Archive for Clinical Trials

Acupuncture for Hot Flashes – Or, Why So Many Worthless Acupuncture Studies?

In yet another round of science by press release, a particularly unimpressive acupuncture study is making the rounds of the major news outlets proclaiming that acupuncture works. I guess that is a sort-of answer to my title question – why are so many scientifically worthless acupuncture studies being done?

Let’s take a look at this particular study to see why it is so weak. All I have to go on is the press release, since the study is not published. It was presented at a scientific meeting – which is legitimate, I just don’t have access to it. (The bar for publication in a peer-reviewed journal is much higher than presentation at a meeting, and there may, in fact, be changes to the text prior to publication.) But we can still say a great deal about this study from the information provided.


Posted in: Acupuncture, Clinical Trials, Energy Medicine

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FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.

Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

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Sometimes science and ethics win out

Yesterday was a good day.It was a good day because it was one of the days that shows that, sometimes, science and ethics do win out after all:

CHICAGO (AP) — A government agency has dropped plans for a study of a controversial treatment for autism that critics had called an unethical experiment on children.

The National Institute of Mental Health said in a statement Wednesday that the study of the treatment — called chelation — has been abandoned. The agency decided the money would be better used testing other potential therapies for autism and related disorders, the statement said.

The study had been on hold because of safety concerns after another study published last year linked a drug used in the treatment to lasting brain problems in rats.Chelation (kee-LAY’-shun) removes heavy metals from the body and is used to treat lead poisoning. Its use as an autism treatment is based on the fringe theory that mercury in vaccines triggers autism — a theory never proved and rejected by mainstream science. Mercury hasn’t been in childhood vaccines since 2001, except for certain flu shots.

But many parents of autistic children are believers in the treatment, and NIMH agreed to test it.The researchers had proposed recruiting 120 autistic children ages 4 to 10 and giving half a chelation drug and the other half a dummy pill. The 12-week test would measure before-and-after blood mercury levels and autism symptoms.The study outline said that failing to find a difference between the two groups would counteract “anecdotal reports and widespread belief” that chelation works.

Except that it wouldn’t have.

Posted in: Clinical Trials, Neuroscience/Mental Health, Vaccines

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Postmodernist attacks on science-based medicine

The postmodernist critique of science consists of two interrelated arguments, epistemological and ideological. Both are based on subjectivity. First, because of the subjectivity of the human object, anthropology, according to the epistemological argument cannot be a science; and in any event the subjectivity of the human subject precludes the possibility of science discovering objective truth. Second, since objectivity is an illusion, science according to the ideological argument, subverts oppressed groups, females, ethnics, third-world peoples.

Postmodernism and science

I detest postmodernism.

Well, it’s not really postmodernism per se that I detest. In the humanities, I don’t mind it so much, although reading postmodernist texts in college did make my head hurt. I suppose that in the humanities postmodernism provides a sometimes useful methodology for providing insights into interpretation of a wide variety of subjects in literature and the arts, although much of the time it seems to exist mainly to try to make texts mean exactly the opposite of what the words on the page say. Relying as it does on deconstruction, which is primarily a form of literary analysis, postmodern analysis is built on questioning the assumptions underlying any text, “deconstructing” its meaning. The problem is, it’s rare that a postmodernist critique of anything doesn’t consist of some of the densest, most impenetrable verbiage in existence.

Since I don’t claim to be a philosopher, and I haven’t studied postmodernism since college, I don’t intend to embarrass myself by trying to do a detailed–ahem–deconstruction of what postmodernism is. Many are the trees that have been killed to write books trying to explain what postmodernism is and how to apply it to various subjects. I do know, however, that postmodern philosphy is skeptical–even nihilistic–when it comes to the values of what is considered “modernity.” Unfortunately, to some, science is one of these modern values that is viewed with extreme skepticism, even to the point of representing the very essence of science as nothing more than one narrative among many. True, Spiro was writing primarily about anthropological science, but medicine is a “soft” enough science to be just as easily attacked in such a manner, and postmodernists don’t limit themselves to the “soft” sciences, anyway. Even worse, these sorts of arguments often claim that science (or, in this case, evidence-based medicine) is nothing more than a sort of hegemony of the power structure being imposed upon the very definition of “data” or “reality,” the implication that it’s us white males whose hegemony is being served (and whose hegemony, presumably, must be resisted) doing the imposing, as if there are no inherent characteristics in science that make it a more reliable means of assessing reality as it exists than, for example, personal anecdote and “experience.”

No wonder woo-meisters and those who hate the very concept of evidence-based medicine (as opposed to the deficiencies in how EBM ranks evidence, which in fact were the reason why this blog is called Science-Based Medicine and not Evidence-based Medcine) love postmodernism so much. It’s the perfect tool for them to appeal to other ways of knowing and try to make it seem as though scientific medicine is no more valid a construct to describe reality than that of the shaman who invokes incantations and prayers to heal, the homeopath who postulates “healing mechanisms” that blatantly contradict everything we know about multiple areas of science, or reiki practitioners who think they can redirect “life energy” (or qi) for therapeutic effect. In the postmodernist realm all are equally valid, as there is no solid reason to make distinctions between these competing “narratives” and the “narrative” of scientific or evidence-based medicine.

Perhaps the best quick explanation of how postmodernism is used to attack science comes from Rob Helpy-Chalk:

Knowledge was always in some way relativized to culture, so that it was possible to talk about many “equally valid ways of knowing” of which enlightenment science was only one. For instance, contemporary biologists say that the cassowary (an ostrich-like creature) is a bird, albeit one that cannot fly. The Karam people of New Guinea, who live alongside the cassowary, say that the cassowary does not belong in the same category as the birds (which they call yakt) but bats do belong to that category. So who’s to say that the biologists are right and the Karam are wrong? Knowledge is all relative.

Claims to knowledge were also always in some way “constructed” or “socially constructed” in the postmodernist movements. This meant that they had less to do with grasping the way the world actually works and more to do with creating social structures that advanced the interests of the people who claimed to have knowledge. The science of thermodynamics was not really a description of the properties of heat. It was about convincing people to buy steam engines and arranging society so that they would be happy when they bought one.

Thus, one of the key tenets of some strains postmodernism is that knowledge is relative and “socially constructed,” usually for the purpose of reinforcing the existing power structure or furthering the interests of the “elite” who have the knowledge. It is therefore not surprising that critics of evidence-based and science-based medicine would find postmodernism to be a very attractive philosophical mantle in which to wrap their objections to the science that does not support their favored understanding of how disease works or what treatments are effective. After all, if all knowledge is relative, then why shouldn’t their way of knowing be just as valid as that of science, given that in the postmodernist view as used (or, as many philosophers would characterize it, abused) by “postmodernist” critics, science is just “another narrative.”

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

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The worst of times for antivaccine believers: Yet another study fails to show any link between the MMR vaccine and autism

ResearchBlogging.orgTHE BEST OF TIMES

It was the best of times (for antivaccinationists). It was the worst of times (for antivaccinationists). It was the age of wisdom (definitely not for antivaccinationists). It was the age of foolishness (definitely for antivaccinationists). It was the epoch of belief (for antivaccinationists).

Such is the time we live in, my apologies to Charles Dickens, even though he is long dead.

Let’s face it. If we ignore the science, it is, alas, indeed the best of times for antivaccinationists. I’ve lamented the rise of non-science-based fearmongering among the antivaccine brigade before many times. Indeed, I’ve lamented how the influence of ignorant, unscientific dolts like Jenny McCarthy spouting nonsense about vaccines has already resulted in the resurgence of vaccine-preventable diseases such as measles in areas of the U.S. to the point where I’m not along in fearing that the bad old days will soon return, just as Andrew Wakefield’s litigation- and money-driven “studies” suggesting that the MMR was somehow responsible for autism and GI problems linked with autism resulted in the measles going from being conquered in the U.K. 14 years ago to being declared endemic again there, all because of the fear stoked in parents by bad science, paranoia, and anti-vaccine fearmongering.

Truly, it is the best of times for antivaccinationists, or so it seems from a superficial view.

Posted in: Clinical Trials, Public Health, Science and the Media, Vaccines

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The Importance and Limitations of Peer-Review

Peer-review is a critical part of the functioning of the scientific community, of quality control, and the self corrective nature of science. But it is no panacea. It is helpful to understand what it is, and what it isn’t, its uses and abuses.


When the statement is made that research is “peer-reviewed” this is usually meant to refer to the fact that it has been published in a peer-reviewed journal. Different scientific disciplines have different mechanisms for determining which journals are legitimately peer-reviewed. In medicine the National Library of Medicine (NLM) has rules for peer-review and they decide on a case by case basis which journals get their stamp of approval. Such journals are then listed as peer-reviewed.


Posted in: Clinical Trials, Science and Medicine

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Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division


The theme of this blog is science-based medicine. It’s even the name given the blog by our fearless leader, Steve Novella. By “science-based” medicine we generally mean medicine that is both grounded in scientific plausibility based on our best understanding of human physiology and disease as well as in strong evidence from well-designed clinical trials, both of which are extremely important We SBM bloggers tend to concentrate mainly on so-called “alternative,” “complementary and alternative,” or “integrative” medicine because it does indeed represent a major threat to the consensus among medical professionals that medicine should be science- and evidence-based. Moreover, the infiltration of pseudoscientific and antiscientific woo into medical schools, academic medical centers, and medicine at large, coupled with large amounts of money going to promote CAM, both from the government and wealthy private foundations, does represent an extremely worrisome trend that makes all of us, who range from mid-career to retired physicians, fear for the future generation of physicians and their ability to apply science and critical thinking to the evaluation of implausible health claims, such as reiki, homeopathy, applied kinesiology, and the large variety of woo that falls under the rubric of CAM. Worse, this trend began not long after a concerted push to make medicine more science- and evidence-based and less dogma- and authority-based.

Unfortunately, though, the antiscience of implausible health claims is not the only threat that science-based medicine faces. We bloggers here at Science-Based Medicine concentrate on it because its resurgence and infiltration into the very heart of academic medicine represent a sea change in the culture of scientific medicine, which once rightly and without reservation rejected much of what CAM represents as quackery. Also, I can’t speak for others, but pseudoscience interests me; it brings up questions of why people believe irrational and clearly false propositions. That being said, at the risk of ruffling a few feathers among my co-bloggers, I have observed that, if there is one thing that this blog has not to this point emphasized sufficiently, it’s that the commerce of medicine, the very manner in which we develop new therapies, can, if not carefully observed and regulated, represent a threat to science-based medicine even more potent than Andrew Weil, David Katz, and their all-out assault on the very foundations of scientific medicine and drive to return medicine to the days of anecdote-based rather than science-based medicine.

I’m talking about pharmaceutical companies. I’m also about to destroy any opportunity I might ever have to work for or receive any funding from Merck & Company. C’est la vie. A skeptical doc’s got to do what a skeptical doc’s got to do. Not that I won’t at least partially protect myself by adding the disclaimer that the following represents my opinion, and my opinion alone. It does not represent the opinion of my university, cancer institute, or partners.

Now that that’s taken care of, let’s start with a little primer on a pernicious phenomenon known as the “seeding trial.”

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Politics and Regulation

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High dose vitamin C and cancer: Has Linus Pauling been vindicated?

ResearchBlogging.orgTHE ZOMBIE RISES AGAIN

Vitamin C as a treatment for cancer is back in the news again.

I’m not surprised. This is one therapy favored by advocates of “alternative” medicine that keeps popping up periodically (seemingly every couple of years or so). This latest bit of news has turned up almost right on time after the last time there was a push for rehabilitating vitamin C as a cancer cure a couple of years ago. Back in the spring of 2006, there were two studies published (more on them later) which were touted by the “complementary and alternative medicine” (CAM) crowd as evidence that Linus Pauling was supposedly vindicated. A little less than two weeks ago, an animal study was published suggesting that high-dose intravenous vitamin C had antitumor activity in mouse models. A couple of weeks prior, there had also been published a phase I clinical trial that showed that megadoses of IV ascorbate were safe and well-tolerated in cancer patients if they were appropriately screened for renal disease. Given the latest studies of this particular modality against cancer, it seemed like an opportune time for me to examine this new evidence and ask the question: Has Linus Pauling been vindicated?

I’ll cut to the chase. The short answer is: Not really, with the qualification that it depends on what you mean by “vindicated.” The long answer follows.

Posted in: Basic Science, Cancer, Clinical Trials, Nutrition, Science and the Media

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The Orange Man

The first thing that struck me about him was that he was orange.

It was not a shade of orange I had ever ever encountered before in a patient. It was a yellowish orange, an almost artificial-looking color. At first I wondered if he was suffering from liver failure with jaundice, but this orange was just not the right shade of yellow for jaundice, and his sclerae were not yellow. I also considered whether he was suffering from renal failure, but the orange color of his skin didn’t quite match the rather coppery color that some patients suffering from longstanding renal failure necessitating dialysis sometimes acquire. I was puzzled. His chart said that he was being admitted for surgery for rectal cancer. So I sent the intern in to get the story, do the history and physical, and get him all plugged in for his bowel prep. Believe it or not, there was actually a time when it was not all that uncommon for patients to come into the hospital the night before major abdominal surgery in order to undergo a preoperative bowel prep, rather than being forced by their insurance companies to undergo the torture of drinking four liters of the purgative known as Go-Lytely–a misnomer, if ever there was one!–at home and spending the next several hours having to rush periodically to the toilet, waiting in vain for the liquid exploding out of their hind end to run clear.

Posted in: Cancer, Clinical Trials, Science and Medicine, Surgical Procedures

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Sterile Water Injections for Pain Relief

Before ethical standards changed, doctors used to occasionally fool patients with placebo injections of sterile saline or water. If my obstetrician had tried to give me sterile water instead of an epidural, I probably would have hit him. But apparently women are getting sterile water injections for childbirth and are telling us they work. What’s going on?

A recent study in Sweden compared sterile water injections to acupuncture for relief of labor pain. It found that sterile water produced significantly greater pain relief and relaxation. It concluded, “Women given sterile water injection experience less labor pain compared to women given acupuncture.”

I’m puzzled, because the study also says “there were no significant differences regarding requirements for additional pain relief after treatment between the 2 groups.” 85% and 90% got nitrous oxide, 40% and 47% got epidurals, and other conventional interventions were also used. It seems to me the conclusion could just as well have been “Women given sterile water injections report less labor pain than women given acupuncture, but require just as much additional pain relief.” (more…)

Posted in: Clinical Trials

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