Product News and Recalls

Tarceva Settlement Highlights Flaws in FDA Drug Approval Process

tarceva shows flaws in FDA approvalsIn June of 2016 Genentech, Inc issued a letter to doctors telling them to stop prescribing Tarceva, a lung cancer drug, to patients unless those patients presented with a specific gene mutation. A recent story in the Los Angeles Times details how the drug was showing only a 10 percent effectiveness rate in patients taking it, while simultaneously causing rashes all over those patient’s bodies.

Tarceva was designed to block an enzyme associated with epidermal growth factor receptor (EGFR), a protein thought to contribute to the formation of cancer.

The letter came as a result of a whistleblower lawsuit filed by Brian Shields, a former sales representative for the company. In it, Shields revealed the results of a study the FDA requested in 2010 but failed to follow up on. The results of the study showed that patients died at the same rate whether they received Tarceva or a placebo; even if they had the EGFR mutation. Genentech settled the suit for $67 million, which they did “only to avoid more costly litigation,” according to the Times.

Tarceva was initially approved by the FDA in 2004, and then again for expanded use in 2010. The drug went from being used as a treatment for critically ill patients who had failed to respond to chemotherapy to “‘a maintenance therapy for patients who were not as ill and had responded to chemotherapy.”

It was then that the FDA first requested the study of Tarceva’s effectiveness.

At the same time, a panel of 13 experts was advising the FDA on whether or not to expand Tarceva’s prescribed use. The panel voted 12-1 against the expansion, with some saying there was “substantial uncertainty” and “very modest or even minimal benefit” to prescribing Tarceva for patients suffering from lung cancer. The expansion was approved anyway. Robert Justice, a former senior scientist at Genentech who is now an Associate Director of Clinical Science at the FDA, was a signatory on the approval.

The following year, Genentech made more than $1.5 billion worldwide, largely because it could now be prescribed more frequently. Tarceva could cost a single patient $7,800 a month, or nearly $100,000 per year. Combined with soft approval guidelines and drastically low effectiveness, Vinay Prasad, a hematologist-oncologist at Oregon Health and Science University, feels “that’s not good enough for the people” he treats because it “open[s] the floodgates” for feeble drugs to enter the market.

According to the letter, Genentech is “working with the FDA on revisions to the currently approved” prescription information on Tarceva. Prasad has said that “for many of these drugs, we just don’t know” if the side effects they can cause are worth rushing their approval. He conducted a study that showed only five of 36 drugs approved by the FDA between 2008 and 2012 could actually extend a patient’s life.

In fact, cancer drugs approved by the FDA between 2002 and 2014 have been shown to give patients only a mere 2.1 additional months to live. These medications are often ineffective because they are rushed to market before being properly tested. Tarceva illustrates just one example of flaws in the FDA’s approval process.

The FDA has since changed back the prescribed use of Tarceva to being only for those it’s known to help; i.e., those with the specific EGFR mutation. In a statement issued by the agency responsible for ensuring that Americans are not needlessly taking ineffective and dangerous medications, they claim that there is “no difference in progression-free survival between” Tarceva and a placebo.

One has to wonder then why they weren’t motivated to make this modification until the drug’s ineffectiveness was made public by a whistleblower. Because, in the meantime, patients were in pain and spending billions on a mostly useless medication; all while hoping for a few more months with their loved ones.