We now know that OxyContin is a dangerous, highly addictive painkiller that has turned normal, law-abiding Americans into “hillbilly” heroin addicts and criminals. We also know that executives at Purdue Pharma, the company that manufactures OxyContin, covered up the data that would have predicted such a result.
The investigation into the mismarketing of OxyContin is novel in that it did not begin with prosecutors hoping to impose civil fines on a pharmaceutical company that engaged in wrongdoing. Instead, the government wanted to put those responsible in jail.
Over the years federal prosecutors realized that the threat of civil fines on the corporate coffers did nothing to deter executives from continuing to mislead and endanger the public. They also suspected that the cost of settling lawsuits had been factored into the cost of doing business and, thus, made continued wrongdoing an acceptable risk for the bottom line (much like the Ford Pinto gas tank debacle).
Fed up with these executives and their flouting of the law, the feds shifted focus to prosecuting individuals, hoping that the threat of prison might be enough to make them behave. On the state level, however, officials are hoping to recoup the millions of dollars lost on the OxyContin myth.
Mounting Evidence of Wrongdoing
The State of Kentucky recently filed a lawsuit against Purdue Pharma, alleging that the big pharmaceutical company took steps to hide the addictive nature of the drug. OxyContin is one of the most powerful pain medications on the market today and has been blamed for a dramatic rise in both the number of people addicted to prescription medication and the amount of crime associated with the illicit drug market.
Lawyers representing Kentucky contend that Purdue falsified data related to the amount of time OxyContin actually stays in a patient’s blood. The faster the drug disappears, the more a patient will have to take to relieve pain.
One of the most damning pieces of evidence against Purdue is a chart that seems to indicate that the effects of OxyContin last longer than they actually do. After the initial peak, the level seems to plateau, offering a constant level of relief. In reality, the amount of OxyContin in the body falls off dramatically, which can result in withdrawal symptoms and dependence. Purdue employed the chart when marketing the drug to doctors, boasting that it was less addictive than it really is.
Although states all over the U.S. spend millions of dollars providing OxyContin to patients on Medicaid, Kentucky is seeking compensation for more than just the cost of the medication. The suit also seeks reimbursement for all costs related to OxyContin addiction, such as drug education and money spent having to catch, prosecute, incarcerate and rehabilitate those who became addicted and resorted to illegal means to obtain the drug.
Had the true nature of OxyContin been revealed to doctors, Kentucky claims the drug never would have made it to market and citizens would not have ruined their lives as a result of taking the drug. Should Kentucky be successful in the suit, Purdue could be looking at a billion-dollar judgment.
After the OxyContin blood level chart controversy became public, it was discovered that the chart in question was a logarithmic chart, not a linear chart. In a logarithmic chart, each point on the chart is a multiple of the point that comes just before it. However, in a traditional linear chart, the points come at equal intervals. As a result, those who assumed the OxyContin chart was linear would have noticed a much less dramatic decline in blood levels than actually existed.
Kentucky claims that the company initially made the chart as part of a study conducted in the 1990s in an attempt to compare the efficacies of both a time-released and immediate-release version of the drug. That first chart was in linear form. However, when Purdue submitted the time-release data to the FDA for approval of that version of the drug, it converted the chart to logarithmic form, which resulted in a smoother curve. Although the chart only contained the curve for time-release OxyContin, the company claimed that the chart proved the time-release version had less peaks and valleys than the immediate-release version.
In addition to using an obscure form of data chart, Purdue has also been accused of using a clinical trial that failed to report withdrawal as an adverse event, although data actually showed that roughly 20 percent of the patients experienced withdrawal symptoms.
Previous Guilty Pleas to Falsely Marketing OxyContin
Shady corporate executives, be wary. You may be able to fleece the American public. You may even be able to maim and kill them without recourse. But woe be the businessman who tries to cheat Uncle Sam.
Michael Friedman, Paul Goldenheim and Howard Udell, three pharmaceutical executives who previously worked on OxyContin, are likely regretting their criminal plea agreement that led to a 12-year ban on doing business with Medicare and Medicaid. The trio found themselves in hot water with federal regulators over the mismarketing of OxyContin and agreed to plead guilty as a way to avoid jail time.
The men pled guilty to falsely marketing OxyContin as being less addictive than other painkillers. They were accused of releasing erroneous data related to clinical trials and burying the relatively dramatic fall-off in blood levels by using a different type of data table than the majority of us are used to reading.
In a move that showed just how self-interested he can be, Uncle Sam focused not on the millions of Americans who have been affected by this destructive substance, but rather on the fact that he paid for people to take this drug based on the defendants’ false assurances of its efficacy.
However, after the threat of prison became a distant memory, the group sought to have the ban overturned by arguing that they did nothing wrong. This is not surprising, given that a ban on doing business with Medicare and Medicaid means that these pharmaceutical executives cannot work in the pharmaceutical industry. They may as well have gone to jail. A federal judge recently upheld the ban, pointing out that the defendants cannot now claim they are innocent after having pled guilty to the crimes.
Other Cases Against Big Pharma
Purdue Pharma executives aren’t the only individuals who have been targeted by federal prosecutors in recent years. Leaders at GlaxoSmithKline and Jazz Pharma have been called out for their misdeeds. Federal prosecutors typically rely on the theory that the misdeeds caused doctors to erroneously prescribe certain drugs, which resulted in false claims for reimbursement from government health programs.
Lauren Stevens was a corporate lawyer working at big pharma powerhouse GlaxoSmithKline (GSK) when she caught the attention of federal prosecutors and was indicted for having lied to the Food and Drug Administration (FDA) about the antidepressant drug Wellbutrin. GSK, the makers of Wellbutrin, paid over 2,500 physicians to appear at speaking engagements and promote the drug to peers. Stevens was aware that around 30 of the doctors were actually recommending off-label uses, which is not allowed under FDA rules when it comes to marketing a drug.
A salesman for Jazz Pharmaceuticals was convicted of marketing GHB (the “date rape” drug) as something useful in helping patients with other problems. Alfred Coronia argued that it was his first amendment right to advise customers about all potential uses of the drug he was selling. However, the FDA had only approved the drug for use in treating daytime fatigue.
Orphan Medical, the salesman’s employer, was acquired by Jazz in 2005. Earlier, the company had a paid a physician to appear at medical seminars to convince fellow doctors about how miraculous GHB could be. Then sold under the brand name Xyrem, the liquid GHB was touted as being good for treating a host of ailments, including obesity, depression and bipolar disorder. Both the doctor and the salesman also told lies about the drug, including that it was appropriate for young children and that an overdose would not be harmful.