Myth Versus Reality: Promoting A Pricey Gout Pill

Myth Versus Reality: Promoting A Pricey Gout Pill

January 10th, 2012 // 1:23 pm @ jmpickett

Nearly three years ago, the FDA approved a version of colchicine – a cheap, decades-old treatment for gout – and a controversy quickly ensued. The new med won approval under the Orphan Drug Act, which means the manufacturer received seven years of marketing exclusivity. And the FDA later forced other manufacturers to halt marketing on the grounds their own pills were never approved (see this).

The real ruckus, however, arose when URL Pharma began selling its newly approved Colcrys for about $5 a pill, compared with just pennies for the older colchichine. Some rheumatologists complained on an online message board, prompting the drugmaker to send letters to some docs about the “potential risks and liability” of using unapproved versions (read here). Later, Herb Kohl, who chairs the Senate Special Committee on Aging, and three members of the House, began a probe (look here).

Now, URL Pharma has drawn more attention to itself. The FDA has issued a warning letter to a URL Pharma subsidiary for developing a so-called pharmacy sell sheet and a video that are called false or misleading, because they omit and minimize risk information, as well as make unsubstantiated safety superiority claims and overstate efficacy. Ironically, the video is called ‘Myth Vs. Reality.’

The FDA, however, says URL Pharma emphasizes myth. For instance, the promotional pieces claim that Colcrys tolerability is comparable or similar to placebo. But as the agency notes, this implies that safety profiles are no different or are minimally different, “when this is not the case.” The agency points out that the adverse reactions section of the labeling states that the percentage of patients who experienced diarrhea was 23 percent in the recommended low-dose group versus 14 percent in the
placebo group. Comparable? No. Similar? No.

During the first 15 minutes and 14 seconds of the video, there is a discussion by URL Pharma chief medical officer Matthew Davis about unapproved colchicine products and Colcrys benefits. The FDA notes there are also large, bolded claims on the right-hand side of the screen with a continuous display of the Colcrys logo and tagline on the bottom, right-hand side of the screen.

But most of the risk information is presented after what the agency calls a “prominent presentation in a running telescript format with accompanying voiceover,” and “there is no signal to alert the viewer that important risk information follows the presentation of benefit information. The only risk information included during the main part of the video are statements regarding drug interactions,” dosing modifications and a lower rate of diarrhea seen in the low dose arm of the Colcrys trial.”

Moreover, the main part of the video omits discussion of serious and significant risks, including contraindications, warnings and precautions such as fatal overdoses, blood dyscrasias, monitoring for toxicity, and neuromuscular toxicity, and the most commonly reported adverse reactions, the FDA writes. The upshot? The video undermines communication of important risk info.

There’s more. The video boasts that, in a randomized clinical trial, Colcrys showed significant separation from placebo when looking at pain in 16 hours and reached its primary outcome measure in 24 hours, and that Colcrys significantly reduced pain associated with gout flares within 16 hours. But as they say, numbers can tell a story.

According to the clinical studies section of the Colcrys product labeling, “the efficacy in the treatment of gout flares was assessed at 24 hours following the time of first dose in the clinical trial. This study was not appropriately powered to evaluate outcomes at the 16-hour time point, nor were appropriate pre-specified adjustments for multiple comparisons between treatment groups applied during the analysis of the study data”

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