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

Continued from Yesterday

ii. Dr. DPA’s sweeping statement that "the anti-epileptic drugs (generic) imported on Prof. Senake Bibile’s recommendation never controlled fits and the entire stock had to be destroyed" is totally false. He has not cited a shred of supporting evidence. It is possible that he knew of a patient whose fits during a particular phase of the illness continued unabated despite taking a specific anti-epileptic drug supplied by the SPC. Given his notorious tendency to confuse chronological succession with causal link, he may well have jumped to the conclusion that anti-epileptic drugs (generic) imported on Prof. SB’s recommendation never controlled fits. If Dr. DPA bothers to read any good modern textbook of Clinical Pharmacology he will learn that when a patient is given a drug, the response is the resultant of at least ten different factors. The quality of the drug is only one among them. (But I will not elaborate on that matter here. I participate in this debate not to contribute to the Continued Medical Education (CME) which Dr. DPA seems to require so badly, but to clarify things for people like my friend EJdeS.) I challenge him once again to furnish the evidence for his statement that large stocks of anti-epileptic drugs had to be destroyed during Prof. SB’s time as Chairman of the SPC. The question of bioequivalence of some generic anti-epileptic drugs may have arisen. But there is no evidence that large stocks had to be destroyed. I am given to understand that under the terms of the relevant contracts, the suppliers are obliged to replace any defective stocks free of charge.

iii. What Dr. DPA says about a batch of amoxycillin capsules is perfectly true. A fraudulent local manufacture had delivered to the SPC dud capsules without antibiotic which, of course, did not work. Dr DPA says that he believes that a large number of patients who received those dud capsules would have died. If he truly believes that all patients who don’t swallow all the antibiotics that doctors prescribe for them necessarily die, he has still to learn about the phenomenon called patient "non-compliance". My friend EJdeS is one who by his own admission (innocently) believes that his body and soul are kept together by the drugs he religiously swallows. For the benefit of his health and peace of mind let me quote from Clinical Pharmacology by Bennett & Brown: "Having obtained the medicine, some 25-50% (sometimes even more) of patients either fail to follow the instruction to a significant extent (taking 50-90% of the prescribed dose) or they do not take it at all." (p. 19) The good news is that the vast majority of them live to tell the tale. It is mainly their physiology that keeps them going and not the poisons they swallow in small doses in the form of drugs. But that is another story. To return now to the story of the dud amoxycillin capsules: this act of outright fraud does not prove that generic drugs do not work. What it demonstrates is the greed and fraud of people in the drug industry and the importance of unfailing vigilance in preventing corrupt practices by undertaking rigorous quality assurance of drugs.

iv. What Dr. DPA says about Prof. CC de Silva and Vitamin A is again anecdotal and I for one will not accept on Dr. DPA’s authority that children went blind as a result of this alleged lapse. I knew Prof. CC de Silva very well, first as his student and then as a colleague in the UCFM. If as Dr. DPA alleges children went blind as the result of taking dud capsules of Vitamin-A supplied by the SPC, Prof. CCdeS would surely have gone public about it and made one almighty fuss. To my knowledge he didn’t. Let Dr. DPA furnish the evidence required to prove that children went blind as a result of taking dud capsules of Vitamin-A supplied by the SPC or be damned as a retailer of imaginary horror stories for the benefit of the drug industry.

In this context it is relevant to remember that the SPC happens to be the only drug importing institution in Sri Lanka which has a well equipped Drug Quality Assurance Laboratory. Most varieties of drugs that the SPC imports are scheduled to be tested for quality on at least three occasions, namely, when they are submitted for registration; on arrival of their first stocks in the country; and at some point during their circulation to patients. About 5-10% of drugs so tested fail the test and are promptly eliminated. In Sri Lanka proportionately more generics fail the tests than do proprietary drugs, although in developed countries the failure rates of the generic and branded categories are not significantly different. That is why standard text-books unhesitatingly recommend prescription of drugs by generic names. In Sri Lanka although drugs imported by the SPC are subjected to quality assurance tests, proprietary drugs imported by the private sector are not tested for quality at all. Importers of proprietary drugs and doctors who habitually prescribe them seem to believe without a whisper of doubt that drug companies with famous names are models of scientific integrity and ethical propriety. The stark truth about these drug companies has been laid bare recently by Dr. Marcia Angell, MD. Currently she is a professor of Social Medicine in the Harvard Medical School. Before that she was Editor in Chief of the prestigious New England Journal of Medicine. TIME magazine has named her one of the 25 most influential people in America. In her book titled ‘THE TRUTH ABOUT THE DRUG COMPANIES. HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT’ published in 2004 she says; " … defrauding the government by rigging prices and offering kickbacks is not the only charge that drug companies are facing…other charges include marketing drugs for unapproved uses and misleading advertising. Still others allege substandard manufacturing practices… four of those companies… pleaded guilty to criminal charges." (Chapter12) It is the exorbitant profits that such companies make which some doctors like Dr. DPA implicitly promote by touting brand names. Dr. DPA’s stated reason for doing so is to save "dying heart patients" (Don’t make me laugh!). If patients who receive branded (proprietary) drugs imported by the private sector die, most doctors do not even consider the possibility that the drugs may have been substandard. All concerned implicitly attribute the deaths to the bad karma of the patients on the ground that they died even after receiving the most expensive drugs on earth!

3. "All the essential life saving drugs used today have been discovered by famous brand drug companies"

Perhaps the most authoritative comment on this matter would be to quote from Dr. Marcia Angell’s book cited above: "As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies or the National Institutes of Health (NIH). The great majority of "new" drugs are not new at all but merely variations of older drugs already on the market. These are called "me-too" drugs. The idea is to grab a share of an established lucrative market by producing something very similar to a "top-selling" drug. For instance, we now have six statins …on the market to lower cholesterol… all variants of the first." (p. xv - xvi) Dr. Angell has marshalled evidence that in recent times a large proportion of the expenditure of the big drug companies has been on "Marketing Masquerading as Education" and "Marketing Masquerading as Research". (These phrases are the headings of chapter 8 and 9 respectively of Dr. Angell’s "tell it like it is" book on the drug industry.)

4. "Less than 0.5% of all drugs available in SL pharmacies are pure generic drugs and the remaining 99.5% consist of both cheap and expensive brands"

In The Island of 9 January 2008 Dr. Mahinda de Silva, a physician who has worked for 23 years in New York City and knows a thing or two about the gigantic racket called the drug industry, has rightly dismissed the above assertion of Dr. DPA as "gibberish".

The matter is indeed a bit confusing. Let me state my understanding of it as simply as I can.

i. Every drug has three names, namely, a chemical name, a generic name and a trade name. The chemical name is not relevant to practical medicine.

ii. The generic name of a drug is officially given by globally accepted international agencies. It is also known as the official or approved name. It is not the commercial property of any drug company. So it is also called the non-proprietary name. Thus generic name, official name, approved name and non-proprietary name are synonyms. When there are four terms to describe one and the same thing some confusion is inevitable.

iii. When a drug company markets a drug it has developed it almost always gives it a name which is easier to remember than its generic name. This is the trade name or brand name or proprietary name of the drug. For example, one brand name for Paracetamol is Panadol; for Aspirin one brand name is Disprin; for Diazepam one brand name is Valium.

iv. A company which develops a drug and markets it under a trade name or brand name patents the product and the trade name. During the period the patent operates the drug becomes known to the public only by the trade name or brand name given to it by the innovator company.

During this period no other company can lawfully manufacture and market it.

v. When the patent period of a drug expires, companies other than the innovator company can lawfully manufacture it and market it. But they have to do so under the generic name of the drug or under new brand names which are different from the brand name which had been given to it by the innovator company. So it comes about that a generic drug maybe known to the public either by its generic name or by several trade names or brand names. For example, the drug whose generic name is Salbutamol is marketed under its generic name Salbutamol itself and under trade names such as Ventolin, Volmax and Salmol.

vi. A generic drug is simply a copy of an original brand name drug whose patent period has expired. Therefore chemically, a generic drug is the same as its branded counterpart. This point must be clearly remembered during this debate. So let me repeat that a generic drug is nothing but a branded drug whose patent period has expired. Theoretically, therefore, other things being equal, how on earth could a generic drug be worse than the branded product?

vii. It goes without saying that all proprietary drugs have brand names. In addition, as indicated above, generic drugs can also have brand names. Thus both proprietary drugs and non-proprietary or generic can have brand or trade names. If this sounds a bit confusing EJdeS should recall the silly joke used by our political enemies to taunt us in our undergraduate days: "All commies are jokers; but all jokers are not commies; because some are Trots". By the same logic, all proprietary drugs are branded; but all branded drugs are not proprietary; because some are generics.

viii. If a country does not recognise drug patent rights, companies other than the one which originally developed and marketed a given drug would be free to manufacture and market it. In this business, patents are of two kinds, namely product patents and process patents. A process patent covers the specific chemical process by which a drug is manufactured. India recognises process patents but not product patents. Just as there’s more ways than one to skin a cat, there can be several chemical ways of manufacturing a given drug. Because India recognises only process patents and not product patents, once a drug appears in the market, various companies may manufacture it using processes different from the process used and patented by the innovator company. This generates commercial competition between drug companies. Such competition is one reason why drugs manufactured in India can be very cheap.

ix. The great thing about generic drugs is that they are almost always cheaper, often unbelievably cheaper, than the branded drugs of which they are true copies. Being the same chemically they have to be equally effective.

x. That is why in the interest of patients, the case for prescribing by generic names becomes unanswerable and compelling. This must be why our academic clinicians who are also world class clinical researchers like Prof Janaka De Silva and Prof Nimal Senanayake are not known to oppose prescription by generic names. In fact, Prof Janaka De Silva is the editor of an Online Appendix to Clinical Medicine by Kumar&Clark which forthrightly and unequivocally recommends that "all drugs should be prescribed by their generic (approved) names rather than their brand ones" as I quoted in the opening paragraph of this article. Only hack clinicians are dogmatic about the superiority of branded drugs.

5. "When doctors prescribe drugs using generic names it is the pharmacist who decides which cheap brand should be issued to the patients"

EJdeS may be amused to hear that one of the three main reasons given in Clinical Pharmacology by Bennett & Brown for advocating the habitual prescription of drugs by generic names is "convenience". How come "convenience" you may wonder. It is like this. When a drug is prescribed by a particular brand name the pharmacist is obliged to supply that brand and none other. If that brand is out of stock the patient does not get the drug at all. To remedy this, the patient may have to meet by appointment the extremely busy doctor who prescribed the branded drug and perhaps pay him another fee. On the other hand, when a drug is prescribed by generic name the pharmacist is free to supply whatever version of it is in stock. Unfortunately, in Sri Lanka we still don’t have enough qualified pharmacists. Therefore in the interests of patients, the practical course for doctors to adopt at present would be to prescribe by generic names and specify the brands they recommend to patients.

To resolve this matter in a rational way the fundamental question to which an answer must be found is the following: Which category of medical professional is best equipped scientifically and academically to determine which drug is the best treatment for a given disease? The answer, as already indicated, is Clinical Pharmacologists. It is certainly not hack clinicians like Dr. DPA who on the basis of their un-audited, unmonitored, uncritical, anecdotal clinical experience passionately believe that they know best what is good for their patients. For such doctors forty-three years of experience may mean nothing more than one year’s mistakes multiplied by 43!

Having dealt with the five matters raised by my friend EJdeS I will conclude this contribution to the debate by remarking that when the history of newspapers in this country comes to be written, The Island will surely merit a high place of honour for devoting so much space for promoting open debates like this in the public interest.

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