Cancer, facts and fiction

Firstly, a big thank you to those who have used the new webstore linked to my website, and made favourable comments on the style and ease of use of the store.

But then, what is going on in modern cancer medicine? Amidst reports that new drugs are too expensive with too few life-saving benefits, how much can we trust what is in the scientific literature and what is being recommended?

As the ABC’s investigative program Four Corners is about to broadcast an examination of the cost/benefits of modern cancer drugs and their impact on quality of life and survival (Monday 26th August at 8.30pm), there is growing concern amongst health professionals and those closely affected by cancer that trust is being lost.

This week, a look at a rather extensive selection of recent research studies that highlight some of the problems and a reminder to watch and consider joining the comments on the Four Corners program. Next week, back to the good news with research on the positive benefits of lifestyle based medicine, and the obvious question: why is it not being promoted more strongly by modern oncologists? But first





Thought for the day

Good judgement comes from experience
Experience comes from bad judgement
                   Dr K L White







                                                                   Spring is in the air - and the daffodils are on the move
DID YOU KNOW?

Over the last 10 years, 8 times more is now being spent on cancer drugs
Annual PBS expenditure for all cancer drugs has increased almost 8 times between 2000 and 2012, from $65 to $508 million. During the same time, the average price paid by the PBS for an anti-cancer drug increased almost 4 times, from $237 to $801.

Reference: Dr D Kariokios, who presented the findings in November 2012 to the Clinical Oncology Society of Australia’s annual scientific meeting.

Breast cancer trials guilty of spin and bias
Analysis of 164 phase 3 Randomised Controlled Trials from 1995-2011 for breast cancer demonstrated the under-reporting of toxic effects and the over-emphasis of secondary outcomes when primary results were negative.

In two-thirds of trials there was poor reporting of the toxic effects of the treatment being investigated, with only a third detailing the frequency of grade 3 or 4 toxicities in the abstract. Toxicity was even more likely to be under-reported if the trial showed significant treatment benefit.

Around a third of trials were reported as positive based on secondary endpoints only, and of the trials that failed to find a statistically significant treatment benefit, 58% used secondary endpoints to suggest benefit.

“Clinicians, reviewers, journal editors and regulators should apply a critical eye to trial reports and be wary of the possibility of biased reporting,” they concluded.

Vera-Badillo et al. Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer. Ann Oncol (2013) doi:10.1093/annonc/mds636

Selective drug trials, unreliable outcomes. Is less more?
Melbourne’s Age newspaper on  23rd  January 2012 quoted Professor John Zalcberg of the Peter Mac Hospital as saying “many clinical trials - used by Australian health authorities to decide which techniques to use or subsidise - involved carefully selected groups of patients most likely to respond well to the study treatment.

“But the treatment might be less effective in more typical patients. It was important for government to pay for studies that directly compared alternative approaches, to ensure researchers could pursue an independent agenda, even if it might undermine industry revenue.”

Further, Zalcberg said “A key question in cancer treatment was whether shorter courses of chemotherapy would work as well as longer courses already endorsed by industry-sponsored studies, But such trials, despite potential savings to the health budget, were ''not seen as innovative'' and were unlikely to be funded under the usual competitive research grants process.”

Most falsely believe chemo is curative
According to a study in the New England Journal of Medicine although chemotherapy is the primary treatment for patients with lung and colorectal cancer, it is not curative.

In an American national survey of 1193 advanced-stage patients, 69% of patients with lung cancer and 81% of those with colorectal cancer misunderstood the intent of chemotherapy, mistakenly believed that chemotherapy might cure their disease.

The authors commented “this study fills a gap in the medical knowledge about what advanced cancer patients understand about chemotherapy. These findings raise questions about whether patients have "met the standard for...consent to their treatment."

Weeks et al, N Engl J Med. 2012;367:1616-1625, 1651-1652.  

Call to publish all clinical trial data to protect patients
Currently, researchers, pharmaceutical companies and institutions are free to not publish research data that may be detrimental to their professional reputations and bottom line, but potentially vital to public health. Clearly, if negative findings are not published, it could powerfully skew the overall impression of a drug’s effectiveness, leading to bad treatment decisions and missed opportunities for good medicine.

Speaking in the British Medical Journal, Australian professor of evidence-based medicine Paul Glasziou said the current system “betrays” patients who volunteer for clinical trials, thinking they are contributing to the advancement of medical knowledge. “Non-publication negates this reasonable assumption,” and “distorts the evidence base for clinical decisions.”

BMJ editor in Chief Fiona Godlee commented “Patients who are invited to participate in trials should consider the track record of the institutions and funders concerned and refuse to participate unless they receive written assurance that the full study results will be made publicly available and freely accessible."

Chalmers I, Glasziou P, Godlee F. All trials must be registered and the results published. BMJ 2013; 346:f105.

Key research unable to be reproduced
A top researcher has found that many recent basic studies on cancer -- a high proportion of them from university labs -- are unreliable.

Over the last two decades, the most promising route to new cancer drugs has been one pioneered by the discoverers of Gleevec, the Novartis drug that targets a form of leukemia, and Herceptin, Genentech's breast-cancer drug.

In each case, scientists discovered a genetic change that turned a normal cell into a malignant one. Those findings allowed them to develop a molecule that blocks the cancer-producing process. This approach led to an explosion of claims of other potential "druggable" targets.

During a decade as head of global cancer research at Amgen, C. Glenn Begley identified 53 "landmark" publications -- papers in top journals, from reputable labs -- for his team to reproduce. Begley sought to double-check the findings before trying to build on them for new drug development. He found 47 of the 53 could not be replicated.

Part way through his project to reproduce promising studies, Begley met for breakfast at a cancer conference with the lead scientist of one of the problematic studies.

"We went through the paper line by line, figure by figure," said Begley. "I explained that we re-did their experiment 50 times and never got their result. He said they'd done it six times and got this result once, but put it in the paper because it made the best story. It's very disillusioning."

As recently as the late 1990s, most potential cancer-drug targets were backed by 100 to 200 publications. Now each may have fewer than half a dozen.

Begley, CG. Nature 483, 531–533 (29 March 2012) 

New Anticancer Drugs are more Toxic
Modern cancer drugs are increasingly aiming to be “biologically elegant”. Many are designed to block cancer by interfering with specific molecules involved in tumor growth and progression.

One of the main promises of targeted therapies has been less toxic side effects. But a meta-analysis has found a significant overall increase in the odds of toxic death with the new targeted agents, compared with the older drugs that were used as controls. The new targeted agents were also associated with a statistically significant increase in grade 3 or 4 adverse events.

The authors point out that virtually all new drugs undergo evaluation in early-phase clinical trials designed to assess toxic effects and tolerance. However, these trials tend to be small and can only detect common toxic effects, and some agents receive their approval on the basis of smaller, nonrandomized, unblinded trials "in which detection of toxicity can be severely impaired."

Our group has already established that, "in the postmarketing period, there are frequently new toxicities," Dr. Amir added. "The problem is that these are not usually reported in the scientific literature, but simply submitted to regulatory agencies. As such, some clinicians may be unaware of these."

In addition, they note that "despite improvements in efficacy with the use of new molecular targeted and chemotherapeutic agents, most cancers remain incurable."

"Therefore, maintenance of quality of life and minimization of treatment-related toxicity are key objectives of drug development," the authors write. "This is especially important in settings in which improvements in efficacy are modest and might be counterbalanced by an increase in toxicity."

"We recommend that treatment decisions be based on a more holistic assessment of patients, rather than an empirical approach based on tumor characteristics," he said.

Niraula et al. The Price We Pay for Progress: A Meta-Analysis of Harms of Newly Approved Anticancer Drugs. J Clin Oncol. 2012;30:3012-3019.

Editorial from Lancet Oncology on this problem.
"These data raise the question of whether the pursuit of improved survival outcomes come with a trade off in tolerability that is reaching an unsustainable level,"

The editorial continues: "… new drugs are not as clean in their targeting as anticipated, and, ironically, are perhaps not as predictable as the older pancytotoxic chemotherapy drugs."

Editorial, Lancet Oncol. 2012;13:849. 

Chemotherapy affects brain function and memory.
This meta-analysis (that included 13 studies) assessed whether chemotherapy-related cognitive impairment is consistently observed in cancer patients.

Evidence for the presence of cognitive impairment following cancer treatment was established for executive function and memory. No relationship was found between cognitive impairment and time since treatment cessation but a significant negative relationship was found for treatment duration. Age had no impact on treatment-related cognitive impairment.
A meta-analysis of the effects of chemotherapy on cognition in patients with cancer.

Hodgson KD et al, Cancer Treatment Reviews, Volume 39, Issue 3, May 2013, Pages 297–304

New study shows chemotherapy effects last twice as long
While earlier studies suggested the cognitive effects of chemotherapy could 
last 10 years, new data suggest they could last for more than 20 years.

Almost 300 women who had been treated with adjuvant cyclo-phosmamide, methotrexate, and fluoroacil (CMF) chemotherapy an average of 21 years earlier were studied.

Researchers found their processing speed, executive functioning, psychomotor speed, and immediate and delayed verbal memory were all “significantly worse” than a control group of women who had never had cancer.

The authors cautioned that the impact of their study was tempered by the fact that CMF was “no longer the most optimal adjuvant therapy for early-stage breast cancer,” and admitted it was impossible to glean if they were applicable to other forms of chemotherapy.
Given advances in treatment are increasing the number of long-term breast cancer survivors, their research into long-term cognitive effects was “highly relevant”, they said.

Koppelmans et al, Journal of Clinical Oncology, 2012; 10.1200/JCO.2011.37.0189

Chemotherapy linked to Risk for Acute Myeloid Leukemia
A study of acute myeloid leukemia (AML) from 1975 to 2008 indicates that the incidence is almost 5 times higher in patients treated with chemotherapy than in the general population
The researchers warn that the overall incidence of treatment-related AML (tAML) is likely to increase in the future, because increasing numbers of patients have received cytotoxic agents during the past decade.

Although radiation therapy has also been implicated in tAML, the risk appears to be substantially higher with chemotherapy. But also, the risk for tAML was higher with radiotherapy plus chemotherapy than with chemotherapy alone.

Morton L et al, Evolving risk of therapy-related acute myeloid leukemia following cancer chemotherapy among adults in the United States, 1975-2008. Blood. Published online February 14, 2013 

Is this what optimism looks like?
New metastatic melanoma drug ipilimumab (Yervoy) is approved for listing on the PBS. It costs more than $110,000 a year per person, up to $60 million per year for the public purse, has a significant side-effects profile including potential fatalities, and it increases survival on average from 6 months to 10 months.

Co-author of the research that led to Yervoy being listed, Richard Kefford of the University of Sydney reported that “It’s not a cure but it’s a definite step ahead.” He added “that there was a revolution underway in the care of patients with metastatic melanoma, with a host of new therapies on the horizon” and “there is a lot to be optimistic about.”

Flaherty KT et al. Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations. N Engl J Med 2012; 367:1694-1703

Oncologists are doing a poor job of informing American women with early-stage breast cancer about the disease or their options in terms of surgery. 
Among 440 surveyed women, less than half (about 46%) knew that local recurrence risk is higher after breast-conserving surgery (lumpectomy) than after mastectomy, and only about 56% of women knew that survival rates are equivalent for both options.

Many women did not recall being asked for their preference. The fact that less than half of the patients recalled being asked their preference was particularly concerning to Dr. (Clara) Lee.

“It would be one thing if we were talking about decisions for which there is clearly a superior treatment, such as treatment for an inflamed gallbladder. In this case, it’s reasonable and actually better for the surgeon to make a recommendation. But here we’re talking about a decision where there is no medically right answer, and it really depends on the patient’s preference. In that situation, it makes sense to ask the patient what she prefers.”

Lee C et al. Many Breast Cancer Patients Uninformed About Options: Journal of the American College of Surgeons; 2012, Volume 214, Issue 1, Pages 1-10

Palliative care and multiple medications
Terminally ill patients often remain on unnecessary medications, and regular reviews are needed to prevent polypharmacy (the use – often overuse – of multiple prescription drugs).

Almost half of the 50 patients were admitted to a Brisbane palliative care service were on nine or more medications and a study found two-thirds of their medications could be stopped within three days.

Another study published in the Australasian Journal on Ageing found 54% of patients aged 65 and over requiring hospitalization in a Melbourne teaching hospital had been prescribed a potentially inappropriate medication, either before or during admission.
Cruikshank R, MJA 2013; 199:29. 

Early palliative care increases survival and quality of life for people with metastatic non–small-cell lung cancer – when compared to aggressive treatment.
Patients assigned to early palliative care had a better quality of life than did patients assigned to standard care. In addition, fewer patients in the palliative care group than in the standard care group had depressive symptoms. Despite the fact that fewer patients in the early palliative care group than in the standard care group received aggressive end-of-life care (33% vs. 54%, P=0.05), median survival was longer among patients receiving early palliative care (11.6 months vs. 8.9 months, P=0.02).

Temel et al, N Engl J Med 2010; 363:733-742

The drug companies and the doctors – tough reading
There is widespread concern within the medical profession and the community about the conflict of interest that exists between for-profit drug companies – with their obligations to maximise sales of their products for the benefit of shareholders – and members of the medical profession who recommend these products to patients.

Pharmaceutical companies are known to be among the most profitable companies in the world. Proceedings of legal cases and published research provide insights into the nature of the influence of drug companies on research and publication practices relating to the drugs they manufacture, on marketing disguised as “education” and on doctors who prescribe their drugs. The influence of drug companies extends further to sponsorship of opinion leaders who promote their drugs and groups that produce clinical guidelines. More rigorous regulation of the relationship between the pharmaceutical industry and medicine is required.

This article explores the influence of the pharmaceutical industry on medical research and practice. It seeks to discover from the medical literature the extent of such conflict of interest, and the effects of that conflict on the conduct and outcomes of research and its publication, and hence clinical practice.

A lengthy article, it makes for compelling but very important reading.

George A Jelinek and Sandra L Neate. The influence of the pharmaceutical industry in medicine; J Law Med. 2009 Oct ;17 (2):216-23   

The article can be downloaded from www.overcomingmultiplesclerosis.com.au

Pay rates for US cancer specialists slipping.  April 26, 2013
Oncologists remain among the highest earners of all American medical specialists, but their ranking has slipped a little over the past year, according to figures just released in the Physician Compensation Report 2013.

The mean income for an oncologist in 2012 was $287,000, according to the report, although 10% of oncologists earned more than $500,000 and 14% earned less than $100,000. This places oncologists tenth in the rankings. Topping the chart were orthopaedic surgeons (with a mean income of $405,000), cardiologists ($357,000), and radiologists ($349,000).

Also earning more than oncologists were gastroenterologists, urologists, anesthesiologists, plastic surgeons, dermatologists, and general surgeons.

At the bottom of the rankings were specialists in infectious disease (with a mean income of $175,000), pediatricians ($173,000), and family medicine practitioners (GPs) ($170,000).

These rankings of 2012 income show a drop from 7th place in 2011 and oncologists reported the biggest decrease (4%).

A cautionary tale – a profoundly sad letter received recently, and reproduced with permission.

The oncologist gave us 3 different options for treatment. His preference was the middle one, saying that side affects were minimum and chance of success almost the same as the hard one. How much difference in chance of success, he could not say, not even ball-park figure.

We (my partner and I) had chosen to try the hard treatment first (hoping to increase our chances of success and the side affects would be not too bad). The oncologist nurse told me that that was fine and that they would be monitoring my partner’s condition during the treatment and if it would get too difficult the treatment would be changed. 

During the first 8 days of the first treatment cycle, she went into emergency hospital to be looked at on day 6, 7 & 8. There were signs of a stroke, she was very sick, tired & very nauseous and did not get out of bed after day number 3. My partner passed away on day 9 due to a blood-cloth / fluids in her lungs (today – 3 months later - we are still waiting on the post mortem report).

RELATED BLOGS

Buying time - Four Corners, Monday 26th August - must see television

NOTICEBOARD

IMAGES, WORDS and SILENCE 
Training/retreat for those interested in mind made healing – either for personal use or as a health professional.
With Dr Nimrod Sheinman, Ruth and myself in the Yarra Valley. Details: CLICK HERE

MEDITATION UNDER the LONG WHITE CLOUD
Ruth and I are leading our first meditation retreat in New Zealand in December at the beautiful Mana Retreat centre that has a similar high reputation for a good environment and great food as the Foundation. Details: CLICK HERE

5 DAY FOLLOW-UP CANCER PROGRAM
Specifically for people who have attended a CanLive program in NZ, or Gawler Foundation program. November 18 – 22 at Wanaka out of Queenstown - one of the most beautiful environments there is. Details: CLICK HERE

Buying time - Four Corners

Are new cancer drugs worth the price and are there realistic options available?

Would you buy one of these? Yervoy is a new cancer drug that improves survival time for those eligible from an average of 6 months to 10 months. It costs over $110,000 per person per year. Monday, 26th August and Four Corners will be examining this and other drugs that have led leading cancer specialists to state that modern oncology is costing too much for too little benefit.

Speaking personally, I am deeply concerned by clear scientific evidence demonstrating that many people with cancer are being over treated with drugs that have a very high price tag (including serious side-effects) and yet have only marginal benefits. Also, it would seem that many of these same people are either unaware, uninformed , or worse being dissuaded from genuine self-help options that could be helping them to live better and longer.

I believe there is need for urgent discussion at all levels on these issues. Changes in management and attitudes would seem warranted. I hope the Four Corners program may break the taboos that seem to have been in place for too long when it comes to open discussion around these issues.

So this week we go Out on a Limb, reflect on the facts and question what is happening and why. But first





Thought for the day

Action without vision

Is only passing time.
Vision with out action
Is merely daydreaming,
But vision with action
Can change the world.
                 
               Nelson Mandela





What does this turn into? See below.
The magnolias are on!




Yervoy. If you pay your taxes, then you have already bought it.
This new cancer drug (which is not a new chemotherapy, but a more biologically elegant way of attacking cancer metabolically - which does make it something of a step forward) was recently added to the PBS – the Government’s free (to the patients) drug scheme. But all of us who pay taxes are helping to pay for it. Described by the Health Minister Tanya Plibersek as “a major breakthrough”, what wonders what small progress looks like? She also called Yervoy “an important treatment option for patients who are not well enough to tolerate further chemotherapy”.

And there is more to all this. It seems that one in five who take Yervoy live an extra 3 years, a good result for them. But statistically, if the drug only takes average survival from 6 months to 10 months, it seems certain those who survive longer must be offset by others who die quicker than average, and yes, the drug does have a raft of side-effects some of which have been proven to be lethal.

How much will we the taxpayers be paying for this new drug? Somewhere between 30 and 60 million dollars a year.

While all my sympathy goes to people eligible for this new drug and we can easily understand their enthusiasm, the question has to be asked. If a top ten list had been made of things that need extra funding in cancer medicine, where would Yervoy have appeared? If you had $60 million to spend on cancer, how would you allocate it? I would love to hear your response via the comments section below.

Then there is the question of what is influencing our decision makers, as well as the public to support the use of so much chemotherapy and other cancer drugs in current time?

Consider this. Back in 2004 it was shown that when 22 of the common cancer types (which included 90% of all cancers) were investigated in Australia, chemotherapy was shown to increase the average 5 year survival time by only 2.3%.

Amazingly, that study was published in 2004 and to my knowledge there has been no up-date. We do not know what the overall success rate for chemo is in current time. This seems a major oversight or error of omission.

Then we have the deeply disturbing evidence from the medical literature that the drug companies are heavily distorting cancer drug trials, and in the process, powerfully influencing the recommendations of doctors and creating unrealistic expectations in patients, families and whole communities.

For example, the literature makes it clear that drug company cancer drug trials are twice as likely to feature positive findings as independent trials. Even more disturbing, published drug company sponsored trials are twenty times less likely to record a negative finding as independent trials. Get a negative finding? Simple. Do not publish it. The result? Distort the overall results and give a falsely positive indication of benefit.

So this means that the 2.3% benefit attributed to chemotherapy in 2004 was highly likely to be inflated. The real effect on 5 year survival actually may have been a negative one.

But it is not just the researchers and the doctors who are being influenced. Women in Sydney already treated for breast cancer with surgery and chemotherapy were asked how much benefit they would need to gain to agree to have more chemotherapy.

Asked to imagine they had 5 years to live from the time of the survey, and offered to imagine another round of chemotherapy that would add just one day to that five years; how many women do you think would agree to take the extra chemo?

In fact, over 50% said they would. (Ref 5 below).

Some time back two women sat talking in a group I was leading.  Both had been treated surgically for early breast cancer, both had 2 children under ten. Both said they had considered the evidence, had found that chemo could probably improve their chances of 5 year survival by around 4 to 4.5% and that the treatment would probably involve a series of side-effects.

Both said they had discussed their options widely, had thought about it a lot and wanted to do the best for themselves and their families.

One decided to have the chemo – fair enough; the other decided not to – again, in my opinion, fair enough. Both made well informed, well considered choices and decided what they thought best for them and their personal circumstances.

The outcomes? Very different. The woman who accepted the chemo was well supported by her doctors, all the support systems of her hospital and the breast cancer networks. She was treated as something of a hero by her family and friends, courageously going through a tough treatment. She received full support.

The lady who declined chemo described a nightmare. Firstly her male doctor overlooked the fact that she was a highly competent businesswoman with intelligence and no neurotic pathology. He told her she was “being a naughty girl” and that “if you did not take the chemo you will be putting your life at risk and so unless you change your mind, I do not want to see you again”.

But while this woman received no help from her hospital, her biggest problem turned out to be from amongst her extended family and friends. They pressured her relentlessly to accept the treatment; constantly challenging her decision and questioning her lack of consideration for her children.

They overlooked the evidence that simply exercising most days would reduce their friend’s risk of dying twice as much as the chemo (and no-one knows as yet how chemo and exercise really interact). She had good support from her immediate family and was strong enough to persevere through all the difficulties, but what is going on?

What has got into the popular psyche that chemotherapy and the newer cancer drugs like Yervoy have become embraced so thoroughly by the medical profession and the public alike? Has our obsession with quick fix drugs reached a point where evidence and cost is overlooked and hope at any price is acceptable? Are we so scared of dying that we are seeking survival at any price?

I will be fascinated to watch the Four Corners program and see what they have made of it. And I would love to hear your own thoughts. Are you a health professional with a different view? Are you a patient faced with choices, or someone who has made choices with particular consequences? Are you a family member or friend who has shared in or observed someone dear to you making their own choices? How do you feel about all this? What are your thoughts?

At the very least, I am hoping the program will stimulate discussion, maybe even constructive debate on these topics which to date have felt surrounded by unspoken taboos. So do consider adding your voice to the feedback on the program, either on the ABC website, or in your own social media pages, or via the wider media. Maybe this is a good blog to share. Please do add to the comments section below. My sense is we are long overdue for lengthy discussion in this challenging area.

RESOURCES
You Can Conquer Cancer – outlines what I do recommend for people with cancer – and how to do it!

The Gawler Cancer Program – the CD or MP3 download that features how cancer develops and how the body and mind can be activated to counteract it.

What to do when someone you love has cancer - the CD or MP3 download that features the combined feedback from thousands of families and friends of people with cancer. What to do, how to be most helpful, how to look after yourself while looking after someone else.

Cancer, lifestyle and chemotherapy. – a detailed and documented analysis of this area that I wrote in 2006.

RELATED BLOGS

The Cancer Council, the survivors and the book

Twenty years and what has changed?

NOTICEBOARD

1. Mt Macedon workshop next weekend
Saturday August 24th, 10am (arrive 9.30) to 4.30pm
Duneira is an exquisite heritage hill station property on the slopes of Mt Macedon. The garden is like a meditative space, so beautiful and filled with majestic trees. I love being there!

Then the house itself is grand enough to host good sized but still quite intimate events. There is a tradition now at Duneira of hosting community events that range from music to personal development and Ruth and I have become regulars.

So, fancy a nice drive to a beautiful place for a meaningful event? If so, CLICK HERE

2. Retreats / Trainings filling 
MEDITATION in the DESERT
If anyone is still thinking of joining us in the desert, you will need to let us know very soon.
Details: CLICK HERE

IMAGES, WORDS and SILENCE 

Training/retreat for those interested in mind made healing – either for personal use or as a health professional.
With Dr Nimrod Sheinman, Ruth and myself in the Yarra Valley. Details: CLICK HERE

MEDITATION UNDER the LONG WHITE CLOUD
Ruth and I are leading our first meditation retreat in New Zealand in December at the beautiful Mana Retreat centre that has a similar high reputation for a good environment and great food as the Foundation. Details: CLICK HERE

5 DAY FOLLOW-UP CANCER PROGRAM
Specifically for people who have attended a CanLive program in NZ, or Gawler Foundation program. November 18 – 22 at Wanaka out of Queenstown - one of the most beautiful environments there is. Details: CLICK HERE

REFERENCES
1. Flaherty KT et al. Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations. N Engl J Med 2012; 367:1694-1703

2. THE HON TANYA PLIBERSEK MP, Minister for Health, MEDIA RELEASE: Sunday, 5 May, 2013

3. Morgan G, Ward R, Barton M. The contribution of cytotoxic chemotherapy to 5 year survival in adult malignancies. Clin Oncol. 2004; 16:549-60.

4. Segelov, E. The emperor’s new clothes: Can chemotherapy survive? AustralianPrescriber. 2006; 29 (1):2-3.

5. Duric V et al. Ann Oncol 2005 Nov;16(11):1786-94. Epub 2005 Aug 26.

6. Delivering affordable cancer care in high-income countries. Sullivan R, Zalcberg J et al. Lancet Oncol. 2011;12:933-980. 

Ian Gawler Blog: Learning, money and Four Corners

I have to confess to being a little excited this week as Ruth and I launch our new webstore. To celebrate we have some great specials featuring discounted meditation CDs, a great new concept with Starter Packs, and for the first time, all our CDs are now available as MP3 downloads and on special for 2 weeks! Postage is free for all Australian orders over $70. To connect, CLICK HERE

And then it does seem timely to have some discussion around the financial issues involved with teaching a person to fish – metaphorically that is. Plus there is news of a Four Corners program that I had some part in that will go to air Monday, 19th August. But first,

Thought for the day
If you give a man a fish you feed him for a day. 
If you teach a man to fish you feed him for a lifetime
Chinese Proverb






The camellias and magnolias in the garden 
are spectacular, so here are a few: 






It is an interesting thing to work in the “Health Industry”. I remember back in 1973 when I first began working as a veterinarian in my own practice, how confronting some of the money issues were. What to charge? What to do when owners say “we cannot afford to pay”, or did not want to pay, or thought things too expensive? How do you put a price on an animal’s health, or even moreso, their life?

I was caring for people’s pets, often the embodiments of their emotional lives, as well as for those magnificent, compliant yet powerful creatures we know and love as horses, plus a few farm animals that bore the brunt of food production.

And then courtesy of my own illness I moved into human health, most particularly the charged atmosphere of cancer medicine. And here I was, not handing out a metaphorical fish to eat, like a drug or some other possibly very valid external form of treatment. No, here I was attempting to teach people “how to fish”, how to manage their own health, healing, recovery and long-term wellbeing.

How do you price that? People have told me that they believed my book “You Can Conquer Cancer” saved their life. How do you price that? $34.95. Seems reasonable enough!

But now, here is a little known secret. When I began to run cancer groups in 1981, I wanted to do it using a donation system. I discussed this at length with my main mentor of the time, Dr Ainslie Meares, and he convinced me that in our culture, people put little value on what they get for free; that they relate price to value and even to meaning and significance.

I often wonder how this work would have developed if we had charged twice as much? What about four times? But I opted to charge at the minimal end of the scale and while people may not be aware, for many years the Gawler Foundation programs have been subsidised by fundraising in a way that reduces everyone’s fees by around 25 to 30%.

The Transcendental Meditation group provide an interesting contrast, charging a large amount for their TM courses and being very successful both in making TM widely used and having a stable and sustainable financial system. Another thing their extra income enabled was the funding of major research which in turn has played a formative role in establishing the credibility of meditation in the scientific world.

Anyway, in the early days I wrote books and recorded tapes then CDs to help people learn and be supported in applying what I valued. In the beginning I was very shy about recommending my own material. It actually took years to get over that hang-up and realise that was acting like a schoolteacher who was not telling their students about the textbooks they needed. Like asking people to learn to fish without the manual to refer back to. Or if you prefer, how to grow carrots without a good gardening reference book.

So, being over that, Ruth and I are excited to be able to offer our resources on line again. We used to do this through the Gawler Foundation, but they upgraded their website some months back and dropped their webstore.

Creating our own has been a 3 month process and we have had terrific help from Joel Whitford – very skilled web developer, designer; great with words, highly systematic and thoughtful, creative, great communicator. Made the process a creative delight.

Creating our own store has meant we can offer more detailed suggestions for people with specific interest or needs around meditation, nutrition, the power of the mind and healing. One reminder, if you do download an MP3, the process is relatively easy via computer or android phone (especially if you are under or have access to someone under 30!), but if you want to listen on a Mac device like iPhone or iPad, you need to download via computer, transfer into iTunes and then sync with your device. There is a pdf available on the site and that is sent with each download that explains all this in detail.

 So please do check it out, we hope you find it helpful and that proverbially you catch many good quality, sustainable fish; or if you prefer, grow heaps of excellent organic carrots!

Anyway, do have a look, maybe take advantage of a bargain and do give us your feedback; we are always keen to do things even better. Postage is free for all Australian orders over $70.

To connect CLICK HERE

NOTICEBOARD

1. Next workshop in the Melbourne region: 
Mt Macedon on Saturday August 24th, 10am (arr 9.30) to 4.30pm

Duneira is an exquisite heritage hill station property on the slopes of Mt Macedon. The garden is like a meditative space, so beautiful and filled with majestic trees. I love being there!

Then the house itself is grand enough to host good sized but still quite intimate events. There is a tradition now at Duneira of hosting community events that range from music to personal development and Ruth and I have become regulars.

So, fancy a nice drive to a beautiful place for a meaningful event? If so, CLICK HERE



2. Retreats / Trainings filling 
MEDITATION in the DESERT
If anyone is still thinking of joining us in the desert, we could take a couple more, so let us know very soon. Details: CLICK HERE

IMAGES, WORDS and SILENCE 
Training/retreat with Dr Nimrod Sheinman, Ruth and myself in the Yarra Valley is filling steadily, so if interested, book directly with the Gawler Foundation. Details: CLICK HERE

MEDITATION UNDER the LONG WHITE CLOUD
Ruth and I are leading our first meditation retreat in New Zealand in December at the beautiful Mana Retreat centre that has a similar high reputation for a good environment and great food as the Foundation. Details: CLICK HERE

5 DAY FOLLOW-UP CANCER PROGRAM
Specifically for people who have attended a CanLive program in NZ, or Gawler Foundation program. November 18 – 22 at Wanaka out of Queenstown - one of the most beautiful environments there is. Details: CLICK HERE

NEWS
The ABC documentary program Four Corners is planning to screen what could be a very significant program on Monday 19th August (available via streaming shortly thereafter). Initially the program was to investigate current mainstream cancer research and treatment, and compare costs and outcomes with the more integrative approach.

Early in the program’s development I was told “we want to look at the costs, over-utilization and efficacy of drugs; and the influence of pharmaceutical companies on research findings and promotion of cancer medicines. We also want to have a look at the most up-to-date research on integrative medicine in cancer treatment.

“As always, to tell this story we will be hoping to engage with real people grappling with decisions about their own cancer treatments. We would very much like to engage with the Gawler Foundation and film with cancer patients taking part in your program - people who may have experienced conflict in deciding about their own treatments, or tried one way and then gone another who could help us illustrate the complex issues our audience can engage with. We are very mindful of telling a balanced story, as I know are you.”

I was very enthusiastic, helped connecting Four Corners with relevant patients and their families, and was filmed by them presenting some of my recent Sydney workshop.

Unfortunately, as the program developed, the focus needed to narrow. It seems that covering the cost/benefits of new cancer drugs adequately is big enough! So again I was told “It is a disappointment that our thesis has gone in a direction that doesn't allow for inclusion of the Gawler program and lifestyle medicine in the story… We still very much hope to provide a forum for discussion about where we are going in future with cancer treatments, their cost to the community and the individual, and the bar we set for acceptance of new drugs onto the market…. I remain hopeful that we will do another story around these issues, and I hope you would be prepared to be as generous again with your time if we can do so.”


So do watch the program, do be a little socially active. Give the program feedback. Encourage them. Say what you do like about the program. Say we want to see Lifestyle Medicine in cancer investigated. Ask why is it that something that is so cost-effective, that is so empowering and that has so many benefits as Lifestyle Medicine does, is not part of the mainstream treatment of cancer everywhere? By contrast, why do expensive treatments with high side-effect profiles and often small gains get so much support from the medical world and the wider community?


Hopefully the Four Corners program will break the apparent taboo that has existed for too long around discussing in public the cost/benefits of modern oncology and it will beg the question, what else is there that can help people to manage their cancer, their treatments, and their recoveries? This may well be a good time to speak up.

Ian Gawler Blog: Is soy safe? – part 2

Please note: This blog has been re-posted as there were some technical issues in the original post.

As you tuck into a delightful tofu and veggie stir-fry, or maybe even some tofu ice-cream, is there a lingering doubt? Is this really doing me good? Am I contributing to the prevention of breast and prostate cancer, or am I, as some would have us believe, contributing to their increased likelihood?

If so, you need the answer to this question: Do the phyto-oestrogens in soybeans act like oestrogen or Tamoxifen? Need a full explanation? Let us go Out on a Limb once again, follow on from last week’s exploration of the soybean itself, and explore how cancer and soy beans interact.



Then news of my next workshop; this time in one of Mt Macedon’s most beautiful estates, complete with a gorgeous garden. Duneira on Saturday August 24th. But first




Thought for the day
The doctor of the future will give no medicine, 
But will instruct his patient in the care of the human frame, 
In diet and in the cause and prevention of disease.
                                         Thomas Edison, 1902




WHY LINK SOY and BREAST CANCER?
1. There are historically low breast cancer incidence rates in Asia, where traditional soyfoods are a staple.

2. Research demonstrates isoflavones in soy may exert anti-oestrogenic effects.

3. Some epidemiologic data shows a higher soy intake results in a lower breast cancer risk.

4. Rodent studies demonstrate soy protects against carcinogen-induced mammary cancer.

HOW BREAST CANCER IS EFFECTED BY OESTROGEN
In broad terms, there are 2 types of breast cancer; oestrogen positive and oestrogen negative. Our discussion relates to oestrogen positive cancers in particular and these make up about 70% of all breast cancers.

Oestrogen positive cancers are aggravated by oestrogen (the main female sex hormone). How this happens is that on the surface of oestrogen positive cancer cells there are receptors for oestrogen. When an oestrogen molecule comes into proximity with such a receptor, it attaches (but does not go into the cell) and creates a cascade of reactions within the cell that speeds up the cancer’s progression.

In earlier times, removal of the ovaries was attempted as a way to reduce oestrogen levels in women with breast cancer. But oestrogen is made in other parts of the body, so only in exceptional circumstances has this proven useful.

Many people will have heard of tamoxifen. This was heralded as a breakthrough drug as it attaches to the oestrogen receptors, but does not cause the internal reaction and so blocks the effects of oestrogen. Unfortunately, it does aggravate uterine tissue and is associated with increased uterine cancer, but on balance it remains a widely used anti-cancer drug. Simply put, tamoxifen is an oestrogen antagonist.

WHAT OESTROGEN IS IN SOY?
There are 3 main oestrogen-like chemicals in soybeans; genistein, daidzein, and glycitein. They are present in their beta glycoside forms: genistin, daidzin, and glycitin, hence you may see them written differently.

Genistin/genistein, daidzin/daidzein, and glycitin/glycitein account for approximately 50–55%, 40–45%, and 5–10% of total isoflavone content, respectively in soybeans.

Older adults in Japan and Shanghai, China, typically consume between 25 and 50 mg/day of isoflavones and probably no more than 5% of these populations consume more than 100 mg/day. In contrast, people in the United States and Europe consume an average of less than3 mg/day.

Isoflavones have a chemical structure similar to human oestrogen but bind to estrogen receptors more weakly. Significantly, it has been suggested that genistein, which is the best-studied isoflavone, along with the other isoflavones may act like tamoxifen as estrogen receptor blockers.

What has also drawn attention in recent years are conflicting concerns that isoflavones may stimulate the growth of existing estrogen-sensitive breast tumors. These concerns are based on evidence gathered from studies involving tissue cultures and rodents. However, they do contrast with the human epidemiological evidence that shows among Asian women higher soy intake is associated with a nearly one-third reduction in breast cancer risk and that Japanese breast cancer patients, in comparison to Western women, exhibit better survival rates even after controlling for stage of diagnosis.

SOY FOR THE PREVENTION OF BREAST CANCER
In Asia, isoflavones are consumed as traditional soy foods and not in pure or enriched forms. Epidemiological data associates lifetime, and particularly pre-adolescent consumption of traditional soy with a decreased risk of breast cancer development in humans.

An Asian-American study on soy found that women, pre- and postmenopausal, who consumed tofu, had a 15% reduced risk of breast cancer with each additional serving per week.

Wu AH, Ziegler, et al. Tofu and risk of breast cancer in Asian- Americans. Cancer Epidemiol Biomarkers Prev. 1996;5(11):901-906.

Another trial reported that women in the highest tertile intake of tofu had a 51% decrease risk of premenopausal breast cancer when compared with women in the lowest tertile. In this study, no statistical significant association was observed between soy intake and breast cancer risk among postmenopausal women.

Hirose K, Imaeda N, Tokudome Y, Goto C, Wakai K, Matsuo K, et al. Soybean products and reduction of breast cancer risk: a case-control study in Japan. Br J Cancer 2005;93(1):15-22.

Messina and colleagues published a major review on this subject in 2008 and here I quote from what I consider to be one of the very the best review articles on this topic:

The conclusion drawn from this extensive review of the available literature is that currently there is little evidence to suggest that any potential weak estrogenic effects of dietary isoflavones have a clinically relevant impact on breast tissue in healthy women. Limited data suggest this is also the case for breast cancer survivors.

This evidence includes multiple trials showing no effects on breast proliferation or mammographic density and considerable epidemiologic data showing either no effect or a modest protective role of soy/isoflavone intake on breast cancer risk.

Based on this evidence it seems unlikely that isoflavone consumption at dietary levels (i.e. <100 mg/day) elicits adverse breast cancer-promoting effects in healthy women or breast cancer survivors not undergoing active treatment.

Messina MJ and Wood CE; Nutrition Journal 2008.  For the full reference, CLICK HERE 

SOY AND ITS AFFECTS ON BREAST CANCER
Several earlier studies suggested that whole soy foods appeared to have no negative or positive effect on breast cancer. For example the following two studies found soy foods had no negative impact on breast cancer survival.

Boyapati SM, et al. Soyfood intake and breast cancer survival: a followup of the Shanghai Breast Cancer Study. Breast Cancer Res Treat. 2005;92(1):11-17.

Nishio K, et al. Consumption of soy foods and the risk of breast cancer: findings from the Japan Collaborative Cohort (JACC) Study. Cancer Causes Control. 2007;18(8):801-808.

This, and other evidence, prompted Messina and colleagues in their 2008 review quoted above to state:

Available data on breast cancer recurrence and mortality provide some assurance for breast cancer patients that soyfoods/isoflavone supplements, when taken at dietary levels, do not contribute to recurrence rates although more data are clearly needed to better address this issue.

Currently there are no data to support the idea that soyfoods or isoflavone supplements improve the prognosis of breast cancer patients.

However, in 2009, following more analysis of the Shanghai study, strong new evidence was published showing significant benefits of consuming soy for women with breast cancer in terms of better survival and less cancer recurrence, making Messina’s claim seem outdated.

Women consuming soy in the highest quartile had a 29% lower death rate over the 4 year follow up, and 32% reduced risk of recurrence. The protective effect was present regardless of oestrogen receptor status of the cancer, or whether tamoxifen was used or not.

This is the most compelling evidence to date of a benefit for soy consumption by women with breast cancer (as opposed to no harm). It is important because it shows a benefit for increased soy consumption irrespective of oestrogen receptor status or tamoxifen use.
Shu XO et al. Soy food intake and breast cancer survival; JAMA. 2009 Dec 9; 302(22):2437-43.
For the full reference, CLICK HERE

BUT BEWARE:  NATURAL SOY, PROCESSED SOY – DIFFERENT OUTCOMES
However, it may be that the non-traditional soy foods do create problems. Significantly, soy protein isolates do not contain many of the bioactive components present in whole soy. As we clarified last week, refined products include soy flour and its processed derivatives.

Research has demonstrated that soy protein isolates (85–90% soy protein) do stimulate the growth of estrogen-dependent tumors. Another study evaluated the relative effects of different degrees of soy processing on the growth of pre-existing tumors and demonstrated that consumption of isoflavones in increasingly purer or more highly enriched forms may have a proportionally worse effect on estrogen-dependent tumor growth.

Allred CD,et al. Soy processing influences growth of estrogen-dependent breast cancer tumors. Carcinogenesis 2004;25:1649-1657.

Some research has shown that soy processing increases breast cancer growth in mice. This may be related to isoflavone metabolism and bioavailability, but more research is needed.
Allred CD, et al. Soy processing influences growth of estrogen-dependent breast cancer tumors. Carcinogenesis 2004;25:1649-1657.

SOY AND TAMOXIFEN
There has also been some concern expressed that soy products may actually interfere with the action of tamoxifen itself. However, recent studies examining the interaction between soy and tamoxifen have yielded neutral or beneficial findings.

In one study, soy intake had no effect on levels of tamoxifen or its metabolites.
Wu AH, et al. Tamoxifen, soy, and lifestyle factors in Asian American women with breast cancer. J Clin Oncol. 2007;25(21):3024-3030.

In another, the combination of tamoxifen and genistein inhibited the growth of human breast cancer cells in a synergistic manner in vitro.
Mai Z, et al. Genistein sensitizes inhibitory effect of tamoxifen on the growth of estrogen receptor- positive and HER2-overexpressing human breast cancer cells. Mol Carcinog. 2007;46(7):534-542.

SOY AND YOUNG GIRLS
Of great interest is research that demonstrates eating soy foods during childhood and adolescence in women, and before puberty onset in animals, appears to significantly reduce the risk of breast cancer later in life.

SYNERGISTIC EFFECTS OF SOY
Research evidence indicates a possible synergistic relationship between soy and green tea consumption.

SOY AND THE AUTHORITIES
The American Cancer Society in 2006 concluded that breast cancer patients can safely consume up to three servings of traditional soyfoods per day, although the group advised against the use of more concentrated sources of isoflavones such as powders and supplements.

The United States Health and Human Services Agency for Healthcare Research and Quality (AHRQ) conducted a review of the available studies and found little evidence of substantial health improvements and no adverse effects, but also noted that there was no long-term safety data on estrogenic effects from soy consumption.

The AHRQ report notes that future studies of the health effects of soy need to better address the complex relationship between health and food components, including how variations in the diets, lifestyles, and health of participants might affect the results. Also, studies that substitute practical amounts of soy products into people's diets would better address the question of whether people should make the effort to include more soy in their diet.

The Cancer Council of New South Wales released a statement saying scientific research suggests that overall the moderate consumption of soy products does not appear to present a risk to women with breast cancer, and there is equivocal evidence that consuming large amounts of soy products may have a protective effect against developing breast and prostate cancer. However, the Council does not recommend taking soy dietary supplements as there is no evidence they are either effective or safe at preventing or treating cancers.

WHAT RUTH AND I DO
We regularly eat organic tofu and soy yoghurt (which Ruth makes from Bonsoy). Ruth drinks small amounts of soymilk (mostly Bonsoy in teas), but I do not – I do not like it and have teas and dandelion coffee black). We eat some tempeh but only have silken tofu if ordered by mistake when eating out! We avoid processed soy products and read labels to avoid the myriad of foods with these products added to them.

MY OWN CONCLUSIONS and RECOMMENDATIONS
In answer to the key question, I conclude the phyto-oestrogens in soy act like tamoxifen not like oestrogen. Based on the evidence available, soy eaten in its traditional forms acts as an oestrogen antagonist, making it helpful in preventing and overcoming both breast cancer and prostate cancer. I also conclude:

1. Traditional soy foods are almost certainly safe and warrant being a part of a healthy diet for healthy people. I recommend them. I particularly recommend regular soy consumption for young and adolescent girls; but then lifetime consumption seems ideal.

2. Processed or refined or concentrated soy products run the real risk of being problematic for everyone. I do not recommend them.

3. For women with breast cancer, the best evidence currently available suggests traditional soy foods, eaten in traditional amounts are likely to be safe and may well be helpful in reducing recurrences and extending survival. I recommend them.

RELATED BLOGS
Is soy safe? - Part 1

Coconut oil – are you nuts?

Food for life – what to eat when

RESOURCES
You Can Conquer Cancer – the revised edition has many other explanations like this one on soy. What type of protein and how much? Which are the best fats to eat and to avoid, and so on. This book is about prevention and long-term good health, as well as cancer recovery.

NOTICEBOARD
1. NEXT WORKSHOP in the Melbourne region: Inner Peace, Outer Health

Mt Macedon on Saturday August 24th, 10am (arrive 9.30) to 4.30pm

Duneira is an exquisite heritage hill station property on the slopes of Mt Macedon. The garden is like a meditative space, so beautiful and filled with majestic trees. I love being there!

Then the house itself is grand enough to host good sized but still quite intimate events. There is a tradition now at Duneira of hosting community events that range from music to personal development and Ruth and I have become regulars.

So, fancy a nice drive to a beautiful place for a meaningful event? If so, CLICK HERE





2. MEDITATION in the DESERT

The experience of a lifetime. Seven day meditation retreat with Ian and Ruth in the extraordinary, natural meditation space of the Central Australian Desert, followed by a few days being in the company of senior local indigenous leaders.

For full details, CLICK HERE










3. IMAGES, WORDS AND SILENCE


Five day retreat/training for everyone interested in Insight, Healing and Wellbeing.

At the Foundation's centre in the Yarra Valley with Drs Ruth and Ian Gawler and Dr Nimrod Sheinman, world authority on the use of creative imagery for healing and personal development.

For full details, CLICK HERE