New Charges of Fraud on Heels of Abbott’s $1.5 Billion Plea Agreement
September 05, 2012
By Dr. Mercola
Only weeks after pleading guilty to criminal charges that it promoted its anti-seizure drug Depakote for uses not approved by the U.S. Food and Drug Administration (FDA), Abbott Labs is being sued again for similar charges with a different drug.
The new lawsuit alleges similar practices with Abbott's cholesterol drug, TriCor. A former employee filed the whistleblower lawsuit.
Illegal Marketing Practices Mean More Trouble for Abbott
Earlier this year, Abbott settled for $1.6 billion for aggressively promoting their seizure drug Depakote to physicians for off-label use in elderly dementia patients, despite lacking evidence of safety or effectiveness.
In most cases, a billion-dollar (or more) fraud settlement would be a death-sentence for a business, but for the drug industry, it's just another cost of doing business.
Now, just weeks later, Abbott is in the hot seat again after Amy Bergman, a former Abbott saleswoman, filed a federal lawsuit against them, alleging the company illegally promoted the drug TriCor for uses not approved by the FDA, such as reducing cardiac health risks in patients with diabetes.
The suit, which was filed under the False Claims Act in September 2009, was previously kept confidential in order to protect the whistleblower, but it was recently unsealed after federal and state governments declined to intervene.
Doctors are well within their legal rights to prescribe a drug for off-label use; it's actually a common, albeit sometimes dangerous, practice. However, drug companies may not promote them for uses other than those that are FDA-approved.
According to a report in the Chicago Tribune:1
"Bergman, who says she was an Abbott saleswoman from 1999 through 2008, alleges in the suit that she was 'trained, directed, incentivized, and encouraged' by Abbott to promote TriCor for so-called off-label and medically unnecessary uses. She also claims the company directed her to give illegal kickbacks to doctors to encourage them to prescribe the drug.
In doing so, she alleges, the company defrauded federal health programs, including Medicaid, for an eight-year period between 2000 and 2008."
Even Billion-Dollar Settlements are Not Enough to Ensure Public Safety
The idea behind Big Pharma lawsuits, especially those that settle in the hundreds of millions or billions, is that the punishment will make these criminal corporations start to straighten out, abandon their fraud and deception, their kickbacks, price-setting, bribery and all other illegal sales activities in favor of looking out for public health, which to date has been clearly ineffective.
It would appear that a far better strategy would be to file criminal charges against the responsible individuals and put them in prison. This would make them think hard and long about trying to get away with these types of illegal behaviors in the future.
In the pharmaceutical world, there seem to be few crimes that don't pay off – as long as you don't get caught (and even then, all you're bound to receive is a fine (a mere slap on the wrist) as long as you're large and important enough). So make no mistake – the leading pharmaceutical companies are also among the largest corporate criminals in the world, behaving as if they are little more than white-collar drug dealers.
Two years ago, I set out to investigate some of the criminal activities that some of the largest pharmaceutical companies had been convicted of lately, and the amount of gross misconduct, fraud and deceit I found was so insidious, so massive, and so overwhelming that it shocked even me. In all, no less than 19 drug companies made AllBusiness.com's Top 100 Corporate Criminals List! And if it seems like the number of lawsuits that Big Pharma is settling – many of them out of court without going to trial – are rising, it's because they are.
To get a picture of what's been going on, FiercePharma compiled a list of top marketing settlements that the industry has made in the past 10 years. In total, drug makers have agreed to pay more than $11 billion so far for their misdoings. But the worst may yet be ahead: more than 900 whistleblower lawsuits were filed in the last year alone. Some of the most not able in history include:2
- 2012: GlaxoSmithKline to pay $3 billion for illegal marketing of Paxil, Welbutrin and downplaying safety risks of Avandia.
- 2009: Pfizer pays $2.3 billion for marketing fraud related to Bextra, Lyrica and other drugs.
- 2012: Johnson & Johnson will pay anywhere from $1.5 to $2.2 billion for illegal marketing of Risperdal.
- 2012: Abbott Laboratories settles for $1.6 billion for aggressively promoting their seizure drug Depakote for off-label use in elderly dementia patients, despite lacking evidence of safety or effectiveness.
- 2009: Eli Lilly pays $1.4 billion for promoting Zyprexa for off-label uses, often to children and the elderly.
- 2011: Merck settles for $950 million to resolve fraudulent marketing allegations related to Vioxx.
- 2005: Serono (now Merck Serono) paid $704 million after pleading guilty to two felony charges for fraudulent marketing related to a growth hormone to treat wasting in HIV patients.
- 2007: Purdue Pharma paid $634.5 million for fraudulently misbranding Oxycontin, and suggesting it was less addictive and less abused than other painkillers.
- 2010: Allergan paid $600 million for aggressively pushing Botox for unapproved uses.
- 2010: AstraZeneca settled for $520 million for trying to persuade doctors to prescribe its psychotropic drug Seroquel for unapproved uses ranging from Alzheimer's disease and ADHD to sleeplessness and post-traumatic stress disorder (PTSD).
- 2007: Bristol-Myers Squibb paid $515 million for illegally promoting its atypical antipsychotic drug Abilify to kids and seniors.
Drug Company Fines
Drug Companies Control the System
It is a well-documented fact that the drug companies have the largest political lobbying organizations. They are some of the most clever marketers on the planet, as they know how to leverage their resources by bribing politicians to give them an unfair advantage in the marketplace, often "buying" legislation that is devastating to their competition. This is typically implemented through federal regulatory agencies like the FDA and the U.S. Centers for Disease Control and Prevention (CDC).
The pharmaceutical industry spent $1.5 billion lobbying Congress in the last decade, and in so doing has manipulated the government's involvement with the way medicine is being practiced and secondarily reinforced our dependence on pharmaceuticals, through government policies. So it should come as no surprise that the federal government has a long history of siding with, and protecting, the drug companies, such as:
- Previous drug company funding – to the tune of $2 billion – in helping drug companies bring flu vaccines to the market faster3
- Letting drug giants like Pfizer off the hook for fraudulent marketing charges so their products could continue to flow through Medicare and Medicaid
- Including incentives in the "Affordable Health Care for America Act" for people to purchase more expensive prescription drugs in favor of their less expensive over-the-counter cousins4
So there should be no doubt about the power the drug industry wields in shaping the U.S. health care system. There are simply so many revolving doors between the pharmaceutical industry and the government that it makes your head spin. Here are just a few examples:
- The American Cancer Society has close financial ties to both makers of mammography equipment and breast cancer drugs. Other conflicts of interest include ties to, and financial support from, the pesticide, petrochemical, biotech, cosmetics, and junk food industries – the very industries whose products are the primary contributors to cancer!
- The second-highest funding source for drug studies is the National Institute of Health (NIH), which is not the group of neutral government experts you may have assumed them to be. In fact, NIH accepts a great deal of money from Big Pharma and is deeply enmeshed with the industry.
- Drug companies pay seven-figure amounts into FDA coffers to gain approval of their drugs. FDA staff knows that the cash means higher salaries and more perks in the agency budget. (Incidentally, the FDA's commissioner Margaret Hamburg came straight from the boardroom of America's largest seller of dental amalgam, Henry Schein, Inc.)
- Conflicts of interest are also rampant in a mass vaccination infrastructure that has the same people who are regulating and promoting vaccines also evaluating vaccine safety.
- The vaccine industry gives millions for conferences, grants, and medical education classes sponsored by the American Academy of Pediatrics (AAP). The vaccine industry even helped build AAP's headquarters.
Who Can You Trust With Your Life?
This is the question you need to ask yourself when deciding on a plan for your own health care, as your very life is at stake and depends on the options you choose.
Unfortunately, as the ever increasing slew of pharmaceutical company lawsuits and settlements reveal, when it comes to making money, many industries throw ethics and integrity out the window. You cannot blindly trust that the companies making your medications have your best interest at heart.
There's a mountain of evidence supporting the use of drug alternatives, and there's very strong evidence that some "alternative" treatments, such as diet and exercise, are FAR more effective than any of the drugs currently in use. But if your doctor is also under the spell of drug-industry influence, you also cannot trust that he or she will inform you of them (or even be aware of their benefit).
You can review my comprehensive and newly revised Nutrition Plan, which will serve as an excellent starting point to break free of this corruption. The tools I provide on this site will help you to reduce your reliance on the broken health care system, including its overuse of drugs, and provide you with the tools and resources to take control of your health.