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Letters to the Editor Issue 142

by Letters(more info)

listed in letters to the editor, originally published in issue 142 - December 2007

Obituary:  Canon Christopher Pilkington – 1923-2007

Canon Christopher Pilkington was born in 1923, the third of five children. His grandfather was the founder of the glassmakers Pilkington Brothers. Educated at Clifton and Trinity College, Cambridge, he spent five years in the Air Force and thereafter prepared for the Ministry at Ridley Hall, Cambridge.

He met his wife, Pat, whom he married in 1954 in Worcester; the family moved to Bromsgrove, when he became interested in the Ministry of Healing that was to play a significant role in his life. In 1968 the family moved to Bristol; Canon Pilkington became Rector of the City Parish, St Stephen’s. His skill, experience, and charming, self-effacing manner won him many friends, enabling him to play a significant role in Bristol. He established a Healing Centre, first in the church, and later in a house bought for the purpose in Clifton. It was this Healing Centre that became the Bristol Cancer Help Centre (now Penny Brohn Cancer Care) in which he worked tirelessly, and which he funded from his own pocket in the early years.

The Centre enabled him to do his most profound spiritual work, combining healing and compassion in an accessible way for people caught up in crisis. People without faith found nothing ‘religious’ to put them off. Others found their way back to the Divinity. With his modest, accepting manner, he became everyone’s friend, and thought nothing of crossing the country to pay pastoral visits to those in his care, as priest, healer and friend. 

Retirement enabled him to fulfil a life’s ambition: to write a children’s book. The Fish and the Waterwheel, published in 2006, combined an exciting story with an underlying spiritual message. He was working on a sequel to this story when Parkinson’s disease overtook him. He died October 22nd 2007, leaving Pat his wife, 3 children, and 5 grandchildren.

Ernst Report ‘Essentially Flawed’ Say Herbal Experts

A recent report on the efficacy of herbal medicine, published in the Journal of Postgraduate Medicine, is “of limited value and essentially flawed” a spokesman for the National Institute of Medical Herbalists commented today.

The report, compiled by Professor Edzard Ernst, of the Peninsula Medical School, University of Exeter, claims that there is no good evidence that “individualized” herbal medicine prescriptions are effective.

Basing his comments on a review of just three studies, Professor Ernst claims that his conclusions prove the inefficacy of this traditional application of herbal medicine.

In response to his report, the National Institute of Herbal Medicine (NIMH) – whose members make up the majority of western medical herbalists practising in the UK – has issued this statement:

“We believe that the report issued by Professor Ernst is of limited value and essentially flawed. There is no evidence to support his statement that individualised herbal medicine is ineffective. The very small number of studies upon which he has based his findings is insufficient to reach a conclusion of any kind on herbal medicine in general.

“In addition, only one of the studies reviewed was on western herbal medicine as our members practise it, and this was merely a pilot study on only 14 patients, instituted to ascertain whether it was either possible or indeed relevant to undertake a randomized double blind controlled trial (RCT) in this field.

“The pilot study did show that an RCT was viable, and Guo et al1 (see Ernst report) concur with our findings. However, we and they differ fundamentally in various areas. Amongst these are:

•    We believe that Western Herbal Medicine and Traditional Chinese Medicine should not be grouped together, as they use radically different diagnostic techniques and materia medica;
•    We believe that it is poor science to draw, from this single pilot study, any conclusion on the benefits of western herbal medicine;
•    The pilot study showed positive trends which should be followed up by a larger study.”

The NIMH spokesman, Vice President Jane Gray,  pointed out that their members, all of whom are traditional herbalists, have diagnostic and clinical training at a degree level comparable to that of ‘orthodox’ medical practitioners. In addition, they have a rigorous training in phytochemistry and prescribe, as do ‘orthodox’ practitioners, on the basis of pathophysiology.

To the accusation that traditional herbalists do “more harm than good”, Mrs Gray commented that if that were true, then evidence would have surfaced by now via the Yellow Card reporting system administered by the Medicines and Healthcare Products Regulatory Agency (MHRA). NIMH has reported via the Yellow Card system for some 10 years, and the public have been able to do so directly since 2005. However, unlike ‘orthodox’ medicine, which is the acknowledged cause of thousands of deaths annually, by misadministration, inappropriate prescription, and inappropriate self-medication, no such evidence existed.

To the contrary, evidence that traditional western herbal medicine, as practised by members of NIMH, was an effective and  positive force for good, existed in abundance, in clinical audit and collected case studies, and in empirical and anecdotal evidence.

The need for further research  is recognized and embraced, says Mrs Gray. “Phytotherapeutic research is highly relevant to traditional herbal medicine “ she said. “Herbal medicine is firmly rooted in physiology and pathophysiology, and advances in knowledge are taken on board just as  they are in ‘orthodox’ medical practice. Because we are trained in the biomedical sciences, we recognize the value of all good research, and our adoption of new techniques and new knowledge is part of our continuing post-graduate study.”

References

1.    R Guo, PH Canter and E Ernst. A Systematic Review of Randomised Clinical Trials of Individualised Herbal Medicine in Any Indication. Postgraduate Medical Journal. 83: 633-7. 2007.

 

Further Information

1.    The National Institute of Medical Herbalists is the UK’s leading professional body representing herbal medicine practitioners. First established as the National Association of Medical Herbalists in 1864, today the National Institute of Medical Herbalists has more than 700 members across the UK and beyond.

NIMH members undergo a lengthy training programme before they can register as qualified medical herbalists. Practitioners train for at least three years and adhere to a strict code of conduct before they can gain MNIMH or FNIMH after their name. Recently qualified practitioners will have taken a BSc in Phytotherapy (herbal medicine). All NIMH-registered herbalists are fully insured, and follow a strict code of conduct.

NIMH-registered medical herbalists are trained in the same diagnostic skills as mainstream doctors but take a more holistic approach to treating illness. Herbalists treat a wide range of acute and chronic conditions and frequently work in collaboration with GPs and consultants to achieve the best combination of treatments for individual patients.

NIMH can be contacted at Elm House 54 Mary Arches Street Exeter EX4 3BA Tel: 01392 426022 Fax: 01392 498963; info@nimh.org.uk

2.    The Peninsula Medical School is a centre for research in complementary and alternative medicine based at Exeter University. It is, or has been, funded by, amongst other organisations, pharmaceutical companies such as Boots The Chemist, Lichtwer Pharma, Pharmaton SA, Schwabe GmBH, and Novogen.

Comment: Attack on Herbal Medicine by Prof Ernst and Colleagues

CAM bashing seems to have become a sport for Prof Ernst and colleagues at Peninsula Medical School, University of Exeter, UK. This more recent instance reminds us just how far the science needs to be twisted for Prof Ernst to have managed to make headlines over the risks and lack of efficacy of herbal medicines.

Guo, Canter and Ernst saw their paper entitled ‘A systematic review of randomised clinical trials of individualised herbal medicine in any indication’ today in the Postgraduate Medical Journal.[1]

Prof Ernst and colleagues have done it again. It seems they have wanted to find an excuse to abolish the practice of patient-specific herbal medicine, a healthcare approach that spans several millennia in different, often extremely diverse, parts of the world. In the authors’ minds they may have succeeded as, lo and behold, they have got themselves headlines in newspapers across the globe which suggest that such herbal medicines are ineffective. However, when you read between the lines, it’s not hard to see where the hocus pocus truly lies.

Science or Hocus Pocus?
Guo, Canter and Ernst have entitled their paper: A systematic review of randomized clinical trials of individualised herbal medicine in any indication. You would be forgiven for thinking that this was a review of dozens or even hundreds of studies. But just three? Yes, although Prof Ernst and colleagues started their review with a hopeful 1345 references in the peer reviewed literature, their particular and harsh inclusion criteria managed to whittle away some 98.8% of the references leaving just 0.2% – i.e. three! How the journal allowed this paper to be titled a “systematic review” and how they allowed the title to include its relevance to “any indication” – is anyone’s guess.

Of the three papers, one ran for 16 weeks and involved IBS sufferers, another for just 10 weeks concerning patients with knee osteoarthritis and the final one covered durations between 12 weeks and 6 months, in the case of patients suffering breast or colon cancer. Can these three trials really be extrapolated to apply to “any condition” and all forms of individualized herbal medicine? Of course not! And more importantly, are they scientifically meaningful as compared when they apply to just three types of conditions and cover such short durations, when the real knowledge about these products is among practitioners who have benefited from thousands of years of clinical practice.

One Step Closer to the Medicalization of Herbs?
So while Guo et al may have donned their anoraks and applied their scalpels to an arbitrary package of research that happened to have made it through the peer review publication process, it is the authors’ choice of blatantly incorrect title and conclusion that appears to have been carefully selected to do damage to the herbal medicine sector. Strange as this might seem, regulators around the world are looking for excuses to medicalize herbal products… wouldn’t this be just the ticket, or at least another nail in the coffin, to try to show that the evidence base is weak, that herbal medicines might be dangerous and that they, in any case, don’t work? Although the authors claim to have consulted herbal practitioner associations during the course of their work, judging by the reaction we’ve heard just today, on the day of release of the study’s findings, we’re not convinced many herbal medicine practitioners will support the study’s conclusion, which states:

“Individualized herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended.”

We have a Fundamental Problem
Scientists like Prof Ernst have become so introspective over their worship of their reductionist methods that they fail to see how they do or don’t relate to the much, much bigger picture of how extremely complex and diverse, natural substances interplay with even more complex and diverse genomes. This truly is an abuse of science.

References

1.    R Guo, PH Canter and E Ernst. A Systematic Review of Randomised Clinical Trials of Individualised Herbal Medicine in Any Indication. Postgraduate Medical Journal. 83: 633-7. 2007. http://press.psprings.co.uk/pgmj/
october/633_pj60202.pdf

Source

Alliance for Natural Health info@alliance-natural-health.org

Why Community Oncology Can Benefit From Cell Function Analysis

As increasing numbers and types of anti-cancer drugs are developed, Oncologists become increasingly likely to misuse them in their practice. There is seldom a ‘standard’ therapy which has been proven to be superior to any other therapy. When all studies are compared by meta-analysis, there is no difference. What may work for one, may not work for another.

Cancer chemotherapy could save more lives if pre-testing were incorporated into clinical medicine. The respected cancer journals are publishing articles that identify safer and more effective treatment regimens, yet few community Oncologists are incorporating these synergistic methods into their clinical practice. Cancer patients suffer through chemotherapy sessions that do not integrate all possibilities.

Distinguishing between patients with a ‘high’ or ‘low’ risk for early recurrence after surgical resection and identifying those who may respond to correct adjuvant therapy have been topics of great interest for many years. Both genetic and functional assay analyses share a role in the development of ‘personalized’ patient care.

A genomic test can help to find out if a cancer patient will likely have a recurrence after surgery. If a recurrence isn’t likely, they don’t need chemotherapy. Genetic tests have been developed for breast and lung cancers. Hopefully, there will be more tests for other types of cancer to guide physicians as to which ‘high’ risk patient will likely have a recurrence if treated with surgery alone.[1]

If the test finds a patient to be at ‘high’ risk, it is impossible to design a single chemotherapy protocol that is effective against all types of cancer. The oncologist might need to administer several chemotherapy drugs at varying doses because tumour cells express survival factors with a wide degree of individual cell variability. A cell culture assay test, using a cell-death endpoint, can help see what treatments will not have the best opportunity of being successful (resistant) and identify drugs that have the best opportunity of being successful (sensitive).

The current clinical applications of in vitro chemosensitivity testing is ever more important with the influx of new ‘targeted’ therapies. Given the technical and conceptual advantages of ‘functional profiling’ of cell culture assays together with their performance and the modest efficacy for therapy prediction on analysis of genome expression, there is reason for renewed interest in these assays for optimized use of medical treatment of malignant disease.[2]

The chemotherapy regimen chosen by most community oncologists is based on the type of cancer being treated. However, there are factors other than the type of cancer that can be used to determine the ideal chemotherapy drugs that should be used to treat an individual patient.

It is highly desirable to know what drugs are effective against particular cancer cells before these toxic agents are systemically administered. Pre-testing on ‘fresh’ specimens of cancer cells to determine the optimal combination of chemotherapy drugs could be highly beneficial.

Following the collection of ‘fresh’ cancer cells obtained at the time of biopsy or surgery, a cell culture assay is performed on the tumour sample to measure drug activity (sensitivity and resistance). This will pinpoint which drug(s) are most effective. The treatment program developed through this approach is known as assay-directed therapy.

At present, medical oncologists prescribe chemotherapy according to ‘fixed’ schedules. These schedules are standardized drug regimens that correspond to specific cancers by type or diagnosis. These regimens, developed over many years of clinical trials, assign patients to the drugs which previously worked for some percentage of patients.

However, cancer is a disease whose hallmark is heterogeneity. It is well known that drugs which work for one patient often don’t work for another and patients who fail to respond to first line chemotherapy with one regimen often respond to second or third line therapy with alternative drugs. Why not identify the right regimen before ever exposing a patient to a single course of chemotherapy? A failed attempt at chemotherapy is detrimental to the physical and emotional well being of patients, is financially burdensome, and may promote the onset of clinically acquired multi-drug resistance.

A ‘fresh’ sample tumour can be obtained from surgery or biopsy (Tru-cut needle biopsies). Tissue, blood, bone marrow, and ascites and pleural effusions are possibilities, providing tumour cells are present, and only live cells should be used. At least one gram of fresh biopsy tissue is needed to perform the tests, and a special kit is obtained in advance from the lab. Arrangements are made with the surgeon and/or pathologist for preparation and sending of the specimen.

Upgrading clinical therapy by using drug sensitivity assays measuring ‘cell death’ of three dimensional microclusters of live ‘fresh’ tumour cells can improve the conventional situation by allowing more drugs to be considered. The key to improving drug sensitivity tests is related to the number and types of drugs tested. The more anti-cancer drug types there are in the selective arsenal, the more likely the system is to prove beneficial.

In order to acquire sufficient data, tumours should be tested with at least two assay endpoints, and most often three, for sensitivity tests in any one patient. On average, up to twenty drugs and combinations at two concentrations in three different assay systems, is an effective way to avoid false-positive or false-negative data.

Assays based on ‘cell-death’ occur in the entire population of tumour cells, as opposed to only in a small fraction of the tumour cells occurring in ‘cell-growth’ assays. Drug ‘sensitivity’ testing is merely a point a little farther along on the very same continuum upon which ‘resistance’ testing resides, which has been proven to be accurate and reliable, as reported in numerous peer-reviewed publications.

Good review papers exist on cell culture assays and are increasingly appreciated and applied in the private sector by European clinicians and scientists. The literature on these assays have not been understood by many NCI investigators and by NCI-funded university investigators, because their knowledge has been based largely on an assay technique (cell-growth) that hasn’t been used in most private labs for over fifteen years.[3]

Data show conclusively that patients benefit both in terms of response and survival from drugs and drug combinations found to be ‘active’ in the assay even after treatment failure with several other drugs, many of which are in the same class, and even with combinations of drugs found to have low or no activity as single agents but which are found in the assay to produce a synergistic and not merely an additive anti-tumour effect.

Patients receiving a drug that tested ‘sensitive’ were 1.44 times [i.e. 44%] more likely to respond compared to all patients treated in studies, while patients testing ‘resistant’ were 0.23 as likely to respond as all patients. Patients receiving treatment with drugs testing ‘sensitive’ enjoyed a 6-fold advantage (1.44/0.23 = 6.23) over patients treated with drugs testing ‘resistant.’

This data includes both patients with solid tumours (e.g., breast cancer, lung cancer) and hematological (blood system) tumours (e.g. leukaemia, lymphoma). In the case of solid tumours only, the advantage to receiving sensitive versus resistant drugs was 9.3 fold. In the case of breast cancer, it was more than 10-fold. Furthermore, patients receiving ‘sensitive’ drugs were shown in many studies to enjoy significantly longer durations of survival than patients treated with ‘resistant’ drugs.

Patients treated with a ‘positive’ (sensitive) drug would respond 79.1% of the time, while patients treated with a ‘negative’ (resistant) drug would respond only 12.6% of the time. Once again, there would be a huge advantage to the patient to receive a ‘positive/sensitive’ drug, compared to a ‘negative/resistant’ drug .[4]

Profiles from DNA and RNA expression analysis can help define patients at risk for early recurrence. Cell Culture Assays with ‘functional profiling’ have a role in eliminating ineffective agents and avoid unnecessary toxicity and in directing ‘correct’ therapy.

An ASCO tech review of drug sensitivity and resistance assays, concluded that the use of these assays for selection of chemotherapeutic agents for individual patients is not recommended outside the clinical trial setting.[5]

However, Medicare contractor National Heritage Insurance Company spent a whole year reviewing everything about the cell culture assay, read all of ASCO arguments, and upon reviewing all available information, made the decision to reverse trend and go on record as formally approving the service and providing coverage.

They found that even back in 1999, the Medicare Advisory Panel concluded that cell culture assays tests offered clinical utility. After listening to detailed clinical evidence, the Medicare Coverage Advisory Committee found that these assay systems can aid physicians in deciding which chemotherapies work best in battling an individual patient’s form of cancer.[6]

Although Medicare had been reimbursing for cell culture drug ‘resistance’ tests since 2000, it wasn’t until the beginning of this year that they abandoned the artificial distinction between ‘resistance’ testing and ‘sensitivity’ testing and are providing coverage for the whole FDA-approved kit. The decision had been made that the assay is a perfectly appropriate medical service, worthy of coverage on a non-investigational basis.[7]

References

1.    Chemotherapy Resistance and Oncogene Expression in NSCLC. J Thorac Cardiovasc Surg 133: 352-363. 2007.  http://jtcs.ctsnetjournals.org/cgi/c...ract/133/ 2/352
2.    Genfitinib-Induced Cell Death in Short Term Fresh Tumour Cultures Predicts for Long Term Patient Survival in Previously-Treated NSCLC. J Clin Onco. 2006. ASCO Annual Meeting Proceedings Part 1. Vol 24, No. 18S (June 20 Supplement), 17117. 2006. www.asco.org/portal/site/ASCO...erm=
weisenthal
3.    Functional Profiling with Cell Culture-Based Assays for Kinase Inhibitors and Anti-Angiogenic Agents. Eur J Clin Invest. Volume 37(suppl. 1): 60, April 2007.http://weisenthal.org/Weisenthal_ESCIa.
pdf
4.    Weisenthal Cancer Group, Huntington Beach, CA and Departments of Clinical Pharmacology and Oncology, Uppsala University, Uppsala, Sweden. Current Status of Cell Culture Drug Resistance Testing (CCDRT) May, 2002. http://weisenthal.org/ccdrtrev.pdf
5.    Journal of Clinical Oncology Reviews on Chemotherapy Sensitivity and Resistance Assays. September1. 2004. http://weisenthal.org/jco_response.htm
6.    Verbatim Transcript of Medicare Coverage Advisory Committee (MCAC) Meeting, November 15-16, 1999. http://weisenthal.org/hcfa_1.htm http://weisenthal.org/hcfa_2.htm http://weisenthal.org/hcfa_3.htm
7.    Centers for Medicare & Medicaid Services. www.medicarenhic.com/cal_prov...ytest_0107.
htm

Source

Gregory D. Pawelski gdpawel@comcast.net

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