the alternative fix

stephen straus, m.d.
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An internationally recognized expert in clinical research and clinical trials, Straus was appointed the first director of the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health in October 1999. In this interview, he discusses the economic, ethical, and methodological challenges of designing and conducting research on alternative medicine. He also defends a highly criticized NCCAM study on the popular herbal anti-depressant, St. John's Wort. This interview was conducted in October, 2002.

What do the terms "complementary" and "alternative" medicine mean?

Alternative medicine is a name that was given in place of unconventional medicine or quackery...But alternative medicine is not a good name because it says that it's in opposition to something, it's an alternative to something. Medicine should be about what's right and what's good, not about I don't like you, you don't like me.

Complementary medicine is a bit more embracing notion - that people are using these practices while going to their physician, while taking antibiotics, while having surgical procedures and undergoing mammograms. The idea of integrative medicine is even a little more embracing and optimistic.

But ultimately the issue is, medicine is constantly evolving. It's not something that's stagnant, that was set in concrete fifty years ago, and we're all reading off an old script. We do not practice medicine today the way we did fifty years ago. Fifty years ago, there was a doctor, and he might have a nurse. Now it's a doctor and a physical therapist and a social worker. It's a radiation therapist, a dental hygienist, a physician's assistant, and a laboratory technician. There are a hundred and thirty-four allied health professions. There is an opportunity to embrace expertise that enlarges our capacity to make people stay well and get better.

If complementary and alternative medicine, or whatever you want to call it, is going to succeed, those things that prove safe and effective will be integrated - not because of a political decision to do so, but because that's how medicine has always evolved. Accept that which is the best idea of its generation, and reject those that no longer have currency.

Medicine has always been about science and art.  In recent decades wežve increasingly emphasized the science. ä Alternative practitioners may not be very good in the science or the technology, but they may be very good in the art.

Why has alternative medicine surged in popularity in recent years? Is it a generational thing?

There is always an issue of what is considered acceptable medical practice and what's outside of acceptable practice...The definitions of what's in and outside the mainstream have changed.

In the end of the 20th century, people had the opportunity to make more choices than they ever did before. There were so many health care options, people are much more affluent, and they have much greater sources of information. The marketplace delivers today on your shelf in Manhattan the product that may have been in Beijing the day before. So it's a small, resourceful, informed world today, and people are exercising choice.

...I believe that people all around the world want essentially the same thing. They want to be free of suffering, they want to expect to live a productive, purposeful life, and to turn the world over to children who have it even better than they have. Americans have the luxury of living that dream in terms of health care. We have a choice of a heart transplant, the latest drugs, and we have choices of other things as well - things that may not be scientifically proven, [but] we think will make us feel better. …

Some people object to conventional practitioners as being too "business-like" in their treatment of patients. What is it about the culture of doctors that lends itself to this interpretation?

Medicine has always been about science and art. In recent decades we've increasingly emphasized the science. We become very skilled at technology, and it's permitted us to make advances that we would not have dreamed of even fifty years ago. When I was a medical student, there was no such thing as a CAT scan or an MRI yet. Patients with abdominal problems often had to go to exploratory surgery to see what's inside, to figure out why. That's almost never done today.

So the advances have been fantastic. But there's been pressure to contain costs and to deliver more care to more people, and that's constrained the ability of the physician to also practice the art of medicine that he or she knows is necessary. Alternative practitioners may not be very good in the science or the technology, but they may be very good in the art. ...Physicians want to practice that way, and they can't. As somebody who has practiced medicine for thirty years, I resent the claim that it's only alternative therapists who know how to really be sensitive to patients and care for them. I don't believe that for a minute. …

I strongly believe that there really is only good medicine and bad medicine. Good medicine is delivered by people who care, who engage sensitively with their patients, who work with them to negotiate the best possible health outcomes, and who prescribe the best treatments for which there's the most evidence. Bad medicine is given by individuals who are impersonal, who are impatient, who are insensitive, who are ruthless, who want to make a profit, and who don't care about evidence.

What is the history behind the creation of the National Center for Complementary and Alternative Medicine (NCCAM), the agency you head, at the National Institutes of Health (NIH)?

In 1992, the National Institutes of Health created an office of alternative medicine. Its purpose was to stimulate interest and research in alternative and complementary medicine on the part of the other NIH institutes. This was a small office with about two million dollars to begin with.

Over the next several years, it was successful to the extent that it stimulated work and provided seed money for research projects in many institutions, and it created a legitimate place of discussion within academic institutions for research on complementary and alternative medicine.

By 1998, [the Office of Alternative Medicine] was deemed inadequate to meet the public's needs to understand complementary and alternative medicine. The responsibilities of those offices were elevated with more resources and more independent authority by creating a new institute at the NIH called the National Center for Complementary and Alternative Medicine (NCCAM).

To give you some sense of the transformation, in 1992 [the Office of Alternative Medicine had] a budget of $2 million, and a staff of a handful of people. In 2002, [NCCAM had] a budget of nearly $105 million and a staff of about seventy people. We're funding two to three hundred research and research training projects around the United States. We're collaborating with many of the other NIH institutes, [which are] funding an additional $120 million worth of work in the field. This is a huge evolution in ten years.

How does NCCAM decide what to study?

We study approaches that will address the most important public health indications. We study approaches that we can study in terms of the ethical constraints, in terms of the resource restraints. We study modalities that are the most promising and we don't study things that are the least promising. We don't have enough money, enough time, and enough resources to study everything. ...

We at the NIH, in partnership with our sister institutes, are funding about ten large multi-centered trials: saw palmetto for benign prostatic enlargement in aging men; shark cartilage as adjunctive therapy for lung cancer; kelation therapy for cardiovascular disease, acupuncture for degenerative arthritis and the like.

For more on current research, see this list of NCCAM's ongoing clinical trials of over more than 80 types of alternative and complementary medicine, from acupuncture to yoga. Entries are indexed both by treatment or by disease or condition treated, with contact information and the status of each project.

Of these studies, all of which are multi-million dollar, multi-year studies, there's only one that's been completed so far. That's the study of St. John's Wort for treatment of major depression of moderate severity. St. John's Wort has undergone about two dozen studies in the past thirty years suggesting that it's beneficial for one or more forms of depression. Most of the prior studies were small and highly positive.

There have now been two large American studies of St. John's Wort for a certain type of depression - not the full spectrum, not milder depression and the blues - but the form of depression that requires professional evaluation and care. The kind that can progress to tremendous limitations of life and even risk of suicide. Major depression of moderate severity. The two studies both showed St. John's Wort not to be superior to placebo.

Now the study that we at the NIH funded had a third arm, where we used a conventional anti-depressant. In that study, patients on the conventional anti-depressant did better than they did on placebo, but not in all important measures of depression severity. So in that regard, the conventional anti-depressant didn't work as well as prior large studies had suggested. But St. John's Wort was not better than a placebo. The conclusion of the trial is that St. John's Wort was not better than placebo but the conventional anti-depressant sertraline was, at least in some measures of depression severity.

What about the critics who claim that most people use St. John's Wort for minor depression?

Actually, surveys show that the more depressed people are, the more likely they are to use herbal products. The research that has been published [is] mostly from Germany, and most of [those] studies included individuals with major forms of depression as opposed to milder forms of depression. So to claim that we studied St. John's Wort in the wrong population is a disingenuous claim.

We in fact use the dose and the product recommended for the patient population in several of the larger, better studies done in Europe. Many of the studies included a wide spectrum of depression, from mild to moderate. There were even studies of severe forms of major depression which we did not study, because we did not think it was ethically acceptable here to withhold the conventional anti-depressant for somebody with truly severe depression.

...We simply pursued the published data in the most important public health venue. People weren't satisfied with the result. Now, it was not a perfect study. It would have been more convincing...if the conventional anti-depressant arm was even more effective than it was. There was an advantage to adding the conventional anti-depressant arm in this study: we had a comparison between a conventional treatment and an alternative treatment, to give you some sense of relative effects.

But there was also a disadvantage. If you have depression and you're interested in participating in a research study of an herbal medicine, it means that you want to avoid conventional anti-depressants... So the psychiatrists and the teams of psychiatrists who designed this particular study chose to not use the maximal dose of the conventional anti-depressant for fear that there'd be more side effects, and many more people would drop out of that arm of the study.... So it's very complex doing these studies, and what you choose to do and what you choose not to do. At the end of the day, somebody is still going to criticize you.

What can you say definitely about St. John's Wort?

What I can say about St. John's Wort is the body of evidence does not suggest that St. John's Wort is sufficiently beneficial with enough reliability for people with major depression. Maybe it is beneficial for milder forms of depression, and we are funding a multi-center trial for minor depression. ...

What do you say to critics who claim that NCCAM researchers are biased in favor of finding that alternative therapies work?

...My work is about encouraging good research. We have the responsibility to engage in research in complementary and alternative medicine in an open-minded fashion, not to enter into it with a prejudice that it must work, or it must not work. In fact, I would not have taken this job if it were about debunking things and proving that they can't work. I took this job because it's about the opportunity to prove that there are new things, that we can expand opportunities for health care. But along the way, we have to accept the possibility that some will not be good, some will not be safe, some will not be better than existing therapies. The public is going to have to accept it. People who have vested interests, they're going to have to get over it.

Given that large clinical studies take lots of time and money, how important a role should anecdotal evidence play in determining the safety and efficacy of alternative therapies?

... If the American public is going to get the kinds of answers they deserve, those answers are only going to come from careful, fair research. We can't invest in replicating anecdotes. An individual's experience is immensely important to that individual, but it's the experience of many individuals that begins to allow people to make public health recommendations...

Anecdotes are vitally important to medicine because they provide us the germ of an idea. But the obligation is to convert that anecdote into evidence. You do that by pursuing the anecdote in a critical way, asking whether it's correct or not. If all we do is base our decisions on anecdotes, we're not doing ourselves a good service.

People are impatient with how long the scientific research is taking. Why aren't there more definitive answers?

There's nothing in science about a final answer. Science is about replication. Now, very large, multi-centered trials only become believable if they're built on a body of smaller studies with the same kinds of outcomes. So we don't do a very large trial without that foundation of evidence.

...When I was a medical student and I saw my first child with leukemia, I had to walk out of the room. I didn't understand why the pediatricians were exposing this poor, suffering child to such toxic chemicals. I knew this child was going to die anyway. Today, eighty percent of those children are cured. It's not by replicating anecdote. It's by careful research.

We have a responsibility to tell the truth, at least as we know it. Part of the truth is to say, 'This is not a good decision, this is a good decision, this is an okay decision. You want to try this? Reasonable. Okay, we don't have all the evidence, but I can understand you wanting to try it. Let's do it together so I can monitor you when you take the treatment.'

Why have there been so few conclusive studies in the ten-year period since the office of alternative medicine was created? Are there specific challenges to studying alternative therapies?

You don't engage in a multi-million dollar trial until you know exactly what kinds of patients to recruit, how long to follow them, how to deliver the treatment, in what dose, and what the best measure would be of their improvement. That's what one does in pilot studies throughout biomedical research. We do have about a dozen studies that are large, multi-million dollar trials, and a couple of hundred studies that are much smaller.

The conclusions of the smaller studies will be this approach looks promising, we now know how to study it, this is ready for larger study. Or the conclusion may be the data are not that encouraging and we're not sure yet that this is an area ripe for more investment. That is a perfectly satisfactory and appropriate scientific outcome. The public should be satisfied with that.

There are thousands of potential approaches in complementary and alternative medicine, and we can't take them on all equally. There are some things we can't even study, not just because they're too expensive, but because it would be unethical to do so. Individuals may choose themselves to do a certain treatment but I can't ethically ask a research subject to withhold a life-saving treatment for an alternative treatment.

There are unique challenges to doing research in complementary and alternative medicine, on top of the traditional challenges of research in general. One of the challenges has to do with standardization of the product or the practice. If you want to study an herb, whose herb are you going to study?...

Now if we're going to study these things, we have to guarantee what we're studying because at the end of the day, if the study is positive, we're going to want people to be able to replicate our experience and expect beneficial outcomes. If the study is negative, we're not going to wish for the then-justifiable criticism that we studied the wrong product, or you think you studied echinacea but really, there was no echinacea in the bottle. In some cases we have to contract with manufacturers specifically to make the product to proper standards.

Why aren't manufacturers legislated to ensure quality-assurance measures are followed?

For decades, there's been a tension about how herbs and dietary supplements should be [treated]. Are they medicines, are they foods, are they drugs, are they natural products, are they synthetic things, what are they? In 1994, Congress decided to pass the Dietary Supplement Health and Education Act (DSHEA), which said that dietary supplements, vitamins, minerals, herbs of all stripes, all botanical products that you ingest, other than tobacco, is to be regulated as a food. Now of course we ingest them, and in that regard they're foods...But they're given for health promotion purposes, which means really considering them to be drugs, but they're not regulated as drugs...The reality is in the American marketplace, the American consumer is fairly sophisticated, and for many years, when it came to dietary supplements, the consumer was totally unsophisticated. We trusted that these things were standardized just like aspirin and they're not.

...Americans will go to the store and they'll buy the most expensive bottle with the fanciest label, and they'll think that they're getting the best product. But they're not necessarily getting the best product. Imagine if you were going to buy a Mercedes and somebody told you that there was a considerable chance that there was a Chevrolet engine under the hood and it was not a Mercedes. You might be upset. But that's the position Americans are in in the marketplace today in buying dietary supplements. There's no guarantee that what's on the label is in the bottle.

But many Americans showed a lot of support for DSHEA. Is there a disconnect here?

The public believed that these products were natural and therefore safe... that they are well standardized and free of contaminants. That led to an explosive growth in sales of these products throughout the 1990s, but that growth has stopped and it is now declining. It's now declining because the promise of dietary supplements has not been met with the reality of dietary supplements. There are products that have been pulled from the shelves of various health food stores [and] supermarkets, because they are contaminated with prescription drugs or heavy metals.

We know today that dietary supplements are chemically active. They must be, of course, if they're going to be beneficial to one's health. [But] those activities can interfere with the body's handling of life saving drugs. When people ate herbs 100,000 ago, they didn't have to worry about whether it was going to interfere with their AIDS drug, but today we have that concern and some do interfere with AIDS drugs.

The public has learned largely through very good reporting from the media that these products are not necessarily safe. They're not necessarily as they claim to be. One needs to exercise caution and discuss the decision with a physician.

Given all the facts that have come to light about dietary supplements, what should a doctor do? How should they advise their patients?

Here at the National Institutes of Health, we have a new policy that I helped craft over a year ago. It says that every patient admitted to the National Institutes of Health clinical center has to be asked what dietary supplements he or she is taking. The admitting physician has the responsibility of deciding whether he or she can continue to take them while they're in the hospital.

To help [physicians] make that decision, we provide them online resources to look up the specific herb: does it interact with drugs? Are there side effects? Are there issues that one should be concerned about if the patient is facing surgery? Physicians are constantly learning and constantly trying to do a better job. Right now, they're not armed with all the information we would wish them to have, and that's where we come in at the NIH.

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posted november 4, 2003

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