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Comparative Clinical Effectiveness Research: Setting Priorities At The IOM

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…

  1. The process for establishing research priorities should be transparent and inclusive of all opinions.
  2. 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…

  1. Preventive health research should be a priority – so that we can find out how to head off chronic disease earlier in life.
  2. CCER should be considered separately from cost effectiveness decisions.
  3. One size doesn’t fit all when it comes to patient needs and best disease treatments.
  4. Physicians should be included in the CCER research and clinical application of the findings.
  5. Research must include women and minorities.
  6. CCER should not just be about head-to-head drug studies, but about comparing care delivery models and studying approaches to patient behavior modification.
  7. 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…

  1. There is a lack of consistent methodology in conducting CCER.
  2. 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.

The Friday Funny: Kids Today

pediatrician1

Neuroticism Versus Hypochondria: Dr. Jon LaPook Explores The Differences

In this week’s CBSdoc.com video, Dr. Jon LaPook conducts a two-part interview with a colleague who thinks he might be a hypochondriac. I miss New York.

Trial Lawyers Fight For Status Quo In Healthcare

In a surprise, President Obama has signaled a willingness to discuss medical liability as part of the health reform process.

Good for him for standing up to the trial lawyers, a core constituency of the left.

That’s a good sign, as the costs of defensive medicine brought on by the broken malpractice system, should be addressed if there is any hope of reducing health care spending.

Trial lawyers like to say that medical malpractice represents “less than one percent of the cost of health care,” but that fails to account for the substantial sum attributed to defensive medicine doctors practice to avoid the threat of malpractice, estimated to be $210 billion annually.

Furthermore, the argument that malpractice reform will harm patients “by limiting their ability to seek compensation through the courts” doesn’t hold water either.

That’s because the current system does a miserable job of compensating patients for medical errors, where more than 50 cents on every compensated dollar goes to pay lawyers and the courts. Not to mention that a typical malpractice trial may last years before an injured patient receives a single penny.

So, don’t believe the arguments of the trial lawyers, who prefer the financial security of the status quo.

Any alternative system, such as no-fault malpractice, mediation, or health courts, will go a long way both to reduce the cost of medical care, and fairly compensate more patients for medical errors at a significantly more expedient rate.

Lawyers are aware of these facts, and to their credit, are going on a preemptive offensive to head off tort reform. If I were the AMA, I would start pro-actively circulating some of the above talking points, rather than reacting to the trial lawyers.

**This post was originally published at KevinMD**

A day to celebrate humor and laughter?!!

It’s already March 19th and I don’t have any ideas for April Fool’s Day for my kids. I am desperate and need help. In previous years I have put gummy worms in their sandwiches, short-sheeted their beds, convinced them school was cancelled, given them mashed potatoes that looked like ice cream sundaes, and offered cookies with (fluoride-free, of course) toothpaste as the filling. Last year I tried to pretend I had broken my arm. While my adult friends believed me, my kids just rolled their eyes. So, as you can see, my ideas are not working anymore and I need something grand and convincing.

Humor has always been an important part of our family. When my children were younger, we used humor to convince them to do things they didn’t want to do. For instance, in order to get them to clean their rooms we would put shoes on our heads, walk to their rooms, and dump them in the closet. My older daughter’s favorite game was to dress up as Cinderella (in rags, of course) and have me shout orders at her — I was not allowed to say “please” because I was, obviously, the evil stepmother. It’s amazing how clean the playroom could become those days.

When my husband had a brain tumor, I used humor to temporarily destress an incredibly difficult time period. Those days it was not uncommon to see us eating jello through a straw, dessert before dinner, or ice cream without a spoon. One desperate day we all dressed up in our rain gear, with umbrellas, and took a shower together while singing, “I’m singing in the Rain.”

Last year my daughter had 2 friends spend the night before presenting a history project in a county contest. They had worked incredibly hard on this project while continuing their other demanding curriculum, and they were exhausted, nervous, and stressed. So I went to the store and bought shaving cream and whip cream. After dinner I sent them outside in old clothes and let them spray each other. They ran around for over an hour in the dark, laughing and playing. To this day they still talk about it.

Humor and laughter are an important part of our lives. They relieve tension, reduce stress, and provide us with a temporary distraction from unpleasant thoughts or lives. They allow people to forget about anxiety and pain, even if it’s momentary. Scientific studies that have even shown that humor improves overall health and, more specifically, the ability to fight off infections, decrease the risk of developing a heart attack, and improve blood sugar control . Psychologically, it has been related to decreased loneliness and depression, and improved self esteem and feelings of hopefulness . Laughter clubs and therapy have been developed and exist in and out of hospitals throughout the United States.

humor in our family (response to "smelly" fish)

humor in our family (response to "smelly" fish)

So, now you understand why it is so important for me to find some new, more exciting April Fool’s Day gimmicks for my family – ones that will really make them laugh! I am willing to share my “Vanilla” Sundae recipe with you, which has been used by many extended family members and friends.

April Fool’s Day Ice Cream Sundaes

Ingredients:

1. Instant mashed potatoes

2. Chocolate sauce

3. Whip cream

4. Maraschino cherry

5. Vanilla ice cream

Make the mashed potatoes according to directions and let them cool. Use an ice cream scoop to put 2 scoops in a bowl. Top with chocolate sauce, whip cream and, of course, a cherry. Serve. Have real vanilla ice cream available to serve so the victim can actually enjoy dessert in the end.

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