Buyer Beware - "Illicit Botox Sparks Alert"

Illicit Botox Sparks Alert reads a recent headline in the Wall Street Journal. In the current case, physicians purchasing illicit Botox from outside the US likely received counterfeit medications. It is unclear whether the vials contain Botox and if they do whether the drug is provided at safe concentrations. 

Only MDs in the United States are allowed to purchase Botox from its manufacturer, Allergan. There are illegal arrangements where nurses, estheticians or those with even less training  obtain Botox from an absentee physician and then perform unsupervised injections. This practice is unsafe, unethical and unfortunate. This is, however, increasing in frequency as poorly trained "practitioners" or "injectors" swarm the field of cosmetic medicine and, in some tragic cases, plastic surgery.

Like many ethical issues, these practices result from financial pressure. An ethical physician would never put his or her patients at risk to make a profit. However, there are those physicians and other providers who have decided that offering cut rate injectable treatments (Botox, Dysport, Juvederm, Restylane, Perlane) is the path to a tidy sum. For very good reasons, legitimate FDA-approved drugs are not cheap (hence the higher cost of being treated by a reputable Plastic Surgeon or Dermatologist). 

When the $8 per unit Botox provider realizes that they lose money on every unit injected, there is tremendous pressure to reduce costs. This can sometimes involve overly diluting the medication such that patients receive fewer units of Botox than they paid for. Alternatively, medications can be purchased from foreign companies in India, China and Canada, to name a few. In some cases, there is no active medication in the purchased product. In other, more dangerous cases, there is excessive or non-medical grade product masquerading as an FDA-approved, safe medication. 

I am reminded of a case in which research grade Botulinum toxin was reconstituted and injected by a chiropractor. He injected himself, his (soon to be ex-) girlfriend and another couple. All four survived but wound up in the hospital for prolonged periods due to a ludicrous overdose of the drug. This type of complication is a "never event" and does not occur when Botox is purchased from its manufacturer in the US. 

The take home message is that there is an increasing number of unscrupulous providers entering the practice of cosmetic medicine. There will always be those that look to make a quick buck rather than building relationships and providing exceptional, long-term care to their patients. Warning signs include:

1. non-core physicians (those other than Facial Plastic Surgeons, Plastic Surgeons and Dermatologists) offering cosmetic services. Many among us have seen ads for injectable treatments at their internal medicine or OB-GYN office. A patient of mine was actually offered Botox by his gastroenterologist! 
2. non-physician "injectors" with no physician affiliation are suspect. To reiterate, they cannot legally buy the product they're offering to inject at bargain basement prices. Thus, you must ask where the product came from. 
3. prices that are too good to be true. In fact, they are. 

It is important to note, that fixing bad Botox is much more expensive than having it done right the first time. There is no substitute for exceptional training and experience.

If you would like to discuss Botox or other injectable treatments with a board-certified Facial Plastic Surgeon in the Denver area, schedule a consultation.

Stephen Weber, M.D., F.A.C.S.
Lone Tree, Colorado

What does "off label" mean?

"Off label" is a term frequently used in the practice of cosmetic medicine. But what exactly does "off label" mean and is it safe for patients?

Background:

All drugs and devices are tightly controlled by the US Food and Drug Administration to ensure safety and effectiveness. Drug and device companies spend years and untold millions of dollars running trials to satisfy the demands of the FDA in order to receive approval. However, FDA approval is limited to the indication for which those time-consuming and expensive studies are performed.

Example:

In the case of the available neuromodulators (Botox, Dysport, Xeomin) that treat facial wrinkles, FDA approval was sought for the treatment of glabellar lines. The FDA did approve these three medications for softening of the "11s" or lines between the eyebrows. Thus, their FDA-approved use is for one specific area of the face.

How does "off label" use evolve?

After years of safe and effective use for treatment of lines between the eyebrows, plastic surgeons and dermatologists began expanding use of Botox, Dysport and Xeomin to other areas of the face. In the United States, this is perfectly legal. Since FDA-approval is costly and time consuming, physicians will often use medications for reasons other than the initial FDA indication. Thus, we began using Botox for softening of horizontal lines in the forehead, wrinkles around the eyes, "bunny lines" or wrinkles in the nose, treatment of muscles around the mouth to accentuate the smile as well as treatment of the masseter muscle to slim the lower face. We also began using Botox to treat migraine headaches which after years of successful use recently received FDA approval.

What are the advantages of "off label" medication use?

If "off label" use was not available, the pace of medical advances would be dramatically slowed. Thus, physicians have the option in the United States to use an FDA-approved medication outside of its initial indication to provide cutting-edge treatment to patients. This is only done after significant thought. Typically, a new technique will be presented at a national meeting of plastic surgeons that catches on. A physician will present data and patient photos that demonstrate safety and effectiveness for a medication beyond what the FDA had considered. This is slowly adopted by physicians in practice and the drug company might, or might not, perform a study and submit the new indication for FDA-approval. Regardless of whether that costly study is performed, physicians and patients will benefit from the new information and it can be immediately deployed to improve patient care.

Botox, Dysport, Xeomin: How Many Neuromodulators Should Your Practice Offer?

Excerpted from an article I authored at medicalspamd.com:


http://medicalspamd.com/the-blog/2012/6/11/botox-dysport-xeomin-how-many-neuromodulators-should-your-pr.html

With Botox, Dysport, and Xeomin available and being marketed directly to your patients by their manufacturers, how many — and which ones — do you need?

In the United States, we currently have three neuromodulator products (Botox - Allergan, Dysport - Medicis and Xeomin - Merz) approved by the FDA for treatment of the glabella complex.

These products are also frequently used “off-label” for treatment of the upper-, mid- and lower-face. Botox has over a ten year-track record of safe and effective use and is the best-selling neuromodulator worldwide. Dysport was similarly approved as a cosmetic treatment in 2009. Of note, a recent injunction against Merz unrelated to safety or efficacy has delayed the nationwide rollout of Xeomin.

Given that we have multiple agents to choose from, there are a number of issues to consider when choosing which neuromodulator(s) to offer to your patients. I’ll focus on Botox and Dysport as Xeomin is currently unavailable and has yet to receive its nationwide rollout pending the legal controversy.

Is one agent safer and/or more effective?

Clearly safety and efficacy are paramount when it comes to choosing a neuromodulator. All available neuromodulators are FDA-approved for treatment of the glabella and are frequently used off label with a favorable safety profile. There is evidence that Dysport has a greater tendency to diffuse and most injectors at some point will experience this. The risk of diffusion appears to be higher with more dilute/ larger volume injections. This is worth considering if you have less experienced injectors in your practice.

With regard to effectiveness, an important point that should be well understood by all injectors is that 2.5 Dysport units are typically required to provide an effect and duration similar to 1 unit of Botox. The issues that we often see with the effectiveness of Dysport are often remedied when patients are treated with an adequate dose of Dysport. When patients are treated with adequate amounts of either agent, similar clinical effects are typically observed.

Does one injectable last longer or have faster onset?

In some studies, Dysport has a slight advantage in time to effect over Botox but this is a small difference. Duration of action will clearly differ depending upon the number of units administered and treatment must be tailored to the patient’s muscle bulk. While Dysport is often touted as having longer duration of action, I have not found this to be the case in practice. In my experience Botox and Dysport have similar onset (about 3 days) and length of efficacy (about 3 months). Again, the issue of appropriate dosing is critical. As long as a 2.5: 1 unit ratio of Dysport to Botox is provided, most patients can expect at least three months of benefit. Those patients who require a higher dose of one agent due to relatively greater muscle mass typically require similarly elevated doses of another agent. This reinforces the point that treatment must be tailored to the patient's anatomy regardless of which agent is chosen. 

Is there a certain facial region that is more suited to a certain agent?

While several studies have suggested that one agent is more effective than another in certain facial regions, I have found the difference to be negligible in practice. 

Does one drug have a higher incidence of "non-responders" or "resistance"?

“Resistance” to neuromodulator is highly uncommon. I have not seen this in the past four years of using both Botox and Dysport. I have experienced the patient who describes a neuromodulator “not working” who then responded beautifully to a repeat treatment. There are obviously numerous injector and toxin preparation explanations for this failure but this is clearly not immunologically-based resistance to treatment. Further, in my experience, patients who do require higher doses of one agent typically require higher doses of another. 

With regard to the newcomer Xeomin, it’s formulated as a “naked” toxin without other associated proteins. Thus, it is possible that the risk of immunologic reactivity will be lower following Xeomin treatment but this theory will takes years to be fully investigated. 

Is one neuromodulator “cheaper”?

While Dysport was initially touted as being cheaper to the patient than Botox, this has not been the case. When patients are treated to effect, most injectors will agree that a ratio of 2.5 Dysport U: 1 Botox U is most appropriate. At current pricing in the Denver area ($12/ Botox U and $5/ Dysport U) the cost to the consumer is actually slightly higher for Dysport than Botox. 

Does one company offer better rebates to our patients?

Both Allergan and Medicis offer consumer rebates of similar dollar amounts to assist patients in purchasing their products. Allergan typically provides instant rebates for product which reduces the point of sale cost to patients. Medicis provides mail-in rebates that are received after the treatment is rendered. 

Allergan also offers the Brilliant Distinctions program that provides “points” for future purchases of Botox, Juvederm and Vivité skin care products. This builds brand loyalty for Allergan by reducing the cost of future treatments but also appears to build practice loyalty. Although, these points can be used at any practice we find that the vast majority of these patients return to our practice to use their points for future treatments, aiding us with patient retention. 

Does one manufacturer offer better customer (physician) support?

Both Allergan and Medicis offer significant support of injectors. Both companies also provide product and experts to train new injectors and expand the skill set of advanced injectors. Both offer volume discounts that increase as practices begin ordering larger amounts of product. Of note, Allergan also makes available marketing and practice building experts to its higher volume customers. As far as I am aware, this service is not offered by Medicis. 

Conclusion

As a Facial Plastic Surgeon with a busy medi-spa component to my practice, I've considered which products we need to offer to our patients. Our goals are to provide the safest and most effective treatments to our patients, to minimize our cost, to maximize our ability to generate revenue and to grow our business. Promoting a single neuromodulator product, in our case Botox, has allowed us to create a clear, consistent marketing message. We have also been able to boost our volume discounts and achieve a lower cost for Allergan products including Botox, Juvederm and Vivité products. This has allowed us to offer better package pricing and cross-promote neuromodulator, dermal filler and skincare products. We’ve also been able to tap the wealth of Allergan’s marketing expertise to better promote our practice at minimal additional cost.

An additional advantage we’ve noted is less confusion among our patients. When most new patients ask for “Botox” they’re actually requesting a result rather than a specific product. Patients are seeking an improvement in their appearance, not a fellowship in available neuromodulator products! It is our job to determine which product will be most effective at delivering that result while at the same time allowing us to cover our overhead. Thus, the choice of which neuromodulator(s) to offer is a very personal decision based on concrete data and anecdotal experience. I’ve tried to outline our reasoning for limiting our practice to a single agent and I hope you’ve found this to be helpful

Is there a clinically-significant difference between Botox and Dysport?

This is a common question among our patients at Lone Tree Facial Plastic & Cosmetic Surgery Center. We answer alot of specific questions about these products. Some ask for Brand X or Y because they saw an ad or because a girlfriend recommended it. Some of our clients have been told to "avoid" certain products. I hope to dispel some of this misinformation and allow you to become a more informed consumer of neuromodulator products by answering a series of questions for you.

What is the difference between these two products?

Botox (onabotulinumtoxin A) and Dysport (abobotulinumtoxin A) are different at a molecular level but act via the same mechanism. They block communication between nerve endings and the facial muscles that those nerves control. The clinical effect is softening or weakening of muscle contraction rather than "paralysis." The effects are temporary and any muscle weakening resolves once new nerve endings have sprouted and connected with the muscle. This typically requires two to three months.

Of note, Dysport is a smaller molecule and thus has some tendency to "spread" from the site of injection. In my experience this is an issue when higher dilutions (larger volumes of injection) of the product are used. This is mainly a concern during injection of the forehead, where excess "spread" can lead to temporary heaviness of the eyebrow. The best option when treating forehead wrinkles in a person who already has heavy brows is to use a lower dilution of the product (we always do) or using Botox to minimize the risk of "spread" and excessive forehead weakening. 

Are Botox and Dysport safe? 

Yes. Both Botox and Dysport are FDA-approved for the treatment of dynamic facial wrinkles. They have both undergone significant study demonstrating their effectiveness and safety. The doses used for aesthetic treatments are significantly lower than those used for treatment of medical problems such as cervical dystonia. 

Do the risks or side effects differ between the two products?


Both Botox and Dysport have similar side effect profiles. The most common risk is a bruise at the site of injection. This is uncommon but can be camouflaged with makeup immediately. Most complications with neuromodulator products result from injection technique. If the wrong muscle is injected or if the target muscle is overtreated, inadvertent or excessive muscle weakness can result. For example, overtreatment of the forehead can result in drooping of the eyebrows and increased fullness in the eyelids. Temporary headache, allergy and lack of effect have also been described but are unusual.

Can these products be used together or sequentially?  

Botox and Dysport can be used at the same time. For example, for a woman with drooping eyebrows Botox might be used in the forehead to minimize the risk of spread which could result in further drooping of the eyebrows. In this case, Dysport might be used to treat the remainder of the upper facial areas. This is typically not necessary as an experienced injector who does not over-dilute Dysport should not have significant difficulty preventing drooping of the eyebrows. These products can also be alternated - Botox today and Dysport in three months when the wrinkles need to be re-treated. 

What's the deal with the "units" of Botox and Dysport? Are they the same?

No, units of Botox and Dysport cannot be compared as these are similar but different medications. Most injectors will agree that roughly 2.5 to 3 units of Dysport are required to achieve results equivalent to 1 unit of Botox. If Dysport seems like a "steal" on a per unit cost basis, there's a very good reason for this. You will need alot more units of Dysport to achieve the same effect. In practice, I find that the cost is roughly the same when achieving a similar result.

Is there a cost difference for either product? 

No. I do not believe so. In our hands, 2.5 to 3 times the number of Dysport units is required to achieve the same results as Botox. In most practices, ours included, the cost of Botox is about 2.5 times higher per unit than Dysport. Given the need for more Dysport to achieve equivalence with Botox this results in a similar cost. Of course, this is practice specific.

Which should I choose?


This is a great question! The answer does differ from person to person. Some of our patients prefer one product over the other for reasons including a more natural effect, longer duration of effect or better response to X over Y. Some patients will request Botox specifically after having had a previous issue with drooping of the eyebrows after Dysport treatment. As mentioned earlier, this issue is probably related to the manner in which the product was injected rather than the product itself. Most importantly, the practical consideration of cost is highly important to our patients. Because of this, we'll perform more injections with a given neuromodulator product if the manufactured is offering a special that month. As both products are safe and effective and well-researched this makes perfect sense.

I hope that this post answers some questions you might have had about Botox and Dysport. I will be updating this post as our experience with Xeomin, the newest neuromodulator product, grows.

I encourage you to visit Lone Tree Facial Plastic & Cosmetic Surgery Center if you have any additional questions.