Healthy Skepticism Library item: 19829

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lexchin J, Mintzes B
Transparency in drug regulation: Mirage or oasis?
CMAJ 2004 Nov 23; 171:(11):1363-5
http://www.cmaj.ca/content/171/11/1363

Abstract:

In Canada, the information used to approve new drugs is deemed commercially sensitive and hence confidential under the Access to Information Act,1 and the Therapeutic Products Directorate (TPD) will not release such information without the manufacturer’s approval. As a consequence, safety and efficacy information contained in unpublished trials submitted to the TPD is generally unavailable to researchers, physicians and patients, a situation that can potentially lead to the inappropriate prescribing and use of medications.

Figure

Figure.

The standard argument for the legal protection of these data is that their disclosure would compromise the economic interests of drug manufacturers. This rationale is difficult to credit in view of experience in other jurisdictions. The US Food and Drug Administration (FDA) discloses research information from preclinical and clinical trials that is considered proprietary in Canada, without apparent negative effects on companies’ profitability or willingness to operate in the US market. For example, extensive information on rosuvastatin is available on the FDA’s Web site.2

On the other hand, nondisclosure has serious disadvantages for the TPD, health professionals and the Canadian public. If scientific data submitted to regulatory agencies are never disclosed or allowed to enter normal peer-review channels, neither these data nor TPD reviewers’ evaluations can become subject to scrutiny by independent scientists. The scientific atmosphere of the agency may be stifled and the professional growth of its staff severely inhibited.3 Deprived of any independent access to information, health professionals and the public must accept the TPD’s judgement about the safety and effectiveness of products.

The level of secrecy in the TPD has been criticized on a number of occasions, including in a 2000 report by the ad hoc Committee on the Drug Review Process of Health Canada’s own Science Advisory Board. The report stated:

[I]n our view and that of many stakeholders, the current drug review process is unnecessarily opaque. Health Canada persists in maintaining a level of confidentiality that is inconsistent with public expectation and contributes to a public cynicism about the integrity of the process.4

To remedy this situation the Committee recommended

that HPB [Health Protection Branch, now Health Products and Food Branch] should set new standards of access to information at all stages of the drug review process, enhancing transparency and public confidence.4

In 2004 a report by the House of Commons Standing Committee on Health supported the development of mechanisms to enable greater public disclosure of information about clinical trials.5

In response to these calls for greater transparency, the TPD announced in 2004 that when new drugs and devices are approved it would publish a document entitled the Summary Basis of Decision (SBD). The SBD would outline the scientific and benefit/risk-based reasons for the TPD’s decision to grant market authorization for a product.6

The key part of the SBD of importance to prescribers and consumers is the clinical information on drug effectiveness and safety. Is enough information provided to allow for the safe and rational use of new medications or extension of indications for previously approved drugs?

To evaluate the adequacy of information in the SBDs, we examine 3 recent cases in which unpublished data submitted to drug regulators contained important clinical information that was either unavailable or misrepresented within the published literature. We ask whether the same discoveries would have been possible using Health Canada’s SBDs. We based our assessment on 2 pilot SBDs published to date, one for rosuvastatin,7 a cholesterol-lowering medication, the second for agalsidase beta,8 an enzyme replacement for use in Fabry’s disease.