Sunday, January 26, 2014

Left Hand Pocket to the Right Hand Pocket

In a recent announcement, PCORI, the Government sponsored and funded entity which get about $500M pa from the added taxes on our new health care plans has awarded some $5M contract to NIH to fund work on its internal PRO system. They state:

The Patient-Centered Outcomes Research Institute (PCORI) has approved $5 million in funding for research focused on the Patient Reported Outcomes Measurement Information System (PROMIS) of the National Institutes of Health (NIH). “Funding PCORI projects focused on PROMIS will allow us to substantially advance the use of these tools in comparative effectiveness research,” said PCORI .... “Working with the NIH allows us to build on its investment in a comprehensive, flexible, and patient-centered measurement system.”

 Now this means that the money we all pay for our health care now has a tax which is collected by the Government and then handed over to PCOR which then as a non-governmental entity adds its costs and then transfers the $% M to NIH a governmental entity. One wonders how much money there was before it got down to the $5 M going to NIH. Why not just give NIH the money outright rather than burdening the taxpayers with the added overhead. Only the Government could conceive of this mess.

But read the words, "advance the use of these tools in comparative effectiveness research" Namely, this is a CCE tool, and although it focuses on PRO information it will be used for CCE or CER results.

Now just a remark on CCE. FDA does randomized trials using well accepted gold standard statistical techniques. CER examines procedure in a real life clinical setting. Patients just do what they want. That means if we compare weight reduction to metformin for Type 2 Diabetes, we all know that most people just do not do what they are supposed to in managing food intake. Thus we know a priori that there is a bias. Also the people will not tell the truth, they fear being criticized. Thus CER has at best highly questionable results.

So why do this work? If NIH is doing this for drug approval support then we have the FDA involved. If it is for CER/CEE work then PCORI is now the new kid on the block. But somehow this flipping the money around so everyone gets a bite is rather silly, and wasteful of the taxpayers money, but alas it is what we have come to see in the ACA. Just a little corner of the effort.

Now let us examine what this $5M may cost the Taxpayer. Below is a reasonable flow chart of what Government entity handles each step.
The money is paid by the Taxpayer. It is collected and validated by the IRS who hands it to the Comptroller of the Currency, who pays PCORI. Remember PCORI us guaranteed a minimum of $500M per year!. Now PCORI works through RFPs etc and ultimately the $5 million goes to NIH. Along the way I estimate that the Taxpayer had to pay in $25 million to get the $5 million out the other end! Why not just give it directly to NIH? Simple, ACA will not allow that! And folks, you are just seeing the beginning. Don't say we did not warn you!