Friday, October 08, 2010

Another Wheel Already Invented (in 1988) - the WHO Ethical Criteria for Medicinal Drug Promotion

At the 2010 Gezonde Scepsis (Healthy Skepticism) "Selling Sickness" conference, I was made aware of another wheel invented a long time ago, the 1988 WHO Ethical Criteria for Medicinal Drug Promotion, a document about which few now seem to be aware.  Were this code to have been widely followed, it might have prevented some of the problems afflicting the pharmaceutical industry today.

Some relevant quotes follow:

Drug Promotion

6. In this context, 'promotion' refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.

7. Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word 'safe' should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature.

8. Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs.

9. Scientific and educational activities should not be deliberately used for promotional purposes.

Note that these provisions would seem to prohibit promotional efforts begun before a drug is legally approved (e.g., ghost-writing as in this case), the use of "key opinion leaders" without full disclosure of their role as marketers of drugs, suppression of clinical research sponsored by pharmaceutical companies whose results did not support these companies' marketing interests, e.g. studies which failed to show efficacy of their products, nearly all kinds of payments to physicians, and nearly all pharmaceutical sponsored continuing medical education.

Medical Representatives

17. Medical representatives should have an appropriate educational background. They should be adequately trained. They should possess sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers are responsible for the basic and continuing training of their representatives. Such training should include instruction regarding appropriate ethical conduct taking into consideration the WHO criteria. In this context, exposure of medical representatives and trainees to feed-back from the medical and allied professions and from independent members of the public, particularly regarding risks, can be salutary.

18. Medical representatives should make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data sheet or other source of information with similar content.

19. Employers should be responsible for the statements and activities of their medical representatives. Medical representatives should not offer inducements to prescribers and dispensers. Prescribers and dispensers should not solicit such inducements. In order to avoid over-promotion, the main part of the remuneration of medical representatives should not be directly related to the volume of sales they generate.

Note that these provisions appear to prohibit the current cheer leader/ ex-athlete model of the drug representative, and to prohibit many of the current activities of such representative, including providing gifts, meals, travel to meetings, honoraria, etc  (e.g., see posts here and here).

If only these standards had gotten some traction, think of the trouble that could have been averted.  On the other hand, it is obvious that such traction would have threatened some peoples' lucrative incomes and power, who may have worked hard to make sure it did not happen.

1 comment:

"Guppy" Honaker said...

The "Drug Promotion" heading makes me think back to 1910 when Marijuana, heroin, and morphine were all available over the counter at the local corner drugstores. "Pharmacists said, 'Heroin clears the complexion, gives buoyancy to the mind, regulates the stomach and bowels, and is, in fact, a perfect guardian of health'

While I'm not a huge fan of government regulation, in the areas of health and medications, I think it's critical.

- David

Aloe Vera Juice Benefits
Holistic Nutrition and Health