Clinical Trials

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Medical science policy in the U.S. under Donald Trump

When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

When Dr. Oz met Donald Trump: Somehow this photo just seemed appropriate for this post.

Last week, in an unexpected upset, Donald Trump won the Presidential election in the Electoral College while losing the popular vote and is now President-Elect. Regular readers of my not-so-super-secret other blog know my opinion of this; so I won’t belabor it too much here. If you’re curious, I have written about Donald Trump’s antivaccine views here before in the context of last year’s Republican debates, and, amusingly, I’ve even been at the receiving end of criticism from an “integrative medicine” activist in which my snark was compared to that of Donald Trump and my criticism labeled “Trumpism.” As you might imagine, I was not pleased.

Leaving all that aside and leaving aside how we’ve now had two Presidential elections out of the last five in which the candidate with fewer popular votes became President (no, I’m not a fan of the Electoral College), Donald Trump won fair and square and will be our next President. As an advocate of science-based medicine, naturally I wondered: What can we expect in terms of medical science under President Trump next year? Jann Bellamy already began the discussion on this blog by undertaking a fairly comprehensive overview of the disturbing anti-science positions Donald Trump and many now coming into his new administration espouse. I’m going to do a bit of the same, but I’m going to drill down and focus solely on medical science. While I agree that Trump’s position on human-caused climate change and his stated intent to pull out of important climate treaties and, in essence, cease any attempt to mitigate the effects of human activity on climate change is a looming disaster that our grandchildren and great-grandchildren and beyond will likely curse our generation for, this blog is Science-Based Medicine.
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Posted in: Basic Science, Clinical Trials, Medical devices, Pharmaceuticals, Politics and Regulation

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German alternative cancer clinics: Combining experimental therapeutics with rank quackery and charging big bucks for it

Pauline Gahan in front of the Hallwang Private Oncology Clinic
A couple of months ago, I discussed patient deaths at an alternative medicine clinic in Europe, where a naturopath named Klaus Ross had been administering an experimental cancer drug (3-bromopyruvate, or 3-BP) to patients outside the auspices of a clinical trial. 3-BP is a drug that targets the Warburg effect, a characteristic of cancer cells first reported in the 1920s by Otto Warburg in which the cancer cell changes its metabolism to shut off oxidative phosphorylation (the part of glucose metabolism requiring oxygen that produces the most energy) to rely almost exclusively on glycolysis and anaerobic metabolism. From a cancer cell evolution standpoint, one can understand why cancer cells would behave this way, as this change allows them to survive in environments with much less oxygen than normal cells, but the side effect of the Warburg effect is that cancer cells consume a lot of glucose for their energy needs. Indeed, positron emission tomography (PET scanning) takes advantage of this characteristic of cancer cells to use glucose labeled with a positron-emitting isotope that accumulates in cells. The result is that cancer cells, which in general use a lot more glucose than normal cells, light up compared to the surrounding tissue, allowing the identification of areas suspicious for cancer. Targeting the Warburg effect is therefore a strategy to attack cancer cells preferentially.

Since I wrote about the tragic deaths of those cancer patients, I’ve been seeing stories about German alternative medicine cancer clinics popping up in my newsfeed over and over again. Intuitively, you’d think that a scientifically advanced economic powerhouse like Germany would have stricter regulations over the practice of medicine, but, the more I looked into these clinics, the more I realized that there are a lot of quack clinics in Germany every bit as quacky as any clinic in Tijuana, but with a twist. Like Mexican alternative medicine clinics, German clinics often charge enormous sums of money for treatments that range from the unproven to the dubious to pure quackery. However, in addition to the rank quackery, German cancer clinics include legitimate experimental drugs that are as yet unproven and might even only have cell culture or animal evidence supporting its potential efficacy. Indeed, 3-BP is just such an example. It is a legitimate candidate cancer drug that’s in the pipeline, having shown promise in cell culture and animal experiments, but that has no human data from systematic clinical trials yet, just a handful of anecdotes when it was tried in humans under desperate circumstances. Not surprisingly, Klaus Ross’ main clinic is in Germany, and, like so many other clinics there, he was administering an as-yet-unapproved drug to humans.

So, prodded by a couple of recent stories from the UK, I decided to take another look at these German cancer clinics.
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Posted in: Cancer, Clinical Trials, Health Fraud

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A Credible Placebo Control for Chiropractic Research

D.D. Palmer, the father of chiropractic, died in 1913. Over a century later, his ideas have never been properly tested with placebo controls - until now.

D.D. Palmer, the father of chiropractic, died in 1913. Over a century later, his ideas have never been properly tested with placebo controls – until now.

The research on chiropractic has been far from rigorous. One of the problems is that studies of spinal manipulation therapy (SMT) can’t be double blinded, and it is very difficult to even do single blinding. So most studies resort to non-manipulation control groups like “usual care” or “wait list” or “pain medication.” Those studies are practically guaranteed to lead to false positive conclusions: they make SMT look more effective than it would look if you could provide a control that patients couldn’t distinguish from real SMT.

In a study just published in the European Journal of Neurology, Chaibi et al. successfully used a credible placebo manipulation on patients with migraine. It showed that SMT doesn’t work for migraine, but that’s not news. The news is that it showed how to improve the methodology of SMT studies to get more reliable results. (more…)

Posted in: Chiropractic, Clinical Trials

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In which we are accused of “polarization-based medicine”

hillary-clinton-donald-trump-presidential-debate

A little over a month ago, I wrote about how proponents of “complementary and alternative medicine” (CAM), now more frequently called “integrative medicine,” go to great lengths to claim nonpharmacological treatments for, well, just about anything as somehow being CAM or “integrative.” The example I used was a systematic review article published by several of the bigwigs at that government font of pseudoscience, the National Center for Complementary and Integrative Health (NCCIH) about CAM approaches for the management of chronic pain. You can read my whole post for yourself if you want the details (and read Edzard Ernst and Steve Novella for more), but the CliffsNotes version consists of two main points. First, the review didn’t really show that any CAM approach worked, given how the authors included so many studies with no placebo or sham control and didn’t systematically assess the quality of the studies. Second, this study is the best publicized example of how NCCIH, looking for a reason to justify itself, has latched on to the opioid addiction crisis in this country and gone “all in” with CAM for chronic pain. Of course, the problem is that none of the real “alternative” treatments show any convincing evidence of efficacy; so NCCIH has to claim exercise (in the form of yoga and Tai Chi, for instance) and various other modalities that aren’t really “alternative” as being part of CAM. True, the authors did try to claim that acupuncture works for back pain and osteoarthritis of the knee, but the flaw of including mostly studies with no placebo/sham control completely undermined that claim. Basically, taken in its entirety, the NCCIH’s systematic review failed to find convincing evidence that any CAM therapy really works for chronic pain.

So I wrote my post, noting also how this review article and its framing of CAM as equivalent to any nonpharmacologic treatment were clearly in line with the last two NCCIH strategic plans, perused the comments our readers left, and pretty much forgot about the study, because fortunately, it didn’t seem to get much traction. (Releasing it right before the Labor Day weekend probably didn’t help NCCIH much.) However, there is one person who did not forget, and that person is John Weeks. Last week, he published a response to the criticisms of the NCCIH review in the Journal of Alternative and Complementary Medicine (JACM) entitled “Polarization-Based Medicine: Protests Against the Mayo-NCCIH Pain Guidance Evoke the Bigotry of the Political Season.”

As they say, it’s on.
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Posted in: Clinical Trials, Critical Thinking, Medical Academia, Politics and Regulation

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Infectious Diseases and Cancer

coley

Dr. William Coley. Not a brain surgeon.

With apologies to my colleagues, but infectious diseases really is the most interesting specialty in medicine. There are innumerable interesting associations and interactions of infectious diseases in medicine, history, art, science, and, well, life, the universe and everything. ID is so 42.

A recent email led me to wander the numerous interactions between infections and cancer.

There are the cancers that are caused by infection. HPV and cervical and throat cancer. EBV and lymphoma. HHV8 and Kaposi’s Sarcoma. I certainly hope I am not reincarnated as a Tasmanian Devil. (more…)

Posted in: Basic Science, Cancer, Clinical Trials, Epidemiology, Science and Medicine, Vaccines

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The stem cell hard sell, Stemedica edition

The stem cell hard sell returns.

The stem cell hard sell returns.

I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.

Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. So Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.

Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the waived $30,000 an investment in publicity. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.
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Posted in: Clinical Trials, Politics and Regulation, Science and the Media

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NCCIH funds sauna “detoxification” study at naturopathic school

Where's the sauna detox?

Where’s the sauna detox?

It is no secret that we at SBM are not particularly fond of the National Center for Complementary and Integrative Medicine (NCCIH; formerly, the National Center for Complementary and Alternative Medicine). We’ve lamented NCCIH’s use of limited public funds for researching implausible treatments, the unwarranted luster NIH/NCCIH funding bestows on quack institutions, the lack of useful research it has produced, and its failure to shoot straight with the public when discussing alternative/ complementary/ integrative medicine. Nor does NCCIH’s research appear to affect CAM practice. Lack of evidence of safety or effectiveness is no impediment to use among CAM practitioners or “integrative” physicians.

So I shouldn’t have been surprised (NCCIH’s promise to “do some real science for a change” notwithstanding) when, a few days ago, I ran across a study of which I was previously unaware (for good reason, as you’ll see) on clinicaltrials.gov:

Sauna Detoxification Study: Pilot Feasibility

The goal of this study is to assess the feasibility of the approach, conduct a dose-finding investigation, and obtain pilot data on hyperthermia via sauna to apply in follow-up trials in the assessment of human chemical body burden reduction, for general wellness, detoxification, and pain reduction.

The investigators wish to determine if a hyperthermia-based detoxification protocol is feasible to conduct: including assessment of recruitment, enrollment, retention, protocol adherence, adverse events, and changes in serum polychlorinated biphenyls (PCBs).

And:

Complementary and Alternative Medicine Sauna Detoxification Study: Phase I

The purpose of this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, and effects on quality of life and wellness. We hope to determine if there is a link between lower PCB levels in blood and sauna use.

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Posted in: Clinical Trials, Naturopathy

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The Cancer Moonshot: Hype versus reality

Joe Biden promotes the Cancer Moonshot initiative.

Joe Biden promotes the Cancer Moonshot initiative.

The Cancer Moonshot. It’s a topic that I’ve been meaning to address ever since President Barack Obama announced it in his State of the Union address this year and tasked Vice President Joe Biden to head up the initiative. Biden, you’ll recall, lost his son to a brain tumor. Yet here it is, nearly eight months later, and somehow I still haven’t gotten around to it. The goal of the initiative is to “eliminate cancer as we know it,” and to that end, with $195 million invested immediately in new cancer activities at the National Institutes of Health and $755 million proposed for FY 2017. My first thought at the time was that that wasn’t nearly enough money to achieve the ambitious goals set out by the President. That has now become particularly clear now that the National Cancer Institute has released the report from the initiative’s blue ribbon panel suggesting ten ways to speed up progress against cancer.
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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“Non-pharmacological treatments for pain” ≠ CAM, no matter how much NCCIH wishes it so

NCCIH #TalkPain

I’ve had the Monday spot on this blog for quite a long time now. While there are many advantages to posting on Monday, not the least of which is having more time to put a post together (although that is also a disadvantage because it incentivizes my taking more time than I sometimes should), one distinct disadvantage is that all the Monday holidays are mine. That leaves me a choice on, for example, Memorial Day and Labor Day every year. It’s a choice with three options: The first is: Don’t post. (Do stop laughing, please. I know it’s me.) The second is: Use a guest post. I thought about this, and there are guest posts in the pipeline, but I don’t like to use a guest post just because I’m feeling lazy. It strikes me as an abuse of being the managing editor. Finally, I could post, which is what I decided to do.

I mainly decided to do a post because late last week there was something to blog about that was pretty important and interesting, courtesy of the National Center for Complementary and Integrative Health (NCCIH), which was formerly known as the National Center for Complementary and Alternative Medicine (NCCAM). Basically, on September 1, the NCCIH published a press release, “Review Examines Clinical Trial Evidence on Complementary Approaches for Five Painful Conditions.” Elsewhere, NCCIH Lead Epidemiologist and first author of the review, Richard Nahin, PhD, MPH, bragged on the NCCIH blog, “New Review Offers Providers and Researchers Evidence-Based Information on Complementary Health Approaches for Pain.” It didn’t take long for headlines to start appearing that said things like:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Politics and Regulation

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Nada for NADA: “acudetox” not effective in addiction treatment

NADA auricular acupuncture
The National Acupuncture Detoxification Association (NADA) teaches and promotes a standardized auricular acupuncture protocol, sometimes called “acudetox.” NADA claims acudetox

encourages community wellness . . . for behavioral health, including addictions, mental health, and disaster & emotional trauma.

I do not know what “community wellness” is or how one measures whether wellness has been successfully “encouraged.” In any event, in the NADA protocol, acupuncture needles are inserted bilaterally into the auricle (outer portion) of the ear at a depth of 1-3 mm at five specific points (sympathetic, shen men, lung, liver, and kidney) and left in place for 45 minutes.

And:

Beyond the actual needling treatment, a key element of the protocol specifies qualities of behavior and attitude on the part of the clinician, consistent with what is known as the Spirit of NADA.

NADA claims there is

strong evidence for the effect of the NADA protocol in improving patient outcomes [in addiction treatment] in terms of program retention, reductions in cravings, anxiety, sleep disturbance and need for pharmaceuticals.

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Posted in: Acupuncture, Clinical Trials, Legal, Politics and Regulation

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