The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.
Chelation and Autism
Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.
Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.
Savvy consumers are familiar with the classic scam of the “bait and switch” – in practice if not the term itself. My wife and I ran across it when we were shopping for our first car. We needed a bargain and so we were attracted to the ads that promised a new Colt for only $9,000 (that’s the bait). Of course when we got to the dealership they were all out of Colts with the configuration advertised, but they had plenty of others that had different options that cost several thousand dollars more (that’s the switch).
It’s a basic and very successful form of deception, and so even though there are laws against such practices it is impossible to eliminate in all its various and more subtle forms. It even permeates scientific, political, and other intellectual endeavors – anytime a more palatable idea or claim is put forward to represent the less acceptable truth.
Science, however, requires transparent honesty to function properly, and therefore scientific practitioners must vigilantly guard against the cognitive bait and switch. Generic intellectual virtues incorporate this vigilance – they include the need to unambiguously define terms, to make claims as specific and operational as possible, and the use of valid logic. Beware of any claims that subtly violate these rules because they are probably setting you up for a bait and switch.
The purveyors of unscientific medical claims have become as expert at this classic deception as the slickest used-car salesman – in fact they have left the hawkers of dubious transportation in the dust.
When politics and science collide, shenanigans are likely to ensue. Politics is often antithetical to science because the former is about persuasion and value judgments while the latter is about objectivity and transparency. Science cannot function properly under the yoke of political ideology.
The infiltration of unscientific and anti-scientific practices and ideas into mainstream medicine is primarily an act of politics and ideology trumping science. The latest example of this comes from the Department of Health and Human Services (HHS) who put out a press release on June 16th declaring that: “HHS Secretary and Chinese Minister of Health Sign Memorandum of Understanding on Traditional Chinese Medicine Research.” The press release states:
“Many Americans incorporate alternative medical practices into their personal health care and are interested in the potential of a variety of traditional Chinese medicine approaches,” Secretary Leavitt said. “This project will advance our understanding of when and how to appropriately integrate traditional Chinese medicine with Western medical approaches to improve the health of the American and Chinese people.”
This statement is so common among the political apologists for unscientific medicine that is has become almost a cliche. The first claim in Secretary Leavitt’s statement is that “Many Americans incorporate alternative medical practices into their personal health care…” This is misleading and irrelevant. The primary problem is with the use of the term “alternative medicine” without providing any kind of definition. This is a false category because the modalities that are generally included in so-called CAM do not necessarily have anything in common except for the fact that they lack adequate scientific justification to be considered part of mainstream medicine. That is, except for those treatments that CAM proponents sneak into this category to misleadingly inflate its apparent size and impact – like exercise, nutrition, physical therapy, etc. These modalities can be scientific (depending upon how they are applied) and have no place under the CAM umbrella.
The Food and Drug Administration (FDA), the agency that regulates the drug industry in the US, put out a press release yesterday warning “Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The press release reports:
“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”
The FDA therefore recognizes that this is a serious problem, and that is good. They also acknowledge that the problem of “bogus cancer cures” is a longstanding one, not a new or recent problem, but the reason they are taking action now is because the internet is significantly increasing the reach of these fake cures.
Recently I have been generally critical of how mainstream media deals with scientific topics. Science is often complex and requires hard work and diligence on the part of a journalist to get the story right. In recent years mainstream news outlets have been downsizing or eliminating their science journalists and tasking general reporters and editors to handle science stories.
Meanwhile, as science progresses it grows more complex and challenging to distill for a lay audience. At the same time there are growing pseudoscientific institutions and social forces making it even more difficult to sort out the reliable from the nonsense. This is especially true, in my opinion, when it comes to medical reporting of controversial treatments and claims.
Dr. Geeta Shroff is an Indian physician who is running a New Delhi clinic offering embryonic stem cell therapies for a large number of various medical conditions. The only thing these medical conditions have in common is that they are incurable. Indian law allows for the use of unproven treatments for terminal or incurable diseases. I cannot know Dr. Shroff’s intentions, but she has rejected the ethics and standards of science-based medicine and in so doing has transformed herself into a dangerous charlatan.
Embryonic Stem Cell Therapy
Embryonic Stem Cells (ESC) are controversial because of the ethical and moral consideration regarding harvesting ESC and the rights of an embryo. But that is not what makes Dr. Shroff’s treatments controversial, and not what I am going to write about here. The question, rather, is the state of the science of ESC therapy.
ESC’s are scientifically interesting because they have the potential to turn into any type of cell in the body. The hope for ESC therapy is that they can be used to replace dead or abnormal tissue in the body, something which is not now possible for many conditions. (Organ and bone marrow transplants are among the current treatments to replace failing tissue.) For example, an injured spinal cord might be repaired by using ESC’s to replace the damaged motor neurons and reestablish a connection between the brain and muscles. Atrophied muscles themselves can be repaired by having ESC’s turn into working muscle cells.
As the name of this blog makes clear, the authors believe that the public is best served when the institutions of medicine and health care are science-based. The basis of medicine has many levels and institutions in our society. They include not only the practitioners of medicine, but hospitals, medical schools and other academic institutions, government and regulatory agencies, industry, insurance companies, the legal system, media, and (last but not least) the public. Defending science-based medicine requires advocacy at every level.
Arguably, the acceptance of science-based medicine at all levels is influenced greatly by public opinion (too much, in my opinion, as a profession, almost by definition, should rise above the lowest common denominator of public opinion), and public opinion is influenced greatly by the mainstream media. There is one issue, however, for which public opinion has a direct and measurable effect on the efficacy of a medical intervention and that is the vaccination program. Therefore we pay particular interest to how the media deals with the issue of vaccines, especially the recent false controversy over an alleged link between vaccines and autism.
It is my observation (and also supported by a recent study) that the quality of mainstream science reporting has been generally low, attributed to the scaling back of dedicated science journalists. On this issue I have found the reporting to be mixed, with both good and bad examples, but with the highest quality outlets generally getting the story right. This week Time magazine’s cover story is The Truth About Vaccines by Alice Park. The article is excellent – it covers the controversy without pandering and without pretending that there is more of a scientific controversy than there is. She states quite succinctly that the evidence has been evaluated by scientific organizations and there simply is no credible evidence for a link between autism and vaccines.
My daughter, Julia, loves to play games and has a bit of a competitive streak. She can make any activity into a game and is adept at making up rules on the spot. When she was younger, like most children, she had a tendency to add to or change the rules on the fly – usually to ensure a favorable outcome for herself. “Oh, Daddy, I forgot to mention that the ball can bounce once and that still counts.”
It was an opportunity for me to gently teach her that in order for rules to work everyone has to know what they are ahead of time and you can’t change them after the fact. Her smile told me that even at five she intuitively knew this already – that changing or making up new rules was not fair. What I was really teaching her was that she wasn’t going to get away with it with me, and by extension that it is socially unacceptable to mess with the rules to suit oneself.
Adults are really no different than children in our basic emotional makeup. We all want to change the rules to suit our own needs. The true difference is that as we mature we become more socially sophisticated; we become more subtle in our manipulations, and we develop the capacity to rationalize our wants and desires. We also learn that we are playing a bigger game – the social game. So we adhere to the rules of fairness, even if it means losing a competition, because we want to succeed at the more important game of socialization. (I’m not making any moral or ethical judgments here, just observing human behavior.)
In Canada a new bill has been proposed, Bill C-51, that would make changes to the Food and Drug Act – the body of laws by which the Canadian federal government regulates food and health products in Canada. This is the equivalent of the Food and Drug Administration (FDA) in the US. It seems that Canada, like the US, is struggling to deal with a burgeoning industry of “natural health products” that are minimally regulated.
The new bill will increase government oversight of natural health products (NHP) for the purpose of ensuring higher quality standards for products and accuracy in the claims that are made for them. Proponents of the bill claim that it will serve to improve consumer protection. But the NHP industry is not happy with the increased oversight the bill would bring. Their hysterical reaction to the proposed bill is very revealing about the propaganda and deception used by the NHP industry.
This history of NHP regulation in Canada also reveals the two primary strategies by which the promoters of unscientific medicine and health products seek to advance their business. On the one hand they seek licensure, certification, and other formal recognition by the government in order to bolster their legitimacy with the public and also to keep competition at bay. When seeking such things they argue that licensure etc. will give the government the opportunity to regulate the industry and ensure quality control. They therefore take the position of consumer protection.
Last week it was widely reported that an Ohio man, Lee Spievak, had regrown the end of his finger that had been chopped off in an accident. Reporters informed us, for example:
A man who sliced off the end of his finger in an accident has re-grown the digit thanks to pioneering regenerative medicine.
But this was not the real story. The true and amazing tale, rather, is of how the mainstream news media utterly failed to properly report this story. This is not an isolated incident, but a commonplace example of a broken system, and one that is getting worse. But first, let’s see how this reporting went wrong.