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Archive for Clinical Trials

Tens of millions for CAM research — and it’s all on your dime

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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…)

Posted in: Acupuncture, Chiropractic, Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Naturopathy, Politics and Regulation

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Clinical trials of integrative medicine: testing whether magic works?

 

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:

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.

Posted in: Basic Science, Clinical Trials, Homeopathy

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“Atavistic oncology” revisited: Dr. Frank Arguello responds

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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:
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Posted in: Cancer, Clinical Trials, Evolution

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The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

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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…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Consortium of Academic Health Centers for Integrative Medicine research conference disappoints even NCCAM

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

From the Wikimedia Commons, originally posted by Flickr user Alex E. Proimos (link)

In May, the International Research Congress on Integrative Medicine and Health (IRCIMH) conference was held in Miami. In the words of its website, the conference was “convened by” the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM), “in association with” the International Society for Complementary Medicine Research. As CAHCIM chirped in this tweet: “Three days, 22 countries, 100 academic medical institutions, [and] 900 researchers, physicians, educators, and trainees…” Interestingly, despite the fact that “use of all appropriate … healthcare professionals and disciplines to achieve optimal health and healing” is part of CAHCIM’s definition of integrative medicine, actual CAM providers were barely visible among the conference committee bigwigs.

Emmeline Edwards, Ph.D., Director, Division of Extramural Research at the National Center for Complementary and Alternative Medicine (NCCAM), herself on the conference’s Program Committee, was decidedly underwhelmed. (NCCAM helped fund the conference. Additional funding information here.) After offering rather tepid congratulations to the organizers and participants, Dr. Edwards launched into a pointed, but very politely delivered, criticism of the research presented (emphasis mine):

The poster sessions offered a great opportunity to meet many new investigators engaged in exciting research in the field of integrative health. Reflecting on some highlights of these sessions, I was brought to the realization that we could strive for better balance in the science featured in the IRCIMH poster presentations. The clinical research posters outnumbered the basic research presentations 3:1, and research on mind and body strategies dominated the research landscape. One concern is that many clinical research projects were not developed from adequate mechanistic studies and, hence, the outcomes from these projects may not be very informative, provide a well-defined path for the next study, or give direction for future research programs.

How right you are, Dr. Edwards! We’ve been saying some of the same things here at SBM for years. We’ve noticed these very same problems in the organization you work for. Recently, as a matter of fact. (more…)

Posted in: Acupuncture, Basic Science, Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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The Center for Inquiry weighs in on the FDA’s mishandling of Stanislaw Burzynski’s clinical trials

We interrupt our usually scheduled post for an important announcement. OK, we do nothing of the sort. Scott Gavura’s post will go live a little later this morning. In the meantime, here’s a public service announcement about a frequent topic of mine, Stanislaw Burzynski, that I’d like you to read.

As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski’s bogus clinical trials of antineoplastons, which he’s used since the 1990s as a pretext to charge huge sums of money for “case management fees” to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators:

“We are frankly stunned to hear that the clinical hold against Dr. Burzynski has been lifted,” writes CFI in its letter. For decades, Dr. Burzynski and the Houston-based Burzynski Research Institute have been trafficking in unproven and scientifically baseless cancer treatments based on compounds known as antineoplastons, derived from human urine, which Burzynski claims — without evidence — can target and destroy cancer cells. He has taken advantage of desperate patients who are at their most vulnerable, and willing to pay any price.

After the death of a six-year-old patient in 2012, the FDA placed a hold on Burzynski’s trials with children, followed by a hold on trials with adults in 2013, prohibiting him from taking on new patients on whom he could experiment and from whom he could extract more money.

Over several decades, his clinic has proven it is unable to properly protect patient rights, adhere to basic ethical or scientific protocols, or even maintain correct patient records. It has also shown it is willing to exploit desperate cancer patients and their families, milking them out of enormous sums of money. But it has yet to show even a shred of evidence that its cancer treatments have any positive effect whatsoever.

“We struggle to see why the FDA continues to enable this deceptive, antiscientific, and unethical medical adventurism and profiteering, even for patients who are terminally ill,” writes CFI. “Given the behavior of Dr. Burzynski and the Burzynski Research Institute over the course of nearly three decades of failed research and trials, and in the face of a complete lack of scientific evidence demonstrating the efficacy of their expensive and dangerous antineoplaston treatment, we find the FDA’s decision perplexing and profoundly disturbing.”

The full text of the letter can be found here.

If only groups like the American Cancer Society would write similar letters. Cancer patients have been taken advantage of for nearly four decades, and Burzynski has made a mockery of the clinical trial process for nearly 20 years. It’s gone on way too long.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Beware The P-Value

Part of the mission of SBM is to continually prod discussion and examination of the relationship between science and medicine, with special attention on those beliefs and movements within medicine that we feel run counter to science and good medical practice. Chief among them is so-called complementary and alternative medicine (CAM) – although proponents are constantly tweaking the branding, for convenience I will simply refer to it as CAM.

Within academia I have found that CAM is promoted largely below the radar, with the deliberate absence of public debate and discussion. I have been told this directly, and that the reason is to avoid controversy. This stance assumes that CAM is a good thing and that any controversy would be unjustified, perhaps the result of bigotry rather than reason. It’s sad to see how successful this campaign has been, even among my fellow academics and scientists who should know better.

The reality is that CAM is fatally flawed in both philosophy and practice, and the claims of CAM proponents wither under direct light. I take some small solace in the observation that CAM is starting to be the victim of its own success – growing awareness of CAM is shedding some inevitable light on what it actually is. Further, because CAM proponents are constantly trying to bend and even break the rules of science, this forces a close examination of what those rules should actually be, how they work, and their strengths and weaknesses.

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Posted in: Clinical Trials

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Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA really caves

It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Did Facebook and PNAS violate human research protections in an unethical experiment?

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Ed. Note: NOTE ADDENDUM

I daresay that I’m like a lot of you in that I spend a fair bit of time on Facebook. This blog has a Facebook page (which, by the way, you should head on over and Like immediately). I have a Facebook page, several of our bloggers, such as Harriet Hall, Steve Novella, Mark Crislip, Scott Gavura, Paul Ingraham, Jann Bellamy, Kimball Atwood, John Snyder, and Clay Jones, have Facebook pages. It’s a ubiquitous part of life, and arguably part of the reason for our large increase in traffic over the last year. There are many great things about Facebook, although there are a fair number of issues as well, mostly having to do with privacy and a tendency to use automated scripts that can be easily abused by cranks like antivaccine activists to silence skeptics refuting their pseudoscience. Also, of course, every Facebook user has to realize that Facebook makes most of its money through targeted advertising directed at its users; so the more its users reveal the better it is for Facebook, which can more precisely target advertising.

Whatever good and bad things about Facebook there are, however, there’s one thing that I never expected the company to be engaging in, and that’s unethical human subjects research, but if stories and blog posts appearing over the weekend are to be believed, that’s exactly what it did, and, worse, it’s not very good research. The study, entitled “Experimental evidence of massive-scale emotional contagion through social networks“, was published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS), and its corresponding (and first) author is Adam D. I. Kramer, who is listed as being part of the Core Data Science Team at Facebook. Co-authors include Jamie E. Guillory at the Center for Tobacco Control Research and Education, University of California, San Francisco and Jeffrey T. Hancock from the Departments of Communication and Information Science, Cornell University, Ithaca, NY. (more…)

Posted in: Clinical Trials, Computers & Internet, Neuroscience/Mental Health, Science and the Media

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Acupuncture for Macular Degeneration: Why I Reject the Evidence

This post is dedicated to two people who are frequent commenters on SBM, Stephen S. Rodrigues and Peter Moran. Rodrigues is an MD/acupuncturist who tries to persuade us that acupuncture is effective. Moran is a retired surgeon who objects to insulting language and thinks more can be accomplished by trying to better understand why people turn to CAM and by explaining the facts and reasons politely and dispassionately. He has claimed that he “could probably help [Rodrigues] understand better why his views are not having much impact.”

I recently wrote about supplements for age-related macular degeneration (AMD). There is evidence that the supplement mixture tested in the AREDS trial slows the progression of moderate to advanced disease. That is based on a good scientific study, although the study has not been replicated and there is reason to interpret its results with caution. Dr. Rodrigues commented with a link to a website advertising the Santa Fe acupuncture protocol, saying that he uses the method in his office and it helps some of his patients with AMD. The website claims that the Santa Fe acupuncture protocol will reverse vision loss from macular degeneration in 4 days or your money back. That is a bold claim. I will try to explain, as politely as possible, why I reject the claim, and why the evidence for it is unacceptable. (more…)

Posted in: Acupuncture, Clinical Trials, Ophthalmology

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