POSITION LETTER ON FDA BLUPRINT FOR PRESCRIBER EDUCATION FOR EXTENDED-RELEASE AND LONG-ACTING OPIOIDS ANALGESICS

07/09/2017
Author: 
Arthur Yin Fan

POSITION LETTER

ON FDA BLUPRINT FOR PRESCRIBER EDUCATION

FOR EXTENDED-RELEASE AND LONG-ACTING OPIOIDS ANALGESICS

July 5, 2017

Ref: Docket No. FDA–2017–D–2497

We welcome the FDA’s position with regard to extended-release and long-acting opioids analgesics.  Patients need medications without severe side effects and addictive effects, as well as acupuncture, which belongs to safe, non-pharmacological therapies.

Acupuncture is an effective, cost-effective therapy without adverse side-effects.

The facts:

1. Acupuncture is a cost effective therapy1:  
Acupuncture is a proven modality that saves thousands of dollars from pain medications when used in conjunction with a treatment plan focused on acupuncture. If using acupuncture for pain management, the patients and insurers can save money and successfully manage their pain and other symptoms without the adverse risks associated with prescription medications. Here are some examples: For post-stroke treatment, acupuncture saves $26,000 per patient; For Migraine, acupuncture saves $35,480 per patient; For Angina Pectoris, acupuncture saves $32,000 per patient; For severe osteoarthritis, acupuncture saves $9,000 per patient; For Carpal Tunnel Syndrome, acupuncture saves $4,246 per patient.

2. Clinical Efficacy: 
There are many acupuncture studies in both basic science and clinical trials, supported by National Center for Complementary and Integrative health (NCCIH) and National Cancer Institute (NCI), of the National Institutes of Health (NIH).  For the studies regarding acupuncture for pain, there are more than 7,000 articles published and documented in PUBMED or Medline. Almost all of the acupuncture studies in the basic science studies have positive results; they show that acupuncture has positive effects on the decrease of pain in both human and animal studies. Acupuncture can increase endorphins, serotonin, dopamine, and other internal neurotransmitters, and heal the course of pain (such as caused by various inflammatory, and neurogenic issues), and also directly treat the pain. For acupuncture clinical trials, most of them show that acupuncture is both safe and effective if the studies have large-enough patient samples (i.e. P<0.05). However, we should be aware of the methodology flaws, as some trial designs have obvious mistakes. For example, some researchers adopted so-called “sham acupuncture” to mimic the trials for pharmaceutic medication; they did not consider the difference between acupuncture, as an external nervous system stimulation therapy, and internal medications which requires absorbing into the blood steam to have some pharmacological actions. Most “sham acupuncture”, without validating study, is actually just one style of real acupuncture used by acupuncturists around the world. It is not a placebo. So while some people try to disregard the effectiveness of acupuncture by stating that acupuncture is just a placebo, they actually made their judgement based on a wrong term used in acupuncture clinical trials. 2

NIH reports that the data in support of acupuncture is as strong as those for many accepted Western medical therapies. In 1997 the NIH approved acupuncture as an adjunctive treatment for several conditions including pain, nausea, asthma, carpal tunnel syndrome and paralysis from stroke.  Over 500 positive clinical trials measuring the efficacy of acupuncture have been conducted in the past three decades. There are 50 systematic reviews of acupuncture in the Cochrane databases. Overall, the trend has been favorable, advocating the use of acupuncture in a clinical setting as an adjunct treatment with conventional therapies, where suitable (Witt et al. 2006). Positive studies include acupuncture treatment for low back pain, neck pain, osteoarthritis of the knee and hip, fibromyalgia, rheumatoid arthritis, TMJ, headaches, infertility, pain and nausea in cancer patients. 1,3

Acupuncture is also effective way to treat the opioids addition, there are 32 basic studies and clinical trials included in PUBMED.4

3. Acupuncture is not expensive:3

Insurance coverage shows that: Federal employees have had acupuncture coverage for more than ten years (with the coverage beginning around 2006). Many other commercial healthcare insurances also have acupuncture coverage plans. Such insurance plans are aware that acupuncture is effective in pain management, and that there is solid evidence to support acupuncture as an effective therapy. Insurance coverage for acupuncture only costs a typical member’s monthly health insurance premiums of between $0.38 (0.08%) and $0.76 (0.16%) per year, based on a recent Massachusetts study.3

4. Many people are consciously deciding to choose natural therapies, including acupuncture.
People are aware that chemicals (such as those in prescription medications, especially opioids) may cause potential problems and adversely affect people’s health. More and more people are turning to natural medical therapies, like acupuncture, to avoid the adverse risks and side effects associated with pharmacologic therapies. Furthermore, patient satisfaction is incredibly high from acupuncture use.  One of the largest surveys of 89,000 U.S. acupuncture patients treated by over 6,000 acupuncturists in the American Specialty Health network found that 99% reported good, very good, or excellent service quality from licensed acupuncturists in 2014.  An impressive 93% of the respondents said that their provider was successful in treating their primary condition in 2014 and 2015.5

5. There has been a recent, big trend of building up integrative medicine centers in conventional medicine facilities and medical schools in the USA and around the world.
In the USA, most of the prestigious medical schools and hospitals have already had integrative medicine centers for years, including Harvard University School of Medicine and its affiliate hospitals Johns Hopkins, Cleveland Clinic, and Beth Israel in New York City. Among integrative medicine, as an important non-pharmacological therapy, acupuncture is an extensively used one. In the USA, the biggest healthcare system is the Veteran Affairs healthcare system (VA); the VA has more than 1,700 facilities as of 2015, in which 93% have established integrative medicine centers or programs which provide veterans acupuncture. In the U.S. military, many hospitals and clinics provide acupuncture service; even more, the experience of applying acupuncture has been introduced to the European military system (NATO). There are tons of news on TVs, newspapers, magazines and academic journals about the effectiveness of acupuncture. 

6. There are close to 50,000 acupuncture providers in the USA (including 34,682 active licensed acupuncturists, more than 6,000 physician acupuncturists and more than 6,000 chiropractors who adopt acupuncture in their practice). Modern acupuncture education or training and the practice provide patients an excellent resource for non-pharmaceutic pain managements and for other diseases or disorders’ treatments as well. There are already licensed and well-educated practitioners ready to serve these important groups within our population.

7.In the USA, there were about 100 million acupuncture treatments, or 25 million patients per year (estimation based on there being about 500 million acupuncture treatments per year around the world in 2015 (a survey shows at least 5 billion acupuncture needles used in that year).

In summary, acupuncture is an effective therapy, with very minor side effects, and is also effective for the treatment of opioids addiction. ATCMA strongly supports the FDA’s position on including acupuncture as a non-pharmacological therapy in the Blueprint for prescriber education for extended-release and longacting opioids analgesics.

References:

1. Acupuncture and Oriental Medicine Society of Massachusetts .Why an “Act Relative to the Practice of Acupuncture” is important: fact sheet. http://www.aomsm.org/resources/Documents/Legislature/Legislation%20relat... 02017-2018/Acupuncture%20Insurance%20Fact%20Sheet.pdf. Accessed July 5, 2017.

2.  Fan AY. Dialogue with Dr. Lixing Lao: from a factory electrician to an international scholar of Chinese medicine. J Integr Med. 2013; 11(4): 278-284.

3. CHIA center for health information and analysis. MANDATED BENEFIT REVIEW OF H.B. 3972: AN ACT RELATIVE TO THE PRACTICE OF ACUPUNCTURE. file:///C:/Users/Arthur%20Fan/Downloads/MBR-H3972-Acupuncture%20%20CHIA%20report.pdf  Accessed July 5, 2017.

4. US National Library of Medicine National Institutes of Health,Search database. https://www.ncbi.nlm.nih.gov/pubmed/?term=opioids+addiction+acupuncture Accessed July 5, 2017.

5.  American Specialty Health White Paper:  http://files.clickdimensions.com/ashcompaniescoma7oce/files/acupuncturec... Accessed July 5, 2017