FDA-approved vs. Off-Label Drugs: Which Is Best?

  By Dr. Jeffrey Maehara | February 20, 2012 - 6:29 am | Uncategorized
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The Food and Drug Administration is an agency of the US department of Health and Human Services.  The approval of pharmaceutical drugs is one of the agency’s many duties.  A drug that has met the Agency’s criteria via testing and review, is stamped “FDA-Approved.”  Those drugs which have not met criteria, sadly, are “UNapproved.”  The process of approval is intended to determine drugs as safe for an intended use, and also to thoroughly evaluate any adverse reactions and risks.

Now, we all know the story of drugs removed from the market due to severe side effects, health complications, and even death.  The recalled products are many, and this should be a clear indication that the FDA-Approval system is certainly no more fool-proof than a presidential election.  Caveat emptor never rang more true than today.

It is simply not possible for the FDA to evaluate all drugs and medications on the market.  Mostly, this limitation is financial.  The process of obtaining new drug FDA approval entails a horrifically enormous price tag.  Trust me, Nieman Marcus aint got nothing on the FDA.  If you ever wondered why an approved drug is so expensive at the pharmacy counter, this is where you start looking (in contrast to assuming the pharma companies are stealing from you).   Remember, for both drugs that ultimately are approved AND those that fail the approval process, the financial burden on the pharmaceutical company must be recovered somehow… unfortunately, we are the somehow.  Also note, when this process is no longer financially feasible for the pharma companies, who will bring innovative new drugs through research and development and to the market?  The government?  NO!  That’s when the medical marvel gears of innovation stop… but that’s a whole other blog… back on topic…

Drugs that are both FDA-approved and unapproved are also strictly limited in how they can advertise a drug- for benefits, risks, etc.  A drug approved for the use in a specific type of infection, can only be labeled and advertised to treat that specific type of infection.  A drug that may clinically work for several conditions can only be labeled to treat those conditions which have gone through the FDA process and been approved.  A product or drug that has been approved to treat a specific condition but is used to treat a condition NOT part of the approval, is then being used in an “off-label” fashion.

When estradiol (a common form of bioidentical estrogen replacement), an approved drug, is “compounded” by a pharmacist (under direction by a physician) into a cream containing a specific dosage – it now becomes “off-label.”  It’s now off-label because the dosage is different, the form (vehicle) is different, and possibly the indication (what the drug is being used to treat) is different.   The FDA recognizes that compounding pharmaceuticals can be a more effective mode of treatment for some patients, and it does not seek to halt pharmaceutical compounding.  At the same time, you must realize that the risks and safety of this altered form of use has not be evaluated by the FDA.

To emphasize the functional limitations of FDA-approval in real-life medical practice, consider the following example:  Antibiotic eye drops are FDA-approved and indicated ONLY for bacterial conjunctivitis (bacterial surface eye infections).   The most common prescribed use of the product is pre-operative and post-operative eye surgery (cataract surgery, LASIK, etc).  Every one of these peri-operative prescriptions is then off-label.  What I’m saying is that these drugs are used more off-label than on-label.  Furthermore, you would be a fool not to insist on using these eyedrops before and after any eye surgery, despite its off-label use.  Can you say, “system FAIL?”

So we’re back where we started- caveat emptor…well, not exactly.  Now that you understand the definitions, your experienced bioidentical hormone expert can help you decide on the treatment that is best for you.  It goes without saying that the FDA could never replace a knowledgeable physician with your best interests at heart.  We have experience with many compounding pharmacies, but have maintained relationships with only those that have proven consistent quality control as evident by happy patients.  How happy are you now?

 


Stress, Anxiety, Life… What’s your FIX?

  By Dr. Jeffrey Maehara | February 16, 2012 - 7:41 am | Key Hormones
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There’s a new TV program on the National Geographic Channel – Doomsday Preppers.  It’s a program about real life people who are preparing for any interpretation of Doomsday.   I mention it because we’re about to talk about cortisol.  Cortisol imbalance often leads to Adrenal Fatigue- one of the biggest hit phrases for hormone imbalances.

Even without seeing the TV program, you can imagine the Doomsday Preppers stock piling supplies, food, and other essentials.  In similar fashion, when your body is stressed in any way, it releases excess cortisol.   Cortisol is your personal doomsday prepper.  It will make all preparations for survival in your stressed state.  Foremost, you’ll need energy stores.  Cortisol will alter your insulin utilization so you will store energy… essentially, it will make you fat.  Yeah, now you’re paying attention!  Well, there are many other undesirable cortisol interactions, but a second of interest to you might be lowered libido.  Cortisol abnormalities are also the most likely cause for limited subjective benefit from bioidentical hormone replacement therapy.  In that sense, I call it the “cort-blocker,” due to its ability to prevent the benefit of other hormones.

So what do we do to keep cortisol in check with our American lifestyle of long work hours, financial stressors, and inadequate sleep?  We often prescribe adaptogenic herbs, adrenal extracts, and relaxation: Tai Chi, yoga, prayer, massage, chi-gong.  The fact is, it doesn’t matter- pick your fix.  Choose anything that is truly relaxing to you.  I discourage exercise as an answer.  Most people over-exercise, stress their system and release even more cortisol…that’s not relaxation.

It took me years to find my fix.  I tended to linger around massage.  The problem is it was difficult to schedule a massage in advance.   It was also costly, and sometimes the massage was too hard, sometimes too gentle.  I finally purchased a massaging hot tub for my fix.  15minutes and I can melt a full day’s stress.  I’ve used it at least 5 days a week since I’ve gotten it- probably the best purchase I’ve ever made in my life.  The point here is everyone’s fix can be unique and different.  It doesn’t matter, as long as it works for you.   Most of the battle is to actually discover your fix… so what’s YOUR fix??


Longevity vs Inflammation

  By Dr. Jeffrey Maehara | November 18, 2011 - 3:22 am | Supplements
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Longevity vs. Inflammation. This is the “Rumble in the Jungle,” the MAC vs PC – a battle of true superpowers. The outcome of this continual confrontation will determine your destiny. Will it be cardiovascular disease, stroke, colon cancer or maybe… you’ll literally lose your mind. At this point, the method of your demise doesn’t matter (later it will). What does matter, however, is your ability to modify the outcome of this parable.

Studies have provided convincing evidence that chronic inflammatory disease is associated with increased mortality. Essentially, chronic inflammatory conditions result in you dying sooner. By dying, I mean death by all causes. By sooner, I mean prematurely. Thus, inflammation is continuously at war with longevity.

An additional thorn is that some inflammation is sub-clinical. That means you may not even know you live with this festering problem. Like a sleeper-cell terrorist living in our midst, inflammation is planning your demise. What you need here is the greatest weapon of all – knowledge and intelligence.

Directed and purposeful lab testing can identify many of the hidden sources of inflammation within your body. A well devised attack planned by your BodyLogicMD physician can then put this inflammation back in check. Yet some early and dangerous inflammation still will evade modern reconnaissance missions. So what to do but die slowly? Inflammation wins!!

Not so fast, there’s a few laps left in this race. Our last chance here rests purely on our medical knowledge. Let’s think, why does aspirin, given in cardiovascular disease, decrease mortality? Because it thins your blood… BZZZZ! Not necessarily. The effect is also, and possibly more so, associated with it’s anti-inflammatory effect.

So, how about a good plan for anti-inflammatory supplemention? Perhaps, EVERYONE should be on one… But what would that plan consist of? Here’s a hint. … and then some… hey, this is a blog, not a textbook :)


The Magic Bullet: Testosterone Pellets

  By Dr. Jeffrey Maehara | October 29, 2011 - 8:15 am | Testosterone
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Well folks, I’m flying back to Honolulu from a medical conference in Orlando and I feel my T pellet fading… A little less driven, less motivated, a little foggy and just a tad less sharp overall. So what better time to blog about the magic bullet: the bioidentical testosterone pellet. By the way, I opted out of the TSA image screening at the airport (even millimeter wave) but that’s a whole other blog.

I find there are two important aspects of hormone therapy that are commonly overlooked by patients. The first is that individual hormones have a plethora of benefits throughout your body. Everyone knows testosterone improves muscle mass and many also know it supports libido. Did you also know it supports your bones, blood, cholesterol balance, cardiovascular function, and your mind? – just to name a few. When your wife calls you grouchy and you can’t remember names of people you met last week- that’s your low T. Your wife never gives it up anymore- that’s probably her low T… But please remember these are just the obvious symptoms.

The second commonly overlooked aspect is delivery. Would you simply mail your wife her engagement ring? Did you hand it over like a set of keys? No! However you planned your proposal was all part of your DELIVERY. Your delivery had a role in her RESPONSE. Likewise, the method of hormone delivery can drastically alter response. All aspects of why response can vary amongst hormone delivery methods are not completely understood. In terms of libido, there are countless women who obtain lab-value improvement with T cream but who also DO NOT feel improvement in libido. Enter the magic bullet…

Like a grumpy old werewolf hit by a silver bullet, a testosterone pellet will convert you back to the human you once knew and the man you want to be again. With a quick numbing shot and a tiny hairline incision, I can insert one or more bioidentical testosterone pellets into your buttocks that will deliver physiologic testosterone over the next 3-5 months, hassle-free. I recently saw a patient with super-high topical testosterone cream dosing that was horribly frustrated with “failure to respond.”. I prefer to call it, “failure to deliver.”. When we deal with creams, there simply is no way to determine exactly how much T you are getting with each delivery and how your levels fluctuate throughout a 24-hour period. This is not to say that creams don’t work, but some patients may be very sensitive to this dosing fluctuation- and that may limit their clinical response. We know pellets release T in a steady and predictable fashion that probably accounts for the improved patient clinical response and the magic bullet theory. In addition, studies have shown that the testosterone in pellets, in contrast to topical and injection delivery methods, is not readily converted to estrogen by enzymes found in fat throughout your body. And we all know, too much estrogen is very undesirable (again, another blog).

So why not injections?
Think of your car’s gas tank. Assume you only fill the tank on Mondays (since T shots are usually given weekly). What does your tank look like on Wednesday? How about Saturday? I’m sure you now see this dosing is not very physiologic. When patients ask for this form of delivery, I simply request they schedule all hot dates on Monday, Tuesday, or Wednesday when the tank is still half full. Again, this is not to say that injections don’t work but you can see why I prefer pellets.

So How well do pellets work?
Pellets work so well for most patients that they are acutely aware of the time when their pellets wear out. The last male .patient in for replacement pellets this week described feeling like he “has the flu” when the pellets start fading. It’s a good thing this “flu” isn’t contagious, I commented, since most people actually prefer the real flu to T deficiency!

As a final note:
Diet, disease, smoking, obesity, elevated cortisol from stress, and common medications can also decrease your T. A thorough health evaluation with lab assessment is essential to successful bioidentical hormone replacement therapy. Everyone, male and female, should know their T level. I know mine, do you know yours?


Andropause… Where’s your ManCard?

  By Dr. Jeffrey Maehara | October 20, 2011 - 2:17 pm | Male Hormones/Andropause
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Andropause?  Fat and soggy with lack-luster performance… just getting by?

Feel like your mind speed can’t surpass the old Intel 486 cpu’s?  Not you… or Not sure?  Luckily, this is a blog so go ahead and list your symptoms for review.  Meanwhile, let’s take a closer look at this irritable, forgetfull, and fluffy shell of the former you.  Select an applicable definition:

andropause /an·dro·pause/ (an´dro-pawz) a variable complex of symptoms, including decreased Leydig cell numbers and androgen production, occurring in men after middle age, purported to be analogous to menopause in women. Dorland’s Medical Dictionary for Health Consumers. © 2007 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

Nope, too technical, let’s try again:

andropause  A constellation of changes that occur in older men, including decreased libido, sexual performance, decreased sperm quantity and quality, erectile dysfunction, frailty, decreased muscle and bone mass, and increased body fat.   Segen’s Medical Dictionary. © 2011 Farlex, Inc. All rights reserved.

Better, but here’s my favorite, the consequential definition:

 andropause [an′drəpôs] a change of life for males that may be expressed in terms of a career change, divorce, or reordering of life. It is associated with a decline in androgen levels that occurs in men during their late 40s or early 50s.  Mosby’s Medical Dictionary, 8th edition. © 2009, Elsevier.

Yikes!  This certainly doesn’t sound socially acceptable to me.  But, it naturally occurs to all men in some form.  The good news is we can grind down your prickly edges.  Yes, YOU can be fixed!  You can, indeed, be restored to enjoy the glory of your past vitality.  The secret is bioidentical hormone replacement therapy.  But where do we start?

Lab tests!  There’s nothing better than an abnormal lab result to end one’s relentless denial and stamp your biceps with a reality check.  It can also show how far “off-balance” you are, and pin-point the severity of your testosterone deficiency.  So, let’s put this in MANLY terms we all can understand.  Men like fast cars, right?  (Please don’t say you “used to”)

In the year surrounding 1963, Ferrari made 36 examples of the 250 GTO.  It is extremely rare, and perhaps the most prized auto ever.  In it’s prime, it was a devastating competitor.  Just like you in your prime—morning erections, energy for a run before work, 10-hour work days, and juice leftover for evening playtime.  Sadly, over time, you just couldn’t keep up with yourself.  Like the 250GTO, eventually your valves got leaky and the chassis rusty- Glory no more.  Surprisingly, there’s more good news in this scenario.  The last 250 GTO exchanged hands for reportedly $28 million (you heard right, 28 million dollars!@#$%)… so, you think it might be worth the tune-up??

That’s exactly what you need — a “tune-up”… a bioidentical hormone tune-up.  In this case, your mechanic is a Bioidentical Hormone Expert.  I measure, diagnose, and provide treatment.  I restore and balance hormones.  I encourage healthy lifestyle choices in diet, exercise, relaxation, and directed supplementation (zinc, for example, in the case of testosterone deficiency).  That’s how this works, that’s how you get that “edge” back.  It’s time to turn-in your dilapidated man-card for a new hand.  Before you know it, you’ll be getting offers for millions… but guess what?  You’re not selling!