Bill to Control Alternative Health

Submission by Michael Sichel ND  DO  PhD - 2007 

 This submission shows clear evidence from world leaders in medicine that the foundation of your Bill is deeply flawed: that is, the premise that ‘world’s best medical practice’ is a successful option for New Zealand and Australia. It is imperative that this submission be considered relevant to your deliberations.

If your committee chooses to ignore this clear evidence, then you ignore the warnings of the very experts you propose to rely upon.

Part I

The factual warnings given by experts in medical research:

Witnesses One & Two:  

The Editors of both the “Journal of the American Medical Association” (JAMA) and “The British Journal of Medicine” (BMJ). [i]

In the last 12 months, both journals have made extraordinary editorial statements concerning the serious situation that has developed in the practice of prescriptive and general medicine, caused by the virtual  ‘take-over’ of their crucial role as leaders in advancing medical knowledge, by the pharmaceutical industry.

 In October 2005, the editor of the British Journal of Medicine reported  that unlawful and deceptive medical ‘ghostwriting’ (written by a person other than the stated author – often paid $15,000-$20,000 )[ii], has become a serious problem for his publication:

“We are being hoodwinked by the drug companies. The articles come in with doctors’ names on them, and we often find some of them have little or no idea about what they have written.”

This unlawful situation was further commented on by this statement published in JAMA, by the assistant Editor:

“This is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors don’t know what papers they can trust in the journals, and the public doesn’t want to believe.”

Witness Three:  

Immediate past Editor (for ten years) of the prestigious New England Journal of Medicine (NEJM), Dr Marcia Angell, a nationally recognised authority in the field of health policy and medical ethics and winner of the Polk Award for Medical Journalism:

 In her recent book (The Truth About the Drug Companies – How They Deceive Us and What to Do About It (2004) Dr Angell exposes in detail the ‘take-over’ of medicine by the pharmaceutical industry, as elucidated by witnesses One and Two (above).

Dr Marcia Angell describes how during her twenty years with the NEJM she saw the pharmaceutical industry “Gain nearly limitless influence over medical research, education, and how doctors do their jobs”.  She describes the subsequent $200 billion annual cost to Americans of prescription drugs.

Witness Four: 

The serious results of this virtual take-over of modern medicine are seen most clearly in two recent papers published in American medical journals, one by the American Society of Public Health (in JAMA 2001)[iii] the other by a research team’s 2005 study on alarming outcomes in the world’s leading advocate of “best practice”.

The JAMA paper found the American “world’s best practice medical model” to be the third leading cause of death.  Moreover, three years further on, the  2005 research team found “the world’s best practice” to have become the first cause of death in the USA.

And this at the astronomical financial cost to the nation of 15% of  GNP, higher than the OECD average by six percentage points *.   See this chart summary of the study:

·         inadvertent medically induced deaths     … 783,936

·         heart disease annual death rate               …  699,697  

·         annual cancer death rate                          … 553,251

ANNUAL PHYSICAL & ECONOMIC COST OF U.S. MEDICAL INTERVENTIONS

Prepared by:  Gary Null, PhD, Carolyn Dean, MD, ND, Martin Feldman MD, Debora Rasio, MD, Dorothy Smith, PhD.

                    See References in Reference Appendix Dr Gary Null et al [iv]

OECD health data[v] shows Americans now spend twice the amount of the OECD average on health (adjusted for purchasing power parity). This equates to almost twice that spent in Australia or New Zealand, both of which have significantly better health status indices outcome.

   In fact, in spite of these high expenditures, and being the nation using more pharmaceutical drugs than any other OECD nation, the USA is now ranks only 16 th in the world in its total health and mortality indices.

WITNESS FIVE:

Recent BMJ Editor (for 13 years) Dr Richard Smith:

 “Medical journals have become creatures of the drug industry, rife with fraudulent research and packed with articles ghost written by pharmaceutical companies.”

  From the Guardian, UK. Thursday June 30, 2005

In his highly critical book (The Trouble With Medical Journals) Dr Richard Smith, who edited the BMJ for 13 years, wrote: "Medical journals have many problems and need reform. The research they contain is hard to interpret and prone to bias and peer review. The process at the heart of journals and all of science, is deeply flawed."

      Dr Smith is now chief executive of United Healthcare Europe. He said the book was an honest analysis of trends in medical journal publishing and a frank account of his own experiences as editor of the BMJ.

      He said: "It is increasingly apparent that many of the studies journals contain are fraudulent, and the scientific community has not responded adequately to the problem of fraud.  Medical journals have increasingly become creatures of the drug industry. The authors of studies in journals have often had little do with the work they are reporting.

 The use of ghost writers by pharmaceutical companies is rampant and many studies have conflicts of interest that are not declared.  Similar research fraud is probably common in the 30,000 or so scientific journals published throughout the world.”

    Richard Smith thinks that the way medical journals make their money, by publishing scientific papers, is immoral. He also says they are little more than a marketing tool of the drug companies. That's harsh talk from anybody

- but even more remarkable from Smith, who was editor of the British Medical Journal for 25 years until his departure last summer.

     Smith, like his outspoken former counterpart, Lancet editor Richard Horton, is unafraid of controversy. The two of them used to do a lively double-act now and again, exposing the sharp practices of ambitious or desperate academics and single-minded drug companies bent on publication in prestigious peer-reviewed journals. But now it appears that Smith's thinking has moved on to question the very existence of medical journals in their present form.”

WITNESS SIX

Memorandum by Professor Andrew Herxheimer

(Speaking to British Parliamentary Sub-Committee - Select Committee on Health Minutes of Evidence 2006-2007)

PERSONAL STATEMENT

  I have taught clinical pharmacology and therapeutics at London University from 1960 to 1991, most recently at Charing Cross and Westminster Medical School. I founded Drug and Therapeutics Bulletin, published by Consumers' Association, in 1962 and edited it until 1992. I chaired the International Society of Drug Bulletins from its foundation in 1986 till 1996, and the Health Working Group of Consumers International. I have many times been a consultant to the World Health Organization. I am interested in all aspects of providing independent, unbiased, clear and concise information about therapeutic interventions to professionals and the public, and have long experience of observing the pharmaceutical industry at work.

  Since 1992 I have worked in the Cochrane Collaboration and am now Emeritus Fellow of the UK Cochrane Centre in Oxford.

  If the Committee wishes, I would be willing to give oral evidence.

THIS MEMORANDUM FOCUSES ON THE FOLLOWING MAIN ISSUES, THE FIRST THREE OF WHICH CONTRIBUTE SUBSTANTIALLY TO A SYSTEMATIC OVER-ESTIMATION OF DRUG BENEFIT AND UNDERESTIMATION OF HARM

  1.  The influence of the industry on medical practice and on the regulation of medicines is pervasive, overwhelming and relentless. The problem of undue and unhelpful influence is, arguably, related much more to the extent and volume of industry influence, rather than to outright malpractice.

  2.  The industry takes little pro-active interest in adverse effects of drugs; only legal or commercial concerns move it to do more than the regulators require. The drug regulatory framework encourages this complacency by relying excessively on pre-marketing clinical trials in defining drug safety profiles.

  3.  The nature and extent of drug marketing is worrying, not least because of the intensity of promotion at and soon after a drug is launched—ie when relatively little is known about the performance of a drug in clinical practice. A conspicuous example of the negative impact of drug marketing relates to recommended drug dosage, which is often inappropriately uniform. It is not true that one size fits all, as marketing often demands; industry and the regulators need to take much more account of important differences among users.

  4.  What might be the most effective ways of containing undue industry influence in the future?

                         END OF THE EVIDENTIAL BRIEF

FOUR QUESTIONS THAT YOU MUST CONSIDER:

QUESTION:  The above research and comment from those who umpire the knowledge-base used by ‘evidence based medicine’ clearly shows they do not trust the foundation on which this medicine is built.  If these acknowledged leaders cannot trust their own pivotal journals, how can you make sound and vital decisions for our families and communities?

QUESTION:  In light of this plain evidence, why would you  legislate against a well established and popular alternative health movement, which has almost NIL of the above draconian statistics and tends to produce a healthier outcome rather than a chronically ill population?

QUESTION : Is it wise to legislate in favour of a health system that brings in its wake huge costs, shorter actual life expectancy, more infant mortality, and less expected healthy life expectancy (HALE)? [vi]

QUESTION: Should not the harsh penalties in your Bill be directed at those responsible for the morbidity and deaths we find in your current health system, rather than suppliers of inherently safe products, already regulated?   (Current system Example: the now notorious recent meningococcal vaccine program and the damaged young people throughout your Dominion – see world-wide medical opinions below[vii] ). 

REFERENCES & ENDNOTES:

“What makes all science plain and clear? About 200  pounds a year.

And that which was proved true before, proved false – 200 more”    Samuel Butler 1670

Comments by Dr Marcia Angell, while still Editor of NEJM, May 2000:

The New England Journal of Medicine  By JEFF DONN, Associated Press (May 18, 2000)

- The editor of one of the world's premier medical journals has written a withering critique of the research system, saying science is being compromised by the growing influence of industry money.

Dr. Marcia Angell, editor of The New England Journal of Medicine, joins a wave of critics who say an explosion of research funding from drug and medical-equipment makers has added commercial concerns to the scientific process.

"When the boundaries between industry and academic medicine become as blurred as they are now, the business goals of industry influence the mission of medical schools in multiple ways," she cautioned.

She raised the questions in today's issue of the journal in an editorial headlined "Is Academic Medicine for Sale?" The Boston-based journal is widely regarded as medicine's most distinguished periodical.

Angell, the journal's outgoing editor, acknowledged that rising research funding from biotechnology and drug companies has helped lead to dramatic advances against many diseases in recent years.

At the same time, she said, medical schools have struck a "Faustian bargain" with industry.

Total health spending accounted for 15% of GDP in the United States in 2003, the highest share in the OECD and more than six percentage points higher than the average of 8.6% in OECD countries. By comparison, Switzerland and Germany allocated 11 and 11.5% of their GDP to health, respectively, and Canada and France about 10%.

The United States also ranks far ahead of other OECD countries in terms of total health spending per capita, with spending of 5,635 USD (adjusted for purchasing power parity), more than twice the OECD average of 2,307 USD in 2003. Switzerland and Norway come just after with spending of about 3,800 USD per capita. Differences in health spending across countries may reflect differences in price, volume and quality of medical goods and services consumed.

Between 1998 and 2003, health spending per capita in the United States increased in real terms by 4.6% per year on average, a growth rate comparable to the OECD average of 4.5% per year.  (Source: OECD Health Data, 2006)

Medical ghostwriting (See source, Ref 1). You may not have heard of it, but you'll
probably want to know about it. It's a world that could make your doctor
prescribe the wrong drug.
For trusted guidance - articles rigorously reviewed in medical
journals are the gold standard when it comes to scrutinized, scientific
reports. They're what our doctors rely on to make decisions affecting our
health. But more and more - we can't be sure who's serving up that medical
advice.
Medical ghostwriting can be as scary as it is spooky. People with
scientific backgrounds - often, with PhDs - are paid to stay in the shadows
and crank out Medical Ghostwriter can make $100,000 a year writing
favourable drug reports or favourable reports for drug companies. Then, drug companies get
doctors to put their names on the studies - for money, prestige, or perks.
Marketplace tracked down ghostwriters in Vancouver, Montreal and
Ottawa - one agreed to talk with us, but only if we protected their
identity. Their job could vanish if their identity is revealed. We'll call
our busy ghostwriter, Blair Snitch.
Blair Snitch: “I'm given an outline about what to talk about, what
studies to site. They want us to be talking about the stuff that makes the
drug look good.
Erica Johnson : They don't give you the negative studies?
Blair Snitch: There's no discussion of certain adverse events. That's
just not brought up.
Blair Snitch is paid to write up positive reports. So bad side effects
that could affect patient safety, are sometimes completely ignored.
Snitch makes over $100,000 a year as a medical ghostwriter. An article
that makes its way into a prestigious medical journal - like the Lancet,
British Medical Journal, New England Journal of Medicine - will earn up to
$20,000.
Snitch's work is brisk and busy, but not problem free.
Erica Johnson: How much pressure is there from the drug company to
write something favourable?
Blair Snitch: You're being told what to do. And if you don't do it,
you've lost the job.”