The High Cost of Fast-Tracking Drugs at the FDA

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The Los Angeles Times recently explored the high cost of fast tracking drugs at the Food and Drug Administration.

One drug that was prominently featured was Tarcevea, a $94,000 a year drug that received FDA approval for a wide range of lung cancer patients when, in fact, it only worked for a very small percentage of lung cancer patients who carried a specific genetic anomaly. 

Genentech, which made Tarcevea, knew the drug was ineffectual for more than 90 percent of all lung cancer patients, and left many users with terrible rashes covering their faces and body.  The company decided to hold back on that information, however, in order to boost the company’s bottom line by as much as $150 million a year. The drug was approved for patients with severe symptoms and those who were not responding to other lung cancer treatments like chemotherapy.

Not content to limit poisoning for profit to lung cancer patients, Genentech went to the FDA to get Tarcevea approved for a wider swath of lung cancer patients, including those who were responding well to traditional treatments.  The FDA’s committee of advisors that looked at the evidence voted 12-1 against such an expanded approval, but a former Genentech senior scientist working at the FDA overruled the committee, and granted broad approval in 2010.  That approval boosted Tarceva’s global sales to nearly $1.5 billion in 2011.

Off-label marketing of Tarceva was brought to a halt by False Claims Act whistleblower Brian Shields.  He says the FDA approval process is subject to systematic failure, and that “FDA approval doesn’t necessarily mean that a drug works.”  While a sales representative at Genentech, Shields notified the company that they were promoting the drug using kickbacks which included sending doctors and nurses to attend all-expense-paid retreats at resorts where they were “groomed” to tell others about how Tarceva could extend survival in “a broad range of patients.”  For his troubles, he was told he was not a “team player”

Only when he hit the wall inside the company did Mr. Shields file a False Claims Act lawsuit which the government ultimately joined.  On June 6, 2016, the Department of Justice announced that Genentech and Astellas Pharma, a company that Genetech marketing partner OSI Pharmaceuticals in 2010, had agreed to pay $67 million to settle the lawsuit.

Tarceva is not the only drug where approval in haste has resulted in regret at leisure. 

FDA approval of Vioxx and Bextra may have resulted in as many as 40,000 deaths from heart attacks or strokes. In Europe more than 55 years ago, thousands of babies were born seriously deformed. The Thalidomide Tragedy was avoided in the United States because of the rigor of an FDA employee Frances Oldham Kelsey. When the FDA is properly working it can protect the population from unintended side-effects and complications.

Unbelievably, Thalidomide is back in the news again, as a False Claims Act whistleblower has alleged that Celgene is off-label marketing the drug for broad cancer treatment rather than restricting its marketing to multiple myeloma treatment.