A dozen years ago, Vioxx was given the axe. This pain medicine, developed by Merck, was considered to be a menace. Because the risk of heart attacks were much higher than expected.

But…

Let’s consider this. It’s drug twin- Celebrex (produced by Pfizer)- has been on the market for years. It works almost the same way as did Vioxx. These drugs inhibit the enzyme (cyclooxygenase-2 or Cox-2) that produces a prostaglandin that controls inflammation and pain, as do most of the NSAIDs (Non-Steroidal, Anti-Inflammatory Drugs), such as naproxen and ibuprofen (over-the-counter [OTC] versions of NSAIDs). These other drugs (but not Vioxx) also block the Cox-1 enzyme, which monitors and maintains the stomach lining. That’s why the side effect of gastrointestinal bleeding obtains with the administration of these other NSAIDs.

Moreover, one of the biggest problems with Vioxx was that it was being used for unapproved conditions. Merck was promoting these applications (oftentimes these unapproved uses are directly due to physician choice), which is against FDA regulations. It was these unapproved applications where the increased risk of heart attacks were evident.

But, Celebrex has now been shown to not have these cardiovascular risks, such as heart attack. The results from an almost decade long [2006 to 2014] study at the Cleveland Clinic and 925 other medical centers in 13 countries, headed by Dr. Steven Nissen [with 17 other researchers that comprised the PRECISION Trial Investigation] has just been published. Moreover, the researchers reported that that the risk is even lower than those that result from naproxen or ibuprofen (OTC drug) usage.

But,  many of the subject in this contingent were afforded a low dosage of the prescription medicine. Because many countries disallow dosages over 200 mg. About 1/3 of the patients received a dosage of 100 mg, twice a day (200 mg); 1/3 were provided 600 mg thrice daily (1800 mg), with the rest prescribed 375 mg twice daily (750 mg). This is a critical consideration since the study did indicate  the side effects are augmented with dosage.

Consider this… 70% of US Seniors take NSAIDs at least once a week- with 35% or so taking 7 doses.  That statistic is for OTC drugs. Who probably don’t have arthritis or cardiovascular problems. Which is what comprised the 24081 patients in Nissen’s study.

(Bayer has already tried to claim it’s NSAID, Aleve, had much lower risks of cardiovascular complications. But, the FDA nixed their submission!)

These results will clearly of interest to another population (other than those suffering from arthritis). Dr. Alberto Ascherio (Harvard Public Health) (with Drs. X. Gao, H. Chen, M.A. Schwarzschild) published a study of some 135000 people, which indicated that  ibuprofen (OTC NSAID) usage (two or more times a week)  lowered the chance of developing Parkinson’s Disease by about 40%.  Parkinson’s Disease is an affliction that affects 1 of every 500 people, and is related to a dopamine (or dopamine receptor) deficiency.

Ascherio et. al. made this logical jump (to study NSAID effects on Parkinson’s) , since Parkinson’s is related to the death of nerve cells; inflammation of those cells in the brain can lead to nerve death, and ibuprofen alleviates inflammatory changes. Research is now ongoing to determine what role ibuprofen may play in blocking cell damage or death (i.e., which pathway is affected).

By the way, that last study was funded by the Michael J. Fox Foundation.

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