It’s that time of year again, namely flu vaccine time. My very own cancer institute will be offering the flu vaccine for its staff beginning October 1, and I plan on getting mine just as soon as I get back from the American College of Surgeons Clinical Congress in Chicago early next week. In the meantime, it’s always great to read Mark Crislip’s take on the yearly flu vaccine kerfuffle, particularly this part:
I have little (actually none) respect for HCW’s [health care workers] who do not get vaccinated. We have a professional and moral obligation to place our patients first. I think those who do not get vaccinated, except for a minority with a valid allergy, are dumb asses.
Preach it, Dr. Crislip!
However, this time of year is also a vaccine time of year for another reason (well, actually it was about a month ago). That’s because in late August or early September, depending on your state, the little kiddies (and not-so-little kiddies) return to school and therefore have to be up to date on their required vaccines or face not being able to go to school. No wonder the antivaccine movement goes nuts this time of the year, given the double whammy of antivaccine parents trying to avoid vaccinating their children before going to school by hook or by crook and the yearly promotion of flu vaccines and mandates that health care workers get them. (For the record, my cancer center requires it, and if there’s one thing the administration of my hospital has done that I fully support it’s the yearly vaccine requirement. We’re a cancer hospital, fer cryin’ out loud, and we have lots of immunosuppressed patients that we take care of!) The only other time of year when antivaccinationists are even close to this actively ridiculous is every April, which is Autism Awareness Month, when they start trying to tar attempts to highlight autism and autism research with demands that antivaccine pseudoscience be thrown into the mix like the proverbial cow pie added to the apple pie.
Since Mark’s already covered the flu vaccine so well, let’s talk about the topic of nonmedical exemptions to school vaccine mandates. This topic came up when I noticed that the bloggers and denizens of that most wretched hive of antivaccine scum and quackery, Age of Autism, have swarmed over to a news story about how Washington State has made it harder for parents to obtain nonmedical exemptions to school vaccine requirements:
In the last 20 or so years, the popularity of so-called “complementary and alternative medicine” began to lure physicians (M.D.s and D.O.s) into employing CAM treatments, or what is now rebranded as “integrative medicine.” Of course, CAM use by a physician necessarily requires some deviation from the “conventional” standard of care. Because deviation from the standard of care can be grounds for discipline by the state medical board, state legislatures and medical boards in the United States have had to grapple with just how much medical practice acts and regulations should accommodate CAM use by physicians.
As it turns out, less than you might think.
There is a disturbing effort afoot to rebrand chiropractors as primary care physicians, a subject both Harriet Hall and I have discussed in previous posts. Part of this effort includes convincing state legislatures to grant prescription privileges to chiropractors, an effort that succeeded in New Mexico, as reported in a post a couple of years ago. Let’s return to New Mexico and see how that is working out for everyone.
By way of background, in 2008, the New Mexico legislature created a new iteration of chiropractor called “certified advanced practice chiropractic physicians” with the authority to
prescribe, administer and dispense herbal medicine, homeopathic medicines, vitamins, minerals, enzymes, glandular products, naturally derived substances, protomorphogens, live cell products, gerovital, amino acids, dietary supplements, foods for special dietary use, bioidentical hormones, sterile water, sterile saline, sarapin or its generic, caffeine, procaine, oxygen, epinephrine and vapocoolants.
As Ben Kavoussi observed recently,
[o]nce considered archaic and obsolete, Oriental Medicine has greatly benefited from the postmodern attitudes towards science and knowledge. This is because postmodernists consider the ‘truth’ as being relative to one’s viewpoint or stance. They do not see science as a superior process of acquiring knowledge, but as a ‘belief system,’ a ‘language game,’ which does not give more access to truth than other conceptual constructs.
This “postmodern fallacy,” he continued,
has allowed the return of mass professional delusions under the label of Chinese, Oriental or Asian Medicine. As an unfortunate byproduct, dangerous and outdated therapies have been legitimized, and quacks and charlatans can overtly defraud those who cannot distinguish scientific medicine from lore and fantasy.
There is probably no better example of this “unfortunate byproduct” than the state acupuncture and oriental medicine practice acts. These laws have indeed legitimized dangerous and outdated therapies, allowing quacks and charlatans to defraud the public.
The burgeoning U.S. stem cell therapy industry was delivered a setback last month in the form of a U.S. District Court injunction against use of the “Regenexx™ Procedure,” which purports to treat joint, muscle, tendon or bone pain due to injury or other conditions. The court agreed with the FDA that the cell product used in the procedure is both a drug and a “biological product” subject to FDA regulation. Because a similar process is used in other stem cell therapies the decision increases the possibility that the FDA will take a like position in other cases.
The general term “stem cell therapy” comprises an array of treatments which range from the clinically proven to quackery. On one end of the spectrum is blood stem cell transplantation to treat diseases and conditions of the blood and immune system. On the other lies the kind of stem cell therapy tourism addressed by both Steve Novella (here and here) and Orac (here and here), which involves the injection of what may, or may not be, stem cells from what may, or may not be, humans. In between fall therapies which are plausible and have promise but have not been adequately tested in clinical trials. There is a concern that these therapies are being oversold by clinics which charge thousands of dollars (not reimbursed by insurance) to treat conditions including multiple sclerosis, musculoskeletal pain, and cardiac disease.
One issue that keeps coming up time and time again for me is the issue of screening for cancer. Because I’m primarily a breast cancer surgeon in my clinical life, that means mammography, although many of the same issues come up time and time again in discussions of using prostate-specific antigen (PSA) screening for prostate cancer. Over time, my position regarding how to screen and when to screen has vacillated—er, um, evolved, yeah, that’s it—in response to new evidence, although the core, including my conclusion that women should definitely be screened beginning at age 50 and that it’s probably also a good idea to begin at age 40 but less frequently during that decade, has never changed. What does change is how strongly I feel about screening before 50.
My changes in emphasis and conclusions regarding screening mammography derive from my reading of the latest scientific and clinical evidence, but it’s more than just evidence that is in play here. Mammography, perhaps more than screening for any disease, is affected by more than just science. Policies regarding mammographic screening are also based on value judgments, politics, and awareness and advocacy campaigns going back decades. To some extent, this is true of many common diseases (i.e., that whether and how to screen for them are about more than just science), but in breast cancer arguably these issues are more intense. Add to that the seemingly eternal conflict between science and medicine communication, in which a simple message, repeated over and over, is required to get through, versus the messy science that tells us that the benefits of mammography are confounded by issues such as lead time and length bias that make it difficult indeed to tell if mammography—or any screening test for cancer, for that matter—saves lives and, if it does, how many. Part of the problem is that mammography tends to detect preferentially the very tumors that are less likely to be deadly, and it’s not surprising that periodically what I like to call the “mammography wars” heat up. This is not a new issue, but rather a controversy that flares up periodically. Usually this is a good thing.
And these wars just just heated up a little bit again late last week.
“Complementary and alternative medicine,” as pediatrician and fellow blogger John Snyder aptly stated in a recent journal article on CAM and children,
is a term used to describe a disparate, poorly defined set of practices and treatment modalities presumed to be distinct from so-called ‘conventional medicine’.
As we have discussed here at Science-Based Medicine, this amorphous concept facilitates a convenient fluidity in delineating the parameters of CAM. Without a clear definition, CAM (and integrative medicine) proponents are able to rebrand plausible and evidence-based practices such as diet, exercise and relaxation as CAM, a tactic we at SBM call “bait and switch.” This results in inflation in the figures of CAM use (important because CAM is all about popularity) and claims that CAM “works.”
I’ve just returned from TAM, along with Steve Novella and Harriet Hall. While there, we joined up with Rachael Dunlop to do what has become a yearly feature of TAM, the Science-Based Medicine workshop, as well as a panel discussion on one of our favorite subjects, “integrative” medicine. Between it all, I did the usual TAM thing, meeting up with old friends, taking in some talks, and, of course, spending the evenings imbibing more alcohol than I probably should have so that I could look and feel my best for our morning sessions, particularly given my difficulty adapting to the time change. One thing I did was completely unexpected, something I learned about the night before our workshop when I happened to run into Evan Bernstein. He informed me of something that our fearless leader Steve Novella was going to do the next day right after our workshop. In a nutshell, Evan told me that Steve was going to debate an antivaccinationist. Evan didn’t know any details other than that Michael Shermer had arranged it and that Steve had been tapped at the last minute. Evan didn’t even know who the antivaccinationist was going to be or what the event was. Naturally, I was intrigued.
So, the next morning I asked Steve about it. I turns out that the event was FreedomFest, a right-wing/Libertarian confab that happened to be going on at the same time as TAM up the road a piece on the Strip at Bally’s. Steve didn’t know who the antivaccinationist was going to be either, which made me marvel at him. I don’t know that I’d have the confidence agree to walk into the lion’s den with less than a day’s notice not even knowing who my opponent is. Steve was more than happy to invite me along. Clearly, this was was an opportunity that I couldn’t resist. So we met up with Michael Shermer, and it was from him that I learned that Steve’s opponent was to be Dr. Julian Whitaker.
My eyes lit up.
Practitioners of so-called “complementary and alternative medicine” currently enjoy a certain measure of government largesse in the form of state laws mandating coverage of their services by private health insurance plans. The federal Patient Protection and Affordable Care Act (often referred to as the Affordable Care Act, or “ACA,” and sometimes as “Obamacare”) has the potential of putting a significant dent in this forced coverage of pseudoscientific health care.
All states require private health insurers to cover certain health care services by law. These mandates can be in the form of requirements that specific health care services or treatments be covered, that certain providers be covered, or that certain populations be covered.
Mandates are ubiquitous, inconsistent among states and costly. One insurance industry trade group calculates that there are currently 2,262 separate state mandates. Some are supported by clear evidence of benefit, such as immunizations and mammograms. Others, unfortunately, require coverage of “CAM” services, such as acupuncture and chiropractic. (In fact, acupuncture is typically not covered by small group plans unless required by state mandate.) Whether beneficial or not, all agree that these mandates increase premium costs to the consumer, most estimated to be from less than one percent to five percent of premiums, depending on the mandate. Chiropractic coverage, for example, can vary from state to state, from limiting the insured to a specific number of visits per year all the way to requiring chiropractors to be covered on par with medical doctors.
The following article is reposted from NeuroLogicaBlog. Happy Independence Day to all our American readers.
The pharmaceutical giant, GlaxoSmithKline, has agreed to pay three billion dollars in fines to settle three charges of fraud brought by the FDA. This is the largest health fraud settlement in US history. What are the implications of this settlement for how the pharmaceutical industry is regulated in the US and for the role that “Big Pharma” allegedly plays in US health care?
The three fraud charges admitted to by GSK include promoting the off-label use of two anti-depressant drugs – Paxil and Wellbutrin. In the US drugs are approved for specific indications, and they can only be marketed for those indications. So-called off-label use of drugs, however, is very common. Off-label does not necessarily equate to bad medicine, or to lack of scientific evidence or rationale. Often there is solid basic science and clinical evidence to support a specific use of a drug that is not approved by the FDA. That simply means the manufacturer did not apply to the FDA for that indication, which could simply be because they did not feel they would recoup the millions of dollars they would need to spend to get approval for the additional indication. In other words, FDA approval for secondary indications is as much about marketing and finance as it is about the science.
Regardless of whether or not a specific use is evidence-based, however, the rules regulating pharmaceutical companies are very clear – they cannot market a drug for a non-approved use. Doing so breaks the law. GSK broke the law.