An Interview With Dr. Mary Lupo Of Lupo Center For Aesthetic Dermatology

Since 1983, Dr. Mary Lupo has been at the forefront of non-surgical skin rejuvenation.

As the founder of Tulane University's resident's cosmetic clinic, a Platinum plus Botox and Juvederm provider, and a clinical instructor for Allergan, Dr. Mary Lupo knows her way around injectables. In fact, she launched Botox to physicians in Austrailia in 2007. We wanted to hear what Dr. Lupo has to say about how she manages her dermatology clinic and her lifestyle as a physician.

Name: Mary P. Lupo MD FAAD
Location: New Orleans, LA
Website: drmarylupo.com/index.html

That's interesting: Dr. Lupo received the Peterkin Award for original research in skin lipids and inflammation in patients with atopic dermatitis. Author of over 50 publications and presentor of over 230 presentations. Researcher, author, lecturer, teacher. Founding co-director of the Cosmetic Boot Camp in 2005. Past-president of the Women’s Dermatological Society and former member of the board of directors of the American Society for Dermatologic Surgery.

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Botox: Allergans (Still) Big Seller

Every successful cosmetic clinic that I know of is a big consumer of Botox by necessity. Medspas, derms, clinics and in many places dentists offer Botox and move a lot of it.

Most of my clinics averaged about $20-25k a month in Botox sales which was healthy but not the biggest portion of sales - usually between third and fifth place by revenue - and we were offering that at $10/mu at the time so we had to squirt a lot of Botox to hit those numbers. Of course, in the old days we didnt' have access to Medical Spa RX's group buy Botox plan at the time either so we we're paying full retail and that always takes a bite out of your profitability.

Here's a really good artitlce on how Allergan has positioned Botox to be a really stable source of income over the long term.

Via CNN Money

Alergans Survival Strategy: Botox Everlasting

Most big, mainstream pharma companies are desperately working to develop new expensive drugs and filing lawsuits to extend patents on old ones. But to dodge that deadline, Allergan is using another strategy; let’s call it the “stay small and make weird products” approach.

The company behind Botox, the “face-lift in a bottle,” is itself aging rather gracefully. Net sales increased by 13.3%, to roughly $1.3 billion, in the first quarter of 2011 compared with the same period last year, and the company has given analysts no reason to think it won’t put together a string of good quarters.

That’s because Allergan’s product portfolio is looking first class: “We believe Allergan has one of the most compelling growth profiles in specialty pharma,” a May report by Piper Jaffray analysts David Amsellem and Michael Dinerman said. But pharma companies need more than a good growth strategy, says Ken Cacciatore, an analyst with Cowen Group. They should also develop new products and have plans to keep the patent rights for the ones that they already have. “That’s really the holy grail of pharmaceuticals,” he says, “and Allergan has it.”

The holy grail

A huge part of Allergan’s patent-cliff immunity is its blockbuster Botox, which has helped the company evade the patent problems facing others in the industry in two ways: First, Allergan has continued to discover new applications for it. “Really, Botox is a Russian doll,” says Allergan CEO David Pyott, because Allergan keeps discovering new uses stacked inside the original treatment.

Second, Botox is also a special pharmaceutical because of the way it’s made. “It’s going to be very difficult for anyone to get a truly substitutable product through the FDA,” says Cacciatore.

That’s because Botox is something called a biologic, which means it isn’t man-made. Instead, Botox is created by making a solution that contains trace concentrations of the deadly botulinum toxin. Botox works in both the medical and cosmetic arenas by temporarily paralyzing targeted muscles. For example, Botox injections into the eye muscles can help patients suffering from a condition called strabismus, in which their eyes are misaligned. In a more vain vein, cosmetic Botox reduces the appearance of wrinkles in the forehead by numbing facial muscles so that they can’t contract to form creases.

Allergan and doctors have found muscle paralysis can be useful in other places: Allergan plans on getting Botox approved to treat patients with neurogenic detrusor overactivity, or overactive bladders, this year. Last year Botox was approved to treat chronic migraines, which is one of Allergan’s most promising markets, according to Ben Andrew, an analyst from William Blair & Co. Botox has the potential to be the first treatment of its kind in that space, he says, because it’s preventive: “Every other FDA-approved product is used in response.”

Botox’s success as a treatment for chronic migraines could surprise the market, according to Gary Nachman, a senior analyst in specialty pharmaceuticals with Susquehanna Financial Group: “You’re looking at a potentially huge blockbuster that people are really not giving them full credit for.”

Product diversity

Allergan is unique, says Lavin, because it has positioned itself well in three distinct sectors: ophthalmology, obesity, and cosmetics, all of which target the aging, sedentary population of U.S. consumers. “I think of aging and obesity as two areas I’d like to invest in,” he says.

Allergan can develop in seemingly strange sectors because of its relatively small size. It has a market cap of about $25 billion, compared with, say, J&J (JNJ, Fortune 500) and Novartis (NVS), which have market caps of $183 billion and $145 billion, respectively. “A company like Allergan still has a small enough base revenue that incremental hundreds of millions matter,” says Cacciatore. “Large pharma companies have consolidated themselves into a box where they need incremental billions.”

Allergan’s growth strategy allows it to invest in niche markets heavily enough to be a persistent threat to much larger companies. It’s a phenomenon that CEO David Pyott enjoys: “I remember years ago when I was relatively new at this job, and people said, ‘Do you really think you can compete against Pfizer in ophthalmology?’ We’d just smile and say, ‘We love taking market share from those guys.’ ”

Method to the madness

Allergan’s portfolio looks bizarre at first glance, but there is a pattern to much of its drug development.

Take Latisse, for example. Allergan researchers noticed that patients using its glaucoma treatment Lumigan were also growing longer lashes. The company then conjured up a medical condition, hypotrichosis, or inadequate eyelashes, to pair with its newly made drug. Allergan essentially created the market for Latisse, which was approved by the FDA in 2008. The company expects to make over $500 million from Latisse — again, a drug it had already invented and released as Lumigan.

Latisse is just one example of how Allergan aims to keep improving its own technology to discover new drugs, renew patents for existing ones, and find new uses for both. Pyott says he has overseen the growth of the company’s research and development budget from $80 million when he joined 10 years ago to $800 million this year. That’s about 16% of total sales that Allergan plows back into R&D.

Dysport hasn't really made a huge difference and for most medspas or clinics it's certainly still playing second-fiddle. )I'd be interested if anyone has information they could add as a comment as to exactly where Dysport sits as a percentage of market share right now.)

Allergan Shifting Headache Sales Reps to Botox

Allergan sales forces previously working on GlaxoSmithKline headache drugs Imitrex and Amerge as part of a co-promotion will be reassigned to Botox, in support of the drug's new headache indication.

The move,  confirmed by a company spokesperson,  gives Allergan a jump start with headache specialists, since the GSK co-promotion deal was “a very good way for Allergan to learn the headache market,” Allergan CEO David Pyott told the Journal. Crystal Muilenburg, a spokesperson for Allergan, says that sales forces will initially target neurologists, pain, and headache specialists, to train them on Botox's “injection protocol and dosing regimen.” Muilenburg declined to estimate the number of reps that will support the headache indication, which received an FDA green light on October 15. GSK drugs Imitrex and Amerge have lost patent protection.

A key challenge that we started addressing immediately upon FDA approval is reimbursement,” said Muilenburg. “As with many new drugs, reimbursement is not widely established for Botox in this new therapeutic category.”

Physicians or patients looking for information on reimbursement can visit a dedicated website, call 1-800-44-BOTOX (option 4), or locate a Botox reimbursement business manager for “on-site education, training, and support,” according to the website. Physicians can also sign up to receive forthcoming treatment records and case studies on the headache indication, as they become available.

Allergan paid $600 million to settle Justice Department charges of off-label marketing in September, and pled guilty to marketing Botox off-label for conditions including headache. As part of the settlement, Allergan was forced to drop a First Amendment lawsuit challenging FDA policy on the exchange of “truthful scientific and medical information,” a spokesperson reported at the time. The pending approval in September of Botox for an ailment that previously existed as an off-label use sparked rumors about a relationship between Allergan's lawsuit and FDA's approval of the headache indication, rumors which Muilenburg quelled: “The FDA granted approval of Botox for the treatment of chronic migraine patients based on two phase III pivotal trials, and on its own merit,” she said. “The two actions are completely separate matters.”

Botox's headache indication, specifically, is for the prophylaxis of headaches in adult patients with chronic migraines. GCI Health has been awarded the PR account for the indication. Muilenburg declined to reveal other agency partners for the headache indication launch.

Allergan Starts Trials for Hair-Growth Treatment

Botox maker Allergan is about to launch clinical trials of a hair-growth treatment similar to its drug Latisse, which stimulates the growth of eyelashes.

The Phase 1 trial, scheduled to start this month, will focus on the safety of two formulations of bimatoprost, which is the active ingredient in Latisse.

This phase of the trials will include a total of about 28 patients — men with moderate male-pattern baldness and women with moderate female-pattern hair loss.

The FDA approved Latisse as a treatment for eyelashes, with a warning that it can cause hair growth on other parts of the body that come in contact with the drug.  Some doctors have already tried using Latisse as an “off-label” treatment for hair loss.

Hair-restoration expert Dr. Alan Bauman of Boca Raton, Fla., reported “modest hair growth” among patients who have been applying Latisse daily to their scalp.

Irvine-based Allergan might want more impressive results than that in order to make its hoped-for baldness remedy more commercially successful.

Bauman predicted that “Allergan will likely test a stronger concentration for the use on the scalp than the 0.03% bimatoprost found in Latisse.”

If Phase One (safety) trials are successful and Phase Two and Three trials (efficacy) are eventually completed, bimatoprost could become the third FDA-approved drug for the treatment of baldness in men and only the second FDA-approved drug for women with hereditary hair thinning or female pattern baldness,” Bauman said. Those conditions affect an estimated 60 million-100 million Americans, he said.

The clinical trial will be run out of Tempe, Ariz.  It is scheduled to be completed in February.

FDA Approves Botox as Migraine Preventive

Federal health authorities on Friday approved Botox injections for the prevention of chronic migraines in adults, an advance experts described as "modest."

In a statement, the Food and Drug Administration recommended Botox be injected approximately every three months around the head and neck to dull future headache symptoms.

The drug -- whose generic name is onabotulinumtoxinA -- has not been shown to work against migraines that occur 14 days or fewer per month, nor has it been shown to work for other forms of headache, said the statement.

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Allergan: $600 Million Poorer, but Closer to New Botox Uses

Sounds like Allergan may have been getting a little greedy and got busted....

Allergan, the maker of Botox, will pay $600 million in fines and civil settlements after pleading guilty to marketing their product for uses for which it hasn't been FDA approved.

The Justice Department accused Allergan of encouraging doctors to use the powerful neurotoxin through kickbacks and by teaching them how to forge drug reports.

"The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA," U.S. Attorney Sally Yates explained.

Botox is most famous for its use by dermatologists to temporarily diminish the appearance of facial wrinkles, but the drug, which is scientifically known as Botulinum toxin and works by temporarily paralyzing nerves, has been approved for rare conditions like eye muscle spasms since 1989.  In March, the FDA approved Botox use to treat muscle spasms in elbow, wrist and finger injuries among adults.

According to the suit, Allergan paid doctors millions and taught them how to miscode the drug to avoid being caught, all so that they would use Botox for "off-label" treatments – uses for which it has never been approved, though it may be effective. Botox was promoted for migraine relief and juvenile cerebral palsy, for which observational data suggests it is effective.

When a drug has been approved for a certain medical use, it cannot be marketed to treat other uses, even if patients report those other uses as a side benefit. Still, marketing drugs for side benefits is common. In 2008, Bayer ran afoul of the FDA when it over-emphasized the acne reducing benefits of its popular birth control pill, Yaz.

Though off-label usage is legal and often beneficial for patients, it can be dangerous. In April 2009, after repeated reports of side effects among children with cerebral palsy that mimicked botulism poisoning, the FDA ordered Botox to carry "black box labeling," the strictest possible warning for a product.  Doctors reported respiratory problems, muscle weakness, loss of bladder control and double vision among their young patients, along with hospitalizations.

Currently, the FDA is reviewing Allergan's application to approve Botox for migraine headaches. The agency is not reviewing information on juvenile cerebral palsy and no known tests are in the works, though CBS is reporting that Botox is being tested in countries like India, Poland, Serbia and Turkey for a host of ailments, including Parkinson's disease, spinal cord injuries, excessive perspiration, depression and something called "curvature of the penis."

If any of these studies abroad provide conclusive data, they could potentially spur bids for approval of new uses of Botox in the United States.

Botox News: Allergans Profits Jump 36%

Botox continues to be a golden child for Allergan, but there are a number of other products that are bolstering the drug giant's sales.

Allergan, and most especially Botox, is always on my radar... Since we opened the first medical spa back in 2000, I'm sure that we've put more than one of Allergan's sales reps into a new house. (Perhaps not, I'm not really sure what Alergan's sales reps make.)

While there Medial Spa MD's physician members who are in a position to take advantage of our Select Partners have less expensive ways to get Botox than paying sales commissions, Allergan certainly still takes the lion's share of the profits from most Botox treatments that are performed. Botox has become something of a commodity, with almost every medical spa and laser clinic (and a few day spas) offering it.

For those of you who are interested in the Botox Behemeth's contnued rise, I give you the following compiled from their latest earnings report.

Allergans second-quarter earnings soared 36% with accelerating sales spurred on by their cosmetic products. There have also been recent developments that mark progress toward FDA approval to sell Botox injections to treat migraine headaches.

Allergan said the FDA has asked the company for certain material, such as a modified Botox "risk evaluation and mitigation strategy" that includes information about thepreventive treatment of migraines. Allergan has 3 months to provide the information. Allergan says it continues to expect an FDA answer this year.

Evidently wall street liked the news... especially the rising Botox sales since shares of Allergan traded up 5.4%. The company also raised its 2010 sales estimate for Botox. (Allergan posted total Botox sales of $1.31 billion last year, split evenly between cosmetic usage and various medical treatments.)

Allergan's total revenue rose 10% to $1.25 billion with double-digit gains in both its specialty pharmaceutical and medical device businesses. (Facial aesthetic products wer up 32% and skin-care products up 40%.)

Allergan's second quarter "benefited from a continued recovery in our cash-pay aesthetics business around the world," said Pyott said in a company press release.

Botox sales rose 7% in the quarter to $360.5 million. Looking ahead, Allergan said it now believes the drug will post sales of $1.36 billion to $1.39 billion this year, which compares with a forecast in February for $1.33 billion to $1.37 billion.

It dropped its forecast for the eyelash-enhancing drug Latisse, however, to a range of $90 million to $100 million, down from February's $140 million target. A big issue is that consumers have learned to stretch their supplies, which means Allergan has to figure out how to broaden the market to offset that effect.

Allergans Outlook For the full year of 2010

Total product net sales between $4,620 million and $4,750 million.

Total specialty pharmaceuticals net sales between $3,835 million and $3,930 million.

Total medical devices net sales between $785 million and $820 million.

• ALPHAGAN  franchise product net sales between $370 million and $390 million.
• LUMIGAN  franchise product net sales between $490 million and $510 million.
• RESTASIS  product net sales between $580 million and $600 million.
• SANCTURA  franchise product net sales between $70 million and $80 million.
• BOTOX  product net sales between $1,360 million and $1,390 million.
• LATISSE  product net sales between $90 million and $100 million.
• Breast aesthetics product net sales between $290 million and $300 million.
• Obesity intervention product net sales between $235 million and $250 million.
• Facial aesthetics product net sales between $260 million and $270 million.
• Non-GAAP cost of sales to product net sales ratio between 15.5% and 16.0%.
• Other revenue at approximately $50 million.
• Non-GAAP selling, general and administrative expenses to product net sales ratio between 39% and 40%.
• Non-GAAP research and development expenses to product net sales ratio between 15% and 16%.
• Non-GAAP amortization of acquired intangible assets at approximately $20 million. This expectation excludes the amortization of acquired intangible assets associated with the Inamed, Cornéal, EndoArt, Esprit, Samil and Serica acquisitions and the ACZONE(R) asset purchase.
• Non-GAAP diluted earnings per share attributable to stockholders between $3.11 and $3.15.
• Diluted shares outstanding between approximately 307 million and 308 million.
• Effective tax rate on non-GAAP earnings at approximately 28%.

For the third quarter of 2010, Allergan expects:

Total product net sales between $1.13 billion and $1.18 billion.

Allergan Q1 Profits: Botox, Dysport, Juvederm Ultra XC

Allergan's Q1 Earnings Call: Allergan's thoughts on it's Botox and Juvederm Ultra XC growth.

You might want to visit our Select Partner Medical Spa RX after reading this.

First quarter sales increased year-over-year 11.2% in dollars and 6.9% in local currencies, boosted by the strong pickup in the sales of medical devices, which grew 18.4% in dollars and 13.4% in local currencies. The growth in the Medical Aesthetics businesses was even stronger outside the U.S. in all regions and across a wide range of countries, with surprisingly strong performance in Europe.

Operating performance was strong, with non-GAAP earnings per share at $0.65, marking an increase of 18.2% versus the result for Q1 of 2009, and comfortably exceeding the Q1 expectations shared with you, the investment community, of $0.57 to $0.59.

Earnings growth was driven by strong gross margin expansion, especially in the Medical Device segment. Careful spending in the selling, general administrative area, whilst we increased investment in R&D by 11.1% on a non-GAAP.

Within SG&A, we however doubled our DTC expenditures versus Q1 of 2009, which of course was the low watermark for spending when the world economy was in crisis. Our plan is to continue to invest in 2010 across our brands and into the recovery of our markets.

During the quarter, we were pleased that we continued to strengthen our R&D pipeline, supplementing our internally development programs with acquisitions and licenses. In January, we acquired Serica, a company with proprietary technology for use in tissue regeneration especially applicable to breast reconstruction, as well as the license for Ser-120 in Phase III clinical development for nocturia. Strategically, we have made good progress in building up a portfolio of urology assets.

We also furthered our aspirations to be the leader in medical aesthetics also in Asia, by reacquiring the rights to BOTOX Cosmetic in Japan and China and expanded our footprint in fast-growing emerging markets by establishing direct operations for all of our businesses in Turkey, effective from the second quarter.

After the out-licensing transaction with Bristol-Myers for neuropathic pain, we've increased our degree of R&D focus on our core specialty areas.

Now I’d like to comment on our expectations for 2010. For the full year earnings outlook, we have brought up the bottom of the EPS range by $0.02 to $3.11 and have left the top end of the range at $3.15 which at the time of the last earnings call expressly excluded the costs of any healthcare reform bill in the United States. With the increase of the Medicaid rebate, extension to managed Medicaid and expansion of eligible hospitals in the so-called 340B program, we estimate that the cost of healthcare reform in 2010 will be approximately $12 million. This is now included in our outlook.

Turning to BOTOX

Sales growth has picked up relative to trends seen across 2009, with growth versus the first quarter of 2009 at 11.3% in dollars and at 6.6% in local currencies. Sales of $331 million were only modestly lower sequentially than Q4, which is always seasonally the highest quarter of the year. Most of this increase was due to the more economically sensitive aesthetic side of the business, as the benefits of the upper-limb spasticity FDA approval in March occurred too late in the quarter to contribute to our sales results.

Outside the U.S., we enjoyed very strong double-digit increases across a wide range of countries, with surprisingly strong growth in several of the main European markets. These global markets are precisely where we are successfully dealing with multiple competitors.

It would therefore seem that the market is recovering as we can measure our market share with only a short time lag. In Europe, on the aesthetic side, we’re holding share at just under 80%, as we deal with the incursions of both Merck’s, with their Zymine and Bocatua [ph] brands and Galderma with Azzalure.

On the therapeutic side, it seems that most of ZMM’s market share gains have been at the expense of Dysport. In the U.S., BOTOX sales growth is less buoyant, as there was no base of Dysport sales in the prior year, but it is clear that the market is growing again.

We estimate that in the aesthetic market, Dysport had somewhere between 13% and 14% share in the first quarter. We'll be curious to see the lasting impact of the Dysport Love It or Leave It promotion after it terminates at the end of May.

In the therapeutic market, Dysport’s share is so far negligible, given the long history and experience of BOTOX use. In Europe and the U.S., we have recently introduced a 200-unit vial, which is useful for injectors treating large muscle groups, as well as for differentiation from competition. Regarding global market share for the fourth quarter, the last quarter for which data is available, we estimate that BOTOX held 79% share in a market growing 13% year-over-year.

Regarding the clinical program for BOTOX for chronic migraine, the clinical trial results of our PREEMPT program were published in Cephalalgia, the journal of the International Headache Society. Regarding facial aesthetics, we've experienced an even stronger rebound in sales than observed with BOTOX. Dermal filler sales grew year-over-year, a very strong 42.4% in dollars, and 34.5% in local currencies, with great growth in all operating regions of the world, with Europe again surprising on the upside.

Juvederm & Juvederm Ultra XC

In the U.S., we've seen huge growth in the JUVÉDERM line since the launch of JUVÉDERM Ultra XC, this is the lidocaine-containing product, in early February. Although we have gained some market share, it would seem that the market is responding strongly to the reduction in treatment pain experienced with this lidocaine-containing product and already a substantial share of the mix is attributable to JUVÉDERM Ultra XC.

We have just initiated print advertising for JUVÉDERM XC and have a PR campaign with TV host Dayna Devon, as our spokesperson to further drive growth. In Europe, we launched new additions to the JUVÉDERM product line, JUVÉDERM Smile at the IMCAS Conference in Paris in January and JUVÉDERM Hydrate at the Anti-Aging Conference in Monaco in March. JUVÉDERM Smile was also approved in South Africa, JUVÉDERM XC in Korea and JUVÉDERM Ultra Plus in Taiwan.

Voluma was recently launched in Brazil and also approved in Taiwan.

Based on our analysis of the world market in Q4, which we estimate grew 12%, it is clear that global market growth has accelerated since then. Our analysis also points to JUVÉDERM market share gains in all regions of the world. Beyond superior product performance characteristics, Allergan also benefits from having full product line.

At the end of the first quarter, Allergan's cash and cash net of debt positions totaled approximately $2 billion and $471 million, respectively. Allergan continued to maintain exceptional cash flow generation capabilities in the first quarter, with operating cash flow after capital expenditures of approximately $161 million, an increase of approximately $56 million over the first quarter of 2009.

Allergan - Botox Cosmetic

No need to shed tears for Allergan with a market cap of nearly $18 billion last week.

Allergan Inc. Chief Executive David Pyott is guarded about 2010 as the drug maker faces competition, uncertain spending on its medical cosmetics and a relatively quiet year for product launches.

“It’s sensible to remain conservative in our forecast given there are still a number of challenges to be accounted for,” Pyott said. “You need to think about 2010 potentially being the most challenging of the coming years.”

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Allergan's Botox Profits Jump 51%

Allergan's profits bounced up an impressive 51%... Could this signal a medical spa rebound?

Allergan Inc.'s (AGN) fourth-quarter profit jumped 51% from a charge-addled period last year while product sales surged 16% amid continued improvements in markets for cosmetic medical procedures following the recession, the company said Thursday.

The Botox-maker forecast weaker-than-expected earnings in the first quarter, which it pegged to increased spending on advertising and product launches. It also projected full-year earnings mostly below Wall Street's forecast while being cautious about economic recovery and challenges for certain products.

Still, shares of the Irvine, Calif., company, which also makes eye drugs, breast implants and fillers for facial wrinkles, recently traded up 2.3% to $58.09.

Physician Training Review: How to inject Juvederm Injectable Gel by Allergan

By CHMD: Just viewed "How to inject Juvederm Injectable Gel" by Allergan 2007.  This instructional video was terrible! 

The technique was poor and anyone who tried to inject after watching this video is sure to get bad results.  Allergen should be embarrassed to put this video out. 

 

This points up two big problems with the injectable industry.

 

First, the instruction from the big companies is terrible, it stinks.  There videos are horrible and their instructional seminars are usually very bad as well.  They only show you one way to do things and you have to know many techniques.  The instructors many times don't know HOW they get the results and cannot explain and demonstrate how.  They use 3-4 syringes when we are only able to use 1 or 2 in clinical practice.

 

This is my recommendation to Allergan, Medicis and the others.  Make a great set of instructional videos which demonstrate and instruct how to do injections well.  Make them easily available to everyone.  Work together and share costs if you want.

 

Second, the FDA does not let the big companies instruct us how to do injections unless it is FDA approved for that area.  Since only the Nasolabial folds are FDA approved, that is the only instruction we get.  Allergan and Medicis TELL us to inject it everywhere, but they don't and can't tell us how to do it and get the best results.

 

My recommendation.  FDA, your rules are hurting, not helping us.  "Unintended Consequences"! Open your eyes and take a look at what is going on and modify your rules.

 

My other recommendation.  Allergan and Medicis, open your eyes and see how many BAD injections are done which turn patients (and their friends and family)off to injectables. Teach us how to do these injections correctly.  Don't just hire a plastic surgeon who does good work (and can't teach), hire someone who can teach.