Health Canada's fast-tracked drug approvals can put public at risk

Public release date: 8-Oct-2012
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Contact: Janice Walls
wallsj@yorku.ca
416-736-2100 x22101
York University

TORONTO, October 4, 2012 Drugs streamed into Health Canada's accelerated review process are more likely to be withdrawn from the market or earn a serious safety warning than those that undergo the standard review, according to a recent paper out of York University.

The study, published online by the Archives of Internal Medicine on Oct. 8, is the first of its kind undertaken in Canada. It tracked a total of 434 new active substances (NASs) approved by Health Canada between 1995 and 2010, examining how many subsequently acquired either serious safety warnings or had to be withdrawn from the market for safety reasons. The NASs were then compared to see whether a difference in safety existed between those that had gone through Health Canada's standard 300 day review period vs. the 180 day priority process.

"I found that drugs that went through the standard process had a 1 in 5 chance of either having a serious safety warning issued or being withdrawn from the market for being unsafe," says study author Dr. Joel Lexchin, Professor in York's Faculty of Health. "However, if the drug goes through the priority process, it has a greater than 1 in 3 chance of having the same outcome."

Though some drugs are moved into the priority process because they provide major therapeutic advances for serious illnesses, such as cancer, HIV/AIDS, and multiple sclerosis, and thus may be put through with a lower benefit to harm safety ratio, Lexchin found that the types of drugs in the priority category, and the types of diseases they treated, did not account for the difference in safety issues.

"Even drugs that provided no major therapeutic advances were still more likely to acquire serious safety issues if they were put through the priority review," says Lexchin. "This indicates that the difference is likely due to the faster review missing serious safety issues."

The study concludes that new products that offer major therapeutic advantages should be embraced, even with the significant gaps that exist about their safety, but because most NASs do not fall into this category, clinicians and patients should be using these drugs very cautiously.

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York University is helping to shape the global thinkers and thinking that will define tomorrow. York's unwavering commitment to excellence reflects a rich diversity of perspectives and a strong sense of social responsibility that sets us apart. A York U degree empowers graduates to thrive in the world and achieve their life goals through a rigorous academic foundation balanced by real-world experiential education. As a globally recognized research centre, York is fully engaged in the critical discussions that lead to innovative solutions to the most pressing local and global social challenges. York's 11 faculties and 28 research centres are thinking bigger, broader and more globally, partnering with 288 leading universities worldwide. York's community is strong ? 55,000 students, 7,000 faculty and staff, and more than 250,000 alumni.

Media Contact:

Robin Heron, Media Relations, York University, 416 736 2100 x22097 / rheron@yorku.ca

Janice Walls, Media Relations, York University, 416 736 2100 x22101 / wallsj@yorku.ca

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Public release date: 8-Oct-2012
[ | E-mail | Share ]

Contact: Janice Walls
wallsj@yorku.ca
416-736-2100 x22101
York University

TORONTO, October 4, 2012 Drugs streamed into Health Canada's accelerated review process are more likely to be withdrawn from the market or earn a serious safety warning than those that undergo the standard review, according to a recent paper out of York University.

The study, published online by the Archives of Internal Medicine on Oct. 8, is the first of its kind undertaken in Canada. It tracked a total of 434 new active substances (NASs) approved by Health Canada between 1995 and 2010, examining how many subsequently acquired either serious safety warnings or had to be withdrawn from the market for safety reasons. The NASs were then compared to see whether a difference in safety existed between those that had gone through Health Canada's standard 300 day review period vs. the 180 day priority process.

"I found that drugs that went through the standard process had a 1 in 5 chance of either having a serious safety warning issued or being withdrawn from the market for being unsafe," says study author Dr. Joel Lexchin, Professor in York's Faculty of Health. "However, if the drug goes through the priority process, it has a greater than 1 in 3 chance of having the same outcome."

Though some drugs are moved into the priority process because they provide major therapeutic advances for serious illnesses, such as cancer, HIV/AIDS, and multiple sclerosis, and thus may be put through with a lower benefit to harm safety ratio, Lexchin found that the types of drugs in the priority category, and the types of diseases they treated, did not account for the difference in safety issues.

"Even drugs that provided no major therapeutic advances were still more likely to acquire serious safety issues if they were put through the priority review," says Lexchin. "This indicates that the difference is likely due to the faster review missing serious safety issues."

The study concludes that new products that offer major therapeutic advantages should be embraced, even with the significant gaps that exist about their safety, but because most NASs do not fall into this category, clinicians and patients should be using these drugs very cautiously.

###

York University is helping to shape the global thinkers and thinking that will define tomorrow. York's unwavering commitment to excellence reflects a rich diversity of perspectives and a strong sense of social responsibility that sets us apart. A York U degree empowers graduates to thrive in the world and achieve their life goals through a rigorous academic foundation balanced by real-world experiential education. As a globally recognized research centre, York is fully engaged in the critical discussions that lead to innovative solutions to the most pressing local and global social challenges. York's 11 faculties and 28 research centres are thinking bigger, broader and more globally, partnering with 288 leading universities worldwide. York's community is strong ? 55,000 students, 7,000 faculty and staff, and more than 250,000 alumni.

Media Contact:

Robin Heron, Media Relations, York University, 416 736 2100 x22097 / rheron@yorku.ca

Janice Walls, Media Relations, York University, 416 736 2100 x22101 / wallsj@yorku.ca

---

[ | E-mail | Share ]

?

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Source: http://www.eurekalert.org/pub_releases/2012-10/yu-hcf100412.php

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