Marks Daily Apple
Serving up health and fitness insights (daily, of course) with a side of irreverence.
20 Dec

Off-Label Cosmetic Prescriptions

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)

Further Reading:

Off-Label Pharmaceutical Promotion

Health Engagement – Where Do You Find that Personal Touch?

The High-Tech, High-Risk State of Maternity Care

You want comments? We got comments:

Imagine you’re George Clooney. Take a moment to admire your grooming and wit. Okay, now imagine someone walks up to you and asks, “What’s your name?” You say, “I’m George Clooney.” Or maybe you say, “I’m the Clooninator!” You don’t say “I’m George of George Clooney Sells Movies Blog” and you certainly don’t say, “I’m Clooney Weight Loss Plan”. So while spam is technically meat, it ain’t anywhere near Primal. Please nickname yourself something your friends would call you.

  1. I’m in my 65th week (out of 72) of chemo for HCV (Hepatitis C). While the treatment is excruciating beyond description and basically destroys the human body, the “muscle drug,” PEGASYS (Peginterferon alfa-2a), has one delightful cosmetic side effect: Hypertrichosis of the eyelashes. For many, myself included, HCV treatment causes one to grow extremely long, silky, ridiculously attractive eyelashes. Not sure it compensates for other things, like barely being able to move, severe depression, having a hemoglobin of 9, etc. But HEY…

    Carbon Based wrote on December 20th, 2008
  2. The trade name for Lumigan for cosmetic purposes is Latisse. In clinical trials, they found that 4 out of 137 had negative side effects like eye inflammation. They didn’t say what the other side effects were.

    Dr Behnaz Yazdanfar wrote on December 20th, 2008
  3. Eyelashes? I mean really?… eyelashes?

    The SoG

    Son of Grok wrote on December 20th, 2008
  4. Yeah really eyelashes. Who has time to pay attention to those.

    wisdom wrote on December 20th, 2008
  5. Injecting plastic into your face just doesn’t sound very appealing, I’ll take the wrinkles!

    All the Best,

    Andrew R

    Andrew R - Go Healthy Go Fit wrote on December 20th, 2008
  6. I read about this a few weeks ago when it came out. Crazy if you ask me. http://sec.online.wsj.com/article/SB122833625879476661.html

    As to the clinical trial comments, 4 of the 137 people *dropped out* of the trial because of their side effects.

    Also, avoidance of more serious or common side effects (like those seem with Lumigan) is dependent upon the application quality (keeping Latisse entirely out of the eye). Finally, the FDA panel strongly encouraged the company to pursue further testing for long-term safety and use in younger adults and those undergoing chemotherapy. Doesn’t sound to me like it’s been proven safe.

    I’ll keep my mascara, thank you very much.

    Jen wrote on December 20th, 2008
  7. My cousin has been using Retin-A for about 11 years now, she is 6 years older than i, and she looks great! Retin-A is very strong, but it works very well, it even got rid of her freckles.

    Donna wrote on December 20th, 2008
  8. I must add: You have to get Retin-A prescribed by a Doctor.

    Donna wrote on December 20th, 2008
  9. Don’t people realize that its all in the eyelashes of the beholder?

    Zen Frittata wrote on December 21st, 2008
  10. I think this just shows the great need to address the underlying issue: our society’s obsession with a very narrow standard of beauty for women. Why can’t we just do away with mascara and such products all together? If no one wore make-up we’d all learn to find beauty in the natural face. I know this sounds extreme but it’s insidious how marketing products exactly like this rely on making us feel bad about ourselves first.

    charlotte wrote on December 21st, 2008
    • Amen to that! I have recently developed an allergy to mascara and I’m learning to like my face without a lot of makeup (this from a 36 year old former teenage goth queen). I only wear concealer and lipstick most of the time, and I’m seeing beauty in myself that I never saw before simply from not being conditioned to expect the look of makeup.

      It’s most definitely a reflection of emotional security and self-love more than anything else. The more wisdom I get under my belt, the less crap I put on my face.

      Emmay wrote on January 7th, 2010

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