Articles

Archive for Politics and Regulation

Evidence-Based Legislation? Lessons From Abroad

President Obama appears to be refreshingly pro-science in his outlook, publicly lauding objectivity and careful analysis. He has even been credited with saying that “we need evidence-based legislation” in regards to public policy. The New York Times reports:

Agencies will be expected to pick science advisers based on expertise, not political ideology, the memorandum said, and will offer whistle-blower protections to employees who expose the misuse or suppression of scientific information.

The idea, the president said in remarks before an audience of lawmakers, scientists, patients advocates and patients in the East Room, is to ensure that “we make scientific decisions based on facts, not ideology”: a line that drew more applause than any other.

But when it comes to healthcare reform, many policy decisions put us in uncharted territory, with intelligent arguments on both sides of many legislative options and no American historical frame of reference to help us determine the best course of action. In times like these, perhaps the best we can do (to promote “evidence-based legislation”) is to study similar policy decisions made by our Canadian and European counterparts.

(more…)

Posted in: Politics and Regulation

Leave a Comment (72) →

The GAO Report on Supplement Regulation

We advocate for Science-Based Medicine partly because science incorporates various generic intellectual virtues to which everyone should aspire. These include logical and clear thinking, unambiguous definitions, and internal consistency. In fact it is demonstrably true that opposing science often equates to promoting muddied and sloppy thinking, ambiguous language, and self-contradiction.

Last week I wrote about that latter virtue – consistency – and its lack when dealing with regulating physicians vs regulating so-called complementary and alternative medicine (CAM). In fact CAM exists, in my opinion, specifically to create a double-standard to disguise contradictory standards. It is institutionalized compartmentalization to minimize public cognitive dissonance.

This week, as promised, I will discuss how the same double standard has been made to apply to the regulation of supplements vs pharmaceuticals. The recently published Government Accountability Office (GAO) report on supplement regulation by the FDA brings this to light.

(more…)

Posted in: Herbs & Supplements, Politics and Regulation

Leave a Comment (9) →

NCCAM is a victim of its own history

Let me begin with a story. An assistant professor submits a reasonable application to NCCAM to investigate the potential metabolic and pharmacodynamic interactions of St. Johns wort with conventional chemotherapy. This was the year or year-and-a-half before SJW was known to have significant CYP3A4 inductive activity due primarily to its component, hyperforin. Said investigator used this preliminary data, not explicitly required for theNIH funding mechanism (called an R21), to question whether St. John’s wort used by depressed cancer patients might interfere with chemotherapy. The original proposal earned a priority score of 228 (as with golf, the lower the better: the best is 100, the worst is 500.)

The major reviewer critique was that the assistant professor, Your Humble Pharmacologist, lacked, at the time, significant natural products chemistry expertise. YHP was then doing his sabbatical in the NC Research Triangle area and wisely sought the support and expertise of the now-late Dr. Monroe Wall and surviving Dr. Manuskh Wani. These gentlemen discovered and solved the structures of taxol from Taxus brevifolia and camptothecin from Camptotheca acuminata. Taxol itself became a blockbuster drug for Bristol-Myers Squibb while camptothecin required water-soluble modifications to foster topotecan (Hycamptin) and irinotecan (Camptosar) that collectively saved or prolonged the lives of thousands of men and women subjected to breast, ovarian, lung, and gastrointestinal tumors. In 2003, they received the designation of an American Chemical Society National Historic Chemical Landmark for their three decades of work in this area. (Sadly, they received none of the profits from these drugs as their discoveries pre-dated the Bayh-Dole Act that allowed NIH funded researchers to share in the revenues of intellectual property emerging from their work.).

Being a savvy young investigator, I sought and enlisted the assistance and support of Dr. Wall and colleagues to provide my team with world-class, natural products expertise. Stunningly, the subsequent application was awared a score of 345 (*much worse than the original) with the criticism from reviewers that all Dr. Wall did was to lend a drug development aspect to an otherwise “herbal” applicaton.

To this day, I cannot fathom who better I could have sought for natural products expertise on this grant application.

Since then, three of my colleagues and I have submitted 13 applications to NCCAM, including an application for a comprehensive Botanical Research Center grant. All 13 received unfundable scores. Among these was a 279-page application for a NCCAM Botanical Research Center – reviewed but not discussed by the evaluation panel.

Nonetheless, I have taken the approach that if NCCAM were to continue its existence, I would try to be part of the solution.  I have accepted several invitations to review research and training grants for NCCAM and I am pleased to say that one or two projects that I ranked highly ended up being very productive, specifically in the area of natural products and traditional herbal medicines.  I also have some friends and valued colleagues who contribute to the scientific integrity of NCCAM. However, my collective experiences lead me to believe that they are voices quenched by the vast wilderness of the promotion and advocacy of “integrative medicine” and CAM.
(more…)

Posted in: Basic Science, Herbs & Supplements, Politics and Regulation, Science and Medicine

Leave a Comment (19) →

Lies, Damned Lies, and ‘Integrative Medicine’

Last week, two events took place in Washington that ought to inspire trepidation in the minds of all who value ethical, rational, science-based medicine and ethical, rational, biomedical research. One was the Senate Panel titled Integrative Care: A Pathway to a Healthier Nation, previously discussed by my fellow bloggers David Gorski, Peter Lipson, and Steve Novella, and also by the indefatigable Orac (here and here); the other was the ”Summit on Integrative Medicine and the Health of the Public“ convened by the Institute of Medicine (IOM) and paid for by the Bravewell Collaborative, previewed six weeks ago by fellow blogger Wally Sampson. This post will make a few additional comments about those meetings.

Senator Harkin and the Scientific Method

Thanks to Dr. Lipson, I didn’t have to listen to the Senate Panel video to find out that Senator Tom Harkin (D-Iowa) made this statement of disappointment regarding his own creation, the National Center for Complementary and Alternative Medicine (NCCAM):

One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving. (from last week’s hearings, time marker approx. 17:20)

Are scientists at the NIH really too afraid of Harkin to explain to him how science works? Apparently so. Otherwise Harkin might learn that his statement is more wrong-headed than it would be for one of us to complain that the Supreme Court ought to assume that a defendant is guilty until proven innocent, rather than the other way around. In scientific inquiry, for those who don’t know, good experimental design is always directed at disproving a hypothesis, even one that pleases its investigator. The rest of Harkin’s sentiment—”seeking out and approving”—is incoherent.

The Selling of ‘Integrative Medicine’: Snyderman Trumps Weil

Spin doctors shilling for ‘integrative medicine,’ which the NCCAM defines as “combining treatments from conventional medicine and CAM,” appear to have now decided that subtler language is more likely to sell the product. We’ve previously seen an example offered by ‘integrative’ Mad Man Andrew Weil:

(more…)

Posted in: Medical Academia, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Science and the Media, Vaccines

Leave a Comment (41) →

Wyeth Vs. Levine: Joe Six Pack Trumps The FDA

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug -  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here are the highlights from the interview (a podcast is available here)…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

(more…)

Posted in: Pharmaceuticals, Politics and Regulation

Leave a Comment (18) →

Double Standards – Newsweek and Tom Harkin

There has been a flurry of news relevant to science-based medicine in the last week – more than enough to keep a bevy of bloggers busy. More important than the individual news items themselves is the striking pattern they bring into focus when viewed together – the growing and pernicious double-standard between mainstream medicine and so-called CAM.

Begley vs Doctors

Science editor Sharon Begley wrote an interesting piece in Newsweek with the provocative title: Why Doctors Hate Science.  I was not particularly impressed with the article – it took a rather narrow approach to a complex problem and ran with it. She writes:

It’s hard not to scream when you see how many physicians, pharmaceutical companies, medical-device makers and, lately, hysterical conservatives seem to hate science, or at best ignore it. These days the science that inspires fear and loathing is “comparative-effectiveness research” (CER), which is receiving $1 billion under the stimulus bill President Obama signed. CER means studies to determine which treatments, including drugs, are more medically and cost-effective for a given ailment than others.

(more…)

Posted in: Politics and Regulation, Public Health

Leave a Comment (10) →

Tom Harkin’s War on Science (or, “meet the new boss…”)

This was cross-posted at White Coat Underground, despite the topic having been covered by Dr. Gorski yesterday. The topic is important enough that many of us in the medical blogosphere are going to be talking about this.

Remember when President Obama said something about returning science to it’s rightful place? Well, our new president has a real tough climb ahead of him. The previous administration shoved science aside for political expediency and religious ideology. Now, forces in the president’s own party are trying to insert their own quasi-religious beliefs into health care reform, leaving science in a whole different place altogether.

Here’s the deal. Some years back, Senator Tom Harkin (D-IA) helped set up the National Center on Complementary and Alternative Medicine (NCCAM). The whole idea of setting up such an agency is a bit quixotic—after all, the National Institutes of Health already study health science. As my colleagues and I have written many times before, the very idea of the agency seems ridiculous. Many, many studies have been funded which fail basic tests of plausibility and ethical propriety. Also, a huge percentage of the studies funded fail to ever publish their results. Still, some studies have been published, and more often than not, they find that the “alternative” modality being studied fails to behave better than placebo. That’s probably the sole redeeming quality of the agency, but not enough to keep it open, as these studies could have been done under the auspices of the NIH.

It turns out that Senator Harkin agrees with me on one point: NCCAM is failing to validate many alternative modalities. The difference is that I find it heartening and Harkin finds it disturbing:

“One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.”(from last week’s hearings, time marker approx. 17:20)

Well, at least he’s honest. He comes right out and bemoans the fact that science hasn’t upheld his quasi-religious medical beliefs. He just doesn’t get it. If you choose to investigate a scientific question, you have to be prepared for “bad news”. You don’t get to decide the outcome before the fact.

But Harkin makes his goals very clear, from his prepared statement, to the “experts” from whom he took testimony.
(more…)

Posted in: Politics and Regulation, Science and Medicine

Leave a Comment (20) →

Senator Tom Harkin: “Disappointed” that NCCAM hasn’t “validated” more CAM

Senator Tom Harkin (D-Iowa) owes me a new irony meter.

I’ll explain in a minute, but first you have to know why I even care about what Harkin says or does, given that he’s not my Senator. As you may recall, arguably no single legislator in the U.S. has done more to harm to the cause of promoting science- and evidence-based medicine than Tom Harkin. That’s because it was primarily through Harkin’s efforts that the National Institutes of Health, despite the fact that its scientists were not agitating for it, had the National Center for Complementary and Alternative Medicine (NCCAM) rammed down its throat in 1992, first as the Office of Alternative Medicine (OAM), then in 1998, when NIH Director Harold Varmus tried to place OAM under more scientific NIH control, by elevating OAM to a full and independent Center within the NIH. Thus was NCCAM born.

I’ve complained many times about how NCCAM funds studies that, let’s face it, are of pseudoscience and quackery (homeopathy, anyone?) and even more about how it promotes unscientific medical practices. I’ve argued time and time again that there is no research that is funded by NCCAM that couldn’t be dealt with as well or better by other Centers or Institutes within the NIH. I’ve even argued that NCCAM should be defunded and dismantled, allowing CAM grant applications to be evaluated by the most appropriate center, as has our fearless leader Steve Novella. Most vociferous of all has been my fellow SBM blogger Kimball Atwood, who has made similar arguments at even greater length. I’ve also pointed out Harkin and other CAM-friendly legislators created and managed to increase the funding of NCCAM to the tune of $120+ million a year not for the purpose of rigorous scientific evaluation of CAM practices, but rather to promote CAM and ultimately “integrate” it with scientific medicine. At this they have been enormously successful.

Let me clarify. What I meant is that NCCAM, along with the Bravewell Collaborative, has been very successful in popularizing CAM in medical academia; at “proving” that CAM works, not so much. Evidence that this is so comes from a recent observation that Senator Tom Harkin is very, very unhappy with NCCAM these days and has publicly said so recently, as pointed out by Lindsay Beyerstein, daughter of the late, great skeptical psychologist Barry Beyerstein. On Thursday, Harkin told a Senate panel, Integrative Care: A Pathway to a Healthier Nation, that he was disappointed that NCCAM had disproven too many alternative therapies. (His remarks begin about 17 minutes into the video on the webpage to which I linked.) In addition, Harkin’s statements have also been posted to his Senate blog:
(more…)

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

Leave a Comment (24) →

How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
(more…)

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

Leave a Comment (21) →

2009: Shaping up to be a really bad year for antivaccinationists

I will begin this post with a bit of an explanation. Between one and two weeks ago, there appeared two momentous news about the manufactroversy regarding vaccines and autism. No doubt, many SBM readers were expecting that I, as the resident maven of this particular bit of pseudoscience, would have been here last week to give you, our readers, the skinny on all of this. Unfortunately, as some know, my wife’s mother died, coincidentally enough, on the 200th anniversary of Darwin’s birthday and a day when one of those two momentous bits of news was released to the public, which is why I used one of my handful of posts written and then held in reserve. I’m back now, though, and I don’t think it’s too late to comment on these bits of news because now that over a week has gone by what I’ve seen has led me to draw some conclusions that I might not have been able to do, had I done my usual bit and been first off the mark (at least among SBM bloggers) discussing the story.

2008: The Best of Years for the Antivaccine Movement

But first, let’s take a look at last year. In 2008, Jenny McCarthy was the new and fresh celebrity face of the movement that believes that autism and all manner of other neurodevelopmental disorders are caused by vaccines and that the government and big pharma are suppressing The Truth. She had emerged in the fall of 2007 after having tried to erase from the Internet her previous involvement in the “Indigo Child” movement in preparation for becoming an “autism advocate” who could write a book that could land her on Oprah’s show. Thanks to her and, perhaps even more so to the star power of her boyfriend Jim Carrey, who is just as wrong about vaccines and medicine as Jenny is, the antivaccine movement came roaring into prominence in a way that it had never managed to pull off before. After all, let’s face it, a former Playboy Playmate of the Year and a famous comedian are far more “interesting” public figures for various media outlets to interview than previous celebrities who spearheaded the vaccine manufactroversy, such as Robert F. Kennedy, Jr. or Don Imus and his wife Deirdre.

Indeed, Jenny’s combination of good looks and utter obnoxiousness led to her showing up all over the media in 2008. For example, on April 1 (appropriately enough), she appeared on Larry King Live! and shouted down physicians who had the temerity to tell her that her Google University knowledge was just plain wrong. The pinnacle of her influence came during the summer, when, having now supplanted J.B. Handley as the public face of the antivaccine group Generation Rescue and transforming GR into “Jenny McCarthy’s autism charity,” she led the “Green Our Vaccines” rally in Washington, DC. True, at most there were several hundred people there, but it got wide news attention, and Jenny was all over the news. She rapidly followed it up by releasing a second book Mother Warriors: A Nation of Parents Healing Autism Against All Odds and appearing on The Oprah Winfrey Show yet again.
(more…)

Posted in: Politics and Regulation, Public Health, Science and Medicine, Science and the Media, Vaccines

Leave a Comment (85) →
Page 29 of 37 «...10202728293031...»