Botox Chapter 2: Is it safe?


5 Ways To Avoid A Running Injury Featuring fresh takes and real-time analysis from HuffPost's signature lineup of contributors HOT ON THE BLOG Clarence B. JonesKeith BoykinJohn KerryToni Collette Dr. Arnold Klein Professor of Medicine and Dermatology at UCLA's David Geffen School of Medicine GET Read more

Patient Safety


  Recently a patient came to see me after being treated with Botox®. She could only open one eye and could barely smile. She looked more like she had a stroke than an aesthetic treatment. I called the physician who Read more

Cheekbones


    High cheekbones refers to the zygomatic bones in the face of primates, which in certain individuals may be more pronounced than others, causing the upper part of the cheeks to jut out and form a line cut into the sides of the face. Read more

Top 16 Docs in LA


At a recent convention for health care workers in Ft. Lauderdale, Fla., the conversation turned to a discussion of the nation’s best doctors. Gary Barg, editor-in-chief of Today’s Caregiver, a trade magazine, remembers standing in a group with several people Read more

20 minute rule


Twenty Minute Rule- Whenever I would come home from a long day at work or school,  I was so tired the only things I could find energy to do were mindless life-negating nonsense-- television, Netflix, Reddit, Facebook, whatever. Every night I Read more

To get what you want don't over Botox


          If you’ve ever gotten the death glare from your parent, child or S.O., you already know the results of this new study to be true.New research in the journal Psychological Science shows that people are more likely to give Read more

hairy palms,melanoma on your skin - skin,melanoma & Viagra?


The little blue pill used by men to boost bedroom performance may be detrimental in the great outdoors, according to new research. The study, published in JAMA Internal Medicine, found sildenafil, commonly known as Viagra, may increase a man's risk Read more

How does one perceive age from the face


Methods for diagnosing perceived age on the basis of an ensemble of phenotypic features Mireia Coma1 Raquel Valls1 José Manuel Mas1 Albert Pujol1 Miquel Angel Herranz2 Vicente Alonso2,3 Jordi Naval2 1Anaxomics Biotech, Barcelona, Spain; 2\Genocosmetics Laboratory, Barcelona, Spain; 3Unidad de   Background: Perceived age has been defined as the age that a Read more

Arimidex and Shingles


        On May, 17, 2014: 14,490 people reported to have side effects when taking Arimidex. Among them, 120 people (0.83%) have Herpes Zoster. They amount to 0.10% of all the 115,596 people who have Herpes Zoster on eHealthMe. Time on Arimidex when people have Herpes zoster * :   < 1 Read more

don't take your face to Costco


  World-Renown Dermatologist warns the public not to cut corners on his or her choice of cosmetic surgery centers.               Artefill   90210 LOS ANGELES, CA -- 02/26/14 - It's not surprising that in times like these, people are trying to save money. But according to Read more

0vermerdicating Children for ADHD - We forget hyperactivity and impulsivity are appropriate for toddlers !


              More than 10,000 American toddlers 2 or 3 years old are being medicated for attention deficit hyperactivity disorder outside established pediatric guidelines, according to data presented on Friday by an official at the Center. The report, which found that toddlers Read more

How greed and ignorance are destroying the world of injectables -Sculptra!


Count on New England Journal of Medicine's  Journal Watch to bring you the most important medical developments framed in a clinical context. In the article below all the Doctors are misrepresenting the truth about Sculptra for $$$         Thank you so Read more

Treating Depression with Botox!


  Nearly 150 years ago, Charles Darwin recognized that facial expressions not only communicate the emotions we feel but intensify them, by sending cues back to the brain. In the ensuing decades, researchers proved again and again that we can Read more

Botched Fillers


Botched  cosmetic fillers  cases are at an all time high - buying on the internet.  at doctor's office or at spa will not assure you a good result  ......stick with Hyaluronic Acid injectables.     Doctors are seeing an increasing number of Read more

tightening the neck: making the impossible possible!


    One of the most obvious signs of aging is the lack of firmness in the skin. As we age our skin loses the elasticity that it had in our younger years, and this causes it to become loose and Read more

PRP for growing hair?


u     I reviewed 14,000 articles on Platelet Rich Plasma for growing hair. There are are only two on this subject with very unimpressive results. Arnie Klein Arnold W. Klein, MD Professor of Medicine and Dermatology UCLA,Retired Professor of Dermatology Stanford , Inaugural Visiting Read more

hyaluronidase allergy


  Hi Dr Klein,   I hope this message finds you well. I found you through my research searching for an issue with a medical/filler issue. I understand you are the world authority and wonder if you have any ideas concerning the Read more

The Melting people of Brazil


ARARAS, Brazil (AP) — This is a village where the people melt away.Tucked into the sunbaked rolling hills of Brazil’s midwest, Araras is home to what is thought to be the largest single group of people suffering from a rare inherited Read more

The Master's Stroke!


  World-Renown Dermatologist Develops revolutionary injection Technique – The Masterstroke Press Releases Categories LOS ANGELES, CA - It's not surprising that in times like these, people are trying to save money. But according to Dr. Arnold William Klein, the international authority on minimally Read more

COLOR BLOCKING


         What is color blocking? \ Color blocking isn't for the faint of heart; it also isn't necessarily for the short of stature. This season's big trend of color blocking takes bold opposites on the color wheel (as Ogi Read more

Be Careful what you put in your face.


World-Renown Dermatologist Warns Public of Rising Dangers in American Aesthetics LOS ANGELES, CA - It's not surprising that in times like these, people are trying to save money. But according to Dr. Arnold William Klein, the international authority on minimally invasive aesthetics and renowned for Read more

Saving Babies from Aids


In 2014 Dr. Arnold Klein had saved over a million lives of Babies  in Africa by preventing them from  getting HIV.......Dr. Arnold  Klein  was embezzled through 10 totally  fraudulent accounts at Private Bank of California and 4 fraudulent accounts Read more

The Great Oxycontin Spill off the coast of LA


Arnie: thanks for your cogent and important analysis of the filler advertising/article scam. You hit the nail on the head. I am determined to help get someone to listen. Will make a couple of calls this am and get Read more

8 things you do not know about sperm


Sperm Bank Find A Donor. Get Pregnant Today Request Free Info Kit Today. www.cryobank.com/Sperm-Bank Sperm are single-purposed: They're optimized to get to an egg and inseminate it. But that doesn't mean there isn't more to this cell than meets the ovum. Sperm, Read more

1 millionth baby born Aids Free in Africa ---- This all began with Michael Jackson, President Bush Sr., Ryan White and me


   Happy New Year 2014 This all began with Michael Jackson, President Bush, Ryan White and me                      HRSA Global HIV/AIDS HRSA’s earliest global HIV/AIDS activities began in 1998. The HRSA Global HIV/AIDS Program was officially established in 2001 and vastly expanded Read more

What is the most important piece of clothing in your wardrobe? while most people would say shoes my friends said---


Dianne Chilgren, RD WD, Lynn Cathryn Walters and 12 others like this. 1 share Les Bear Unable to share . Too sensitive to divulge lol 20 hours ago · Like Gary Byrne Comfortable pair of jeans and t shirt sandals. Or. My Tom Ford suit 20 hours ago · Edited · Like Tami Neal My bra 20 hours ago · Like Tami Neal Lol 20 Read more

Aaron Beck and the effect of drugs on the brain as we age


  The sun comes up, I think about you. The coffee cup, I think about you. I want you so, It's like I'm losing my mind. The morning ends, I think about you. I talk to friends, I think about you. And do they know? It's like I'm losing my mind   Aaron Read more

body dysmorphic disorder (BDD ) & Cognitive-behavioral therapy (CBT)


If  a patient has body dysmorphic disorder (BDD), says Neelam Vashi, M.D., a dermatologist, it’s very unlikely that the aesthetic treatment being sought will improve the patient’s quality of life. In this regard,a study has show that less than Read more

The Cosmetic Revolution 2014


  the 5 who revolutionized Cosmesis         Arnold William Klein:  How I built my incredible collection of Art and Furniture by trading it for Services rendered, and  when did this love affair begin?         Jeff Koons Michael and Bubbles gift in Rome from Michael Read more

The Truth on Botox and Fillers: Drug companies owe me 15 million and the public the truth!


  The Huffington Post     Dr. Arnold Klein   Professor of Medicine and Dermatology at UCLA's David Geffen School of Medicine Posted: May 9, 2013, 12:30 AM Menage-a-trois:The FDA, Political Physicians and Drug Companies   (A Letter to Peggy Hamburg, Chief of the FDA)   From where does the power of Read more

Toxin Toxicity:Botoxicated!


When one talks of adverse reactions to Botulinum Toxins they vary according to toxin used,age of patient, weight of patient, dilution, condition treated, dose and frequency. While  authors states there is a set Dysport to Botox ratio this is Read more

Facial Harmony - The World of injectables has changed!


English physicist and mathematician Sir Isaac Newton was most famous for his law of gravitation and  was instrumental in the scientific revolution of the 17th century.     Our faces and bodies are governed by gravity. Everything eventually goes down. The Read more

A Discussion on Skin Lightening


      Global Aesthetic Dermatology & Cosmetology Group 14,863 members Faramarz Laser for Treatment of Melasma and PIH: Faramarz RafieCanadian Association of Medical Spas and Aesthetic surgeons(Exclusive agent of the Camacs ,Turkey&Middle East)Top Contributor Choosing the appropriate laser and the correct settings is Read more

Topical Estrogen will grow hair so I have make some!


KLEINMD,ARNOLD FRI MAY 3,2013 3:10 PM PaperChase provides 22,614,070 references -- all references found in the MEDLINE and OLDMEDLINE databases of the National Library of Medicine. Indexing began in 1966 and is current through the MAY 02,2013 Update. LIST Read more

Anti-Psychotic Drugs Do Not Belong in Nursing Homes or Prisons Governor Brown


      This is not the problem in California. In California they is such an over medication of the prison population they are turned into virtual zombies. While at Penn I saw them doing medical experiments on prisoners and had to Read more

Sigmund Freud (1856-1939) claimed that anatomy is destiny, that is, one's gender determines one's main personality traits.


            Sigmund Freud (1856-1939) claimed that anatomy is destiny, that is, one's gender determines one's main personality traits. Karen Horney (1885-1952), while considering herself a disciple of Freud, disagreed. Beginning in 1923, she began publishing papers arguing for culture over biology Read more

Sculptra: An Injectable Disaster


    Sculptra: An Injectable Disaster     The use of fillers has always involved both art and science. The art is both in determining the areas requiring volumetric /structural enhancement and creating reproducible injection techniques for implanting the material, Science is also vital Read more

Blood + Mesotherapy=Kim Kardashian's blood vampire facial


              Mesotherapy (from Greek mesos, "middle", and therapy from Greek therapeia, "to treat medically") is a non-surgical cosmetic  medicine treatment where  by small tiny shots of material are injected into the skin. Mesotherapy employs multiple injections of pharmaceutical and homeopathic medications, plant extracts, vitamins, and Read more

Injecticide!


  Artefill :  recently saw a young women lose sight  from this.       Sculptra reaction: had to be excised Arnold Klein, Professor of Dermatology and Medicine at UCLA, is considered to be the founder and best in the field of modern day facial Read more

Have you Had Cymbalta Withdrawal?


It has become clear that drug-company estimates that at most a few percent of those who took antidepressants would have a hard time getting off were far too low. Jerrold Rosenbaum and Maurizio Fava, researchers at Massachusetts General Hospital, found Read more

Atopic Dermatitis and Hand Eczema


  Arnold W. Klein, World Renown Dermatologist Causes of Atopic Dermatitis and Hand Eczema The cause of atopic dermatitis is not known, but seems to result from a combination of genetic (hereditary) and environmental factors. Children are more likely to develop this disorder if a parent has Read more

How Liz came back from the dead


How Liz came back from the dead Last updated at 09:21 01 March 200 Only a couple of years ago, Elizabeth Taylor was planning her imminent interment next to the favourite of her seven husbands, Richard Burton.This week, she cast aside Read more

On the 8th day Adam and Eve hated their bodies. Eve's forehead moved and Adam's member was small


On the 8th day Adam and Eve hated their bodies. Eve's forehead moved and Adam's member was small by Arnold Klein MD Bulge-Enhancing Underwear for Men on Sale at M&S? Public Friends Friends except Acquaintances Only Me Custom Close Read more

Botox : can paralyze your emotions


The market for Botox has taken a different turn, started by a doctor in New York who feels he knows the secret to the next big cosmetic crazeDr. Jack Berdy has introduced a new procedure called “Pokertox” for the Read more

MESOTHERAPY: HEALER OR HOAX


    Mesotherapy (from Greek mesos, "middle", and therapy from Greek therapeia, "to treat medically") is a non-surgical cosmetic medicine treatment.   Mesotherapy employs multiple injections of pharmaceutical and homeopathic medications, plant extracts, vitamins, and other ingredients into subcutaneous fat. Mesotherapy injections allegedly target adipose fat cells, apparently by Read more

Sculptra: An Injectable Nightmare


            Liquid Facelift With Sculptra(An Injectable Nightmare)December 12, 2012 | Category: Anti-aging treatments, Cosmetic dermatology, Dermatologic procedures/surgery     Gary Goldenberg, MD Dr. Goldenberg is Assistant Professor, Department of Dermatology, Mount Sinai School of Medicine, New York, New York, and Medical Director of the Dermatology Faculty Practice, Read more

The Brow: The Aesthetic Focus of your Upper Face!


  Do you back away from the tweezers when it comes to brows? Eyebrows are arguably one of the most important features on your face—they frame your eyes and express your personality. That’s why  Anastasia Soare—who has tweezed every celebrity Read more

Welcome!

admin General Leave a comment  

Welcome to my Medical Blog Website!

 

Check out some of the articles that I’ve written on the latest in Dermatology and about drug interactions that some of my patients have experienced.

 

If you’d like to make an appointment to see me please call 310-275-5136.  I’m available Monday through Thursday.

 

Arnold W. Klein, MD

 

dr-klein-with-syringesm

 

 

 

 


Botox Chapter 2: Is it safe?

AWKMD Fillers Leave a comment  


5 Ways To Avoid A Running Injury

Featuring fresh takes and real-time analysis from HuffPost’s signature lineup of contributors
Dr. Arnold Klein

Professor of Medicine and Dermatology at UCLA’s David Geffen School of Medicine

GET UPDATES FROM DR. ARNOLD KLEIN

3

Botox Chapter 2: Is It Safe?

In 2005, four hundred thirty six “serious adverse event” reports related to Botox had been reported to Allergan, the manufacturer of Botox. Two hundred one of these cases were possibly or probably due to remote spread of the toxin, including 42 cases reported after wrinkle injections. Also in 2005, Allergan had reported to the FDA that they had identified 38 patients — 20 children, most of them with cerebral palsy, and 18 adults — who had suffered seizures after Botox injections.

 

During May 2007, European regulators requested that Allergan and two other toxin competitors add information to their product labels and to warn doctors that the toxin could spread, causing botulism like symptoms (dry mouth, difficulty swallowing, blurred or double vision, drooping eyelids, slurred speech and progressive muscle weakness). In July of that same year a confidential report made to Allergan by a consulting firm showed 207 patients had developed medical problems associated with the spread of toxin, including several deaths. A third of the cases reported occurred in people treated for wrinkles. The rest were treated for muscle spasms, muscle spasticity and eye problems. Proportionately more problems were reported amongst children who had received Botox.

 

Given those statistics, however, it must be stated that Botox and Botox Cosmetic are extraordinarily safe drugs when used correctly by a qualified physician. Issues occur when medical literature is, at times, totally incorrect and when you have a manufacturer who is unwilling to admit the true number of adverse reactions. The accurate and safe usage of this toxin becomes problematic when a physician’s or injector’s expertise and knowledge become questionable. Therefore, one must choose their physician carefully.

 

Recently, the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society stated:

“Botulinum toxin type A was found to be generally safe in children with cerebral palsy. However, the Food and Drug Administration is presently investigating isolated cases of generalized weakness resulting in poor outcomes.”

 

I think that rather than use words like “poor outcomes”; it would be more accurate to use the word “deaths.” Indeed, in Orange County, California, there is a trial currently underway concerning the death of a seven-year-old girl after she was treated with Botox–not for cosmetic purposes, but for cerebral palsy. While it is widely known that Botox will reduce the spasticity of the leg and arm muscles in individuals with cerebral palsy, the question that must be answered is “Is it safe?”

 

How does Allergan educate physicians for the use of this product for cerebral palsy when it is not approved for this indication? Allergan, through its extensive chain of paid consultants, has created a vast array of courses they sponsor through assorted CME (Continuing Medical Education) programs. This is not widely known outside of a select medical community. The FDA has seemingly turned a blind eye toward Allergan’s off-label promotion of this drug for a myriad of purposes.

 

In the deposition for this trial, the treating physician (Dr X) stated that he went to two Allergan-sponsored symposiums to learn how to treat cerebral palsy with Botox. Indeed, Allergan has been known to pay the travel expenses of physicians to attend such meetings. While the physician named in this suit is not a neurologist, he was trained to use Botox in cerebral palsy by a pediatric neurologist. Would you not think training of this type be best left to training other pediatric neurologists? He was taught to use a dose of Botox in treating children which in reality is twice the maximum dose. What makes no sense is that even though sales representatives of Allergan visited the physician’s office over 50 times; maximum dosing was never discussed nor was why the patient was hospitalized 10 times for difficulties breathing while undergoing Botox therapy. This is a well known side-effect which occurs with spread of a botulism based toxin. Why was the treating physician unaware of this sign that the toxin had spread? Was he unaware that death can happen as a complication if you have severe problems with swallowing or breathing after treatment?

 

What is even stranger is that, according to Mitchell Brin, Vice-President of Allergan for Botox/Neurology, the company has never shared its maximum dosage information with physicians due to a federal ban on marketing for non-approved uses. What is meant by maximum dose is even confusing. Some individuals consider the maximum dose in cerebral palsy to be 400 units per visit. However, the child’s weight, muscle mass and acute nature of the illness will modify this dose. So the idea of a maximum dose for a specific condition is indeed variable and physicians should be aware that there are no specific rules, but rather the physician must understand the toxin, the disease and various factors that determine the treating dose to be used in a given patient.

So, apparently, Allergan can teach physicians how to treat cerebral palsy with Botox, but not how to treat it safely? Furthermore, there is literature that supports the use of low-dose rather than high-dose toxin in treating cerebral palsy. Was Dr X aware of this or the fact that low volume with precise injections produces the best results? Maybe he believed volume does not matter in that it has been printed in a journal?

 

Why have there recently been so many more reports of severe adverse reactions and deaths associated with botulinum toxins, which never seem to find their way into public awareness? Certainly, it could be the greater number of physicians using the toxin. But there is a much more serious issue; the current medical literature on Botox should be approached with caution, in that many of the articles are far from accurate. Also, they have not recognized or have even ignored the dangers that accompany the use of this product, even in cosmetic settings.

 

The following illustrates how physicians and pharmaceutical companies can attempt to compromise the medical literature, the cornerstone of medicine:

 

A few years ago, the lead consultant for Allergan (who was a foreign doctor and not even licensed to practice in the US) attempted to publish a manuscript that supported the concept that dilution of the agent did not matter, even though it has long been known that large dilutions of the vial of toxin could result in the toxin migrating and reaching unintended muscle areas. Additionally, FDA studies had found that problems with dilution were the greatest cause of adverse reactions with Botox. A review of the submitted paper uncovered serious problems and contradictory data, including graphs which suggested a worsening of wrinkle severity from baseline after the Botox wore off. Additionally, small sample size and adverse events in the larger dilution groups were noted. In light of these concerns, the article was rejected for publication.

 

The authors then resubmitted this article, choosing to alter the data and remove the results which suggested wrinkles worsened after the toxin wore off. I spoke to the editor of the journal and, once aware, he promised to address the problem with the authors. Two years later, in a special issue of the journal, Dermatologic Surgery, an issue sponsored by Allergan, this article was published with the altered data and the conclusion that “dilution used when administering Botox was unimportant.” When I brought this to the attention of David Pyott, Allergan’s chief executive, he stated that while they financially supported the issue and this foreign physician who authored the piece (their chief consultant and their aesthetic Czar), they could do nothing about the altered data.

 

In another article in the same issue of Dermatologic Surgery, this very same foreign physician attempted to include my name on an article regarding the supposed safety of an injectable type B toxin. I demanded that my name be removed. I was then offered $10,000 by Soltace, who manufactured this toxin (Myobloc), to include my name on this paper. This is supposedly the same sum they paid the lead author.

 

I voiced my concern that this article was incomplete and did not reflect the true toxicity of this agent as had been indicated in other studies, including Japanese studies which have shown this toxin to be much more toxic than originally believed. In clinical use, this toxin had been known to cause distant side effects such as dysphagia (inability to swallow) when it was used in normal doses. My name was removed from the article but the manufacturer refused to include this important safety data. The article concluded that this toxin was both safe and effective. The field of aesthetics has been badly damaged by these acts.

 

My voicing of serious concerns and having raised questions about the alteration of data published in peer-reviewed journals did not go unnoticed. As a result of trying to inform the medical community of these issues, I was terminated from two manufacturer’s advisory boards and from the editorial board of three peer-reviewed publications (Dermatologic SurgeryJournal of the American Society of Dermatology and the Archives of Dermatology).

 

Interestingly enough, William Coleman, who was editor during the entire altered-literature episode, remains at the helm of Dermatologic Surgery today. Furthermore, due to the power of Allergan and other companies, I am no longer invited to speak at any Dermatologic or Plastic Surgery meetings. Recently, Allergen used a patient of mine in an advertising program. My long-standing patient was told that I could no longer be his treating physician. Is this not illegal?

 

I have been disinvited from CME meetings, as well as being prevented from using an educational grant they had provided me to teach courses. Finally, Robert Grant, the president of Allergan Medical, called me and stated that even though I was the best injector in the world, my services would no longer be needed.

 

Having read of the problems in Europe and Canada and being aware of Allergan’s tendency not to reveal severe adverse reactions to Botox, the black box warning they received in 2009 from the FDA vindicated me and the allegations I had made against Allergan, according to BNET/money.com. While consultants to Allergan, as well as the company itself, have publicly denied any problems with the cosmetic use of Botox, the previous data indicate fatalities can occur.

 

Through all the above and despite multiple letters to the FDA, I never have met once or heard from the FDA regarding the information I had provided regarding botulinum.toxin. In that the chief aesthetic czar to Allergan, Alastair Carruthers, is a foreign national not licensed to practice in the US, I would have expected at least a response in that he injected and demonstrated Botox injections throughout the USA without a license in any state.

 

I also expected to get a response to the information I provided in regard to dilution of toxin wherein the authors suggested it did not matter. Even though I proved the authors had altered their data to reach this conclusion, again I heard nothing.

 

So while the FDA has seemed disinterested in forged literature and unlicensed physicians injecting Botox, the FDA has changed and there is now new leadership. There may still be hope.

 

The following is something I hope never comes to be:

Allergan recently filed a lawsuit stating that the ban on off-label marketing of Botox violates its First Amendment rights to free speech. In that a significant portion of their product’s $1.3 billion in annual sales comes from off-label prescriptions, to treat everything from migraine headaches to juvenile cerebral palsy, they feel they have the right to sell it for these purposes. Just remember that people have died from wrinkle treatment with this toxin. Do we want to see more children dying when it is used in cerebral palsy? We do not want abuse of this drug, we should want proper use. How can this happen when the studies surrounding approved applications include data that has been forged?

 

Next week: Cosmeceuticals 2- or where did all my Vitamin D Go?

Follow Dr. Arnold Klein on Twitter: www.twitter.com/awkmd

  • MOST POPULAR
 

 


1 2 3 4 5 6 7 8 9 10 ... 75 76   Next »