By Domenic Rosati (MLIS candidate 2017)

Matthew Herder’s lecture about the history and present state of Canada’s drug fraud regulations was particularly interesting from an information management point of view because the central theme was the communication of information. The lecture was called “Fraud Forgotten” because recent/current drug regulation is characterized by elusiveness. Why? Herder asserts that over half of studies about drugs are not published and half of those published are likely to be distorted. Investigators of drug data receive little support, have to undergo rigorous procedures to request this information, and promise that they will not divulge any of the data publicly. The majority of communication that takes place between the drug companies and the regulators is closed

In order to understand how we got here, Herder took us on a journey through drug regulation history in Canada. One of the illustrations that he showed was an early Canadian drug fraud bulletin. This was a historical example of open communication where the public was involved in the process. After the 1887 Adulteration act, Canada’s drug regulation body began to publish fraud bulletins that reported known adulterated ‘nostrums’ or medicines and persons who were committing drug fraud. While Herder notes that much of the reporting in the bulletin was often not strong enough evidence for court action against fraud offences, the bulletin was important in the court of public opinion. If adulteration cases escaped the courts, the public was still aware of the offences and infractions, so Herder argued that the possibility of shame deterred potential fraud. Another function the bulletin served was establishing drug adulteration standards. Importantly, bulletins provided the potential for independent testing.

Around the 1920’s, relations between the drug industry and the medical profession, combined with changes in drug production contributed to a new perspective on drug regulation in Canada. There was a diminishing criticism of drug companies and a movement to try and protect proprietary information about the pharmaceutical industry. The result was a closed circuit regulatory communication channel wherein the bulletin was no longer published and drug fraud investigation and enforcement were now managed between by regulators and the drug industry. This trend has continued to the present day resulting in a lack of transparency, a narrow definition of fraud, and a weak drug fraud prosecution system.

While it is tempting to think the solution to drug fraud regulation is to open all communication to the public, Herder said we cannot assume transparency will automatically lead to effective regulatory practices. In other words, having access to drug fraud information does not mean that we are putting that information to good use. He argues that transparency and regulation practices have to go hand in hand. What we learn from Canada’s drug bulletin was that it was great for circulating standards, but failed to remain a strong regulator because it was not integrated with other areas of enforcement. A completely open channel of communication is complicated by proprietary information, the requirement for competent independent investigators, and more. Drug fraud policies also don’t account for contemporary ways of manipulating data.

Herder offers two steps that we can take to at least start thinking about more transparent communication with drug companies: de-antiquating adulteration (which is an attempt at revealing alternative methods of regulation and transparency with regard to drug fraud in Canada) and re-imagining local analysts (why do regulation bodies have to be in Ottawa, or government-centric? Perhaps better funding support could be provided to scientific researchers in order to empower them as analysts).

Herder’s lecture revealed the complications of regulating drug fraud. Importantly, he showed that an understanding of how the communication of information is vital to the understanding of this complex issue.