Post by Deleted on Feb 4, 2017 23:25:16 GMT
www.latimes.com/business/la-fi-fda-tarceva-approval-20170204-htmlstory.html
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 news upended a 2010 decision by the Food and Drug Administration to greatly expand use of the $94,000-a-year drug, despite warnings from a panel of experts that said there was little evidence it actually worked.
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.
Pressured by powerful pharmaceutical company lobbyists and often dramatic testimony by patient groups looking for hope, Congress has repeatedly loosened regulations to speed medicines to sale.
Some doctors fear the bar for approval will be lowered even more.
The FDA is now examining how to comply with the 21st Century Cures Act, a law Congress passed in December to hasten the approval of drugs and medical devices.
And critics of the FDA who say the review process still moves too slowly — including drug companies, their investors and patients desperate for new medicines — hope that President Trump will go even further. At a White House meeting with pharmaceutical executives this week, Trump promised them he was “going to streamline” FDA regulations.
“Every medicine puts you at risk of side effects,” said Vinay Prasad, a hematologist-oncologist at Oregon Health and Science University who has studied the FDA’s accelerated approval of cancer drugs. “The question is: Are those side effects worth it? For many of these drugs, we just don’t know.”
THERE IS MORE.
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 news upended a 2010 decision by the Food and Drug Administration to greatly expand use of the $94,000-a-year drug, despite warnings from a panel of experts that said there was little evidence it actually worked.
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.
Pressured by powerful pharmaceutical company lobbyists and often dramatic testimony by patient groups looking for hope, Congress has repeatedly loosened regulations to speed medicines to sale.
Some doctors fear the bar for approval will be lowered even more.
The FDA is now examining how to comply with the 21st Century Cures Act, a law Congress passed in December to hasten the approval of drugs and medical devices.
And critics of the FDA who say the review process still moves too slowly — including drug companies, their investors and patients desperate for new medicines — hope that President Trump will go even further. At a White House meeting with pharmaceutical executives this week, Trump promised them he was “going to streamline” FDA regulations.
“Every medicine puts you at risk of side effects,” said Vinay Prasad, a hematologist-oncologist at Oregon Health and Science University who has studied the FDA’s accelerated approval of cancer drugs. “The question is: Are those side effects worth it? For many of these drugs, we just don’t know.”
THERE IS MORE.