Recent headlines concerning pharmaceutical profits, how drug companies feel about the customers they serve and the ongoing overdose crisis provide evidence that U.S. patients are playing roulette by placing faith in drug makers.
Heavy duty painkillers for patients who don’t need them
NBC News on Monday reported that Arizona-based drug company Insys Therapeutics has sold “almost a billion dollars worth” of a highly addictive pain medication over the past five years.
Remarkably, highly-addictive is probably an understatement.
That’s because the drug referenced in the article, Subsys, is an extremely powerful pain killer which includes as an ingredient fentanyl. In case you’ve been hiding under a rock for the past several months, fentanyl is the drug being blamed in part for the nation’s massive opioid overdose crisis.
A former sales rep for the company named Patty Nixon is blowing the whistle on how the drug company billed insurance companies thousands of dollars for a drug many patients didn’t need. In some cases, those patients died.
Nixon said her job was to make sure Subsys got into the hands of as many patients as possible.
“My job responsibilities were to contact insurance companies on behalf of the patients and the doctors to get the medication approved and paid for by their insurance company,” she told NBC.
Subsys is not cheap. A 30-day supply costs anywhere from $3,000 to $30,000.
Nixon told NBC that her supervisor told her ways to trick the insurers into believing it was “medically necessary.”
“I would say, ‘Hi, this is Patty. I’m calling from Dr. Smith’s office. I’m calling to request prior authorization for a medication called Subsys,’” she told McFadden. Nixon says she would also mention oncology records that didn’t exist and provide insurance companies with specific diagnosis codes, whether or not the patients had those conditions.
Was that a lie? “Absolutely,” Nixon replied. “It was a complete bold-faced lie.”
Sarah Fuller was one of the patients who was prescribed Subsys even though she didn’t have cancer.
In her case, it was chronic neck and back pain from two car accidents. And when her doctor prescribed Subsys, an Insys sales rep was sitting in the room with them, her father Dave Fuller told NBC News.
Within a month, Fuller’s prescription was tripled. And 14 months after she started using the drug, she was found dead on a bathroom floor.
The investigative report goes on to note that Fuller is just one of hundreds of patients the FDA now believes were killed after being prescribed a drug they likely didn’t need to be taking in the first place.
More prescriptions and more deaths are coming
A separate report out from The New York Time’s Upshot blog reveals that drug overdoses “are now the leading cause of death among Americans under 50.”
According to the report, between 59,000 and 65,000 Americans died as a result of overdoses last year.
Many of the deaths were associated with opioid drugs—and many of the people who died didn’t start out as the junkie caricatures society often assumes they were. In fact, evidence is mounting that opioid addicts often get the first taste of a high via a doctor’s prescription, either written for them or someone they know.
From the report:
Early data from 2017 suggests that drug overdose deaths will continue to rise this year. It’s the only aspect of American health, said Dr. Tom Frieden, the former director of the C.D.C., that is getting significantly worse. Over two million Americans are estimated to be dependent on opioids, and an additional 95 million used prescription painkillers in the past year — more than used tobacco. “This epidemic, it’s got no face,” said Chris Eisele, the president of the Warren County Fire Chiefs’ Association and fire chief of Deerfield Township. The Narcotics Anonymous meetings here are populated by lawyers, accountants, young adults and teenagers who described comfortable middle-class upbringings.
By the time a prescription drug addiction ends in death, an addict has often moved on to more powerful drugs. Street dealers have responded to demand for increasingly powerful narcotics by peddling substances not fit for human consumption.
Again from NYT:
Fentanyl isn’t new. But over the past three years, it has been popping up in drug seizures across the country.
Most of the time, it’s sold on the street as heroin, or drug traffickers use it to make cheap counterfeit prescription opioids. Fentanyls are showing up in cocaine as well, contributing to an increase in cocaine-related overdoses.
The most deadly of the fentanyl analogs is carfentanil, an elephant tranquilizer 5,000 times stronger than heroin. An amount smaller than a few grains of salt can be a lethal dose.
What’s the difference?
What should be striking to anyone reading this is not that street dealers’ desire for profits often eliminates any concern for their customers’ well-being— it’s that the average heroin dealer is no more ruthless than the sales department at a major drug company.
In fact, it might be accurate to say that the street dealer is even in a way less sinister.
After all, aren’t you bound to be far less suspicious of the potential dangers of an FDA-approved medication your doctor prescribes and your insurance company agrees to pay for than something you bought on the street? We lock up drug dealers. We give government approval to companies like Insys.
Are drug companies all the same?
Reports that a company would ignore the very serious consequences of pushing a powerful painkiller on patients who don’t need it are alarming.
Perhaps it’s just an isolated incident, though… Shouldn’t we give drug makers the benefit of the doubt?
The nation’s medical regulatory structure has, it seems, created a class of entitled super predators who aren’t all that concerned about how their products or pricing schemes affect patients.
Revolving doors between the FDA, K-Street and the pharmaceutical industry mean that the system is designed to protect the pharmaceutical world’s biggest players.
Remember when Mylan jacked prices for the Epipen and everyone began hoping for a competitor?
A couple of would-be alternatives got some attention—and then they disappeared.
FiercePharma reported last summer:
The FDA stiff-armed Adamis’ ($ADMP) prefilled epinephrine syringe, asking for more data. Regulators want the San Diego-based company to expand a patient usability study and product stress testing studies included in the original application.
The way Evercore ISI analyst Umer Raffat sees it, Adamis’ product wouldn’t have been “a large competitor” for EpiPen, given the difference between its prefilled syringe and Mylan’s more convenient injection pen device. But “Adamis could have added to managed care pressures,” through its stated strategy of acting as a discounted product.
Instead, Mylan is home free–a status it must be getting used to, given the failures that have repeatedly befallen its competitors. Back in November, Sanofi’s ($SNY) Auvi-Q hit a wall, when an injector fault triggered a hefty recall. Ultimately, the pharma giant yanked Auvi-Q from the market, and then bailed on its marketing partnership with developer PDL BioPharma ($PDLI), putting the med’s future up in the air. It was EpiPen’s first real challenger in years.
More recently, the FDA handed generics giant Teva ($TEVA) a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharma. With serious issues to work through, Teva said earlier this year that it expects its product to be “significantly delayed”–meaning it doesn’t expect a rollout before 2017.
Sure, there may have been some legitimate issues—but only a really trusting person would accept that there’s zero potential for corruption within the FDA.
And it doesn’t help that Mylan’s top leaders seem to believe they are above reproach by customers or regulators.
At least that’s the impression one gets reading a Sunday report from NY Times columnist Charles Duhigg:
A group of midlevel executives was concerned about the soaring price of EpiPens, which had more than doubled in the previous four years; there were rumors that even more aggressive hikes were planned. (Former executives who related this and other anecdotes requested anonymity because they had nondisclosure agreements or feared retaliation. Aspects of their accounts were disputed by Mylan.)
In meetings, the executives began warning Mylan’s top leaders that the price increases seemed like unethical profiteering at the expense of sick children and adults, according to people who participated in the conversations. Over the next 16 months, those internal warnings were repeatedly aired. At one gathering, executives shared their concerns with Mylan’s chairman, Robert Coury.
Mr. Coury replied that he was untroubled. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment.
Will Americans ever learn?
We saw this sort of psychopathy exhibited by the heads of another very wealthy industry not that many years ago. Selling people things they didn’t need and couldn’t handle, regulators be damned, without regard for the human consequences.
Those guys were well-protected by a crony regulatory system as well. We even took to calling some of them “too big to fail.”
But the reality is that they failed the customers who made them wealthy. And their friends in Washington got wealthy failing American voters.
We’re witnessing similar cronyism in the prescription drug industry. It isn’t new, it’s just becoming more evident.
The answer, for now, isn’t more regulation. It’s an honest accounting of the regulations already in place and a serious examination of whether, despite their original intent, those regulations have been turned against consumers.
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