March 20th, 2009 by Dr. Val Jones in Health Policy
2 Comments »
What would it be like to have most of healthcare’s key stakeholders in one room, and allow each of them to take turns at a podium in 3 minute intervals? It would be like the meeting I attended today at the Institute of Medicine.
The goal of this public forum was to allow all interested Americans to weigh in on prioritization rankings for comparative clinical effectiveness research (CCER). CCER, as you may recall from my recent blog post on the subject, is the government’s new initiative to try to establish “what works and what doesn’t” in medicine. Instead of answering the usual FDA question of “is this treatment safe and effective?” We will now be asking, “is this treatment more safe or more effective than the one(s) we already have?”
There are many different treatments we could study – but let’s face it, 1.1 billion isn’t a whole lot when you consider that some CCER studies (like the ALLHAT trial) cost upwards of 100 million a piece. So we have to think long and hard about where to channel our limited resources, and which treatments or practices we want to compare first.
The public forum attracted most of the usual suspects: professional societies, research organizations, industry stakeholders, health plans, and advocacy groups. But the imposed time limit forced them to really crystallize their views and agendas in a way I’d never seen before.
I “live-blogged” the event on Twitter today and if you’d like to see the detailed quotes from all the presenters, feel free to wade through the couple of hundred comments here.
For those of you more interested in the “big picture” I’ll summarize my take home points for you:
Almost everyone agreed that…
- The process for establishing research priorities should be transparent and inclusive of all opinions.
- More information is good, and that CCER is a valuable enterprise insofar as it provides greater insight into best practices for disease management.
Most agreed that…
- Preventive health research should be a priority – so that we can find out how to head off chronic disease earlier in life.
- CCER should be considered separately from cost effectiveness decisions.
- One size doesn’t fit all when it comes to patient needs and best disease treatments.
- Physicians should be included in the CCER research and clinical application of the findings.
- Research must include women and minorities.
- CCER should not just be about head-to-head drug studies, but about comparing care delivery models and studying approaches to patient behavior modification.
- CCER should build upon currently available data – and that all those who are collecting data should share it as much as possible.
Some agreed that…
- There is a lack of consistent methodology in conducting CCER.
- We need to be very careful in concluding cause and effects from CCER alone.
The best organized 3 minute presentations:
In my opinion, the industry folks had the best presentations, followed by a powerful and witty 3 minutes from the American Association for Dental Research. Who knew the dentists had such a great sense of humor? Here are the top 4 presentations:
#1. Teresa Lee, AdvaMed – best all around pitch. In three short minutes, Teresa persuasively argued for transparency in CCER priority-setting, presented her top disease research picks (including hospital acquired infections and chronic diseases like asthma, diabetes, and clinical depression), the importance of physicians and patients making shared decisions about care (rather than the government imposing it), and the need to distinguish CCER from cost effectiveness.
#2. Randy Burkholder, PhRMA – “Without physician input, the questions we pose via CCER will not be clinically relevant.”
#3. Ted Buckley, BIO – “What’s best for the average patient is not necessarily best for every specific patient.”
#4. Christopher Fox, American Association for Dental Research – he said that “his good oral hygiene made it possible for him to deliver his presentation today.”
Most innovative idea
Dr. Erick Turner of Oregon Health and Science University suggested that FDA trial data be used as the primary source of CCER-related data analysis rather than the published, peer-reviewed literature since journals engage in publication bias – they tend to publish positive studies only.
Most shocking moment
Merrill Goozner, from the Center for Science In The Public Interest, essentially told the public forum hosts that the event was a terrible idea. He suggested that industry stakeholders were inherently biased by profit motives and should therefore not be allowed to influence the IOM’s CCER priority list. The crowd squirmed in its seats. For me, Merrill’s suggestion was like saying that a plan to reform the auto industry should exclude car manufacturers because they have a profit motive. Sure profit is a part of it, but reform is just not going to happen without buy in and collaboration. As I’ve argued before – there’s no such thing as complete lack of bias on anyone’s part (patients, doctors, nurses, dentists, health plans, advocates, or industry). The best we can do is be transparent about our biases and include checks and balances along the way – such as inviting all of us biased folks to the table at once.
I’m glad that happened.
March 17th, 2009 by Dr. Val Jones in Humor, True Stories
8 Comments »
As some of my Twitter friends already know, I had a bit of a scare a few days ago with my cat. I know that I more-or-less promised not to let this blog degenerate into cat talk (and for the record I love dogs too), but please indulge me because I think there’s a larger lesson to be learned.
A few days ago I was emailing away on my computer when I heard an odd thud behind me. I turned around to find my cat lying on her back with one leg fully extended, her pupils dilated, and a fine tremor in all four legs. This lasted for about 10 seconds and then she jumped back onto her feet and walked away as if nothing had happened.
My husband denied giving her any catnip, and since I hadn’t seen this odd behavior in her before I decided to keep a close eye on her. About an hour later she was walking across the floor when she suddenly raised her back rear leg, hopped a few steps, flopped onto her back and did the same weird leg extension, trembling, and let out a bizarre yowl.
That buys her a trip to the vet – and I started running my differential diagnosis through my head. It seemed to me that she was having some kind of focal seizures – and I wondered if she could be in renal failure (she had had a UTI earlier in the year) with metabolic encephalopathy, or perhaps a small tumor that had started to trigger some seizure activity. The episodes seemed to resolve completely in between episodes so I didn’t think she was having a stroke, she also wasn’t continuing to limp and when I pressed on her bones she didn’t flinch so I didn’t think she had broken anything. I called the vet and when asked for the “chief complaint” I was just as helpful as many ER patients:
Dr. Val: My cat’s ‘acting weird.
Receptionist: Could you be more specific?
Dr. Val: Well, she’s acting like she’s had catnip, but she hasn’t.
Receptionist: Uh huh… And what do you mean by that?
Dr. Val: She keeps falling on the floor and stiffening her rear leg. Then she gets up as if everything’s fine. This seems to be happening every hour or so.
Receptionist: I see. And is it possible that she could have eaten something toxic? Do you have poison lying around the house?
Dr. Val: Not that I’m aware of.
Receptionist: Well it sounds like you should bring her in. Can you be here in 15 minutes?
Dr. Val: Wow, that’s not much time. But I can try! I think she might be having seizures…
And so with the vet’s office being 15 minutes away, you can imagine the frenzied efforts that ensued – I managed (single handedly) to put together a cat carrier and stuff the “seizing” feline into it and hoist her onto a cart and push her down the city sidewalks, much to the amusement of onlookers, who probably fully believed that I was a cat-abuser, hearing the pitiful cries coming from inside the cage.
To make a long story short, I explained to the vet-on-call what I’d witnessed, and suggested that my cat might have a brain tumor. Luckily for me, the vet did not blindly take my diagnosis for granted, but performed her own physical exam.
The conclusion?
Vet: Dr. Jones I don’t believe your cat is having seizures. She has a subluxing patella.
Dr. Val: Um, so you’re saying that her knee cap popped out of place?
Vet: Pretty much, yes. That’s why she flops on the floor and stiffens her leg. She’s trying to get the knee cap to slide back into place. It’s a grade 3 subluxation, which means it pops out easily, but still goes back into place on its own.
Dr. Val: How do we fix it?
Vet: She’s a surgical candidate. We can create a divot in her femur to help keep the knee cap in the right groove.
Dr. Val: Wow, we don’t do that for humans. Are you sure that will work?
Vet: Well, you can try glucosamine. It will reduce the inflammation.
Dr. Val: Glucosamine doesn’t reduce inflammation in humans – and there’s no conclusive evidence that it improves joint health either. Isn’t this more of a mechanical problem that needs a mechanical solution?
Vet: [Becoming irritated] Yes, well you can see our orthopedic specialist. She’s not board certified though – but she has a lot of experience with these kinds of things.
Dr. Val: Well, is there a board-certified orthopedic veterinary surgeon that we could consult with? How much do you think that would cost?
Vet: There’s an animal hospital in Friendship Heights. I’m sure their surgeons are all equally well qualified. I guess the procedure would cost around $2000.
Dr. Val: Wow, $2000 to put a divot in a cat’s femur? Gee… I don’t know…
Vet: You should also know that your cat needs her rabies shot.
Dr. Val: She needs another one?
Vet: Yes, they need one every year.
Dr. Val: How likely is a house cat to get rabies? Are there rabid mice that could get into our condo?
Vet: [Scowling] It’s the law. All cats must get a rabies shot every year. There is one rabies shot that can be given every three years, but it’s been associated with osteosarcomas in cats. Would you like to give her that vaccine?
Dr. Val: Uh, no. But seriously, where is my cat going to catch rabies?
Vet: Maybe she’ll catch it from the other pets at the animal hospital when she goes for surgery?
Dr. Val: [Visions of Cujo dancing in her head] Well, that doesn’t sound like a very safe place to take her.
Vet: Would you like to buy some glucosamine?
Dr. Val: No thanks, I think I’ll go now.
***
I learned a few things from this amusing interaction:
1. People should try not to make diagnoses beyond their level of expertise. (Brain tumor versus subluxing patella? Yikes.)
2. Vets do not necessarily practice evidence-based medicine. (Glucosamine for a subluxing patella?)
3. There’s a lot of money in cat vaccines.
4. Cash-only practices are quite lucrative. My little visit cost $300.
What do you think I should do with/for my poor cat?
