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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, Pharmaceuticals, Science and the Media

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The new Surgeon General nominee and CAM: Is there a problem here?

Our fearless leader, Steve Novella, has informed me that he is traveling today. Unfortunately, I am preparing a talk for later today, and no one else seemed able to come up with a post; so I decided to adapt a recent post from my not-so-super-secret other blog and see what a different readership thought of it. I realize that I’m risking subjecting you all to Gorski overload, but, hey, if the world needs more Mark Crislip, why wouldn’t the world need more David Gorski too? Steve will return next Wednesday, as usual.

I don’t normally give a lot of thought to the Surgeon General because, quite frankly, in recent years it hasn’t been a position of much authority or influence. That’s why I didn’t noticed late last week that President Obama had nominated a new Surgeon General. Normally, my failure to notice isn’t such a big deal, because there really hasn’t been a Surgeon General who has really been particularly well-known or had much of an impact since Dr. C. Everett Koop, although back when President Obama first took office Dr. Sanjay Gupta’s name was floated as a possibility for the position. Obviously, he didn’t get it. (I’m guessing that being a neurosurgeon and CNN’s chief medical correspondent probably pays much better than being Surgeon General.) To be honest, I didn’t even know that the prior Surgeon General had stepped down, but apparently she did in July, leaving the position filled by an interim Surgeon General until a new one could be nominated.

The other day, I learned whom President Obama nominated to be her successor, Dr. Vivek Murthy, a faculty member at the Harvard Medical School:

President Obama will nominate Dr. Vivek Murthy of Harvard Medical School and Brigham and Women’s Hospital as surgeon general of the United States, the White House announced Thursday night.

Murthy is a hospitalist at the Brigham and is co-founder and president of Doctors for America, a Washington, D.C.-based group of 16,000 physicians and medical students that advocates for access to affordable, high quality health care and has been a strong supporter of the Affordable Care Act.

If he’s confirmed by the Senate, Murthy would replace acting surgeon general Boris Lushniak. The surgeon general serves a four-year term and the post is essentially a bully pulpit to speak out on public health issues.

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Posted in: Acupuncture, Politics and Regulation, Public Health, 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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Irritated by the Skeptical Inquirer. Again.

I have a confession. I have been interested in issues skeptical since high school when I came across a copy of the Zetetic at Powells. In the pre-digital era I had a complete library of Zetetic-Skeptical Inquirers (SI) that a decade ago was tossed in the recycle bin along with a similar collection of MacWorlds. I have been interested in skepticism a long time and, here is my confession, I no longer find much of the subject matter covered by SI all that interesting. Even big ticket topics like the existence of God are uninteresting. It is not that the topics are not important, they are, and each generation has to relearn why Bigfoot or haunted houses or UFO’s are nonsense. But for me it is a large serving of been-there, done-that.

So while I subscribe to SI, it is more from a sense of obligation to support institutions I think are important than from an expectation that I will be either educated by the content or entertained by the style of the writers. I usually skim the magazine while accomplishing tasks that do not require my full attention probably because SI is the only magazine I still receive in dead tree format, the rest of my life being digital.

So I ran across “Taking our medicine: What hope for skepticism in healthcare?” by Kenneth W. Krause and after skimming it I was irritated. So I read it again and I was more irritated, which is often a good sign. But I could not quite put a finger on what it was. So I read it again and then went for a walk and thought about it.

All the facts were fine. I had no issue with the content of the article. It was the adjectives that irritated me. And the essay was, from my perspective, incomplete. It was like reading a relationship/birth control article by the Pope. Sure, he knows the facts of the situation, but not being an active participant in the process and with an agenda to promote, vital information will be missing or distorted. (more…)

Posted in: Random Thoughts Cause I Can, Science and Medicine, Science and the Media

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Medical cranks: Why we fight

Never let it be said that I can’t match Mark Crislip in shameless self-promotion. The world might indeed need more Mark Crislip™, but I like to think that it needs a bit more David Gorski, too. So, in that spirit, here are the videos, recently released by the James Randi Educational Foundation, of Bob Blaskiewicz, myself, and some key SBM players that you’ve come to know and love. The first video is my talk at The Amazing Meeting in July about Stanislaw Burzynski, MD, PhD. It’s entitled Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine. The second video is Bob Blaskiewicz, of Skeptical Humanities and The Other Burzynski Patient Group, It’s entitled, appropriately enough, Why We Fight (Part II): It’s All About the Patients. The third video is of the panel that followed to discuss Medical Cranks and Quacks. Enjoy!

Oh, and consider it a bit of a taste of what’s to come tomorrow…and don’t forget to pay attention to Bob Blaskiewicz’s plea at the end of his talk to contact him if you’re interested in becoming active. At TAM, he had a sign-up sheet that he discussed at around 21:06 in the video. Online, just mosey on over to The Other Burzynski Patient Group and contact Bob Blaskiewicz. We will very likely be asking you to help very soon.

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

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Redefining cancer

Blogging is a rather immediate endeavor. Over the last nine years (nearly), I’ve lost track of how many times I saw something that I wanted to blog about but by the time I got around to it, it was no longer topical. Usually what happens is that my Dug the Dog tendencies take over, as I’m distracted by yet another squirrel, although sometimes there are just too many targets topics and too little time. Fortunately, however, sometimes the issue is resurrected, sometimes in a really dumb way, such that I have an excuse to correct my previous oversight. This is just such a time, and the manner in which the topic has been resurrected is every bit as dumb as the rant by the Food Babe that Mark Crislip so delightfully deconstructed last Friday. Unfortunately, for purposes of snark, I’m not Mark Crislip—but, then, who is?—but fortunately I am known elsewhere (and sometimes here) for being a bit “insolent.” So let’s dig in. We’ll start with the idiocy and then use that as a “teachable moment” about cancer biology. Funny how I manage to do that sort of thing so often.

Abuse of cancer science for political purposes

I realize that we at SBM are supposed to stay, for the most part, apolitical, but the idiocy that’s leading me to revisit a topic is unavoidably political because it involves using a profound misunderstanding of science for political ends. Specifically, I’m referring to the misuse of a legitimate scientific debate about cancer screening and diagnosis for purely political ends. First, however, for those not living in the US or my fellow citizens who might be blissfully unaware (in this case) of recent events, during the first half of October, our nation underwent what can only be described as a self-inflicted crisis that could have caused worldwide economic turmoil if it hadn’t been (sort of) resolved at the last minute. The reason for the crisis boiled down to the extreme resistance of some of our more radically conservative Representatives to the Patient Protection and Affordable Care Act, usually referred to as just the Affordable Care Act (ACA) or, colloquially, Obamacare. Normally when we write about Obamacare here on SBM, it’s to complain about how advocates of unscientific medicine and outright quackery have tried to piggyback their advocacy on the ACA in order to have health insurance plans sold through government exchanges cover modalities like naturopathy, chiropractic, and other so-called “complementary and alternative medicine” (CAM) or “integrative medicine.” In related posts, I’ve examined the evidence with respect to the relationship between health insurance and mortality and whether attacks on Medicaid as not improving the health of patients insured by it have any validity. (Let’s just say they are oversimplifications and distortions.)
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Posted in: Cancer, Politics and Regulation, Science and the Media, Surgical Procedures

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Scam Stud

We have evolved in order to survive reality, not to understand it. And it is a good thing that understanding and survival are not tightly linked as many people are apparently totally disconnected from the reality I inhabit, the one described by the natural sciences. When I started writing and podcasting about the SCAMverse I was under the impression that people who used SCAMs were simply misinformed. If people were made aware of the facts of the matter, they would see the error of their ways and put away their SCAMs as the childish thoughts they are.

Silly me. Reality, as I understand it, is often if little interest to proponents of SCAM. This was brought home by the Food Babe with an essay Should I get the Flu Shot? Spoiler alert. Her answer is “No, I’m not taking the Flu Shot. Ever.”

It is how she reaches that conclusion that is amazing. There are nouns and adjectives and adverbs and verbs and article and prepositions. They are strung together to form sentences and paragraphs, but somehow, though an almost magical alchemy, all that writing transmutes into content that is completely divorced from reality as I understand it. It is a tour de farce that reaches the definition of the Pauli Principle, where “It is not only not right, it is not even wrong.” (more…)

Posted in: Science and the Media, Vaccines

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Obamacare, the Oregon Experiment, and Medicaid

Tomorrow, as mandated by the Patient Protection and the Affordable Care Act (PPACA, often called just the Affordable Care Act, or ACA, or “Obamacare”), the government-maintained health insurance exchanges will open for business (that is, assuming the likely government shutdown doesn’t stop them temporarily). We here at SBM have written about the ACA quite a few times, but I would like to write about it in perhaps an entirely different context than you’re used to now that the biggest change mandated by the law is here. Just to see the contrast, I’ll mention that Jann Bellamy has written about the ACA in the context of how provisions have been inserted by promoters of “complementary and alternative medicine” (CAM) could potentially provide an “in” for requiring reimbursement of CAM practitioners for their services by insurance plans sold through the exchanges or even how CAM practitioners might promote themselves as primary care providers (PCPs) under Obamacare, as did Matt Roman. I myself warned about legislative meddling that might permit funding of religion-based health care in the exchanges, and Kimball Atwood sounded early warnings about insertion of the provisions that Jann warned about. Instead, view this discussion as a follow-up to a post I did almost a year ago that used a statement by Mitt Romney during the height of the Presidential campaign as a jumping off point to look at the relationship between health insurance status and mortality. While we at SBM try to remain more or less apolitical, in some cases (licensing of naturopaths, for example) it is not possible to disentangle science from politics, and we have to dive in. Also, politics is the art of the possible; so, policy-wise, what is best as determined by science might well not be what is possible politically.

The reason I wanted to revisit this topic is because of a political battle that went on for quite some time over the last several months to expand Medicaid in Michigan according to the dictates of the ACA. The reason that this battle is occurring in many states is because when the Supreme Court ruled last year that the individual mandate requiring that citizens have health insurance was Constitutional, one provision that it ruled unconstitutional was the mandatory expansion of Medicaid in states participating in the Medicaid program to cover all people under 65 up to 133% of the federal poverty level. States thus had to decide whether or not they would accept the Medicaid expansion. In our state, Governor Rick Snyder supported the expansion. Even though he is Republican, he is also a businessman and realized that it was a good deal, with the federal government covering 100% of the cost for the first three years and then phase down to 90% of the cost in 2020. The bill to expand Medicaid managed to pass the House of Representatives, but then it stalled in the Senate. Unfortunately—and this is what got me involved—my state Senator Patrick Colbeck led the opposition to the Medicaid expansion in the Senate, much to my chagrin and disappointment. His argument, which is being repeated elsewhere in the blogosphere, is that Medicaid is worthless and doesn’t improve health outcomes. Instead, he endorsed an alternative that (or so he claimed) places Medicaid-eligible patients into in essence low cost, high deductible concierge practices, with health savings accounts. This was a plan promoted by practices like BlueSky Health. Ultimately Mr. Colbeck lost, and Medicaid was expanded in Michigan in a plan that was characterized by John Z. Ayanian in this week’s New England Journal of Medicine as “a pragmatic pathway to link Republican and Democratic priorities for health care.”

However, the whole kerfuffle got me to thinking. In my post a year ago, I basically asked what the evidence was that access to health insurance improves health outcomes, but I didn’t really stratify the question into kinds of health insurance. Rather, I just looked at being uninsured versus having health insurance. After my little Facebook encounter with one of my elected representatives, I wondered what, exactly, was the state of evidence. So I decided to do this post. In the U.S., currently we have in essence three kinds of health insurance, broadly speaking: private insurance, Medicare, and Medicaid. Medicare, for those of our readers from other countries, is a plan that covers the medical care of people 65 and over and those receiving Social Security disability benefits. It is funded through payroll taxes and directly paid for by the federal government. Medicaid, in contrast, is a plan designed for low income people who fall below certain income levels. Also in contrast, it is jointly funded by the states and the federal government with each participating state administering the plan and having wide leeway to decide eligibility requirements within the limits of federal regulations that determine the minimal standards necessary for states to receive matching funds. Indeed, the loss of this leeway to determine the income level at which a person is eligible for Medicaid is one of the reasons the provision for Medicaid expansion was part of the Supreme Court challenge to the ACA. These days, most Medicaid plans hire private health maintenance organizations (HMOs) to provide insurance. Finally, what needs to be understood is that, compared to private insurance, Medicare reimbursement rates tend to be lower and Medicaid reimbursement rates are lower still, which is part of the reason why a lot of doctors don’t accept Medicaid. Increases in reimbursement under the ACA might well help this situation. (more…)

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

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Naturopathic Medicine Week 2013, or: Quackery Week 2013

[Ed. Note: This is an extra "bonus" post from Dr. Gorski's not-so-super-secret other blog. He thought the topic would be of interest to SBM readers as well. Fear not. There will be a post on Monday, as usual.]

The vast majority of ideas and treatments that make up the “complementary and alternative medicine” (CAM) specialty known as naturopathy are quackery. There, I said it. No doubt I will be castigated for being too “blunt,” “dismissive,” or “insulting,” but I don’t care. It is my opinion based on science, and I’m sticking to it.

The problem with naturopathy, of course, is that it is so diffuse and encompasses so many different forms of quackery that it’s hard to categorize. Basically, it’s anything that can be portrayed as “natural,” be it traditional Chinese medicine, homeopathy (which is an integral component of naturopathy, something that should tell you all you need to know about naturopathy), herbalism, energy healing, Ayurvedic medicine, the four humors, or whatever. Add to that a number of bogus diagnostic modalities, such as applied kinesiology, live blood cell analysis, iridology, tests for imaginary “food allergies” and “nutrient deficiencies” that conventional medicine doesn’t recognize, plus an overwhelming emphasis on purging the body of “toxins,” unnamed and named but all unvalidated by science, and it rapidly becomes apparent that naturopathy is a veritable cornucopia of pseudoscience and quackery. Seemingly, there is no quackery that naturopathy does not credulously embrace, which is why the success of recent efforts of naturopaths to achieve licensure in several states and even obtain limited privileges to prescribe real pharmaceutical drugs is so alarming, as are their efforts to become recognized as primary care providers under the Affordable Care Act. Basically, naturopathy is a hodge-podge of quackery mixed with science-based modalities magically “rebranded” as “alternative” and “natural.” In that, naturopathy is the ultimate in “integrative medicine,” in which quackery is “integrated” with science-based medicine. As I’ve pointed out many times before, integrating quackery and pseudoscience with real medicine does not elevate the quackery and pseudoscience, but it does contaminate the real medicine with quackery to no good benefit. Unfortunately, it’s insinuating itself into the law.

With that introduction in mind, did you know that the week of October 7 through 13 is Quackery Week in the U.S.? No, seriously, it is. The Senate just passed a resolution declaring that this is so. Oh, it’s true that the Senate didn’t actually call it that. Instead, the resolution (S.Res. 221) was passed, and it declares the week of October 7 to 13, 2013 to be Naturopathic Medicine Week, which is the same thing as declaring it Quackery Week:

S.Res.221 – A resolution designating the week of October 7 through October 13, 2013, as “Naturopathic Medicine Week” to recognize the value of naturopathic medicine in providing safe, effective, and affordable health care.

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Posted in: Homeopathy, Naturopathy, Science and the Media

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