Archive for Clinical Trials

Changing Your Mind

Why is my mind so clean and pure?  Because I am always changing it.
In medical school the old saying is that half of everything you learn will not be true in 10 years, the problem being they do not tell which half.
In medicine, the approach is, one hopes, that data leads to an opinion.  You have to be careful not to let opinion guide how you evaluate the data.  It is difficult to do, and I tell myself that my ego is not invested my interpretation of the data. I am not wrong, I am giving the best interpretation I can at the time. For years  I yammered on about how it made no sense to give a beta-lactam and a quinolone for sepsis until a retrospective study suggested benefit of the combination.  Bummer. Now when I talk to the housestaff about sepsis, I have to add a caveat about combination therapy.  It is why my motto is, only half jokingly,  ”Frequently in error, never in doubt”.
At what point do you start to change you mind?  Alter your message as a teacher?  Have new behavior?  Medicine is not all or nothing, black and white.  Changes are incremental, and opinions change slowly, especially if results of a new study contradict commonly held conclusions from prior investigations.
Nevertheless, I am in the process of changing my mind, and it hurts.  I feel like Mr. Gumby. ( v=IIlKiRPSNGA)
It is rare that there is one study that changes everything; medicine is not an Apple product.  Occasionally that there is a landmark  study that alters practice in such a dramatic way that there is a before and after.  As I write this I cannot think of a recent example in infectious diseases, but I am sure there is one.  The problem is that once practice changes, it seems as we have always done it that way.
For me, three is the magic number.  One study that goes against received wisdom warrants an ‘interesting, but give me more.”
Two studies, especially if using different methodologies with the same results gives and ‘well, two is interesting, but I can argue against it.”  However, with two studies the seed of doubt is planted, waiting to be watered with the water of further confirmation.  Yeah. Bad metaphor.
Three studies with different methodologies independently confirming new concepts?  Then I say, “I change my mind. My brain hurts.”
There are now three studies concerning the issue of efficacy of the flu vaccine in the elderly.  You might remember my discussion of the Atlantic article several months ago. In that entry I discussed two articles  that suggested the flu vaccine may be less effective in the elderly than the studies demonstrated.
The argument was that the elderly who received the influenza vaccine were healthier at baseline than those that didn’t receive the vaccine and the deaths during flu season was not due to the protection from the vaccine, but due to the fact that healthier people are less likely to die when they get ill. In part this was demonstrated by showing decreased deaths in vaccinated populations when influenza was not circulating.  If insomnia is a problem, you can go back and read my post.   To quote my favorite author, me, I said
“One, it is an outlier, and outliers need confirmation. The preponderance of all the literature suggests that influenza vaccine prevents disease and death. If you do not get flu, you cannot die from flu or flu related illnesses. When outliers are published, people read them, think, “huh, that’s interesting”, but there is going to have to be more than one contradictory study to change my practice. But if “study after study” shows mortality benefit, and one study does not, it is food for thought, but not necessarily the basis of changing practice. The results, above all, needs to be repeated by others… In medicine we tend to be conservative about changing practice unless there is a preponderance of data to suggest a change is reasonable. Except, of course, if our big pharma overlords take us to a good streak house.”
Now we have a third article, “Evidence of Bias in Studies of Influenza Vaccine Effectiveness in Elderly Patients” from the Journal of Infectious Diseases.
In the study they examined the records of the elderly in the Kaiser Health System, their vaccination records, and their risk of death.  And the results were interesting.
“The percentage of the population that was vaccinated varied with age. After age 65, influenza vaccination increased until age 78 in women and age 81 in men, then decreased with increasing age. Vaccination coverage also varied in a curvilinear fashion with risk score, increasing with risk score to a risk score percentile of ∼80%, then decreasing. In addition, as the predicted probability of death increased, vaccination coverage increased. Vaccination coverage was highest among members with a probability of death of 3%–7.5%. Those with a predicted probability of death in the coming year of 17.5% had a de- creasing likelihood of influenza vaccination”
They then looked at mortality when flu was not circulating.
“A change in the pattern of vaccination had a striking effect on mortality. For members > 75 years old who had been receiving influenza vaccinations in previous years, not receiving a seasonal influenza vaccination was strongly associated with mortality in the months ahead (Table 1). A person who had received an influenza vaccination every year in the previous 5 years had a more than double probability of death outside the influenza season if he or she missed a vaccination in the current year, compared with a person who was vaccinated as usual (odds ratio, 2.17; P < .001). On the other hand, if a person did not receive any seasonal influenza vaccination in the previous 5 years, then receipt of a vaccination in the current year was associated with a greater probability of death. “
If they had a history of flu vaccine for five years and missed it, the probability of death went up.
If they did not have a flu vaccine for five years and got one, the probability of death went up.
They suggest in the first case, the patients may have had an increase in their co-morbidities and as a result did not get the vaccine and died of underlying diseases. Their increased risk of death was from accumulating prior illnesses.
In the second case, people who were healthy and did not seek care subsequently developed diseases that lead them to a doctor who advised the vaccine.  Their increase risk of death was due to new illnesses.
Either way, the uptake of the flu vaccine is more complicated than I had suspected and makes interpretation of efficacy of the vaccine in prior studies harder to evaluate.  The table shows an unexpected relationship between age, risk of death and use of the flu vaccine.
table here
They say in the discussion
“We showed that, despite strong efforts to increase vaccination among the elderly population, vaccination is relatively low in the oldest and sickest portions of the population. Persons 65 years old with a 17.5% chance of death in the upcoming year are less likely to receive the influenza vaccine. Because persons who are most likely to die are less likely to receive the vaccine, vaccination appears to be associated with a much lower chance of dying; thus, the “effectiveness” of the vaccine is in great part due to the selection of healthier individuals for vaccination, rather than due to true effectiveness of the vaccine. Previous studies have argued that worsening health is associated with increasing vaccination. We found this to be a curvilinear relationship, in which increasing illness means increasing vaccination, up to a point, and then, as people come closer to the end of life, there is a decrease in vaccination coverage.”
They do not say the vaccine is not effective, but they suggest that there is a bias that may make the vaccine appear more effective in the elderly than it really is.  Reality is often more complex than one would think at the beginning.
After three studies I am reasonably convinced that efficacy of the flu vaccine in the elderly is potentially not as well understood as I had thought.
So do I think the flu vaccine is no longer useful in the elderly?  No.  I still think it is a reasonable intervention but it may not have the efficacy I would like.  But I have always known that, for a variety of reasons, the flu vaccine is not a great vaccine. But it is better than no vaccine. There are, as discussed in the earlier post on the vaccine, many lines of evidence to show that the flu vaccine has benefit; at issue is the degree of the benefit.  Perhaps what is needed is a better vaccine with adjuvants or multiple injections to get a better result in the elderly, who respond poorly to the vaccine.  Or perhaps it will be better to focus on increasing vaccination in those who care for or have contact with the elderly.  But when I talk to my patients and residents, when I get to part about flu vaccine efficacy, I will be a little more nuanced, use more qualifiers. I will tell them that the vaccine is like seat belts.  It does not prevent all death and injury, but if you had a choice, would you not choose to use seat belts?
In the end the data has to change the way I think about medicine, not matter how much it hurts.
Compare and contrast that with the anti-vaxers who have the belief that vaccines cause autism.  They look for data to support the pre-existing belief and ignore contrary data.  Opinion does not follow from data.
The most representative statement of their approach is on the 14 studies website where they say  ”“We gave this study our highest score because it appears to actually show that MMR contributes to higher autism rates.”
The key phrase in the whole site. Data that supports their position is good, data that does not is bad. What makes a study good is not its methodology or its rigor, or its reproducibility, or its biologic plausibility,  but if it supports vaccines casing autism.
Dr. Wakefield, as has been noted over the last week, had his MMR/autism paper withdrawn from Lancet not for bad science, but for dishonest science.  In medicine you can be wrong, but you cannot lie.  If the results of medical papers were shown to be fabrications, such as the papers of Scott S. Reuben, no one the medical field would defend the results.  Dr. Reuben, as you may remember, was found to have fabricated multiple studies on the treatment of pain.  Nowhere can I find web sites defending his faked research.  No suggestions it was due to a conspiracy of big pharma to hide the truth. No assertions that he is still a physician of great renown.   He lied and is consigned to ignominy.   Physicians who used his papers as a basis of practice no longer do so, or so I would hope.
The response to Dr. Reuban is in striking contrast to the defense of Dr Wakefield, where bad research combined with unethical behavior, results in reactions like this
“It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction of a paper published in The Lancet in 1998 by Dr. Wakefield and his colleagues.
The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers served as judge and jury. Dr. Wakefield strenuously denies all the findings of the GMC and plans a vigorous appeal.”
Opinions did not change when the Wakefield paper was demonstrated to be not just wrong but false, the researcher’s behavior unethical, and the study could not be reproduced using similar methodologies (  Instead, the defense of Dr. Wakefield became, well, like a Jim Carrey shtick. The Mask defends retracted autism research. Fire Marshall Bill on the medical literature.  Jenny and Jim’s defense does make more sense read as comic performance art.  Andy Kaufmann would have been proud.
I wonder if the more grounded in fiction an opinion is, the harder it is to change, the more difficult it is to admit error.  I have to admit I cannot wrap my head around the ability of people to deny reality.  It is the old Groucho line come to life, “Who are you going to believe, science or your lying eyes?”
So I will, I hope, keep changing my mind as new information come in.  It is what separates real health care providers from acupuncturists and homeopaths and naturopaths and anti-vaxers.  It is what some truly great minds admit to doing (  As one deeper thinker and better writer ( than I said, kind of,
“The other terror that scares us from self-trust is our consistency; a reverence for our past act or word, because the eyes of others have no other data for computing our orbit than our past acts, and we are loath to disappoint them.
But why should you keep your head over your shoulder? Why drag about this corpse of your memory, lest you contradict somewhat you have stated in this or that public place? Suppose you should contradict yourself; what then? It seems to be a rule of wisdom never to rely on your memory alone, scarcely even in acts of pure memory, but to bring the past for judgment into the thousand-eyed present, and live ever in a new day. In your metaphysics you have denied personality to the Deity: yet when the devout motions of the soul come, yield to them heart and life, though they should clothe God with shape and color. Leave your theory, as Joseph his coat in the hand of the harlot, and flee.
A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines and anti-vaxers. With consistency a great soul has simply nothing to do. He may as well concern himself with his shadow on the wall. Speak what you think now in hard words, and to-morrow speak what to-morrow thinks in hard words again, though it contradict every thing you said to-day. — ‘Ah, so you shall be sure to be misunderstood.’ — Is it so bad, then, to be misunderstood?”

Why is my mind so clean and pure?  Because I am always changing it.

In medical school the old saying is that half of everything you learn will not be true in 10 years, the problem being they do not tell which half.

In medicine, the approach is, one hopes, that data leads to an opinion.  You have to be careful not to let opinion guide how you evaluate the data.  It is difficult to do, and I tell myself that my ego is not invested my interpretation of the data. I am not wrong, I am giving the best interpretation I can at the time. For years  I yammered on about how it made no sense to give a beta-lactam and a quinolone for sepsis until a retrospective study suggested benefit of the combination.  Bummer. Now when I talk to the housestaff about sepsis, I have to add a caveat about combination therapy.  It is why my motto is, only half jokingly,  ”Frequently in error, never in doubt”.

At what point do you start to change you mind?  Alter your message as a teacher?  Have new behavior?  Medicine is not all or nothing, black and white.  Changes are incremental, and opinions change slowly, especially if results of a new study contradict commonly held conclusions from prior investigations.

Nevertheless, I am in the process of changing my mind, and it hurts.  I feel like Mr. Gumby.


Posted in: Clinical Trials, Science and Medicine, Vaccines

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Yes, Jacqueline: EBM ought to be Synonymous with SBM

“Ridiculing RCTs and EBM”

Last week Val Jones posted a short piece on her BetterHealth blog in which she expressed her appreciation for a well-known spoof that had appeared in the British Medical Journal (BMJ) in 2003:

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

Dr. Val included the spoof’s abstract in her post linked above. The parachute article was intended to be humorous, and it was. It was a satire, of course. Its point was to call attention to excesses associated with the Evidence-Based Medicine (EBM) movement, especially the claim that in the absence of randomized, controlled trials (RCTs), it is not possible to comment upon the safety or efficacy of a treatment—other than to declare the treatment unproven.

A thoughtful blogger who goes by the pseudonym Laika Spoetnik took issue both with Val’s short post and with the parachute article itself, in a post entitled #NotSoFunny – Ridiculing RCTs and EBM.

Laika, whose real name is Jacqueline, identifies herself as a PhD biologist whose “work is split 75%-25% between two jobs: one as a clinical librarian in the Medical Library and one as a Trial Search Coordinator (TSC) for the Dutch Cochrane Centre.” In her post she recalled an experience that would make anyone’s blood boil:

I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark that made the whole room of scientists laugh, but was really beside the point…

This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.

I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.

Jacqueline had this to say about the parachute article:

I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but absurdities should not assume a life of their own.  In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.


Posted in: Clinical Trials, Medical Academia, Medical Ethics, Science and Medicine

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On the “individualization” of treatments in “alternative medicine”

One of the claims most frequently made by “alternative medicine” advocates regarding why alt-med is supposedly superior (or at least equal) to “conventional” medicine and should not be dismissed, regardless of how scientifically improbable any individual alt-med modality may be, is that the treatments are, if you believe many of the practitioners touting them, highly “individualized.” In other words, the “entire patient” is taken into account with what is frequently referred to as a “holistic approach” that looks at “every aspect” of the patient, with the result that every patient requires a different treatment, sometimes even for the exact same disease of very close to the same severity. Indeed, as I have described before, a variant of this claim, often laden with meaningless pseudoscientific babble about “emergent systems,” is sometimes used to claim that the standard methods of science- and evidence-based medicine are not appropriate to studying the efficacy of alternative medicine. Of course, this is, in nearly all cases, simply an excuse to dismiss scientific studies that fail to find efficacy for various “alt-med” modalities, but, even so, it is a claim that irritates me to no end, because it is so clearly nonsense. As Harriet Hall pointed out, alt-med “practitioners” frequently ascribe One True Cause to All Disease, which is about as far from “individualization” as you can get, when you come right down to it. More on that later.

A couple of years ago, before I became involved with this blog, I was surprised to learn that even some advocates of alt-med have their doubts that “individualization” is such a great strength. I had never realized that this might be the case until I came across a post by naturopath Travis Elliott, who runs a pro-alt-med blog, Dr. Travis Elliott and the Two-Sided Coin, entitled The Single Most Frustrating Thing About (Most) Alternative Medicine. In this article, Elliott referred to a case written up by a fellow naturopath, who used an anecdote about the evaluation and treatment plan by a naturopath of a pregnant woman with nausea to show what is supposedly the “unique power of our medicine.” Unexpectedly (to me at least at the time), Elliott did not quite see it that way:

Posted in: Clinical Trials, Energy Medicine, Homeopathy, Science and Medicine

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The life cycle of translational research

ResearchBlogging.orgI’m a translational researcher. To those of you who aren’t familiar with what that means, it means (I hope) that I study potential therapies in the lab and try to translate them into actual therapies that will cure patients of breast cancer — or, at the very least, improve their odds of survival or prolong survival when cure is not possible. Translational research is extremely important; indeed, it is the life blood of science-based medicine, with basic science producing the discoveries and clinical research the applications of these discoveries. When it works, it’s the way that science leads medicine to advance. However, sometimes I think that it’s a bit oversold. For one thing, it’s not easy, and it’s not always obvious what basic science findings can be translated into useful therapies, be it for cancer (my specialty) or any other disease. For another thing, it takes a long time. The problem is that the hype about how much we as a nation invest in translational research all too often leads to a not unreasonable expectation that there will be a rapid return on that investment. Such an expectation is often not realized, at least not as fast and frequently as we would like, and the reason has little to do with the quality of the science being funded. It has arguably more to do with how long it takes for a basic science observation to follow the long and winding road to producing a viable therapy. But how long is that long and winding road?

A lot longer than many, even many scientists, realize. At least, that’s the case if a paper from about a year ago by John Ioannidis in Science is any indication. The article appeared in the Policy Forum in the September 5 issue and is entitled Life Cycle of Translational Research for Medical Interventions. As you may recall, Dr. Ioannidis made a name for himself a couple of years ago by publishing a pair of articles provocatively entitled Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False, which Steve Novella blogged about a couple of years ago.

Dr. Ioannidis lays it out right in the first paragraph:

Posted in: Clinical Trials, Science and Medicine

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Acupuncture, the P-Value Fallacy, and Honesty

Credibility alert: the following post contains assertions and speculations by yours truly that are subject to, er, different interpretations by those who actually know what the hell they’re talking about when it comes to statistics. With hat in hand, I thank reader BKsea for calling attention to some of them. I have changed some of the wording—competently, I hope—so as not to poison the minds of less wary readers, but my original faux pas are immortalized in BKsea’s comment.

Lies, Damned Lies, and…

A few days ago my colleague, Dr. Harriet Hall, posted an article about acupuncture treatment for chronic prostatitis/chronic pelvic pain syndrome. She discussed a study that had been performed in Malaysia and reported in the American Journal of Medicine. According to the investigators,

After 10 weeks of treatment, acupuncture proved almost twice as likely as sham treatment to improve CP/CPPS symptoms. Participants receiving acupuncture were 2.4-fold more likely to experience long-term benefit than were participants receiving sham acupuncture.

The primary endpoint was to be “a 6-point decrease in NIH-CSPI total score from baseline to week 10.” At week 10, 32 of 44 subjects (73%) in the acupuncture group had experienced such a decrease, compared to 21 of 45 subjects (47%) in the sham acupuncture group. Although the authors didn’t report these statistics per se, a simple “two-proportion Z-test” (Minitab) yields the following:

Sample X   N   Sample p

1            32  44   0.727273

2           21  45   0.466667

Difference = p (1) – p (2)

Estimate for difference: 0.260606

95% CI for difference: (0.0642303, 0.456982)

Test for difference = 0 (vs not = 0): Z = 2.60 P-Value = 0.009

Fisher’s exact test: P-Value = 0.017

Wow! A P-value of 0.009! That’s some serious statistical significance. Even Fisher’s more conservative “exact test” is substantially less than the 0.05 that we’ve come to associate with “rejecting the null hypothesis,” which in this case is that there was no difference in the proportion of subjects who had experienced a 6-point decrease in NIH-CSPI scores at 10 weeks. Surely there is a big difference between getting “real” acupuncture and getting sham acupuncture if you’ve got chronic prostatitis/chronic pelvic pain syndrome, and this study proves it!


Posted in: Acupuncture, Clinical Trials, Science and Medicine

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Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women?

A while back I wrote about rethinking how we screen for breast cancer using mammography. Basically, the USPSTF, an independent panel of physicians and health experts that makes nonbinding recommendations for the government on various health issues, reevaluated the evidence for routine screening mammography and concluded that for women at normal risk for breast cancer, mammography before age 50 should not be recommended routinely and should be ordered on an individualized basis, and that routine formalized breast self-examination (BSE) should also not be routinely recommended. In addition, for women over 50, it was recommended that they undergo mammography every other year, rather than every year. These recommendations were based on a review of the literature, including newer studies.

To say that these new recommendations caused a firestorm in the breast cancer world is an understatement. The USPSTF was accused of misogyny; opponents of health care reform leapt on them as evidence that President Obama really is preparing “death panels”; and HHS secretary Kathleen Sebelius couldn’t run away from the guidelines fast enough. Meanwhile, a society I belong to (the American Society of Breast Surgeons) issued a press release accusing the USPSTF of sending us back to the “pre-mammography” days when, presumably women only found breast cancer after it had grown to huge size (just like Europe and Canada, I guess, given that the recommendations for screening there closely mirrors those recommended by the USPSTF). Meanwhile, in the most blatant example of protecting its turf I’ve seen in a very long time, the American College of Radiology went full mental jacket with a press release that was as biased as it was insulting. Meanwhile some physicians even likened the recommendations to going back to being like Africa, Southeast Asia and China as far as breast screening goes in that he actually speculated that he’d now become very busy treating advanced, neglected breast cancers. Unfortunately, as Val pointed out, the communication of the USPSTF guidelines to the public was almost a perfect case study in how not to do it. Even though the science was in general sound and the USPSTF recommendations were in essence close to identical to what other industrialized nations do, they were communicated in just such a way as to produce maximum misunderstanding and misuse for political purposes.

Despite all the hysterical and in some cases disingenuous attacks on the new guidelines, there is one criticism that actually resonates with me because I work at a cancer center in a very urban environment with a large population of African-American women. Last week I heard on NPR this story:

Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Public Health

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Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer! (revisited)

ResearchBlogging.orgIt’s been about a year and a half since I’ve written about this topic; so I thought I’d better update the disclaimer that I wrote at the beginning:

Before I start into the meat of this post, I feel the need to emphasize, as strongly as I can, four things:

  1. I do not receive any funding from the telecommunications industry in general, or wireless phone companies in particular. None at all. In other words, I’m not in the pocket of “big mobile” any more than I am in the pocket of big pharma.
  2. I don’t own any stock in telecommunications companies, other than as parts of mutual funds in which my retirement funds are invested that purchase shares in many, many different companies, some of which may or may not be telecommunications companies.
  3. None of my friends or family work for cell phone companies.
  4. I don’t have a dog in this hunt. I really don’t.

There. That’s better. Hopefully that will, as it did last time, serve as a shield against the “shill” argument, which is among the frequent accusations I hear whenever I venture into this particular topic area. So, as I did back in 2008, I just thought I’d clear that up right away in order (hopefully) to preempt any similar comments after this post. Unfortunately, as I have known for a long time, I’m sure someone will probably show his or her lack of reading comprehension and post one of those very criticisms of me. It’s almost inevitable, either here or elsewhere. Posting such disclaimers never seems to work against the “pharma shill” gambit when I write about vaccines or dubious cancer cures. Even so, even after nearly ten years involved in skepticism and promoting science-based medicine, hope still springs eternal.

There are two reasons that I think the issue of mobile phones and cancer needs an update on our blog: First, it has been a year and a half since I last wrote about it. At that time I castigated Dr. Ronald B. Herberman, who at that time was director of the University of Pittsburgh Cancer Institute for what I viewed as fear mongering over cell phones and cancer based on at best flimsy evidence. Second, there have been two fairly high profile studies looking at whether there is a link between mobile phone use and cancer. One of these our fearless leader Steve Novella has already discussed, but there was another one that he didn’t see because it didn’t get quite as much publicity, possibly because the corresponding author is based in Korea. I will take this opportunity to discuss them both.

Posted in: Cancer, Clinical Trials, Public Health

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Yet another nail in the coffin of the myth that the MMR vaccine causes autism

Arguably, the genesis of the most recent iteration of the anti-vaccine movement dates back to 1998, when a remarkably incompetent researcher named Andrew Wakefield published a trial lawyer-funded “study” in the Lancet that purported to find a link between “autistic enterocolitis” and measles vaccination with the measles-mumps-rubella (MMR) trivalent vaccine. In the wake of that publication was born a scare over the MMR that persists to this day, 11 years later. Although peer reviewers forced the actual contents of the paper to be more circumspect, in the press Wakefield promoted the idea that the MMR vaccine either predisposes, causes, or triggers autistic regressions. Even though over the next several years, investigations by investigative journalist Brian Deer revealed that not only was Wakefield’s research funded by trial lawyers looking to sue vaccine manufacturers for “vaccine injury” when he did his research (for which he is now being charged by the U.K.’s General Medical Council with scientific misconduct), but during the Autism Omnibus trial testimony by a world-renowed expert in PCR technology showed that he was incompetent. Even worse for Wakefield, in February 2009 Brian Deer published a news expose based on strong evidence that Wakefield may very well have falsified data for his Lancet paper.

None of this mattered. Andrew Wakefield still enjoys a cult of personality among the anti-vaccine crowd that no revelation seems able to dislodge, even the revelation that at the time he was both in the pay of trial lawyers and working on his study, Andrew Wakefield was also applying for a patent for a rival measles vaccine. Indeed, the anti-vaccine propaganda blog Age of Autism bestowed upon him last year its “Galileo Award” as the “persecuted” scientist supposedly fighting for truth, justice, and anti-vaccinationism against the pharma-funded or brainwashed minions of the “Church of the Immaculate Vaccination.” In the meantime, MMR uptake rates in the U.K. have plummeted over the last decade, far below the level needed for herd immunity, to the point where, last year the Health Protection Agency declared measles to be once again endemic in the U.K., 14 years after the local transmission of measles had been halted.

Since Wakefield’s study was released, a number of studies have shown that there is no epidemiologically detectable link between vaccination with MMR and autism, including one by a researcher who once appeared to be a believer in the idea that vaccines are somehow linked with autism, Mady Hornig. Hornig actually tried very hard to replicate Wakefield’s 1998 Lancet study, only this time with more children, and she found no link between MMR and autism using methodology similar to Wakefield’s. None of these studies has had any effect on the anti-vaccine movement, except to motivate them to circle the wagons even more, as J.B. Handley of Generation Rescue did when he launched a website called Fourteen Studies, whose purposes are to launch fallacious and pseudoscientific attacks on studies failing to find a link between vaccines and autism (often involving accusations of being a “pharma shill”), to promote the lousy science that gives the appearance of supporting the hypothesis that there is a link between the MMR vaccine and autism, and then slime anyone who points out how deceptive their attacks were.

Now, yet another study has been released studying whether there is a link between MMR vaccination and autism. Yet another study has failed to find a link between MMR vaccination and autism. Yet another study is all set to be attacked by Generation Rescue and the anti-vaccine movement. The sad and sordid history of reactions of the anti-vaccine movement to studies that do not support its belief in the unsinkable rubber duck of a myth that vaccines cause autism. This study was published online in The Pediatric Infectious Disease Journal by a group from Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland (a Polish group, my people!) and entitled Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study. It’s yet another nail in the coffin of the myth that the MMR causes or contributes to autism. Indeed, this study not only shows that MMR vaccination is not associated with autism but that it may even be protective against autism. True, for reasons I will discuss shortly, I doubt that that latter interpretation is true, but there’s no doubt that this study is powerful evidence against the view that there is an association between MMR and autism. Unfortunately, I fear that all the nails in my local Home Depot would not be enough to keep the zombie of this pseudoscience from rising from its grave yet again.

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Neti pots – Ancient Ayurvedic Treatment Validated by Scientific Evidence

Nasal irrigation with salt water is recommended by 87% of family doctors as an adjunctive treatment to relieve the symptoms of nasal congestion and sinusitis. The simplest method is to hold salt water in your cupped hand, block one nostril while you inhale the water into the other nostril, then blow your nose. The high-tech version is to use a Neti pot, a little jug with a spout. You pour the salt solution from the Neti pot into one nostril and it drains out the other nostril. The technique is described here.  Neti pot

The Neti pot originated in India in Ayurvedic medicine. Neti is Sanskrit for “nasal cleansing.” Other related ancient techniques that have not been adopted by scientific medicine include using a string instead of water and a yoga technique where you close one nostril, pour the solution into the other nostril and allow it to run out of the mouth. 

Nasal irrigation provides short-term symptomatic relief and may improve nasal mucociliary clearance. It removes mucus not only from the nose but also from the maxillary and ethmoid sinuses.   (more…)

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Cancer prevention: The forgotten stepchild of cancer research?

The New York Times has been periodically running a series about the “40 years’ war” on cancer, with most articles by Gina Kolata. I’ve touched on this series before, liking some parts of it, while others not so much. In particular, I criticized an article one article that I thought to be so misguided about how the NIH grant system leads researchers to “play it safe” and how we could cure cancer if we could just fund “riskier” research that I had to write an extended screed about the misconceptions in the article. The latest installment, Medicines to Deter Some Cancers Are Not Taken, also by Kolata, is much better in that it discusses a problem at the heart of cancer, namely that we have developed drugs that can decrease the risk of specific cancers but they are not as widely used as they could be.

The first part of the article contrasts a seeming incongruity:

Many Americans do not think twice about taking medicines to prevent heart disease and stroke. But cancer is different. Much of what Americans do in the name of warding off cancer has not been shown to matter, and some things are actually harmful. Yet the few medicines proved to deter cancer are widely ignored.

Take prostate cancer, the second-most commonly diagnosed cancer in the United States, surpassed only by easily treated skin cancers. More than 192,000 cases of it will be diagnosed this year, and more than 27,000 men will die from it.

And, it turns out, there is a way to prevent many cases of prostate cancer. A large and rigorous study found that a generic drug, finasteride, costing about $2 a day, could prevent as many as 50,000 cases each year. Another study found that finasteride’s close cousin, dutasteride, about $3.50 a day, has the same effect.

This is indeed a contrast. Think about it. Millions of Americans take statins, for instance, to lower their cholesterol and thereby try to prevent the complications of elevated cholesterol, such as heart disease, vascular disease, and strokes. Yet, for at least two common cancers, there are proven effective drugs that will lower the risk of cancer considerably with a side effect profile at least as favorable as that of statins.

Posted in: Cancer, Clinical Trials, Herbs & Supplements, Nutrition, Politics and Regulation

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