Articles

Archive for Politics and Regulation

Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

So Burzynski operated from the late 1990s until summer 2012, charging exorbitant “case management” fees to enroll patients in his clinical trials, working with a credulous filmmaker who wanted to make a movie about him—twice—and flouting regulations designed to protect human subjects involved in clinical trials. Meanwhile, he branched out to “personalized gene-targeted cancer therapy,” which he promoted through Suzanne Somers; to AminoCare, which is basically antineoplastons sold as an antiaging nostrum (or, as Burzynski puts it, a “genetic solution to aging“); and to selling an orphan drug as a “prodrug” for antineoplastons.

So what happened in the summer of 2012? Apparently, there was a treatment-related death of a child, which led the FDA to issue a partial clinical hold on the Burzynski Clinic that prevented him from enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients. That partial clinical hold was extended to adults in January 2013, at which time the FDA arrived at the Burzynski Clinic to investigate. It was an event that was included at the tail end of Eric Merola’s second propaganda film about Stanislaw Burzynski and represented as, in essence, jackbooted fascists trying to keep the cure for cancer from The People. None of this stops credulous reporters from writing misleading articles with titles like Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US, which is a story about Laura Hymas, a woman whose good fortune is most likely not due to Burzynski. Not long before that, there was another credulous article featuring another Burzynski patient, Hannah Bradley, as one of four patients treated for cancer with alternative therapies who are allegedly doing well. Again, Hannah Bradley’s good fortune is highly unlikely to be due to Burzynski’s nostrums.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.
(more…)

Posted in: Cancer, Clinical Trials, Medical Ethics, Politics and Regulation

Leave a Comment (47) →

Redefining cancer

Blogging is a rather immediate endeavor. Over the last nine years (nearly), I’ve lost track of how many times I saw something that I wanted to blog about but by the time I got around to it, it was no longer topical. Usually what happens is that my Dug the Dog tendencies take over, as I’m distracted by yet another squirrel, although sometimes there are just too many targets topics and too little time. Fortunately, however, sometimes the issue is resurrected, sometimes in a really dumb way, such that I have an excuse to correct my previous oversight. This is just such a time, and the manner in which the topic has been resurrected is every bit as dumb as the rant by the Food Babe that Mark Crislip so delightfully deconstructed last Friday. Unfortunately, for purposes of snark, I’m not Mark Crislip—but, then, who is?—but fortunately I am known elsewhere (and sometimes here) for being a bit “insolent.” So let’s dig in. We’ll start with the idiocy and then use that as a “teachable moment” about cancer biology. Funny how I manage to do that sort of thing so often.

Abuse of cancer science for political purposes

I realize that we at SBM are supposed to stay, for the most part, apolitical, but the idiocy that’s leading me to revisit a topic is unavoidably political because it involves using a profound misunderstanding of science for political ends. Specifically, I’m referring to the misuse of a legitimate scientific debate about cancer screening and diagnosis for purely political ends. First, however, for those not living in the US or my fellow citizens who might be blissfully unaware (in this case) of recent events, during the first half of October, our nation underwent what can only be described as a self-inflicted crisis that could have caused worldwide economic turmoil if it hadn’t been (sort of) resolved at the last minute. The reason for the crisis boiled down to the extreme resistance of some of our more radically conservative Representatives to the Patient Protection and Affordable Care Act, usually referred to as just the Affordable Care Act (ACA) or, colloquially, Obamacare. Normally when we write about Obamacare here on SBM, it’s to complain about how advocates of unscientific medicine and outright quackery have tried to piggyback their advocacy on the ACA in order to have health insurance plans sold through government exchanges cover modalities like naturopathy, chiropractic, and other so-called “complementary and alternative medicine” (CAM) or “integrative medicine.” In related posts, I’ve examined the evidence with respect to the relationship between health insurance and mortality and whether attacks on Medicaid as not improving the health of patients insured by it have any validity. (Let’s just say they are oversimplifications and distortions.)
(more…)

Posted in: Cancer, Politics and Regulation, Science and the Media, Surgical Procedures

Leave a Comment (58) →

Acetaminophen: Still the pain reliever you should trust?

Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.

The investigation summarizes the key “Takeaways” as follows:

  • 150 Americans die per year from accidental acetaminophen overdoses
  • The safety margin (safe dose vs. toxic dose) with acetaminophen is small
  • Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
  • For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
  • The manufacturer has taken steps to protect consumers but has also opposed other safety measures

While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)

Posted in: Pharmaceuticals, Politics and Regulation, Science and Medicine

Leave a Comment (34) →

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

Leave a Comment (48) →

Dietary supplement industry says “no” to more information for consumers (again)

Once again, the dietary supplement industry is fighting efforts to give consumers more information about the safety and effectiveness of dietary supplements.

Big Supp is very clever. It sells consumers on the phony idea that they need dietary supplements for good health. Even as the evidence continues to mount that consumers don’t need supplements and shouldn’t take them, the industry continues to convince the public otherwise. And in 2011 they raked in $30 billion.

The state and federal governments have served as handmaidens to the industry in this clever marketing strategy. Congress’s gift to the supplement industry, the Orwellian-named Dietary Supplement Health and Education Act (DSHEA) “effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective,” as SBM’s Scott Gavura pointed out. DSHEA allows supplements to make “structure and function” claims, although no one seems to know what that means, including the FDA.

States have done their part in granting chiropractors and naturopaths the authority to give “nutritional” advice and recommend dietary supplements, sometimes on the basis of dubious diagnostic testing purporting to reveal imagined nutritional deficiencies. This gives them carte blanche to sell supplements to their patients, a clear conflict of interest.

And when proposed regulation threatens their profits, the dietary supplement industry and its surrogates enlist the very public it duped to join the battle. The industry convinces the public that someone is trying to take away their access to supplements they never needed in the first place. This threat is dressed up in terms designed to push all the buttons of a public already primed to be leery of “the government” – their “health freedom” may be taken away. Actually, freedom to choose among health care practices is most threatened by withholding readily-available information which would adequately inform health care decisions. (more…)

Posted in: Herbs & Supplements, Legal, Politics and Regulation, Public Health

Leave a Comment (51) →

Obamacare, the Oregon Experiment, and Medicaid

Tomorrow, as mandated by the Patient Protection and the Affordable Care Act (PPACA, often called just the Affordable Care Act, or ACA, or “Obamacare”), the government-maintained health insurance exchanges will open for business (that is, assuming the likely government shutdown doesn’t stop them temporarily). We here at SBM have written about the ACA quite a few times, but I would like to write about it in perhaps an entirely different context than you’re used to now that the biggest change mandated by the law is here. Just to see the contrast, I’ll mention that Jann Bellamy has written about the ACA in the context of how provisions have been inserted by promoters of “complementary and alternative medicine” (CAM) could potentially provide an “in” for requiring reimbursement of CAM practitioners for their services by insurance plans sold through the exchanges or even how CAM practitioners might promote themselves as primary care providers (PCPs) under Obamacare, as did Matt Roman. I myself warned about legislative meddling that might permit funding of religion-based health care in the exchanges, and Kimball Atwood sounded early warnings about insertion of the provisions that Jann warned about. Instead, view this discussion as a follow-up to a post I did almost a year ago that used a statement by Mitt Romney during the height of the Presidential campaign as a jumping off point to look at the relationship between health insurance status and mortality. While we at SBM try to remain more or less apolitical, in some cases (licensing of naturopaths, for example) it is not possible to disentangle science from politics, and we have to dive in. Also, politics is the art of the possible; so, policy-wise, what is best as determined by science might well not be what is possible politically.

The reason I wanted to revisit this topic is because of a political battle that went on for quite some time over the last several months to expand Medicaid in Michigan according to the dictates of the ACA. The reason that this battle is occurring in many states is because when the Supreme Court ruled last year that the individual mandate requiring that citizens have health insurance was Constitutional, one provision that it ruled unconstitutional was the mandatory expansion of Medicaid in states participating in the Medicaid program to cover all people under 65 up to 133% of the federal poverty level. States thus had to decide whether or not they would accept the Medicaid expansion. In our state, Governor Rick Snyder supported the expansion. Even though he is Republican, he is also a businessman and realized that it was a good deal, with the federal government covering 100% of the cost for the first three years and then phase down to 90% of the cost in 2020. The bill to expand Medicaid managed to pass the House of Representatives, but then it stalled in the Senate. Unfortunately—and this is what got me involved—my state Senator Patrick Colbeck led the opposition to the Medicaid expansion in the Senate, much to my chagrin and disappointment. His argument, which is being repeated elsewhere in the blogosphere, is that Medicaid is worthless and doesn’t improve health outcomes. Instead, he endorsed an alternative that (or so he claimed) places Medicaid-eligible patients into in essence low cost, high deductible concierge practices, with health savings accounts. This was a plan promoted by practices like BlueSky Health. Ultimately Mr. Colbeck lost, and Medicaid was expanded in Michigan in a plan that was characterized by John Z. Ayanian in this week’s New England Journal of Medicine as “a pragmatic pathway to link Republican and Democratic priorities for health care.”

However, the whole kerfuffle got me to thinking. In my post a year ago, I basically asked what the evidence was that access to health insurance improves health outcomes, but I didn’t really stratify the question into kinds of health insurance. Rather, I just looked at being uninsured versus having health insurance. After my little Facebook encounter with one of my elected representatives, I wondered what, exactly, was the state of evidence. So I decided to do this post. In the U.S., currently we have in essence three kinds of health insurance, broadly speaking: private insurance, Medicare, and Medicaid. Medicare, for those of our readers from other countries, is a plan that covers the medical care of people 65 and over and those receiving Social Security disability benefits. It is funded through payroll taxes and directly paid for by the federal government. Medicaid, in contrast, is a plan designed for low income people who fall below certain income levels. Also in contrast, it is jointly funded by the states and the federal government with each participating state administering the plan and having wide leeway to decide eligibility requirements within the limits of federal regulations that determine the minimal standards necessary for states to receive matching funds. Indeed, the loss of this leeway to determine the income level at which a person is eligible for Medicaid is one of the reasons the provision for Medicaid expansion was part of the Supreme Court challenge to the ACA. These days, most Medicaid plans hire private health maintenance organizations (HMOs) to provide insurance. Finally, what needs to be understood is that, compared to private insurance, Medicare reimbursement rates tend to be lower and Medicaid reimbursement rates are lower still, which is part of the reason why a lot of doctors don’t accept Medicaid. Increases in reimbursement under the ACA might well help this situation. (more…)

Posted in: Clinical Trials, Epidemiology, Politics and Regulation, Science and the Media

Leave a Comment (74) →

CAM practitioners as primary care providers under the Affordable Care Act: Part 2

In the last post, we took another look at Section 2607 of the Affordable Care Act, which prohibits “discrimination” against licensed CAM practitioners by insurers, and how chiropractors are continuing their PR campaign to rebrand themselves as primary care physicians. This time, we review a recent white paper by the Academic Consortium of Complementary and Alternative Healthcare, an organization that might be seen as CAM’s answer to the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM). The Academic Consortium for Complementary and Alternative Health Care (ACCAHC) is a group of “complementary and alternative medicine” educational organizations representing chiropractors, naturopaths, acupuncturists, homeopaths, ayurvedic practitioners, direct entry midwives and massage therapists. The executive director is John Weeks, a relentless promoter of “integrative medicine,” both on the Integrator Blog website and in the Huffington Post. The ACCAHC is dedicated to ensuring that its members and the practitioners they represent are included in all aspects of health care, such insurance reimbursement, financial resources for education and delivery models. ACCAHC’s stock-in-trade is its practitioners’ supposed expertise is being patient-centered, holistic, taking into account the whole person and such, as well as an alleged emphasis on healthy lifestyles, nutrition, well-being, and the like.

In fact, the stated vision of the ACCAHC is remarkably similar to that of the CAHCIM:

ACCAHC envisions a healthcare system that is multidisciplinary and enhances competence, mutual respect and collaboration across all healthcare disciplines. This system will deliver effective care that is patient centered, focused on health creation and healing, and readily accessible to all populations.

The CAHCIC’s vision is:

A comprehensive and compassionate health care system offering seamless integration of effective complementary and conventional approaches to promote healing and health in every individual and community.

Indeed, there is an overlap in governance of the two organizations. Benjamin Kligner, MD, Adam Perlman, MD, Mary Jo Kreitzer, PhD, RN, and Aviad Haramati, PhD, are all on the ACCAHC’s Board of Advisers, as well as being either current or former members of the CAHCIM’s Executive Committee. The Board of Advisers also includes other integrative medicine luminaries such as Brian Berman, MD, Wayne Jonas, MD, and David Katz, MD. The two organizations have worked together in several endeavors. One wonders why the they don’t just go ahead and merge. (Actually, one knows perfectly well why they don’t.)
(more…)

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

Leave a Comment (44) →

California Acupuncturists Don’t Need to Know English!

English proficiency is not a necessary precursor to becoming a contributing citizen in California’s economy and should not be used by the Board to discriminate against talented and skilled individuals who seek to provide high-quality acupuncture services in California.

— State Senators Curren D. Price Jr. and Darrell Steinberg, letter to the California Acupuncture Board, March 22, 2013.

To appreciate the recklessness of this statement, and to illustrate the Senators’ disconnect with the reality of Oriental medicine, let’s take a look at a consummate example of services provided by acupuncturists. The following video features the “Master” Kim Nam-soo demonstrating his moxibustion technique. He conducted a similar workshop for future acupuncturists in 2010 at Emperor’s College of Traditional Oriental Medicine in Santa Monica, CA. Make sure you do not miss the part where the Master is skillfully adding his own spit to the treatment!

Kim Nam-Soo (also known as “Gudang”) is a 97-year-old acupuncturist from South Korea. In this video, he is teaching a form of moxibustion (burning of a mugwort cone on or near the skin). He is first preparing a wad of mugwort (Artemisia vulgaris), he is then placing it on an acupuncture point and burning it with an incense stick. Note that he is using his own saliva to make the mugwort more malleable before sticking it to the patient’s skin!

Besides acupuncture and moxibustion, the other services these “talented and skilled” individuals provide consist of massage, cupping, breathing techniques, and the use of herbal, animal and mineral products. In most states, bloodletting is not part of their scope of practice — except for Arkansas.
(more…)

Posted in: Acupuncture, Politics and Regulation, Public Health, Science and Medicine, Traditional Chinese Medicine

Leave a Comment (48) →

CAM practitioners as primary care providers under the Affordable Care Act: Part 1

Section 2607 (42 U.S.C. Sec. 300gg-5) of the Affordable Care Act (the “ACA” or “Obamacare”) prevents “discrimination” against any health care provider acting within the scope of his or her state license. The provision, supported by the American Chiropractic Association and other CAM practitioners, was inserted, without a hearing, under the leadership of Sen. Tom Harkin. Sec. 2607 is of concern to advocates of science-based medicine due to the broad scope of practice granted chiropractors, naturopaths, homeopaths, acupuncturists and direct-entry midwives under state law, as well as their over-confident view of themselves and their abilities. As we have previously discussed, for example, both naturopaths and chiropractors fancy themselves as primary care physicians able to differentially diagnose any patient with any disease or condition and, in many cases, treat or “co-manage” these patients.

As might be expected, a brouhaha is brewing over just what Section 2607 means. And there is one attempt to repeal it outright.

In all cases of statutory interpretation, the proper starting point is the statutory language itself.

SEC. 2706. NON-DISCRIMINATION IN HEALTH CARE.

(a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary [of Health and Human Services] from establishing varying reimbursement rates based on quality or performance measures.

In short, while broadly prohibiting discrimination, there are two important limitations. This is not an “any willing provider law” requiring an insurance company to contract with any provider agreeing to the insurer’s contract. And insurers can pay different rates to different providers as long as these rates are “based on quality or performance measures.” (more…)

Posted in: Chiropractic, Legal, Politics and Regulation

Leave a Comment (84) →

E-cigarettes: The growing popularity of an unregulated drug delivery device

This post is not about vaccines (for a change).

However, I deem it appropriate to mention that one of the topics that I blog most frequently about is vaccines and how the antivaccine movement pushes pseudoscience and quackery based on its apparently implacable hatred of vaccines. (You’ll see why very shortly.) It seems almost as long as my interest in the topic since I first noticed that the antivaccine movement acquired its very own celebrity spokesperson in Jenny McCarthy, who at least since 2007 has been promoting outrageous quackery and pseudoscience associated with her antivaccine views. To her, vaccines are chock full of “toxins” and all sorts of evil humors that will turn your child autistic in a heartbeat and in general “steal” your “real” child away from you the way she thinks vaccines “stole” her son Evan away from her. Indeed, among other “achievements,” she’s written multiple books about autism in which vaccines feature prominently as a cause, led a march on Washington to “green our vaccines” and has been the president of the antivaccine group Generation Rescue for the last few years. None of this stopped ABC from foolishly hiring her to join the regular cast on The View beginning in a few short weeks.

Because I occasionally check on what Jenny McCarthy is up to, I noticed a couple of weeks ago that she had been hired to be a celebrity spokesperson for blu™ e-cigarettes. Here she is, hawking the blu™ Starter Pack:

(more…)

Posted in: Cancer, Politics and Regulation, Public Health

Leave a Comment (166) →
Page 5 of 37 «...34567...»