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The Compassionate Freedom of Choice Act: Ill-advised “right to try” goes federal

Not too long ago, I expressed alarm at a series of bills that were popping up like so much kudzu in various state legislatures, namely “right to try” bills. Both Jann Bellamy and I warned that these bills gave a false illusion of hope to patients with terminal illnesses. Basically, these laws claim to grant the “right” of patients with terminal illnesses to access promising experimental medicines that have not yet been approved by the FDA. Indeed, these investigational drugs need merely to have passed phase I trials, and these “right to try” laws would allow them to be used in pretty much any human with a terminal illness who can persuade a pharmaceutical company to let them have such drugs. Of course, as I pointed out, such laws are based on a false premise, namely that there are lots of promising drugs out there that could save lots of lives of terminally ill patients, if only the hidebound FDA would get out of the way and let the people try them. The problem (besides the false assumption behind such laws) is that they are all state laws, and the FDA and federal law still trump state laws with respect to drug approval.

Apparently, advocates of “right to try” laws have gotten around to trying to take care of that little obstacle, too. I’m referring to a federal law under consideration in the House of Representatives and championed by the usual suspects, including the Alliance for Natural Health USA, a “health freedom” group that has yet to see a pro-quackery bill it doesn’t like.

In any case, at the time I originally learned about this bill, HR 4475, which was introduced by Rep. Morgan Griffith (R-VA) and entitled “The Compassionate Freedom of Choice Act of 2014,” its text hadn’t yet been published to the Congressional website. I did learn that the bill has been floating around for a while in various forms (for instance, former Representative Ron Paul (R-TX) apparently introduced it.) Now its text has been published, as Guy Chapman has noted. He calls it a “quack’s charter,” and he’s only off by a bit. The bill doesn’t go quite as far as he believes, but the bill is still plenty bad, man. If enacted, HR 4475 would amend the Food, Drug, and Cosmetic Act by inserting after section 561 (21 U.S.C. 360bbb) the text of HR 4475. This section of the Food, Drug, and Cosmetic Act is entitled “Expanded Access to Unapproved Therapies and Diagnostics,” and it’s the section of the act that regulates exactly that. The interesting thing is that this particular section of existing law is the framework under which the whole system of single patient INDs (also known as “compassionate use exemptions”) is already based. As I’ve described before, single patients can receive promising unapproved drugs under what’s known as a single patient IND, which has to be approved by the Institutional Review Board and the FDA and allows single patients to receive unapproved drugs. You can (and many have) argued that the single patient IND process is too cumbersome and restrictive, but HR 4475 seeks to (mostly) nuke this requirement. You’ll see what I mean in a minute.
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Posted in: Clinical Trials, Politics and Regulation

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Traditional Chinese herbalism at the Cleveland Clinic? What happened to science-based medicine?

I don’t recall if I’ve ever mentioned my connection with the Cleveland Clinic Foundation (CCF). I probably have, but just don’t remember it. Long-time readers might recall that I did my general surgery training at Case Western Reserve University at University Hospitals of Cleveland. Indeed, I did my PhD there as well in the Department of Physiology and Biophysics. Up the road less than a mile from UH is the Cleveland Clinic. As it turns out, during my stint in Physiology and Biophysics at CWRU, I happened to do a research rotation in a lab at the CCF, which lasted a few months. OK, so it’s not much of a connection. It was over 20 years ago and only lasted a few months, but it’s something that gives me an obvious and blatant hook to start out this post, particularly given the number of cardiac patients I delivered to the CCF back in the early 1990s when I moonlighted as a flight physician for Metro LifeFlight.

Obvious and clunky introduction aside (hey, they can’t all be brilliant; so I’ll settle for nauseatingly self-deprecating), several of my readers have been sending me a link to a story that appeared in the Wall Street Journal the other day: A Top Hospital Opens Up to Chinese Herbs as Medicines: Evidence is lacking that herbs are effective. I also noticed that our fearless leader Steve Novella blogged about it and was tempted to let it pass, given that I had seemingly lost my window, but then I realized that there’s always something I can add to a post, even after the topic’s been blogged by Steve Novella. Whether that something is of value or not, I leave to the reader. So here we go. Besides, if this article truly indicates a new trend in academic medical centers, it’s—if you’ll excuse the term—quantum leap in the infiltration of quackademic medicine into formerly reputable medical centers. It’s a depressing thing, and it needs to be publicized.
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Posted in: Herbs & Supplements, Medical Academia

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Gluten-free skin and beauty products: Extracting cash from the gullible

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Even though yesterday was Easter, and, as unreligious as I am, I was still thinking of taking it easy, there was one target that popped up that I just couldn’t resist. My wife and I were sitting around yesterday reading the Sunday papers and perusing the Internet (as is frequently our wont on Sunday mornings), when I heard a contemptuous harrumph coming from her direction. She then pointed me to an article in our local newspaper entitled Gluten-free beauty products in demand among some customers. Now, I must admit that I haven’t been keeping up with the gluten-free trend, other than how easily it fits within the niche of “autism biomed” quackery, where, apparently, nearly every “biomed” protocol for autistic children demands that gluten be stripped completely from their diets, lest the evil molecule continue to infect them with the dreaded autism. I’ve kept an eye the literature, but haven’t really written about gluten. That’s why I could immediately tell why my wife had called my attention to the article:

Amy Soergel’s lip gloss was making her sick. The problem, she realized, was gluten — hydrologized wheat protein, to be exact. Then she went to the hairdresser who used a shampoo that made her neck burn. Again, it contained gluten.

“There’s hidden gluten in many places you may not consider,” including stamp and envelope glues, toothpaste and lip balms, said Soergel, who has a store, Naturally Soergel’s, near Pittsburgh that caters to people with allergies. Indeed, for people with celiac disease, a bit of gluten that might get swallowed from a lipstick or a stream of shampoo in the shower can be enough to cause illness.

A slew of gluten-free skin care products have come on the market, including items from well-known companies such as Murad, Dr. Hauschka, EO, MyChelle, Suntegrity, Acure and derma-e. Many are sold in Whole Foods and other health food stores. If they’ve been certified by a third-party agency, an icon usually appears on the packaging.

Whole Foods. Of course, it had to be Whole Foods (among others). Let’s take a look at the whole gluten-free movement and then at the end I’ll revisit the question of gluten-free cosmetics and skin products.
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Posted in: Basic Science, Clinical Trials, Nutrition

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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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Mammography and the acute discomfort of change

As I write this, I am attending the 2014 meeting of the American Association for Cancer Research (AACR, Twitter hashtag #AACR14) in San Diego. Basically, it’s one of the largest meetings of basic and translational cancer researchers in the world. I try to go every year, and pretty much have succeeded since around 1998 or 1999. As an “old-timer” who’s attended at least a dozen AACR meetings and presented many abstracts, I can see various trends and observe the attitudes of researchers involved in basic research, contrasting them to that of clinicians. One difference is, as you might expect, that basic and translational researchers tend to embrace new findings and ideas much more rapidly than clinicians do. This is not unexpected because the reason scientists and clinical researchers actually do research is because they want to discover something new. Physicians who are not also researchers become physicians because they want to take care of patients. Because they represent the direct interface between (hopefully) science-based medicine and actual patients, they have a tendency to be more conservative about embracing new findings or rejecting current treatments found not to be effective.

While basic scientists are as human anyone else and therefore just as prone to be suspicious and dismissive of findings that do not jibe with their scientific world view, they can (usually) eventually be convinced by experimental observations and evidence. As I’ve said many times before, the process is messy and frequently combative, but eventually science wins out, although sometimes it takes far longer than in retrospect we think it should have, an observations frequently exploited by advocates of pseudoscience and quackery to claim that their pseudoscience or quackery must be taken seriously because “science was wrong before.” To this, I like to paraphrase Dara O’Briain’s famous adage that just because science doesn’t know everything doesn’t mean you can fill in the gaps with whatever fairy tale that you want. But I digress (although only a little). In accepting the validity of science that indicates either that a medical intervention that was commonly used either doesn’t help, doesn’t help as much as we thought it did, or can even be harmful, they have to contend with the normal human reluctance to admit to oneself that what one was doing before might not have been of value (or might have been of less value than previously believed) or that, worst of all, might have caused harm. Or, to put it differently, physicians understandably become acutely uncomfortable when faced with evidence that the benefit-risk profile of common treatment or test might not be as favorable as previously believed. Add to that the investment that various specialties have in such treatments, which lead to financial conflicts of interest (COI) and desires to protect turf (and therefore income), and negative evidence can have a hard go among clinicians.
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Posted in: Cancer, Diagnostic tests & procedures, Public Health, Science and the Media

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Bob and I are now published in Skeptical Inquirer

As regular readers know, I was quite happy that Skeptical Inquirer (SI) agreed to publish articles by Bob Blaskiewicz and myself about the highly dubious cancer doctor in Houston known as Stanislaw Burzynski. Indeed, Bob and I have been busily doing our best to promote it, appearing on various podcasts, including Point of Inquiry and, most recently, The Skeptics’ Guide to the Universe, where once again we’ve called on skeptics to help us put pressure on our elected officials to prevent Dr. Burzynski from continuing to take advantage of desperate cancer patients, many with incurable disease, particularly incurable brain cancers. It’s in this spirit that I write this uncharacteristically brief post.

My only disappointment thus far was that SI is still largely print-only, which meant that I could only expose our article to subscribers and urge nonsubscribers to pick up a copy (which, by the way, you can still do, as I believe the issue with Bob’s and my articles is still on the stands). Given that my article was designed to be a primer on Stanislaw Burzynski for skeptics, while Bob’s article was intended to make suggestions about what you as supporters of science-based medicine can do to try to protect cancer patients, I’m now happy to announce that SI has published both of our articles online:

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Posted in: Cancer, Politics and Regulation

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Autism prevalence: Now estimated to be one in 68, and the antivaccine movement goes wild

There used to be a time when I dreaded Autism Awareness Month, which begins tomorrow. The reason was simple. Several years ago to perhaps as recently as three years ago, I could always count on a flurry of stories about autism towards the end of March and the beginning of April about autism. That in and of itself isn’t bad. Sometimes the stories were actually informative and useful. However, in variably there would be a flurry of truly aggravating stories in which the reporter, either through laziness, lack of ideas, or the desire to add some spice and controversy to his story, would cover the “vaccine angle.” Invariably, the reporter would either fall for the “false balance” fallacy, in which advocates of antivaccine pseudoscience like Barbara Loe Fisher, Jenny McCarthy, J. B. Handley, Dr. Jay Gordon, and others would be interviewed in the same story as though they expressed a viewpoint that was equally valid as that of real scientists like Paul Offit, representatives of the CDC, and the like. Even if the view that there is no good evidence that vaccines are associated with an increased risk of autism were forcefully expressed, the impression left behind would be that there was actually a scientific debate when there is not. Sometimes, antivaccine-sympathetic reporters would simply write antivaccine stories.

I could also count on the antivaccine movement to go out of its way to try to implicate vaccines as a cause of the “autism” epidemic, taking advantage of the increased media interest that exists every year around this time. Examples abound, such as five years ago when Generation Rescue issued its misinformation-laden “Fourteen Studies” website, to be followed by a propaganda tour by Jenny McCarthy and her then-boyfriend Jim Carrey visiting various media outlets to promote the antivaccine message.
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Posted in: Diagnostic tests & procedures, Epidemiology, Neuroscience/Mental Health, Science and the Media, Vaccines

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A little more weekend shameless self-promotion to spread an important message about Stanislaw Burzynski

Weekends seem to be the time for shameless self-promotion. At least, some weekends are. So, in that tradition, I can’t help blowing my own horn a bit and urging SBM readers to head on over to listen to The Skeptics’ Guide to the Universe, Episode #455, March 29, 2014. There, Bob Blaskiewicz and I are interviewed about Stanislaw Burzynski and what you, as supporters of science-based medicine, can do to counter the efforts of his supporters to pressure the FDA to let children with cancer receive antineoplastons, efforts that are yielding fruit.

Bob Blaskiewicz has set up a Change.org petition “Protect Desperate Patients from the Houston Cancer Quack“. Bob and I urge you to check it out and sign it.

In the meantime, for those of you in Rep. Darrell Issa’s district, note that I will be in San Diego from April 5th to 9th attending the American Association for Cancer Research Meeting. If there are any skeptics in the San Diego area who would like advice on getting this message to Rep. Issa and/or having a meetup, drop me a line at my e-mail address on our contact page.

Posted in: Announcements, Cancer

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

Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.

Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.

This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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A bit of shameless self-promotion: Dr. Gorski interviewed by Point of Inquiry about Stanislaw Burzynski

Every so often, I or one of my fellow SBM bloggers, is interviewed somewhere. This time, it’s my turn, and this time I was interviewed by Lindsay Beyerstein over at Point of Inquiry. In these days when credulous reporters still, in essence, do Burzynski’s bidding with respect to the message he wants to get out, while Burzynski takes advantage of the desperation of patients with incurable cancers, every little bit helps to counter that message.

Hopefully that’s what I’ve done. Please check out the interview.

Posted in: Cancer

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