Crazy Week for Suboxone

Originally Posted 3/3/2013
What a crazy week for buprenorphine.  I’ve written about the FDA slapping the face of Reckitt Benckiser by denying their Citizens’ Petition.  Adding insult to injury, the FDA then approved two generic formulations of Suboxone tabs (actually, the correct name is buprenorphine/naloxone combination tabs).  Stock in RB dropped about 5%, but shares regained most of their price within a couple days, reflecting the balance of pessimism vs. optimism in the company’s ability to maintain stellar profit growth going forward.
In case anyone is wondering, I do not own shares in Reckitt Benckiser, and I have never owned shares in Reckitt Benckiser.  One nice thing about NOT having significant savings, I supposed, is that I can report my holdings (or lack of holdings) without too much effort!
If I WAS an investor, though, I’d wonder about the future of Reckitt Benckiser’s Suboxone, now that two generic competitors are hitting the market.  Some patients clearly prefer the tablet over the film;  will state medicaid agencies go back to covering the tablet, which will likely be cheaper than the film?  Will insurers cover the tabs?  Or will both groups continue to buy into the marketing scheme of Reckitt-Benckiser, and the company’s claim that only the film is ‘safe’?
Many patients strongly favor the tablet over the film, and if given the opportunity to choose would definitely choose generic tablets over film.  So here is where things get interesting…..   if the generic tablets become popular, will RB go back to making tabs?  After their RADARS-assisted claim about the danger of tabs, such a move would be a clear indicator of the company’s truthfulness on the issue.

Reckitt Benckiser Citizen Petition for Suboxone: DENIED

Posted 2/23/2013
For those who missed my explanation, I’m adding these old posts to reconstruct the archive.  The site’s database was damaged by something, somehow… New posts coming soon.
Find a copy of the response here, or at this url:www.suboxonetalkzone.com/cpresponse.pdf

Suboxone Maker's Petition Denied by FDA

Originally Posted 2/23/2013
I’ve written in detail about the bold move by Reckitt-Benckiser, maker of Suboxone, that few people outside the company saw coming. In brief, the company has been cruising across the Atlantic for the past ten years, fueled by stellar growth of its flagship medication, even as the expiration of the patent on Suboxone loomed ahead (y’know– like an iceberg).
But unlike the Titanic, RB had a secret plan to deal with icebergs. A couple months ago, the company hired a company that investigates bad drugs to look into its OWN product, Suboxone tabs, and used those findings to tell the FDA that the source of their profits for the past ten years is a BAD DRUG. In fact, it is SO bad that they insisted on doing the right thing—file a Citizens Petition with the FDA to make sure that NOBODY ever makes that bad drug again.
By coincidence, RB happened to have a DIFFERENT drug with a fresh, new patent expiration date that they promised was much safer than the drug they used to make. And by coincidence (insert more sarcasm), this all happened a year or so after the patent on the bad drug ran out, so RB was willing to just get rid of the bad drug completely. Never mind that a bunch of other companies were about to make less-expensive generic forms of Suboxone; RB asked the FDA to protect the American people by banning those awful Suboxone tabs that used to make them so much money.
But on Friday, the FDA essentially told RB ‘thanks for the warning… but we’re cool.’ They denied RB’s request to block the tablets, opening the door to generic manufacturers to consider making less-expensive forms of buprenorphine/naloxone, what RB calls ‘Suboxone.’
RB (stock symbol RBGPF) has been dodging icebergs for ten years. I’ve wondered over the years how they would navigate through some very treacherous passages. How did they get everyone to buy into the idea that Suboxone is significantly different than plain, cheap buprenorphine? How did they get state Medicaid agencies to cover ONLY the branded product, when the generic buprenorphine is clinically identical to Suboxone? A glance at the price of shares in RB shows that they have been doing it well—at least up to now.

Reckitt-Benckiser Stock Price
Reckitt-Benckiser Stock Price

But the seas are getting choppy. There are two lawsuits directed at the company, accusing RB of running a grand scheme to block generic manufacturers from entering the buprenorphine market. And in denying of the Citizens Petition the FDA adds credence to the lawsuits, even writing that they will refer concerns over anti-competitive business practices to the FTC. Amazing how quickly things can change; one minute you’re sitting in a deck chair, whistling a happy tune with the wind in your hair… the next, everyone is looking for a lifeboat.
I’ve been writing for years that the company that wants to be viewed as a shiny rescue vessel has been acting more like a pirate ship. Hopefully last week’s collision will give them pause, and help then realize that it’s not about being the first ship to get to those in need; it’s more about making sure, once there, that other ships are on the way—and that everybody gets a seat in a lifeboat.

Reckitt Benckiser is Smarter than I Thought

Originally published 10/14/2012
Regarding a prior post, I carefully read through the entire Citizens Petition’ filed with the FDA by Reckitt-Benckiser. I have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone.
The document explains that the company hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film. The results are spelled out in detail in the Citizens Petition.
They show an increase in exposure to Suboxone Tabs over the past ten years. They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed. Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?
From the FDA site: ‘The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.’
To meet that requirement, RB claims that they instructed their sales force to be double, extra-especially careful to tell doctors to remind patients to avoid giving Suboxone tablets to their children. No, I’m not making this stuff up… although the ‘double, extra-especially’ part is my own hyperbole. I don’t remember exactly how it was worded in the petition.
RB wrote that the warning is actually part of their mitigation strategy—that they expect an impact on pediatric exposure, if their salespeople tell doctors to tell patients to keep the pills out of the hands of children. Gosh—good thing they did that! I’m picturing all those people who having their 2-year-old kids managing their Suboxone!
But telling doctors to tell patients this ridiculous bit of information did not solve the problem, so RB claims they needed to do more. They decided that every dose of Suboxone must be individually packaged. But they had problems with the stability of naloxone while producing individually-packaged Suboxone Tabs, leading them to make the Film form of the drug.
To read the petition, the expiration of their patent on the tabs had nothing to do with anything. And the long, new patent on the Film has nothing to do with anything.
I have a couple questions at this point. First, the obvious one—did RB REALLY have a discussion about having their salespeople remind doctors to remind patients to protect their children? Do they really think that patients and doctors are that stupid—that their salespeople can make a difference in that regard?
Second, do they really find it necessary to individually wrap each dose of Suboxone, a combination of an opioid partial agonist plus an opioid antagonist, when oxycodone, hydromorphone, hydrocodone, and other potent opioid agonists are sold by the bottle? I could go on and on about this issue… most patients on Suboxone guard each tablet carefully, as they are prescribed to match up with the number of days in each month… whereas opioid agonists are usually prescribed to take ‘as needed’, meaning the tabs are much more likely to end up in kitchen cupboards or otherwise unaccounted for.
Why would a company hire another company to find fault with their product? One might think that the manufacturer of a substance would be, if anything, pointing out the safety of their product—not arguing that it is unsafe. This is where cynicism starts to set in; where I wonoder if they are really just ‘Here to Help.’ I’m supposed to believe that RB discovered a problem with their product, hired a company to assess that problem, and then voluntarily withdrew the product from the market.
To believe the RB line, I have to accept a number of coincidences. They wrung profits out of the tabs for almost ten years, and just happened to figure out this danger within a year after patent expiration—just when generic pharmaceutical companies were able to manufacture cheaper forms of buprenorphine. The company has been dreading the flow of generics for years; heck, their reps spend more time talking about THAT issue than they do about pediatric exposures! It is also an odd coincidence that RB just happened to be pushing the Film like crazy to insurers and Medicaid agencies, well before their ‘discovery’ of the danger of pediatric exposure to tablets.
To really understand the situation, you must read all the way to the top of page 29 of the Citizens Petition. There, the attorneys for RB point out to the FDA that if a manufacturer voluntarily withdraws a medication for safety reasons, the FDA is not allowed to approve any new drug application for a generic that is based on the withdrawn medication.
Wow. They have some darn good attorneys at RB.

Dear CEO

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?