make. They cite a secondary source and claim this explains what they say is a problem with McIndoe et al – “He points out that, not only were the two group retrospectively divided on the basis of persistent abnormal cytology during follow-up and not prospectively as experimental groups for the comparison of different treatment strategies…” They misread the letter12 which does not appear to state anything regarding type of study and apparently draw from Overton’s misleading statement that “…Green and other senior NWH clinicians endorsed policy changes in dysplasia management. Younger women were to be continuously monitored, by repeat smears, colposcopy, lesser biopsies and appropriate more major surgery if evidence of early cancer.” which omits mention of Green’s role and his published studies. Sandercock and Burls then make an erroneous conclusion that McIndoe’s research should have been prospective and be following different treatments without realising that prospective research had already been done by Green. They cannot have read McIndoe et al despite citing the paper otherwise they would have seen the paper outlined the 1966 proposal. A few minutes reading would have shown the difference in between the statements which if they were honestly critiquing the study they should have checked.

Sandercock and Burls then claim a similar “problem” with McCredie et al even though they are aware it was retrospective. This might be correct to say for prospective studies that ask a question and look forward such as Green’s as this type of study should assess outcomes relative to interventions but retrospective studies are meant to pose a question and then look back. McIndoe et al looked at the question of outcomes for patients with CIS with the patient groups defined by presence of positive or negative cytology which categorised according to the risk they had persistent disease. McCredie13 takes this a step further with the approach being to look at the question of outcomes for patient groups classified by management that was adequate or inadequate. There is no problem with this approach; the problem lies with Sandercock and Burls.

13. “…It should be noted a study on outcomes cannot make such pronouncements…”

It can however tell a story, one that is further strengthened by understanding what the author is trying to achieve. Papers are meant to be considered in the light of all the evidence and that includes context. McCredie et al shows half the cancers in women initially managed with punch/wedge biopsy were diagnosed within 5 years of a finding of CIN3. It can be judged objectively there that merely doing a diagnostic procedure in patients with CIN3 leads to a high risk of developing cancer in a relatively short period of time, while the context shows up much more and shows the unethical nature of the original research which meant they were managed in that manner.

14. “Yet Green’s achievement was to encourage an openness to look at the evidence.”

Which story is it that is being referred to? The one where there is a controversy in medicine? If so, he wasn’t the spirited free-thinker he is being cast as. If it is the one where Green was the controversial one, willing to question modern medicine then the controversy wasn’t in medicine. If he is going to be cast as Galileo type of figure, persecuted for his heresy, the critical point is that Galileo was proven correct. So where are his papers? Even his supporters never present his papers to support their claims. Their resort is to complain about everything else.

Green’s ‘achievement’ was the reverse. On p108 of the report, in an Auckland Star article in 1972 it was reported that “Professor Green asserted that a woman with a positive cervical smear showing what is called [CIS] is no more likely to develop invasive or malignant cancer of the cervix than any other woman of the same age. In other words, in situ cancer is not a forerunner of invasive cancer, and the smear test is over-rated.” There is no shift in attitude over time, despite that over the years, much more would have been studied on the matter and medical practice would have changed. Green’s set views were taught, leading to Registrars and other staff being under the impression that screening for cancer precursors was a waste of time. Apparently he kept an Ogden Nash quotation on his blackboard for many years saying “My mind is made up – don’t confuse me with the facts”. None of this shows any willingness to debate the evidence; on the contrary when faced with evidence of patients with invasive cancer that he had originally diagnosed with CIS though not a trained pathologist, he reclassified them and excluded them from the study. They did not fit, so he changed the evidence to suit his theory. True scepticism is not about holding an idea or defending a position but about being open to the evidence and being willing to examine it and change if necessary. Hitting on the hard edges of scientific debate is a tough experience but it serves no one if the record is distorted to hold an untenable position and legitimate questioning of this is taken to be persecution instead of honestly examining whether the position is, in fact, a correct one to hold.

References

  1. “The Cartwright Report”: http://www.nsu.govt.nz/current-nsu-programmes/3233.asp
  2. “Screening for cervical cancer” 1976: BMJ 659-60
  3. The Walden Report: June 5, 1976: CMA Journal Vol. 114 1003-1012
  4. Ostor, AG 1993: Intern. J. Gyn. Path. 12, 2, 186-92
  5. Lowy, I July 2010 Historia, Ciencias, Saude – Manguinhos V. 17, supl. 1, 53-67
  6. Heslop, B 2004: NZMJ 117,1199
  7. Liley, A.W. 2 November 1963: BMJ Vol 2, Issue 5365 1107-1108
  8. McIndoe, WA; McLean, MR; Jones, RW; Mullins, PR 1984: Obstet Gynecol. 64, 4, 454.
  9. Bryder, L 2009: A history of the ‘Unfortunate Experiment’ at National Women’s Hospital, Auckland University Press, Auckland
  10. Jones, RW; McLean, MR; 1986: Obstet Gynecol. 68, 4, 499-503.
  11. Sandercock, J. Burls, A. 2010, NZMJ 123, 1320
  12. Overton, G.H. 2010, NZMJ 123, 1319
  13. McCredie, M. 2010, NZMJ 123, 1321

The Unfortunate Experiment: Revisiting the Cartwright Report

This article is a response to ‘Truth is the daughter of time, and not of authority’: Aspects of the Cartwright Affair by Martin Wallace, NZ Skeptic 96.

The Cartwright Inquiry1 was held after the publication of “An Unfortunate Experiment at National Women’s” in Metro magazine in June 1987. The events leading up to the publication of the article and the findings of the subsequent inquiry have been contested ever since.

The inquiry heard from 67 witnesses, many doctors, 84 patients and relatives, and four nurses. In addition, 1200 patient records were reviewed, with 226 used as exhibits. The final report released in August 1988 has had a long-lasting impact. It recommended many changes in the practice of medicine and research, including measures designed to protect patients’ rights and a national cervical screening programme. These have since been implemented. The Medical Council announced in 1990 that four doctors were to face disciplinary charges resulting from the inquiry’s findings of disgraceful conduct and conduct unbecoming a medical practitioner. Charges against Dr Herbert Green were dropped due to ill health.

The report of the Committee of Inquiry has withstood many challenges, including judicial reviews and many articles alleging its findings to be flawed. Yet there have been allegations of a miscarriage of justice, charges of a witch-hunt, even a feminist conspiracy.

Where does this leave Dr McIndoe and others who had mounting concerns for so many years? Why did so many women develop cancer? In this article I will explore the findings of the Cartwright Inquiry, its context, the research and the criticisms, and attempt to find a more nuanced understanding of the “unfortunate experiment” and its ongoing effects. Page numbers in parentheses refer to pages in the Cartwright Report. CIN3 and CIS are interchangeable terms for a lesion of the cervical epithelium which can be a precursor to invasive cancer.

The Findings of the Inquiry

The report found that Green, rather than developing a hypothesis, aimed to prove a point (p 21) that even at the time was known not to be the case. A 1961 compilation of studies from Paris, Copenhagen, Stockholm, Warsaw, and New York showed CIS progressed to invasive cancer in 28.3 percent of cases (p 23). As at 1958 the official policy was “… treatment of carcinoma of the cervix Stage 0, [CIS] should be adequate cone biopsy … provided the immediate follow-up is negative and … the pathologist is satisfied that the cone biopsy has included all the carcinomatous tissue” (p 26). Standard treatment of the time involved excising all affected tissue and the ‘conservative’ treatment of conisation was in use well prior to 1966.

Green’s initial proposal stated “… It is considered that the time has come to diagnose and treat by lesser procedures than hitherto, a selected group of patients with positive (A3-A5) smears. Including the four 1965 cases, there are at present under clinical, colposcopic, and cytological observation, 8 patients who have not had a cone or ring biopsy. All of these continue to have positive smears in which there is no clinical or colposcopic evidence of invasive cancer”… The minutes then record that “… Professor Green said his aim was to attempt to prove that carcinoma-in-situ (CIS) is not a premalignant disease”… (p 22). This appeared to come about because of concern about unnecessarily extensive surgery for CIS between 1949 and 1962. During this period, some centres were beginning to use cone biopsy as effective treatment; however there were limitations to its use (p 27).

There were some questions over whether the work was a research project. The inquiry concluded this was the case and that a research protocol, however flawed, was put in place (p 69). Green published in peer-reviewed journals on his hypothesis and findings. By 1969, three cases of invasive disease had occurred in patients with positive cytology monitored for more than a year, and this should have made it clear that following patients with persistent CIS was unsafe (p 52).

Green then explained those patients by concluding that they’d had invasive cancer that was missed at the outset. The report contends this was dangerous to the patients as it demonstrated that the proposal was incapable of testing the hypothesis. These patients were reclassified by Green and the patients removed from the study (p 55). In addition, patients over the age of 35 were included in the research in breach of the protocol vp 49).

There were many subsequent issues, including lack of patient consent (p 136). Patients also had to return for repeated tests and other invasive procedures, often receiving general anaesthetics in the process (p 42-49). A collection of cervices from foetuses and stillborn infants and another of baby uteri in wax were collected by Green for research which was later abandoned. This did not appear to comply with the Human Tissue Act (1964) as no consent was obtained from the parents of the stillborn infants (p 141).

As part of an earlier 1963 trial to test whether abnormal cytology in women later developing CIS or invasive cancer was present at birth (pp 34 & 140), 2,244 new-born babies had their vaginas swabbed without formal consent from the parents (there was a decision to abandon this trial soon after it started but this wasn’t communicated to nursing staff until 1966).

Procedures such as vaginal examinations and IUD insertions/removals on hysterectomy cases were performed by students without patient knowledge or consent while they were under anaesthetic (p 172). There was a further study on carcinoma of the cervix treatment, where patients either had radiotherapy alone or hysterectomy and radiation (p 170). The method of randomisation was by coin toss.

The Research

The idea that patients were divided into two experimental groups arose from McIndoe et al (1984)2. The patients were divided retrospectively into two groups which overlapped strongly but not completely with groups defined by Green, that he called “special series”. In his 1969 paper, cited in the report (p 40-41) he stated: “The only way to settle the question as to what happens to carcinoma in situ is to follow adequately diagnosed but untreated lesions indefinitely … it is being attempted at NWH by means of 2 series of cases. (I) A group of 27 women … are being followed, without ‘treatment’, by clinical, colposcopic, and cytologic examination after initial histological diagnosis of carcinoma in situ … has been established by punch biopsy … (II) A group of 25 women who have had a hysterectomy (4 for cervical carcinoma in situ) and who now have histologically-proven vaginal carcinoma in situ, has been accumulated …” This was done semi-randomly, with cases presenting themselves fortuitously.

The outcome for the group of 25 who were included in the punch biopsy “special series” was summarised in the McIndoe et al (1984) paper. Nine out of 10 women who were monitored with continuing positive smears developed invasive cancer. Only one out of 15 women who had normal follow-up cytology later developed invasive cancer. While Coney and Bunkle may have made a mistake, it’s clear the judge didn’t. The report states: “Green’s 1966 proposal was not a randomised control trial, but it was experimental research combined with patient care” (p 63).

Green’s interpretation of the data in his 1974 paper is suspect, having concluded that the progression rate was 7-10/750 (0.9 to 1.3 percent) or 6/96 (6.3 percent) of ‘incompletely treated’ lesions (p 54). These were explained by suggesting that either invasive cancer was missed at the start, or over-diagnosed at the end. Dr Jordan (expert witness) deemed this interpretation incorrect as of the 750 cases, 96 had continuing positive cytology, meaning that the other 654 patients could be considered free of disease. Of that 96, 52 patients had not been assessed further, making it impossible to know whether or not this group already had unsuspected invasion. Of the 44 patients remaining with ongoing carcinoma in situ who had more investigations, seven were found with invasive carcinoma. The incidence of known progression was therefore 7/44 (16 percent), which approximates McIndoe et al (1984) findings. This means that the proportion of invasive cancer cases in those inadequately treated was much higher compared with those who had returned to negative cytology, even before any cases where slides were re-read and excluded are considered.

McIndoe et al (1984) covered the follow-up data for 948 patients with a histological diagnosis of CIS patients who had been followed for a minimum of five years; there was a further paper in 1986 regarding CIS of the vulva. The same method used by Dr Green to group women by cytology after diagnosis and treatment was used, but using the correct denominators and the original diagnosis. Patients who were diagnosed with invasive cancer within one year were excluded to avoid the possibility the cancer had been missed initially. The management was cone biopsy or amputation of the cervix in 673 patients, with 250 managed by hysterectomy. The only biopsies in 25 women were punch biopsy (11), wedge preceded by punch biopsy (7) and wedge biopsy alone (7). Twelve out of 817 (1.5 percent) of group 1 patients developed invasive cancer. Given the lengthy follow-up with negative cytology for group 1 patients, the authors concluded these represented the development of new carcinoma. There were marked differences in the completeness of excision between the two groups and the second group shows markedly different results, with 29/131 (22 percent or 24.8-fold higher chance) with positive cytology developing invasive cancer. At 10 years this was 18 percent rising to 36 percent after 20 years, irrespective of the initial management or histologic completeness of excision. This needs to be explained, as those figures strongly suggest the progression of CIS to invasion when it is and was a totally curable lesion. The answer is that a prospective investigation, as done by Green, has to establish that invasive disease is not present, while conserving affected tissue that is required for later study. The argument has been posed that women in the second group did get cone biopsies and hysterectomies. This ignores the fact that while many women were treated with various procedures, there was evidence of continuing disease, demonstrating that the intervention was inadequate. This was not followed up, posing a high risk of development of invasive disease.

This differs from group 1 patients, who were successfully treated at the outset. It’s pertinent to point out that the Cartwright Report did not rely on this study (or the Metro article) to reach its conclusions, but on review of patient records.

There have been two follow-up studies. McCredie et al (2008)3 examined medical records, cytology and histopathology for all women diagnosed with CIN3 between 1955 and 1976, whose treatment was reviewed by judicial inquiry. This paper gave a direct estimate of the rate of progression from CIN3 to invasive cancer. For 143 women that were managed by only punch or wedge biopsy the cumulative incidence was 31.3 percent at 30 years and 50.3 percent in a subgroup who had persistent disease at 24 months.

The cancer risk for 593 women who received adequate treatment and who were treated conventionally for recurrent disease was 0.7 percent at 30 years. These findings support McIndoe et al (1984) and extend the period of follow-up.

McCredie et al (2010)4, described the management and outcomes for women during the period 1965-74 and makes comparisons with women diagnosed 1955-64 and 1975-76. This showed that women diagnosed with CIN3 in 1965-74 were less likely to have treatment with curative intent (51 percent vs 95 percent and 85 percent), had more follow-up biopsies, were more likely to have positive cytology during follow-up and positive smears that were not followed by curative treatment within six months, as well as a higher risk of cancer of the cervix or vaginal vault.

Those women initially managed by punch or wedge biopsy alone in the period 1965-74 had a cancer risk 10 times higher that women treated with intention to cure. This was despite the 1955-64 group being largely unscreened, which would have delayed diagnosis. This study is important as it shows the medical experience of the women, where they were subjected to many interventions that were not meant to treat but rather to monitor.

Whistle blowing

Scientific misconduct happens, and for those trying to address it the risks are high. Brian Martin5 looked at several cases, and stated: “In each case it was hard to mobilize institutions to take action against prestigious figures. Formal procedures, even when invoked, were slow and often indecisive.”

McIndoe and others encountered similar difficulties and ultimately failed to get Green’s proposal reviewed. The concept of “clinical freedom” (p 127), where the doctor was the arbiter of the best course of action for the patient, was one major issue to emerge from the report. Colleagues tended to be very reluctant to intrude upon this, and this meant that the proposal could continue with little oversight or intervention. McIndoe had mounting concerns, particularly after 1969, which were disregarded or treated lightly.

These concerns were shared by pathologist-in-charge Dr McLean, and were raised internally with Medical Superintendent Dr Warren, who consulted with the Superintendent-in-Chief, Dr Moody and an internal working party set up to look at the issue in 1975. Twenty-nine cases that had developed invasive disease were referred to it; however only 13 were examined, and having set up its own terms of reference it only considered whether the protocol had been adhered to and disregarded concerns about patient safety (p 83).

The 1966 proposal effectively ceased when McIndoe withdrew colposcopic services and Green reverted to cone biopsy in most new cases (p 88), but it was never formally terminated. While Green himself did not take any steps to prevent the review of records by McIndoe and colleagues, Bonham did, and wrote a letter to the Medical Superintendent (p 92).

There are some important lessons to be learned from this, including that those with the authority to deal with the situation should make the best effort to achieve a balanced view of the situation and assess it fairly to allow the claimant a fair hearing.

Conclusions

The potential risks of Green’s proposal outweighed any benefits such as avoiding hysterectomy or cone biopsy. Invasive cancer could not be ruled out because there were poor safeguards against the risk of progression. This was unethical from the outset, regardless of the issue of informed consent. In addition, patients that developed invasive disease had their slides reclassified and were removed by Dr Green from the study. This would be considered research misconduct then and now as it manipulated the data.

It does not matter if the initial motivations were sincere; they ultimately fail on these points. This proposal had a very human cost. Moreover Green’s views had long-term effects, including influence on undergraduate and postgraduate medical students, and support for the attitude that cervical screening was not worthwhile. This ‘atypical’ viewpoint was also promoted in the scientific literature and in the press, creating confusion within the medical scene and with the public.

It can be incredibly hard to admit our failings and let go of old loyalties. In the aftermath of the report many doctors objected to cervical screening, ‘unworkable’ consent forms and the intrusion of lay committees on practice6. It’s true this had negative effects on the perception of doctors overall, particularly in regard to practices that were widespread in hospitals at the time, and there were times that unfair criticisms were aired. This impacted on the nursing profession as well, for nurses are meant to be patient advocates.

This was also about power. The really unfortunate thing is that medical responsibilities to patients are almost totally ignored in the midst of the argument, when they should be brought to the forefront. Likewise respect, justice and beneficence were lacking for the patients involved. No doctor raised concerns about the lack of consent, even though from the 1950s there was the growing expectation that this be sought, particularly with participants in research.

The Medical Association working party that examined this stated that it was “regrettable that the trial deteriorated scientifically and ethically and did not change as scientific knowledge advanced or as adverse results were observed”7. They found it deplorable that patients involved did not know they were part of a trial, and that it took a magazine article for it to be investigated.

Unfortunately, instead of addressing this and examining whether Dr Green made any errors or misinterpretations himself, the findings in McIndoe et al (1984) and other papers were not accepted. There is the unfortunate implication that, rather than there being mounting and valid concerns over decades, that Green was unfairly toppled and the resulting inquiry was a whitewash.

The report couldn’t have been written without the assistance of the medical community as expert witnesses and advisors. It’s not surprising that there would be loyalty for a colleague, but perhaps instead of attempting to rehabilitate Green it’s time McIndoe and his colleagues were vindicated. Morality did not totally fail and attempts were made to prevent patients being harmed8.

Acknowledgements: many thanks to Dr. Margaret McCredie of Otago University who assisted me with my research.

  1. The Cartwright Report: www.nsu.govt.nz/current-nsu-programmes/3233.asp
  2. W.A. Mcindoe; M.R. McLean; R.W. Jones; P.R. Mullins 1984: J. Am. Coll. Obst. 64(4).
  3. M.R.E. McCredie; K.J. Sharples; C. Paul; J. Baranyai; G. Medley; R.W. Jones; D.C. Skegg 2008: The Lancet Oncology DOI:10.1016/S1470-2045(08)70103-7
  4. M.R.E. McCredie; C. Paul; K.J. Sharples; J. Baranyai; G. Medley; D.C. Skegg; R.W. Jones 2010: A&NZ J. Obst. Gyn. DOI:10.1111/j.1479-828X.2010.01170.x
  5. B. Martin 1989: Thought and Action 5(2), 95-102.
  6. J. Manning (Ed.) 2009: The Cartwright Papers: Essays on the Cervical Cancer Inquiry 1987-88. Bridget Williams Books Ltd.
  7. L. Bryder 2009: A History of the “Unfortunate Experiment” at National Women’s Hospital. Auckland University Press.
  8. C. Paul 2000: BMJ 320, 499-503.

Truth is the daughter of time, and not of authority: Aspects of the Cartwright Affair

The ‘Unfortunate Experiment’ at National Women’s Hospital has entered the national folklore as a notorious case of medical misconduct. But there is still disagreement about what actually happened.

It is 22 years since the Cartwright Inquiry published its findings. Arguments about the whole affair persist, with repeated public support from those who say it was a valuable and proper exposure of damaging improprieties by the medical profession, and from those who say that the inquiry and the events which led to it are based on an erroneous interpretation of a scientific paper, and selective evidence gathering at the Inquiry.

If indeed an error has been made, then the vilification of the medical people involved, which has occurred and which still goes on, must be redressed.

I want to consider two aspects of this affair, and if the evidence shows a miscarriage of justice, to offer reasons as to why this might have happened.

I shall:

  • consider the contention that an unethical experiment was performed at National Women’s Hospital (NWH) by Professor Green and his associates, and whether or not the Inquiry made a fair and just assessment of the current (1988) internationally accepted management of carcinoma-in-situ of the cervix (CIN3);
  • discuss what factors in our scientific literary world might be contributing to error.
  • describe unwelcome aspects of our human behaviour which allow an issue of this magnitude to survive in our society, unresolved for 22 years, and how writers have described these for many centuries. I have chosen as my title a quotation from Aulus Gellius in his Attic Nights, written in c.150 CE to emphasise the long-standing nature of the problem.

It is important to have a clear outline of the sequence of events over time at NWH and here is a timeline for reference:

1966: Green proposed to the NWH Medical Committee that CIN3 should be managed by cone biopsy if indicated and regular review. This was in response to considerable doubt worldwide about the natural history of the condition, for which many advocated hysterectomy. The committee agreed.

1973: Editorial in the British Medical Journal, “Uncertainties of Cervical Cytology.”1

1974: Article in New Zealand Medical Journal (NZMJ) by Green showing evidence that “The proportion progressing to invasion must be small.”2

1975: The NWH Medical Committee reviewed the management protocol and agreed it should continue.

1982: Professor Green retired.

1984: “The Invasive Potential of Carcinoma-in-situ of the cervix” was published.3 This was the paper on which Sandra Coney and Phillida Bunkle based their Metro article.

1985: A letter to the NZMJ by Skrabanek and Jamieson was critical of a national cervical screening programme for CIN3 as a detection and treatment method for carcinoma of the cervix (14 August).

1986: A letter from David Skegg was published in the NZMJ supporting a cervical screening programme. “The case for the effectiveness of screening does not rest on the unfortunate experiment at NWH in which women with abnormal smears were treated conservatively and a proportion have developed invasive cancer” (22 January).

1987: “An Unfortunate Experiment at National Women’s” appeared in the June issue of an Auckland magazine,Metro. Within 10 days the Minister of Health (Michael Bassett) has announced the inquiry, and that it was to be chaired by Sylvia Cartwright.

1987/1988: The inquiry sat, and published its report in 1988.

1988: A book, An Unfortunate Experiment, by Sandra Coney was published.

1990: Jan Corbett, a journalist, wrote an article in the July issue of Metro reviewing the errors in the Coney and Bunkle paper, and the way in which the data in the 1984 paper had been distorted.

2008: A conference was held to commemorate the Cartwright Inquiry. A number of papers including Charlotte Paul (a medical adviser to the inquiry), and Sandra Coney, were presented endorsing the inquiry findings.

2009: A book, A History of the ‘Unfortunate Experiment’ at National Women’s Hospital, by Linda Bryder, a professional historian, was published.

2009: A book, The Cartwright Papers, published by participants in the 2008 conference, and now including a vehement criticism of Linda Bryder and of her book.

2010: The NZMJ publishes a letter from Dr Helen Overton, “In defence of Linda Bryder’s Book.”4

The 1984 paper

“The Invasive Potential of Carcinoma-in-situ of the Cervix” was written by two gynaecologists from NWH (McIndoe and Jones), a pathologist from NWH (McLean) and a statistician (Mullins).

I have read this carefully, and made a summary of its contents. It described the follow-up data for 948 women with carcinoma-in-situ of the cervix. The women were followed for five-28 years by repeated smears and observation according to the 1966 proposal, unless they showed evidence for spreading cancer. The women were seen at three, six, and 12 months after presentation, and yearly after that. The women’s records showed that at 24 months after presentation, 131 continued to have an abnormal smear. (Of course, the other 817 had normal smears, or had had removal of the cervix by hysterectomy or other treatment.) There was no difference in age or parity between those in either group.

The division into the two groups was made retrospectively by the authors on the evidence for the presence or absence of an abnormal smear at 24 months.

They compared the outcomes in the two groups in terms of the development of invasive cancer (22.1 percent in the group with positive smears at 24 months, 1.5 percent in the larger group). They also compared the number of deaths in each group at the end of the observation period (June 1983). Four women who had had normal smears at 24 months had died (0.5 percent) and eight women had died who had had abnormal smears at 24 months (6 percent).

Treatment

There was no withholding of treatment in that group with the persistently abnormal smears – see Table 1.

Initial treatment Eventual treatment
Total hysterectomy Cone biopsy or amputation Total hysterectomy Cone biopsy or amputation
Group 1 (n=817) 217 (26.6%) 576 (70.9%)
Group 2 (n=131) 33 (25.2%) 88 (67.2%) 62 (47.3%) 166 (126.7%)

Table 1. Initial and eventual treatment of patients with normal smears, or who had cervixes removed by hysterectomy or other treatment (Group 1), and of patients with persistent abnormal smears (Group 2). Percentages exceeding 100 percent reflect the need for two cervical procedures in some women.
The authors said in the paper’s discussion, “the almost universal acceptance of the malign potential of this lesion has made prospective investigation into the natural progression of CIS ethically impossible”. That would require an experiment where women had no treatment. This is quite clearly not the case in this reported series.

It is clear that in this report of the management of CIS there is no evidence of withholding of treatment, nor of an experiment.

Three years after this paper was published, it was used by Sandra Coney and Phillida Bunkle as evidence for gross wrongdoing by the medical staff at NWH. Here is what they wrote:

“The study divided the women into two groups – 817 who had normal smears after treatment by conventional techniques, and a second group of 131 women who continued to produce persistently abnormal smears. This group is called in the study the conservative treatment group. Some had only biopsies to establish the presence of disease and no further treatment.”

Later in the article the authors refer to “group two women who had little or no treatment”.

This paper in a popular magazine was used by the Cartwright Inquiry as some of the evidence which led to its conclusions.

In 1990, Liggins said, “The famous 1984 article which emanated from the National Women’s Hospital and on which the Metro article which stimulated the cervical cancer inquiry was based, was misinterpreted by the authors of the Metro article and by the judge”.5

Was the management of cervical carcinoma-in-situ unethical?

This is the second aspect of the Cartwright affair that I wish to examine. In June 2010 the statement was made that “treatment with curative intent was withheld in an unethical study” at NWH from 1965 to 1974.6

It is important to make clear what we understand by ‘ethical’, ‘unethical’ and ‘conventional’, or we shall be reduced to the state of the Looking-Glass world: “‘When I use a word,’ Humpty Dumpty said in a rather scornful tone, ‘it means just what I choose it to mean – neither more nor less.'”7

Ethical: “In accordance with principles of conduct that are considered correct, especially those of a given profession or group”. (Collins Concise Dictionary, 1988.)

Unethical: Not in accordance with these principles.

Conventional: Relating to convention or general agreement. (OED)

Convention is a general agreement or consent. (OED)

Was the protocol for the management of CIN3 by Prof Green and his colleagues at NWH an unethical experiment? If he had proposed to divide the women as they presented into two groups, one of which was treated and the other not, then that would have been unethical. Although uncertainty existed as to what proportion of women with an abnormal cervical smear developed an invasive cancer, it was agreed that an abnormal smear meant that the woman was more likely to develop cancer than if she had a normal smear.

His protocol did not deny women treatment.

There was widespread international uncertainty as to the best form of management. If Prof Green had withheld an acknowledged proven treatment that was agreed to by the majority of workers in the field, and replaced it with an unproven treatment, then that would indeed have been unethical.

He didn’t do that.

During 1966-1984 there was no international agreed conventional treatment for this condition. As Iain Chalmers of the James Lind Library in Oxford points out, 8 Linda Bryder in her book has made a thorough review of the contemporary medical literature on this subject which makes it clear that there was no worldwide, generally accepted treatment of CIN3. The evidence called by the Cartwright Inquiry did not reflect the lack of an international consensus. It was indicative of only one aspect of the issue. It has all the attributes of ‘cherry-picking’.

The accusation that Green and his colleagues behaved unethically in these matters is not sustainable. Unless his detractors can show that there was a single international conventional treatment which he ignored, then repeated accusations of “unethical behaviour” are wrong. These accusations continue to be made, as recently as 1 June, 2010.6

Why do manifestly false beliefs persist over time?

There are features of our human behaviour which are conducive to the persistence of untruths, and they include a desire for uniformity in the interest of the maintenance of a coherent and more easily managed society.

Once a decision has been made, it is easier for all of us to go along with it, and not to ‘rock the boat’.

There have been trenchant criticisms of the Cartwright affair and its outcomes, often met with strident objections and not much logic. To accuse the whistle blower of “intransigence and arrogance” rather than meet the questions fairly is shameful.

Another feature of the last 22 years is the increasing number of papers published in the medical literature which on close examination are of poor quality. An example of this is the paper published on 1 June, 2010.

This was published as an abstract online. The authors include a medical adviser to the Cartwright Inquiry, a medical witness at the inquiry, and one of the authors of the 1984 paper. There is the old accusation that “treatment with curative intent was withheld in an unethical clinical study of the natural history of CIS at NWH in the years 1965-1974.” But in the results it is stated that 51 percent of these women had treatment with curative intent! The group treated with the diagnosis made in 1975-1976 had curative intent treatment in 85 percent. Prof Green retired in 1982; his proposal for the management of carcinoma in situ was approved in 1966.

Treatment with curative intent was not defined in the abstract.

The results include P values of 0.0005 for the significance of differences between groups, for a difference which defines the grouping.

The number of new patients in the year 1975-1976 was half that in each of the two previous decades. There is no explanation for this in the abstract. This group was not included in the comparison of risk for cancer of the cervix or vaginal vault. There is no explanation for this.

The medical science literature shares with all scientific paper publishing a current deterioration in standards. This contributes to the persistence of error. This issue has been recently addressed in an editorial in The European Journal of Clinical Investigation.9

“Why would scientists publish junk? Apparently the current system does not penalise its publication. Conversely, it rewards productivity.
Nowadays, some authors have been co-authoring more than 100 papers annually. Some of these researchers only published three or four papers per year until their mid-forties and fifties. Then suddenly they developed this agonising writing incontinence.”

Another factor in our society which feeds our appetite for orthodoxy is the popular press. Truth is often submerged in the sensational. An example of this occurred in the NZ Herald on 1 June, when their health reporter wrote a report of the on-line article6 with the headline:

“Otago research backs cancer inquiry findings: Unfortunate experiment at National Women’s not imagined, says report”

There followed 40 column centimetres supporting the headline, including two which stated: “The cancer death rate differences between the periods and sub-groups are not significantly different”. This information is not included in the on-line published paper. The reporter’s statement is not correct in his summary of the report. In addition he cites information which suggests he has access to the complete (as yet unpublished on June 1st) paper.

The television ‘press’ included that morning an interview with Charlotte Paul, one of the authors, and that evening, an interview with Clare Matheson, the woman named as ‘Ruth’ in the original Metro article. There was no reference to the valid criticisms of the Cartwright affair which have been made over the years.

It is not my case that the medical profession to which I belong is without fault, and I accept that since 1988 more attention has been paid by doctors to issues such as informed consent. But the means, by this miscarriage of justice, do not justify the ends.

Our human desire not to alter our beliefs in the face of contrary evidence, the willingness of the popular press not to disturb established ‘truth’, the current deterioration in the standards of the world medical press, and an unquestioning respect for ‘authority’ are factors recognisably active in the persistence of the myths surrounding the Cartwright affair. These behaviours are not new, and their effects on the emergence of truth have been recognised for centuries. Francis Bacon (1561-1626) in his Axioms wrote, in number 46:

“The human understanding when it has once adopted an opinion (either as being the received opinion, or as being agreeable to itself) draws all things else to support and agree with it. And though here be a greater number and weight of instances to be found on the other side, yet these it either neglects and despises, or else by some distinction sets aside and rejects; in order that by this great and pernicious predetermination the authority of its former conclusions may remain inviolate.”

References

  1. Editorial. 1974: BMJ, 5891, 561-2.
  2. Green, GH. 1974: NZMJ 80, 279-287.
  3. McIndoe, WA; McLean, MA; Jones, RW; Mullins, PR. 1984: Obstetrics and Gynecology 64, 451-458.
  4. Overton, H. 2010: NZMJ 123, 95-96.
  5. Liggins, CC. 1991: Australia and New Zealand J. Surgery 61, 169-172.
  6. McCredie, MRE; Paul, C; Sharples KJ; Baranyai, J; Medley, G; Skegg, DCG; Jones, RW. 2010: Australia and New Zealand J Obstetrics and Gynaecology, ‘earlyview’ on-line 1 June.
  7. Carroll, L. 1871: Through the Looking-Glass. Chapter 6.
  8. Chalmers, I. 2010: NZMJ Letters to the Editor. 30 July.
  9. Editorial. 2010: European J Clinical Investigation 40(4), 285-7.

History repeats

A visit to the birthplace of science prompts some thoughts on spatial and temporal patterns in alternative medicine.

There is no special reason for skeptics in New Zealand to follow news from Greece. Last year, however, Waikato University signed an agreement for staff exchanges with Aristotle University in Thessaloniki, and I put my hand up to go. The GNP per head in Greece is about the same as in New Zealand, and teaching at Aristotle University is in English, so exchanges between the two institutions are feasible. As someone who is as good at learning foreign languages as chiropractors are at curing diseases, I was delighted that learning Greek was not necessary. Plus, when I visited there in 2004, a barman refused to let me pay for my drinks because Kiwis and Greeks fought alongside each other in the 1941 Battle of Greece. Now, a mention of anything Greekish makes me take notice. What I have learned is that Greece-arguably the birthplace of science – has repeatedly faced issues similar to those that occupy us in New Zealand.

For example, after World War II, Greece was struggling to rebuild after great suffering. For example, thousands of Jewish men, women and children in Thessaloniki had been packed on to trains and killed in gas chambers. A civil war then had restarted widespread suffering. In 1952, the good news broke of a drink, made from the root of the wild cucumber, which supposedly cured cancer. Mass hysteria swept the country, with crowds going out to uproot a weed that thrived in vacant lots and fields. Some scientists spoke out.

“A disease that is as serious, chronic and incurable as cancer gives rise to profiteers who prey on sick people seeking a cure after having been disappointed by the medical establishment,” wrote university professor Dr G Papayiannopoulos (No, I don’t know how to say his name.). The Supreme Health Council declared the consumption of the brew to be useless and even dangerous.

“It is extremely sad that the daily press has been promoting cures for cancer without any scientific basis,” said the council.

In 1955, a Thessaloniki drinks manufacturer called Georgiadis claimed to have found a drug to cure cancer. Two patients who drank the concoction died suddenly, however. Athens University’s toxicology laboratory found that the brew did not combat cancer and was a mixture of wild cucumber, strawberry essence, sugar and alcohol. Georgiadis was charged with practising medicine without a licence. (Why does this not happen in New Zealand, instead of quacks enjoying public funding?)

In 1975, a newspaper reported that a 36-year-old lawyer from the Greek Island of Kos, Giorgos Kamateros, claimed that the water of his home village cured cancer. He distributed the water in tanker trucks around Athens and in the countryside. Headlines reported daily that the water cured everything: that it had brought a mad woman to her senses, that it had restored the sight of a blind woman. Studies found no curative properties in the water, but Kamateros continued to claim that the secret lay in the minerals dissolved in the water. According to the Institute for Minerals and Mining Exploration, the minerals were simply calcium, carbon and quartz. The parents of 18 children being treated for cancer at the Aglaia Kyriakou Hospital stopped their treatment and gave them the special water. The condition of the children worsened, and one died. A few days later, the death of a cancer patient a day after drinking the water brought an end to the story. Scientists found high levels of radiation in the water. Kamateros held marches with hundreds of fervent supporters. He was charged, and the consumption of his water was banned.

In February of this year, 2007, a state television channel announced the therapeutic powers of the juice of olive leaves. Several chat shows said a thick, green drink made from olive leaves and water, mixed in a blender, was doing wonders for cancer patients. Several electrical appliance stores reported selling out of blenders. Health officials publicly warned that drinking the olive beverage could be harmful. Zoe Bazou, a member of a Athens-Piraeus cancer victims group, Keff, said patients who had tired of strong chemo-therapy treatments or been fooled by profiteers were turning to alternative medicines.

“The result is death,” she said.

Back in New Zealand, the Lake Taupo Primary Health Organisation announced in March that, starting in July, traditional Maori medicine will be funded from the public purse. The PHO has signed an agreement with Nga Ringa Whakahaere o te Iwi Maori, the national body for traditional Maori providers, who sell massages, poultices, natural medicines, spiritual healing, bath therapy and other services. “What does it matter if it makes them feel better?” said the PHO’s chief executive, Jeremy Mihaka-Dyer. Useless Chinese and Ayurvedic (Indian) medicine already waste our taxes.

The more we look, the more we find that history repeats itself, not only from time to time, but also from place to place.

Defrauding the dying


Mexican cancer clinics continue to do a roaring trade, despite their poor track record.

When civil rights leader Martin Luther King was assassinated in 1968, the world lost a voice for decency and truth. The death of his widow earlier this year, however, was attended by greed and lies. The family of Coretta Scott King rushed her to Hospital Santa Monica at Rosarito Beach, Mexico, on 26 January. She died five days later. The underlying cause of her death was ovarian cancer. King’s death in one of alternative medicine’s dodgiest facilities highlights a relationship between quacks and Mexicans that is evil.

Hospital Santa Monica is located near crashing surf, 25 kilometres south of San Diego. The climate there may be the best in the world, consistently pleasant. Cruise ships call at beach resorts along the coast, unloading passengers who like the sunshine and the cheap peso. The region also has about 20 alternative medical clinics for desperate patients, almost all from the United States. Coretta Scott King was barely alive when she arrived in Mexico, but like the tourists, she had money. She was one of perhaps 10,000 paying US citizens who check into some Mexican clinic every year. Mexican locals and authorities welcome money from both the tourists and the sick.

Sadly, Hospital Santa Monica and the dozens of similar facilities sell patients only false hope. Kurt W Donsbach founded the Rosarito Beach facility. “The major patient clientele is comprised of cancer patients who have been told that there is no more hope, all traditional therapies having failed,” he boasts on his website. Donsbach claims to use “wholistic” techniques to treat the “whole” person; body, mind and spirit. He repeats the usual twaddle favoured by quacks: about how orthodox doctors treat only symptoms, not the disease; about detoxing the body and boosting the immune system; about avoiding standard treatments because they make cancer worse. Hospital Santa Monica offers “a very eclectic approach,” he says, including ultraviolet blood purification, mag-ray lamps, hydrogen peroxide solutions dripped into veins, ozone gas blown into the colon, a microwave hyperthermia machine (with a rectal probe), induced hypoglycemia by administering insulin, shark cartilage, a Rife frequency generator machine (remember Liam Williams-Holloway?), magnet therapy and other nonsense. Deluded groups such as the so-called Cancer Control Society, based in Pasadena, California, run trips to such Mexican clinics, taking thousands of cancer patients there for useless treatment.

Donsbach fails to reveal on his website that he has a criminal record but no medical degree. Born in 1933, he graduated in 1957 from a chiropractic college in Oregon. By the late 1960s he was running a health-food store in California, selling supplements that he said treated cancer. Throughout the 1970s and 1980s, he was repeatedly in legal trouble for practising medicine without a licence, selling unapproved drugs and related wrongs. In 1979 he founded a correspondence school – the nonaccredited Donsbach University – that awarded bogus degrees in nutrition, and he sold his own supplements. Officials in New York said the products were useless and sued him. Under pressure in the US, Donsbach started the Mexican clinic in 1983. In 1996 he pleaded guilty to charges of smuggling $250,000 worth of unapproved, adulterated or misbranded medicines from Mexico into the US. Sentenced to prison, he avoided serving time by plea bargaining. In other words, Kurt W Donsbach’s life has been devoted to a range of health-related scams.

The Mexican medical clinics are a blot on the page of human history, but they continue to exist because they attract money. Mexico is a very corrupt country, and bribes and fraud allow unconscionable activity to thrive there. Mexican officials claim they can investigate the facilities only if there are complaints, which are rare because the clinics usually treat non-Mexicans and do not advertise in Mexico. Sometimes clinics get shut down, but they re-open. A week after Coretta Scott King died, the Mexican government closed Hospital Santa Monica, saying it lacked authority to carry out some of its treatments and that several of its unconventional practices put patients at high risk. Patients from the US, Canada, Australia and Italy were at the facility when it was closed. Interviewed by the Los Angeles Times, Donsbach was shameless. He blamed the closure on the US medical establishment and predicted that his clinic would reopen soon: “The moment they close down a clinic, they open it up very quickly, the same place, same people.” Immoral quacks and their allies continue to fleece the dying.

Newsfront

Elephants in Loch Ness?

Nessie’s an elephant, says a leading British palaeontologist (Dominion Post, 7 March).

Neil Clark, curator of palaeontology at Glasgow University’s Hunterian Museum, spent two years investigating the Loch Ness myth and suggested the idea for Nessie was dreamt up as a “magnificent piece of marketing” by a circus impresario after he saw one of his elephants bathing in the loch.

In 1933, the same year as the first modern ‘sighting’ of Nessie, Bertram Mills offered £20,000 to anyone who could capture the monster for his circus, sparking international interest. Most sightings could be explained by floating logs or waves, but there were a number, particularly from 1933, were more difficult to account for.

He believed some were elephants belonging to circuses – which visited Inverness and stopped along the banks of the loch to allow their animals to rest. When they swam in the loch, only the trunk and two humps could be seen – the first hump being the head and the second the animal’s back.

University fears cancer from wireless internet…

Lakehead University, in Ontario, Canada, won’t allow campus-wide internet access because of health worries (Dominion Post, 1 March.)

President Fred Gilbert told a university meeting that some studies showed links to carcinogenic occurences in animals, including humans, related to energy fields associated with wireless hotspots – “whether these hotspots are transmissions lines, whether they’re outlets, plasma screens or microwave ovens that leak.” The university has only limited Wi-Fi connections, in places where there is no fibre-optic internet connection. The decision, apparently, was a personal decision by Gilbert.

The stance has caused a backlash from students and Canadian health authorities. “Considering this is a university known for its great use of technology it’s kind of bad that we can’t get Wi-Fi,” student union president Adam Krupper said.

…but cell phones are OK

Meanwhile, according to a new study, cell phones do not increase the risk of developing brain tumours, the Dominion Post reported (21 January.)

After a four-year survey, scientists at the Institute of Cancer Research in London and British universities in Leeds, Manchester and Nottingham found no link between regular, long-term use of cellphones and glioma brain tumours.

The results were consistent with the findings of most studies done in the US and Europe, although this survey was bigger than any previous research and involved 13 countries.

The researchers questioned 966 people with glioma and 1716 healthy volunteers about how long they had used mobile phones, the make and model, how many calls they made and how long the calls lasted. Earlier mobile phones used analogue signals, which emitted higher power signals than the later digital models. Any health danger would be more likely to result from the earlier models, but the scientists found no evidence of it.

Ghosts keep the tourists away

The existence of ghosts may be debated, but the impact of traditional Asian beliefs on Thailand’s tourism trade since the December 26, 2004, tsunami appears indisputable (National Geographic News, January 6).

Tourism from Europe, Australia, and the United States has rebounded since the disaster, but tourist arrivals from elsewhere in Asia have not. Industry observers cite Asian tourists’ fears of ghosts in tsunami-stricken areas as the main reason for the decline.

Buddhism and other Asian belief systems hold that if bodies are not properly buried, their spirits restlessly wander the Earth, and may try to drag living beings into a spiritual limbo.

“Please tell your fellow Japanese and Chinese back home to stop fearing ghosts and return to this region again,” Thailand’s Prime Minister Thaksin Shinawatra reportedly told tourists after a memorial service to commemorate the victims of the tsunami.

Since the disaster, tales of ghost sightings have become endemic. Foreign ghosts seem to be particularly common, and many of the accounts are being covered in local newspapers.

One Phuket taxi driver reportedly said he was hailed by four western tourists who asked to go to the airport. The driver chatted as he drove, but when he pulled up at the airport to let the passengers out there was no one there.

Police procedure allows for sorcery concerns

Maori should not be forced to give DNA samples because of concerns over sorcery, says a report in the Dominion Post (5 December 05). A new police manual says Maori have spiritual beliefs about samples taken from the body, and that “a person should not be forced to provide samples for testing purposes”. Police management said the direction would be amended or deleted in future editions.

‘John of God’: it’s all been seen before

Chair-entity Vicki Hyde is gnashing her teeth over the upcoming visit to New Zealand of Joao Teixeira de Faria, ‘one of the world’s most powerful spiritual healers.’

In a full-page feature on the ‘healer’ in the Dominion Post (28 January) Vicki told reporter Stefan Herrick she was convinced Teixeira de Faria, who goes by the name John of God, was a con man “who peddles miracle cures that don’t withstand even light scientific scrutiny.

“Sad to see this chap coming here as it just means more exploitation of vulnerable people.”

Hundreds of foreigners visit Abadiania, the small village in Brazil where Teixeira de Faria has established a clinic where ‘miraculous cures’ take place. He is promoted as “the greatest healer of the past 2000 years”, and claims to be guided by 35 healing spirits.

Vicki Hyde said if it looks like a duck, swims like a duck and quacks like a duck, “it’s probably just another duck…”

John of God, the report said, doesn’t charge for visits to his clinic (although the Wellington sessions will cost $115) but he appeared to be well off. The ABC network reported that he owned a 400-hectare ranch down the road from his clinic.

Magnets attract support

Magnet therapy, said to be favoured by Cherie Blair, is to be made available on Britain’s National Health Service (NZ Herald, 11 March).

The 4UlcerCare – a strap containing four magnets that is wrapped around the leg – is available on prescription from GPs. Its maker, Magnopulse, claims that it speeds the healing of leg ulcers and keeps them from coming back.

The announcement has created excitement in the world of alternative medicine. Lilias Curtin, one-time therapist to Cherie Blair, sent a poster-sized announcement to newspapers declaring her “sincere belief that, in the next five to 10 years, magnets will be seen in first-aid boxes”.

Other experts are sceptical. Professor Edzard Ernst, head of complementary medicine at the University of Exeter, said that he was puzzled by the NHS decision. “As far as I can see, there hasn’t yet been enough research to prove that these magnets help people with ulcers.”

More powerful electromagnets could help to heal tissue injuries, but that was different, he said. His own study of small magnets on arthritis sufferers had failed to yield compelling results.

In January, researchers from the Kaiser Permanente Medical Center, in California, published a paper in the British Medical Journal that cast doubt on the therapeutic use of magnets. “Patients should be advised that magnet therapy has no proven benefits. If they insist on using a magnetic device, they could be advised to buy the cheapest – this will alleviate the pain in their wallet,” they wrote.