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Poor Quality Reporting for GAIT Results on Arthritis Supplements


As an oversight committee member of the NIH Glucosamine/Chondroitin Arthritis Intervention trial (GAIT), and someone who is required to speak out on the fair and balanced interpretation of the study, I am astounded by the under simplification contained in the reporting of the study's findings in the newspapers. I have to wonder, do medical writers actually read the complete study or just comment on a paragraph in the abstract?

In GAIT, there were 14 different outcome measures listed in the results section of the study for each of the three groups: All Subjects, Moderate/Severe Pain group, and Mild/Moderate Pain group. Thus, three groups for each of the 14 measures (42 outcomes total).

Mentioning only two outcomes (as was done in the conclusion of the GAIT as it appeared in the New England Journal of Medicine), with no reference to the other 40 outcomes leads to false conclusions and ultimately damages public health, especially since arthritis drugs account for about 45 deaths per day in the U.S. alone.

Celebrex, the positive control for the study, was no better than placebo in 12 out of 14 measures for the All Subjects; no better than placebo in 12 out of 14 measures for the Moderate/Severe Pain group; and in the subjects who started the study with mild/moderate pain from osteoarthritis, Celebrex failed in 14/14 outcomes!

In contrast, study subjects who started with moderate/severe pain (the very patients we are most concerned since they are more likely to miss work, need therapy or surgery), the supplements beat out Celebrex in 12/14 outcome measures.

View all of the outcomes here

What does this mean? When the control agent that was assumed to have a positive effect (Celebrex) mostly failed, this should have served as a warning that the study was flawed and the results proclaimed “inconclusive.” The authors might have not wanted this to get out for fear of being chastised for wasting $16 million of taxpayer money, or they may have wanted to underplay or even hide this obvious point - since many have affiliations with the pharmaceutical companies who compete against the supplements. A good reporter should have easily uncovered this major red flag rather than misreporting the true meaning of the study.

Perhaps a more appropriate headline for GAIT: “Celebrex equal to placebo for the very patients it was intended to treat (those with moderate to severe pain.)” Then we might see, “Insurers form class action suit to recover the $10 billion they were charged for useless Celebrex prescriptions.” As a Pfizer stockholder, this wouldn’t be so funny to me, but it does make as much logical sense as undereducated health writers calling the supplements a failure.

Glucosamine/Chondroitin Well Established Internationally

There are over 35 human, clinical studies with glucosamine and/or chondroitin worldwide. The supplements are so well studied and accepted that one or both are actually over-the-counter or prescription drugs in over 40 countries. Indeed, many government health plans subsidize or reimburse the costs of glucosamine and chondroitin for their citizens. The safety data on these treatments is meticulously tracked, and guess what? Not a single death has ever been attributed to glucosamine or chondroitin – ever.

The domestic arrogance of the U.S. in failing to embrace these completely non-toxic arthritis treatments has lead to the unnecessary deaths of over 100,000 people as victims of arthritis, clamoring for pain relief, suffer the effects of liver failure from acetaminophen, or worse: kidney and liver damage, hypertension, bleeding ulcers, strokes and heart attacks from the anti-inflammatory drugs, including the newer COX-2 inhibitors.

If you think the US pharmaceutical companies haven’t noticed, you’re wrong. Several pharmaceutical companies have marketed and sold glucosamine and chondroitin products and they have been pushing to get these supplements converted to “drug status” in other countries. In Scandinavia, they were successful. Now they can make real money selling products they know are superior to their anti-inflammatory drugs from a risk/benefit and cost standpoint. With higher infrastructure costs, pharmaceutical companies' glucosamine/chondroitin products have not been able to compete against smaller and more nimble supplement manufacturers.

Since glucosamine and chondroitin have almost no chance of becoming drugs in the U.S. and the supplements replace about $2 billion per year in drug sales, perhaps Pharmaceutical companies are employing a different approach.

If one were cynical enough to want to damage the popularity of a product, they could design a study that would appear to be sound quality, but would lead to a negative conclusion. Pfizer may have done this with the depression treatment St. John’s Wort (supplement) versus Zoloft (drug). Researchers chose the wrong group to study, moderate to severe depression, even though St. John’s Wort is supposed to be used in milder cases. When the results proclaimed “St. John’s Wort no better than placebo,” few mentioned that the prescription drug Zoloft also failed to work.

Curiously, Pfizer’s product (Celebrex) was involved in this supplement study. It’s easy to postulate a motive – glucosamine and chondroitin are known to reduce the need for anti-inflammatory drugs like Celebrex.

Study design - this can be used to make or break a product. Ladies and gentleman, that’s what we might have here with GAIT. This may be good for my Pfizer stock, but will likely be bad for your arthritis.

Jason Theodosakis, MD, MS, MPH, FACPM
Asst. Professor, University of Arizona College of Medicine
Steering Oversight Committee, GAIT





 
 

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90% of people who follow The Arthritis Cure treatment program don't need anti-inflammatories (like Aleve, Celebrex or Advil).
Dr. Theo warned people that these drugs, used first... read more

 

  

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