OK, Last Vioxx Settlement, Honest!

Yesterday, Merck (NYSE: MRK  ) put one more chapter of the Vioxx story behind it.

The drugmaker settled its suit with 29 states and the District of Columbia for $58 million. The states' suit against Merck claimed that advertisements for Vioxx caused patients to demand prescriptions before doctors had a chance to assess its safety (but obviously after the FDA had approved the drug).

The charges sound ludicrous to me -- unfortunately, the only way for doctors to figure out whether a drug causes unwanted side effects is for patients to take the drug. But settling the lawsuit was probably better for Merck than fighting it out in court. The settlement wasn't a big surprise; Merck set aside $55 million last quarter in anticipation of it.

As part of the agreement, for the next seven years, Merck will submit all new TV commercials for its drugs to the FDA before they are aired -- something most drugmakers don't have to do. Merck also agreed not to ghostwrite any research articles.

The settlement is pocket change compared to the $4.85 billion Merck's shelling out to resolve claims by patients and their families that Vioxx caused heart attacks and strokes. It's even pretty small compared to Cephalon's (Nasdaq: CEPH  ) $425 million settlement over its sales and marketing practices, and to the $1 billion Eli Lilly (NYSE: LLY  ) could potentially pay to settle a federal investigation into its marketing practices for its schizophrenia and bipolar disorder treatment Zyprexa.

Now that Merck has most of its Vioxx issues behind it, the drugmaker can get back to more pressing issues -- like joining Schering-Plough (NYSE: SGP  ) in answering the seemingly neverending questions from Congress about why it took so long to release the results of the ENHANCE trial. Oh, and maybe it can develop some new drugs, too.

More Foolishness about the drugmaker's woes:

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool's disclosure policy keeps you out of trouble.


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  • Report this Comment On June 09, 2008, at 8:54 PM, badbonehealing wrote:

    Cox--2 inhibitors (Vioxx, Celebrex…) & Bio-phosphates such as FOSAMAX

    Mis-aligned or Mismanaged?

    Train coming!

    This is not about the well known, highly publicized tendency towards heart/CV issues which can be caused by Cox-2 inhibitors. This is about another potentially major problem simmering below the surface, apparently waiting for independent forces outside of the drug companies to free it from the bonds of neglect, deceit, fraud, and feigned ignorance! It almost seems that there is a plan to fund the defense of each issue with the fruits of the next problem! But what is unimaginable is that in the meantime, needlessly, so many people are duped into a false sense of security and were not even warned to step out of the way of the coming freight train. And all along, those that could have warned the poor souls about to be stampeded into the ground just let it happen – no shouts to move or get out of the way, just a methodical viewing as each increment of time brought ever increasing amounts of revenue and profit as the train gets closer, closer and closer…

    This is about the very likely thousands of individuals who have tragically been negatively impacted by cox-2 inhibitors, whether off or on the market. This is about spine/bone issues(s) that are more than likely happening RIGHT NOW as well as in the past (e.g. before VIOXX was taken off of the market), as well as more “misrepaired” bones and spines in the future as the newer cox-2 inhibitors try to get FDA approval. This is about understanding why the heart/CV issues seem to use all of the air in the room and bones and spines have suffered without recourse, or even being aware of what happened!

    Let’s get started; the tip of an iceberg!

    Here is an introduction to some Independent Research- and it is only the tip of an iceberg!

    …"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! Note by this author (Dennis Harrison) - Vioxx is a Cox-2 inhibitor and apparently the strongest of the group.

    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

    A deft ear?

    There are many Independent Research articles on this topic. There has been testing – analysis of the bone/spine healing process – at least one existing lawsuit which claims to have significant evidence - general drug company and R&D thoughts of similar issue(s) with the Cox-2 inhibitor predecessors (Cox-1) (which also never made it to a formal warning/education stage).

    With so many converging evidence and analysis over Cox-2 inhibitors and bone/spine repair/healing problems, it is beyond incredible that the several drug companies involved in Cox-2 inhibitors just are not working the issue! Celebrex is still is on the market, and Novartis (Prexige) and Merck (Arcoxcia) are attempting market entry - why in the world are there no real investigations going on? It would seem that the drug companies already have some explaining to do – and if as of this writing STILL are not seriously addressing this issue.

    Apparently and allegedly, even one of Merck's paid consultant's, long ago stated that the evidence was "compelling" and it is "time to tell the public"...

    Allegedly Merck has turned a deft ear to the industry warnings, its OWN paid consultant, and the increasing amount of Independent Research.

    One would assume that Phizer and Novartis must have a clue that there is a potential major issue here – so one needs to ask - where are they on all of this? What is their position? Could they possibly think that the problem will go away all by itself? Don’t they even feel that they should investigate it? Shouldn’t they, in the meantime provide the fair and proper warnings to head off a problem that just does not have to exist?

    This is about the things that should take place but are not.

    Why was the issue apparently just ignored in spite of several converging areas of concern?

    Why weren’t there any warnings about a problem that was allegedly known by the drug companies involved as far back as the year 2000 and possibly before?

    Why is the issue not being actively investigated by the drug companies involved RIGHT NOW?

    Why aren't there any warnings now?

    Why isn't there active work going on to research the problem and decide on how to move forward with proper warnings and education for physicians and consumers?

    With the other warnings provided by Cox-2 inhibitors, how could the respective drug companies possibly justify never mentioning this issue, anywhere?

    Could it be that proper warnings and education of physicians and consumers is purposely being ignored and dismissed? Could it be that even though it would not cost much for the drug companies to do it (relative to the number of sales), the drug companies are very worried that this issue would adversely impact sales. Could it be that the drug companies well know that many, many people have been very much damaged - permanently - by this problem but that they (i.e. the drug companies) have been so successful in not pursuing the issue, that they just don't care that so many people have been hurt? Why are all three of the drug companies burying their heads in the sand as the wagons are drawn around them – is there some collusion here?

    Apparently, even when an issue is so well understood proper warnings and education are trumped by short term revenue/profit and individual’s promotions and career advancements. I am ALL FOR revenue and profit. But I am also for fair warnings for gosh sake! You know, the two are not incompatible by any means! One merely needs to maintain a moderate view of longer term corporate success and stability versus short term profits, quarterly results, and advancing their careers as quickly as possible, damn the torpedoes!

    The cox-2 inhibitors, heart/CV issues aside, VIOXX could still be marketed even if the drug companies had done the right and fair things - educated physicians and consumers and provide fair warnings and labeling changes. What is necessary, relative to bone/spine problems is this relatively simple and straightforward stance: DON'T TAKE THE COX-2 INHIBITORS WHILE UNDERGOING BONE OR SPINE REPAIR AND HEALING! Take them before, take them after (about 6 weeks) - but don't take them DURING THE HEALING PROCESS!

    The issue may well come to an abrupt peak in a couple of years if ignored. Wouldn't it be much more humane to address it now - before many, many more bones and spines remain broken, poorly, or improperly healed?

    ---------

    Don't believe it?

    Do a GOOGLE (no quotes needed) on:

    "bone spine repair healing cox-2 inhibitor";

    "Vioxx bone healing";

    "Vioxx Harrison Exhibits".

    Go the extra effort and just spend a little of time reading and analyzing. It won't take much effort to understand the past, present and (unless something is done) future tragedies of broken bones and spines that never healed correctly. And just think of the disease victims, sports victims, accident victims, early nursing and medical care for those impacted, etc.

    This issue is becoming increasingly apparent Research and Development field. It is allegedly also very well known by the drug companies – Merck is on record as implying that a public dialogue has gone on! Do you know of that – did/does your physician? If it was a public “dialogue”, then why wasn’t Merck part of the dialogue? It wasn't known by consumers and physicians virtually at all for many years. Today, it is really still not understood by the vast majority of physicians - only some murky not understood thoughts here and there and Merck apparently would rather keep it that way; (allegedly) as well as other cox-2 inhibitor drug companies!

    And while you are at it think of the growing number of problems allegedly associated with bio-phosphates and drugs like FOSAMAX. Seriously, spend a bit of time understanding the bone/spine repair/healing problems then investigate bio-phosphates such as FOSAMAX. You may well just throw your bio-phosphates down the toilet when you REALLY understand how they work; and when you merely speculate on the potential issues of concurrent biophophate and Cox-2 inhibitor usage. Of course, you should discuss the situation with your physician. And while doing so, ask about the difference, and there is one, of bone density and bone strength. Did your Dr. know that bio-phosphates work by imbedding the bones with bio-phosphates – NO bone is added, and in fact, bio-phosphates work by interfering with the natural process of bone re-generation. They stop normal bone growth! It is highly debatable if in the long run they will help osteoporosis, and also osteopenia (which was defined as a “disease” by the same makers of the bio-phosphates).

    Meanwhile - bones and spines break and don't mend. Revenue and profit keeps pouring in. The poor souls with broken bones and spines suffer with no recourse as the drug companies just keep stamping the issue into the ground.

    This is a horrible, ugly shame that is going on right now!

    Dennis Harrison

    NY

    badbonehealing@hvc.rr.com

  • Report this Comment On June 09, 2008, at 8:55 PM, badbonehealing wrote:

    VIOXX victims – we gain no comfort with the arrogant anti civil right violation HAWKS, also apparently many of your attorneys, and certainly not Merck. Take some heart, and join a growing movement… there is a group of individuals in a similar situation and KNOW what you are going through. In MANY ways they are on the leading edge of knowing what the heck is going on (after much dialogue and some action - they have more than got "it" correct...).

    Whether an "opt-in" who was also "boxed-in" -or- and "opt-out" who Merck is trying to "box-out"; if you are a vIOXX Plaintiff and wish to become part of a dialogue of nearly 350 individuals and growing, WHO HAVE NOT GIVEN UP and are a bunch of decent, compassionate, human beings - all damaged by (allgedly...) Merck, in the vIOXX debacle...feel free to submit a request to join the VIOXX PLAINTIFF EDUCATION GRUOP (VPEG) - at:

    ..

    http://groups.yahoo.com/group/MerckSettlement/

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