Articles

Archive for Politics and Regulation

GSK Investigated for Bribing Doctors

The BBC reports that 11 doctors and a GlaxoSmithKline regional manager in Poland have been charged with alleged corruption. The apparent scheme was simple — GSK sales reps are given targets for new prescriptions for whatever drugs they are promoting. In order to meet those targets, it is alleged that one sales rep agreed to pay doctors £100 to give educational lectures to patients. The lectures never took place, and it was understood that in exchange for the payment the doctors would prescribe more of the rep’s drug.

The case is still under investigation but one doctor has already admitted guilt, stating that the £100 was simply too tempting.

Assuming the charges are upheld, such cases are very damaging to public confidence in the system. This is similar to cases of researchers faking their published research — I cringe every time I read about such cases.

(more…)

Posted in: Medical Ethics, Pharmaceuticals, Politics and Regulation

Leave a Comment (85) →

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.
(more…)

Posted in: Politics and Regulation, Public Health, Science and the Media

Leave a Comment (74) →

Maryland legislature passes naturopathic licensing bill, but with damage control

It looks like Maryland is about to become the 18th state licensing (or registering) naturopaths unless the governor vetoes this legislation. That is unlikely to happen because the licensing bills passed overwhelmingly in the House and Senate. But becoming licensed in Maryland may turn out to be something of a pyrrhic victory.

The companion House (HB 402) and Senate (SB 314) bills moved through the General Assembly with lightning speed, suggesting the legislative wheels were well-greased behind the scenes. The lubricant was compromise by all parties: the NDs, the Maryland Board of Physicians, and Med Chi, the state’s medical association. The result seems to be the product of the legislature giving everyone some of what they want, but no one got it all. The baby got split, and that is never good for the baby’s health.

The warhorse parade

The bills originally introduced were obviously drafted by the naturopaths. It gave them their own governing board. They would be able to perform minor office procedures, use colon hydrotherapy, dispense therapeutic devices for barrier contraception, and durable medical equipment. They could administer homeopathic remedies, nutritional “medicine,” vitamins, minerals and so forth via intradermal, subcutaneous and intravenous routes. And they could practice independently, free of any supervision by a physician. Basically, they would be primary care physicians, which is what they claim they are.

Fortunately, all of that is gone in the version that passed. Unfortunately, there is still plenty to be concerned about. We’ll get to those features in a minute.

I listened to recordings of a couple of hours of testimony before two committees, one House, one Senate. (You’re welcome.) But the groundwork for licensing was laid last year, with a report from the Maryland Board of Physicians based on “Practitioner Workgroup” meetings that included representatives from state government and medical, chiropractic, acupuncture, occupational therapy, naturopathic and “chain drug store” (go figure) organizations, a law/lobbying firm (can’t tell who they represented), and Dr. Linda Lee, the Director of the Center for Integrative Medicine at Johns Hopkins. These “stakeholders” decided to try to iron out their differences rather than duke out all the issues in front of the legislature.

(more…)

Posted in: Naturopathy, Politics and Regulation

Leave a Comment (21) →

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:

(more…)

Posted in: Cancer, Politics and Regulation

Leave a Comment (18) →

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.
(more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (60) →

When healing turns into killing: religious and philosophical exemptions from parental accountability

Parents have a fundamental right to guide the upbringing of their children protected under the Due Process Clause of the U.S. Constitution. This includes the choice of medical care for the child. They also have a First Amendment right to the free exercise of their religious beliefs, including the right to care for their children in accordance with the tenets of their religion. In a better world, these rights would be exercised in a manner that is consistent with a reasoned selection of medical care among choices supported by the best available scientific evidence. If, for example, deeply religious parents choose to forego a treatment that had only a minimal chance of extending their child’s life and terrible side effects in favor of palliative care because they believe that their child would be better off in heaven we could all agree that their choice is constitutionally protected.

Unfortunately, that is not the case. Religious believers and those whose “philosophy” favors pseudoscience in child medical care (surveys bloviating about the popularity of CAM to the contrary) are in fact a tiny minority of the American population who influence public policy in a manner that far exceeds their actual numbers. This influence allows these special interest groups to cause needless suffering and death among children and their families. As well, their actions siphon off medical and legal resources that could more properly be directed toward the common good when states and medical institutions are put in the position of having to go to court to protect children from their parents. And, by giving parents false choices between a belief in magic and standard medical care, unnecessary complications are introduced into what are already difficult and heart-wrenching decisions by parents who truly want to act in the best interests of their children. (more…)

Posted in: Cancer, Epidemiology, Legal, Medical Ethics, Politics and Regulation, Religion, Vaccines

Leave a Comment (74) →

“Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy

One of my favorite shows right now is True Detective, an HBO show in which two cops pursue a serial killer over the course of over 17 years. Starring Woody Harrelson and Matthew McConaughey, it’s an amazingly creepy show, and McConaughey is amazing at playing his character, Rustin Cohle. I’m sad that the show will be ending tomorrow, but I really do want to see how it ends.

Unfortunately, as much as I like Matthew McConaughey as an actor, he is in part responsible for re-inspiring a movement that has the potential to do profound harm to patients and cancer research. That’s because his other big role over the last year has been in an Oscar-nominated movie, Dallas Buyers Club, where he plays Ron Woodroof, an early AIDS patient who in the 1980s smuggled unapproved pharmaceutical drugs into Texas when he thought he found them effective at alleviating his symptoms, distributing them to fellow sufferers by establishing the “Dallas Buyers Club” while battling the FDA. I haven’t seen the movie, and I really don’t want to, given that, from everything I’ve heard about it, it’s basically the story of a “brave maverick” who bucks the FDA, complete with all the tropes about indifferent bureaucrats who don’t care if these brave patients die. That might not be so bad if it weren’t also riddled with inaccuracies and misinterpretations of the AIDS crisis in the 1980s. Worse, the real Woodruff rejected the one truly promising drug at the time, AZT, as hopelessly toxic and instead smuggled drugs like Peptide T, which never panned out. Basically, what Woodruff appears to have smuggled as part of his activities for the “Dallas Buyers Club” was a mixture of useless supplements, experimental drugs that were never approved, and a handful of experimental drugs that showed promise. Meanwhile, the movie portrays the FDA as the implacable enemy of these sorts of activities, jackbooted thugs not unlike the stereotype promoted by “health freedom” quacks who don’t like the FDA preventing them from selling their quackery. As far as I can tell without actually seeing the movie, the overall message is a typical uplifting story of an underdog who fights the power and in doing so finds redemption. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation, Public Health

Leave a Comment (57) →

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

Leave a Comment (62) →

Measles gets a helping hand

In a recent post I shared a bit of my personal, near-death experience with measles during the US epidemic of 1989-1991. As I describe in that post, I contracted a very serious measles infection at the end of medical school, and was highly infectious when I interviewed for a residency position at Seattle Children’s Hospital. Like others my age who received an ineffective, killed measles vaccine between 1963 and 1967, I had not been adequately protected. The MMR vaccine was not yet available, and no boosters were recommended at the time. Unfortunately, though my measles titers (a test of immunity to measles) were checked when I entered medical school, the school’s student health department failed to notice or respond to the results – I was not immune and did not receive a booster dose at that time, as I should have. That mistake was huge, and could have cost me my life. It also caused me to potentially sicken many vulnerable children during my tour of the hospital, as well as others I may have inadvertently exposed during the window of communicability as I walked the streets of Seattle. The Department of Health had to be called to trace all of my steps and attempt to track down and protect any potential contacts.
(more…)

Posted in: Epidemiology, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Vaccines

Leave a Comment (67) →

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.
(more…)

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (25) →
Page 1 of 35 12345...»