To benefit from new cancer drugs, reform the regulatory regime

January 29th, 2015

Dr. David J. Stewart is a professor of medicine and head of the Division of Medical Oncology at the University of Ottawa; John-Peter Bradford is a member of the Research Advisory Group of the Canadian Partnership Against Cancer and the Cancer Care Committee of the Ottawa Regional Cancer Foundation.

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.

Approximately 46 per cent of all Canadian men and 41 per cent of all women will suffer from cancer at some time during their lives. It is by far our leading cause of death, causing almost 30 percent of deaths in Canada.

We believe that regulatory oversight for clinical research in lethal diseases such as cancer must be simplified to allow for much quicker development of new approaches. Current regulation is cumbersome, costly and inefficient. The delays it causes mean that many Canadians with cancer do not get access to effective new agents that could save or extend lives, save money, relieve suffering and/or decrease hospitalizations. Effective new therapies do not just save lives and give incurable patients more valuable time with their loved ones. They also can have a very positive impact on quality of life and markedly reduce cancer-related symptoms.

Regulations are important because they help to ensure a patient’s safety, privacy and right to make informed decisions regarding research participation, while also safeguarding research data integrity and the scientific validity of the trials required to assess a drug’s effectiveness and toxicity. This is important, but the current regulatory burden associated with bringing new drugs to market contributes significantly to health care costs. Large amounts of money could be saved without sacrificing safety by streamlining these regulatory processes.

Here’s why: A new therapy is generally considered to be cost effective if it can be provided for less than $100,000 per year of life gained. In clinical trials of new anticancer agents, it now costs an average of several thousands of dollars per patient just to comply with current research regulation, and the cost of compliance is rising much faster than the rate of inflation. While some anticancer agents can be quite toxic, the rate of death from toxicity is low (generally 0.5-2 per cent). This rate has fallen only minimally as regulation that is intended to improve safety has become much more cumbersome and costly. The cost per life-year saved by this regulation is measured in the millions of dollars – far higher than the amount that society would generally pay for a new drug to treat a patient with a lethal disease.

This is important for two reasons. First, if it costs a large amount of money to bring a drug to market, then the drug will be very expensive, and this drives up health care costs. Research costs must be recouped and a profit has to be added or no company could afford to develop a drug.

Second, if a large amount of money is used to test one new treatment, then less money is available to test other ideas. This greatly slows progress and increases suffering.

Additionally, cumbersome regulatory processes act as a series of speed bumps on the highway to drug approval. Hundreds of regulatory processes can be required just to initiate a single clinical trial. Each of these slows progress. Various piecemeal initiatives have addressed parts of the problem, but with too little benefit. A large number of speed bumps remain.

Increased regulatory complexity has saved very few lives while it has slowed development of drugs that could save lives and enhance quality of life. If a new drug increased the cure rate of a common cancer by just 1 per cent and only modestly increased life expectancy of those not cured, then streamlining unnecessarily complex regulation could save thousands of life-years in Canada alone, or millions on a global scale.

This is an international problem. Canada is in a position to lead; local action here could have benefits not only at home, but elsewhere. If you agree that this is an urgent problem, please let your government know. Together we can make a difference. As Sir Winston Churchill said, “It’s not enough that we do our best; sometimes we have to do what’s required.”