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Evil Pharma II, or How a Candidate Drug Progresses to Market

When last we left off (Evil Pharma section), we had just discovered a very promising drug, but knew little about it other than it seemed to work well in our screening of hundreds of thousands of drugs for efficacy. For the sake of this discussion, let's say that the drug is an anti-anxiety drug (a huge market) and we'll give it a name: Ateez.  From what we know about Ateez so far, it is relaxing without causing sleepiness, mental confusion, or dependence (dependence means that if you take the drug for a long enough period of time, you'll have to slowly "taper" your dose downward if you want to stop taking it without discomfort, rather than just stopping taking it abruptly; tapering is a good idea with most drugs, by the way). Speeding forward a few years, we now have Ateez in a nice pure form, in a formulation (tablet) and we've made enough of it for the drug's first test: safety (Phase I clinical).  We're all excited about the outcome, because Ateez looks like it will help a lot of people without the side effects of current drugs.

The results of the safety clinical are finally available!  Ateez was apparently safe, but the people that took the drug didn't report any sensation of feeling more relaxed.  How could that be when it worked so well on mice?  When we did the safety tests on mice, the mice  were very mellow.  Hummm...bad sign, but Ateez has looked so promising and everyone is so excited about it, we'll have to have a clinical trial with Ateez versus placebo to see how well Ateez works, for a few million dollars.

The results of the efficacy clinical are finally available!  Ateez was slightly better than placebo in relieving anxiety.  Oh, and about 10% of the people that took Ateez had heartburn.

Before this becomes a Shaggy Dog Story of several pages length, here's the point: pharmaceutical companies are always faced with the question of whether to try and market a less-than-perfect drug-because all drugs are less-than-perfect.  And remember, the company has been developing Ateez for years now and everyone associated has gone from hoping that it will be a good drug to being absolutely convinced it will be a Great Drug, probably worth a billion dollars a year, like the CEO said in many a press release.

Go put your best business suit on: you're going to go and talk to the CEO about Ateez.  Here are your two possible speeches:

1] "Dick, (ever notice how many CEO's have the first name 'Dick' or 'Peter'?) here's what we know about Ateez: it works very well for some people, some people it sort of works, and some people just get heartburn.  Sure, it has a better side effect profile than, say alprazolam (trade name Xanax), but it is not in the same league as alprazolam in terms of it's ability to help people with Generalized Anxiety Disorder, Panic Disorder, etc.  I know we've invested a couple hundred million dollars in this drug, but do we really want to put more money into it and put a second-rate drug on the market?  I know you've told everyone in the civilized world that Ateez will be a billion dollar drug for our Company and I also know that if an employee even questioned the wonderfulness of Ateez, she might get herself fired, but how about we just take our $300 million loss and move on to something more promising.  Oh, yes sir, I know we don't have  a lot of promising drugs to fall back on and that you and The Board were absolutely counting on Ateez".

or

2] "Dick, the safety and efficacy trials went well...it's just like you've been saying, we have a big winner here with Ateez.  Sure, some people  get heartburn, but all drugs have side effects-and with our aggressive sales force, they can convince the physicians they visit that Ateez is so much better than, say, alprazolam-after all, fewer side effects!- and you know how huge the market is for alprazolam!  And our employees and project managers think of Ateez as "their baby"-we don't want to disappoint them, either, after all, how long can you motivate employees if you don't bring their last five years of dedicated work to market to help people?"

I hope my little tale has given you the feeling that drugs take on a life of their own which is independent of their therapeutic value-the drug becomes valued because so much money has been put into it, so many people have parroted how wonderful the drug is, and how much money it will make for the company.

Unlike what is sometimes written, pharmaceutical companies are not Evil, they just are comprised of fallible human beings-for example, did you pick [1] or [2] above for your speech to the CEO?  Good.  I didn't want you to lose your job.

Another consideration, which I'll write about at length another time, is the role of side effects.  Alprazolam, the drug I mention in my story, is a real drug and is used as an anti-anxiety medication.  Search the internet and it won't take you long to find entire Web sites that dedicate themselves to the horrors of taking alprazolam or other benzodiazepines like Ativan, Valium, or Klonopin (I'm using the trade names in the hopes they are more likely to be familiar to you).  Depending on which source I cite, alprazolam (Xanax) is the most prescribed drug for anxiety, period.  But wait!  What about the side effect-that is strongly "addicting" (the Web sites really mean "causes dependence", but forgive those Web sites, they are trying to scare you (and your physician), not to inform you.  Yes, alprazolam does cause dependence, but the reason it is prescribed so frequently is because it works. Putting yourself in the role of either the patient or the physician, do you want to be prescribed/prescribe a drug that is somewhat safer, but doesn't work, or a drug that does work but has undesirable side effects?   So maybe sometimes it makes sense to put a drug on the market knowing full well that it has significant side effects.  Or maybe not.  You decide.

 

 

 

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