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Archive for 2014

The Buzzy: Revolutionary Acute Pain Management or Simple Distraction…

Buzzy

I’ve written about the management of acute pain in children in the past, and unfortunately my feelings haven’t changed in the interim. Acute pain, particularly pain related to procedures such as venipuncture for blood sampling and intravenous access, and intramuscular administration of medications such as antibiotics and vaccines, is commonly undertreated, downplayed and even ignored altogether by medical professionals and even caregivers. So when I was made aware of a device being used in pediatric clinics and emergency departments (and even available for home use) with apparent success in preventing or reducing procedural pain in children, I was intrigued and more than a bit hopeful. (more…)

Posted in: Science and Medicine

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Multiple Chemical Sensitivity: Separating facts from fiction

gas-mask

One of the challenges to providing science-based medicine is managing debilitating symptoms in patients who lack a clear diagnosis. If a comprehensive workup on an ill patient reveals nothing conclusive, patients and their health care providers are equally puzzled and frustrated. A diagnosis is seen as giving legitimacy to symptoms, and can be the first step towards defining a science-based treatment plan. Vague or “medically unexplained” symptoms are among the most difficult therapeutic challenges. To patients, the science and profession of medicine has failed to “deliver” and the patient can be left feeling their condition lacks legitimacy. These patients are at the greatest risk for alternative medicine approaches, such as unorthodox diagnoses and treatments. In this world, the lack of objective evidence is no barrier to defining conditions and their treatments. One of the most problematic tactics used is the attribution of these symptoms to conditions known as fake diseases. (more…)

Posted in: Science and Medicine

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The Center for Inquiry weighs in on the FDA’s mishandling of Stanislaw Burzynski’s clinical trials

We interrupt our usually scheduled post for an important announcement. OK, we do nothing of the sort. Scott Gavura’s post will go live a little later this morning. In the meantime, here’s a public service announcement about a frequent topic of mine, Stanislaw Burzynski, that I’d like you to read.

As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski’s bogus clinical trials of antineoplastons, which he’s used since the 1990s as a pretext to charge huge sums of money for “case management fees” to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators:

“We are frankly stunned to hear that the clinical hold against Dr. Burzynski has been lifted,” writes CFI in its letter. For decades, Dr. Burzynski and the Houston-based Burzynski Research Institute have been trafficking in unproven and scientifically baseless cancer treatments based on compounds known as antineoplastons, derived from human urine, which Burzynski claims — without evidence — can target and destroy cancer cells. He has taken advantage of desperate patients who are at their most vulnerable, and willing to pay any price.

After the death of a six-year-old patient in 2012, the FDA placed a hold on Burzynski’s trials with children, followed by a hold on trials with adults in 2013, prohibiting him from taking on new patients on whom he could experiment and from whom he could extract more money.

Over several decades, his clinic has proven it is unable to properly protect patient rights, adhere to basic ethical or scientific protocols, or even maintain correct patient records. It has also shown it is willing to exploit desperate cancer patients and their families, milking them out of enormous sums of money. But it has yet to show even a shred of evidence that its cancer treatments have any positive effect whatsoever.

“We struggle to see why the FDA continues to enable this deceptive, antiscientific, and unethical medical adventurism and profiteering, even for patients who are terminally ill,” writes CFI. “Given the behavior of Dr. Burzynski and the Burzynski Research Institute over the course of nearly three decades of failed research and trials, and in the face of a complete lack of scientific evidence demonstrating the efficacy of their expensive and dangerous antineoplaston treatment, we find the FDA’s decision perplexing and profoundly disturbing.”

The full text of the letter can be found here.

If only groups like the American Cancer Society would write similar letters. Cancer patients have been taken advantage of for nearly four decades, and Burzynski has made a mockery of the clinical trial process for nearly 20 years. It’s gone on way too long.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Beware The P-Value

Part of the mission of SBM is to continually prod discussion and examination of the relationship between science and medicine, with special attention on those beliefs and movements within medicine that we feel run counter to science and good medical practice. Chief among them is so-called complementary and alternative medicine (CAM) – although proponents are constantly tweaking the branding, for convenience I will simply refer to it as CAM.

Within academia I have found that CAM is promoted largely below the radar, with the deliberate absence of public debate and discussion. I have been told this directly, and that the reason is to avoid controversy. This stance assumes that CAM is a good thing and that any controversy would be unjustified, perhaps the result of bigotry rather than reason. It’s sad to see how successful this campaign has been, even among my fellow academics and scientists who should know better.

The reality is that CAM is fatally flawed in both philosophy and practice, and the claims of CAM proponents wither under direct light. I take some small solace in the observation that CAM is starting to be the victim of its own success – growing awareness of CAM is shedding some inevitable light on what it actually is. Further, because CAM proponents are constantly trying to bend and even break the rules of science, this forces a close examination of what those rules should actually be, how they work, and their strengths and weaknesses.

(more…)

Posted in: Clinical Trials

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Why Doctors Order Too Many Tests

While cleaning out some old files, I was delighted to find an article I had clipped and saved 35 years ago: a “Sounding Boards” article from the January 25, 1979 issue of The New England Journal of Medicine. It was written by Joseph E. Hardison, MD, from the Emory University School of Medicine; it addresses the reasons doctors order unnecessary tests, and its title is “To Be Complete.” Today we have many more tests that can be ordered inappropriately and the article is even more pertinent and deserves to be re-cycled. He says,

When challenged and asked to defend their reasons for ordering or performing unnecessary tests and procedures, the reasons given usually fall under one of the following excuses…

(more…)

Posted in: Diagnostic tests & procedures

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Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA really caves

It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Did Facebook and PNAS violate human research protections in an unethical experiment?

Facebookfail

Ed. Note: NOTE ADDENDUM

I daresay that I’m like a lot of you in that I spend a fair bit of time on Facebook. This blog has a Facebook page (which, by the way, you should head on over and Like immediately). I have a Facebook page, several of our bloggers, such as Harriet Hall, Steve Novella, Mark Crislip, Scott Gavura, Paul Ingraham, Jann Bellamy, Kimball Atwood, John Snyder, and Clay Jones, have Facebook pages. It’s a ubiquitous part of life, and arguably part of the reason for our large increase in traffic over the last year. There are many great things about Facebook, although there are a fair number of issues as well, mostly having to do with privacy and a tendency to use automated scripts that can be easily abused by cranks like antivaccine activists to silence skeptics refuting their pseudoscience. Also, of course, every Facebook user has to realize that Facebook makes most of its money through targeted advertising directed at its users; so the more its users reveal the better it is for Facebook, which can more precisely target advertising.

Whatever good and bad things about Facebook there are, however, there’s one thing that I never expected the company to be engaging in, and that’s unethical human subjects research, but if stories and blog posts appearing over the weekend are to be believed, that’s exactly what it did, and, worse, it’s not very good research. The study, entitled “Experimental evidence of massive-scale emotional contagion through social networks“, was published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS), and its corresponding (and first) author is Adam D. I. Kramer, who is listed as being part of the Core Data Science Team at Facebook. Co-authors include Jamie E. Guillory at the Center for Tobacco Control Research and Education, University of California, San Francisco and Jeffrey T. Hancock from the Departments of Communication and Information Science, Cornell University, Ithaca, NY. (more…)

Posted in: Clinical Trials, Computers & Internet, Neuroscience/Mental Health, Science and the Media

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One Million Page Views

For the first time, ScienceBasedMedicine.org has reached a million page views in a month, thanks to a surge in social media buzz. We’ve come close before, but finally pushed comfortably past that major milestone earlier this week. As of today, SBM served 1,051,943 pages to 649,315 visitors in the last thirty days. These are mainstream-scale numbers: SBM is now competing effectively with many popular websites about not-so-science-based medicine.

Dr. Evil: “One MILLION visits.”

What articles are attracting so much attention? The traffic surge is powered by several popular recent posts, but mostly two of Dr. Gorski’s, about the Food Babe and John Oliver skewering Dr. Oz. Dr. Novella’s Food Fears post isn’t far behind. Other respectable slices of the traffic pie chart include Dr. Hall’s perpetually popular Isagenix post, and Scott Gavura’s coffee enema post — which also happen to be the two busiest SBM pages of all time, with Aspartame — Truth vs Fiction in third place.

graph of one million pageviews

SBM’s inaugural post was on January 1, 2008. Unfortunately, we have no traffic data until the middle of 2013. Since then, we’ve seen a doubling in average monthly traffic. It’s been a team effort, of course, but Facebook and Twitter have been huge factors in that steady growth. Bobby Hannum manages those accounts for us, and somehow manages to post and tweet for us almost every single day while going to medical school. If you haven’t already, please like and follow.

Next stop: a million views per week…

~ Paul Ingraham, Assistant Editor

Posted in: Announcements

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TCM Hodgepodge

acupuncture
I suspect there is more published about traditional Chinese medicine than any other SCAM. Here are some of the recent curiosities of TCM.

Burning genitals

The little girls laughed about the germs, because they didn’t believe in them; but they believed about the disease, because they’d seen that happen. Spirits caused it, everyone knew that. Spirits and bad luck. Jack had not said the right prayers.
- Oryx and Crake

I long ago gave up on the idea that there are a finite number of pseudo-medical treatments. Anything a human can imagine will probably be used as a SCAM intervention. I remain amazed at the permutations that occur in the pseudo-medical world, not unlike the mix and match bioforms in Oryx and Crake.

Not everyone knows basic anatomy and physiology that allows for understanding of disease. Instead, people often rely on metaphor and magic for their understanding, especially in the world of pseudo-medicine. Sympathetic magic lies at the heart of many SCAMs. (more…)

Posted in: Acupuncture, Traditional Chinese Medicine

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NY federal court hands triple loss to anti-vaccination ideology

vacccine preventable disease plane ride away

The state of New York allows religious and medical (but not philosophical) exemptions from school vaccination mandates. New York City has a policy of excluding unvaccinated schoolchildren from classes when there is an outbreak of vaccine-preventable disease reported in a particular school. Two sets of parents whose children had religious exemptions sued New York City and the state in federal court when their children were temporarily excluded from school under the policy, in some cases for up to a month. In other words, they were demanding that their unvaccinated children be allowed to attend even though there was an outbreak of vaccine-preventable disease at the school.

These cases were consolidated with another filed by parents, the Checks, who claimed their child had been improperly denied a religious exemption. The parents had applied for a medical exemption, which was denied, as well as a religious exemption, which was granted, but then revoked. (The record is somewhat confusing on this sequence of events, but that sequence is not relevant to our discussion.) The unvaccinated child was ultimately sent to a private school, even though she should have been excluded from admission under New York City law there as well.

Last week, a federal judge dismissed all three cases (they had been consolidated and assigned to one judge) in an opinion holding that neither the students’ nor the parents’ constitutional rights were violated, including their First Amendment right to free exercise of religion. The plaintiffs have filed an appeal. (more…)

Posted in: Critical Thinking, Legal, Politics and Regulation, Public Health, Religion, Vaccines

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