Articles

Archive for Politics and Regulation

Colorado is Nearer to Promoting Naturopathic Pseudomedicine—Aided by the Colorado Medical Society

This week we’ll take a break from lambasting the National Center for Complementary and Alternative Medicine, as worthy as that task is, in order to confront some of the latest events involving the pseudomedical cult that calls itself “naturopathic medicine.”* Intrepid nurse and anti-healthfraud activist Linda Rosa reports that Colorado is dangerously close to becoming the next state to endorse ”NDs” as health care practitioners, and Scott Gavura of Science-Based Pharmacy called my attention to a report that British Columbia is considering enlarging the scope of practice for NDs, who are already licensed there, and that Alberta is on the verge of licensing them. In each case, those whom the public trusts to make wise decisions have betrayed their ignorance of both pseudomedicine and the realities of governmental regulation.

To explain why, it will first be necessary to make a few assertions, which are linked to developed arguments where necessary:

(more…)

Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Nutrition, Politics and Regulation, Public Health, Science and Medicine

Leave a Comment (41) →

Comparative Clinical Effectiveness Research: Good News In Shades Of Gray

When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

(more…)

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation, Public Health

Leave a Comment (14) →

Obama and Stem Cells

In 2001 George Bush signed an executive order banning federal funding for embryonic stem cell research, except for those lines that were already established. As a result such research ground to a halt in the US.

While the order was presented as a compromise, the effect was chilling in its application. No researcher receiving federal dollars (even for a separate project) could do embryonic stem cell research, except on the approved lines.  Institutions could not risk losing federal grants and so had to purge themselves of any banned research. The approved lines did not turn out to be as useful as was originally claims, and they became progressively obsolete as new techniques were being developed through state and private funding.

It is impossible to measure the effect that Bush’s ban had on ultimate scientific progress in this area. It is not just that we lost eight years – expertise in a cutting-edge scientific area can be a tenuous cultural and institutional thread, once broken it is difficult to recreate.

We will hopefully have a chance to find out. It was expected that one of the first measures of the Obama administration would be to lift the federal ban. In fact, I am a bit surprised it has not happened already. But it seems it soon will – insiders are saying that Obama plans to lift the ban soon.

(more…)

Posted in: Medical Ethics, Politics and Regulation

Leave a Comment (5) →

More evidence that CAM/IM advocates see health care reform as an opportunity to claim legitimacy

Four weeks ago (was it really that long?), I wrote one of my usual lengthy essays for this blog in which I analyzed two editorials published by some very famous advocates of “complementary and alternative medicine” (CAM)/”integrative medicine” (IM). They included one in that credulous repository of all things antivaccine The Huffington Post (no, this isn’t about vaccines, but I can’t resist pointing out at every turn the antivaccine slant of that rather famous political blog) and in the Wall Street Journal. The first, published in HuffPo and written by Deepak Chopra, Andrew Weil, and Rustum Roy, was entitled Leaving the Sinking Ship, while the second added Dean Ornish to its team, switched from the highly liberal venue of hte previous article to the conservative WSJ, and was entitled “Alternative” Medicine Is Mainstream: The evidence is mounting that diet and lifestyle are the best cures for our worst afflictions. In doing so, advocates of unscientific and even pseudoscientific faith-based medical treatments seemingly covered the entire span of political thought, from highly liberal to highly conservative, with their message.

That message, as I have argued, along with Wally Sampson, Kimball Atwood, Val Jones, and Peter Lipson, is, to boil it down to its essence, this: The new Obama Administration has promised to make health care reform one of its top priorities, and CAM/IM advocates want to take advantage of this movement for reform as the “foot in the door” behind which they try to muscle their way in to be treated by the government as co-equal with established, science- and evidence-based medicine. How do they plan on doing this? As I have discussed before, they plan on doing this by coopting disease “prevention” strategies as being CAM/IM and using them as a Trojan horse. When the government brings the giant wooden horse into the fortress of government health care, along with the bona fide prevention strategies of diet and exercise a whole lot of woo will jump out of the belly of that horse and open the fortress doors to let in its comrades. Indeed, the same strategy can be seen in how CAM/IM advocates have coopted the Institute of Medicine with a joint conference.

In other words, because CAM/IM advocates have succeeded so well in tying the perfectly acceptable science- and evidence-based modalities of diet and exercise, as well as ghettoizing the respected pharmacology discipline of pharmacognosy by associating it with herbalism and, in essence, bringing it under the CAM umbrella, where it became unfairly and incorrectly tainted with its association with all the other woo that falls under the CAM/IM mantle, they expect that renewing an emphasis on diet and exercise by their definition and on their terms will lead to the opening of the door into the promised land of having their modalities be funded by the government. It’s a very conscious strategy, which is why Chopra et al’s articles so clearly tried to convince readers that diet and exercise are CAM/IM. Unfortunately, that they are able to do this with such success is in part because science- and evidence-based practitioners arguably underemphasize such health prevention strategies.

I learned of another salvo fired off by CAM/IM advocates through my somehow finding myself on the mailing list for The Mary Ann Liebert, Inc. family of medical journals. Unfortunately, one of the journals published by the Liebert group is the Journal of Alternative and Complementary Medicine. This particular e-mail was advertising an editorial written by a chiropractor named Daniel Redwood that spells out in the most detailed manner exactly how CAM/IM advocates plan on hijacking any health care reform that the Obama Administration might come up in order to persuade the government to fund what Wally frequently terms “sectarian medicine” and I simply like to call unscientific. The editorial is freely available to all (unlike the contents of JACM) and entitled Alternative and Complementary Medicine Should Have Role in New Era of Health Care Reform. It’s about as blatant a description of the goals of the CAM/IM movement as I have ever seen.
(more…)

Posted in: Politics and Regulation, Public Health, Science and Medicine

Leave a Comment (12) →

Yes We Can! We Can Abolish the NCCAM! Part III

A Reminder…

…of why we keep harping on this. A couple of days ago The Scientist reported that the “economic stimulus package” may include a windfall for the NIH:

Senate OKs big NIH bump

Posted by Bob Grant

[Entry posted at 4th February 2009 04:12 PM GMT]

The US Senate, which is furiously debating the details of the economic stimulus package making its way through Congress, passed an amendment yesterday (Feb. 3) to add $6.5 billion in National Institutes of Health funding on top of the $3.5 billion already allotted to the agency in the bill…

Exactly how an NIH funding increase will be spent remains to be determined.

You can bet that if this happens, the NCCAM will be licking its chops for some of that lettuce. Let’s continue to explore why it shouldn’t get any…

(more…)

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

Leave a Comment (4) →

The Anniversary

I received a surprising morning call several weeks ago

“Wally?”

“This is he.”

“This is Judy V…. I just wanted to call and thank you again for what you did for me. It’s the 35th anniversary of my cancer…“

Judy V. is a physician’s widow. Her husband, a surgical specialist died in his 40s, 20plus years ago.   She had a Stage II breast cancer; the surgeon had done a modified radical, and I was consulted for possible adjuvant chemotherapy.

Thirty-five years ago the standard was simpler. Same for our knowledge of staging and biological behavior. Genomics was not a word yet. Targeted therapy was not a concept. Tamoxifen was the ony estrogen agonist and had just been introduced.  The standard adjuvant therapy was single agent melphalan or its equivalent. But even then, patients had choices. The surgery had probably cured her, but then… Chemo or none.
(more…)

Posted in: Cancer, Health Fraud, Herbs & Supplements, Nutrition, Pharmaceuticals, Politics and Regulation

Leave a Comment (6) →

Since when did an apologist for the antivaccination movement, Dr. Jay Gordon, become an “expert” in vaccine law?

I am an alumnus of the University of Michigan twice over. I completed a B.S. in Chemistry with Honors there in 1984 and then I stayed on to do obtain my M.D. in 1988. I look back very fondly on those eight years spent in Ann Arbor, as several of my longtime friendships were forged or solidified during those years. Consequently, I still care about the place. Indeed, I even once tried to see if I could get a position in the Department of Surgery there a few years back, but unfortunately the “fit” just wasn’t there at the time. That’s why it distresses me when I see my alma mater suffer from a self-inflicted wound, almost as much as the plight of the Michigan Wolverines bothers me, given that never before in my life (at least not since I was old enough to pay attention), have the Wolverines sucked so badly and so hard. Given that level of football futility, though, I consider it even more important that my alma mater not provide any more ammunition to those who would enjoy making fun of it. It doesn’t matter to me that I never went to law school at Michigan; it’s all part of the same campus to me.

This time, the embarrassment comes in the form of an article in the Michigan Law Review by a person who has previously been a subject of posts by both Dr. Novella and me. I’m referring to Dr. Jay Gordon, whom we have both–correctly, I believe–labeled as being, if not fully anti-vaccine, at least a prominent and major apologist for the anti-vaccine movement. Unfortunately, because he is the pediatrician taking care of Jenny McCarthy’s son Evan, he has gained even greater prominence in the antivaccine movement than ever, to the point where he gave a speech last summer to the antivaccine “Green Our Vaccines” march on Washington and where he is regularly called up by TV producers to give a false “balance” whenever a discussion of vaccines and/or autism comes up. He also wrote the foreword to Jenny McCarthy’s latest paean to autism quackery and attack on vaccines as the cause of autism in which he blithely repeated some of the worst distortions of the antivaccine movement. Unfortunately, Dr. Gordon lacks the intestinal fortitude to stop the piteous denials any time he is called out for his parroting of antivaccine pseudsocience and to embrace his inner antivaccinationist. Then, at least, we wouldn’t be treated to the spectacle of his simultaneously claiming he is “pro-safe vaccine, not anti-vaccine” while at the same time saying he “doesn’t give a lot of vaccines” and admitting that parents have actually had to persuade him to vaccinate “reluctantly.”

So what was the topic of the Michigan Law Review article that Dr. Gordon was apparently asked to pen? It’s actually an interesting question from a legal, political and civil rights standpoint, specifically: Whether or not parents should be held legally liable for refusing to vaccinate their children. Not surprisingly, Dr. Gordon took the “no” position. Unfortunately, as we’ve come to expect of Dr. Gordon, he uses a number of highly dubious arguments. However, more interesting to me, having had a nearly four year history sparring online with him off and on, was the seemingly “kinder and gentler” antivaccine stance that he took in this article.

But first, let’s take a look at the debate. The symposium published in First Impressions (the online companion to the Michigan Law Review) was entitled Liability for Exercising Personal Belief Exemptions from Vaccination, and it contained the following articles:

  1. Choices Should Have Consequences: Failure to Vaccinate, Harm to Others, and Civil Liability by Douglas S. Diekema.
  2. Parents Should Not be Legally Liable for Refusing to Vaccinate their Children by Dr. Jay Gordon.
  3. Unintended Consequences: The Primacy of Public Trust in Vaccination by Jason L. Schwartz.
  4. Challenging Personal Belief Immunization Exemptions: Considering Legal Responses by Alexandra Stewart.
  5. Gambling with the Health of Others by Stephen P. Teret and John S. Vernick.
  6. The Problem of Vaccination Noncompliance: Public Health Goals and the Limitations of Tort Law by Daniel B. Rubin and Sophie Kasimow

There were a number of fascinating issues raised here. Although it’s obvious that universal vaccination is a public health policy good, given that the higher percentage of vaccinated children, the greater the herd immunity, there is always the nagging question of how far the state should go to mandate vaccination in a free society; i.e., how much coercion is acceptable to bring about maximal levels of vaccination? In other words, what is the proper balance between the needs of society as a whole and the rights of the individual? The next interesting legal and moral question is whether parents who refuse to vaccinate should be held liable for injuries to other children if their unvaccinated child passes on an infectious disease. Personally, I tend to believe that it is entirely reasonable to require vaccination as a precondition for school or day care and that exemptions should be primarily medical in nature. I grudgingly allow that the freedom of religion guaranteed in the First Amendment probably requires religious exemptions (although I do not understand why religion should be given such a privileged place in society that it can endanger public health), I am far less convinced that philosophical exemptions should be mandated. I realize many may disagree with this position, but I would hope that our disagreements would be based on (1) the best science regarding the benefits and risks of vaccination and (2) honest beliefs regarding the proper balance between public health concerns and individual liberty. Clearly, this is an area of debate. I also tend to believe that if parents refuse to vaccinate their child and that child passes an infectious disease to another child, then those parents should be potentially legally liable. Indeed, Douglas Diekema argues this position very well.

Unfortunately, Dr. Gordon does not meet at least condition #1 above. He does not base his arguments on the best science.
(more…)

Posted in: Politics and Regulation, Public Health, Vaccines

Leave a Comment (18) →

Dismantling NCCAM: A How-To Primer

Two of the earliest posts I wrote for Science-Based Medicine were entitled The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia and The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Both were intended as a lament over how not only is pseudoscientific quackery, much of it based on a prescientific understanding of how the human body works and disease occurs, finding its way into some of the most prestigious academic medical centers in the U.S. (for example, Georgetown and Beth Israel) but it’s even finding its way into the heart of the U.S. military.

Worse, aiding and abetting this infiltration is the federal government itself in the form of NCCAM. As I discussed in my usual excruciating detail in my original post and as Steve Novella, Kimball Atwood, and I have subsequently discussed many times on this very blog, particularly recently (so much so that I’m thinking of giving NCCAM its very own category here on SBM), NCCAM not only funds studies of dubious “alternative” therapies, such as reiki and homeopathy, that estimates of prior probability alone would argue to be so close to impossible as to be not worth spending millions, much less thousands, of dollars upon, but it also promotes quackery by funding “fellowships” at various institutions to teach “complementary and alterantive medicine” (CAM) sometimes also called “integrative medicine” (IM). Given that it spends over $120 million a year on mostly dubious studies and CAM promotion, we all have called for NCCAM to be defunded and disbanded.

Nearly a year has passed since I wrote those two posts. Ironically enough, at the time I wrote my first post about NCCAM for this blog, I pointed out that at first I had disagreed with my co-blogger Wally Sampson and his call to “defund” the NCCAM in an article published on Quackwatch nearly five years ago. My original reason was that I thought that there was value in studying these therapies to find out once and for all whether these therapies do anything greater than placebo or not. I now admit that I was very naive, and this was how I admitted it:

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine.

Nothing has changed since I wrote those words–except for one thing. We now have a new President who stated in his inaugural address:

We will restore science to its rightful place, and wield technology’s wonders to raise health care’s quality and lower its cost. We will harness the sun and the winds and the soil to fuel our cars and run our factories. And we will transform our schools and colleges and universities to meet the demands of a new age. All this we can do. And all this we will do.

As Kimball Atwood put it, Yes We Can! We Can Abolish the NCCAM! The big and as yet unasked (and unanswered) question is: How? Neither defunding nor dismantling NCCAM will be easy, and we have to think about how to preserve the functions of NCCAM that might be worth saving.
(more…)

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

Leave a Comment (27) →

Yes We Can! We Can Abolish the NCCAM!

…and in so doing, President Obama, you and we would abolish the NIH’s second most prodigious squanderer of precious research funds! Surprise: The National Cancer Institute (NCI) spends slightly more on humbug than does the Center created for that purpose. All told, the NIH squanders almost 1/3 of a billion dollars per year promoting pseudoscience.

I’ve decided to add my two cents to the recent groundswell of demand to stop this sordid and embarrassing chapter in NIH history—even more sordid and embarrassing, in its way, than NIH researchers being on the take: pseudoscience is exactly antithetical to the mission of the NIH, which sponsors it repeatedly, officially, overtly, unethically, and dangerously. At least, in the case of Big Pharma greasing the palms of NIH researchers, those involved generally prefer to obscure the transactions, as good sense and traditional mores dictate.

My comments will be somewhat different from others’, not because I disagree with theirs but because it’s worthwhile to stress points that have not been stressed or even mentioned. I won’t bother to justify the assertion that “promoting pseudoscience” is an accurate description of what the NCCAM and the OCCAM do, because I’ve done that several times in the past, beginning here and here, and more recently here. I will plagiarize myself a bit, but only to introduce certain points.

(more…)

Posted in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (30) →

More on the Bravewell issue

Being on the West Coast places me (and Harriet?) at disadvantage in responding to recent developments, as I find out about them later in the day, if that day. (Retirement doesn’t help.)

First I had some comments on the WSJ article on “CAM,” the NCCAM by Steve Salerno and the response by the pseudoscince leadership. The 4-author response revealed political tactics used by quacks and sectarian medicine advocates to answer with straw man points and especially to ignore what they cannot answer.

In their response to Salerno’s article they accused him of being unqualified to object to “CAM” because he was only a reporter. Fact was that most of his points were from my writings, which Slerno frankly acknowledged. The several rebutting authors never mentioned my name. Of course not. (That it was lost in the SBM analyses is understandable.)

And that is the frank dishonesty we are dealing with when we face off with these characters, who now have the ears and eyes of the Institute of Medicine, academic deans and professors, and government. They are smiling as they read this.
(more…)

Posted in: Basic Science, Health Fraud, Medical Academia, Politics and Regulation, Science and Medicine

Leave a Comment (10) →
Page 30 of 37 «...10202829303132...»