01 Dec 2001

Berita Akademi - Dec 2001

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National Ethics Seminar 2001

The Academy of Medicine of Malaysia and the Ministry of Health, Malaysia jointly organize a one-day seminar on National Ethics on 4 November 2001 at the Renaissance Hotel, Kuala Lumpur. The aim of this annual seminar is to update practising doctors as well as medical students on the current issues in medical ethics. The seminar was attended by over 100 participants from the Ministry, universities as well as from the private practice.

The seminar commenced with a welcome address by Datuk Dr Yeoh Poh Hong, the Master of the Academy of Medicine. The first presentation was by Dato’ M Shanker on "The Right to Health" followed by a paper by Dato’ Dr Mohd Ismail Merican on "Good Clinical Practice in Research".

Dr Milton Lum then presented a draft position paper on "The Relationship between the Medical Profession and Industry". There were diverging views from the audience especially with regard to the gifts and hospitality provided by pharmaceutical industry and suppliers of medical devices to enable doctors to attend continuing professional development activities, both locally and abroad, and also promotional activities aimed at doctors.

Dr Ong Lean Swee, a qualified doctor who turned lawyer, then elaborated on "Informed Consent - The Patient’s Standard vs the Professional Standard". This was followed by the presentation of a draft position paper on "Ethical Aspects of Complementary & Alternative Medicine" by Prof Yip Cheng Har.

Both the draft position papers are published in this issue of the Berita MMA. Academicians are requested to give their feedback and input on the papers before 31 January 2002 so that the Academy could formalise its official stand on these two issues.


 

News from the College of Physicians - Asia Pacific Clinical Trials Conference
24 - 26 September 2001

The College has the privilege of holding an Asia Pacific Clinical Trials Conference from 24 to 26 September 2001 at the Sunway Lagoon Resort Hotel, Petaling Jaya with the support of the Ministry of Health, Malaysia and the Drug Information Association. The theme was "To wards Excellence in Clinical Trials - The Way Forward" and this is the first such conference to be held in Malaysia. The meeting was a great success despite the prevailing global situation at that time.



YB Mr Sothinathan declaring
the conference open on behalf of the Minister of Health.

Opening Ceremony

The Opening Ceremony was held on 25 September 2001 and was officiated by YB Mr Sothinathan, the Parliamentary Secretary of the Ministry of Health, who represented the Minister of Health. Dr Peter Maurice who represented the Drug Information Association gave some insight into the objectives and functions of DIA.

 

Registration

A total of 360 participants attended the conference including 73 from overseas.


Scientific Content

The scientific programme was well planned. A few speakers withdrew at the last minute because of the disaster in USA but the Organising Committee was able to find replacements to take over some of the lectures. Seven plenary lectures, four symposia, a special session and a special forum were included in the programme. The focus was on Investigational New Drug, the Industry and CRO Perspective of Clinical Trials in Asia Pacific, Pharmacovigilance, Monitoring and Compliance Issues in Good Clinical Practice as well as Regulatory Practice in New Drug Application.

In addition, there were four pre-conference workshops on

  • Introduction to Monitoring, Auditing & Inspection
  • Clinical Data Management
  • New Drug Application in Malaysia
  • An Effective Ethics Committee -Requirements and Considerations


Some of the Organising Committee members, speakers and participants.

These were held at the hotel itself. A post-conference workshop on “Clinical Trial in Herbal Medicine Research” was held at the Institute for Medical Research, Kuala Lumpur.


Malaysia Nite

The Malaysia Nite was held on 25 September 2001. This function provided an opportunity for the faculty, the organising committee members and the participants to interact.
 
Trade Exhibition

Nine agencies including the local clinical research centres participated in the conference by taking up exhibition spaces.


Conclusion

The Organising Committee is encouraged by the positive feedback which has been received from some of the faculty and participants and will consider organizing the second conference in 2003.


YB Mr Sothinathan accompanied by Dato’ Dr Mohd Ismail Merican visiting the exhibition booths.

 

 


From The Desk of The Scribe


The History of Medicine in Peninsular Malaysia

The book is nearing completion and we look forward to its publication in 2002. Sadly the author, Desmond Tate, suffered a personal tragedy recently having lost his house and a son in a landslide.


Consensus Statements/Clinical Practice Guidelines

Seven national workshops were held during the 35th Malaysia-Singapore Congress of Medicine. The documents discussed were:

Peri-operative Blood Transfusion
Acute Gastroenteritis in Children
Childhood Pneumonia and Respiratory Infection
Management of Osteoarthritis
Update on Antenatal Steroids
Postnatal Steroids for the Prevention of Chronic Lung Disease in the Preterm Infant
ESBL Infection
Anti-Retroviral Therapy
The Academy hopes to work closely with the Health Technology Assessment (HTA) Unit of the Medical Development Division of the Ministry of Health for more efficient dissemination of the documents.


National Credentialing Committee

A National Credentialing Committee (NCC) comprising officials of the Ministry of Health and the Academy of Medicine of Malaysia has been set up to coordinate all activities related to the Specialist Register and Accreditation of Specialists. The National Credentialing Committee is chaired by the Director-General of Health and the first meeting was held recently. For this purpose Specialty Subcommittees will be set up to advise the National Committee.


4th MOH-AMM Joint Scientific Meeting


This fourth joint meeting between the Ministry of Health and the Academy of Medicine will be held on 10-12 October 2002. Dr Narimah Awin has been appointed Chairman of the Organising Committee. The proposed theme for the Congress is “Child Health”. The 5th Tunku Abdul Rahman Putra Lecture will be held in conjunction with this meeting.


Academy Homepage (http://www.acadmed.org.my)

The Academy homepage has been revised and updated. Please visit the website and give us your feedback for further improvement.The Academy has also signed a MOU with Medical Online for the provision and vetting of content on the Internet.


Merger of the Malaysian Radiological Society with the Academy

The Malaysian Radiological Society has merged with the Academy of Medicine of Malaysia and its members were formally inducted into the Academy by the Royal Patron at the recent Malaysia-Singapore Congress.


Academic Regalia

Council has agreed that every College will have its own academic regalia which will be worn by their Council Members at formal occasions of the Academy. The College of Physicians, the College of Surgeons and the College of Pathologist already have their own distinctive gowns. The other Colleges are in the process of designing their gowns.


Postgraduate Medical Training and Certification

A Subcommittee on Postgraduate Medical Training and Certification has been set up. This subcommittee will be chaired by Prof Dato’ Khalid Kadir. The subcommittee will make recommendations to the Ministry of Health and the universities for improvements in the system of postgraduate medical training in Malaysia.


Joint Project between the Academi es of Medicine of Malaysia and Singapore

At the recent Joint Council meeting of the Academies it was agreed that the Academies undertake projects of mutual benefit.The first project identified will be a system of Quality Assurance/Clinical Audit where the specialist can undertake self-assessment.

 


Fellowship of the ACADEMY
Congratulations to the following who were conferred the Fellowship of the Academy of Medicine of Malaysia on 13 October 2001.


College of Anaesthesiologists

Prof Chan Yoo Kuen
Prof Gracie Ong Siok Yan


College of Paediatrics
Dr Hussain Imam b Hj Muhammad Ismail


College of Pathologists
Dato’ Dr Lim Teong Wah


College of Physicians

Dr S Mahendra Raj
Prof Raymond Azman b Ali
Dr Roshidah bt Baba
Dr Tan Hoo Kin
Prof Wan Mohamad b Wan Bebakar


College of Public Health Medicine

Dr Lokman Hakim b Sulaiman
Datu Dr Hj Mohamad Taha b Arif
Prof Syed Mohamed Aljunid b Syed Junid

College of Surgeons
Prof Lim Yew Cheng
Dr Raveendran a/l S Kandiah
Dato’ Dr Tan Hui Meng


Academicians are welcomed to submit nominations for fellowship. Fellowship is conferred on academicians who:

  1. have been members for at least ten years and are in good standing and have contributed significantly to the advancement of the practice of medicine
  2. may not have been members for ten years but have contributed significantly to the improvement of specialist practice in the country in the last ten years and have at least ten credited publications.

The process of elevation to Fellowship shall be decided by the Colleges and the Chief Censor who shall make their recommendations to the Council.


 

Implications of Globalisation and Multilateral Trade Agreements on Healthcare Services - by Dato’ Dr Abdul Hamid, Council Member

(Dato' Dr A K Abdul Hamid represented the Academy of Medicine of Malaysia at the above Workshop which was organized by the Ministry of Health on 12-13 November 2001)


Background

WTO was established on 1 January 1995, to incorporate GATT (General Agreement on Trade & Tariffs), General Agreement on Trade in Services (GATS) and Trade Related Intellectual Property Rights (TRIPS).

Medical and Health Related Social Services are covered under GATS. Some of the legal obligations that member governments must commit under GATS are the Most Favoured Nation (MFN) principle, transparency, market access, national treatment, proportionality of domestic regulations and other specific provisions. Under GATS, medical and health related social services are classified under the general categories of business services. The rules are legally enforce able 10 years after ratification.


There are four modes of supply:

  1. Cross Border Supply (non-resident supply of services)
  2. Consumption Abroad (freedom from Member's residents to purchase services in territory to another member)
  3. Commercial Presence (foreign service suppliers to establish, operate or expand a commercial presence, such as a branch, agency or wholly-owned subsidiary)
  4. Presence of Natural Persons (foreign individuals to enter and temporarily stay in a Member country’s territory to supply a service).

 

In submitting various commitments, the Member countries are allowed provisions to safeguard national government policies and establish national interests in all schedules of specific commitments under WTO.


Delegates

The Workshop was held at the Hotel Grand Seasons, Kuala Lumpur, organized by Bahagian Amalan Perubatan, Kementerian Kesihatan Malaysia, and was attended by about 25 delegates. Besides the Academy of Medicine, the NGO representatives were from APHM, PMPASKL, MPS, MOPL, FOMCA, Malaysian Dental Association, Federation of Malaysia Manufacturers (FMM), The Small and Medium Industries (SMI) Association, and the MMA. Other MOH departments, besides Bahagian Amalan Perubatan, were also represented, along with EPU, Ministry of International Trade & Industries (MITI) and Malaysian Medical Council (MMC). Speakers were from KKM and other Ministries.


Lecturers Programme

Day One was dedicated to ground work lectures as follows:

  1. Impact of Globalisation & SPS Agreement in Food Safety (Datin Dr Harrison Aziz, Bhg Kawalan Mutu Makanan, KKM) (Note: SPS is Sanitary and Phytosanitary)
  2. Globalisation and Liberalisation of Trade & Services under the WTO (Cik Mariam Md Salleh, MITI)
  3. General Agreement on Trade in Services (GATS) and Public Health (Dr Kalsom Maskon, Bhg Perancang & Pembangunan, KKM)
  4. Patent Act & Public Health (En Kamal Korman, Intellectual Property Division, Ministry of Domestic Trade & Consumer Affairs)
  5. Agreement on Trade - Related Aspects of Intellectual Property Rights (TRIPS) and Access to Medicines (En Farid Wong Abdullah, Bhg Perkhidmatan Farmasi, KKM)
  6. Implementation Issues on SPS & TBT Agreements (Cik Khazlita Adzim, Pegawai Perikanan, Jabatan Perikanan; En Raginder Raj, SIRIM) (Note: TBT is Technical Barriers to Trade)
  7. Brief on Specific Commitments (Cik Mariam Md Salleh, MITI)

 

An 8th talk on Globalisation & Its Impact on Healthcare Services, to be delivered by the Honorary General Secretary/Immediate Past President, MMA, did not happen as the MMA representative was apparently not available on Day One.

Group Discussions

Towards the end of Day One, the delegates were divided into four small groups to discuss specific topics.

Presentations were made by the groups on Day Two.


Proposals

The following proposals were made by the Workshop for liberalisation under sector specific commitments under WTO.


Medical Services

  1. Foreign Specialists

    In the original commitment made by MOH (after consultation with the private healthcare sector) in 1992, foreign specialists in Geriatrics, Forensic Medicine, Nuclear Medicine and Microvascular Surgery were permitted. Somewhere along the line, through unidentifiable sources, many other specialty services had been added into the WTO Schedule of Specific Commitments by Malaysia (neurosurgery, cardiothoracic surgery, plastic surgery, clinical immunology and oncology, traumatology, anaesthesiology, intensive care, child psychiatry and physical medicine). The workshop recognized that many of these fields had sufficient locally trained specialists, and therefore only the following should be committed from foreign specialists as natural persons:

    Geriatrics, Forensic Medicine, Nuclear Medicine, Clinical Immunology and Oncology, and Clinical Genetics.

    Such entry and stay of natural persons will be on contract for three (3) to five (5) years, renewable on expiry and depending on local availability of the specialist (amended from 5 years in p revious commitment).

    The foreign specialists in the above specialties will be permitted to practise in private hospitals of more than 150 beds ( as against 100 beds previously committed), on the argument that the smaller hospitals may not have facilities for these specialities, unless so dedicated.
  2. The Right to Practise

    On the limitation to Malaysian market access by foreign healthcare natural persons, the evaluation of necessary credentials and professional qualifications, etc., will be based as recognized by “the professional bodies” in Malaysia, to be amended to re a d “professional licensing bodies.”
  3. Quota of Specialists

    Under Intra-corporate Transferees in the Schedule, two specialists as committed above, will be allowed to be engaged per hospital (instead of ‘per organisation’ as in previous commitment).

Hospital Services (Under Health Related Social Services)

  1. Joint Venture Hospitals

    A foreign joint venture corporation shall operate a hospital with a minimum of 150 beds (increased from 100 in previous Schedule) on the argument that 100-bed hospitals are within the economic capability of local corporations. (There will be aggregate foreign shareholding in the joint venture corporation not exceeding 30 per cent. The venture will be based on economic needs test, as provided for in previous Schedule).

    On the limitations on national treatment, the establishment of feeder outpatient clinics is not permitted by private hospital services. The words “outpatient clinics” are to be amended to read “outpatient clinics and services”.
  2. Management Post

    Foreign managers for joint-venture hospitals will be allowed when the staff in that corporation is more than 300 (from 200 in previous commitment). For the next 300, one more foreign manager will be allowed, to a maximum of two such natural persons per establishment.

General

Further to the provisions under WTO, the workshop delegates emphasized in the horizontal commitments that

 

  1. practice contrary to moral and religious values of the country should be prohibited, and
  2. National Vision Policy, besides NEP and NDP, should be kept in sight.

The Ministry of Health was urged to have a final dialogue with the private sector and other interested parties to firm up on the proposals before submission to WTO.

 


 

Ethical Aspects of Complementary and Alternative Medicine
(This draft position paper was presented at the National Ethics Seminar organized by the Academy of Medicine and the Ministry of Health on 4 November 2001 and incorporated the feedback and comments by the participants. Academicians are requested to send their comments and suggestions to the Academy Secretariat by 31 January 2002.)


Introduction

Complementary and alternative medicine (CAM) covers a broad range of healing philosophies (schools of thought), approaches and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand or make available. A few of the many CAM practices include the use of acupuncture , herbs, homeopathy, therapeutic massage, and traditional oriental medicine to promote well-being or treat health conditions.

CAM treatments and therapies are used in a variety of ways. They may be used alone (as in alternative medicine) and the patient rejects conventional treatment, or in combination with conventional medicine, referred to as complementary medicine. Some patients use a combination of the two methods, but most of them change from one to another or back again, since there is a belief that conventional and alternative therapies may oppose each other.

CAM therapies are becoming increasingly more popular. The approach of the CAM practitioners are considered to be more "holistic" taking into account the whole person, including physical, mental, emotional and spiritual aspect, whereas Western medicine is more "clinical" looking into mainly the physical aspect of the patient’s illness.


Definitions of CAM

To avoid confusion, "alternative" methods should be classified as genuine, experimental, or questionable. Genuine alternatives are comparable methods that have met science-based criteria for safety and effectiveness. Experimental alternatives are unproven but have a plausible rationale and are undergoing responsible investigation. Questionable alternatives are groundless and lack a scientifically plausible rationale. An even better way of classifying them is into three groups:

  1. those that work
  2. those that do not work and
  3. those we are not sure about

Most methods fall into the second group. Under the rules of science, people who make fantastic claims bear the burden of proof. However instead of subjecting their work to scientific standards, promoters of questionable "alternatives" regard personal experience, subjective judgement and emotional satisfaction as preferable to objectivity and hard evidence. Instead of conducting scientific studies, they use anecdotes and testimonials to promote their practice and political maneuvoring to keep regulatory agencies at bay 5.

Theories of CAM Therapies

  1. Mind-body interventions

    • meditation, music and art therapy, hypnosis
  2. Diet/Nutrition

    • Nutraceuticals, vitamins, diets
  3. Herbal remedies

    • practised by bomohs, sinsehs, natural therapists, botanists, biochemists to treat or prevent specific conditions
    • no standardization of dosage
    • potential toxicity
  4. Manual healing methods

    • based on physical touch or energy fields
    • e.g. osteopathy, chiropractice, reflexology, acupuncture, suction therapy
    • energy healing involving moving hands over patient’s body to create a general state of well-being by enhancing "energy flow" in the subject
  5. Pharmacologic methods

    • clinical trials required to test efficacy
    • many therapies actually are health frauds
    • Includes use of antitumour antibodies, antineoplastons (peptides derived fro murine), chelation therapy with EDTA to treat cardiovascular disease, ozone therapy, bee pollen, shark cartilage, etc

Types of Alternative Therapy

  1. Acupuncture

    • practised in traditional Chinese medicine
    • used for acute/chronic pain relief
    • American Academy of Medical Acupuncturists formed
    • Fairly well-accepted in mainstream medicine
  2. Homeopathy

    • Started in Germany in 1800 by Samuel Hahnemanne
    • Involves using small amounts of a drug to treat various diseases
    • In the 19 th century it was popular in USA with 22 schools of homeopathy
    • However the practice declined in the early 20 th century
    • Homeopathists are licensed as a physician or holding a license allowing the prescription of drugs
    • However many are now lay healers who use health foods, massage, acupuncture, aromatherapy
    • Although the efficacy of homeopathy is not proven, it is generally believed to harmless since very small doses of pharmacologic agents are used
  3. Naturopathy

    • 4-year course in naturopathic college
    • Started in 1895
    • Uses manipulation, massage, herbs, acupuncture, traditional oriental medicine, colonic irrigation, chelation therapy to remove toxins from patient’s body, ozone therapy
    • Diagnostic technique using iridology hair shaft analysis
    • Licensed in some states in USA but not covered by insurance
  4. Ayurdevic

    • Mind-body set of beliefs and principles
    • Uses meditation, exercises, herbal oil massage
  5. Folk therapies

    • Traditional Malay and Chinese remedies (bomohs and sinsehs)
    • Usually based on herbal remedies which may be taken orally or applied to the parts of the body
    • Also includes spiritual therapy, especially in cases of psychiatric illness where the cause is believed to be possession by demons

 

CAM in USA

A published survey in the USA showed that the number of Americans using an alternative therapy rose from about 33% in 1990 to more than 42% in 1997. The following therapies were most often used: herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing and homeopathy. In addition, Americans spent more than $27 billion on these therapies in 1997, exceeding out-of-pocket spending for all US hospitalizations. Another survey in 1994 revealed that 60% of doctors recommended alternative therapies to their patients at least once. In addition 47% of doctors in this study reported using alternative therapies themselves. An article in 1998 reported that 75 out of 117 US medical schools offered elective courses or even required courses in CAM. Another survey found that people use CAM not because they were dissatisfied with conventional medicine, but because the CAM therapies mirrored their own beliefs and philosophical orientation towards health and life.

In October 1998, the National Centre for Complementary and Alternative Medicine (NCCAM) was set up by a congressional mandate (under the 1999 Omnibus appropriations bill) signed by President Bill Clinton. Before that, an Office of Alternative Medicine (OAM) had been established in 1992 within the NIH, and its job was to facilitate and coordinate the evaluation of alternative medical treatment modalities through research projects and other initiatives. OAM’s expansion into a center (NCCAM) provides greater ability to initiate and fund additional research projects and to provide information to the public at a time when a growing number of people are interested in CAM therapies. At the same time, the 1999 Omnibus legislation also established a White House Commission on CAM Policy. This Commission will study issues regarding research, training and certification of CAM practitioners, insurance coverage, and other alternative medicine issues. At least half the members of the Commission are practitioners licensed in one or more of the main substreams of CAM, and at least three members are consumer representatives.

One of the main functions of NCCAM was to set up a Scientific Database which contains bibliographic summaries of books, journal articles, research reports, audiovisuals and other materials on CAM. NCCAM has also set up a CAM on PubMed, which contains bibliographic citations related to CAM.


CAM in Malaysia

The practice of CAM in Malaysia is disorganized. CAM practitioners are unlicensed and unregulated. Various natural therapy agents and herbal products are marketed in retail pharmacies or by direct selling companies without the Drug Control Authority (DCA) review and approval as "nutritional/dietary supplements". There are also several Chinese medicinal shops throughout Malaysia selling all types of Chinese herbal remedies for every thing from piles to bone pains. Despite these problems, it was reported in the press that Malaysia has plans to become a centre for alternative therapy.

Several general practitioners make extra money from selling health-related multi-level (direct selling) products (such as Amway) to their patients in their clinics. Although some of these products may be still within the borders of mainstream medicine, there are also many products with unproven claims from some of the direct selling companies especially for patients with cancer such as shark’s cartilage, Lingzhi (Reishi mushroom ) spirulina (a blue-green algae), Tian Xian liquid from China, selenium, barley green and a whole host of other products said to be a "cure" for cancer. Some of these products are also said to be "immune boosters" so that even if you are healthy, these products will help you to stay healthy and free of disease. However the contents in these products are unknown, dosage is not standardized, and toxicities may occur. Anecdotal stories of liver or renal failure from use of such products have surfaced off and on. Chronic use of products containing steroids have led to unexplained sepsis in patients presenting with minor infections, and also massive upper gastrointestinal bleeding. A recent report from CNN showed that anaesthetists in USA are advising patients going for surgery to refrain from herbal products such as Ginseng, and even Garlic, for at least 2 weeks before surgery as such agents have been shown to cause prolonged bleeding.

Culturally, traditional medicine (whether Chinese, Malay or Indian) still has a big following among even modern Malaysians. These can range from herbal to spiritual remedies to get rid of illness. Psychiatric illness is still believed by many among the Malay and Chinese people to be due to possession by demons and hence only spiritual therapy will cure the illness. There is no formal training or licensing of these traditional Malay and Chinese practitioners. and the trade appear to be learnt by apprenticeship or passed down from generation to generation. Although some of these practitioners are genuine, there are a lot of quacks among these traditional medicine practitioners who cheat patients out of a lot of money.

The use of unknown and untested products is becoming popular because people believe that "natural is always safe". Most producers of these herbal preparations sell their products with the slogan "100% natural". The use of traditional preparations have increased dramatically over the last 2 years and this includes the use of tongkat Ali, Kacip Fatimah, noni fruit, ginseng, pegaga etc. Some natural products from animals are also abused such as gamat which is claimed to be good for encephalitis and cardiac disease. In 1999, Assoc Prof Mustafa Ali Mohd from the Department of Pharmacology, University of Malaya Medical Centre, conducted a study on 198 traditional preparations sold in Malaysia and found that 22.72% were adulterated with various modern medicine including steroids, glibenclamide and clorpheniramine. Among the adulterated specimens, 82.2% contain steroids 6. Assoc Prof Abdul Rashid Rahman from USM has conducted Phase 1 trials on curcumin and its effects as a cholekinetic agent 7,8,9 and is currently doing Phase 1 trials on Misai Kuching, looking at its effects on haemodynamics, natriuretics and anti-oxidant properties. The Medical School in USM has been granted research funds to do trials on Hempedu Bumi and Kacip Fatimah. These are the sort of evidence-based research needed to prove or disprove the efficacy of these products.

There are also several "natural therapy centres" and more seem to be coming up all over the country. Whether or not they have the qualifications, practitioners running these centers give themselves titles like "Doctor" or even "Professor". These centers probably cost the patient a lot more than conventional treatment; however these practitioners are able to inspire a lot more confidence in patients than conventional Western-trained physicians. Some of these centers also use sophisticated computerized equipment which run tests on patients to determine what disease they have, or whether their disease is in remission.

Added to the confusion of these "direct-sellers", traditional medical practitioners and "naturopathists" are the professional biochemists/botanists, who have done some research on medicinal plants but without any clinical trials on human subjects, have started producing and marketing their products.

Where does the public get access to information about CAM? The most common method is by word of mouth. There are websites on the Internet which advertise CAM. There are also general practitioners who recommend their patients to try CAM as well. There are articles in newspapers and magazines which appear to encourage the use of CAM. For example, the Star newspaper on Sunday has a regular column on natural therapy called "Natural Way".

In Malaysia, the practitioners of CAM have formed loose groups. These are

  1. The Malaysian Society for Complementary Therapies
  2. Persekutuan Perubatan Tradisional Melayu Malaysia
  3. Federation of Chinese Physicians and Medicine Dealers Association of Malaysia
  4. Pertubuhan Persatuan Perubatan Tradisional India Malaysia
  5. Majlis Perubatan Homeopathi Malaysia

 

The Role of The Ministry of Health in CAM

The Ministry of Health has a committee on traditional and alternative medicine that was formed over two years ago. In the committee are public health specialists, representatives from universities, MMA and MMC, and also representatives from five umbrella bodies representing various CAM disciplines. These bodies are supposed to come up with a proposal for certification, code of practice and training in their respective disciplines. These proposals will be vetted by the MOH and used by the umbrella bodies to register their members. Each umbrella body is responsible for ensuring that their members abide with their respective code of practice and regulations. In the pipeline is a webpage allowing the public to search for names of registered CAM practitioners. So it does appear that there is some attempt to regulate the practice of CAM in Malaysia.

 

The Involvement of Registered Doctors in CAM and Direct Selling

It is well-known that several doctors, general practitioners as well as specialists, offer CAM-like therapy to patients. The current fad appears to be chelation therapy and ozone therapy. There are also doctors practising acupuncture and selling everything from human growth hormone to vitamins; and money appears to be the incentive. As some doctors say, the GP’s business is not so good, and direct selling may be a better alternative than selling cough mixtures and medical certificates. We do not have any figures on how many physicians actually are distributors for the various "direct-selling" companies like Amway or Cosway; it is unlikely that we will ever be able to get an accurate figure as most doctors will deny being agents for these companies.

From the Ethics Seminar held recently, it appears that there are doctors who support the practice of CAM. So even though we can say that it is not right for registered Western-trained physicians to indulge in the practice and promotion of CAM, is it merely from the commercial viewpoint that doctors practice CAM, or do they sincerely and honestly believe that CAM works and will benefit their patients?

However, are doctors aware of the legal aspects of such largely unproven practices? The majority of doctors probably are not aware of the "Code of Professional Conduct" which is published by the Malaysian Medical Council. Under Part II – Forms of Infamous Conduct, Section 3.4 (The Practitioner and Commercial Undertakings), states the following:

The practitioner is the trustee for the patient and accordingly must avoid any situation in which there is a conflict of interest with the patient.

A general ethical principle is that a practitioner should not associate himself with commerce in such a way as to let it influence, or appear to influence, his attitude towards the treatment of his patients.

The association of a practitioner with any commercial enterprise engaged in the manufacture or sale of any substance which is claimed to be of value or of an undisclosed nature or composition will be considered as infamous conduct in a professional respect.

A practitioner has a duty to declare an interest before participating in discussion which could lead to the purchase by a public authority of goods or services in which he, or a member of his immediate family, has a direct or indirect pecuniary interest. Non-disclosure of such information may under certain circumstances amount to infamous conduct in a professional respect.

Where the practitioner has a financial interest in any facility to which he refers patients for diagnostic tests, for procedures or for inpatient care, it is ethically necessary for him to disclose his interest in the institution to the patient.
.

Under the Code of Professional Conduct, direct selling is definitely considered a form of infamous conduct and if the practitioner is reported to the Medical Council by one of his patients, he would have a hard time defending himself. Ignorance of the rules of professional conduct does not excuse his conduct. Included under the heading of "any commercial enterprise engaged in the manufacture or sale of any substance which is claimed to be of value or of an undisclosed nature or composition" would include the various forms of natural therapy such as ozone therapy, IV chelation, colon cleansing, etc.

What about the situation in other countries? In December 1997, the American Medical Association Council on Ethical and Judicial Affairs (CEJA) formulated a policy statement that hit hard at the potential conflict of interest and pressure inherent in such sales:

The for-profit sale of goods to patients by physicians inherently creates a conflict of interest. Physicians engaging in this activity have a direct financial interest in selling the goods to patients; but the sale may or may not be in the best interests of the patients. Physicians may be tempted to sell items for profit even though their patients do not need the products. Even if most physicians are capable of resisting such temptation, the more ethical course is for professionals to avoid placing themselves in temptation’s way. The conflict of interest is particularly troubling in the office setting, where most patients appear because they are in need of medical attention. In the normal market setting, consumers can be trusted not to purchase items they do not want, thus a voluntary sales transaction is taken to be in the best interests of both parties. But the voluntariness of any sale to a patient in a medical office setting is open to serious question….

The offer of goods in the treatment setting puts subtle pressure on sick and vulnerable patients to purchase them. Patients may purchase goods out of a misplaced desire to please or to "get in good" with their physician. They may feel they have to purchase the goods in order to secure the physician’s favor. These feelings, whether justified or not, may interfere with the open exchange and the level of trust between physician and patient.

In June 1999, the AMA House of Delegates narrowly approved new ethical guidelines emphasizing that physicians should not coerce patients to purchase health-related products or to recruit them to participate in marketing programs in which the physician personally benefits, financially or otherwise, from the efforts of their patients. The guidelines clearly frown on doctors profiting from the sale of health-related non-prescription products such as dietary supplements, safety devices, and skin-care products, similar to those available at local pharmacies or health-products stores.

In the same way, the Academy of Medicine of Malaysia should send out a statement to all medical practitioners (and this does not include just the general practitioners as quite a number of specialists are also involved), warning them that what they are practising in getting involved with direct selling and alternative therapy, is contravening the code of conduct set out by the Malaysian Medical Council, and as such, may face disciplinary action if a complaint is made against them by a patient. The Malaysian Medical Council is given disciplinary jurisdiction over all persons registered under the Medical Act, 1971.


Conclusion

The practice of CAM in Malaysia is disorganized and unregulated; however in recent years it appears to be gaining in popularity among the population. Although there are probably some sincere and genuine CAM practitioners, there are a lot of quacks making unfounded claims on the efficacy of their therapy. Hence legislation is required to license CAM practitioners the same way as doctors are licensed. The Ministry of Health has a moral and ethical responsibility to control the sale of traditional medicinal preparations. Properly prepared traditional preparations should follow strict guidelines and documentation. The contents of any adulterations should be disclosed to the public, and the preparation should be subjected to analysis in named laboratories to prevent addition of modern medicine preparations. An even more important aspect is to educate registered doctors in the ethical issues of practicing CAM-like therapy and in getting involved in direct selling operations. They should be aware that they may be actually contravening the professional code of conduct as laid down by the Medical Council of Malaysia, and may face disciplinary action.

What about the possibility of integrating alternative and mainstream medicine? After all, some of the CAM therapies, especially chiropracty and acupuncture, have found themselves almost in mainstream medicine. For integration to be successful, CAM therapies must be subjected to the rigorous testing that occurs in mainstream medicine; ie, there must be proof of efficacy. This again would require research into the efficacy and safety of CAM therapies.


References

  1. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompey M, Kessler RC. Trends in Alternative Medicine Use in the United States, 1990-1997: Results of a follow-up National Survey. Journal of the American Medical Association. Nov 11, 1998. 280(18):1569-75.
  2. Borkan J, Neher JO, Anson O, Smoker B. Referrals for Alternative Therapies. Journal of Family Practice. 1994;39(6):545-50.
  3. Wetzel MS, Eisenberg DM, Kaptchuk TJ. Courses involving Complementary and Alternative Medicine at US Medical Schools. Journal of the American Medical Association Sept 2,1998;280(9):784-7.
  4. Astin JA. Why Patients use Alternative Medicine: Results of a National Study. Journal of the Amerrican Medical Association. May 20, 1998. 279(19):1548-53.
  5. Angell M, Kassirer J. Alternative Medicine – the risks of untested and unregulated remedies. New England Journal of Medicine 1998;339:839-841
  6. Mustafa Ali Mohd – Report in UMMC Research Bulletin 1:2001.
  7. Abdul Rasyid and Aznan Lelo. An ultrasonographic measurement used for studying agents acting on the gallbladder. Asian Oceanian Journal of Radiology 1998:13(2):70-74
  8. Abdul Rasyid and Aznan Lelo. The effect of curcumin and placebo on human gallbladder function : an ultrasound study. Alimentary Pharmacology and therapeutics 1999;13:245-249.
  9. Abdul Rasyid, Adbul Rashid Abdul Rahman, Kamaruddin Jaalam and Aznan Lelo. Variation in human gallbladder forms:The need for pharmaco-sonography studies. Asian Oceania Journal of Radiology 2000;5:240-243.


The Relationship Between The Medical Profession and Industry
(This draft position paper was presented at the National Ethics Seminar organized by the Academy of Medicine and the Ministry of Health on 4 November 2001 and incorporated the feedback and comments by the participants. Academicians are requested to send their comments and suggestions to the Academy Secretariat by 31 January 2002.)

The limited resources and the economic imperative influencing the practice of Medicine today often place doctors in situations when they have to make decisions about their relationship with industry, especially the acceptability of receiving inducements from other health care providers or product manufacturers. Inducements, however, do not always come in the form of straight forward rewards for acting in a particular way.


Code of Professional Conduct of The Malaysian Medical Council

The ethical principles that should be adhered to are provided in the Code of Professional Conduct of the Malaysian Medical Council (MMC). In essence, there should be avoidance of any conflict of interest situations. It means that there should be avoidance of participation in any scheme or programme which may influence medical decision making, or which may be perceived as so doing.

Sections 1.6 and 3.4 of the MMC's code 1 titled "The Practitioner and the Pharmaceutical / Medical Equipment Industry" and "The Practitioner and Commercial Undertakings" respectively are of particular relevance.

Section 1.6 states:

"The medical profession and the pharmaceutical industry have common interests in the research and development of new drugs of therapeutic value.

A prescribing practitioner should not only choose but also be seen to be choosing the drug or appliance which, in his independent professional judgement, and having due regard to economy, will best serve the medical interests of his patient. Practitioners should therefore avoid accepting any pecuniary or material inducement which might compromise, or be regarded by others as likely to compromise, the independent exercise of their professional judgement in prescribing matters.

It is improper for an individual practitioner to accept from a pharmaceutical firm monetary gifts or loans or expensive items of equipment for his personal use.

No objection can, however, be taken to grants of money or equipment by firms for institutions such as hospitals, health care centres and university departments, when they are donated specifically for purposes of research or patient care."

Section 3.4 states:

"The practitioner is the trustee for the patient and accordingly must avoid any situation in which there is a conflict of interest with the patient.

A general ethical principle is that a practitioner should not associate himself with commerce in such a way as to let it influence, or appear to influence, his attitude towards the treatment of his patients.

The association of a practitioner with any commercial enterprise engaged in the manufacture or sale of any substance, which is claimed to be of value in the prevention or treatment of disease, but is unproven or of an undisclosed nature or composition will be considered as infamous conduct in a professional respect.

A practitioner has a duty to declare an interest before participating in discussion which could lead to the purchase by a public authority of goods or services in which he, or a member of his immediate family, has a direct or indirect pecuniary interest. Non-disclosure of such information may, under certain circumstances, amount to infamous conduct in a professional respect.

Where the practitioner has a financial interest in any facility to which he refers patients for diagnostic tests, for procedures or for inpatient care, it is ethically necessary for him to disclose his interest in the institution to the patient."

These guidelines provide advice to doctors who may be approached by organizations offering incentives for medical decisions. Whilst they are not intended to include all situations, the general principles would apply to the latter.

The Academy of Medicine believes that it is unethical to give priority to aspects other than the best interests of patients when making clinical decisions. If patients believe that treatment decisions are influenced by financial or other inducements to the doctor, this may profoundly damage the patient-doctor relationship.

 

Prescribing Criteria

The commonly accepted definition of good quality prescribing is that which is based on appropriateness, effectiveness, safety and economy. The prescribing decision must be based on the medical interests of the patient and must not be influenced by factors such as financial profit to the doctor.

The doctor who participates in a scheme offering pecuniary or other incentives may be in breach of sections 1.6 and 3.4 of the MMC's code and other sections as well. The MMC's code makes it clear that not only measures which compromise the doctor's decision making are prohibited but also those which may be regarded by others as likely to compromise the independent exercise of their professional judgement.


Rererral Criteria

Referrals often have to be made by doctors and must be done after considering the clinical needs of the patient. Referrals must be made to the practitioner, organization or institution the doctor feels is most appropriate in the particular case bearing in mind other constraints, such as the limited resources. It is therefore unacceptable to accept inducements to refer patients to particular health care facilities or practitioners as this is likely to compromise the doctor's independent judgement.

The perception of bias in referral may be as detrimental as the fact.

Doctors who are part owners of health care facilities must always bear in mind section 3.4 of the MMC's code viz:

"Where the practitioner has a financial interest in any facility to which he refers patients for diagnostic tests, for procedures or for inpatient care, it is ethically necessary for him to disclose his interest in the institution to the patient."

In addition, all doctors must adhere to section 3.2.2 of the MMC's code which states:

"The Council also regards fee splitting or any form of kick back arrangement as an inducement to refer or to receive a patient to or from another practitioner, institution, organization or individual, as unethical. The premise for referral must be quality of care. Violation of this will be considered by the Council as infamous conduct in a professional respect."

Gifts and Hospitality

The pharmaceutical industry and suppliers of medical devices recognize that promotional activities aimed at doctors may raise serious ethical problems. Doctors must be seen to be uninfluenced by any non-scientific promotion directed towards them by industry.

Doctors need to keep their relationship with industry in accordance with the MMC's Guidelines on Good Medical Practice2 which states:

"The doctor may be offered fully paid trips, travel grants and hospitality to attend conferences or some equally attractive inducement, promoting a single new pharmaceutical product. Although these may have educational value, the doctor must carefully evaluate the motives, expectations and the hidden agenda of such firms, and the ultimate payback expected. Discretion in dealing with such matters will help to preserve the credibility and impartiality of the medical profession."


Medical Research

It is the duty of the doctor to protect the life, health, privacy and dignity of the human subject when carrying out medical research. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.

The researcher is advised to conform to the Malaysian Good Clinical Practice in Research Guidelines.


Academy of Medicine and Industry

The Academy recognizes that commercial organizations in the healthcare industry may assist the Academy in the pursuit of its objectives and educational goals through financial support of the various activities of the Academy and its Colleges. The interaction between the Academy, its Colleges and industry may include the following:

  1. industry support of educational activities, programmes, awards and research grants
  2. product promotion by advertisements in the publications of the Academy and its Colleges
  3. exhibition by industry.

In order that these interactions do not give the erroneous perception that the Academy or its Colleges endorse particular commercial product(s), the relationship between the Academy and industry should be governed by the following principles viz:

  1. The integrity, independence and public image of the Academy of Medicine must be preserved and upheld at all times.
  2. The Academy or its Colleges should not allow industry to control, in any way, the content or organization of its activities.
  3. Members of the Councils of the Academy and its Colleges as well as the organizing committees must avoid conflicts of interest, real, potential or perceived, in their dealings with commercial organizations.
  4. The activities of the Academy and its Colleges provide opportunities for Academicians and their local and foreign colleagues in the health care sector to meet one another, develop collaborations and share developments in Medicine worldwide.

As such, the following guidelines should be adhered to in all interactions between the Academy and industry viz:

  1. The organizers of scientific meetings, programmes, research and other educational activities may seek or accept funding from commercial sponsors provided that the terms of the funding are in accordance with these guidelines and are approved by the Councils of the Academy or its Colleges.
  2. Acceptance of commercial sponsorship does not imply, nor should it be allowed to appear to imply, endorsement by the Academy or its Colleges of the commercial sponsor, its products or its practices.
  3. No obligations are made or implied on the Academy, its Colleges, its Councils members or its employees by the provision of funding.
  4. Funding from commercial sponsors may only be used for:

    • Costs normally associated with sientific meetings
    • Invited plenary speakers, panelists or workshop leaders (Including travel, accommodation and a modest honorarium)
    • awards for papers
    • research and programmes
  5. The Academy or its Colleges will retain full authority and control over the content of the programme of its scientific meetings. Thus, the ultimate decision regarding the organization of the meeting, choice of speakers and selection of papers for awards must remain in the hands of the Academy and its Colleges.
  6. Sponsored activities, plenary sessions and awards must not be named after the commercial sponsor or any of its products.
  7. The Academy, its Colleges or the organizing committee shall acknowledge educational grants received from commercial sponsors in an appropriate manner.
  8. The organizers of activities and scientific meetings of the Academy or its Colleges are obliged to act impartially in offering advertisers to promote their products through the publications of the Academy, provided that the format and wording of the advertisement complies with accepted medical and advertising standards and does not imply endorsement by the Academy or its Colleges.
  9. The rental of space to commercial organizations to display their products in conjunction with scientific meetings of the Academy or its Colleges does not mean endorsement of the products. It would be advisable to include a clear statement to this effect in the programme of the meetings.
  10. The provision of funds must not affect the experimental design, methodology, results or publication of the results of grant supported research or programmes. All research or educational programmes carried out by the Academy or its Colleges, with the support of industry, must present balanced and unbiased views of the medical topic(s) and not the commercial sponsor, its products or practices.
  11. Upon conclusion of the scientific meetings, research or programmes, the Academy, its Colleges or the organizing committee shall be prepared, if required, to present a statement of accounts of the activity to the commercial sponsor.
  12. Funding from commercial sponsors must only be payable to the Academy or its Colleges.

 

Conclusions

The Academy's advice are as follows:

  1. The clinical need of the patient must be paramount, and be seen to be of prime consideration.
  2. Doctors must be cautious of participating in any acheme or programme which offers, or appears to offer, pecuniary or other incentives for prescribing or referral decisions.
  3. Care must be taken at all times to avoid potential conflicts or interest between financial considerations and clinical judgement.
  4. The Academy itself must ensure that its integrity, independence and public image is maintained at all times.

References

  1. Code of Professional Conduct, Malaysian Medical Council,1987
  2. Good Medical Practice, Malaysian Medical Council, 2001