Clinical Trials

Archive for Clinical Trials

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.

Posted in: Clinical Trials, Ethics, Politics and Regulation

Leave a Comment (0) →

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 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?

Posted in: Basic Science, Cancer, Clinical Trials, Health Fraud

Leave a Comment (0) →

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

Leave a Comment (0) →

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.

Posted in: Acupuncture, Clinical Trials

Leave a Comment (0) →

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

Leave a Comment (0) →

Forget stem cell tourism: Stem cell clinics in the US are plentiful

Snake Oil Salesman & Wagon
I had planned on writing about something else this week, but late last week another story caught my eye, because it served as a perfect follow-up to what I wrote about last week. To recap, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that left him without the use of his left arm, and weak left leg. He could still walk with a cane, but was understandably desperate to try anything to be able to function more normally in life. Mr. Gass was both driven enough, credulous enough, and wealthy enough to spend $300,000 pursuing stem cell tourism in China, Mexico, and Argentina over the course of four years. The result is that he now has a tumor growing in his spinal column, as reported in The New England Journal of Medicine (NEJM) and The New York Times (NYT). Genetic analysis has demonstrated that the cells in this tumor mass did not come from Jim Gass, and the mass has left him paralyzed from the neck down, except for his right arm, incontinent, and with severe chronic back pain. Worse, although radiation temporarily stopped the tumor from growing, apparently it’s growing again, and no one seems to know how to stop it. Given that the traits that make stem cells so desirable as a regenerative treatment, their plasticity and immortality (ability to divide indefinitely), are shared with cancer, scientists doing legitimate stem cell research have always tried to take precautions to stop just this sort of thing from happening in clinical trials. Clearly, “stem cell tourist” clinics, which intentionally operate in countries where the regulatory environment is—shall we say?—less than rigorous are nowhere near as cautious, as they charge tens of thousands of dollars a pop for stem cell treatments that might or might not actually have real stem cells in them.

At the time I wrote that article, I emphasized primarily clinics outside of the US, where shady operators locate in order to be able to operate largely unhindered by local governments. You’d think that such a thing couldn’t possibly be going on in the US. You’d be wrong. Last week, Paul Knoepfler, a stem cell scientist who has previously contributed to Science-Based Medicine, teamed up with Leigh Turner to publish a paper in Cell Stem Cell estimating the number of stem cell clinics in the US. The number they came up with astonished me. (more…)

Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

Leave a Comment (0) →

A systematic review about nothing

There is dubious content in PubMed that you won’t find unless you look for it, or stumble across it inadvertently. It’s the entire field of alternative medicine which is abstracted and complied along with the actual medical literature. In this world, the impossible is accepted as fact, and journal articles focus on the medical equivalent of counting angels on pinheads. I’ve been trying to avoid blogging about alternative medicine practices like homeopathy lately because the practice itself is a scientific dead end. There is no emerging evidence or interesting research to describe, because there is no science to build on. But research on homeopathy is interesting if one wants to understand how placebo effects can appear to be real. Importantly, research and clinical trials of homeopathy allow us to see the underlying (baseline) challenges, flaws, and biases in evaluating real medicine more clearly. Today I want to review a newly-published systematic review of, adverse effects attributed to homeopathy. The casual reader might not see the multiple problems with this type of research. But once you understand the basis of homeopathy, the conclusion that one can draw is quite different from that of the author’s. And if inert sugar pills can appear to have medicinal effects, and even adverse effects, then we can better adjust for these biases when we’re studying actual medicine. (more…)

Posted in: Clinical Trials, Homeopathy

Leave a Comment (0) →

What’s the harm? Stem cell tourism edition

What's the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There's the harm.

What’s the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There’s the harm.

It’s been over two weeks now since hockey legend Gordie Howe died at the age of 88. Detroit, as I’ve pointed out elsewhere, is a serious hockey town, as hockey-crazy as any town in Canada (just look at the fancy new hockey arena named after crappy pizza being built downtown only a mile from where I work), and it worshiped Gordie Howe for as long as I can remember growing up here.

The reason I mentioned this is because in late 2014, Howe suffered a series of debilitating strokes that brought him close to death. He survived, but with major neurologic deficits. As a result of Gordie Howe’s fame, representatives of a company known as Stemedica who were also fans of Gordie Howe and whose company is developing stem cell treatments for a variety of illnesses, approached the family and persuaded them to take Gordie Howe to the Novastem Clinic in Tijuana, a clinic that to me appeared to exist mainly as a means for patients not eligible for Stemedica’s clinical trials in the US to receive Stemedica’s stem cells outside of a clinical trial, cash on the barrelhead, no questions asked. In a rather ethically dubious move that could only be viewed as paying for publicity (which it got in abundance), Stemedica administered its stem cells to Gordie Howe for free. If you’re not Gordie Howe, however, it’ll cost you about $32,000.

As is the case for most anecdotes like this, Gordie Howe did improve. That is not surprising, because, as Steve Novella, who is a neurologist and thus takes care of stroke patients as part of his practice, told me at the time, the natural history of stroke is neurologic recovery that eventually plateaus several months after the stroke. This occurs as the inflammation from the initial stroke abates and as much regeneration as the body can muster occurs. Also, as I noted before, Howe had a hemorrhagic stroke, which is more dangerous and likely to kill early but, if the victim survives, he is more likely to experience better functional recovery than in the case of the much more common ischemic stroke, in which a blood clot clogs a blood vessel, resulting in the death of brain tissue supplied by that vessel. In any case, as I described in a three part series of posts (part one, part two, part three), it’s impossible to know whether the stem cell infusion that Howe underwent had anything whatsoever with his partial recovery that allowed him to make a few public appearances in 2015 and 2016.

Unfortunately, the offer by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies to treat Gordie Howe at Novastem worked brilliantly. Gordie Howe quickly became the poster child for dubious stem cell therapies. Local and national news aired credulous, feel-good human interest stories about his seemingly miraculous recovery, while Keith Olbermann practically served as a pitch man for Stemedica and didn’t take kindly at all to any criticism of his—shall we say?—enthusiastic coverage. The predominant angle taken in stories about Gordie Howe was he had undergone Stemedica’s stem cell therapy and, as result, enjoyed a “miraculous recovery” from his stroke. The vast majority of news coverage also tended to present the magic of stem cell therapies credulously, as all benefit and no risk, as a qualitative analysis published last year clearly showed, finding that the “efficacy of stem cell treatments is often assumed in news coverage and readers’ comments” and that media coverage “that presents uncritical perspectives on unproven stem cell therapies may create patient expectations, may have an affect [sic] on policy discussions, and help to feed the marketing of unproven therapies.”

No kidding.

Why, you might ask, am I reminding you of Gordie Howe’s use of stem cells to treat his strokes? Simple, it became part of a marketing blitz, credulously swallowed whole by Keith Olbermann and many reporters, for unproven stem cell therapies, which have been portrayed as very promising (which is likely true, although that promise hasn’t yet been proven or realized) and harmless, which is definitely not true, as evidenced by the story of Jim Gass, as published last week in The New England Journal of Medicine, The New York Times, The Boston Globe, and a variety of other media. Before I discuss Mr. Gass in more detail, however, let’s recap a bit about stem cells. (more…)

Posted in: Clinical Trials, Ethics, Health Fraud, Science and the Media

Leave a Comment (0) →

Whither the randomized controlled clinical trial?

Whither the randomized controlled clinical trial?

One of the most frequent complaints about evidence-based medicine (EBM), in contrast to science-based medicine (SBM), is its elevation of the randomized clinical trial as the be-all and end-all for clinical evidence for an intervention for a particular disease or condition. Unknown but enormous quantities of “digital ink” have been spilled explaining this distinction right here on this blog, beginning with our founder’s very first post, continuing with Kimball Atwood’s series of posts explaining the shortcomings of EBM’s reliance on clinical trials über alles using homeopathy as his example, to my referring to this aspect of EBM as “methodolatry,” defined as profane worship of the randomized controlled clinical trial (RCT) as the only valid method of clinical investigation. The problem, of course, with methodolatry, is that it completely ignores prior plausibility, and when that prior plausibility is as close to zero as you can imagine (e.g., for clinical trials of homeopathy), then the only positive results that you see in such trials can reasonably be concluded to be due to noise, shortcomings in trial design, and bias. Unfortunately, a failure to realize this has led to many pointless clinical trials and contributed to the rise of a whole new “specialty” known as integrative medicine, dedicated to “integrating” quackery and pseudoscience into science-based medicine.

So we know that practitioners of “complementary and alternative medicine” (CAM), now referred to more frequently as integrative medicine, don’t like RCTs. They love pragmatic trials, because such trials are usually unblinded, often not randomized, and generally face a lower bar of evidence. That pragmatic trials are intended to test the “real world” use of medical and surgical interventions that have already been shown to be safe and effective in RCTs and that the vast majority of CAM nostrums have not met that standard appears not to concern them in the least. However, CAM practitioners are not the only ones critical of RCTs, as I learned when, via Steve Novella, I came across an article in The New England Journal of Medicine entitled “Assessing the Gold Standard — Lessons from the History of RCTs” by Bothwell et al. Given that the article is two weeks old, I wonder how I missed it. Be that as it may, although Bothwell et al make some good points, I tend to agree with Steve that the overall gist of the article is overly critical, to the point of, as Steve put it, portraying the RCT as broken rather than flawed and advocating revolution rather than reform.

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

Leave a Comment (0) →

False balance about Stanislaw Burzynski and his disproven cancer therapy, courtesy of STAT News

Stanislaw Burzynski: 40 years of failure to prove that his antineoplastons are effective against cancer.

Stanislaw Burzynski: 40 years of failure to prove that his antineoplastons are effective against cancer.

One common theme that has been revisited time and time again on this blog since its very founding is the problem of how science and medicine are reported. For example, back when I first started blogging, years before I joined Science-Based Medicine in 2008, one thing that used to drive me absolutely nuts was the tendency of the press to include in any story about vaccines an antivaccine activist to “tell the other side” or to “balance” the story. So in a story on vaccines, on one side you would have Paul Offit, a bona fide, legitimate vaccine expert, and on the other side you would have J.B. Handley, Jenny McCarthy, Andrew Wakefield, or a lesser light of the antivaccine movement. This same trope included stories about autistic children in which a reporter does a human interest story about a family struggling with raising an autistic child in which he lets the parents spout antivaccine misinformation, providing only a brief token quote by a scientist for “balance.” Thus, whether they intended it or not, the reporter would let the emotional impact of the story serve as persuasion to believe the parents’ antivaccine views. So, even though there was not (and hasn’t been at least since 2001 or probably much earlier) anything resembling legitimate scientific controversy over the question of whether vaccines cause or contribute to autism, the press aided the antivaccine movement in keeping alive the appearance of a controversy. It was, as I like to call these things, a manufactroversy, a controversy manufactured by the antivaccine movement to give the appearance of an actual scientific controversy. It’s a time-dishonored journalistic failing that is still a major problem with reporting on, for example, anthropogenic global climate change and genetically modified organisms (GMOs).

Sometimes, however, the press is teachable. A few years ago, after already having blogged about vaccines and autism for several years, I started noticing fewer stories with false “balance” and more stories that simply treated the antivaccine movement like the fringe movement it was, either not bothering to mention it or, if it had to mention it, basically letting scientists explain why it’s bad science and dangerous to public health. These days, false balance and stories that are antivaccine propaganda are relatively rare, aside from stories by fringe journalists like Sharyl Attkisson and Ben Swann. That’s a good thing. Unfortunately, I wish I could say that I really believe it was due to the efforts of skeptics and science advocates more than it was due to the discrediting of a major antivaccine figure, Andrew Wakefield, but even six years after Wakefield lost his medical license and saw his infamous 1998 Lancet paper linking the MMR vaccine to bowel disease in autistic children (the one that ignited the MMR scare in the UK) retracted, I’m not entirely sure. Be that as it may, there still remain blind spots in the press. (more…)

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

Leave a Comment (0) →
Page 2 of 40 12345...»