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Karl Schembri
The Health Department is still distributing a drug to treat Parkinson’s disease that has been found to damage heart valves, with potentially fatal consequences, even though alternative medication is available on the market.
The drug pergolide – brand named “Permax” – is being supplied to Parkinson’s disease patients from the state pharmacy through the yellow card scheme, despite extensive research abroad which points towards serious cardiovascular side effects, as well as promises from the health minister that the drug would be replaced.
Heart valves, essential for the normal flow of blood, are known to overgrow and become floppy and leaky because of this drug. Classified under the “ergot-derived dopamine receptor agonists” group (i.e., medication used to control involuntary movements), pergolide falls within the same drug class as the now-banned diet drug Fen-phen – also associated with heart valve disease.
While acknowledging its harmful effects on patients, particularly those who suffer from heart ailments, a spokesperson for the Health Department said Permax will remain distributed until a tender for the supply of an alternative drug is adjudicated.
A call for tenders was closed just last Thursday, and according to the spokesperson, the adjudication process and delivery of the new drug will take “at least another two months”.
But already in February last year, Health Minister Louis Deguara had promised Parkinson’s disease patients that the department was about to supply an alternative drug called ropinirole, branded as “Requip”, which has no known side effects on heart valves.
Patients who spoke to MaltaToday, and who switched over to Requip on their neurologists’ advice, have been paying up to Lm60 a month: a price which is set to go higher as the dosage is increased over time, until the drug is made available through the health service.
“It’s good to hear that the call for tenders has finally been closed, because for months we’ve been promised that the tender was about to be issued,” said one patient, whom the toll of government red tape has cost over Lm700 in less than a year. “What bothers me most is not the price of the drug, but that there are patients out there who do not know of the extremely harmful effects of Permax because of the total silence there is about our disease, and that they keep taking it just because they have no choice.”
The health department spokesperson said Permax “can be used with caution by most patients with Parkinson’s Disease” but added that “it is absolutely contra-indicated for patients suffering from fibrosis and cardiac valvulopathy.”
According to a report from the Institute of Clinical Parmacology of Berlin’s University Medicine, 30 per cent of patients taking pergolide were at increased risk for heart valve problems.
Another team of Italian researchers from the Istituti Clinici di Perfezionamento, Milan, found that 23 per cent of patients taking pergolide had developed heart valve problems. They also found that the higher the doses of pergolide, the more advanced their heart valve disease.
The studies confirmed earlier research conducted by the prestigious Mayo Clinic in the US, which had warned that Permax patients studied needed heart valve replacement, while others suffered serious damage to the valves.
In the US, the study results have led the medical establishment to call on the Food and Drug Administration to consider banning pergolide.
“This side effect is very dangerous,” said Dr Bryan L. Roth of the Department of Pharmacology at the University of North Carolina. “It could result in an individual’s death or undergoing valve replacement surgery… If you have Parkinson’s, you need to find out from your doctor if you’re taking a medication that could incur this risk of serious heart damage. I would recommend not prescribing these medications at all.”
The health department spokesperson admitted that alternative drugs ropinirole or parmipexole were finally approved as “first line drugs” for the treatement of Parkinson’s disease, meaning that they “will replace in most part the consumption of pergolide”.
“The tender specifications for the first line non-ergot dopamine receptor agonists were drafted so that prices for either ropinirole or pramipexole (both belong to the same pharmacological class) could be quoted,” the spokesperson added. “The cheapest drug offered will then be adjudicated. The closing date for this tender is 8 February 2007, that is this week, and it is expected that the adjudication process and the delivery of the chosen product takes at least another two months.”
The spokesman added that once the government starts getting supplies of the new drug, it will be made available to:
i) all new patients starting treatment with a dopamine agonist;
ii) patients for whom pergolide is contra-indicated as they suffer from fibrosis or cardiac problems;
iii) young patients and patients under 60 years of age who are already on treatment with pergolide.
Parkinson’s disease, of which Pope John Paul II was among the most renowned sufferers, is an as-yet incurable, progressive neurological disorder resulting from the degeneration of neurons in a region of the brain that controls movement.
The degeneration creates a shortage of the brain-signalling chemical known as dopamine, causing the involuntary movements that characterise the disease and rendering its patients progressively helpless.
kschembri@mediatoday.com.mt
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