GLG News by Adam Schaffner

Implications: Most people agree that the healthcare system in the United States is in need of a complete overhaul.  Unfortunately, the many competing interests in the current system make such overhaul extremely challenging.  This contest certainly provides much incentive for the best and brightest to put forth their ideas on how to improve the system.  Overcoming the obstacles to implenting such ideas will potentially be the biggest challenge of all.  Therefore, I believe the answer to the question "Will it work?" will only come when the healthcare system reaches the same critical threshold that our financial markets recently met.

Analysis: Providing a $10 million prize creates quite an incentive to devise feasbile solutions that will help improve the healthcare system in the United States.  Will such a prize work?  I believe there are any superb ideas that have already been put forth for consideration and many more that have not.  Overcoming the obstacles to implenting these ideas will potentially be the biggest challenge of all.  Much cost savings can be derived from consolidating the administrative infrastructure.  However, how could such an idea be implemented without it begin forced upon the marketplace by the government?  Large health insurance carriers are not going to willingly consolidate, reduce their profit margins, increase coverage of services, and pay fair fees to healthcare providers all in the name of improving the healthcare system.  Therefore, I believe the answer to the question "Will it work?" will only come when the healthcare system reaches the same critical threshold that our financial markets recently met.

Implications: Evolence is an injectable filler material that is made by an "advanced collagen GLYMATRIX™ Technology."  Collagen has generally fallen out of favor amongst aesthetic physicians due to its short duration of action.  Evolence will have to demonstrate that it is superior to the plethora of other injectable filler materials currently available to gain market share.  To do so will not only require clinical efficacy, it will also require a tremendous marketing effort to penetrate a market where there is no shortage of injectable filler materials from which to choose.

Analysis: The market currently has a variety of injectable filler materials from which to choose.  The leaders are hyaluronic acid-based materials such as Restylane/Perlane (Medicis) and Juvederm Ultra/Juvederm Ultra Plus (Allergan).  Other fillers that are widely used include Radiesse (BioForm) and Scultpra (Dermik/Sanofi-Aventis).  Artefill (Artes Medical) is also used, though not as widely due to many concerns due to its permanence.  Evolence introduces collagen back into the market.  Previously, collagen based products either required allergy testing (e.g., Zyderm/Zyplast) or were relatively short in its duration of effect (e.g., CosmoDerm/CosmoPlast).  If Evolence can demonstrate some superiority over the plethora of products currently available, it may gain some market share.  However, to do so will require a tremendous marketing effort and potential financial incentives as well. 

Implications: Allergan has a strong infrastructure to support dermatologic and aesthetic products.  Aczone, an aqueous topical gel containing 5% dapsone, will be a new product which will help treat patients with acne.  "The strength of topical dapsone gel appears to be its high efficacy against inflammatory acne lesions.  Both rapid onset of action and tolerability make this agent a potentially nice complement to traditional antimicrobial and comedolytic acne regimens." (Draelos ZD, Carter E, Maloney JM, et al, J Am Acad Dermatol. 2007;56:439.e1-e10.)  Based on the study results available, it appears Aczone will provide an additional treatment option which will benefit patients.  Given the number of patients afflicted with acne, I believe Allergan will ultimately view this as a favorable acquisition.

Analysis: In two randomized double-blind, vehicle-controlled clinical studies in 3,000 acne patients, Aczone Gel achieved statistically significant percent reduction in the number of acne lesions and better success rate on the Global Acne Assessment Score."  Although approved by the FDA in July 2005, this medication has not been widely used to treat acne on patients in the United States.  Therefore, Allergan is betting that (1) the findings of the clinical study will be consistent with the experience patients have post-launch and (2) physicians will embrace this new medication.  Allergan has an excellent track record with launching and integrating new products into its armamentarium.  The study, which was published in a reputable peer-reviewed journal, appears to describe an effective product which will help many patients and, ultimately, Allergan's bottom line.

Implications: There is no revelation in stating that obese people move slower or have more health problems compared to skinny people.  High blood pressure and diabetes are commonly associated with obesity.  Morbidly obese people may have difficulty sitting in a single coach airplane seat, fitting through a doorway, or bending over to pick up an item.  Such obesity is associated with higher healthcare costs, more time away from work, and lower productivity when compared to people who are not obese.  In short, obese Americans need to lose weight to improve their waistline and the bottom line.

Analysis: If so many Americans are obese and are experiencing the adverse effects of obesity, why are they and their employers not motivated to do something about it?  This is an extraordinarily complex problem which must be addressed from multiple perspectives to achieve success.  First, people must be educated on the causes of obesity and know that they do not have to be obese.  It is not all "genetics."  Television shows like "The Biggest Loser" have brought this to the forefront.  Once educated about diet, exercise, and the need to have total caloric intake not exceed total caloric demand, people need to have the ability to take action.  This means having the time and money to be able to exercise and eat a well-balanced diet.  Fish costs more money and takes more time to prepare than pasta.  Exercising takes time away from work and family.  Work and family need to support a healthy lifestyle.  People who have grown up and/or currently live in an environment where others are obese may find it more challenging as they lack some of the support systems others take for granted.  Lastly, employers can provide incentives for employees have a healthy lifestyle (and ultimately lose weight) by providing discounts for or contribute towards the cost of a healthclub membership.  In the end, a healthier employee is a more productive employee, regardless of the duration of the person's employment.  Ultimately, the responsibility falls on the individual to take charge of his/her own life.  However, employers can help by providing financial support and flexibility in the work schedule to encourage physical fitness as well as a healthy lifestyle.  In doing so, the company's bottom line and the employee will both be healthier.

Implications: Hair used to be something we all accepted.  Now, unwanted hair is viewed as unacceptable.  The market for hair removal is almost endless.  Men want hair removed from the nostrils, neck, back, and chest.  Women want hair removed from the upper lip, chin, sideburns, arms, legs, and bikini area.  Treatment options are as varied as the types and colors of hair that exist.  Patients will subject themselves to many different treatments, including shaving, plucking, bleaching, waxing, threading, lasers, intense pulsed light, electrolysis, and medications.  Recently, lasers have become more popular due to their effectiveness in achieving the goal of permanent hair removal.  However, their use is not without risk.  Patients can get burned or lose skin pigment.  Therefore, such treatments should only be administered by licensed healthcare professionals with proper training and experience. 

Analysis: Some people will stop at nothing to get hair removed.  Hair can negatively impact one's self-esteem, resulting in social and psychological harm.  It can also adversely impact one's professional performance.  People that fall into these categories include teenagers, swimmers, models, professionals, housemoms, adult entertainers, and anyone with a heartbeat.  The market demand is huge, which is why hair removal is offered in many different environments, from doctors' offices to salons.  Unfortunately, some states do not require a license to perform hair removal.  This subjects patients to tremendous risk of permanent injury such as burns, scars, and altered skin pigmentation.  Patients need to know the credentials and background of the person performing hair removal.  Requiring a license to remove hair would improve patient safety, minimize the risk of permanent injury, and restore confidence in the general public.     

Implications: Looking rested and refreshed is big business.  Dark circles can make one appear tired and old - even at the young age of 25.  Therefore, some people will stop at nothing to conceal these circles.  53% of 13,000 Clinique users cited dark under-eye circles and puffiness as their number one beauty concern.  Consequently, it is not surprising that sales of anti-aging skin care treatments, which includes products designed to get rid of dark circles under the eyes, increased from $588 million in 2001 to $1.08 billion in 2006.   The causes of such circles are multi-factorial, including heredity, genetics, skin pigmentation, and skin thickness.  As there is no single cause for this problem, there is no single cure.  Hence, it is not surprising that Sephora sells more than 50 products "designed to specifically treat under-eye circles."  With time, the demand and number of products to treat this problem will only continue to grow. 

Analysis: There is no single treatment to address the problem of dark circles and puffiness under the eyes.  If there was, every dermatologist and plastic surgeon would be using it.  Consequently, there are more treatments than one could imagine.  Aging, which causes skin to thin, can darken the under-eye area.  Some creams and potions claim to "plump up," "thicken," or "add volume" to the skin by increasing collagen production or by causing local tissue swelling.  Environmental allergies can cause "too much puffiness" which can be treated with anti-histamines and/or immunotherapy ("allergy shots").  Sometimes, dilated blood vessels under the skin can be seen.  For this, fillers such as Restylane or Juvederm may be injected to place a layer between the skin and melanin or blood vessels.  It should be noted that this is an off-label use of these products with potential side effects.  Therefore, it should only be performed by a licensed healthcare professional that is experienced in such treatments.  Some will use bleaching agents or lasers, though this is not recommended by most healthcare professionals to treat this problem.  Until more specific and effective treatments are developed, patients will continue to try different treatments in their quest to look younger and refreshed in a competitive marketplace that values youthful appearances.

Implications: For years, doctors have been taught to deny medical errors and defend themselves to the end.  Such denial is contrary to the honesty doctors and patients desire in a patient-physician relationship.  However, the risk of medical malpractice has led physicians to pursue this practice.  With medical malpractice insurance premiums escalating at an alarming rate, physicians at prominent institutions like Johns Hopkins and Stanford are trying a new, "disarming" approach:  promptly disclosing errors, then offering an earnest apology and fair compensation for such errors.  The hope is to restore integrity in the patient-physician relationship, learn from such mistakes, and decrease the likelihood of other healthcare professionals making the same mistake in the future. 

Analysis: Most of the time, patients become plaintiffs when they believe information has been withheld or concealed.  Therefore, it is no surprise that hospitals are reporting decreases in malpractice suits and premiums with the implementation of a policy that encourages healthcare professionals to disclose and apologize for medical errors.  The net result of such a policy is improved patient safety, overall cost savings, and happier patients.  Now, the challenge is to get doctors to believe that if they are open and honest that they will not be sued by their patients.  JCAHO, AMA, and AHA have all encouraged such disclosure.  Their support is not surprising since research has shown that improvements in institutional policies result when such disclosures are shared with colleagues.  It may take a generation to have generalized acceptance of this philosophical shift.  However, the apparent decrease in medical malpractice judgments and premiums may help expedite the acceptance rate of this new paradigm. 

Implications: Adolescent acne is a challenging problem to treat.  This is a medical problem that has social and psychological consequences.  Acne can affect one's self-esteem, psychological growth, and adversely impact one's educational and career development.  Therefore, it is of paramount importance that adolescent acne be treated effectively.  Unfortunately, there is no cure - only a plethora of treatments.  Determining which one is most effective in a given patient requires patience and perseverance. 

Analysis: Despite the plethora of products available to treat acne, there are very few "cures" for adolescent acne.  This has led to an explosion in the number of products available in the marketplace.  If a cure existed for this problem, every dermatologist and plastic surgeon would be prescribing a similar regimen.  There are, however, many different treatment options available.  Trying different treatments increases the likelihood of finding which one which is most effective for a given patient.  The earlier treatment is started, the more likely one is to be successful.  Using gentle skin cleansers with alpha- or beta-hydroxy acid will help soften and dissolve the keratin plugs at the end of the pilosebaceous units.  Some of these products contain salicylic acid as well.  A popular regimen using this combination is ProActiv solution.  Reducing the bacterial load is also of benefit.  This is usually accomplished by using topical medications and/or oral antibiotics.  Applying a benzoyl peroxide aqueous gel increases the concentration of free oxygen radicals in pores and kills Propionibacterium acnes, the bacteria that multiply in clogged follicles.  Other treatment options include topical retinoids, oral contraceptives, or oral retinoids (e.g., Accutane).  Before prescribing a treatment regimen, it is important for healthcare professionals to counsel patients and their parents on the risks and side effects of using each of the aforementioned medications. 

Implications: On December 27, 2007, the North Carolina Division of Public Health (NCDPH) was notified of three cases of renal failure occurring among women who had received cosmetic soft-tissue filler injections at a facility in North Carolina.  All injections were administered by a practitioner with no medical training or supervision.  The practioner was apparently trained as a radiology technician but had no other medical training or supervision.  Investigators were not able to identify the injected substances.  Although records indicated that the injections contained liquid silicone, this substance has not previously been associated with renal failure.  These findings underscore the risks posed by cosmetic injections administered by unlicensed practitioners.  Patients should only seek care from licensed healthcare professionals.  Such publicity will hopefully result in more patients doing their due diligence rather than avoiding such injections altogether.

Analysis: Soft-tissue fillers are substances injected to augment the appearance of lips and cheeks as well as fill lines, groove, and wrinkles.  Cosmetic silicone injections have been associated with severe adverse events, including granuloma formation, infection, pneumonitis, pulmonary embolism, ulceration, product migration, and death, mostly after injections by unlicensed practitioners using formulations not intended for medical use.  Risks are incurred with the injection of any substance.  However, the risks are much greater when cosmetic injections are administered by unlicensed practitioners.  Soft-tissue filler injections should only be administered licensed healthcare professionals with appropriate medical training.  Hopefully, this type of publicity will educate the public on the importance of understanding the risks of such injections.  Ultimately, each patient must be motivated to research the substance being injected as well as the credentials and experience of the person offering such injections.  Doing so will increase the likelihood of a good result with minimal complications.  Failure to do so will likely result in more patients being harmed.

Implications: Electronic medical records (EMR) have been shown to enable physicians and other healthcare professionals to provide higher quality and more efficient healthcare.  The problem is getting EMR systems implemented in healthcare facilities across the country.  Given the declining reimbursements from insurance companies, most doctors cannot afford to pay for the installation and upkeep of such systems.  Without financial assistance, use of such systems will not be widespread outside of large hospitals and medical groups.

Analysis: Most doctors and healthcare professionals agree that the use of electronic medical records (EMR) results in higher quality and more efficient healthcare.  Test results are easily accessible, resulting in less duplication of tests.  Prescriptions are legible and, in many cases, may be electronically transmitted to the pharmacy.  Coding for diagnoses (ICD-10) and procedures (CPT) are checked for accuracy, compatibility, and validated with the documented medical record to minimize the risk of denial by the insurance company.  These codes may be linked to pre-authorizations/pre-certifications to make billing more efficient and collections more rapid.  The downside:  COST.  Doctors in small private practices lack the time and money needed to install and maintain these systems.  Given that there is little likelihood of improvement in reimbursement rates from insurance companies, the federal government must provide financial assistance in order to make the implementation of EMR systems widespread.  They must also provide leadership to enable EMR systems to communicate between various hospital systems, private medical practices, ambulatory surgery centers, insurance carriers, Medicare, Medicaid, and billing services.  This will ultimately maximize efficiency and improve the overall quality and cost of healthcare in the United States. 

Implications: Controlled substances are invaluable in the attempt to control pain for many patients.  Unfortunately, some criminals attempt to obtain these substances for personal gain as they are a valuable commodity on the black market.  Therefore, it is of the utmost importance that industry and the DEA work closely together to strengthen and protect the integrity of the supply chain.  Strengthening all links of the supply chain may result in a stronger economy which benefits all Americans. 

Analysis: Controlled substances are invaluable in the attempt to control pain for many patients.  Unfortunately, some criminals desire to obtain these substances for personal gain.  These criminals find the weakest links in the supply chain and exploit them to divert controlled substances, often to those who use them in an illicit manner.  Therefore, it is of the utmost importance that industry and the DEA work closely together to strengthen and protect the integrity of the supply chain.  They must also collaborate to catch and prosecute those individuals who illegally divert controlled substances.  The ultimate goal of these efforts must be to continue to supply patients with the medications they desperately need while keeping it out of the hands of those who desire to sell it for personal gain.  Failure to work together will result in further penetration of the weakest links of the supply chain, continued diversion, and more illicit drug use.  Such drug use is associated with increased violence, unemployment, and lack of productivity.  Therefore, strengthening all links of the supply chain may result in a stronger economy which benefits all Americans. 

Implications: Private companies have vast resources to underwrite the costs associated with research activities.  It is difficult to ensure that financial assistance and fees paid to researchers do not result in undue influence that may affect the results of research.  To avoid the appearance of any bias, all financial support should be reported.  Failure to do so may result in the appearance of improper conduct, whether or not such improper conduct occurred.

Analysis: In recent years, much emphasis has been placed on avoiding undue influence of healthcare professionals and researchers by pharmaceutical and medical device manufacturers.  The days of these companies paying for golf outings, sporting events, and family vacations are long gone.  Now, the focus is to ensure that all financial support received is reported.  This is important to avoid undue influence that may affect the results of research.  It is also important to avoid the appearance of any bias or improper conduct.  Failure to comply with current rules and regulations should result in appropriate corrective action and, when indicated, disciplinary action.  Such action will serve to motivate all to comply and avoid the appearance of improper conduct.

Implications: Any publicized adverse events following the injection of filler materials or BOTOX Cosmetic will draw attention to risks inherent in such procedures.  This will likely have a temporary impact on the level of concern and possibly result in a transient decrease in use amongst patients.  To minimize the risk of developing complications, these injections should be performed by a well-trained, licensed medical professional who is experienced in administering such injections. 

Analysis: Any publicized adverse events following the injection of filler materials or BOTOX Cosmetic will draw attention to the fact that patients who have such injections are subject to the risk of developing complications from these injections.  This may have a temporary impact on the level of concern and even possibly the level of usage amongst patients.  In this article, the patients described were injected by a "radiology technician but had no other medical training or supervision."  Using medical grade silicone for aesthetic purposes is an off-label use.  In this article, it notes the "investigators could not identify what substances were injected."  The lesson to be learned is that to minimize the risk of complications, a patient should use a well-trained, licensed medical professional who is experienced in administering such injections and know the risks of using the substance(s) being injected.

Implications: On nights, weekends, and holidays, senior healthcare professionals are rarely found in the hospital.  Problems arise from (1) too few qualified personnel available to address the needs of patients, (2) inability to obtain physician coverage for some specialties, and (3) inability to obtain and/or service medical supplies/equipment.  Therefore, innovative and creative solutions need to be implemented to improve the morality, readmission, complication, and error rates.  Failure to provide such novel approaches will lead to stagnation and further decline in the quality of care which will adversely affect the bottom line and increase liability exposure of the institution and healthcare professionals.

Analysis: On nights, weekends, and holidays, senior healthcare professionals are rarely found in the hospital.  They have earned the privilege to stay at home and have little incentive to work after hours.  This often leaves too few qualified healthcare professionals after hours to address the needs of sick patients with multiple medical problems.  Problems especially arise when there is a delay in obtaining physician coverage for some specialties.  Problems also arise when it is difficult or impossible to obtain technical support for medical supplies/equipment.  As the article states, “The consequences of service deficiencies during off-hours include higher mortality rates and readmission rates, more surgical complications, and more medical errors.”  To successfully address these problems, it will require one to think “outside the box.”  Insurance reimbursements continue to decrease.  Therefore, one needs to be innovative and creative.  Without such innovation and creativity, there will be no improvement in the morality, readmission, complication, and error rates.  This will adversely affect the bottom line and increase liability exposure of the institution and healthcare professionals.   

Implications: All necessary precautions need to be taken to prevent injury or exposure to infectious fluids/materials.  It is of paramount importance that surgeons understand that failure to obtain proper diagnosis or treatment after suffering injury or infectious exposure not only places themselves at risk, it places their patients at risk as well.  Hence, despite the time and inconvenience incurred, it is vital for surgeons to report injuries/exposure to infectious materials, undergo the appropriate diagnostic tests, and, when indicated, be treated.

Analysis: All necessary precautions need to be taken to prevent injury or exposure to infectious fluids/materials.  If a surgeon does not protect himself/herself, that surgeon is not acting in his/her best interest or in the best interest of his/her patients.  In the event injury occurs which results in possible infectious transmission to a surgeon, all necessary diagnostic and treatment measures must be implemented.  The article raises issues which may impede such diagnosis or treatment from taking place.  It is of paramount importance that surgeons understand that failure to obtain proper diagnosis or treatment after suffering injury or infectious exposure not only places themselves at risk, it places their patients at risk as well.  Moreover, such failure may also shorten the lifespan and career of that surgeon.  Hence, despite the time and inconvenience incurred, it is vital for surgeons to report injuries/exposure to infectious materials, undergo the appropriate diagnostic tests, and, when indicated, be treated.

Implications: The health insurance industry has, as its primary focus, making money - not taking care of patients.  Therefore, it is not suprising to learn that health insurance plans have misled individuals, most notably the elderly, into enrolling in plans which were not in their best interest.  It is likely that only minimal change will occur to address these acts which result in poor publicity for the insurance companies and attract the attention of government officials. 

Analysis: The health insurance industry has, as its primary focus, making money - not taking care of patients.  Therefore, it is not suprising to learn that health insurance plans have misled individuals, most notably the elderly, into enrolling in plans which were not in their best interest.  It is quite unfortunate that people who are deceased were enrolled in plans as well.  Given the track record of the industry, this is not shocking.  One would hope, but not expect, sweeping changes to prevent such activities from occurring in the future.  Such changes are unlikely to occur.  It is likely that only minimal change will occur to address these acts which result in poor publicity for the insurance companies and attract the attention of government officials.

Implications: Laser liposuction is a new technology which has not, in my opinion, yet been proven to be superior to conventional liposuction.  The potential benefit of less bruising and swelling following "laser liposuction" is outweighed, in my opinion, by the risk of the patient incurring burns from the laser.  I am aware of cases in which patients of board certified plastic surgeons have suffered burns following the use of "laser liposuction."

Analysis: Laser liposuction is a new technology which has not, in my opinion, yet been proven to be superior to conventional liposuction.  The potential benefit of less bruising and swelling following "laser liposuction" is outweighed, in my opinion, by the risk of the patient incurring burns from the laser.  I am aware of cases in which patients of board certified plastic surgeons have suffered burns following the use of "laser liposuction."  Therefore, while this is a good device in theory, I do not yet believe it will become the next "big thing" in plastic surgery.

Implications: Men are frequently taking advantage of advances in facial rejuvenation.  They desire to maintain a youth appearance to outwardly reflect an energy and cutting edge image that is vital to maintaining one's marketablility in a competitive workforce.  They frequently enjoy the benefits of BOTOX and injectable filler materials.  Some are also having aesthetic plastic surgery performed to reverse some of the signs of aging.

Analysis: Men are frequently taking advantage of advances in facial rejuvenation.  They desire to maintain a youth appearance to outwardly reflect an energy and cutting edge image that is vital to maintaining one's marketablility in a competitive workforce.  Men desire minimal downtime in order to minimize time away from work and/or family.  Therefore, they frequently enjoy the benefits of BOTOX and injectable filler materials.  Some men desire facial rejuvenation surgery (e.g., facelifts, eyelid surgery) to address signs of facial aging such as jowls and droopy eyelids.  Men are also taking advantage of body plastic surgery (e.g., liposuction) to improve body contour.  The acceptance of plastic surgery among the male population is increasing with time as they realize the potential benefits. 

Implications: Rarely, if ever, will a non-surgical modality be able to deliver the same results as a surgical procedure.  The use of an injectable filler material (e.g., Radiesse), is no different.  Without question, its use is not "risk free."

Analysis: Rarely, if ever, will a non-surgical modality be able to deliver the same results as a surgical procedure. The use of an injectable filler material (e.g., Radiesse), is no different. Without question, its use is not "risk free."  In this article, the dermatologist is quoted as stating that the procedure is risk-free.  In addition to bruising and swelling whcih may occur, one can get an infection, have extrusion of the material, or movement of the injected material.  While this is an excellent additional modality to use in contouring the nose, it is best used to improve minor defects.  Patients must understand that it is not the equivalent of a rhinoplasty (nosejob) and is not risk free.

Implications: Patients want to minimize signs of aging, look natural, and minimize downtime while maximizing results.  Therefore, people are often choosing to have treatments such as BOTOX, injectable fillers, and mild skin resurfacing which require little downtime.

Analysis: More than ever before, patients desire to minimize signs of facial aging.  People find this necessary not only to help maintain a high self-esteem, but to remain competitive in the marketplace where looking "tired" or "old" is undesirable.  This is the main impetus behind men seeking options for facial rejuvenation.  As most people have limited time to be away from work, people are often choosing to have treatments such as BOTOX, injectable fillers, and mild skin resurfacing which require little downtime.  Frequently, these same individuals often have a facial plastic surgical procedure performed - just later than they would have had these other minimally invasive options not been available.