ALSUntangled® reviews alternative and off label treatments (AOTs), with the goal of helping people with ALS make more informed decisions about them.
In conclusion, we find few plausible mechanisms by which components of the EIW regimen might impact ALS progression, and no pre-clinical or clinical evidence to support using this complicated, expensive and potentially risky treatment. Mr. Edney appears to have had very slow ALS progression even before he started his protocol, and there is no convincing evidence that the EIW regimen slowed, stopped or reversed his disease.
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Acuscope appears reasonably safe, but it is not clear that it has a mechanism of action that would be useful to PALS. One person with PLS experienced slightly slower ALSFRS-R measurements while using Acuscope than she did before starting it, but a PALS had slightly faster ALSFRS-R progression during treatment. Since the natural history of motor neuron disease progression can vary spontaneously, it is not clear that either of these slight changes in progression were related to the treatment. Given these limitations, at this time we cannot endorse the use of Acuscope to slow, stop or reverse ALS progression.
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At this time ALSUntangled finds no independently verifiable data supporting the efficacy or even the safety of GM604 in patients with ALS. We believe that independent peer review and replication are fundamentals of good science (36,37). Accordingly, we share the FDA’s April 2015 opinion that the data on GM604 in ALS should be released now for
independent peer review (38). If these preliminary data are confirmed to be positive, statistics on the false-positive rate of small trials (29,30) and consensus ALS trial guidelines (35) dictate that they be replicated in a larger, longer duration study before GM604 is deemed effective or even safe for patients with ALS.
ALSUntangled generally supports the use of expanded access programs during ALS drug development. We believe that these should be reserved for treatments that have at least some independently verifiable safety data. In our opinion, that is not the case with GM604, so we feel that expanded access is premature at this time. When we can independently verify safety data, we hope to see a GM604 group expanded access program that has transparent entry criteria, systematic objective outcome measures, full disclosure of results, and, as suggested by the FDA, allows for a sponsor’s cost recovery but not for profit (39).
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Endotherapia has a proposed mechanism that hinges on the ability of an isolated laboratory’s immunoblots to identify the cause and specific pathways that are driving ALS progression. In our opinion this ability has never been convincingly demonstrated. While there is a flawed animal study supporting the utility of Endotherapia in rats, such studies rarely translate into useful human treatments (29). The data on Endotherapia in PALS have so many problems that we believe they are uninterpretable. ALSUntangled does not recommend the use of Endotherapia for ALS at this time. A reasonable next step would be a study to validate the utility of the above-described immunoblots, ideally by a group without a potential conflict of interest.
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The monograph “When ALS Is Lyme” is filled with errors in logic, misinterpretations of scientific papers, controversial statements that are either not referenced or refer to unverifiable anecdotes, and omissions of data contradicting its authors’ opinions. It fails in its attempt to argue that there is a connection between ALS and Lyme disease. At this time ALSUntangled does not recommend Lyme testing for patients with classical ALS. We sincerely hope that the Vaughters’ unqualified medical advice, baseless conspiracy theories and accusations do not alienate PALS from mainstream specialized multidisciplinary ALS clinics. Within these clinics appropriate patients with atypical motor neuron diseases (pure lower, pure upper, accompanied by rash, headache, stiff neck, photosensitivity, fever, reversible facial nerve palsy, eye movement abnormalities, dermatomal pain and sensory loss), especially those coming from Lyme-endemic areas, will be tested for Lyme according to CDC criteria, and also treated rationally according to validated guidelines if Lyme is diagnosed. More importantly for the vast majority, those who come to specialized ALS clinics will receive competent and caring healthcare teams that will work to optimize the length and quality of their lives, and facilitate their participation in research toward a cure.
Additional pharmacologic studies of LDN are needed to clarify its mechanisms of action. Some of its proposed mechanisms such as immunomodulation and neuroprotection could potentially be useful in ALS. However, there are no convincing data thus far to suggest that this is the case, and some limited data even raise a theoretical potential for a harmful effect. The benefits reported by a small Patients Like Me cohort are not consistent across participants, nor are they objectively verifiable. A small pilot study of a drug with similar mechanisms found no objective benefits in patients with ALS. Although reported costs are not exorbitant, there are reported and potential side-effects including liver toxicity. ALSUntangled does not recommend LDN use by patients with ALS at this time.
We applaud the openness of this clinic in publishing its preliminary results. However, at the present time, there are insufficient safety or efficacy data to support stem cell transplants at the Hospital San Jose Tecnologico de Monterrey as a treatment option for ALS. Also, more rigorous studies are needed to clarify safety and efficacy concerns.
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The Hickey Wellness Center infrastructure is clean and professional. Dr. Hickey has a good bedside manner, and clearly believes in his protocol (indeed he himself is on it, and has had his own fillings removed). However, at this time, we are not convinced of a link between heavy metal toxicity and ALS. The metal testing performed in the Center is un-interpretable given the lack of ‘normal’ post- chelation metal ranges. Similarly, concerning are the lack of validated diagnoses, an appropriately detailed informed consent form, a consistent protocol across patients, objective outcome measures, or even adverse event tracking. As a result of these problems, ALSUntangled cannot currently condone most of the Hickey Wellness Center’s approach toward ALS. We do endorse two of Dr. Hickey’s practices: stressing hope, and once all the important information about an alternative therapy has been provided, respecting a patient’s wish to pursue it even if it is against our advice.