Through my website I became aware of a drug that has stopped the progression of Multiple Sclerosis and enhanced quality of life for many Multiple Sclerosis (MS) sufferers. The drug is Naltrexone (also known as ReVia) and my Health Success Stories database contains a growing body of compelling anecdotal evidence that it works, and it works well - but, sufferers can’t get it.
Dr Bernard Bihari (from the US), a long advocate and prescriber of Naltrexone, has alleviated the symptoms and or progression of MS sufferers by prescribing low doses of Naltrexone (LDN). His groundbreaking work, commenced in the mid 1980s, has resulted in a small but growing number of physicians prescribing Naltrexone to minimise both progression and symptoms of MS for their patients.
MS is not the only disease Dr Bihari has treated successfully with low doses of Naltrexone. LDN is cited as being beneficial across a broad range of chronic diseases such as HIV-AIDS, lupus, Parkinson’s, Crohn’s disease, breast and other cancers, and even fibromyalgia. If you’re wondering how these diseases are linked look no further than an errant immune system.
Due to the wonder that is the Internet, word is spreading. A maiden conference dedicated to LDN was held in New York earlier this year, with a second planned for 2006.
MS sufferers whose symptoms or progression have been alleviated by treatment with LDN have formed support groups and are dedicated to spreading the word. They’re striving to help fellow MS sufferers via information sharing, emotional support and fundraising for clinical trials.
At this time Naltrexone is only “officially” approved as a treatment for alcohol or drug dependence, at doses much higher (around 50mg) than the very low doses (up to 4.5mg) prescribed for the management of MS or other diseases.
Naltrexone has not achieved mainstream acceptance as a treatment option for MS due to absence of clinical trial data. While a handful of doctors will prescribe LDN for MS (if pressed), most are too cautious to prescribe a treatment they perceive as clinically unproven.
Clinical trials answer the “who, what, why, where, how, and when” questions that must be answered to establish patient profile, efficacy, optimum dose, safety and so on. Clinical trials establish evidence of successful, safe outcomes or unsuccessful, unsafe outcomes. Doctors therefore, quite rightly, base treatment decisions on clinical trials because this is the safest system to follow and patients wouldn’t want it any other way.
Health success stories written by patients and attributed to LDN are growing exponentially. The many stories from MS sufferers who’ve improved or halted progression of their disease after taking LDN are building a compelling case, but these stories represent only one facet of evidence. Health success stories alone don’t provide sufficient evidence for most doctors to prescribe LDN.
A large number of health success stories does, however; and provides sufficient evidence to advocate a clinical trial.
Clinical trials cost money and are typically initiated or sponsored by those who expect to recoup the cost outlaid for the trial by commercialising its successful results. That’s business and how it should be. If an organisation is prepared to fund the very high cost of research, development and clinical trials, then they are entitled to view the costs as an investment that will turn a profit.
However, Naltrexone has long passed its patent protection period. Drugs outside patent protection are classed as “generic” or “orphan” drugs, because they no longer have a sponsor. A clinical trial, therefore, does not present an attractive commercial proposition for those sponsoring organisations that have traditionally initiated clinical trials - because they wouldn’t gain exclusive rights (and subsequent profits) from a successful outcome. So regardless of the promise Naltrexone holds, nothing happens.
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