November 28, 2011

By Martha Rosenberg

The pharmaceutical industry had two things to be thankful for this Thanksgiving season. Three new wrongdoing settlements that broke right before the holiday were buried among yam and traffic jam news--and a new sleeping pill that isn't new at all but just Ambien with a new name became a leading "news" story.

The pharmaceutical industry had two things to be thankful for this Thanksgiving season. Three new wrongdoing settlements that broke right before the holiday were buried among yam and traffic jam news--and a new sleeping pill that isn't new at all but just Ambien with a new name became a leading "news" story.

Of course everyone knows that the time for corporations and governments to dump bad news is Friday at 5:00 PM because no one hears the tree fall in the forest and by Monday something else will have happened. Did anyone notice that Merck pled guilty to criminal marketing of the painkiller Vioxx and agreed to pay $950 million before the holiday? In addition to the $4.85 billion it has already paid to victims?

Vioxx was billed as a "super-aspirin" for everyday pain until it was removed from the market in 2004 for doubling heart attack risks and causing between 27,000 and 50,000 heart events and deaths. Merck knew the heart risks and pushed Vioxx for non-approved uses according to published reports, but no corporate executives ever went up the river. "There was no basis for a finding of high-level management participation in the violation," Merck's pre-Thanksgiving news release self-congratulates.

Then there's Pfizer. The drug giant agreed to pay more than $60 million to resolve federal probes into alleged bribes to overseas doctors to use Pfizer drugs, reported the Wall Street Journal before the holiday. Penalties were probably reduced because Pfizer was willing to help the government by "ratting" on its competitors, says the Journal.

Meanwhile, the Chicago Tribune reported before Thanksgiving that Abbott is about to settle lawsuits that it illegally marketed the epilepsy drug Depakote to nursing home directors, geriatric doctors and other long-term care facilities and greased palms with kickbacks.   Abbott has set aside $1.5 billion for a settlement, says the Trib.

While the Merck, Pfizer and Abbott settlements may look sizeable, copping to a settlement allows drug companies to keep the Medicare and Medicaid reimbursement which is their lifeblood. Profits from the alleged wrongdoing usually dwarf penalties, too. "Even with these large fines, it is still good business to promote drugs illegally," says Dr. Adriane Fugh-Berman, director of PharmedOut, a project at Georgetown University Medical Center.

And there was more good news for Pharma during Thanksgiving. A newly approved sleeping pill, Intermezzo, received millions of dollars of publicity from news reports that it was a "new drug" for a "new type of insomnia" characterized by middle-of-the-night awakenings.

Actually, it's the same drug as Ambien and "middle-of-the-night" insomnia is one of many varieties of insomnia Pharma has rolled out to churn the insomnia drug market. Others are chronic, acute, transient, initial, delayed-onset, and terminal insomnia and don't forget non-restful sleep which can co-exist with all of the above.

Of course the only thing more lucrative to Pharma than a new variation on a disease is a new patent on an existing drug because no research and development is necessary. Remember how Prozac resurfaced as the PMS pill Sarafem? The antidepressant Effexor was tweaked into Pristiq? And most recently Neurontin resurfaced as Horizant, a treatment for restless legs (though many say Neurontin causes restless legs)?

Of course, Ambien also has quite a pedigree. It is the drug Tiger Woods reportedly cavorted with his consorts on and the drug former Rhode Island Representative Patrick Kennedy crashed his car on in 2006. He drove to Capitol Hill to "vote" at 2:45 AM.

Nor was Kennedy the only person to walk, drive and engage in purposeful behavior in an Ambien blackout. Law enforcement officials reported that traffic accidents increased under Ambien, with some drivers not even recognizing the police officers there to arrest them. ("Dude--where's my car?") Ambien's manufacturer was forced to publish ads telling people if they were going to take Ambien, to get in bed and stay there after Kennedy's over zealous parliamentarianism. (Or you'll break out in handcuffs, added cynics.) The FDA issued warnings about the potential of "complex sleep-related behaviors" on Ambien and other sleeping pills which may include "sleep-driving, making phone calls and preparing and eating food (while asleep)."

In fact it was EWI-- eating while intoxicated or "preparing and eating food (while asleep)" -- that gave Ambien its worst rap. Fit and sexy people awoke amid mountains of pizza, Krispy Kreme and Häagen-Dazs cartons consumed by their evil twin, on Ambien. Weeks of dieting and treadmill time shot to hell.

In fact, waking up in the middle of the night and "sleep feasting" is such an Ambien side effect, people might need to take Intermezzo for the middle-of-the-night awakening! Unless, of course, they want "Thanksgiving remorse" to continue day after day.