“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that went through the standard process had a 1 in 5 chance of either having a serious safety warning issued or being withdrawn from the market for being unsafe,” says study author Dr.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.”
Joel Lexchin
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.