Articles

Archive for Politics and Regulation

Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

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

Leave a Comment (54) →

Harkin’s folly, or how forcing insurers to cover CAM undermines the ACA

Bloodletting: a good reason to discard disproven therapies

Bloodletting: a good reason to discard disproven therapies

All of us at SBM have repeatedly expressed frustration at the continuing influx of pseudoscience into the health care system. Judging from comments posted on this site and private communications we receive, our readers share this frustration but are at a loss to figure out how to get through to legislators and other policy makers. Unlike naturopaths and chiropractors, we don’t have the money to hire professional lobbyists. Fortunately, an opportunity to sound off against SCAMs has presented itself, completely free of charge.

How?

Now that the Affordable Care Act enrollment debacle is dying down, the Department of Health and Human Services (HHS) is turning its attention to divining just what the heck Section 2706 of the ACA, the non-discrimination provision, means. (Actually there are other federal agencies involved; to simplify things, here we’ll refer to them collectively as “HHS.”) HHS has opened the issue to public comment, but only until June 10. Let’s take a look at why this is important and what you can do about it.

(There are providers other than chiropractors, naturopaths and acupuncturists involved in this fight. For example, you’ll see public comments from nurse anesthetists and nurse practitioners. But I’m not worried about providers who stick to science.) (more…)

Posted in: Acupuncture, Chiropractic, Legal, Naturopathy, Politics and Regulation, Science and Medicine, Traditional Chinese Medicine, Vaccines

Leave a Comment (114) →

Beware the Integrative Pharmacy

pharmacy window

Imagine a retail pharmacy where some of the medicines on the shelves have been replaced with similar-looking packages that contain no active ingredients at all. There is no easy way to distinguish between the real and the fake.

Another section of the store offers a number of remedies with fantastic claims, such as “boosting” the immune system, “detoxifying” the body, or “cleansing” you of microscopic Candida. They look sciencey, unless you realize that they treat imaginary medical conditions.

A corner of the store offers unpurified drugs supplied as tinctures and teas. The active ingredients aren’t known, and the batch-to-batch consistency of the product is unclear. The store will suggest products for you based on your symptoms.

Walk past the enormous wall of vitamins and other supplements and you’ll find a nutritionist who will tell you what products you should be taking. You’ll also find a weight loss section. From a science-based perspective, this shouldn’t even exist, given no product has been shown to offer any meaningful benefit. But there are dozens of products for sale.

At the back of the store you’ll finally find the pharmacist. A sign on the counter offers blood- and saliva-based tests for food “intolerance” and adrenal “fatigue”, claiming to test for medical conditions that actually don’t exist or lack an evidence base. The pharmacy also offers a large compounding practice, advertising what it calls “personalized” approaches to hormone replacement with “bioidentical” hormones.

Welcome to the “integrative” pharmacy.

You may not see all these features in your local drug store, but they’re coming: claims of a new “integrative” way to provide health care that is changing the face of retail pharmacy. Unfortunately, it’s harkening back to the era of patent medicines and snake oil. It’s not good for the pharmacists and the profession of pharmacy, and it’s even worse for patients. (more…)

Posted in: Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (99) →

What’s in a name?: NCCAM tries to polish a turd

turdpolish

What’s in a name? that which we call a rose
By any other name would smell as sweet;
So Romeo would, were he not Romeo call’d,
Retain that dear perfection which he owes
Without that title. Romeo, doff thy name,
And for that name which is no part of thee
Take all myself.

William Shakespeare, Romeo and Juliet, Act II, Scene 2

You can clean up a pig, put a ribbon on its tail, spray it with perfume, but it is still a pig.

You can paint a turd red, but it’s still a turd.

There’s a colloquial phrase commonly used to describe an effort to sell or promote something that is so inherently awful or at least so flawed as to be unsalvageable without either a radical rethinking or such a major overhaul that it would be impractical or impossible to do: Polishing a turd. In this, advocates of so-called “complementary and alternative medicine” (CAM) have been very successful. Mark Crislip, in his usual inimitable fashion, just reminded us why CAM is a turd that needs polishing. Unfortunately, on Friday, I learned that the National Center for Complementary and Alternative Medicine unveiled a proposal to help it be more efficient in polishing the turd that is CAM through the clever use of language, and it wants your feedback. There were lots of other things that happened over the last few days that tempted me to write about them that will likely have to appear over at my not-so-secret other blog, but this one caught my attention and held it, given that it goes to the very heart of the deceptive use of language that is at the heart of giving CAM the appearance of legitimacy. In this specific case, NCCAM wants a new name. Dr. Briggs wants to rename NCCAM the National Center for Research on Complementary and Integrative Health (NCRCI). (I have no idea why the abbreviation of the proposed new center name isn’t NCRCIH.) Here’s Dr. Briggs explaining the rationale for the proposal and urging feedback by June 6 at http://nccam.nih.gov/about/offices/od/comments. I urge you to watch the whole video, or at least read the transcript:

Thus does Dr. Briggs propose polishing the turd that is NCCAM.
(more…)

Posted in: Clinical Trials, Medical Academia, Politics and Regulation

Leave a Comment (138) →

Legislative Alchemy 2014 (so far)

Legislative Alchemy is the process by which credulous state legislators turn practitioners of pseudoscience into state-licensed health care professionals. In addition to unleashing quackery such as homeopathy, colonic irrigation, moxibustion, reiki, cranial sacral therapy and the detection and correction of subluxations on the public, these practice acts typically give chiropractors, naturopaths and acupuncturists the freedom of being governed by their own regulatory boards, to which the practitioners themselves are appointed. The boards, in turn, write the administrative rules governing practitioners and handle public complaints about their services. In the worst cases, legislatures simply hand out the privilege of practicing medicine to pretty much anyone.

legislative-alchemy-image

State practice acts also establish the education and training standards for practitioners by requiring graduation from their accredited schools. Here the federal government lends a hand, by turning accreditation over to private agencies run by the practitioners themselves. The federal government also supports the schools by giving them taxpayer-funded student loans and research money. (more…)

Posted in: Acupuncture, Chiropractic, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

Leave a Comment (30) →

Telemedicine: Click and the doctor will see you now

Think you need to see a doctor? How about seeing him (or her) on your computer (or tablet or smart phone) screen instead of in the doctor’s office?

The technology of telemedicine, or telehealth, is here. So far, there is no single definition of what it does, and does not, encompass. For example, in some definitions, one of which we discuss today, it includes only video communication. Other definitions are broader, including fax, telephone, and e-mail. Here, we focus mainly on the direct patient-physician telemedicine encounter, unmediated by the presence of a physician who has actually seen the patient face-to-face. This is unlike, for example, the more common specialist consultation, in which the patient and physician have met face-to-face and the specialist is brought in via technology. A typical example of this is the radiologist who reads x-rays from a remote location. (Sometimes so remote that the radiologist isn’t even in the same country.) There is some evidence, but not much yet, that certain kinds of physician-mediated telemedicine can benefit the patient.

One can think of many ways a patient’s accessing a doctor via computer might improve access to healthcare. This could be a godsend for patients in rural areas who must drive an hour or more to find a doctor’s office. For example, here’s a program from the University of Mississippi Medical Center:

The Diabetes Telehealth Network will [put telemedicine] technology in the hands of the patients themselves in the form of Internet-capable tablets equipped with the Care Innovations™ Guide platform.

The Care Innovations™ Guide platform enables health-care providers to offer a clinically driven, fully integrated remote care management solution for populations with chronic conditions. The project will recruit up to 200 patients in Sunflower County, MS, who will use Care Innovations technology to share health data, such as weight, blood pressure, and glucose levels, daily with clinicians.

(more…)

Posted in: Acupuncture, Chiropractic, Computers & Internet, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Pharmaceuticals, Politics and Regulation

Leave a Comment (39) →

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.
(more…)

Posted in: Clinical Trials, Politics and Regulation

Leave a Comment (57) →

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 (165) →

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 (132) →

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 (55) →
Page 3 of 38 12345...»