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What We Can Learn From Another Disproven Herbal Remedy (Ginko Biloba)

Another one bites the dust.

The National Center for Complementary and Alternative Medicine (NCCAM) is generally a waste of taxpayer money, but they have sponsored several well-designed large trials of popular herbal supplements. And one by one these studies have shown these popular products, such as echinacea for the common cold, to be ineffective.

To add to the list, published in JAMA this week are the results of the largest and longest trial to date of Gingko biloba for the improvement of cognitive function and to treat, prevent, or reduce the effects of Alzheimers disease or other dementia. The results of the study are completely negative. Read more »

*This blog post was originally published at Science-Based Medicine*

The Decade’s Top 5 Threats To Science In Medicine

As 2009 comes to an end, it seems that everyone is creating year-in-review lists. I thought I’d jump on the list band wagon and offer my purely subjective top 5 threats to rational thought in healthcare and medicine.

Of course, it strikes me as rather ironic that we’re having this discussion – who knew that medicine could be divorced from science in the first place? I thought the two went hand-in-hand, like a nice antigen and its receptor… and yet, here we are, on the verge of tremendous technological breakthroughs (thanks to advances in our understanding of molecular genetics, immunology, and biochemistry, etc.), faced with a growing number of people who prefer to resort to placebo-based remedies (such as heavy-metal laced herbs or vigorously shaken water) and Christian Science Prayer.

And so, without further ado, here’s my list of the top 5 threats to science in medicine for 2009 and beyond: Read more »

*This blog post was originally published at Science-Based Medicine*

Why Dr. Rich Is Encouraged By Alternative Medicine

It is quite popular among certain medical bloggers, who count themselves as scientifically sophisticated, to disparage so-called “alternative medicine.”

Indeed, there are entire websites devoted to demonstrating (in homage to Penn and Teller) that various forms of alternative medicine – such as homeopathy, therapeutic touch, the medical application of crystals, Reiki, naturopathy, water therapy, bio-photons, mindfulness training, energy healing and a host of others – are completely devoid of any scientific merit whatsoever; are pablum for the uneducated masses; are, in short, irreducibly and unredeemably woo.

These same medical authors are scandalized into virtual apoplexy by the fact that the NIH has funded an entire section to “study” alternative medicine, and worse, that most respected university medical centers in the land now seem to have embraced alternative medicine, and have established well-funded and heavily-marketed “Centers for Integrative Medicine” (or other similarly-named op-centers for pushing medically suspect alternative “services”).*

Until quite recently, DrRich counted himself among the stalwarts of scientific strict constructionism. He was truly dismayed that the NIH and some of our most well-regarded academic centers (under the guise of wanting to conduct objective “studies” of alternative medicine) have lent an aura of respectability and legitimacy to numerous bizarre ideas and fraudulent claims masquerading as legitimate medical practices. To DrRich, such developments were yet another clear and unmistakable sign of the End Times.

Furthermore, DrRich (a well-known paranoid when it comes to covert rationing) saw a more sinister advantage to the official and well-publicized support that government-funded institutions were giving to the alternative medicine movement. Namely, fostering a widespread impression among the unwashed rabble that alternative medicine is at least somewhat legitimate (and plenty respectable) will further the cause of covert rationing. That is, the more people who can be enticed to seek their diagnoses and their cures from the alternative medicine universe, where they are often spending their own money, the less money these people will soak up from the real healthcare system. With luck, real diagnoses can be delayed and real therapy put off until it’s far too late to achieve a useful outcome by more traditional (and far more expensive) medical means.

So, for several years alternative medicine was seen by DrRich pretty much as it is seen by all of the anti-woo crowd – as an unvarnished evil.

But in recent days the scales have fallen from DrRich’s eyes. He now realizes he was sadly mistaken. Rather than a term of opprobrium, “alternative medicine” may actually be our most direct road to salvation. Indeed, DrRich thinks that far from damning alternative medicine, we should be blessing it, nurturing it, worrying over it, in the precise manner that a mountaineer trapped in a deadly blizzard would worry over the last embers of his dying campfire.

What turned the tide for DrRich was a recent report, issued by the U.S. Centers for Disease Control and Prevention, estimating that in 2007, Americans spent a whopping $34 billion on alternative medicine. Even more remarkably, a goodly chunk of this money was paid by Americans themselves, out of their own pockets.

The implications of this report should be highly encouraging to those of us who lament the impending creation of a monolithic government-controlled healthcare system, and who have been struggling to imagine ways of circumventing the legions of stone-witted, soul-eating bureaucrats now being prepared (Sauron-like) to descend upon us all, doctor and patient alike.

This is why DrRich has urged primary care physicians to break the bonds of servitude while they still can, strike out on their own, and set up practices in which they are paid directly by their patients. Such arrangements are the only practical means by which individual doctors and patients can immediately restore the broken doctor-patient relationship, and place themselves within a protective enclosure impervious to the slavering soul-eaters.

One reason so few primary care doctors have taken this route (choosing instead to retire, to change careers and become deep-sea fishermen, or simply to give up and become abject minions of the forces of evil) is that they do not believe patients will actually pay them out of their own pockets.

Well, ladies and gentlemen, this new report from the CDCP demonstrates once and for all that Americans will, indeed, pay billions of dollars from their own pockets for their own healthcare – even the varieties of healthcare whose only possible benefits are mediated by the placebo effect.  DrRich believes that many of the people buying homeopathic remedies are doing so less because they believe homeopathy works, and more because they feel abandoned by the healthcare system and by their own doctors, and realize they have to do SOMETHING. The CDCP report, in DrRich’s estimation, reflects the magnitude of the American public’s pent-up demand for doctors whose chief concern is for them, and not for the demands of third party payers.

Perhaps more importantly, this new report implies that it will be somewhat more difficult than DrRich previously believed for the government to outlaw private-sector healthcare activities. Creating a monolithic government-controlled healthcare system would naturally require the authorities to make it illegal for Americans to spend their own money on their own healthcare, thus rendering direct-pay medical practices illegal, and putting the final stake into the heart of the doctor-patient relationship. But the rousing success of the alternative medicine universe will make such laws difficult to enact.

To see why, consider just how encouraging this new CDCP report must be to the third-party payers. Thanks in no small part to the efforts of the government (and the academy) to legitimize alternative medicine, Americans are spending $34 billion a year on woo. This amount indicates tremendous savings for the traditional healthcare system. The actual amount saved, of course, is impossible to measure, but has to be far greater than just $34 billion. Some substantial proportion of patients spending money on alternative medicine, had they chosen traditional medical care instead, might have consumed expensive diagnostic tests, surgery, expensive prescription drugs, and other legitimate medical services. Furthermore, those legitimate medical services (as legitimate medical services are wont to do) often would have generated even more expenditures – by extending the survival of patients with chronic diseases, by identifying the need for even more diagnostic and therapeutic services, and by causing side effects requiring expensive remedies. (While alternative medicine is famous for being useless, it is also most often pretty harmless, and tends to produce relatively few serious side effects – except, of course, for causing a delay in making actual diagnoses and administering useful therapy, but that’s a good thing if you’re a payer.) So the amount of money the payers actually save thanks to alternative medicine must be some multiplier of the amount spent on the alternative medicine itself.

What this means is payers (which under a government system means the government) will be loathe to do anything that might discourage the success and growth of alternative medicine, and this fact alone may stop them from making it illegal for Americans to pay for their own healthcare.

Still, we musn’t be too sanguine about these prospects. Under a government-controlled system, the imperative to control every aspect of healthcare (in the name of fairness) will be very, very strong. It is easy to envision the feds declaring several varieties of alternative medicine to be covered services, so people wouldn’t have to buy alternative medicine themselves.

But alternative medicine (bless it) will be impervious to government control. Practitioners of alternative medicine aren’t doing what they are doing in order to be subject to federal regulation and bureaucratic meddling. If the feds declare, say, homeopathy and therapeutic touch to be legitimate, covered services under the universal health plan, why, the alternative medicine gurus will simply come up with entirely new forms of alternative medicine specifically to remain outside the universal plan. (New varieties of alternative medicine already appear with dizzying speed, and can be invented at will. No bureaucracy could ever hope to keep up.)

Therefore, as long as the central authorities depend on alternative medicine as a robust avenue for covertly rationing healthcare, the purveyors of woo will always be able to flourish outside the real healthcare system. And this, DrRich believes, represents the ultimate value of woo, and establishes why we should all be encouraging and nurturing woo instead of disparaging it.

DrRich has speculated before on various black market approaches to healthcare which could be attempted by American doctors (and investors) should restrictive, government-controlled healthcare become a reality.  Some of these were: medical speakeasies; floating off-shore medical centers on old aircraft carriers; medical centers just south of the border (the establishment of which, at last, would stimulate the feds to seal the borders against illegal passage once and for all); and combination medical center/casinos on the sovereign land of Native American reservations.

But now, thanks to the success of alternative medicine, there is a direct and straightforward path for American primary care physicians to practice a form of now-long-gone “traditional” American medicine, replete with a robust doctor-patient relationship, right out in the open. Simply declare this kind of practice to be a new variety of alternative medicine. Likely, you will need to come up with a new name for it (such as “Therapeutic Allopathy,” or “Reciprocal Duty Therapeutics”), and perhaps invent some new terminology to describe what you’re doing. But what you’re actually doing will be so fundamentally different from what PCPs will be doing under government-controlled healthcare as to be unrecognizable, and nobody will be able to argue it’s not alternative medicine. In fact, it will seem nearly as wierd as Reiki.

Alternative medicine, in other words, will provide American doctors who want to practice the kind of medicine they should be and want to be practicing with the cover they need to do so. And this is why we must support medical woo, and celebrate its continued growth and success.

* A list of these academic medical institutions now sporting Centers of Woo is maintained by Orac, and can be found here. The length of Orac’s cavalcade of woo, and the famous names appearing on it, is truly stunning. The sinking feeling one gets from looking at Orac’s list can only be surpassed by actually clicking on a few of the links he provides, and sampling some of the actual woo-sites offered by these prestigious academic centers, which read like excerpts of some of the more unguarded moments from Oprah, or even the Huffington post.

*This blog post was originally published at The Covert Rationing Blog*

Political Meddling Forces Approval Of Dangerous Clinical Trial (TACT)

In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

Why Non-Scientists Should Not Direct Scientific Efforts: Senator Harkin’s Misguided Beliefs Exposed

I’ve been blogging a lot recently about the problems caused by health policy makers who don’t appear to understand medicine or science. I’ve also been lamenting the relative lack of physician input at the highest level of health reform. But today I’d like to present a prime example of the perfect storm in health policy: when willfulness, ignorance, and magical thinking combine to push an agenda despite billions of tax payer research dollars proving the futility of such efforts.

In this video, Senator Tom Harkin describes the impetus behind the creation of the National Center for Complementary and Alternative Medicine (NCCAM). Harkin suggests that he single-handedly introduced legislation in 1992 that created the Office of Alternative Medicine at the National Institutes of Health (NIH). This office paved the way for an entire new branch of research at NIH devoted to exploring the potential validity of non-science based medical practices such as homeopathy, acupuncture, traditional Chinese medicine, energy healing, meditation and more. He introduced the legislation because a friend of his experienced a substantial health improvement after trying one of these non-science based therapies. Essentially, an entire branch of the NIH was founded on an anecdote.

What’s worse is that after a decade of careful analysis of these alternative therapies, science has shown that not a single one of them appears to be efficacious beyond placebo. One would think that Senator Harkin would be embarrassed by the colossal waste of tax payer resources spent on this pet project of his. But no, instead he chastises the scientists who did the research, saying that they had failed to do their job of “validating” the therapeutic modalities. Wow. I guess he was never interested in finding out the truth about what works and what doesn’t – because when objective analysis reveals that these modalities don’t work, then the science must be flawed.

Now don’t get me wrong – healthy eating, regular exercise, emotional and psychological support are critical factors in good healthcare, and I fully believe that America needs to become a “wellness culture” in order to prevent chronic diseases and improve quality of life. I also believe that Americans are often over-treated and over-medicated when lifestyle interventions might be their best treatment option. However, in encouraging behavior modifications, we don’t need to foist placebo therapies on them under the banner of science. The problem with “integrative medicine” is that it takes some good medical principles and infuses them with scientifically debunked and outdated systems of thought (debunked repeatedly by NCCAM, the very scientific body that Harkin hoped would validate them.)

What we really need to do is stop splitting the practice of medicine into “integrative” vs “non-integrative” and simply follow scientifically vetted best practices. Patients need a comprehensive approach to their health, a medical home with a good primary care physician coordinating their care, reliable health information to support their decision-making, a strategy to eat well and exercise regularly, and mental health services as needed.

Senator Harkins’ plan to continue flogging the alternative medicine “dead horse” is not helpful – it’s not good science, and it’s not a good way to spend our tax dollars. I can only hope that one of the positive effects of Comparative Clinical Effectiveness Research will be to put an end to the promotion of the ineffective therapies that Harkin fervently hoped would be validated. I also hope that the new Federal Coordinating Council will not support funding to pet projects that are founded upon anecdotes, pseudoscience, and wishful thinking. Now more than ever we need good science underpinning our healthcare spending, and we need informed scientists advising our government on priorities for America’s health.

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Addendum:

More outrage from the medical blogosphere over Harkin’s views:

1. Dr. David Gorski:  Senator Tom Harkin: “Disappointed” that NCCAM hasn’t “validated” more CAM

2. Dr. Peter Lipson: Harkin’s War On Science

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Richmond, VA – In an effort to simplify inpatient medical billing, one area hospitalist group has determined that “altered mental status” (ICD-9 780.97) is the most efficient code for use in any patient work up.

“When you enter a hospital, you’re bound to have some kind of mental status change,” said Dr. Fishbinder, co-partner of Area Hospitalists, PLLC. “Whether it’s confusion about where your room is located in relationship to the visitor’s parking structure, frustration with being woken up every hour or two to check your vital signs, or just plain old fatigue from being sick, you are not thinking as clearly as before you were admitted. And that’s all the justification we need to order anything from drug and toxin screens, to blood cultures, brain MRIs, tagged red blood cell nuclear scans, or cardiac Holter monitoring. There really is no limit to what we can pursue with our tests.”

Common causes of mental status changes in the elderly include medicine-induced cognitive side effects, disorientation due to disruption in daily routines, age-related memory impairment, and urinary tract infections.

“The urinalysis is not a very exciting medical test,” stated Dr. Fishbinder. “It doesn’t matter that it’s cheap, fast, and most likely to provide an explanation for strange behavior in hospitalized patients. It’s really not as elegant as the testing involved in a chronic anemia or metabolic encephalopathy work up. I keep it in my back pocket in case all other tests are negative, including brain MRIs and PET scans.”

Nursing staff at Richmond Medical Hospital report that efforts to inform hospitalists about foul smelling urine have generally fallen on deaf ears. “I have tried to tell the hospitalists about cloudy or bloody urine that I see in patients who are undergoing extensive work ups for mental status changes,” reports nurse Sandy Anderson. “But they insist that ‘all urine smells bad’ and it’s really more of a red herring.”

Another nurse reports that delay in diagnosing urinary tract infections (while patients are scheduled for brain MRIs, nuclear scans, and biopsies) can lead to worsening symptoms which accelerate and expand testing. “Some of my patients are transferred to the ICU during the altered mental status work up,” states nurse Anita Misra. “The doctors seem to be very excited about the additional technology available to them in the intensive care setting. Between the central line placement, arterial blood gasses, and vast array of IV fluid and medication options, urosepsis is really an excellent entré into a whole new level of care.”

“As far as medicine-induced mental status changes are concerned,” added Dr. Fishbinder, “We’ve never seen a single case in the past 10 years. Today’s patients are incredibly resilient and can tolerate mixes of opioids, anti-depressants, anti-histamines, and benzodiazepines without any difficulty. We know this because most patients have been prescribed these cocktails and have been taking them for years.”

Patient family members have expressed gratitude for Dr. Fishbinder’s diagnostic process, and report that they are very pleased that he is doing everything in his power to “get to the bottom” of why their loved one isn’t as sharp as they used to be.

“I thought my mom was acting strange ever since she started taking stronger pain medicine for her arthritis,” says Nelly Hurtong, the daughter of one of Dr. Fishbinder’s inpatients. “But now I see that there are deeper reasons for her ‘altered mental status’ thanks to the brain MRI that showed some mild generalized atrophy.”

Hospital administrators praise Dr. Fishbinder as one of their top physicians. “He will do whatever it takes to figure out the true cause of patients’ cognitive impairments.” Says CEO, Daniel Griffiths. “And not only is that good medicine, it is great for our Press Ganey scores and our bottom line.”

As for the nursing staff, Griffiths offered a less glowing review. “It’s unfortunate that our nurses seem preoccupied with urine testing and medication reconciliation. I think it might be time for us to mandate further training to help them appreciate more of the medical nuances inherent in quality patient care.”

Dr. Fishbinder is in the process of creating a half-day seminar on ‘altered mental status in the inpatient setting,’ offering CME credits to physicians who enroll. Richmond Medical Hospital intends to sponsor Dr. Fishbinder’s course, and franchise it to other hospitals in the state, and ultimately nationally.

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Click here for a musical take on over-testing.

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