World of medicine divided by 'wonder drug'

Doctors are at odds over Low Dose Naltrexone whose supporters claim is effective in treating MS and other autoimmune illnesses…

Doctors are at odds over Low Dose Naltrexone whose supporters claim is effective in treating MS and other autoimmune illnesses, writes MICHELLE McDONAGH

PROPONENTS OF Low Dose Naltrexone (LDN) claim the cheap out-of-patent drug may well be the most important therapeutic breakthrough in more than 50 years, providing a new, safe and inexpensive way of treating MS and other autoimmune diseases.

However, Irish and international medical professionals remain dubious about the claims surrounding LDN and the lack of any solid scientific evidence backing up these claims.

New York neurologist Dr Bernard Bihari, who died in May 2010, is the man credited with having discovered the effectiveness of LDN in the treatment of not only MS and other autoimmune diseases such as HIV, but even cancer.

The generic drug, which affects opiate metabolism, was first licensed by the FDA in the 1980s as a treatment for heroin addiction.

Since 2002, a worldwide campaign has been under way to get LDN medically recognised as a treatment for MS and all autoimmune disorders. However, campaigners – including Galway woman Mary Bradley who lives in New Jersey with her husband Noel – claim the lack of any financial incentive for the big pharmaceutical companies to investigate new uses for the drug means there has been no large-scale clinical trial of LDN.

Now, Dubliner John Donnelly is adopting another way to raise funds for the clinical trial he so fervently believes should take place. He has entered the Your Country, Your Call competition with his proposal to use LDN “to save millions of euro and many lives in Ireland”.

His proposal is to investigate the use of LDN as a very cost-effective and efficacious treatment for a host of autoimmune system related illnesses such as MS, Crohn’s disease, cancer, chronic fatigue, fibromyalgia and others. His proposal received the highest number of votes (1,947) out of almost 7,000 proposals – the overall competition winner will be announced on September 17th.

Approved in high-dose format, Naltrexone has been available for some 25 years but has only recently been used to treat conditions such as MS with a low dose of 4.5mg at a cost of about €1 per day.

Donnelly’s interest in LDN began in August 2008 when his wife Jacinta was diagnosed with lung cancer and given only a few months to live. Determined to help her fight the disease, he found out about LDN on the internet and started his wife on the drug. Although he admits they still have a battle ahead, he says Jacinta is doing well at the moment. which he believes is down to LDN.

“It is madness that this drug which is known to the Minister for Health is not being investigated and prescribed by every doctor in Ireland. Drugs which do very little for people with MS, etc, cost the country millions every month and these people could do a lot better, with no side effects, on LDN,” he states.

The Your Country Your Call competition is designed to find two major proposals that will transform the economy – or significant elements of it – by creating jobs and opportunity, and a development fund of up to €500,000 is committed for the implementation of each of the winning proposals.

If Donnelly wins, he will use his prize to invest in a full clinical trial to try to prove that LDN is a safe and effective treatment which should be freely available and prescribed by every doctor.

However, Dr Orla Hardiman, consultant neurologist at Beaumont Hospital, advises patients to be very sceptical of unproven or alternative treatments for chronic disease, particularly where, like LDN, it is proposed that the drugs have beneficial effects in many different diseases.

“What happens is that information becomes available on the internet on a regular basis about potential alternative or unvalidated treatments for a range of chronic illnesses, including MS.

“I have a lot of patients regularly asking me about different treatments – everything from goat serum and snake venom to bee stings have done the rounds over the years. However, the rationale for all of these treatments, including LDN, is based on pseudoscience.”

The bottom line, according to Hardiman, is that personal testimony does not equate to good science, and there is no scientific evidence for Naltrexone having any effectiveness in treating disease, either in the laboratory or clinical setting.

She remarks: “We do know that LDN is a safe drug and on that basis, I would say the effect that people are describing is not a biological effect but a placebo effect. If you give somebody a dummy or placebo drug, it will be effective in up to 30 per cent of cases.

“However, the placebo effect tends to wear off over time and obviously has no impact on the course of the illness. I think LDN falls into this category.”

Hardiman takes great exception to the suggestion by LDN campaigners that clinical investigators are in the pocket of big pharma, pointing out that if a product looks like it has potential therapeutic benefit or if there is strong solid scientific basis, investigators will seek independent funding for studies.

Co Kilkenny GP Dr Pat Crowley claims that LDN is a very effective drug but most people never hear about it. He currently has more than 80 patients from all over the country on the medication for a range of autoimmune illnesses including MS, lupus and various forms of arthritis.

He is one of about four doctors prescribing LDN to patients and is trying to get more doctors involved. The drug is available from only a handful of pharmacies located in Dublin, Cork and Kilkenny.

He explains: “I developed an interest in neurology during my time working in the US with a big neurology team in the 1960s. When I first read about LDN about six years ago, I decided to research it further because all of my patients with MS were getting worse despite being on treatment.”

As part of his research, Crowley flew to New York to meet Dr Bihari and spoke to him at length about LDN. He says he started using it quite sceptically initially and even took a couple of patients off the drug, but gradually realised that it was having quite an impact on his patients with MS and other autoimmune diseases, particularly on younger patients.

“I have found that LDN works in 70-80 per cent of my patients with auto- immune illness in stopping the progression of disease.

“I am using it in rare forms of arthritis and am particularly impressed with how some of my younger patients are improving. I’m not saying it works for everybody because it doesn’t, and we don’t know why yet because there hasn’t been enough research done.”

Since September 2002, Mary Bradley has spearheaded a global campaign to get LDN medically recognised and into the hands of as many people who need it as possible. After years of battling with the onslaught of her husband Noel’s primary progressive MS, Bradley stumbled on Bihari and LDN.

The couple decided to put Bihari’s claims to the test and eight years on, Bradley says her husband’s disease has not progressed. So strongly does she feel about the need to spread the word about LDN that she has written a book about her experience called Up The Creek with a Paddle.

The youngest son of Pulitzer Prize winning author Herman Wouk, Joseph has also written a book about his experience with the drug entitled Google LDN.

Diagnosed with progressive relapsing MS, Wouk claims LDN halted the progression of his disease after he refused to accept his doctors’ opinion that there was nothing more to be done for the medical condition.

Naltrexone has been around in a high dose form for 25 years €1 per day is the cost of a low dose of 4.5mg.

“It is madness that this drug which is known to the Minister for Health is not being investigated and prescribed by every doctor in Ireland. Drugs which do very little for people with MS etc, cost the country millions every month