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Pharma Drug Money and Executive Personal Responsibility

September 16, 2010

From JM Mercola.

www.mercola.com

Botox Found Guilty of Illegal Marketing and Promotion

Allergan, which manufactures the cosmetic medication Botox, has agreed to pay $600 million to settle a federal investigation into its marketing of the botulin-based drug.

The company will plead guilty to one misdemeanor charge of “misbranding” – meaning the company’s marketing led physicians to use Botox for unapproved uses. These uses included treatment of headache, pain, spasticity and cerebral palsy in children.

According to ABC News:

“Allergan said it will pay $375 million in connection with the plea, which includes the forfeiture of $25 million in assets. Additionally, the company will pay $225 million in civil fines — $210 million to the federal governments and the rest to several states — related to the investigation, although the company denies liability for the civil claims.”

The case of Allergan Inc. stealing taxpayer money and putting people’s health at risk through fraudulent marketing practices is just the last in a long line of such cases that have come to light in recent years.

Several major drug companies have recently been scrutinized and reached multibillion dollar settlements over their illegal marketing practices.

One notable example was Pfizer, who earlier this year got away with what amounted to a slap on the wrist because they were deemed “too big to nail.”

Most people are familiar with Botox Cosmetic, a botulin-based drug that temporarily paralyzes your facial muscles, which will smooth out wrinkles.

But the US Food and Drug Administration (FDA) has also approved the drug Botox Therapeutic for a very limited number of therapeutic uses, such as cervical dystonia in adults.

ABC News quotes Sally Yates, U.S. Attorney for the Northern District of Georgia as saying:

“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA.

Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective.”

Some of the off-label uses Allergan is accused of directly promoting to doctors include the treatment of:

  • Headaches
  • Pain
  • Spasticity and cerebral palsy in children

The off-label use for pediatric patients is perhaps one of the more disturbing, as safety and effectiveness in children have never been established for this drug.

This became clear six years ago, when Irena Medavoy, the wife of a Hollywood producer, sued Allergan after suffering “life-altering intractable headaches, fibromyalgia, extreme neck weakness, difficulty breathing, difficulty swallowing, and extreme fatigue,” after receiving Botox injections for her migraines – an off-label use — according to one report.

That was the first trial involving Botox, and Medavoy lost her case.

Fortunately, since then the promotion of off-label uses have started receiving more scrutiny, and when a company is found to actively educate doctors on these illegal uses, federal investigators have gotten better at clamping down.

According to ABC News:

“Allergan “paid kickbacks to induce physicals to inject Botox for off-label uses and Allergan also taught doctors how to bill for off-label uses, including coaching doctors how to miscode Botox claims leading to millions of dollars of false claims being to submitted to federal and state programs,” Assistant Attorney General Tony West said.”

In this case, Allergan will plead guilty to the misdemeanor charge of “misbranding,” and will pay $600 million to settle the case against them. This may sound like a lot of money, but it’s really peanuts when you consider the fact that the Botox brand brought in more than $1.3 BILLION last year alone.

More Illegal Activities…

Like so many other pharmaceutical companies, Allergan Inc. appears to have been more committed to illegal activities than protecting the health and welfare of patients.

Promoting Unsafe Injection Practices

In October 2009, another federal lawsuit against the company alleged that its sales representatives promoted the single-use vials for multi-patient use, which public health officials claimed contributed to a hepatitis C outbreak in the Las Vegas Valley.

“The Botox business model “created an unacceptable and unreasonable risk of serious and debilitating injuries and illnesses, including HIV and Hepatitis B and C”…”

Company Officers May Also Be Sued

In order for there to be effective reform, actual people must be held accountable.

Another trend that appears to be taking form these days are class action lawsuits by investors against officers and directors responsible for allowing illegal activities to occur.

On September 2, the law office of Robbins Umeda LLP announced it was launching an investigation into “possible breaches of fiduciary duty and other violations of the law” by Allergan’s directors, claiming the officers may have damaged the company by permitting “illegal tactics to promote Botox for these unapproved uses, including paying kickbacks to doctors.”

The law office is urging shareholders to jump on the class action bandwagon.

Regardless of whether anything comes of it, I truly believe that one of the more effective ways to begin to curtail this behavior of pandemic corruption and fraud is by forcing actual people to face the music.

When there is no risk whatsoever, the worst human inclinations tend to flourish, and there should be little doubt that greed has taken over most Big Pharma business models at this point.

The Pandemic of Medical Fraud and Illegal Activities

The corruption, fraud, and illegal activities of pharmaceutical companies appear to have reached a hitherto unprecedented high.

The False Claims Act Legal Center’s web site contains a long, nauseating list of criminal activities by Big Pharma. I urge you to take a look for yourself, to gain some perspective – these are the companies your doctor places his trust in. And by default, by listening to your doctor, you’re putting your life in their hands as well.

I challenge you to take a look at the list of criminal activities perpetrated by some of the biggest, most well-known companies in the world, and still come to the conclusion that your health is in good hands.

Another recent False Claims Act case is that of Seroquel. The maker of the atypical anti-psychotic drug, AstraZeneca, has also recently agreed to pay $520 million to settle charges that it marketed this dangerous drug for off-label uses.

The Illusions are Breaking…

Fortunately, more people are finally waking up to the illusion and deception of the drug industry as a whole, and starting to clearly see the truth.

The public is absolutely correct in their conclusion that drug companies manipulate or suppress negative clinical trials, promote their toxic products for unapproved uses, and focus on developing drugs that are no better than older ones.

Watch the Pharma Fraud Show

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