This is the ninth in a series of interviews between Jessie Gruman and patient and consumer group leaders about their experiences with and attitudes toward comparative effectiveness research (CER).
Gruman: Tell me about yourself and your organization.
Arthur Levin: I am the director of the Center for Medical Consumers. We are a national organization that represents all people who have business with the health care system, not just patients.
The genesis of the Center for Medical Consumers back in 1976 was the inability of people encountering the health care system to have access to any information that would guide their decision-making, and on top of that, the lack of receptivity to patient and family participation in the decision making process. Decisions were the purview of the professional to make and the person on the receiving end of that decision was not invited to weigh in as to their preferences.
If you believe that patients have the right as citizens in a democracy to participate in decisions that affect their lives and if you believe in the transparency of information and freedom of the press, the fact that people aren't invited to participate is a real problem.
Gruman: Tell me how your organization views the relationship between comparative effectiveness research (CER) and patient-centered outcomes research (PCOR).
Arthur Levin: I think the transformation of CER into PCOR is interesting ' it's kind of a 'tinting' exercise. We're trying to figure out if it's just more of the same. Health policy has a love affair with old wine in new bottles, that is, rebranding old solutions with new acronyms. Because patient-centered care and engagement are fashionable at the moment, is PCOR merely a way to dress up CER to be more exciting and attractive (or palatable)?
Here's what I'm talking about: Until a few years ago, I was involved in an ad hoc group to help nominate consumer reps for the Food and Drug Administration (FDA). When I started, the effort was well-funded. We had a very interesting discussion with the Office of Consumer Affairs. The representative from Public Citizen and I made the point that 'You don't get it: you want whoever you nominate to have the patient or consumer perspective but they also need so much other knowledge and so many other attributes in order to actually contribute. They need to know how research operates; how it is designed and conducted. They have to know the respective roles of industry, NIH, FDA and CROS. They have to understand the various advisory processes and how research findings make their way into use. They have to be able to represent the experiences of many people with their condition or in their situation as a consumer, not just their own.'
Imagine if you have one consumer representative sitting there on panel'?¦there is often a bunch of white guys, mostly doctors, who know each other and speak the same 'foreign' language. The patient or consumer rep comes into that environment and we expect her to be an effective spokesperson? This is heady and hard work. The assumption that the patient or consumers perspective can be effectively represented by a patient or advocate no matter their skill level and subject matter experience is nuts.
This made me question the value of consumer/patients on those panels. There is no inherent value in having a 'public rep' at the table. Yes, yes, of course you need to work hard to get 'sunshine.' I just don't think this approach reliably sheds any light at all, especially when the process is transparent as a matter of law. And I'm not convinced that we've figured out how to pick people and get value from them.
We think we're making strides in getting the public and professionals to understand that patient, family and consumer voices should be heard. And we say that this time we're going to change the process. But as far as I can tell, we are making a lot of assumptions about patient and consumer abilities and even willingness to contribute to the design and conduct of research.
Gruman: How do you see the increased attention to CER affecting the care your constituents will receive in the future?'
Arthur Levin: I think if done well, CER can help patients and families make informed decisions and ones that are a 'good fit' with their individual needs and beliefs. But that will mean putting a lot of effort into making CER findings understandable for the public and useful for decision-making.
Gruman: Some professionals believe that patients or patient groups are opposed to comparative effectiveness research. Do you think this is accurate? What do you think is behind this view?
Arthur Levin: I don't think it is accurate. Most patients and families don't have any notion about what CER is, and if they are against it, my best guess is that they have been exposed to the lie that this is a death panel exercise, that it's about cost or restricting access to treatment. In the abstract, most patients would say 'I want to get well' and so anything that can be framed as getting in the way of that, people won't have great affection for.
The problem is more that there is little awareness of how CER is conducted and used. Most thinking people are astonished that it doesn't happen already.
It would be great if you could figure out how to explain to people in a technical but non-visceral way what CER is. I believe they'd be surprised at how seldom it currently serves as the basis for medical decisions, and they'd be befuddled by current FDA laws that say you only have to show that one treatment or drug is not inferior to existing drugs.
Gruman: What are your fears and hopes for CER?
Arthur Levin: My biggest fear is that CER is getting morphed into other related types of research and that it's getting acronym-ized to not mean anything at all.
To be meaningful in the world of medicine today, we need to change the statutory regulations underlying how drugs and devices are approved by the FDA. I say give the FDA authority to not approve anything that doesn't represent improvement on an existing product. We need to confine new products and technologies to things that represent improvement on efficacy and safety. Unfortunately, we don't live in a political climate that would sustain this. And we need to remember that we have no process at all for vetting procedures that do not involve administration of a drug or use of a device. Surgery is truly the Wild West of trial and error, but on real people not white mice.
And on the hope side: Who is the object of all this health care?' It's people. The health care sector should be centered on this: sick people looking for help. The IOM's To Err is Human report includes some moving words:
'Errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them. It is not acceptable for patients to be harmed by the health care system that is supposed to offer healing and comfort'a system that promises, 'First, do no harm.''
It's immoral that we should accept the status quo that people are being hurt instead of helped. There is something ethically challenging about this. This is why I keep going.
More CER Interviews by Jessie Gruman