Who Coined the Term "The Gold Standard" for Levodopa?

If you have read any of my recent posts, you will know that I don’t think too highly of the drug most commonly prescribed for Parkinson’s, levodopa/carbidopa (often referred to as l-dopa). Because of its obvious deficits, I have marveled at its having acquired the moniker “the gold standard,” and have long since concluded that it must have been a stroke of genius on the part of some marketing person, probably at a time when the drug’s public image needed a boost. This weekend, I decided to try and figure out who first used the term, and when. The following is what I found.

The term "the gold standard" with reference to levodopa makes its first appearance in PubMed in 1996, in a study by a fellow named Mark D Lindner, sponsored by company called Cytotherapeutics:

" Although the therapeutic gold standard, L-DOPA:carbidopa (Sinemet), effectively attenuates parkinsonian symptoms..."(1)

And then, again, in 1997, the second time “the gold standard” appears on PubMed, Mark D. Lindner is one of the authors:“

Guidelines for clinical transplantation studies for Parkinson's disease emphasize that transplants should be considered as an adjunct to systemic L-DOPA, yet few preclinical studies have specifically assessed the potential of transplants as an adjunct to the clinical gold standard treatment.” (2)

Interestingly, In 1992, there was a Mark D. Lindner at Bristol-Myers Squibb Pharmaceutical Research Institute (3), and he was still there in 2003 (4).

The most interesting part is, however, that in 1997, a Mark D. Lindner published a paper entitled “Reliability, Distribution, and Validity of Age-Related Cognitive Deficits in the Morris Water Maze,” in which he says both:

“The data presented in this study were collected by the author as a Post-doctoral Research Fellow at Bristol-Myers Squibb Pharmaceutical Research Institute.” (5)

And

“Address correspondence and reprint requests to Mark D. Lindner, CytoTherapeutics, 701 George Washington Highway, Lincoln, RI 02865. E-mail: MLINDNER@CYTO.COM.” (5)

There is no mention of an affiliation with Bristol-Myers Squibb in either of the two papers that use the term "the gold standard."

Bristol-Myers Squibb makes Sinemet (the original levodopa/carbidopa). Sinemet lost patent protection somewhere in the early to mid 90s.

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(1) Lindner, Mark D., et al. Validation of a Rodent Model of Parkinson's Disease: Evidence of a Therapeutic Window for Oral Sinemet. Brain Research Bulletin, Vol. 39, No. 6, pp. 367-372, 1996 (CytoTherapeutics, Inc., Provicence, RI 02906, USA. MLINDNER@CTYO.COM)

(2) Lindner, Mark D., et al., Somatic delivery of catecholamines in the striatum attenuate parkinsonian symptoms and widen the therapeutic window of oral sinemet in rats. Experimental Neurology, May;145(1):130-40. 1997 (Cyto Therapeutics Inc., Providence, Rhode Island 02906, USA. mlindner@cyto.com)

(3) Lindner MD, Gribkoff VK. Effects of oral BMY 21502 on Morris water task performance in 16-18 month old F-344 rats. Psychopharmacology (Berl). 107(4):485-8, 1992. (Department of Neuropharmacology, Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, CT 06492)

(4) Lindner MD, Gribkoff VK, Donlan NA, Jones TA. Long-lasting functional disabilities in middle-aged rats with small cerebral infarcts. J Neurosci. Nov 26;23(34):10913-22, 2003. (Neuroscience Drug Discovery, Bristol-Myers Squibb Pharmaceutical Research Institute, Wallingford, Connecticut 06492, USA. Mark.Lindner@BMS.com)

(5) Lindner, Mark D. Reliability, Distribution, and Validity of Age-Related Cognitive Deficits in the Morris Water Maze. Neurobiology of Learning and Memory, 68, 203–220 1997. (Department of CNS Biology, Bristol-Myers Squibb Pharmaceutical Research Institute)

Rush Didn't Do His Homework

Rush Limbaugh recently opined at how unfortunate it was that Michael J Fox exploits folks by going off his meds for public appearances - he knows that Mr. Fox does this because, you see, "people" have told him. This is my response to Mr. Limbaugh - too long and no, i don't really expect him to take up the challenge, but a girl's gotta try.

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I would recommend doing a little homework before you slap the "exploitative" label on someone because of what "people" have told you.

What you saw Mr. Fox experiencing on the McCaskill ad is a side effect of the most prescribed medication for Parkinson's, levodopa/carbidopa.

Looks pretty bad, right?

If you REALLY wanted to make a difference in people's lives, you might try drawing attention to the fact that this drug has dominated the field of Parkinson's therapies for 36 years - this is a drug that causes a side effect that, when it occurs in the absence of a causal drug, is evidence of neurological disease (Huntington's chorea).

Every single one of the big companies that makes a levodopa product, which causes a plethora of frequently disabling side effects, either makes, or has a generic arm that makes, or is affiliated in some way with a company or companies that make the myriad other drugs that are billed as fixing the problems levodopa causes - pretty neat set up, eh? Sell something that screws people up, then sell them something, and something else, and yet something else, telling them each time that adding THIS drug to the 47 other pills you take every day will surely fix the problem.

Levodopa is generic, you see, so lots of companies rely on that income stream, and the bigger ones have expanded their markets using the means described above – and while current income streams are important, potential for future growth is as, or more, important –and as long as no one breaks the unwritten rule and invents a drug that actually works for Parkinson’s, industry can happily just go on churning out adjunct after adjunct after adjunct – levodopa offers industry infinite potential for growth.

A drug that actually worked destroy all of that. Levodopa has been touted as “the best we have” for 36 years – the best for whom is the question, and the answer is obvious.

If you are REALLY interested in protecting people from exploitation, do something about THAT!

You are no doubt being flooded with emails telling you how badly you screwed up, so for pete’s sake, do the right thing an apologize to Mr. Fox.