Research and Development of Drugs for Developing Countries Faces Many Barriers

R&D for neglected diseases faces a number of barriers. In order to expand R&D, all of the actors – governments, companies, and NGOs, among others – need to work together on solutions. The limitations of the prize fund model and PPPs need to be addressed.York's Knowledge Mobilization Unit provides services and funding for faculty, graduate students, and community organizations seeking to maximize the impact of academic research and expertise on public policy, social programming, and professional practice. It is supported by SSHRC and CIHR grants, and by the Office of the Vice-President Research & Innovation. [email protected] www.researchimpact.c

Réglementation pharmaceutique au Canada et prescription inadéquate de médicaments : le cas des psychotropes dans les années 60 et au début des années 70

Le processus d'approbation des médicaments joue un rôle déterminant dans la façon dont les médicaments sont prescrits au Canada. Cet article examine la nature de la réglementation du processus d'approbation, les décisions qui en découlent, la manière dont ces dernières s'expriment dans la publicité pharmaceutique, et l'impact ultime de ces facteurs sur la prescription des psychotropes en général, et plus particulièrement, des benzodiazépines. Un grand nombre de preuves empiriques portent à croire que les benzodiazépines ont été approuvées à la suite d'essais cliniques inadéquats, entraînant la prescription de ces médicaments pour des états où ils s'avéraient inefficaces et ce, sans tenir compte de certaines mesures de sécurité importantes. Ces déficiences du processus de réglementation ont été amplifiées dans la publicité s'adressant aux médecins, contribuant ainsi à une prescription inappropriée dans quatre cas : la prescription pour des problèmes d'ordre psychosocial, la prescription excessive pour la somatisation, pour les femmes et pour les troubles d'anxiété. Le processus d'approbation présente encore plusieurs lacunes et elles continueront de se manifester par une prescription inadéquate de psychotropes et d'autres médicaments.The outcome of the drug approval process plays a major role in determining how drugs will be prescribed in Canada. The objective of this paper is to examine the nature of the regulatory approval process, its decisions, how these are expressed in pharmaceutical promotion and the ultimate impact of these factors on the prescribing of psychotropic drugs in general and particularly with regard to the benzodiazepines. There is strong circumstantial evidence that the benzodiazepines were approved on the basis of inadequate clinical trials resulting in these drugs being indicated for conditions for which they were not useful and significant safety issues being ignored. These deficiencies in the regulatory process were magnified in the advertising of these products to physicians, thus contributing to inappropriate prescribing in four areas: prescribing for psychosocial problems, overprescribing for somatic complaints, overprescribing to women and overprescribing for anxiety disorders. Problems in the approval process continue to exist and these will manifest themselves in ongoing inappropriate prescribing of psychotropic, and other, medications

Bigger and Better: How Pfizer Redefined Erectile Dysfunction

Lexchin examines how Pfizer transformed sildenafil from an effective product for erectile dysfunction due to illness or injury into a drug that healthy men can use to enhance their erections

Models for financing the regulation of pharmaceutical promotion

Abstract Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs.</p

Drug Safety Is Influenced More by Business Interests Rather Than Public Health

The safety of pharmaceutical drugs in Canada is a concern. While Health Canada is given the power to measure safety and approve drugs, the process has its limits. There is a growing trend towards practicing “risk management” rather than the “precautionary principle” when drugs are approved. There is also a greater priority put on meeting the interest of drug companies compared to the potential harm to public health. “Progressive licensing” would allow for drugs to be assessed for safety even after it’s approved.York's Knowledge Mobilization Unit provides services and funding for faculty, graduate students, and community organizations seeking to maximize the impact of academic research and expertise on public policy, social programming, and professional practice. It is supported by SSHRC and CIHR grants, and by the Office of the Vice-President Research & Innovation. [email protected] www.researchimpact.c

Quality and quantity of data used by Health Canada in approving new drugs

BackgroundThis study examined multiple aspects about the approval of new drugs: the characteristics of the drugs, the quality and quantity of information that Health Canada discloses about the demographics of patients enrolled in clinical trials, the characteristics of the trial, and the type of review that it uses. It examines whether there have been changes in these measures between 1 September 2012 and 31 March 2022.MethodsA list of all new drugs approved, type of review used, and drug characteristics was generated from Health Canada annual reports. Therapeutic categories were identified from the World Health Organization Collaborating Center for Drugs Statistics Methodology. The Summary Basis of Decision documents of Health Canada were used to identify patient demographics in clinical trials and clinical trial characteristics.ResultsHealth Canada approved 326 new drugs for 407 indications. The percent of orphan drugs approved increased from 35.6 to 51.3%. The number of indications per drug decreased (p = 0.0817) as did the number of pivotal trials per drug (p = 0.0091). The percent of Phase 3 trials dropped from 76.3% in 2012–2015 to 64.8% in 2019–2022 (p = 0.005). There was also a statistically significant decrease in the percent of trials that were randomized, controlled, and blinded. The clinical trial characteristics of orphan drugs and the type of review used were both significantly different compared with non-orphan drugs. The percent of trials which had information about the number of patients enrolled, the percent of trials that provided the age of the patients, and the sex breakdown all significantly increased.ConclusionThe results show that there has been a change in regulatory standards that may be due to them becoming less rigorous, because of an adaptation to the number of orphan drugs being submitted or a combination of both reasons. At the same time, there has been some improvement in the transparency of data. Health Canada has recently embarked on a series of reforms in drug regulation and clinical trial management. These changes need to be closely evaluated to be sure that they enhance the efficacy and safety of new drugs

Politics and its intersection with coverage with evidence development: a qualitative analysis from expert interviews

BACKGROUND: Pressures on health care budgets have led policy makers to discuss how to balance the provision of costly technologies to populations in need and making coverage decisions under uncertainty. Coverage with evidence development (CED) is being employed to meet these challenges. METHODS: Twenty-four interviews were carried out between June 2009 and December 2010 with researchers, decision makers and policy makers from Australia, Canada, United Kingdom and United States. Three phases of coding occurred, the first being manual coding where the interviews were read and notes were taken and nodes were extracted and imputed. NVIVO coding was applied to the interview transcripts, with both broad general searches for word usages and imputed nodes. RESULTS: Four overarching thematic areas emerged out of contextual analysis of the interviews – (1) what constitutes CED; (2) the lack of a systematic approach/governance structure; (3) the role of the pharmaceutical industry and overt political considerations in CED; and (4) alternatives and barriers to CED. We explore these themes and then use concrete examples of CED projects in each of the four countries to illustrate the political issues that our interviewees raised. CONCLUSION: Until the underlying political nature of CED is recognized then fundamental questions about its usefulness and operation will remain unresolved

It’s Time to Finally Kill the Zombies; Comment on “Universal Pharmacare in Canada”

The movement for a national pharmacare plan in Canada is growing, but at the same time the multinational pharmaceutical companies and their supporters are critical of such a move. The three major arguments that they make are that all that is needed is to “fill in the gaps,” ie, cover those who currently are uninsured or underinsured, that private drug plans are superior to public ones because they cover a larger number of drugs and that Canada cannot afford pharmacare. This commentary examines each of these arguments and makes the case that none of them is valid and that it is time to get on with implementing pharmacare