“This is a recent post by Dr. Jacob Teitelbaum for Dr. Oz’s blog. This is most interesting, and our clinical observations completely support Dr. T’s, as well as the study results–the older medicines, used judiciously and in combination, usually trump the newer more expensive meds in better symptom relief and fewer side effects.”
5¢/day medication beats $8/day medication in recent Fibromyalgia studies
Two new studies give a fascinating insight into medications for Fibromyalgia pain and sleep– that you won’t likely hear about elsewhere. It will also help you understand first hand why our health care system costs are unnecessarily spiraling out of control.
A large study of 747 patients taking Lyrica (Pregabalin)1 showed that the 300 and 600 mg dose did not have a significant pain benefit overall, but they were able to show mild benefit from the 450 mg/day dose—in part, largely because of the large number of patients in the study allowed modest benefits to be statistically significant.
On the other hand, another placebo controlled study2 by Dr Harvey Moldofsky, my favorite FMS Sleep researcher, showed that very low dose Flexeril (generic cyclobenzaprine) was very effective for Fibromyalgia sleep and pain. Though in most cases, I find generics and brand name medications to work equally well (with some rare exceptions), this is a case where the generic will even work BETTER than the expensive brand name, whose release to too slow to give the benefits here, where you want a quick bedtime rise in blood level, but still have the medication out of your system by morning to avoid side effects.
In the Flexeril study, pain dropped 25% and energy improved 14% by 8 weeks. Sleep also improved significantly. Patients were given a very low doses (beginning with 1 mg at bedtime and increasing to a maximum 4 mg at bedtime). Severe side effects were more common in the placebo group than the treatment group. The medication was well tolerated overall, but mild side effects (mild enough that no patient needed to stop the medication for side effects) included headache, sedation, dry mouth, dizziness and constipation. If side effects are an issue, the dose can even be lowered further. The lower doses work better than the standard 10 mg 3 x day dose used for muscle pain, which is more likely to cause side effects than this very low dose. So more is not better!
So let’s do the math
Lyrica at 150 mg 3 x day costs $8.64/day (Costco price—which is usually lower than elsewhere), is high in side effects and has modest benefit (though it can be very helpful in some patients, so I am glad to have it in our “tool kit”)
Flexeril (Cyclobenzaprine) 5 mg generic 10 CENTS a pill (So the treatment cost is 2 to 8 Cents a day—less than 1% of the cost of Lyrica). It has less side effects and appears to be more effective in both the studies and my experience than the Lyrica.
So which one will most physicians likely hear about? The Lyrica of course! Why???? Being over 100 times the cost makes it far more profitable, so the company can spend $70 million a year advertising it to you and your physician. At 2 cents a day, no one will pay to advertise the Flexeril, so most physicians will never hear about this research (though I keep the Fibromyalgia and Fatigue Center physicians up to daye). In fact, keep an eye out and see how many times you see ads for each (a lot for Lyrica and none for flexeril will be my bet), so you can see for yourself that this is so.
This same scenario plays itself out for literally hundreds of medical treatments (In fact, I suspect for most of them). So it should be no surprise that health care costs are skyrocketing.
So which health care plan will solve this? Will it be the president’s plan (dubbed “ObamaCare”) or our current system? If you guessed neither, you guessed correctly. This is why I consider the current health care debate to be doomed to failure, as both sides recommendations will cause prices to skyrocket without improving care.
There is a 3rd alternative which would work though. Reread the above and see if you can figure it out. If you guessed have expert panels decide, recent studies showed that most of these expert panels are stacked with doctors paid by the drug companies—so that doesn’t work.4
Can you figure it out? Stay tuned!
1- An International, Randomized, Double-blind, Placebo-controlled, Phase III Trial of Pregabalin Monotherapy in Treatment of Patients with Fibromyalgia
LYNNE PAUER, ANDREAS WINKELMANN, PIERRE ARSENAULT, ANDERS JESPERSEN, LAURENCE WHELAN, GARY ATKINSON, TERESA LEON, BERNHARDT ZEIHER on Behalf of the A0081100 Investigators
J Rheumatol. 2011; 38:2643-2652.
2-Effects of Bedtime Very Low Dose Cyclobenzaprine on Symptoms and Sleep Physiology in Patients with Fibromyalgia Syndrome: A Double-blind Randomized Placebo-controlled Study
HARVEY MOLDOFSKY, HERBERT W. HARRIS, W. TAD ARCHAMBAULT, TERENCE KWONG, and SETH LEDERMAN
J Rheumatol. 2011; 38:2653-2663.
3- Costco Price Checker (a VERY helpful tool!) http://www.costco.com/Pharmacy/DrugInformation.aspx?p=1
4-“Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and the United States: cross sectional study.” Neuman J, Korenstein D, Ross J, and Keyhani S. BMJ 2011; DOI: 10.1136/bmj.d5621.
“Practice guidelines developed by specialty societies: The need for a critical appraisal.” Grilli R, Magrini N, Penna A, et al. Lancet2000; 355:103-106.
“Conflicts of Interest Abound in Diabetes Guidelines Committees.” Gale EAM. BMJ 2011; DOI: 10.1136/bmj.d5728.