Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Tuesday, June 28, 2005

Sticking Pins In Homeopathy

The following article is a mixture of good points and confusing messages. It's too bad the author couldn't present a clear message. Some of his reasoning reminds me of this quote:

"When, predictably, the alternative technique ignominiously flunked the double blind test, its practitioner delivered himself of the following immortal response: 'You see: That is why we never do double-blind testing any more. It never works!'" - Richard Dawkins

Sticking Pins In Homeopathy
posted by alexon Jun 27, 2005 - 08:32 AM

Sylvia Millecam, a successful Dutch actress and comedienne, died of breast cancer at age 45, about two years after her diagnosis was made. Throughout her illness, she opted to be treated with alternative medicine rather than conventional scientific medicine. Statistics indicate that had she received the latter type of treatment, her chances of living beyond two years would have been higher than 95 percent.

Despite the dramatic achievements of scientific medicine, the use of alternative medicine in the Western world is soaring. Contrary to the prevailing view, there are increasing reports that many alternative therapists are not presenting themselves as a complement to conventional medicine, but rather as a substitute for it.

Some had hoped that a scientific examination of alternative practices would lead to a change in this trend. But after two decades of collecting empirical data about the effectiveness of alternative treatment methods, one can say that this expectation has been disappointed. What has happened instead, is that these experiments have sparked an important discussion about the limits of the scientific method, as well as doubts about its credibility.

Anyone who cares deeply about the welfare of human beings must observe these processes with great concern. The way to alter the course and fortify the hegemony of scientific medicine is to keep those with vested interests away from the scientists and to renew and strengthen the therapeutic ritual - listening, understanding and genuine dialogue - in conventional medicine.

Fashionable alternative

Alternative medicine is a collection of treatment methods that are offered to people as a cure for their illness and suffering, without their safety and effectiveness having undergone an exacting study according to the criteria of scientific medicine. The "basket" of alternative treatments includes a highly varied group of theories and practices, which are sometimes divided into a number of main categories: alternative medicine systems (homeopathy, acupuncture, etc.); treatments with a biological basis (natural substances, various diets, megavitamins, etc.); therapies that involve bodily manipulation (chiropractics, various kinds of massages); and mind-body therapies (meditation, hypnosis, yoga, prayer).

In an editorial that accompanied two articles about the unexpected biological activity of alternative herbal remedies, Marcia Angell and Jerome Kassirer, editors of the prestigious New England Journal of Medicine, described the difference between conventional and alternative medicine: "It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine - conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work."

Nevertheless, the use of alternative medicine is rapidly growing. A comprehensive survey of 13,044 people, conducted in 2002 and published about a year ago in the United States, indicated that 62 percent of Americans received therapy in one branch of alternative medicine in the year prior to the survey.

In 1997, David Eisenberg of Harvard University published a comprehensive survey on the extent of the use of alternative medicine in America. He found that the number of visits to alternative healers rose from 427 million in 1990 to 629 million in 1997 - more than the total number of visits to conventional physicians. All in all, Americans spent $27 billion on alternative medical services, a figure similar to the amount spent on conventional medical services.

With the market economy being the motivating force behind today's health industry, the medical establishment has recognized the economic potential of alternative medicine. Many hospitals are opening institutes devoted to the various types of alternative medicine, and health maintenance organizations (HMOs) are offering expanded policies that include alternative medicine.

More than 60 percent of family doctors referred patients to alternative medical services at least once in the year preceding the survey, and 38 percent did so in the month preceding the survey. The American federal government allocates tens of millions of dollars a year to research related to alternative medicine. The decision-makers have chosen to ignore the possibility that this trend might end up blurring the public's perception of the fundamental distinction between the two approaches.

Uproar in Holland

While there is an internal division between the various branches of alternative medicine and complementary medicine, the general perception is that all types of alternative medicine constitute a supplement to scientific medicine - not a substitute. Politicians and the medical establishment use this argument to bestow legitimacy on the broad support they give to alternative medicine. Nonetheless, there is growing evidence that this is not really the case.

Not long ago, there was a public debate in Holland on the subject, prompted by an investigation into the circumstances of the death of Sylvia Millecam, who had been referred to a surgeon for a biopsy of a lump in her breast. She chose to go instead to an electro-acupuncturist who assured her that she was healthy. After a delay of eight months, a conventional physician diagnosed breast cancer and proposed that she undergo a mastectomy and chemotherapy. She refused and instead sought treatment from many alternative therapists. 28 doctors and institutions were involved in Millecam's treatment. Some of them dismissed the diagnosis of breast cancer outright. She was treated with a wide range of methods, including anti-cancer cell therapy, halotherapy (also known as salt therapy), psychological approaches and so on. She died two years later.

A recently published study found that the survival rate for women diagnosed with breast cancer before age 50 is about 95 percent after two years, 85 percent after five years, and 70 percent after 15 years.

In addition to a recommendation that disciplinary measures be taken and criminal charges be brought against some of those involved in the Millecam case, the authors of the report also proposed that Dutch legislators amend the existing law to require from now on that all those who work in alternative medicine be registered and that their activity be subject to oversight. They also recommended that a law be enacted stating that only a certified physician is permitted to make or change a medical diagnosis.

Apart from extreme cases like this that raise public consciousness about dangerous practices whose true extent is unknown, other public data also clearly illustrate the fierce competition being waged by alternative medicine against conventional medicine. At a time when there is a grave shortage in the resources allocated to scientific medical services, people are spending a fortune on alternative treatments. If just part of this money went to fund medical services that have been scientifically proved, the ability to provide vital services to needy populations and to expand scientific research and technological development would be dramatically increased.

As already noted, the medical establishment prefers to hide its head in the sand, as long as it can share in some of the income that originates with alternative medicine. In the past decades, as part of the attempt to grant legitimacy to this field, we have seen an effort to examine its various branches using scientific tools. And it appears that this tendency is causing a further erosion of the status of scientific medicine.

Homeopathy put to the test

Homeopathy was created in the late 18th century by Samuel Hahnemann. In an attempt to test the effects of the Cinchona plant, which was touted as a treatment for malaria, Hahnemann took a number of doses of the plant extract even though he was not ill with the disease. He found that the symptoms he experienced were surprisingly similar to the symptoms of malaria.

This finding led Hahnemann to formulate the "similarity principle," which lies at the basis of the homeopathic method. According to this principle, chemical preparations whose ingestion causes symptoms similar to those that appear in certain illnesses have the potential to cure patients of these illnesses. With the aim of reducing the toxicity of the preparations to a minimum, while preserving their curative potential, Hahnemann proposed that the active ingredient be "diluted" as much as possible. In the absence of suitable scientific knowledge, the progenitors of the method diluted the solutions to such a degree that the concoctions they sold as remedies did not include even a single molecule of the active ingredient. This tradition has been preserved to this day.

Homeopathy as a holistic system ignores the achievements of many generations of biological research that are based on the reductionist method. This method says that the way to develop effective healing methods is through a deep understanding of the components that make up the whole person at different levels: molecular, cellular, tissue and organ. The dilution principle contradicts basic physical laws (such as the law of mass preservation) that have been proved in thousands of experiments in different and complex systems. Still, there have been numerous attempts to validate the homeopathic method on the basis of the scientific method's principles.

In June 1988, the important scientific journal Nature published an article that caused a major uproar. A group of scientists led by Jacques Benveniste of the University of Paris, in collaboration with other laboratories (in Rehovot, Milan and Toronto), reported that in their experimental environment, a solution was able to preserve the biological activity of antibodies that were in it even when it no longer contained a single molecule of a single antibody.

At the end of the article a paragraph appeared under the heading, "Editorial reservation," that said: "Readers of this article may share the incredulity of the many referees who have commented on several versions of it during the past several months. The essence of the result is that an aqueous solution of an antibody retains its ability to evoke a biological response even when diluted to such an extent that there is a negligible chance of there being a single molecule in any sample. There is no physical basis for such an activity. With the kind collaboration of Prof. Benveniste, Nature has therefore arranged for independent investigators to observe repetitions of the experiments. A report of this investigation will appear shortly."

In an editorial entitled "When to believe the unbelievable?" the editors wrote: "Benveniste's observations, on the other hand, are startling not merely because they point to a novel phenomenon, but because they strike at the roots of two centuries of observation and rationalization of physical phenomena. Where, for example, would elementary principles such as the Law of Mass Action be if Benveniste is proved correct? The principle of restraint which applies is simply that, when an unexpected observation requires that a substantial part of our intellectual heritage should be thrown away, it is prudent to ask more carefully than usual whether the observation may be correct."

The investigating team's report and Benveniste's response that was published four weeks later are both fascinating documents, depicting a laboratory located in the western suburbs of Paris that serves as the setting for a major drama.

Benveniste backs down

The composition of the team of investigators sent by the journal was somewhat odd: In addition to John Maddox, the editor of Nature, it included a professional magician, James Randi, and Walter Stewart, a respected investigator of scientific fraud. Not one of them had training in the laboratory's field of work. Nonetheless, their report indicates that during the week they spent in Paris, they went about their tasks quite diligently.

It did not take long for the team to find that two senior members of Benveniste's research team were receiving their salaries from a company that markets homeopathic drugs. In going over the records, the investigators were surprised to discover that the experiments conducted in the lab had not always confirmed the premise that the activity of the antibody was also preserved in the solution that did not contain it. The "unsuccessful" experiments were not included in the article, and there was not sufficient justification for this omission.

After observing four experiments, the members of the team concluded that the cell counts, on whose basis the results of the experiment were determined, were done by scientists who were aware of the level of dilution of the solution. Therefore, there was a concern that the result of the count was influenced by their expectations and their strong desire to corroborate the premise of the research.

So, the members of the team initiated three new experiments. This time, the samples were coded and the people counting the cells did not know the dilution level of the solution. The matching codes to the samples were revealed on the last day the investigating team was in Paris. And the results were unequivocal: The antibody was not active in the samples in which it was not present.

The bottles of Champagne that had been readied for the farewell meeting remained unopened and the atmosphere was tense. In light of the results of the last experiments, the team gave Benveniste three options: withdraw the article, write a clear disavowal of its findings or publish a response to the team's report that would be published in full. Benveniste chose the third option.

The report was published under a stinging headline: "High-Dilution Experiments a Delusion." In response, Benveniste harshly criticized the members of the team, describing them as amateurs in terms of their training. He disparaged the level of their arguments and claimed to have found numerous inaccuracies in their report. Indignant, he accused the inspection team of witch-hunting and McCarthyism. Benveniste called on the scientific community not to allow inspectors into laboratories and to return to the good old method by which one lab seeks to substantiate the findings of another lab by independently reproducing the results using an equivalent experimental system.

Five years later, an article responding to Benveniste's call was finally published in Nature. Unfortunately for him, the results did not meet his expectations. A team from the pharmacology department of the University of London repeated Benveniste's experiments, but were unable to reproduce the results, and reported that their findings did not support the claims of the French team.

The attempt to give homeopathy validity also spilled over into another arena: controlled clinical experiments.

In the past two decades, numerous clinical studies have purported to examine the effect of homeopathy on various illnesses. Four different groups systematically summarized these studies. Despite many reservations about the quality of the studies, and about the possibility of biases that cannot be measured, the researchers found that homeopathy has a positive effect.

But empirical findings such as these, which stand in total contradiction to established theories, are not sufficient to alter our current understanding of reality. Therefore, the positive findings in the clinical experiments arouse skepticism among many both inside and outside the scientific community.

God is put to the test

Long-distance healing has been described as "a conscious spiritual activity directed at benefiting the physical or emotional welfare of another person." Long-distance healing by means of prayer essentially involves asking God or some other supreme power to intervene in the condition of a specific individual or patient. This is the most popular method of alternative medicine in the Western world. In England, there are 14,000 long-distance healers. A controlled clinical study published in 1998 in one of the less prestigious medical journal made big waves. 40 AIDS patients in an advanced stage of the disease were randomly divided into two groups: a control group and an experimental group that was given "long-distance healing" for 10 weeks. The long-distance healing was done by healers of various types and traditions who were scattered around the United States and never met the patients they were supposed to be healing. Six months later, the group that received long-distance healing was found to have a lower incidence of AIDS-related illnesses, fewer doctor visits and fewer hospitalizations. Their illness was less severe. And their mood was better.

Anyone who wanted to believe that this was simply an esoteric, anecdotal and basically meaningless study was soon proved wrong. In 1999, a leading medical journal published a study that examined the effect of prayer on patients hospitalized in the cardiac ICU. A group of 990 patients was randomly divided into two subgroups: The patients in the control group received the standard treatment and the patients in the experimental group received the standard treatment plus long-distance healing. Without their knowledge, another person was asked to pray for their recovery.

The researchers reported that the mortality rate in the two groups was identical, but the clinical progress of those who received long-distance healing involved fewer serious complications. The difference in the amount and severity of complications between the two groups was statistically clear.

After a lengthy concerted effort, more than 100 studies examining the effects of long-distance healing were found in the medical literature. After sifting out the studies that did not meet basic methodological standards, 23 studies remained, covering 2,774 patients: 13 of them (57 percent) found a positive effect; nine found no effect and one found a negative effect.

The intensive debate that followed the publication of these studies focused mainly on the questions asked by the research. The basic claim made by the healers was that it was not the effect of prayer on disease that was tested, but rather God's intervention in response to human mediation, with divine intervention being statistically measured.

Putting a question of this sort to the scientific test seems like a dubious proposition. Is it logical to assume that God will act in accordance with the laws of probability? According to the great monotheistic religions, God is not bound by the laws of nature, and certainly not by the laws of probability. Moreover, the great religions attribute unlimited powers to God. He is omnipotent. Is it reasonable to assume that God needs the prodding of prayers in order to ensure the well-being of people whose welfare he cares about?

There are people who have drawn encouragement from the (even partial) success of scientific experiments that appear to corroborate the power of the Creator and they propose to continue to advance and to look at the effects of the various components of ritual prayer: i.e., quantity, type, form, duration, frequency, degree of fervor, number of people praying at one time, the type of belief held by the person praying or the patient. For example, it would be interesting to test the premise that the effect of five people praying for two minutes is identical to the effect of two people praying for five minutes. Some suggest using such a method to test what is the "correct" faith - by examining whether the prayer of a Christian for a Jew has more effect than the prayer of a Jew for a Christian.

But many are troubled by the acceptance of these studies, feeling that the idea that the efficacy of long-distance healing can be proved through clinical experiments actually calls into question the credibility of such experiments.

A survey published in the most recent issue of Nature indicates that at least one out of three scientists in America who receives a government-funded grant is too forgiving of inaccuracies and is not averse to "rounding out the corners" in his or her scientific work. Approximately 15 percent admitted that they had omitted data from a study and 27 percent admitted that they had not preserved the data properly. Such "inaccuracies" could easily transform a negative result into a positive one. The scientific method is based on a broad system of rules that determine the way in which it is possible to obtain reliable evidence and the way in which reliable evidence becomes a scientific truth. The achievements of science and the public's trust are dependent in large part on the degree of commitment that scientists have to strictly upholding these rules. Wild competition between scientists and the deep involvement of vested interests in scientific research have dealt a serious blow - some would even call it a mortal blow - to the integrity of the scientific community.

Ritual and healing

Up until the mid-20th century, medical practice was based on the fundamental premise of ergo propter hoc - the attribution of a certain effect exclusively to the action that preceded it chronologically. This is one of the most common errors in human thinking. The penetration of the scientific method into clinical medicine derives from the understanding that the juxtaposition of an action and an effect cannot serve as decisive proof of a causal relation between them. Reality is more complex than that: There are many variables in the system and their influence may be more important than that of the action that was intended to alter the reality. The objective of the controlled clinical experiment is to distinguish between the effect of the drug and the effects of other factors that could cause changes in the patient's condition.

The successes of alternative medicine are based on the faulty thinking inherent in ergo propter hoc: The improvement in the patient's condition in homeopathy or prayers to the Creator is attributed to "therapy," while its source almost certainly lies in other influential factors such as natural healing and therapeutic ritual. Bear in mind: Nearly every treatment for the flu (whether with antibiotics or homeopathy) will be an apparent success simply because in the vast majority of cases, the body itself overcomes the illness.

The therapeutic ritual, which includes listening, conveying information and expressions of empathy and understanding, may lead to a change in the patient's opinions, expectations, beliefs and mental state. Despite its importance, studies show that in most cases the effect of therapeutic ritual is of limited duration and becomes smaller and less significant in inverse proportion to the severity of the illness.

Nevertheless, it appears that the human need for the therapeutic ritual, despite its limited effect, is a very basic, perhaps primeval one. Therefore, many people are ready to make every effort to satisfy this need, even if it sometimes means forgoing other tools that could bring them much benefit in the long run. In other words, patients turn their backs on conventional medicine and seek out alternative medicine in part because only it satisfies their deep need for a sympathetic ear and acknowledgment of their physical and emotional distress.

Unfortunately, the physicians who apply the achievements of scientific medicine had almost completely abandoned the therapeutic ritual - sometimes because of their work conditions (the number of patients they are required to see within a certain period of time), and sometimes because of their belief that the effective tools they possess enable them to function as technicians.

Anyone who cares deeply about human welfare must view the growth of alternative medicine and the erosion of the status of conventional medicine with great concern. Initial attempts to protect scientific research from the taint of vested interests and repeated calls from leaders of the medical establishment to strengthen the therapeutic ritual attest that in the strongholds of scientific medicine, there is also a sense that the foundations are shaking.

Benny Mozes is a physician, researcher and a lecturer on health policy.