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Urinary Tract Infections Cause Depression. Directors Cut.*

As some may know I am infectious disease doctor. Urinary tract infections (UTI) butter my bread. Figuratively speaking. There is an enormous amount known about the pathophysiology of UTI’s. It is both a common and complex problem. But for all our knowledge, chronic and recurrent UTI’s remain a vexing issue for the patient and the doctor.

One reason people develop recurrent UTI’s is not because of altered chi along meridians altered by needles stuck in the skin distant from the bladder. That would be ridiculous. I like reasoning from basic principles. Given what we know about anatomy, physiology and microbiology, how might acupuncture interfere with the development of a urinary tract infection? Would it prevent colonization with pathogenic E. coli? Prevent retrograde travel of bacteria up the urethra into the bladder? Stop E. coli from binding to uroepithelial cells? Have a bactericidal or bacteriostatic effect?

None of the above seem likely. To my mind, postulating any of the above as a potential mechanism for acupuncture as a preventative for UTI’s would be ludicrous. And spare me your Boosting the Immune System, a concept that exists as a marketing tool, not a useful therapeutic intervention. My boss used to say that many an academic career floundered on attempting to prevent and treat UTI’s using an immune system approach. With some exceptions, and there are always exceptions, recurrent UTI’s in normal humans are usually due to anatomic or microbiological anomalies.

Despite its popularity, it is clear that acupuncture is not based on reality and, like all pseudo-medicine, only has demonstrable efficacy in poorly-designed studies. Acupuncture displays the usual progression of all pseudo-medicines. Increasingly-well-done studies show decreasing effect until a study that removes all bias shows it to be no better than placebo. Which one would expect for an intervention based on fantasy. Prior plausibility (the toy boat of SBM, try saying it three times very fast) would predict that acupuncture is worthless. And that should be acupunctures, all 6 styles are an elaborate ritual with no more likelihood of efficacy than the superstitions in a Budweiser commercial. (more…)

Posted in: Acupuncture, Clinical Trials, Traditional Chinese Medicine

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Stanislaw Burzynski: Using 1990s techniques to battle the FDA today

It figures that I couldn’t go three weeks into 2014 without the topic of Stanislaw Burzynski rearing its ugly head. I had hoped to make it to February or even beyond before feeling the gravitational tug of the wretched hive of ignominious and unethical behavior, but here we are, only 20 days into the new year. So be it.

2013 finished with serious setbacks for Stanislaw Burzynski and his unproven cancer treatment that he dubbed “antineoplastons” (ANPs) way back in the early 1970s. As you might recall, in November, two things happened. First, the FDA released its initial reports on its inspection of the Burzynski Clinic and Burzynski Research Institute (BRI) carried out from January to March 2013. They were damning in the extreme, pointing out the shoddy operating methods of the institutional review board (IRB) used by the BRI to approve and oversee Burzynski’s “clinical trials” (and I use the term loosely) of ANPs. Violations included using expedited approvals to review single patient protocols, something so far outside the purview of what the expedited approval process was intended for, namely approving minor tweaks to human subjects research protocols without requiring a full meeting of the IRB, that the FDA called Burzynski out for it. Other violations included failure to report serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or the IRB, failure to follow proper informed consent procedures, failure to determine that risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, and a lot of other violations, which are listed in my previous post on the subject. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Acupuncture Whac-a-Mole ™

Those who cannot remember the past are condemned to repeat it.
- George Santayana

Most people don’t have that willingness to break bad habits. They have a lot of excuses and they continue to produce bad clinical studies.
- Carlos Santana (Well, not the last 4 words.)

One is a guitar player, one is a philosopher. I get them confused.

I think George was in charge of SCAM research at the NIH. It was Dr. Gorski who first used the term Whac-a-Mole to describe what we do. The same badly-done studies are done over and over and misrepresented over and over, with only very minor variations on a theme. This is especially true of acupuncture, the most extensively studied pseudo-medicine in search of something, anything, for which it might be effective. They are still searching.

I loved going mano-a-mano with my kids when they were younger on the Whac-a-Mole machine in the Seaside arcade followed by root beer and elephant ears. It was the last time I beat either of them at any athletic endeavor. So I enjoy Whac-a-Mole, with mechanical rodents or bad research. (more…)

Posted in: Acupuncture, Clinical Trials, Critical Thinking, Science and Medicine

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Vitamin E for Alzheimer’s

Recently you may have seen headlines like “Vitamin E slows decline in patients with mild Alzheimer’s” or “There’s still no cure for Alzheimer’s disease, but the latest hope for slowing its progression is already on drugstore shelves.” They were referring to an article in the January 1, 2014 issue of the Journal of the American Medical Association (JAMA) announcing the results of the TEAM-AD VA Cooperative Randomized Trial of vitamin E and memantine (Namenda) for Alzheimer’s disease (AD).

The study attracted a lot of media attention. Most of the news reports I have seen were accurate and cautious, explaining the nuances of the study rather than suggesting that everyone should run out and buy vitamin E; but I wouldn’t be surprised to learn that a lot of readers ignored the fine print and did just that. It would be interesting to track sales of vitamin E and see if there was a bump following the publicity.

We know of no treatment that will delay, prevent or cure Alzheimer’s disease, or that affects the underlying disease process. It’s a tragic, frustrating disease that takes away the very things that make us who we are: memory and personality. It is affecting more and more people as the numbers of elderly increase. Available prescription medications are only modestly effective in slowing functional decline and delaying the need for institutionalization. They are expensive, they don’t help everyone, and when they do help, they only help for a limited time. It is very exciting to think an inexpensive vitamin could help patients with mild to moderate AD, but we must resist the temptation to read too much into this study. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Neuroscience/Mental Health

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An experiment in paying through the nose for “unnecessary care”

Rats. Harriet stole what was going to be the title of this post! This is going to be something completely different than what I usually write about. Well, maybe not completely different, but different from the vast majority of my posts. As Dr. Snyder noted on Friday, it’s easy to find new woo-filled claims or dangerous, evidence-lacking trends to write about. Heck, I did it just last week, much to the continued consternation of one of our regular readers and commenters. Examining certain other health-related issues from a science-based perspective is more difficult, but I feel obligated to do it from time to time, not just for a change of pace but to stimulate the synapses and educate myself—and, I hope, you as well—about areas outside of my usual expertise.

We spend a lot of time writing about the scientific basis of medicine, clinical trials, what is and isn’t quackery, and how “complementary and alternative medicine” (CAM) subverts the scientific basis of medicine. However, SBM goes far beyond just that. At least I think of it this way. That’s why I’ve looked at issues that go more to the heart of health policy, which should be based on sound science and evidence. That evidence might take different forms than it does for determining, for example, whether Medicaid results in better health outcomes and by how much health insurance does the same. As is the case with policy issues and economics, conclusions are muddled and messy. The error bars are huge, and the number of potential confounders even huger. (more…)

Posted in: Clinical Trials, Diagnostic tests & procedures, Politics and Regulation, Public Health

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And Now for Something Completely Different

This will be a departure from my usual posts. Several announcements in the news and medical journals have caught my attention recently, and as I delved into the details, I thought I would share them with our SBM readers. Topics include AIDS cures, the continuing danger of polio, eating nuts for longevity, racial differences in vitamin D, and the use of pharmacogenetic testing to guide the dosage of anticoagulant drugs. They are all examples of science-based medicine in action.

Have patients been cured of AIDS?

I read that the HIV virus had returned in patients thought to have been cured by bone marrow transplants, and I mistakenly thought they were referring to the original claim of cure I had read about. Nope, that one still stands. (more…)

Posted in: Clinical Trials, Nutrition, Pharmaceuticals, Vaccines

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The Skeptics for the Protection of Cancer Patients need your help

We at SBM don’t normally ask our readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it. However, given the story of Stanislaw Burzysnki, which I’ve been covering with frequent blog posts for over two years now, how could I not listen to the appeal of my friend and co-conspirator (note to Burzysnki fans: that “co-conspirator” bit was sarcasm) to take action in the wake of the USA TODAY story that ran two and a half weeks ago. Despite the disingenuousness of Burzynski’s response, unfortunately he’s still managing to find his way into legitimate scientific meetings.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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“Low T”: The triumph of marketing over science

A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.

The Colbert Report, December 2012

 

And now for something completely different…sort of.

After writing so much about the latest developments in the ongoing saga of the cancer doctor who is not an oncologist and not a legitimate cancer researcher, plus a rumination on what’s up with President Obama’s nominee for Surgeon General and our favorite form of unscientific medicine, so-called complementary and alternative medicine (CAM), also known as “integrative medicine,” I thought it was time for a change of pace. I wasn’t sure what I was going to write about as Sunday rolled around, but fortunately, as sometimes happens, the New York Times dropped a topic right in my lap, so to speak, both figuratively and literally. It comes in the form of a long article on something that directly concerns men of a certain age, which unfortunately happens to mean men of my age and older. I’m referring to what pharmaceutical company advertising campaigns have dubbed “low T,” short for low testosterone. It’s not clear how the term “low T” originated but Dr. Abraham Morgentaler, founder of Men’s Health Boston, claims to have coined the term when his patients were embarrassed by their difficulty pronouncing the word “testosterone.” Other sources report that it was Solvay Pharmaceuticals that coined the phrase. It doesn’t really matter where the term “low T” came from. The term has stuck, even though the more “correct” medical term would be hypogonadism, as in a man’s testes not working.
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Posted in: Clinical Trials, Diagnostic tests & procedures, Pharmaceuticals, Science and the Media

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The Burzynski Empire strikes back

You might have noticed that I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly-unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners. Most of this, of course, is no news to SBM readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over two years now. It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog. Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1:

As far as clinical trials go, it was a joke…it was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

And Jaffe’s characterization of the six dozen phase II clinical trials that Burzynski submitted in the late 1990s was this:

A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

I’m just repeating those quotes again, because they can’t be emphasized enough. Quite frankly, if I were Burzynski, I’d fire Jaffe for having published such statements in his book. But that’s just me. In the meantime, let’s take a look at the counterattack and why Burzynski’s excuses regarding the deficiencies found in the FDA reports do not ring true.
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Posted in: Cancer, Clinical Trials, Science and the Media

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USA Today versus Stanislaw Burzynski

This is an SBM public service announcement—with blogging! Think of it as a bonus post, and don’t forget to read Mark Crislip’s regular biweekly offering, as it’s about an article in Skeptical Inquirer that particularly irritated him—and me, as well. Because, as we all know, the world needs more Mark Crislip.

I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Indeed, just type his name in the search box of this blog, and you will see copious evidence of my disdain for the man. Over 37 years, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made two astoundingly bad documentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one at least, was very popular.

For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four-decade-long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled, but patients already on them could continue to receive treatment. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.

Now, thanks to Liz Szabo at USA Toda, we know from her article “Doctor accused of selling false hope to families“:
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Posted in: Cancer, Clinical Trials, Science and the Media

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