Proteins May Be Key To Identifying New Drug Side Effects: Study
California researchers indicate that they may have identified a way of looking at key proteins to identify potential adverse side effects associated with new drugs before they hit the market.
In a study published in the science journal PLOSOne last month, researchers from the Lawrence Livermore National Laboratory appear to have developed a computerized method of identifying proteins that cause a number of common adverse drug reactions.
Researchers used a computer model to look at 906 small molecule drugs and referenced them against a bank of 409 protein targets. They were able to use them to predict 85 side effects by running them through high performance computers with a specific algorithm.
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Developing a new drug costs about $2 billion and takes about 15 years, according to experts. Even then the FDA predicts there is only about an 8% chance that drug will be approved to go to the market.
Often, the clinical trials needed for approval fail to screen out a number of dangerous drug side effects. In some cases, the post-marketing data raises enough concern that the company is forced to recall the drug for public safety.
The method was a combination high performance computers and molecular docking which led to a technique that appeared to be about 70% accurate. Current side effects screening methods are only slightly better than guess work at about 50%, the researchers noted.
Researchers hope that the new method, if verified, will allow drug companies and the FDA to screen for many common and lethal side effects before the drugs are sold to the public.
While the methodology at this stage would not catch everything, it could eliminate some of the more debilitating and worrisome side effects, potentially including the development of tumors and some heart-related issues.
“Late-stage or post-market identification of adverse drug reactions (ADRs) is a significant public health issue and a source of major economic liability for drug development,” researchers noted. “Thus, reliable in silico screening of drug candidates for possible ADRs would be advantageous.”
They pointed specifically to how drug companies failed to detect Avandia heart attack risks and Vioxx heart attack risks until the drugs were on the market.
“As a result, billions of research and development dollars are wasted as drugs present with serious ADRs either in late stage development or post-market approval,” they wrote. “Early identification of serious ADRs would be ideal.”
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