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BLOG: March 2007

Parkinson's disease drug withdrawn

Pergolide, Parkinson's disease drug is withdrawn from the market, after being linked to potentially fatal heart valve damage (New York Times).

Reasoning of the head of the FDA drug evaluation office, Dr William Temple, is that other dopamine agonists "don't do that". And, since Pergolide is not more efficient in relieving symptoms of Parkinson's than other available medications, it has no place on the market.

Does this imply that if it was more efficient, it would have been allowed to remain in use? Sounds as if it's hard to part with a drug that's been on the market for so long (since 1988). Reported hart valve problems resulted in label warning added in 2002, upgraded to boxed warning four years latter.

It took two recent publicized studies (The New England Journal of Medicine), which have found that up to 20% of the patients on Pergolide suffered valve leakage caused by it, to force the FDA to take the right step. The 20% figure implies thousands of folks affected, which explains why the official figure of "at least" 14 patients that needed to have their heart valves replaced is "believed to be an underestimate".

By the way, another dopamine agonist, cabergoline (Dostinex), was also cited for heart damage in the two studies published by the New England Journal of Medicine. For that reason, its use is dosage limited in the US. In Europe, however, it is cleared for Parkinson's, requiring higher doses.

Hmh, who's the sissy here? They are not made of better materials over there, are they? Or is it that you can't rely on the officials - whatever country you have happened to be in - when it comes to drug safety?

Not that dopamine agonists (sedatives) are otherwise safe. Among other symptoms that they can cause are sudden and unpredictable episodes of extreme drowsiness (pretty much like falling asleep), nausea, vomiting, orthostatic hypotension, and psychotic symptoms (hallucinations, vivid and disturbing dreams, paranoia, confusion). Longer term, they also can contribute to muscle/movement incoordination (shaking, or twitching movements).

Yet another possible side effect of dopamine agonists is obsessive compulsive disorder (Mayo Clinic). That can make your life interesting beyond your wildest dreams and desires: you may not be able to stop eating, or to control your sex drive, or you may develop a sudden irresistible gambling problem. Ongoing lawsuits blame these drugs for destroyed health, marriages, lives...

Is that really so surprising and unexpected from the substance that directly affect levels of neurochemical as important as dopamine? It isn't. Seems that the only party certain to benefit from their use are the manufacturers themselves. Yet, doctors keep prescribing this class of drugs not only for Parkinson's, but for

anything from depression to sleep disorders.

As always, much more prudent is to turn to what could be causing the disease symptoms, and that is brain tissue damage by excessive oxidation (free radicals), toxic metals like aluminum and mercury, or toxic chemicals, including pesticides. Vitamin C and E alone can delay the need for drug treatment for as long as 3 years6.

At the time they had the highest soil aluminum levels in the world, Guam, the Key Peninsula in Japan and north west New Guinea also had very high incidence of amyotrophic lateral sclerosis (neuro-motor disorder, also known as Lou Gehrig's disease) and Parkinson's. It was likely worsened by the environmental deficiency of calcium and magnesium, resulting in elevated absorption rate of aluminum and its deposition in brain tissue4.

 It is all too often neglected that many Parkinson's sufferers have food and chemical sensitivities, possibly causing brain tissue inflammation, causing or contributing to the damage to its function. All these, and other possible factors should be considered, and addressed. While neural damage in any form is very difficult - although still possible - to reverse, addressing the actual causes would certainly slow down progression of the disease, without inflicting adverse health effects.