Saturday, September 27, 2008

And Now, A Drug Recommendation From Our Sponsor

Today I received my summer issue of The Pain Practitioner (1), and just like a box of Crack Jack (2), there was a prize inside. Actually, there were two prizes (Oh goodie!). I received two CME booklets (Score!). At the bottom of each booklet was this sentence "Supported by an unrestricted education grant from..."

For those of you who may not be well versed in pharmaceuticalese, when the phrase "unrestricted education grant" is translated into English, it means restricted (i.e., biased) education grant. Kind of the same way "bad" means "good" and "it's not you, it's me" means "it's you."

In the CME booklet that was "support by an unrestricted education grant from Elan," two articles are included. The second article is titled, "Interventional Modalities for the Treatment of Refractory Neuropathic Pain" By Lynn R. Webster (Can you guess the drug company to which she is a consultant?) Anyway, this article is about implantable therapies for people with severe chronic back pain. In the last section of her article, she reviews the recommendations from the 2007 Polyanalgesic Consensus Conference (3).

The purpose of this conference was "to update previous recommendations and to form guidelines for the rational use of intrathecal opioid and nonopioid agents." These recommendations were made by an "expert" (I use that word loosely) panel of physicians and nonphysicians in the field of intrathecal therapies (i.e., spinal injection).

As a neuropsychologist, I often assess people's reasoning skills, specifically, deductive reasoning. Here's you're test. Don't worry, it's only 1 question in length. In the polyanalgesic article, the respective literatures of 20 different drugs were reviewed. In addition to opioid therapy, a new drug was christened as a first line monotherapy. What is the new drug that was recommended as a monotherapy?

Here's a couple hints. This sentence appears in the acknowledgments section, "The authors would like to acknowledge Elan Pharmaceuticals for its most generous financial support of the consensus conference and 'hands off ' approach to the final writing of this article."

Second hint. On Elan's website, there four drugs, which are marketed in the U.S. (4). It's one of those four drugs. Still not sure which drug to chose? I'll list the top 5 drugs (out of the 20 reviewed in the polyanalgesic article), by the number of mentions.

1. Morphine - mentioned over 160 times
2. Prialt (ziconotide) - 84 mentions
3. Clonidine - 58 mentions
4. Hydromorphone - 50 mentions
5. Adenosine - 50 mentions

If you guessed Prialt (ziconotide), then you're correct. Now, I'll admit that I have not read this article in its entirety (it's 29 pages), and I have not reviewed all the literature on the effectiveness of ziconotide; however, I'm not making any claims about it's effective or utility (that's outside the scope of my practice). It very well could be worthy of its first-line treatment status. However, a few curiosities continue to bug me.

Morphine has been around for a long time, so 160 mentions in the article makes sense. It's literature is quite extensive. Ziconotide was approved by the FDA in December of 2004, yet it received the second highest number of mentions at 84 (repetition is the key to memorization; repetition is the key to memorization; repetition is the key to memorization...) . If you average the number of mentions from the remaining 15 drugs, the number is 19.7; that's four time less than ziconotide (Yes, I actually counted all mentions for all 20 drugs).

Moreover, it is the only drug mentioned in the abstract, which states "Of note is that the panelists felt that ziconotide, based on new and relevant literature and experience, should be updated to a line one intrathecal drug." I see, so the decision had everything to do with the "relevant literature" and clinical "experience," and nothing to do with the "generous financial support" from Elan.

Here is where they use psychology on their readers; of the 20 drugs reviewed, ziconotide was the last drug reviewed, taking advantage of the recency effect. Also, it's section is the longest of all the other drugs (morphine was in a close second). Did I mention that ziconotide is also the only drug that is mentioned in the conclusions section? I didn't? Well, it is. Maybe Elan was a little more hands on than the authors are willing to admit. In the CME article written by Dr. Webster, ziconotide is the only drug that receives its own section as well (Remember, this is an "unrestricted" education grant).

At the end of the CME booklet there are 15 questions. The last 7 questions are derived from Dr. Webster's article. Can you guess which drug had its own questions?

Question 14 reads, "According to the expert panelist of the 2007 Polyanalgesic Consensus Conference, which of the following is a recommended first-line agent for pain?"
a. clonidine
b. bupivacain
c. ziconotide (<- correct answer; like you didn't know that one)
d. baclofen

Question 15 reads, "According to this article, which of the following is true regarding ziconotide?"
a. It must be titrated slowly (<- correct answer)
b. It must be discontinued slowly so that the patient does not experience withdrawal syndrome.
c. The primary side effects are cardiovascular.
d. The primary side effects are respiratory.

For some strange reason, I'm not quite convinced by this "expert" panel's recommendations. I know that Elan supposedly had a "hands off" approach to the "final" writing the article, but nothing is said about the conference itself. How "hands off" was Elan during the planning of that? The fact that their four-year-old drug made it to the top based on "expert" opinion is a hard pill to swallow (technically, it's not a pill, it's a liquid). I guess that means if Elan had not provided "generous financial support" for that conference, then the "expert" recommendations would have been the same. Right?


Anonymous said...

I've only discovered your blog today. It looks like thelastpsychiatrisis is contagious. You don't seem to exhibit simptoms of narcissismistherootofallevilisis yet. I wonder if that's a more advanced stage of the disease or distinct subtype.

NeuroPsych said...

If that's a compliment, then thank you?

I'm fortunate enough that my extreme neuroticism keeps my narcissism in check.