Drug Firm Agrees to Pay One Billion Dollars in Major Scandal
A nearly decade-long civil investigation into the fraudulent marketing of Johnson & Johnson's antipsychotic drug Risperdal may soon be coming to a close, with the drug giant agreeing to pay more than $1 billion to the United States and individual states to resolve the matter.
Negotiations over a criminal plea are still ongoing, and individual states may choose to pursue their own cases rather than join in to the federal government's settlement.
This means J&J may be liable for far more money… considering the state of Texas alone is asking for more than $1 billion over Risperdal marketing.
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.
J&J Markets Drug for Unapproved Uses to Boost Profits at the Expense of Patients' Health
At the heart of the latest settlement is J&J's, and particularly their Janssen unit's, attempt to market Risperdal for bipolar disorder, dementia, mood and anxiety disorders, when it had only been approved, initially, for psychotic disorders such as schizophrenia.
Of course, only so many people have schizophrenia, so marketing the drug for the slew of conditions noted above boosted their customer base tremendously. Never mind that it wasn't approved for those conditions …
J&J's Janssen sent out an army of salespeople to doctor's offices, nursing homes, Veteran's Administration facilities, and jails to tout Risperdal as a proverbial miracle drug for mental illness and dementia. The U.S. Food and Drug Administration (FDA) told the company to stop the false and misleading marketing claims not once, not twice, but three times from 1994-2004, but the company reportedly continued to include marketing the drug for unapproved uses right in their business plan. In the years to follow, the FDA did eventually approve Risperdal for bipolar disorder and autism symptoms, but it was never approved for dementia (even though it was heavily marketed as a dementia drug).
In 2006, research showed that up to two-thirds of prescriptions for Risperdal were for unapproved uses that had little or no scientific support. Worse yet, elderly dementia patients who were prescribed Risperdal for off-label uses were found to increase their chances of death by 54 percent within the first 12 weeks of taking it!
Other research published in the Journal of the American Medical Association (JAMA) found Risperdal is no more effective than a placebo, and is associated with a long list of potentially devastating side effects.
The study included 123 veterans with PTSD who received Risperdal, and another 124 who received a placebo. After six months of treatment, about 5 percent of the participants in both groups recovered, and between 10-20 percent in each group reported minor improvement. According to the lead author, Dr. John H. Krystal, who is also the director of the clinical neurosciences division of the Department of Veterans Affairs' National Center for PTSD:
"We didn't find any suggestion that the drug treatment was having an overall benefit on their lives."
So it appears in many cases the joke is on the patient -- who takes a drug for no benefit, and is exposed to serious risks of side effects, some of which may be permanent, including:
|Somnolence and fatigue||Increased appetite and weight gain||Upper respiratory tract infection|
|Restlessness||Metabolic disorders||Muscular tics, tremors, muscle stiffness|
|Vomiting, coughing, fever||Indigestion||Urinary incontinence|
And all the while, Johnson & Johnson is laughing all the way to the bank. More serious side effects include:
- Neuroleptic Malignant Syndrome, which can be fatal
- Hormone disruption (including breasts producing milk and breast development in males)
- High blood sugar and diabetes
Drug Companies are the Top Thugs of the Medical World
Johnson & Johnson is no stranger to being slapped with billion-dollar lawsuits. You probably don't need to be reminded of all the recalls this company has had over the years with its pain products, specifically Motrin, Tylenol and Fentanyl (pain killer patches). The fact that Johnson & Johnson has paid out over $1 billion in the last few years in fines and judgments alone probably comes as no surprise either.
But did you know that in May 2011 the company pleaded guilty to illegally promoting its epilepsy drug Topamax for psychiatric purposes, and in so doing, settled a civil lawsuit in the case for $75 million? You probably didn't realize, either, that last January the U.S. Department of Justice accused Johnson & Johnson of paying tens of millions of dollars in kickbacks to Omnicare Inc to buy and recommend Johnson & Johnson drugs.
This latest scheme is the subject of a federal lawsuit that has 18 states suing not just Omnicare, but 14 other major drug companies, alleging that they ran this scheme together.
The bottom line is this: pharmaceutical companies – the same ones you trust to safely manufacture medications that could alter your very life – are the top corporate criminals on the planet, and this is not unique to only Johnson & Johnson. A large number of pharmaceutical companies are guilty of fraud, cover-ups of fatal side effects, and huge kickbacks paid to doctors.
Charges run the gamut from international price-setting, illegal marketing, false claims, hiding serious problems with their drugs and, in one case (Ortho, a subsidiary of Johnson & Johnson), obstruction of justice and eight counts of persuading employees to destroy documents in a federal investigation.
Yet toxic drugs designed, manufactured, and peddled by these top criminals are what the medical industry and government health agencies try to pass off as the "best" route to good health … despite the fact that pharmaceutical drugs, taken as prescribed, are also directly responsible for the death of at least 125,000 people annually, on top of everything else.
What Common, Illegal Drug Company Practice Earned the Most Penalties from the U.S. Government in the Last 20 Years?
Off-label drug promotion! By scouring through comprehensive databases of all major criminal and civil settlements between federal and state governments and pharmaceutical companies occurring between 1990 and 2010, the Public Citizen's Health Research Group made some sobering discoveries.
For example, they revealed the illegal practice that has earned the largest amount of financial penalties levied by the U.S. government:
"Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
… The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time."
I have also done some of my own research into the biggest wrong-doers. The chart below shows the type of criminal activity, lawsuits and fines or judgments I was able to find for six drug companies. Keep in mind that these are conservative numbers as many records are not available without a Freedom of Information Act (FOIA) request. Also, many are not readily available online unless you know exactly what you're looking for, and what year.
|Type of criminal activity||Merck & Co.||Pfizer||GSK||Baxter||Roche||Johnson & Johnson|
|Guilty of fraud and/or Illegal sales activity||7||9||11||8||4||14|
|Federal and/or Civil lawsuits||100,000 Individuals or together in class action suits||10,000+ Individuals or together in class action suits||800+||226+ Unnamed number of persons w/AIDS||5,000+ Individual and/or class action||500+ Individual and/or class action|
|Dollar Amount of fines, judgments as a result of criminal or civil litigation||$5.5 Billion+||$4 Billion+||$5 Billion+||$1.3 Billion+||$1.7 Billion+||$1 Billion+|
What We Can Learn From How Doctors Choose to Die
What is perhaps most poignant of all of this is not the fact that corporations could be engaged in so much fraud and deception – it is the fact that so many have embraced the products of these deceptions as veritable life lines.
In the face of illness, we are taught, often from a young age, that pharmaceuticals are the answer. In reality, your own body has healing potential that is, in many cases, far superior to that offered by synthetic drugs, provided it is given the proper tools to harness its healing potential. Yet, those who are at the front lines – the doctors themselves – will often choose to forgo these "solutions" because, quite simply, they've seen the cycle before. Oftentimes, drugs only serve to create more problems – new symptoms and serious, sometimes deadly, side effects with little or no measurable benefit.
In fact, in the face of death, many doctors will choose to skip drugs and medical interventions entirely, choosing, instead, to die naturally. Ken Murray, MD, a Clinical Assistant Professor of Family Medicine at USC, said it well in a recent essay:
"It's not a frequent topic of discussion, but doctors die, too. And they don't die like the rest of us. What's unusual about them is not how much treatment they get compared to most Americans, but how little. For all the time they spend fending off the deaths of others, they tend to be fairly serene when faced with death themselves. They know exactly what is going to happen, they know the choices, and they generally have access to any sort of medical care they could want. But they go gently.
… To administer medical care that makes people suffer is anguishing. Physicians are trained to gather information without revealing any of their own feelings, but in private, among fellow doctors, they'll vent. "How can anyone do that to their family members?" they'll ask. I suspect it's one reason physicians have higher rates of alcohol abuse and depression than professionals in most other fields. I know it's one reason I stopped participating in hospital care for the last 10 years of my practice.
How has it come to this—that doctors administer so much care that they wouldn't want for themselves? The simple, or not-so-simple, answer is this: patients, doctors, and the system."
The truth is, you cannot trust that the companies making your medications have your best interest at heart. Their behavior is among the most criminal on the planet! The only way to avoid all risk, including death, from prescription drugs is to not take them at all. It is your body, not your doctor's and not your pharmacist's, so it is up to you to make the decision of what drugs to take, if any. Be SURE you are aware of the risks of any medication prescribed to you, and weigh them against any possible benefit. Then you can make a well-informed decision of whether it's a risk you're willing to take.
Of course, of paramount importance is also taking control of your health so you can stay well naturally, without the use of drugs or even frequent conventional medical care. If you adhere to a healthy lifestyle, you most likely will significantly reduce your need for medications in the first place.