Feature Article: April 2020 – Update on Peptides
Edwin Lee, M.D., and Luis Martinez, M.D.
The Clinical Peptide Society is aware of some recent FDA positions and actions which could severely restrict physicians’ prescribing of peptides and patients’ access to such important therapies. We are currently gathering additional information to better assess the situation and our response to it.
On April 2, 2020 Tailor Made Compounding received a warning letter from the FDA in response to the 2018 inspection of that pharmacy. As of today, April 8, 2020, we have not seen FDA Form 483 sent out to Tailor Made.
Speculation abounds concerning the future of peptides, and we feel that some peptides will be taken away. For instance, Cerebrolysin, a mixture of growth factors and peptides derived from young pigs’ brains, has been recently classified as a biologic. It appears that both growth hormone-releasing hormones and peptides are being restricted, and we feel that the pharmaceutical companies which deal with HGH are pressuring the FDA to impose these limitations. We are not sure what the future holds for other peptides. We suspect that some peptides will be available, like Thymosin Alpha 1, Thymosin Beta 4 and PT 141, but this is only our best guess.
In February, 2019 the FDA defined a peptide as having fewer than 40 amino acids. Anything above that number now constitutes a protein and a biologic. Tesamorelin, a 44-amino acid peptide, is now considered a biologic by the FDA. Thus, this substance cannot be compounded, even though it is FDA approved, unless the pharmacy has a biologic license. Compounding pharmacies are excluded from obtaining a biologic license.
This arbitrary FDA definition of a peptide is contrary to all the research and published data from the 1970s about what a peptide is. Most scholarly articles refer to peptides as having fewer than 100 amino acids. Insulin, consisting of 52 amino acids, is the most famous example of a peptide. Its discovery won the Nobel Prize in Medicine in 1923. With the new FDA definition for these substances, all the textbooks on endocrinology will need to be updated since insulin will no longer be a peptide.
What constitutes a biologic is debatable. Biologics are produced from living organisms or contain components of living organisms. On March 23, 2020 the FDA classified HCG as a biologic, so it can no longer be compounded. Three days later, Dr. Lee called the Center for Biologics Evaluation and Research at 1-800-835-4709 and asked whether HCG was categorized as a biologic. The FDA agent who works for this center replied that she did not consider HCG to be a biologic and had no idea why it was classified as one.
We as a professional society will do everything in our power to assure that peptides continue to be available through reputable compounding pharmacies so that physicians may continue to use these therapies as part of their armamentarium to help patients. However, the range of peptides will be limited, and not all the peptides that we once used will be available.
We will continue to update our members as the situation evolves. The only possibility for change is legislative action. Later on, we will mount a campaign so that all of us and our patients can petition our lawmakers to reverse this new ruling. If peptides compounded in a well-regulated, FDA-approved pharmacy are no longer available, then the huge demand for them on the dark side of the internet will be dangerous to our patients’ health.
Drs. Edwin Lee and Luis Martinez
Clinical Peptide Society
April 8, 2020
Peptide therapies are a quickly evolving therapeutic area of medicine with wide-ranging impacts on clinical care and patient health.
Peptides are of particular interest as therapeutic drugs because the body naturally produces many different peptides, this means they are relatively well-tolerated as therapeutics and have fewer side effects.
The majority of naturally occurring peptides bind to cell surface receptors triggering intracellular responses. With over 7,000 peptides that occur naturally in the body, this represents a wide pool of peptides and functions to work with.
Naturally occurring peptides have many different functions from hormones, growth factors, neurotransmitters and more. Therefore, the use of peptides as therapeutics provides a method of targeting a wide range of cells and manipulating their response.
Through cell signaling amino acid sequences, the targeted use of peptides has the potential to rewrite bodily chemistry relationships and build towards regenerative health.
Welcome to Clinical Peptide Society
*COMPLIANCE DISCLOSURE: Clinical Peptide Society has made every effort to have all lectures and statements made regarding Peptides comply with all FDA and State and Local laws. There are some Peptides which the FDA has not approved for compounding. This is a new and potentially changing area of medicine and we encourage you to frequently check for new policies, laws and rules which may apply to your practice and to strictly adhere to all laws which apply.
Sign Petition Now
Save Peptides is an organization created so that the FDA will allow compounding pharmacies to continue to produce these regenerative substances. We need your help to preserve the availability of peptides. First, we must raise the money for each peptide to be studied and sent to the United States Pharmacopeia for a monograph. The FDA requires a monograph, costing an estimated $300,000 for each peptide, before it can be approved for use. Only then can compounding pharmacies produce that peptide. While Big Pharma has the resources to obtain the necessary documentation for their products, compounding pharmacies do not have such plentiful funding. We have only one last chance for peptides to obtain FDA approval. Please donate generously to our 501(c)(3) tax-exempt nonprofit organization and pass the word along to your family and friends.
Preserve the use of Peptides
Testimonial on Peptides
My name is Matt Langan. I am a 5’ 11” male. My normal, healthy weight is 155 lbs. In 2018, I was normal and healthy. In 2019, I was in a wheelchair, unable to walk on my own, and I weighed nearly 100 lbs. due to suffering from severe ulcerative pan-colitis. I tried every pharmaceutical option recommended and made available to me from gastroenterologists and nothing worked. I flew down to Orlando to see Rebecca Murray at the Institute for Hormonal Balance. A vital part of our protocol was the subcutaneous use of Thymosin and BPC-157 peptides. Within months of beginning the use of these peptides, I had gained 40 lbs. of lean muscle and reclaimed my health and life. To this day, over two years later, I remain asymptomatic and thriving. I used the peptides in conjunction with other nutritional supplementation and lifestyle changes but I remain convinced that they played a significant positive contributor to my healing journey. In my use of the peptides, they were beneficial, affordable and safe. I fear that if I were to flare again, if peptides are no longer made available, I may not be able to heal again. I also fear for those who haven’t been able to heal using traditional pharmaceutical medications and need another option like peptides. If peptides are no longer made available to them, then that would be one less possible solution that they could pursue. Peptides saved and changed my life in a significantly positive way and need to remain available as a powerful healing tool.
International Regulatory Peptide Society (REGPEP Society)
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Peptide society clinical
The American Peptide Society, a nonprofit scientific and educational organization founded in 1990, provides a forum for advancing and promoting knowledge of the chemistry and biology of peptides. The approximately one thousand members of the Society come from North America and from more than thirty other countries throughout the world. Establishment of the American Peptide Society was a result of the rapid worldwide growth that has occurred in peptide-related research, and of the increasing interaction of peptide scientists with virtually all fields of science.
Peptides are chains of amino acid residues with remarkable biological functions, ranging from hormonal regulation to antibiotic activities. Members of the American Peptide Society are involved in research in academia, industry, and government, covering all aspects of peptide chemistry, biology, and pharmaceutical science. Research topics include synthesis of biologically important targets, isolation and characterization of new products, structure-activity relationship studies, molecular diversity, de novo design, drug delivery, and the discovery of new pharmaceutical agents.
A major function of the Society is the biennial American Peptide Symposium.The Society also sponsors the Journal of Peptide Research and Biopolymers (Peptide Science), recommends awards to outstanding peptide scientists, works to foster the professional development of its student members, interacts and coordinates activities with other national and international scientific societies, sponsors travel awards to the American Peptide Symposium, and maintains a web site at www.chem.umn.edu/orgs/ampepsoc.
The American Peptide Society is administered by Officers and Councilors who are nominated and elected by members of the Society. The officers are Robert S. Hodges, President (University of Alberta); Tomi K. Sawyer, President-Elect (ARIAD Pharmaceuticals); Richard A. Houghten, Secretary (Torrey Pines Institute for Molecular Studies); and Teresa M. Kubiak, Treasurer (Pharmacia & Upjohn Company). The councilors are George Barany (University of Minnesota); Charles M. Deber (University of Toronto); Gregg B. Fields (Florida Atlantic University); Lila M. Gierasch (University of Massachusetts); Murray Goodman (University of California-San Diego); Victor J. Hruby (University of Arizona); Barbara Imperiali (California Institute of Technology); Thomas J. Lobl (Coulter Pharmaceutical); Ruth Nutt (Santa Fe, New Mexico); Daniel H. Rich (University of Wisconsin-Madison); and Peter W. Schiller (Clinical Research Institute of Montreal).
Membership in the American Peptide Society is open to scientists throughout the world who are engaged or interested in the chemistry or biology of peptides and small proteins. Categories of membership include Active Member, Associate Member, Student Member, Emeritus Member and Honorary Member. For application forms or further information on the American Peptide Society, please visit the Society web site at www.chem.umn.edu/orgs/ampepsoc or contact Ms. Susan Henry, 713 Heritage Medical Research Centre, University of Alberta, Edmonton, Alberta, T6G 2S2, Canada; phone 780-492-6540, fax 780-492-1473, e-mail [email protected]
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