Op-Ed: Comparisons are odious
Agency sets an unhealthy precedent for ‘effectiveness’ research
By Trevor Butterworth Tuesday, May 29, 2012Imagine that all the pharmaceutical companies united to create an institute for quality research, and gave it $1 billion to study “comparative effectiveness” — whether drugs still under patent worked better for people than cheaper generics. Imagine that the pharma companies dug farther into their pockets and came up with another $11 million to train physicians, pharmacists and nurses to be ambassadors for this institute, and that these ambassadors would travel the country offering $4 million worth of further education credits to any doctors or nurses who would agree to listen to their spiel.
If you’re thinking that this is, in fact, what Big Pharma already does, remember, this is still a hypothetical exercise. In reality, such a plan would never get by the Food and Drug Administration, which is to drug marketing what the Spanish Inquisition was to heresy. But if, somehow, such a project were ever to happen, you’d seriously doubt whether it would be unbiased, wouldn’t you? It strains credibility to think that the pharmaceutical industry would go to such expense to say that the cheaper drugs were just as good as the expensive ones.
So guess what the U.S. government has gone and done? It’s given $1 billion to the Agency for Healthcare Research and Quality (AHRQ) to study “comparative effectiveness.” And the agency, in turn, is paying a company — Total Therapeutic Management — $11.6 million to recruit and train doctors, pharmacists and nurses to shill the findings of these comparative-effectiveness studies at high-volume medical practices. As a reward for listening to the government’s spiel, you get a continuing education credit from a $4 million fund.
It’s not clear why the government is using taxpayer money to pay people to sit in a doctor’s office and explain the wonders to be found by going to AHRQ’s website (at present, not many). But in case these busy physicians miss out on this wonderful opportunity for no-cost, taxpayer-funded education, the government is spending another $26 million for a national and regional PR campaign to raise awareness about the program.
But here’s the really amazing thing about the government doing what pharmaceutical companies would be hung, drawn and quartered for doing: Because the government is doing this, it doesn’t need government oversight! Yes, the FDA, which normally polices what can and cannot be said in the promotion of health care, will have no jurisdiction at all over what this sales force will tell health care providers about how medicine should be practiced.
The immediate problem with this is simply the reverse of the problem dogging Big Pharma: If you’ve spent a billion dollars on a new drug, you have an interest in touting it as vastly better than the drug that preceded it. But if you have an interest in saving a billion dollars — and the U.S. government, as the world’s largest payer for health care, most certainly has such an interest — then surely you have a corresponding incentive to recommend cheaper treatments.
All of which leads to the multimillion-dollar, devil-in-the-details question: What does “comparative effectiveness” actually mean?
In theory, it means finding the best treatment for any given medical problem. But how are decisions made about what’s best? What if drug A cures 50 percent of people and costs $1 a pill and drug B cures 52 percent of people with the same problem but costs $10 a pill? The cost savings of, say, treating a million people each year on Medicare by using drug A are huge — but what if you happen to be in the 2 percent for whom only drug B works, and there’s no surefire way to figure that out before treatment?
The problem with comparative effectiveness (according to Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner) is that it’s very different from clinical effectiveness. The former aggregates health care outcomes for a given treatment, while the latter addresses variation within those outcomes — what works best and why, for the individual.
In a recent commentary in Drug Information Journal, Pitts warns that comparative effectiveness, as presently conceived, not only risks derailing the development of personalized medicine, it could end up pushing health care toward the slippery slope of rationing. There is always a trade-off between care and cost, but that trade-off keeps changing as medicine advances. What’s crazy expensive today could be far cheaper in five years’ time, and it could trigger further incremental breakthroughs in treatment.
A glance at the AHRQ’s link-heavy website shows that a lot of its reports are already old, while the billion dollars it got from Congress has yet to deliver any major new findings. This isn’t particularly surprising: Comparative effectiveness research takes time. But what if the eventual results end up being out of date — or get challenged as critically flawed? What will a government “comparative effectiveness” health rep say in such cases?
Again, we don’t know, because the government doesn’t think it needs to regulate itself as a provider of health care research and purchaser of health care. Even if you are an opponent of so-called socialized medicine, you, me and everyone else needs socialized regulation for promoting medicine and treatment. Government should play by the same rules it sets for others. In this case, our future depends on its doing so.
