The cost of designing, developing, and marketing a new pharmaceutical drug can literally exceed a billion dollars. Even millions more are invested in non-industry trials to demonstrate the efficacy — or lack thereof — of these drugs with certain medical conditions or clinical parameters. The process of getting FDA approval is another separate adventure in itself. Given the enormous effort in ensuring that drugs are safe and efficacious, it is curious that the same stringency is not applied in prescribing these drugs at the time of health care delivery.
Disclaimer: this is not a critique of health care professionals, but a discussion of some challenges surrounding medication reconciliation.
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The FDA (Food and Drug Administration) recently released a public health advisory on Chantix (varenicline), a smoking cessation drug manufactured by Pfizer. This follows an earlier investigation last year on reported behavioral changes associated with use of the drug. The presence of neurologic or psychiatric effects is not completely surprising, considering that Chantix interferes with the brain’s dopamine system. The dysregulation of dopamine has already been implicated in some neuropsychiatric disorders, such as Parkinson’s disease and schizophrenia. Although the drug does not necessarily need to be withdrawn from the market, the FDA cautions both patients and health care providers to be vigilant about past psychiatric conditions and noted mood/behavior changes while on the drug. The FDA adds that use of the drug may interfere with the ability to drive.
Given that lung cancer and heart disease remain among the top killers in the United States, smoking cessation is a key strategy in preventive health. It is hard enough for a smoker to quit. Fortunately there are still several other pharmacologic and non-pharmacologic tools to aid in smoking cessation, including nicotine patches, Wellbutrin (bupropion), and a great coach-physician.
Since the FDA (Food and Drug Administration) does not regulate dietary supplements as stringently as pharmaceutical drugs, manufacturers of the former can market their products with untested and unsupported claims. While some claims border on fantasy and may breach ethical standards (”pill that cures all cancers”), most claims are plausible. Calcium and vitamin D supplements may build bones. Iron sulfate may help with some forms of anemia. But, do we know whether the supplements truly provide their advertised effect?
Chondroitin sulfate and glucosamine have long been marketed as substances to alleviate the arthritides. This is a reasonable conjecture, given that chondroitin sulfate is a polysaccharide found in joint cartilage. One would logically assume that oral supplementation of this substance would help replenish eroded joints. Even the Mayo Clinic states that “consensus of expert and industry opinions support the use of chondroitin and its common partner agent, glucosamine, for improving symptoms and arresting (or possibly reversing) the degenerative process of osteoarthritis.” The Mayo Clinic, however, does not go so far as to fully endorse chondroitin use. It admits that “(s)afety and effectiveness have not always been proven”.
So, does it work? A meta-analysis published this week in the Annals of Internal Medicine hopes to address the question and controversy. The study included 22 independent research trials examining the efficacy of chondroitin use with osteoarthritis of the knee or hip. Twenty trials (3846 patients) had sufficient data to calculate effect of chondroitin use on joint pain. Twelve trials were used to assess adverse events, and 5 trials reported radiologic measurements of joint space width.
The authors understand the limitations of their study and concede to the variable experimental and reporting methodologies among the trials. They nevertheless assert that the “large-scale, methodologically sound trials indicate that the symptomatic benefit of chondroitin sulfate is minimal or nonexistant. Use of chondroitin in routine clinical practice should therefore be discouraged.” On the flip side, they did not identify any significant adverse effect. I suppose one downside of continued use would be wasted money.
In our subjective world, evidence-based medicine does not always determine our health choices. As long as there are proponents of chondroitin use, and deep pockets to keep the marketing campaigns moving, the sale of chondroitin and similarly questionable supplements will retain their presence on store shelves. At least we have the freedom of choice.
- Reichenbach S, Sterchi R, Scherer M, Trelle S, Burgi E, Burgi U, Dieppe PA, Juni P. Meta-analysis: chondroitin for osteoarthritis of the knee or hip. Ann Intern Med 2007;146:580-90.
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Melatonin is a hormone produced by the pineal gland and associated with regulation of the sleep cycle. There have consequently been melatonin products, and biosynthetic variants (i.e., ramelteon), marketed as sleep aid products. A popular use for melatonin has been to combat jet lag or for adaptation to different time zones. Two recurring questions I have encountered regarding melatonin are whether it actually works and whether there are any adverse side-effects.
The February 10 issue of the British Medical Journal includes a study by a Canadian group that reviewed the efficacy and safety of melatonin use with secondary sleep disorders and sleep restriction. Secondary sleep disorders are sleep problems with a physiologic cause, such as hyperthyroidism or substance abuse (toxicity). Sleep restriction, on the other hand, results from voluntary sleep disruption. On-call physicians or third-shift police officers are examples of people who endure sleep restriction.
According to the meta-analysis (a review of several research efforts examining the same topic) of 15 separate studies (524 participants), melatonin is not effective for both secondary sleep disorders and sleep restriction. Commonly reported side-effects were drowsiness, headache, nausea, and dizziness. Otherwise, the report does not indicate significant adverse effects of short-term melatonin use (3 months or less).
In another meta-analysis performed by the same group, and published two months earlier in the Journal of General Internal Medicine, there is some evidence of efficacy in delayed sleep phase syndrome (DSPS), a shift in the circadian rhythm that makes it difficult for the person to fall asleep and wake up. Study participants who suffered from this disorder were able to fall asleep around 38.8 minutes earlier with melatonin. The study does not however report significant improvement in sleep onset with melatonin use for other sleep disorders. The findings on safety are similar here as in the BMJ article.
In short, melatonin is not effective for most sleep disorders, but it is safe with short-term use.
- Buscemi N, Vandermeer B, Hooton N, Pandya R, Tjosvold L, Hartling L, Baker G, Klassen TP, Vohra S. The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen Intern Med 2005;20:1151-8.
- Buscemi N, Vandermeer B, Hooton N, Pandya R, Tjosvold L, Hartling L, Vohra S, Klassen TP, Baker G. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. BMJ 2006.
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