Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue–Based Products – Postponed
This came out just prior to our "going to press"
There has been considerable interest in the Public Hearing, "Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue–Based Products," scheduled to take place on April 13, 2016. Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined. The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.
Information on the rescheduled hearing, including date, location and registration information, will be made available on FDA's website and will be published in the Federal Register. We will announce the dates for the hearing and the workshop in the near future.FDA's announcement will contain information on how stakeholders interested in speaking, including those who were scheduled to speak at the hearing on April 13th, can sign up to speak at the rescheduled hearing.
A Big Break is Needed to Resolve the Bone Headed Confrontation Between The Unstoppable Force (IROM) Versus The Immovable Object (FDA)
David L. Harshfield, MD, MS
The previously indistinct lines separating vague government policies and well defined private interests in cellular medicine are finally coming into focus. Previously, the factions on both sides had been practicing relative "peace" – that break in time between all–out war in which everyone stands around reloading, steeling their swords and reinforcing their castle walls and populating their moats with alligators and piranhas.
Read full article >
U.S. Senate Confirms Dr. Robert Califf to Lead FDA
The agency will be tackling thorny topics including food safety, biologic drugs and how to regulate e–cigarettes.
Read full article >
NEWS FROM THE AAOM
2016 AAOM Lifetime Achievement Award RecipientAndrew Kochan, MD
Dr. Kochan has been in private practice since 1984. He remains committed to furthering research and sound clinical practice in integrative pain medicine, combining conventional and proven complementary approaches for relieving acute and chronic pain.
Dr. Kochan began practicing prolotherapy, well over twenty years ago– well before its present–day surge in popularity. In 1989 Dr. Kochan incorporated apitherapy, particularly bee venom therapy, into his practice as a treatment for chronic and acute pain. His clinical success with both prolotherapy and apitherapy inspired him to open the Kochan Institute of Healing Arts Research in 2001. Today, Dr. Kochan is a leading international authority in apitherapy. In his current role as President of the American Apitherapy Society, Dr. Kochan continues to promote public and professional awareness about the medicinal value of honey bee venom and other substances produced by bees for a wide range of disorders.
As a part of his residency training from 1981 to 1984 Dr. Kochan was evaluating and attempting to treat patients who were having chronic pain and the attendant social and physical problems that result from inadequate treatment and over or under medication. He was acutely aware of the discomfort, disability and frustration of patients living with musculo–skeletal injuries as a result of an injury to his own anterior cruciate ligament when playing basketball in college and the three subsequent knee surgeries that followed. Thus, his frustration over modern medicine's inability to relieve the pain and suffering of many of his patients led him to examine complementary healing modalities years before this trend became fashionable. Dr. Kochan discovered first-hand that certain complementary therapies are effective for reducing symptoms of painful conditions in cases where pharmacologic drugs and surgery have failed.
Dr. Kochan will be presented with the AAOM 2016 Lifetime Achievement Award on Thursday, April 14, 2016 at the AAOM Annual Conference at the Hilton Clearwater Beach Resort in Clearwater, Florida at 8:00 pm.
SAVE THE DATE
2016 AAOM Annual Conference – Faculty
Where Every Speaker is a Highlight in IROM Interventional Regenerative Orthopaedic Medicine
The 2016 AAOM Annual Conference and Scientific Seminar is planned for April 13 – 16, 2016 at the Hilton Clearwater Beach Resort in Clearwater, Florida. The AAOM, a not–for–profit organization, now hosting its 34th Annual Conference, has consistently provided noncommercial, AMA Category 1 CME approved programming. You can trust that what you learn at the AAOM is based on the latest science, evidence based research, established protocols, from the world's leading experts.
Stay tuned to www.aaomed.org for details.
Learn more >
Original Research Case Study
By Dean Reeves, MD
Marc Dubick, M.D., has been member of AAOM for over 20 years. A PubMed publication on prolotherapy is quite a lot of work as those of you that do research can appreciate. We thought you would be interested in Marc's comments on his paper, done in conjunction with Paul Ravin. Those of you that work with stem cells are aware that IRB approval is not enough to protect you from potential trouble if an unapproved process or method is used in the process of research. Marc jumped through the right hoops prior to beginning this study and this is an encouragement to all of us to do the same thing in terms of checking what the hoops are and how high we need to jump in order to do research that is Pub Med level and will potentially change the world. AAOM colleagues can be a big help in this as well as specialty IRBs such as the International Cellular Medicine Society IRB. Thanks to Marc for sharing this. His contagious interest in regenerative medicine has been an inspiration to many.
As many AAOM members may remember, in 2013 I presented the findings of a comprehensive IRB sanctioned study that I had undertaken using the anabolic hormones rhGH and testosterone in Regenerative Therapy Injections. The results were very encouraging and included injections in the following areas: cervical spine, thoracic spine, lumbar spine, sacrum, shoulder, elbow, hip, wrist/hand, knee, ankle/foot. A PDF file of that lecture is available below. My goal was to publish a paper describing this study as the first step to seeing the rhGH/testosterone cocktail become a standard of care in Prolotherapy/Regenerative Injection Therapy. Tom Ravin came on board, and we used the body area with the most participants, the low back/sacroiliac region, for the paper. I'm pleased to announce the manuscript has been published and was added to PubMed in early August, 2015. The link to the manuscript is found below. Our manuscript is listed as an original research case study and has received positive responses throughout the Internet. This is the first published manuscript world wide describing this injection technique.
The group I'm currently working with in Charleston, SC, hopes to obtain a grant and perform a blinded placebo controlled study as a follow–up. I encourage further research in this area by interested practitioners. I'm obviously biased, but I feel that the use of these anabolic hormones can be an important addition to our available injection armamentarium.
I also feel that it is important to obtain an Investigational Review Board approval while developing future studies in an effort to avoid any political issues. On that subject, below is one further link to the federal government's position on the use of rhGH. Please read and decide the direction you take for yourselves.
Marc N. Dubick, MD
Michelle "Shelly" Voelker, BA, Biological Sciences
CASE OF THE MONTH
David L. Harshfield, Jr. M.D. M.S.
Regenerative Injection Therapy (RIT) Rotator Cuff and Shoulder Ligament Platelet Rich Plasma PRP Injection Therapy
Read case >
ORTHOPAEDIC MEDICINE MATTERS
David L. Harshfield, MD, MS
IN THIS ISSUENews Flash
News From the AAOM
Case of the Month
33rd AAOM Annual Conference
FIND A DOCTOR
You can heal...
Some of the best Orthopaedic doctors are just a click away!
Review past issues of the AAOM eNewsletter
The AAOM Newsletter is always
looking for scholarly contributions from its members. The newsletter is growing and evolving
in an attempt to meet the needs of the membership. If you have a passion for a specific topic,
a lecture or presentation that you have done that you feel would benefit the membership
and make a good article, please contact us:
© 2016 American Association of Orthopaedic Medicine. All Rights Reserved.