S. GOPALAKRISHNAN, R. MURALI*
* Dr Gopalakrishnan is Assistant Professor, and Dr Murali is Professor and Head, Department of Community Medicine, Kilpauk Medical College, Chennai-10, Tamil Nadu, India. E-mail: email@example.com
EVERY year many new drugs enter the Indian market. Most are "metoo" products, not genuine innovations. They join more than 20,000 drug formulations already on the market. In stark contrast, the Tamil Nadu State Essential Drugs List contains just 270 drug formulations, all identified through a scientific process as sufficient to treat over 90% of illness at primary, secondary and tertiary level care. This figure is similar to essential drugs lists from many other countries and also the WHO Model List.
The huge number of products on the market make the selection of the right drug and its proper use an increasingly difficult task. Commercial drug information far outweighs the independent and scientific therapeutic information that is essential if drugs are to be used rationally. Ensuring that all health professionals have access to such information is an important State responsibility. Although the State of Tamil Nadu is committed to the essential drugs concept and rational drug use, it will take time and increased resources to educate and motivate all prescribers and dispensers.
The reality at present is that most health professionals get their information from commercial sources, usually through an extensive network of medical representatives. The pharmaceutical companies claim that their new formulations are superior to existing, effective and inexpensive products with which prescribers and consumers are familiar. They target prescribers through weekly or monthly visits, distributing samples and attractive, eye-catching brochures. These materials are often misleading and confusing. The intensive marketing motivates unwary doctors to prescribe the new products, often without verifying whether the claims made are justified.
Growing concern about this situation and its negative impact on rational drug use, and the need to alert the medical profession to the extent of the problem, led the Department of Community Medicine, Kilpauk Medical College, Chennai, to set up an Ethical Committee to monitor, act and report on unethical drug promotion (see Box 1 for examples reported). The Committee's membership is drawn from various medical specialities, including interns. A special student's sub-committee has also been formed.
A recent analysis of drug information materials distributed by pharmaceutical companies to prescribers identified many discrepancies between claims made and independent scientific data on the efficacy and safety of the drugs in question.
Box 1 gives a few examples of unethical pharmaceutical advertisements that are thought misleading and confusing.
Examples of misleading drug information materials
• A company that manufactures gliclazide 80 mg., an antidiabetic drug, claims that the drug ensures glucose control throughout 24 hours without hypoglycaemia. But in reality the actual duration of action of this drug is only 12 to 16 hours.
• Indopamide 2.5 mg. is claimed to be cardio-protective and an internationally acclaimed diuretic. But in reality it has little action as a diuretic. It has antihypertensive action but has no cardio-protective action as claimed.
• Amoxycillin with clavulanic acid for "enhanced kill-power" is described as being effective against Community Acquired Pneumonia. Clavulanic acid has no bactericidal action on its own. The meaning of Community Acquired Pneumonia is not explained.
• A vitamin E preparation is claimed to be an "important prophylactic in photo-ageing", "scientific approach to treat muscle cramps" and "effective antiatherosclerotic". But in reality vitamin E has only non specific roles in muscle cramps, no convincing evidence of benefit in atherosclerotic and skin diseases like photo-ageing. Ketonurea and impaired wound healing are reported as an adverse effect of vitamin E.
We have forwarded this information to the Central Ethical Committee, constituted to tackle unethical promotion of drugs, for further action.
The Central Ethical Committee has been formed to collect information on the unethical advertising practices of pharmaceutical companies. Complaints and other information received from professionals and the public are reviewed by an Expert Committee at central level in New Delhi. The information is sent to the various state drug control authorities, which can pursue the matter through the Drugs and Magical Remedies Act and the Drugs and Cosmetics Act. These Acts empower drug control authorities to take necessary legal action on unethical advertisements.
Currently, regional committees are constituted at Chandigarh, Mumbai and New Delhi as well as Chennai, and they will be extended to other states. The central and regional/state committees will coordinate their activities, and will also provide professional and expert opinions on matters relating to unethical drug promotion.
Ethical Committee activities
• Systematically collect and review promotional material distributed by pharmaceutical companies to medical professionals.
• Compile and publish data on discrepancies in promotional material and unethical practices; disseminate this information to health professionals and other interested parties.
• Report on unethical promotion to the Food and Drug Administration and request remedial action.
• Involve all medical colleges and professional associations in creating awareness of the extent and nature of unethical promotion. This should be done through existing newsletters, student magazines and professional journals, as well as through students, postgraduates and other professionals updated on the subject in continuing medical education programmes.
• Coordinate with agencies and other state ethical committees to launch a national campaign against unethical advertising practices.