Leave it to AEI writing for the WSJ editorial page to allege a grand conspiracy of the government against pharmaceutical companies. Their proof? The government wants to compare the efficacy of new drugs to older ones to make sure they're actually better.
The reauthorization of the State Children's Health Insurance Program (Schip), created in 1997 to cover children from lower-income families who make too much to qualify for Medicaid, is up for renewal this fall. Tucked into page 414, section 904 of the House bill is a provision to spend more than $300 million to establish a new federal "Center for Comparative Effectiveness" to conduct government-run studies of the economic considerations that go into drug choices.
The center will initially be funded through Medicare but will soon get its own "trust fund." The aim is to arm government actuaries with data that proponents hope will provide "scientific" proof that expensive new drugs are no better than their older alternatives. The trick is to maintain just enough credibility around the conduct of these trials to justify unpopular decisions not to pay for newer medicines.
While there's nothing inherently wrong with this sort of fiscally minded clinical research, Medicare is no ordinary payer: It dictates decisions made in the private market. So as the government begins tying its own payment decisions to the results of its own studies, there's a great temptation to selectively interpret data and arbitrarily release results. Clearly, this obvious conflict of interest demands even more outside scrutiny and transparency than has been the usual fare when it comes to government research.
Yes, because private research is so much more transparent than studies performed by the government. Gottlieb's example of a government hit on expensive drugs, was of all things, the Women's Health Initiative.
More insane conspiratorial nonsense from AEI and the WSJ below the fold.
The $725 million Women's Health Initiative was rooted in some good intentions, but was set against a backdrop of fiscal and political bickering over the efficacy of the costly drugs. Unfortunately, this influenced not only how the findings were computed but also how they were received. As this newspaper's Tara Parker-Pope first reported in July, when initial results confirmed populist refrains that the drugs were being overused, the data were rushed to print with a carefully orchestrated PR blitz, while subsequent efforts to test the initial conclusions were sluggish.
Here is a man, writing for a major newspaper, suggesting that because some of the initial findings of the WHI suggested increased risks from hormone-replacement, scientists rushed to publish it to save the government money! Always attuned to "populist" desires those NIH researchers. They weren't concerned about the conflicts between various trials about the potential risks of hormone-replacement therapy, no. They were interested in confirming popular opinion about overuse of prescription drugs.
Am I the only one who finds this hysterical? This guy is a physician, and the only reason he can think of that scientists would rush a result like that to print, is actuarial. Really? The increased risk, of say, thousands of cases of cardiovascular death a year might not be a motivation too? The NIH stopped the trial they were so concerned about the increased risk. And actually knowing how the NIH works, as well as some NIH employees, trust me, they're not sitting around looking at actuarial tables to try to figure out how best to skew results for the benefit of Medicare. This conspiratorial view is so unbelievably disturbed and misplaced, I would expect it from NewsTarget before even the WSJ editorial page. Except they would argue the opposite. That the evil guv'mint is eternally funding studies to justify pushing more pills on people. I guess you just can't win.
What is it with AEI and the big bogey-man of guv'mint?
In the case of the hormone-replacement study, although the government initially said the findings applied to all women -- regardless of age or health status -- subsequent studies using the same data show that the age of a woman and the timing of hormone use dramatically change the risk and benefits. In fact, the findings of these studies seem to directly contradict some of the government's initial conclusions.
The Government, the Government. Does this guy even understand that the researchers that perform these studies don't sit around thinking, "I work for the government. Government, government, government. And as a government worker I speak for the government, and the government is all about saving government money for the government."
If you want to read what he's talking about, the early result is open access at JAMA. Here was the disturbing result at the time:
For the outcomes significantly affected by CEE, there was an absolute excess risk of 12 additional strokes per 10 000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10 000 person-years. The estimated excess risk for all monitored events in the global index was a nonsignificant 2 events per 10 000 person-years.
And where were the study authors from, the Congressional Budget office? Wait no, when one actually looks at who was doing the research you see a bunch of universities and medical centers, and yes, some NHLBI researchers too, but the study leaders were both from non-governmental institutions.
But is this the only study that's an example of this great government conspiracy? Of course not.
The Women's Health Initiative is hardly the first study to affirm that medical advancement and government cost minimization often make uncomfortable bedfellows. The $135 million, federally run Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (Allhat) was designed in part to test whether older, less expensive blood pressure pills were as good as newer, costlier drugs. No surprise, the study showed they were, a selective interpretation of results that has subsequently been called into question by many leading experts, including Dr. Michael A. Weber, professor of medicine and associate dean for research at the State University of New York, who was on the original team of Allhat investigators.
Ooooh, it's federally-funded. Guess what. You know who else is federally-funded? Just about everybody at every public university in the country. And what about the ALLHAT study? It is generally considered to have been poorly-designed, not selectively interpreted. Here is the relevant study free again from JAMA. Again, the lead author? Barry R. Davis, MD, PhD, University of Texas-Houston Health Science Center, School of Public Health. Same with the list of hundreds of other authors on the study.
Gottlieb brings up one more study:
Meanwhile, the $40 million federally funded Clinical Antipsychotic Trials in Intervention Effectiveness (Catie) trial "found" that older and less expensive schizophrenia medications were just as good as newer, more expensive ( and many believe far more tolerable) "atypical" anti-psychotic drugs. This result, however, has made little impact on real world medical practice -- because few physicians believe the study was credible.
Like the Women's Health Initiative, bottom-line data from Allhat and Catie were subject to parochial secrecy. Catie's complete safety data are only being released this September, almost four years after the study was completed.
This article would more appropriately be from some 9/11 conspiracy crank. It's a secret! It must be a grand conspiracy to fool the public, authored by hundreds of individuals from dozens of institutions, all towing the same line - let's save guv'mint some money! Not only has the result from CATIE been confirmed by another study, this accusation suffers from yet another non-parsimonious conspiracy theory about the motives of the hundreds of researchers involved in this major multi-center trial.
The political cover offered by government-directed research will surely help when it comes time to impose unpopular limits on prescribing. That's about the only certainty in this legislative gambit, and maybe the only one that mattered when it was drafted. For many, these proposals weren't about medical discovery but bean counting. What Medicare hasn't achieved in policy circles, it's hoping to impose through the fiat of "science."
There you have it folks. The wisdom of AEI and the WSJ editorial page. Government funded research is "government-directed", and all those researchers from all those medical centers are all obsessed with the same goal - saving Medicare money. I think this editorial needs a big fat tinfoil hat, and of course, fake expertise from AEI.
**Update - I accidentally had one of his paragraphs un-blockquoted and unaddressed there - fixed since it probably seemed like a strange non-sequiter.
So as the government begins tying its own payment decisions to the results of its own studies, there's a great temptation to selectively interpret data and arbitrarily release results.
I'm feeling a bit slow on a Friday afternoon - this is a non-sequitur, isn't it?
The $725 million Women's Health Initiative was rooted in some good intentions
Ah, good intentions. I sometimes wonder if this isn't the driver behind a lot of this denialism: the authors are wealthy, selfish individuals, but underneath they desperately need an ideology that tells them that's OK - selfish intentions in reality are morally and pragmatically superior to 'good' ones. Oh, hi there, Ayn Rand.
towing the same line
I think that should be 'toeing'.
The "Center for Comparative Effectiveness" sounds a bit like the UK's NICE, which has its own love/hate relationship with the drug industry. I suspect the industry will love it just as much...
The WSJ wants to INCREASE government spending?
Been some of this kind of thinking locally too, involving housing. See, areas "not" incorporated into the town have only required some sort of resident permit or something, which doesn't require inspections, or other actions. So, people built a lot of cheap homes, many probably not up to code. In other words, the health, safety and wellbeing of the people there is uncertain, since there is no way to know how safe anything from the electrical wiring to the septic lines are. Now, the county has decided to require inspections, out of fear of the possible conditions of some of the places, which might require permits, upgrades, etc., to bring them to code. The argument being used by the people that are against this? Condemning houses that are unsafe would be detrimental to the health, safety and well fair of the people currently living in them. What? More so than living someplace the **requires** condemning for being unsafe? lol
I just don't get it.