Treating Arthritis: Why the Truth Hurts

Jerry Quartley of Brooklyn, N.Y., who’s a 47-year-old technology consultant, was diagnosed with rheumatoid arthritis (RA) more than 2 decades ago. For years, prescription medications kept him in neutral. “I wouldn’t say I was getting any better, but I wasn’t getting any worse,” he says.

Newer medications, exercise and coping techniques now help Quartley to control the disease, but he also regularly writes down how he feels, which helps him and his doctor decide whether his medications need to be changed.

And they will need to be changed—that’s the reality that anyone who has RA faces. Even the most recent formulations lose their effectiveness over a few years and come with potential serious health risks.

Rheumatoid arthritis affects an estimated 1.3 million Americans, according to Arthritis Foundation. Another 33 million have osteoarthritis (OA). But Centers for Disease Control and Prevention (CDC) puts the numbers much higher. In a 2010 report that was based on a 2007–2009 survey, CDC says 50 million adults have doctor-diagnosed arthritis. That’s up from 46.4 million from a 2003–2005 survey.

What’s worse, the number of people who say arthritis affects their quality of life is on the rise. In a survey of more than 1 million people by researchers at University of Illinois and CDC, 27 percent of participants who have arthritis rated their health as fair or poor, compared with 12 percent of participants who don’t have the disease. So it’s no surprise that fighting arthritis has become a big business. At least 68 RA drugs are in development, according to Pharmaceutical Research and Manufacturers of America. Fifteen drugs are in development for OA, some of which also are meant for RA.

Treatment of arthritis is a moving target, and no magic bullets exist that are certain to hit the bull’s-eye. Consequently, unproven solutions and treatment scams abound, and Federal Trade Commission has managed to rein in only a handful of those.

RA RESPONSES. If you’re diagnosed with RA, you face an array of pharmaceutical choices but, sadly, none that guarantees relief or comes without risks. (RA is an autoimmune disease in which the body attacks itself, targeting the joints. OA, which is the so-called wear-and-tear arthritis, involves the breakdown of cartilage, which cushions the ends of bones and allows for easy movement, and also is marked by inflammation.)

Your doctor is likely to prescribe nonsteroidal anti-inflammatory drugs (NSAIDs) for OA, or NSAIDs and disease-modifying anti-rheumatic drugs (DMARDs) for RA. These medications are intended to suppress inflammation and the resulting pain. (As inflammation is reduced, pain subsides and it’s easier to move your joints.) In the past 3 years, the choices among DMARDs that are labeled as biologics—the formulations that finally gave Quartley relief—have expanded, and more are on the way. (Of the 68 drugs that are under development, at least 29 are biologics.)

Biologics are genetically engineered medications—altered genetic material that’s from a living organism—instead of synthesized chemicals, as are other medications. Different biologic RA medications target the body and the disease in different ways, but the goal is the same: to stop the excess activation of the immune system that leads to inflammation of the joints.

No matter which class of medications that you receive—for RA, it’s typical for doctors to prescribe both DMARDs and NSAIDs—you should know that potential side effects range from annoying, such as constipation; to deadly, such as intestinal bleeding or kidney and liver failure.

For instance, Food and Drug Administration issued a black-box warning—FDA’s most serious caution—for the biologic RA medication leflunomide (marketed by Sanofi-aventis as Arava) in July 2010 after reports of liver damage from the medication were linked to as many as 14 deaths from 2002 to 2009.

Before biologics came along, RA could be controlled in only one-third of patients, says Dr. Stanley Cohen, who is medical director of the rheumatology department at Presbyterian Hospital in Dallas. Now, 60 percent of patients can have normal lives. Many others can achieve “low disease activity,” says Dr. Yusuf Yazici, who is a rheumatologist at New York University’s Langone Medical Center.

But both Yazici and Cohen receive money from makers of arthritis medications. Such relationships typically raise questions about conflicts of interest. Unfortunately, we found that it’s typical for arthritis experts (and specialists in other fields as well) to receive consultation or grant money from drugmakers.  Most, if not all, of the top doctors are consultants for drug companies, which is a relationship that has existed for at least a decade. In other words, you should take glowing reviews with at least a few grains of salt.

Biologics have been studied for a decade, and they generally are safe and quicker at relieving inflammation and pain than are other arthritis medications, according to American College of Rheumatology (ACR), which focuses on education, research and advocacy.

But, as the figures that Cohen cites suggest, biologics don’t work for every patient. Even when a biologic works well, the effectiveness can wear off over time in a single patient. So it’s typical for RA patients to switch medications after a few years. (This phenomenon, sometimes called the “poop out” effect, also happens with other long-term drugs, such as antidepressants.)

And to top it all off, biologics are expensive. The annual cost to the consumer of these medications, which are considered “specialty drugs,” typically is least $12,800 annually. Insurance plans vary greatly on coverage.

SOBERING RESEARCH. Among the newest biologics is a class of drugs that are called JAK inhibitors, which work by blocking specific molecules that are found within the cells that cause inflammation, experts say. One JAK inhibitor that might be submitted for FDA approval this year is the first biologic RA medication that would be in pill form—tofacitinib. (Other RA medications are injected or infused—introduced directly into a vein through an IV drip.)

Tofacitinib is different from other medications, because it’s in oral form and also because it inhibits multiple proteins that can trigger inflammation. Other biologics typically inhibit a single protein. Theoretically, the advantage of targeting multiple proteins is that the medication will reduce inflammation more quickly and completely and thus produce more relief.

But, like other medications, tofacitinib isn’t without potential serious risk. At a London medical conference in May, Dr. Joel Kremer of Albany Medical College (New York) reported on a study of 792 RA patients in which tofacitinib eased symptoms in RA patients who hadn’t responded to other biologics. Four test subjects died during the study, and one of those deaths might have been related to the medication, Kremer says. The rate of 1 death in 792 patients isn’t unexpected for drug trials, he says. Pfizer, which developed the drug, says the death rate is within the range of rates that are reported for similar RA therapies.

Pfizer plans to ask for FDA approval before the end of 2011, says Victoria Davis, a company spokesperson. The drugmaker’s stance isn’t surprising. And, the fact that FDA won’t comment on any not-yet-approved drug, even one that has a lethal risk, isn’t comforting.

SCIENCE OR SCAM? Because of the expense and the uncertainty of effectiveness and safety of prescriptions, arthritis patients ask regularly about the latest “miracle” treatments, doctors say. Many patients who have arthritis try alternative or complementary treatments, such as herbal remedies, doctors say.

Doctors tell us that they spend a lot of time warning patients not to use treatments that claim to treat RA by increasing the activity of the immune system. Doing so could make the RA symptoms worse, experts tell us. Websites that peddle products to increase immune-system activity, such as “super” antioxidant vitamins, are easy to find. But RA patients already have an overactive immune system, experts say. The last thing that they’d want would be to make it more active.

Federal Trade Commission warns consumers to be wary of unproven arthritis remedies that abound on the Internet. These remedies include curious “dietary” and “natural” remedies, such as cetylmyristoleate (CMO), copper bracelets, desiccated-liver pills, honey-and-vinegar mixtures, magnets, mussel extract and shark cartilage. None of these, FTC says, is backed by adequate science to show that it results in long-term arthritis relief.

FTC can’t say exactly how much Americans spend annually on unproven arthritis treatments, spokesperson Elizabeth Lordan says, but it’s a big number. FDA states on its website that Americans spend $2 billion a year on unproven arthritis remedies, citing FTC as the source. Lordan says that number is outdated. (An older estimate that’s cited by FTC and Arthritis Foundation pegs the number as high as $10 billion annually.)

Even without hard statistics, it’s likely that—because more of us are getting arthritis—sales of so-called miracle treatments will become more pervasive.

FTC has cracked down on a few scams that promise to cure or treat arthritis. But “few” is the key word: Since 2004, Lordan says, FTC has brought just four cases against companies that are involved in the selling of products that are promoted as treatments for arthritis. For example, in 2009, FTC filed suit against Roex for promoting dietary supplements that claim to reduce the risk of—or even to prevent—arthritis without evidence that the products do so. In March 2010, the company mailed $3 million in refunds to those who bought the products, FTC says.

FTC urges consumers to watch out for red flags that a product is a scam. A big one is exaggeration—a product that claims a long list of benefits, such as “treats rheumatism, arthritis, infections, prostate problems, ulcers, cancer, baldness and more!” Another scam giveaway: The product will claim to cure something in a matter of days. Not likely. And, it should go without saying, FTC says, you should talk to your doctor first before you try any new treatment.

MAYBE, MAYBE NOT. Not all nonpharmaceutical treatments are scams, but they still draw mixed reactions from arthritis doctors and researchers—none more so than chondroitin and glucosamine, which are pitched to relieve OA symptoms. Advocates say chondroitin helps to prevent cartilage breakdown by inhibiting the enzymes that destroy it, and glucosamine promotes cartilage repair.

In 2008, consumers worldwide spent about $2 billion on the combination, and those sales are expected to reach $2.3 billion by 2013, according to British Medical Journal.

But that might be money that arthritis patients are throwing away. In March, a review that was published in Annals of Internal Medicine looked at 10 previously published clinical trials that involved nearly 4,000 people. Reviewers concluded that neither chondroitin nor glucosamine clinically relieves joint pain in patients who have OA of the hip or knee, both of which are common OA locations.

As a result of that review, some doctors say they now tell OA patients not to bother taking chondroitin or glucosamine.

But Yazici believes that the combination might work in some people, so, if patients press him about using it, he gives them a tentative green light. “If it doesn’t have a side effect and you can afford it, try it,” he says.

It typically takes 6 months to notice any pain relief if you use chondroitin and glucosamine, doctors tell us. That means that you typically will spend about $100 on pills before you find out that they might not work.

Another alternative treatment has shown promise in easing arthritis symptoms but comes with caveats—Tripterygium wilfordii Hook F, which is a Chinese plant that also is called thunder god vine. In a study that was funded by National Institutes of Health (NIH) and published in Annals of Internal Medicine in August 2009, an extraction of the plant that was given in oral form was judged effective when compared with the RA drug sulfasalazine.

The study was small. The 121 patients were randomly assigned to take thunder god vine or sulfasalazine for 24 weeks. More of the herbal group reported joint-symptom improvement than the drug group did.

But NIH’s National Center for Complementary and Alternative Medicine (NCCAM) says it isn’t possible to verify the safety or effectiveness of what goes into thunder-god-vine remedies that are made outside of the United States—for example, in China—because U.S. regulators have no jurisdiction over those products. And no consistent, high-quality thunder-god-vine products are being manufactured in the United States, according to NCCAM.

The catch is that the herbal remedy must be extracted carefully from the thunder god vine’s skinned root, NCCAM says. Other plant parts, including the flowers, leaves and skin of the root, potentially are lethal. Also NIH’s thunder-god-vine/sulfasalazine study tracked just symptom relief and didn’t track other health dangers. Consequently, we believe that this remedy isn’t worth the risk, because the lack of governmental oversight means that there’s no way for you to know what’s in the pills that you buy.

Of course, as we noted, pharmaceutical remedies also carry risks, but you can find out what’s supposed to be in those formulas, which must gain FDA approval. And insurance plans are more likely to cover pharmaceuticals than they are herbal remedies. So, if a prescription medication turns out to be ineffective, you’ll be out less financially than if you buy a supply of an ineffective herbal remedy.

ON THE HORIZON. The hope of any treatment, of course, is to ease arthritis symptoms. Even Congress has tried to help, although its effort to pass legislation to boost arthritis research has stalled. The House of Representatives passed the Arthritis Prevention, Control and Cure Act of 2010 a year ago, and the Senate introduced it, but now it’s referred to committees in both chambers. The bill appropriates an estimated $52 million through 2015 to create a “national arthritis action plan” that would fund RA research grants and pay for training for juvenile-RA doctors.

Despite the bill’s derailment in Congress, a recent study suggests that, believe it or not, there might be a way to eliminate RA. In 2010, Dr. Harris Perlman of Northwestern University’s Feinberg School of Medicine in Chicago, found that people who have RA have immune cells that are low in a critical molecule. To correct the shortage, Perlman developed a synthetic molecule that floats into overactive immune cells and makes the troublesome cells self-destruct.

Perlman tested his fake molecule in animals that have RA, and the test was successful, he reported in the February 2010 issue of Arthritis & Rheumatism. The imitation molecule can both trigger a remission of RA when it was present and prevent the development of RA, he says.

Perlman’s work is continuing, and he’s hopeful of the outcome. “Not only can we prevent RA, but use [the imitation molecule] as a therapy,” he tells Consumers Digest. However, Perlman says much more work has to be done before his approach is ready to test in people, and he couldn’t predict how soon any treatment might become reality. Yazici, who studied Perlman’s research, says the science is promising, but it’s all speculation until it can be studied in humans.

Another line of research that’s emerging deals with how aging affects genes. Researchers hope to identify the genes that are key to the development of OA. The ultimate goal is to develop therapies that could turn off those genes.

A cure for arthritis? That’s something that we ache to see.

Kathleen Doheny has written about health topics for 30 years. Her reporting has appeared in Consumers Digest, the Los Angeles Times, Prevention and other publications.