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?
Among the myriad of supplements being offered to the public are various bee products, including bee pollen. The claims made for bee pollen supplements are typically over-hyped and evidence-free, as is typical of this poorly regulated industry. The claims from bee-pollen-supplements.com are representative:
The benefits are enormous and the substance has been proven by many health experts. This particular substance is known as an effective immune booster and one of the best ways to achieve a sound nutritional regime.
The pollen from the bee has been proven to increase sexual functions in both men and women. It stimulates our organs, as well as our glands and is known to improve the natural increase on a person’s lifespan.
What you never find on such websites are references to published peer-reviewed studies that substantiate the specific claims being made. There are also concerns about safety which have not been adequately studied.
A recent case report highlights one safety concern regarding bee pollen products – allergic and even anaphylactic reactions. The Canadian Medical Association Journal reports:
A 30-year-old woman with seasonal allergies but no history of allergies to food, drugs, insects or latex had an anaphylactic reaction after taking bee pollen. She had swelling of the eyelids, lips and throat, difficulty swallowing, hives and other life-threatening symptoms. After emergency treatment and discontinuation of the bee pollen supplements, there were no further reactions.
The Princes Foundation for Integrated Health closed shop in 2010. Now the company that ran the foundation has officially closed. The foundation was a vanity project by Prince Charles, who had a soft spot for so-called alternative medicine and natural therapies. The foundation was established in 1993 and in the last 19 years has misinformed the public about CAM therapies, promoted nonsense like homeopathy, and has been an official royal seal of approval on the anti-science in medicine movement in the UK.
In short the foundation was an excellent example of why political ideology should not interfere with the normal process of science. The website for the charity no longer exists, but this is what it said about it’s mission:
“The Prince’s Foundation for Integrated Health is a UK charity championing an integrated approach to health.
“The Foundation works towards a culture of health and wellbeing with people and communities taking more responsibility for their own health, and where health professionals collaborate and share learning in the best interests of their patients.
“Integrated health means an approach to health which:
- “emphasises prevention and self-care
- “looks at the person in the round, taking into account the effects on health of lifestyle, environment and emotional wellbeing
- “brings together the safest and most effective aspects of mainstream medical science and complementary healthcare.”
This is typical CAM bait and switch. Preventive medicine, healthy lifestyles, and taking a complete approach to health is not alternative or complementary – it is part of mainstream science-based medicine. All of that is actually a misdirection from the real goal of the CAM or “integrative” movement – to promote health products and services that fail to meet minimal standards of evidence and plausibility, or which have already been shown to be ineffective. The Prince’s Foundation was not exception, promoting over the years every form of quackery from homeopathy to Reiki.
Industrialized nations are in the middle of a health care crisis (some more than others), or at least a dilemma. As our medical technology advances, people are living longer, they are living with chronic diseases, and they are consuming more health care. The cost of this health care is rising faster than economic growth, so it is becoming a greater and greater burden on society. Many countries ration health care in one way or another in order to contain costs. Otherwise there is no easy or obvious solution and it’s likely that difficult choices will have to be made.
An interesting side effect of this dilemma is a renewed focus on the cost effectiveness of medicine. Effectiveness alone is not enough. We simply cannot afford, for example, to introduce a very expensive treatment for marginal improvement in outcome in a common disease. Different options can also be compared not only for their safety and efficacy, but for their cost effectiveness. In other words, we need to use cheaper alternatives when available rather than always reaching for the latest and greatest (and most expensive) treatment.
This situation provides an opportunity for science-based medicine. Treatments that are promoted as complementary and alternative (CAM) are often sold as cost effective because they are less expensive up front than standard medical care. We cannot, however, cede this argument to proponents of dubious therapies. Cheap does not mean cost effective. You have to be effective in order to be cost effective, and most of the dubious treatments that are marketed under the CAM umbrella are ineffective.