Dear CEOOctober 3, 2012 • By Jeffrey Junig MD PhD
This is a repost of an article from 10/2/2012
I’m going to start by paraphrasing John Le Carre’s comments in his book The Constant Gardener: “Nobody in the letter below is based upon an actual person or outfit in the real world. But I can tell you this; as my knowledge of the pharmaceutical world increases, I come to realize that, by comparison with the reality, my letter is as tame as a holiday postcard.”
Dear Fictional CEO,
I have a question about your company.
Over a decade ago, you took an action unprecedented among cleaning-supply companies by gaining FDA approval to market a combination of two generic compounds. I do not know if you thought that compound N was necessary to gain approval of the medication, or if someone at your company had the prescience to know how things would eventually play out in your marketing department. Kudos if it was the latter.
You now know, I suspect, that compound N is irrelevant to the use of Product S to treat opioid dependence. You are aware that many people, even prescribers, often confuse the actions of compound B and compound N, mistakenly thinking that compound N does something to reduce cravings or improve the safety of Product S. It isn’t your fault that people get it wrong. True, you spent only fractions of your huge profits on educating psychiatrists, surgeons, ER doctors, and nurses. But just because their ignorance plays into your marketing strategy does not prove that you WANTED them to remain ignorant. Perhaps you figured that education about your product was the responsibility of someone else.
Speaking of education, 12 years ago you fooled the FDA by showing cases of several French people who died from improperly using compound B, and used the cases to justify adding compound N to your product. Never mind that those deaths would not have been prevented by compound N, a low-affinity, short half-life opioid antagonist with little ability to out-compete compound B at the mu receptor— the idea– that the compound N would precipitate withdrawal if Product S is injected, yet do nothing when taken properly, was pretty cool– especially compared to the drudgery of making rat poison!
Maybe the FDA needs more cynics, because they didn’t notice that adding compound N was an effective way to turn a cheap, generic compound– B– into Product S, a cash cow for your company. Even if they had noticed, would anyone really expect you to save opioid addicts WITHOUT the huge profits? I don’t think so!
So I cannot blame you for how things have played out up to now. Almost all is fair, in the world of business. And I understand how horrible it must have been over the last five years, as generics threatened to kill off that cash cow. You needed a strategy to protect Product S. That unfair Patent Office only gave you a few (well, 8 or 10) years to rake in profits, before going back to the unglamorous, less-profitable world of cleaning supplies. No limos for those guys! Time flies when you’re making money… and next thing you know ANYONE can make Product S! How uncool is that– suddenly you would have to live on only typical profit margins, or even invent a new product like other companies have to do to keep the cash flowing. Bummer.
I get a bit confused at this point. Let me get this straight… after making tons of money off Product S, knowing that someone ELSE is going to make their own cheaper version of Product S, you decide to kill off Product S for EVERYONE? You make Product S-F, and go back to the FDA (heck, they covered your back once!), and say that the product that made us ALL THAT MONEY is a BAD PRODUCT. And you just figure this out now, at the same time your patent expired—just when other people are able to make Product S. Am I getting it right?
Correct me if I’m wrong, but it looks like you somehow got a whole bunch of people—insurance companies, state Medicaid agencies, etc— to require the use of ONLY Product S-F. You told everyone that Product S (that you were still selling tons of) wasn’t as ‘safe’ as Product S-F, so they should only use S-F. It somehow worked; you got close to 70% of those people to require patients to take Product S-F… even though your claims about safety were pretty silly. Never mind—they actually believed you!
I admit that I do not understand why those insurers and Medicaid agencies were so short-sighted. Surely they knew what was going on—that you were only trying to destroy Product S for everyone, and take away a market for generic competitors. Didn’t they recognize that whatever discounts you bribed them with, would be peanuts compared to the savings they would eventually get from generics? How did you pull it off?
The icing on the cake… I read last week that you are PULLING Product S and ONLY selling Product S-F. You hired a company (YOU hired THEM!) to show that Product S was unsafe, to justify pulling it. Again, you did this just as other companies were in a place to make Product S themselves… at a much lower cost than YOUR product. Your people are saying that 4 kids died from Product-S over the past 5 years. They didn’t mention that Product-S saved tens of thousands of teenagers over the same time, and they didn’t say that the companies about to make it so much cheaper would save tens of thousands more. I guess that is a tough calculation— I mean, who is worth more, 4 young kids or 20,000 teenagers?
Most people would be satisfied with the sequence of events and call it a day. In fact, most people would feel a bit shameful, knowing that they just completed a strategy that 1. Mislead medical science into buying your product for ten years, when plain old compound B would have done the same thing all that time—at a fraction of the cost; 2. Prevented effective education about compound B that could have saved many thousands of those who died from overdose over the past ten years; 3. Bypassed the usual conditions in the world of pharma where a company can make billions of dollars for years, but eventually allows generics to make the product, so that poor people and people without insurance get a chance to save THEIR lives too; and 4. Tricked insurers and agencies into forcing patients to use not the cheaper drug, like they usually do, but your EXPENSIVE drug—causing those same groups to limit life-saving use of the drug to only a year or two, since they can’t afford to cover your expensive one indefinitely.
You’ve accomplished quite a bit. But I just read that you aren’t resting on wilted laurels. Even though insurers and agencies are forcing people to buy your expensive product, there are people with no insurance and no Medicaid who have the gall to buy a generic form of compound B. Sales of the generic are only a fraction of your sales, and some reasonable people would say that even poor people have the right to take life-saving medication, just like the rest of us. But you are filing a ‘citizens’ petition’ with the FDA to have that medication—the affordable one that is saving all those poor people—taken OFF THE MARKET.
And now my question:
Are you SERIOUS?