Ethical criteria for medicinal drug promotion; where does Sri lanka stand?

World Health Organisation has laid down ethical criteria for drug promotion based on the updating and extension of ethical and scientific criteria under the revised drug strategy. The main objective of the ethical criteria for drug promotion is to support and encourage the improvement of health care through the rational use of medicinal drugs.
Ethical criteria relates to the proper behaviour in drug promotion consistent with the search for truthfulness and righteousness. The criteria should assist in judging whether promotion of drugs is in accordance with acceptable ethical standards. These standards need to be applied to Over The Counter(OTC) as well as prescription medicine, medicines of western and other systems and any product promoted as a medicine.In the WHO document, promotion refers to all informational and persuasive activities by manufacturers and distributors, effect of which is to induce the prescription, supply, purchase and /or use of medicinal drugs.

Contrary to laid down ethical criteria, many have pointed out the manipulation of various methods by the industry to change the behaviour of prescribers. There is substantial evidence to show that advertising influences doctors' behaviour more than they might think. This applies to our setting as well though the published scientific evidence in this regard is sparse.

One of the methods used by the industry to change the behaviour of prescribers is advertising in medical journals. Advertising is reported to be a privileged channel of communication between the pharmaceutical industry and clinicians. It is invariably one of the most powerful weapons of drug promotion. Studies have demonstrated that drug advertising uses strong imagery to fabricate mythical associations between medical conditions and branded drugs, to depict exaggerated therapeutic efficacy . Ultimately clinicians have to give in to a rhetorical mode of persuasion in advertisements than making a decision based on a rational argument

Currently a large number of medical journals are published in the country. Except for a handful of them, others are sponsored by pharmaceutical companies and it is understandable considering the colossal sum of money that has to be spent by a professional organization to print a considerable amount of prints. These journals carry a large number of advertisements. Do all these advertisements adhere to ethical criteria? Are they consistent with approved scientific data sheet of the drugs concerned? Are they in contradiction with other sources of similar content? These issues may be a topic for a student looking for a research topic .

Exposing the mechanism of how advertisements change the behaviour of doctors, researchers quote semiologists according to whom we primarily consume not things but the meanings attached to them. On the basis of that drug advertising uses strong imagery to fabricate mythical associations between medical conditions and branded drugs. Armed with such drugs, the clinician believes that they can liberate patients from the oppression of disease and restore them to normality. Advertisement makes its “killing” (an aggressive metaphor for selling) softly. This effective use of mythology in drug promotion has prompted researchers to suggest a need for closer regulation of journals as a privileged channel of communication from the drug industry to clinicians.

Another area which needs focussed attention is the educational and training background of medical representatives. The companies must have passed the skills necessary to increase sales of drugs on to them. However, an interesting aspect is their knowledge on ethical behaviour in drug promotion based on the WHO criteria.The representatives are expected to provide unbiased information for each product discussed with the prescriber. How unbiased can be information provided by an employee of a particular commercial establishment geared to maximise their profits by selling pharmaceuticals? There is a huge question mark hanging over the validity of the results of the clinical trials disseminated by representatives of pharmaceutical companies. Comparison of measures of effect in clinical trials suggest wherever there had been statistically not significant effects, the majority of drug company sponsored trials have demonstrated statistically significant effects. This is very clearly seen in the “ forest plots “ of meta analyses. This leads to a situation where clinicians need to depend on multiple sources of evidences in selecting a drug rather than being confined to information provided by an interested corporate. Toady, the validity of many research findings is also questioned on the basis of the exposure of secret corporate funding behind health research . Academics are now blamed for failing to ask the crucial question when scientist make a scientific claim “ Who is paying you ? rather than the internal and external validity of research findings. Thus it is apparent that not only the corporate sector , highly esteemed professionals too violate their professional ethics. Researchers are only a part in the chain that eat the bait. There are numbers of prescribers who are offered inducements by the drug representatives. WHO criteria clearly state that prescribers and dispensers should not solicit inducements. We have first hand experience in collecting evidence on over promotion of drugs by prescribers and various strategies adopted by them in a study carried out in pharmacies in Gampaha and Polonnaruwa districts. It is our opinion that certain regulations are essential to preserve the rights of the consumers in making his decision although the prescriber acts as the intermediate purchaser of drugs for the patient. Undoubtedly, there could be valid reasons from the prescribers point of view to persist with a particular brand. But this should be evidence based and not anecdotal . Otherwise it is unavoidable to think that such an act as soliciting inducements.
The industry has been accused of medicalising normal phenomena and promoting drugs as solutions to social problems. In direct to consumer advertising, drug companies target advertisements for prescription drugs directly at the public. Some pharmacologists argue that this type of advertising risks medicalising normal human conditions, with the drug companies raking in increasingly healthy profits. New Zealand and United States are the only countries in the world that allow direct to consumer advertising of prescription drugs. However, in these countries, consumers need to persuade general practitioners to write a prescription if and when they need to purchase a prescription drug. In Sri Lanka, direct to consumer advertising is relatively uncommon even for schedule I, II A drugs. However, our observations in Gampaha and Polonnaruwa suggest that lay individuals are increasingly becoming familiar with medicines. Among the clients patronising pharmacies, one of the most common methods of ordering drugs was naming the drug. Otherwise, blister pack, used container or labels are produced to the counter to purchase schedule II B drugs without a prescription. Exit interviews revealed that the perceived indications and doses could prove to be harmful to the health of these individuals. This applied not only to prescription drugs but also to schedule I drugs advertised on television channels. Therefore it is timely that basic information such as generic name of the brand with the name, major indication(s), precautions and contraindications and warnings should be displayed in the advertisements to the lay public. In Sri Lankan setting, pharmacists/ pharmacy staff find no time to explain the required information to consumers. Nor do the consumers anticipate waiting for such information. Therefore, as pointed out in the WHO document of ethical criteria, instruction leaflet should carry adequate and relevant information. However, quite often, this information is in English language and manufacturers and importers of medicines should be encouraged to include instructions in Sinhala and Tamil languages for the benefit of lay individuals. Our observations revealed the use of corticosteroids by self medicated consumers without a control for years not knowing the implications of its use. There were many more such examples of abuse of drugs.
It is sad to observe that some unscrupulous elements in the pharmaceutical sector manipulate some of the achievements of the primary health care as a disguised means to promote their products. Immunization is such an example. It has been reported to the Epidemiology unit that sometimes some medical representatives attempt to introduce certain vaccines which are not in the National schedule through local health managers. These attempts violate the ethical criteria of medicines promotion as they are not in line with national requirements while the non availability or non provision of concerned vaccines for the subsequent doses also is a gross violation of ethics and consumer rights.
Public health managers also could learn a lot from drug promoters and advertisers how to change beliefs and behaviour more effectively than by reason alone. Public health managers attempt to initiate certain behavioural changes and inculcate some positive behaviour with the hope of preventing certain health conditions. Iron and Folic acid deficiency in pregnancy and lactation, lack of fibre in diets are two simple examples where drug advertising manipulates consumers need. Relationship between the condition and the remedy are made to seem natural in the advertisements. Every mother’s perception of healthy baby image is focussed intensely to the heart of the consumer and makes the kill. Condition and the product are demonstrated as each other belonging to a sequential order . It is so naturalised at the end, the slightest suspicion will not be aroused in the consumer that it was an intentional promotion.

References
Scott T, Stanford N, Thompson DR. Killing me softly: myth in pharmaceutical advertising BMJ. 2004 December 18; 329(7480): 1484–1487.
Pauline Norris et al, Advertising of medicines on New Zealand television. Journal of the New Zealand Medical Association. 2005;118, Journal of the New Zealand
World Health Organisation. Ethical Criteria for medicinal drug promotion . Geneva:WHO.1988
Wijesinghe P.R. Medication use in the community, Good pharmacy practice and implementation of drug regulation in an urban and rural area in Sri L anka. Thesis submitted to the PGIM for the degree of MD ( Community Medicine)