Regulatory agencies have the difficult task of setting standards that new drugs and health care technology must satisfy before the product can be placed for consumer use.
Researchers, policy makers and clinical practitioners often lament the length of time and the prolonged human suffering that may occur during the 10-12 years that it takes to develop a drug and bring it to market. As such, agencies have initiated new efforts to stream line or “fast-track” drug development.
Unfortunately, this process may also have unintended consequences as drugs placed in the fast review line are more likely to be withdrawn from the market or earn a serious safety warning than those that undergo the standard review.
The findings stem from an analysis of Health Canada’s accelerated review process as published online by the Archives of Internal Medicine.
In the study, researchers tracked a total of 434 new active substances — new drugs being tested for approval — 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Canada between 1995 and 2010, examining how many subsequently acquired either serious safety warnings or had to be withdrawn from the market for safety reasons.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 new active substances 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that went through the standard process had a 1 in 5 chance of either having a serious safety warning issued or being withdrawn from the market for being unsafe,” says study author Dr.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.
“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.”
Nevertheless, researchers believe new products that offer major therapeutic advantages should be embraced, even with the significant gaps that exist about their safety. However, because most new active substances do not fall into this category, clinicians and patients should be advised to use these drugs cautiously.
Source: York University