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...I was not a well published veteran of academic affairs, but the data spoke for themselves, they made the case convincingly with really excellent science that these are the facts, incontrovertible as they are. And that was the beginning....That was the first time the American medical community saw the extent to which complementary, alternative, integrative, unproven therapies were part of the American medical system.
What does the phrase 'alternative medicine' really mean?
What do we mean by alternative medicine or complementary medicine? I, as a board certified internist on the faculty at Harvard Medical School, am not a fan of any of these labels - complementary, alternative, unproven, disproven, unconventional, integrative even. I'm in favor of comprehensive health care. I think that's at the common core of all of this. What are the best options for a given patient in a given situation? And the goal is not to integrate a little of this and a little of that, but to create a comprehensive health care program which we now call integrative care, which incorporates the best of conventional evidence-based Western bioscience with evidence-based complementary therapies. …
What are the different kinds of studies and existing research? Are some studies more reliable than others?
It usually takes several studies looking at the same question from different frames of reference for a consensus to be built, particularly among skeptics...There are observational studies, sort of empiricism. This is what we all do in life, you see that something appears to be helpful for something else and you use it...[In] observational experiments, you give a certain therapy to a group of patients that have headache or a cold, many appear to get better and the observation is many appear to get better. That's not enough.
There's also something called anecdotal evidence, the story of one patient who had an extraordinary response to a therapy. This patient took that herb or followed this diet or took this drug and remarkably their serious illness went away. Was it related to the herb, the diet, the new drug, or was it just chance, it was going to go away anyway? Even though the likelihood was small, it happened.
Then there's the study that says, is this approach or this therapy better than no therapy? Or is this approach better than the old therapy? Now we're talking about a controlled experiment, whether this drug works better than no drug, or this surgery is better than just watching and waiting. These are controlled experiments. To do a controlled experiment you have to have two groups, one group that gets the therapy and one group that doesn't...The higher standard is a controlled experiment.
Can something that you believe works withstand my attempts as a skeptic to prove that it's worthless? That's the highest standard. And to do that you need to do a controlled experiment where you give the therapy that you think is valuable, you contrast it with a therapy that for all intents and purposes looks, smells, feels, tastes, identical, and then say, did the therapy you believe in do that much better than the other one? That's a controlled trial and if you use humans it's a controlled clinical trial. You could do experiments with animals or test tubes or cell lines, but again, did the intervention that you believe in do better than the other therapy, which is either the old therapy or a placebo therapy?
The highest degree of knowledge comes from multiple controlled experiments done by multiple skeptics in multiple places over time. The combination of all that information is often called a meta-analysis, an analysis of all the analyses. If those findings say incontrovertibly, aspirin does reduce the risk of a second heart attack, or lowering cholesterol really does make a difference in heart disease risk, then the evidence is accepted, then there's a consensus. And then the way we practice medicine changes.
Should the government be conducting more studies?
I wish there were more, but the excuse is there was no money from the NIH to fund any of them until two or three years ago...We need more clinical trials to prove or disprove these therapies. I think the answer is more science, more money for resources to do this, more mechanistic research. We haven't been sleeping at the wheel here, we've been moving as fast as we can and trying to access the resources as they've become available. So I agree that there needs to be more science but these things take time.
What are the research issues in alternative medicine? Why isn't more research being done?
The issue isn't that complementary alternative and integrative medicine has been disproven, but that very little research in the last decade has been done to prove or disprove its efficacy or its cost effectiveness. We have so few studies that have been done to a level of excellence that they can authoritatively and definitively tell us, this does work, this doesn't.
I think the impatience on the part of the American public is totally understandable. Many of these therapies have been around or are available off the shelves now and people rightfully ask themselves and their doctors in white coats and nurses and pharmacists, does it work, yes or not? We don't have the information yet. So I understand the impatience.
But the researcher in me, not the clinician or the human being says, now wait a second, some things take time...Things don't grow well when they're terribly rushed. The same is true for large clinical trials. Often the first thing that has to happen with a large clinical trial is asking the right question. Does gingko do anything to change the mental competence of people with dementia? Important question. Does acupuncture, chiropractic, massage and having those therapies available to people in our workforce change the course of acute low back pain or chronic low back pain for people on assembly lines? Good questions. To do those studies often takes five, six, seven, ten years.
The reason it takes so long is as follows. A pilot study could prove that people would enter an experiment and that you could collect information. It might take you two or three years to convince the federal government or a foundation or yourself to do the study and get twenty people in the study. So you might have to write a proposal, get approval from your hospital and the institutional review board, get funding for it. Let's say that that takes two years. Then we have to do the pilot study and prove to those who are skeptical that you can do the experiment and that from that experiment you can design a larger experiment to answer more definitively whether it works, yes or no. Let's say that takes two years.
Then you have to reapply and get funding for the larger experiment, which in the case of a back pain trial might be two or three million dollars. You might have to go to the National Institutes of Health or other parts of the government and say, I now want two and a half million dollars to do this properly. By the way, I and my colleagues and my statistician and the acupuncturists and the chiropractors are not making a dime on this, we're just salaried clinicians as part of a research venture, but it's going to cost two and a half million dollars. That might take two years.
Then you have to recruit the patients...It took us over two years to recruit four hundred and fifty patients [for our back pain study]. It'll take us another year to carefully analyze the data. We will finish our analyses, submit it for publication, and it will probably take another year before it's published because it will go through multiple [revisions] and the constructive criticism by our thoughtful colleagues who say, convince me. Then it's published.… It's taking nine years, seven years, that's how long it sometimes takes.
Are the rules for designing studies of alternative techniques different than studies involving conventional medicine? Is there a double standard?
Absolutely not. I don't think there's a double standard. You have to apply the same rules of evidence to any therapy regardless of its pedigree, whether it comes from another culture, involves herbs, acupuncture, massage, or is a new drug or device. I think the rules of evidence are the rules of evidence.
...My approach to every project we do, whether it's a large clinical trial or a policy statement or a fellows experiment, is I try to find the most sophisticated skeptic who is open-minded to guide us in the science, in the methodology, to set up an experiment where that skeptic could work as a co-investigator. I say to him or her, "If we do it this way and if it turns out positively, will you then be convinced or almost convinced?" If I can't find that group of people to get it to that level of excellence, it's not worth doing. It just won't make an impact. Bad science doesn't impress anyone.
...Now it's not enough to just say, it looks like this acupuncture helps people with that condition. We have to understand the mechanism, because in the absence of a mechanistic explanation for something that is foreign, it's rare that the therapy will be embraced by the community. So we need both evidence that it really works beyond a shadow of a doubt and some sense of how.
Does the evidence show that complementary and alternative medicine work?
Let's put it a different way. Would you consider exercise, diet, lowering of cholesterol and stress management to be conventional therapies for heart disease or alternative therapies for heart disease? When I went through internal medicine training in the early 1980s, the notion that one could stabilize or reverse cardiovascular disease through diet, exercise and stress management was deemed as fairly preposterous. There's an example of where over twenty years the evidence showed that lifestyle mattered. That what you ate mattered. That folate mattered. That stress management mattered. This has morphed from a very alternative vantage point first made popular by Dean Ornish in the late 1970s to now part of conventional academic cardiology.
So we have to put these things into a historical perspective. Some things that are deemed alternative, complementary, unproven today, when passed through the prism of science, will come out the other side as evidence-based, helpful therapies that will become conventional. And then they will disappear into the mainstream of conventional medical care. That's the natural flow of things in clinical medicine.
Are there any clinical trials that have proven alternative therapies effective?
I think there's only been one federally funded NIH sponsored large clinical trial. It involves St. John's Wort for depression. Specifically it looked at whether St. John's Wort was better than a standard antidepressant as compared to a placebo for depression. And in that instance none of the groups did better than any of the other groups.
...I turn the question around and say has any large federal trial that had adequate sample size and power shown that complementary therapies do not work? The historical example might be Laetrile, which twenty years ago there were people who believed that Laetrile, which was a derivative of the apricot pit if I'm not mistaken and had cyanide in it and was therefore potentially dangerous, might cure breast cancer, or cancer in general. There was an outcry on the part of the American public to insist that Laetrile be available in our cancer centers.
It was through a series of randomized controlled experiments paid for by the government that we unequivocally proved that Laetrile did not benefit patients with cancer, and then it went away. So I think the power of science should not be understated to prove or disprove. When it's done properly with all of the stakeholders bearing witness, I think the market then speaks again and says, we won't buy that, it's been shown not to work, let's not use it any more. So I think that's the classic example of large studies that disproved a claim that something worked, in this case Laetrile.
I think the job of the academician and the government and somebody who is a dispassionate evaluator of these therapies is to say, "Let's get the best evidence we can, as quickly as we can, to inform every patient of their options." That's what I do as a doctor every day. That's what any health care provider is supposed to do, give the best advice about what somebody's options are and then bow to their decision as to what they choose to do.
Why aren't we seeing any consensus?
Why do people seek complementary therapy? They seek it for diseases that are complicated, that are chronic or are life threatening or are untreatable. Those are the hardest to treat. So the notion of some magic bullet or wonder drug is a fantasy, and we have not yet found one that is a magic bullet for any one disease. So when you take a complicated disease where the outcome is not always clear, some people get better, some people don't, some people go into remission, some people don't, you then usually need hundreds or thousands of patients followed over months or years. That takes time, that takes a lot of money, that takes a lot of applications...That's the work of the NIH and I give them a lot of credit.
Why is there so much criticism of the government's decision to fund studies that evaluate alternative therapies?
I think there is the argument, which I understand, that says the government's investing in this area smacks of advocacy of complementary therapies. I would confront that and respectfully disagree. The government's investment in this area is advocacy for the application of science to distinguish useful from useless, safe from unsafe, and look at the dollars and where they could be best spent. ...I think the answer to the critics who say we should stop spending money on this area is no, we should spend more and we should do it with the people who can judiciously study this without a bias and figure out what's useful and what's not.
On the international front, I think the world is watching the research done by the United States and particularly studies funded by our government. I think it's fair to say our government spends much more on research in this area than any other country in the world.
...Everything we're wrestling with in the United States, people are wrestling with in Europe and all over Asia. What about the quality assurance of herbs? What about an international network to safeguard everyone on the planet when we find a particular herb is poisonous, or that it interacts with a particular drug? What about a global conference on intellectual property and sharing royalties?...My point is that there is now a willingness that I never thought I would see in my lifetime of my counterparts in Beijing and Hong Kong and Singapore and Taiwan and Japan...to get the policy right, to deliver herbs planet-wide that are consistent and helpful and safe.
This speaks to an even more enormous potential for this field, to go beyond just the American market, and say how do we improve health care worldwide. We know for a fact that three quarters of the human population of the Earth are using complementary and integrative therapies every day. That's exciting.
Why are people confused about what works and what doesn't?
I think the field of complementary and alternative medicine is at a disadvantage in that we're often testing therapies that are already there. The herbs are on the shelf. Acupuncture has been around for thousands of years. There are fifty thousand licensed chiropractors. So here we are, testing therapies that are already available, that Americans are already spending about thirty billion dollars a year on.
...Less than a decade ago a national survey said to the American public, this is huge, this is a hidden mainstream of American medicine. That was our New England Journal piece. Within minutes, it seems in retrospect, Congress said, this matters; we must have an office in the National Institutes of Health that studies these things. So there was congressional passion as a reflection of the community's passion for these therapies that said, let's test them. The NIH had an original budget of two million dollars in 1992. Their budget now is over a hundred million dollars for the National Center for Complementary and Alternative Medicine. And there are at least another hundred million dollars in the other NIH institutes...Look how fast that has evolved.
...Does acupuncture work for arthritis of the knee? Does shark cartilage help for cancer? Does chondroitin sulfate do anything for my uncle's hip arthritis? Does St. John's Wort do something for depression? Large clinical trials. Does gingko prevent Alzheimer's in millions of people? We will get answers to these questions. But those projects are ongoing. Only one has been completed [for St. John's Wort], as we mentioned earlier. The others, we're waiting for the answer.
In the last two years, the NIH to its credit has said, when these things work, let's focus on how. What is the mechanism?...In the absence of an explanation that makes scientific sense, it will be difficult if not impossible to incorporate them into mainstream medical care. So the scientific community, those people who work on animals and genes and test tubes are now involved. And they are saying, hmm, when this herb causes an interaction with this drug as we now know it does, what is happening? Hmm, when acupuncture changes the perception of pain, where in the brain does it change the perception and what switches get turned on and off?
The excitement I have is...there are now scientists who are filled with the optimism of discovery saying, we will learn new things about basic principles of life and biology and what helps patients. That's new, the scientific community is now involved. When all of these pieces are in place, the clinical trials, the basic science, a look at whether these therapies save money or cost money, we will deliver what the American public wants, which is answers to their basic questions: Does this work? Who should I see? When should I use it? How much should it cost? Will you pay for it?...I wouldn't be surprised if we make phenomenal progress in the next ten years. …
Are there ever conflicts of interest, where doctors have a personal financial stake in which alternative therapy they recommend?
I think every profession has people who are questionable in the eyes of the mainstream of that profession. Some people are well-intentioned but misguided, and some people are manipulative. That's true about business, law, economics.
The Federation of State Medical Boards recently published guidelines about the use of complementary therapies for MDs. Their guidelines, if you really boil them down, say that physicians who either use complementary therapies or refer to licensed providers of complementary therapies should be subject to the same rules of evidence, the same statutes and regulatory issues, and high level of professionalism that they would be subject to if they were prescribing a drug or recommending surgery.
There was a lot of discussion about whether a physician could sell herbs, vitamins, and supplements and make a sizable profit. The discussion for which there was tremendous consensus and I certainly agreed was it should be no different for the physician selling herbs, vitamins and supplements than it is the physician who is next to a pharmacy that's selling prescription chemotherapy.
The rules for physician behavior are that physicians should not make large, sizable gouging profits every time they write a prescription or sell a prescription drug. That's unethical, that's unacceptable. There is a separation between the profits that a physician makes in his or her care and prescription writing. Imagine if we had a society where every time a doctor wrote a prescription, they got a kickback or made money. That's not acceptable.
Some people say that there's a lot of money being misspent on unproven alternative methods, like supplements. Would you agree?
There is the argument that a lot of people, some healthy, some sick, some rich, some very poor, are wasting money on unproven, over-the-counter dietary supplements. I think that that's a valid concern of our whole society. There are tens of millions, if not billions of dollars being spent on herbs, vitamins and supplements that have not been subjected to tests. The FDA does not have to test these things for efficacy or safety before they're put on the shelf...But from my vantage point as a clinician that makes no sense. I'd like to see things on the shelf - particularly vitamins, supplements, minerals, extracts - tested for quality. I'd love for the American consumer to know that what's in the bottle is what it says it is on the label. I'd like some evidence of safety first, if not efficacy and safety. And that hasn't happened, because of our legislation.
I'd love to see that reconsidered nationally. Physicians are in the impossible position right now and I speak for my colleagues who are white coat wearing folks of this country, how do they advise a patient about the use or avoidance of an herb where you're not even sure...that what's in the bottle is what it says in the bottle and we don't know whether it will interact with your prescription drug? How do you advise a patient? I actually understand when some of my colleagues say, we tell our patients not to take any of it. I think a more rational view would be to review the evidence and guide a patient as to what is dangerous, what might be tolerable, what should definitely be avoided.
If you look at it from Congress's vantage point there are over a hundred million adults in this country using acupuncture, chiropractic massage, herbs, supplements, doing meditation, yoga, spending upwards of thirty billion dollars, most of it out of pocket, making two-thirds of a billion office visits to licensed care providers in all fifty states. Most of this is happening below the radar screen of conventional medicine. Most of these therapies are not discussed in medical school. There's a problem. From a public health standpoint - whether you're Congress or the head of the Department of Public Health - I think you'd say, should people be doing this? Is it safe? Is it worth the money? So I think if you're developing scientific policy there is an argument that says, we need to know which of these therapies should be allowed.
...People whose back surgery doesn't work need advice from their orthopedic surgeon and their rheumatologist and their pain management expert as to whether, when, and how to seek acupuncture, chiropractic massage, or none of the above. So I would argue from an ethical vantage point it is imperative that we study these therapies to give patients the information that they rightfully demand of white-coat wearing specialists and generalists: Doctor, will these help me or not? Will it interact with my drug prescriptions, with my radiation, with my chemo? Should my child be exposed to this? Is it safe? How can we not answer these questions?
How has the use of herbs resurged in modern times?
It was a great success of modern technology and modern chemistry that the use of crude extracts - take the digitalis plant - ultimately led to the development of modern drugs for cardiologic problems. But when they started, they were used as crude extracts. They were dangerous and the people who used them knew they were dangerous. Modern chemistry and technology allowed the scientists to find out what were the most active components of the crude extract. Those were ultimately synthesized into single compounds that could be recreated in the laboratory as synthetics, patented and sold as drugs.
So you go from a messy kind of therapy of crude extracts of plants, which is what herbalists around the planet have used for thousands of years, to this marvel of modern biochemistry that says the most active ingredient does something to the heart muscle, let's recreate it in the laboratory, patent it, own it, sell it, use it as a drug. Probably half or more of our most respected pharmacological interventions come from plants.
What are some of the problems with today's herbal supplements?
The notion that herbs are safe is false. Just because they're natural doesn't mean they're safe. We have to respect them as though they could conceivably be drugs...What makes it a bit complicated is we can't lose sight of the fact that modern medicine is a lot about being sure of what we have, being sure of what we use, and promoting safety over efficacy. Safety will always trump efficacy, as far back as Hippocrates. So one of the fundamental issues about herbs that are available over the counter is they're not regulated like drugs. They're treated more like foods, like carrots and onions and coffee.
Another issue is that you're not sure that this batch of echinacea, even from the same company, is identical to the batch they harvested a year before. We don't know how long the shelf life is. We don't know if they will interact with the prescription drugs we're using. And there's no burden of proof on the company marketing it that it's consistent in terms of quality - that what's in the bottle is what's on the label, and that it works and is safe. So these, these prerequisites that we have for drugs and over-the-counter therapies do not apply to herbs as we know them in the industrialized world.
As a clinician, that's very troubling and very complicated. How do you advise a patient who is on chemotherapy as to whether they should begin or continue a whole bag full of Chinese herbs just when they're about to start a new series of very potentially toxic drugs?...Will they increase the effect of the chemotherapy or the radiation or decrease it? There's an example of where the notion of doing no harm has to trump the notion of try it, you may like it.
What would you propose instead of the current situation?
I don't think [herbs are] like foods because you can't kill yourself on garlic or carrots. I think you can really hurt yourself with chaparral or some of the other herbs [like] ephedrine. People do die from that in overdoses predictably. Other herbs people die from because one in a thousand or one in a million people have what's called an idiosyncratic reaction. Like a bee sting, they just die. They go into anaphylaxis and die. It's very rare, but it can happen. So you can't compare them to foods.
Now having said all that, in the business world they're treated like foods because you can't patent them. They're treated like plants, like basil. Could you imagine somebody saying I want to patent all the basil on the planet? It's not allowed. There's no regulatory authority. They're not drugs and they're not foods. This leads to a real problem. From my vantage point, the first place to start is quality. Can we create consistency of the extract of the plant?
There's another complexity. Most herbalists around the planet don't use one plant...Most herbalists use six, eight, ten, twelve plants for a given individual. Some of the plants will be used to diminish symptoms of the disease. Some will be used to treat the underlying abnormality. Some will be used to improve the digestion of the rest of the plant so it can be absorbed more completely. You get the picture.
Now it gets very complicated. How do you study that? Do we deal with individual plants?...How do we prove to ourselves that we can recreate this batch of magic elixir extract of herb X every time? Historically the only group that's tried to do that has been the for-profit companies that sell these things. I think that's a problem...What happens when the first or second study are not so impressive, or worse yet, are negative? There's certainly no incentive for the private sector to produce those extracts again.
I think universities and governments should begin to build the infrastructure that can recreate standardized extracts, strip them apart or add them together with other herbs and test them in an unbiased, non-for-profit way, and let the scientific games begin. That's what we need.
This I think is a challenge back to our country and Congress and the industry to say, okay, is there a way to incentivize the private sector to invest in serious science about herbs - stripping them apart, looking at the mechanisms, looking at clinical effectiveness. And if you the company do this, give you something back as a return on your investment. When that happens I think there will be an improvement in quality assurance. We will know what works and what doesn't. [Herbs] will treated more like drugs than like carrots and garlic, and I think that will be better for the public.
How do you see the conventional and alternative approaches to medical care fitting together?
Do we want to imagine that physicians, MDs can be credibly trained acupuncture or herbal medicine in a matter of months? I think not. On the other hand, can fellows in a Harvard program or a program at any other university be trained sufficiently to know when to refer [a patient] to an acupuncturist or a chiropractor or massage therapist [and] how to co-manage a patient who is being seen by one of those licensed providers?...Yes, I think we can.
It would be wonderful, would it not, if in every part of this country, in every hospital, there was at least one doctor in every discipline - oncology, rheumatology, internal medicine, and family medicine - who knew a lot about herbs, acupuncture and massage and could say,...'This is not safe, I wouldn't do that.' And, 'I know from where I'm speaking, I spent a lot of time with them, I would not do that.' Wouldn't the population feel safer?
Wouldn't it be great if there were physicians who were expert in medicine as we know it, conventional biomedicine, who knew enough about complementary techniques and the approach to patient care to advise patients about the use or avoidance of individual therapies? And wouldn't it be great if their mindset was one of facilitating patient participation and encouraging the patient to do things that they could for themselves? That's the future, I think that's what the public wants.
How could this logistically be accomplished?
The precedent here is primary care in the 1970's when a physician, usually an internist or family practitioner working with a psychiatrist [and] a nurse practitioner, came together to become a more efficient and effective care team for the patient. That works, that's now standard. What if you could have an expanded team now for pain, or an expanded team for cancer?
What made it efficient is the individuals within that team learned enough about what each other did and respected each other enough to know when, as a team member, to pass. The doc said, I don't need to see you, please see the nurse practitioner or my fellow or the psychiatrist...That's what we need to spend time developing, these teams of conventional and complementary providers.
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What do you think the future holds for alternative medicine?
I think we'll have a lot of answers over the next ten years. I think more importantly, I think we will have scientists engaged in the more fundamental and extraordinary pursuit of the science behind it. When these things are shown to be clinically effective, we will have many more scientists involved in the discovery of why... I think we'll have new drugs that come out of our exploration of herbs. I think we'll be more sensible in terms of which of these therapies should be paid for for everyone, regardless of income or insurance status
I think we will make discoveries there that give us insight into the why and how. How does acupuncture affect pain? How does hypnosis or meditation change somebody's symptom or outlook on life or depression? How does massage and touch change neurological function and by extension the endocrine system, the nervous system, growth in newborns and neonatal intensive care units? I think many of the discoveries will be made in the brain and the matter of the mind - the neurons, the chemistry that bathes the brain. I think there's fertile ground for discovery. When our scientists say, how is it that our mind and our belief and our expectation and our response to placebo can cause a cascade of physiologic change? I think in my lifetime there will be some discoveries that will be of monumental importance to our understanding of health and illness that will come from complementary medicine.
...I hope that we have an improved comprehensive health care delivery model, not just in the United States, but worldwide, that incorporates those elements of complementary and integrative care that should be available to everyone because they work, not because they come from some distant place or were alternative...It would be nice for our children and grandchildren to not see this as an enormous controversy but rather an extension of what science, good will, compassion, and policymakers can put together. I think that's our future.
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