Tuesday, April 12, 2016

Direct to Consumer Drug Advertising: There's a Sucker Born Every Minute

Have you seen them? TV and print ads advocating the use of a new drug called Rexulti as something that can be used to augment an antidepressant when the antidepressant alone does not completely relieve all of your symptoms. These ads are only slightly different than ads you may have seen in the past for Abilify, which was also touted for the exact same indication.

As it turns out, both of these drugs are manufactured and distributed by the same companies: Otsuka Pharmacuetical Company and its marketing partner Bristol-Myers Squibb. And guess what? Abilify recently went generic (which means its original manufacturer has lost its patent protection and therefore its monopoly on the drug) under its chemical name, aripiprazole. 

Rexulti's chemical name seems oddly similar: brexpiprazole. Coincidence?

Well here are pictures of the chemical structures of the two compounds.

Remarkably similar, no? In fact, these drugs have effects on people that are nearly identical, have only slightly different side effects, and they both have the exact same indications. And of course they are not antidepressants at all as many of you have probably been led to believe, but antipsychotics: meant to treat delusions and hallucinations in schizophrenia, bipolar disorder (the real kind), and major depression with psychotic features.

(BTW, we've always known that any antipsychotic medication can augment an antidepressant in some patients. However, they have potentially very toxic side effects, and there are other, safer drugs which can also augment an antidepressant, such as lithium and a thyroid hormone named T3. I think benzodiazepine drugs such as clonazepam do as well, but drug companies are not about to do studies confirming that, because benzo's are so cheap and free of side effects).

There is one very big difference between Rexulti and Aripriprazole: the price. Generic Aripiprazole will be much, much cheaper. Why on earth would anyone ask for an expensive drug when a cheaper, nearly identical drug with the same effectiveness and nearly the same side effects is available?

Well of course they would not. Which is where the direct to consumer ads come in. The company wants to keep up its profits, so it pushes their new drug without any reference to their old one. And people are suckered into demanding it from their doctors. As someone once said, no one ever went broke underestimating the intelligence of the American people.

Now I can't prove that the company developed Rexulti in anticipation of losing its patient protection on Abilify, but the timing is a bit suspicious, wouldn't you say?

Drug companies have lots of tricks to extend their patent protections aside from just coming up with new conditions for which a drug is indicated, coming up with an extended release version of the same drug, or newly combining the drug with a second drug. 

Some drugs are converted to other drugs in the body which are in fact the compounds that have the desired effects (active metabolites). So after the parent drug goes off patent, they release the active metabolite as a "new" drug. Think Effexor vs. Prestique.

Some drug compounds come in two different versions which have the same chemical formula but different geometry - the two molecules (enantiomers) are mirror images of one another. One of the two versions may be effective for a given symptom while the other may have little effect. So drug companies first issue a mix of both versions (racemic mixtures), and when that drug goes off patent, they release a drug which is  the pure, active enantomier. Voila, new more expensive drug, new patent, and the clock keeping track of how long the company retains exclusive ownership of the drug starts to tick anew. Think: Celexa vs. Lexapro, and Prilosec vs. Nexium.

So if you pay attention to those ads, you will be being taken as sucker.

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