A federal court ruling that ends a class-action case against Amgen (AMGN) provides an unfortunate set of instructions for unscrupulous pharmaceutical managers on how to promote drugs for unapproved "off-label" uses while hiding negative data -- all without incurring legal liability! As long as the data the company is hiding is not about the off-label uses the company is promoting, then the company is not liable for RICO racketeering fraud, the Ninth Circuit Court of Appeals ruled.
In the case, Amgen was accused of promoting its drugs Aranesp and Epogen as treatments to help anemia in various types of cancer. The two drugs are technically approved only to treat anemia in patients with kidney disease or on chemotherapy. Obviously, a patient on chemo is likely to be a cancer patient -- which is why the Ninth Circuit ruling's onion-skin-separation of the facts is so crucial.
Amgen was clearly promoting the drugs for uses beyond its technical label. It still has a number of press releases on its web site that clearly talk about off-label uses, such as this one about a study of how "Aranesp Benefits Patients Suffering From Anemia of Cancer, Who Are Not Receiving Chemotherapy." The words "Not Receiving Chemotherapy" are clearly outside the on-label approval for the drug. The suit alleged that the release did not disclose that the study author was an Amgen employee and that it was financed and controlled by Amgen. (Although given that it's an Amgen press release about an Amgen drug, one wonders why anyone would think it was not authored and funded by the company.)
Separately, Amgen dragged on releasing clinical data whenever it discovered that Epogen and Aranesp harmed patients. In 2003, a study by Johnson & Johnson (JNJ), Amgen's partner on Epogen, found that 70 non-small cell lung cancer patients died in half the time of those on placebo. The companies did not publish that information until 2007. Similarly, a 2006 head and neck cancer study found that patients on Amgen's drugs were 10 percent more likely to see their tumors grow than those not. That data was not published in The Cancer Letter until February 2007.
The court ruled that this shell game was irrelevant:
The complaint did not identify statements or representations made by Amgen that were literally false or misleading at the time they were made, as required in a civil RICO action based on mail and wire fraud.
Though the complaint alleged that Amgen concealed adverse test results while promoting Aranesp and Epogen for various off-label uses, the complaint did not identify any concealed study results that involved the drugs and uses that Amgen is alleged to have directly promoted, and Appellants confirmed at oral argument that there were none.In other words, as long as the off-label promotion was for slightly different cancer and anemia patients than those in the negative data that Amgen was sitting on, then there's not enough of a connection to create class-action fraud liability.
It would be nice to think that Big Pharma's corporate ethics codes are robust enough to prevent sales managers from taking advantage of such a loophole. But given recent events, don't get your hopes up.
- Are Amgen Sales Reps Looking At Your Medical Records?
- When Is a Kickback Not a Kickback? In Amgen Case, It's When You Filled Out Paperwork to Get It
- Aranesp Suit: What Did Amgen CEO Sharer Know (and Did He Read It in His Company's PowerPoint Slides)?
- Suit: Amgen Under-Reported Adverse Events to FDA on All Products
- Amgen Accused of Falsifying Medical Records, Lying to Patient in Enbrel Trial