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.
The Centers for Disease Control (CDC) currently recommends that children 6 month to 18 years old receive an annual flu vaccine. There are two types of flu vaccines used in the US: a live attenuated virus (LAIV) and a trivalent inactivated virus (TIV) vaccine. Both are safe and effective – while efficacy varies from year to year, they are 70-90% effective in healthy adults. Efficacy is young children appears to be slightly less, about 66%.
There remains, however, many sub-questions about the flu vaccines and by the time researchers have thoroughly explored them vaccine technology is likely to have progressed, and therefore any new vaccines will have to be tested all over again.
One of those sub-questions about vaccine safety and efficacy is the net effect of the flu vaccine in children with asthma. Some have raised concerns that the vaccine may exacerbate asthma, a 1-2% increased wheezing and 3% increased hospitalizations have been reported, although so far the bulk of the data suggests that both types of flu vaccines are safe in children with asthma. There is evidence to suggest that the LAIV may be superior to the TIV in children, particularly with asthma.
Last week I discussed a clinical trial comparing standardized acupuncture, individualized acupuncture, placebo-acupuncture, and usual care. In that discussion I emphasized the comparison between the three acupuncture groups, which did not show any difference in outcome. These results are consistent with the overall acupuncture literature, which shows in the better controlled trials that it does not matter where you stick the needles or even if you stick them through the skin. Therefore the scientific evidence fails to reject the null hypothesis (that acupuncture does not work). This did not stop the press from declaring, almost uniformly, that acupuncture works for back pain, contributing to the public misunderstanding of clinical science.
This week I am going to focus on the other aspect of the trial – the one the researchers and the press chose to focus on – the comparison of the two real and one placebo acupuncture arms to “usual care.” This too was misrepresented by the press, encouraged by the overinterpretation of the evidence by the researchers.
In the comments to Part I of this discussion David Gorski correctly pointed out that the study in fact did not even constitute a comparison of acupuncture to standard medical treatment. He is absolutely correct, and the many reasons for this are worth explaining in detail. Understanding the technology of clinical trials is central to science-based medicine, including all of their pitfalls and limitations. For practical and logistical reasons there is almost never a perfect clinical trial, but mischief only ensues when limitations are not understood, leading to a misinterpretation (and almost always an overinterpretation in the direction of the researcher’s bias) of the evidence.
A new study which randomized 638 adults to either standard acupuncture, individualized acupuncture, placebo acupuncture using tooth picks that did not penetrate the skin, and standard therapy found exactly what previous evidence has also suggested – it does not seem to matter where you stick the needles or even if you stick the needles through the skin. The only reasonable scientific conclusion to draw from this is that acupuncture does not work.
But let me back up a minute. Imagine if we were evaluating the efficacy of a new pain drug. This drug, when tested in open trials (no blinding or control) has an effect on reducing pain – it is superior to no treatment. When compared to a placebo, however, the drug is no more effective than the placebo, although both are more effective than no treatment.
Now imagine that the pharmaceutical company who manufactures this drug sends out a press release declaring that their drug is effective for pain, but that their research shows that a placebo of their drug is also effective (FDA applications are pending). Therefore more research is needed to determine how their drug works. Would you buy it?
That is the exact situation we are facing with acupuncture research.
In 1918 the Spanish Flu (named after the country of origin of the first reported case) swept the globe, killing 20-40 million people – more than the First World War (which killed 15 million) which was just ending. When an epidemic spreads to multiple regions, especially multiple countries or continents, it becomes a pandemic. Flu pandemics happen 2-3 times each century.
This is probably partly why there has been so much news attention, even some mild hysteria, surrounding recent outbreaks of swine flu, beginning in Mexico. It is hard to say how many cases and how many deaths there have been so far, because information from Mexico is spotty. Specifically it is difficult to say if people who have died with flu-like symptoms really had the swine flu or something else.
Estimates are that more than 800 people have contracted the swine flu in Mexico with 29 confirmed deaths, although none in the last week. The Centers for Disease Control (CDC) reports as of May 5th that there have been 403 confirmed cases in the United States, with the first death just reported. World-wide there have been 1,490 cases in 21 countries (according to the World Health Organization– WHO).
Some Background on Influenza
The influenza or flu virus is an RNA virus that comes in three genera – A, B, and C. Influenza A is the most common type. It can infect mammals and birds, with aquatic birds being its natural endemic host. Each year there is a seasonal epidemic of Influenza A, infecting millions of people world-wide and killing 100-200,000 – mostly the very old, the very young, and the sick.
It is unfortunately a common human reaction to respond to criticism by attacking those leveling the criticism, rather than addressing the points being made. This is especially true if the criticism is legitimate and one cannot reasonably counter it.
Substantive criticism is also a central part of the scientific endeavor, and so the culture of science has developed a tolerance for harsh criticism and a general understanding that the only proper response is with logic and evidence. Examples of exceptions are legion, human frailty being what it is, but you cannot live in the world of science for long without learning the rules of the game. Peers are expected to pull no punches when criticizing the errors or countering the arguments of their colleagues. Everyone is expected to be their own harshest critic (criticize your own data before someone has a chance to). And when criticized yourself, acknowledge what is legitimate and make appropriate corrections, but feel free to defend yourself against weak criticisms by pointing out additional data, interpretations, or errors in the arguments of your critics.
This meat grinder approach to scientific discourse works. Slowly, bad ideas and claims are beaten down, and only good ideas have the stamina to persist.
But here at science-based medicine we engage not only with the scientific community, but also with the public, and with those on the fringes of science. This means we often engage with those who do not play by the rules of science. A recent example is that of J.B. Handley from Age of Autism. David Gorski and I (and later Mark Crislip) wrote blog entries criticizing their 14 studies website with a detailed analysis. Handley responded with a full frontal personal assault sprinkled with irrelevant accusations. He ignored the vast majority of our actual criticisms, and those few he took on he completely botched.
As many have pointed out, we are in the midst of a transformation in the way news is created, distributed, and monetized – all brought on by the internet. Access to information has dramatically increased, while the traditional news outlets are fading away. The new internet-based outlets that are cropping up are often hybrids that do not fit into any existing definition. Science-based medicine itself is such an outlet – it’s primarily a group professional blog, but we have editors and take submissions. We also plan to expand the type of resources available on SBM. We’re experimenting.
Others, like Plos ONE, are experimenting with open-access peer-reviewed journals. And there are online newspapers that are part blog, part news feed, part something else.
While we are in this phase of experimentation it is important to monitor quality control, as the old institutions lose their grip on the flow of information. Health information in particular, now the most common type of information on the internet, suffers from poor quality control, leading the average consumer with too much information of too low quality.
Recently my co-blogger David Gorski wrote an excellent analysis of the latest propaganda effort from the anti-vaccine crowd – a website that attempts to deconstruct the fourteen studies most often cited to argue for a lack of association between vaccines and autism. As David pointed out, there are many more than 14 studies which demonstrate this, and no credible studies showing that there is any correlation. David covered some of the 14 discussed studies, and today I will discuss one more.
On that anti-vaccine propaganda site J.B. Handley begins his introduction with this logical fallacy:
Of all the remarkable frauds that will one day surround the autism epidemic, perhaps one of the most galling is the simple statement that the “science has spoken” and “vaccines don’t cause autism.” Anytime a public health official or other talking head states this, you can be assured that one of two things is true: they have never read the studies they are talking about, or they are lying through their teeth.
Of course this is a false dichotomy, or forced choice. I personally know of many people, including myself and David, who have both read all the studies and are telling the truth about our opinions that they do not support a link between autism and vaccines. It seems to be inconceivable to Mr. Handley that an informed professional could honestly disagree with his opinions – such is the nature of fanaticism.