Pharmaceutical Companies Still Behaving Badly

 

 

 

 

Reckitt Benckiser, the drug company that used to make the brands Suboxone and Subutex forms of buprenorphine, is now owned by a company named Indivior. Earlier this month, the company was fined a whopping $1.4 billion for fraudulent marketing of their brand Suboxone.

To put this in perspective, Purdue Pharma paid $600 million in 2007 for criminally misleading marketing of the drug OxyContin.

The suit against Indivior claimed that Reckitt Benckiser made false claims to physicians, saying their Suboxone film was safer and better than competitor’s tablet versions of the medication buprenorphine, and the risk of pediatric exposure was lower with the film than the tablet.

I blogged about this issue in May of 2012, saying that I thought the RB drug representatives were pressuring me to prescribe the films, and I felt their arguments lacked credibility. Here’s that blog post from seven years ago:

 

Pharmaceutical Companies Behaving Badly

I’ve been relatively supportive of the Reckitt-Benckiser pharmaceutical company until now. I’m impressed this drug company was willing to market a medication to treat opioid addiction. Other companies may not have wanted the stigma of producing a medication to treat addicts, and Reckitt has done a great many beneficial things for opioids addicts. In the past they sponsored eight-hour training sessions that doctors needed to get the special license to prescribe Suboxone/Subutex. They have a patient-assistance program that can help up to two patients out of a hundred get free medication, which a generous program. And their target patient population often lacks both money and insurance to pay for treatment.

But now they are starting to irritate me. At the ASAM conference last month, I heard doctors say how the Suboxone drug reps are starting to pressure them in to prescribing only the name-brand Suboxone film. I’ve encountered similar pressure, and it makes me cranky.

I know the score. Reckitt’s patent on the Suboxone and Subutex tablets has run out, and there are a few Subutex-equivalents now on the market, selling for about half the cost of the name-brand. Reckitt waited until both tablet’s patents were ready to expire to release the film, because the film will be protected under patent for years to come. From a business point of view, all that makes good sense. And of course, now Reckitt wants doctors to switch to the new and improved film.

But if the drug company salesperson starts telling me how harmful Suboxone tablets are to get me to switch patients to the film…they will lose credibility. Am I to believe the same medication, Suboxone tablets, which you were pushing so hard two years ago now is dangerous and must be replaced by films?? No. If the company believed this, why did they release the tablets in the first place? And why wait until the tablet patent expires to release their new “safer” form?

I like the Reckitt-Benckiser drug rep who comes to my office. Let’s call her Mary. Mary is intelligent and personable, as drug reps tend to be. She’s been helpful, and listened to my concerns about the film when patients reported it was flaking and crumbling, a problem that does seem to have resolved

But now, she’s annoying me. She goes into her company’s song and dance and I can’t help needling her. Here’s a reproduction of a portion of one of our latest conversations as I remember it.

“Doctor, are you at all concerned about the pediatric overdoses with the tablets?” Mary said.

“No I don’t often prescribe them to toddlers.”

Mary’s eyes get a little wide until I start to laugh.

“I’m not sure the films are safer than the tablets when it comes to pediatric overdoses.” I say. “I think it’s all about making sure the patient knows how to store them safely. I had a comment to my blog say the films were harder to keep track of than the tablets.”

“There have been pediatric overdose deaths with the tablets and none so far with the film.” Mary tells me in what I hear as a slightly accusatory tone.

“And the tablets have been on the market longer.” I counter, just to be contrary. I do think the films are less likely to cause accidental overdoses, because those packages are so hard to get open.

“And don’t you think the tablets are a relapse trigger? Nearly all patients had been addicted to opioid tablets and using them to get high. Now if you prescribe a tablet to treat the addiction…the sound of pills rattling in a bottle is a trigger for many addicts. If the patient has snorted pills, they may misuse the tablets and crush them into a powder to snort.”

What gall, I thought. “Mary, why didn’t you tell me all of this two years ago when you were encouraging me to prescribe more Suboxone tablets? Why didn’t you tell me then I was triggering my patients to snort pills and endangering their children?” She and I both know she was touting the healing properties of Suboxone tablets two years ago, right up until the film was released onto the market in the fall on 2010.

Mary was silent for a long moment, apparently at a loss for words. This is a rare thing to see in a drug rep. finally, she said with a laugh, “It’s hard to try to sell against yourself.”

The drug company says the film is less divertible than the tablets because of the unique ten-digit number on each pouch. This number can be traced back to the patient for whom it was prescribed. If a patient sells his medication and it’s eventually confiscated by police, the authorities can tell who it came from. Plus, if the doctor wants to do a film count, the patient won’t have the correct numbers on the foil pouches if he’s sold them. All of that’s true but doesn’t give the average addict/dealer much credit for intelligence. It’s likely the person wishing to sell Suboxone films would just open the pouch and remove the film, saving the pouch in case it’s needed later. The numbering of the pouches is a good idea, and according to some information I heard at the ASAM conference, it probably is a little less likely to be diverted. But pill and film counts don’t work unless doctors do them.

As far as the “snortability” of a tablet, I don’t know. I’ve been surprised by the number of blog commenters who snort their Suboxone tablets, so there’s some validity to the argument that the tablets are snortable and the films not snortable. But then I have had commenters say the film is easier to inject, so what do I make of that?

I must cautiously evaluate each patient. I have patients that I am certain would never even think of selling their prescription. I have had patients I think could possibly be selling. I’ve done pill counts on them and for the most part was pleasantly surprised their count was correct. Then I’ve had patients fail pill counts, and I will no longer prescribe for them.

Risks of medications must be balanced. I do agree the film is somewhat better because it dissolves faster, and early reports show it’s less desirable on the black market than the tablets are. But for some patients, that name brand is unaffordable. If they have no insurance and will have to drop out of treatment unless a cheaper alternative can be found, I feel it’s OK to use the generic tablets. I take more precautions with those patients and check their arms for track marks at office visits. I do more frequent pill counts. I do frequent urine drug screens. I don’t use generic buprenorphine in patients with a history of IV drug use.

Addiction treatment is expensive. If I can use caution and prescribe the generic to save a previously stable patient from dropping out of treatment because of the cost, I may do it, if the patient agrees to the above safeguards.

 

So now the chickens are coming home to roost in Indivior/Reckitt Benckiser’s coop…

I read the court document filed by prosecutors of the U.S. District Court in the Western District of Virginia (https://www.justice.gov/opa/press-release/file/1153066/download ). It’s an interesting read.

In this document filed in Abingdon, Virginia, the government says Indivior deceived health care providers and healthcare programs by saying that the film was safer and less susceptible to diversion. The document also says the drug company established a telephone program for patients to be connected to physicians who, in some cases, they knew were prescribing their product in a careless manner. The drug company also trained their representatives to tell providers that the films carried a lower risk of child exposure, despite a lack of evidence for that claim. In fact, some authorities at the FDA worried the films might be more dangerous and difficult to remove from a child’s mouth than a tablet, because they dissolve more quickly

In the end, Indivior/Reckitt Benckiser agreed to a negotiated fine of $1.4 billion, but admitted no wrongdoing, stating they had “acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct.” Thus far, it’s the biggest fine paid by a drug company related to the opioid epidemic.

As for me, I haven’t seen an Indivior/Reckitt Benckiser drug representative since 2012. After I posted the blog above, the RB representative for my area saw me one more time. She told me she was disappointed I had chosen to blog about our interaction in a public forum.

I hate I offended her, because she was a nice lady, but I think time has proven my criticisms about RB’s behavior to be well-founded.

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7 responses to this post.

  1. Posted by Alan Wartenberg MD on July 21, 2019 at 12:58 pm

    I think the biggest and most ironic recent development was a news report that Purdue Pharma and the Sackler family were considering going into the buprenorphine business. Don’t know if it was true or whether it will happen, but it would be a great example of a company that gets you both coming and going.

    Reply

  2. Posted by Ronny Freedom on July 22, 2019 at 12:11 pm

    Getting rid of US patent laws regarding medications would have prevented this from happening. It would also prevent the artificial price controls on many life-saving medications.

    Reply

  3. Posted by Simon on July 22, 2019 at 8:39 pm

    In my opinion the only thing that makes the wafers safer around kids is how hard they are to open. I assume pills came in blisters or bottles? Before my time.

    What worries me is if that a kid got the wafer in their mouth is how it adheres. At least a pill can be spit out. The wafer doesn’t come out once it’s glued on.

    It was obvious patent extension. I’m glad they got caught out.

    Reply

  4. Posted by Don H on August 8, 2019 at 7:00 pm

    This indictment is an amazing read! I had heard and read several doc’s accounts and thoughts on this (including yours) when it was going on, but many, many, many other docs, including mine at the time, drank the cool-aide and forced patients onto the strips. The things they did were outright criminal, but wow, it’s an amazing read – not much different than hearing about things the mob and gangs have done!

    Reply

  5. Posted by Colleen Casey on August 18, 2019 at 2:19 am

    I wonder if there has been any research on the overall effects, misuse, abuse and safety of Tablets vs Films. Has treatment with the Films improved the intended outcomes of using this medication overall? Also, how patients who have used both tablets, then films, think about the real factors such as any differences in getting off the medication, increased risks of abuse/dependence, length of treatment and use necessary for individual outcomes..just to name a few off the top of my head. Interesting information. Thank you.

    Reply

    • I’m not aware of any studies comparing the tablets to films.
      The biggest benefit that I’ve seen from films is it’s easier to taper the dose using them.
      I wish drug companies made a .5mg SL tablet or film, for patients in a taper phase.

      Reply

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