Glaxo Consistently Shared Avandia Data, Except…
14 CommentsBy Ed Silverman // February 22nd, 2010 // 8:38 am
Over the weekend, GlaxoSmithKline issued a strongly worded rejection of the US Senate Finance Committee report alleging the drugmaker downplayed and hid knowledge of various safety issues concerning its Avandia diabetes drug. Glaxo complained the report (see here) drew inconsistent conclusions, cherry picked information from documents and mischaracterized “efforts to research Avandia and communicate those findings to regulators, physicians and patients.”
The statement went on to say that Glaxo “has consistently shared…data with regulators around the world, and worked with them to ensure that the Avandia product labeling is updated to add cardiovascular and other safety information as new data become available so that physicians can make the best treatment choices for their patients.”
Well….sort of… There was this March 25, 2008, letter from the FDA to former Glaxo ceo JP Garnier, chastising the drugmaker because it “failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports.” The letter followed an inspection of Glaxo’s North Carolina office.
Specifically, Glaxo’s didn’t convey “a status report for all postmarketing studies being performed by, or on behalf of, GlaxoSmithKline as required….” and not all of the periodic reports “contained a history of actions taken because of adverse drug experiences since the last adverse drug experience report, as required.” One report failed to include info about initiating a 5,000-patient study called RECORD trial that Glaxo hoped would prove Avandia was safe.
There are oversights in this world, and then there are oversights.
MsPiggy
“Glaxo complained the report drew inconsistent conclusions, cherry picked information from documents and mischaracterized”
This statement really would be laughable, if they weren’t killing people after all.
I guess Glaxo means the pharmaceutical industry believes it has an exclusive patent on lies, cherry picking, and mischaracterizing data.
MedEthix
Isn’t this also the same company that went after Dr. John Buse for raising concerns over Avandia. They have some nerve to state that they have never tried to stifle scientific debate.
Justice in MI
Re: John Buse, as usual with such episodes, GSK would say that they were just wanting to insure “balanced, scientific info” or some such. Intimidation? Never crossed their mind.
Whatever else one says, Kindler of Pfizer at least had the wherewithal to say that genuine change was needed: “This starts by acknowledging where we’ve gone wrong, showing that we’re making real changes…We know we need to be straight with people. No one has any tolerance any more for corporate spin.”
Of course, this was _after_ the big busts, whereas GSK is looking _toward_ that potential, not to mention a ton of private litigation.
If Pfizer finally lives up to some version of what Kindler said, perhaps we’ll have the chance to see which approach, in the end, serves a company best–financially and beyond.
elmore
It’s amazing how fast they were able to determine which numbers might or might not–from their perspective–be legit, considering how many years it took to bring some of these numbers to light in the first place.
riv
Great work Ed. I know you don’t do it for our approval, foot-kissing and all, but merci anyway.
Terry
Here’s the Grassley report on the intimidation of John Buse
http://finance.senate.gov/press/Bpress/2007press/prb111507a.pdf
Justice in MI
Thanks, Terry. Certainly no question in Buse’s mind that he was being intimidated, and his communications with several colleagues (including Nissen, toward the end) recurrently include his regret over “caving.”
JaT
JiM,
For Kindler to not make such a statement ‘after the fact’ would be as reckless as Pfizer’s previous behavior. In my opinion that’s a bell that just doesn’t ring true. It never will until “genuine change” involves atoning for consumer losses.
Someone needs to discriminate between the nuances of the words Research and Experimentation. They are not exactly synonymous. Either one is worthless if the data is minimalized or ignored.
Justice in MI
JaT–I hear what you’re saying overall, but what does “atoning” mean, in your view?
drifter
just read new NYT story regarding Dr. Nissen. Man he taped a convo. taped all over the place, video maybe?
JaT
I’ve spent all of this time trying to find an answer to your question, JiM.
Turns out that I have no idea.
JaT
People like that are incapable of making amends- is maybe the better answer.
Or more, there is no way to atone for knowingly endangering a group of people and then attempting to cover your ass.
JaT
Sorry, I just went through the whole range of emotions considering everything that happened.
patrons99
Here’s a non-lawyer’s take on this topic:
Generally speaking, not necessarily with reference to Avandia: Intentional endangerment which results in death: is that called an inchoate crime or a completed crime? There was motive, means, and opportunity. There was probably an agreement to commit the crime which can be inferred from the totality of circumstances. There was probable complicity of multiple conspirators. Can’t proximate cause be shown? Can’t criminal intent (mens rea) be inferred by the totality of circumstances?
Again, generally speaking, why aren’t crimes of this type, referred to the criminal department of DOJ? Wrist slapping, righteous indignation, and even public apologies by pharma is not much of an atonement. Intentional endangerment of the public (and clinical research subjects as well) is RAMPANT. DEATHS have resulted. If they “do the crime”, shouldn’t they “do the time”? Or does DOJ consider pharma to be off limits and above the law?