Evidence-based Medicine - Is This New?

I am hearing this catch phrase fairly regularly recently, and I have to ask - is this actually something new? i mean, newer than, say, 50 years old, at least? Because if it is, good lord what has medicine been based on up until now? Tea leaves? Magic 8 balls? The whims of medical practitioners? Old wives' tales? All those millions of research studies that have been undertaken in the last half century - were they done purely for their entertainment value?

I must be missing something.

Pathological Gambling Caused by Drugs Used to Treat Parkinson’s Disease: Yet Another Closer Look, Part Two

Welcome to Part Two of a three part series.

To recap the background provided in Part One, in the 2005 study entitled “Pathological Gambling Caused by Drugs Used to Treat Parkinson’s Disease,” the authors mine records of Parkinson’s patients seen at the Mayo Clinic in Rochester, MN (MCR), between 2002 and 2004, and find 11 people who had developed pathological gambling (PG) - they conclude that the PG was caused by Parkinson's drugs. The authors so completely fail to provide evidence compelling enough to support this conclusion that the fact that this study was published in a peer-reviewed journal boggles the mind. It is available online for free at the Archives of Neurology, if you are interested. It may actually be necessary to read the study for what I am about to say to make sense – I don’t know.

According to the authors of this study, the 11 people who gambled fit the DSM-IV-TR criteria for PG.* They also say that the PG was temporally associated with the commencement, increase, and/or cessation of dopamine agonist (DA) therapy, a type of drug used to treat Parkinson’s disease (PD), and, for a disproportionate percentage of these people, the culprit was a DA called pramipexole.

Finally, the authors provide the results of their survey of the field of literature, and present in a table six studies in support of their conclusion that Parkinson’s drugs cause – not just “are associated with,” but cause PG.

In Part One, I addressed the authors’ failure to adequately support their central assertion, that DAs cause PG, in the context of what criteria must be met to identify a causal relationship. In Part Two, I will address specifically the authors’ failure to provide any indication of the prevalence of this phenomenon and show how that pretty much single handedly invalidates the study. And in Part Three, I will address several other questions that come up when one actually reads the study rather than the press coverage it received.

Prevalence is defined by the Centers for Disease Control as “the number of existing disease cases [or, in this case, adverse events of a specific nature] in a defined group of people during a specific time period.”

So there are three parts to prevalence, each of which consists of a number – (1) the number of existing cases; (2) a defined [read: finite, i.e., quantifiable] group of people among whom those cases are found; and (3) a specific time period.

Prevalence is calculated by dividing the number of existing cases by the quantity of people in the specific population in which those cases were found, which yields a percent of people affected. In this study, the authors provide the number of existing cases, which is 11, and they denote a specific time period, which is 2002 to 2004. However, the authors omit (2), the total number of people with Parkinson’s (PWP) being treated at MCR and taking DAs between 2002 and 2004, and that really makes the claim that an association was found groundless.

In order to illustrate why this is true, and because I was unable to find any relevant stats regarding the MCR, I extrapolated a value for the missing piece of data from information found in various places on the internet, and using this method (which I have detailed below, in case you are interested)** I came up with the number 1195 for the total number of PWP taking DAs that were seen at MCR between 2002 and 2004. 11/1195 returns a prevalence of PG of 0.09% among those who were taking DAs.

But even that is not enough information. The authors also fail to provide the prevalence of PG in the general population or in untreated PD, which is just as crucial as the total number of (PWP) being treated at MCR and taking DAs between 2002 and 2004, because the only way a prevalence in a certain population has meaning is in relation to the prevalence of the same phenomenon in a different population.

So, I looked around and found the following stats for the general population from 1999. Estimates of the lifetime prevalence of PG in the general population in the US in the late 90s range from 1.2-3.9%, while estimates of past year prevalence of PG in the general population range from 0.6-2%.***

As you might have noticed, the prevalence I have extrapolated for the 11 who gambled is far lower than even the lowest estimated prevalence I could find for the general population. One might argue that my method of deriving that prevalence was not scientific, and that may be true.

However, in the absence of the total number of (PWP) being treated at MCR and taking DAs between 2002 and 2004, there is no way of knowing whether the prevalence of PG among those taking DAs is higher or lower than that of the general population.

And if the prevalence really were 0.09%, i.e., significantly lower than that of the general population, then I would think the makers of pramipexole would be doing the victory dance, because they would then be purveyors of a treatment for, not a cause of, PG.

And it is in that way that the authors fail to provide evidence sufficient and compelling enough to support their conclusion.

If I have not explained my thoughts clearly, please let me know and I will try again.

On to Part Three.

*************************
* Pathological gambling is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DMS-IV-TR) as follows, and the study does not describe in which five each patient has engaged:

A. Persistent and recurrent maladaptive gambling behavior as indicated by five (or more) of the following:

1. is preoccupied with gambling (e.g., preoccupied with reliving past gambling experiences, handicapping or planning the next venture, or thinking of ways to get money with which to gamble)
   
2. needs to gamble with increasing amounts of money in order to achieve the desired excitement
   
3. has repeated unsuccessful efforts to control, cut back, or stop gambling
   
4. is restless or irritable when attempting to cut down or stop gambling
   
5. gambles as a way of escaping from problems or of relieving a dysphoric mood (e.g., feelings of helplessness, guilt, anxiety, depression)
   
6. after losing money gambling, often returns another day to get even ("chasing" one's losses)
   
7. lies to family members, therapist, or others to conceal the extent of involvement with gambling
   
8. has committed illegal acts such as forgery, fraud, theft, or embezzlement to finance gambling
   
9. has jeopardized or lost a significant relationship, job, or educational or career opportunity because of gambling
   
10. relies on others to provide money to relieve a desperate financial situation caused by gambling
    

B. The gambling behavior is not better accounted for by a manic episode


**Based on the fact that Ohio State University’s Dept of Neurology’s 28 physicians see 400 PWP annually, I will extrapolate that the 93 neurologists at MCR see 1328 PWP annually, or 3984 PWP over the three year period in question. And according to the website of a law firm selling its services to folks who have gambled while taking a DA, 30% of PWP are prescribed DAs – which would mean 1195 people on DAs were seen at MRC between 2002 and 2004.

*** 3.9% lifetime; 2% past year ~ National Research Council. Pathological Gambling: A Critical Review. Washington, DC: National Academy Press; 1999

1.2% lifetime; 0.6% past year ~ National Opinion Research Center at the University of Chicago, Gemini Research, and The Lewin Group. Gambling Impact and Behavior Study. Report to the National Gambling Impact Study Commission. April 1, 1999. Table 7, p. 26.

Pathological Gambling Caused by Drugs Used to Treat Parkinson’s Disease: Yet Another Closer Look, Part One

In the 2005 study entitled “Pathological Gambling Caused by Drugs Used to Treat Parkinson’s Disease,” the authors mine records of Parkinson’s patients seen at the Mayo Clinic in Rochester, MN (MCR), between 2002 and 2004, and find 11 people who had developed pathological gambling (PG) - they conclude that the PG was caused by Parkinson's drugs. The authors so completely fail to provide evidence compelling enough to support this conclusion that the fact that it was published in a peer-reviewed journal boggles the mind. It is available online for free at the Archives of Neurology, if you are interested. It may actually be necessary to read the study for what I am about to say to make sense – I don’t know.

According to the authors of this study, the 11 people who gambled fit the DSM-IV-TR criteria for PG.* They also say that the PG was temporally associated with the commencement, increase, and/or cessation of dopamine agonist (DA) therapy, a type of drug used to treat Parkinson’s disease (PD), and, for a disproportionate percentage of these people, the culprit was a DA called pramipexole.

Finally, the authors provide the results of their survey of the field of literature, and present in a table six studies in support of their conclusion that Parkinson’s drugs cause – not just “are associated with,” but cause PG.

In Part One, I will address the central assertion, that DAs cause PG, in the context of identifying a causal relationship. In Part Two, I will address the significance of prevalence in that endeavor. And in Part Three, I will address several other questions that come up when one actually reads the study rather than the press coverage it received.

I am probably not telling you anything new when I say that researchers, or responsible ones, at least, can’t just declare that X causes Y, they have to – or are supposed to - prove it, or at least put forth compelling supporting evidence.

Nor can they themselves willy-nilly decide what is compelling and what isn’t – while there is some leeway, there are certain gauges that are accepted as valid, and the degree to which their evidence measures up on those gauges determines its persuasiveness.

One such gauge is Naranjo’s algorithm, which consists of a series of questions to which each possible answer (yes/no/unknown) is assigned a different number of points, thereby weighting the each answer according to its significance. In the end, the total number of points indicates how compelling the evidence is. Below is how this particular study fares using Naranjo’s algorithm:



As you can see, the evidence provided in this study is not compelling enough to indicate even a probable association, never mind definite, or causal, association.

Another set of guidelines can be found on the World Health Organization’s web site – following each bullet point below are my comments on how compellingly the evidence presented in this study fulfills these criteria:

Building on the seminal work on determining causality of the Surgeon General’s Advisory Committee on Smoking and Health (1964),3 the generally established criteria underpinning vaccine [or, in this case, drug] adverse event causality assessment that the GACVS uses may be summarized as follows:

• Consistency. The association of a purported adverse event with the administration of a [drug] should be consistent, i.e. the findings should be replicable in different localities, by different investigators not unduly influencing one another, and by different methods of investigation, all leading to the same conclusion(s).
  
  This study was preceded by a single other study which claimed to have found the same association. Even if that single study had adequately supported its conclusion (which it did not), it would obviously fail to provide what could be called consistency of any sort.
  
  
• Strength of the association. The association should be strong in the magnitude of the association (in an epidemiological sense), and in the dose-response relationship of the [drug] with the adverse effect.
  
  The authors do not provide the information necessary to evaluate the magnitude of the association, i.e. prevalence – see Part Two.
  
  
• Specificity. The association should be distinctive ñ the adverse event should be linked uniquely or specifically with the [drug] concerned, rather than its occurring frequently, spontaneously or commonly in association with other external stimuli or conditions.
  
  PG occurs frequently, spontaneously, and commonly in association with other external stimuli or conditions, like depression and disability.
  
  
• Temporal relation. There should be a clear temporal relationship between the [drug] and the adverse event, in that receipt of the [drug] should precede the earliest manifestation of the event or a clear exacerbation of an ongoing condition. For example, an anaphylactic reaction seconds or minutes following immunization would be strongly suggestive of causality; such a reaction several weeks after vaccination would be less plausible evidence of a causal relation.
  
  The authors neglect to define any parameters for identifying a temporal association, and indeed inclusion of three of the eleven on that basis stretches the bounds of plausibility past the breaking point.
  
  
• Biological plausibility. The association should be coherent; that is, plausible and explicable biologically according to known facts in the natural history and biology of the disease.
  
  There are those who point to the role of dopamine in addiction, but there are serious questions that remain not only unanswered, but unasked. For example, if one’s medication is maintaining an appropriate level of dopamine in the brain, why would one be any more vulnerable to addiction than anyone else?

Clearly, the evidence presented In this study, as evaluated by two widely respected and utilized measures, is not nearly compelling enough to support the conclusion that there is a causal relationship between DAs and PG. But if that doesn’t convince you, read on to Part Two. ****** * Pathological gambling is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DMS-IV-TR) as follows, and the study does not describe in which five each patient has engaged: A. Persistent and recurrent maladaptive gambling behavior as indicated by five (or more) of the following:

1. is preoccupied with gambling (e.g., preoccupied with reliving past gambling experiences, handicapping or planning the next venture, or thinking of ways to get money with which to gamble)
   
2. needs to gamble with increasing amounts of money in order to achieve the desired excitement
   
3. has repeated unsuccessful efforts to control, cut back, or stop gambling
   
4. is restless or irritable when attempting to cut down or stop gambling
   
5. gambles as a way of escaping from problems or of relieving a dysphoric mood (e.g., feelings of helplessness, guilt, anxiety, depression)
   
6. after losing money gambling, often returns another day to get even ("chasing" one's losses)
   
7. lies to family members, therapist, or others to conceal the extent of involvement with gambling
   
8. has committed illegal acts such as forgery, fraud, theft, or embezzlement to finance gambling
   
9. has jeopardized or lost a significant relationship, job, or educational or career opportunity because of gambling
   
10. relies on others to provide money to relieve a desperate financial situation caused by gambling
    

B. The gambling behavior is not better accounted for by a manic episode

My Response to Mr. Gratton Regarding the Parkinson's Blog Network

Thank you for your very thoughtful response, Mr. Gratton. Here are my thoughts on your comments. Your main premises are as follows:

1. Incendia is a “health-focused publishing company,” not a marketing company.
2. Incendia’s goal is to provide a helpful service to the online PD community.
3. Ignite Health LLC, the nature of which entity you do not describe, rather than Ignite Health the healthcare advertising agency, owns Incendia Health Studios.
4. The resources required to develop and maintain The Parkinson's Blog Network (PBN) are significant enough to require advertising dollars to keep it up and running.
5. The advertiser took a big risk on PBN.
6. The advertiser took the risk because it was the “right thing to do.”
7. The advertiser has no influence over the content of the site.
8. This particular pharmaceutical company is just the first advertiser – not intended to be the only advertiser going forward.

Premise #1
Incendia is a “health-focused publishing company,” not a marketing company.

The following is the the text that appears between the "title" tags in the HTML code on Incendia’s homepage. The "title" tag is where one puts the desired title of one's site:

Incendia Health: Community healthcare and medical marketing studio

and in the first "meta" tag:

meta name="description" content="Incendia Health Studios provides dynamic health marketing targeted toward educating and reaching the patient community"

and in the second "meta" tag:

meta name="keywords" content="Incendia Health, Healthcare Marketing, Incendia studios, medical cartoons, interactive health, medical videos, health animation, medical animation, patient advocacy, patient education, patient communities, health community, health communities, patient marketing, medical marketing, dtp marketing, dtc marketing, direct to patient marketing" (all emphases added)

For those unfamiliar with "meta" tags:

“Meta elements provide information about a given webpage, most often to help search engines categorize them correctly. They are inserted into the HTML document, but are often not directly visible to a user visiting the site.” Wikipedia

And, as I already quote in my post:

Ignite formed Incendia to “develop and distribute unbranded disease-education programs targeting the millions of people who use the Internet and other digital technologies to seek and share information on chronic diseases."

“Unbranded” simply means not overtly tied to a particular brand. It does not necessarily indicate a goal more noble than marketing, however. The quote below from a May 2006 article in Med Ad News entitled “DTC Takes a Back Seat” provides some context:

Following a year of uncertainty in the direct-to-consumer [DTC] advertising arena, pharmaceutical marketers identify government regulations and consumer and physician backlash as the biggest challenges... A big shift in industry-wide DTC is expected to occur from branded campaign focus to unbranded campaigns and disease education.

And from the same article:

Ms. [Jackie] Herr [CEO of Ignite Health] says companies that develop and support fresh educational unbranded initiatives, rather than focusing exclusively on branded promotion, will help increase patient compliance, improve consumer health, and build brand loyalty, generating long-term rewards that affect their brands.

And from a July 2006 article entitled “Lost in the Blog,”

"Those marketers who come out ahead will place Web initiatives at the forefront of their product’s promotional efforts, delivering sound, relevant, credible content for access when and how their audiences want it," Ms. Herr says. "When this is done well, patients ultimately find their way to the brand."

Premise #2
Incendia’s goal is to provide a helpful service to the online PD community.

Given that Incendia is a for profit marketing company, it is disingenuous to say that its goal with the PBN is to provide a service to the PD community.

In the limited reading I have had the time to do over the last few days, I have learned a lot. I have learned, if Med Ad News is a reliable source, that the pharmaceutical marketing paradigm is shifting. The Vioxx crisis has given rise to a backlash against direct to consumer marketing at the same time that the internet is providing consumers with the ability to communicate directly with one another about their experiences with particular illnesses and/or therapies.

These changes have demanded changes on the part of pharma. I will try to resist my natural inclination to write a treatise on the subject, but suffice it to say that these changes do not appear to be all bad. One major change, however, is the use of the internet - blogs, online communities, commercial sites – as marketing tools.

Again from “Lost in the Blog” a thought provoking tidbit:

"Communicators and marketers are finding it harder to connect with their audiences at the same time as their audiences are finding it easier to connect with like-minded people," Mr. King said at the Healthcare Marketing & Communications Council’s (hmc-council.org) May Industry Forum.

According to Mr. King, online communities are providing an environment where word-of-mouth communication is thriving. Internet users are online looking for advice and recommendations, making like-minded individuals the key influencers. As a result, a mass audience has been replaced by a small but relevant audience as the key to marketing success. (emphasis added)

The PBN doesn’t just list blogs, it ranks them, and Incendia and the PBN have been endorsed by the number 1 ranked blogger on the PBN. According to the above quote, that is likely to have an impact on traffic to the PBN, and therefore on your advertiser's exposure via the PBN.

And that is, in my opinion, a much more plausible primary reason for the PBN’s existence. That does not preclude the possibility that it may also be a real and valued resource for PWP, but it is, as I said, disingenuous to say that the PBN’s primary raison d’etre is to provide a service to the community.

Premise #3
Ignite Health LLC, the nature of which entity you do not describe, rather than Ignite Health the healthcare advertising agency, owns Incendia Health Studios.

The following is a quote from an Ignite press release dated September 2006:

Ignite Health, one of the country's top 20 independent healthcare advertising agencies, has formed Incendia Health Studios.

It does not say Ignite Health LLC, and what is described is Ignite Health, the "healthcare advertising" agency.

Premise #4
The resources required to develop and maintain PBN are significant enough to require advertising dollars to keep it up and running.

To put this notion into context, I would point out that Ignite recently created an online game for Bayer that is intended to introduce Aleve to a new audience. This project, which had to be conceived of, written, scripted, cast, shot, architected, coded/built, and maintained, accounted for a mere 1% of Bayer's marketing budget – an amount that was characterized as “miniscule” by the New York Times article I read.

Now – no offense intended, but I could probably build a site like the PBN – it could not have cost a lot to build, and given that aside from the bare essentials (legal disclaimer, advisory board, etc) there is no content to generate, it could not cost a lot to maintain. Seems to me this site is virtually self-maintaining, aside from the basic tech support required by any site.

Premise #5
The advertiser took a big risk on PBN.

In what way? It couldn’t have been the cost, because the only costs I can see are those of creating two electronic ads and whatever they are paying you for the space, which could not cost more than a tiny fraction of what Bayer paid for the creation of the infinitely more costly and complex online game, and, as I pointed out elsewhere, the New York times characterized that cost as “miniscule.”

And unless you are suggesting that you did not do your due diligence and determine that the site was indeed likely to attract customers, the advertiser couldn’t have been taking much of a risk there, either.

So what, exactly, was the risk?

Premise #6
The advertiser took the risk because it was the “right thing to do.”

Are you saying that this pharmaceutical company is spending money - on advertising - on the PBN because supporting the PBN is the “right thing to do?” is that what you think guides companies’ advertising decisions?

Premise #7
The advertiser has no influence over the content of the site.

What content?

Premise #8
This particular pharmaceutical company is just the first advertiser – not intended to be the only advertiser going forward.

That may be.

However, it is interesting at this juncture to look at Incendia’s diabetesblognetwork.com. The same template was used in terms of web design as was used with the PBN (very economical). As with PBN, there are banner advertisements. On the Diabetes Blog Network, they lead www.yourdiabetesgoals.com, an interactive site bearing the image of a doctor, and asking the visitor to the site to indicate which of four diabetes goals offered is his or her diabetes goal.

When the visitor chooses a goal, s/he is offered the opportunity to click another link to find out about a treatment option that would appear to be recommended specifically to help one achieve the exact goal that had been chosen. The link takes the visitor to a site promoting the drug Symlin, a diabetes treatment made by Amylin.

There are two interesting twists to this treasure hunt. First, it doesn’t matter which of the four goals one chooses – they all lead to the same site.

Also interesting is the fact that the domain yourdiabetesgoals.com, which, as you recall, is the place with the reassuring doctor image and the interactive interface, is owned by Ignite Health.

But that shouldn’t be surprising. The domains parkinsonsblognetwork.com, diabetesblognetwork.com, breastcancerblognetwork.com, and bannermoments.com – each of whose sites are owned and operated by Incendia as an entity utterly separate from Ignite - are owned by Ignite Health, not Incendia.

In fact, Ignite owns nearly 40 disease-related ‘blognetwork’ domains. Mr. Gratton is the contact person listed for all of them.

Conclusion
To sum up, as I said, the creation of a blognetwork is not in and of itself a bad thing, and it may even be a useful service to the community. But it is disingenuous to say that providing that service is Incendia’s primary goal. You have simply created a vehicle for marketing, the beauty of which lies in the fact that it really could be useful to its audience - but that doesn't change the fact that the audience is a target market.

That is my opinion, anyway.

Fabio Gratton of Ignite Health and Incendia Responds

Please see Fabio Gratton's response to my most recent post. Mr. Gratton is co-founder and chief innovation officer at Ignite Health, and president and CEO of Incendia Health Studios.

Parkinson's Blog Network is a Giant Advertisement

Just in case there are others out there like me who didn't click into this right away, the Parkinson's Blog Network (PBN) is actually a giant advertisement for Valeant's Parkinson's med.

And I don't just mean that Valeant buys space on the PBN, I mean the PBN itself IS the advertisement.

You may have noticed that the Legal Disclaimer states that a company called Incendia Health Studios maintains the Parkinson's Blog Network "as a service to the internet community."

And if you went so far as to check out Incendia's website, you would have seen this description of the company on their homepage:

Incendia Health Studios is the first and only purpose-driven media company for chronic disease education. We leverage the latest technologies to develop and distribute health-related programming for the millions living with chronic illnesses, and those who care for them. Our purpose: to do good.

Well, I think that is just a teensy bit misleading, because if you look up the domain www.parkinsonsblognetwork.com (.com is usually a tip off for all sorts of interesting things), you find it is owned by a company called Ignite Health. The following is a quote from a February 2007 press release that is posted on their site:

Based in Irvine, Calif, Ignite Health specializes in medical advertising and interactive communications targeting patients, caregivers and healthcare professionals. One of the top 20 independent healthcare agencies, Ignite has won more than 100 industry awards since its founding in 2001. Key clients include Amylin Pharmaceuticals, Bausch & Lomb, Cephalon, Eli Lilly and Co., Genomic Health, Gilead Sciences, Merck Publishing, Novacea and Valeant Pharmaceuticals.

Note the use of the word "targeting" in the above quote - interesting that they don't use that word in the Legal Disclaimer - instead, they are providing a "service," and on Incendia's website, their purpose is to "do good."

Also note that Valeant is a client. You may also have noticed the Valeant product plastered all over the site.

Ignite Health formed Incendia in 2006 - again, from a press release on Ignite's site:

Irvine, California, Sept. 28, 2006 — Ignite Health, one of the country's top 20 independent healthcare advertising agencies, has formed Incendia Health Studios to develop and distribute unbranded disease-education programs targeting the millions of people who use the Internet and other digital technologies to seek and share information on chronic diseases. ..

Incendia Health Studios turns the traditional medical marketing and advertising model on its head," [Fabio] Gratton [president of Incendia] says. "By leveraging the power of new and emerging technology, Incendia will provide an unprecedented number of people with engaging health information tailored to their specific needs and interests. Our main objective is to serve patients and caregivers affected by chronic diseases — they, in essence, are our 'clients.' This makes Incendia Health Studios the first and only 'purpose-driven' media company in the field of chronic disease education.

Now, I am not saying that creating a Parkinson's blog network is, in and of itself, a bad thing. I just think people should know what the true goals and priorities of the entity creating it are. So, now you know.

Just for the record, I don't know who registered me there - just know it wasn't me.

Depression and PD - Where's the Beef II

I can't tell you how tired I am of hearing folks who are part of the Parkinson's disease (PD) research machine (who, almost by definition, do not have PD) skip, tra la, right by the need for a symptomatic therapy that works, and I am talking about the cardinal, or defining, symptoms, i.e., motor symptoms, for anywhere near as long as the average life of the disease.

Instead, they are out there funding studies of depression in PD - well, I have asked an authority on that subject, Paul Wicks, resident researcher for PatientsLikeMe, based at King's College Hospital/Institute of Psychiatry in London, to point me in the direction of any study that provides evidence that depression is a symptom of PD and guess what? There is no hard evidence, or even middling evidence, and yet $2 million in his lab alone has been committed to studying this totally unsubstantiated phenomenon. I would link to his response but one must be a member of PatientsLikeMe to access the site, so I am pasting it in below, instead:

In terms of the evidence most of the studies so far have been observational studies of the symptoms of people with PD as compared to say other older people with a diagnsosis of depression.

He did not provide any references.

The dollars available to fund PD research are far exceeded by the quantity of possible research to be funded, and that means there is an additional cost to funding any given study, and that is the opportunity cost of not funding some of the gazillion other possible projects.

That $2 million could have been spent on looking for treatments that would allow us to move freely again, to be pain free, to smile, to play the piano, to work, for pete's sake - treatments for phenomena that are so clearly symptoms of the disease that two or more of them must be present for a diagnosis of PD.

To pour $2 million into the study of a completely unsubstantiated phenomenon could hardly be categorized as the best use of that precious money or time, with "best" defined as the most likely to bring new improvements to the quality of life of PWP, the most quickly.

That, of course, is from the perspective of someone with PD, a perspective that, to my knowledge, is not represented at all, certainly not in any formal capacity, anywhere, in the making of funding decisions.