Two companies to pay $67 million for false claims about cancer drug

That must have been a ploy by the pharmaceutical companies to make extra cash at the expense of someone not feeling better from buying expensive cancer drugs. Not fair.



Two pharmaceutical companies-Genentech, which is based in South San Francisco and is now a part of the Roche Group, and Farmingdale, New York-based OSI Pharmaceuticals, which is now a part of Astellas Pharma- owe $67 million as a part of a court settlement over allegations that they made misleading claims about a drug used to treat lung cancer.

They were taken to court after a former Genentech employee, Brian Shields alleged that the company provided doctors and medical professionals with misleading information about the drug.

Shields was a product manager who tried to bring the problem to the attention of his managers. Instead of receiving an appropriate response, the complaint suggests, he faced retaliation for doing so and was told he was "not a team player."

The drug, Tarceva, is approved to treat non-small-cell lung cancer and advanced-stage pancreatic cancer.

The companies led doctors to believe that the drug would work in a broad patient population, according to the complaint, when, in fact, "there was little evidence to show that Tarceva was effective" to treat certain patients with non-small-cell lung cancer, according to a news release from the Department of Justice.

It worked only on a smaller patient population, as well as patients who had never smoked and people who carried a particular mutation in a protein that is involved in the spread and growth of cancer cells.

The complaint also suggests that the company failed to report all the adverse events related to the drug. That could mean doctors were choosing to use it to treat lung cancer patients instead of a treatment that has been proved to have more success.

Under the False Claims Act, Shields is entitled to about $10 million of the settlement. Another $62.6 million will go to the federal government. State Medicaid programs will get $4.4 million.

"Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers about their prescription drugs," said a statement from the head of the Justice Department's civil division, Benjamin C. Mizer.