Last month, Dublin-based drugmaker Shire made headlines for its pending acquisition by AbbVie, a deal that many saw as a new data point in the growing trend of corporate tax inversions. On Tuesday, following news that the White House was cracking down on tax inversions, AbbVie hinted that it might reconsider the takeover. But all of this news has completely overshadowed another important story about Shire that has been playing out at the same time.
On September 24, the company entered into a $56.5 million settlement with the federal government for having illegally marketed four of its drugs in the U.S., including its two blockbusters, Adderall XR—a drug in such demand that pharmacies ran into supply problems last year—and Vyvanse, a variant of Adderall that is also used to treat ADHD. Companies can’t promote a drug for use with conditions that are not approved by the FDA, and they can’t say the drug is capable of doing things that are not backed by evidence. Shire, the government said, did both.
The settlement means that we’ll never get to see the evidence the Department of Justice had amassed to build its claim against Shire. We can only see the allegations the DoJ made in the original complaint, in which the DoJ was joined by thirty states and three cities [PDF]. According to the complaint, Shire had its drug representatives tout Adderall XR as a panacea for troubled adolescents that would “normalize” them and prevent “poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted diseases.” The reps (who, incidentally, were referred to as “medical science liaisons”—and as someone acquainted with a drug rep, I can verify that term’s inaccuracy) also pushed the drug for the non-approved uses of conduct disorder and oppositional defiant disorder.
The DoJ said that reps told doctors that Adderall XR was better than the drug’s previous (now off-patent) instant-release version, and that they then told docs that the freshly patented Vyvanse was even better than Adderall XR. This is the common pharma practice of “evergreening” a drug by tweaking it and filing for a new patent just as the old one is about to expire.
Shire pushed Vyvanse on the premise that it wasn’t abuseable. According to the government’s complaint, in 2007, the company circulated a memo that Russell Barkley, who is known internally at Shire as an “ADHD guru,” gave a talk at a Wisconsin behavioral health center attended by upwards of 900 people and sang the drug’s praises. “Vyvanse is unlike anything we have ever had,” the complaint claimed the memo of Barkley’s talk said. “It’s really cool. You can’t abuse Vyvanse because it is only metabolized in the stomach, which is absolutely fascinating.”
There’s no such evidence that Vyvanse is druggie-proof, and Barkley’s implication seemed to be that because Vyvanse isn’t able to be snorted, smoked or injected, it isn’t subject to abuse (which means, good news: alcohol is now definitionally unabuseable). A quick search on online drugs forums shows, however, that plenty of people are swallowing a lot of Vyvanse and getting pleasantly fucked up in the process.
The case received fly-over attention in the news: the New York Times gave it a one-paragraph stub in the business section, reprinted from Reuters, and Bloomberg, business’s e-paper of record, didn’t even mention it. At this point, lawsuits and settlements over drug companies’ illegal marketing practices and their suppression of clinical data have become as underwhelmingly ordinary as news of local zoning-board votes.
Johnson & Johnson paid $2.2 billion last year to settle claims that it pushed the antipsychotic drug Risperdal on elderly patients despite a lack of efficacy and knowledge that it could increase stroke risk. Pfizer-owned Wyeth paid $490 million in fines for its kickbacks and off-label marketing of the kidney-transplant drug Rapamune, just four years after Pfizer paid $2.3 billion for allegations that it was similarly mischievous with its painkiller Bextra. In recent years, GlaxoSmithKline has paid $3 billion, AstraZeneca has paid $520 million, and on and on—no firm can be a true pharma brother until it’s reached a settlement with the government, like an inconvenient but necessary form of corporate hazing.
Malfeasant drug marketing is now standard operating procedure in an industry that for decades had the largest profit margin of any, allowing companies to easily fill piggy banks for future settlements. For Shire, the $56.5 million was little more than an annoying tithe on the $359.5 million in revenue Vyvanse alone brought in, just in the second quarter of this year. The day of the settlement, Shire’s stock price increased by about five points.
A week after the settlement, coincidentally, the federal government dumped an unprecedented amount of data on payments made between drug and device manufactures and doctors, revealing an unstoppable virulence in spending. It turns out that the numbers compiled by ProPublica, which for years had used every tool in its investigative arsenal to keep records of pharma’s influence on medicine, weren’t even close to the whole story. In contrast to ProPublica’s figure of $4 billion exchanged since 2009, the federal data showed $3.5 billion just in the last five months of 2013, according to the Washington Post. The New York Times also reported that more than $200,000 went to Dr. David Kessler, the former FDA commissioner in the 1990s.
The overwhelming influence of money in medicine is now such a fait accompli that the photo the Post ran with the article, a pill bottle spilling onto a blanket of $100 bills, was taken by a stock photo company.