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Thread: Lawsuit Claims Merck Overstated Mumps Vaccine Effectiveness

  1. #1
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    Lawsuit Claims Merck Overstated Mumps Vaccine Effectiveness

    Shocking!!!!:rolleyes::rolleyes::rolleyes:

    [quote=WSJ]Two former Merck & Co. Inc. (MRK) employees have sued the company in federal court alleging Merck overstated the effectiveness of a mumps vaccine for which the U.S. government paid hundreds of millions of dollars.

    Merck--which stressed that none of these allegations relate to the safety of its product--said the lawsuit is "completely without merit", and that it plans to "vigorously defend itself." The Whitehouse Station, N.J., drug maker also noted that the U.S. Department of Justice has thus far declined to participate in the case after its own two-year probe.

    Mumps is a contagious disease that causes symptoms like fever, headache and swollen salivary glands. It was a common illness for kids and young adults before childhood vaccinations became common decades ago, according to the Centers for Disease Control and Prevention, although there were outbreaks in 2006 and 2009. The agency says vaccines are the best way to prevent mumps.

    Merck introduced the first vaccine 45 years ago, and since the 1970s it's been part of a combination product that also immunizes children against rubella and measles. According to the lawsuit--filed by former Merck virologists Stephen Krahling and Joan Wlochowski--the company allegedly defrauded the U.S. for more than a decade by hiding the fact the vaccine had become less effective.

    As a result, the former employees say the government has long paid for a product that doesn't live up to Merck's claims. The lawsuit seeks a judgment against Merck equal to three times the damages suffered by the U.S., plus the maximum allowable award for the former employees under federal whistleblower laws.

    The suit was first filed in 2010 in the U.S. District Court for the Eastern District of Pennsylvania. It was unsealed Thursday after the government declined to get involved in the case.

    Merck confirmed Krahling and Wlochowski were former employees, but it said they haven't worked at the company for a decade.

    [B]"It's important to understand that none of the allegations in the complaint relate to the safety of M-M-R II"--the vaccine in question[/B]--[B]"and we remain confident that M-M-R II helps protect against measles, mumps and rubella as described in the labeling for the vaccine,"[/B] Merck said in a statement.

    "M-M-R II continues to be recommended for routine administration to children by public health authorities around the world, including the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration," the company said.

    Merck doesn't specifically break out sales for the vaccine, but the company reported combined U.S. sales of $1.1 billion last year for that product and two other childhood vaccines. Merck shares recently traded up 1.9% to $40.19 and have risen 6.6% this year.[/quote]

    [url]http://online.wsj.com/article/BT-CO-20120622-710001.html[/url]

    LOLtastic on the bolded part; doesn't decreased efficacy basically speak indirectly to the safety of the vaccine? And of course it helps protect, that isn't in question. What is in question is just how well. Cook the books, let a couple of employees complain, then ensure the DOJ doesn't pursue the matter. Business as usual for the untouchable vaccine industry. :disgust:

  2. #2
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    I see you've already decided these allegations are true.

  3. #3
    [QUOTE=JetPotato;4500222]I see you've already decided these allegations are true.[/QUOTE]

    A qui tam case filed by ex-employees, that the government wants no part of despite self-interest. Why wouldn't it be true?

  4. #4
    [QUOTE=JetPotato;4500222]I see you've already decided these allegations are true.[/QUOTE]

    Let's hear you side.

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    [QUOTE=cr726;4500390]Let's hear you side.[/QUOTE]

    Unlike some, I think I'll wait until I have sufficient information on the case before I form my own assessment.

    Feel free to assume the evil corporation is wrong here though, even though you don't know a thing about this.

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    [QUOTE=JetPotato;4500402]Unlike some, I think I'll wait until I have sufficient information on the case before I form my own assessment.

    Feel free to assume the evil corporation is wrong here though, even though you don't know a thing about this.[/QUOTE]

    They're in Jersey, he lives in Jersey, why wouldn't he know!!!

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    [QUOTE=Jungle Shift Jet;4500406]They're in Jersey, he lives in Jersey, why wouldn't he know!!![/QUOTE]

    Actually, they do most of their domestic vaccine work in PA.

    But your point remains.

  8. #8
    [QUOTE=JetPotato;4500402]Unlike some, I think I'll wait until I have sufficient information on the case before I form my own assessment.

    Feel free to assume the evil corporation is wrong here though, even though you don't know a thing about this.[/QUOTE]

    Not assuming anything here at all. You are in this field, thought you might actually have an insiders point of view.

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    [QUOTE=cr726;4500415]Not assuming anything here at all. You are in this field, thought you might actually have an insiders point of view.[/QUOTE]

    I work in the industry, know many people at Merck, but few in the vaccines department. I don't know much about this particular one, but if and when the facts of this case come out, the learning curve should be short on the science and the clinical testing, and I'd be happy to provide some insight to you all. But the OP seems pretty convinced, based only on the fact that a pair of former employees have filed a suit.

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    [QUOTE=JetPotato;4500402]Unlike some, I think I'll wait until I have sufficient information on the case before I form my own assessment.

    Feel free to assume the evil corporation is wrong here though, even though you don't know a thing about this.[/QUOTE]

    The only information you are likely to get from the unsealing of the suit is that of the whistleblowers. So, given what we already know about their decision to come forward, yes, I'm inclined to believe that what they reported is the truth.

    Merck stood (stands) to lose quite a bit (market share, aka profits) had the allegations been proven true. They have little to fear from any kind of civil litigation as their product is 100% exempt from liability with regard to injury, lack of effectiveness, design defects or any other thing under the sun. This is about protecting the bottom line. Anything about the interest of public health is ancillary to that.

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    [QUOTE=Jetworks;4500430]The only information you are likely to get from the unsealing of the suit is that of the whistleblowers. [/QUOTE]

    Interesting. So you figure Merck presented no evidence of its own to defend themselves? You figure that there aren't extensive records of research, development, clinical trails and an FDA filing. Care to explain?

    [QUOTE=Jetworks;4500430]
    So, given what we already know about their decision to come forward, [/QUOTE]

    Which is what again? I see we know these two guys' names, the fact that they are former Merck employees, and we know that they stand to make a 10% whistleblowers fee in any money recouped for the government. What else?

    [QUOTE=Jetworks;4500430]
    yes, I'm inclined to believe that what they reported is the truth. [/QUOTE]

    I see. So you're willing to assume, based on no facts of either sides of the case, based on a gut feeling? Do you think that there's any possibility that you're just a little biased against a company that you misguidedly believe is "untouchable"? Ask Merck how untouchable they were in their dealing with the FDA over Vioxx. Or their merged partner's $500 million consent degree from the agency.

    [QUOTE=Jetworks;4500430]
    Merck stood (stands) to lose quite a bit (market share, aka profits) had the allegations been proven true. They have little to fear from any kind of civil litigation as their product is 100% exempt from liability with regard to injury, lack of effectiveness, design defects or any other thing under the sun. This is about protecting the bottom line. Anything about the interest of public health is ancillary to that.[/QUOTE]

    And what, above all else, guides a pharmaceutical company's bottom line? Hint: it's the trust of doctors and patients who buy their products. Not just their one vaccine, but their entire portfolio. Which is why these companies go to great lengths, investment and sacrifice years of patent exclusivity to get same and effective drugs to their patients. Because as soon as you lose public trust, you are doomed.

    Sorry bud, I understand why you're jaded. But until we know the facts, no conclusion can be made.

  12. #12
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    PS, I'm not going to pretend that Merck (or any other) is the sainthood, by any means, but they certainly aren't the Satan you try to portray them to be either. Here's something I bet you definitely didn't know.

    This is a quote by the founder of the company, that is prominently displayed in buildings throughout the company, and is drilled into the minds of employees on a frequent basis, as it is one of the tenants of the company's business model (I did work there for years) :

    [B][I][I]"We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been." [/I][/I]

    — George W(ilhelm) Merck
    Address to the Medical College of Virginia, Richmond (1 Dec 1950). Quoted in James C. Collins and Jerry I. Porras, Built to Last (1994, 1997), 48.
    [/B]

    Believe it or not, some of us that work in this industry don't take home fat CEO-sized bonus checks, and we take a LOT of pride in knowing that the work we do every day is designed to help people and their health.

  13. #13
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    Guys dealing on the corner have better standards than drug companies. Lolz....


    Sent from my Double-Wide using Semaphore...

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    [QUOTE=PlumberKhan;4500600]Guys dealing on the corner have better standards than drug companies. Lolz....


    Sent from my Double-Wide using Semaphore...[/QUOTE]

    You oughta know! You pay those corner guys in cash on the barrel in a sense of fairness they give you at least a little narcotic to go with the talcum powder corn starch and elephant tranquilizer.

    Big Pharma doesn't really care about the people who head straight for the ER and leave without so much as an IOU...;)

  15. #15
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    [QUOTE=PlumberKhan;4500600]Guys dealing on the corner have better standards than drug companies. Lolz....


    Sent from my Double-Wide using Semaphore...[/QUOTE]

    Really? I didn't realize street dealers were subject to FDA scrutiny. I had no idea weed pushers average 7-10 years of testing and development before market on a 20 year patent. I didn't realize your local meth dealer tested his product in a controlled fashion on 15,000 patients, proving efficacy and safety, then submitting to the government for approval before they can sell a single one.

    :rolleyes: Continue to live uninformed.

  16. #16
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    [QUOTE=JetPotato;4500572]Interesting. So you figure Merck presented no evidence of its own to defend themselves? You figure that there aren't extensive records of research, development, clinical trails and an FDA filing. Care to explain?[/QUOTE]

    At the root of the complaint is the hiding, forging and outright destruction of data and documentation. You'll forgive me if I don't want to give the accused the benefit of the doubt in such a case. I have an open mind, but not so open so as to allow my brain to fall out.

    [QUOTE=JetPotato;4500572]Which is what again? I see we know these two guys' names, the fact that they are former Merck employees, and we know that they stand to make a 10% whistleblowers fee in any money recouped for the government. What else?[/QUOTE]

    Fair enough. But you have to admit, that's some slim motivation to try and work on.

    [QUOTE=JetPotato;4500572]I see. So you're willing to assume, based on no facts of either sides of the case, based on a gut feeling? Do you think that there's any possibility that you're just a little biased against a company that you misguidedly believe is "untouchable"? Ask Merck how untouchable they were in their dealing with the FDA over Vioxx. Or their merged partner's $500 million consent degree from the agency.[/QUOTE]

    Interesting that you referenced Vioxx. Was that not the same slant I am leaning towards, fudged efficacy/safety records that were somehow "missed" by the agency tasked with catching things like that? Consent decrees are a joke, trust me I've seen them in practice for 20+ years.

    [QUOTE=JetPotato;4500572]And what, above all else, guides a pharmaceutical company's bottom line? Hint: it's the trust of doctors and patients who buy their products. Not just their one vaccine, but their entire portfolio. Which is why these companies go to great lengths, investment and sacrifice years of patent exclusivity to get same and effective drugs to their patients. Because as soon as you lose public trust, you are doomed. [/QUOTE]

    That may be the case now, but up until about 10 years ago, before the pharma code was revamped a few times, what sold the products was graft of the doctors and hospital administrators. And what you say may be somewhat true for the drug end of the company, but vaccines are an entire different animal. Their product is mandated by the government, the same entity tasked with overseeing their safe distribution and efficacy. Additionally, their product is completely exempt from the one thing that consumers could use to keep them honest, litigation. I'd say all of that is a huge advantage to have for a business model. So, I would have to say that your argument is mostly invalid for the product under scrutiny, vaccines.

    [QUOTE=JetPotato;4500572]Sorry bud, I understand why you're jaded. But until we know the facts, no conclusion can be made.[/QUOTE]

    I can proffer an opinion, which is what I am doing. Jadedness has nothing to do with it, I just know a lot more about this than the average person.

    [QUOTE=JetPotato;4500594]PS, I'm not going to pretend that Merck (or any other) is the sainthood, by any means, but they certainly aren't the Satan you try to portray them to be either. Here's something I bet you definitely didn't know.

    This is a quote by the founder of the company, that is prominently displayed in buildings throughout the company, and is drilled into the minds of employees on a frequent basis, as it is one of the tenants of the company's business model (I did work there for years) :

    [B][I][I]"We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been." [/I][/I]

    — George W(ilhelm) Merck
    Address to the Medical College of Virginia, Richmond (1 Dec 1950). Quoted in James C. Collins and Jerry I. Porras, Built to Last (1994, 1997), 48.
    [/B]

    Believe it or not, some of us that work in this industry don't take home fat CEO-sized bonus checks, and we take a LOT of pride in knowing that the work we do every day is designed to help people and their health.[/QUOTE]


    I don't doubt that there are quite a few people who toil away long hours for not nearly enough money that they deserve working for these companies. I believe the two virologists may be just that. I also believe that any company, ANY INDUSTRY, that would allow the government to eliminate their responsibility to their consumer because they were being sued out of existence for putting out a crappy product is in fact interested in profits, not the public health. So you'll forgive me if I don't get all warm and fuzzy behind that quote you provided.

    Regardless of anyone's stance on this case, it should give you pause about the direction this industry is going in. Thanks for keeping it civil, JP. Too often these things get out of control.

  17. #17
    [QUOTE=PlumberKhan;4500600]Guys dealing on the corner have better standards than drug companies. Lolz....


    Sent from my Double-Wide using Semaphore...[/QUOTE]

    Thank you for your great contributions to this forum. :rolleyes:

  18. #18
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    [QUOTE=Jetworks;4500659]
    Fair enough. But you have to admit, that's some slim motivation to try and work on.[/QUOTE]

    Really? We're talking millions and millions of dollars. They've been known to be pretty motivating. And do we know the terms of these two former employees departure?

    [QUOTE=Jetworks;4500659]
    Interesting that you referenced Vioxx. Was that not the same slant I am leaning towards, fudged efficacy/safety records that were somehow "missed" by the agency tasked with catching things like that? [/QUOTE]

    Yes, mistakes were made with Vioxx. Big mistakes. And as tragic as those mistakes' results were, equally as tragic is that doctors no longer have access to what was a life-changing (saving) drugs for many. It obviously provided much risk, but also far more reward. I encourage you to speak to cardiologists who prescribed this drug. You'll be hard pressed to find one that doesn't regret it being gone. I've known some to go so far as to call it a "miracle". The reality is the agency should probably allow more of these high risk drugs, provided doctors and patients understand them. The benefits would be enormous to public health overall.

    [QUOTE=Jetworks;4500659]
    Consent decrees are a joke, trust me I've seen them in practice for 20+ years. [/QUOTE]

    Again, I encourage you to speak to any long-time employee of Schering Plough and ask them how the consent decree affected their every day jobs and the fundamental structure of their business.

    [QUOTE=Jetworks;4500659]
    That may be the case now, but up until about 10 years ago, before the pharma code was revamped a few times, what sold the products was graft of the doctors and hospital administrators. And what you say may be somewhat true for the drug end of the company, but vaccines are an entire different animal. Their product is mandated by the government, the same entity tasked with overseeing their safe distribution and efficacy. Additionally, their product is completely exempt from the one thing that consumers could use to keep them honest, litigation. I'd say all of that is a huge advantage to have for a business model. So, I would have to say that your argument is mostly invalid for the product under scrutiny, vaccines.[/QUOTE]

    No, you must have missed the point. The small portion of their business that produces relatively small revenue, is their biggest risk. Litigation is not and never will be as impactful on a single vaccine or drug as the loss of public trust over your entire portfolio. Sales drive these companies and if you can't prove to your patients that one product is safe, they aren't going to buy any of them.

    [QUOTE=Jetworks;4500659]
    I don't doubt that there are quite a few people who toil away long hours for not nearly enough money that they deserve working for these companies. I believe the two virologists may be just that. I also believe that any company, ANY INDUSTRY, that would allow the government to eliminate their responsibility to their consumer because they were being sued out of existence for putting out a crappy product is in fact interested in profits, not the public health. So you'll forgive me if I don't get all warm and fuzzy behind that quote you provided.[/QUOTE]

    Again, how is pharma different than any other industry. Of course they exist for profits. All companies do. But guess what the happy byproduct of profits of a pharma are? Health. The safer and healthier your patients are, the more money you make. It's pretty simple.

    [QUOTE=Jetworks;4500659]
    Regardless of anyone's stance on this case, it should give you pause about the direction this industry is going in. Thanks for keeping it civil, JP. Too often these things get out of control.[/QUOTE]

    Thanks to you too.

  19. #19
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    Merck's MMR and MMRV have not been "proven" to be "crappy"-their competitors products were (they caused aseptic meningitis and other serious health issues)
    Furthermore, they never contained Thimoseral.

    Between compliance laws and various consent decrees - CIAs are binding and last for years - pharma firms do not operate without scrutiny or penalty. Novartis paid a $185M fine and total $422M penalty because some of their gravy sucking pigs aka sales reps got caught promoting Trileptal off-label. Their drugs are efficacious but don't lack risks. The tradeoff is longer/better life.

    Furthermore sh1tty rap artists and filmakers get to own their product for decades yet pharma who make a much larger investment and risk in developing drugs often have to give up their interest in same in a much shorter window to knockoff firms like Teva. Good for patients (we can only hope the quality control is there) but not really fair to them.
    Last edited by Jungle Shift Jet; 06-25-2012 at 08:56 PM.

  20. #20
    [QUOTE=Jetworks;4500430]The only information you are likely to get from the unsealing of the suit is that of the whistleblowers.[B] So, given what we already know about their decision to come forward,[/B] yes, I'm inclined to believe that what they reported is the truth. [/QUOTE]

    What we know is that they had already been fired or left and filed a suit that gives them 25% of whatever they can prove the government is entitled to recover. That doesn't scream "credible" to me

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