LA TIMES: The Food and Drug Administration frequently speeds experimental medicines to sale by approving them before scientific evidence shows they work. For a drug called Tarceva, the FDA’s decisions resulted in thousands of lung cancer patients taking a drug that could not help them. Twelve years passed before the agency warned doctors in October that Tarceva only worked for a small number of patients with a rare gene mutation.
FDA approves Tarceva for severely ill lung cancer patients who have not been helped by chemotherapy and have few options. An FDA scientist warns that Genentech and OSI Pharmaceuticals, the two companies selling the drug, have little incentive to find those patients who could respond to the drug because it “would cut the … market in half.”
Genentech and OSI ask the FDA to expand Tarceva’s approval to lung cancer patients who are not as ill and have been helped by chemotherapy. OSI’s chief executive tells investors the approval could add $500 million to sales.
A committee of cancer experts advising the FDA votes 12 to 1 against expanding the drug’s approval, telling the agency there was little evidence the drug worked.
The FDA agrees to expand the drug’s approval despite the committee’s vote. The agency asks the companies to perform another study to determine which patients benefit from the drug.
European regulators announce the results of the FDA-requested study, which showed the drug did not help 90% or more of patients. They warned European doctors not to prescribe Tarceva unless a patient tested positive for the mutation.
Genentech and OSI pay $67 million to settle a federal whistleblower lawsuit that said they had aggressively promoted the drug for years to patients it could not help. The companies said they did not agree with the claims, but settled to avoid more costly litigation.
Late June 2016
The companies send American doctors a letter with the results of the study and warn them not to prescribe the drug unless a patient has the mutation.
The FDA removes Tarceva’s approval except for the relatively few patients who have the mutation.
Sometimes there are just no words to explain pharma’s actions…