Registering Dismay: the CDC’s (Platinum) Patient Registry

June 18, 2009

Posted by Cort Johnson

CFS has a long and twisted history with the CDC but perhaps nothing in it has been odder  than the strange story of their Patient Registry.  This  project involves contacting physicians in a small county in rural Georgia (Bibb County, population 150,000) and having them refer patients to the CDC. The patient is then screened by telephone to determine if they might have CFS or unexplained fatigue. If they might then they’re invited to spend a day taking tests at a clinic to determine if they do.  The patients that end up with a confirmed diagnosis of CFS or unexplained fatigue will, potentially, be followed for a number of years to see how their disease progresses and will be eligible to participate in future studies.

That’s all well and good; no one’s complaining about the idea of having a patient registry or tracking a patient’s progress over time. (But then again no one would object to the idea of building a bridge to join a small island community to the mainland.)  The problem is the cost. The CFIDS Association of America, particular,  has had trouble swallowing how much this bridge the CDC is building to the patient community has cost. Yes, medical research is expensive but the money the CDC has been shoveling out is incredible. You’ve heard of the Golden Toilet? Welcome to the Platinum Registry.

Simply to get Abt Associates to develop the Patient Registry on paper cost the CDC a whopping $1, 413,000. Let’s put this in some context. $1,413,000 is about half the entire budget of the NIH’s ME/CFS research program . The CFIDS Association of America is funding six pilot studies for less than $1 million. The Whitmore Peterson Institute’s annual budget is $1 million.

Before a single doctor filled a single test tube this project was already one of the most expensive studies ever undertaken in this diseae. Did we mention that this, too, is a pilot study? According to the CDC’s webpage “The Registry is a one-year pilot study.” Hold onto your horses. We haven’t even gotten past the paper stage yet – let alone to that first year.

The next step involved having Abt produce a ’statement of work’ (SOW). SOW ‘s contain the nitty-gritty of the project; it includes such things as project timelines, specific budget requirements , etc. This must have been a very difficult document to get together since the CDC paid Abt. almost $600,000 ($583,767) to do it.

Obviously something’s gone very wrong here. We’re not talking about small overrun’s; this is more like defense contractor type stuff. Many large studies - with their planning, laboratory costs, patient recruitment, data analysis and publishing – don’t cost $600,000. (And we’re still in stage two of the planning stage). If Abt charged the CDC $50 an hour to produce this document it took them $12,000 man-hours to do it That’s six people working 40 hours a week (no vacations) for a year. (On the other hand it did take them a year to simply put the SOW together…).

These figures obviously don’t even begin to make sense. What was going on here? It’s possible Dr. Reeves funnelled money for the entire project into the first two payments. (If that’s true then Abt was allowed to sit on an enormous amount of money for several years as the project wouldn’t even begin for another year and a half after the SOW was completed. CFIDS Association has noted that several payments came just before the end of the CDC’s fiscal year when the CFS research program may have had money left over. In any case it points to a grand budgetary mess.

The next year the CFS team would spend almost $200,000 on the Patient Registry doing some focus groups . It wasn’t until that was done – in the fourth year after the project had began – that Dr. Reeves submitted it to the Office of Management and Budget for approval.   Somehow one of the most expensive project in ME/CFS history essentially got paid for before it was ever approved. No wonder the CDC has been under attack for mismanagement.

Not Research But ….. But calling this project a ‘research project’ is entirely inaccurate -no research will be done here; all this 2+ million dollar I year project will do is provide patients for the CDC to study. The only ‘research’ this project will engage in is determining whether a patient has CFS are not.

Not that this matters to the participants in the study; none of them will ever be told if they have CFS or not. That’s right. Despite CDC statements that getting treatment early in the course of this disease none of the participants in their study are going to be told if they actually have it.

If we were talking about AIDS research a million dollar overrun or so wouldn’t merit mention. But this is ME/CFS – a disease that already sits at the very bottom of the federal government funding priorities. This is a disease the federal government spends only about $6 a year per patient on. A disease that’s suffering dramatic declines in research funding. A disease that the CDC’s own staff admits is receiving 25% less funds that it was 10 years ago. At this level wasting money can really matters.

Opportunity Cost – Opportunity Lost And it has. The evidence suggests that Dr. Reeves has spent so much money getting patients into this registry that he has little money to do much with them afterwards. According to the Five Year Draft Strategic Plan the biggest CFS research effort on the planet will be engaging in just two laboratory research projects over the next five years. It appears that a good chunk of the money the CDC has and will spend on ‘research’ will simply go to finding the ‘right’ patients.

A Cadillac Researcher on a Pinto Budget? Dr. Reeves has always had bigger plans for any ME/CFS than his budget warranted. He initiated a very expensive random sampling scheme to gather his patients in the late 1990’s. Then he created a definition that inflated the patient base so much that efforts to subset them became mandatory. He argued that the criteria and the bloated population figures were irrelevant - that once patients were being rigorously measured the subsets should pop out. Yet the big studies needed to ferret out those subsets were never done and five years and at least $40 million later subsets are still not popping out at the CDC. Instead of the increased rigor and the clean slate we were promised we’re left with a huge population of ‘CFS’ patients that the research community has no faith in and a definition that needs and apparently will be redone.

Hitting the Wall – Dr. Reeve’s ‘big vision’ worked ‘OK’ when he had payback funds to play with and when he and his research team were able to find collaborators to make up for the programs big upfront expenses but the CDC’s research team now appears to be hitting the wall. Dr. Vernon, the program’s lab chief left and has not been replaced and another member of the team that recently left has not been replaced either. At a time when this program desperately needs collaborators to maximize its reduced funding levels the only people it’s collaborating appear to be charging Cadillac prices for their efforts.

Abt Jumps In. Undoubtedly overjoyed at the results from their past efforts Abt. Associates opened a new branch in Atlanta in July , 2008 specifically to drum up more business from the CDC. Kathleen Flanagan, Group Vice President for Social, Economic and Health Policy at Abt Associates stated”We are confident that our new Atlanta office will enable us to strengthen communications with our CDC contacts, maximize project continuity, and enhance both the effectiveness and cost-efficiency of our project work.”

Who would not want to take advantage of research program that paid over $2 million to develop a protocol and a ‘statement of work’? A research program that will doesn’t, from what we can to tell, appear to mind seeing start dates pushed back again and again? That is willing to allow a firm to take a year to develop a ‘Statement of Work’. That appears to respond to delays with even more infusions of money? Given Abt’s apparent windfall with their last CFS project it’s not surprising that the chronic fatigue syndrome was featured prominently in their press release. So long as the CDC is acting like a cash cow they are, like any good business, going to do their best to milk it.

The Patient Registry What has happened to the Patient Registry? It opened in September 2008. It’s apparently enrolling patients and will run for one year and then it will be over – unless the CDC decides it’s been worth the cost…

The Review Continues: We’re in the meat of the review period right now. The CDC has submitted their five year Strategic Draft Plan and is taking comments until June 30. The CFIDS Association of America and the IACFS/ME should be submitting their comments shortly. Sometime after June 30 the CDC will submit a final version of the CFS research teams five year plan.

Kim McCleary on the CDC’s Five Year Plan

Dr. Reeves: Too Little Too Late?

Systemic Change Needed: CAA Hits CDC Again

Patient’s Blast the CDC

5 comments

{ 3 comments… read them below or add one }

Linda C June 19, 2009 at 6:24 pm

I makes me want to hurl when I see figures like this and me trying to live on SSD. I would find it extremely beneficial if after an article such as this that the author give the email address and name of the person who would be the best person to express our opinions to in the hopes that such monies spent on just this stage could be told that this was over the top and unnaceptable to the citizens of this country who can’t even afford a dozen of organic eggs at $4.99 a dozen in Vermont.

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cort June 19, 2009 at 8:08 pm

I agree! It’s just ridiculous. (Everything about the federal governments response to us is pretty damn ridiculous actually). At least in this case there is an avenue to express your disgust. The CDC is taking comments and you can e-mail them at CFSResearchPlan@cdc.gov. For more info you can go here

Check out the CFIDS Association Grassroots Advocacy Center: . They’ve been leading the way on this fight.

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Cheryl Allis November 26, 2009 at 2:10 am

Just another evidence that you can’t count on government to solve anything. You think this is bad, just wait until government-run or public option health care starts. Instead of turning over more of our money and health care decisions to the government, we should be telling governement to get out of the health care business. We know best how to spend our money. We know what works or doesn’t work for us. We should decide where the health care research dollars are going. Why should we continue to let the government take our money from us and waste it like this?????

Notice that it was a private entity, the Whitmore Peterson Institute, that made the XMRV discovery. Private citizens who take up causes have a lot more stake in what they are doing and will be a lot more careful with the money they receive for their projects. And, if they fail to be careful with the money intrusted to them, we can urge people to stop giving to them and direct their funds elsewhere. It’s much more difficult, if not impossible, to get governement to do that.

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