Sunday, March 11, 2007

drugs

The other day i saw a television advertisement for a new medication targeted at people with "Restless Leg Syndrome"--folks who wiggle so much in bed that they have a hard time sleeping.

Um. Wow. Screw searching for treatments for legitimate diseases, lets patent and sell a drug for folks who don't get enough exercise during the day so they have pent-up energy at night. I have a funny feeling pharmaceutical companies have taken to inventing medical conditions so they can invent treatments for them. Restless legs? Take a walk. Go out, buy a dog, buy a leash, and walk it.

Now I recognize that profits are falling for one of the bigger drug companies after a cholesterol-lowering medication, made available to the public, turned out to have some nasty side effects that got it recalled. It came as a biting hit as they were really counting on the patent revenue from this drug (i think its called Lipitor?) to keep them afloat for the next few years. So i can only assume, now that this product has generated a loss, that they're going to be promoting their less-interesting drugs a bit more vehemently to make up for it. Unfortunately, an unwanted side-effect of this marketing campaign is that they make themselves look like dorks.

And i can only hope that this RLS drug occurred completely by accident. I envision a tired chemist mixing, pouring, looking cross-eyed at a sheet of ingredients, filling an eye dropper with a cloudy pink solution and feeding it to one of his twitchier lab rats through the grating on a sterile aluminium cage. After a few minutes the rodent falls asleep and he checks his vitals, takes some blood, pokes and/or prods the animal and records "day 312: Mopsy's tumor is no smaller, but interestingly, though his resting vitals are all normal, he's less wiggly in his sleep."

If anyone actually funded a project to develop a drug to reduce nighttime twitchy-ness...i think the entire medical community should hang its collective head in shame. That's a waste of money, time, resources, and above all, intellect. I would be so embarrassed to go through twenty years of schooling and get four PhDs, only to get a job heading that product team.

5 comments:

Anonymous said...

Kristen, it's easy to look like a dork sometimes. All it takes it talking about something you haven't researched or know anything about.

RLS has been around for centuries. It's not new. However, drugs targeted for it are new. And, thank goodness.

For those with a mild form, no medication is needed. But, activity won't make it go away, as it's a problem in the substantia nigra - the brain cannot use iron correctly (genetic gift) and therefore can't regulate dopamine correctly. Voila! A movement disorder, like Tourette's and Parkinson's.

For those with a more severe form, they cannot sleep for days at a time, often getting no more than 1-3 hours sleep, sometimes none. How do I know? I have it. As does my mother, my sister, my uncle. . .well, you get the picture.

Some brilliant doctor tried the Parkinson's drugs out on RLS in the late 1980's. Thankfully, it worked. For over 15 years, those of us with severe RLS took these drugs "off-label". Someone at GSK got wise, investigated, and decided it was an untapped market.

Are they trying to recoup losses? You bet. Do they hope some people take this that don't really need it? Probably (but I hope not). Would it be better if doctors were better educated about this disease and could better decide if patients needed it? Absolutely. Until then, I have to hope that not too many patients are silly enough to want a drug they don't need and that enough doctors learn about RLS and how to diagnose it so that they don't prescribe it when unwarranted. To me, ultimate responsibility is with the patient and doctor, not the drug company.

Kristen said...

When it comes to legitimate neurological disorders, you've got me there. I haven't researched it. All i know is the hype from the ads, which includes the phrase "to be used in conjunction with regular exercise" as though it is targeted at people who are fidgety on account of a failure to move. and that is true for a lot of people--they sit around and stare at a computer monitor all day, and wonder why they toss and turn all night.

The big issue here is the fact that its a treatment for a neurological disorder. That isn't even mentioned in the ad.

This is not something that needs to be advertised to the general public. It needs to be handed out to the areas of the medical community to which it pertains, in leaflet-form. As it is, just like ritalin, we're going to have a bunch of cranky people going to their doctors demanding this new miracle cure because they think the reason they toss and turn is the same reason they get headaches and a cough sometimes--they're hypochondriacs. the television tells them that normal sleeping discomfort is something they can cure, so they want the drug. That's the whole reason its advertised on tv during prime-time. to make money. I stand my ground in this regard. I'm sorry you have a sleep-related tic, but the advertisements don't so much as mention that it's a spasm. It is clearly targeted at everyone who's ever had trouble sleeping.

Its like ads for anti-depressants--they pop up questions like "do you frequently feel exhausted? anxious? nervous? sad? like you can't get out of the house?" well yeah, who doesn't? nobody said life was fun. fact is they're trying to get everyone to think they need it so everyone asks for it, and of them, a good percentage are going to get it, and get addicted to it. What a business model.

I realize you feel insulted by my trivializing of your disorder, but 1. that's no reason for you to throw out petty insults, and 2. the medical community has already trivialized it for me, by trying to sell it to the mass market.

please include your name with your comment. For all i know you're my sister.

Anonymous said...

... I aint your sister ... nor am i anonymous (although I do know who it is lol)

... If you're going to stick to your guns and respond to those of us who do take offense to dorks who glide blissfully ignorant through this world, taking whatever is transmitted into their living rooms via the tv as gospel, do a little research so you don't continue to look like such a dork ... here's a starting point for you http://www.rls.org and http://bb.rls.org/index.php

... if an ad was to mention every single insy-bitsy possibly related item to one particular drug, the dang ad would go longer than "dances with wolves" and well, there goes the whole budget for R&D into the actual neurological disorder (or any other ailment an ad might be on tv for) itself & any future treatments

... do you actually know how many sleep disorders exist? do you know how dangerous sleep deprivation can be? since when has it been illegal for drug companies to advertise? (look how long alcohol and tobacco companies have been allowed to advertise, and all the lives they've completely screwed because of it) if one simple ad for Requip means that someone ends up at their doctor and ISN'T diagnosed with RLS, ... but instead is diagnosed with sleep apnoena, that's bloody fantastic, coz it means they've just cut out the possibility that they might've died in their sleep one night due to the fact that their brain wasn't receiving enough oxygen because of ... simple snoring ... ever think of it that way?

... hypocondriacs have been around since day dot; how else would general practicioners stay in business? they're trained to spot "hypo's" a mile off, so no, they're not about to start prescribing requip to every tom, dick and harriette who walks through the door complaining that they've had a bad nite's sleep ... those people need to invest in a decent mattress

... ol george dubbya needs to get a new marketing team when it comes to writing ad's, particularly when its for drugs. I was in u.s.a. a few years ago and was literally gob-smacked at the level of crappola that went into an ad for something as simple as paracetamol ... but then again ... ol george needs something to keep the hypercondriacs comin back for more

... Come to think of it, that's the only area ol Oz hasn't followed in the footsteps of ol u.s. of a. so far ... ad's for prescription only drugs. The only ads we get are for good ol colds n flu, hay fever, headaches and multi-vitamins. The rest we have to find out about by actually making an appointment with our doctor, having a conversation with said doctor, submitting ourselves to whatever diagnostic tests might be relevant and only then are we presented with a list of possible drugs to try.

... who am i? i'm a life-time chronic rls sufferer who hails from that country down-under. (My mother has it, my sister has it, my grandfather had it, numerous other relatives have it.) I haven't had a good restful nites sleep for god knows how long . I've had every parkinson's drug available in this country thrown at me (including requip) and for some reason that god only knows (since he's the one who stuffed up my body in the first place), none of them work!

... I'm 31 years old. I RETIRED from full-time work when I was 28. I will only ever be able to manage part-time work because I don't have the energy from sheer exhaustion from getting stuff all sleep. When my RLS really gets into full swing, I have to rely on a walking stick because the muscles and nerves in my legs are screaming so loudly at me because i've subjected them to endless hours of (well hello!) ... WALKING! along with stretching, kicking, thrashing and whatever else I can do to move my legs. At the end of all that I have no energy to enjoy the simple things in life with my partner and three kids; I'm a danger behind the wheel of a car (or any machinery for that matter). Is a simple quest for a bit of improvement in the quality of my life so bad???

... Sweet Dreams Kirsten





... if knowing my name is soooooo important: it's nadia

Anonymous said...

Sorry Kristen ... the typo on your name at the end of my post was completely unintentional

Kristen said...

After your original comment i did start researching RLS on the Foundation site and a lot of their paperwork stated that doctors didn't know a whole lot about it. not to say it isn't real, but research surrounding it appears largely incomplete. I recognize that indicates that it is currently under investigation, but the majority of the foundation's for-patient information indicates that, for most people, it can be eliminated or made tolerable through changes in diet and exercise. In the general-information site, it is not even identified as a neurological condition.

You stated your body has difficulty processing present dietary iron. According to their research, that is only one of several potential explanations. Though your theory is likely, they don't actually have conclusive evidence of this yet.

To paraphrase what I learned today:

RLS is most often caused by anemia, which in most cases (as i know from experience) is a result of an iron-poor diet, not an inherent metabolic or neurological trait. The American diet is distinctly iron-poor these days as cheeto's have replaced spinach in the produce aisle and, when iron is included in vitamin supplements, it is frequently in a form that the body does not absorb. This would also explain why pregnant and lactating women may be prone to developing RLS, as the body displaces a high percentage of her normal iron count into baby and milk manufacture. Pregnant women are notoriously anemic, which can lead to many birth complications if she fails to eat right.

Given current findings, for most people mild to moderate RLS is a preventable side-effect of anemia. AKA Secondary RLS.

What has occurred, in your case, is that you have a real, rare, inherent, debilitating disorder that is not fully understood by medicine or the public and has not undergone significant research to confirm its origins, triggers, or symptoms. Your specific condition, Primary RLS, is what the medicine is designed to treat. "The condition which affects between 8 and 10 percent of the population", to whom the product is being marketed, is actually the treatable, preventable Secondary version, which does not require or respond to this medication. Secondary is a symptom of a lot of different maladies, none of which Requip is designed to treat.

As one who grew up with her nights punctuated by a family member's apnea, i can guarantee you in no way can apnea be mistaken for RLS, or vice versa. Its not the snoring that wakes you--its the haunting silences.

Moreover, as the daughter of a healthcare professional, i've been trained to identify bullshit medical claims and panaceas since I was a kid. I look for inconsistencies in or ballpark figures, or a complete absence of gathered data. I always read the label to see if its an old medicine with a new name. I look for too low a correlation between a symptom and a condition to draw a causal conclusion, or too small or specific study groups for a general conclusion to be drawn. If the phrase "medical experts believe" is used to defend any otherwise-unsubstantiated claim. I look for corporate, religious, or other special-interest sponsorship of controversial claims. And I look for public advertisements that don't actually tell you what the condition or the treatment are.

In the case of the published study on the RLS foundation's website, they state very clearly that they don't know enough yet to substantiate their claims in regard to primary RLS, and they concur that secondary or spontaneous-onset RLS indicates that another condition is likely present. Moreover, all of the studies that have been carried out in regard to RLS have produced different results and pointed to different potential causes.

Not enough is known about the effects of Requip (Ropinirole HCL--exact same drug used for Parkinsons. I believe you. How do they get away with it?) on RLS for it to be considered anything more than a general-population study at this point. A practice which, as we saw with torcetrapib (the companion drug to Lipitor--i was close but not quite before), killed people. The drug company thought it was safe, told people it was medicine, and it gave them heart attacks within six months.

Do you see why we ought be wary of advertising new, unstudied medications for unstudied conditions? Doctors prescribed torcetrapib to millions of people thinking it would help them raise their "good" cholesterol, going off the word of the drug company. And it killed them. Frequently doctors, particularly GPs, don't have a damn clue what they're talking about, and don't read the fine print. I was prescribed the Ortho Evra patch five years ago for menstrual regulation. It caused me all sorts of excessive-estrogen related problems so I changed to something else. Now there's a major class-action lawsuit against the manufacturers of it for its undocumented effects. What was once advertised as a safer alternative to the Pill turned out to cause even more blood clot related incidents than the original. Naturally this didn't come out until the product had been in general use for a few years, but should drugs be made available to the public without the manufacturers having a clear idea of its effects, uses, and dosage?

Should drug companies try and convince consumers to use their medication to treat a disease they don't have? (yours?)