Three years ago, a former Cephalon manager filed a whisteblower lawsuit over alleged illegal marketing of two drugs – the Treanda treatment for chronic lymphocytic leukemia and the Fentora painkiller – prompting the US Attorney in New York to open an investigation into the drugmaker, which is now owned by Teva Pharmaceutical (TEVA).
Now, though, further details are emerging about the extent to which Cephalon executives allegedly conspired to use questionable studies and off-label marketing tactics to boost sales of Treanda, in particular. The allegations, which were made by a former Cephalon employee listed as 'John Doe,’ cite familiar-sounding shenanigans, but an executive strategy session sheds new light on the effort.
Here is the background: Cephalon sought to promote Treanda for an unapproved use - in this case, front-line treatment for indolent, or slowly progressing, non-Hodgkin's lymphoma, according to the lawsuit. The medication was only approved for CLL and second or third-line iNHL. But in 2008, Cephalon executives were nervous that marketing exclusivity tied to orphan drug status would expire in 2015.
A Cephalon vp arranged for waiters to burst into a 2008 launch meeting carrying trays of $50 bills and, as they circulated throughout the room, the drug reps were encouraged to grab fistfuls of money. As they did so, the Cephalon vp told the sales force that promoting Treanda would be like “taking free money.” This was just a few months before the settlement with the feds.
Pharmalive.com - Thu, 06/20/2013 - 10:58am by Ed Silverman
[Edited by CLLSA/Admin 12:32 - 22/06/32 to remove duplicate passage and insert the reference link to the quoted snippets from the article., this gives access to the rest of the story and links it provides to the latest version of the lawsuit and further information.- allowing those who choose to reach it.]
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Kwenda
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I've not heard about the whistleblower lawsuit before, but on recalling Treanda is a trade name for Bendamustine, I remembered that there was a trial that tried to make Bendamustine look better than Campath by changing the dosage and it that drew some unfavourable comments from Chaya Venkat. A quick search lead me to the articles linked below and Cephalon were indeed behind the trial. In the first Chaya quotes Terry Hamblin's criticism of the trial and in the second Chaya discussed her unease with the way some Bendamustine trials had been performed and the data presented in two ASH 2007 papers:
As Chaya says, "Commenting on the financial conflicts and/or ethical behavior of companies is beyond my expertise – but I am sure you can form your own opinions."
Interesting way of motivating promoters. I am not familiar with the journalist Ed Silverman or the lawsuit, so I cannot comment on the allegations? As a candidate for a Bendumustine combination therapy when treatment comes I sure am glad it is available to me here in the UK..(without it there seem to be few alternatives for some groups )
It does help readers understand context if snippets/samples of articles, are identified and a link to reference third party information is included with the post..
I can't comment on the post , however I do know that Dr. Hamblin simply hated the dosing structure of the Bendamustine vs Chlorambucil trials. Through smoke and mirrors and a bit of dose voodoo with body mass, he always maintained that Chlorambucil was given at a reduced dose in the pivot comparison trial...
In reference.. from the late Dr. Hamblin...
'This paper is published in JCO which probably means it was turned down by Blood. The criticism which any reviewer would have made would have been that the dose of chlorambucil was too low. They have answered this criticism by declaring that the dose of chlorambucil was equivalent to 60 mg/meter squared which compares well with comparisons with fludarabine (Rai = 40), alemtuzumab (Hillmen = 40) and FC (Catovsky = 70). That seems to be alright, but then I read the paper more carefully. The two drugs were given according to quite different formulae. Bendamustine was given in a dose of 100mg/sq meter for two days every 4 weeks, while Chlorambucil was given in a dose of 0.8 mg/kg for two days every two weeks. It seems strange that two different calculations were used and even stranger when I see that rather than weighing the patients they used something called Broca's normal weight. Now I had never heard of this so I Googled it. It turns out to be the height in centimetres minus 100. Does this give the same as weighing? By no means. I am 177cm high so my Broca weight is 77kg. Alas my scales make me 83 kg.
If I calculate the dose of chlorambucil I would have got under the LRF4 formula it would have been 143 mg, but under the Bendamustine paper formula it would have been 123 mg. I'm afraid my ideal weight is a little less than my actual weight. For my mother the discrepancy would have been even more. She is only 5ft 3, but weighs about the same as me. The Bendamustine paper would have given her 96 mg of Chlorambucil while the LRF4 calculation would have given her 139 mg. '
He concluded...
'So my original criticism stands - they seriously underdosed the Chlorambucil compared to what is optimum - just as the fludarabine and alemtuzumab trials did. Moreover they offer no description of modern prognostic markers - something I would regard as essential in a clinical trial in CLL. It may be that mutated and unmutated cases and del 11q and 17p cases were equally distributed among the two groups, but it may be that they weren't. This might be another explanation of why the Chlorambucil patients did so badly.'
Dr. Hamblin, also felt that the fludarabine and alemtuzumab trials comparator trials were 'low balled', so this makes me wonder...how frequent are results slewed to favour the new drug???
Clearly, chlorambucil is an older drug, that if used properly can have great benefit to older patients. However, it has become the comparator drug 'whipping- boy' in many trials, because it doesn't work as well as more modern efforts or chemoimmunotherapry.
Drug companies want their new drugs to look good to the authorities so chlorambucil gets the nod as comparator.
This still continues...ibrutinib vs chlorambucil... Hmmmmm....
It will be nice when we can edit these posts...sorry for the few misplaced words and spelling errors, iPad has a mind of its own on occasion... often when mine is flagging
One would like to think of these drug companies as The Knight in Shining Armour, coming to assist the sick people of the world.
In reality they are a money grubbing bunch of bandits, with the morals of some of our bankers..
That does make choosing a therapy, and most certainly a drug trial, extremely worrying. A bit like Russian Roulette unless you educate yourself to the max, and ask the doctors lots of serious questions. We have to be the managers of our own health.
And yes, I agree posting to this site is not the best, I tend to compose first in Word as my spelling is not always the best. Then I can copy and paste to the site.
By the way is it for you Leukaemia or Leukemia..??!!!!!!!!!!!!!!
In Canada we are ambidextrous...I prefer the UK spelling ... OED actually, others use the American spellings... I have my iPad spell checker set to UK... I like 'U's flavour, neighbour, etc.
And we can always expect some changing 'colour' with your posts, Chris with your blog photos and changing profile picture!
Also, I hadn't noticed any misplaced words or spelling errors in your reply. I'd say you are more aware of them as the writer than any readers would be!
Brings to mind this classic:
"i cdnuolt blveiee taht I cluod aulaclty uesdnatnrd waht I was rdanieg.
The phaonmneal pweor of the hmuan mnid, aoccdrnig to a rscheearch at
Cmabrigde Uinervtisy, it dseno't mtaetr in waht oerdr the ltteres in a
wrod are, the olny iproamtnt tihng is taht the frsit and lsat ltteer be
in the rghit pclae. The rset can be a taotl mses and you can sitll raed
it whotuit a pboerlm. Tihs is bcuseae the huamn mnid deos not raed
ervey lteter by istlef, but the wrod as a wlohe. Azanmig huh? yaeh and
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