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Archive for Politics and Regulation

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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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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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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Dr. Oz and the Terrible, Horrible, No Good, Very Bad Day

Not Dr. Oz's usual television audience

Not Dr. Oz’s usual television audience

Dr. Mehmet Oz is one of the most well-known, and possibly the most influential medical doctor in America. The Dr. Oz Show is broadcast in 118 countries and reaches over 3 million viewers in the USA alone. When Oz profiles a product or supplement on his show, sales explode – it’s called “The Dr. Oz Effect”. Regrettably, Oz routinely and consistently gives questionable health advice, particularly when it comes to weight loss products, where Oz regularly uses hyperbolic terms like “miracle” for the products he profiles:

  • (On green coffee extract) — “You may think magic is make-believe, but this little bean has scientists saying they found the magic weight-loss for every body type.”
  • (On raspberry ketone) — “I’ve got the number one miracle in a bottle to burn your fat”
  • (On Garcinia cambogia) — “It may be the simple solution you’ve been looking for to bust your body fat for good.”

Dr. Oz has profiled so many dubious health strategies that “The Dr. Oz Effect” more accurately refers to the wasted time, effort and finances of any consumer that actually follows his health advice and purchases the steady stream of “miracles” that Oz endorses on his television show. Not surprisingly, Science-Based Medicine is probably Oz’s most persistent and tenacious critic. It’s not just that he’s high profile – it’s that Dr. Oz is a bona fide physician who ought to know better, but chooses to ignore science in favour of hyperbole. It’s the antithesis of what a health professional should be doing. And this is the root of the Oz problem: Oz can give good advice, but he regularly combines it with questionable statements and pseudoscience in a way that the casual viewer can’t distinguish between the science and the fiction. So when Oz calls something a miracle – people listen. Even when miracles show up several times per year. (more…)

Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Politics and Regulation

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Don’t supplement users deserve consumer protection, too?

Canada's Parliament buildingThe Canadian Parliament, hypothetically protecting consumers since Confederation.

One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”. (There is an opportunity until June 10 for you to provide feedback on this legislation – see below.) (more…)

Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation

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Harkin’s folly, or how forcing insurers to cover CAM undermines the ACA

Bloodletting: a good reason to discard disproven therapies

Bloodletting: a good reason to discard disproven therapies

All of us at SBM have repeatedly expressed frustration at the continuing influx of pseudoscience into the health care system. Judging from comments posted on this site and private communications we receive, our readers share this frustration but are at a loss to figure out how to get through to legislators and other policy makers. Unlike naturopaths and chiropractors, we don’t have the money to hire professional lobbyists. Fortunately, an opportunity to sound off against SCAMs has presented itself, completely free of charge.

How?

Now that the Affordable Care Act enrollment debacle is dying down, the Department of Health and Human Services (HHS) is turning its attention to divining just what the heck Section 2706 of the ACA, the non-discrimination provision, means. (Actually there are other federal agencies involved; to simplify things, here we’ll refer to them collectively as “HHS.”) HHS has opened the issue to public comment, but only until June 10. Let’s take a look at why this is important and what you can do about it.

(There are providers other than chiropractors, naturopaths and acupuncturists involved in this fight. For example, you’ll see public comments from nurse anesthetists and nurse practitioners. But I’m not worried about providers who stick to science.) (more…)

Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation, Science and Medicine, Traditional Chinese Medicine, Vaccines

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Beware the Integrative Pharmacy

pharmacy window

Imagine a retail pharmacy where some of the medicines on the shelves have been replaced with similar-looking packages that contain no active ingredients at all. There is no easy way to distinguish between the real and the fake.

Another section of the store offers a number of remedies with fantastic claims, such as “boosting” the immune system, “detoxifying” the body, or “cleansing” you of microscopic Candida. They look sciencey, unless you realize that they treat imaginary medical conditions.

A corner of the store offers unpurified drugs supplied as tinctures and teas. The active ingredients aren’t known, and the batch-to-batch consistency of the product is unclear. The store will suggest products for you based on your symptoms.

Walk past the enormous wall of vitamins and other supplements and you’ll find a nutritionist who will tell you what products you should be taking. You’ll also find a weight loss section. From a science-based perspective, this shouldn’t even exist, given no product has been shown to offer any meaningful benefit. But there are dozens of products for sale.

At the back of the store you’ll finally find the pharmacist. A sign on the counter offers blood- and saliva-based tests for food “intolerance” and adrenal “fatigue”, claiming to test for medical conditions that actually don’t exist or lack an evidence base. The pharmacy also offers a large compounding practice, advertising what it calls “personalized” approaches to hormone replacement with “bioidentical” hormones.

Welcome to the “integrative” pharmacy.

You may not see all these features in your local drug store, but they’re coming: claims of a new “integrative” way to provide health care that is changing the face of retail pharmacy. Unfortunately, it’s harkening back to the era of patent medicines and snake oil. It’s not good for the pharmacists and the profession of pharmacy, and it’s even worse for patients. (more…)

Posted in: Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine

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What’s in a name?: NCCAM tries to polish a turd

turdpolish

What’s in a name? that which we call a rose
By any other name would smell as sweet;
So Romeo would, were he not Romeo call’d,
Retain that dear perfection which he owes
Without that title. Romeo, doff thy name,
And for that name which is no part of thee
Take all myself.

William Shakespeare, Romeo and Juliet, Act II, Scene 2

You can clean up a pig, put a ribbon on its tail, spray it with perfume, but it is still a pig.

You can paint a turd red, but it’s still a turd.

There’s a colloquial phrase commonly used to describe an effort to sell or promote something that is so inherently awful or at least so flawed as to be unsalvageable without either a radical rethinking or such a major overhaul that it would be impractical or impossible to do: Polishing a turd. In this, advocates of so-called “complementary and alternative medicine” (CAM) have been very successful. Mark Crislip, in his usual inimitable fashion, just reminded us why CAM is a turd that needs polishing. Unfortunately, on Friday, I learned that the National Center for Complementary and Alternative Medicine unveiled a proposal to help it be more efficient in polishing the turd that is CAM through the clever use of language, and it wants your feedback. There were lots of other things that happened over the last few days that tempted me to write about them that will likely have to appear over at my not-so-secret other blog, but this one caught my attention and held it, given that it goes to the very heart of the deceptive use of language that is at the heart of giving CAM the appearance of legitimacy. In this specific case, NCCAM wants a new name. Dr. Briggs wants to rename NCCAM the National Center for Research on Complementary and Integrative Health (NCRCI). (I have no idea why the abbreviation of the proposed new center name isn’t NCRCIH.) Here’s Dr. Briggs explaining the rationale for the proposal and urging feedback by June 6 at http://nccam.nih.gov/about/offices/od/comments. I urge you to watch the whole video, or at least read the transcript:

Thus does Dr. Briggs propose polishing the turd that is NCCAM.
(more…)

Posted in: Clinical Trials, Medical Academia, Politics and Regulation

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Legislative Alchemy 2014 (so far)

Legislative Alchemy is the process by which credulous state legislators turn practitioners of pseudoscience into state-licensed health care professionals. In addition to unleashing quackery such as homeopathy, colonic irrigation, moxibustion, reiki, cranial sacral therapy and the detection and correction of subluxations on the public, these practice acts typically give chiropractors, naturopaths and acupuncturists the freedom of being governed by their own regulatory boards, to which the practitioners themselves are appointed. The boards, in turn, write the administrative rules governing practitioners and handle public complaints about their services. In the worst cases, legislatures simply hand out the privilege of practicing medicine to pretty much anyone.

legislative-alchemy-image

State practice acts also establish the education and training standards for practitioners by requiring graduation from their accredited schools. Here the federal government lends a hand, by turning accreditation over to private agencies run by the practitioners themselves. The federal government also supports the schools by giving them taxpayer-funded student loans and research money. (more…)

Posted in: Acupuncture, Chiropractic, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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