Retcon (shortened form of RETroactive CONtinuity; first made popular in the comic book world):
- (original meaning) Adding information to the back story of a fictional character or world, without invalidating that which had gone before.
- (more common usage) Adding or altering information regarding the back story of a fictional character or world, regardless of whether the change contradicts what was said before.
Archive for Clinical Trials
Yesterday, I spiffed up a post that some of you might have seen, describing how a particular medical conspiracy theory has dire consequences in terms of promoting non-science-based medical policy. Specifically, I referred to how the myth that there are all sorts of “cures” for deadly and even terminal diseases that are being kept from you by an overweening fascistic FDA’s insistence on its approval process is an important driving force behind ill-advised “right to try” legislation that’s passed in four states and likely to pass in Arizona by referendum tomorrow. I’m not exaggerating, either. If you have the stomach to delve into the deeper, darker recesses of alternative medicine and conspiracy theory websites, you’ll find words far worse than that used to describe the FDA, such as this little gem from everyone’s favorite über-quack Mike Adams basically portraying the FDA as Adolf Hitler. Even more “mainstream” advocates, such as Reason.com’s Ronald Bailey and Nick Gillespie, are not above using a version of this myth stripped of the worst of its conspiracy mongering for public consumption, claiming that the FDA is killing you.
Unfortunately, this sort of medical conspiracy theory is very common. Like all conspiracy theories, medical conspiracy theories tend to involve “someone” hiding something from the public. I like to refer to this as the fallacy of “secret knowledge.” That “someone” hiding the “secret knowledge” is usually the government, big pharma, or other ill-defined nefarious forces. The “secret knowledge” being hidden comes invariably in one of two flavors. Either “they” are hiding cures for all sorts of diseases that conventional medicine can’t cure, or “they” are hiding evidence of harm due to something in medicine. Although examples of the former are common, such as the “hidden cure for cancer,” it is examples of the latter that seem to be even more common, in particular the myth that vaccines cause autism and all sorts of diseases and conditions, that genetically modified organisms (GMOs) are dangerous, or that radiation from cell phones causes cancer. In these latter examples, invariably the motivation is either financial (big pharma profits), ideological (control, although descriptions of how hiding this knowledge results in control are often sketchy at best), or even some seriously out there claims, such as the sometimes invoked story about how mass vaccination programs are about “population control” or even “depopulation.” Either way, “The Truth” needs to be hidden from the population, lest they panic and revolt.
Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.
The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
News this week that a randomized controlled trial of green coffee bean (GCB) has been officially retracted from the medical literature signals what is hopefully the end to one of the most questionable diet products to appear on the market in years. Plucked from obscurity and then subjected to bogus research, it’s now clear that the only people that actually benefited from GCB were those that profited from its sale. GCB had some powerful boosters, too. Once it became one of Dr. Oz’s “miracle” weight loss cures, sales exploded following two hype-filled episodes. Oz even did a made-for TV clinical trial with GCB, ignoring the requirements for researchers to obtain ethical approvals before conducting human subject research. Oz’s promotion of GCB was so breathless and detached from the actual evidence that his actions were subsequently eviscerated by Senator Clair McCaskill during televised hearings on weight loss scams. It’s a long, sordid, ugly and yet entirely predictable story. (more…)
We at the Science-Based Medicine blog believe that all medicine, regardless of where it comes from, should be held to a single science-based standard with regards to efficacy, effectiveness, and safety. We tend to focus primarily on “complementary and alternative medicine” (CAM), now more commonly known as “integrative medicine,” because (1) we believe it to be undermining the scientific basis of medicine and allowing outright quackery (or, as I like to refer to it, quackademic medicine) to infiltrate medical academia, which is fast becoming medical quackademia and (2) because when it comes to the other threats to the scientific basis of medicine as it is practiced today, such as pharma influence and various medical dogmatism, there are a whole host of active critics better equipped and more energetic than we are who can do the job (usually) better. That is why, whenever I hear advocates of CAM/”integrative medicine” attack us for not spending enough time on various corruptions of clinical trial processes or the perfidy of big pharma, I tend to gently tell them in my characteristically diplomatic manner that that’s what I like to call the “Why don’t you blog about what I think is important and interesting instead of what you think is important and interesting?” criticism, then I refer them to our posts on John Ioannidis, overdiagnosis and overtreatment, the shortcomings of mammography, or any number of other posts we at SBM have done through the years pointing out where current medical practice falls short. Indeed, it never fails to amuse me to point out how angry an eminent radiologist became at me for my posts criticizing him for his misleading attacks on certain studies that question the value of screening mammography.
In particular, though, I like to point out a post I did on vertebroplasty as a treatment for vertebral compression fractures (VCFs) due to osteoporosis. Basically, I discussed then recent evidence showing how vertebroplasty for such fractures is, basically, placebo medicine, no better than acupuncture. Indeed, I likened the state of evidence regarding vertebroplasty to that of acupuncture, in which small, pilot studies appear to be positive, but then the follow-up rigorous randomized clinical trials fail to find a benefit greater than that of placebo. It turns out that a rather telling study regarding vertebroplasty was published earlier this year that I somehow missed that addresses a problem we have in “conventional” medicine.
Old bad studies: Fantastical autopsy results
I found the following quote at “Chiropractic care can treat more than just bad backs” (FYI. Chiropractic can’t):
Luse references a study published in The Medical Times authored by Dr. Henry Windsor [sic], M.D. that showcases the correlation of spinal health to overall wellness. Windsor dissected 75 human cadavers to investigate their causes of death. The study showed that 138 of the 139 diseases of the internal organs that were present were in connection to the misalignments of the vertebrae.
But I was intrigued. So I went to the video tape. Well, the PDF.
It is an interesting read by a physician who was looking for an association between curvature of the spine and visceral pathology.
He had 50 corpses, age unknown, that he dissected, looked at the spine for curvature and then looked for pathology in organs in the same distribution of sympathetic nervous system as the level of the spine curvature.
The Federal Funding Accountability and Transparency Act (FFATA) was signed on September 26, 2006. The intent is to empower every American with the ability to hold the government accountable for each spending decision. The end result is to reduce wasteful spending in the government. The FFATA legislation requires information on federal awards (federal financial assistance and expenditures) be made available to the public via a single, searchable website, which is www.USASpending.gov.
And what subject is more deserving of being held accountable by the American people than complementary/alternative/integrative medicine? After all, in what other area of government spending does scientific implausibility – indeed, even scientific impossibility – offer no impediment to spending millions of taxpayer dollars in research funds? We’ve complained about the NCCAM’s wasteful spending on pseudomedicine here on SBM several times: here, here, here and here, among others. As you shall see, the problem doesn’t stop at that particular $2.5 billion. (more…)
I just thought that I’d take the editor’s (and, speaking for Steve, the founder’s) prerogative to promote our own efforts. Regular readers of SBM are familiar with our message with respect to randomized clinical trials of highly implausible “complementary and alternative medicine” treatments, such as homeopathy or reiki. Well, believe it or not, Steve and I managed to get a commentary published in a very good journal in which we present the SBM viewpoint with respect to these trials. Even better, at least for now, you can read it too, because it doesn’t appear to be behind a paywall. (I’m at home as I write this, and I can read the whole thing on my wifi, no VPN needed.)
The article is entitled “Clinical trials of integrative medicine: testing whether magic works?” There’s also been a fair amount of news coverage on the article, and I’ve been frantically doing interviews over the last couple of days, including:
- Clinical trials of ‘quack alternative medicines should be stopped because they are damaging and a waste of money’, say two leading critics
- Doctors Propose End To Reiki Trials, But Practitioners Defend Marriage Of Science And Holistic Healing
- Stop Testing ‘Alternative’ Treatments, Some Researchers Say
There are likely to be at least a couple more, given the interviews I’ve done; that is, unless editors reject the ideas.
In any case, Steve and I are interested in your comments. Trends in Molecular Medicine is good in that it published our article and it’s a pretty high impact review journal, but it doesn’t have a section for comments. So consider this your section for comments on our article.
EDITOR’s NOTE: There are three Addendums after this post, containing the complete text of e-mails.
EDITOR’s NOTE #2 (8/19/14 4:51 PM): There is one more Addendum, as Dr. Arguello has sent me another e-mail.
EDITOR’s NOTE #3 (8/20/14 7:18 PM): There is yet another Addendum, as Dr. Arguello is now complaining to my place of work.
EDITOR’s NOTE #4 (8/21/14 5:30 PM): And the beat goes on. See Dr. Arguello’s next e-mail.
The following post will be of a type that I like to refer to as “taking care of business.” That’s not to say that it won’t be, as my posts usually are, informative and entertaining, but it does say that I’m doing it instead of what I had originally had in mind because something came up. That something is a rather unhappy e-mail from the doctor about whom I wrote three weeks ago. It’s just an indication that, although it’s a great thing that this blog is becoming more and more prominent, it’s also a two-edged sword. People actually notice it when I (or other SBM bloggers) criticize them for dubious medicine. We see this in how Dr. Edward Tobinick has launched what I (and many others) consider to be a frivolous lawsuit against SBM founder Steve Novella over a post from 2013 clearly designed to silence criticism. It’s legal thuggery, pure and simple. That’s the bad end of the spectrum. I’ve been at the receiving end of similar retaliation that could have just as bad an impact on me personally as far as my career goes when antivaccine activists tried to get me fired from my job four years ago.
The more common (and far less agita-inducing) end of the spectrum consists of e-mails or letters of complaint. Sometimes they come from eminent radiologists who don’t like my criticism of their attacks on mammography studies. (Actually, truth be told, it is rarely eminent radiologists—or eminent physicians and scholars—who complain.) More commonly, it’s practitioners who object to how their treatments have been described. This time around, it’s a man named Dr. Frank Arguello, whose “atavistic chemotherapy” I criticized in one of my typical long posts that also explained why. Last week, I received this e-mail from Dr. Arguello:
As I begin this post, I’m on a miserably crowded, hot, stinky flight winging my way home from TAM. This puts me in the perfect mood to write about my bête noire to conquer all bêtes noires, namely Stanislaw Burzynski, the Polish expat doctor who claims to have much better results treating deadly brain cancers than conventional oncology, even though he is not an oncologist and has never even completed the prerequisite training for an oncology fellowship, namely an internal medicine residency. Actually, I don’t mean that in the way that you probably think I mean it. This time around, unlike the last time around, writing about Burzynski will put me in a better mood to endure being slapped into a sardine can in coach, barely able to move, barely able to type, but needing to get a blog post out on Monday.
If you remember, the last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the partial clinical hold on Burzynski’s clinical trials. As is usual with the long and winding saga that is Burzynski, I feel compelled to give a brief review for any newbie who might encounter this post. Old hands at this story can skip ahead or just skim.
Two years ago, a child named Josia Cotto died of hypernatremia (elevated sodium level in the blood) due to receiving treatment for a brain tumor from the Burzynski Clinic using Burzynski’s “miracle drug” antineoplastons. Hypernatremia is a known complication of ANP treatment, and, as a result of this child’s death, the FDA put a partial clinical hold on Burzynski’s clinical trials for pediatric patients, which meant that he could continue to treat children already enrolled in his clinical trials but could not enroll any new patients. Six months later, this partial hold was extended to all of Burzynski’s clinical trials, and in early 2013 the FDA inspected the Burzynski Clinic and Burzynski Research Institute (BRI). (more…)