Saturday, May 23, 2009

A Stealth Campaign to Shanghai CE Research?

I have previously posted on the campaign, apparently launched by the drug industry, to impede and derail comparative effectiveness (CE) research while mouthing approval of it. This is especially the case for any CE research that takes cost into account--as the industry knows full well that in many cases, the expensive brand-name drug would be found no better than cheaper alternatives.

To see how far this campaign has progressed, we can start with Merrill Goozner's blog: http://www.gooznews.com/node/2930. Merrill refers us to the Wall Street Journal Health blog: http://blogs.wsj.com/health/2009/05/20/phrma-tries-to-keep-comparative-effectiveness-in-check/. Finally we are redirected from that blog to the WSJ Washington Wire: http://blogs.wsj.com/washwire/2009/05/19/to-get-bigger-say-in-research-drug-makers-enlist-democrats/.

What we learn from these sources is that there's an organization called the Partnership to Improve Patient Care. It is headed by Tony Coelho, a former Democratic congressman noted for his role in passing the Americans with Disabilities Act (impeccable liberal credentials, you'd think). Now, here's the test. Go to the PIPC website at http://www.improvepatientcare.org/. You'll immediately see a mission statement:

We all need good information to make good decisions about our health, and our health care. Comparative effectiveness research can help us make good health care choices. But it is important to make sure this research isn't misused to make these decisions for us.

The Partnership to Improve Patient Care exists to advance proposals for comparative effectiveness research that are focused on supporting providers and patients with the information they need, improving health care quality and supporting continued medical progress.

Sounds pretty benign, and supportive of CE research, right? Now keep clicking around the website. You'll see that PhRMA is one of a slew of impressive organizations that are all part of the coalition that makes up PIPC, along with a number of medical and patient-advocacy organizations. I challenge you, however, to find on their website what Goozner and WSJ report as the primary characteristic of PIPC--that it is primarily if not solely funded by PhRMA.

Now, let's follow the trail farther. PIPC supports a new CE research bill introduced by Rep. Kurt Schrader, D-OR. which you can read about at http://schrader.house.gov/?sectionid=24&sectiontree=23,24&itemid=141. The news release tells us that the bill is the product of the New Democrat Coalition, and stresses how important CE research is for giving doctors and patients the information necessary to make the best medical decisions. You would never guess from this news release that the supporters of this bill are anything other than big fans of CE research.

At the very bottom the press release describes the features of the bill. Here's the kicker--the bill would:

--Establish a non-government institute responsible for managing and guiding health research programs. The institute will be governed by a board that would include representatives from HHS, NIH, CMS, VA, DOD, physicians, patients, state health agencies, insurance, industry, researchers and other experts.

There is no explanation here of what's wrong with the current conduct of CE research by the NIH or AHRQ. Why should the new institute be "non-governmental"? Just who is the "industry" that will be represented on the governing board? Just who are the "physicians" and "patients"? (Representatives of front organizations claiming to be grass roots, but behind the scenes actually all funded by PhRMA?) Will the governing board simply set an overall research agenda, or will it have a say in which specific projects get funded? How much say?

In short, we currently have a "governmental" approach to CE research, with these projects being conducted by NIH or AHRQ, in accord with the standard system of competitive grant submission followed by scientific peer review. Now, any candid scientist with a couple of beers in him/her would wax eloquent about the flaws and shortcomings of the current peer review system, but the fact remains that it's the best system anyone has yet come up with to assure scientific validity and integrity in the research process. Before somebody sells us a new, "non-governmental" method of doing CE research, we have a right to inquire how this new method would stack up on the science side. What are the safeguards to assure that the scientific quality of the results will be equal to that of the existing system? Especially with a new raft of special interest groups all crowding the table?

Here's more from the PIPC website: The entire research process of a new CE [research] entity – from deciding priorities to finalizing and communicating research results – should be open and transparent to the public.

I'll leave it to you to decide just how "open and transparent to the public" all this activity has been so far.

ADDENDUM: If you want to read a great column from a wise psychiatrist, about the pressing need for CE research as well as the dangers of letting the Pharma fox guard that particular henhouse, check out http://www.nytimes.com/2009/05/19/health/19mind.html?_r=1&ref=todayspaper (thanks again to Merrill Goozner for the tip).

1 comment:

Merrill Goozner said...

Thanks, Howard, for the hat tip. Sen. Max Baucus has sponsored legislation that would create a separate agency to conduct comparative effectiveness research, and readers may want to write to him suggesting that for such an agency to be truly effective, it must be independent in its governance. In a detailed memo to Baucus' staff, I suggested that stakeholders like PhRMA could have input into what research gets done through a "notice and comment" period, which would enable all stakeholders, industry and patient and physicians alike, to participate but not make the final determinations.