“Cancer patients only get one shot at first-line treatments,” the lawsuit said, “and defendants took that opportunity away.”
The drug was Tarceva (erlotinib), the company was Genentech and the cancer was lung cancer, one of the most deadly kinds. Lung cancer is the most commonly diagnosed cancer in the US (except for non-melanoma skin cancer) and it is by far the deadliest. More women die of lung cancer than the combined deaths due to breast, ovarian and cervical combined. About 10% of the people who get lung cancer never smoked. The 5-year survival rate for lung cancer patients is only 17%.
When a Speaker’s Fee is Really a Kickback
That is why the first treatment is the most important, best shot at extending the life of a lung cancer patient. Genentech was accused of “giving doctors illegal kickbacks disguised as fees for making speeches or serving on Genentech’s advisory boards.” (Quotes from the lawsuit and from a Genentech spokesman, below, are as reported by Los Angeles Times,) Tarceva will only work on those who have never smoked or who have an EGFR gene mutation (epidermal growth factor receptor). But sales reps handed out promotional materials discouraging doctors from testing for the genetic mutation.
Genentech also hired “patient ambassadors” who were paid to talk to lung cancer patients about off-label use of Tarceva — circumventing rules that restrict companies from promoting uses of a drug that are not approved as safe and effective by the FDA.
Genentech will pay a $67 million settlement and had the gall to put out this quote: “We believe our Tarceva promotional communications and practices were and are entirely proper and in compliance with the law,” said Andrew Villani, a Genentech spokesman. In 2011, Genentech made $1.833 billion on Tarceva.
The practice stopped in 2011 when a sales rep became a whistleblower and went to the government with evidence.
Billions in Pharma Fines
Can this happen with other drugs? Probably. Last year, Johnson & Johnson was ordered to pay $136 million in a South Carolina lawsuit because they minimized the risks of the antipsychotic Risperdal (risperidone) and focused on the benefits in 7,000 letters sent to doctors.
Fraudulent marketing practices have been the basis for more than $13 billion in payments by pharmaceutical companies to the US Department of Justice. Here’s a link to ProPublica’s list of the major payments.
How do you protect your and your family? It’s not easy, but asking questions of your doctors is the place to start. Here are some questions about drugs you’ve never heard of and here is a link to a downloadable with questions to ask of any drug suggested.
- How long has this drug been on the market?
- Did the FDA approve this drug for what I have?
- Is there a patient registry for this drug so I can be informed of any problems in the future?
- What are the long-term effects of this drug?
- Is this drug better than similar or generic ones?
- Are the other drugs or options we should consider?