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Is acupuncture as effective as antidepressants? Part 2. Blinding readers who try to get an answer

This is the second blog post about a recent PLOS One review claiming that alternative therapies such as acupuncture are as effective as antidepressants and psychotherapy for depression. The article gives a message to depressed consumers that they should consider alternative therapies as a treatment option because they are just as effective as conventional treatments. It gives promoters of alternative therapies  a boost with apparent evidence from a peer-reviewed journal that can be used to advertise their treatment and to persuade third-party payers that alternative treatments are just as effective as antidepressants and should be reimbursed.

In my first post, I could not reconcile what was said in this article with the citations that it provided. The authors also failed to cite some of their own recent work where it would have been embarrassing to arguments they made in the review. Most importantly, other meta-analyses and systematic reviews had raised such serious concerns about the quality of the acupuncture literature that they concluded that any evaluation of its effectiveness for depression would be premature (more…)

Posted in: Clinical Trials, Neuroscience/Mental Health

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One Flu Into the Cuckoo’s Nest*

“I don’t seem able to get it straight in my mind….”
― Ken Kesey, One Flew Over the Cuckoo’s Nest

Influenza is going gangbusters at the moment. I like going to Google Flu trends as well as the CDC flu site to see what flu is doing. Using Google searches as a surrogate for infections is an interesting technique that public health officials have tried with less success in other illnesses but is not without utility. Behaviors of populations can presage a problem, my favorite example is the first hint of the 1993 massive Cryptosporidia diarrhea outbreak in Milwaukee was a sudden shortage of Kaopectate and Peptobismol. It appears there are more patients with flu like symptoms this year than  at the height of the H1N1 epidemic of 2009. We have lots of flu like illness, and per the CDC there are buckets of confirmed influenzaflu, but so far the season, while probably having more cases than 2009, the outbreak is clinically not the same.

Compare and contrast, the two words that defined undergraduate liberal arts essay assignments. Get out your blue books and compare and contrast influenza outbreaks from 2009 and 2013. You have one hour. (more…)

Posted in: Clinical Trials, Epidemiology, Public Health, Science and Medicine, Science and the Media, Vaccines

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Dr. Stanislaw Burzynski’s antineoplastons versus patients

Prelude: Doin’ the Antineoplaston Boogaloo with Eric Merola and Stanislaw Burzynski

In December I noted that Eric Merola, the “film maker” (and, given the quality of his work, I do use that term loosely) who was responsible for a movie that was such blatant propaganda that it would make Leni Riefenstahl blush were she still alive (Burzynski The Movie: Cancer Is Serious Business, in case anyone’s interested), was planning on releasing another propaganda “documentary” about Stanislaw Burzynski later this year. Merola decided to call it Burzynski: Cancer Is Serious Business, Chapter 2 | A Modern Story. Wondering what it is with Merola and the multiple subtitles, I had been hoping he would call the Burzynski sequel something like Burzynski The Movie II: This Time It’s Peer-Reviewed (except that it’s still not, not really, and I can’t take credit for that joke, as much as I wish I could) or Burzynski The Movie II: Even Burzynskier Than The First, or Burzynski The Movie II: Burzynski Harder. Mercifully, I doubt even Merola would call the film Burzynski II: Antineoplaston Boogaloo. (If you don’t get this last joke because you are either not from the US or are too young to remember, check out the Urban Dictionary.)

In any case, Merola named the sequel what he named it, and we can all look forward to yet another propaganda film chock full of conspiracy theories in which the FDA, Texas Medical Board, National Cancer Institute, and, for all I know, the CIA, FBI, and NSA are all out to get Merola’s heroic “brave maverick doctor,” along with a website full of a “sourced transcript” to be used by Burzynski minions and shills everywhere to attack any skeptic who dares to speak out. The only good thing about it, if you can call it that, is that I’m guaranteed material for at least one juicy blog post, at least as long as I can find a copy of Burzysnki II online, as I was able to do with Burzynski I, thanks to Mike Adams at NaturalNews.com and other “alternative sites” that were allowed to show the whole movie for a week or so before folks like Joe Mercola were allowed to feature the complete film on their websites indefinitely.

Maybe Eric Merola will send me a DVD review copy when the movie is released. Or maybe not.
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Posted in: Cancer, Clinical Trials

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Rituximab for Chronic Fatigue Syndrome: Jumping the Gun

Now that the XMRV myth has been put to rest,  patients with Chronic Fatigue Syndrome (CFS) are no longer jumping the gun to demand anti-retroviral treatments. But they are jumping the gun in new ways, based on very preliminary data coming out of Norway.

A correspondent in Norway wrote to tell me patients from Norway with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) are travelling to the US to have Dr. Andreas Kogelnik in San Francisco treat them with IV infusions of rituximab, apparently to no avail. A course of treatment costs over $6000, not to speak of travel and other expenses. (more…)

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals

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The Great and Powerful Oz versus science and research ethics

That Dr. Mehmet Oz uses his show to promote quackery of the vilest sort is no longer in any doubt. I was reminded yet again of this last week when I caught a rerun of one of his shows from earlier this season, when he gazed in wonder at the tired old cold reading schtick used by all “psychic mediums” from time immemorial, long before the current crop of celebrity psychic mediums, such as John Edward, Sylvia Browne, and the “Long Island Medium” Theresa Caputo, discovered how much fame and fortune they could accrue by scamming the current generation of the credulous. Speaking of Theresa Caputo, that’s exactly who was on The Dr. Oz Show last week (in reruns), and, instead of being presented as the scammer that she is, never was heard even a hint of a skeptical word from our erstwhile “America’s doctor,” who cheerily suggested that seeing a psychic medium scammer is a perfectly fine way to treat crippling anxiety because, well, Caputo claims that it is. Even worse, apparently it wasn’t even the first time that Dr. Oz had Caputo on his show, and Caputo wasn’t even the first psychic whose schtick he represented as somehow being a useful therapeutic modality for various psychological issues. “Crossing Over” psychic John Edward was there first in a segment Oz entitled Are Psychics the New Therapists? I could have saved him the embarrassment and simply told him no, but apparently Oz is too easily impressed. As I said before, if he’s impressed by clumsy cold readers like Browne, Caputo, and Edward, it doesn’t take much to impress him. Also, apparently his producers aren’t above editing science-based voices beyond recognition to support their quackery.

I was further reminded how Dr. Oz promotes quackery by an article in Slate yesterday entitled Dr. Oz’s Miraculous Medical Advice: Pay no attention to that man behind the curtain. I suppose it would be mildly hypocritical of me to snark at the rather obvious “Wizard of Oz” jokes aimed at Dr. Oz. After all, I’ve used the same joke myself at one time or another and, in light of the Slate.com article, couldn’t resist using it in the title of my post. However, I wasn’t about to let that distract me from the article itself, which is very good. The reason is that there are two aspects to Dr. Oz’s offenses against medical science. There is the pure quackery that he features and promotes, such as psychic scammers like John Edward and Theresa Caputo, faith healing scammers like Dr. Issam Nemeh, and “alternative health” scammers like reiki masters, practitioners of ayruveda, Dr. Joe Mercola, who was promoted as a “pioneer” that your doctor doesn’t want you to know about. Never was it mentioned that there are very good reasons why a competent science-based physician would prefer that his patients have nothing to do with Dr. Mercola, who runs what is arguably the most popular and lucrative alternative medicine website currently in existence and manages to present himself as reasonable simply because he is not as utterly loony as his main competition, Mike Adams if NaturalNews.com (who has of late let his New World Order, anti-government, “Obama’s coming to take away your guns” conspiracy theory freak flag fly) and Gary Null.
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Posted in: Clinical Trials, Science and the Media

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Dr. Oz Doubles Down on Green Coffee Bean with a Made-for-TV Clinical Trial

“One of the most important discoveries I believe we’ve made that will help you burn fat – green coffee bean extract” – Dr. Oz, September 10, 2012, Episode “The Fat Burner that Works”

Dr. Mehmet Oz may be biggest purveyor of health pseudoscience on television today. How he came to earn this title is a bit baffling, if you look at his history. Oz is a bona fide heart surgeon,  (still operating 100 times per year), an academic, and a research scientist, with 300+ or 400+ (depending on the source) publications to his name. It’s an impressive CV, even before the television fame. He gained widespread recognition as the resident “health expert” on Oprah, and went on to launch his own show in 2009. Today “The Dr. Oz Show” is a worldwide hit, with distribution in 118 countries, a massive pulpit from which he offers daily health advice to over 3 million viewers in the USA alone. For proof of his power to motivate, just look at the “Transformation Nation Million Dollar You” program he launched in 2011, enrolling an amazing 1.25 million participants. Regrettably, what Oz chooses to do with this platform is often disappointing.  While he can offer some sensible, pragmatic health advice, his show’s content seems more focused on TV ratings than medical accuracy, and it’s a regular venue for questionable health advice (his own, or provided by guests) and poorly substantiated “quick fixes” for health issues. (And I won’t even touch Oz’s guests like psychic mediums.) One need only look at the number of times the term “miracle” is used on the show as a marker of the undeserved hyperbole. Just this week, Julia Belluz and Stephen J Hoffman, writing in Slate, itemized some of the dubious advice that Oz has offered on his show, with a reality check against what the scientific evidence says. It’s not pretty. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics

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Isagenix Study Is Not Convincing

Isagenix is a wellness system sold by multilevel marketing. It consists of a suite of products to be used in various combinations for “nutritional cleansing,” detoxification, and supplementation to aid in weight loss, improve energy and performance, and support healthy aging. It allegedly burns fat while supporting lean muscle, maintains healthy cholesterol levels, supports telomeres, improves resistance to illness, reduces cravings, improves body composition, and slows the aging process. And makes millions for distributors who got on the bandwagon early and are high on the pyramid.

I have written about it before and have been roundly criticized by its proponents.   It generated my all-time favorite insult: “Dr Harriet Hall is a refrigerator with a head.”

My biggest concern with Isagenix was that it had not been clinically tested. They claimed that clinical tests were in progress (funded by Isagenix).  An e-mail correspondent recently told me I should take another look at Isagenix, since a clinical study had been completed. It had not yet been published, and I asked her to get back to me when it was. Ask and you shall receive (but you may be sorry!). She contacted me when the study by Kroeger et al. was published in the journal Nutrition and Metabolism.   The full study is available online and I urge readers to click on the link and look at Table 2, which I will be referring to later. The journal is peer-reviewed but, as will become painfully obvious, the peer reviewers did not do a competent job. It is an open-access online journal with a low impact factor. The authors had to pay to get their article published: it cost them $1805.

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Posted in: Clinical Trials, Herbs & Supplements

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The NIH funding process: “Conformity” and “mediocrity”?

When we refer to “science-based medicine” (SBM), it is a very conscious choice to emphasize that good medicine should be based on a solid foundation of science. The name was coined to contrast the difference between the current evidence-based medicine (EBM) paradigm, which fetishizes randomized clinical trial evidence above all else and frequently ignores prior plausibility based on well-established basic science, and the SBM paradigm, which takes prior plausibility into account. The purpose of this post will not be to resurrect old discussions on these differences, but before I attend to the study at hand I bring this up to emphasize that progress in science-based medicine requires progress in science. That means all levels of biological (and even non-biological) basic science, which forms the foundation upon which translational science and clinical trials can be built. Without a robust pipeline of basic science progress upon which to base translational research and clinical trials, progress in SBM will slow and even grind to a halt.

That’s why, in the U.S., the National Institutes of Health (NIH) is so critical. The NIH funds large amounts of biomedical research each year, which means that what the NIH will and will not fund can’t help but have a profound effect shaping the pipeline of the basic and preclinical research that ultimately leads to new treatments and cures. Moreover, NIH funding has a profound effect on the careers of biomedical researchers and clinician-scientists, as having the “gold standard” NIH grant known as the R01 is viewed as a prerequisite for tenure and promotion in many universities and academic medical centers. Certainly this is the case for basic scientists; for clinician-scientists, having an R01 is certainly highly prestigious, but less of a career-killer if an investigator is unable to secure one. That’s why NIH funding levels and how hard (or easy) it is to secure an NIH grant, particularly an R01, are perennial obsessions among those of us in the biomedical research field. It can’t be otherwise, given the centrality of the NIH to research in the U.S.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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What does a new drug cost? Part II: The productivity problem

A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.

The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted.  Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Now that Burzynski has gotten off in 2012, Burzynski The Movie will spawn a sequel in 2013

About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that I had looked into them in a big way.

Having found very few skeptical, science-based takes on Burzynski and having noted that the Quackwatch entries on Burzynski (1, 2, 3) were hopelessly out of date, I wrote a trilogy of posts about him, starting with a review of an execrably bad movie made by a simultaneously credulous yet cynical independent writer, producer, and director named Eric Merola whose primary business, appropriately enough, is mainly marketing. The movie was Burzynski The Movie: Cancer Is A Serious Business, a “documentary” (and I’m being polite here) that I characterized at the time as a bad movie and bad P.R. In brief, I saw this movie as a hagiography, a propaganda film so ham-fisted that, if she were still alive, it would easily simultaneously make Leni Riefenstahl blush at its blatantness and feel nauseated how truly awful it was from a strictly film making standpoint. It was also chock full of highly dubious science, in particular Burzynski’s latest venture, which is to sell “personalized gene-targeted cancer therapy” similarly lacking in oncological insight, so much so that I observed at the time that it was as though Dr. Burzynski read a book called Personalized Cancer Therapy for Dummies and decided he is an expert in genomics-based tailoring of targeted therapies to individual cancer patients. Finally, I completed the trilogy by pointing out that lately Burzynski has been rebranding an orphan drug that showed mild to moderate promise as an anticancer therapy.
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Posted in: Book & movie reviews, Cancer, Clinical Trials

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