By
Scott Gottlieb
July 31, 2014 at 5:00 am ET
“Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied.” So says a research proposal that was awarded more than $2 million under a centerpiece of Obamacare – the new Federal center designed to funnel money into “comparative effectiveness research.
This new agency was supposed to find low cost ways to deliver healthcare. The $2 million spent on the stress study will go to a three-year examination of two approaches designed give people worry-reduction skills. This is Obamacare at work.
Certainly elderly people have unique challenges that come with advanced age, and in turn unique stresses. And I don’t mean to diminish efforts to design life coping skills that can reduce these anxieties. But surely this wasn’t what the architects of Obamacare had in mind when they created the new Patient-Centered Outcomes Research Institute as a cornerstone of Obamacare. The President himself touted PCORI as a key part of his purported goal of lowering healthcare costs. Really.
Part of this story is an illustration of what happens when grants are filtered through a Federal process that is invariably politicized, and influenced, if not spearheaded by an insular crowd of academic types who are the main beneficiaries of the grants. Partly, it’s another illustration of the inefficiency and excesses that must be tolerated any time money is funneled through a government payment system. But mostly, it’s another expression of Obamacare’s false promises.
PCORI has attracted a skilled leadership team that rivals many similar private institutions. But even with its talent, and its $3.5 billion, ten-year trust fund – financed off a tax on Medicare and private health plans – PCORI never had enough resources to fund the rigorous kinds of clinical trials that would actually inspire change in clinical practice. It never aimed to make grants on a scale to accomplish this mission. It’s proponents and opponents alike didn’t want it to. Proponents didn’t really want definitive clinical answers, just policy screeds that government payers could peg decisions to. And opponents didn’t really want to see it work at all.
So the $54.8 million awarded yesterday for 33 projects were mostly trivial awards aimed at studies of how to do studies, several projects looking at rehab techniques, along with about a dozen studies examining various social aspects of healthcare.
The hardest clinical study that got funded compared low and high dose aspirin use in people with coronary artery disease, prescribed for prevention of heart attacks. The aim is to see if the higher doses of aspirin are better than the more commonly used lower doses. Yet even here, the $10 million PCORI set aside is unlikely to finance anything near the scale of research that’s going to nail this question.
The original study establishing the use of aspirin in preventing heart attacks randomized 22,000 doctors and took 8 years to complete. And that study compared aspirin to a placebo. Firmly establishing an expectedly small difference between the benefits offered by low versus high dose aspirin would take a much larger, longer study since it will be comparing two treatments that are each known to work. $10 million won’t get you to first base if you really want an immutable answer.
Among some of the other research PCORI funded was $1.7 for a study of probiotics instilled directly into the bladder for treatment and relief of urinary tract infections in patients with impaired bladder control from nerve injuries, $2.1 million for a three-year study of “The Effectiveness of Peer-to-Peer Community Support to Promote Aging in Place,” and $750,000 for a research study examining a new method for coming up with questions for research studies. About $2 million went to the development of a “graphic novel” (also commonly referred to as a “comic book”) to be used in counseling patients with alcohol abuse disorders.
The architects of Obamacare promised studies that would yield definitive answers to nagging clinical questions where doctors have a hard time selecting between competing treatment options. But these clinical questions persist precisely because studies to rigorously compare active treatments aren’t cheap, or easy. They need to be very large and long to discern what are usually small differences in outcomes. Then there’s the question of whether the answers have any clinical relevance.
The cost of this sort of research, done right, can be enormous, easily topping $100 million a study. Yet PCORI’s largest grants are in the neighborhood of $10 million. It always meant one of two things: Either PCORI would try to do these studies on the cheap — yielding results that would be utterly unconvincing. Or the agency would avoid the tough medical questions altogether. PCORI has chosen both journeys.
Supporters of PCORI will surely find some intriguing studies among the grants. But that isn’t the standard under which the agency was created. PCORI was supposed to channel funds into the most challenging clinical questions that remained unanswered by privately funded research. It was supposed to be a public effort to fill a purported private void. Instead, the agency’s collection of mostly sub $2 million grants look like a permanent subsidy stream for careworn academic projects. It’s a source of seed financing for junior faculty and ambitious grad students.
PCORI has awarded almost $549 million since 2012. It approved a resolution in 2013 to commit up to $1 billion in research funding over the next two fiscal years. For an agency that didn’t exist four years ago, it has almost 150 employees listed on its web site. It’s now a part of Washington’s permanent bureaucracy, with its own advocacy groups to support its growth, and institutions dependent on its largesse.
But will PCORI fulfill its lofty mission? Truth be told; it was never meant to. The gauzy rhetoric about an agency that would take on the tough questions was just a sales pitch to get PCORI through Congress. The agency’s undersized grants, its bureaucratic structure, and its pious mission were always going to frustrate its ambitions. Feel stressed by all this? Don’t worry. PCORI is studying that.