SHOULD DRUG TRIALS BE CONSIDERED RESEARCH?

Vol 2 #8

Over the past several months the Canadian healthcare scene has been hit by a number of journalistic exposés relating to the impact of big Pharma on clinical medicine.

The Globe and Mail, one of Canada’s leading newspapers,  has run a number of stories on the impact and influence of pharmaceutical companies on the development of treatment guidelines. This story broke after new guidelines for the use of opioids were published. Following the release of these guidelines it was learned that many of the guideline authors had links with  pharmaceutical companies giving rise to potential conflicts of interest. As a result the Canadian Minister of Health has ordered an external review of these opioid guidelines.

On June 20, 2017 the Globe and  Mail ran another article that reviewed nine medical and psychiatric treatment guidelines. The journalists found that 46% of the guideline panelists had received some funding from companies that could benefit from included recommendations.

Bias…..What Me?

Research has demonstrated consistently that physicians underestimate the impact of pharmaceutical marketing strategies.

These strategies include:

Advertising in medical journals; on television; direct to consumer.

Direct funding of conferences, gifts, meals.

Research collaboration.

Payment to give presentations.

Development of an emotional relationship with the product or company.

Detailing. This refers to the practice of pharmaceutical company representatives visiting physicians at their place of work to discuss a particular drug and provide educational materials.

Most physicians are aware  that brochures and pamphlets produced by  drug companies  may be selective. Illustrations and coloured graphs may contain unwarranted emphasis or amplification of the benefits of the drug.

The physician’s intellectual insights about marketing  often do not take into account what we know about heuristics and unconscious cognitive bias. Many physicians may not realize that one of the main objectives of detailing is to foster a positive attitude towards  the drug company by creating amical relationships with  representatives.

Providing funding to carry out research on medications has a number of purposes. If the drug company is able to enlist researchers with good academic and research reputations this will add to the marketability of the drug. There have been concerns about the degree of editorial control that the authors retain in a drug trials sponsored by a pharmaceutical company. Researchers who participate in these studies could be prone to unconscious cognitive biases in their interpretations of findings.

Research Or Health Technology Assessment?

One area that has not received critical evaluation is whether drug trials should be considered as research for  academic promotion. Research in an academic context refers to the development or discovery of new knowledge.

The preponderance of drug trials consist of studying  efficacy within existing classes or “Me Too” drugs.  These trials do not offer any novel methods of action and are often developed because of expiration of patents on the original drug. They do not add to scientific knowledge of the basic mechanisms of disease and treatment response.

Insel (2006) in a critical commentary proposes that there needs to be a new approach for medication development within psychiatry.           He states that over the prior five decades the study of mental illness “has been dominated by the study of the action of the available drugs”. What is needed is a focus on the core pathophysiology of psychiatric disorders. To do this it is necessary to identify the key neurobiological underpinnings of psychiatric symptoms. The identification of key cellular pathways is required in order to define targets for medication development. This can be facilitated by the use of  libraries of small molecules which can be screened for target action.

Investigation of “Me Too” drug trials may more appropriately come under the umbrella of Health Technology Assessment. Health technology is the practical application of knowledge to improve or maintain individual and population health.  Health technologies include drugs, vaccines, blood products, diagnostic imaging, medical  devices, procedures, and laboratory  systems,

Health Technology Assessment  is the systematic evaluation of the properties, effects or other impacts of health technology on behalf of regulatory agencies, health care funders, hospitals and government ministries responsible for healthcare funding.  Academically it does not have the same import as basic or clinical research.

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