12/2/06 - Debate in Europe - Pharma vs. Supplements

How Codex and other supplement regulation laws may impact the availability of supplements

12/2/06 - Debate in Europe - Pharma vs. Supplements

Postby pcnetwrx » Sat Dec 02, 2006 7:19 am

There has been quite an exchange going back and forth in the British Medical Journal between the two camps of big pharma (drugs) versus alternatives (mainly supplements). At least we have well-educated people arguing our side as the outcome of this issue threatens to spill over Europe and the rest of the world. The following is what is being said:

PRESS RELEASE FROM WAXMAN ET AL: http://www.alliance-natural-health.org/ ... ews&ID=259

EXTRACTS FROM WAXMAN?S FULL ARTICLE:
BMJ 2006;333:1129 (25 November), doi:10.1136/bmj.39037.692743.59

Shark cartilage in the water

Jonathan Waxman, professor of oncology, Imperial College, London
j.waxman@imperial.ac.uk

"It is estimated that up to 80% of all patients with cancer take a complementary treatment or follow a dietary programme to help treat their cancer. These treatments may often delay the institution of conventional therapy and may result from pressure from family and friends to try an alternative approach to the conventional."

"The current prediction is that sales will increase by 7% per annum. The rationale for the use of many of these approaches is obtuse?one might even be tempted to write misleading."

"It is difficult to provide any sort of objective rationale whatsoever for the sales of any of these products. Indeed the claims made by companies to support the sales of such products may be overtly and malignly incorrect as described with some pathos in patients' websites."

"In many cases the agents that are for sale may be doctored by the addition of chemicals borrowed from the conventional pharmaceutical industry."

"The reason that these products are accessible to patients is that they are not subject to the testing of pharmaceuticals because they are classified as food supplements."

"So why do patients take alternative medicines? Why is it that science is disregarded? How can it be that treatments that don't work are regarded as life saving? In my view it is because the complementary therapists offer something that we doctors do not offer, they offer hope, hope of cure. If you eat this, take that, rub with this, manipulate this bit of your cranium, avoid this, and really believe this then we can promise you sincerely that you will be cured. Yes, we can cure you. And there is such pressure on the patient who has failed to be cured by, for example, the shark cartilage, because sharks allegedly don't get cancer, or the sheep sorrel, because sheep sorrel eats up morbid matter. The patient has failed, not the alternative therapy, and the patient has let down the alternative practitioner and disappointed his family who have encouraged his "treatment." The cost of this approach to the patient is seldom researched, but in one recent study was $345 per month."

"And why is it that patients change their diet? For some it is because these changes are empowering and with that diet they will have taken back an element of control of a situation that is entirely out of their control. For others it is because of the pressure put on them by families, friends or vested interest groups to "go organic." "

"Just as complementary medicines are business driven, money must motivate, in part, the dietary specialists, who are fee for service. It all helps drive the profits of the UK retail sales of organic produce which amount to ?1.2 billion annually."

"As time goes by it is the hope of the clinicians that the snake oil salesmen that peddle cures and exploit the desperate will be tipped in the cobra filled dustbin of oblivion."

"It's time for that legislation to focus on a particularly vulnerable section of our society and do something to limit the exploitation of our patients. Why not subject the alternative medicines industry to the level of scrutiny that defines pharmaceuticals?"

"Reclassify these agents as drugs?for this is after all how they are marketed?and protect our patients from vile and cynical exploitation whose intellectual basis, at best, might be viewed as delusional. In this context the current EU initiative to bring forward legislation on this matter is welcomed."

RAPID RESPONSE BY DR DAMIEN DOWNING, ANH MEDICAL DIRECTOR, PRESIDENT OF THE BRITISH SOCIETY OF ECOLOGICAL MEDICINE, PRACTICING PHYSICIAN, HARLEY STREET

Just who can a cancer patient trust?

25 November 2006

Damien Downing,
Doctor
Harley St W1

Prof Waxman employs and perpetuates a crucial medical myth ? that, in contrast to complementary therapies, conventional therapies are all evidence- based, on sound science. But the BMJ?s website Clinical Evidence reports that, of the 2404 treatments they have surveyed, only 15% are rated as beneficial, while 47% are of unknown effectiveness[1]. In his own speciality, indeed, chemotherapy for cancer was found in a 2004 systematic review of studies in the USA and Australia[2] to improve overall 5-year survival chances by less than 2.5%. Interestingly, the review of dietary interventions he cites[3] derived an odds ratio for the effect of a healthy diet, with or without dietary supplements, of 0.90 ? which appears to make them probably 4 times as effective as chemotherapy. Different end-points, granted, and a big confidence interval, but nevertheless ?absence of evidence is not evidence of absence?.

Talk of ?vile and cynical exploitation? could with equal justification be applied to the cancer industry, into which billions has been poured in recent decades, to very little effect. Surely Prof Waxman should be careful not to become, as discussed in the same issue of BMJ, ?a lapdog to drug firms??

1 http://www.clinicalevidence.com/ceweb/a ... wledge.jsp
2 Morgan G, Ward R, Barton M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin Oncol (R Coll Radiol), 2004; 16(8): 549-60.
3 Davies AA, Davey Smith G, et al.. Nutritional interventions and outcome in patients with cancer or preinvasive lesions: systematic review. J Natl Cancer Inst 2006; 14: 961-73.

Competing interests: I practice, inter alia, nutritional medicine, which everybody, including Prof Waxman, appears to have decided is complementary

REPLY BY WAXMAN:

Re: Just who can a cancer patient trust?

28 November 2006

Jonathan Waxman, Professor
HAMMERSMITH W12 ONN

Dr Downey is critical of Big Pharma. But we know, don't we just know, know if we examine the matter critically, that without the Drug Companies, we would not be able to cure leukaemia, lymphoma, testicular cancer, nor childhood malignancy. Nor would we be at a wonderful point in the history of cancer treatments. We are at this point because of the miracle of molecular biology, because of the profit motive, driving Industry. We can promise so much now and we will be able to give so much more soon, to those women with breast cancer who struggle for treatment with herceptin and to those men and women with colorectal cancer whose life expectancy and been doubled in the last five years. Dr Downing, there is no conspiracy. Be thankful for the profit motive that has driven so much change for the good.

Competing interests: None declared

RAPID RESPONSE BY DR ROBERT VERKERK, ANH EXECUTIVE AND SCIENTIFIC DIRECTOR:

Is the good professor being as objective as he might think he is?

27 November 2006

Robert Verkerk,
Scientific Director
Alliance for Natural Health, The Atrium, Curtis Road, Dorking RH4 1XA, UK

As someone who honed his scientific skills at the same university in which Prof Waxman works (MSc, PhD and a number years as a postdoctoral research fellow), I am left somewhat aghast by many of the statements made in Waxman's 'Personal View'.

Prof Waxman has fallen into the trap of being overtly biased, by criticising a minor element of an industry (eg. "snake oil salesmen") and confusing this with the scientific platform on which this very small minority thrive (eg. clinical nutrition, nutrigenomics, etc.). Prof Waxman would no doubt have some difficulty trying to justify the high level of efficacy of chemotherapy in cancer treatment, when it has been shown to contribute less than 5% to the 5-year survival rates for cancer in Australia and the USA (Clin Oncol (R Coll Radiol) 2004; 16(8): 549-60). Does Prof Waxman honestly believe that chemotherapy and radiotherapy are the sole contributors to improvements in cancer survival rates which can be an order of magnitude greater than this chemotherapy contribution? How can any good scientist rule out the role of altered lifestyles and dietary regimes as potential 'confounding factors' in clinical trials, given the sheer power of the human survival instinct? Ignoring the role of nutrition as a means (text lost)

There are no legitimate food supplements in the UK or Europe sold on the basis of their ability to treat or prevent disease. Such claims for any unlicensed medicine amount to a criminal offence and a very small number of 'snake oil salesman' have been and continue to be prosecuted for this. It seems laws exist for snake oil salesmen, but not for misleading or biased scientists or doctors.

Competing interests: Chair of Scientific Advisory Board, Ultralife (UK) Ltd (a UK-based supplement/functional food company); Director, Alliance for Natural Health, a non-profit campaign organisation working to protect and promote natural health using good science and good law.

REPLY BY WAXMAN:

Re: Is the good professor being as objective as he might think he is?

28 November 2006

Jonathan Waxman, Professor
w12 onn

Yes, there is objectivity in the evidence backing my view that cancer patients are being cynically exploited. I note the relevance of the 'competing interests' cited by Dr Verkerk in correspondence with the BMJ, competing interests that devalue the currency of his own comments.

Competing interests: None declared

FURTHER REPONSE BY VERKERK:

Re: Re: Is the good professor as objective as he thinks he is?

30 November 2006

Robert Verkerk, Executive Director, Alliance for Natural Health
Dorking, Surrey RH4 1XA

I wasn't for a moment suggesting that there is no cynical exploitation of cancer patients - and this I am sure we all condemn. However, I pointed out to you that there is a legal mechanism available for dealing with such offenders - and this instrument finds itself used from time to time. Any of us, you included, are able to report suspected offenders to the MHRA who often respond swiftly to breaches of law.

I am surprised that you point the finger at my declared competing interests, given that you have declared none and that I would be very surprised if you or other members of your department have not received funding or support from pharmaceutical companies or any other element within the private sector.

You may have noted a pertinent comment about disclosure in a recent edition of Nature Medicine (Nat Med. 2006; 12(9): 979) which states: "Researchers' disclosures of competing financial interests are undergoing a dangerous transformation from instruments of transparency to evidence of wrongdoing."

Prof Waxman - you have used an honestly declared competing interest in an attempt to invalidate scientific opinion - and this is hardly cricket. If others in your profession were to follow your example, you would have to devalue the significance of virtually all the drugs and treatments you and your colleagues use in your daily practice.

You leave me wondering if those of you working in senior medical positions in universities and hospitals are being as transparent as you might be when you choose not to declare competing interests.

Competing interests: Chair of Scientific Advisory Board, Ultralife (UK) Ltd (a UK-based supplement/functional food company); Director, Alliance for Natural Health, a non-profit campaign organisation working to protect and promote natural health using good science and good law.

FURTHER RESPONSE SUBMITTED BY DR DOWNING, EXPECTED FOR PUBLICATION ON 2 DECEMBER:

Neither Prof Waxman nor I, nor anyone who practices any form of medicine for a living, is in a good position from which to decry the profit motive in medicine; we?re all like Tom Lehrer?s ?...old dope peddler, doing well by doing good?. And yes, we do need a pharmaceutical industry ? though preferably one that is effectively regulated, sensitive to public needs and not monopolistic. But I didn?t think, or suggest, there was any conspiracy going on until Prof Waxman brought it up in his response to me - then I started to wonder.

A striking parallel emerged between this debate and the circumstances in physics and cosmology, lucidly described by Bryan Appleyard in the BBC?s Today programme debate from the Royal Society on Thursday; for 20 years, Appleyard said, scientists, including Stephen Hawking, have been claiming that we are on the verge of having a workable Theory of Everything (?knowing the Mind of God?) but in fact it?s no nearer now than it was 20 years ago. Oncologists - all of them it seems to me - are currently keen to promise that a new Golden Age of Oncology is just around the corner, in which cancer will be a chronic disease controlled and made non-life-threatening by miraculous new drugs. But 40 years ago we were promised that by throwing dollars at the problem of cancer scientists would soon have it fixed, and they didn?t; what reason to believe the oncologists this time round? Appleyard?s phrase was ?the arrogance of the contemporary?, which is how I saw it until now.

Isn?t this promise of a cancer cure the real ?unsubstantiated claim?? Take the case of herceptin, since Prof Waxman raises it; the media have generally agreed that herceptin increases survival by around 50% ? a conclusion based on the two key studies [1, 2]. But this is based on the figures for the relative risk of disease-free survival; the figures for improvement in absolute risk of overall survival are 4.8% and 0.9% respectively (I would be very interested if Prof Waxman can show otherwise). Hardly a ?miracle?, indeed the campaign to have trastuzumab approved by NICE, on the grounds that it is a breakthrough in treatment, looks to me like the real ?vile and cynical exploitation?.

And when Big Pharma consistently seeks to manipulate the stream of scientific information (as extensively documented, and discussed further in this issue of BMJ), the general media happily cut and paste their press releases (as we all know they often do), and oncologists campaign against alternative therapies which might pinch a fraction of the massive funding needed for the new wave of cancer treatments ? well, doesn?t it start to look like a conspiracy?

1. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-1684.
2. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-1672.

It?s clear from Professor Waxman?s response that a threat is perceived not only from dietary/food supplements used by millions to support their health, but he has also taken a sideswipe at organic food, produced by a branch of agriculture supported by increasing numbers of consumers that is threatening Big Food and agri-business. The irony, of course, is that those most interested in minimising both the burden on the healthcare system and time spent in doctors? waiting rooms are those who will be more likely to consume both organic foods and high quality food supplements. Market research has demonstrated that most users of food supplements do not use these products to counter poor diet, but rather use them to add nutrients that they believe are missing as a result of modern agriculture and food processing methods.

The increasingly vocal hatred expressed by key opinion leaders within the orthodox medical community has to be an expression of the threat that they perceive from the millions of people around the world who continue to use products derived from nature as key components of their healthcare regime.

You?ll appreciate that this is no time for anyone to put their head in the sand!

(end ANH material)
pcnetwrx
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Postby Greg » Sat Dec 02, 2006 1:34 pm

Thanks for the update Kerry.
It's sickening to see individuals like Waxman and his ilk try to defend the indefensable.
I don't think that there is a person alive who will deny that a healthy body and immune system is our best defense against illness and cancer yet Waxman seems to be arguing that point if you boil down his tranparent positioning.
It's my belief that they want you to get sick so they can sell you chemicals at outrageous prices.
Waxman seems to ignore the fact that Doctors, hospitals, and the drugs they worship are the 1st or 3rd leading cause of death.

My favorite corporate drug pushing lately is the rash of arthritis drugs on the market.
Have you listened to the side effects of Humira?
oh...and by the way... you may get Lymphoma.

Well... I could go on and on about medical corruption but that would most likely just turn into a rant so to spare the board all of that I will suffice to say we all need to speak out to defend our right to feed and treat ourselves with whatever substance we see fit.
Greg
 
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