Oct 23, 2013

Do You Believe in Magic? Topol, Offit on Alternative Medicine


Medscape
Eric J. Topol, MD, and Paul A. Offit, MD

In this edition of Medscape One-on-One, Eric J. Topol, MD, and Paul A. Offit, MD, discuss Offit's new book, Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine. In his book, Dr. Offit takes a look at the billion-dollar, unregulated supplement, vitamin, and alternative medicine industries.



October 2, 2013

Editor's Note: Introduction 
Dr. Topol: Hello. I am Dr. Eric Topol, Editor-in-Chief for Medscape. We have a great session of Medscape One-on-One today with Dr. Paul Offit, who is the head of the Infectious Diseases Division at the Children's Hospital of Philadelphia (CHOP).

He has written a very interesting book that takes on the whole supplement, vitamin, alternative medicine, and complementary medicine era. It's really a delight to be able to welcome Paul to Medscape. Welcome, Paul. It is great to be with you.

Dr. Offit: Thanks, Eric. Thanks for having me.
Positive Reaction to a New Book

Dr. Topol: Back in June, you published the book Do You Believe in Magic? What has been the reaction so far?

Dr. Offit: It has been overwhelmingly positive. It is surprising, actually, certainly from academics or those interested in communicating science or health to the public, it has been embraced. People are glad that somebody stood up and tried to explain this in a reasonable way. But not surprisingly, I have also gotten some pretty negative responses because, in a sense, I have attacked the church of vaccines and dietary supplements, and that belief system has been defended by some. 


Exploring Linus Pauling's "Dark Side"

Dr. Topol: You have taken on an industry that takes in almost $40 billion a year -- just immense -- and it has a lot of constituents. I just finished your book. I thought it was excellent, and I learned a lot from you and the research that you did. You had a whole section on Linus Pauling,[1] and obviously he was a legendary scientist. But it seemed like he went over to the dark side -- that is, he believed in magic. Was he really the one that ushered in this era of all the alternative medicine and the vitamins? Or was it actually already there before Linus Pauling?

Dr. Offit: Well, certainly the notion of alternative medicine has been around for 5000 years. Things like acupuncture or using plants as medicinals have been around forever. I think what Linus Pauling did was give birth to the notion that megavitamins -- meaning these large quantities of vitamins greatly in excess of the recommended daily allowance -- have a vast array of beneficial activities. They could cure the common cold. They could cure cancer. They could prevent aging.

He gave that its impetus because he was a brilliant man. He is the only person ever to win 2 unshared Nobel prizes. In many ways he launched the fields of molecular biology and evolutionary biology. He received a Nobel Prize in chemistry as a very young man because he was able to formulate these secondary structures for proteins. He was amazing.

He was a rigorous, thoughtful scientist, and then something happened to him in his mid-60s. Maybe it was just the sin of hubris because he had been so right for so long, where he believed that his notions about megavitamins were correct even when study after study showed that they weren't correct.

Dr. Topol: I was amazed about how he was only 30 when he got the Nobel Prize in chemistry, but it seemed like he snapped along the way. Then, because he was so highly regarded, that had a big impact on American culture.

The Oprah Effect

Dr. Topol: Another part of the story that seems to have had a big impact in the United States is the Oprah effect of creating monsters, if you will -- although you didn't use that term, I don't think. But there are 3 physicians that she kind of brought to the floor. We are going to talk about celebrities in a minute, but Oprah brought 3 physicians to the forefront: Mehmet Oz, Andrew Weil, and Deepak Chopra. And it seems like all 3 of them, as you reviewed in your book, had a big amplification of their impact -- if not even the beginning of their stardom -- with Oprah. Do you want to comment about that?

Dr. Offit: Oprah has a tremendous stage, and she has been very good about many things -- especially, for example, getting this country to read more than they would have otherwise. She is a sympathetic figure who likes to promote people whom she views as potential victims, and in that way she has been very good.

But with regard to science and medicine, she has been pretty awful. She was on the cover of Newsweek with a picture that made her look frankly a little crazy -- and it read just that.[Editor's note: The cover story of the June 8, 2009, issue of Newsweek was "Crazy Talk: Oprah, Wacky Cures, & You."] It was sort of Oprah's crazy science. She gave birth to Jenny McCarthy in many ways and Jenny McCarthy's notions that vaccines could cause autism. And she has given birth to Deepak Chopra -- certainly launched Deepak Chopra and such people as Mehmet Oz -- and she likes at some level the guru phenomenon.

I think that is what Oz and Chopra and Weil all have in common. They sort of present this notion of medicine as a guru, sort of, "Listen to me." And medicine is not that. I mean, science is viewed by some as distant, technological, and cold. What people like Oprah, and like Oz, Chopra, and Weil, do is imbue their medicine with a kind of spirituality. It becomes a matter of them and their personality rather than the data, which is always a little dangerous.

Dr. Topol: Why do you think they are so successful? Is there just this extraordinary need to have the wise leader and the spirituality? Is there a craving for that out there? What do you think is the real underpinning?

Dr. Offit: I think that is it. I don't know if you remember the TV show Star Trek, but there was the doctor on that show -- Bones McCoy. He would take this scanning device, and he would scan up and down, look on that device, and that was the diagnosis. It was immutable. It was clear. There wasn't any question about it, and that is just not medicine.

With medicine, we certainly will know far more 100 years from now than we know now. There is much about medicine that stymies us, but that is not these guys. People like Oz and Chopra and Weil have a certain surety and immutability that I think is very attractive because the fact is that medicine does have limits, and yet that is all we have right now. They sort of go to a level beyond that, and I think that is extremely attractive.

People will say you can't trust science because, for example, one study will show one thing, and then that study will be shown to be incorrect. And you and I would argue that that is good. That means that science is self-correcting. We can take a textbook and throw it over our shoulder without a backward glance as we get more and more information, but to some people that mutability and fluidity is viewed as disconcerting. They want something that is surer, and these people provide that in their books. You look at Andrew Weil's books. He tells you how to be a friend, he tells you how to make low-fat salad dressing, he tells you how to live your life -- and that is attractive.


A Look at Fish Oil

Dr. Topol: You gave a pass to certain things in your book, which I was a little surprised about. For example, you were kind to fish oil. And you probably saw the big paper in the New England Journal of Medicine ? It was a big Italian study that showed that fish oil didn't do anything for preventing heart disease. Would you revise? Would you be a little tougher on fish oils if you were to get the most updated information, or do you still think there is a place for fish oil?

Dr. Offit: Absolutely. Harper Collins is the publisher; it is a big publisher. This book was written a year and a half ago, so it takes a while to get those books out. I absolutely would revise it, and there were some recent studies that showed that at least the antioxidant part of omega-3 fatty acids actually could increase your risk for such things as cancer, so I absolutely would revise it. That is the problem with books -- they are written at a specific point in time.

The Confusion Over Vitamin D

Dr. Topol: I'm with you. I know full well what you are alluding to there -- the delay. Now what about vitamin D? You were kind of positive about some indications for vitamin D. But there is a lot of confusion about what should be a population level of vitamin D that is good for people. Do you have any comments about that particular supplement?

Dr. Offit: Suddenly we are all vitamin D deficient, and the level has changed and now the normal range has been revised so that everybody seems to be vitamin D deficient. Certainly, vitamin D is of value for the child who is exclusively breastfed. The mother doesn't get outside very much. The child doesn't get outside very much. Absolutely, vitamin D is of value there. Otherwise, regarding bone thinning -- the use of vitamin D plus calcium -- I think the data just aren't clear. They are certainly not compelling, and I think 10 years from now we are going to look back and ask, "What is this vitamin D craze?" and be past it.

Dr. Topol: You know, out here in California, my patients come in and they typically have a list of 20 or 30 supplements and vitamins that they're taking. Some of it I have never heard of -- just ridiculous stuff. But invariably, they are taking high doses of vitamin D, and typically they're taking vitamin E, which as you point out is harmful. So it is pretty scary what goes on out there.

Chelation Therapy for Coronary Disease

Dr. Topol: Now another trial that is new since the book came out is the chelation trial for coronary heart disease, and a lot of us felt that it was kind of crazy to put National Institutes of Health (NIH) money, big money, into a chelation trial. But that was reported in JAMA, and it created quite a stir a few months back. What are your views about chelation for prevention of coronary disease?

Dr. Offit: I think there are no data to support its use. I think it is clear that certainly chelation can be harmful. I mean, the Centers for Disease Control's (CDC's) Morbidity and Mortality Weekly Report [2]has reported a handful of children and adults who have died owing to chelation therapy because chelation therapy can chelate calcium, which is important for electroconductivity of the heart, and there have been heart attacks from this therapy. And certainly children with autism who have been treated with chelation therapy have died because of chelation therapy.

So if you look at that chelation trial -- which surprisingly was published in JAMA, given the inferior quality of that study -- it really didn't isolate the one variable they meant to look at: chelation. There were a number of variables in that study, and I think as a consequence it was a useless study. It was a lot of money that was wasted. I think that the consumer should say that at this point and for right now, there are no data to support the use of chelation and there are no clear benefits, although there certainly are clear risks. I would argue that the risks outweigh what are at best theoretical benefits.

Dr. Topol: As you pointed out, there were a lot of other things in the chelation mix that were administered to study participants. And they had a lot of issues with that trial.

Resveratrol: Looking for the Fountain of Youth

Dr. Topol: Now one thing that you didn't get into -- and this has had a much more scientific story with the study by David Sinclair and the group at Harvard[3] -- is resveratrol and its effect on antiaging. Thoughts about that one?

Dr. Offit: The antiaging industry itself is about a $6 billion-a-year industry. It is a huge industry. The notion that we can in some ways turn back the clock has been something that has been attractive to us ever since the days of Ponce de Leon. We are always looking for the fountain of youth, and we do live longer than we used to, but the reason that we live longer than we used to has everything to do with the way that we live and nothing to do with the way that we age.

We have had vaccines. We exercise more. I think we are more careful about our diet, about eating more fruits and vegetables, and trying to avoid stress. All of that has contributed to our living longer, and I think that you can take this entire antiaging industry and say that it has contributed nothing to why we live longer.

I wrote this book because there are about 54,000 dietary supplements on the market; I wanted to find things for which there was clear evidence that they were of value, and so I came up with, for example, folic acid for the pregnant woman. I think you can argue that melatonin actually is of value at some level regarding insomnia. There are even some data that St. John's wort is maybe of value for someone who is mildly depressed. The problem with the industry, though -- and this is what I had trouble getting around -- is that it is unregulated. So you may have a study that shows St. John's wort as having value in mild depression, but it is hard to compare one study with the next because the label that is on the bottle may in no way accurately reflect what is in the bottle because it is unregulated.

What's Really in the Bottle?

Dr. Topol: That is a key point. A number of years ago in The Lancet,[4] you may recall, and I think you referenced it in the book, there was a very nice randomized trial of glucosamine for knee osteoarthritis. But the problem, of course, is that the preparation that was used in the trial -- the one positive trial -- you would have a hard time finding that particular preparation and dose because, as you say, it is an unregulated industry.

I didn't know the background about how unregulated the industry is until I got into your book. I found it fascinating that this cartel of vitamin supplement companies came together in Santa Barbara and put out this big campaign with Mel Gibson [featured in commercials]. That was amazing to me. I really learned a lot about Sen Orrin Hatch (R, Utah) [and his role in the Dietary Supplement Health and Education Act of 1994 (DSHEA).[5]] Can you comment about the politics and the background that has prevented the US Food and Drug Administration (FDA) from having their rightful oversight of this humongous area of health and medicine?

Dr. Offit: It is exactly what you would think it is. Because it now is almost a $34 billion-a-year industry, there are a lot of people making a lot of money, including big pharmaceutical companies. Pfizer bought Alacer recently, which is probably the biggest maker of megavitamins in the United States. Hoffmann-La Roche has been a player in the megavitamin and supplement game since the 1930s.

People have this sort of false notion that there is big pharma on one side and then on this other side, there are just a group of people who want to make natural products, and that they are being made by elves and old hippies on mountainsides. That is not the way that it works, and not surprisingly, when you have a big industry, which at least up until the early 1970s was unregulated, initially the interest by the FDA was to regulate the megavitamin industry -- because they felt that there was no clear evidence that giving vitamins at 150% or more of the recommended daily allowance was of value, and they worried that it would be harmful. At the time, there weren't data to show that it was harmful. Now there are. Now there are more than 20 studies to show that if you take large quantities of vitamin A or vitamin E or beta-carotene, which is a vitamin A precursor, you actually increase your risk for cancer and increase your risk for heart disease.

I believe that if this were a regulated industry, there would be a black box warning on these megavitamins, and this is a problem. I will give you another example. I walked into a GNC store about a week ago and bought a vitamin E preparation that said "natural vitamin E" on the front. On the back, it said "3333% of the RDA" (recommended daily allowance). That is 33 times the recommended daily allowance.

This one capsule was about maybe half the size of an almond. Almonds are an excellent source of vitamin E. You would have to eat 1650 almonds to get what was in that 1 capsule. How is that a natural thing to do? I think if people saw this for what it was, they would be suspicious, and they should be more suspicious about what the word "natural" means.

The industry has been able to keep the FDA at bay, and I don't see this changing anytime soon. So not only do we not know what the potential harms of these products are, not only do we not know that a lot of these claims are simply false claims, but we don't even know what is really in those products. I mean, what is on that label may in no way reflect what is actually in that product.

Look at what happened with this vitamin-maker called Purity First. Purity First, a few weeks ago, had all of its products recalled by the FDA. They made 3 products. They made vitamin C. They made a multimineral preparation, and they made a B-complex vitamin preparation. What happened was there were 25 women in Connecticut who started to develop symptoms of increased hair where they didn't want hair to be, deepening of the voice, and loss of menstrual cycles because they were inadvertently taking anabolic steroids. Anabolic steroids had contaminated those preparations. How does that happen? And yet, when it was taken off the market, the CEO of that company said, you know, it is just big pharma trying to shove out the little guy.

Their vitamins were contaminated with anabolic steroids. Just imagine if vaccines were inadvertently contaminated with anabolic steroids. You would never hear the end of it, but here somehow it all gets a free pass.

Dangerous Side Effects of Little Consequence

Dr. Topol: But Paul, what I don't understand is that you have got large randomized trials published in the highest-impact, most highly regarded journals that take down, like you said, vitamin E, beta-carotene, and vitamin A for various things -- and yet no information goes to the public. There is no oversight. How is this going to get fixed? This is really a very sorry state, don't you think? And you just reviewed another poignant example.

Dr. Offit: You know this better than anybody. I mean, when Vioxx (rofecoxib) was eventually clearly shown to increase one's risk for heart attacks, you knew it. The FDA regulated Vioxx. They put out media releases, and ultimately that product was taken off the market.

Here, because the FDA really doesn't have oversight, they are really only in a reactive mode. When will they get to the point where they take vitamins off the market because they have clearly been shown to be a problem? I don't see it happening until the FDA regulates them, and until the consumer gets smarter and says, "I want to know what I am buying. I want to know whether or not these claims are real or whether there are harms that are in this product. I insist that the industry be regulated."

But that is not how people think about these products. They think about this as their medicine -- their specific, own personal medicine. I can walk into the GNC store and shrink my prostate and reduce my stress and boost my immune system. I don't want the government telling me about this, even though what the government may tell you if they regulated it is that these aren't what they claim to be and the harms are not apparent, but they are there.

Dr. Topol: We are just laying out the facts-- the facts from rigorous research, which set this straight -- and that is the one thing I would have loved to have seen toward the end of your book: recommendations on how we can fix this mess that we are in. That's OK. There is a lot there.

There are a few other things I want to touch on with you. This is just great to have the chance to interact. Now let's talk about the Lyme disease stuff you write about. You called out former Attorney General Richard Blumenthal, who now is a senator of Connecticut, [about his actions on Lyme disease]. I don't know if you saw the New York Times editorial saying that he is introducing further legislation on this.[6] Do you want to comment about how chronic Lyme disease is just kind of intermixed with this tough topic? You had a whole chapter on it.

Dr. Offit: Well, in a better world, obviously politicians wouldn't get involved in science. I think when Orrin Hatch gets involved, and as has former Rep Dan Burton (R, Indiana), we basically had champions of the alternative medicine industry. It should never be about that. It should always be about the data. Is the science there to support a claim? Is the science there to support safety? In a better world, that should be the only thing that we look at.

Blumenthal became very sympathetic, for whatever reason, for those who believe that, despite treatment for their Lyme disease -- or even in those who never had Lyme disease -- that these chronic symptoms were because of this so-called long-term Lyme or post-treatment Lyme disease, which we now know doesn't exist. I think he really did a lot of harm to those people. It certainly meant that there were a lot of people who received antibiotics far longer than they needed to and suffered the consequences of long-term antibiotic therapy, or worse, these crazy kinds of therapies that are associated with this made-up disease, chronic Lyme. I think this is probably an area that is unique in the alternative medicine world. Usually where alternative medicine thrives is where medicine has little to offer.

For example, we don't know the cause or causes of autism. Clearly, we don't have a clear treatment for autism. There are certain cancers, such as pancreatic cancer or brainstem glioblastomas, for which we have very little to offer. That is often where you will see the alternative therapist -- the charlatan, frankly -- step up and say, this is what your doctor doesn't want you to know, this is what the pharmaceutical companies don't want you to know, but we have a treatment.

What is unique about chronic Lyme disease is that they basically made up a disease: "You can have chronic Lyme even if you live in a state that doesn't have ticks that carry Lyme bacteria." So they sort of broadened their market and then used some of these therapies -- malaria therapy, for example -- and that was criminal.

Alternative Medicine and Celebrities

Dr. Topol: We have covered the politicians and the doctors. The last topic we didn't really touch on too much was the celebrities. You called out 2 major ones: Suzanne Somers and Jenny McCarthy. At one point, you even ask why the public is so into Suzanne Somers when there is a really good resource like Siddhartha Mukherjee, an oncologist, who wrote a wonderful book on cancer, The Emperor of All Maladies. Why can't the public have a go-to figure who is trustworthy and knowledgeable, rather than somebody who just invents facts and has an immense impact through media support? Why can't we get this thing straight?

Dr. Offit: I think we tend to trust celebrities and their message because we feel that we know them. Celebrities have been selling products since the beginning of time. Because you see them on the big screen or you see them on the little screen, that familiarly breeds a certain level of trust. We don't know scientists. Name a famous scientist in the past 10 years whom people would know by sight. I don't think we could name one, so that is it.

Siddhartha Mukherjee is a Rhodes Scholar. He trained at Cambridge and then Harvard. He has an expertise and experience in cancer. He wrote a Pulitzer Prize-winning book that really explained cancer for the general public, and yet he is not the person the media go to when they are trying to explain cancer; it is Suzanne Somers. And who is she? She was Chrissy on Three's Company. She was the promoter of the ThighMaster. That is what recommends her to this, and it is sad, but it has always been true. I don't see that changing.
Dr. Topol: And Jenny McCarthy now is going to be on The View and have undue influence. She has already hurt so many kids with the autism vaccine myth -- it's just endless. How are we going to take the reins on this problem? Is there any solution in sight?

Dr. Offit: I don't think The View was ever the Algonquin Round Table, but this is pretty bad even for them. It's a little depressing. I am going to predict that she actually doesn't say much. I think that the antivaccine movement, at least as represented by her, has really lost a lot of steam lately, and this may sound a little counterintuitive, but I think Andrew Wakefield really hurt them. It is not only that he was wrong; it is that he misrepresented data and was wrong, and I think a lot of people were put off by that.

Meditation and the Placebo Response

Dr. Topol: I am not sure that the whole world knows about that whole Wakefield story, but it is nicely reviewed in the book. Now I want to ask your opinion.

We here in San Diego are very close to the Chopra Center. Deepak Chopra, MD, is up in Carlsbad, just a few miles away. He wanted us to use our digital medical tools to understand the physiologic response to meditation, and so we are going to do a study with various sensors (not only EEG but also vital signs and autonomic nervous system metrics, such as galvanic skin response and heart rate variability -- the whole shooting match) to see what happens with meditation. I kind of like that, because we are going to get some objective data, and that is what this field is missing. Do you think that it's OK that we are going to embark on that kind of study?

Dr. Offit: I think it is important. The one thing that changed my mind in writing this book was that when it was originally conceived and written, it had a different title. It was called "Quacks: How They Hurt Us and Why We Let Them." I changed it, and you have seen the last chapter of the book. I talk a lot about the placebo response and the physiology of the placebo response. And because it is real, I think in many ways it is physiologically based.

Can we learn to relieve symptoms with our own endorphins? Can we learn to upregulate and downregulate our own immune system, release our own dopamine, and affect our own mediators of stress, which can have broad negative effects? Yes, I think that is all true, and it is all studyable, and that is why I think that what you are saying is so important. I think Mehmet Oz, for example, will go on his show and will talk wondrously about acupuncture, which no doubt benefits people, and it may be because they are learning how to release their own endorphins.

We don't have to look to the gods to explain these things. We can look into ourselves and try and figure out the physiology so that we can then learn to evoke these behaviors at lowest risk, lowest burden, and lowest cost. I think that is important.

Dr. Topol: The last thing I wanted to ask you about was indeed the placebo effect, because that story is just so rich, and obviously it is not just endorphins and dopamine squirts. You can tell a patient, "I am giving you a placebo," and people get better even when knowing that it's a placebo, so there seems to be a whole science of placebos. Why aren't we actually just calling it placebo and giving placebos in our medical practice and studying it more?

Dr. Offit: First of all, we used to. I am old enough to remember my pediatrician coming to my house -- Dr. Milton Markowitz, who eventually became dean of Connecticut's medical schools and is a very smart man. I remember looking through his big black bag, and he had a bottle in there of these small pills. I asked him what they were, and he said that they were sugar pills for people who were going to get better anyway who just needed to feel that they were taking something. And I thought this was great, because in my little doctor's kit at age 5 I also had sugar pills, so I thought, I am well on my way.

You are right. I think the question is, is it ethical to deceive, and at some level I think the answer is yes. I think we do it all the time. At Children's Hospital of Philadelphia, when we give medicines, we often will say, "We really think this is going to work for you." I think that is part of it. We wear white coats with red lettering. We have big fancy equipment that makes interesting noises. I think people come in with an expectation of therapy, and that goes a long way toward being therapeutic.

I wish we had a word that was different from "placebo," because when people hear that word, they think it is dismissive -- that it is just all in their heads. But in fact it can very much be in their bodies, and so I think it is all worthy of study.

Dr. Topol: This has been so much fun to talk to you about your book. Thanks for all the hard work and research you did to put that together. I give you a lot of credit. I think the whole medical community should be indebted because you have taken on vaccines, the antivaccine movement, and now with this project you have taken on a tough, tough area. Hopefully this will somehow spark some improvement; there is a lot of improvement that could be had here. Thanks a lot, Paul. I really enjoyed the discussion with you.

Dr. Offit: Thank you, Eric. I appreciate you having me on.

Dr. Topol: Well, that is it for Medscape One-on-One today. We're really indebted to have Paul Offit with us, and we will be back with more hopefully interesting looks into various topics that will be pertinent to medical practice and the health of our population in the times ahead. Thank you.