I couldn't believe my eyes and my ears last night when ABC News devoted significant air time to a story that it claimed "will put an end to criticism of Restless leg Syndrome" or something to that effect.
[I wish I had the video to prove to you that was exactly how this story was introduced. I need a TiVO if I am going to continue in this business!]
In reality, this "news" item was a direct to consumer ad (DTC) for Requip, except without the fair balance! Prominently featured in the opening segment of the ad, er, I mean "news story," were clips from the infamous Requip ads showing the specially-made green chair and a physician mouthing the single word "Requip."
Contrary to ABC News's prediction viz-a-viz shutdown of criticism, there is so much to criticize here that I am at a loss where to begin my renewed criticism! But I will give it a stab.
First, the story is about a scientific study published in the New England Journal of Medicine (NEJM) that claims to have found the gene for Restless Leg Syndrome (see "Restless Legs Scientists Find Sleep-Kicking Gene").
Follow the Money
Let's first follow the money to see if we can catch a "tricky dick" here.
The study, "A Genetic Risk Factor for Periodic Limb Movements in Sleep," was sponsored in part by the Restless Leg Syndrome Foundation, which, as I have pointed out before, is an "astroturf" non-profit established and virtually run by GlaxoSmithkline (GSK), the company that markets Requip for the treatment of RLS.
GSK and Boehringer Ingelheim (BI, maker and marketer of Mirapex, another RLS treatment) are "Gold Level Sponsors" of the Foundation (see "Restless Pharma Marketing"). These companies have an even more incestuous relationship with the RLS Foundation:
The first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK! That's a first! Pipe money into a foundation and viola! you (or a VP in your company) gets an award!Undoubtedly, the RLS gene study, which originated in Iceland, was one of those "collaborations." (See the RLS Foundation press release.)
Not only that, Dr. Richard Allen, a member of the RLS Foundation's Medical Advisory Board, proudly reveals in the press release that he had the "pleasure" of "collaborating" with the research team selected by Dr. Krall to do studies supposedly supporting the data on the prevalence of RLS in the US and in Europe.
OK, we have an industry-created and supported astroturf foundation laundering GSK and BI money to support RLS research in Iceland. It doesn't look good, but the researchers could still be independent and credible, right?
Here's the authors' conflict of interest statement at the bottom of the NEJM article:
"Dr. Rye reports receiving consulting fees from or serving on paid advisory boards for GlaxoSmithKline, Boehringer Ingelheim, Ortho-McNeill, and Sepracor and lecture fees from GlaxoSmithKline and Boehringer Ingelheim; Dr. Bliwise, receiving consulting fees from or serving on paid advisory boards for Takeda, Neurocrine, Sepracor, and Cephalon and lecture fees from Takeda and Boehringer Ingelheim. Dr. K. Stefansson is chief executive officer and Dr. Gulcher is chief scientific officer of deCODE Genetics, and both have equity in the company. The company has a financial interest in the results of this study, including diagnostic products and patents. No other potential conflict of interest relevant to this article was reported."OK, so we can't trust some of the authors either. But, maybe the science is still OK.
Forgive me for not wishing to delve too deeply into the science, particularly about how strong the connection is between the newly discovered gene and RLS. Let's just say that I don't question the connection between a gene and the condition that the researchers actually studied, which was NOT RLS.
The study was initially done with 306 Icelanders who fit the criteria for RLS and who kicked their legs once they fell asleep -- an action known as periodic limb movements in sleep, or PLMS.
OMG, another acronym for a "real medical condition"!
They also studied 108 Americans in Atlanta.
Quite a convincing N, don't you think? And here I am criticized for my "unscientific" survey with N=145!
The researchers attached a gizmo to the legs of subjects and measured twitches during sleep. The ABC News report showed a graph of someone suffering from PLMS who twitched 60 times an hour during sleep. I am not sure where the cutoff is -- how many twitches per hour is considered "periodic" enough to be PLMS? This is the level of detail I refuse to sink to.
Anyhoo, what does PLMS have to do with RLS?
That's either the Archille's heel of this study or the genesis of a new indication for Requip and a whole new marketing campaign. I envision late-night DTC ads showing scantily-clad babes like that pictured above kicking in their sleep.
NOTE: The photo above is taken from the ABC News Web site version of the story. In the broadcast -- aired during family hours -- a decidedly less attractive woman in jammies and unsexy white socks(!) was used to illustrate what they dubbed "sleep-kicking."A supposed physician ("docpiner") commenting on the ABC piece had this to say:
"This disease [RLS] has nothing to do sleep kicking. Kicking in sleep is NOT restless leg syndrome. Feeling an uncomfortable sensation in the legs and needing to consciously move the legs to get relief is what this [is] about. This howevere (sic) does not get you your snappy title. You do a disservice to your readers with this type of shoddy reporting."Indeed, even physicians on GSK's and BI's payroll admit the same:
"It is not a gene per se for RLS, but rather for leg movements seen in individuals and families with RLS," said Dr. John Winkelman, medical director of the Sleep Health Center at Brigham and Women's Hospital. "Whether the same gene is associated with periodic leg movements in [other] contexts, we have no information from this study."The RLS Foundation, however, has no qualms about playing up the connection between RLS and PLMS:
[According to ABC News, Dr. Winkelman "has reported receiving financial support for research, as well as consulting and lecture fees, from Boehringer Ingelheim and GlaxoSmithKline."]
"PLMS are present in about 90% of people with RLS and are considered a typical expression of RLS."The Foundation doesn't cite its source for this tidbit of information.
It's interesting that the gene associated with PLMS is found in 65% of all Icelanders and maybe as many Americans.
Whoa boy! Imagine Requip having an new indication for PLMS! Is that a marketer's wet dream or what?!
New Requip Ads Coming Soon?
But new indication or not, I envision new Requip TV ads showing more twitching in sleep than twitching during dinner at a restaurant. GSK already has the YouTube video prototype out there (see "GSK's YouTube Disease Awareness Sponsorship"). Will FDA allow this in branded advertising? Inquiring minds want to know.
Meanwhile, this study sets the stage for the greatest off-label promotion scandal to come. I am sure GSK and BI sales reps and/or Medical Science Liaisons will be out there talking this up to physicians who undoubtedly will be led to equate PLMS with RLS.
Another commenter to the ABC News story shows how easy it will be to confuse RLS with PLM:
I too agree with docpiner it is not sleep kicking. I have had RLS since my last child was born (19 years ago) and it is very annoying. I hated to see evening come. As soon as I would sit or lie down for the evening my legs would start. I finally found Requip about 3 years ago and has provided me with relief so that I could get to sleep. It wears off for me around 6am. My legs get me awake then I have to get up. My legs ache (from the knees down) and also wonder if other RLS sufferers have the same problem.