HONEST MEDICINE: My Dream for the Future

The "Kabuki Play" of Monied Interests Around the $1.1-Billion Comparative Effectiveness Research Initiative, By Daphne White, CHTP

(This column was first published by John Weeks on TheIntegratorBlog.com.)

John Weeks’ Introduction:

In this section of a two-part series, Integrator contributor Daphne White, CHTP focuses on the political-economic dynamics behind the $1.1 billion "clinical effectiveness research" (CER) initiative. White examines what she calls the "Kabuki play" - intense dynamics as the medical industry seeks to gut the value of the initiative, while not appearing to do so.

Would you assume that this initiative would look at cost or would inform the care people receive? As White points out, Congress appears to already have caved in on key aspects of apparent value. One wonders if CER can be the point of leverage for reform which White House Budget Director Philip Orzack thinks it can be. And if Orzack can't get what he wants out of CER, what might the integrative practice community extract from this big money battle in which maybe we can't, well, talk about money. In the other section, White explores the potential value of CER for the integrative practice community. 

I am among those who excitedly greeted the $1.1-billion "comparative effectiveness research"(CER) initiative in Obama's economic stimulus plan as an excellent direction for getting a handle on a medical system in which a third to half of care is deemed wasteful, and much of that harmful, according to our own Institute of Medicine. (See From Waste to Value in Health Care, JAMA, February 2008.) Not a moment too soon for the system, it would seem, and an excellent opening for integrative practice, particularly given the key backing by friends of integrative care.

Integrator contributor journalist, Daphne White does an excellent job of analyzing why this $1.1-billion piece of the Obama stimulus package may never live up to its value for consumers and for policy makers, and may have been partially aborted at birth. This is a sobering look at one of the first battle grounds for healthcare reform, 2009. Blood, it would appear, has already been shed via restrictions placed, at the request of the wasteful industry, by members of Congress who were doing their bidding. White takes you behind what she calls the "Kabuki play" she witnessed at the first 'listening session" of the Federal Coordinating Council for Effectiveness Research. Written comments can be submitted to the Council until May 31, 2009.

Comparative Effectiveness "Listening Session": Research, Politics, Evidence and Money

What happens when you mix together science, politics and $1.1 billion in government money?

When the issue is comparative effectiveness research (CER), the resulting brew is a Health & Human Services “listening session,” with 40 lobbyists, industry reps and advocacy groups each granted three minutes to speak. What you get is a three-hour-long Kabuki play: it’s long, it’s repetitive and it’s tedious.  And you sit there feeling that even though these people are speaking in plain English, what is coming out of their mouths is not even remotely connected to that thought bubble floating above their head.

Before we look at the action, let us review the back story, as explained first by Julie Rovner of National Public Radio. “That $2 trillion we spend on health care every year, every penny of that is someone’s income,” she told an audience at the Institute of Medicine last December, not mincing any words.  “The dirtiest word in health reform [is] not rationing … [it’s] redistribution.  Every time you take one of those dollars and give it to someone else, the donor is going to yelp and hire a lobbyist.” (ED: The text of Ms. Rovner’s statement may be found here.)

CAM and Comparative Effectiveness Research: Are We Going to Play? (By Daphne White, CHTP)

(This column was first published by John Weeks on TheIntegratorBlog.com.)

John Weeks’ Introduction:

The idea of "comparative effectiveness research" (CER), the new $1.1 billion economic stimulus program, strikes a happy chord for many in the integrative practice community. Isn't this the appropriate research terrain for showing value of integrative care?  In this first of two part Integrator series, reporter and regular Integrator contributor Daphne White, CHTP, shares how she attended the "listening session" of the government's CER advisory board to understand what was going on and see if the integrative practice community was showing up. White ended up taking off her journalist hat and testifying. She shares her perspectives on why and how the integrative practice community should be involved. White's second is a very well-reported analysis of the "kabuki dance" she witnessed as vested medical interests developed their strategies to make sure that the CER initiative does not gore their own oxes.    

CAM AND COMPARATIVE EFFECTIVENESS RESEARCH: Are we Going to Play?

By Daphne White, CHTP

When I walked into the HHS “Listening Session” on Comparative Effectiveness Research on April 14, the first thing I saw was a written statement from the American Academy of Orthopedic Surgeons and, for good measure, another from the American Association of Hip and Knee Surgeons.  I picked up a list of the presenting panelists, and found speakers from PhRMA, Johnson & Johnson, the Personalized Medicine Coalition, the Medical Device Manufacturers Association, the National Pharmaceutical Council, and a variety of patient groups (at least some of whom are heavily subsidized by the pharmaceutical and/or device industries.)

Where was the CAM and integrative practice community?  Missing in action, as far as I could tell:  if anyone was representing the acupuncturists, chiropractors, homeopaths or other CAM providers, they certainly weren’t leaving a paper trail.  Although I serve on the Advisory Board of Healing Touch International, I had not come with the intention of making a presentation.  I did not have an official (or even unofficial) statement. 

But since I was present and my CAM and integrative practice community did not seem to be accounted for, I took a risk and put my name on the list of possible last-minute presenters. Naturally, my name was selected and I had one hour to come up with a three-minute statement.  It seemed important, somehow, that CAM was represented at this “listening session.” As John Weeks said in a recent post, we need to start playing in all the playgrounds, just like the hip and knee surgeons.

The emerging policy debate around CER

Comparative effectiveness research (CER) is becoming a huge issue. Senator John Kyl (R-AZ) actually voted against the nomination of Kathleen Sebelius as HHS secretary because of her position on this very issue. At the other end of the spectrum, it turns out that CER is a “pet cause” of Peter Orszag, the director of Obama’s Office of Management and Budget. Orszag sees CER as “an opening to reforming American health care,” and a means of cutting unnecessary fat out of the system.  “They’re going to go after the provider community in a big way,” predicted James Capretta, who worked at OMB during President George W. Bush’s first term.

In fact, there is increasing talk among policymakers about placing more emphasis on wellness, prevention and primary care.  Isn’t that one of the areas where CAM and integrative modalities excel? Shouldn’t we be part of that comparative conversation? 

In their 2005 report called Complementary and Alternative Medicine in the United States, the Institute of Medicine noted that “the extent to which CAM use is a trigger for positive behavioral change is unknown […] and constitutes an important research issue because of the benefit of positive behavioral change to the public’s health.” Can we really expect the hip and knee surgeons to advocate for this kind of research? 

We talk among ourselves about “wellness” and “prevention” and “a heath care system, not a sick care system.”  Isn’t it time we took this private conversation public?

The fact is we are already players:  30 to 62 percent of adults in the U.S. already use CAM, according to the IOM report. And total out-of-pocket expenditures for CAM therapies and integrative practices were “conservatively estimated to be $27 billion in 1997,” according to the IOM.  “This is comparable to the projected out-of-pocket expenditures for all U.S. physician services.”

Getting the Word to Washington About What REAL Comparative Effectiveness Research Would Look Like

As followers of Honest Medicine know, I have personally witnessed and reported on the outrageous amount of money that is being wasted by our healthcare system on expensive treatments that don’t work, while at the same time, ignoring inexpensive, non-toxic treatments that do work. (For two examples, please read here and here; and please take your time, while reading these articles; their contents will trouble, even shock, you.)

Because I have personally witnessed this kind of waste, I am very much in favor of the Comparative Effectiveness Research (CER) that is being championed by the Obama Administration. A lot of money and three government agencies are being committed to this research. According to this March 16, 2009 Washington Post article, the $1.1 billion stimulus funds will be divided among 3 government bodies: the Agency for Healthcare Research and Quality will receive $300 million of the funds, while HHS and the NIH will divide the remainder. Also according to the Washington Post article, “Experts at the Institute of Medicine will spend the next several months prioritizing the research.” And, “For now, Obama has stopped short of advocating coverage decisions that combine clinical finding with cost effectiveness.”

All of this sounds very even-handed; very well-thought out. So, why am I afraid that -- although the administration’s words suggest that they understand that this waste exists, and that it must be controlled -- other evidence suggests that the only treatments that will be compared for effectiveness are the “same old same old” treatments that are considered to be “standard of care”? (Of course, treatments that are considered “standard of care” have undergone the “gold standard” of double-blind randomized clinical trials that have been paid for and supervised by Big Pharma! A troubling puzzle.)

Why am I concerned that only the “same old same old” treatments will be studied?

Julia Schopick’s Comment on the Institute of Medicine’s Proposed Panel: Comparative Effectiveness Research of Medical Treatments

I just posted the comment below to the Institute of Medicine (IOM), recommending that they include people with knowledge of integrative medicine on their panel that will be comparing the effectiveness of medical treatments. Click here to leave your own suggestions/comments about the composition of the proposed panel. (Comments will be accepted until March 23, 2009.) At the end of this posting, I'll give links to other websites with relevant information about this issue.

I urge you to access the above link and offer your own input to the IOM about this very important issue.

TO: The Institute of Medicine

I would like to thank the Institute of Medicine (IOM) for giving me this opportunity to submit my comments and recommendations concerning this panel, which has been slated to make recommendations for the $1.1 billion earmarked for comparative effectiveness research of medical treatments.

In my opinion, it is important to have the right people in on the job from the very beginning, so that the a full range of treatments will be compared, once the real comparative effectiveness research begins.

When I looked at the names on your site of the selected panelists, I could not help but notice that TWO very important groups are not being represented:

1) As has been pointed out by the Center for Science in the Public Interest, there are NO TRUE PATIENT OR CONSUMER REPRESENTATIVES on the panel. In their words, “the only patient or consumer representative named to the panel’s tentative roster was from the Alzheimer’s Association, a single-issue patient advocacy group that RECEIVES SUBSTANTIAL SUPPORT FROM THE DRUG INDUSTRY.” (A coalition of 20 consumer, public health and patient advocacy groups has written to the Institute of Medicine, asking that at least three consumer representatives be added to the panel.)

2) Also, and of equal importance: There are NO MEMBERS ON THE PANEL WHO ARE EITHER CAM PRACTITIONERS, OR CAM ADVOCATES. (By the acronym CAM, I am referring to complementary/holistic/”alternative”/integrative practitioners and patient advocates.)

I was amazed at (and extremely surprised and troubled by) both omissions. But I find the SECOND omission especially puzzling, since in late February, two extremely exciting events took place:

(a) First, the IOM convened a 3-day Summit on Integrative Medicine and the Health of the Public, which was attended by hundreds of people from across the country, excited at the prospect that the new healthcare system would include CAM treatments. The consensus was that the effective use of CAM treatments would save our healthcare system HUGE amounts of money. (Here is a description of this Summit, which integrative healthcare activist and Huffington Post blogger, Alison Rose Levy, called “groundbreaking.” You may also listen to audios of all the speakers’ presentations.)

(b) During the same week, Senate hearings were convened, with several integrative healthcare luminaries testifying. For a video of the complete hearing, go here. 

I would like to suggest that speakers at this hearing, including Drs. Andrew Weil, Mehmet Oz, Mark Hyman and Dean Ornish (as well as several of the Summit speakers and attendees), would be excellent additions to this IOM panel.

Burt Berkson, MD, PhD, Talks With Honest Medicine About His Work and Our Medical System: The Interview Transcribed

I know that several people have already listened to my interview with Dr. Burt Berkson and have found him to be truly inspirational. My decision to transcribe the interview (a very time-consuming process!) began because I wanted my 92-year old Mom to be able to hear it. I knew she would love it: She has been a fan of using innovative treatments, ever since she was 11 years old, when her own mother’s life was saved by going to Germany in the 1920s to receive a treatment -– radiation –- which was not yet available in the US. Since my Mom is now hard of hearing, I knew it would be very difficult, if not impossible, for her to listen to it. Hence, the transcript that follows.

I hope that others of you who are hard of hearing, as well as those without good computer speakers -- and others, who would simply rather read than listen -- will enjoy the printed version this terrific interview!

TRANSCRIPT

Hello, this is Julia Schopick, for HonestMedicine.com. Today, I am honored to have as my guest one of the few people in this world I consider to be a true visionary: Dr. Burt Berkson.

Dr. Berkson’s story, which you’ll hear today, is also the incredible story of how the pharmaceutical industry has kept one very valuable, inexpensive (non-income producing) treatment from becoming standard of care, even though it has cured many patients with some of the most life-threatening conditions for over 30 years.

This treatment is alpha lipoic acid, an antioxidant therapy that Dr. Berkson has been using successfully since the mid-1970s -- first to treat people with terminal liver disease; and then, in ensuing years, also to treat people with many other diseases and conditions, including diabetic neuropathy, several autoimmune diseases, and the very deadly pancreatic cancer -– the cancer that is considered to be one of the most hopeless.

You’ll notice that I haven't started out by listing Dr. Berkson’s credentials. Frankly, that’s because he has so many. Reading them would take too much time away from our interview. Instead, I am posting them on HonestMedicine.com.

Suffice it to say that Dr. Berkson has both an MD degree and a PhD –- the PhD degree came first. In addition, for 23 years he was the principal FDA investigator for the intravenous use of alpha lipoic acid. He is also the expert consultant to the Centers for Disease Control on alpha lipoic acid and liver poisoning. Dr. Berkson has published scientific papers in medical journals throughout Europe, and is an active scientific writer, researcher, and speaker. He is the author of 4 books, including The Alpha Lipoic Acid Breakthrough. I’ll have links to all his books on the website at the end of this transcript.

Today, Dr. Berkson has a very busy nutritional and integrative medicine practice in Las Cruces, NM, where patients come to him from all over the world. He is also an adjunct professor of applied biology at New Mexico State University.

JULIA SCHOPICK – Welcome, Dr. Berkson. The dramatic story of how you first used Alpha Lipoic Acid when you were a young medical resident is the stuff movies are made of. Hearing and reading about your experience was a paradigm-shifting event for me because it taught me, very sadly, that the medical establishment is NOT in the business of saving lives. Can you please tell us the story?

DR. BERKSON: I was a resident in internal medicine in a teaching hospital in Cleveland Ohio, and one day the chief of medicine came by and said, I am very upset with you.” And I said “Why?”. (I thought he was kidding.)  And he said, “You have no deaths on your service. Most people have seen several deaths by now and you haven't seen any.” And I told him that I really try to keep people alive. He said, “It’s very unusual. I’m going to give you two people who will surely die. They have acute and fulminant liver disease. They ate poisonous mushrooms, and the expert on liver disease said we cannot get a transplant for them, and nothing can save them.  So I want you to go upstairs, watch them die, take notes and present this to grand medical rounds.”

And I went upstairs and I looked at these two very sick people. And as a medical doctor, especially in internal medicine, you're supposed to follow the orders of the chief, just like a private would follow the orders of a sergeant.  But I had six years of education above my medical training, for a masters and a PhD in microbiology and cell biology, and I was always looking for new things. So I called Washington and spoke to the head of the National Institutes of Health in Internal Medicine, Dr. Fred Bartter, and I asked him, “Is there anything in the world that he knew of that might regenerate a liver?”  And he said he was studying alpha lipoic acid because he knew it would reverse diabetic neuropathy and other complications of diabetes. But when he gave it to people, it seemed to regenerate their organs. It seemed to stimulate their stem cells and to start growing and regenerating new organ tissue.

Audio Interview: Burt Berkson, MD, PhD, Talks With Honest Medicine About His Work With Alpha Lipoic Acid and Low Dose Naltrexone

It is my honor to introduce you to Dr. Burt Berkson, one of the few physicians I believe to be a true visionary. In this interview, you will hear the true story of Dr. Berkson's successful use for over thirty years of Alpha Lipoic Acid to regenerate livers and other organs. It is also the story of the unfortunate link between money-driven medicine and medical research.

Dr. Berkson’s story originates in the mid to late 1970s, just as the shift from true scientific research to pharmaceutical-company based (and pharmaceutical-company-controlled) research was beginning to take place.

This is the story of an inexpensive, very effective treatment which initially received support from the National Institutes of Health, but was, in the end, abandoned, because no pharmaceutical company would take up the expensive task of officially studying the drug.

In the meantime, though, several studies were conducted, including one, conducted by Dr. Berkson and the National Institutes of Health’s Dr. Fred Bartter, of 79 people with extreme liver disease. 75 of these people fully recovered. Still, no pharmaceutical company was interested in pursuing this drug.

Dr. Berkson suspects that this lack of interest was because liver transplants were becoming very popular and Big Pharma didn’t want to interfere with the business of making money. (Don’t forget. Big Pharma makes a lot of money producing anti-rejection drugs for patients who have undergone organ transplants.)

Dr. Berkson practices medicine in Las Cruces, New Mexico. Patients come to him from all over the world. I know you'll find Dr. Berkson's story fascinating.

DOWNLOAD DR. BERKSON’S INTERVIEW HERE:

(The Interview is also transcribed here.)

Pharmaceutical News by Press Release? (OR: Low Dose Naltrexone Study Doesn't Make the News)

In the article, “Statins (Crestor) for Everyone?”, I wrote about how the AstraZeneca-funded JUPITER study (JUPITER stands for “Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin”) made a case for putting many more people on statins, especially on AstraZeneca's own Crestor. In the article, I pointed out several troubling facts, including that studies funded by pharmaceutical companies are much more likely to have positive results than those that are not industry-funded, and that many of the “news stories” about the JUPITER study reported “the facts” of this study, almost word for word, as they appeared in AstraZeneca’s press release. 

In her November 14, 2008 Columbia Journalism Review article, "Science Reporting by Press Release,”  Cristine Russell calls this kind of “reporting” the “dirty little secret of journalism.”

The subject came up recently in a conversation I had with Burt Berkson, MD, PhD, pioneer in the use of alpha lipoic acid, and more recently, of low dose naltrexone (LDN), as well, for treating some very serious diseases and conditions -- without the side effects of more toxic pharmaceuticals. Dr. Berkson was telling me that, at one of the conferences he spoke at, LDN researcher Dr. Maira Gironi told about the wonderful results she was having in Italy, reversing multiple sclerosis with LDN. (You may read about Dr. Gironi's work with LDN here, here and here.)

Dr. Berkson noted: “But you hear nothing about it because there are no very wealthy corporations promoting it.”

Drug Companies & Doctors: A Story of Corruption -- by Marcia Angell, MD

INTRODUCTION: When an email from Vera Sharav alerted me to the fact that Dr. Marcia Angell, a woman whose writings I have admired for a long time, had just written a book review for the New York Review of Books, I was eager to read it -- AND, after reading it, I immediately decided that I wanted to print it, in its entirety, on HonestMedicine.com.

I want to thank both Patrick Hederman, the New York Review of Books' permissions/rights person, and Dr. Angell herself, who gave me reprint permission.

Although most of my readers probably know this, Dr. Angell is a former editor of the New England Journal of Medicine, a publication that most often is referred to as “prestigious”! For those of you who don’t know of her work, for years, she has been critical of the pharmaceutical industry and its financial ties to researchers, doctors and medical journals –- in fact, to almost every aspect of the conducting and reporting of clinical trials by the pharmaceutical companies.

Currently a Senior Lecturer in the Department of Social Medicine at Harvard Medical School, Dr. Angell is the author of the book, The Truth About Drug Companies: How They Deceive Us and What to Do About It, as well as, of several articles, including “Is Academic Medicine For Sale?,” published in the New England Journal of Medicine, May, 2000. I have quoted from her articles in several of my postings, most notably, in “Is It Possible Some Doctors Still Don’t 'Get' the Extent of Big Pharma’s Financial Ties to 'Standard of Care' Research?"

I am happy to reprint Dr. Angell’s most recent article here, and hope the New York Review of Books  won’t mind that I have provided hyperlinks to actual articles, instead of using footnote form (as is used in print publications.)

On a personal note, The New York Review of Books was one of my husband Tim’s two favorite publications. The other was Fanfare. Whenever he’d come across an article like this one, he’d say, “This one’s for you, Boo.” He always knew which articles I’d love. (You may read about Tim, and his love of books and music, here and here.

Drug Companies & Doctors: A Story of Corruption -- By Marcia Angell

 

(In this article, Dr. Angell reviews these three books. But her article is far more than just a book review!)

1) Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial -- by Alison Bass, Algonquin Books of Chapel Hill, 260 pp., $24.95

2) Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs -- by Melody Petersen, Sarah Crichton/Farrar, Straus and Giroux, 432 pp., $26.00

3) Shyness: How Normal Behavior Became a Sickness -- by Christopher Lane, Yale University Press, 263 pp., $27.50; $18.00 (paper)

Recently Senator Charles Grassley, ranking Republican on the Senate Finance Committee, has been looking into financial ties between the pharmaceutical industry and the academic physicians who largely determine the market value of prescription drugs. He hasn't had to look very hard.

Take the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard's Massachusetts General Hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age.

The Integrative Health Care Solution -- A 2-Part Series

♣ Part 1 -- For Tom Daschle and Barack Obama: Advocating the Integrative Healthcare Solution -- discusses WHY so many experts are now saying that best answer to our healthcare system is Integrative Healthcare, which is a combination of conventional and alternative medicine.

♣ Part 2: Seven of Honest Medicine's Articles / Audios Advocating Integrative Healthcare

 

Julia Schopick’s “Anecdotal” Medical Treatment Series: Eight Articles, So Far

 

I refer to the following eight articles as the beginning of my "Anecdotal" Medical Treatment Series. It is my intention to turn it into a book. Included in the book will be lots of information that is critical of the pharmaceutical industry, as well as of the very expensive clinical trial system -- both of which I believe play a huge role in keeping important treatments like the ones I describe here from being prescribed by American doctors.

 

1) ♦ Silverlon and Surgery: Our Search for Healing -- (Published in the National Brain Tumor Foundation’s Newsletter, SEARCH, Winter, 2003, Issue #54, as their cover article), I wrote this article in an effort to let the world know about Silverlon, so that other brain tumor patients wouldn't have to suffer the way my husband Tim did, when his suture line wouldn't close for eight months following his 2001 brain surgery. (Silverlon is the inexpensive, FDA-approved product that finally healed Tim's skin, which had become infected, and was leaking cranial fluid.)

Unfortunately, by the time I found Silverlon for him, Tim was already severely brain injured, as a result of the numerous "standard of care" surgeries his doctors had performed, in a vain effort to achieve the same result that Silverlon achieved almost instantaneously!

THE RESULT? As far as I know, Silverlon is still not being used in hospitals on post-operative brain tumor patients, like Tim, with non-healing head wounds. In these cases, doctors continue to operate on their patients' skin -- often over and over again, until the skin closes.

Why do they refuse to try something different? Because, they say, without “the studies,” Silverlon will continue to be an “anecdotal” treatment.

2) ♦ Four Lifesaving Medical Treatments: Not So “Anecdotal,” After All!

Here, I tell "The Rest of the Silverlon Story," about how my husbands’ doctors -- and the many other doctors who read our story -- were not at all eager to learn anything about how Silverlon saved Tim’s life. They preferred to just dismiss the product, and our success with it, as being “anecdotal.”

I decided that there must be other treatments that -- like Silverlon -- were saving lives, but that, also like Silverlon, doctors were NOT recommending to their patients.

I was right!