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The Withering of Big Pharma?

By Martha Rosenberg | Dissident Voice | November 7, 2013

It used to be when a drug company settled illegal marketing charges that millions took its drugs under false pretenses, the news would be released on a Friday afternoon when no one would notice. That was then. Now almost all the drug companies have joined the Off label/Kickback club and the public doesn’t seem to notice or care.

On the surface, Johnson & Johnson’s $2.2 billion settlement this week for illegally marketing drugs to the elderly, children and the mentally disabled looks like a victory.  J&J’s subsidiary, Janssen Pharmaceuticals, will plead guilty to illegally promoting the antipsychotic Risperdal for “controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities,” reports Reuters. The promotions included a brazen kickback scheme to Omnicare Inc, a pharmacy supplying nursing homes, exposed by a whistleblower.

At least 15,000 elderly people in nursing homes die a year from drugs like Risperdal said FDA drug reviewer David Graham in Congressional testimony a few years ago. Eli Lilly who makes the similar drug Zyprexa and AstraZeneca who makes Seroquel have also settled charges that they churned the elderly drug market at the price of Grandma and Grandpa’s lives.

But it is not a victory. J&J made $24.2 billion off Risperdal from 2003 to 2010 and shareholders won’t even notice this week’s nano loss. J&J milked Risperdal for all it was worth and the patent had already run out by the time it was charged with illegal schemes. Other drug giants charged with illegal marketing schemes–Abbott for Depakote, Pfizer for Bextra,  Eli Lilly for Zyprexa, AstraZeneca for Seroquel, GlaxoSmithKline for Paxil and Merck for Vioxx–also got their money’s worth before the trivial nuisance of suit. Many, like Pfizer who illegally marketed its seizure drug Neurontin while under probation for illegal Lipitor activities–are brazen and shameless repeat offenders.

Many say the only justice that will get Big Pharma’s attention is frog marching the CEOs off to prison and/or cutting them off from their lucrative public trough of Medicare, Medicaid and military health programs.

Still, Big Pharma’s audacious business plan of asking forgiveness not permission is winding down. Not because Pharma, prescribers, consumers, regulators and health officials have seen the light but because there are no more big drugs to pimp. An estimated 100,000 workers will be losing their jobs at Pfizer, Sanofi, Roche, GlaxoSmithKline, AstraZeneca and Merck reported Yahoo finance last month.

Only two new drug campaigns seem to be brewing and they require a major suspension of reality on the part of doctors and patients. One tries to convince people with low back pain they actually suffer from ankylosing spondylitis an arthritis-like condition that causes chronic inflammation of the spine.  If your spine is stiff when you wake up in the morning you can take an immune suppressor like Humira which puts you at risk of tuberculosis and lethal viral, fungal and bacterial infections while costing you $12,000 to $17,000 a year. Line forms to the left.

The other, even more brazen campaign, tries to convince people with insomnia, tiredness during the day, moodiness and relationship problems that they actually suffer from Non-24-Hour Sleep–Wake Disorder, a disorder that affects mostly blind people. You don’t have to be blind to have the disorder, says the new Pharma message even though there have been fewer than 100 cases of sighted people with non-24 reported in the scientific literature. It sounds like a stretch but so did convincing people with job, money and marriage problems they really had depression or bipolar disorder.

Still it is obvious the bloom has fallen off the Big Pharma rose and it is now paying the piper for the high-flying party with drug settlements like Johnson & Johnson’s this week. But that doesn’t mean shady marketing, hidden risks, kickbacks and outrageous prices are gone from the medical field. They have just moved to the Medical Device industry.

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Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.

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November 8, 2013 Posted by | Corruption, Deception, Economics | , , , , , , , , | 1 Comment

Johnson & Johnson To Pay $2.2 Billion To Settle Deceptive Marketing Claims

By Chris Morran | Consumerist | November 4, 2013

For nearly a decade, various state and federal agencies have been looking into Johnson & Johnson’s marketing of the drugs Risperdal, Invega, Natrecor, and others, claiming the company was putting consumers at risk by paying kickbacks to doctors and pharmacists to suggest these drugs to patients and for pushing unapproved uses for these medications. Today, the Justice Dept. announced that J&J will pay out more than $2.2 billion to settle these claims.

The DOJ alleges that Johnson & Johnson subsidiary Janssen Pharmaceuticals violated the Food, Drug, and Cosmetic Act by introducing the anti-psychotic drug Risperdal — which had only been approved for the treatment of schizophrenia — into the market for unapproved uses, like the treatment of dementia and other non-schizophrenic conditions.

Johnson & Johnson and Janssen Pharmaceuticals are also accused of promoting Risperdal and another anti-psychotic, Invega, to doctors and nursing homes as a way to control behavioral disturbances in elderly dementia patients, children, and the mentally disabled. The drug makers allegedly failed to mention — or downplayed — possible side effects of Risperdal, like the risk of stroke in elderly patients.

Additionally, the DOJ accuses the companies of paying kickbacks to doctors in order to urge them to prescribe these drugs, while also kicking back money to the nation’s largest long-term care pharmacy in order to get pharmacists to recommend off-label use of Risperdal for nursing home patients who exhibited behavioral symptoms associated with Alzheimer’s Disease and dementia.

In addition to this being against the law and unethical, it meant that millions of dollars in Medicare and Medicaid payments were being paid out on prescriptions that should never have been written.

“Through these alleged actions, these companies lined their pockets at the expense of American taxpayers, patients, and the private insurance industry,” said U.S. Attorney General Eric Holder in a statement. “They drove up costs for everyone in the health care system and negatively impacted the long-term solvency of essential health care programs like Medicare.”

Holder says that J&J and Janssen will plead guilty to misbranding Risperdal, and will pay $400 million in criminal fines and forfeitures, in addition to $1.2 billion to resolve their civil liability under the False Claims Act. Johnson & Johnson will pay an additional $149 million to resolve claims relating to alleged kickbacks to a long-term care pharmacy.

But wait. There’s more.

Another J&J subsidiary, Scios, has been accused of promoting the heart drug Natrecor for off-label use without credible scientific evidence that it would have any health benefit. Scios pleaded guilty in 2009 to misbranding Natrecor and paid a criminal fine of $85 million, and along with J&J has agreed to pay an additional $184 million to resolve the latest allegations.

“Put simply, this alleged conduct is shameful and it is unacceptable,” says Holder. “It displayed a reckless indifference to the safety of the American people. And it constituted a clear abuse of the public trust, showing a blatant disregard for systems and laws designed to protect public health.”

“Today we reached closure on complex legal matters spanning almost a decade. This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world,” said Michael Ullmann, Vice President and General Counsel, Johnson & Johnson, in a statement.

November 5, 2013 Posted by | Corruption, Deception, Economics | , , , , , , , | Leave a comment