If Congress overrides President Bush’s veto of the State Children’s Health Insurance Program, a little-known provision of the original House bill could be revived.
As written, the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.
This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.
Why? Drugs must be tested on large, representative populations that must be monitored for years. Because conducting these studies is so tricky, their findings are regularly overturned or modified by further research. In fact, some are so off the mark that doctors ignore them.
But if Medicare starts using flawed studies like these to determine its list of covered drugs, doctors will have to give them respect they probably don’t deserve. There’s also an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as 'wasteful,' the more money it saves.
We have previously posted about comparative effectiveness research, that is, clinical research that compares the plausible management options that might be used to treat particular patients with particular problems. Such research could help physicians pick the best option for particular patients. Yet research directly comparing plausible options has not been done for a large number of important clinical problems affecting many types of patients. Why not? Most research about drugs or devices is currently sponsored, that is, paid for by the companies that make them. Such companies seem primarily concerned with doing the research required by the US Food and Drug Administration (FDA) and other such national regulatory bodies to get their products approved. After that, they are unlikely to fund studies that do not have a really good chance of showing that their products in a favorable light.
Comparative effectiveness research is coming in for more public criticism, and that criticism is showing up in more widely read publications. We posted about two previous examples, one published in the Wall Street Journal (see post here), another in the Washington Times (see post here). In my humble opinion, neither made a lot of sense, and Pitts' latest salvo against comparative effectiveness research, in what many people feel is the US "newspaper of record," does not make much more sense.
Pitts' main concerns amounted to two slippery slope arguments linked together. The first argument went from the reasonable proposition that comparative effectiveness research is difficult, and hence at times may be done badly, but slid down the slope to the implication that most such studies are flawed. The second argument started with the not so obvious assumption that Medicare will, out of ignorance or worse, choose to consider "flawed" studies, and slid down the slope to the conclusion that physicians will be forced to "respect" its bad judgments.
Pitts' next argument focused on the faults of one alternative, so as to avoid comparison with an even worse alternative. That government funded research could be biased by the government's motivation to save money is not an unreasonable concern. But Pitts failed to compare it to the current alternative, research on drugs or devices sponsored by their manufacturers which may be even more biased by the companies' desire to show their products in a favorable light (see relevant posts here, here, and here.)
Readers might better be able to evaluate Pitts' argument if they knew what sort of vested interests he might have. The New York Times did identify Pitts as the leader of not-for-profit organization which received pharmaceutical industry funding. Yet even with this this disclosure, this article, like two previous critiques of comparative effectiveness research that appeared in nationally influential newspapers, did not reveal all of its author's relevant financial interests.
Peter Pitts, as we have noted before when he publicly criticized Dr Steve Nissen during the Avandia affair (see post here), and when he warned against restricting people with conflicts of interest from FDA advisory panels (see post here), holds down the day-job of Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view.
It is disappointing that a newspaper as influential as the New York Times would publish a health policy article without disclosing all the author's relevant financial interests, particularly one so relevant and direct.
Fostering more stealth health policy advocacy in ever more influential venues will just make the already confusing clamor about health care and its reform even muddier.
ADDENDUM (19 October, 2007) - Our post above, Pitts' op-ed article, and the general topic have collectively attracted quite a lot of interest in the blogsphere. See comments by Merrill Goozner on Gooznews (which come from a very interesting journalistic angle), Joe Paduda on Managed Care Matters, and the anonymous "Jack Friday" on PharmaGossip. The issue was picked up by PRWatch as well. Pitts reprinted his op-ed on DrugWonks. The latter blog also now features a rebuttal directed to supporters of comparative effectiveness research, not clearly directed at the post above, but which does include a link to Health Care Renewal, and a really strange question about the treatment of hypertension and congestive heart failure (which I will probably have to address, since it's directed directly to me).
It is not true that drug companies do not do comparative studies. They do them all the time as marketing studies. They only publish the results of favorable studies.
For example Merck compared Celebrex to Vioxx and found that Vioxx was a worse drug (more side effects & no efficacy advantage). (Study 906)(www.fda.gov/ohrms/dockets/ac/07/slides/2007-4290oph1-01-Egilman.ppt) Merck never provided the FDA with the results and when the FDA publically requested the data from any such studies on Vioxx or Arcoxia they lied and denied the studies existed.
(See transcript of arcoxia ACM) http://www.fda.gov/ohrms/dockets/ac/cder07.htm#ArthritisDrugs
These studies were quitre relevant since Merck & its astroturf organization were arguing that although the RCT did not show arcoxia to be any more effective than any comparator it might work on "some" as yet unidentified" mystery patients.
Thank you for this excellent and informative post. I came upon it not too long after writing about the Pitts editorial on my own 6 week old blog (http://healthcareorganizationalethics.blogspot.com). I am happy to find such a kindred spirit at Health Care Renewal and will be setting up a link on my own site. It is good to "meet" you!
Post a Comment