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.
I don’t know how I’ve missed this, given that it’s been in existence now for a month and a half, but I have. Regular readers (and even fairly recent readers, given that I write about this topic relatively frequently) know that I’m not a big fan of the National Center for Complementary and Alternative Medicine (NCCAM). (Come to think of it, neither is anyone else writing for this blog.) Just search this blog for “NCCAM” if you don’t believe me. I’ve explained the reasons many times, but the CliffsNotes version is that NCCAM is an enormous waste of taxpayer money, dedicated as it is to the study of modalities that are at best highly implausible and at worst break well-established laws of physics (i.e., “energy healing”). I do concede that, since the latest NCCAM director (Dr. Josephine Briggs) took over, there has been a noticeable attempt to bring more scientific rigor to NCCAM, and to some extent Dr. Briggs has succeeded. At the very least she is a legitimate scientist with an impressive pre-NCCAM track record, and I do fear who will succeed her when she moves on or retires given that there is enormous pressure from the CAM community to appoint one of their own as director.
Unfortunately, as rigorous a scientist as Dr. Briggs was in her former life, since coming to NCCAM she has gradually been assimilated into the culture of the place. Indeed, although it is good that NCCAM has backed away from studying woo like homeopathy and distance healing, the co-optation of science-based modalities such as exercise, diet, and natural products pharmacology has continued apace. Worse, the recently released five year strategic plan for NCCAM admitted that the science funded by NCCAM in the past was crap and, in essence, promised to do some real science for a change. That’s why on occasion I’ve jokingly said that we should take off and nuke NCCAM from orbit. It’s the only way to be sure. On the other hand, no doubt someone would think I seriously mean that we should nuke NCCAM. Of course, I’d never advocate that! NCCAM is located right smack dab in the middle of the NIH campus. The collateral damage would be unacceptable.
I keed. I keed. I’m not kidding, though, when I echo the questioning of why NCCAM still exists.
Our last look at the Council on Chiropractic Education (CCE), about 18 months ago, found the CCE deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges. Today we offer an update on that situation.
Update: the CCE is deeply embroiled in a heated dispute among various chiropractic factions over new accreditation standards for chiropractic colleges.
As you may recall, the CCE, which accredits chiropractic colleges in the U.S., stood accused of removing the subluxation from its standards for accreditation, so that chiropractic students would no longer be required to learn how to “detect” and “correct” the putative vertebral subluxation. Of course, the chiropractic subluxation doesn’t exist, but we’ll get to that in a minute. This brouhaha was raised by the more traditional wing of the chiropractic community, called “straights,” whose practice (and livelihood) is based on convincing patients that their spines need “adjustments” to remove these subluxations under the threat of ill health should they be left unattended. The straights were also upset at the move by another faction of chiropractic seeking to rebrand chiropractors as primary care physicians who diagnose and treat a wide variety of diseases and conditions.
Many of the specific issues that the Governor and the Legislature asked the Commission to review have festered because the [California] Acupuncture Board has often acted as a venue for promoting the profession rather than regulating the profession.
– Little Hoover Commission, Regulation of Acupuncture: A Complementary Therapy Framework: September 2004, page 63.
On March 12, 2012, during a brief Sunset Review hearing, the California Senate Committee on Business, Professions and Economic Development asked the California Acupuncture Board (the Board) to respond to a set of harsh criticisms.
It is not the first time that the dysfunctional Board — which falls under the Department of Consumer Affairs — is being scrutinized by the legislator. The Board has a long history of operating in an inefficient manner, misreading its governing statutes, and potentially endangering the public by refusing to promulgate regulations concerning the sterilization of acupuncture needles or the wear of medical gloves by practitioners.
In the past, members and affiliates have even been investigated for taking bribes and selling licensing exam answers. The Board was replaced several times in order to clean up the quasi-anarchic and corrupt practice of acupuncture and Oriental medicine in California.
This time, the Senate Committee listed 10 major issues in a Background Paper, which is a worthwhile read for those interested in the regulation of acupuncture. The Senate expressed serious concerns about many administrative, educational, licensing, enforcement, consumer protection and budgetary matters. In response, the Board Chair and Executive Director offered little explanation. The Board now must respond to the Background Paper in specifics.
Legislative alchemy, as faithful SBM readers know, is the process by which state legislatures and Congress take scientifically implausible and unproven treatments and diagnostic methods and turn them into licensed health care practices and legally sold products. Previous posts have explored this phenomenon in naturopathy, chiropractic and acupuncture.
Our last report on the legislative efforts of CAM providers appeared almost six months ago, the beginning of the legislative year for many states. Now, most legislatures have shuttered the statehouse doors and gone home. So let’s see how the CAM practitioners are doing this year.
A goal of the American Association of Naturopathic Physicians (AANP) is “full scope of practice” in all 50 U.S. states. They’ve got a ways to go. Naturopaths are currently licensed to practice in only 17 states and the District of Columbia. Bills to expand licensure failed to make it out of committee again during the 2012 legislative sessions of two states, Iowa and Maryland. In Colorado and Virginia, where licensing bills failed to pass in previous years, no new legislation was introduced to license naturopaths in 2012. Bills to license naturopaths are still pending before legislative committees in Illinois, Massachusetts, Michigan, North Carolina, New York and Pennsylvania. However, in North Carolina and Pennsylvania these bills have been languishing in committee since 2011, making passage appear less likely This is especially true in North Carolina, where the legislative session ends soon.
Another strategy of the AANP is “progressive legislation.” This means that while some compromise in initial licensing legislation may be necessary to get a licensing bill passed, successive attempts can cure any initial disappointments through expansion of scope of practice and insurance coverage, for example. Nowhere was this strategy more successful in 2012 than in Vermont, where “naturopathic physicians” (as the Vermont Legislature calls them) were officially defined as “primary care providers” (PCPs) for the purpose of health insurance coverage. The new law means that naturopathic physician practices can qualify as patient “medical homes” under the state’s Blueprint for Health and that they may practice as such independently and without supervision.