Features
Generic drugs and branded drugs
by Dr. Carlo Fonseka
MA, MBBS, PhD

Fellow of the Ceylon College of Physicians (h.c.)|
Fellow of the Sri Lanka College of General Practitioners (h.c.)
Emeritus Professor of Physiology, Universities of Colombo & Kelaniya
Former Chairman of the Board of Management of the Postgraduate Institute of Medicine

Executive Summary

1. The latest edition (6th) of Clinical Medicine by Kumar & Clark, perhaps the most widely read text-book of its kind in the world says: "In all countries it is Ö inevitable that cost-containment measures will be encouraged (or mandated) ... To reduce costs all drugs should be prescribed by their generic (approved) names rather than their "brand" ones because once their patents have expired, they are cheaper. Despite occasional claims to the contrary, generic products are required to go through the same stringent regulatory processes as their branded counterparts" (p. 996). The latest edition (9th) of Clinical Pharmacology by Bennett & Brown, quoting approvingly an editorial opinion of the British Medical Journal published in 1977 says: "The British National Formulary provides a regularly updated and comprehensive list of drugs in their non-proprietary (generic) and proprietary names. The range of drugs prescribed by any individual is remarkably narrow and once the decision is taken to "think generic" surely the effort required is small. And we would add worthwhile" (p. 86)

Make no mistake about it: if quality assured generic medicines are available current orthodox, mainstream, medical doctrine is that prescription of drugs should be by their generic names.

2. In Sri Lanka there are some solvable but still only partially solved problems of procuring quality assured generic drugs and of establishing that generic and branded drugs are equally absorbed into the blood stream (bioequivalence) and are available for action at the tissue level to the same extent (bioavailability). Therefore doctors should prescribe by generic names and they may specify the brand or trade names they would strongly recommend to their patients. Then those who cannot afford to buy the brand recommended by their doctor would be able to buy the generic equivalent they can afford. They can do so in the firm knowledge that generic drugs are the medicines that about 50% of outdoor patients and about 95% of indoor patients in this country have received during the past several decades. Our continually improving vital statistics suggest that generic drugs have done them good, or at least not harmed them. Let those who are proverbially prone to part quickly with their money, buy the branded drugs recommended by their doctors. Such patients are also the innocents who have a pathetic and absolute faith in the brainy brilliance and ethical integrity of their doctors who swear only by hugely expensive branded proprietary drugs, because pre-capitalist folk wisdom is "cheap things no good, good things no cheap".

Five issues

In a letter published in The Island of 2 January 2008, Eric J de Silva my well-informed, clear-sighted, articulate, ex-civil servant friend with an inquiring mind, has flatly declared that the raging debate on generic and branded drugs has left him thoroughly confused. If so, the debaters are to blame. My contribution to the confusion was no doubt due to its intensely polemical tone. Its polemical thrust was provoked by the moronic attack of Dr. DP Athukorale on my much-lamented guru Professor Senake Bibile whose strategy for delivering safe, effective, quality drugs at affordable prices to the public has been widely acclaimed. Because he can no longer defend himself I had to justify his concepts of essential drugs and prescribing by generic names as best as I could. EJdeS has pointedly remarked that in the process I had completely failed to address five aspects of the substantive issue which are a matter of life and death to lay people like himself. I am sorry for my lapse and I will try to rectify matters as well as I can.

Preliminaries

I took time to double-check with two Professors of Clinical Pharmacology the important technical things I am going to say. Clinical Pharmacologists have specialist qualifications in clinical medicine (e.g. MD, MRCP) and they have specialised in the scientific study of drugs and acquired higher postgraduate degrees. (e.g. M.Phil, Ph.D). Therefore they are the doctors best equipped with the necessary knowledge and skills required to provide facts and opinions about which drug is the best treatment for a patient with a given disease. One clinical pharmacologist whose advice I sought is Dr. K Weerasuriya, MD, MRCP, PhD, formerly Professor of Pharmacology in the University of Colombo Medical Faculty (UCFM) and currently WHO Regional Advisor on Essential Drugs & Medicines Policy. The other is Dr. Laal Jayakody, MBBS, MRCP, PhD, the current UCFM Professor of Pharmacology. I am deliberately name-dropping because an old teacher is entitled to call former pupils who have vastly excelled him in medical knowledge and wisdom to bear witness. In order to buttress my own credentials, allow me to say that in the UCFM I had the privilege of learning pharmacology (and much else) directly from Prof. SB who had got a First in his final MBBS examination in 1945 winning the coveted gold medals for both medicine and surgery. He then chose to specialize in academic pharmacology and acquired a Ph.D. from the University of Edinburgh. His teaching inspired me to study pharmacology with great interest and I won a distinction in that subject. After qualifying as a doctor and doing my internship in medicine under the Professor of Medicine in my time Prof. K Rajasuriya, I chose to specialise in human physiology. But to this day patients have continued to seek medical advice from me. In an article published in the British Medical Journal in 1996 I said: "After two years in state hospitals, I joined the staff of my medical school in Colombo in 1962, holding the posts of lecturer, senior lecturer, associate professor and professor of physiology. In all that time I have practised medicine because I believe that direct contact with patients makes my teaching more relevant". Because my abiding interest in clinical medicine was well known to my peers, the Ceylon College of Physicians and the Sri Lanka College of General Practitioners have thought it fit to elect me to the fellowship of their colleges, honoris causa. I am constrained to boast like this because during this debate one critic has attempted to discredit me by describing me as an aged pupil of Prof. SB (true) and a non-practising, armchair doctor (false). I am called a non-practising doctor simply because upto date I have not felt the need to set up shop to charge fees from patients I have treated. It is true that I cannot claim as Dr DPA has claimed without the trace of a blush to have "saved thousands of dying heart patients". (One wonders what criteria he used to judge that the heart patients he claims to have saved were actually dying.) I am also accused by Dr DPA of being a blindly loyal, simple-minded, acolyte of Prof. SB. He says that I regard "as gospel" what he calls Prof. SBís "outmoded utterances". I am sure readers will note with dismay the intellectual arrogance that 43 years of un-audited, non-monitored medical practice has induced in this village lad who has made good (money) as a doctor mainly by prescribing 7 or 8 branded drugs in his prescriptions. However that may be, it is now time to turn to the five matters raised by EJdeS.

1. "Many of the wonderful drugs available today were completely unknown to Prof. Senake Bibile".

Even schoolchildren know nowadays that medical knowledge has been increasing rapidly and changing constantly during the past few decades. So much so that in the 1950s Sydney Burwell, a dean of the Harvard Medical School went so far as to tell a fresh batch of medical students: "In ten yearsí time you will discover that half of what you were taught has proved to be wrong, and neither I nor any of your teachers knew which half." Therefore for a cardiologist with 43 years of experience to say that many drugs available today were completely unknown to Prof. SB is to say something which is incredibly inane and jejune.

EML Concept

For EJdeSís edification, let me briefly sketch the story of the Essential Medicines List (EML) concept. In 2007, the WHO officially recorded the 30th anniversary of the EML. The publication produced to mark this event has a section titled: "Countries That Set The Example". What it says about Sri Lanka is as follows: "Sri Lanka (then Ceylon) created a medicines list for purchase by the state healthcare system in 1959". Note that 1959 was 49 years ago. In that year Prof. SB in consultation with clinicians and pharmacists published a little pocket book called "The Ceylon Hospitals Formulary". From this formulary about 215 drugs were identified as "Essential Medicines" for import in the context of our health budget of that time. This was the first documented example in the world of the concept of an EML. Today four out of five countries in the world have EMLs. Essential drugs are defined as "those that satisfy the healthcare needs of the majority of the population". This definition implies that there is a minority who may need drugs not included in the EML. So in addition to the EML there is a Complementary List of drugs available for use in special circumstances. In our country during this period of uneasy transition, there is also provision for local purchase of specific drugs for particular patients. Medicines in the EML and the Complementary List of drugs together with locally purchased specific drugs for named patients constitute the pharmacological tools used to treat patients in the entire state healthcare sector. Be it remembered that the state sector provides healthcare to about 50% of outdoor patients and about 95% of indoor patients in the country. There is no evidence that they are being damaged at all by receiving generic drugs. Our vital statistics have been continually improving.

SPC

In 1971 almost single-handedly Prof. SB set up the State Pharmaceuticals Corporation (SPC) to translate into practice his package of measures needed to make safe, effective, quality drugs available to the public at affordable prices. In the foreword to the third revision of the EML of the Ministry of Health published in October 2006, the then Deputy Director General Laboratory Services of the Ministry of Healthcare and Nutrition Dr. UA Mendis states: "The concept of essential drugs can be traced back to the Non-Aligned Summit Conference held in Sri Lanka in 1976. The conference adopted a special resolution on drugs, which included the idea that a list of the most essential medicines be compiled. The World Health Organization published its first list in 1977". (It is of melancholy interest that this happened in Geneva in October 1977, just two weeks after Prof. SBís ashes were deposited in a grave at the Jawatte Cemetery in Colombo.) It was in 1985 that the Ministry of Health of Sri Lanka officially published the first issue of its EML, modelled on the WHO EML compiled in 1977. This list has been revised in 1988, 1999 and in 2006. After the third revision in 2006 the EML contains about 340 drugs. (EJdeS may care to know that according to a standard reference work by Martindale published in 1996, there were some 62,500 medicinal preparations or groups of preparations in the world. Heaven knows how many there are today, in the teeth of the fact that the kinds of drugs humankind needs for all their illnesses are probably less than about a thousand. This is surely free enterprise gone mad! Because the medicinal drug industry is a goldmine, many enterprising businessmen try their luck as manufacturers of medicines coming up with minor modifications of already existing drugs or various combinations thereof).

Latest EML

Anyone who scrutinises with a knowing medical eye the latest EML with 28 different categories of drugs and medicines compiled by a large committee of experts with a diversity of knowledge and skills, can see that it is a rational, systematic, comprehensive and scientific document. Drugs in the EML and the complementary list and those available under the local purchase provision include all the worthwhile modern drugs required to deal with health problems of the people of Sri Lanka. The submerged assumption of the cardiologist with 43 years of experience who implies that todayís EML in use in Sri Lanka is nothing but the list of drugs complied by Prof. SB long ago, is so absurdly false that in my judgement he forfeits all claim to serious attention. (This will not be the last occasion I will waste time responding to the propagandist falsehoods and half-truths he repeatedly writes on behalf of the drug industry.) Dr. DPA concludes his article published in The Island of 29 December 2007 with a sarcastic reference to what he has characterised as "the outmoded views advocated so long ago by our late departed teacher Prof. Senake Bibile ". Here the word "late" means dead and the word "departed" also means dead. Its looks as if Dr. DPA believed (absurdly enough) that Prof. SB died twice, but let that pass. The truth is that he died tragically in Guyana on 29 September 1977 when he was on a UNCTAD mission to reform the drug delivery system in the Caribbean region.

2. "Many of the generic drugs imported during Prof. SBís time were of poor quality and had to be destroyed"

Prof. SB was the Chairman of the SPC from September 1971 to December 1976. During this period over six hundred stocks of different varieties of drugs were imported and it would have been a miracle if all stocks arrived in a perfect condition. A few were found to be defective to a greater or lesser degree and they were identified and excluded from distribution. According to Dr. DPA during this period large stocks of insulin, anti-epileptic drugs, amoxycillin and Vitamin A imported by generic names were found to be defective and had to be destroyed.

i. In regard to a stock of a variety of insulin imported from Poland (Polfa Insulin) a question was raised by a minister of cabinet of the time. Prof. SB was asked to investigate the matter and report to the cabinet of ministers. During the discussion he referred to porcine insulin (insulin obtained from the pig) that had been imported. Predictably this caused a minor blow up among some Muslims. Prof. SB explained that a variety of bovine insulin (beef insulin) was available for those who wished to avoid porcine insulin. The furore provided an opportunity for critics of Prof. SB to sling mud at him and the SPC. Dr. DPAís statement that "hundreds of thousands of rupees worth of insulin (generic) had to be destroyed" is false. It is true that when Dr. Gladys Jayewardene was Chairperson of the SPC in the 1980s, a stock of insulin imported by the SPC was withdrawn. So great appears to be his ingrained hostility to Prof. SB that Dr. DPA uses even that withdrawal to try to discredit a man dead now for some 30 years.

Continued tomorrow

 

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