It is a fact that in today’s Pharmaceutical World there are so 1 hour money loan many manufacturers that when a doctor prescribes by the generic name, it will be the Pharmacist (qualified or unqualified) who will decide what the patient will actually get. Even if the doctor prescribes amoxicillin SPC, Pharmacist may give what they have stocked and what gives them the highest commission. It has been observed that some cheaper amoxicillin brands do not produce the characteristic smell of ampicillin in the urine even after 3 days. This smell is usually observed when 5 doses of amoxicillin with good bio-availability is prescribed. Furthermore there was the instance when SPC did their own brand with paracetamol (pettha pottha controversy) and that would be contrary to Prof Bibile doctrine. Furthermore, one cannot expect generic producers to be more altruistic than brand producers and their intention would also be profitability. So they could adopt ruses that give them greater profit. This would be obviated if a Government begins to manufacture drugs with strict quality control procedures. SPMC is a step in the right direction. The dire need is proper quality control checking for generics or brands that would be approved. As I said at the beginning, when a doctor now prescribes generic what the patient gets is an unknown brand.
Danger of Changing Brands
There are also drugs like phenytoin used for epilepsy with historic examples where changing the manufacturer (brand) has resulted in severe adverse effects or return of seizures depending on the additives in the new brand which could increase the available phenytoin strength causing toxicity or reduce available phenytoin resulting in seizures. One would ask an epilepsy patient to always stick to one brand for the above reasons. This problem arises with drugs that operate in a narrow therapeutic window where slight increase of drug level causes toxicity and slight drop causes loss of therapeutic effect. With such drugs any sane practitioner would prescribe a trusted brand.
Ethical Issues of Brand Prescribing
Yet there are problems in brand prescribing that only doctors can rectify. It is not only a doctor’s political hue or NGO employment that raises issue with certain brand prescription patterns.
While I was in my previous academic post, I observed that a brand of piroxicam was aggressively pushed and was freely prescribed. Piroxicam is an aspirin like drug with far more adverse effects than aspirin. I have produced material and published in the Ceylon Medical Journal and Kandy Medical Journal to prove that, with the exception of ibuprofen in doses less than 20mg per kg body weight per day, aspirin remains the safest and most effective non steroidal anti inflammatory drug (NSAID) for joint disorders. This was demonstrated by a well designed trial conducted by UK Committee for Safe Medicine in 1985. Yet far more expensive drugs (NSAIDS) are prescribed which are less effective and more toxic. Even with ibuprofen the effective antirheumatic dose is often more than the safe dose. Bayer has recognized the safety of aspirin and recently produced a cherry flavoured expensive brand of aspirin.
Co-amoxyclav (Augmentin) is another over-prescribed drug when amoxicillin alone is sufficient. Cost difference is huge and the former has more side effects. It would be unethical to prescribe co-amoxyclav when amoxicillin is sufficient for most upper respiratory bacterial infections.. Brand prescribing of ibuprofen syrup for fever is another undesirable practice considering the many side effects of the drug. There is evidence that anti-inflammatory drugs prolong the viraemia in simple fever. There are scientific reasons to give only paracetamol for viral fever even in adults. Similarly pushing Panadol syrup for fever is another unacceptable brand pressure practice which may end up with a child getting more than six hourly doses which would be toxic. Recent study ascertained that 40% of childhood allergies are traceable to overuse of paracetamol which modulates immune response. Vitamins in expensive brand prescription – especially the dubious benefits of vitamin E (except the proven benefit to reduce incidence of breast cancer in combination with Primrose oil), impoverish the already poor.
Internationally too, there were instances where brand pushing made room for fraud. A well known recent instance is when the results of a drug trial (Rofecoxib) was published only for the first six months because serious adverse effects appeared in the next six months. Results were suppressed and the drug appeared on the market being prescribed as an antirheumatic drug with minimal gastric problems. Patients got heart attacks and the drug was withdrawn. A journalist of New York Times exposed the fraud. Details can be found on www.WorstPills.org
It is also true that in pushing brand drugs many glossy promotional materials quote statistical data without statistical significance to “prove” the superiority of a drug.
Generic or Brand
There is no simple solution to the issue.
- Reliable generics must be available; quality control is must. In the present scenario even the most socially conscious doctors may be reluctant to prescribe generics because of unreliability.
- With manufacturers producing generics under some name, the difference between generic and brand that Prof Bibile identified is at present artificial. The solution is for government sponsored quality drug manufacture. Like the transport system and water supply, drug supply cannot be left in the hands of the Private sector alone.
- An essential drugs list even today will prevent poor people having to buy unnecessary drugs
- When prescribing Drugs with narrow therapeutic window, it is inevitable that doctors will prescribe a trusted brand
- Expensive drugs get prescribed when cheaper more appropriate drugs are available.
- Expensive drugs get prescribed when there is no medical indication E.g. antibiotics within first 24 hours of viral fever.
- Unscientific poly-pharmacy for reasons other than medical.
The Lancet (2003;361:573-574) under the title “Effect of ibuprofen on cardioprotective effect of aspirin” documents how NSAIDS interferes with the cardio-protective effect of low dose aspirin. I documented this ten years previously in 1993, in The Ceylon Medical Journal (1993. 38:145-146) under the title “Do NSAIDs interfere with the action of low dose aspirin.
I cite this issue only because I also documented the factual status of aspirin in analgesia and as an anti-inflammatory drug being probably superior to many recent NSAIDs including ibuprofen. ( Mendis, B. L. J. 1995. Joint disease, aspirin and NSAIDs. Kandy Medical Journal, 5: 1-3. Mendis, B. L. J. 1994. Avoiding nightmares in migraine management. Journal of the Ceylon College of Physicians, 27: 54 – 55. Mendis, BLJ. 1996. Aspirin::friend or fiend. Ceylon Medical Journal. 41:76-77.)
Since The Lancet has concluded as I did on the effect of NSAIDs on the action of low dose aspirin, I am hopeful that my colleagues would seriously consider the conclusion of the aforementioned articles, namely, that soluble aspirin is equal or superior for joint disease and headaches compared to the branded preparations that are much prescribed though expensive, have no proven higher therapeutic efficacy and have more side effects.
I am aware that what I am suggesting sounds incredulous but is based on sound documentation. E.g. soluble aspirin instead of piroxicam. Please take the trouble to read the articles cited in the above references. Should we not be ethically concerned to give the patients a better deal – medically and economically? Drug companies at present do not include aspirin in comparative trials. You are probably aware how a research on COX2 inhibitors was contrived to hide the truth of adverse effects until a journalist on the Washington Post brought it to light. You may read Therapeutic Letter Issue 43 on this.
• NSAIDS in any dosage will interfere with the anti-platelet action of low dose aspirin. This is because low dose aspirin selectively inhibits thromboxane synthase produced by platelets whereas NSAIDS inhibit cyclo-oxygenase thereby blocking beneficial prostacyclin produced by prostacyclin synthase of the capillary wall. If you are prescribing NSAIDS for a patient on low dose aspirin for that duration a different anti-plaetelet drug is needed. You have warn the patient on low dose aspirin about indiscriminate use of NSAIDS as is common. I first reported this in the CMJ in 1993 and was later confirmed by Lancet in 2003. CMJ Volume 38, No.3, September, 1993 – aspirin low dose
• Levodpa absorption is inhibited by Lysine in rice. If on-off phenomenon is troublesome in Parkinson patients on levodopa, the rice meal should be taken in the night. Patient can manage on potatoes or bread for the day. This will significantly improve levodopa absorption.
CMJ Volume 38, No.4, December, 1993- ldopa, rice
• It is to be noted that Asians may have different Pharmacokinetic interactions with anti-epileptic drugs. A survey done in 1998 showed that Sri Lankan population may need lower doses especially in combination. (Scientific Sessions SLMA – 1998)
• An older study in 1985 proved that aspirin remained the most effective and safe NSAIDS. Aspirin is no more included in drug trials for NSAIDS as drug companies only include their branded products in trials. I did a survey of drug trials on NSAIDS and drew this conclusion.
I have proven elsewhere that aspirin remains the safest and most effective non steroidal anti inflammatory drug for joint disease (unless when ibuprofen is prescribed in doses less than 80 mg per kg per day).
Mendis, B. L. J. 1995. Joint disease, aspirin and NSAIDs. Kandy Medical Journal, 5: 1-3. Mendis, BLJ. 1996. Aspirin::friend or fiend. Ceylon Medical Journal. 41:76-77.)
• We discovered the serotoninergic basis of relationship between Migraine and IBS in 1979 in a survey done in the Prof Medicine Unit of Colombo. This means that drugs used for Migraine may be effective for IBS. It was also documented that 50% of Migraine sufferers respond well to non-medical methods of treatment.
Mendis, B. L. J. 1994. Avoiding nightmares in migraine management. Journal of the Ceylon College of Physicians, 27: 54 – 55.
• It is irrational to prescribe Augmentin when the cause of non-resolving bronchitis is PBP mutations of bacteria. Increased doses of amoxicillin is the answer
Article on Resistance to Penicillin G in Streptococcus pneumoniae by L Temime and others (Emerging Infectious Diseases vol 9 no 4 April 2004 p 415)
• Appendix long thought of as useless vestigial organ (according to evolutionary thought) has been proved to be a valuable reservoir to colonise gut with commensals after a bout of diarrhea. Bollinger et al, Journal of Theoretical Biology 249(4):826-31, 2007
MEDICAL ETHICS – Dr. Lalith Mendis.
SOCIAL ASPECTS OF MEDICAL ETHICS. CDN
(Seminar for New Entrants 1994 – Faculty of Medicine, Kelaniya).
It is Rousseau- the French philosopher who said, “It would take gods to give men laws”. He recognized the need to transcend the human level in establishing norms for behaviour and man’s inability to do so. Whereas a law dernands obedience, an ethic compels conformity. Ethics need to come from within. It is appropriate that Prof. Carlo Fonseka has with commendable foresight thought of inculcating an ethical ingredient in the new Medical entrant at the outset of his or her career.
It is an open secret that a patient in Sri Lanka can no longer go to the average doctor completely trusting him. The patient no longer accepts that all what the doctor does is for his or her best. If this kind of seminar helps to dispel that ugly blotch that has come on our noble profession and by ethical instruction restore the fiduciary relationship (faith and trust relationship) between patient and doctor, it would be a great service to the profession and our nation.
Let me commence with a general approach to a work ethic. In work we serve others. I for one believe that all men are created equal by a Benevolent Creator. This means in work we serve others. Work is an institution designed to bring the best of altruism (sacrifice and service to others) in man. While we should and could advance materially and socially, because of our chosen field, that however ought not to be the primary goal of work. Especially the work of a professional cannot be for profit nor is it a business. Webster’s dictionary defines a professional as one who does not engage in trade. If our countrymen have come to think of the medical profession as a lucrative trade, it indeed is a tragedy.
In work we ought to serve others. This should be the chief end of our work as doctors. “The joy of comforting always., relieving often and curing whenever possible” is our noble and rewarding task.
There are three areas of medical ethics-namely:
(a). Doctor-patient ethics.
(b). Doctor-doctor ethics.
(c). Doctor and society ethics.
I would like to focus on a few common areas of present concern and some other areas of remote concern.
PECUNIARY AND SOCIO-ECONOMIC CONCERNS
The medical student embarking on his\her career should not consider the 4 1/2 years in the medical faculty as the doorway to a lucrative business -a business more reliable and predictable than gemming. (after all gems are not found everyday but patients are). The financial difficulties that a medical student may encounter should not drive him in later life to mercenary (money making) attitudes. On the other hand those who have come from affluent backgrounds could want to preserve and even improve on what they already have and attempt to do so within a short space of time since passing out. Those of us who have felt the pangs of poverty should be the very ones who should be in the forefront of a movement amongst doctors for a more socially concerned orientation towards our patients. This is an important ethical consideration that we ought to bring to bear on our guranteed personal loan practice. If a poor patient who can ill-afford the money, is compelled to offer the D.M.O. his private practice fee (P.P.fee!) because he will be better treated, then we are indeed economic oppressors who use our priviledged profession-for which the country has paid-to fleece the sufferer. Even in consultation practice one needs to ask the question, “must I charge every patient I see? Is there anyway to ease the burden on the poorer patient?
A new generation of doctors needs to work together at all levels to prevent the financial drain on poorer patients in doing medical pilgrimages to the provincial capital-be it Colombo, Kandy, Galle or wherever.
1. Our peripheral units and district hospitals. should have caring, capable and confidence-building doctors. Drugs in the DH should not get into the DMO’s private dispensary. There is today a total breakdown of the once efficient CD; PU, DH system.
2. MOH should be active and conscientious in his\her M.C,H. (maternity and child health) and other preventive aspects of medicine. Often MOOH are occupied in private practice and have no time or concern for the improvement of primary health care. Each MOH and his team ought to be conversant with the preventable health problems of the area. In a village where we once had a free clinic the majority of the population was going blind with vit.A deficiency. We were able to. give them a month’s quota of vit.A (cost Rs. 3.60 per person). When we visited this community they were amazed no end that they were seeing better.
3. Such mobile clinics should be arranged into the many inaccessible areas of the area by the DMO and the MOH. This could be done even weekly if one is motivated. Undetected medical problems can be detected and referred to thee nearest General or Base Hospital. Vitamin or mineral deficiencies can be corrected. Since our country has given us a free education right upto the MBBS degree, we owe our people this much of altruism. The AMO, DMO and the MOH can become a source of comfort to the people of the area. A grateflil people will remember. you as their benefactor.
4. In arranging such clinics in your area you could .liaison with in any NGOO who will step in with other welfare schemes. What. the NGOO often lack is someone motivated and knowledgeable. It is unfortunate that knowledgeable people are often unmotivated and vice versa. Even free drugs are available through NGOO, if one can honourably use the same for free clinics and not for PP! Many are the occasions when hospital drugs find their way into the DMO’s private dispensary and even into the PP of the Apothecary and the Attendant!! The old Sinhala adage- “when the teacher performs a certain function standing, will not the pupils do the same running” is so true.
5. Our infant mortality rate is rising and the birth weight is dropping, indicating a downward trend in our health services.
The Quality of Life Index of Sri Lanka which was the highest for countries with a low GNP in the seventy’s, (Prof. Carlo Fonseka; Towards a Peaceftil Sri Lanka;WIDER Research) may not long remain that impressive. While we spent 0.7% for defence and 5% of GNP for welfare in 1978, in 1988 we spent 5% GNP for defence and 0.7% GNP for welfare (Prof. Carlo Fonseka,. ibid.). The doctor closest to the grass-root level ought to be concerned about this decline.
6. The municipality Medical Officers of the large cities see the worst effects of poverty on health-especially maternal and child health. A caring MO in the municipality can do much for the teeming multitudes that come to her.
7. The GP, DMO, AMO can do much to offset the adverse effects poverty has on health. Vit.A and iron deficiency which contributes significantly to maternal and infant morbidity and mortality are easily corrected. Vitamin and iron supplements should be routinely prescribed. There are recent reports of decreased child and infant morbidity and mortality with vit.A supplementation. (BMJ vol.304: 25, Jan1992-207). Will it not weigh on our hearts that we as medical officers stand between poverty and death of our poorer patients? Should it not be a paramount ethical concern that we should do all in our power to prevent our patient’s poverty resulting in increased morbidity and mortality when the cause is preventable or correctable?
Can we merely blame lack of government resources? A tablet of iron costs 5-10 cents; vit.A and D tab. costs 15-20 cents. Would a GP or DMO become poorer if they give a packet of 10 tabs. free to the mother who comes to them.
8. The consultants ought to discourage their patients coming from far away places when they can ill -afford such expenses. Name-building and “channel Antics” leave patients poorer. Every ethically concerned Consultant attached to Base and General Hospitals should assure the poorer patients who come to them for channelled consultations, that the same care and treatment will be accorded them if they follow the government clinic of the same Consultant.. He should ensure that the follow up clinic cares for the patients and that the routine referrals from GPP., AMOO, DM00 should be honoured at the Clinic without pecuniary benefit. This was standard practice 15 years ago.
9. Reduce the number of visits a patient has to make to you to the barest minimum. A bread-winner of a family (an accountant) went to four different specialists once in two weeks for three years, each time paying the fee. The disease was incurable and the drugs which could have been prescribed at a govt. clinic did not control the symptoms. Over the three years the patient was not given a diagnosis card, nor referred to a govt. clinic though all the four specialists were attached to govt. hospitals. The patient cannot work and his wife supports the family working as a stenographer Until I discontinued the habit they were paying the fortnightly fee. Incredible?
10. Prescribe the least number of drugs at the cheapest price. Iron is available at 10 cents per tab. and at Rs. 4 a cap. prescribe thee least costly, appropriate antibiotic, at the minimum needed dosage, for the period required. Do not get taken in by the attractively designed documents with impressive clinical trials. Please remember that the Companies paid for the clinical. trial with all the fringe benefits available to the researchers who fiddle the trial to achieve the desired end. Know your Pharmacology better than the drug rep.
11. Ask only for the most essential investigations. Simple viral or bacterial bronchitis needs no investigation. In fact viral bronchitis should not be treated with antibiotics. Kotthamalli is adequate! WBC/DC or ESR will cost a patient Rs. 20 or more. Dysuria and fever can be treated without a urine FR; go for a culture and ABS if your first line treatment with a cheap antibiotic, such as Nitrofurantoin fails. Accusations are afloat that doctors have shares in firms that offer investigations. The temptation is very real for the GP or DM0 who has his own lab. The patient should. not be treated as a goose that lays the golden egg.
12. There is a tendency to recommend admission to private hospitals because the doctor can earn more from the hospital visit or the operation. The patient is often made to feel that he may not get the best unless he is admitted to a private hospital. In an emergency govt. hospitals still offer the best care.
13. The patient needs to come to a doctor for the least number of visits. The old family doctor of would not charge a patient for the second visit for the same ailment.
14. Preferential treatment to channelled patients, quicker operations for them. Seeing only the channelled patients, are accusations often levelled at the profession.
15. Many interns are tempted to do “locum”. This is illegal.
16. Money for beds, quick operations, for bottle of saline, for false medical certificates are among other modes of illegal solicitation (bribery).
It may be appropriate to quote a composition by the late Professor K.Rajasuriya.
PROFESSIONAL MALPRACTICES AND MORALS .
1 One should not undertake to treat a patient who rightfully falls into another’s speciality. e.g. migraine should be treated by a physician and not a neuro-surgeon.
2 There have been reports in the press of doctors taking sexual advantage while examining female patients. One has to hold a strict control on one’s self to make certain that such physical examination should never be the means of sexual gratification. This applies to medical students too, who should be courteous to the patient they examine, obtain their permission, be respectful in undressing, always have a female colleague when examining a female patient, respect privacy.
3 There seems to be a very real danger of consultants becoming mechanized in seeing so many patients per hour. Adequate care is not given. One who is under constant pressure to clear numbers quickly can miss out on vital diagnoses and loose the science of rational diagnosis arid therapy.
4 Under such. pressure there. could. be no time to update one’s knowledge. Undergraduate and post-graduate teaching wilt be neglected. The next generation of medical students will inevitably suffer. The teacher would have worked froin 4.00 a.m. to 8,00 a.m. and again from 4.00 p.m. to 10.00 p.m. Will he be fit to work or teach between 8.00 a.m. and 12.00 noon. The Establisliment Code has a clause which says that permission should be obtained from the Head of the departinent to work for money after official duty hours. This was a wise statute to ensure maximum performance during official duty hours. Legalization of chanelled practice has invalidated this clause.
5 One shoud be on his guard regarding.nursing staff. A doctor should not take undue advantage of a professional relationship without long term commitment.
6 Competition and personal promotion should be avoided. There is a specific measurement recommended for the name board, Criticism of colleagues and methods of advertisement are to be avoided. Professionals ought not to compete as traders do..
3. Abortion is illegal in Sri Lanka other than in certain strict medical circumstances. However illegal abortions are a lucrative trade. Those who call for liberalization of abortion do not present facts against their case. Proliferation of abortion opportunities tends towards the neglect of more conventional methods of contraception. Abortion entails definite morbidity risks to the mother. In countries where abortion is legalized it has become a thriving business enterprise to the doctor and to the clinics. Even in Sri Lanka “menstrual regulation” is the euphemistic term under which illegal abortions are performed. I would strongly recommend an attitude of reverence to life, even unborn life. It is to be remembered that one line of the Hippocratic oath is-
“and especially I will not aid a woman to procure abortion.” The International Code of Medical Ethics has the following~ “. …I will maintain the. utmost respect for human life from the time of conception;”
4.Informed consent – prior to operations or any other procedure; patient must have satisfactory knowledg of possible consequences. A medical officer can be charged for damages if lack of informed consent can be proved.
5. Professional secrecy-a doctor at no time should use confidential information gathered from professional relationship pecuniary or other advantage.
6. Integrity as an expert witness-gratification should not prejudice the opinion of the doctor as an expert witness.
Remote Concerns .
1. The blood trade -extreme poverty may drive people to donate low Hb% blood which makes profits for private blood banks.
2. The organ trade for organ transplantation – in Calcutta (and probably other major cities of India Dobs caste is employed by agencies to recruit the diseased who are dying to offer their organs for transplant for remuneration. A sum is agreed upon and an advance is paid to the prospective donor.
Upon death the body of the donor provides kidneys, cornea, hair, teeth, skeleton for an extremely lucrative business. The West can look upon third world countries for a cheap harvest of organs that feed a multi-million dollar business.
3.The vast expenses incurred for organ transplantation or coronary surgery facilities could be a drain on the meagre resources of an impoverished developing country. The question arises whether such investments should not go into primary health care thus profiting thousands.
4.Foetuses (abortuses) obtained by surrogate pregnancy are used for plastic surgery and for research. Is this cannibalism?
5.The issue of euthanasia.
6.Genetic engineering should one experiment with human zygotes? What will the end result be? Is it right to attempt to produce high IQ foetuses? (fertilize the ovum with high IQ donor sperms). Has man the right to determine the composition of the future human society? Will genetic engineering produce monsters?
7.Research programmes are sponsored to promote the product of a company with. financial benefits to the researchers.
8.Economic exploitation of the third world by the first world drug companies-royalty rights; ever increasing cost of western drugs. eg.insulin fiasco- “Boots” of India produced a vial of Lente insulin at Rs. 60. Since a western syndicate bought them over the vial has shot up to Rs. 160 and we are under pressure to convert to the even more expensive human insulin.
9 Ethicality and legal issue that may ensue between the genetic mother and the uterine mother in surrogate pregnancies.
10. Stringent conditions for ethical committees to supervise research.
11. Campaign against cigarette smoking and its promotion.
12. Medical patents
13. Avoid plagiarism.