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No Fan of Pills but No Fan of Prejudice Either

Posted Jul 16 2010 9:45am

by Barbara Berkeley, MD

Readers of this blog know very well that I (vastly) prefer healthy behaviors to pills for the prevention and treatment of most of our modern medical problems.  But the FDA's approach to potential weight loss medications is frustrating and, in my view, prejudicial.

First, there was the FDA's denial of Rimonabant, a weight loss med that has been in use in Europe for some time.  The FDA based its thumbs-down ruling on Rimonabant's potential to cause depression and suicidal thoughts.  Data from long term trials in North America and Europe, however, suggest that while these effects are real, they generally occur early in treatment and disappear after the first year(see  Rimonabant Data ). in the European market, this problem was dealt with by new labeling and by educating prescribers on proper drug usage.  American physicians are no strangers to the use of medications that have deleterious side effects,including depression.  Most of our popular (and excessively prescribed) antidepressants carry warnings about increased suicidal ideation.  Beta blockers, routinely used for heart conditions and blood pressure, can intensify or cause depression.  So can anxiety drugs like valium or xanax, narcotic pain relievers, and a host of other medicines.  Why then is Rimonabant denied?

For the past couple of years, there has been a buzz around a new weight loss med called Qnexa.  Like its highly effective but controversial cousin Phen-Fen, Qnexa is a combination medication.  For some time now, obesity specialists have believed that weight gain might be better treated via multiple pathways.  This means mixing drugs in order to strengthen their individual effects. 

Qnexa is a combination of two medicines:  phentermine and topirimate.  The first component, phentermine, is the same drug that formed half of the Phen-Fen combo.  It is an appetite suppressant which has mild stimulatory effects.  When given alone, it has not caused any of the problems seen with Phen-Fen, and has been used safely for many years.  Most weight loss doctors use it (even me, although rarely), but its efficacy is limited by the fact that tolerance develops rather quickly.  Within a fairly short time, appetite suppression is lessened and the drug stops working.  Side effects include increased heart rate and blood pressure and the potential for extra or skipped heartbeats.  Some people report jitteriness or insomnia.  For most, though, these effects can be mitigated by carefully controlled dosing. 

The second component of Qnexa is a relatively small dose of Topirimate, more familiarly known by its brand name Topamax.  Topamax was originally developed as an anti-seizure drug, but soon gained popularity as a migraine preventative.  When patients taking the drug noticed associated weight loss and appetite suppression, it began to be used off-label for weight control.  Topamax can cause confusion, word-finding difficulties, kidney stones, and a serious problem called metabolic acidosis.  However, many people take Topamax for currently approved indications without difficulty and at much higher doses than those included in Qnexa. 

Clinical trials with Qnexa have shown it to be moderately effective as a weight loss drug, but yesterday, the FDA panel charged with reviewing Qnexa disapproved it, citing side effects.  This dismissal is seen as a foreshadowing of the fate of two other drugs (contrave and lorcaserin) that are currently in clinical trials. 

At the moment, doctors basically have only two prescription drugs for treating overweight:  sibutramine (meridia) and phentermine (adipex).  Neither drug is particularly harmful and neither drug is particularly effective.  Despite this fact, these drugs are controlled as if they were the most destructive medications on the face of the earth.  In the state of Ohio, for example, use of the drug phentermine is limited to a three month period (unheard of for any other medication).  Doctors must document that their patient is, in fact, obese prior to prescribing the drug.  The patient must show a documented weight loss while taking the drug.  The prescription must be written for three consecutive months without a break.  If there is a disruption, the prescription will not be filled.  Pharmacists can question the honesty of the physician.  I have personally received calls from pharmacists who wanted to know whether a certain patient really had a BMI of 30. In their judgment, the patient didn't look heavy enough!

  Patients who are given prescriptions for weight loss drugs are often treated as if they were asking for heroin.  Many of my patients have been told, very dismissively, "We don't carry that!".  They are made to feel embarrassed and demeaned.  Contrast this attitude toward weight loss drugs with the attitude toward narcotic pain meds.  Any dentist can prescribe truly dangerous medications like vicodin or percocet in large amounts.  I can send a patient out of my office with a prescription for fistfuls of oxycontin and I can renew that prescription monthly ad infinitum.  No patient will ever be questioned or looked at askance at the pick-up counter.  And I can guarantee that I will never get a call saying that the patient in question looks like someone who doesn't "deserve" their medication.

Weight loss medicines don't work very well, but for some people, they are at least a small raft they can cling to.  Both my patients and I have experienced prejudice around the prescription and consumption of such medicines, despite the fact that in the big pharmaceutical picture (including side effects), weight loss medications are minor players. I believe that the refusal of the FDA to forward new weight loss meds smacks of the same prejudice and hypocrisy as the suspicion at the drug store counter.

Are we saying that it is ok for medications to have multiple side effects so long as they treat "important" and life threatening conditions?  What could be more life threatening and important than a condition that is killing 300,000 people yearly in America and is consuming 147 BILLION dollars of our annual health care budget (CDC estimate)? 

I suppose I should be happy that the FDA is protecting our overweight citizens from medicines that they might take indiscriminately and which might cause them harm, but I can't get past the fact that the FDA seems to be trivializing the obesity epidemic with their decisions.  Personally, I am looking for a medication to help stabilize people in the first year or two of maintenance.  That medication might be one of the recently denied drugs, used judiciously and for a short period.  Now I am left without any ammunition, forced to make a choice as to whether to use drugs in an off-label situation, which shifts the liability to me.

All the blame for our lack of weight loss meds does not fall on the FDA.  One of the major reasons for caution with these medications is the history of the weight loss industry.  If it were not so full of charlatans and pill pushers, if people had better and more thoughtful treatment, and if more physicians understood more about the problem, we would not have such a skittish FDA.  As things stand, I can't blame them for wanting to limit access to drugs that have such potential for over-prescription and abuse.

Still.  These FDA rulings make me feel that, once again, the powers that be are making the statement that obesity is simply a matter of self-control, and unlike those "important" conditions, we can do just fine without adequate medical options.  Will we still feel that way when 90% of our population is overweight?

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