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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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The cruel sham that will not die: Right-to-try marches on in California and beyond

The cruel sham that will not die: Right-to-try marches on in California and beyond

We here at SBM, particularly Jann Bellamy and myself, frequently write about naturopathic licensing laws, noting that naturopaths are relentless. They keep trying and trying to get states to pass laws granting their specialty licensure, and, like the Terminator trying to kill Sarah Connor or her son, they absolutely will not stop, ever, until science-based medicine is dead there are naturopathic licensing laws in all 50 states by 2025. Part of their strategy is that they never give up. No matter how many times a given state legislature denies them what they want, they are soon back, and they keep coming back again and again and again and again until they get the law they want passed. It’s the problem with playing defense, naturopaths can fail as many times as they have resources for, defenders of science-based medicine can’t afford to fail once. Worse, once such laws are passed, naturopaths are back again and again and again and again to keep trying to expand their scope of practice. It never ceases to amaze me that physicians’ groups go ballistic protecting their turf when advance practice nurses lobby to expand their scope of practice to encompass what they are trained for but remain more or less silent when naturopathic quacks push to have the state place its imprimatur on their pseudoscience.

Sadly, I’ve come to the conclusion that “right to try” laws are a lot like naturopathic licensing laws in that respect, only worse. Why worse? Unlike naturopathic licensing bills, right-to-try bills rarely die; most of them pass. In fact, only one right-to-try bill that I’m aware of has ever been successfully resisted and blocked from becoming law, and that required a veto by the governor. I’m referring, of course, to the California right-to-try bill vetoed last fall by Governor Jerry Brown. Amazingly, Brown’s veto held. Well, a new right-to-try bill is back in California, less than a year after the old right-to-try law had been vetoed. Passed in the legislature by overwhelming margins, it’s now back on Gov. Brown’s desk, and he has to decide what to do with it.

Its supporters hope that this time will be different, that this time Gov. Brown will sign the bill. They might be right. The rationale Gov. Brown used when vetoing the bill was that he wanted to wait to see what happened with reform of the FDA Expanded Access (sometimes called “Compassionate Use”) program. It’s quite possible that, despite the FDA moving forward with such reform, right-to-try advocates might persuade the governor that it isn’t enough. They’re wrong. In any case, given the resurrection of the California right-to-try law, now seemed like a good time to review what’s been happening with these laws since last year and discuss the situation in California and at the federal level. It isn’t good for patients or drug development. On the other hand, now that it’s been nearly two and a half years since the first right-to-try law was passed in Colorado, we have time to see just what a sham these laws are.

But first, since it’s been nearly a year since I last discussed right-to-try, let’s review why these laws are so pernicious.
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Posted in: Clinical Trials, Ethics, Politics and Regulation

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3-Bromopyruvate: The latest cancer cure “they” don’t want you to know about

3-BP: A "safe" and "nontoxic" cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

3-BP: A “safe” and “nontoxic” cancer cure targeting the Warburg effect that quite possibly killed three cancer patients in Germany.

I’ve not infrequently written about various dubious and outright quack clinics in different parts of the word with—shall we say?—somewhat less rigorous laws and regulations than the US. Most commonly, given the proximity to the US, the clinics that have drawn my attention are located in Mexico, most commonly right across the border from San Diego in Tijuana for easy access by American patients. Sometimes, in the case of dubious stem cell clinics, they are located in countries like China, Argentina, or Kazakhstan. That’s not to say that there aren’t a lot of quack clinics right here in the US (particularly for stem cell treatments), but, by and large, the clinics doing the truly dangerous stuff tend to be less common in the US.

There is, however, another country where alternative medicine clinics, particularly for cancer, are common and thriving, specifically Germany. I first learned of these clinics when the story of Farrah Fawcett’s battle with anal cancer hit the news nine years ago. Ultimately, she died of her disease at age 62, but before she did she sought treatment at a clinic in Germany, which administered alternative treatments as well as radioactive seed implants, the latter of which, despite sounding nice and “conventional,” were not standard-of-care for recurrent anal cancer. What this led me to learn is that German alternative cancer clinics tend to use both alternative medicine and experimental “conventional” medicine that has not yet been shown to be safe and effective in clinical trials.

I thought of Farrah Fawcett when news about a German cancer clinic hit the news again beginning more than a week ago, when two patients from the Netherlands and one from Belgium died shortly after having undergone treatment at the Biological Cancer Centre, run by alternative practitioner Klaus Ross in the town of Brüggen, Germany. Two others were hospitalized with life-threatening conditions. I didn’t blog about them at the time because the only reports I could find were those sent to me by readers, and they were in German or Dutch. They also didn’t have a lot of detail. Both reported that on July 25, a 43-year-old Dutch woman went to the Biological Cancer Center in Brüggen-Bracht for treatment of breast cancer and that she unexpectedly died on July 30 of unknown causes. The Dutch report stated that the death occurred under mysterious circumstances and that there were two other deaths, that of a Belgian woman the week before, and a Dutch man.

Elsewhere, Irish newspaper TheJournal.ie reports:

Dutch police, who are supporting the inquiry, appealed for information from other patients, as newspapers reported the clinic had been using an experimental transfusion.

Concern was first raised when a 43-year-old Dutch woman with breast cancer complained of headaches and became confused after being treated at the clinic on 25 July.

She later lost the ability to speak, and died on July 30 although the “cause of her death remains unclear,” the German prosecutors said in a statement earlier this week.

Later, it was learned that the identities of the suspected victims were Joke Van der Kolk, age 43; Leentje Callens, age 55; and Peter van Ouwendorp, age 55.

Unfortunately, the early reports were fairly basic, without much detail, and only a couple with any names. Fortunately, now there is an article in Science that reports more. It turns out that the suspected cause of death is an experimental cancer drug known as 3-bromopyruvate (3-BP) that has not yet been approved for use in humans. So what happened?
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Posted in: Basic Science, Cancer, Clinical Trials, Health Fraud

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CARA: Integrating even more pseudoscience into veterans’ healthcare

VA logo
The pixels were barely dry on David Gorski’s lament over the expansive integration of pseudoscience into the care of veterans when President Obama signed legislation that will exacerbate this very problem. The “Comprehensive Addiction and Recovery Act of 2016” (“CARA”) contains provisions that will undoubtedly keep Tracy Gaudet, MD, and her merry band of integrative medicine aficionados at the VA busy for the next few years integrating even more quackery into veterans’ medical care.

CARA is intended to address the serious prescription drug abuse problem in the U.S. It provides grants for local communities dealing with drug abuse crises and for drug abuse programs, improves access to overdose reversal medication and medication-assisted treatment for drug addiction, and assists in training first responders, among other things. It also includes provisions related to pain management, such as development of best practices to treat pain. None of that is the problem.

Deep in the Act, almost at the end, is “Subtitle C – Complementary and Integrative Health,” which begins with “Expansion of research and education on and delivery of complementary and integrative health to veterans.” I am not sure who stuck this into the new law, but it is only tangentially related to addiction and recovery. It establishes the “Creating Options for Veterans’ Expedited Recovery” Commission or, in the acronym-rich language of government, “COVER.” (more…)

Posted in: Acupuncture, Clinical Trials, Politics and Regulation

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On the pointlessness of acupuncture in the emergency room…or anywhere else

"This patient's qi isn't flowing the way it should. Consult Acupuncture, STAT!!"

“This patient’s qi isn’t flowing the way it should. Consult Acupuncture, STAT!!”

Sometimes there is a strange confluence of events that dictate what I feel that I need to write about when my turn here at SBM rolls around each Monday. Last week, a reader sent me a rather bizarre acupuncture study, and I thought I might write about that. Then I saw Mark Crislip’s (as usual) excellent deconstruction of the frequent claim by acupuncture apologists that acupuncture “works” by releasing endorphins and thought, “Maybe another topic.” But then, over the weekend, the Friends of Science in Medicine sent me a link to their latest article, a review of acupuncture entitled “Is there any place for acupuncture in 21st century medical practice?” Not surprisingly, the FSM (Friends of Science in Medicine, not the Flying Spaghetti Monster) concludes that the answer is no. However, in stark contrast to that conclusions are studies like the one mentioned above, studies so ridiculous that, when I discuss it, you will hardly believe that anyone thought it was a good idea to utilize the money, time, and precious, precious human subjects to answer such a ridiculous question. After that discussion, I’ll come back to the FSM’s statement and discuss the evidence base (or rather, lack thereof) for acupuncture for pretty much anything.
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Posted in: Acupuncture, Clinical Trials

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Acupuncture and Endorphins: Not all that Impressive

Acupuncture needling

Pictured: A great way to get a staph infection, not a great way to get an endorphin rush.  Try jogging.  Or heroin.*

I was reading, and deconstructing, a particularly awful bit of advice for acupuncture by Consumer Reports. It was the same old same old, but it was the source that made it particularly awful. I expect more from Consumer Reports than the uncritical regurgitation of the standard mythical acupuncture narrative. The report included the quote

One possible reason for the benefits of acupuncture: Studies show that it causes us to release feel-good hormones, called endorphins, that suppress pain.

I have never bothered to go back and see what the original literature was to support endorphins as a potential mechanism for a beneficial effect of acupuncture on pain.

That endorphins are released as a result of a noxious stimulus didn’t surprise me; that is what endorphins are for. And endorphins are unlikely to be the mechanism for all the other diseases for which the WHO suggests acupuncture benefits.

To my surprise, my brief search that day came up with very little information on the endorphins and acupuncture.

What I wanted to know was the evidence behind the universal meme that acupuncture releases feel-good hormones. If Consumer Reports says it is so, it must be true, right? So I plugged ‘acupuncture endorphin’ into PubMed and went to work. (more…)

Posted in: Acupuncture, Basic Science, Clinical Trials, Traditional Chinese Medicine

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