A bitter battle has broken out among physicians about how best to treat gout, following new guidelines from the American College of Physicians that call for less aggressive pharmaceutical treatment, reports Stat News.
A form of arthritis, gout is characterised 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.
There are several medicines to combat gout, which is caused by a buildup of uric acid in the blood, and more are on the way. But, the report says, the American College of Physicians, the largest specialty medical association in the US, 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 – one to bolster gout research and the other to promote long-term use of medication to lower uric acid.
The report says 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 scrutinised, 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 randomised, 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.
“Strong data just doesn’t exist,” said Dr Robert McLean, a rheumatologist with Northeast Medical Group and associate clinical professor at the Yale School of Medicine. “It may be the right thing to do in many clinical situations, but we don’t have data to say that with certainty, so we can’t endorse it.”
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.
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% 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.
“I would say rheumatologists around the world are upset about the guidelines,” said Dr N Lawrence Edwards, a longtime gout researcher and vice chair of graduate medical education at the University of Florida College of Medicine who also consults for pharmaceutical companies.
The debate is also airing another key question that resonates across the medical community: Does drug company money sway treatment decisions?
Dr Robert Terkeltaub, a professor of medicine at the University of California – San Diego, 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.
Terkeltaub dismissed concerns about a conflict of interest, saying it was unlikely that commercial bias could have tainted three different rheumatology groups that in recent years all came up with similar guidelines for pharmaceutical intervention to treat gout. Others argue that banishing all physicians with ties to drug companies from the debate would mean losing the input of people like Terkeltaub and Edwards, who are considered leaders in the field.
But 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’ gout drug Uloric; he dropped that job to join the ACP committee that was working on treatment guidelines.
The report says 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% in coming years, with AstraZeneca, Horizon Pharma, and Takeda as leading vendors.
The report says the debate frustrates Dr Tuhina Neogi, a rheumatologist, epidemiologist, and professor of medicine at Boston University. She understands the virtues of high-quality evidence, yet said it’s myopic to ignore decades of wisdom that specialists have gained from treating actual patients.
“As an epidemiologist I would love to have clinical trial data for every important clinical question,” Neogi said. “But in the absence of that, we still need to advise our colleagues. We can’t leave physicians blind.”
Neogi, who has no financial conflicts with makers of gout drugs, said she’ll teach her students about the ACP guidelines. But in the clinic? She plans to keep urging patients to take medication to lower uric acid levels.
The report says caught in the middle of the fight: the estimated 8m to 10m Americans with gout.
Abstract
Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of gout.
Methods: Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials; systematic reviews; and large observational studies published between January 2010 and March 2016. Clinical outcomes evaluated included pain, joint swelling and tenderness, activities of daily living, patient global assessment, recurrence, intermediate outcomes of serum urate levels, and harms.
Target Audience and Patient Population: The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute or recurrent gout.
Recommendation 1: ACP recommends that clinicians choose corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or colchicine to treat patients with acute gout. (Grade: strong recommendation, high-quality evidence)
Recommendation 2: ACP recommends that clinicians use low-dose colchicine when using colchicine to treat acute gout. (Grade: strong recommendation, moderate-quality evidence)
Recommendation 3: ACP recommends against initiating long-term urate-lowering therapy in most patients after a first gout attack or in patients with infrequent attacks. (Grade: strong recommendation, moderate-quality evidence)
Recommendation 4: ACP recommends that clinicians discuss benefits, harms, costs, and individual preferences with patients before initiating urate-lowering therapy, including concomitant prophylaxis, in patients with recurrent gout attacks. (Grade: strong recommendation, moderate-quality evidence)
Authors
Amir Qaseem; Russell P Harris; Mary Ann Forciea
[link url="https://www.statnews.com/2017/01/25/gout-treatment-doctors-battle/"]Stat News report[/link]
[link url="http://annals.org/aim/article/2578528/management-acute-recurrent-gout-clinical-practice-guideline-from-american-college"]American College of Physicians guidelines[/link]