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Off-Label Cosmetic Prescriptions
Posted By Worker Bee On December 20, 2008 @ 8:43 am In Big Pharma,Health,Hype,Marketing,Research Analysis | 11 Comments
Last month we brought you news (and humble perspective ) on the pharmaceutical industry’s off-label marketing practices. Just a couple weeks after the fact, what before our wondering eyes should appear? News that a glaucoma drug (Lumigan) was just approved by the FDA for off-label use as an eyelash enhancer . Call us suckers, we know, but we couldn’t resist taking the bite. Finding new uses for existing poor selling drugs has become a cottage industry. Reminds me of the old SNL skit, “Shimmer. It’s a dessert topping AND a floor wax!”
Our first reaction? A certain common, colloquial acronym. Thicker eyelashes? As if our obsession with crow’s feet, laugh lines and lip size weren’t enough, now we’re losing it over eyelashes. (Is the existence of 1200 varieties of mascara no longer enough?) And what are we (and the FDA) apparently willing to weather in pursuit of more lustrous, luxurious lashes? Hmmm….inflammation, itching, burning and eye discharge. (Published side effects of Lumigan , if we lost you.) In lesser numbers, more serious effects like cataracts, inflammation of the cornea, muscle weakness, respiratory infection, and hirsutism (overgrowth of body hair). The kicker? The agency panel “voted unanimously that the drug’s benefits outweigh its risks.” Huh?
Of course, this is one example in a long list of cosmetic-pharmaceutical insanity. Forget botox. We’re onto “facial fillers” now. It’s not enough to administer toxins that act on the muscles for smoother skin. Now we’re injecting, in some cases, bits of plastic into our faces (and we don’t want to think about where else) all to look younger. It gives a whole new angle to the idea of the “Barbie complex.” (And don’t worry – we know Ken is in on this too.) In truth, there are multiple formulations of facial filler. Physicians and researchers are still in the process of trying to ascertain which varieties offer the safest results. (Because their use is generally off-label, there aren’t the same large and rigorous tests to review in most cases.) Although most side effects are cosmetically related (inflammation, discoloration, uneven texture), the FDA has received increasing reports of serious effects  such as “facial, lip and eye paralysis, disfigurement, vision problems and some severe allergic reactions.” One type of filler has been linked to delayed immune conditions like arthritis .
Doctors do not have to tell patients that they are administering a drug off-label, and it appears many take advantage of that situation. And sometimes doctors themselves, particularly those less experienced with new cosmetic drugs, may not understand the lack of study behind certain drugs. As we noted in last month’s post about off-label marketing, pharmaceutical companies aren’t allowed to directly market off-label uses for their products, but many in the industry find ways around the rule. Manufacturers can help fund medical organizations and websites that provide ambiguous information. Some doctors are better than others at doing their homework and offering their patients full disclosure of a drug’s background.
First, the sarcastic part. (How can we resist?) Are longer, lusher lashes really going to be that tantalizing when they line an oozing, red, inflamed eye? On the way to cataract surgery, will the person wish she (or he in some circumstances) had just gone the simple Revlon route? Will muscle weakness and the lack of fitness it will likely lead to seem like a smart trade for longer eyelashes? (Not exactly what you want to disclose on your Yahoo! Personals profile.) As for facial filler? A simple web image search will turn up a more vivid (and sad) illustration than we could ever paint with our commentary.
And now for the serious, sober, unsmiling, crabby grouch part. We realize there’s little anyone can do to prevent irrational people from doing truly stupid things. (There’s the old joke about making a product idiot-proof and somebody just ends up making a better idiot.) And, yes, why should the (more rational) rest of us have to live in a paternalistic state just to shield the most unreasonable among us from themselves. Still, how many of us have done stupid or ill-informed things at some point in our lives (particularly early in our “adulthood,” as debatable as that label may seem to us now)? We’re not talking about giving everyone a padded cubicle or safety scissors. We’re talking about ensuring some kind of reasonable limit on the marketing and distributing of pharmaceutical substances for non-health related purposes or at least creating real transparency in the market and related medical care.
If you ask the majority of people whether they think questionably safe, off-label prescriptions are being peddled to them in their doctors’ offices, we think most people will say no. Most people (or a very significant number, we propose) believe that there is adequate oversight, relevant testing, and full disclosure when it comes to the medications they are given. Though there are many skeptics among us in the MDA community, we think that it’s a relatively rare inclination among the general public. As a society, we often want to believe the best (and most convenient), see no evil, hear no evil until we find ourselves victim to our own blind trust and suddenly crying foul – and asking a jury to help deliver us a big bag-o-cash to atone.
We can argue about trends and the way things should be certainly. But what we’re criticizing is the mixed message-practice in how the system currently operates. It’s irresponsible to send one message (consumer protection – the FDA, medical community and legal system have it covered) and then implement another practice (gradually dismantle and hamstring oversight agencies all the while giving corporations more freedom to do what is in their best financial interest and then attempt to scale back patients’ legal right to sue for damages  if something goes awry). I’m not saying one is right and the other wrong, but this isn’t any kind of coherent socioeconomic philosophy. There’s a certain understanding on the part of the American public that government and nonprofits have consumers’ back. Though many of us might choose (smartly, we’d say) to take full responsibility for not just our lifestyle but all of our medical decisions (and much of the research review that goes into them), most people assume that laws and agencies are supposed to look out for the health and safety of everyone. It’s true that we have medical research and consumer protection policies that, in many cases, offer more safety and information than consumers have in many other countries. But this system isn’t the “fixed” structure many assume it to be. Changes in the market, in legal rulings, in government funding and policies all mean constant revisions in the production, oversight and approval processes we often take for granted. However any of us feel about these particular shifts in the system, we think it’s important to know what exactly is there and what’s not.
What’s our ultimate hope in all this? For our part, we’re interested in exposing the contradictions, highlighting the practices and policies that some of us wouldn’t otherwise hear about, revealing the real way things get done (or don’t) in the medical community and associated industries. We’re not out lobbying for political or legal change or even in most cases supporting particular solutions, but we are in the business of informing individuals. (And for the mavens among us who do pass it on: more power to you!)
We now return to our regularly scheduled program of sarcasm, satire, blithe provocation, and holiday cheer….
Are you asking Santa for Lumigan or Juvaderm in your stocking this year? Have other thoughts on lush lashes, smooth skin or other hot topics for the day? Do pull up a chair and dish! (Wink, wink)
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 humble perspective: http://www.marksdailyapple.com/off-label-pharmaceutical-promotion/
 approved by the FDA for off-label use as an eyelash enhancer: http://abcnews.go.com/Health/story?id=6404155&page=1
 side effects of Lumigan: http://www.rxlist.com/lumigan-drug.htm
 increasing reports of serious effects: http://www.google.com/hostednews/ap/article/ALeqM5gpZ5-z4-krnYlQMbMWhg2f61WV5wD94HJSOG0
 linked to delayed immune conditions like arthritis: http://archderm.ama-assn.org/cgi/content/short/144/5/637
 scale back patients’ legal right to sue for damages: http://www.drug-injury.com/druginjurycom/2008/08/wyeth-v-levine-supreme-court-hearing-on-federal-preemption-of-drug-injury-lawsuits--various-parties-have-filed-amicus-briefs.html
 Health Engagement – Where Do You Find that Personal Touch?: http://www.marksdailyapple.com/health-engagement/
 The High-Tech, High-Risk State of Maternity Care: http://www.marksdailyapple.com/the-high-tech-high-risk-state-of-maternity-care/
 Primal Blueprint Books: http://www.primalblueprint.com/category/Books_and_Media?utm_source=mda_sidebar&utm_medium=banner&utm_campaign=sidebar_like_article_books
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