Updated February 28, 2014, at 10 a.m. with comments from AMRI.
FDA regulators had strong words for Advanced Magnetic Research Institute International following an inspection of the electromagnetic therapy center’s practices.
Inspectors took issue in particular with 3 human clinical studies that the FDA said were conducted without required approval from an Institutional Review Board. The regulators accused AMRI of putting patients at unnecessary risk by subjecting them to a potentially dangerous therapy without sufficient oversight.
The FDA further chided AMRI for illegal promotion of its magnetic therapy and lack of proper records documenting adverse effects, including 3 reported cases of cancer and 2 patient deaths.
ARMI’s Dr. Dean Bonlie told MassDevice.com that the deaths and cancer incidents were mere "red herrings."
"Those 4 cases of adverse events wouldn’t even have had to be reported because they happened weeks-to-months after MME treatment," he said in a voicemail. "They were brought up to the IRB and we ruled that they had no relationship whatsoever to the treatment, so bringing that up now is strictly a red herring."
AMRI develops magnetic molecular energizer (MME) therapy, consisting of targeted high-energy electromagnetic fields generated by large magnets. The energy supposedly influences cells at the atomic level, stimulating some of the electrons and increasing the body’s electron transfer, according to AMRI.
"The magnetic field of the MME device acts as a catalyst to improve chemical reactions occurring in the human body," according to AMRI’s website. "This improves a variety of body functions in the area of the MME focal point, such as oxygen carrying capacity, assimilation of nutrients, manufacture of enzymes, metabolic waste removal, reduction of free radicals, tissue regeneration, and most importantly healing."
Inspectors also noted that AMRI has made comments on its website and in downloadable materials that inappropriately suggest the therapy is safe and effective. FDA regulators haven’t approved the MME device or reviewed the health claims that AMRI has been promoting, according to the letter. Among the purported benefits of the therapy are accelerated healing ("a bone fracture that typically requires 6-8 weeks to heal may require only a few days with MME treatment") and a nearly non-existent risk profile ("MME treatment is painless, non-invasive, and does not have the allergy or interaction problems of multi-prescription medicating and does not carry the risks of more aggressive treatment methods such as experimental drugs or surgery").
The company states on its website that its research is being conducted under IRB approval and that it plans to gather more information in order to submit for FDA approval for MME treatment. The FDA maintained that no such IRB approval was reported.
"Your failure to maintain IRB approval is a serious violation of your responsibilities as a sponsor and placed study subjects at increased risk of adverse health consequences," CDRH Office of Compliance director Steven Silverman wrote in a formal warning letter issued to AMRI. "Without IRB approval, there is no assurance that the risks associated with the device and study procedures are minimized. These risks include the worsening of disease conditions or death due to inadequate or inappropriate treatment of several illnesses that the MME was purported to treat. These include congestive heart failure, cerebral palsy, Alzheimer’s disease, and brain and spinal cord injuries."
Dr. Bonlie admitted that the company had allowed its IRB standing to lapse in recent years, but said that there was very little activity going on MME therapy.
"They are correct in the fact that the IRB oversight has not been what it should have been over the last 4 or 5 years, simply because there was little action done," he said. "We had to close down 3 clinics and had very little action going on in existing clinics, so there was nothing to have an IRB board meeting over."
"We should have had the meetings, but we didn’t due to financial reasons," he added.
The agency further chastised AMRI for missing reports regarding "several serious adverse events," noting in particular a case of breast cancer 6 months following MME treatment, a death related to an undiagnosed cancer 4 months after treatment, a death of unknown cause but suspected to be related to a transient ischemic attack 30 days after treatment and 1 patient who withdrew from a study and was "also newly diagnosed with cancer."
The letter was dated Jan. 16, 2014, and was unsealed this week.
