Reuters recently reported on the raid of a stem-cell clinic in Hungary. This is welcome news, if the allegations are correct, but really is only scratching the surface of this problem – clinics offering dubious stem cell therapies to desperate patients. And in fact this is only one manifestation of a far greater problem – the quack clinic. They represent a serious problem for patients, doctors, and health care regulation.
Stem Cell Clinics
There is a very disturbing trend in the last few years – the proliferation of clinics offering stem cell therapy for a variety of serious, often incurable, diseases such as spinal cord injury, ALS, Parkinson’s disease, and other neurological disorders. These clinics claim to improve and even cure these diseases by injecting stem cells into the spinal cord or other parts of the body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for a single treatment.
The problem is that these clinics do not have any published evidence that their treatments are valid. There is good reason to think that they are not – stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.
Last year Simon Singh wrote a piece for the Guardian that was critical of the modern practice of chiropractic. The core of his complaint was that chiropractors provide services and make claims that are not adequately backed by evidence – they are not evidence-based practitioners. In response to his criticism the British Chiropractic Association (BCA) sued Simon personally for libel. They refused offers to publish a rebuttal to his criticism, or to provide the evidence Simon said was lacking. After they were further criticized for this, the BCA eventually produced an anemic list of studies purported to support the questionable treatments, but really just demonstrating the truth of Simon’s criticism (as I discuss at length here).
In England suing for libel is an effective strategy for silencing critics. The burden of proof is on the one accused (guilty until proven innnocent) and the costs are ruinous. Simon has persisted, however, at great personal expense.
This is an issue of vital importance to science-based medicine. A very necessary feature of science is public debate and criticism – absolute transparency.This is also not an isolated incident. Some in the alternative medicine community are attempting to assert that criticism is unprofessional, and they have used accusations of both unprofessionalism and libel as a method of silencing criticism of their claims and practices. This has happened to David Colquhoun and Ben Goldacre, and others less prominent but who have communicated to me directly attempts at silencing their criticism.
This behavior is intolerable and is itself unprofessional, an assault on academic freedom and free speech, and anathema to science as science is dependent upon open and vigorous critical debate.
What those who will attempt to silence their critics through this type of bullying must understand is that such attempts will only result in the magnification of the criticism by several orders of magnitude. That is why we are reproducing Simon Singh’s original article (with a couple of minor alterations) on this site and many others. Enjoy.
A new study suggests that it may not be uncommon for patients who are in a minimally conscious state to be misdiagnosed as being in a persistent vegetative state. The study underscores the necessity of using standardized and objective diagnostic criteria in diagnosing coma. However, it also leaves some important questions unanswered.
As background it is essential to understand a bit about consciousness and coma, for not all comas are created equally. In order to be conscious a person requires at least one hemisphere of the brain be mostly functioning and they require a functioning brainstem. The cortical hemispheres contain the gray matter – that part of the brain that thinks. So it makes sense that a certain minimal amount of gray matter is necessary to generate consciousness. As gray matter is damaged or inhibited from functioning one’s level of consciousness decreases until it descends beyond that fuzzy boundary into unconsciousness. When such unconsciousness is persistent we call that coma.
But interestingly the cortex by itself cannot generate consciousness. It requires constant prodding by a diffuse region in the brainstem (that primitive part at the base of the brain that connects the brain and the spinal cord) called the brainstem activating system. This region sends a constant barrage of electrical signals through the thalamus (the relay center of the brain) and then onto the cortex. Without this constant stimulation the cortex will lapse into sleep and coma.
On July 9th we held our first Science Based Medicine conference in Las Vegas. The event was definitely a success – we filled our room to capacity (150 attendees) and almost everyone stayed until the end. It also appeared that most attendees were actually awake, a rarity for a full-day medical conference. The Q&A session at the end was lively and interesting.
Kimball Atwood and I covered the history of science-based medicine and explored the differences between EBM and SBM. David Gorski discussed cancer quackery, including specific cases to illustrate the potential harm of pursuing worthless therapies for serious diseases. Harriet Hall gave us an overview of the the pseudoscience endemic in chiropractic. Mark Crislip discussed the chronic Lyme disease controversy. And Val Jones discussed health information online.
Based upon the feedback from those attending the conference, as well as the general enthusiasm, it seems that there is a hunger for this type of information. The audience was split about even between health care professionals and interested lay public. Many people asked if we plan on giving the conference again, and the answer is definitely yes. We have no plans set as of yet, and will certainly announce any future conferences here.
Simon Singh is a science journalist who last year wrote an article in the Guardian critical of the British Chiropractic Association (BCA) for promoting chiropractic treatment for certain childhood ailments. Singh characterized these treatments as “bogus” because they lack evidence to back up claims for clinical efficacy. The BCA responded by suing Singh for libel. In the English court system the person being sued for libel is essentially guilty until proven innocent, and even successfully defending oneself can be ruinously expensive. Therefore suing for libel in English court is a very successful strategy for silencing critics.
This case resulted in a bit of a backlash against the BCA, who were accused of silencing legitimate and very necessary public scientific debate regarding the safety and efficacy of medical interventions. The BCA could have simply responded by providing evidence to back up their claims, and the Guardian even offered them space to do so, but instead they sued.
Part of this backlash is a movement, supported by many scientific organizations, to keep libel laws out of science.
Last week I reviewed the history of chiropractic and discussed issues relating to its underlying claims and treatments for non-musculoskeletal indications. Today I will focus on chiropractic for back pain and similar indications.
There is evidence to support the very narrow indication of spinal manipulation for the symptomatic management of acute uncomplicated lower back strain. The good news for chiropractors is that this is a very common condition and does not respond well to conventional management – actually all treatments: medical management, physical therapy, manipulation, and even just patient education, appear to be equally and quite modestly effective.
There is a body of clinical studies that are relevant to the question of manipulation for lower back strain. A review of this research was published in 1989 by the RAND corporation, an independent research group that put together a panel of both physicians and chiropractors to review the available research on manipulative therapy. They concluded that evidence from 22 studies supported the use of manipulative therapy for acute uncomplicated lower back pain (again – no real pinched nerves). It is important to understand, however, that they were referring to manipulative therapy, not chiropractic. In fact only 4 of the 22 studies mentioned included chiropractors. In the other studies the manipulative therapy was performed by physicians and physical therapists.
When patients ask me if a chiropractor can help them with their problem, I often think to myself, “OK, do I give them the short answer or the long answer?” The difficulty is often in the fact that chiropractic is a diverse profession and it is difficult to even characterize what a “typical” chiropractor is likely to do. As a chiropractor once admitted to me – there are a great many things that happen under the umbrella of “chiropractic.”
In this article I will summarize some of the history and practice of chiropractic, highlighting what I consider to be many of the enduring problems with this profession.
Chiropractic was founded in 1895 by Daniel David Palmer, a grocer with an intense interest in metaphysics. Prior to his “discovery” of chiropractic, D.D. Palmer was a magnetic healer. He also had interests in phrenology (diagnosing disease based on the bumps of the skull) and spiritualism. Palmer reported to have discovered the principle of chiropractic when he allegedly cured a janitor of his deafness by manipulating his neck. The fact that the nerve which conveys sound information from the ears to the brain does not pass through the neck did not seem to bother Palmer, if he was even aware of this fact.
Palmer created the term “chiropractic,” which literally means “done by hand,” to refer to his new therapy. He argued that all disease is caused by subluxated bones, which 95% of the time are spinal bones, and which disrupt the flow of innate intelligence. He did not subject his ideas to any form of research, but rather went directly to treating patients and to teaching his principles to the first generation of chiropractors.
On June 16th the FDA issued a warning advising consumers not to use Zicam Nasal Gel or Nasal Swabs because of reports that it can damage the sense of smell, a condition called anosmia. This event highlights some problems with current regulations of health products.
There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products – sometimes after a single use, sometimes after repeated use. All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.
Anosmia is a serious medical condition. The senses of smell is one of those things we take for granted until it is gone. People who lack a sense of smell cannot tell if milk has gone sour or if their food is bad. They cannot smell smoke to warn of a fire, nor can they smell a gas leak. The FDA fears that some of the cases of anosmia associated with Zicam use may be permanent.
The tick borne spirochete infection known as Lyme disease was named after Lyme, CT – a part of the country where the disease remains endemic. It is therefore especially poignant that the Connecticut state senate unanimously passed Public Act No. 09-128: AN ACT CONCERNING THE USE OF LONG-TERM ANTIBIOTICS FOR THE TREATMENT OF LYME DISEASE.The bill had previously passed the state House, also unanimously.
This is a terrible bill that is both anti-science and anti-consumer protection. How it passed both houses without dissent reflects exactly why such micro-management decisions should not be made by politicians. It is the result of lobbying by a narrow interest group and does not reflect either the state of the science on Lyme disease nor the proper role of regulation to ensure standards of care within medicine.
This is also not an isolated case. There is already a similar law in Rhode Island, and there have been similar bills proposed in Pennsylvania, Massachusetts, and New York, and a bill in Maryland that would compel insurance companies to pay for antibiotic treatment for chronic Lyme disease CLD. This is part of a coordinated effort by individuals and organizations who hold an ideological opinion regarding the cause and treatment of CLD. They wish to use the political process to win a victory for their view that they have been unable to win in the arena of science (sound familiar).
The bill now awaits Governor Rell’s signature, which given the heavy political support for this bill seems almost certain.
This bill represents much which is wrong with the state of science and medicine in the US.
In the US children must have proof of vaccination before entering the public school system, although it is becoming easier in many states for parents to gain exemptions from this requirement. In the UK there is no such requirement. This distinction has allowed for a comparison of the impact of scaremongering about the safety of vaccines and the effectiveness of campaigns to improve vaccination rates.
In the UK the scare that the MMR vaccine may be connected to autism (it isn’t) triggered by the bogus study by Andrew Wakefield resulted in a precipitous drop in vaccination rates down to about 78% overall. This is far below what is necessary for herd immunity, when immunity is prevalent enough to prevent a disease from spreading around a population. And the 78% figure is an average – but there are pockets where the number is even lower. This resulted in a surge of measles – from a low of less than 100 cases per year to 1,348 cases in 2008. The surge contniues despite an aggressive campaign to inform the public about the safety of the MMR vaccine.
By contrast the US has seen continued high overall vaccination rates of about 90%. The MMR and other vaccine scare came to the US a bit later than the UK but it is in full swing here, without much effect on overall vaccination rates. However, we are beginning to see the emergence of low vaccination rates in specific communities, with subsequent outbreaks of measles (131 cases in 2008), mumps, and whooping cough.