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Pfizer's $2 billion fine says more about Obama's health care reform than it does about drug makers

In an FBI press release today, the federal government announced that pharmaceutical giant Pfizer will pay $2.3 billion in civil and criminal fines for promoting "off label" uses of three of its big selling drugs by doctors treating patients in the Defense Department and Postal Service health plans. Even the FBI admits in its release that the "fraud" charges result not from injury or illness suffered by any of these patients, but rather from government payment of health insurance claims for "off label" prescriptions to federal employees.

This sort of cost control is just the kind of thing we can expect under President Obama's proposed federalization of our health care system. While it is legal for doctors to prescribe, and patients to take, legal drugs for purposes not included in the FDA approved labeling for the product in question, federal employee health benefits do not cover such "off label" uses of the drugs, and the federal health plans consider a claim for off label prescriptions as a fraudulent claim. Of course, the FBI did not go after federal employees to get back the billions paid out for uncovered prescriptions, it went after the drug maker instead. Why file a hundred thousand lawsuits when just one will do the same work?

Many patients across the country take prescriptions for off label conditions, including certain so called "orphan drugs" which are labeled for only one obscure use, but which have proven vital in treating other conditions. Blue Cross/Blue Shield and other private health plans will pay patient claims for such prescriptions, but the government employee health plans will not. Just as one example, patients with end stage liver disease have been treated for a long time with a drug called Rifaxamin, an antibiotic labeled for treatment of traveler's diarrhea caused by E. coli. The antibiotic is effective for this use since it stays inside the intestinal tract, instead of passing into the patient's bloodstream. Because Rifaxamin kills the intestinal bacteria which produce ammonia in the gut, it has proven effective to treat ammonia induced brain swelling in patients with end stage liver disease, but it was not until 1998 that FDA granted Rifaxamin orphan drug status for this use. Under the federal health plan's approach to drug coverage, all claims from end stage liver disease patients for buying Rifaxamin prescribed by their doctors before 1998 would have been denied, condemning the patients to perpetual confusion and loss of the ability to recognize their friends and family members, or to know what is going on around them, much like an Alzheimer's disease sufferer.

Obama says his health care plan won't interfere with your treatment if you like the doctor you have, but how can this be true when the government intends to stop the payment for "off label" drug prescriptions, even in cases where both the patient and the doctor believe the off label use is in fact helping the patient improve his or her condition?
 

Comments

  • J. Zaphraud 5 years ago

    I'm totally laughing - it's about time someone handed these crooks a bill like that. Seriously, I've seen those sleazy reps at work, back when Prozac was under patent protection, Lilly sales mouthpieces would leave copies of "studies" done that suggested that fluoxetine (Prozac) could treat all sorts of things - even back pain! All or almost all of the drug companies engage in this sort of behavior, direct marketing to the doctor, of an unapproved use - hopefully, this will send a strong message that it is time for this sort of abuse to stop.

  • cdnphysician 5 years ago

    A doctor can always prescribe drugs for off-label uses and this decision still supports that.

    It is against the law for a pharmaceutical company to promote an unproven use for their drug.

    These two aspects of this decision ensure that a physician is still able to use new and powerful medicines to treat refractory illness. Any reasonable person would agree that a pharmaceutical company is not in a position to make those clinical decisions for the physicians by recommending often very toxic or 'drugs of last resort' (re:linezolid) for unproven uses.

  • Bob 5 years ago

    These smoking bans will probably go down in history as one of the greatest marketing scams ever by drug companies using tax exempt political action committees calling themselves "charities".
    Here's the beginning of the ban movement in the USA.

    www.rwjf.org/pr/product.jsp?ia=143&id=14912

    Here are the instructions from Johnson and Johnsons' (makers of cessation products) RWJ Foundation for their tax exempt political action committees.

    www.no-smoke.org/pdf/CIA_Fundamentals.pdf

  • Chris 5 years ago

    So let me get this straight: a 4 year investigation and prosecution is actually the political posturing and unfair punishment from a president that's been in office for 8 1/2 months? It hasn't even been a tear since he was elected and somehow this is all his fault... It's as intellectually vaccant as saying that the recession is his fault too.

    Anything to bash Obama or health care reform huh?

    No, James, you are the one playing politics here!

  • Monique 5 years ago

    This is horrible journalism here. This is an article based on biased oppinion rather than fact. Its about time a Pharmacutical company be sued for something, anything really.I am not a propent for Obama's Healthcare Reform at all. I don't think the Federal Government should be given that much control over the Health of the American People. But what we have here with this lawsuit is a victory for all of us.
    Here is a little fact for you on the issue of the economy and Healthcare:
    "The results of the first-ever national random-sample survey of bankruptcy filers, conducted by researchers at Cambridge Hospital and Harvard Medical School, Harvard Law School and Ohio University, show that in 2007, 60% of all bankruptcies in the United States were driven by sickness and related medical bills. Moreover, the share of bankruptcies attributable to medical woes over the past few years has been on the upswing."
    -from naturalnews.com-

  • Mike 5 years ago

    We needed the smoking bans. Personally, as a non-smoker myself, I do not want to go anywhere and have to smell cigarettes, cigars, or whatever. If that means businesses go belly-up, oh well! That's their problem, not their customers who have chosen to pout and take their business elsewhere.

  • courtlandistan 5 years ago

    This article is garbage. Just another example of some clown trying to get the elderly worked up over a change. People hate change and fear the unknown because they are soft and lazy and stupid and addicted to medications instead of healthy lifestyles. Pfizer cheated and got busted. "Where the papers at?"

  • Dan 5 years ago

    The only difference between Pfizer and some illegal Columbian empire is that Pfizer's dealers wasted 12 years in med school.

  • employee 5 years ago

    Before people start asking for pharmaceutical companies to be fined for "some reason or another", why don't you ask yourself what would happen if they didn't exist? Do you really think that a government-run pharmaceutical firm will be able to fund and/or support the research for non-business focused drug development? Ummm... let me think about that for a millisecond, NO!!! There is a reason why we have drug companies: TO PRODUCE DRUGS TO SAVE LIVES. Yes, they get mixed up in legal limbo-bimbo, but these drug companies exist, and a LOT of them are from Europe where they HAVE government funded healthcare. So what does that say? No matter what, you'll want that anti-cancer drug when you're 45 and dying of pancreatic cancer because it's hereditary.

  • Ubiq 5 years ago

    Let me get this right; one more example of corruption in private industry should provide a basis for distrusting national health care? Puh-leeze. If the crooks running the private health care industry could step away from the trough for a few seconds, reform would be unnecessary.

  • Alex 5 years ago

    re:"Do you really think that a government-run pharmaceutical firm will be able to fund and/or support the research for non-business focused drug development? Ummm... let me think about that for a millisecond, NO!!! There is a reason why we have drug companies: TO PRODUCE DRUGS TO SAVE LIVES."
    Well, truthfully, the pure research that provides the foundation for many if not most of the major developments in beneficial drugs in the 'free market' is conducted at government funded universities and research institutions. So, yes, this bogeyman called government has not only led to major life saving breakthroughs, but when the research results are handed over to private firms they make billions from these public investments.
    Stop perpetuating the myth the government is the enemy- we the people are the government, and sometimes we do a fine job that we can be proud of. And save lives, too. And make money for the likes of Pfizer.

  • Alex 5 years ago

    re:"Do you really think that a government-run pharmaceutical firm will be able to fund and/or support the research for non-business focused drug development? Ummm... let me think about that for a millisecond, NO!!! There is a reason why we have drug companies: TO PRODUCE DRUGS TO SAVE LIVES."
    Well, truthfully, the pure research that provides the foundation for many if not most of the major developments in beneficial drugs in the 'free market' is conducted at government funded universities and research institutions. So, yes, this bogeyman called government has not only led to major life saving breakthroughs, but when the research results are handed over to private firms they make billions from these public investments.
    Stop perpetuating the myth the government is the enemy- we the people are the government, and sometimes we do a fine job that we can be proud of. And save lives, too. And make money for the likes of Pfizer.

  • Bill Atkinson 5 years ago

    More BS. There are no restrictions for off-label use in Medicare. So what is this about the government will restrict the use? Further, the major restrictions come from the insurance companies who routinely withhold drugs from cancer patients for nausea control, certain forms of chemo and kidney medications.

  • Debokor 5 years ago

    Mr. McConnell,

    Only a true believer could tie the results of an investigation that started long before Obama was in office to an indictment of his policies. If you read the details of the case it is more about the rampant promotion of off label (and unproven) use to make money. This was not about some last ditch effort to save end stage patients. It started because of decent employees shocked by the dishonest business practices of Pfizer. How dishonest of you not to even address the actual criminal and civil wrong doing of Pfizer. Is your position that off label use should not be carefully controlled. If so, then get ready to see alot of viagra prescriptions to lower blood pressure.

  • Astounded 5 years ago

    We rely on the FDA to determine which drugs are safe and to provide guidance as to what constitutes safe and effective use. We need only look at the example of Thalidomide to know that a drug can be helpful to one patient and crippling to another. An off label prescription might provide no benefit at all or worse, do great harm. In a for-profit health care market, the laws against off-label marketing are our only protection that the FDA's instructions are followed and that huge amounts of money are not wasted on selling patients drugs they don't need. It is often the medical professionals in drug companies who blow the whistle on their marketing colleagues. Once the government proves an off-label case on behalf of federal and state insurance plans, private insurance companies bring their own lawsuits. Private insurers use formularies to avoid paying for drugs that either don't provide a benefit or for which there is a cheaper alternative, so the idea is not unique to government plans.

  • Dutch 5 years ago

    The headline alone is a fraud in this article; It puts all other drug makers in the same basket as Pfizer. There are many Pharma companies who have been working dillengently over the past 5 years to clean up their act in the sales department. Some don't even alow their sales people to give the doctor a simple pen with the drugname on it. Among pharma sales people Pfizer is known to be unscrupulous and unethical when it comes to promoting their drugs. To put these companies all in the same basket is just plain wrong. As for the rest of this article? Read all the other comments.

  • Bob 5 years ago

    Hopefully, this will end the "ban frenzy" that ths crippled bingo halls, bars, and the many local activities that depend on these places for their support.

  • Stephen 5 years ago

    This legal outcome was years in the works, unprecedented in scope, and settled allegations rising from an investigation that started during the Bush Administration. So, does Barrack have a time machine, or what?

  • Cmon 4 years ago

    This company have involved in fradulent activities for the last many years n playing with the live's of innocent ppls.it must be banned for 2 years to manufacture or marketing.Inother countries,like India n pakistan,the medical society hates Pfizerians.In pakistan the plants n company must be locked for one year to teach pfizer some lessons.cuz here is hell of abuse.Here in pak the MD is a dummy guy.All de promotions are based on personal relations not de ability of guys.THE COMPANY IS KNOWN AS (DIRECTOR'S COMPANY)