March 9th, 2009 by DrRob in Better Health Network
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Healthcare is bizarre. Anyone who spends significant time in its ranks will attest to the many quirky and downright ludicrous things that go on all the time. But I am not sure people realize just how strange our system is. Perhaps it would be interesting to see what it would be like if other parts of our lives were like healthcare.
1. Get up in the Morning
The first thing that happens in your day is that your alarm fails to go off. Although you have major things happening, nobody ever has explained to you exactly what you are supposed to do and when. You watch the morning TV show and it seems that some experts say you should go to school while others say you should avoid school at all cost. You call a friend who says that she knows someone who went to school and it destroyed their liver. Another friend goes to school every day and is just fine.
Confused, you turn to the Internet and go to a website that explains that you should base your schedule on the pattern of tea leaves in a cup. This site claims that your normal schedule is actually fraught with secret appointments that will, unbeknown to you, make you have cancer. It states that those people in power are making you go through this dangerous schedule so they can make money off of you. They don’t care for you like the people who made this webpage (and for $400 you can have 6-months of magic tea leaves).
Finally, you decide that you are going to go with the majority opinion and go to school.
2. School
You go to your bus stop and wait. You keep waiting. You know that the bus was supposed to come at 8 AM, but after an hour you begin to wonder if you missed it. Calling the bus service, you find out that the bus got caught up doing some extra routes. There is a shortage of buses, and so the ones that remain have to do twice as many routes as is feasible. After a two hour wait, the bus finally arrives to take you to school.
The first teacher comes into the classroom and looks very distracted. She teaches general studies and is staring at a curriculum that contains a huge amount of subjects. As she is doing her lessons, she furiously takes notes on her own teaching so that she can submit documentation to the school board and prove that she taught you. This is the only way she gets paid.
In total, she teaches for about 15 minutes and documents her teaching for 45 minutes. You want to ask questions, but the bell rings and you have to move on to your next class before any can be answered.
The next teacher only teaches a small specialized subject. This teacher is paid four times more than the first teacher. Instead of teaching and answering questions, however, he is constantly making you take tests. Apparently, the school system pays a huge amount for making you take tests, but very little for teaching lessons that would make you do well on those tests in the first place.
School is finally over, but you don’t feel like you got much out of it (except for taking a lot of tests and getting more confused). You decide that a trip to the store would perhaps make you feel better.
3. The Grocery Store
Upon entering the grocery store, you notice something odd. There are very few different brands of items stocked on the shelves. Your choice is limited to only the brands that have struck the best deal with the grocery chain. These brands have to send the grocery store a large “rebate” check because they are carried exclusively in this store.
When you go to the meat counter and ask for some steak, the butcher asks you if you have first tried the ground beef. You may not purchase steak unless you have first tried and disliked the ground beef. The ground beef, of course, is actually ground turkey, but the butcher says that these two are basically interchangeable and so the substitution is permitted.
The grocer can’t post prices because all customers have different negotiated prices. Posting prices, in fact, would be considered collusion since other grocers could find out exactly what this grocer is charging. Some congressman in California decided that grocers are all crooks and should not be allowed to share what they charge for things.
You go to the cash register to pay. The total is $380, but the cashier informs you that your negotiated price is only $150. A poor person behind you has not had the chance to negotiate a price and so must pay full price for everything.
There are a few people in the store who don’t have to pay anything. They have had the price negotiated for them by the government, and so will come to the store very often. They sometimes come for real food, but are often coming for candy and cigarettes – all paid for by the government.
This experience leaves you more tired and confused, and so you decide to go home.
4. Home
Coming home, you notice that your house is under construction. There is a new wing being built that contains all sorts of the newest and fanciest gadgets, such as flat-screen TV’s, the fastest computers, and wonderful new kitchen appliances. Going into the house, you notice that there is no running water or heat. Apparently, there are all sorts of grants and low-interest loans to pay for the fancy gadgets, and so contractors find it much more profitable to do that instead of fixing water or heating.
Your mother is in the kitchen trying to make dinner, but instead of cooking she is staring into a cookbook and at the ingredients you brought from the grocery store. You assume she can make due with what you brought, but she just sighs helplessly. Despite the fact that your mother is incredible at improvising meals, she is required to follow a cookbook that doesn’t fit the ingredients that are available. This makes dinner taste pretty bad. Your mother, obviously angry about this, gives you a weak smile and tells you to finish what is on your plate.
After dinner, you settle down to watch some television. As you are finally starting to relax, a knock on the front door breaks your peace. At the front door stands a police officer. ”You are only authorized to be in the house for two hours today, so I am going to have to ask you to leave.”
You try to explain that two hours is not enough to get the rest you need, but the officer threatens a stiff fine and forces you to leave. Before you can get your necessary things, you are forced to leave – without an explanation of how you are supposed to survive on the streets.
(to be continued)
**This blog post originally appeared at Dr. Rob Lamberts’ blog, Musings of a Distractible Mind.**
February 24th, 2009 by Dr. Val Jones in Health Policy, Opinion
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When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.
What Is Comparative Clinical Effectiveness Research?
The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:
“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”
Any mention of “comparative cost effectiveness” or value-based language is notably absent.
How Does It Work?
The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).
The budget for the CCER will be divvied up as follows:
400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ
Here is a quote from the ARRA bill, discussing the mechanics of CCER:
“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”
A Game-Changer For Pharma, Medical Technology, and Biotech
There is no doubt that CCER stands to radically change how industry does business. I anticipate that industry will develop their own internal CCER teams, and begin the process of comparing their new product (to others currently available) as early as phase 3 clinical trials. By and large, that’s probably a good thing – though there are potential unintended consequences that deserve mention.
While it’s appropriate for drug, device, and equipment manufacturers to consider whether or not their new product actually contributes something new/better to our current cadre of treatment options, there will be clear winners and losers in this game. And when companies lose, we lose companies. That’s generally not good for the economy. Manufacturers without diversified product lines are more likely to go out of business – and it will become more difficult for new players to enter the marketplace.
Although comparative clinical effectiveness research is distinct from comparative cost effectiveness research – it is likely that payers will use CCER to build their formularies. This means that even though the government (at this point in time) is not mandating coverage decisions based on CCER, health insurers are going to be using the information liberally to justify coverage preferences and even potential denials of coverage.
There’s also the question of stifling innovation. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.
As Dr. Rich argues in his excellent blog: healthcare rationing is inevitable – but it’s more ethical to do it overtly than covertly. I would also like to suggest that insofar as physicians can be enlisted to translate CCER for patients (rather than being handed down inflexible rules from on high) and help them make the best decision for them – that would be even better. The inflexibility of national decisions about healthcare rationing does make me nervous.
What’s Good For The Geese Isn’t Necessarily Good For The Goose
First of all, most key healthcare stakeholders would like to be able to compare efficacy of one treatment option over another. Informed decision-making is hard to do when head-to-head studies are simply not available for most treatment options.
However, population-based conclusions do not always provide a clear “best choice” for individual patients. Individual genetic differences, allergy profiles, complicated drug regimens, unique constellations of diseases, socioeconomic factors, and psychological issues all influence clinical decision-making.
Dr. Nancy Nielsen recently voiced concern about CCER at the Medicare Policy Summit. She said that the AMA’s position is that CCER is for information purposes, not for coverage decisions. CCER’s goal is to help patients make informed choices, not limit their choices. I’m afraid the horse may have already left the barn on that one – but I agree with Dr. Nielsen’s sentiment. It would be wonderful if CCER could remain in its supportive role for shared physician-patient informed decision-making. My fervent wish is that in doing the right thing by the geese, we don’t kill off the occasional goose. Physicians need the flexibility to make exceptions when necessary for their patients.
Republican Unrest
A certain degree of hysteria related to CCER has recently wafted up through the hallowed halls of government. Are republicans overreacting to the bill? Maybe – though the bill doesn’t include any provisions for using CCER to mandate coverage decisions or ration care, it seems that Pete Stark has made it clear that he’d like the FCC to “direct medicine” which does kind of send a shiver down my physician spine, and provides some insight into what some democrats are hoping to accomplish with CCER – laying the foundation for future government involvement in the diagnosis and treatment of patients.
Also one particular congressional report is proving helpful in “reading the tea leaves” regarding the democrats’ plan for CCER. In describing the comparative effectiveness provision, the report states that items, procedures, and interventions “that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”
While congressional reports are not binding, they do give an indication of intent.
The bottom line is that though CCER is not supposed to be used for “cost effectiveness” decisions – there’s no policy in place to protect that from happening.
Conclusion
Information about the comparative clinical effectiveness of treatment options is critical for the practice of evidence based medicine. Such information supports informed decision-making, and could be the single most important strategy for reducing the use of wasteful or ineffective therapies in healthcare.
On the other hand, CCER will certainly have some negative consequences, both anticipated and unanticipated. When “cost effectiveness” conclusions are drawn from clinical effectiveness data, rationing ensues, patient choices are limited, people lose their jobs, and some companies go out of business. As a recent article in the New England Journal of Medicine points out, “saying no isn’t nice.” I greet this 1.1 billion dollar initiative with muted enthusiasm.
Post Script
In my research for this blog post I came across some interesting quotes. I thought I’d add them here for your consideration:
***
And before you tell me we need such bills in order to be more scientific, take a minute and ask yourself just how scientific you think the government will be when it applies cost-cutting measures to medicine. The congress is certainly a hot-bed of evidence-based legislation, isn’t it?
– Edwin Leap, M.D.
When things go wrong, which of course they will, we reach for 2 tools to try to fix them: rules, and incentives. We see this at work in our response to the current financial crisis – but the truth is that neither rules nor incentives are enough to do the job.
When we turn increasingly to rules and incentives, they may make things better in the short run but they create a downward spiral that makes them worse in the long run. Moral skill is chipped away by an over reliance on rules that deprive us of the opportunity to improvise and learn from our improvisations, and moral will is undermined by an incessant appeal to incentives that destroy our desire to do the right thing.
Without intending it, by appealing to rules and incentives we are engaging in a war on wisdom.
Don’t get me wrong, we need rules. Most Jazz musicians need some notes on the page, and we need more rules for the bankers, God knows. But too many rules prevent jazz musicians from improvising and as a result, they lose their gifts – or worse, they stop playing altogether.
We need incentives – people have to make a living. But over-reliance on incentives demoralizes professional activity. It causes people who engage in that activity to lose morale, and it causes the activity itself to lose morality.
– Barry Schwartz, Ph.D. from his lecture at TED
Healthcare is bizarre. Anyone who spends significant time in its ranks will attest to the many quirky and downright ludicrous things that go on all the time. But I am not sure people realize just how strange our system is. Perhaps it would be interesting to see what it would be like if other parts of our lives were like healthcare.
