Drug Makers Pay Billions in Fines — and Continue Business as Usual : Exclusive Renegade Health Article

Monday Jun 4 | BY |
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Even after paying billions in fines, pharmaceutical companies continue to illegally market their drugs.

On May 7, 2012, CNN News reported on the latest in a long list of companies fined for trying to mislead the public.

This time it was Abbott Laboratories, who makes the anti-seizure medication Depakote. This drug has come under fire in courts around the country for allegedly causing birth defects in women taking it during pregnancy. Four studies appearing in reputable journals have supported the women’s claims, and the FDA has warned about them twice.

Now Abbot has agreed to pay $1.6 billion for misbranding the drug, promoting its use to control agitation and agression in patients with elderly dementia when these uses were not approved by the FDA. Part of that fine—$700 million—is a criminal fine, and the rest goes to civil settlements with states and the federal government.

“This is an elder abuse case,” said U.S. Attorney Timothy Heaphy of the Western District of Virginia.

And it’s not the first of it’s kind.

Abbott Markets the Drugs to Nursing Homes
It’s not uncommon for doctors to prescribe certain drugs for so-called “off-label” use. The FDA may approve a drug for the treatment of depression, for instance, but a doctor may prescribe it for treating anxiety in some patients, if he thinks it may help to do so. A company, however, is not supposed to advertise or promote drugs for uses not approved by the FDA, as there are typically few if any scientific studies supporting the drug’s efficacy for those uses. But that’s exactly what Abbott did.

In fact, they went so far as to market Depakote directly to nursing homes for the control of agitation and aggression in elderly dementia patients—despite any scientific evidence that the drug was effective for that use. The FDA had approved it only for epileptic seizures, bipolar mania and the prevention of migraines.

It gets worse. As far back as 1999, Abbott stopped a study examining the use of Depakote in the treatment of dementia because of adverse events like drowsiness, dehydration, and anorexia. Of course, the company didn’t bother to alert physicians and users to these side effects.

Abbott Promotes Depakote for Schizophrenia, Hiding Study Results
The story goes even further. Abbott admitted to marketing Depakote for the treatment of schizophrenia, even though their own studies failed to show a statistically significant difference between antipsychotic drugs used in combination with Depakote, and antipsychotic drugs used alone. In other words, Abbott’s drug wasn’t really helping schizophrenic patients, but they promoted it for that use anyway, and for two years failed to notify even their own sales force about the study results. They waited another two years to publish those results.

Abbott’s Actions Not Unusual
It would be one thing if this was an unusual story, but it’s not. Those in the industry know that the risks of punishment for off-label marketing are often worth the profits achieved.

A report in the British Medical Journal, for example, notes that illegal marketing activities by drug companies has risen over the past five years, moving ahead of the defence industry and all other industry sectors in the amount of civil penalties for faud under the False Claims Act against the federal government.

Here are a few examples of recent cases:

  • Pfizer, maker of such products as Lipitor (cholesterol-lowering), Viagra, and Zithromax (antibiotic), paid $2.3 billion in 2009 to settle civil and criminal allegations that it had illegally marketed the painkiller Bextra. This after the company paid $430 million fine in 2004 for illegally marketing Neurontin, an epilepsy drug. According to a New York Times article, Pfizer sales representative John Kopchinski said the company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra. “The whole culture of Pfizer is driven by sales,” Kopchinski said, “and if you didn’t sell drugs illegally, you were not seen as a team player.”
  • Eli Lilly, maker of such products as Prozac (antidepressant), Cymbalta (antidepressant), and many more, settled civil and criminal charges earlier in 2009 for $1.4 billion for illegally promoting off-label uses for Zyprexa, their antipsychotic drug. Zyprexa was originally approved for treating psychotic disorders and acute manic episodes associated with Bipolar disorder, and later for the short-term treatment of schizophrenia. Eli Lilly promoted it for the treatment of dementia and Alzheimer’s dementia in the elderly. (Sound familiar?)
  • GlaxoSmithKline, maker of such products as Advair (asthma), Boniva (bone loss), Paxil (antidepressant), and more, announced in November 2011 that it had reached an agreement in principle to pay $3 billion to resolve multiple government investigations into is sales and marketing practices, including those used in the development and marketing of Avandia, it’s diabetes drug.
  • Johnson & Johnson, makers of such products as the DePuy ASR hip implant systme, which was recalled in 2010, is in negotiations with the government to pay more than $1 billion to settle civil charges for the off-label marketing of Risperdal (schizophrenia) and Invega (shizophrenia), and for claiming that Risperdal was safer than other antipsychotics. A report in Pharma Times, however, noted that the Department of Justice has yet to approve the deal, and is seeking a settlement closer to $1.4 billion.

Companies Likely to Continue Business as Usual
According to the article in Forbes, these fines are no more than business as usual to most of these companies. Meanwhile, many continue to engage in practices they’ve been fined for:

  • Illegally promoting drugs for off-label, unapproved uses that may put patients at unnecessary risk
  • Presenting financial inducements to doctors and pharmacists to get them to prescribe or sell certain prescription drugs
  • Using incomplete or sometimes even phony science to gain the FDA’s approval of a drug
  • Withholding study results that demonstrate risk for years while continuing to rake in the profits

What is it going to take to create changes? So far, it’s unclear. In addition to fines, some of these settlements include a “corporate integrity agreement” which involves yearly audits to be sure the company continues to comply with the law. How well these agreements are enforced is questionable, however. Gregory Demske, assistant inspector general for legal affairs for Health and Human Services, notes that the corporate integrity agreement is not sufficient to detect further misconduct.

Some of our elected officials in government have introduced bills to make changes, but pharmaceutical companies have a huge lobbying presence, having spent more than $200 million in 2011 lobbying against these types of bills.

Meanwhile, our health is more and more up to us. Do everything you can to prevent disease, and if you are looking at a prescription, do your research. The best drugs are those that have been on the market long enough to work out all the kinks. “New” drugs less than ten years old are often still going through postmarketing tests that show additional side effects that may not be revealed until after you start taking it.

What do you think should be done about big pharma’s “business as usual?”

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Photo courtesy Hellebardius via Flickr.com.

Sources
Terry Frieden, “Abbot Laboratories to Pay $1.6 Billion Over Misbranding Drug,” CNN Justice, May 7, 2012, http://www.cnn.com/2012/05/07/justice/abbott-fine-drug/index.html?hpt=hp_t3.

Janice Hopkins Tanne, “U.S. Drug companies Paid $15bn Fines for Criminal and Civial Violations Over the Past Five Years,” BMJ, December 21, 2010, http://www.bmj.com/content/341/bmj.c7360.extract.

Erika Kelton, “More Drug Companies to Pay Billions for Fraud, Join the ‘Dishonor Roll’ After Abbott Settlement,” Forbes, May 10, 2012, http://www.forbes.com/sites/erikakelton/2012/05/10/more-pharma-companies-to-join-the-dishonor-roll-pay-billions-for-fraud-following-abbotts-settlement/.

Gardiner Harris, “Pfizer Pays $2.3 Billion to Settle Marketing Case,” The New York Times, September 2, 2009, http://www.nytimes.com/2009/09/03/business/03health.html.

Kevin Grogan, “U.S. DoJ Rejects J&J’s $1 Billion Risperdal Settlement—WSJ,” World News, March 12, 2012, http://www.pharmatimes.com/article/12-03-12/US_DoJ_rejects_J_J_s_1_billion_Risperdal_settlement_-_WSJ.aspx.

Kelly Kennedy, “Drugmakers Have Paid $8 Billion in Fraud Fines,” USA Today, March 6, 2012, http://www.usatoday.com/news/washington/story/2012-03-05/health-drugmakers-fraud-fines/53372792/1.

“Big Pharma Behaving Badly: A Timeline of Settlements,” Fierce Pharma, October 5, 2010, http://www.fiercepharma.com/special-reports/big-pharma-behaving-badly-timeline-settlements.

Kevin Gianni

Kevin Gianni is a health author, activist and blogger. He started seriously researching personal and preventative natural health therapies in 2002 when he was struck with the reality that cancer ran deep in his family and if he didn’t change the way he was living — he might go down that same path. Since then, he’s written and edited 6 books on the subject of natural health, diet and fitness. During this time, he’s constantly been humbled by what experts claim they know and what actually is true. This has led him to experiment with many diets and protocols — including vegan, raw food, fasting, medical treatments and more — to find out what is myth and what really works in the real world.

Kevin has also traveled around the world searching for the best protocols, foods, medicines and clinics around and bringing them to the readers of his blog RenegadeHealth.com — which is one of the most widely read natural health blogs in the world with hundreds of thousands of visitors a month from over 150 countries around the world.

15 COMMENTS ON THIS POST

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  1. RACHEL says:

    This article really reminds me that we have to be our own health advocates. It is sad we live in an age when we cannot trust our doctors to heal our bodies or our minds.

  2. Debbie says:

    I think they should also face jail time or be shut down especially for multiple offenses. They are a bunch of serial killers, really, it is premeditated, they know exactly what they are doing, and they are doing it for one reason only, profit. Money is nothing to them they are the richest or one of the richest (oil) industries in the world. When one billion dollars is no big deal, it is not a punishment to get a fine anymore and better methods must be used to stop them. They are knowingly commiting crimes and getting away with it all the time. They constantly promote off label usage of a good portion of their drugs. I know, I worked in Marketing for one of the big pharma companies for 11 years. They have meetings to discuss how to cover their rear ends when they get caught promoting off-label.

  3. Lori says:

    Thank you for bringing these facts and stats to light.
    I think Debbie makes some really strong, valid points.

  4. R F says:

    Great article, Kev. My Dear Mom was horribly murdered by big pharma drugs and her best friend’s husband also suffered a horrendous death as a direct result of big pharma drugs. I’m pretty sure that most if not all of the few remaining members of my immediate family are on at least one big pharma drug either for “treatment” or “preventatively”. I wonder how these companies can remain profitable while paying such big fines. I suppose the fines are used as corporate tax write-offs. I also wonder who actually ends up with the proceeds of the portion of the fines that are not used to pay civil settlements. It feels like big pharma is a primary structure of the “powers that were” (and are on the way out) and that at this time although politicians and legislators may be able to help us here and there, that they will also need our help to protect us all from this scourge. We need to keep ourselves as clean as possible with regard to drug use, and in any situation where alternatives haven’t helped or we are for any reason considering pharma drug use, as you mentioned, Kev, we must do our own serious research and/or employ the advice of a well qualified holistic practitioner who has experience and knowledge in the area of pharma drugs. Thank you for the article, Kev.

  5. Lance says:

    I think it’s like you said, more and more our health is up to us. A great way to put these companies out of business is for people top needing them. Unfortunately, I don’t think more people are willing to educate themselves about the problems with these companies… and unfortunately those same people are probably the ones not willing to educate themselves about taking control of their health. But it seems like more and more people are ‘waking’ up. I hope that trend continues!

  6. Jean says:

    No doubt serious jail time for intentional offenders,
    I am a Nurse and have a Natural Health and Wellbeing business. I promote isotonic (highly absorbable) supplements (www.nutrametrix.com/nhwn) to help people stay well and a nutritional weight loss program ( low glycemic) to do the same. We all have a choice to prevent many health issues. I also provide a gene analysis which is really beneficial tool. I am all about prevention and you need to know what you are taking! Ask questions, research yourself. As a public we have expected a pill for every ill but now we are waking up. It is lifestyle and nutrition that will have the greatest impact on all chronic diseases.

  7. Thomas says:

    I don’t expect the government to change its attitude at all as long as the corruption of lobbying exists.

    I remember the FDA allowing for the Dalkon shield (http://en.wikipedia.org/wiki/Dalkon_Shield) and thalidomide (http://en.wikipedia.org/wiki/Thalidomide), plus numerous other dangerous products.

    The fines are small compared to the profits, and the government collects a little revenue this way.

    Remember, this is a government that calls mass civilian murders “collateral damage”. It has no heart. 🙂

  8. Roberta says:

    Unfortunately, money talks so we will likely never be able to beat the drug companies nor the FDA, and doctors continue to prescibe what they are taught from the supposedly valid studies provided to them which are mostly funded by pharma. It also shows that any drugs developed in the last 15 years really should be questioned and avoided when possible. I am fortunate to have an educational background starting in biochemistry, but not everyone can understand or interpret biochemisty. You can do your part by learning what you can, and getting 2nd or even 3rd opinions. My vote is to get those opinions from valid NDs or MDh docs that started as MDs. Then you get someone who really knows both ends and what works and what doesn’t and potential consequences. Did you know that US is the only country in the world that allows pharmaceutical advertising to consumers, what does that say? Good healthcare starts with selfcare. Get as educated as you can and validate your sources and information as much as possible to make sure it is valid information.

  9. Faye says:

    As a Canadian living in China, reading these articles and watching some of the documentaries available online in regard to healthcare in America; all this information really angers me!
    I recently watched a documentary about Dr. Burzynski and his fight to treat cancer patients in America. Then reading this article, it really makes me wonder how people in North America can be so “concerned” about peoples rights in China. Sure we have corruption here in China, but it’s nothing like the corruption that many of discussed in the above messages.
    I agree, we really need to self care as many have mentioned and be willing to share as much with people who are open or in need of hearing.
    We, in North America, need to take back our health for the sake of the next generation!
    Sorry for the rant, but I feel quite passionate about this topic. 😉

  10. Heather says:

    The first thing needed is to remove ‘person’ status for all businesses, regardless of their ethical or non ethical practices.

    This will pave the way to making it possible to penalise their boards for these decisions that place customers at risk.

    Perhaps once this is done the board will feel more than just accountable to shareholders – knowing that if they are found to have played loose with the truth they will PERSONALLY face losses. At the moment only the company is fined, and as long as the income flow continues and the directors and shareholders accrue their benefits it is not really a financial risk situation – the penalties never really cut into profitability at all – in fact it is likely that if you view the financial statements provision for fines and penalties is built in.

  11. sue says:

    You certainly presented quite a lot of information here, Kevin. Thanks! I personally took Bextra (thought it was the best NSAID I ever had) and got a check for $500 in the 2009 settlement. HOWEVER! one thing not mentioned are the horrors forced on us by the drug companies who have WON these cases and never had to pay a penny even though people died or suffered violence from spouses and relatives who took extremely dangerous drugs: like Prozac, like Halcyon which caused documented violence in patients who took them. Also, I believe Pfizer (?) won their case for Vioxx which led to deaths from serious heart problems. Off label uses are common and sometimes people do get healed from those types of uses. The lawyers get most of the money (notice the $500 I got in the $2.3 BILLION Bextra settlement. One big case was an I.U.D. for women which led to one of my close friends having to have a hysterectomy too early. Happily she got $10,000 and went on a long Caribbean cruise 🙂

  12. susan says:

    I have a friend who was in perfect health and when she hit 60 her regular check up doctor said oh your cholesterol is a little high you need to be on statins for the rest of her life. She swelled up and itched all over, they gave her a lesser dose, same thing happened. Since i’m not a doctor no one listens to me but i told her get off the statins and stop eating dairy. she was desperate so she started eating celery by the carload and the next doctor visit her cholesterol was down and she never took them again. The same thing happened to my neighbor and i told him its those darn statins. he felt better when he stopped, he is on a myriad of drugs for OCPD and i diplomatically told him but your 100 pounds overweight, just maybe if you lost some weight you could breath easier. I think for some things a pill is the lazy way out, instead of people having to work at their food choices and exercise. I’ve never been to China but it seems they might exercise alot more than we do and eat more vege’s and herbs. maybe this pill company thing is just another symptom of a gluttonous society mainstream america has become and weakened by this makes us ripe for parasites like drug companies. Why people blindly believe doctors word to be god i’ll never know

  13. Derek says:

    There are many things that can be done to stop the nonsense from the drug companies, but I certainly wont claim to have “the answer.”

    I do believe that one great thing would be people taking personal responsibility for their health and educating themselves. Fortunately, more and more people are waking up to how ineffective most drugs are at actually fixing their problems and usually result in things becoming far worse.

    That’s why it’s great that people like Kevin are putting this information out there. Sure, not everyone will want to hear it, but as more people take note, the more it spreads. Even just 10 years ago a lot of stuff that might be considered “radical” like how dangerous some drugs are have much more mainstream acceptance.

    Is that enough to stop the insidious tactics used by some drug companies? Probably not, but it’s a critically important part of the solution.

  14. Cardencopy says:

    Thanks so much for compiling this info and bringing it to our attention. I’ll bookmark it for friends who insist, ‘I’m just trusting my doctor.’ I keep a binder full of stories like these to refer back to when having discussions with the uninformed.

  15. Cardencopy says:

    I just discussed this with my husband, who has worked for years in the homebuilding industry. He said the same dynamic happens in all the big companies. For instance, heating and air guys work on quotas and will actually *create* problems with a unit in order to “repair” it and bill for it. Knowing this, he chose as often as possible to work with independent service people and small companies. I guess that’s the best we can do in all areas, just circumvent the big, impersonal, uncaring corporations as much as we can. We may have to buy less, and be willing to pay more, to support local economies.

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