Merck Agrees To Boost Drug-Safety Procedures
40 CommentsBy Ed Silverman // February 10th, 2010 // 8:32 am
As part of a deal to settle shareholder lawsuits over Vioxx, the drugmaker will appoint a committee to address safety risks, another to monitor drug safey and appoint a new chief medical officer, Bloomberg News reports. Merck will also amend its code of conduct to promote scientific and academic integrity as well “honest communication” with doctors.
“In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,” according to the amended code. “We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.”
Under the settlement, which was announced this week, Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party, Bloomberg writes. The chief medical officer would have an “executive voice” on product safety issues independent of Merck and serve as a “medical ambassador,” report to ceo Dick Clark and serve on the executive committee.
The settlement, which won preliminary approval from a New Jersey state judge last week, would resolve all so-called derivative lawsuits, and a hearing is scheduled for March 22 in Atlantic City, N.J., Bloomberg writes. The deal, which covers federal and New Jersey state shareholder cases, isn’t an admission of wrongdoing, a Merck spokesman tells Bloomberg. The company will have to make corporate governance changes and “supplement existing policies and procedures,” he adds.
Bloombern then adds some background: In 2006 testimony, Harvard Medical School professor Jerome Avorn said Merck failed to conduct adequate safety studies before launching Vioxx in 1999 and misled docs about a 2000 study showing Vioxx caused five times more heart attacks than another painkiller. “There was a pattern of what I would characterize as systematic distortion that rose almost to the level of grotesque,” Avorn said in a tape played in federal court in New Orleans.
One Merck study called Advantage was actually a marketing tool, according to a 2008 report in the Annals of Internal Medicine. The study, which began in 1999 as Vioxx was cleared for sale, was designed by Merck’s marketing department, according to researchers who reviewed internal company memos and reports. The study “was marketing masquerading as science,” the lead author of the Annals report, Kevin Hill of Harvard Medical School in Boston, said in a 2008 interview.
Justice in MI
In late 2004, two weeks post Vioxx withdrawl, then CEO Gilmartin was here to give a talk on “business ethics” at our Business School. It has been scheduled months before.
Still, the opportunity to talk about Vioxx was not missed. Gilmartin said that Merck still fully believed in the product, that his wife used it for knee pain up to the day it was withdrawn, that whatever problem was a “stochastic event” and thus not worth analaysis and certainly not worth organizational change. Essentially, he said the same thing to the Senate Finance Committee shortly thereafter.
My question is this: How much do people believe that institutional changes of the sort described here are likely to make any difference?
As usual, real question.
Lisa Van Syckel
Justice, I have a question,.. why dont you use your real name?
MsPiggy
Oh Yes by Golly, this will make a world of difference (LMAO)
I know for a fact that when known pathological liars like “Merck” make these heart felt promises, you can bet your bottom stock dollar they are telling the truth this time around, well maybe?
(you can also refer to the ghost written published research paper, mull over the skewed clinical data as indisputable proof, or just watch the newest TV commercial)
Condor
JiM — Let me first laugh a little at Lisa’s question — does a name make an idea any more or less worthy?
The marketplace of ideas will decide — and I think it has voted in JiM’s favor, here, Lisa.
Now — please keep in mind that the basis of this settlement agreement is not new — it is pinned to, and cribbed from, an Oregon AG settlement from 2008. That was State of Oregon ex rel. Hardy Myers v. Merck & Co., Inc., Case No. 08C16426 (Or. Cir. Ct., Marion Cty.), filed May 20, 2008.
So, this will in no way resolve all the Vioxx matters more generally, for New Merck. Still remaining are the securities cases, and the “opt-out” personal injury lawsuits, as well as active government investigations — at least some of them criminal, in nature.
This is about Act I of a three Act play.
Namaste
M. Black
A promise is only as good as the level of rigorous enforcement that is applied (or allowed to be applied by companies statements of “confidentiality”) to these promises. Until then, it’s just more bullshit that the company will use to make themselves look better in the camera’s eye.
I don’t forsee this happening anytime soon, but I hope that it does.
patrons99
Several thoughts come to mind about this post. Why did Annals publish the Advantage seeding study (a prototypical ghostwritten market-based medicine article) in the first place? Annals appears to pass the buck, blaming everyone except Annals for this publication. Nearly 200,000 vioxx-related deaths later, did Annals ever formally retract the Advantage publication? If not, why not? What track record does Annals and other “prestigious” medical journals have for retractions of ghostwritten clinical research publications?
Merck’s commitment to “boost drug safety procedures” rings completely hollow. A wolf in sheeps clothing is still a wolf. In the case of drug safety, pharma cannot be trusted to monitor and report it properly. A wolf cannot watch over a henhouse. [Sorry about the overworked cliches.] Drug safety should be monitored and reported completely independent of pharma. Drug safety should also be made completely independent and autonomous of FDA. FDA has shown itself to have too much on its plate. Such an independent Drug (and Biologic) Safety Agency would be a great improvement over the current system. FDA senior management has been known to actively suppress their own drug safety staff from faithfully executing their responsibility, by means of retaliation and threats of retaliation in the workplace. Amazingly, in another recent pharmalot thread, an ex-FDA went so far as to state that they had been offered a bribe from pharma. Sounds a whole lot like Hobbs Act extortion and bribery to me. I’ll try to find the specific thread, if anyone’s interested. I remain totally astounded by that disclosure.
Lisa Van Syckel
Condor,
I take it, that, you are easily amused, it was just a question.
Condor
Apparently, I am actually, Lisa — sorry if I offended. I took it as a request for JiM’s “guberment name“. I now understand you didn’t mean it that way.
I just think using a pseudonym doesn’t detract from the merit of anyone’s reasoning (or lack thereof) — in any fashion.
Namaste
Lisa Van Syckel
Not offended, just missing the white stuff up north.
John
Condor-
Strange you say that using a pseudonym doesn’t detract from merit. Comments here keep throwing around the word “ghostwritten” a lot.
IMHO, The problem is not so much that the Annals article was ghostwritten (despite what Sen Grassley might say), the problem primarily comes down to 2 issues:
1. Merck (allegedly) concealing some of the negative data on Vioxx deaths.
2. The named authors not adequately participating in the preparation of the manuscript (an act which entails accepting responsibility for data interpretation and message of efficacy/safety.
Granted, if the problem in #1 above was truly an attempt to hide negative data, then it is very likely that the physician authors and/or “ghostwriter” could not have been aware of the deception and should not be held responsible.
Sure, to make readers aware of potential bias, the writer should have been acknowledged as being an employee of Merck or of being an employee of an agency paid by Merck.
All things being equal, if the data provided by the sponsor to the “ghostwriter” and physician authors were accurate and without important omissions in reporting adverse events, then the merit of the scientific paper would stand alone, just as you say that “using a pseudonym doesn’t detract from the merit of anyone’s reasoning (or lack thereof) — in any fashion”
Namaste right back at ya’
pharmavet
I would change the regs to make Data Safety Monitoring Boards (DSMB’s) mandatory for all clinical trials no matter how small. Currently they are usually reserved for larger trials. They should be completely independent of the company. Only those members with absolutely no COI’s with Pharma should be selected. They should be appointed and compensated by an independent entity. It’s well beyond time that Pharma go completely transparent, at least with respect to clinical trials safety. DSMB’s should not be hidebound by arbitray “safety stopping rules”. To use the automobile analogy, when Toyota was making quality cars, anyone on the assembly line had the power to shut down the entire operation even upon the slightest suspicion of a safety problem. Same should hold true for DSMB’S.
Justice in MI
Holy cow! I expressed no opinion on this thread at all. Just queried about whether poeple thought the institutional changes would make a difference? As I said, real question. (To which, as far as I can tell, no one has offered their thoughts.)
As for names, it’s Ed Silverman.
Justice in MI
p.s. OK, I lied. Lisa is Ed Silverman. My own “real name” is very easy to find for anyone interested. But, if people called you “Justice,” would you give it up? Heck, no.
As for the connection that John (real name?) seems to be making to ghostwriting, I genuinely don’t follow the connection. Perhaps there is one to “guest-writing” in which a KOL adds their imprimatur to an article without having written it. Whether or not the study is valid, selling one’s known “name” in order to attract more attention to an article–and perhaps pad a CV–is intellectual prostitution, no?
Mr. Wrong
Sorry–there are, indeed, some interesting opinions above, which I missed on first read. Thanks for that.
david egilman MD
The main issue with the Advantage trial was the fact that it was a large seeding trial (5000 pts). The second point was that Merck manipulated the adjudication of MIs to delete one case that made the MI/Sudden death increase on Vioxx just miss statistical sig. 6 to 1 vs 7 to 1.
The final point was that it was ghostwritten. I was an author on the major Vioxx papers & got access to the documents because I was an expert witness for several of the victims
M. Black
Intermission:
Lets go out to the kitchen to grab ourselves a snack.
You can’t convince someone the “sky” is blue, if that person doesn’t know what the “sky” is.
Think about it.
Ok, back to ranting. Enjoy!
Justice in MI
M. Black–You’ve totally lost me. Sorry. Translation appreciated.
pharmavet
Ed Silverman is an award winning investigative reporter, far more gifted than anyone posting on these boards. Please do not denigrate his name, even if it is only in jest.
laura
Pharmavet,
You’re right, Ed Silverman is a “pharma saint” and many of us are truly indebted to him for his amazing reporting along with the forum that he provides. Justice in MI is a legend in his own right, however, and I don’t believe that he was denigrating Ed’s name by using it as an alternative pseudonym. I think most people were aware that he was just making a joke…why can’t we all just get along?
et al
Dr Egilman mentioned that he was an expert witness for several of the ‘victims’.
Shouldn’t that be ‘plaintiffs’? Serious question. I suppose going into the hearing one would hope for impartiality but post hoc perhaps terms such as this are OK.
Anyone enlighten me? Thank you.
Christopher
I’m feeling a whole lotta love on this site tonight. Well just this post really, but Ed deserves it. Not the beatitudes, just a firm handshake and the merest hint of a nod of appreciation.
;-)
Justice in MI
Yikes. Ed is, indeed, a mensch of the highest order. I’m pretty confident that a moment of levity (OK, six by the Pharmalot clock) would only add a little cream to his coffee.
Beyond that, there’s probably a new DSM category for whatever has infected this thread.
But let’s just pray for healing.
patrons99
Amen!
Condor
John — Again, you commit the fallacy of composition:
I genuinely think peer-reviewed journal articles — in the NEJM, for example — are a different sort of cat than blog comments (not even blog-posts, mind you). [I know you do too -- you are smarter than this would suggest.]
If your point is that you’d like to know someone’s bias, upfront — fine. Read his/her posts.
Figure it out — none of us are giving medical or legal advice here. No one’s life depends on what we write. We are, afterall, only trying to convince one another.
Again, in this little world, writing under a pseudonym allows a candor that our employers might be less than enthusiastic about, were it attributed to the employer’s business interests. It doesn’t make anything written here more (or less) worthy. This is not the NEJM — that is all.
[Sorry to bust-up the love-fest.]
Namaste
Condor
Now — let me rise, to confess to a little of the bromance, here, as well — for our estimable host — Sir Ed, of the kingdom (far-far-away) called “Pharmalot“.
Just to get this one spinnin’ in good karma, again.
Namaste
harpy
y’all are silly.
Getting back to JiM’s question -
“My question is this: How much do people believe that institutional changes of the sort described here are likely to make any difference?”
I still think the answer depends on the company. But I also think there truly is a sea-change coming in the industry - slowly, yes, but inevitably. Honestly, they can’t go on doing business like this going toe to toe with the DoJ. Statistics from a few years back said for every lone, single dollar ($1) invested by the government in pursuing pharmaceutical fraud, they make $15! what a cash cow! And this was before the jaw-dropping Lilly and Pfizer settlements.
So, pharma is breeding its own destruction if it continues to follow this course. As many of us have decried all along, these are businessmen, meaning that eventually they will realize what is good for business - i.e. making a profit that doesn’t get you fined and derided in the press and keeping your a$$ out of jail. Because that is what is coming next.
Jaynesday
Finally maybe some serious internal control of product safety. When the stockholder (money holders) of the company apply pressure maybe something will get done.
A couple of hopes - First I hope that the company isn’t just pulling the wool over the stockholder’s eyes and second I hope that Merk becomes a shining example to the rest of the industry.
Who can be the first company name to be synonymous with trustworthy? May that race begin.
Oh, and I hope we get an early spring this year.
Justice in MI
Thanks for the good and interesting word, Harpy. Needless to say, I hope you are right.
As relayed in another thread, if there were also some positive incentives for doing the right thing (e.g., completing useful phase IVs on time and even initiating important ones)–like extending patent protection for some relevant period while balancing cost in some reasonable way–I’d be for that too.
I hope my students are tuned in and listening up. We’ve been discussing
Justice in MI
…positive and negative incentives for self-regulation.
Myrtle Williams
Boosting their drug safety procedures is the very least they could do. I wonder if Merck’s executives at the time even lost an wink of sleep knowing their product killed nearly 30,000 people..?
Josh
A few consent decrees can go a long way….if you can’t sell or manufacture, that will make companies change their tune.
pharmavet
Phase IV safety studies should be made to complete in a timely fashion. Time committments are stated in the approval letters, but approval should be subject to revocation if the study is not completed in a timely fashion. I’m not a lawyer but I’ve heard that the FDA lacks legal authority to recall a product on its own absent an overwhelming threat to public safety.
A good example is Meridia. The drug was approved in 1997. The required Phase IV safety study (without deadline) results have just come out, confirming the CV risks that were suspected back in 1996 by the FDA Advisory Committee. Many now are calling for Meridia to be removed from gthe market. Would anyone agree that 13 years is a too long to complete a Phase IV committment study?
Justice in MI
Hi Vet–As I understand the FDAAA, FDA can now levy fines for incomplete, required phase IVS–they accrue each day the study is missing–but, like library books, it still doesn’t add up to much. The size of the fines was batted around a lot in the reconciliation process on FDAAA, and they kept shrinking.
I think you’re right re: recalls, even with FDAAA. Labels can now be changed without extended negotiation (a la Vioxx) although companies can appeal, etc..
Of course, FDA has always been extremely reticent on recalls–and, I think, always would be–for some good and not good reasons.
Josh
FDA has no authority to force a pharma company to recall, unlike medical device. They may suggest a company to recall a product, and if the company does not, FDA is more likely to move to seizure. You would much ratherbrecall than have them seize product.
Keith ATL-L-14475-M06 #619
Prosecution for criminal acts should be next. Vioxx put me into cardiac arrest and caused me stokes, if this happened to you…you would feel the same way!
pharmavet
Merck has been settling these cases not as an admission of guilt but rather due to escalating legal costs. In fact, in the 14 federal and state cases that have come to verdict, Merck is batting almost 65% due to the fact that most of the plaintiffs had too many pre-existing cardiovascular risk factors that made it impossible to pin the blame on Vioxx.
Keith atl-l-14475-m06 #619
Pharmvet what is fact is not support by Merck’s successful litigation:
1. 2004 independent study of 59,000 with one heart attack had 16,000 (27%) taking vioxx DIED!
2. Another study evidence vioxx was 5 times more likely to cause heart attack and/or stroke than celebrix or bexstra or naproxen.
3. A marketing study was presented as a medical study. Study participants were not imformed of risks before or after accual medical study was conducted.
Given Merck’s litigation statistics, empirical data evidences they are guilty of murder by proxy in only 35% of cases.
M. Black
In the past 24 hours or so, I’ve been humbled by a couple of items that just called for a randomly delayed and inetched (if it’s not a word now, consider my application for intellectual property as on it’s way) response to said items.
First and foremost:
1) Ed Silverman is the man. Without equivocation.
2) Unemployment extension may cause temporary random fits of thought and at times, just plain silliness if you are of the sculptor ilk. And in the very best of good intentions, this may lead one to situations of fiddle, faddle, and boo have unintended intertwinizations (application on the way), a.k.a. karma, though need explaining, acts just as to tickle the mind, while striving to maintain an overall bias, and, assumedly, the overall integrity of the intention of finding truth, HAS ruptured a vessel (vellels…) of agitae.
3) Pepto shake. Now THERE’s a product. A product to emulate the almost (dare I say, this schmuckedly lowly awarded / degreed philosopher / biologist say - BIOCHEMICAL) … biochemical properties of when one gets to that last dose or two of a good ol’ doctors favorite PINK BISMUTH solution when the flush of vigorously shaken with the addition of water, adding the benefit of functionality, as a greater area of surface coverage, and thus, agitae destruction occurs at a much higher efficacy.
4) The use of pseudonyms (as described) was phenomenal. For the longest time (and maybe, in the line of a Kierkegaardian approach to
author his pieces - with the author name actually represented an actual being of certain ways or lack of ways of thinking - probably won’t stop) I’ve been posting with random / regular pseudonyms without intention of confusing the living hell out of bloggers / onlookers.
JP’s “TRUE” Report
for the day 03-31-10:
“I think my eye just ingested and is now in the process of digesting a small insect that was e’stunad and landed on it’s retinal glaze like an inverted Venus”
Silence contrasts. Sanka shower.
M. Black
“And when the guy from Twin Peaks
Rides aimless, through your fun,
I’ll see you on the Equator of the Sun.”
M. Black
M. Black
Is that the Trackwise number, Keith?
Forever, the public record lasts…
M. Black
(apologies for the multi post)