Indict Merck & Schering-Plough Over Vytorin?
31 CommentsBy Ed Silverman // July 29th, 2008 // 4:11 pm
By outward appearances, the lawsuit filed this week by Suffolk County, New York, officials to recover public funds used to pay for the controversial cholesterol drug is run-of-the-mill. The document cites what is quickly becoming boilerplate language among governments and shareholders alleging a drug was improperly marketed, ineffective or unsafe - there was a pattern of racketeering and a fraudulent scheme.
But buried on page 25, line 6, an interesting word is tossed out - indictable. In other words, Suffolk County (the eastern portion of Long Island that includes the Hamptons, for those of you who care) appears to be going a step further in waving its claim in front of the drugmakers. Maybe, just maybe, county officials are not-so-subtly suggesting that a prosecutor may be compelled to take a look at how the Enhance trial was handled, a bone of contention that has embroiled doctors and patients nationwide.
Then again, Merck and Schering-Plough may not have to find out. They can always settle.
Hat tip to Shearlings Got Plowed
Paul G
Indict for what? For doing a study that was novel and had a high risk of failure and ended up failing?
Talk about sending a message to stop innovation!
Jack2
I don’t see how you can indict them for delaying data release. The rules governing data release require release (in a publication or by posting study results to a government website) by one year from last patient out. I don’t know if they met that metric, I suspect they didn’t, but either way, those rules only came out in Dec 2007. I believe they only apply to studies starting after that time, but eithe rway they wouldn’t apply to the Enhance study.
Ed Silverman
Hi Paul G and Jack2,
I understand your concerns and your points. I don’t pretend to know on what particular basis ‘indictable’ could be pursued, but the county raised it, nonetheless. Whether those folks do anything about it remains to be seen.
Regards
ed
Practicing Doc
Paul G and Jack2,
Hmmm. Coming to the defense of MSP. Just like every other governemnet entity looking into this issue, it seems that the concern is the potential defrauding of the public because of dragging out the release of the result, thereby selling extra billions of the drugs that may not have been sold if the public knew what was going on. FYI, ENHANCE was not high risk as several other agents have produced positive findings using the design and the method. It simply failed. Also FYI, the FDA directive as to reporting study results within one year of completion has been around for several (>5 years). I don’t think this is blowing smoke. There are certainly very serious issues. Time will tell and hopely justice will rule!
Piper
If there is anything worthy of indictment, it’s the number of lawyers trying to make a case out of nothing. The rules governing data release are 2 years, not one, and they made it just fine. I wonder if these same lawyers plan to “indict” Pfizer for Lipitor’s failure vs. a placebo in CASHMERE….or better yet, what about Lipitor’s all-out failure vs. pravastatin (a generic) in the BELLES trial?! Oh, I know, they should sue Bristol for the now generic pravastatin, which “caused” a 25% increase in cancer deaths during the PROSPER trial. Stupid. The FDA put the following Vytorin update on their site last week: http://www.fda.gov/consumer/updates/vytorin071818.html
Nothing nefarious that I can see….
Piper
Here’s a functioning link, to replace the one above:
http://www.fda.gov/consumer/updates/vytorin071808.html
My apologies for the inconvenience.
Condor
Well — let me chime in — since I called Ed with the above “tip”:
RICO makes pattern, repeated and concerted efforts (by any two or more persons, or actors) at mail and wire fraud, a felony — RICO defines anyone that shares profits — here Merck and Schering (via the Cholesterol/Vytorin/Zetia Joint Venture), using mail or wire fraud, “co-racketeers”, if you will! Welcome to being wise-guys, wiseguys!
The allegation by the county officials is that the county’s governmental purchasers relied on Schering and Merck to be honest in pricing Vytorin. Vytorin was badly overpriced, given what (they allege) Merck and Schering knew about ENHANCE — having failed the end-point, as early as January 2007, via “functional unblinding”. . . .
So, the good people of Suffolk County, and the rest of the nation, for that matter, overpaid — or more precisely, were OVERCHARGED for Vytorin.
And, overcharging the government — any government entity — is easily to plead-out, as a crime.
Ipso Facto! Presto Change-o!
See the comments on my blog on this.
It is a proverbial “shot across the bow”, in my estimation.
Schering and Merck should come-about, and fly a white flag. Now. Before Capt. Jack Sparrow bears down. JMHO.
Paul G
Sorry Condor, don’t buy your argument or metaphors.
It’s nothing but blackmail one more time. Fortunately, we are starting to see companies standing out to this practice of extracting settlements.
Paul Vadera
Seems like other government entities are trolling for dollars, trying to use a catch-all charge to allege fraud. In May I was contacted by the Texas Attorney General’s Office, asking questions about Merck’s Vytorin and Zetia marketing practices. There’s nothing there, but it’s like the bust-out cop who can’t find anything to arrest you for, then gets into your face until you flinch and then calls it resisting arrest. Using the RICO statutes and “wire fraud” is a long, long, long shot. You’d do better laying odds on Mike Huckabee being the next president.
Condor
TO: The “Pauls” — Paul G. and Paul V.
I don’t profess to like the idea — I do profess to understand reality. The reality is — in Health Care — whenever the government feels it has been over-charged, it can likely find an applicable criminal statute to extract a return of the “overcharged” amount. That said, I do not think some county prosecutor should be at the TOP of Schering’s list of worries. I think the SEC, and the DoJ — as Schering has admitted — are its current highest-probability exposures to criminal indictments. And, there are the CT, NY and WA AG investigations, as well as two congressional committees, and the feds, proper.
I gather you gents missed the part where the DoJ U.S. Attorney in the Health-Care Fraud Unit in New Jersey has been “investigating” the company’s handling of ENHANCE.
I know we will all learn much more in under 20 days time, when Schering files its next 10-Q with the SEC — all governmental investigations and material litigation must be disclosed — as well as any material developments on any of those matters.
Stay tuned. But whistle “Dixie” until then — if it makes you feel better.
Cheers!
Conn
Why do you insist on publishing this stuff from Condor, or Rainn from the Yahoo Boards. He obviously has a strange, unhealthy and negative fascination with Schering Plough and to me it takes away from the quality of your blog. JMO.
Condor
Gee — I think I’m flattered, Conn.
Thanks for that entirely-stellar “arm-chair” diagnosis.
Where shall I send my check? Do tell. And do ALSO tell — where did you got your doctorate in psychology? I am curious.
Namaste
Ed Silverman
Hi Conn,
Do you mean his comments here or the item about the lawsuit?
If you’re referring to his comments, my basic philosophy is that this is like a big lawn party in which different groups hold simultaneous discussions about different, if related topics. One can stop by to listen or participate, while flitting among groups. His voice is just one among many.
As to the lawsuit, I found it interesting for the reason I mentioned in the post - it appeared unusual and, perhaps, suggests a ratcheting up by local governments that may seek to recover funds paid for a drug.
I don’t know if this helps answer your question, but that’s the long and short of it.
Regards
ed
SP Holder
IMO, like Linda R. once said, “Gypsies, Tramps and Thieves.”
harpy
I think you mean Cher.
Condor
harpy is absolutely right — Cher is the correct reference-point — on those quoted lyrics. But maybe — just MAYBE — “SP Holder” DID mean Linda Ronstadt — but got his/her songs mixed up, thus:
“. . .You cry and moan and say it will work out
But honey child I’ve got my doubts
You can’t see the forest for the trees. . .
Oh don’t get me wrong
It’s not that I knock it
It’s just that I am not in the market
For a [stock with endlessly-inept management]. . .”
[With my sincere apologies to Mike Nesmith.]
http://www.ronstadt-linda.com/thestoneponeys2.htm#Ramblin
Namaste
Condor
Long believing the axiom “Nothing EXCEEDS, like EXCESS. . .” — please do consider these youtubes. Heh!
So. Yeah — I’ll wax just a little excessive, here — TWO video clips — one of the Stone Ponies 45 (I am crappin’ you negative!) — and the other, a more modern version of the above Mike Nesmith (yes, the Monkees’ own!) penned-hit, as warbled by Miss Linda:
Old School (Very!):
http://www.youtube.com/watch?v=7aEZwrSXHX0
New[er]:
http://www.youtube.com/watch?v=KPvqFkCtAqw
Namaste
SP Holder
Cher it is! My mistake. Here’s a little on it from 1971!
It hit #1 on the Billboard Hot 100 on November 6, 1971, and it remained for two consecutive weeks. The single also reached #1 in Canada and the Top 10 in many European countries, and it became the number-one selling single of 1971 at more than 3 million copies worldwide. [1] Today it remains one of her signature songs.
The song describes the life of a girl, the narrator of the song, who was “born in the wagon of a traveling show”. Her mother “used to dance for the money they’d throw”, while her father would do “whatever he could; preach a little gospel, sell a couple bottles of doctor good”. Although the people of the town called them “gypsies, tramps and thieves”, every night “all the men would come around, and lay their money down”.
How appropriate!
Condor
SP Holder — you know I can’t resist THAT hangin’ curve ball(!) — BAM! — it’s headed out onto Waveland Avenue, now — like a 747 takin’ off:
. . .So, you MUST mean that Schering CEO Fred Hassan is the “tramp” — and Goldman Sachs, CS First Boston, Bear Stearns and B of A are “the men who come around, to lay their money down. . .”
Right?
Right.
SP Holder
I was simply thinking of the top management team as “Gypsies, Tramps and Thieves.” With the initial Linda R. reference, perhaps I was thinking about “You’re No Good.”
Piper
Condor - here’s a little run-down on the obvious for you:
The FDA approved Zetia and Vytorin on their ability to lower LDL (which they do - NO LIE, REALLY!)
Zetia is marketed as a drug that lowers LDL by inhibiting its absorption from the intestines (AND IT DOES!) - 50% of the cholesterol in our bodies come from food (hopefully you get where this is going…)
Zocor is approved to lower cholesterol AND it has been shown to reduce CV risk vs. placebo (wow!).
Vytorin is Zocor and Zetia combined. Vytorin is lowers cholesterol more than Zocor alone, because of the Zetia component. Vytorin still lowers a person’s total CV risk, because of the Zocor component. Vytorin is marketed as an effective way to: 1)lower the body’s production of cholesterol (IT DOES! It contains ZOCOR!) and 2)lower the body’s uptake of cholesterol from food (IT DOES! It contains Zetia - the only cholesterol absorption inhibitor on the mkt)
In the ENHANCE trial, Vytorin lowered cholesterol more than Zocor (good thing, b/c that’s what it is approved to do) and showed comparable efficacy to Zocor in IMT change, a still questionable surrogate marker for CV risk (well, Vytorin doesn’t say that it reduces CV risk better than Zocor)
Vytorin was/is promoted as the MOST EFFECTIVE CHOLESTEROL REDUCER on the market (which it is -80/10 beats any high-dose statin). Vytorin was NEVER promoted as a superior CV risk-reducer - BECAUSE THAT WOULD BE FALSE ADVERTISING! If doctors prescribed Vytorin on the aforementioned assumption (which would stand to reason, given the direct correlation seen for lower LDL levels and CV risk), it’s because they were using common sense.
Condor - it’s like you lack common sense, because you have so much HATE for Schering. It just gets old.
Condor
Gee, Piper — that’s a lot of talk. And no action.
Please explain for me — as I apparently lack common sense — why it would be that the FDA would REQUIRE Schering to put this bold black warning on Vytorin (and a similar one — for Zetia, too). . . . ONLY AFTER “ENHANCE” was disclosed:
“VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone.”
That was new, at the demand of the FDA, post-ENHANCE — LINK:
http://www.vytorin.com/ezetimibe_simvastatin/vytorin/consumer/index.jsp
So — if you are right about the above, WHY on EARTH would FDA EVER NEED toorder this change?
Said another way — why didn’t Schering TELL US all this — right along — ever since FDA approval in 2002?
Why? — I’d tell you why, but I don’t need to — Suffolk County, NY governmental officials already have. [Hint: It's the oldest reason in the world.]
Cheers!
Ethicist
Kudos to Suffock County, new York, for having the guts to take on an extremely important challenge - holding Big Pharma companies responsible and accountable for their actions! This is all too rare an occurrence and i hope they are successful.
Piper
Condor - the FDA requested the change afterwards, because it was only then that they realized how stupid the average person really is.
Said another way - Schering didn’t have to TELL US that “Vytorin had not been shown to reduce heart attacks or strokes more than Zocor alone”, for the same reason that Crestor has never had to tell us that (even though it would apply)- because it is completely irrelevant to the approval and assumed use of the drug.
I bet you still don’t get it Condor, so how’s this sound: Lipitor was approved based on its ability to lower LDL. Later, Zetia was approved based on its ability to lower LDL. Then, Lipitor was shown to reduce the odds of a heart attack for every 1 out of 30 over a five year period. That was added to Lipitor label. The 4S trial had already shown a CV risk reduction for Zocor, which had been applied to its label. No such trial has yet to apply to Zetia, or Crestor for that matter (although Crestor has been shown to regress plaque). Thus, Zetia’s label has not been UPDATED to show CV risk reduction and Vytorin’s label had not been UPDATED to show CV risk reduction beyond that of Zocor. That’s how drug labels work. They include what has been proven.
So let’s try this again Condor. What’s on a drug label? A drug’s proven benefits. What’s not on a drug label? A long list of benefits the drug does not provide (example: prozac has not been proven to clear skin, increase intelligence, or augment muscle tone). Most drugs haven’t been proven to do a lot of things, that’s why their labels only include what they HAVE been proven to do.
Ethicist
The problem here is the appearance of MSP misleading the public for at least 9 months while they continued to profit from the sales of Zetia and Vytorin. The FDA guide for study results is within a year of study completion, which would have been in early 2007. If cardiologists had not made such an issue of not seeing the data in the Fall of 2007, who knows how long we would have waited. The study was high-profile because MSP had made it that way. Physicians had heard that the study would be presented at AHA 2006, ACC 2007 and AHA 2007, but hadn’t heard a thing. When the study came out negative, MSP had a huge problem. It seems as though they didn’t handle that very well, particularly with the public knowledge that SP key execs sold huge blocks of stock in the Spring of 2007 when the stock was riding a high from its’ expanding cholesterol-fighting market!
Big Pharma Guy
Definitely!!!!! I also hope that they take the execs to court and throw them in the slammer!
Condor
Okay, Piper — I’ll need to slow this down for you — You are wrong on the law. It is that simple. Let’s read from 21 USC § 352, et seq. EMPHASIS supplied for CLARITY:
“. . .Food, Drug & Cosmetics Act § 201:
. . . .(m) The term “labeling” means all labels and other written, printed, or GRAPHIC matters (1) upon any article or any of its containers or wrappers, or (2) ACCOMPANYING such article.
(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations MADE or SUGGESTED by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising FAILS to REVEAL FACTS material in the light of such representations or MATERIAL with respect to CONSEQUENCES which may result from the use of the article to which the labeling or advertising relates. . . .”
Okay — didja’ catch that? Does Vytorin reduce heart attacks? Or doesn’t it? Is heart attack risk “material” — if one is taking a drug to lower cholesterol? That is the issue, for me.
Now, look closely at this one and a half minute video I made:
http://blip.tv/play/AbjLe4eodQ
Now, the object lesson, here: “omissions” can be the basis for civil and criminal liability. In fact, the Chairmen of two Congressional Committees believe the ommissions in Vytorin’s ads. . . . were “material”. Each has said, and written, as much. In any event. . . .
Namaste
SP Guy
Do us a favor and nail them to the wall!
Piper
Condor, the only thing you proved with your ridiculous diatribe was that YOU are the target audience of the revised label for Vytorin. Apparently, YOU are the average person that can’t figure out a drug label. I guess that’s why we now get multi-paged, tiny print booklets with our prescriptions - so people like you can understand which drugs will NOT cure cancer, make you smarter, or grow hair.
You are wrong Condor. And you know why? Because the FDA approved Vytorin’s label. For 4 years, Vytorin’s label did not have to state it’s UNKNOWN (still unproven) lack of efficacy beyond that of Zocor in preventing heart attacks. I guess they assumed you were smart enough to figure out the facts. Oh, but that’s right…..you were probably taking all the pills you could get your hands on, since none of the labels say: “will NOT make you smarter”, which to you must mean: “WILL make you smarter”, b/c surely they would have to put it on the label if it didn’t….
CV MD
Yeah, it’s simply too bad that pharma firms can’t seem to stick to the label. Money drives them crazy and appears to make them do crazy things!
Face it, nobody knows if ezetimibe does anything other than lowering LDL. And nobody knows if it works with or against the beneficial event effects of a statin. And we won’t know for at least 4-5 years. Close just doesn’t count in evidenced-based medicine and extrapolation is for fools!
Sick & Tired
I say, “String them up!”