Inside the Painkiller Business: Golf, Laptops and Theater Trips for Prescribing Doctors

The whistleblower complaint against King Pharmaceuticals (KG)'s Alpharma unit, unsealed by the Department of Justice a few days ago, gives a depressing look inside the painkiller business. Some doctors can be persuaded to put patients on morphine-based Kadian with trips to fancy golf courses or laptops, the suit claims. And Alpharma allegedly performed the same kind of spin on its data that Purdue Pharma, maker of rival painkiller OxyContin, did before the feds got a grip on that company.

The suit, brought by a former Alpharma sales rep and joined by the DOJ, alleges that doctors were paid $1,000 to attend speaker training events at "lavish" resorts, with more doctors being trained than Alpharma needed as speakers. Once trained, they earned another $1,500 per 45-minute speech. The complaint claims the program was a thinly disguised kickback scheme, and that doctors in the program wrote more prescriptions for Alpharma's Kadian brand as a result.

Two doctors stand out in the claim: Sami Moufawad, described as an anesthesiologist at the Cleveland Clinic, and Mark Coleman, described as "an anesthesiologist and a golfer." The suit says:

Alpharma's sales manager Craig LaFay directed the [plaintiff] to tell Dr. Moufawad that if he wrote 50 Kadian prescriptions over the next month Alpharma would add him to the Kadian speakers board. Dr. Moufawad could not speak English well, so Alpharma approved an arrangement whereby Dr. Moufawad [would be] set up, and be paid for, his own speaking meetings, which few if any other physicians or staff attended. Dr. Moufawad commented that he "just wanted [to be paid] enough to buy a laptop [computer]" and that "if you get me a new computer, I will convert every patient to Kadian." Alpharma approved three dinner programs to pay for the computer and Dr. Moufawad became one of the larger prescribers of Kadian.

... Dr. Mark Coleman wanted Alpharma to send him to an Advisory Board at a prime golfing resort. District Sales Manager Craig LaFay promised Dr. Coleman that he would send him to Pebble Beach if he agreed to write Kadian prescriptions. Dr, Coleman agreed. Shortly thereafter, [plaintiff] was directed by Mr. LaFay to invite Dr. Coleman to the Pebble Beach Advisory Board. Dr. Mark Coleman went to Pebble Beach, played three rounds of golf at Alpharma's expense. Upon his return from Pebble Beach, Dr. Coleman began to prescribe Kadian.

A third doctor was persuaded to write about $20,000 in Kadian prescriptions per month after being given an all-expenses-paid trip to the theater in New York.

The Cleveland Clinic said it did not have currently have a doctor named Moufawad, and an executive at a clinic which listed Coleman as a doctor declined comment. The doctors themselves could not be reached.

One of the FDA's early concerns about Kadian was "dose dumping." The pills were supposed to release their painkilling medicine over time, but if patients took them when drinking alcohol the entire dose would be released at once. As many morphine pill users are also drinkers, simply warning the patients not to drink was not good enough. The suit says:

The FDA required Alpharma to conduct clinical tests to determine whether Kadian was susceptible to "dose dumping." Within weeks of beginning its clinical testing, the results indicated that Kadian was, in fact, susceptible to "dose dumping" at certain strengths. Rather than reporting those results, Alpharma stopped the study.

Alpharma later agreed to add a "black box" warning about dose dumping on the drug, but it didn't tell the FDA about its data, the suit claims.

Another study, called "Kronus," was riddled with patients who should not have been in it and not "blinded" (meaning properly anonymously randomized) to the researchers conducting it, the suit says:

Even with the study design so stacked in favor of Kadian, nearly a quarter of the study participants showed no improvement, or actually got worse, while taking Kadian. Alpharma's [sales] presentations about the study ignored this fact.

Both those incidents recall the way Purdue manipulated data for OxyContin. On Purdue study downplayed withdrawal-rate data while another, used to promote the drug, contained a misleading chart.

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