To Fight Against Gout Treatment Guidelines, Pharma Uses Surrogates: i.e., Paid Physicians | Pharmaguy's Insights Into Drug Industry News |

It was once seen as the disease of kings, afflicting only the lazy and gluttonous. These days, however, gout is everywhere — and a bitter battle has broken out among physicians about how best to treat it.


A form of arthritis, gout is characterized by unsightly bulges under the skin and incredible pain in the joints. Typically seen in older men, the disease now increasingly afflicts women and younger adults, often accompanied by obesity, diabetes, and high blood pressure.


“It used to be the disease of kings, but now it’s really the disease of the people,” said Dr. Robert Terkeltaub, a professor of medicine at the University of California, San Diego.


Gout is a booming market and many drug companies are rushing to get a piece of it — and to win over physicians. As many as 10 novel compounds to lower uric acid levels are in various stages of testing. A recent report estimated the global market for gout drugs will grow 17 percent in coming years, with AstraZeneca, Horizon Pharma, and Takeda as leading vendors (“Gout is Serious Disease Education Website” by AstraZeneca won a Choice Award;


But the American College of Physicians, the nation’s largest specialty medical association, this month put out new guidelines that call for less aggressive pharmaceutical treatment. That’s angered many gout specialists, who in recent years have created two new professional groups — both backed by drug companies — to bolster gout research and promote long-term use of medication to lower uric acid.


In an era when many long-standing medical guidelines — such as how often to get a mammogram or how aggressively to target blood pressure — are being vigorously scrutinized, the terse disagreement highlights recurring tensions over just what constitutes scientific evidence.


It’s true, as the ACP says, that there’s a lack of gold-standard evidence — in the form of randomized, controlled clinical trials — to prove that patients with gout should be put on a long-term drug regimen to lower their uric acid to any specific level.


But rheumatologists argue that the expensive clinical trials that the ACP wants to see are unlikely to be conducted on already approved drugs and that it makes no sense to wait until a patient suffers from a painful flare-up before treating him or her (read “Only Old Drugs That Don't Need Safety Tests Get Studied & Win Monopoly Status from FDA”;


They say their own experience in the clinic and numerous observational studies — which don’t control for the placebo effect — show that lowering uric acid prevents the recurring, painful flares that bedevil 70 percent of gout patients and may also prevent permanent bone and joint damage. They recommend reducing uric acid to levels of 6 mg/dL or lower as a matter of course.


“Would you manage hypertension without looking at blood pressure?” Terkeltaub asked.


Terkeltaub, a staunch advocate for medication, has received about $35,000 in consulting fees from drug companies that make gout medications in recent years, according to the Open Payments database that tracks such payments. Many of the rheumatologists who have called for treating gout with drugs have also received money from pharmaceutical companies. Edwards, for instance, received about $27,000 in 2015.


Studies have shown that doctors who receive compensation (even in the form of inexpensive lunches) from pharma companies are more likely to prescribe brand-name drugs than their peers. The Institute of Medicine urges professional physicians’ groups to limit such conflicts of interest on any panel that writes up treatment guidelines. Most groups do not do that.


The American College of Physicians, which published the guidelines that urged less pharmaceutical intervention, does maintain a strict policy: Committee members cannot have any pharma ties. McLean, for instance, used to serve as a paid speaker for Takeda Pharmaceuticals’s gout drug Uloric; he dropped that job to join the ACP committee that was working on treatment guidelines.