The Irish Times  
Tuesday May 18th 2004


Calls for the radical treatment

MS Sufferers in Ireland have begun a campaign for a clinical trial to be carried out on a radical treatment pioneered by a New York medic using a low dosage of Naltrexone (LDN), a generic drug first licensed in the 1980's to treat heroin users.

About 6,000 people in Ireland have MS, a disabling neurological disease that interrupts "message traffic" between the brain and the body. Sufferers may lose muscle control, sight and experience fatigue.

LDN has apparently yielded positive results for neurologist Dr. Bernard Bihari of Beth Israel Hospital, New York, in halting the progression of MS and reversing its effects to a limited but, in some cases, significant degree for people with the more acute, progressive form.

LDN has also been used to treat different types of cancer and other auto-immune diseases such as HIV.

Once their petition is complete, the group, headed by Robert Joyce and Edwina Dennehy, intends making a submission to the Minister for Health, Mr. Martin, calling on a clinical trial carried out in Ireland, despite the negative implications for the leading pharmaceutical companies that produce the costly current MS interferon - 'CRAB' treatments, i.e. Copaxone, Rebiff, Avonex and Beta-Interferons.

Such MS Treatments are expensive and earn the drug companies massive profits. Witness the surge in Biogen Idec and Elan's share price back in February on the day when a new type of MS CRAB treatment - Antegren was announced.

Biogen Idex shares jumped $8.91, or 20 per cent, to $53.23, as of 4 p.m., New York time, in Nasdaq Stock Market composite trading, bringing the gain since the year began to 45 per cent. Elan gained 1.85 euro, or 27 per cent, to 8.77 euro in Dublin.

Joyce estimates these treatments are currently costing the Irish Government upwards of 24 million euros a year. Joyce believes that if LDN was licensed in Ireland, instead of an annual minimum medication cost of 12,000 euro per patient using one of the beta or interferon treatments, the cost would fall to a fraction of this, with a month's supply costing less than 50 euros.

Theoretically, however, the treatment flies in the face of conventional thinking on the underlying dynamic of MS, which effectively sees the erosion of the nerve channel's protective sheet - myelin - over time. Instead of the erosion of the myelin sheet being caused by an over-active immune system, according to Dr. Bihari and advocates of LDN, the opposite is the case.

 By administering low doses of the drug, which is an "opiate antagonist", an immune system deficiency triggered by a lack of secreted endorphins in the brain is reversed.

This would open up the possible causes of the predominantly Western disease to such factors as lifestyle, stress and bad diet in addition to other possible causes - viral infection and genetic inheritance.

According to Dr Bihari: "Up to the present time, the question of 'What controls the immune system?' has not been present in the curricula of medical colleges and the issue has not formed a part of the perceived wisdom of practicing physicians"

Nonetheless, he says a body of research over the past two decades has pointed repeatedly to the body's own endorphin secretion (our internal opiods) as playing the central role in the beneficial orchestration of the immune system, and the recognition of this is growing, he insists.

Support for this view was published in November 2003 issue of the prestigious New England Journal of Medicine.

The MS Resource Centre in Britain is frank in its advise to patients: "LDN is a treatment method that has been in use in the US since 1985 but is relatively new in this country. Despite its claimed successful use in America, until fully proven here, it must be considered as experimental and that no beneficial response can be guaranteed. In addition, despite the fact that the drug is very low dose, the absence of significant introductory or prolonged side-effects cannot be excluded".

It adds: " The treatment can only be provided if these conditions are accepted. Naltrexone is a drug, referred to as an opiate antagonist. Its normal use is to treat opiate drug addicts addicted to [drugs] such as heroin or morphine".

Its supporters in the medical profession say the brief blockade of opioid receptors between 2 a.m. and 4 a.m. that is caused by taking LDN at bedtime each night is believed to produce a prolonged "up-regulation" of vital elements of the immune system by causing an increase in endorphin and enkephalin production.

Normal volunteers who have taken LDN in this fashion have been found to have much higher levels of beta-endorphins circulating in their blood during the following days.

According to Joyce, he has seen a dramatic reduction in one of his main symptoms, fatigue, since taking the drug last August.

"I've found I have much more energy and was able to drive five hours from Oughterard to Valentia, whereas prior to beginning LDN I was exhausted on much shorter business trips in the passenger seat".

He said he first heard of the drug from a friend of his sister-in-law, whose husband also has MS and was seeing the prospect of using a wheelchair loom closer after prolonged attack.

"After a few weeks on the treatment he saw a marked halt to his progression and is still walking" he says.

However, the view from within the neurological establishment is less positive in the absence of clinical trials with hard scientific evidence gleaned from the much vaunted 'double blind trial' testing method.

One of the Republic's leading neurologists, Dr. Brian Sweeney of Cork University Hospital, refuses to entertain such anecdotal claims as a basis for prescribing the drug.

Dr. Sweeney says: "Without the scientific data backed up by a double-blind trial, where half the trial group are using a placebo and the other half are using the treatment, it's impossible to accurately say what the actual benefits of the drug administered in this way would be".

It is a view shared among his neurological colleagues in Ireland and MS Ireland, whose chief executive Michael Dineen, says it will not be recommending the treatment based on anecdotal evidence alone.

The organizations spokeswoman, Maura McKeon, adds: "Until trials are carried out on it, we cannot advise people to try this particular product. Up to now, we have received only anecdotal evidence of it's effects".

While LDN is not licensed by the Irish Medicines Board (IMB), some GPs are prescribing it on an "experimental basis" when met with patient demands that they as doctors honor their Hippocratic Oath. But for the most part, the few Irish patients who are taking LDN, such as Edwina Dennehy, had to go through Welsh physician Br Bob Lawrence.

"I'm in my mid 20s and was diagnosed two years ago, having complained for several years of various symptoms such as fatigue, numbness and stiffness in my legs, etc. However, I found no benefits from the interferon treatments which, like many people, seemed to just make me feel worse," says Dennehy.

Disillusioned by the CRAB set of treatments and the growing feeling of her illness progressing, she has been very keen to get on LDN, having researched the treatment through the Web and heard of its benefits from Members of her MS mailing group. Her neurologist, she says, declined to prescribe it on legal grounds.

The problem, according to Joyce, lies in the fact there is no money for the big pharmaceutical players bringing on stream a treatment that already exists.

"Naltrexone is now a generic drug and is past patenting, so it's not worth a pharmaceutical company's while spending several millions on trials and marketing of the drug, because it's already open season and any low-cost drug company from say India could come along and under-cut their market share in the global treatment of MS".

If LDN is to come into greater usage by MS patients, he believes it will most likely be from an Indian drugs company, which are beginning to develop their pharmaceutical sector quickly by manufacturing generic drugs much cheaper than their Western competitors.

In the meantime, the campaign to raise awareness of the benefits of LDN continues. Dennehy set up an online petition for a trial to be carried out in Ireland.

She started her treatment over three weeks ago and says apart from initial disturbance to her sleeping pattern, she has found she has more energy and problems with her bladder have settled.

*Details of the petition are on