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The illusions of “right to try” laws

There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside the FDA’s clinical trial process have touching anecdotes in spades. If I, or a loved one, had a terminal cancer, I’d probably be right there with them, telling my story and hoping to get my hands on an investigational drug, no matter how slim the chance for improvement it offered. But a less emotion-driven analysis of so-called “Right to Try” bills currently before several state legislatures reveals some sobering truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

“Right to Try” bills are pending before four state legislatures: Colorado, Louisiana, Arizona and Missouri. We’ll get to the details of these in a bit. Legislators in other states have expressed an interest in filing similar bills. On February 26th, a Missouri legislative committee “heard emotional debate from supporters of a bill that would allow makers of investigational drugs, biological products or devices to make them available to eligible terminal patients.” Among those testifying were the parents of a young girl with a brain tumor and the father, a physician, of a patient with metastatic colon cancer. These stories are hard to hear and make it hard to say no.

The Right to Try bill has been christened with another catchy name (Warning! Link to credulous media report!) – the Dallas Buyer’s Club bill after the terrific movie which just won Matthew McConaughey and Jared Leto Academy Awards for best actor and best supporting actor, and deservedly so. It depicts a macho, homophobic, HIV-infected cowboy (McConaughey) who saves the day battling the evil, bureaucratic FDA and the medical establishment. He skirts the law to bring life-saving drugs to AIDS patients at a time when AIDS was pretty much a death sentence. The plot even includes a delicensed American doctor who supplies the unapproved drugs from his Mexican clinic. And dietary supplements, of course. (You’d be tempted to suspect Stanislaw Burzynski, Hulda Clark and a naturopath co-authored the script.) But no matter its merits as a movie, it is just that, a movie. It is based on a true story but its interpretation of events has been called into question. (Orac also deconstructs the factual inaccuracies on Respectful Insolence today.) Nevertheless, it is a public relations boon to the Right to Try promoters, although, considering their decidedly right-leaning political inclinations, there has to be a certain amount of squeamishness in associating their cause with a movie featuring raunchy, sexually-explicit scenes, lots and lots of cussing, and a colorfully dressed trans-gender person (Leto) as its most sympathetic character. (more…)

Posted in: Cancer, Clinical Trials, Legal, Politics and Regulation, Science and Medicine

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Eric Merola and Ralph Moss try to exhume the rotting corpse of Laetrile in a new movie

Note: Some of you have probably seen a different version of this post fairly recently. I have a grant deadline this week and just didn’t have time to come up with fresh material up to the standards of SBM. This left me with two choices: Post a “rerun” of an old post, or recycle something. I decided to recycle something for reasons explained in the first paragraph of this post.

As I was deciding what to write about this week, I realized that, surprisingly, there is precious little on Science-Based Medicine about the granddaddy of modern cancer quackery, Laetrile. Given that the final nails were placed in the coffin of the quackery that was Laetrile more than 30 years ago in the form of a clinical trial that didn’t show a hint of a whiff of benefit in cancer patients, many of our younger readers might not even know what Laetrile is. But, as I explained when I wrote about Stanislaw Burzynski’s early years in the 1970s, which happened to be they heyday of Laetrile, in cancer quackery everything old is eventually new again, and Laetrile is apparently soon to be new again. True, it’s never really disappeared completely, because, again, no matter how discredited a cancer quackery is, someone somewhere will keep selling it and some poor cancer patient somewhere will be taken in. In any case, it occurred to me that we at SBM have discussed the politics of Laetrile. Indeed, Kimball Atwood once referred to it as the “the most lucrative health fraud ever perpetrated in the United States.” Moreover, Kimball makes a convincing case that the Laetrile controversy was an important precursor that laid the groundwork for advocates of “alternative medicine”—or, as it later became known, “complementary and alternative medicine” (CAM) or “integrative medicine—to successfully lobby for the founding at the National Institutes of Health of what later was named the National Center for Complementary and Alternative Medicine (NCCAM). However, there didn’t appear to be a post dedicated to discussing Laetrile itself, and something happened last week that allows me to rectify that situation.

So how is Laetrile about to become new again? Remember our old buddy Eric Merola? He’s the guy who made two—count ‘em—two conspiracy-laden, misinformation-ridden, astonishingly bad bits of “great man” propaganda disguised as documentaries about a Houston cancer doctor peddling unproven cancer treatments and charging his patients tens and even hundreds of thousands of dollars for the privilege of being under his care while receiving this magic elixir, known as antineoplastons. Over the last several months, ever since he unleashed Burzynski: The Sequel on an unprepared and uninterested world, Merola has been hinting about his next project. Given Merola’s involvement in Zeitgeist: The Movie and his primary role in throwing together two hack propaganda pieces that were so blatantly worshipful of Burzynski that Leni Riefenstahl, were she still alive and able to see them, would have told Merola to cool it with the overheated hero worship and portrayal of his movie’s subject as a god-man a bit, I knew his next movie would be more of the same. I also knew it would not be about Burzynski.
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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The Canadian National Breast Screening Study ignites a new round in the mammography wars

The last couple of weeks, I’ve made allusions to the “Bat Signal” (or, as I called it, the “Cancer Signal,” although that’s a horrible name and I need to think of a better one). Basically, when the Bat Cancer Signal goes up (hey, I like that one better, but do bats get cancer?), it means that a study or story has hit the press that demands my attention. It happened again just last week, when stories started hitting the press hot and heavy about a new study of mammography, stories with titles like Vast Study Casts Doubts on Value of Mammograms and Do Mammograms Save Lives? ‘Hardly,’ a New Study Finds, but I had a dilemma. The reason is that the stories about this new study hit the press largely last Tuesday and Wednesday, the study having apparently been released “in the wild” Monday night. People were e-mailing me and Tweeting at me the study and asking if I was going to blog it. Even Harriet Hall wanted to know if I was going to cover it. (And you know we all have a damned hard time denying such a request when Harriet makes it.) Even worse, the PR person at my cancer center was sending out frantic e-mails to breast cancer clinicians because the press had been calling her and wanted expert comment. Yikes!

What to do? What to do? My turn to blog here wasn’t for five more days, and, although I have in the past occasionally jumped my turn and posted on a day not my own, I hate to draw attention from one of our other fine bloggers unless it’s something really critical. Yet, in the blogosphere, stories like this have a short half-life. I could have written something up and posted it on my not-so-secret other blog (NSSOB, for you newbies), but I like to save studies like this to appear either first here or, at worst, concurrently with a crosspost at my NSSOB. (Guess what’s happening today?) So that’s what I ended up doing, and in a way I’m glad I did. The reason is that it gave me time to cogitate and wait for reactions. True, it’s at the risk of the study fading from the public consciousness, as it had already begun to do by Friday, but such is life.
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Posted in: Cancer, Clinical Trials, Public Health

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The return of the revenge of high dose vitamin C for cancer

Somehow, I’ve a feeling we’re not in Kansas anymore—except that we are, as you will soon see.

Because I’m the resident cancer specialist on this blog, it usually falls on me to discuss the various bits of science, pseudoscience, and quackery that come up around the vast collection of diseases known collectively as “cancer.” I don’t mind, any more than my esteemed colleague Dr. Crislip minds discussing infectious diseases and, of course, vaccines, the most effective tool there is to prevent said infectious diseases. In any case, there are certain things that can happen during a week leading up to my Monday posting slot on SBM that are the equivalent of the Bat Signal. Call them the Cancer Signal, if you will. One of these happened last week, thus displacing that post I’ve been meaning to write on a particular topic once again. At this rate, I might just have to find a way to write an extra bonus post. But not this week.

In any case, this week’s Cancer Signal consisted of a series of articles and news reports with titles like:

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Posted in: Basic Science, Cancer, Clinical Trials

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Animal rights activism: Petitions aren’t science

I had originally planned on writing about a different topic today, but, as is so often the case in blogging, something came up that caught my attention, much as the errant thought of a squirrel distracts Dug the Dog. It’s no big deal. My original topic is not time-sensitive, and I’ll get to it next week (that is, unless something like this happens again). In any case, my tendency towards blogging ADHD notwithstanding, the “inspiration” for this post began on Friday morning, making it timely. Let me tell you what happened, and then I’ll delve into the topic.

We all have our daily rituals, and I’m no different. When I wake up in the morning, I usually check my iPhone to see how many e-mails I’ve gotten overnight. If there’s time before I have to leave for work, I’ll frequently go through them all right then, answering ones I can answer quickly and filing for later responses those that I can’t. If I don’t have time (as in I overslept), I’ll check them whenever I get an opportunity. Last Friday, I was rather surprised to see that the little badge on the Mail app showed well over three times the usual number of messages I get overnight, even accounting for e-mail notifications of comments on the blogs and the usual smattering of mailing list messages and the odd junk spam that got through the filters. So having that many messages in my unread mail queue caught my attention. Even when a new troll shows up in the comments of one of the blogs, I usually don’t get that many notifications. I figured I’d better go and check to see what was going on right then, rather than waiting until later. What I found was something that I never would have guessed.

As odd as it seems to me now, I had apparently been targeted by a Change.org petition Animal Experimenters – JUSTIFY YOUR SCIENCE CLAIMS. (more…)

Posted in: Basic Science, Cancer, Evolution

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pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

Being a cancer surgeon and researcher, naturally I tend to write about cancer a lot more than other areas of medicine and science. It’s what I know best. Also, cancer is a very common area for unscientific practices to insinuate themselves, something that’s been true for a very long time. The ideas don’t change very rapidly, either. Drop a cancer quack from 2014 into 1979, and he would probably be right at home. Of course, part of the reason is because the “elder statesmen” of cancer quackery today were getting their starts in 1979. Still, the same ideas keep recurring even as far back as a century ago and even older, and if you broaden your criteria, these ideas exist on a continuum, either having descended directly from various ancient ideas such as vitalism, miasmas, or humoral theory or branched off somewhere along the way. Others branch off from the progress of science, taking a germ of a seemingly reasonable idea and turning it into quackery. It is the latter with which I plan on concerning myself today, the reason being that over the weekend I heard some truly awesome news. One of the most egregiously practicing non-physicians who claim to be able to cure cancer that I’ve ever encountered was arrested—yes, arrested!—and arraigned on criminal charges. I’m referring to “Dr. Alkaline” himself, he of the pH Miracle Living program and his Articles of Health blog, “Dr.” Robert O. Young. Behold:
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Posted in: Cancer, Naturopathy, Politics and Regulation

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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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Science-based medicine throughout time

As 2013 comes to a close, because this probably will be my last post of 2013 (unless, of course, something comes up that I can’t resist blogging about before my next turn a week from now), I had thought of doing one of those cheesy end-of-year lists related to the topic of science-based medicine. Unfortunately, I couldn’t come up with anything I haven’t already done. I even thought of coming up with a list of New Year’s resolutions for 2014. In fact, I even thought of making the first one—in a self-deprecating manner, of course—to be to stop being so mean, nasty, and dogmatic, the better to satisfy my detractors. But then I remembered that nothing is likely to satisfy my detractors and, besides, my ever-lovin’ cuddliness is what makes me so popular. Besides, I have to be me and gotta be true to myself, and all that rot, so that idea went out the window. Of course, what was worse than my inability to come up with something was that I couldn’t think of a way to make it funny. When you’re trying to be funny following the inimitable Mark Crislip, you’d damned well better be funny. So, until my humorous instincts come back, serious it has to be.

But serious doesn’t necessarily mean heavy. The end of a year is a time both to look back on the year before and look forward to the year to come. This year in many ways was a good year for us here at SBM. We launched a Facebook page, reinvigorated our Twitter feed, and have experienced a significant growth in our traffic. Those who know me and/or follow me on various social media know that I’m a big Doctor Who fan, I have been since the 1980s. So the last two big events of the year, the 50th anniversary special in November and the Christmas special on, well, Christmas got me to thinking about time travel, and thinking about time travel revived memories of a topic I covered on my not-so-super-secret other blog four years ago and had been meaning to treat here sometime. It’s a fun topic to finish out the year, not to mention a way for me to blatantly sneak Doctor Who references into an SBM post.

Being a Doctor Who fan and all, not surprisingly, I’ve often wondered what it would be like to be able to travel through time and visit times and places in history that I’m most interested in. For instance, being a World War II buff, I’d certainly want to be able to check out what everyday life was like here in the U.S. during World War II. Given my affinity for psychedelic music and that I was only four years old during most of the Summer of Love, I’d think it cool to check out Haight-Ashbury, although I suspect my reaction to the reality of it would be similar to that of George Harrison when he checked it out for the first time. I guess, if pushed, I’d have to admit that if I were old enough to have been a high school or college student in 1967, I probably would have been one of those straight-laced, short-haired types destined either to go to college to become a doctor or engineer, or to go to Vietnam to fight. Despite loving the music, I never had any interest in experimenting with the drugs. Beer, wine, and—occasionally—a martini or two are my drugs of choice and then only for medicinal purposes, as they say. Heck, I never even tried to smoke tobacco. Even as a child I couldn’t stand the smell of cigarette smoke to the point where it was never even really a temptation.

In any case, what provoked my original bit of musing was a post a few years ago by Martin Rundkvist, who wrote about Fear of Time Travel, where he imagines what it would be like for a modern person to be transported back in time:

First, imagine that you’re dropped into a foreign city with only the clothes you wear. No wallet, no hand bag, no money, no cell phone, no identification. Pretty scary, huh? But still, most of us would get out of the situation fairly easily. We would find the embassy of our country of origin, or if it were in another city, contact the local police and ask to use their phone. A few days later we would be home.

That’s not the scary scenario I rehearse. Imagine that you’re dropped into the city you live in with only the clothes you wear. No wallet, no hand bag, no money, no cell phone, no identification. And it’s 500 years ago. (Or for you colonial types, 300 years ago in one of your country’s first cities.)

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Posted in: Cancer, Critical Thinking, Science and the Media, Surgical Procedures

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No, carrying your cell phone in your bra will not cause breast cancer, no matter what Dr. Oz says

I don’t think very highly of Dr. Oz.

Yes, yes, I realize that saying that is akin to saying that water is wet, the sun rises in the east, and that it gets damned cold here in the upper Midwest in December, but there you go. This year, I’ve been mostly avoiding the now un-esteemed Dr. Mehmet Oz, a.k.a. “America’s doctor,” even though his show could, if I paid much attention to it anymore, provide me with copious blogging material, because I’ve come to the conclusion that he is beyond redemption. He’s gone over to the Dark Side and is profiting handsomely from it. There’s little I can do about it except for, from time to time, writing about some of Dr. Oz’s more egregious offenses against medical science and reason, putting our tens of thousands of readers per day against his millions of viewers per day. It’s an asymmetric battle that we don’t have much of a shot at winning. However, at least from time to time I can correct misinformation that Oz promotes, particularly when it impacts my speciality. Consider it doing something pre-emptively to help myself. When one of my patients ask about something that’s been on Oz’s show, I can simply point her to specific blog posts, as I did the last time around when Oz arguably flouted the human subjects protection regulations of his own university and of the Department of Health and Human Services by running in essence a poorly-designed clinical trial to show that green coffee bean extract can promote weight loss. Of course, it showed nothing of the sort.

This time around, Dr. Oz caught my attention about a week and a half ago. I had planned on blogging about it last week, but the case of the Amish girl with cancer whose parents stopped her chemotherapy after less than two full courses, thus endangering her life, intervened. (It also didn’t help that I hadn’t recorded the show and the segment hadn’t shown up on Dr. Oz’s website by Sunday night last week.) I figured that I probably wouldn’t get back to Oz, but—wouldn’t you know it?—a week later I’m still annoyed at this story. So better late than never. (more…)

Posted in: Cancer, Science and the Media

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An update on the case of Sarah Hershberger: Parental rights trump the right of a child with cancer to live

Five weeks ago, when last I touched on the case of Sarah Hershberger, the now 11-year-old Amish girl from Medina County, Ohio near Akron with lymphoblastic lymphoma whose parents had taken her off of chemotherapy after only two rounds, reports had been coming out of the cancer quackery underground that Sarah’s parents, Andy and Anna Hershberger, had fled to avoid a court order that appointed a medical guardian for her to make sure that she received appropriate science-based therapy. At the time I was unable to confirm these stories in the mainstream press. However, over the last month there have been significant developments in this case and even over the last week; so I thought that now would be a good time to update SBM readers on developments in the case.

The Thanksgiving confirmation

One thing that I didn’t mention a month ago is that David Michael and others have been actively raising money to support the Hershbergers’ legal battles. Then, over the long Thanksgiving Day weekend news reports began to trickle out confirming what the “alternative” health sites had been reporting, namely that the Hershbergers had fled. These reports started with story from a local Medina newspaper, then spread to a northeast Ohio television stations, and then to national news sources (like Good Morning America and CNN) and international news outlets. The Medina Gazette first reported:
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Posted in: Cancer, Medical Academia, Medical Ethics, Politics and Regulation

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