Joel Lexchin

York University · School of Health Policy and Management

The New Zealand government is this year developing a new Therapeutic Products Bill to replace the antiquated Medicines Act 1981. Among the many issues at stake is whether direct-to-consumer advertising (DTCA) of prescription medicines will continue to be permitted. Besides the United States, New Zealand is the only other high-income country that al...

Objectives: To examine whether there has been a change in the number of therapeutically important new medicines not being introduced into the Canadian market in light of the December 2017 announcement of regulatory changes to lower Canadian prices. Methods: A list was compiled of medicines approved by the Food and Drug Administration (FDA) betwe...

Background: Health Canada posts the outcomes of all New Drug Submissions. In some cases, companies have withdrawn submissions or submissions have been rejected by Health Canada for new active substances (NAS). This study explores the reasons for those decisions and compares them with decisions made by the Food and Drug Administration (FDA) and the...

Objectives To examine whether a combination of three characteristics of new drugs – review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value. Design Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020. Setting Canada....

Background Health Canada conditionally approves new drugs using its Notice of Compliance with conditions (NOC/c) policy. Under this policy Qualifying Notices (QNs) list confirmatory studies that need to be conducted to confirm the drug’s efficacy. This study examines the depth of information about methodology and patient demographics in the confirm...

Introduction: Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in Brit...

Objectives: This study investigates the information and policies that Canadian patient groups post on their publicly available websites about their relationships with pharmaceutical companies. Design: Cross-sectional study. Setting: Canadian national patient groups. Participants: Ninety-seven patient groups with publicly available websites....

Objective To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. Design We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weig...

Objectives This study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission (NDS) and compares Canadian and...

A major cause of hospitalizations and death in modern medicine comes from hidden risks, or 'lemons', in prescription drugs or vaccines. Regulators approve them as "safe and effective," but based on how companies define what "safe" and "effective" mean, based on rules and procedures that companies largely shape. They also control market information...

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada....

Canada has become a global leader in publicly releasing clinical data behind therapeutic products since 2019. Disclosure of clinical data is, however, limited to the point of product approval. The COVID-19 pandemic has underscored the limitations of such a point-in-time approach to transparency. As interventions are rapidly authorized for clinical...

In the wake of the rofecoxib withdrawal, regulators worldwide reconsidered their approach to post‐market safety. Many regulators have since adopted a life‐cycle approach to regulation of medicines, facilitating faster approval of new medicines while recognising and planning for post‐market safety issues. A crucial aspect of post‐market safety is th...

Purpose To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US). Methods This retrospective analysis examines medicines safety warnings issued by the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Ther...

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for prescription drugs by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and marke...

Background: The producers of clinical practice guidelines (CPGs) may not disclose industry funding in their CPGs. We reviewed Canadian national CPGs to examine the existence and disclosure of industry-related organizational funding in the CPGs, financial conflicts of interest of committee members and organizational procedures for managing financia...

Objective To investigate the nature and extent of financial relationships between leaders of influential professional medical associations in the United States and pharmaceutical and device companies. Design Cross sectional study. Setting Professional associations for the 10 costliest disease areas in the US according to the US Agency for Healthc...

Objective To (1) investigate the extent to which recently published meta-analyses report trial funding, author–industry financial ties and author–industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporti...

Pharmaceutical companies have moved beyond just producing medicines to also controlling the knowledge about the products that they make and the diseases they are designed to treat. One of the tools that they employ in this pursuit is the use of experts or people known as Key Opinion Leaders (KOLs). Although KOLs are paid by pharmaceutical companies...

Background: A previous study found that 2 of 29 (6.9%) meta-analyses published in high-impact journals in 2009 reported included drug trials' funding sources, and none reported trial authors' financial conflicts of interest (FCOIs) or industry employment. It is not known if reporting has improved since 2009. Our objectives were to (1) investigate...

Background: A previous study found that 2 of 29 (6.9%) meta-analyses published in high-impact journals in 2009 reported included drug trials’ funding sources, and none reported trial authors’ financial conflicts of interest (FCOIs) or industry employment. It is not known if reporting has improved since 2009. Our objectives were to (1) investigate t...

The thesis of this chapter is that the long-standing relationship between Health Canada and the pharmaceutical industry has corrupted the Canadian regulatory system. Health Canada is much more geared to the philosophy that drug regulation is primarily a commercial activity to help manufacturers get their products to the market as quickly as possibl...

Background: Because not all medicines are equally safe, effective, and affordable, health systems often use formularies to define explicitly which medicines will be included and excluded from coverage. Objective: We sought to synthesize methods and findings from published studies of formulary variation across health systems in high-income countr...

Background: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the lar...

Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutic...

The government of New Zealand is currently considering a new Therapeutic Products Regulatory Scheme that includes how direct-to-consumer advertising (DTCA) of prescription drugs should be regulated. This article reviews three different types of possible regulation of DTCA: government regulation, industry self-regulation and a mixture of the two. Re...

National regulatory agencies’ decisions to approve new drugs are based on limited safety evidence collected during clinical development. Often, only when a drug enters general use do rarer or longer-term adverse events become known or better understood, prompting regulators to issue safety advisories.¹ We examined how often medicines regulators in...

Purpose There has been less attention to the transparency of postmarket evidence of harmful effects of medicines than of premarket clinical trial data. This is a case study of requests for Australian “direct health professional communications” (DHPCs). These letters are used by regulators and manufacturers to inform clinicians of emergent evidence...

Background Patient groups represent the interest of their members when it comes to drug funding. Many patient groups receive grants from pharmaceutical companies that make products being considered for funding. This research examines whether there is an association between the positions that Canadian groups take about the products and conflicts of...

Number of submissions per patient group. (DOCX)

Patient groups declaring what percent of budget came from donations from pharmaceutical companies. (DOCX)

Firstly, the authors merely adapted, without critical review, Furukawa et al.'s study of placebo‐controlled, double‐blind randomised trials of new generation antidepressants in Japan.(2) Although Furukawa et al. initially identified 11 trials for inclusion, sponsoring companies only agreed to provide access to patient‐level data for six. Two of the...

Nursing home (NH) residents are increasingly in need of timely and frequent medical care, presupposing not only available but perhaps also continual medical care provision in NHs. The provision of this medical care is organized differently both within and across countries, which may in turn profoundly affect the overall quality of care provided to...

Health Canada has developed its Notice of Compliance with conditions (NOC/c) policy to get promising new drugs for serious diseases to market faster than would be possible through its standard approval process. Companies can receive an NOC/c for a new drug or a new indication based on incomplete evidence in return for agreeing to conduct post-marke...

Background Competing claims are made about the amount of money that pharmaceutical companies spend on research and development (R&D) versus promotion. This study investigates this question in the Canadian context. Methods Two methods for determining industry-wide figures for spending on promotion were employed. First, total industry spending on de...

Background: As a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members in...

Purpose Clinical research is widely sponsored by drug and device companies. We investigated whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. This review is an update of a previous Cochrane review. Methods In this update we searched...

Objectives This study examines the use of expedited approval pathways by Health Canada over the period 1995 to 2016 inclusive and the relationship between the use of these pathways and the therapeutic gain offered by new products. Design Cross-sectional study. Data sources Therapeutic Products Directorate, Biologics and Genetic Therapies Director...

Canada has strengthened intellectual property (IP) protections for pharmaceutical drugs several times over the last 3 decades. This study investigates whether the IP changes had an effect on the market exclusivity time of brand products on the Ontario Drug Benefit (ODB) formulary. We constructed a database that included the first brand approval dat...

Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural...

Objectives: To examine and compare the experiences and attitudes of primary care physicians in three different regulatory environments (United States, Canada, and France) towards interactions with pharmaceutical sales representatives, particularly their perspectives on safety information provision and self-reported influences on prescribing. Meth...

Background: Professional medical associations (PMAs) play a crucial role in providing accredited continuing medical education (CME) to physicians. Funding from the pharmaceutical industry may lead to biases in CME. Objective: This study examines publicly available policies on CME, adopted by Canadian PMAs as of December 2015. Methods: Policies...

Background: Clinicians are faced with a plethora of guidelines. To rate guidelines, they can select from a number of evaluation tools, most of which are long and difficult to apply. The goal of this project was to develop a simple, easy-to-use checklist for clinicians to use to identify trustworthy, relevant, and useful practice guidelines, the Gu...

Aim: This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, versus those approved on the basis of a serious morbidity or mortality (clinical) outcome. Methods: Physicians...

Prescription medications cost more in the USA than in any other developed country. The reasons for those high prices are contested between defenders of the pharmaceutical industry and critics. The industry claims that prices are due to the high cost of research and development necessary to bring a new drug to market and because high US prices subsi...

Background: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar...

Diverse legal and regulatory measures are used internationally to control the information provided during pharmaceutical sales visits. Little is known about the comparative effectiveness of these measures however. We analyzed the perceptions of regulators, pharmaceutical industry officials, health professionals, and consumer respondents concerning...

Background Clinical practice guidelines are widely distributed by medical associations and relied upon by physicians for the best available clinical evidence. International findings report that financial conflicts of interest (FCOI) with drug companies may influence drug recommendations and are common among guideline authors. There is no comparable...

Canada needs a national strategy to fulfill its obligation to ensure universal access to necessary healthcare, including prescription drugs. A 2004 attempt at a national strategy for pharmaceutical policy failed because it lacked clear vision, logical planning and commitment from federal and provincial governments. The result of uncoordinated pharm...

Margaret McGregor and colleagues consider Bradford Hill's framework for examining causation in observational research for the association between nursing home care quality and for-profit ownership.

McCartney draws attention to the enduring problem of the media being all too ready to oversimplify, dramatise, and rehash medical science.1 Such “churnalism” benefits the media, in revenue if not reputation, often at the expense …

Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs)...

Drug pricing in Canada is a divided responsibility between the federal and provincial governments. The price of patented medicines is largely controlled at the federal level through the Patented Medicine Prices Review Board that sets a maximum introductory price for new medicines and then limits the rate of rise of those prices to the rate of infla...

Background: Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive. Sources of data: Authors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed. Areas of agreement: Existing sources of i...

Background: Health Canada approves drugs on the basis of evidence from clinical trials using clinical or surrogate outcomes. This study compares the postmarket safety of these 2 groups of drugs. Methods: Information about whether clinical or surrogate outcomes were used and the date of market approval were obtained from Health Canada's Summary B...

Background: Drugs are approved for formulary listing based on limited knowledge of their safety. Serious safety issues are often identified after a drug is marketed. Objective: To determine whether the listing status of drugs on the Ontario Drug Benefit (ODB) Formulary changes following the identification of safety concerns by Health Canada and...

The FDA does not protect patients from harmful or ineffective drugs, but approves both The Vioxx disaster in the early 2000s triggered a crisis of mistrust in the US Food and Drug Administration (FDA), as evidence emerged that it had downplayed or ignored evidence of serious cardiovascular harm associated with Vioxx (rofecoxib), a cyclo-oxygenase-...

Priority reviews of new drug applications are resource intensive and drugs approved through this process have a greater likelihood of acquiring a serious safety warning compared to drugs approved through the standard process. Therefore, when Health Canada uses priority reviews, it is important that it accurately identifies products that represent a...

On Nov. 6, 2014, the Canadian government passed Bill C-17 (Vanessa’s Law), aimed at strengthening the powers of government to recall a drug that is shown to have harmful effects.1 The bill is expected to strengthen postmarket surveillance and research, and allow the Minister of Health to compel the release of proprietary information and drug safety...