Cataracts Are A Risk You Take for Long Eyelashes That You May Not Get

by Heidi Stevenson

Long thick eyelashes are certainly alluring—but it requires good vision to appreciate them. And that's what's put at risk by taking the so-called "new" drug that may grow longer thicker fringe around your eyelids. Allergan will be selling it under the lovely name Latisse. They are hoping for another blockbuster like Botox, the paralyzing poison injected to temporarily remove wrinkles, along with the ability to make facial expressions.

Latisse is not a new drug. Under the name Lumigan, it is used to treat glaucoma. The patent is near expiration. Therefore, there is longterm experience with the drug. The total spectrum of its effects—more generally known as "side effects"—is well known. For treatment of glaucoma, the risks may be worthwhile.

Risks of Latisse

Would you want to risk blindness for a chance at growing long eyelashes? That is, literally, the risk you'd be taking. According to Medscape, a good source for drug information, adverse effects include a variety of eye damage. For example:

• Blepharitis: Inflammation of the eyelid.
• Ocular pain: Pain in the eye.
• Punctate keratitis: Cornea inflammation in tiny spots or depressions.
• Visual changes.
• Heterochromia: Dark spots on the eyelid, sometimes extending to entire lid.
• Cataracts: Cloudiness or opacity of the lens of the eye.
• Hypertrichosis of eyelid: Excess growth of body hair.
• Hirsutism: Excess hair growth caused by endocrine dysfunction, specifically excess adrenocortical function.
• Conditions considered to be rare:
• Iris hyperpigmentation: Darkening of the iris.
• Asthenopia: Eye weakness/fatigue, often accompanied by headache.
• Chemosis: Swelling of mucous membranes over the eyeball and inner lids.
• Ocular inflammation: Eye inflammation.
• Photophobia: Intolerance of light.
• Teratogenic effects: Birth defects (level of risk unknown)

Did you notice that cataracts are not considered a rare adverse effect? Consider also that hirsutism—the effect that's hoped for with Latisse—is indicative of disruption of the hormone system. This can have far-reaching effects over the entire body, effects that tend not to be noted as connected to use of a drug.

Isn't it interesting that an adverse effect that may be indicative of a serious underlying disorder is being promoted for precisely that effect?

Add to all these risks, liver disease is a contraindication for use of bimatoprost. That can be the case only when a drug is metabolized by the liver, thus placing extra stress on it. So, in exchange for long lashes, you are putting your liver at risk.

The next generation could be affected by a mother's use of Latisse. Studies in mice have indicated a problem, but little more has been done to identify how serious the risk might be.

For its original purpose, treatment of glaucoma, Lumigan's risks may make sense. For the purpose of making one's eyelashes sexier, how could the risks possibly be justified? As you'll see later, the lack of efficacy hammers this point home even further.

Marketing of Latisse

Hypotrichosis. It sounds like a terrible disease. What it means is deficiency (hypo-) of hair (-trich) condition or disease (-osis). This is another case of disease mongering. Pharmaceutical companies are masters at creating the image of a disease to sell a drug. So now, along with the made-up disorders of menopause, a condition of being female, and old age, for which statins are being prescribed, we can add the heartbreak of hypotrichosis.

Of course, the drug being sold needs to appear relatively harmless. News reports of Latisse are starting to come out. They tend to pay lip service to adverse effects, noting things like darker skin and itchy red eyes, the serious risks are ignored.

The New York Times has produced an article that purports to present a balanced view. The first concern it cites is the possibility of itchy red eyes. The second is its cost, questioning whether women will be willing to pay it. At no point is a risk more serious than excess pigmentation discussed. The end of the article suggests that some doctors wonder if Latisse might produce hair growth elsewhere on the body, with a quote from Allergan representative, Mr. Pyott: "For a lot of women, the eyebrow is every bit as important as the eyelash."

The serious concerns in use of Latisse are not even noted in the New York Times article. (The "paper of record"?)

In marketing to doctors, Allergan provides less than complete information in its "Highlights of Prescribing Information". It references only hypersensitivity as a contraindication to use of Latisse. The liver disease concern isn't referenced. It does list the adverse reactions noted above, though not in an easy-to-read list, but one after another in no particular order. The potential for teratogenic effects is noted, but downplayed by saying that they occurred only at 33-97 times the prescribed human dose. Allergan advises only "caution" in prescribing Latisse to pregnant women!

Efficacy of Latisse

For all its risks, how effective is Latisse in thickening and lengthening eyelashes?

In studies reviewed by the FDA before approval, the GEA (global eyelash assessment) of the guinea pigs in the study was assessed and rated for what the FDA's describes as "Primary Efficacy". Potential results were:

• 1: none to minimal improvement
• 2: moderate improvment
• 3: marked improvement
• 4: very marked improvement

Out of a total of 137 subjects, 3 men and 134 women, and 141 controls given placebo, 5 men and 136 women, the results were:

GEA Score	Received Latisse	Received Placebo
1 (minimal)	29 (21.2%)	27 (19.1%)
2 (moderate)	108 (78.8%)	114 (80.9%)
3 (marked)	0 (0.0%)	0 (0.0%)
4 (very marked)	0 (0.0%)	0 (0.0%)

Looking at this, it's quite clear that one's likelihood of achieving wonderful results of a GEA score 3 or 4 points higher than at the start are vanishingly slim. Not a single test subject achieved such a result. Then, there is the question of whether there was any significant change at all, since the results for those who received placebo were almost the same!

This, of course, is not what Allergan wanted to see. So, apparently, they found another way to measure results. A calculating tool called LOCF was used. This means that only those cases that were recorded during each recordable session (weekly for 20 weeks in this study). If data is not available for any particular point, then the previous week's data is carried forward. As the FDA's report states, "In the event that a subject’s digital image was not able to be interpreted due to the presence of spectral noise, he or she was not included in the analysis population for that particular secondary endpoint...Missing data were imputed up to week 16 using the LOCF method." Very small numbers from the placebo group are recorded for a secondary analysis—the one used to gain FDA approval.

As the graph show from the FDA report, displayed below, the LOCF technique was applied far more heavily to the placebo group.

The placebo group's results are only minimally included. The totality of the placebo group's data was not included in the final analysis. They were not used by the FDA to determine whether to approve Latisse. Indeed, the FDA reviewer made favorable comments that are included in the report—but not in regard to the original data, which clearly documents the lack of efficacy.

What Is the Real Truth of Latisse's Efficacy?

How the study was able to distinguish between guinea pig and placebo groups is unexplained, but the fact is clear that using the LOCF technique, fewer of the placebo results were recorded. It is, of course, these results that were used by the FDA to grant approval for the use of Latisse to grow tall fat eyelashes.

It's difficult to know the full story about how well Latisse produces fat eyelashes. From the decision to use LOCF, it seems possible that the placebo group tended to actually develop thicker longer eyelashes, but that they didn't last, or that the researchers' own bias slanted the results.

There is one more bit of information available from Medscape. Latisse is merely Lumigan repackaged and remarketed. Hirsutism and Hypertrichosis of Eyelid are both listed among the most frequent adverse effects. This would seem to imply that it's not unusual for thicker and longer eyelashes to develop while using it. However, in line with that, one must also consider that hyperpigmentation of the eyelid, which appears to be permanent or nearly so, headaches, dry eye, and eye irritation are equally common, since they're also listed among the most frequent adverse effects.

A Typical Example of Big Pharma's "Research"

In starting this article, my intent was to do a brief piece about the ridiculous sorts of drugs being produced now and the methods used to market them—all the while pointing out the real risks associated with Latisse. Unfortunately, what was uncovered proved to be indicative of even more:

• Disease mongering.
• Pseudo-science in the pay of pharmaceuticals.
• Doctors who have forgotten their calling: to first do no harm and to heal. This product has nothing to do with either, but you know that there will be plenty of doctors who get rich from it.
• FDA corruption.

What more could you ask for in the service of mammon?

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