A Global Threat to Complementary and Alternative Medicine?
by Carol Boyce
The issues threatening homeopathy in the UK, threaten all CAMs, cross national borders and are set to affect all countries in the near future.
Homeopathy: legislation in the E.U.
In the European Union, each country currently has its own specific regulations with regard to the practice of homeopathy, for example: medical doctors only in Eastern Europe; medical doctors and registered Heilpraktikers (health practitioners) in Germany; in Portugal medical doctors are not allowed to practice homeopathy but non-medical practitioners have permission; and in the U.K., practitioners are free to practice any therapy under common law, as long as they do not describe themselves as practicing medicine.
The popularity of homeopathic medicine among the medical profession in much of Europe makes the negative outbursts of the U.K. medical fraternity that much more astonishing. In 1992, Europe adopted two directives concerning homeopathic medicine for human and veterinary use, marking the official recognition of homeopathic medicine in all E.U. countries. In 1995 the first publication of a monograph titled “Homeopathic Preparations” appeared in the European Pharmacopoeia. Homeopathic products are classed as medicines throughout the E.U., and since 2004 have been controlled under the Human Medicinal Products Directive, the same Directive as conventional pharmaceuticals, subject to tighter regulations and overseen by the European Directorate for the Quality of Medicines. Although in terms of safety, manufacturing, control, and stability they are subject to the same rules as all other medicines, they do not as yet, have to provide evidence of efficacy. (1)
Codex affects everyone, everyday
The Codex Alimentarius, or the food code, is a collection of standards, codes of practice and guidelines that has become “the seminal global reference point for consumers, food producers and processors, national food control agencies and the international food trade”.(2) Codex affects everyone, every day.
The Codex Alimentarius Commission is the bureaucratic body charged with developing the codes of practice for harmonization of global food standards and simplifying trade between countries, and the commission is closely tied to the World Trade Organization (WTO). Superficially this looks like a good idea: if standards are harmonized, we know what we are getting when we buy and sell goods. The problem lies in who sets the standards and why. The WTO is run by huge, self-serving corporations. Closed-door meetings and a restricted appeals process mean that no nation can retain its sovereignty. In recent years, Codex has expanded its scope and is currently setting enforceable directives on nutritional supplements and from there potentially reaching into the wider CAM arena. Although adoption of the regulations is described as voluntary, compliance will be required in order to trade with countries that have adopted them, so there will be considerable pressure on individual countries to comply. The European Union is currently the most powerful trading group in the world. The power of the E.U. to set the Codex agenda, and potentially to affect trade regulations everywhere, is significant, and the E.U.’s current trend toward increasingly restrictive trade practices assumes critical importance, via Codex, for the entire global CAM community.
It’s just a precaution
In April 2007, Europe and the U.S. signed a transatlantic trade agreement with the express intent of making trade between these two powerful regions easier. Harmonization of regulations is crucial to this agreement, and the powerful vested interests that originally pushed for the restrictive Food Supplements Directive in Europe is set to push for its adoption in the U.S. In the name of consumer protection, Codex uses what it calls the “precautionary principle”. Originally developed by activists to protect the environment, it is now in use as an unlimited regulatory instrument.(3) If there is any suggestion of a risk and “scientific uncertainty persists” that there is no risk, then Codex can impose provisional restrictions until that scientific information becomes available.
In reality there is always a risk to everything; drinking too much water will kill you. Asking science to definitively prove there is no risk makes risk assessment redundant and provides Codex with a tool that can be used to restrict anything that can be described as food-related. It may all seem to make sense in the interests of consumer safety, but in these days of corporate interests taking precedence over consumer protection, as and when it suits, it could spell the end of free access to the nutritional supplements we take for granted in places like the U.K., the U.S., the Netherlands, and New Zealand.
The Alliance for Natural Health (ANH), a non-profit organization based in the U.K., challenged the European Food Supplements Directive all the way to the European Court of Justice in Luxembourg. The court found in the ANH’s favor in 2005, but the legal discussions and challenges continue. In a minefield of bureaucracy, and against mighty corporations pushing for the restrictions, this small group of committed individuals is determined to take a stand for all of us. Future access to a wide range of nutritional supplements in therapeutic doses hangs in the balance, not just in Europe but potentially for all trading countries. (4)
In the name of consumer safety therefore, the trend in all areas of CAM is toward more-restrictive regulation. Given confinement of ingredients, to those synthetic and patented, and defined as safe and efficacious by extremely expensive trials, rather than natural ingredients tested by decades of safe clinical use, only the most powerful manufacturing companies will be able to compete in the marketplace. Add to that the confinement of higher therapeutic doses of nutritional supplements to medical prescription, and a significant portion of CAM is moved into the hands of Big Pharma.
There seems little doubt that there is a conscious push by the pharmaceutical companies to move into the CAM arena, but on their own terms: monopoly. Though the European Union currently favors homeopathy, recent E.U. legislation restricting access to supplements suggests that any harmonization of legislation relating to homeopathy would tend toward similar restriction: medically qualified prescription-only homeopathy, as is already the case in much of Europe. Homeopaths everywhere should take heed. Our freedom to do our work can rapidly be compromised through commercial pressures for new legislation.
Big Pharma Democracy
A brief look at the 2007 push by pharmaceutical companies for permission to communicate directly with the European public (for which read “advertise prescription drugs”) serves to illustrate the extent to which they have inserted themselves into the democratic process. If it were successful, it would ease the path for similar changes worldwide.
To date, the U.S.A. and N.Z. are the only countries where drug companies are allowed to advertise prescription drugs. Some countries allow vaccine campaigns; and some, advertisements for products to help smokers withdraw from nicotine, but the drug companies already circumvent all such restrictions by presenting the information in “news articles”, describing a specific health condition and then mentioning the imminent arrival of a new drug that will address it. In 2001, the most influential drug companies, via the European Commission (the executive arm of the European Union), pushed for a pilot project targeting asthma, diabetes, and HIV infection, stating that the public needed information on these diseases and their treatment. The European Parliament reviewed the results of direct-to-consumer advertising of prescription drugs in the U.S. and N.Z. and solidly rejected the proposal (494 against, 42 in favor).
In 2005, the same European Commission created a new group, the Pharmaceutical Forum, to add to the pressure. Despite a call for transparency of committees, no full list of participants, how they were selected, how conflicts of interest are managed, or even how the forum works has ever been made public. Patient representation on the Pharmaceutical Forum is provided by the European Patient’s Forum, a group funded by drug companies. Friends of Europe, another “patient” group, has thrown its weight behind the push for prescription-drug advertising. Its report, concluding that the paucity of health information in Europe needs to be addressed, was funded entirely by Pfizer. The report is based partly on information from the Cambridge University Informed Patient Project, funded by Johnson and Johnson. (5)
Conflicts of interest
By any recognized standards, conventional medicine is failing the public and bankrupting companies, countries and private citizens. Held to ransom by the pharmaceutical industry, Americans pay the highest prices anywhere on earth for their drugs; price markups of 1000%– 50,000% over manufacturing costs are not unusual. Iatrogenic disease is now accepted as the third-leading cause of death in the U.S. Some say that this is an underestimate; that it is now actually the leading cause of death. (6) Alarming numbers of pre- schoolers are prescribed psychotropic drugs in the medicalizing of what was once considered normal childhood behaviour. (7) According to the U.S. Institute of Medicine’s 2007 report, pharmaceutical drugs injure at least 1.5 million Americans each year. Given the power of the Internet, efficient dissemination of information, and the consequent empowerment of the public, it can only be a matter of time before the system implodes upon itself.
In a desperate attempt to protect its medical monopoly, Big Pharma buys out dissenters; directly affects the democratic process with millions paid to lobbyists ($75 million and 678 lobbyists in Washington DC in 2001); pays doctors handsomely to lecture about specific drugs in the guise of seminars; pays commissions to clinics prescribing specific drug protocols; sponsors undergraduate medical training; funds university research; finances trips to exotic locations for product placements thinly disguised as conferences; funds scientific journals with advertising dollars; manipulates the media in places like the U.S. via its advertising revenue; and sends armies of drug representatives to offer GPs pizza and coffee in the middle of their busy day. These can surely only be the actions of a failing system. If we factor in that the majority of pharmaceutical best-sellers (those responsible for between 14% and 41% of Big Pharma revenues) have patents due to expire before 2012, we can better appreciate the pressure these companies are under to satisfy their shareholders. Amongst the expiring patents are those for Viagra and Lipitor, the world’s bestselling medicines (that fact in itself perhaps a reflection on the health of conventional medicine), are worth 41% of Pfizer’s revenue stream. (8)
It seems that the only certain way the system can maintain itself is by legislating against consumer choice! The estimate in the WHO report of 2005 that homeopathy is the fastest growing modality on planet earth with more than half a billion users must put it firmly in the firing line.
The FDA goes into business for itself
In the U.S., a new business model for industry regulation was rushed through the democratic process in late 2007, as Bill S1082 created the Reagan–Udall Foundation, a joint commercial venture between industry, private investors, academia, and philanthropic organizations working together with the FDA to research and develop new drugs and procedures and bring them to market in a timely manner. Conflicts of interest were already rife in the FDA, with more than 50% of its funding paid by the pharmaceutical industry to fast-track drugs through to market, and the revolving door between FDA officials and high-level positions in the same commercial companies. The inclusion of “foods and food ingredients” in this bill potentially allows the FDA to extend its reach to nutritional supplements and declare them unsafe according to the FDA’s latest development, the Critical Path Initiative: a department responsible for designing methods of predicting safety and effectiveness, in an attempt to streamline drug development and bring products more quickly to market.
A new drug in development has only an 8% chance of ever reaching the marketplace. A 10% improvement in failure prediction (safety issues and lack of effectiveness) before clinical trials could save $100 million in development costs per drug. The Critical Path Initiative will develop new assays, computer-modeling techniques, biomarkers, and clinical-trial endpoints, refining the development process. Drugs will be brought to clinical trial based on computer-modeled safety predictions or specific isolated bio-markers, with the associated potential risks when patients, for instance, do not behave like the computer models. In terms of nutritional supplements, it again boils down to who identifies the criteria and why. These new tools, in particular the use of FDA selected bio-markers, could provide a means by which nutritional supplements, proven perfectly safe in decades of clinical use, might be declared unsafe according to an arbitrarily chosen biomarker. Given the complex mix of vested interests, it must be another cause for concern.
More of the same
Another legislative trend, this time in Canada, is exemplified in the tabling of Bill C-51 in April 2008 by the Canadian Health minister and being debated in parliament. Health Canada, the official government website, states clearly that neither Codex nor Bill C-51 will affect regulation of Canada’s natural health products since they are not considered food and are already defined as a subset of “drug” with separate regulations. But in C-51, “drug” would be replaced by the term “therapeutic product”, and the word “sell” would be extended to mean “distribute to one or more people”, thereby potentially including a whole range of natural health products under the same definition as pharmaceutical drugs. In addition, the bill extends powers of enforcement and, perhaps most crucially, shifts decisions from elected officials to administrative bodies in closed meetings. Codex remains the most obvious example of this recent legislative trend, but other current examples include allowing administrators to decide funding withdrawal for U.K. N.H.S. homeopathy, and giving the (non-elected) U.S. Federal Advisory Committee the power to set regulations governing a major increase in the state’s mandatory vaccination schedule (proposed New York Assembly Bill 10942 currently on the table). A strong Canadian grassroots campaign successfully mobilized and called for clarification of Bill C-51’s possible effect on access to natural health products, and, depending on the government’s response, will oppose its ratification. Initially the CAM community’s sensitivity to the changes in terminology was dismissed as a question of semantics, but in the face of public pressure, the Canadian government was forced to make amendments to the bill, including a clearer definition of “natural health products”. (9) Major concerns about the Bill remain, and the scene is still potentially set to restrict all things natural in favor of all things pharmaceutical and to remove the public’s power to influence the decisions directly affecting its health. (10) Grassroots opposition continues to make headway and provides a great example of the power of consumers to effect change.
There is no sign that the anti-homeopathy - indeed, anti-CAM - movement is running out of steam. It is clearly active at media level, as exemplified by the ongoing series of negative articles in the press; but given the pressure exerted on Primary Care Trusts to withdraw N.H.S. funding for homeopathy and the legislation currently under examination in the European Union and Canada, it is also equally active, and potentially much more dangerously so, at administrative and governmental level. There is no reason to imagine that similar legislation regarding CAMs is not already being written in the US. Indeed, the American Medical Association, the doctor’s trade organization, has been extending its Scope of Practice Project (SOPP) during the last two years in order to ensure that legislation is in place to firmly establish allopathic medicine as the only provider of primary care medicine. All other disciplines, including specialties such as optometry, podiatry and CAMs, would be limited to that available as part of a licensed medical practice. “…During 2008, SOPP is attempting to limit non-physician scope of practice through a combination of legislative and regulatory activities, "judicial advocacy," and "programs of information, research, and education," ..” (11)
Getting a seat at the table
Professional homeopaths are working hard to promote homeopathy and to protect patient access to homeopathic treatment. They should also remember that in places like Europe and North America, Australia and New Zealand, they have the largest professional homeopathic organizations; offer the most comprehensive homeopathic education programs; conduct the majority of provings; write almost all contemporary homeopathic literature and strive to maintain homeopathic prescribing in its purest form. In the current climate, it would seem imperative to build a cohesive and collaborative movement that will ensure the professional homeopathic community has a prominent place at the table of future healthcare providers.
Based on a series of articles published in Similia:
Magnus Pharma and the Golden Goose Similia vol. 19 no. 1 June 2007
Homeopathy and Humbug Similia vol. 19 no. 2 Dec 2007
Edzard Ernst and the Ultimate Delusion Similia vol. 20 no. 1 June 2008
1. Community code relating to medicinal products for human use
http://europa.eu/scadplus/leg/en/lvb/l21230.htm
2. http://www.codexalimentarius.net
3. Raffensperger C. and deFur P.L. Implementing the Precautionary Principle: Rigorous science and solid ethics. Human and Ecological Risk1999;5:933–941
4. Alliance for Natural Health http://www.anhcampaign.org/
5. Big Pharma’s health information: a growing danger. Transl. from Rev Prescrire 2006;26(278):863-865
6. U.S. National Center for Health Statistics. National Vital Statistics Report 2003;51(5)
7. Coyle J.T. Psychotropic Drug Use in Very Young Children. JAMA 2000;283:1025–1030
8. Mike Nagle. Pfizer axes jobs and closes plants. DrugResearcher.com, http://www.drugresearcher.com/news/ng.asp?n=73592-pfizer-prudential-equity-group-job-cuts- plant-closure-patent-expiry
9. Schmidt S. Amendment to provide new bill of health for natural remedies.
The Montreal Gazette 14 Jun 2008.
10. Buckley, S. Draft Discussion Paper on Bill C-51, 9 Apr 2008.
<http://www.healthcanadaexposed.com/discussion.htm>.
11. AMA Scope of Practice Initiative Advances. American Optometric Association June 2008 http://www.aoanews.org/x7856.xml?AOAMember
Carol Boyce, BSc, MCH, CCH, RSHom(NA), homeopath, teacher, writer.
