December 14, 2006

If You Are Surprised By Vioxx's Risks, You're Fired

This was an op-ed I had written two years ago.  In light of the 12th trial win for Merck (they chose to fight each suit individually, rather than settle a class action), I'm reposting it here.

In the current politically polarized climate it is no surprise that yet another story of the evils of Big Pharma should surface. And why not? When everyone else abdicates responsibility, the easiest maneuver is to scapegoat the ones who actually create anything.

Consider the Vioxx debacle. By now, everyone knows that it was recently discovered that taking Vioxx is associated with an increased risk of heart attacks and strokes. What is not obvious from the news is that the data used to make this discovery has been in the public domain for years.  I even found it in a Yahoo! News article from 1999.

Merck halted a recent trial because it detected this increased risk; but other studies had already found this same risk even four years ago. So why now? And why are any doctors surprised? Were they not reading the journals all along? Were they simply accepting the word of the drug companies? But a recent New England Journal editorial goes further, blaming the Merck and the FDA for failing to protect the public. You’re blaming the FDA? Is the FDA prescribing the drug? Again, the data was already available to anyone with internet access. The fact is that any doctor who is surprised by the “new” data on Vioxx’s cardiovascular risk should never have been prescribing it in the first place.

The Journal goes on to say that Merck tried to minimize the significance of the risk. Even if true, it is irrelevant. The data was available. It doesn’t matter how marketing spins the data, because doctors, as medical scientists, are supposed to be able to ignore marketing and focus on the data. Doctors are supposed to know the data before they prescribe a medicine. Quoth the Journal:“If Merck would not initiate an appropriate trial (to formally asses cardiovascular risk) and the FDA did not ask them to do so, how would the truth ever be known?”

This is a joke, right? Is he seriously suggesting that it is the government’s responsibility to evaluate existing data? Yes: “I believe that there should be a full Congressional review of this case.”

The author fails to separate the responsibility of Merck with the responsibility of the physicians. Understand that I am not trying to absolve drug companies of their responsibility; I am trying to differentiate their responsibility from doctors' responsibility.   Published data becomes the responsibility of the doctor. They are practitioners; their role is to determine, specifically, if the risks of a treatment outweigh the benefits (and vise versa.) If they choose not to read everything available on their own, and to rely on the words of the FDA, or the drug companies, or anyone else—then the fault is the theirs, the liability is the theirs. Ask any lawyer. The data is the data. It doesn’t matter what the drug companies say, or the FDA says, or even what another doctor says, because this is science. it has hard facts I can check, I don’t actually have to trust anyone’s word. Medicine is still a science, right? We’re still sticking with that story?

But this almost never happens in actual practice, hence surprise at the "discovery" that Vioxx has cardiac effects. If doctors had done their jobs and understood, from the beginning, that Vioxx had a minor but still real increased cardiac risk, and modified their use of it  (i.e. not hadning it out like water) then Vioxx would still be on the market and this controversy would never exist.

Drug companies are an easy target, because they are large, impersonal, and very, very rich. The zeal which doctors now attack drug companies as “commercial” (seriously?) and “biased” borders on oedipal. This is because doctors do not create anything new. They are not inventors. When the TV tells you that “doctors have discovered a new cure for X” what they really mean is that a drug company has made this invention, and your doctor is using it. But to believe that doctors are making treatment discoveries during the course of ordinary practice completely misses how progress in medicine is made.

This is not to minimize their role; obviously, they are the ones who are doing the treating. But by consistently framing the issue for the public, politicians, and other doctors, as one of doctors against the pharmaceutical industry, or Pharma against the weak and the oppressed, we are grinding progress to a slow and purposeful halt.

Vioxx is an easy target because we don't "need" it.  But how do we know that someday they wouldn't discover it cured, for example, cancer?  Don't laugh: the trial Merck interrupted to pull Vioxx was for the prevention of colonic polyps. Is that worth the very small (1%) risk of a heart attack?   Now we'll never know.  That would have been a decision for doctors to make with their patients. This is the point, the only point.  But now, because doctors were not rigorous about their own practice or education, no one gets to try it. Who suffers? Answer: you. And this barely accounts for the massive strategic harm this does to Merck, in lost revenue as well as increased paranoia, risk aversion, etc.   It is unlikely that Merck will be as aggressive or spend as much to find the cure for, say, AIDS, tuberculosis, or cancer. Everyone happy with this outcome?


Kudos for a thoughtful post... (Below threshold)

December 17, 2006 6:28 PM | Posted by CP: | Reply

Kudos for a thoughtful post. I agree with you to an extent. Doctors must take SOME responsibility for their prescribing practices. It is abundantly clear that the great majority of Vioxx patients were not those who stood to gain anything from the treatment, as Vioxx was allegedly intended for patients who could not tolerate other painkillers. Yet doctors handed it out as gratuitously as violence in a Rambo movie.
Granted, one could place a lot of blame on aggressive marketing and on data being interpreted "carefully" by Merck. I'm thinking of the "it's not that Vioxx is bad for your heart -- it's that naproxen is GOOD for your heart" argument. Oy vey, was THAT a stretch to avoid responsibility for Vioxx's effects!

Medical education is certainly lacking in training physicians how to interpret data and research design, yet there is no substantial movement to change this deficiency. Doctors also claim they lack sufficient time to read medical journals -- that's one hell of a strange argument when lives hang in the balance! Keep your clinic open for two hours less per week and spend that time doing some research. Physicians are generally well-paid and this should be reflected by a willingness to take time and look at the data.

The question is: Who takes responsibility for misleading marketing's effects on prescribing practices? The doctor or the drug company?

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If I have 1 in my email doe... (Below threshold)

December 31, 2006 5:10 PM | Posted by Dr. Charles Parker: | Reply

If I have 1 in my email does that mean I'm narcissistic?

Long distance high five for your remarks here on the easy targets and complex problems associated with not thinking, and not asking basic brain questions. If we don't ask the right questions, how can we blame the meds?

Technology and modern labs have changed the questions dramatically, and, as you have said elsewhere, it appears that many think depression, for example, is like a hangnail.

And the fix is like a turkey shoot. Load up the 00 buckshot, take aim and blast away at the paper turkey. -Then calmly walk over and count the holes. How are we doing?

My view: Phenotypic thinking is actually killing people, and it is really simple to just ask a few more questions - to get past point and shoot.

The further compelling issue: what do you do if you have the answer and don't have the proper weapon? "It's a real problem, but... I don't know how to fix it...." Thus begins humility.

Appreciate your voice, you are not alone out there. Excellent material.
Best of luck with your new blog,

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Dr. Parker, are you the Dr.... (Below threshold)

January 1, 2007 5:07 PM | Posted by tanM: | Reply

Dr. Parker, are you the Dr. Parker at the Amen clinic?

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I really can't see how the ... (Below threshold)

January 13, 2007 7:24 PM | Posted by Dennis Harrison: | Reply

I really can't see how the physicians are at fault. Merck absolutely does have the responsibility of educating physicians and consumers.

Anyway, here are my thoughts on an issue that Merck just won't fess up to:


Version 1.0 – January 13, 2007 (will be updated and refined periodically)

Just to get started – here is an introduction to some Independent Research!

…"It's time to tell the public"… Einhorn TA. – Professor & Chairman, Department of Orthopedic Surgery, Boston
University Medical Center…this is due to the inhibition of Cox-2 and not COX-1! Vioxx is a Cox-2 inhibitor

HSS Physicians Review Literature on the Safety of COX-2 Inhibitors…effect fracture healing and spine fusion…
should never be used in spinal fusion…

Bone Fractures…Cox-2 Inhibitors interfere with bone growth and, healing…

Journal of Bone and Mineral Research - COX-2 inhibitors Decrease Bone Healing…
. and there is so much more!

Do some Googling – you will “get” it!
Do a Google on “Vioxx bone repair” or “Cox-2 bone repair” for many full articles on the bone/spine issue(s). Also, enter a Google search for such as “bone lawsuit Vioxx" and "Cox-2 bone lawsuit Dennis Harrison" - NO QUOTES ARE NEEDED! You will then have plenty of information that identifies the situation.

Did you take a cox-2 inhibitor (like VIOXX) and have bone/spine repair/healing issue(s)?
Have or had a broken bone or spine issue?Especially a serious one? Do you have arthritis? Did you take Vioxx, Celebrex or Bextra (all called “Cox-2 inhibitors”) while waiting for bone or spine to heal from an operation or other means? Even without arthritis, were you given a Cox-2 inhibitor for pain relief while waiting for that bone or spine to heal? This not only relates to the past, but (allegedly) you MUST be “on your toes” today, and most likely as it stands well into the future!

If the above concerns you, & even if it doesn’t now – you should read this!
It is not hard to interpolate that thousands of Americans have (allegedly) been duped by what this author calls a “Veil of Safety” which he alleges Merck purposely created to provide “cover” for this very, very important issue (among other alleged issues! This “Veil of Safety”, as alleged by this author, provided enough “cover” so that even well qualified spinal and orthopedic surgeons (allegedly) basically assumed that Vioxx was safe to give after an operation. Read on…

General and healthy skepticism of the former (prior to Cox-2 inhibitor NSAIDS) Cox-1 inhibitors, which may have allegedly at least provided some kind of helter skelter, informal rumors to consumers and physicians, as well as a healthy “wariness” by the drug industry - should have been a “red flag” for the same drug companies, and this writing concentrates mainly on the bone/spine repair/healing (alleged) issues of Vioxx, though there are other Cox-2 inhibitor drugs - VIOXX and Bextra off of the market, Celebrex still on the market, and two potentially new entries (Arcoxia - Merck; Prexige - Novartis). All of these drug companies should, obviously very seriously consider the alleged bone/spine issue(s) with responsible testing, patient follow-ups, analysis, etc. Also, per the allegations, the past, current and future (until proven otherwise) should have certainly led to fair surgeon, physician and consumer education and simple warnings

SO MANY Independent Studies (IR) concluding the “alleged” issue of Vioxx and bone/spine issues! -
And there were other factors that should have caused responsible actions but allegdly failed to. Quite frankly, it certainly would seem that even just the general industry “wariness” SHOULD have motivated Merck to address the matter. Remember, one would think that they would be the SUBJECT MATTER EXPERTS! This is not brain surgery! There are many means to fairly address the matter. There certainly seems to be no reasonable explanation as to why Merck did not tackle the mounting Independent Research (IR) that was pointing to Cox-2 (hence Vioxx, and though less mentioned implicitly Celebrex and Bextra). Just read the following - perhaps you may share the shock and anger that I had! Just some example excerpts from virtually hundreds of articles:

FEBRUARY 02, 2005 - HSS PHYSICIANS REVIEW LITERATURE ON THE SAFETY OF COX-2 INHIBITORS - COX-2 inhibitors effect fracture healing and spine fusion… should never be used in spinal fusion…

DECEMBER 23, 2002 - BONE FRACTURES - Cox-2 Inhibitors interfere with bone growth and, healing… Researchers at Stanford Univ. University Medical Center…COX-2 inhibitors also impede the new bone growth that normally helps heal a fracture or stabilize a joint implant…

MAY 21, 2002 - JOURNAL OF BONE AND MINERAL RESEARCH - COX-2 DECREASES BONE HEALING? - mechanical testing revealed that COX-2 inhibitors…reduce bone strength…expression of COX-2 is critical for bone healing…essential for fracture healing…the inhibition of prostaglandin synthesis stops normal fracture healing.

COX-2: WHERE ARE WE IN 2003? - THE ROLE OF CYCLOOXYGENASE-2 IN BONE REPAIR - EINHORN TA. PROFESSOR AND CHAIRMAN, DEPARTMENT OF ORTHOPEDIC SURGERY, BOSTON UNIVERSITY MEDICAL CENTER, BOSTON, MASSACHUSETTS - both non-specific and specific inhibitors of cyclooxygenases impair fracture healing - but that this is due to the inhibition of Cox-2 and not COX-1! Vioxx is a Cox-2 inhibitor. "It's time to tell the public," concludes Dr. Thomas Einhorn.

JOURNAL OF BONE MINERAL RESEARCH 1999 JUN;14(6):969-79 - initial immune response is crucial to fracture healing…

REPRINTED FROM: WWW.USATODAY.COM/NEWS - "It's time to tell the public," concludes Dr. Thomas Einhorn, Boston University's orthopedic surgery chairman. New research suggests some of the most widely used painkillers may delay healing of a broken bone… "If it were my fracture ... to me every day counts," he says. Vioxx and Celebrex are among the culprits…. the makers of Vioxx and Celebrex deny any link.

DECEMBER 2002 NEW ENGLAND JOURNAL OF MEDICINE - haven’t lived up to their earlier promise… Even worse, the largest study ever done looking at joint-disease modification, published in the journal Arthritis & Rheumatism, found that people using 25 mg of Vioxx lost 0.27 mm of cartilage in just one year. That number was expected to be 0.1 mm.

“Somehow, this study flew under the radar,” SAYS JASON THEODOSAKIS, MD, MS, MPH., AUTHOR OF THE ARTHRITIS CURE (ST. MARTIN’S PRESS 2004). This information is unlikely to be broadcast by pharmaceutical companies, he explains: “It could affect the billions of dollars in sales of the COX-2 inhibitors if people knew they might be destroying cartilage while they’re trying to relieve their pain.”

KOMATSUBARA S ET AL. SPINE 2006; 31:E528-34. - "High-grade slippage of the lumbar spine in a rat model of spondylolisthesis: effects of cyclooxygenase-2 inhibitor on its deformity" (shows COX-2 inhibitor led to deterioration of bone healing which worsened vertebral slippage)

O'KEEFE R ET AL. ANN NY ACAD SCI 2006; 1068:532-42. - "COX-2 has a critical role during incorporation of structural bone allografts" (findings indicate that COX-2 dependent PGE2 production in the early stage of bone healing is needed for efficient skeletal repair and is essential for bone allograft incorporation; COX-2 inhibitor (Celecoxib or Ketorolac) reduced bone formation and boney ingrowths)

DALUISKI A ET AL. ORTHOPEDICS. 2006; 29:259-61. - "Cyclooxygenase-2 inhibitors in human skeletal fracture healing" (study indicates that COX-2 is naturally lower in nonunion fractures that don't heal well, may reduce the bone-forming potential of precursor cells, and they note that limited use should be made of COX-2 inhibitors in patients with healing fractures since they need to mount an initial immune response in order to achieve fracture healing)

LI L, ET AL. CYTOKINE GROWTH FACTOR REV 2006; 17:203-16. - "Regulation of bone biology by prostaglandin endoperoxide H synthases (PGHS): a rose by any other name..." (this is a review article that includes some discussion of the importance of COX-2 (also known as PGHS-2) in bone fracture repair)

HILL K ET AL. FOOT ANKLE CLIN 2005; 10:729-42. "The role of cyclooxygenase-2 inhibition in foot and ankle arthrodesis" (this article notes that COX-2 inhibitors are valuable to help control postoperative pain but may have deleterious impacts on bone healing in patients undergoing hind foot arthrodesis)

ORTHOPAEDICS TODAY INTERNATIONAL 2006; 9:12 - “And those biopsies showed us irregular fiber structure, high concentrations of matrix, vascular ingrowths but no inflammatory cell traits. But, despite that, we gave these patients tons of NSAIDs. … We wanted to use a new method to try to evaluate whether there was any inflammation in these tendons.” In vivo micro dialysis...Decreased prostaglandin may impair bone healing, and the COX-2 enzyme is critical for fracture healing, he said. Dimmen and his group tested how short-term doses of parecoxib, a COX-2 inhibitor, and indomethacin, a COX-1 inhibitor, affect long-bone fracture healing. The parecoxib and indomethacin groups had lower bone mineral density than the control group…”

So, our findings with parecoxib had the higher delay in the fracture healing than indomethacin, with the assumption that the COX-2 enzyme is responsible for impaired fracture healing,” he said.

“Never give NSAIDs for stress fractures or for cartilage damage. NSAIDs hate chondrocytes.” — Sigbjørn Dimmen, MD

Another relate issues – not good news either!
DECEMBER 2002 NEW ENGLAND JOURNAL OF MEDICINE… Jason Theodosakis, MD, MS, MPH., author of The Arthritis Cure (St. Martin’s Press 2004) – “This information is unlikely to be broadcast by pharmaceutical companies, he explains: “It could affect the billions of dollars in sales of the COX-2 …”.

It is fair to say that the above statement is about yet ANOTHER potential and alleged issue - that of potential cartilage destruction while taking Vioxx - not only during bone/spine healing. However, the alleged implications should be clear; and healthy bone needs cartiliage for bone “cushioning” and development”.

You may very well have been impacted or know some-one who was – the scale is likely very large!
You may have taken Vioxx in the past, and if in fact you were recovering from a significant broken bone or spine issue, very well were given it, as the (alleged) uneducated and thus unknowing surgeons, physicians and consumers were provided an effective pain medication that just happened to be (allegedly) ruining their patient’s healing process. As it turns out and very unfortunately, Vioxx was a very effective medication to treat pain after a major bone or spine operation – except for what it (allegedly) was doing to the body’s normal, natural process of bone/spine repair/healing! However, there are other well-established means to do so, and Vioxx certainly was not required. So, meanwhile, pain, which could have alternatively been managed by other effective means, was (allegedly) too often addressed with VIOXX and pathetically was (allegedly) ruining many critical bone/spine operations. Of course, even without an operation, just in general ruining bone/spine healing. Would you have asked for Vioxx under these alleged conditions if you were warned? - or would you have made sure that an alternative means of pain control, already well proven, was your method of control. It is an easy question to answer for me!

Just a brief change in subject concerning another Merck drug – FOSAMAX
…and then we will get back to VIOXX and the kind of business strategy that this author SUSPECTS and has developed by research and “educated thoughts”. FOSAMAX – another Merck Headache – apparently not only the increasingly alleged “Dead Jaw”issue! - YET another MAJOR potential issue which MUST BE STUDIED by unbiased individuals!

To make matters potentially much worse, and while not the current topic of serious IR (that I have found), at least not now, there may be further potential issues when concurrently taking a bio-phosphate (like FOSAMAX) and any Cox-2 inhibitor (past, current, or future). This author is quite perplexed as to why this is not an issue of study for Merck, Pfizer or Novartis. While in a manner it is hypothesis, but could they (the drug companies) have “bad feelings” about where that (their own studies) may lead? Are they nervous where their sanctioned studies may go? Why don’t they have any real position on the alleged bone/spine issue(s); why aren’t they looking at concurrent Fosamax usage WITH Vioxx – which certainly seems to be a really bad combination. Aren’t they the subject matter experts? Shouldn’t answers just flow automatically from them? Shouldn’t they seem very, very knowledgeable on these topics. Wouldn’t you feel that they should address the issue(s) – tests, warnings (even of the potential), follow-ups of past and current concurrent medication users, analysis, etc. The issue just seems dead in the water and eerily silent? Please realize that BOTH Cox-2 inhibitor and bio-phosphates work by modifying the body’s natural response to bone healing (Cox-2 inhibitors) and healthy bone regeneration (bio-phosphates). Fosamax was available before any of the Cox-2 inhibitors - how could the “original Cox-2 inhibitors not have formally addressed this? How could one possibly justify the newer proposed Cox-2’s without also addressing this issue! It takes only common sense to realize these issue(s) need to be addressed – the thought process does not involve brain surgery! Think about it! Also, think about this – if a drug company already had enough suspicion and wants to ignore it in view of its impact on profits (even over safety!), would likely be the subject of investigation?

By the way – recent studies of FOSAMAX are very enlightening – why hasn’t Merck done the same study funding for Vioxx while Independent Research has been very active and seems to be accelerating? This author, for one, would not want to be on a Cox-2 inhibitor and Fosamax concurrently in the past, current, or future – until much, unbiased, research is finally done! Hey – the drug companies should at least provide some type of warning so the physician and patient can make an informed, individualized, benefit/risk decision – Merck, nor any drug company should be making it for them!

Submitted by Martha on January 8, 2007 - 1:15pm.

Let no one say the studies in JAMA are funded by hidden drug company money. The funding is right out in the open.
"Effects of Continuing or Stopping Alendronate After 5 Years of Treatment," in the December 27, 2006 issue of JAMA was funded by Merck who manufactures alendronate, a bisphosphonate, under the patent name Fosamax.
The study's 11 non-Merck authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth, Novartis, Procter & Gamble and of course Merck.
"Many people believe that these drugs are 'bone builders,' but the evidence shows they are actually bone hardeners," wrote Dr. Susan M. Ott in the Annals of Internal Medicine in 2004 pointing out that they depress "the bone resorption rate as well as the bone formation rate" and "bones could become brittle with long-term accumulation."
Indeed, problems from lack of bone formation is exactly what a study in the March 2005 issue of the Journal of Clinical Endocrinology & Metabolism [Severely suppressed bone turnover: a potential complication of alendronate therapy] found.
"We report on nine patients who sustained spontaneous nonspinal fractures while on alendronate therapy, six of whom displayed either delayed or absent fracture healing for 3 months to 2 years during therapy," wrote the authors.
"Our findings raise the possibility that severe suppression of bone turnover may develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures."
And there were patients themselves.
"I still suspect I have been permanently (or hopefully semi-permanently) altered by Fosamax," wrote one woman on the web site Ask a Patient where over 450 rate the drug. "It is as though my ligaments became crystallized, without elasticity."
"After six years of taking Fosamax, I slipped in ice in my driveway and broke my femur (thigh bone). Two years later, still taking Fosamax, I fell in the snow and my other femur snapped before I hit the ground," wrote another woman.
"My condition is basically the same as rickets," wrote a third after going off Fosamax.
And there was more bad news.
Merck concludes the residual effects of Fosamax in women who have taken the drug for five years will last indefinitely. (Just what many feared.) What else will last indefinitely is the effect of Merck's shameless and deceptive marketing.
Martha Rosenberg is at the Evanston Roundtable

Back to VIOXX…
Merck COULD have been direct and honest and still had a very large Cox-2 inhibitor market! After all we are referring to what allegedly should have been a warning not to take the medication while undergoing Spinal and or Bone healing – the safety (relative to bone/spine issues) aspects are relative to when one is temporarily undergoing bone/spine healing. The Independent Research does not question the normal time frame of taking the medication (when NOT undergoing bone/spine healing). If managed responsibly and properly, (from a bone/spine basis); there was still a very, very significant market for Cox-2 inhibitors, AND all Cox-2 inhibitor producers. Merck apparently so wanted to catch up and surpass Celebrex, which had gotten to the market first. Witness the alleged rush to market, the alleged cutting corners, the alleged neglect, deceit and fraud. Witness the very, very MASSIVE and successful marketing campaign.

The relative advantage/disadvantage of one Cox-2 to another seems not to be well enough known. This author views the situation as something Merck could have utilized to level the playing field with its competition - instead of the alleged reckless and neglectful manner it was “managed”- with maximum profits over even reasonable safety on this (alleged) issue (bone/spine). It is not hard to imagine that if Merck had properly managed the situation, it may have found a way to get on the market and get Celebrex temporarily off of it! Nope, easier to (allegedly) cut corners and time, then market the you know what out of it!

Thus, a very, very large arthritis market (save for the all important current allegations/litigation relative to heart and cardiovascular) would have still existed. This article relates to the alleged bone/spine healing issues and speeding Vioxx to the market with profit over reasonable safety. Even with profit as the obvious motivator, it just does not seem to have been necessary if calmer, less greedy heads had prevailed. And regardless, (allegedly) it was illegal and immoral!

Simply having had a program for proper education and warnings of potential inadequate or non-existing bone/spine healing to physicians and consumers to make informed decisions and proper monitoring was indeed possible. VIOXX could have still have had great successes if Merck had just properly executed caution, education, and warnings. After all, as someone impacted by VIOXX I can say that even though it was a very good arthritis medication – I certainly would have STOPPED TAKING IT while bone/spine healing took place. Then, after that (relatively) short time I would have had no problem taking it again if I was given fair instructions when to stop and start it. If only I had been warned…!

Just imagine the MAJOR public implications, as well as many corporations that were so negatively financially impacted. Here are just a few examples to think about:

It is not hard to imagine:
1 – so, so many normal, average persons impacted and losing time from work, and or losing their job!
2 – so, so many automobile accidents – a major source of broken bones and damaged spines; hospital costs,
rehabilitation costs, physician costs, and so many other costs from an issue, which should not have existed.
3 – so, so many other types of accidents resulting in the above.
4 – how about the budding careers of young athletes or a well-paid athlete whose career prematurely ends?
5 – and insurance companies, with individual in accidents not healing well or at all, paying very excessive lawsuits and
settlements for a relatively routine operation gone so, so wrong!
6 – the cost to medical insurance companies – not just in the cost of the drugs, which is major in itself. But the otherwise
un-needed extra days in hospitals, nursing homes, home health care, etc.
7 – Physicians and surgeons wrongly sued by patients blaming them for their “routine” healings gone awry because
(allegedly) Merck didn’t even provide fair education and warning for the physician and patient to make informed decisions.

…one is left with their imagination to carry this further! If the allegations by so, so much Independent Research are true – imagine the potential liability of Cox-2 inhibitors, including Vioxx? If you ran a corporation, and aside from the issue of doing the right moral thing; would you want to open up this can of worms?

A current lawsuit of the bone/spine issues exists, despite hurdles – but it is not enough!
Public Awareness issues are even more important - the lawsuit is a type of injury that thousands have likely suffered! Your help is needed! A “lonely voice in the woods” (this author) has filed a bone/spine issue(s) Vioxx lawsuit. Originally filed in NY it appears to be in the process of moving to the much more difficult “arena” than the state in which it was filed. Merck, you may believe it or not, has the ability to move many such cases (filed in the state and moved to the Federal court system which Merck seems to very, very much want)! Why is this? There may be many reasons – but one in particular seems to provide much food for thought: by clogging the Federal Court system and having a case by case strategy, the whole process drags on and contributes to a “lower average value per case” – besides getting a lot of individuals so disgusted that they just drop out. Also, consider that in general it is felt that the State Court systems in general are felt to have more leniency towards the Plaintiff. Certainly, Merck seems to really want a case in the Federal System instead of the State. There are some good reasons why the Federal System accepts these cases, often including common Discovery, case streamlining, and lower overall costs. That certainly makes sense in theory and in much practice. But I would allege that Merck is leveraging their “right” to move cases to the Federal Courts not necessarily for the charter that the Federal Court system’s common pre-trial and Discovery procedures are supposed to gain; but allegedly for clogging up the court while stubbornly adhering to it’s stance of one lawsuit at a time. There is such a concept of meeting the “spirit” of the law, and not only the “letter” of the law.

One theory that perhaps the Federal Courts will realize the issue of too many cases – and find some type of hybrid approach. I might favor one potential theory – allowing each state to have it’s own class action lawsuit! There was a recent ruling against a National Class Action lawsuit, but apparently the door was not shut on individual State Class Action lawsuits – which at this time seems the only way to get through the massive amount of litigation. Obviously, that could speed up the process and take away the implicit advantage Merck has gained via the Federal Courts common Discovery and pre-trial charter, the generalized lawsuit form an attorney can use to do cut/paste lawsuits quite easily and in large numbers and clogging up the Federal Court system. Sure, there is a reason for the current process of allowing cases to be moved to the Federal Court system – but perhaps that right should be suspended if it is determined that the defendant is utilizing it for strategic strategy rather than the charter of streamlining, etc. for which it was intended. Think about it!

I do want to say that having some knowledge of the process that spans many Federal Courts (MDL - Multi-District Litigation Process) and the involved PSC (Plaintiff Steering Committee) that some very, very good and knowledgeable individuals are working hard for the Plaintiffs and they are to be commended. The major player(s) in the Federal Court system certainly seem to be only interested in fairness – and can only be commended. I have an increasingly amount of respect for them, but they can only work with what they have! Help is needed by the PUBLIC on the bone/spine issue(s). With the amount of research I have done, it is not hard to have the view that the heart/CV cases are taking the center stage, currently crowding out the bone/spine issue, severe as it is. The Public needs to speak out to help and protect itself, legally and medically! By the way, I call this one “The Veil of Cover”(vs the “ Veil of Safety” – termed and alleged by this author as an alleged technique by Merck to broadly define Vioxx safety to stunt the healthy and so important healthy skepticism.)

There are alleged reasons why the typical attorney will not embrace a bone/spine case!
The attorneys across the country seem (obviously as you will see) to prefer the much easier and less riskier (read less $ risk and less work) than relatively ordinary (yet emotional and high profile) heart cases. In fact, a lawyer, just knowing how to cut and past, armed with a list of the names, addresses, basic alleged issues, (EVEN if not an issue that would withstand the issue of causation - i.e. the case is not strong) could EASILY file several hundred heart/Cardiovascular “cases” in less than one week. There would be relatively little time involved because of the cut and paste procedures from an EXISTING WORD PROCESSING file. With a goal of the most income with the least time and risk - which type of lawsuit would you file? – the one (bone/spine) that will cost you up to $150,000 (estimate) and have risk and much more of your valuable time consumed - or the one(s) to cut and paste from a “generic” lawsuit, add a bit of uniqueness, submit the lawsuit matter of factly – and basically sit back and wait how the heart/CV cases are going? And one shouldn’t blame these attorney’s; they are doing what people do – make the most dollar for the least work and the least risk. I don’t see their fault, just the circumstances that led up to it, some inadvertently, and perhaps some not!

Merck Business Strategy at this point? – “educated” thoughts by the author
A Veil of Safety? – a means to keep the public in the dark? Allegations against Merck include keeping the issue(s) suppressed, a reckless and neglectful development stage rushing the drug to market, not educating physicians, surgeons and the public, not providing even the simple warnings that it could have so easily done (and had a second chance when the drug was withdrawn from the market), and a massive – deceptive Marketing campaign – creating what this author terms a “veil of safety” to blunt healthy questions and skepticism and lull surgeons, physicians, and consumers asleep at the wheel…. Besides myself, perhaps at least 10,000 individuals (my estimate) easily could have been impacted. This is a big deal! These individuals did not, do not, and will not know why they did not or will not heal, and why their various damages, severe, mid-line or moderate (mine are severe) occurred unless the PUBLIC demands that this issue (bone/spine) receives fair treatment. This is not a past issue only, it’s likely going on today (current Cox-2 inhibitor) and the stage is being set for it to continue with new proposed Cox-2 inhibitor which, INCREDIBLY, seemingly just ignore the bone/spine issue(s).

Merck is (allegedly) attempting, very hard to create the lowest possible value on the average lawsuit. Suppressing the bone/spine issue(s) would certainly seem to be of great benefit of Merck, and likely will damage fair treatment for all, including the “heart” cases!

There very well may eventually be a “value” on the average lawsuit which is lower than it should be. Merck seems to be doing well with their current strategy of “one lawsuit at a time; massive “feel good about Merck” advertising, etc.). When Merck gets the value low enough, they may well decide to utilize that leverage to settle cases AT THAT TIME. Perhaps creating a process which evaluates, in a quicker pace – the causation issue; which is of course central. Unfortunately, should this happen BEFORE the bone/spine issue(s) of (allegedly) Vioxx become sufficiently known, and now, a seemingly more apparent and alleged wider scope of Fosamax issues – (and don’t forget the as yet still not studied (incredible!) issue of concurrent usage) Merck may well gain its goal of the lowest possible “average value” which it utilizes to negotiate a settlement(s)! The longer Merck can (allegedly) suppress the bone/spine and Fosamax (thoughts and allegedly) the lower that they can drive the “average value”. Since it would seem that Merck only has a limited time to successfully suppress the newer alleged issues (approximately two years unless the PUBLIC DEMANDS FAIRNESS) it would seem that Merck needs to seriously consider settlements within one year, possibly sooner. Otherwise, when finally the newer alleged issues do become well enough known, their “average value” will skyrocket.

For example, if Merck can “thread the needle of time” they could possibly move to have a “panel” of medical experts decide causation on a case by case basis, then also settle, and do so on a hard nosed basis to further keep overall costs down. However, even with a relatively low average “value”, so many attorneys across the country have had to do very little work and assume very little risk to collect their “basket” of cases. For the most part, and with some exceptions, they can wait it out, and then collect huge amounts. At the same time, Merck by getting that “average case value” low will minimize its potentially much higher liability. That would certainly seem to help explain the frenetic pace by the law field on gaining litigants for their Vioxx heart/CV “basket”.

It also would explain why some of the early cases just do not seem strong cases. Think about this. An attorney, seeking to gain a large “basket” of Vioxx cases, perhaps does not adequately consider the causation part of the lawsuit. The same attorney merely takes as much as he/she can if it even has a hint of causation, without adequately addressing causation. The very easy cut/paste of the general lawsuit progresses, and voila – a lawsuit! The attorney, for the most part, waits to see what happens. If there is a settlement, his/her “basket” increases tremendously in value; the reward becomes very substantial for what basically amounts to a relatively quick interview and easy cut and pasting of the lawsuit(s). The attorney will undoubtedly have a reasonable amount of cases that withstand the causation test, and those that don’t – well they just go by the wayside as they are weeded out by the medical expert “panel”. To further understand why the early cases involve what seem to be very weak causation realize this: the Federal court rules allow the Federal Plaintiff’s representation to pick a case, then Merck to pick a case. It would be obvious that Merck would pick the worst cases - which should never have even be submitted! However, and this is really important, remember that the risk for the average attorney is low, the cost is low, and the ease of cut/paste is high!. As Merck begins stacking up their “wins” they gain public support as the cases just seem so poor that the public begins to sympathize with Merck (remember – Merck is allowed to “pick” a case when it is their turn). Add that to the massive “feel good” about Merck advertisement that is in process (and note it didn’t exist nearly to this extent before the lawsuits!). Quite unfortunately, the process is working against itself, and it would seem that smart Merck business people, working with their legal counterparts, would easily be able to figure this out. Please remember that this author is doing his best to understand what is happening, and these are not facts, but what he calls “educated thoughts”. It is unfortunate that Merck has the ability to combine business and legal talent and is virtually unconstrained in how it does so, while the legal system would seem to have many more constraints and cannot effectively really combine the trained acumen of sharp business people and legal representation. There is a world of difference between business planning and execution (e.g. “feel good about Merck” advertisements – which even the Federal lawyers have complained about; BUT COULD NOT COUNTER ACT EFFECTIVELY!) and the understanding and application of the legal system. Aside from the moral issue(s), whose side would you want to be on – a sharp business representation and planning WITH top notch high paid legal representation, or the side of legal representation only!

It is also not hard to imagine, as Merck fans its lawyers out across the country to work with these field lawyers – that Merck may frown upon anything but the heart/CV cases, and negotiate harder to those attorneys who may bring up anything else (like a bone/spine case). Maybe the broader legal system has some thoughts on this already… Between all of it’s business acumen, buying time in general, and continuing to let the clock to tick on the all important issue of the statute of limitations for the alleged bone/spine issue(s) – Merck would be doing everything it could to lower its liability, even though a trail of unfairness and broken bones may be left behind, eventually fading like dust in the wind! It is not difficult to understand that a successful suppression of the bone/spine issue(s), and the impact that it could have on the “average value” in the heart/CV cases could be approximately $10 billion. And the more time that goes by, the harder it will be for the public to unwind the clock and gain justice. Yes, this author feels that Merck is doing just fine in executing its strategie(s).

The IR quotes above don’t even seem to gain Merck’s attention! The IR seems, amazingly, to be just ignored! At least as far as the Public Good is concerned. Perhaps in the “back rooms” there is a lot of information Merck has which it will eventually use in its defense. In fact, it seems that Merck is trying to take the ridiculous a position that the IR studies should be good enough. First, Merck (allegedly) denies and ignores them; Second – shouldn’t Merck take heed and do their own studies! Their attitude sure makes me shake my head in absolute disbelief. Ask yourself, with all of this IR, Merck, and the others ought to be doing their own research and post usage follow-up(s). I certainly am not aware of any. Even if Merck continues not to want the issue to “surface” and potentially face tens of thousands of lawsuits, it would seem to make sense that it would have to do so in order to protect itself as the IR is accelerating and at least one PhD in research indicated to me that they would expect that in two years, the issue to become well acknowledged. The time will come that Merck has a lot of explaining to do – and when that time comes, there would seem to be very worthy reasons to extend the statute of limitations, and Merck could find itself in even worse trouble than if it just owned up to the issue, and not just for Vioxx, but for Fosamax and Merck’s new proposed entry (Arcoxia).

To sum up, Merck’s strategy seems to be - buy time: heart/CV – clog the Federal court system moving the cases from the State to the Federal Courts and then prosecute one by one!; maintain the bone/spine alleged issue(s) under wraps as long as possible – should it become well known Merck would undoubtedly have its “average” case cost skyrocket, lose a great deal of the public support it is so carefully (allegedly) has crafted; and have thousands of more lawsuits on the currently (alleged) suppressed issues. – this author would allege RIGHT now that this is all happening. Yes, sounds like a good strategy - get well past the statute of limitations, get the “average value” of the heart/CV case as low as possible as mentioned, ignore the bone/spine issue as mentioned, and without government and PUBLIC interventions, magically wave goodbye to the potentially tens of thousands of people that have never had a clue, and in no way would meet the statute of limitations by the time the problem is known – which seems inevitable, just not timely (unless the Public demands fairness). Unless someone in a position to influence fairness REALLY understands Merck’s business strategy at this point, Merck will likely succeed in its strategy. This author would maintain that Merck’s strategy is currently working! – to its benefit and to the detriment (allegedly) to the many, many thousands of not only the alleged suppressed bone/spine cases, but the lower value that will be placed upon the “average heart/CV case”.

At the risk of redundancy it is worth repeating, the reasons of (allegedly) suppressing the bone/spine issue(s) become obvious – it will keep the average $ amount of the heart/CV cases as low as possible, keep the public at bay concentrating on the heart/CV cases which are publicly disclosed anyway, and perhaps sympathizing with Merck from the massive Merck “feel good” advertising and the very poor cases which are presented in court (Merck has the right to pick them also, and obviously would pick the weakest ones so the public begins to feel the issue is not justified!), and by buying time, perhaps bypass the bone/spine issue via the statute of limitations and (allegedly) keeping the public in the dark about it. Thus (allegedly) have gotten away with one of the, what I feel is one of the largest “dupes” of the Public we may very well have ever, and will ever have seen!

This author only wants fairness – just objectively and methodically peel the onion, and let the chips fall where they may!
ONLY THE PUBLIC CAN CHANGE THE SITUATION DESCRIBED AND DEMAND FAIRNESS AND JUSTICE. Even if one does not buy into all the theories provided here, and ignores the very, very significant Independent Research, everyone really has a stake in this. This type of (alleged) behavior must be punished or it will continue again and again! Let’s at least ask for a fair review of the bone/spine (alleged) issue(s); surely any reasonable person would feel that fair to all parties.

Independent Research goes back a long way in which Merck (allegedly) ignored it; it is accelerating; how long can Merck (allegedly) ignore it. My guess would be that they would be satisfied with getting by the “statute of limitations let alone the potential and probably financial strategy similar to above that would seem to be going on”. This litigant has asked for the court system to consider EXTENDING THE STATUTES. This litigant has protected his rights, but needs your help in order for you to help protect your right!

It is important to note that Independent Research which again, goes back to the very early days of Vioxx certainly have been a “clue” to Merck – yet it seems that Merck just denies it and doesn't even wish to pursue the possibility. It seems perplexing to me that Merck, a major “subject matter expert” seems to express (or feign) no interest; just incredible!

Unless this potential trainwreck is stopped, it is going to continue! The seeds are being planted right NOW!
Meanwhile, the existing drug Celebrex and some new proposed drugs (Arexia - Merck; Prexige - Novartis) are (brazingly?) attempting to get FDA approval AND they don't seem to even have researched the issue. It is incredible that this could happen, but I guess not un-expected since it is increasingly understood that the drug companies, funding the FDA, are perhaps more of a customer to the FDA than the PUBLIC itself. This seems to be a result of cost-cutting activities in the 1990’s in which government funding was cut and the drug companies were “forced” to fund the FDA. Don’t have the “FOX guard the chicken house is a well-known saying”. Think about it!

HISTORY repeats itself:
Remember, the Vioxx heartCV issues were somewhat under suspicion, but Merck’s slowness caused not only greater incremental profits, but continued to buy it time – a precious element for the drug companies in general, and one in which it would seem that Merck (allegedly) has come to well understood and execute. There was a lot of industry and physician suspicion - allegedly before Merck admitted it. The bone/spine issue(s) seem to be following a similar tract, however in this case there is NOT even reasonable suspicion of physicians, surgeons, or consumer wariness. In fact the WOW impact of the heart/CV issue(s) seem to be providing “cover” in what I would define another concept that the bone/spine issue(s) are being protected by the “Veil of Cover” naturally provided by the drama and large public numbers associated with the heart/CV cases!

Remember, the Ford Pinto! Again, history repeats itself. For some spine chilling reading, Google the Ford Pinto and understands its shocking history and one can see a lot of parallels... AND, it is only a small scale as to the possibilities today in the drug industry that seem to be cropping up. In this regard, perhaps the FDA can learn some very important lessons from the National Highway Transportation Association (NHTSA) as it developed from fledgling, industry driven regulators (similar to the FDA), to something with some teeth and respected by the Public. Perhaps some of the people who “turned around” the NHTSA could do so with the FDA. The FDA clearly needs an outsider who will address the FDA issues as a well-heeled outsider should. There are just so many things that the FDA can indeed do to make itself viable and relative.

It is so easy to get disgusted and give-up; and that is what Merck would seem to want!
In the very few cases that even pursue any legal support, individuals are most likely to just accept the very unmotivated attorneys across the country’s view that they are just not going to take a case and go up against the risk and cost of challenging Merck. I don’t really feel that too many individuals would do the research and the “pro se” lawsuit route. Worse, the public at large doesn’t even know there is an issue! Luckily, I was able to file my own, “pro se” lawsuit and protect my legal rights. If only the PUBLIC at large had been able to do so! This could still change with Public Awareness and the public demanding the obviously fair act of extending the Statute of Limitations. Remember, when Merck announced the withdrawal, NOTHING was stated about the bone/spine issue(s). Combine that with no label or otherwise warnings, and the lack of surgeon, physician and consumer education, and it certainly would seem fair to finally expose the issue to the public and extend the Statute of Limitations. Further, it would make sense, especially for the Federal Court Arena, to define a whole new class of litigants (i.e. bone/spine repair/healing). I certainly would expect the many thousands that would then likely to file lawsuit to justify even separate (than the heart/CV) common Federal Discovery.

Where will leadership on this issue finally arise?
These are the kinds of situations where one can only hope that some-one, perhaps a natural leader or some-one advocating fairness in the drug industry, or even some-one wishing to become a well-known and high profile attorney, virtually overnight, might rise to the occasion. Gee it is not like they don’t have a LOT of evidence… and a lot of potential customers!

The bottom line – Public safety needs Public Awareness!
You may have a very valid issue, may be impacted in the current or future without knowing what is going to "hit" you, or you may know some one.

Public Awareness of the allegations is only a good thing. Should the allegations and so many Independent studies and conclusions be true, Merck has much, much more explaining to do, and we must MAKE the drug companies Merck, Pfizer, Novartis study the bone/spine issue(s), and as appropriate FINALLY EDUCATE PHYSICIANS AND SURGEONS AS WELL AS CONSUMERS - AND FINALLY PROVIDE PROPER WARNINGS. I can tell you now; only a PUBLIC demand of this issue will intervene in this very, very damaging (allegation) issue.

Anyone out there, please help in anyway you can.

Thank You,

Sincerely -

Dennis Harrison
Cementon, NY
[email protected]
[email protected]

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I love every word of this, ... (Below threshold)

May 1, 2014 4:19 PM | Posted by johnnycoconut: | Reply

I love every word of this, the Alone.

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When we say "Merck," we thi... (Below threshold)

May 1, 2014 4:57 PM | Posted by johnnycoconut: | Reply

When we say "Merck," we think of it as a person whose name is "Merck." We judge it as a person--a giant person. But really, Merck is not a giant person, or even a person--it is the Merck. So if you judge the Merck (or FDA, or whatever), you should really be judging the people who make decisions for the Merck/FDA, and the people who create the cultures that facilitate these decisions. And the Merck/FDA are not the biggest people in the room; they are not even people in the room; it is the people from the Merck/FDA who are in the room. And they're not the only people in the room. And that's your point.

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