A Message to the Public

  After devoting most of my life to the field of minimally invasive aesthetics, it is difficult for me to comprehend the total rampant disregard for patient safety in this field. I am outraged because I developed a safe and effective injection pattern of the frown lines that was used in the FDA approval studies of Botox. Many individuals who are now injecting Botox do not know this pattern, nor do they understand why dilution is critical. Injecting Botox into the skin is not a simple procedure, easily performed by anyone. It requires a great deal of scientific understanding and finesse. The FDA knows this, so why are there hundreds of uneducated and inexperienced technicians acting as Michelangelos of the syringe and leaving emotional and physical scars on thousands of innocent Americans who trust in the safety of minimally invasive aesthetics?

  Furthermore, published altered data on dilution is causing additional unnecessary harm to innocent people. Worse even than the flagrant misuse of Botox, however, is the approval by the FDA of a list of synthetic injectable fillers—some of which were banned in other countries prior to their approval in the United States—that have severely scarred and impaired the health of people around the world.

  So why is it that the Food and Drug Administration (responsible for protecting public health) is approving disfiguring, dangerous fillers for cosmetic use? And why are we seeing problems with these fillers now rather than when they were first approved? Additionally, it’s been over a year since the advocacy group Public Citizen petitioned the FDA to require a black box warning label be placed on Botox, alerting doctors and patients that the drug can spread to distant parts of the body. Just last week, the FDA finally announced that it will now require Botox, Myobloc and the other botulinum drugs to carry this black box warning. The FDA is also requiring manufacturers to send doctors a letter warning of the risk. But why so many months AFTER the initial petition. How many people have suffered from this gross negligence?

  The answer to all of these questions might also answer why Allergan (the manufacturer of Botox) was allowed to hire a foreign physician to conduct their studies and speak before the FDA even though this physician was unlicensed in the United States and didn’t even have a green card.

  Over the years, I have watched the profession of medicine be severely abused by doctors in high level political positions who’ve used their positions to develop fiscal ties with pharmaceutical companies. The FDA, medical societies, continuing medical education organizations, and physicians (once distinguishable entities) have so enmeshed themselves with pharmaceutical companies that it is all but impossible to see where one begins and the other ends. Physicians supported by these companies promote their products, not only to other doctors but to the public as well (and in many cases, despite proven evidence of the safety of the product or products). These same doctors run medical societies, edit and advise trade publications, appear on the Internet and television, and speak before the FDA. They conduct the studies and write the papers necessary for FDA approval—papers published in leading medical journals that often contain inaccurate data.

  The public should be alarmed and changes in the pharmaceutical industry and the FDA need to happen immediately. Somehow and in some way, I must warn the public of the potential danger that exists at the end of the needle. The next innocent person to be exposed to this danger could be you. If you are reading this, please help me spread the word.

Arnold William Klein, MD

Professor of Dermatology and Medicine

David Geffen School of Medicine at UCLA

Arnold Klein Chair in Dermatology at UCLA