Its written as mentioned in the article: Arnold W. Klein. If you go to his website http://www.drarnoldklein.com/ you will find on the side a link to FB. Once you have joined you can log onto that site using your FB account.
One Nation Under Greed: The FDA and me
by Arnold W. Klein on Monday, 25 April 2011 at 07:01
In the recent December 2010 issue of Vanity Fair articles both on the FDA and one on a doctor who was guilty of multiple cases of malpractice appeared. In the malpractice article they referred to an article concerning Irena and Michael Medavoy suing me,Anold Klein MD, over the treatment of her migraines with Botox. What follows is where I have been since the lawsuit.
One Nation Under Greed:
The FDA and me
Arnold Klein MD
From where does the power of Medicine arise? It is a power that is responsible for the creative motivation of this once lofty profession. Can it be found in the sacred Hippocratic Oath, which is one of oldest binding documents of mankind, or is it sequestered at the National Institutes of health, which is the steward of medical and behavioral research? Dr. Arnold Klein, a Beverly Hills Dermatologist and Professor of dermatology and medicine at UCLA is considered to be the founder of modern day facial aesthetics for his contributions to the field. He remains by all accounts at top of his field and Dr. Klein or ‘Arnie’ as his celebrity patients often call him also considers himself a modern day David in a world of Pharmaceutical Goliaths. He is a watchdog and whistleblower who has been punished repeatedly for his actions. He’s been removed from his posts as contributor for many medical journals after speaking out against certain products and pharmaceutical companies in defense of public safety. He continues to spread his word on the dangers of Dermatology by paying for his own lectures usually done guerrilla style by renting restaurants to host the event and college students to pass out flyers during conventions.
Dr. Klein has now turned his attention to the FDA in the hopes he can convince them to take a harsher stand on certain policies and to revamp their processes for approving new products and devices for Dermatology.
Dr. Klein, what is wrong with the FDA in your opinion?
Klein: Medicine is run by a triumvirate. First there is an organization that is hidden in the corridors of buildings in Silver Springs, Maryland. The organization of power is the US Food and Drug Administration known as the FDA. The FDA is fed by large sums of money, casually given to individuals who work there. The money comes not from the government, but rather from pharmaceutical companies. It is under the control of the big business which neither the Republicans or Democratd control You called it a ‘triumvirate” though; you’ve only mentioned two.
Klein: The triumvirate's missing links are the politically active physicians who control what appears in medical journals and who speaks at the FDA, as well as control what is presented at medical meetings.
What makes you feel that you are qualified to speak out on these subjects?
Klein: I first achieved distinction in the dermatologic world by developing the injection techniques for bovine collagen for use in wrinkles and facial scars. These techniques helped to get FDA approval for bovine collagen and launched the field of minimally invasive aesthetic enhancements in 1979. This discovery enabled me to speak at medical meetings in the USA and abroad. In 1984 I developed the injection technique for lip enhancement with bovine collagen.
You called the FDA a “Drug Cartel” recently. What did you mean by that?
Klein: When we use to hear of deaths of celebrities as well as anyone due to the use of drugs this was almost uniformly due tothe illicit drug market which spans our country. In recent years the enabling drug dealer is no longer the black market but the FDA itself. For example Oxycotin wasfirst marketed by Purdue Pharma starting in late 1995 .They apparently realized that marketing a product similar to heroin would be highly profitable. The FDA was well aware of Oxycontin’s limitations in the practice of medicine as well as Purdue’s marketing tactics, and was aware that the question of the risks exceeding the rewards for the use of Oxycontin. At present Oxycotin has flooded the medicine cabinets in every city and once it was widely distributed, it became increasingly used non-medically. An investigation uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of Oxycontin through various illegal schemes. To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead.
As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States. In addition, Purdue’s current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications. Never the less this drugs availability continues but in a different and supposedly safer form and the FDA plays on. While initially the death of my dear friend Michael Jackson was blamed on Oxycotin by family members and such noted medical specialists as Deepak Choprah. We all know now this was not the case. Mr. Jackson died as the result of the misuse of the intravenous sedative Propofol.,
While the FDA recommends that healthcare professionals who administer Propofol for sedation or general anesthesia carefully follow the recommendations for handling and use found in the current product labeling and the drug is so powerful that it is critical to have someone in attendance who has the ability to properly monitor a patient and rescue them should the patient’s breathing cease or some other critical failure occur. Furthermore, addiction to this drug has been noted. Yet any physician in the US can buy and use this agent. But while the problem of prescription drug abuse is significant in the USA the relative weakness of FDA control is one of most important forces behind this. Addiction. This is far from the only problem with the FDA.
How does that make the FDA a “Drug Cartel” though?
Klein: The FDA controls the approval process of all drug products. They knew exactly what Purdue was doing and why they were doing it; yet they did nothing to stop them and they approved the product. In addition they had the ability to put certain drugs under a ‘triplicate prescription’ yet they did not. In regard to Propofol this contributed to the death of Michael Jackson When did you start noticing problems in Dermatology with the FDA?
Klein: It’s been a long time. My issues with drugs and the FDA in my field of minimally invasive cosmetics and devices started off with Botox in 1989-1990. Doctors Alastair* and Jean Carruthers, who are Canadian citizens and unlicensed to practice medicine in the USA, have reported to the US medical community on the cosmetic applications of Botox. At that time Botox was considered an orphan drug. Physicians at Columbia University including Dr. Andrew Blitzer had also made this observation, but were advised by the members of the University not to publish it because of David Kessler.
Who is David Kessler?
Klein: David Kessler was appointed as FDA commissioner in 1990 by President George H. W. Bush. He won bipartisan approval of the appointment. Many of Kessler's actions were honest yet controversial, and he soon became more popular with Democrats than Republicans. He moved quickly to make the agency more efficient, cutting the time needed to approve or reject new drugs, including AIDS drugs, and more vigilant in protecting consumers against unsafe products and inflated label claims. The FDA under David Kessler began to investigate cosmetic devices; among them breast implants along with fillers. He investigated bovine collagen's possible link to causing arthritic-type illnesses and questioned the safety of permanent injectables.
On Feb. 28, 1992, the US Justice Department reacted against several doctors and admonished them about using injectable liquid silicone on their patients. One point was that this admonishment would later prove contradictory when injectable silicone was reintroduced for use in the eyes of individuals with Aids related Retinitis and physicians again began to use it cosmetically in the face. When Kessler left the FDA, though, things began to go wrong. During the mid-1990’s, various doctors lectured on Botox throughout the United States. I introduced Botox to Europe, South America and Asia. While abroad I viewed various fillers which were capable of causing disastrous results. Little did I know these agents would soon make their way into the USA on the shoulders of Pharmaceutical Companies, Political Physicians and device panel members. The FDA was now controlled by Big Pharma. In the 90’s Allergan, the manufacturer of Botox®, appointed a Botox® panel to teach and promote Botox® injection techniques and off-label uses through Continuing Medical Education (CME) courses. The doctors chosen included myself, Drs. Alastair* and Jean Carruthers, Dr. Andrew Blitzer, Dr. Nick Lowe, and Dr. Richard Glogau. Although the Carruthers had no green card nor US license to practice medicine, they began to practice medicine across the USA without seeing a need to obtain proper licensing. It should be noted that my glabellar injection points and dilution were adopted by Allergan and were used for its FDA clinical trials for that ultimately resulted in FDA approval of Botox . Allergan never credited me with this which I developed long before I was a consultant to the company.
A pattern soon developed post-Kessler wherein devices and drugs would be approved on a rapid track for use in HIV then heavily promoted by physician consultants for cosmeti use in HIV- individuals. One product that immediately comes to mind is the product Sculptra.
What happened with Sculptra?
Klein: Sculptra was an agent which was approved only for facial fat loss in HIV patients. Even in this population it caused reactions consisting of nodules and lumps. The reason is that it’s a synthetic agent that the body is unable to recognize. This causes the body to use its cells to build a wall around each of these synthetic fragments causing a foreignbody reaction or a clinical bump. Not one slide that exhibited how this agent behaved once injected was presented when this agent was being approved. Furthermore, why did the FDA allow the manufacturer to actively promote this agent in HIV negative patients when this was contrary to what the panel approved? ( slide 1). Sculptra was eventually approved for use in HIV- patients and continues to cause problems to this day.
What are some of the other problem products you are aware of?
Klein: In 2003, Dr. Alastair* Carruthers advised the use of Artecoll/Artefill in the American Society of Dermatological Surgery newsletter (Currents). This was one of the first widely promoted synthetic Injectables. In Europe and Canada, this agent proved to be a disaster. It was composed primarily of injectable Plexiglas suspended in a weak solution of collagen that quickly gets absorbed by the body leaving only the Plexiglas material t inside the skin!
One can imagine what it would be like to inject such a material under the skin; this creates again a granuloma around which is the walling off of a foreign material under the skin. As a result many patients who were injected with the Artecoll/Artefill product developed lumps in their face that had to be removed by surgery. Yet Dr. Carruthers not only advocated use of this product but helped to get it approved by the FDA! (slide2)
How did that happen?
Klein: Dr. Carruthers wrote in an issue of a dermatology newsletter Currents regarding the excellence of Artefill and in the same issue of Currents assembled an expert injection panel. They excluded me from this panel, yet I was the accepted world authority on Injectables. The Carruthers (according to their business manager) had decided to become the Botox and Filler authorities. What is not widely known is that Alstair* Carruthers was given at that time 35,000 shares of stock in Artes; the parent company of Artefill..I openly criticized the promotion of Artecoll, in that world-wide it has been associated with scarring which can only be corrected by surgical excision. The human body does not know how to handle synthetic injectables like Artefill or silicone, so it walls them off and these sites become large lumps and sites of infection. Artefill was approved by the FDA based on statements made by Allistair Carruthers who, incidentally, failed to reveal his financial connection to Artes. I contacted Cecelia Watkins and Steven Rhodes at the FDA and asked why no data was presented on how the agent behaved once injected under the skin. Were they aware that Germany and Switzerland advised doctors not to use this product or why the European and Canadian history was not considered during the approval process? I never received an answer.
It sounds like a horrible product; why would anyone use it?
Klein: The filler’s package-insert promises that Artecoll/Artefill improves wrinkles by promoting collagen production and collagen development. There is no medical way that injecting Plexiglas is going to induce collagen production. In truth it promotes lumps caused by severe foreign body reactions. I even sent articles on Artecoll's experience in Europe to other members of the FDA. I later lobbied to have Artefill banned by being interviewed by the Wall Street Journal. The company did eventually go bankrupt. In recent months I understand however that another company has acquired the product and that they are trying to reintroduce Artefill in the US.
How could the Carruthers have that much power to influence the FDA?
Klein: During 2000-03, Alistair and Jean Carruthers were injecting and working throughout the USA for various pharmaceutical companies, but majorly working for Allergan. Remember, they had neither a green card nor a license. I wondered if they even paid income tax? I openly complained to the American Academy of Dermatology and American Association of Dermatologic Surgery but the physician’s who control these organizations are, for the most, part politicians in the societies and they and the societies are controlled by Big Pharma. Basically, my complaints fell on deaf ears and later I was punished for complaining.
You stated that you were later punished. Could you expand on that?
Klein: In 2003, a Carruthers Article was sent to me for review prior to it being published in Dermatologic Surgery. It stated that dilution of Botox does not matter. This is contrary to findings of the FDA. The FDA reported that dilution was the greatest problem with the use of Botox. That is as the dilution increased, the more Botox would spread in the body, which could lead to disastrous results if the product reached areas it should not. The Carruthers’ article contained graphs which made no sense. I rejected the article so they simply altered the graphs and resubmitted it. William P Coleman III*, Editor In Chief ofmDermatologic Surgery who said it was impossible that they would have changed data. When I proved to him they had altered graphs and he invited me to write a counterpoint to the article.
One interesting connection to note is that Dr. Jean Carruthers lists in her 2003 CV which has now been removed from her website that William P. Coleman* was a graduate student she supervised. Dr. Coleman* would later ban me from publishing any articles in the journal he runs; Dermatologic Surgery and removed me from the Journal as ‘Filler Editor’ with no notice.
In 2004, the hyaluronic acid, Restylane, was approved by the FDA, followed by Hylaform, I had taught a series of courses for Medicis, Inc. on the proper hyaluronic acid injection (Restylane) technique.
The Carruthers and a select group of their friends wrote articles which took credit for my techniques of injection of hyaluronic acids and Botox. Remember that Dermatology journals would not let me publish at the time so they took full advantage of my censure.
You were one of the premiere Dermatologists at the time (and currently.) Were you recognized as such?
Klein: Yes. I received the first annual aesthetic award from Allergan in 2006.
What every happened with the Carruther’s article with the changed data?
Klein: In 2007 Dermatologic Surgery came out with a special issue on Botox®, sponsored by Allergan, in which was published the Carruthers’ article from 2003 that said dilution of Botox® did not matter. The article was not even updated to use the new name of the cosmetic form of the drug – Botox Cosmetic®. It still referred to the toxin as Botox®. This theory, if true, would increase sales and profitability of Botox® for Allergan in that physicians could just use large dilutions and not worry about its spread. Unfortunately, large dilutions of the toxin could cause it to reach unintended places which could be lethal depending on the amount used and the location it was injected.
Also in that journal is an article by the Carruthers it states that a type B toxin called Myobloc®, was safe and effective. Interestingly, they tried initially to include my name on this manuscript which I had never seen. Solstace who is the manufacturer of Myobloc ®®offered me $10,000 to use my name for the article. I refused. I later found out that this manuscript was, in fact, written by the vice president of Solstace. I requested that data showing potentially severe adverse effects of Myobloc® be included and that which indicated a greater toxicity. They refused to provide the data. I later complained in a counterpoint letter to the Dermatologic Surgery Journal about the forged data and the fact that the manufacturer had attempted to add my name and another doctor's name to the list of authors on the article on Myobloc®.
What happened with that counterpoint letter?
Klein: Nothing. On May 13, 2007, Dr. William Coleman*, the editor of the journal who had initially offered me the opportunity to write a counterpoint article decided to not publish my counterpoint article. He personally, responded to me instead of publishing it. In the letter he again came to the rescue of his former instructor (Jean Carruthers) and brushes off the authorship and payment issues of the article. In a letter, the Carruthers defended the removed data calling it “confusing ” The only reason it was “confusing” was that it showed that their study was entirely faulty.
Did you contact anyone else?
Klein: Yes. I made an appointment with David Pyott, who is the CEO of Allergan; the manufacturer of Botox® . I wanted to talk about my great concern that they had made Alastair Carruthers* their Aesthetic Czar and especially since he was the lead author on both the Myobloc ®and Botox® articles. We specifically talked about the forged data at that time. Mr. Pyott indicated that they had only supported the journal and had no control over content.
Yet the publication was an Allegan special edition.
Wouldn’t you think given that it was a special edition for Allergan that they’d have at least SOME say into it?
You would think so. What was going on in the world of Botox at that time?
Klein: Allergan was also very involved in buying licensing agreements on toxins other than Botox to see how they behaved in the market. Allergan had 15 lobbyists in Washington, DC. I then wrote a letter to Allergan complaining about how I was being treated, about the forged data, and that the company had promised me long ago that I would be their filler expert. They had instead, selected other physicians.
What did Allergan say about that?
Klein: They countered with the notion that I had almost lost the Botox Trial (Note: the Irena Medavoy trial) due to my testimony and demeanor, and that I was “out of control" when the trial began.(article in Vaniity Fare.)\. This was ridiculous. Judge Chavez who presided over the trial has stated that my testimony essentially won the 'non guilty' verdict in the trial and statements made by Allergan were very damaging. The lawsuit personally cost me $500,000.00
Robert Grant (of Allergan) and my assistant had a discussion about my continuing consultancy and Mr. Grant assured him that Allergan intended to renew my consulting agreement, providing I conduct my "general affairs" in a manner conducive to a mutual working relationship. I was told to "sit back, relax, don't pick up the phone and don't send email, and don't open your mouth." Less then two weeks later, I received a call and was told that I was no longer employed by Allergan. Mr Grant indicated that, despite me being the best injector in the world, they had decided that I would no longer sit on the executive committee and that Allergan would not be renewing my agreement. Furthermore, I had been disinvited to a CME meeting which was supposed to be free of any involvement with Allergan. Grant informed me that they (Allergan) would not want me to attend this consensus CME meeting in Dallas.
So it seems you were again “punished” for trying to inform the industry about a potential conflict of interest for public safety. Did you ever consider taking your message directly to the public?
Klein: Yes. The Wall Street Journal featured me in an article in May of 2007 concerning the adverse side-effects of Artecoll/Artefill. I purposely sought the article in that my prior attempts to inform the public that these products are detrimental to their health and associated with deforming consequences had been blocked.
What precipitated this article being published?
Klein: Subsequent to this article, an internal evaluation on fillers had occurred at the FDA and a public hearing was planned. The moderator who ran the meeting was an Oncologic surgeon and most of the reporting physicians were plastic surgeons. These individuals had at best a remedial knowledge of injectable fillers and the panel had only one member who could be considered knowledgeable about injectables. They evaluated the injectables as one large group and since the hyaluronic acid products such as Restylane and Juvederm are the most frequently employed agents, this resulted in these agents causing the greatest number of adverse reactions.
In regard to both of these products, contrary to what was stated, there has never been a true allergic reaction to a hyaluronic acid filler with a low protein load. The culprits in severe reactions are Sculptra, Radiesse, Silicone and Artefill. These are all synthetic agents and can frequently cause lumps as the body reacts against these foreign substances. I was told I could speak at this/hearing. I flew 3000 miles and was limited to 4 1/2 minutes as the meeting adjourned for lunch. Their invited speakers were given unlimited time and their thoughts were at best confusing. I realized at that point that the FDA was not interested in the truth. Kessler was long gone and the FDA was run basically by members who were controlled by the drug companies. In fact, I spoke in front of the Plastic Surgical Device panel and the next day a member of the panel asked me to teach him to inject Botox so that he could work at health clubs on weekends injecting Botox to make extra money.
What happened next?
Klein: With my reading I learned that members of the US Justice Department were investigating Allergan in Georgia for off-label promotion for migraines. After having been made aware of this investigation of Allergan, I wrote a letter to the US attorney expressing my concerns regarding the forged data which had been published, as noted above. I was asked to meet with the FBI agents and the US Attorney’s office. The meeting took place in Los Angeles. The result of the meeting was that I was asked to provide the government with all of my records detailing all of the foregoing. 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® for cerebral palsy!
The member of the Justice Department who interviewed me, Randy Charash, was unaware of the off-label label promotion Allergan had been doing for cerebral palsy and the deaths that occurred,Furthermore, I was contacted by the Immigration and Customs enforcement agents regarding the lack of a US license by the Canadian doctors. At that time, I was made aware that they (Note: the Drs. Carruthers), in fact, did not have or hold any license to teach and/or work in the USA for the past number of years which in I knew.
What was the outcome in the industry to this article and your subsequent whistle blowing?
Klein: When news got out about the actions I was taking, I was removed from my editorial positions at the Archives of Dermatology and Journal of the American Academy of Dermatology. Then in September 2010 Allergan Inc., has agreed to settle a federal investigation over how it marketed Botox, said the Associated Press (AP). Allergan Inc. allegedly promoted Botox Therapeutic for unapproved medical uses through Medicaid resulting in a combined $600 million in civil and criminal penalties. The settlement becomes official once a federal judge approves it, said the AP.
A whistleblower complaint led to the probe that lasted one year, with the Justice Department looking at Allergan’s marketing of Botox from 2001 through 2008. The five whistleblowers will split $37.8 million of the government’s settlement. I was not one of the five but petitioned the justice apartment to be included.
Private citizens who file lawsuits on behalf of the government alleging fraud are eligible for up to 18 percent of whatever is recovered as the result of a qui tam lawsuit. According to a press release, Allergan Inc. agreed to pay state governments and the federal government a combined $225 million civil settlement to compensate Medicaid, Medicare and other federal health programs for reimbursements wrongly paid for Botox Therapeutic. This includes $210 million to the federal government—the rest to a number of states—connected to the probe.
Has the retribution and punishment stopped?
Klein: Hardly. , I taught a CME course in Las Vegas which was primarily sponsored by Allergan through an unrestricted research grant. The night before the lecture, the president of the CME company called a special meeting with my office manager to request that I not say anything negative about Allergan, any of its products, or its consultants.
This same CME company holds $600,000 of the grant money in escrow, but now refuses to schedule any further courses with me despite a signed agreement calling for five such courses. Their excuse is a lack of interest in the course! Meanwhile, my office has been barraged by calls requesting information on attending these courses.
Allergan has now developed a special division, targeting non-specialist physicians, such as OBGYN's, Urologists, Pediatricians and nurse practitioners, to teach these physicians how to inject Botox and fillers.
So how are you now able to spread your teachings and warnings?
Klein: From 2008 until present, I have been teaching courses during the American Academy of Dermatology and the American Association of Dermatologic Surgery annual meetings. These courses are not sanctioned by the Academy. I personally paid for and supported these courses. The courses reveal the altered data published in the American literature regarding both toxins and fillers.
True adverse reaction profiles of the injectables are presented, as well as the proper dilution and injection patterns of the various botulinum toxins to prevent adverse reactions and even death.
Allergan is certainly not the only Pharmaceutical company out there. Have you looked into their competition?
Klein: Of course! While working with Allergan I also worked with Medicis. While I popularized their product, Restylane, for wrinkle injection;, they allowed Dr. Jean Carruthers to create and distribute a CD of my work and injection techniques from Johns Hopkins! Jean decided she would be the senior author on my lip injection paper, which was published in Dermatologic Surgery. She is now credited with inventing my lip injection pattern.
So again the Carruther’s strike back. What has since happened?
Klein: I did a lip study for Medicis and had spent over 40 hours rewriting the lip paper with the assistance of Joe Burns to assure that it was written by me and not authored totally by someone at Medicis. I had replaced the diagrams in this paper on several occasions.
Frequently, in lip articles, the lip evaluation lines are put in the wrong place. I felt the paper had to be as accurate as possible. I also warned Medicis to not present this data to the FDA in that it contained my personal injection techniques. I would expect that it is very unusual for someone else to present the data. Contrary to the agreement, someone did present my data to the FDA in order to expand the lip study. Medicis was now aware of the value of using people with political positions in Dermatology such as Drs. Ron Moy*, Rhoda Narins* and Gary Monheit* as consultants. Since Pharmaceutical companies like Medicis wanted presentations at meetings and these people planned the meetings and controlled the Dermatologic journals, they could remain one happy family. One only needs to look at the literature on Dysport and compare it with the literature from Europe 10 years ago. Suddenly they want us to believe Dysport diffuses like Botox and that it virtually acts in an identical manner. One must ask themselves, why did earlier studies show that it acts quicker? It is a scientific fact that smaller molecules diffuse further(Note: spread from the point of injection) . Diffusion depends on molecular size and Dysport diffuses more than Botox. This is why injecting the frown with Dysport usually will affect most of the forehead area above the frown. I shared over 35 articles with Medicis about this, but they just don't want or care to understand the truth. Their theory, espoused by Monheit for Medicis is that when toxins, including Dysport, reach the pH-neutral environment of the body and leave their acidic environment that the protein envelope surrounding the toxin opens, releasing the pure botulinum molecule. And this is why all type A toxins diffuse equally. However Dr Monheit* obviously does not realize that Dysport is stored at a neutral pH. That means that it is not suddenly exposed to a pH change that causes its surrounding protein to leave. Well, there goes Monheit's* theory; yet they still espouse Monehit’s* theory to this day.
It does sound like a medical impossibility. How can this continue to happen?
Klein: It happens all the time in this field. For example during a recent edition in the Journal of The American Academy of Dermatology, I came across an article on Sculptra by a number authors, including Narins* and Monheit*. Every single author was a consultant to Dermik, who manufactures Sculptra. They compared the product to human collagen. the authors got lots of lumps with collagen, which means that they did not know how to inject anything. If they had skin tested with Sculptra, they could have seen the notoriousreactions I seen with this product.
So sum this all up for us, Dr. Klein.
Klein: We have all the makings of a great suspense novel here. We have an ineffective government agency which was duped into approving medicines and devices that did not have sufficient testing. We have a small "old boy, old girl network" of doctors who run the journals, which are monetarily supported by the drug companies. They protect the drug companies from any adverse opinions of drugs and devices by doctors. Additionally, we have foreign doctors on the payroll of the drug companies, changing data to make their studies relevant.,I have brought forward the truth and been silenced by the drug companies, medical societies, medical journals, and political physicians. I like Kessler when he went to UCSF must become a whistleblower or maybe I blew it and did not know.
However the media must improve its message and not be controlled by big Pharma. Doctors should stop promoting and return to medicine with integrity. Medicine is both a science and art. Physicians must remember that and also that if your looking for a great cosmetic doctor he schooled be practicing and not selling worthies creams and schemes. Nevertheless there is some good news and some bad (* Editor of a large journal or president of a large Dermatologic organization)
What s the good and what is the bad? It takes a long time to get people to look and see. Like with Aids Amfar was founded in my home in 1984 and the mainstream finally saw what was happening through the eyes of Elizabeth Taylor and Sharon Stone within 5 years.People are beginning to see what is wrong with medicine and the FDA. Big Business is encroaching on our freedom in every direction and cost of medicine and treatments are increasing, Why I feel more positive these days I am not standing alone but have others questioning the actions of the FDA. Furthermore I have been appointed a consultant to the FDA itself. My only hope is that this appointment will allow me a voice that will be heard among th Nevertheless within days of the Whistleblower Suite Allergan received approval of Botox®®®Chronic migraine (CM) with episodes > 15 month.It is a disabling and undertreated headache disorder affecting 1.3% of the US population. The conclusion was that a fixed-dose fixed-site treatment of 155 units was the best approach. There were two pivotal studies presented to the FDA.. In this one the senior author Andrew Blumenfeld feels that a 2cc dilution is best because there are far less adverse reactions due spread of toxin to unintended locations. The 3rd author who holds the use patent on Botox® treatment for migraines uses 80-155 units and a 4cc dil
Either way if the forged paper that said dilution did not matter was never published people would pay more attention to where the toxin went, specifically unintended muscles which can result in severe adverse reactions. Furthermore Irena if you are still reading I used around 80 units the lowest possible dose. All I can say is watch out Medicare when you see tons of migraine treatments when most of the dose is freely used in cosmetic patients. Also remember the injection of Botox is an art and Neurologists may not be the most painless group and would never care if your eyebrows ended up around your knee’s. Furthermore, I hope they know excessive doses or improper injection sites can stop one from breathing.