In June, pharmaceutical giant Genentech sent doctors a letter saying they should no longer prescribe a blockbuster drug called Tarceva to most patients suffering from lung cancer.
A study had found that only a small number of patients — those with a certain gene mutation — might be helped by the drug, the company said.
The FDA’s decision resulted in more harm than the hundreds of millions of dollars wasted on a drug that was ineffective for 90% or more of patients.
Over the years, thousands of patients were prescribed a drug that had no chance of helping them but could frequently cause terrible rashes covering their faces and bodies, according to prescription data and adverse event reports. Some patients with the most aggressively growing cancers died before trying other treatments that may have lengthened their lives.
The story of Tarceva shows the danger of approving experimental medicines before reliable scientific data show they are effective — which regulators are now doing more frequently.
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