Topiramate: A Jack Of All Trade Drug, But Effective Treatment For None?

As you already know, there is no shortage of newsworthy information that crosses my virtual (and even physical) desk on a daily basis.  When combined with my undeniably insatiable curiosity, this usually means that I could spend 25 hours a day and 8 days per week writing, or on the radio talking with a notable expert.

What this has also meant is that I have had to implement a filtering system that incorporates the intuitive ache of my right knee just before it rains, the experience of a natural newshound and a compelling story that ultimately will prove to be informative, entertaining and yes hopefully necessary to you my faithful readers.

Right at this very moment, and similar to an O’Hare Airport at peak times when one jet is lined up behind another in a seemingly endless line of inbound flights waiting to land, there are several stories and two pending radio shows that need to be put to bed by tomorrow at the latest.

Among the topics I will be covering in this flurry of literal activity will be the effectiveness of the Stumbleupon model at driving meaningful traffic with increasing stickiness – re when people visit a site they stay around for a minute or two, and the elder of the social networks Ecademy and their new Blackstar program with collaborative conference rooms.

On the virtual airwaves side of the equation, there is a first time candidate in Florida who is leading in the polls and looks like he has a very good chance of winning – the segment is titled Uncommon Valor: Unquestionable Dedication, and will air on Friday at 8:00 PM EST.

Certainly these are all mutually timely and I would think interesting topics to be certain.  So in the context of what is currently waiting for the final edits, what story could jump to the front of the line and, perhaps even more interesting, why?

When I first reported on the over-prescribing of anti-psychotic drugs to children between the ages of 3 and 17 this past December, followed by the Johnson & Johnson and AstraZeneca stories in which both companies were charged with illegally promoting off-label use of their respective anti-depressant medication, it seemed that there was an emerging pattern.

For those who may not be familiar with the term off-label, what it basically means is that a pharmaceutical company produces a drug to treat condition “A,” but through physician experience with prescribing the drug, it is discovered that it is effective in treating ailment “B.”

At that point studies are to be conduct to test the veracity of the empirical findings.  During the intervening period, physicians are free to continue prescribing the drug as part of a treatment course for ailment “B,” hence the reference to it being an off-label drug in that it is being used for something other than which the pharmaceutical company recieved FDA approval.

Because the pharmaceutical company did not have it approved by the FDA for treating ailment “B,” they are not allowed to promote or market the drug for that particular use.  Part of the aforementioned restrictions includes offering incentives to clinics or doctors to prescribe it for treating ailment “B.”

This of course is where both Johnson & Johnson and AstraZeneca ran afoul of the law, as it was proven that they did in fact promote the off-label use of their drugs.  To make matters worse in the case of J&J, the off-label use was actually linked to an increase in the mortality rate of the drug’s biggest users . . . seniors.

Then in September, when the Avandia scandal broke in which GlaxoSmithKline had admitted to withholding vital data which indicated that their diabetes drug substantially increased the risk of heart attack in those to whom it was prescribed, it became clear that medicine had become blatantly commodotized.  Yes I know, big pharma equals big business, commercialization and commoditization are two very different things however.  Kind of like off label drugs if you get my drift.

So when I received information on an antiseizure drug prescribed under the brand name Topamax touting its effectiveness in treating alcoholism as well as other conditions including obsessive-compulsive disorder that old right knee started to ache.

For the purposes of clarity when prescribing Topamax (nee topiramate) as a viable treatment for alcohol dependency, a drug it is worth noting that was originally introduced as an anticonvulsant for patients with epilepsy,  doctors are basing its effectiveness on clinical trials in which it was proven that topiramate was “more effective than a placebo at reducing drinking and promoting abstinence in alcohol-dependent patients seeking treatment.  In short, and unlike my right knee, there is actually solid data behind the claimed effectiveness of the drug in terms of treating alcohol addiction.

So far so good . . .

It likely doesn’t surprise you that I did not stop there but, chose to dig a little deeper as the off-label effectiveness of any drug is to me reflective of a Reese’s Peanut Butter Cup commercial where after colliding the person eating  the peanut butter exclaims “hey, you got chocolate on my peanut butter,” while the other person who was eating the chocolate cries out “hey, you got peanut butter on my chocolate.”  A great way for a tasty candy treat to be created but, I am not so sure that accidents of a similar nature in the discovery of off-label usage is always a good idea.

Overlooking the fact that topiramate’s creator Ortho-McNeil plead guilty in May 2010 to promoting the drug’s off-label use for the treatment of psychiatric disorders despite the fact that there was no supporting data regarding its effectiveness – they paid a fine of $6.14 million U.S. which is the equivalent of half a day’s pay of the company’s CEO (just kidding about the CEO part?) – the list on adjunct diseases topiramate purportedly treats is well . . . astounding!

Once again, you have to keep in mind that this drug was originally introduced solely for the treatment of convulsions in epilepsy patients.

Since its introduction in 1979, it has received FDA approval and is prescribed most for the treatment of migraines, as well as being used in clinical trials to treat patients with post traumatic stress disorder, and being touted in studies as an effective drug for – do you have a pen handy? – infantile spasms, periventricular leukomalacia in preterm infants after an hypoxic-ischemic injury, essential tremor, bulimia nervosa, obsessive-compulsive disorder, alcoholism, smoking cessation, idiopathic intracranial hypertension, neuropathic pain, cluster headache, cocaine dependence and, when mixed with phentermine forms a drug called Qnexa which treats obesity.  It was the “mixture” reference that conjured up images of a mad scientist – or my older brother with his first chemistry set, relative to the obesity concoction.

Now don’t get me started on the equally lengthy list of possible side effects and patient warnings!

Of course the big question is this, how effective was topiramate at treating the original ailment for which it was developed and received FDA approval?  Based on research to this point in time i.e. a paper in the European Journal of Pharmacology dated March 11th, 1994 and titled “Inhibition by topiramate of seizures in spontaneously epileptic rats and DBA/2 mice” it seems to have done the job.

Further research pending, and referencing our Reese’s Peanut Butter Cup analogy, the question as to whether it can be mixed with the pharmacological equivalent of peanut butter, strawberries, whipped cream or any other “ingredient” to produce a new product remains to be seen.  The fact that it treats so many different (and I am certain that guys in white lab coats will say “related”) illnesses makes one wonder if perhaps the drug company’s primary objective with topiramate is to generate residual income from an old product in which the lions share of the costs have already been expended and handsomely covered?  Given the off-label fiascoes as of late, placing company profits ahead of patient interest is not an unthinkable scenario.

Now someone please point me to the nearest vending machine as I suddenly have an urge for a chocolate bar (or cup)!

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