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.
The cornerstone of science-based medicine is, of course, scientific research. The integrity and quality of biomedical research is therefore of critical importance and to be thoughtfully and jealously guarded, if we care about maintaining an optimal standard of care. There are many threats and hazards to the institutions of medical research – mostly ideological. One that has not been discussed much on this blog but has been in the news recently is that of conflict of interest. Upon close examination this is a more complex issue than it may at first appear.
The most recent controversy over conflicts of interest were sparked by an article published in JAMA in which the authors allege that published studies that downplayed the risks of Vioxx (A Cox-2 inhibitor marketed as a pain killer that was removed from the market for increased cardiac risk) were in fact ghost-written by employees of Merck, the manufacturer of Vioxx. The names of two academic researchers were then attached to the studies to give them legitimacy. If true this is a damning episode, and no one would reasonably disagree with the contention that companies writing research on their own products represents an unacceptable conflict of interest. For the record, both Merk and the one surviving academic deny the accusations completely.
A new study sheds more light on the question of what is causing the recent increase in the rate of diagnosis of autism. Professor Dorothy Bishop from the University of Oxford studied adults who were diagnosed in 1980 with a developmental language disorder. She asked the question – if these people were subjected to current diagnostic criteria for autism, how many of them would be diagnosed today as having autism? She found that 25% of them would. (Bishop 2008)
This epidemiological question has been at the center of a controversy over whether or not there is a link between vaccines (or the mercury-based preservative, thimerosal, that was previously in routine childhood vaccines) and autism. The primary evidence for this claim put forward by proponents of a link is that the number of diagnoses of autism increased dramatically at the same time that the number of vaccines routinely given to children was increasing in the 1990′s. They are calling this rise in autism an “epidemic” and argue that such an increase requires an environmental factor, which they believe is linked to vaccines.
That the number of new autism diagnoses is dramatically increasing is generally accepted and not a point of debate. The historical rate of autism is about 4 per 10,000 and the more recent estimates are in the range of 15-20 per 10,000 (30-60 per 10,000 for all pervasive developmental disorders of which autism is one type). (Rutter 2005) The controversy is about what is causing this rise in diagnoses. There are two basic hypotheses: 1) That the true incidence of autism is rising due to an environmental cause, 2) That the rise in incidence is mostly or completely an artifact of increased surveillance and broadening of the definition of autism. These two hypotheses make specific predictions, and there is much evidence to bring to bear on their predictions – this recent study only being the latest.
Measuring placebo effects (often misleadingly referred to as the placebo effect – singular) is a part of standard clinical trial design, because they need to be distinguished from the physiological effects of the treatment under study. Rarely, however, are placebo effects the actual target being measured, but such is the case with a new study published in the most recent edition of the British Medical Journal (BMJ) – Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. (Here is a summary if you cannot access the article directly.)
Dr. Ted Kaptchuk et.al. studied the response to various placebo treatments in 262 adults with irritable bowel syndrome (IBS). The three groups were designed to address three major categories of placebo effects: 1) response to the process of being assessed and observed, 2) response to being given a placebo treatment, and 3) response to the patient-practitioner relationship. These types of placebo effects were represented by three treatment arms: 1) observation alone, 2) placebo acupuncture, 3) placebo acupuncture plus an “augmented” practitioner-patient relationship – with added “warmth, attention, and confidence.”
The question of whether or not there is a link between the use of mobile phones (also called cell phones) and the risk of brain tumors has been cropping up more and more frequently in the media – every time a new study or analysis comes out. This is a very important question of public health as cell phone use is becoming more common, and brain tumors are a very serious and often life-threatening category of diseases.
Of course such questions are best answered by a dispassionate, careful, and systematic look at the science – what is the plausibility of a link and what is the evidence that there actually is one. At this point we are somewhere in the middle of studying this problem. We already have substantial data, but it is conflicting and the research community is still debating on how to get more definitive data everyone can agree upon. So at present there is a variety of opinions on the matter. The consensus seems to be that cell phones probably do not cause brain tumors, but we’re not sure, there is meaningful dissent from this opinion, and so more study is needed.
There are two types of scientific studies we can do to answer this question. The first is biological and looks at the effects of radiation, and specifically the type and strength of radiation emitted by cell phones, on cells in a test tube and on animals. This will tell us if a risk from cell phones is plausible, if there is a mechanism, and what, if any, the effects are likely to be. But this kind of data will not tell us if cell phones in fact have caused or are causing brain tumors.
The story of Airborne – a popular supplement marketed as an “herbal health formula that boosts your immune system to help your body combat germs” – is representative of what is wrong with the supplement industry and how it is regulated in the US. Recently the company that sells Airborne – Airborne Health, Inc – agreed to pay $23.3 million to refund consumers who purchased the product (if they have proof of purchase). This was to settle a class-action law suit brought by the Center for Science in the Public Interest (CSPI) and others claiming false advertising. In the settlement the company did not admit any wrongdoing. While this can be viewed as a minor victory for science-based medicine, it actually highlights the many deficiencies in the system.
For background, Airborne was launched in 1999 as a supplement designed to ward off the common cold. It has been extremely successful, due largely to its slick packaging, a clever slogan that it was developed by a school teacher, and promotion by Oprah Winfrey. The Airborne brand of products has expanded, including pixie powder for children, Airborne seasonal, Airborne Jr., Airborne on-the-go, and others. Advertising urged users to take Airborne at the first sign of a cold or as a preventive treatment if about to enter a germ-filled area, like an airplane. They also cited a “scientific” study that demonstrated Airborne is effective.
At the end of the 18th and beginning of the 19th century electricity and magnetism were cutting edge science, full of excitement and unknown potential. Capitalizing on this excitement, Franz Anton Mesmer captured the imagination of the European intelligentsia with his bogus claims of animal magnetism. At the turning of the next century radioactivity was the new and fascinating scientific discovery, and this lead to a market for radioactive tonics good for a multitude of complaints, or just for extra energy. A few decades later radio waves were the latest healing craze.
Cutting edge science is cool and exciting, it evokes the promise of the future and the public has learned to expect that the latest gee whiz science appears like magic. Its newness also virtually guarantees that the public at large will mostly not understand the science or its true implications. This is a situation ripe for exploitation.
Today one medical technology that does possess great promise but is not yet ready for prime time is stem cell therapy. Legitimate scientists involved in stem cell research are almost giddy about the possibilities. Early applications are possibly just around the corner, and only time will tell what the full potential of this technology is. But right now there are no legitimate stem cell therapies outside of research protocols. It is therefore not surprising that the con artists of today are exploiting the tremendous hype of stem cells.
A recent meta-analysis of the most commonly prescribed antidepressant drugs raises some very important questions for science-based medicine. The study: Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration, was conducted by Irving Kirsch and colleagues, who reviewed clinical trials of six antidepressants (fluoxetine, venlafaxine, nefazodone, paroxetine, sertraline, and citalopram). They looked at all studies submitted to the FDA prior to approval, whether published or unpublished. They found:
Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.
The press has largely reported this study as showing that “antidepressants don’t work” but the full story is more complex. This analysis certainly has important implications for how we should view the body of evidence for these antidepressants. It also illuminates the possible role of publication bias in the body of scientific literature – something that has far ranging implications for science-based medicine.
One of the most successful propaganda campaigns within health care in the last few decades has been the re-branding of nutrition as “alternative” or out of the mainstream of scientific medicine. I have marveled at how successful this campaign has been, despite all the historical evidence to the contrary. I suppose this is partly a manifestation of the public’s short-term memory, but it also seems to reflect basic psychology.
There is evidence that most ancient cultures recognized the importance of diet in health. The Greeks recognized both the benefits of a varied diet and the negative health consequences of obesity, for example. But knowledge of nutrition was limited to these broad observations and was mixed with superstition and cultural beliefs.
The science of nutrition probably dates back to 1614 when scurvy (the disease that results from vitamin C deficiency) was first recognized as a dietary deficiency, one that could be cured by eating fresh fruits and vegetables. In 1747 Lind conducted what might be the first clinical trial – systematically comparing various diets for the treatment of scurvy and finding that citrus fruits were the key to treatment.