Amgen Agrees to Pay $762 Million in Drug Marketing Case
January 02, 2013
By Dr. Mercola
In recent years, drug companies have paid out billions in fines to settle various federal, state and civil lawsuits.
Among the charges is promoting drugs illegally for off label use, which is common, even when it puts patients lives at risk.
It's been said that imposing fines – even those that approach $1 billion or more – is simply not enough to deter this type of criminal behavior, as the drug company executives sitting at the helm are not held personally accountable (or subject to personal prosecution) and jail time.
This appears to be precisely the case, as time and time again drug companies are allowed to promote drugs for uses that could actually harm patients, or engage in other illegal, criminal activities, and they receive what amounts to a slap on the wrist as punishment.
Two drug giants, Amgen and Sanofi, are the latest to add hundreds of millions in settlement monies to the growing stash …
Amgen to Pay $762 Million in Criminal Penalties for Illegal Drug Marketing
According to one U.S. attorney, Amgen was "pursuing profits at the risk of patient safety"1 by selling and promoting the drug for unapproved uses. Prosecutors alleged that Amgen had promoted the anemia drug Aranesp to treat cancer patients not undergoing chemotherapy (the drug is only approved for those receiving chemotherapy). A later Amgen study actually showed that giving cancer patients who were not receiving chemo Aranesp increased their risk of death.
The company also was federally charged with promoting larger, but less frequent, injections of Aranesp as a way to edge out competing drugs – even though the U.S. Food and Drug Administration (FDA) had turned down Amgen's requests for this approval, citing inadequate safety studies. In fact, one study actually found giving the drug at higher doses may increase cardiovascular risks …
Drug Promoted Off-Label Despite Research Showing Increased Heart Risks
In 1998, the Normal Hematocrit Trial was published, which explored giving higher doses of drugs to dialysis patients in order to boost their red blood cell count above those generally achieved with transfusion.2 The study found that patients receiving the higher drug dose were dying or having heart attacks at a higher rate than those receiving the lower dose; the trial was actually halted because of this.
However, rather than sounding an alarm bell, when the study was published the authors downplayed the danger, calling the increased death and heart attack rate "not significant." And while no difference was found in quality of life between patients receiving the higher or lower dose, this was not noted in the published study. (Four of the study's eight authors were employed by Amgen, and two have served as consultants.)
As the years went by, health care providers and the drug companies continued to profit from the ever-rising doses of these drugs being prescribed – despite continued studies coming out questioning their safety. It wasn't until years later, in 2011, that the FDA put out a safety announcement calling for more conservative dosing of the drugs "because of data showing increased risks of cardiovascular events."3
The New York Times further reported on Amgen's charges:4
"A document summarizing the charges says that while sales representatives were not supposed to initiate discussions of off-label uses, they were trained to elicit questions from doctors. Such questions would provide the "necessary cover" for the sales representatives to provide the doctor with studies supporting the off-label use. Amgen referred to this as "reactive" marketing, the document said.
Amgen also managed to list the unapproved uses in a reference called a compendium. Medicare is required to pay for off-label uses of cancer drugs listed in an approved compendium. The compendium system is intended to make drugs more easily available to cancer patients, but critics say the compendiums do not adequately review the evidence."
To settle the charges, Amgen has agreed to pay $612 million for civil litigation, along with $136 million in criminal fines and forfeit $14 million. The company has also agreed to sign a Corporate Integrity Agreement that requires executives to certify compliance with regulations, which would theoretically make it easier to prosecute them personally for any future offense. This is, unfortunately, just the latest drug scandal to be brought to the public's attention… and it surely won't be the last.
Sanofi to Pay $109 Million to Settle U.S. Kickback Charges
You might remember drug maker Sanofi, as I recently ran articles on them describing the revolving door between federal agencies and the drug companies. The chief and major science officer from the U.S. National Institutes of Health (NIH) took jobs at Sanofi as their president and chief scientific officer. Now the company has agreed to pay $109 million to resolve allegations that it gave free drugs to physicians as a form of kickbacks, which violates the False Claims Act.
The company allegedly gave out thousands of free "samples" of the arthritis drug Hyalgan that were contingent on future purchases and essentially used to lower the drug's effective price. Sanofi then submitted false average sales price reports, which are used to determine reimbursements rates from Medicare and other government health programs, thereby causing the government to pay inflated rates for the drug.5
In this case no criminal charges were filed and, other than the paltry $109 million settlement, Sanofi only has to enter into a Corporate Integrity Agreement with the government that is supposed to leave them under enhanced scrutiny.
The Top 10 Drug Company Settlements
Big Pharma lawsuits, especially those that settle in the hundreds of millions or billions, are intended to compel these criminal corporations 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.
Most of these settlements amount to a mere slap on the wrist for the drug company, which typically will continue right along with their deceitful behaviors. This is evidenced by the stunning frequency with which these major settlements occur:6
- 2007: Bristol-Myers Squibb paid $515 million for illegally promoting its atypical antipsychotic drug Abilify to kids and seniors (despite a black box warning that warned of potentially fatal side effects in the elderly). Other accusations included giving payments, kickbacks and expensive vacations to medical professionals and pharmacist to dispense its drugs.
- 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). Using Seroquel for improper use has been linked to an increased risk of death.
Company executives also promoted the drug for weight loss, highlighting one favorable study while burying others that linked it to substantial weight gain.
- 2007: Purdue Pharma paid $634.5 million for fraudulently misbranding Oxycontin, and suggesting it was less addictive and less abused than other painkillers. The company was charged with using misleading sales tactics, minimizing risks and promoting it for uses for which it was not appropriately studied.
- 2012: Amgen, the makers of anemia drugs Aranesp and Epogen, has been accused of handing extra profits to doctors who prescribe the drugs (by overfilling vials, then allowing doctors to charge insurance companies for drugs they got for free). Other accusations include misconduct involving claims of safety and efficacy, marketing, pricing and dosing of the drugs. Amgen has agreed to pay $762 million to settle the suits.
- 2011: Merck settles for $950 million to resolve fraudulent marketing allegations and safety claims related to Vioxx. Vioxx was pulled from the market in 2004, after it was shown to double the risk of heart attack and stroke. In addition to the $950 million, Merck paid hundreds of millions more to harmed patients and their families (Vioxx contributed to causing heart attacks in up to 140,000 people, half of which were fatal).
- 2009: Eli Lilly pays $1.4 billion for promoting Zyprexa for off-label uses, often to children and the elderly, and not properly divulging side effect information. For instance, Zyprexa was marketed as a sleeping aid for the elderly because one of its side effects is sedation, even though the drug also increases the risk of death.
- 2012: Abbott Laboratories settles for $1.5 billion for aggressively promoting their seizure drug Depakote for off-label use in elderly dementia patients, despite lacking evidence of safety or effectiveness (and a known increase of serious side effects, like anorexia, in the elderly).
- Currently pending: Johnson & Johnson will pay anywhere from $1.5 to $2 billion for illegal marketing of Risperdal and other drugs. The company not only heavily marketed drugs to children and the elderly despite inadequate evidence of safety or efficacy, they also hid data about drugs' side effects.
- 2009: Pfizer pays $2.3 billion for marketing fraud related to Bextra, Lyrica and other drugs. Charges included marketing drugs to doctors for uses for which they had not been approved and giving kickbacks to doctors and other health care professionals for prescribing their drugs. This was Pfizer's fourth settlement numbering in the multimillions in less than a decade.
- 2012: GlaxoSmithKline (GSK) to pay $3 billion for illegal marketing of Paxil and Welbutrin and downplaying safety risks of Avandia, among other charges. The company hid data about drug risks, marketed drugs for unapproved uses, and paid doctors (or gave them lavish gifts like expensive vacations) for prescribing their drugs. One of the most high-profile accounts involved television celebrity Dr. Drew, who reportedly received $275,000 from GSK to promote Welbutrin to treat sexual dysfunction associated with depression even though it hasn't been proven effective for this purpose.
Are You Putting Your Health in the Hands of Criminals?
If you rely on drugs to stay well, or believe that if you get sick one day you'll simply take a medication to "get better," it's worth recognizing that the same companies that are manufacturing and promoting those drugs have probably been convicted of criminal and fraudulent charges. You might want to reconsider your decision in light of these circumstances.
Putting your health, your very life, in the hands of these drug companies is a frightening prospect because the leading pharmaceutical companies are also among the largest corporate criminals in the world, often behaving as if they are little more than white-collar drug dealers. As these companies have shown time and again, they consistently put profits above human health … and this includes your health.
Adding salt to the wound, most of the top-selling drugs treat conditions that are better treated with lifestyle changes, healthy food and other forms of natural healing!
You don't want to be their next victim. My site is chock full of free comprehensive recommendations that can serve as an excellent starting point to break free from this fatally flawed paradigm. The tools I provide will help you to reduce your reliance on the broken health care system, including its overuse of often-dangerous drugs, and provide you with the tools and resources to take control of your health.