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Nevada’s new quack protection law

Nevada state seal

Practicing a licensed health care profession, such as medicine, without a license used to be a felony in Nevada. Not any more. As of July 1, quacks and charlatans are free to ply their trades unencumbered by the threat that they might have to answer to the regulatory authorities for their misdeeds, as long as they follow a few simple rules.

This new law, passed overwhelmingly in the Legislature and signed by the Governor, is yet another success of the “health care freedom” movement. It was shepherded through the legislative process by Alexis Miller, a lobbyist for the Sunshine Health Freedom Foundation (Sunshine), which is affiliated with the National Health Freedom Coalition. It’s Director of Law and Public Policy, Diane Miller, also spoke in favor of the bill. We’ll get back to these groups and their comrades in arms in a moment.

First, let’s take a look at what the new law does. A person who provides “wellness services” is protected from prosecution as long has he doesn’t practice medicine, podiatry, chiropractic, homeopathy (homeopaths are licensed in Nevada) or another licensed profession. Some forbidden services are listed in the law, including surgery, setting fractures, prescribing or administering x-rays or prescription drugs, or providing mental health services in the exclusive domain of psychiatrists and psychologists. Of course, while there is certainly danger in untrained persons doing any of these things, they aren’t generally on your average quack’s list of services, nor are they likely interested in them in the first place. (more…)

Posted in: Energy Medicine, Health Fraud, Herbs & Supplements, Legal, Politics and Regulation, Vaccines

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Mandatory breast density reporting legislation: The law outpaces science, and not in a good way

Over the years, our bloggers here at Science-Based Medicine have written time and time again about the intersection of law and science in medicine. Sometimes, we support a particular bill or law, such as laws to protect children against religion-inspired medical neglect; laws making it harder for manufacturers of homeopathic “medicines” to deceive the public; or California Bill AB 2109, a bill whose intent was to make it more difficult for parents to obtain nonmedical exemptions to vaccine mandates but whose implementation after being passed into law was profoundly sabotaged by Governor Jerry Brown. or, more recently, California SB 277, a bill currently wending its way through the California legislature that would eliminate nonmedical exemptions to school vaccine mandates and has, not surprisingly, engendered extreme resistance from the antivaccine crowd, including by Robert F. Kennedy, Jr. In the vast majority of cases we explain how the law lets us down when it comes to science in medicine, and, unfortunately, examples are many: Naturopathic licensing laws; supplement regulation (or, more appropriately, lack of regulation); misguided, deceptive, and patient-hostile “right-to-try” laws; state laws regulating medical practice that allow quackery to flourish unchecked; laws regulating pharmaceutical cost transparency that ask the wrong question.

The case I will discuss here is unusual in that it is a case of the law getting ahead of what the science says in a manner that will likely do little, if any, good for patients, cause a lot of confusion until the science is worked out better, and end up costing patients money for little or no benefit. I am referring to laws mandating the reporting of high-breast-density to women with dense breasts undergoing mammography. These laws are sweeping the country (albeit not as rapidly as “right-to-try” laws), with a total of 22 states having passed them as of today since Connecticut became the first to do so in 2009. The most recent of these laws went into effect in my own state of Michigan exactly one week ago:

Women with dense breast tissue — the sort that can hide potentially deadly tumors from routine mammograms — must be notified in writing and encouraged to consider additional tests under a new state law that is effective Monday.

While mammograms remain the gold standard for detecting breast tumors, they’re less reliable in almost half of women with dense breast tissue. Dense or fibrous tissue shows up as splotches of white on a mammogram — so do tumors.

That will likely surprise many of the millions of women who rely on mammography for catching the earliest signs of cancer, said Nancy Cappello. The Connecticut woman was shocked in 2004, when her gynecologist found a lump — advanced cancer that had already spread to her lymph nodes — just months after a mammogram deemed her cancer-free.

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Posted in: Cancer, Politics and Regulation, Public Health

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As in 2014, “right-to-try” laws continue to metastasize in 2015

As in 2014, “right-to-try” laws continue to metastasize in 2015

Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as “right-to-try.” Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures, which I likened to Dallas Buyers Club laws. Both Jann Bellamy and I wrote about how these laws are far more likely to do harm than good, and that is a position that I maintain today. The idea behind these laws is to give terminally ill patients access to experimental drugs—in some cases drugs that have only passed phase I testing—that might help them. It’s an understandable, albeit flawed argument. After all, it’s perfectly understandable why terminally ill patients would fight for drugs that give them hope, and it’s just as understandable why politicians and the public would see such a goal as a good thing. In practice, as I will explain again in the context of this update, such laws are far more likely to harm patients than help them. Indeed, as you will see, in the year since the first wave of right-to-try laws have passed, not a single patient that I can find has obtained access to experimental drugs under a right-to-try law, much less been helped by them.

Unfortunately, given how effectively “right to try” has been sold on grounds of providing terminally ill patients hope and as a matter of personal freedom, it’s clear that this wave is not going to abate. Since Colorado passed the very first right-to-try law almost exactly a year ago today, a total of 17 more states now have passed passed similar legislation, the most recent being Tennessee, and 22 others have introduced legislation. It’s a good bet that right-to-try will pass in all of those states, because, as I’ve explained many times before and in many interviews, if you don’t understand clinical trial ethics and science, opposing the concept of right-to-try comes across like opposing Mom, apple pie, and the American flag. It also leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of taking pleasure from drop kicking yipping puppies through flaming goalposts. (I exaggerate, but only slightly, I assure you.)
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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SFSBM Report upsets naturopaths. We’re fine with that.

Sisyphus
The Maryland Naturopathic Doctors Association is not pleased with the Society for Science-Based Medicine. Not at all.

That is a good thing, for several reasons. It demonstrates the importance of stopping naturopathic licensing (and practice expansion) legislation in the state legislatures. It shows how they handle legitimate criticism of their practices. And it is a lesson in their modus operandi of obfuscating the facts with platitudinous- but-vague pronouncements about their education, training and practice, pronouncements that wither under criticism.

Why is the MNDA so upset with the SFSBM?

We’ll answer that question soon, but some background first. The Maryland Legislature passed a naturopathic licensing bill this year. Fortunately, as I’ve written, the Legislature didn’t give naturopaths everything they wanted, such as the right to prescribe real drugs. That’s not stopping them from coming back to the Legislature to revisit the issue. According to naturopathic school Bastyr’s website:

The [Maryland] law limits some parts of the naturopathic scope of practice — such as intravenous (IV) therapies and prescription drugs — that the state association will work to secure in the future.

Instead of giving naturopaths their own regulatory board, like they wanted, the Legislature put them under the authority of the Maryland Board of Physicians. The Legislature created a Naturopathic Advisory Committee to recommend regulations governing naturopathic practice to the Board. The Maryland Naturopathic Doctors Association (MNDA) states, incorrectly, on its website that the Committee will actually be promulgating the regulations and implementing the law. The statute is quite clear that this is not the case. Those duties are entirely within the jurisdiction of the Board. (more…)

Posted in: Diagnostic tests & procedures, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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Legislating Ignorance

Child-GUN

Science is under attack, and not just from anti-vaccine celebrities and parents with degrees from Google University. Scientific illiteracy is being woven into the very fabric of our society through legislative assault. If you dismiss this as alarmist hyperbole, you haven’t been paying close enough attention.

Every day thousands of pediatric health care providers throughout the country provide safety advice to patients and their parents during routine health maintenance visits. As part of this important routine we ask a series of standard questions to assess the safety of our patients’ environment. Some of these questions are easy and straightforward, and some are more personal and potentially awkward for patients and their parents, including questions pertaining to sexual practices and preferences and psychosocial history. An important series of questions focuses on potential hazards in the home, such as how toxins and medicines are stored, how pools are secured against curious toddlers, and whether there are guns in the home and how they are stored and secured. Parents are usually appreciative of the advice we provide, and thankful for our concern and attention to these issues. Occasionally patients or parents are taken aback by some of these questions, and very rarely they prefer not to answer them (in my 20 years in practice, I can recall only one time this has occurred). We ask these questions because accidental injuries and deaths are common occurrences in the pediatric population, and there is good evidence that patients tend to follow the advice we provide our patients. (more…)

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

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Maryland legislature passes naturopathic licensing bill, but with damage control

Legislative Alchemy

Legislative Alchemy

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.

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Posted in: Naturopathy, Politics and Regulation

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The illusions of “right to try” laws

[Ed. Note: For additional commentary on why “right-to-try” laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.]

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

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Licensing Naturopaths: the triumph of politics over science

Naturopaths shouldn’t get too excited about having a special week in their honor. The U.S. House of Representatives gave watermelons a whole month. As between naturopathy and watermelons for my good health, I’ll go with the watermelons any day. You’ll soon understand why.

Today is not my usual blogging day. But when David Gorksi announced SBM’s celebration of Naturopathic Medicine Week, I volunteered an extra post to answer the question I am sure is on everyone’s mind: How in the heck do they get away with this stuff?

The answer lies in the creation of Naturopathic Medicine Week itself: politics. Just as Sen. Barbara Mikulski turned her credulous acceptance of naturopathy into a Senate Resolution and slipped it by her Senate colleagues, clueless legislators around the country are sponsoring bills to license naturopaths, in some cases as primary care physicians. And it’s not as if these legislators don’t know they are incorporating quackery into primary care. Practices such as naturopathic “organ repositioning” (an anatomical impossibility) and Mark Crislip noted, what little data there is suggests that naturopathic primary care is associated with worse outcomes. But evidence is not necessary in the political realm. And now the political process has given naturopaths an additional incentive for licensure. They argue that the Affordable Care Act mandates reimbursement for their services. (more…)

Posted in: Cancer, Energy Medicine, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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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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