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Bill and Hillary Clinton go woo with Dr. Mark Hyman and “functional medicine”

Dug the Dog strikes again.

I was all set to write about a mass of pseudoscience published in a prominent online news/comment site, one that addressed a topic near and not-so-dear to my heart, mainly EMF and cell phone radiation as an alleged cause of cancer and many health problems. Ready to rip into it with gusto, I did have a bit of reservation because I had recently addressed the very same topic when Dr. Oz engaged in a bit of fear mongering about it. It must have been posted to various breast cancer forums or forums dedicated to discussing the purported health issues due to cell phones, because every so often, for the last three months, outraged commenters would show up and lash out at me. But, then, I was made aware of an article that appeared in the New York Times a couple of days ago that brought up memories of something I haven’t written about for a long time.

Squirrel!

Besides, I can always blog about the other execrable article on my not-so-super-secret other blog. That’s what it’s there for.

In any case, the NYT article appeared, appropriately enough, in the Fashion & Style section, not the Health section, and is entitled “He Tells the Clintons How to Lose a Little. Dr. Mark Hyman: Advising the Clintons on Their Health.” It’s written by Amy Chozick, a reporter I’ve never heard of, probably because I know the names of most, if not all, of the health reporters for the NYT and national news outlets, but am blissfully unfamiliar with reporters covering the fashion and style beat. Actually, it turns out that Chozick is a political reporter “with a focus on covering Hillary Clinton.” Obviously her focus isn’t on covering health, as her article makes clear.
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Posted in: Politics and Regulation, Public Health, Science and the Media

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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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A favorite tactic of the antivaccine movement: When science doesn’t support you, use the law

As I’ve joked about before, I’m a bit like Dug the Dog from the movie Up whenever a squirrel goes by. In other words, I’m easily distracted by things that interest my primal urge to chase pseudoscience. I originally had a cancer-related topic in mind for this week’s foray into science-based medicine, but then on Friday our favorite group of antivaccine activists over at the antivaccine crank blog Age of Autism induced a squirrel to run in front of me, and the rest is history, at least for the moment. I’ll try to get back to my original topic either as a bonus post later this week or as next week’s post (unlike the topic of today’s post it’s not really particularly time sensitive). In the meantime, I’ll chase this squirrel. Sorry about that. But Dug’s gotta do what Dug’s gotta do. Besides, the topic I had in mind for this week is sufficiently complex that my ultimate post will probably end up being much better if I have a few more days to a week to think about it. At least, that’s what I keep telling myself.

If there’s one thing I’ve learned over the years opposing the antivaccine movement, it’s that these days its “Holy Grail” (well, a “holy grail”) is to have a “vaccinated versus unvaccinated” study performed, or, as it’s frequently abbreviated, a “vaxed verus unvaxed” study. The reason they want such a study so badly is not because they think there’s a scientific question that genuinely cries out for an answer. Rather, they believe it will confirm their fixed, unalterable belief that vaccines are the root of nearly all chronic health conditions children suffer today, particularly autism and autism spectrum disorders. In particular, they believe that a “vaxed versus unvaxed” study would demonstrate once and for all that vaccines are the cause of the “autism epidemic.” Hilariously, a few years back, the antivaccine group Generation Rescue tried to do such a study. It was more an utterly incompetently administered and analyzed telephone survey than anything else, and, ironically, its results actually were just as consistent with the conclusions that vaccines protect against autism as that they predispose to autism. And don’t even get me started on an even more hilariously incompetent vaxed versus unvaxed study by a German antivaccine homeopath (I know; “antivaccine homeopath” is redundant) that antivaccinationists were touting a while back. That took attempts to ape science to depressingly ridiculous extremes.
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Posted in: Politics and Regulation, Vaccines

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Progressive Mythology

In their book Science Left Behind: Feel-Good Fallacies and the Rise of the Anti-Scientific Left, Alex Berezow and Hank Campbell counter allegations of a Republican war on science by pointing out how political progressives are equally anti-science. According to Berezow and Campbell, progressives hold opinions that are not based on physical reality, and claim that their beliefs are based on science even when they are not.

I try to stay out of politics, but anti-science attitudes should be discouraged wherever they are found, and the mythology of progressives as described by Berezow and Campbell is very much like the thinking of alternative medicine:

  1. Everything natural is good
  2. Everything unnatural is bad
  3. Unchecked science and progress will destroy us
  4. Science is only relative anyway

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Posted in: Book & movie reviews, Politics and Regulation

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“Moneyball,” the 2012 election, and science- and evidence-based medicine

Regular readers of my other blog probably know that I’m into more than just science, skepticism, and promoting science-based medicine (SBM). I’m also into science fiction, computers, and baseball, not to mention politics (at least more than average). That’s why our recent election, coming as it did hot on the heels of the World Series in which my beloved Detroit Tigers utterly choked got me to thinking. Actually, it was more than just that. It was also an article that appeared a couple of weeks before the election in the New England Journal of Medicine entitled Moneyball and Medicine, by Christopher J. Phillips, PhD, Jeremy A. Greene, MD, PhD, and Scott H. Podolsky, MD. In it, they compare what they call “evidence-based” baseball to “evidence-based medicine,” something that is not as far-fetched as one might think.

“Moneyball,” as baseball fans know, refers to a book by Michael Lewis entitled Moneyball: The Art of Winning an Unfair Game. Published in 2003, Moneyball is the story of the Oakland Athletics and their manager Billy Beane and how the A’s managed to field a competitive team even though the organization was—shall we say?—”revenue challenged” compared to big market teams like the New York Yankees. The central premise of the book was that that the collective wisdom of baseball leaders, such as managers, coaches, scouts, owners, and general managers, was flawed and too subjective. Using rigorous statistical analysis, the A’s front office determined various metrics that were better predictors of offensive success than previously used indicators. For example, conventional wisdom at the time valued stolen bases, runs batted in, and batting average, but the A’s determined that on-base percentage and slugging percentage were better predictors, and cheaper to obtain on the free market, to boot. As a result, the 2002 Athletics, with a payroll of $41 million (the third lowest in baseball), were able to compete in the market against teams like the Yankees, which had a payroll of $125 million. The book also discussed the A’s farm system and how it determined which players were more likely to develop into solid major league players, as well as the history of sabermetric analysis, a term coined by one of its pioneers Bill James after SABR, the Society for American Baseball Research. Sabermetrics is basically concerned with determining the value of a player or team in current or past seasons and with predicting the value of a player or team in the future.
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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine, Science and the Media

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Cancer care in the U.S. versus Europe: Is more necessarily better?

The U.S. is widely known to have the highest health care expenditures per capita in the world, and not just by a little, but by a lot. I’m not going to go into the reasons for this so much, other than to point out that how to rein in these costs has long been a flashpoint for debate. Indeed, most of the resistance to the Patient Protection and Affordable Care Act (PPACA), otherwise known in popular parlance as “Obamacare,” has been fueled by two things: (1) resistance to the mandate that everyone has to buy health insurance, and (2) the parts of the law designed to control the rise in health care costs. This later aspect of the PPACA has inspired cries of “Rationing!” and “Death panels!” Whenever science-based recommendations are made that suggest ways to decrease costs by reevaluating screening tests or decreasing various tests and interventions in situations where their use is not supported by scientific and clinical evidence, whether by the government or professional societies, you can count on it not being long before these cries go up, often from doctors themselves.

My perspective on this issue is that we already “ration” care. It’s just that government-controlled single payer plans and hybrid private-public universal health care plans use different criteria to ration care than our current system does. In the case of government-run health care systems, what will and will not be reimbursed is generally chosen based on evidence, politics, and cost, while in a system like the U.S. system what will and will not be reimbursed tends to be decided by insurance companies based on evidence leavened heavily with business considerations that involve appealing to the largest number of employers (who, let’s face it, are the primary customers of health insurance companies, not individuals insured by their health insurance plans). So what the debate is really about is, when boiled down to its essence, how to ration care and by how much, not whether care will be rationed. Ideally, how funding allocations are decided would be based on the best scientific evidence in a transparent fashion.

The study I’m about to discuss is anything but the best scientific evidence.
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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Science and the Media

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Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience

Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.
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Posted in: Herbs & Supplements, Politics and Regulation, Public Health, Vaccines

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NIH Awards $30 Million Research Dollars To Convicted Felons: Cliff’s Notes Version

In case you’re coming late to this discussion (or have ADD), I’ve summarized Dr. Kimball Atwood’s terrific analysis of the ongoing clinical trial (TACT trial) in which convicted felons were awarded $30 million by the NIH.

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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

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

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The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:

  • Explore complementary and alternative healing practices in the context of rigorous science.
  • Train complementary and alternative medicine researchers.
  • Disseminate authoritative information to the public and professionals.

If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.

Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.
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Posted in: Basic Science, Clinical Trials, Medical Academia, Politics and Regulation, Science and Medicine

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