Quality Assurance In Medicine and Alternative Medicine
Willem Betz University of Brussels VUB, Department of Family Medicine. Laarbeeklaan, 103, B-1090 Brussels, Belgium
Today all branches of normal health care accept the need for quality control and quality assurance. This implies that all diagnostic and therapeutic procedures, institutes, products, devices or medications, must be subjected to a continuous process of evaluation. Much literature has been written on the aspects of quality in medicine, and they are many. Quality has to be evaluated not only from the point of view of the doctor's, but also that of the patient, the epidemiologist, the pharmacologist, and the health insurance.
This implies that Quality in Medicine has many aspects such as:
· Effectiveness and Efficiency
· Correct and Complete Information
· Safety: Risk-Benefit ratio.
· Patients' Satisfaction and Compliance.
· Patient Friendly
· Quality of Life
· Patients' Rights
· Availability — Low threshold
· Cost-benefit ratio
· Reproducibility of Diagnostic and Therapeutic procedures.
All of those aspects can be important, but the point I want to make is that there is a gradient of importance in those criteria. What is the use of a procedure that is cheap, friendly, available, and harmless but does not work? Effectiveness is the cardinal criterion. Once this has been proven, the Risk/Benefit ratio comes next. If the questions on those two criteria are not answered satisfactorily, all the other criteria become less important or meaningless.
The main questions for any treatment are «Can it alter the natural course of a disease or complaint for the better?» and « What harm can it do?»
In this paper we will focus on the main topic for quality: Effectiveness = Does it work?
How to measure Effectiveness?
Evidence Based Medicine
Medicine has entered a phase where it is accepted that all diagnostic and therapeutic acts should be based on evidence. This rule should be applied to all medical procedures without exception, whether they are based on the supernatural, folklore, tradition, logical deduction or reasoning. This implies that all medical interventions without any exception or discrimination must pass the test. The accepted procedure to evaluate medical procedures is the RCT, the randomized clinical trial with control group, but one positive trial is not sufficient. The results must be reproduced by multiple independent researchers. Another important factor determining the acceptance of any medical act is safety. Immediate dangers are relatively easy to detect but the long-term side effects can only be detected by objective methods of registration and diagnosis.
Those rules are the main pillars of today's evidence based medicine (EBM) and one might hope that in the near future only EBM should be offered to the public and that all non-EBM should be abandoned.
This consequence is that all acts of Medicine can be placed in one of 3 categories:
1. EBM = having sufficient proof.
2. 1.a. EBM and today's best choice.
3. 1.b. EB but obsolete: to be discarded and replaced by better, cheaper or safer
4. Experimental medicine = in the process of evaluation, under strict ethical conditions as prescribed by the Helsinki declaration.1 The path to progress or rejection.
5. Non-EBM: having no convincing or negative evidence. Quackery
Who decides in which category a treatment is to be placed?
The decisions are based on publications in quality medical journals. Other independent authors confirm or refute the results. When sufficient evidence is accumulated, the results can be translated into recommendations, guidelines or standards for the medical community, often, by process of consensus conferences. This procedure of acceptance is gradual and gains momentum with the accumulation of the evidence, or is stopped by lack of confirmation.
In a later stage the guidelines can be adopted by the medical profession, the Health Insurance Organizations or Health Maintenance Organizations.
Alternative Medicine (AltMed)
Some groups are pretending that there is a fourth kind of medicine that should be exempted from the rules for EBM. They call it Alternative Medicine or complementary or CAM, or many other names. I shall call it here Altmed.
They want to gain official recognition for it by other means than scientific proof. Not succeeding in convincing the academic world with evidence, or simply ignoring them, they try to bypass the requirements for evidence by appealing directly to the population and the politicians to gain official recognition, not without some success.
Many academic doctors naively think that the matter will be decided in the medical journals. They are wrong, it will be decided by the politicians. Therefore it is necessary to look at some of the tactics, arguments and methods and analyze them, so that we can recognize, expose and counter them.
It is the duty of the honest medical profession to meet them in the field, to write letters to the editors, to give interviews in the media, to seek contact with political decision makers, to answer their arguments.
ARGUMENTS TO GAIN RECOGNITION
1. Proof by many years of experience: They claim that a method that has been in use during many years does not need proof anymore. Very often the popularity in another far away country is used as «evidence».
Comment: Popularity has but little relation with efficacy. Too many remedies are sold for self-limiting diseases. We can only wonder what conspiracy has made that bloodletting and cow dung plasters are less common today and why is chicken soup not registered as an official treatment.
2. Safety by many years of experience: This is repeated in the WHO «doctrine of assumed safety» that has been adopted by the USA NCCAM.2 The Belgian drama with Chinese herbs and 100 women with destroyed kidneys and cancers do not confirm this doctrine.3 Safety of long-term adverse effects can only be evaluated by careful diagnosing and monitoring. The rising popularity of some old remedies brings to light more and more serious problems, but those problems are not discovered by CAM practitioners who still try to deny them.
3. Proof by Popularity:
The political impact of this argument is not to be ignored. Claiming that many people use it and want it (20% -40%- 60% 80%!) is good bait for many politicians who can see a potential source of voters.
Comment: Those survey figures are usually boosted by the way the questions are phrased and in the broad definition of CAM used in some surveys, even defining dieting, healthy eating, regular physical exercise as altmed. The figures vary in different countries but a more realistic figure is that 8% of the population has regular recourse to altmed.4 Those 8% are generally also high consumers of normal medicine. Only a small fraction of them uses altmed exclusively.
4. Satisfied patients are proof enough.
We do not need scientific proof; our satisfied customers are proof enough. If our method were not good, it would have disappeared a long time ago.
Comment: Popularity is not evidence of efficacy, though is can be an indicator of a certain satisfaction or pleasure found in the procedure but mostly it is the result of a campaign of false promises and misguiding. An individual patient cannot judge if he became better by the treatment or it was a spontaneous recovery. Sometimes the cure was just an illusion: there are too many documented examples of patients who publicly testified that they were cured who were not cured at all or even died shortly after the cure.
5. We have evidence but the establishment ignores it
This is part of the Great Conspiracy hoax. They suggest that the medical «establishment» ignores the existing excellent evidence for reasons of greed or stupidity. Very often the pharmaceutical industry is pointed as the great culprit who tries to stop a competition that is cheap, natural and safe. The oncologists are afraid of loosing their high income if it became known how good altmed is.
Comment: Please show us your best evidence. This has been done also in the EU International Scientific Collaboration Project on Alternative Medicine COSTB4. A special workgroup called «Constraints for recognition» was formed to examine this. The results can be found in the COSTB4 report.5 The conclusion was clearly that there is no convincing evidence that altmed has any clinical use, (apart from some slight effects on nausea by acupuncture and perhaps some effects of manipulations on low back pain. There are some trials that seem to show a very slight positive result but they have not been reproduced. The results of some meta analyses have no clinical value because they are a mixture of many different treatments on many different diseases.
6. We cannot produce evidence in the orthodox way because
6.1. The scientific method is not suited to test altmed. In one of the official documents of the European Parliament one can even read that homeopathy cannot be tested with «conventional» statistics. Another remarkable statement was: «If the scientific method can not prove Altmed, then something is wrong with that method».
Comment: This argument is of course in contradiction with the previous one, but it does not seem to bother them to declare in one breath that the have it and that they can not have it. Is this AltLogic? Nowhere have we found an explanation of what is wrong with conventional statistics and what non-conventional statistics they propose.
6.2. It is a different Paradigm. It has to be judged by different Criteria,
Comment: Even in a different paradigm there should be criteria. Please show us your criteria so we can evaluate them and perhaps learn from them. When asked to explain what they mean by a different paradigm, it usually amounts to a distortion of what Thomas Kuhn meant by this word. It amounts to «anything goes if one believes in it» and «science is just a social construction made by the establishment»
6.3. No Money: We are not able to produce evidence because we lack the financial means to do the trials, since our treatments are cheap and can not be patented.
Comment: The altmed industry makes profits that can be situated in the billions of $. Many countries and organizations have spent and still spend enormous budgets to support research on altmed. We are still waiting for any convincing results.
7. You can not judge us: «Only a homeopath can judge a homeopath»
Comment: It is perhaps correct that we can not (or do not want) to judge if a homeopath has acted according to the rules of his very peculiar system, but as doctors we can very well evaluate if his intervention has more effect than a placebo or no treatment.
8. We do not treat Diseases. We treat People:
Comment: This is a very fundamentally wrong argument. When put to the direct question if they deny the existence of diseases the answer is usually very misty. The discovery of diseases as an entity with their own causes, diagnosis, prognosis and treatment is one of the great steps forward that has brought medicine out of the age of superstition. Do they want to go back to the dark Middle Ages?
9. We are recognized in other countries, why not here?
Comment: It all depends on what grounds those other countries made their decisions. On the EU this has been a very hot issue. A motion by a group of green party member to start immediate recognition of altmed has been amended in the last round of the discussion by the parliament by adding the words «if the evidence warrants it».
The proponents of the proposition were furious.
10. AltMed is cheap:
The Economical Argument.
Comment: Some are and some are certainly not, but that goes also for real medicine. Experiments with re-imbursing altmed by health insurance have not shown diminished costs of health care, on the contrary. 6
11. Altmed is Natural, is Safe, is Soft, is Non-Toxic:
Comment: That statement is certainly not correct. Some treatments are indeed very safe because they do nothing, but others have caused many victims by the method itself. Even the so-called safe ones can be dangerous because they often make the patient for the sake a treatment that could have cured him.
12. AltMed improves the Quality of Life:
Comment: Where is the proof for that statement. This argument is often used on patients who have to undergo a treatment that has known serious side effects (e.g. radiotherapy or chemotherapy). Indeed, no treatment does not produce those nasty complications but the progression of the disease will.
13. We want to Protect the People against Charlatans:
Or also: The people have a right to Good Quality AltMed.
Comment: Some groups of altmed say that there are many incompetents on the field and the people must be protected against them, but they fail to produce objective reproducible criteria how they will make the difference. Mostly it amounts to «the members of our organization are the good ones». This has already leaded to hilarious situations of rival organizations of homeopaths and also acupuncturists calling each other quacks. Perhaps the government should organize a state exam for coffee enema therapists.
It is futile to test for a skill or knowledge that has never shown to objectively benefit the patients.
methods USED to obtain recognition
Refer to Surveys of patient satisfaction:
This is a very devious way that has been used many times and has to be watched closely. That there is no relation between satisfaction and efficiency or safety has been proven many times but the most striking was the survey in Belgium (1990, G. Adriaenssens for the department of Medical Sociology of the VUB University of Brussels in collaboration with the National Consumers Organization) on the use of blatantly fraudulent health devices (excluding so called alternative medicines). The results were puzzling: «only» 57% of the users of worthless therapies thought they saw a positive result, but 77% declared they were globally satisfied and 45% had recommended it to other persons. This shows how dangerous it can be to trust those satisfaction surveys. One might as well inquire about the satisfaction of alcohol and cigarettes and then conclude that they are very good.
Abuse of the Status of Controlled experiment:
The fact that permission for experiment was issued is abused to falsely create the impression that the therapy is recognized. The «trials» are sometimes prolonged for years (e.g. USA: Burzinsky with his neoplastons)
The remedy should be to limit the trials in time and to give the ethical committee the power to halt a trial if the rules are not met.
Direct recourse to Politicians and Media
False or Twisted Information: Presenting incorrect information to the press, the public and politicians.
Creation of recognition boards composed of only adepts.
Create monopolies. Binnenanerkennung, Dutch macrobiologists
Re-baptise: treatments become food supplements.
Attack Academic Medicine:
«Cut Burn and poison».
«Only 15% is EBM»
«Millions op people die in hospitals»
Corrupted by the pharmacy industry.
Since SciMed is so bad, then Altmed must be Good
Appeal to Freedom: Right to Freedom of Choice.
Equal rights: Stop the Discrimination!
A flock of birds:
Dispersing after negative results.
Regrouping when positive study appears.
Plain cheating: Ignore the laws and pay the modest fines.
DISCUSSION OF SOME SUCCESSES OBTAINED
1. In the EU: The Simplified registration of Homeopathic and Anthroposophic Medication.
2. In Germany: Binnenanerkennung, The E -Commission.
3. In Belgium: Classification of herbal drugs as food supplements.
4. In The Netherlands: Abolition of doctors' monopoly on diagnosis and treatment. Recognition by boards of peers. Homeopathic medication registered with indication but without proof.
5. In the USA: Escaping control by the FDA. The Acupuncture Board. The DSHEA.
6. In the WHO: The rule of assumed safety. The indications for acupuncture.
7. Several Laws have been passed silently.
RECOMMENDATIONS FOR THE FUTURE:
· The patient will not be protected by publications in medical journals.
· The lawmakers and the courts will decide.
· Doctors must assume their responsibilities: inform themselves, talk to the media.
· Close surveillance and follow up on planned laws on Medicine and Pharmacy.
· Watch over strict application of EU directives or national laws against charlatanism.
· Do not count on the magistrates or governments to do this.
· File complaints against advertisements with false health claims and use the laws on false commercial advertising.
· Contest recognition as food supplements for product that are not food.
· Do not underestimate the power of the altmed lobbies.
· No more subsidies for research unless EU COSTB4 rules applied.
* * *
2 The National Council for Complementary and Alternative Medicine (USA), previously the OAM Office of Alternative Medicine.
3 Herbal Crisis in Europe: A Review of the Epidemic of Renotoxicity from Chinese Herbal Remedies, by Willem Betz, MD; SRAM, The Scientific Review of Alternative medicine; Fall/Winter 2000 (Volume 4, Number 2)
4 The Belgian National Health Survey: http://www.iph.fgov.be/epidemio/epinl/index000.htm
5 Monckton J, Betz W et al. COST action B4 ~Unconventional medicine. Final report of the management committee. 1993-1998. Office for official publications of the European Communities. ISBN 92-828-4672-5. EUR 18420 EN.
6 Costs of Alternative medicine + comments; Nature,» 395: 316, 1998.