POLITICS
My Restless Legs Are Killing Us!
By Stump Connolly
Somewhere in the middle of MSNBC’s day long lead-up to the Democratic presidential debate in Chicago, somewhere between the never-ending ads for Flomax, Nexium, Lunesta, Ambien, Cialis, Cymbalta, Advocil, Enfacil, Expandex ad nauseum, it hit me.
How are these candidates going to fight the pernicious influence of the drug lobby in Washington when the drug companies are paying for this whole campaign? It’s not just the bundled contributions they pour into the candidate coffers that influence campaigns but also the parade of TV drug advertising that fuels the cable news channels and underwrites the network news programs that cover them.
Not that I don’t appreciate constant reminders that my bladder is leaking, my face is wrinkling, my prostrate is growing, and my cholestrol is too high (or too low.) That’s why, in fact, I go see a doctor every year for a physical. But doctors will tell you they too are tired of patients coming in to their office asking, as the TV ads instruct them, whether they might have less weary bones if they took this or that drug.
The pharmaceutical lobby would have you believe this “direct to consumer” advertising is raising public awareness of health issues. They conveniently want you to forget that, prior to 1997, prescription drug advertising was banned on TV, just as is it in all other countries of the world except New Zealand. Sure, the ads come with disclaimers, but the disclaimers are so artfully integrated into the small type as to make doctors into footnotes to be consulted along with other reliable sources, like magazine ads in Good Housekeeping or websites sponsored by the drug companies.
Lifting the ban on TV prescription drug advertising has been a boon to the drug companies. In the first year, spending in this category went from zero to $1.1 billion. It doubled the following year and continued to grow at an astounding pace until in 2006, it amounted to $5.3 billion, making drug advertising the fastest growing category on TV (except political ads.) So politicians who vow to stand up to the drug companies must actually take on not one but two of the most entrenched lobbyists in Washington: the drug companies and the media companies who thrive on their advertising dollars.
But it is a fight worth fighting, if only to rein in the kind of disease mongering that GlaxoSmithKline is conducting for a new drug called Requip™ designed to alleviate the suffering of “Restless Legs Syndrome.”
Clinically, Restless Legs Syndrome is defined as a “creepy-crawly” sensation in your legs that keeps you up at night. It is often misdiagnosed as insomnia. Drinking and smoking exacerbate the condition, and one of the potential drawbacks of the drug treatment, the ads alluringly suggest, is a heightening urge to gamble and have sex. [editor’s note: how can I get me some?]
Little was known about Restless Legs Syndrome (RLS) until scientists at GlaxoSmithKline presented a paper on the disease to the American Academy of Neurology in 2003. By altering a drug called ropinirole used to treat Parkinson’s Disease, they claimed to have found something that might alleviate some of the Restless Legs symptoms.
They submitted their findings to the Food and Drug Administration, including a telephone survey suggesting as many as 12 million Americans might be suffering from RLS, and helped underwrite a Restless Legs Foundation that turned this number into the oft-quoted factoid that one in ten Americans suffer from RLS.
The FDA reviewed the research (along with 54,000 other cases it handles every year) and in 2005 authorized GlaxoSmithKline to market Requip™ as a prescription drug remedy for Restless Legs. Over the next 12 months, Glaxo SmithKline spent $108 million advertising Requip™ on cable and broadcast TV. According to the disclaimer formula, the ads suggest I ask my doctor about Restless Legs Syndrome – so I did.
He is a highly respected internal medicine doctor with the Northwestern Medical Group in Chicago. In his 35 years of practice, he said he has seen 5,000-7,000 patients and diagnosed RLS in, at most, 10 to 20 instances. So far he has prescribed Requip ™ twice and, thankfully or not, neither patient reported elevated gambling or sexual activity.
One doctor’s experience doesn’t negate the raft of studies I’m sure GlaxoSmithKline amassed for FDA approval. But it does suggest that, in real life, the incidence of Restless Legs Syndrome is more like one out of 250 patients (.04%) than the one of out ten (10%) coming out of the company’s research. But, of course, that could change the more GlaxoSmithKline advertises the disease – and its remedy.
“Disease mongering" is a term Steve Woloshin and Lisa M. Schwartz, two researchers at the Dartmouth Medical School and Veteran Affairs Outcomes Group, came up with after a study of the Requip marketing campaign. They describe it as "the effort by pharmaceutical companies to enlarge the market for a treatment by convincing people they are sick and need medical intervention.
“Typically, the disease is vague, with nonspecific symptoms spanning a broad spectrum of severity – from everyday experiences many people would not even call ‘symptoms’ to profound suffering,” they wrote.
After GlaxoSmithKline introduced Requip™ to the market, the researchers found 33 articles in the media about the new drug, most of which closely followed the GlaxoSmithKline press releases. Invariably, reporters uncritically accepted the contention of widespread RLS suffering, relied on anecdotal stories from worst-case patients and glossed over possible longterm effects – never explored because FDA approval took only two years.
Through extensive advertising and PR campaigns, Woloshin and Schwartz concluded, drug companies expand the market for drugs like Requip™ “by narrowing the definition of health so normal experiences get labeled as pathologic” and including “earlier, milder, and presymptomiatic forms."
Democratic candidates returning to Washington this September – they will return to Washington, won’t they? – will have a clear opportunity to demonstrate their prowess in fighting the drug lobby, not just talk about it. They have, in fact, had that opportunity all year long as the House and Senate considered a re-authorization of the FDA through what is now called the drug safety bill.
Last January, buoyed by Democratic majorities in both the House and Senate, Rep. Henry Waxman (D-Ca) inserted a provision in the House version that would have forced drug companies to delay TV advertising for three years after FDA approval to allow more study of long term effects.
But even this mild reform was stripped away last June in a house sub-committee where nine Democrats joined 14 Republicans to remove the restriction. As a result, neither the House nor Senate versions of the bill, now in a conference committee, contain limits on TV drug advertising, so that train has probably pulled out of the station.
But five of the eight Democratic candidates for president still have desks in Congress with microphones in front of them and cameras pointed at them. What better place to call out the Congressmen who caved in to the drug lobby or talk, in specifics and detail, about how the lobbying really works?
If Hillary Clinton is ready on day one to lead, why doesn’t she call this “day one” and explain why, as leader of the New York Democratic delegation, she didn’t raise a finger to stop Rep. Ed Towns (D-NY) and two other House Democrats from New York from nixing the Waxman proposal?
If Barack Obama wants to create a consensus for change, why doesn’t he point the way by making it happen?
If Joe Biden or Chris Dodd or Dennis Kucinich aren't satisfied with the 90 seconds they get in debates to address the American people, why don’t they use that bully pulpit, in this critical issue of health care, to show how they have made one iota of difference in this bill?
C-SPAN isn't YouTube and it's easy to dismiss the broadcast of Congressional speeches as so much pablum. People said the same thing about internet videos three years ago. But if we’re going to fight the drug lobby, let’s do it in Congress where the battle might do some good.
Otherwise, all this campaign posturing is so much blather. My attention will wander -- and there’s no telling what my restless legs will make me do.
