Prescription Diet Drug Makes Food Taste Horrible

My psychopharmacology preceptor told me a long time ago that the best and most efficient way to know what is happening in pharmacology is to check out the business news.  He was right.

I want to applaud the FDA for doing something perhaps a bit audacious, surely without precedent, but something I consider correct and appropriate.

They declined acceptance of Contrave, a pill for obesity, and requested a longer term and larger study.Bravo.  It’s rare that I give the FDA a “standing O.” The folks at Orexigen pharmaceuticals concocted Contrave — an amalgam of 400mg. of Wellbutrin sustained release and a couple of different doses of naltrexone, 48 and 16 mg. Here is the clinical trials record if you are interested.

Anyone who puts together a drug that is a combination of two previously approved drugs is doing it exclusively to make money with as few clinical trials as possible.

Making money from existing compounds is not all that tough.  Coming up with original compounds is. The two drugs in Contrave are both safe enough to have been already approved separately by our friends at the FDA.  Wellbutrin is a well-established antidepressant which I would say when consulting at a county clinic I dish out at least 10 times weekly. I know it has raised pulse and blood pressure in some folks and there were some cardiac problems with it in earlier clinical trials.  Of course, anyplace I work I am compulsive about testing pulse and blood pressure and if the clinic has no way to monitor this before I prescribe, I kick up an unparalleled fuss. (Yes, I’ve practiced in clinics that lacked so much as a blood pressure cuff – too many clinics like that). Chemically, let’s just say it is a really distant cousin to the amphetamines, and is often used as an antidepressant for people who are coming down from amphetamines (or crystal meth) kind of depression.

I will admit that my attitudes have been colored by the fact that some of my less discerning patients — the inmates of California state penitentiaries — have crushed it and snorted it and some have even died that way.

When it first came out, major concerns were that it lowered one’s seizure threshhold. Whatever.  I have certainly dished out my share of Wellbutrin (bupropion) in all its incarnations, including a recent one called Aplenzin which is a long sustained release – which is another ploy a company comes up with to make money when their patents are about to expire.

They tried to score some brownie points by giving a bunch of it free to clinics serving indigent people in forgotten areas of rural California. But the catch is that when the company decides they’ve given enough away, at least some people will have to go off it and it might be difficult to transition them to something else (if the clinic is as poor as the people it serves). This has been my experience which comes with longevity and I have seen this problem happen time and again with all kinds of drugs.  The patients get stuck with nothing or something substandard. My real problem with this drug is with the side effects that are less likely to be reported on the FDA system.  The differences between it and other antidepressants that may be serotonergic. The latter (Prozac, Zoloft, Paxil) have some anti-anxiety effects.  Not so Wellbutrin, where patients have come up with everything from panic attacks to general anxiety.  I get lots of patients who have needed benzodiazepines, my un-favorite medications, with this antidepressant, just to hold it together. Naltrexone is more likely to be used by an emergency room physician than by a psychiatrist.  If someone comes in with what looks like an overdose of opioids (heroin or similar drugs) you give them some of this, and they often come out of it. They also are not always happy.

I remember vividly the one time I gave the intravenous form to an overdose victim in a life-threatening coma, he sat up and belted me in the mouth.  It happened in France, but such reactions are reported in the US also, probably by other doctors who’ve been belted in the chops.

There are recent trials that show that this drug screws up the taste of things – which would certainly make people want to eat less.  I have also prescribed an unrelated drug (topiramate or Topamax) which has been shown to have some weight loss properties — mainly because it makes foods taste like cardboard according to more than a few of the patients I have given it to. The 48mg. dose of naltrexone is only 2 mg. away from the 50mg. dose that I use, at least at the outset, whenever I can convince someone to take it as a treatment for — would you believe — alcoholism.  I don’t give out Antabuse anymore, as it can kill a person, but naltrexone is harmless.  It seems to do a pretty good job of stopping alcohol cravings.

Of course, before prescribing naltrexone safely, it is necessary (in my estimation) to check the person’s liver functions, as although I can avoid killing someone by prescribing this drug, I also want to avoid screwing up their liver, which in at least some cases is already seriously screwed up by alcohol. Back, however, to the idea of giving something that could make food taste rotten in order to lose weight. Naltrexone is an anti-opiate.  We’ve all got opiate receptors in our own brains.  They are responsible for so-called “runner’s high,” as well as intellectual high, which is more my speed (thank you universe).

What happens to these sensations with this kind of a drug?  Nobody knows for sure if they disappear as most patients known to me have never had them anyway.  I have had patients go off this and sometimes they don’t want to tell me why.  When I dig a bit, I get answers that sometimes have to do with “nothing is fun anymore.” Look, anti-obesity drugs have a big market.  The 5% body weight loss in 50% is pretty good, admittedly.  For the mathematically challenged, that means that half of the people who take the drug will lose about 10 lbs. if they weight 200 lbs. People will dive for a pill to solve this problem. Medical science has little or no handle on what causes the problem, but I will bet all the money in my purse that it is not something that could be reasonably expected to be treated by either of these drugs. It is certainly not taking excessive pleasure in food, which may be what naltrexone corrects. It is not low dopamine or noradrenalin, which may be characteristic of depression, which may be what bupropion corrects. “Safe” does not mean “comfortable”  or even “pleasant” — and may not mean, in at least some cases, compatible with other commonly taken drugs or pre-existing conditions.  We have no idea about drug interactions yet, and many obese people are on blood pressure, cholesterol and maybe even more serious medicine – like heart or kidney. When family practice doctors started using bupropion wholesale for smoking cessation, it only took me a few days to see a previously stable bipolar patient who went manic.  Not just hypomanic (mildly manic), but so wildly manic he had to be hospitalized in the psych unit. This is going to sound familiar to you — the attempt to market this cheap-to-develop drug for obesity is not a pharmacological decision, but an economic one.  In other words, it’s not done for the good of the patients or for public health, it’s done for the economic health of the corporate bottom line – which keeps the stockholders really happy.

The proof is that after the FDA asked for a longer term study before considering approval on February 2, the CEO of the company was fired on February 16. People are wailing.  The FDA went against its own advisory committee. The FDA has not approved a diet drug since Orlistat in 1999 — known as “Alli” to the general public, but known to us specialists as “poopie-pants” because it causes diarrhea.  Talk about unwanted side-effects.  I would think most people would be more comfortable in public with obesity than to be shunned for – umm – hygienic reasons.

Let’s just call it a “socially stigmatizing situation.”

The truth of the matter is that people will probably end up taking this medication for a lot longer than any of the cheap clinical trials to date have tested it for and will probably end up abusing it.

Somebody at the FDA is more insightful than I have given them credit for. The FDA finally got rid of Meridia — an amphetamine that sometimes caused sudden death — a few years after I told my physician I would not risk taking this dangerous crap and he should be ashamed to be pushing it on people.

I told him then and would tell him again that with even a little chance of that side effect, I would rather be a live overweight human being than a dead doctor. My old preceptor was right.  I learn more about drug development from the business pages than anywhere else. As for obesity, the biggest danger is desperation and impatience.

You don’t have to get radical surgery, you don’t have to take dangerous drugs, you don’t have to work out until you either get a heart attack or just plain collapse, and you don’t have to eat nothing but salads.

I’ve been on that journey myself, and I’m happy to share my personal experiences in hopes that it helps others who are as unhappy with their bodies as I was.

Life should be a happy experience, and every facet of life should give you pleasure.

You shouldn’t have to take extreme risks to become healthier and happier.

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