Thursday, March 12, 2009

Comparative Effectiveness Research

"Health Care and the American Recovery and Reinvestment Act," an article today's New England Journal of Medicine, should be read by anyone who has not been following the arcane details of the U.S. stimulus program.

The part of the article I want to focus on in this post is funding for comparative effectiveness research (CER). I've put my comments in bold italics:
On the medical research front, comparative effectiveness studies that directly compare the risks and benefits of different treatments for a particular condition are essential for improving practice and slowing cost escalation. Such studies, however, have been controversial; the pharmaceutical and medical device industries may not fund them, and some are concerned that the government or insurers may use the results to mandate specific approaches to treatment or to deny coverage.

I don't believe there is much public concern about CER. In every other aspect of our lives we compare the effectiveness and relative value of the options we must choose among. We also make personal rationing decisions every day when we decide that our resources require us to forgo a benefit - perhaps just a Latte at Starbucks, but possibly attending a lower cost college than our more costly first choice.

We are already seeing, however, a fear-mongering campaign against CER. Harry and Louise haven't come back yet but they will soon be reincarnated as the bogeyman of a "government bureaucrat getting between you and your doctor." More subtly, we will also see efforts to block research on the cost component of CER and to insert regulatory language that forbids Medicare to make use of CER in its coverage decisions!


...With the money allocated in the stimulus bill, the government will be able to fund many more [CER] trials, as well as clinical registries, clinical data networks, and systematic reviews. Indeed, the $1.1 billion in new funding for comparative effectiveness research dwarfs the current $334 million annual budget of the Agency for Healthcare Research and Quality, which will administer $300 million of the funds; the NIH and the DHHS will administer the rest.

We shouldn't expect CER to drive sensible health coverage on its own - that will require active, and often courageous, management and leadership. But as more and more studies are done an embarassment factor may set in for advocates who plead for expenditure of collective funds (public and private insurance) on costlier alternatives.

In addition, the act includes funds for a contract under which the Institute of Medicine will make recommendations (by June 30, 2009) for “national priorities for comparative effectiveness research.” It establishes a Federal Coordinating Council for Comparative Effectiveness Research, which will be composed of up to 15 federal officials (at least half of whom are physicians or others with clinical expertise) and chaired by the secretary of health and human services. The council will be tasked with recommending and coordinating research but will not be able to establish clinical guidelines or to “mandate coverage, reimbursement, or other policies for any public or private payer.

If the Federal Coordinating Council doesn't get hijacked by industry it has the potential of becoming an honest broker and public educator, much as has happened over time with the Federal Reserve. And having three agencies administer CER funding may make it more difficult for commercial foxes to capture the public chicken coop!
Comparative effectiveness research may seem like a wonky topic, but it is central to improving the disgraceful state of our health care "system." The president understands this. I hope that he will bring his superb communication skills to bear on educating us about the common sense validity of using CER to guide health care and the moral and fiscal necessity for doing this.

As a poignant lesson about what is at stake globally for health care, the article I've quoted is immediately followed by "A Lion in Our Village - The Unconscionable Tragedy of Cholera in Africa." A tiny fraction of the funds that produce no benefit at best and harm at worst could save thousands of lives elsewhere in the world!

2 comments:

Julia Schopick said...

Jim:

Thanks for this posting on CER. I also believe that we need to have CER, in order for our healthcare system to be efficient -– and not beholden to Big Pharma.

But I am worried about the possible glitches that are already revealing themselves. Rachel Walden, on the blog ourbodiesourblog.org (the blog that is run by the Our Bodies Ourselves people, who have been advocates for women’s healthcare for decades now), has written several pieces on CER. In her most recent (3-23-09), she points out that the instruments that have been created for consumer “input” are very user-UNfriendly. (See Rachel’s very balanced posting at http://tinyurl.com/d7o56f). Not a good sign.

But I am also worried that there will be another problem with the proposed CER, and I am hoping that you (and other healthcare advocates) will check into this potential problem, and will help me to bring it to the attention to those in Washington, DC, who are working on healthcare reform.

My fear: that the CER folks will end up recommending more of the “same-old-same-old” treatments -- AND that the “same-old-same-old” treatments they recommend will just be of a less costly variety than those that are already used! I fear this outcome because the only treatments that doctors in this country know about at this point in time are those that have been produced by (and are funded by) Big Pharma.

This could be a real problem since, according to many estimates -- including estimates made by John Abramson, MD, in his eye-opening book, “Overdosed America” -- Big Pharma now funds a huge percentage of this country’s clinical trials. I've seen the estimate as high as over 80%!

With this in mind, there is an important point that NO ONE has yet adequately addressed when discussing CER. That is, that several extremely effective, lifesaving, inexpensive treatments may be completely LEFT OUT of the comparative effectiveness research mix. Why? Because they are treatments that are NOT manufactured by Big Pharma.

I am referring here to two kinds of treatments: (a) “alternative” treatments; and (b) several science-based treatments that are, unfortunately, often unfairly labeled “anecdotal.” These treatments are called “anecdotal” for (as far as I can tell) only one reason: that they haven't gone through the billion+ dollar double-blind randomized clinical trials. And one important reason they haven't gone through these trials is that the trials are most often conducted and paid for by Big Pharma. (And Big Pharma, of course, is NOT interested in conducting trials on treatments that won’t make them Big Money -– or that are in conflict with other money-making pharmaceuticals they already manufacture.)

I have interviewed pioneers in the successful use of several of these science-based, so-called-“anecdotal” treatments on my website, HonestMedicine.com. The specific treatments I have written about so far are: LOW DOSE NALTREXONE for autoimmune diseases, such as multiple sclerosis and lupus; the KETOGENIC DIET for pediatric epilepsy; and INTRAVENOUS ALPHA LIPOIC ACID, for diabetic neuropathy and organ regeneration.

Each of these three treatments has been helping thousands of people with very serious, often life-threatening conditions for OVER THIRTY YEARS. (I urge you to read this article -- http://tinyurl.com/cspj99 . It contains lots of hyperlinks to information that explains the background of Big Pharma’s lack of interest in these treatments.)

Why, then, don’t I think that these treatments (and others like them) will be included in the comparative effectiveness research?

For a glint of “proof” that my suspicions may be well-founded, please go to http://tinyurl.com/bfc6wg, for a video of the recent Senate Hearings on Integrative Medicine and the new health plan, where Drs. Mehmet Oz, Mark Hyman, Andrew Weil and Dean Ornish testified.

There, you will find the following interchange between Dr. Mark Hyman and Sen. Tom Harkin (at 142:00 to 142:36) :

DR. HYMAN: (re the Comparative Effectiveness Research that will be done to determine which treatments work best for patients): "What are we comparing things TO? Drug to drug? Procedure to procedure? Or are we comparing the current medical practice with the best available things we're talking about [e.g., integrative treatments]?"

SEN. HARKIN: "I'm afraid -- I share your fear -- that it's going to be a comparative analysis between this treatment and that treatment.”

DR. HYMAN: "Within the allopathic model."

I realize that in this particular discussion, Dr. Hyman and Sen. Harkin are referring more to “alternative” treatments. But when Dr. Hyman talks about the “allopathic model,” he really is, of course, referring to the PHARMACEUTICAL COMPANY MODEL. (It’s the only model the American Medical System acknowledges at this time.)

To listen to my interview with Dr. Burt Berkson (MD, PhD), pioneer since the 1970s in the use of Intravenous Alpha Lipoic Acid, please go to http://tinyurl.com/cgfjh3 . In it, Dr. Berkson speaks eloquently about how our medical education system teaches doctors NOT to be curious about more innovative, less expensive treatments -- such as the three I have written about, both here and on my website.

I realize that my comment here contains almost "too much information." But I hope that you will check out all my links, and join with me to help get "the word" to the folks that will be administering the CER in Washington, DC.

I wish us ALL the best of luck with our new healthcare system!

Thanks very much.
Julia Schopick
www.HonestMedicine.com

Jim Sabin said...

Hi Julia -

Thank you for this very full, constructive and informative comment. And, thanks for guiding me to your excellent website and the Our Bodies Ourselves blog, which I'd not seen before.

I agree that clinicians and CER should be open to a wide range of interventions. In my practice, when patients told me they wanted to try "alternative" methods I followed a three step sequence: (1) was there any reason to see the "alternative" approach as dangerous? (2) was the person open to approaching use of the "alternative" in a scientific manner? If the answer to (1) was "no" and to (2) was "yes," then my inclinication was (3) "let's hope for the best, see how it goes, and learn from the experience..."

I've taken the liberty of copying the biography you wrote on your website below. You tell a vivid and moving story, and I thought readers of this blog would appreciate seeing it.

Best

Jim
***
Biography
I have created this website, HONESTMEDICINE.COM, in honor (and memory) of my late husband Tim Fisher, who has been my inspiration ever since we met over 25 years ago.

During much of our life together – from 1990 until his death in 2005 --Tim and I were to experience the medical system at both its technological best and its chaotic, uncaring worst.

Our medical odyssey began on September 15, 1990, with Tim’s first diagnosed grand mal seizure; two weeks later, he underwent brain surgery for a huge, cancerous tumor “the size of an orange.” This was soon followed by chemotherapy and radiation; and throughout the years, there were many complications -- seizures, stroke, more surgeries, etc. -- from these initial treatments.

Tim died by my side on November 8, 2005.

During those 15 years, most probably because we knew our life together would be shortened, Tim and I lived life fully and enjoyed some truly wonderful times -- interrupted, of course, by medical crises and lengthy hospitalizations.

Our odyssey through the medical system is what led me to my mission to change the way people interact with this system.

The day I realized that his doctors didn’t have all the answers was the day Tim and I started to work together to find treatments that might extend both the length and the quality of his life -–and by extension, our lives.

Fortunately for us, we both believed that several of the treatments we found lengthened Tim’s life by many years. (The truth is, he outlived his prognosis by at least 10 years!)

But the truth also is that, in far too many cases, his doctors (especially the specialists) were not at all open to the treatments we found. So, for much of the time, we were on our own.

Tim and I both came to believe that the medical profession (or “medical industry,” as we often referred to it) was in dire need of change. Naively, I vowed to be personally responsible for making some of these changes singlehandedly. In fact, one day, I confidently announced: “Before I die, I intend to change the medical system!!” To which Tim replied, with that wonderfully skeptical stare of his: “Jule, you know that’s ridicu. . .” Then, he paused, looking quite terrified, and said: “Knowing you, I think you may actually do it!”

I have long ago given up on the idea of changing the medical system. Frankly, I no longer think it’s possible. But many years after I made that confident (no, arrogant) statement, I still fervently believe I can help people by educating them and giving them confidence, so that they will be able to change themselves. If they become more knowledgeable, hopefully, they won’t need to use this flawed medical system so much; and when they do need to use it, they will be in a more educated, powerful position.

That’s what I hope to accomplish with HONESTMEDICINE.COM. Thanks very much for joining me!
***