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Major Drug Company to Pay at Least $1.5 Billion Over Fraudulent Risperdal Marketing

Story at-a-glance -

  • Johnson & Johnson’s illegal marketing of the drug Risperdal for unapproved uses is set to cost them at least $1.5 billion in a settlement with the U.S. Justice Department, and sources say the final amount could end up exceeding $2 billion
  • Risperdal was heavily promoted for unproven off-label uses for more than a decade, even after the U.S. Food and Drug Administration (FDA) issued warnings against the misleading claims
  • Another drug company is also in the hot seat, as advocacy groups have asked the Federal Trade Commission (FTC) to investigate Merck’s marketing campaign for the over-the counter allergy drug Grape-Flavored Children’s Claritin, which uses characters from the animated movie Madagascar 3
  • When it comes to making money, many industries throw ethics and integrity out the window, so keep your eyes wide open when making choices about medications, and even foods, for yourself and your family
 

Major Drug Company to Pay at Least $1.5 Billion Over Fraudulent Risperdal Marketing

July 04, 2012 | 41,204 views

By Dr. Mercola

Earlier this year, Johnson & Johnson (J&J) agreed to pay more than $1 billion in a civil settlement involving fraudulent marketing of their antipsychotic drug Risperdal – but federal prosecutors decided to hold out for more.

Now their illegal marketing of Risperdal for unapproved uses is set to cost them at least $1.5 billion in a settlement with the U.S. Justice Department, and sources say the final amount could end up exceeding $2 billion.

The amount could end up rivaling the largest health care fraud settlement in history -- $2.3 billion paid by Pfizer in 2009, also for illegally promoting uses of four of its drugs.

Risperdal Aggressively Promoted for Unapproved Uses for More Than a Decade

Risperdal was heavily promoted for unproven off-label uses for more than a decade, even after the U.S. Food and Drug Administration (FDA) issued warnings against the misleading claims. 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.

Research has shown that up to two-thirds of prescriptions for Risperdal were for unapproved uses that had little or no scientific support.i How did this happen? Simple -- J&J 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 FDA told the company to stop the false and misleading marketing claims not once, not twice, but three times from 1994-2004, but J&J 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. Outrageously, 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!ii

Another off-label use for which Risperdal was marketed was post-traumatic stress disorder (PTSD) – even though research in JAMA found Risperdal is no more effective than a placebo,iii and is associated with a long list of potentially devastating side effects, some of which may be permanent, including those in the chart below. J&J, of course, is not unique among drug companies when it comes to questionable advertising campaigns...

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

Merck Using Cartoon Movie Characters to Promote Children's Claritin – Prompting Calls for a Federal Investigation

Eleven advocacy groups have asked the Federal Trade Commission (FTC) to investigate Merck's marketing campaign for the over-the-counter allergy drug Grape-Flavored Children's Claritin, which uses characters from the animated movie Madagascar 3. Not only are the characters also used on packages for candy and fruit snacks, giving the impression that the drug is candy, but Merck has been offering free movie tickets and stickers with the purchase of the drugs and has a Facebook page that offers free Madagascar games.

But it gets even more egregious than that, as Merck has "mom crews" that are holding movie-viewing parties where attendees can get popcorn, stickers, DVDs... and a sample of Claritin. CBS News reported:iv

"Other evidence submitted by the [advocacy] group states that Merck told its "Children's Claritin Mom Crew" bloggers to hold Madagascar-themed viewing parties, with one blogger writing that Merck distributed "full size Claritin product featuring 'Madagascar 3,' product samples and coupons to share with my mommy friends, stickers for the kids, popcorn boxes and Madagascar 1 and 2 DVDs.""

The advocacy groups are calling for the FTC to take action to stop child-directed marketing of over-the-counter medications, stating it is "unfair and deceptive and violates longstanding FTC precedent."

It Gets Worse as Even Cereal Companies are Targeting Your Kids

It's a close call as to which is worse – grape-flavored allergy medications being pawned off as a "fun" treat, or hooking kids on sugar-laden breakfast cereals, which are among the worst foods you can eat.

A study from Yale researchers revealed that spending to promote child-targeted cereals was $264 million in 2011, up more than 30 percent from 2008. During that period, kids' exposure to TV ads for Froot Loops cereal increased 79 percent, to ads for Reese's Puffs by 55 percent and to Pebbles by 25 percent.v The very cereal products that score lowest on nutrition and the highest on added sugar are among the most aggressively marketed directly to your kids.

"It is obvious that industry regulating itself is a failure. If there is to be any hope of protecting children from predatory marketing, either public outcry or government action will be necessary to force the companies to change," said study co-author Kelly Brownell, director of the Rudd Center.vi

How to Stay Safe (and Sane) in an Era of Fraudulent, Aggressive Marketing

When it comes to making money, many industries throw ethics and integrity out the window. Whether it's J&J illegally promoting Risperdal for dementia, Merck making kids equate its allergy medication with candy, or Kellogg targeting your kids and making them crave junk food like Froot Loops for breakfast, it's a buyer beware world out there.

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.

You cannot trust that the companies making your medications have your best interest at heart any more than the makers of your sugary breakfast cereals do. While medications remain one of the leading causes of death in the United States, processed foods, which contain few nutrients and plenty of disease-promoting sugar and poorly tested chemicals, are at the heart of the obesity epidemic and promoting chronic disease in millions of people.

But if you thought the federal government was really going to do something about all of this, think again, as the pharmaceutical industry and the food industry are two of the biggest lobby groups around – and you can often follow the corporate money trail directly to the front door of Congress.

As discussed by former lobbyist Jack Abramoff, who served 3.5 years in federal prison after pleading guilty to corrupting public officials, tax evasion and fraud, our current political system basically runs on bribes. So one necessary step to have any chance of quelling this out-of-control corruption, fraud, and criminal activity is to prohibit all members of Congress and their staff from ever becoming a lobbyist after their service on the Hill is over.

The good news is that increasing numbers of people are now waking up to these harsh realities, and you, being among those who are informed, can help share this knowledge with others. Remember that the definition of fascism is a government system that has complete power in regimenting all industry and forcibly suppressing opposition and criticism. What we have here is a hybrid—a sort of corporate fascism, where industry has powerful control over government, and forcefully suppresses anything that threatens their monopoly on profits.

But, this doesn't mean that you have to buy into their agenda.

The ultimate goal is to reach a critical mass of people who refuse the unnecessarily dangerous and counterproductive solutions currently offered by all of these industries, and demand that our public servants serve the public rather than corporate interests. That will serve as the powerful stimulus to generate authentic change. More than 1.6 million people receive this newsletter, and together we can make a huge difference.

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