The following story is updated from the original story posted May 13, 2011, and updated July 11, 2011.
June 17, 2013 – Two years ago, the makers of the Obagi Nu-Derm system broke the news that the Texas Attorney General’s office had informed them that selling hydroquinone (one of the key ingredients of Obagi skincare) through physician and medi-spa offices is against the Texas Food Drug and Cosmetic Act and the Texas Deceptive Trade Practices Act, and hydroquinone (HQ) is an “unapproved Drug” (at least as far as Texas is concerned). In short – Texas Authorities banned the distribution and sale of HQ through physician offices.
In connection with that announcement, Texas authorities had confiscated Obagi products containing hydroquinone, including their Nu-Derm®, Obagi-C® Rx, and ELASTIderm® brands, citing the doctors for “dispensing drugs without a pharmaceutical license”. Obagi voluntarily ceased shipping any products containing HQ and subsequently the Attorney General of Texas closed its investigation, rendering no penalties against the company. Presumably, this affected several other companies that make prescription-strength HQ products for sell through a physician’s office in Texas, just as they do in other states. Obagi was simply one of the more visible examples, due to the volume of product they sold in Texas at the time and their strong HQ focus.
Then in May of the following year, the way seemed to be cleared for HQ to be sold through the physicians’ offices once more. A legislative bill (SB 227) was being brought forward in the Texas legislature that would allow doctors to sell certain prescription products, including those used primarily for “aesthetic purposes” (including products containing HQ). In fact, Obagi announced at that time that they would already begin to re-introduce their HQ products in the coming months. The bill was passed in early 2013 during a regular session of the Texas legislature.
And so ends the saga, right? Well – not so fast. On June 14, 2013, when it came to the desk of Texas Governor Rick Perry, he veto’d the bill, effectively killing it. This has apparently placed HQ back in the category of being banned from sale by a physician or any other entity outside of a licensed pharmacy.
Why did Governor Perry veto the bill? He cited two specific reasons. First, he stated that had he allowed the bill to pass it, ”would circumvent existing safeguards for the dispensing of certain prescription cosmetic drugs by allowing physicians and optometrists to sell these medications directly.” Stating more directly that, “It is the role of pharmacists – who are trained specifically in drug interactions, side effects and allergies – to dispense the medications. Additionally, the State Board of Pharmacy has the authority to inspect pharmacies to ensure drugs are stored securely and at safe temperatures.”
Secondly, Governor Perry noted that he shared “concerns from within the health care community that though these drugs are used for aesthetic purposes, they are still prescription-strength drugs with potentially dangerous side effects and interactions, and therefore should remain subject to existing safety protocols and oversight.”
This last objection went even further than the original issue raised by the Attorney General’s office two years earlier. In taking action to stop the import and sale of HQ products in Texas, the Attorney General did not specifically indicate that they had an issue with the safety of hydroquinone administered under a physician’s care. Rather, the issue was presented more as an enforcement against the sale of the product outside of a licensed pharmacy, in line with Governor Perry’s first stated objection.
These events, however framed, are a concern for physicians, as they once more can become the target of investigative office “visits”, product confiscations, and agency citations. Their distress is completely understandable, especially as one looks at the larger trend over the last three years that goes beyond state legislative activities.
Exactly what new restrictions could be placed on those physicians operating retail and online shops in the state is not yet completely clear. It does, however, signal the continued reversal of the 50-year trend worldwide where people were increasingly using HQ as if it were a daily cosmetic lotion. What is important for dermatologists to understand is that the potential for liability is trending upward just as quickly.
A case in point can be found in an ongoing lawsuit brought by a consumer/patient in California superior court against her dermatologists. In this case, a dermatology company operated by dermatologists Dr. Fields and Dr. Rodan, has been sued by a woman who claims she has suffered “irreversible skin discoloration and permanent disfiguration to the skin on her face”, alleging it comes from the use of the Rodan & Field’s hydroquinone products manufactured under the “Reverse” brand. The plaintiff also claims that she was never properly informed of the risks associated with hydroquinone or that there are other safer alternatives commercially available and furthermore, the defendant “knew or should have known” about these risks before recommending and supplying the product.
For the most part, this is not an issue that was created by physicians. Over the last twenty years, hydroquinone has found its way into marketed skincare brands that promote long term use. This has created a growing problem that has not gone unnoticed by some medical professionals. The Dr. Oz show featured a segment on this issue, with guest Eliot Battle, MD, a prominent dermatologist based in the Washington D.C. area.
Dr. Battle noted that the #1 concern from patients in his offices is how to get a clear complexion. Dr. Oz showed a case of a woman who suffered a permanent darkening, or “bluing” of the skin due to ochronosis, associated with hydroquinone use (or misuse). While he noted that under proper medical supervision hydroquinone can be quite beneficial, he also described the growing concern with wide-spread use of these products. Dr. Battle noted that in the past, he would see patients coming in to his practice with hydroquinone or topical steroid related skin damage about once a year.
“We are now seeing this monthly, or weekly, most of the patients are getting these drugs, these medications, from the internet or over-the-counter,” commented Dr. Battle. “This condition now has gotten to be so popular unfortunately, that we are nervous about this.”
Dr. Zein Obagi, who is the principle creator of the Obagi Nu-Derm system, has added his voice to the concern, recently going on record in confirming that most patients build a resistance to hydroquinone, such that the hyperpigmentation they were trying to treat not only comes back, but will no longer respond to even prescription levels of hydroquinone. When that happens, you have a real problem. In Dr. Obagi’s own words, he says, “For example, where hydroquinone might have previously been used, it is now known that 80% of patients can develop a resistance if used for more than a few months.”
Fortunately, there really are safe new technologies for addressing hyperpigmentation on the face and other parts of the body. One example is a new peptide technology discovered by Stanford University dermatology researchers, and developed under the trade name Lumixyl. Several clinical studies evaluating both the safety and efficacy of the Lumixyl Topical Brightening System have been published, including one in the April 2012 issue of the Journal of Cosmetic and Laser Therapy, and the June 2013 Journal of Drugs in Dermatology. That study on 15 women with moderate to severe photo-damage related hyperpigmentation showed significant improvement in all of the study participants. Earlier studies have documented that the peptide technology is completely non-toxic, and therefore safe to use in topical cosmetic formulations.
According to dermatologist Dr. David J. Goldberg (www.skinandlasers.com), one of the lead authors from one of these studies, “It is particularly valuable for treating chronic or persistent hyperpigmentation conditions, where longer term use of prescription products are a concern. This study suggests that a decapeptide-12 based regimen can achieve excellent results, without the risk of side effects commonly associated with hydroquinone.”
If you find yourself plagued by hyperpigmentation, blotchy and uneven tone, or discolored patches due to years of sun exposure, there are two pieces of sage advice to be gleaned. First, be skeptical of lotions and potions making promises online or at the local store. The risks often outweigh the benefit. And second, be proactive in consulting with your doctor on the best way to achieve long term results that translate into healthy skin function. There are new alternatives, and where a prescription product is needed, there should be a timeframe discussed for getting the desired result, and close monitoring to ensure your skin is safely on track to a healthy positive outcome.
3) Skin whitening creams found to contain toxic mercury. Chicago Tribune
9 ) Information about Lumixyl www.lumixyl.com
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