Letter to the Prime Minister
May 11, 2021 The Right Honourable Justin Trudeau, P.C., M.P. Prime Minister of Canada 80 Wellington St. Ottawa, ON, K1A 0A2 Subject: Delay and reconsider the PMPRB regulations Dear Prime Minister Trudeau, I am [...]
Let’s fight cancer like we’re fighting COVID-19
As we battle the pandemic, we should remember that cancer kills 7,000 Canadians every month and put the same effort into reducing that sad toll. In the three months since COVID-19 started shutting down the [...]
Potential Life-Years Lost: The Impact of the Cancer Drug Regulatory and Funding Process in Canada
Background Canada has an established publicly funded health care system with a complex drug approval and funding process. After proof of efficacy (POE; key publication/presentation) and before becoming publicly accessible, each drug undergoes a Health [...]
The importance of greater speed in drug development for advanced malignancies
It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life-years potentially saved if selected agents [...]
Cancer research in the United States: A critical review of current status and proposal for alternative models
This commentary reviews the evolution of the process of cancer research in the United States over the past 6 decades, from an academic-based to drug industry-based research, and the advantages and concerns. It proposes a [...]
The Urgent Need for Clinical Research Reform to Permit Faster, Less Expensive Access to New Therapies for Lethal Diseases
High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs...
Is HTA unfairly limiting access to treatments for rare disorders?
Interesting new research suggests that the burden of proof required by Canada’s health technology assessment (HTA) process for new drugs is too rigid and unfairly excludes many treatments for rare disorders from public drug insurance coverage...
To benefit from new cancer drugs, reform the regulatory regime
We are concerned Canadians who have been impacted deeply by cancer. One of us (Stewart) is a cancer physician who has seen far too many patients die; the other (Bradford) is a cancer survivor who has recently lost his beloved wife to cancer. She was directly affected by the issues we raise below...
U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research is responsible for evaluating drug safety and efficacy, including oversight of clinical trials and principal investigators...
Redefining cancer: a new paradigm for better and faster treatment innovation
Common cancers may arise from several different mutations, and each causative mutation may require different treatment approaches. There are also several mechanisms by which malignancies may become resistant to therapy, and each mechanism will also require a different therapeutic strategy.