I have nothing against berries. I, in fact, enjoy many kinds of berries in my diet. My favorite fruit, the banana, is actually a berry (botanically speaking). I am disturbed, however, at the extent to which various kinds of berries are being sold as the latest superfood cure-all.
Dr. Oz, for example, has been pushing the lingonberry (a relative of the cranberry and blueberry) as “a new superfruit for longevity.” An attached article on his site states:
“Today, scientists are showing its value in both human and animal studies that are proving to have positive results.”
Curiously, there are no links or references to these studies.
Polyphenols and Antioxidants
We are still in the midst of the “antioxidant craze” – if you read the justification for just about any so-called “superfood” or longevity supplement you are sure to read about antioxidants. I have already covered antioxidants, but briefly: Cell metabolism in part creates oxygen free radicals which are molecules that steal electrons from other molecules, causing a cascade of reactions that can damage proteins and other chemicals in the body. Anti-oxidants are chemicals that can stop free radicals and limit the damage. They therefore decrease “oxidative stress” on cells. So far it sounds like anti-oxidants are therefore a good thing and we should be gobbling up as much as we can. However – free radicals and anti-oxidants exist in cells in a homeostasis. Free radicals are used by the immune system, for example, to fight invading organisms. They are also important signaling molecules, triggering other cell-protective mechanisms.
There is a movement in the US to oppose a public health measure that is backed by impressive evidence showing it is safe and effective, as well as highly cost effective. For as long as the government has supported this health measure, there have been those opposed to it, claiming (against the evidence) that it is unsafe, ineffective, and represents a violation of personal freedom and the right to refuse an unwanted medical intervention. I could be talking about vaccines and the anti-vaccine movement, but in this case I am talking about the fluoridation of public water supplies and the antifluoridation movement.
This social debate (there isn’t much of a scientific debate) crops up in the news every now and then – mostly prompted by an antifluoridation activist or group making noise, or by a local referendum to block fluoridation in a community. Recently there has been a Harvard study making the rounds of social media, Developmental Fluoride Neurotoxicity: A Systematic Review and Meta-Analysis. The actual findings of the study do not show that there is any risk to public water fluoridation (if anything, they show that it is safe), but the study was seized upon by antifluoridation activists and distorted for their propaganda purposes. Unfortunately, the internet is now fertile ground for the spreading of propaganda.
The NYS Coalition Opposed to Fluoridation put out a press release distorting the findings of the study. Their press release (“Harvard Study Finds Fluoride Lowers IQ – Published in Federal Gov’t Journal”) was then printed as a science news item by many online news outlets. Reprinting press releases, without any editorial filter, is a cheap and easy way to add news-like content to your website. The Sacramento Bee, for example, published the press release under their “News” tab. Near the top of the page, in small print, they did put a disclaimer (which is better than most sites):
This section contains unedited press releases distributed by PR Newswire. These releases reflect the views of the issuing entity and are not reviewed or edited by the Sacramento Bee staff. More information on PR Newswire can be found on their web site.
That’s better than nothing, but I wonder how many people reading the press release will notice and read the disclaimer. In my opinion, a news outlet should not reprint press releases sent out from advocacy organizations clearly intended to promote an agenda. They especially should not print them under the banner of “News.” The disclaimer is not adequate. The spreading of this “news item” around Facebook and other social media demonstrates this.
The Summer Olympics are coming up, which means that, in addition to world-class athletic performance, the public will be exposed to a variety of sports-related pseudoscience. This is not unique to the Olympics, of course. The world of sports competition is rife with pseudoscience, false claims, dubious products, superstitions, and magical charms. The most egregious example of this recently has been the energy bracelet scam – multiple companies have and are marketing little bits of rubber, plastic, or metal that you wear on your wrist and they claim (based on parlor tricks rather than evidence) will improve athletic performance. They give classically pseudoscientific explanations for the alleged effect, such as negative ions or energy frequencies. In fact the new icon of the entanglement of sports with pseudoscience is the Power Balance Stadium.
Occasionally the scientific community takes notice of such claims and bothers to review them. Also, in the internet age, the information is actually available to the public (rather than buried in an obscure journal). A recent joint investigation by BBC Panorama and the British Medical Journal (BMJ) recently found a shocking (to them) lack of evidence for many claims made to market performance-enhancing products. The BBC reports:
A team at Oxford University examined 431 claims in 104 sport product adverts and found a “worrying” lack of high-quality research, calling for better studies to help inform consumers.
High quality studies would be nice, but the article fails to ask the question – who is going to fund those studies? What incentive do manufacturers have in proving their products don’t work?
Since the development of the vaccine, perhaps the most effective public health measure we have yet devised, only one human disease has been completely eradicated from the world – smallpox. The last case was reported in Somalia in 1977. Eradication was the result of a deliberate and intense campaign, requiring almost complete vaccination of the population, especially in certain population dense areas. Countries such as India and Nigeria were among the last to achieve eradication. Some of the lessons learned were that very high compliance rates were needed and that even small communities could harbor the virus and prevent eradication.
Several decades later, at the beginning of the 21st century, we are on the verge of eradicating a second major human infectious disease, polio. Like smallpox, polio is a virus that has no major non-human host, so eradication is possible. The polio virus enters the anterior horn cells of the spinal cord, the lower motor neuron – cells that connect the brain to muscles. When those cells die muscles lose their connection causing weakness and atrophy. Vaccine campaigns have successfully eliminated polio from most countries, but the wild type of the virus remains endemic in Nigeria, India, Pakistan, and Afghanistan.
We have the potential, with one final push (which is being spearheaded by the World Health Organization – WHO) to eradicate wild type polio from the world, but these efforts are being hampered by politics and ideology.
The following article is reposted from NeuroLogicaBlog. Happy Independence Day to all our American readers.
The pharmaceutical giant, GlaxoSmithKline, has agreed to pay three billion dollars in fines to settle three charges of fraud brought by the FDA. This is the largest health fraud settlement in US history. What are the implications of this settlement for how the pharmaceutical industry is regulated in the US and for the role that “Big Pharma” allegedly plays in US health care?
The three fraud charges admitted to by GSK include promoting the off-label use of two anti-depressant drugs – Paxil and Wellbutrin. In the US drugs are approved for specific indications, and they can only be marketed for those indications. So-called off-label use of drugs, however, is very common. Off-label does not necessarily equate to bad medicine, or to lack of scientific evidence or rationale. Often there is solid basic science and clinical evidence to support a specific use of a drug that is not approved by the FDA. That simply means the manufacturer did not apply to the FDA for that indication, which could simply be because they did not feel they would recoup the millions of dollars they would need to spend to get approval for the additional indication. In other words, FDA approval for secondary indications is as much about marketing and finance as it is about the science.
Regardless of whether or not a specific use is evidence-based, however, the rules regulating pharmaceutical companies are very clear – they cannot market a drug for a non-approved use. Doing so breaks the law. GSK broke the law.
In 2011 the Swiss government completed an official examination of homeopathy, as part of its consideration of whether or not insurance companies should be made to cover homeopathic treatment. Their report, which concluded homeopathy is effective and should be covered, was published in English in February 2012. Not surprisingly, homeopathy promoters, like Dana Ullman writing for the Huffington Post, were quick to proclaim the virtues of the Swiss report and tout it as evidence for the effectiveness of homeopathy. Recently, however, a more critical review of the Swiss report has been published, revealing the report to be biased and scientifically suspect.
Ullman begins his crowing about the Swiss report with this dubious statement:
The Swiss government has a long and widely-respected history of neutrality, and therefore, reports from this government on controversial subjects need to be taken more seriously than other reports from countries that are more strongly influenced by present economic and political constituencies.
Political neutrality is not equivalent to being scientifically unbiased. Ullman, and other homeopaths, however, are keen to prefer the Swiss report over other government reports. This is because in 2010 the UK government performed their own systematic review of homeopathy – Evidence Check 2: Homeopathy. In their report they concluded that homeopathy is essentially witchcraft – that it does not work, its underlying principles are scientifically invalid and tantamount to magic, that it should not be covered by the national health service, and that it is not even worth any further research. Ullman strangely does not mention this report directly in his article.
I wrote previously about bee venom therapy (BVT), also called apitherapy or bee sting therapy, as an emerging “alternative” therapy. Both use and research into BVT continue, providing an excellent example of the many things that are wrong with the CAM movement.
A recent Reuters article on the topic is also an excellent example of the frequent complete failure of the mainstream media in dealing with such topics. The articles discusses a Filipino bee keeper who decided to practice medicine based upon his personal anecdotal experience. Joel Magsaysay suffered a stroke and right-sided weakness. He attributes his recovery from the stroke partly to bee stings.
He admits he is not a physician and has no medical or scientific background. He has concluded that BVT works based upon anecdote along. He seems to be unaware of the unreliability of individual anecdotes in stroke recovery. Most patients will improve following a stroke. There are also two kinds of recovery, including neurological recovery from brain plasticity.
It has been very instructive, from a science-based medicine perspective, to watch the story of alleged chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS) unfold over the last three years. In 2009 Dr. Paolo Zamboni, an Italian vascular surgeon, published a paper in which he claimed that 100% of MS patients he investigated showed signs of blockage in the veins that drain blood from the brain, a condition he named CCSVI. This paper sparked immediate controversy. This controversy has been in the news again recently with the making public of the results of an observational study of the liberation procedure to treat CCSVI.
Existing research over the last half century strongly indicate that MS is primarily a disease of immune dysfunction (an autoimmune disease), resulting in inflammation in the brain that causes damage, specifically to the myelin, the insulation around nerve fibers that allows them to conduct signals efficiently. Zamboni is suggesting that MS is primarily a vascular disease causing back pressure on the veins in the brain and iron deposition which secondarily results in inflammation. This would be a significant paradigm shift in MS. It would also not be the first time such a dramatic shift in MS science has been proposed but failed in replication.
The MS community did not give much credence to the notion of CCSVI, but despite this there has been an incredible amount of research on the idea over the last three years (a PubMed search on “CCSVI” gives 103 results). Most of the research has simply attempted to replicate Zamboni’s findings, with mixed but generally unimpressive results. No one has found the 100% results that Zamboni originally reported. The studies have found a range of venous insufficiency in MS patients, down to 0%, but many finding results in the range of 20-40%. However, patients with other neurological disease and healthy controls have also been found to have similar rates of venous insufficiency. Some studies have found a positive correlation with MS, others have not.
“The forces of graft and unrighteousness are peculiar to no country or clime, and they have their champions in the high places and the low. Until the people themselves are better educated concerning the danger and iniquity of quackery, they must be protected from the forces that prey. The popular understanding of these matters is becoming better every day, and, aided by proper laws, the time will come, perhaps, when quackery will be unprofitable.”
The above quote is from a recently published JAMA (Journal of the American Medical Association) article. I should say that it is republished, because it first appeared on June 8, 1912. The brief article outlines the issues surrounding the regulation of medical practice so as to protect the public from “quackery.” It is interesting to see that the issues faced 100 years ago are virtually identical (in broad brush strokes) to those we face today. Despite the fact that so much has changed in medicine over the last century, in this regard very little has changed.
To put this article into historical context, it was published just two years after the Flexner Report, generally recognized as the turning point in American and Canadian medical education when it truly embraced scientific and evidence-based practices. Mainstream medicine in 1912 was barely making the transition from being based upon tradition and authority to having scientific backing and genuine standards. Life expectancy in the US had just passed 50, up from a low of around 40 thirty years earlier. Phrenology was still practiced by mainstream psychiatrists and neurologists – although it was on the way out (having recently been refuted by scientific studies) and was increasingly being pushed to the fringe. The last purely homeopathic medical school in the US would not close until 1920. Patent medicines were still the norm, and the 1906 Pure Food and Drugs Act had only recently been enacted to establish some standards of safety in the medicine marketplace (this would essentially transform into the FDA in 1930).
While scanning through recent science press releases I came across an interesting study looking at the use of a pharmaceutical grade antioxidant, N-Acetylcysteine (NAC), in the treatment of certain symptoms of autism. This is a small pilot study, but it did have a double-blind placebo controlled design. The press release reports:
During the 12-week trial, NAC treatment decreased irritability scores from 13.1 to 7.2 on the Aberrant Behavior Checklist, a widely used clinical scale for assessing irritability. The change is not as large as that seen in children taking antipsychotics. “But this is still a potentially valuable tool to have before jumping on these big guns,” Hardan said.
“This was a pilot study,” Hardan said. “Final conclusions cannot be made before we do a larger trial.”
I also noticed that two of the authors list significant conflicts of interest – patents on the use of NAC, and one has equity in the company that makes it. It occurred to me that a larger question than the efficacy of NAC for these autism symptoms is this – if this is a pilot study only and we should not base any firm conclusions on the results, then why the press release?