A former safety consultant to Takeda Pharmaceuticals has accused the drugmaker of deliberately failing to inform physicians that some of its medicines can interact poorly with other drugs and cause serious adverse events. As a result, countless prescriptions for the Takeda drugs were written unnecessarily, causing Medicare and Medicaid to overpay for the medications, according to a lawsuit.
Three years ago, Helen Ge, a former associate medical director at Harvard Clinical Research Institute, was hired by Takeda to review adverse event reports for Uloric, a treatment for gout that was approved in 2009 and costs $5 a pill or more, compared with an older medication known as allopurinol, which costs anywhere from 10 cents to 20 cents a pill. However, she alleges that Takeda knowingly hid information about drug interactions for economic gain.
Specifically, she charges that Takeda avoided reporting adverse events caused by the drug, such as bone marrow failure, or that occurred after patients took Uloric and one of several other medications - Imuran, Methadone, Digoxin or Warfarin. Such interactions caused some patients to experience fatal reactions, severe bleeding or renal failure, according to the lawsuit, which was filed in federal court in Boston as a whistleblower action.
She also claims that Takeda failed to properly amend the labeling to reflect the alleged harm that could be caused by interactions. Ge made similar allegations concerning the Prevacid medication for GERD. And she further alleges that significant details concerning some adverse event reports were changed prior to submission to the FDA in order to suppress the seriousness of the side effects that should be conveyed to the agency.
"Had Takeda properly reported Uloric’s adverse reactions, the unsafe drug interactions for the gout patient population would have undermined Uloric’s claimed advantages over allopurinol, which ostensibly justified the added expense. Acutely aware of its precarious marketing posture relative to a cheaper, safer, established gout treatment, Takeda resorted to deceitful reporting," the lawsuit states.
"On each of these points, Takeda knowingly and falsely claimed, and its labeling indicated, a marketing advantage over allopurinol. In order to obtain, and retain, government payment for Uloric gout treatment, the company evaded accurate reporting of the adverse events related to these claimed marketing superiorities. The evidence demonstrates Takeda knowingly hid and/or minimized these risks for pure economic reasons" (here is the lawsuit).
The lawsuit also describes how studies that Takeda submitted to the FDA found interactions between Uloric and Warfarin, prompting concern from an FDA medical reviewer. But a follow-up study did not find the same problem, and "Ge suspects that there was an intentional manipulation of the second study because Takeda already knew from the first study that there was an interaction between these two drugs," according to the lawsuit. The labeling, consequently, only described results from the more recent study, which she charges was misleading.
We asked Takeda for a response and will update you accordingly. [UPDATE: A Takeda spokeswoman send us this: "At this time, Takeda has not been served with the complaint, so we are not able to comment. Takeda complies with all laws and regulations regarding the reporting of adverse events."
3 Comments
I don't believe the charges. As soon as I saw the plaintiff characterize herself as having been "wrongfully terminated", the jig was up. A disgruntled employee; how novel. This may be news to Dr. Ge, but the FDA has a little say-so into what goes in the labeling. I don't understand the rationale for invoking the TAP pharmaceutical case in this complaint. TAP was a separate entity from Takeda when the TAP settlement took place. Moreover, perhaps Mr. Sullivan the plaintiff's attorney forgot that his TAP case resulted in exoneration for all 8 defendants. I don't doubt Takeda will be forced to give Dr.Ge and Mr.Sullivan a nice payday, but the case looks like something I would expect from Weitz and Luxemborg. All IMHO.
Kerry, I'm with you. Here's where I smell a dead fish. Just about every physician and scientist I know of exhaustively lists their professional accomplishments on Linkedin, save for those like myself that are too lazy to do so. Dr Ge doesn't sound like the lazy type. Her bio in the lawsuit says she has been consulting to pharma since 1998, yet her Linkedin account only goes back to 2008.
My guess is that if we follow the breadcrumbs back far enough this may not be the the first case of Dr Ge vs Big Pharma. Something rotten in Shanghai.
Personally I prefer Dr G the Medical Examimer in Orlando, FL. Does pretty cool work. Also Kenny G ain't bad either. I just don't know about this Dr Ge, however.
Once again, a healthcare fraud case comes forward with a central argument that study data submitted to the FDA was manipulated in order to suppress findings of side effects or enhance the drug's effectiveness. That's three different cases in one week reported by Ed.
If found to be true, it really would seem to invalidate nearly all CMS funds spent on a drug therapy in the first place.