Is conventional medicine a cult?

Journalist and health crusader Mike Adams recently blasted conventional medicine with a tirade entitled The false gods of scientific medicine revealed: It's a cult, not a science. I would have dismissed the article (pointed out by Science Blogger Mark Hoofnagle) as just another piece of anti-science trash but for something that piqued my interest in a certain way.

Let me explain. I have long puzzled over some activist groups which criticize the pharmaceutical industry for its corrupting influence on science but are silent (or worse yet, promotional) concerning the implausible and unproven claims of alternative medicine. Adams’s article may help resolve the inconsistency. It reinforces an idea I considered before when I tried to reconcile the American Medical Student Association’s Pharm Free campaign with its promotion of quackery: that the purveyors of pseudoscientific woo share a common mindset with anti-Pharma activists. As I posted on this subject about a year ago:

That suggests a common thread in the AMSA’s seemingly contradictory positions: the notion that Big Pharma is leading a medical-industrial conspiracy to suppress research in (and the integration of) alternative methods.

Adams’s depiction of mainstream medicine as a cult certainly has a conspiratorial flavor. (And if you wonder whether or not he pushes woo, decide for yourself after you take a gander at his web site).

So, let’s examine some of the claims in the article. From the opening paragraph:

…what passes for "science" today is a collection of health myths, half-truths, intellectual dishonesty, self delusion, fraudulent reporting and wishful thinking.

Though Adams engages in a bit of hyperbole here I’ll meet him half way and acknowledge that there are some shortcomings in the application of conventional medical science. The problem is, aside from a few testimonials his arguments for his own incredible health claims amount to little more than bashing mainstream medicine with exaggerated and often baseless statements, such as:

This is how doctors have come to believe the incredible: That food has nothing to do with health, that antioxidants will kill you, that herbs interfere with drugs, and that only drugs can treat or cure disease.

These straw man positions have been advanced many times before. It would be amusing, I’m sure, to see Adams try and provide evidence that doctors believe food has nothing to do with health or only drugs cure disease.

Adams goes on---

Mainstream media stories that parrot the cult-like beliefs of conventional medicine are the singing of the church choir, and the altar boys getting sodomized in the back room by high priests are like the public being chemically assaulted by pharmaceuticals. (A kind of "medical violence" perpetrated against the general public.)

And there’s this:

All drugs get an automatic thumbs up, no matter how ludicrous the underlying science, while all natural therapies are automatically and routinely criticized by skeptics who equate their own lack of understanding with proof that something mysterious can't possibly work. They say homeopathy can't work, for example, simply because they can't find any mechanism to explain how it could work.

Well, not quite. Many drugs have been rejected by mainstream science, based on clinical trials. As for homeopathy, the “mechanisms” that have been purported have no plausible basis in chemistry or physics.

Rather than pick apart the rest of the article I’ll jump down to this little gem:

Cholesterol drugs, for example, may artificially lower cholesterol numbers, but they completely ignore the root cause of elevated cholesterol. This is why cholesterol drugs have been scientifically proven worthless in preventing heart attacks or other fatal cardiovascular events.

One little problem with that. It disregards the overwhelming evidence proving cholesterol drugs quite effective in preventing heart attacks and other fatal cardiovascular events.

The piece concludes with:

After the collapse of Western medicine, real health care will inevitably end up returning to its roots: The healing power of nature.

The irony of that statement is that all too many of today’s “natural” healing claims are based on anything and everything but an understanding of nature.

By the way, Hoofnagle’s post does a good job of debunking Adams’s claims about chemotherapy and biomarkers.

Texas medical board plans to fingerprint doctors

This will include new applicants and currently licensed physicians. KTVT channel 11, Dallas, Fort Worth reports:

The call for mandatory background checks comes in the wake of a CBS 11 investigation which uncovered that a registered sex offender was honored by the Texas Legislature as their “Doctor of the Day” twice over the past two years.

Given the flood of applications to practice in Texas following tort reform, this will be quite a task.

Management of heat stroke

This topic is timely and of increasing importance, what with global warming and all. Critical Care has a nice review. Good studies are in short supply, but it appears that the management, in terms of optimal cooling methods and hemodynamic support may differ between classic heat stroke and exertional heat stroke.

By the way, in applying published literature to treatment, Google calculator may come in handy.

Pacemaker information for patients and physicians

There’s a huge repository if information here.

Radiopaedia---an open radiology resource

This site is relatively new and appears to be a wiki of sorts.

Psychiatrists arise!

Shame people into saving the planet! I thought psychiatrists were supposed to be about the business of relieving mental anguish. Not necessarily so when it comes to environmental concerns, says Dr. Steven Moffic, Professor of Psychiatry at the Medical College of Wisconsin in a MedGenMed video editorial:

Therefore, instead of using psychiatric insight and techniques to reduce excessive anxiety, shame, and guilt for global warming these emotions will need to be increased in the unconcerned. This kind of 'help' runs counter to our usual goal of not making people feel worse!

Practicing doctors’ reactions to Avandia controversy predictable

Many will be switching patients to insulin according to a survey. What’s this going to do to the problem of insulin resistance and the metabolic syndrome?

Prescription fish oil

Prescription fish oil (Omacor) is approved in the U.S. for treatment of patients with very high triglyceride levels. In some other countries it is also approved for secondary prevention following myocardial infarction.

A review of prescription omega-3 fatty acids in the American Journal of Health-System Pharmacy addresses both indications as well as issues relating to safety, tolerability, drug interactions and the use of non-prescription (supplement) forms of fish oil.

Takotsubo cardiomyopathy

Here is a presentation of 4 cases and literature discussion in the Texas Heart Institute Journal. It’s one of the brain-heart conditions I discussed here.

Where did you get your MD?

---asks emergency physician Edwin Leap.

So here is our announcement. Attention patients and families of patients, regulators, government officials, commentators, angry bloggers, and reporters: I am the physician. That makes me the expert. I realize that we live in the age of polls, surveys, empowerment, and self-help. I realize that the opinion of the masses generally matters more than the opinion of the educated. But as one of the educated, as one of those who considers his opinion more valid than many others, let me say what most physicians are too nice to say. Medicine is not a democracy.

Read the rest.

PharmaGossip with some suggestions in the wake of the Avandia controversy

Acknowledge that your drug is not "God's Gift to Diabetics"
- Start proper mortality studies earlier
- Don't bully medics who raise legitimate concerns
- Don't promote the hell out of product and deny any issues exist.

Well said.

Is this hospitalist program in trouble?

Whether you’re job hunting or evaluating your own program, watch out for these red flags. From Today’s Hospitalist.

Fibrate review

Why are they so controversial after 40 years? What is their role today? Some answers are here in a review from Pharmacotherapy.

Whither the routine electrocardiogram?

Electrocardiograms were once performed on virtually all adult hospital admissions. Although that changed in the era of cost containment there may be legitimate indications for screening electrocardiography. This company promotes screening for kids and young adults. Kevin recently linked to this skeptical piece concerning the practice. Indeed, given the rarity with which a cardiac channelopathy would be detected and appropriately acted on in a healthy population one has to wonder about cost effectiveness.

On the other hand how good is the stethoscope (or, more to the point, the thing between the ear pieces) in those assembly line style athletic pre-participation school physicals? To address that concern, investigators have looked at not only EKGs but also routine limited echocardiography as part of pre-participation screening (Clin J. Sports Med.). By doing echos at $7.34 a whack (no doubt utilizing volunteers and loaner equipment) they were able to detect a sufficient number of abnormalities to conclude it was useful. More importantly they demonstrated very poor performance of physical examination. (By the way, here’s a nice review of the topic from Clinics in Sports Medicine and here’s the AHA 2007 update).

There is some evidence that silent electrocardiographic abnormalities are quite common in older folk and that such abnormalities portend mortality and functional decline. A more liberal strategy for admission electrocardiograms may be warranted in adult hospital admissions.

Update from Kevin here.

Where the grass is greener

Best places to practice, according to Medical Economics.

Varied reactions to the Avandia meta-analysis

---were cited in a report from DOC News. Despite widespread criticism of the meta-analysis lead author Steven E. Nissen thinks he’s had the last word:

"We're in a very tough quandary here in that we don't have the data that definitely answer the [heart attack] question," he says. "We just have the meta-analysis, which is all we're ever going to have because it looks like RECORD isn't going to give us the answer either."

And Dr. Sidney Wolfe, director of the Public Citizen Health Research Group implies that Avandia is useless with this statement:

"A diabetes drug is only important or effective if it prevents cardiovascular problems, and Avandia doesn't prevent them; if anything, it makes them worse," says Wolfe, who has called on the FDA to withdraw the drug, or at the very least issue a "black-box" warning about the heart attack risk.

Well, Dr. Wolfe, if prevention of cardiovascular disease is the only standard, what do you want to do about insulin?

When we’re forced to play insane quality games we make more mistakes

Of course we already knew this. Here’s even more evidence from the current issue of Chest.

Inventors of perpetual motion machine keep the world waiting

Orac has been following this story closely. Why doesn’t this get published in a reputable journal? And why don’t the independent observers come forward? Says Orac:

It must be that nasty conspiracy by the oil, coal, and natural gas companies whose livelihoods would be threatened by the Orbo. Yes, that's definitely it.

Ah, yes. Another example of financial conflicts of interest and the suppression of open science by evil industry.

Eastern religion is often sterilized for Western consumption

---and marketed as health methodology, science, self help or, as in the case of this recent Medscape article, stress management. The article, innocuously titled “Stress and the Mind”, reminds us that stress results from a mismatch between what we expect and what the environment delivers; that we can help reduce this stress by adjusting our own attitudes and expectations; that we should count our blessings and cultivate altruism.

Well, there are no overtly religious themes there. At first glance it sounds like nothing more than sage advice. But, on closer inspection, the article appears to be a promotional piece for Vedanta, an ancient branch of Hinduism. One of the problems with the piece is a lack of full disclosure. Although the article has a link to the vedantausa page (which itself appears to be almost stripped of religious references---one has to go deep into the website to find them) and, for purposes of attribution, an acknowledgement of Swami A. Parthasarathy there is no author information and there are no references (this may be a site error---the links don’t work!).

In Medscape of all places.

Scientology implicated in stabbings

---according to this report from the Sidney Morning Herald.

THE young woman needed psychiatric care, and she knew it. She tried to get help twice, but her Scientologist parents had a religious objection to psychiatric intervention.

Read the rest.

The American Medical Student Association flunks the Quackometer test

I’ve cited many examples of quackery promotion by the AMSA before, but have not subjected the organization to any sort of quantitative analysis. So, I decided to plug their url into the Quackometer and this is what I found:

This web site is using lots of alternative medicine terms. It is full of scientific jargon that is out of place and probably doesn't know the meaning of any of the terms. It shows no sceptical awareness and so should be treated with a suspicious mind.

Now the Quackometer, mind you, is an experiment in whether quacky web sites can be identified by automation. Take that for what it’s worth. But its “reading” on AMSA pretty well matches my own observations.

It's been a good week (nonmedical)

I had some time off last week, so my wife and I joined the RW sibs in our home town (and the place we generally converge for family reunions), St. Louis. In addition to family time the trip afforded me an opportunity to visit some old haunts and play with my Sony Cyber-shot, some results of which are shown. I could have spent an entire day or two grabbing images of the architectural wonders of my beloved St. Louis, but I tried the patience of my family just to get these. (They'd probably think I was being dorky).

Above is the view looking east down Market Street. Union Station is on the right. The building on the left in front of the Arch is the St. Louis Civil Courts building.

Below is Aloe Plaza, across Market Street from Union Station.

Finally, a shot of my kid bro showing off atop the steps of Brookings Hall on the beautiful campus of his alma mater, Washington University.

Introducing the Quackometer

Boy am I gonna have some fun with this.

The latest buzz on hospital medicine

---with hospitalist thought leader Bob Wachter. You can access his podcast interview at the SHM national meeting here. Interesting how his projections on the number of future hospitalists keep increasing.

When medical ingenuity outpaces bureaucracy

The government is not, and should not be, the final arbiter of medical progress. This is particularly true in the field of electrophysiology. Dr. Wes drives the point home as he comments on a New York Times article about government scrutiny of the profusion of devices and ablation procedures for atrial fibrillation:

The field of electrophysiology has a history of far-exceeding regulatory capabilities in the bureaucracy of government. Look at radiofrequency catheter ablation. If we hadn't moved from DC shock to radiofrequency energy sources, many, many more people would have been harmed during catheter ablation procedures. Doctors did this because it was safer for patients and less anxiety-provoking for them during the procedure - not because of governmental regulations.

Patient empowerment: can it go too far?

In the last 30 years or so we have moved from medical paternalism to medical consumerism. An About.com article entitled Are You an Empowered Patient...or a Pain in the Neck? addresses some unintended consequences. (Via Kevin M.D.).

Among the questions asked are Do You Bring in Pages of Printouts from the Internet?

If so, you could be interfering with the effectiveness of your visit. One of two things may happen: Your doctor may spend most of your appointment time reading through your printouts, or your doctor may decide that he/she doesn't have time to even look at the printouts at all, and ignore them completely.

I would add that if Internet homework presented at the appointment is to be anything more than a distraction it needs to be evidence based. But evidence based patient participation, as I demonstrated before, is arduous and requires a certain degree of skill. How many patients can do it?

Exchanging anecdotes: Sicko versus Dead Meat

Kurt Loder’s critical review of Michael Moore’s Sicko makes the case that the film is unbalanced and non-evidence based:

Unfortunately, Moore is also a con man of a very brazen sort, and never more so than in this film. His cherry-picked facts, manipulative interviews (with lingering close-ups of distraught people breaking down in tears) and blithe assertions (how does he know 18,000* people will die this year because they have no health insurance?) are so stacked that you can feel his whole argument sliding sideways as the picture unspools.

Moore and others clamor for universal access. But as Loder illustrates, in socialized healthcare systems this access is often merely access to waiting lists. That point is also well made in the 2005 documentary Dead Meat which portrays Canada’s system in a negative light.

When it comes right down to it, the two films constitute an exchange of anecdotes. A balanced view of the controversy might require viewing both.

Neuromuscular disorders in the ICU

Acute Neuromuscular Weakness In The Intensive Care Unit was reviewed in a recent issue of Critical Care Medicine.

Katrina charges against nurses dropped

---in exchange for their testimony in the continuing grand jury proceedings against Dr. Anna Pou. Via Forbes.

Forensic scientist tests DNA in her husband’s underwear

---to prove infidelity.

A state forensics scientist who said she tested DNA in her husband's underwear to find out whether he was cheating could be disciplined if investigators determine she violated the use of state equipment.

Her findings? “Another female. It wasn't me.”

P4P for patients

That’s what the Healthy Americans Act, S.334, cosponsored by Senators Bob Bennett (R-Utah) and Ron Wyden (D-Ore.) seems to offer. Patients would have financial incentives to lead healthy lifestyles.

Healthy behavior incentives are working in other countries around the world. For example, in Switzerland, where only 11 percent of GDP is spent on health care and everyone is required to purchase his own private health plan, competition has led to innovative incentives. Some plans offer lump-sum cash awards for those who stay healthy; others penalize unhealthy habits or behaviors.

People respond to incentives, and if there are incentives for individuals to stay healthy, we will make a significant difference in driving down health care costs. The Healthy Americans Act promotes personal responsibility and prevention by offering discounted premiums for participation in wellness programs and by rewarding providers for helping their patients stay healthy.

How are doctors reacting to the Avandia meta-analysis?

The July 1 issue of DOC News tackled that question. Doctors are reporting a range of actions:

Therein lies the dilemma for physicians: How should they advise the legions of patients calling with rosiglitazone questions? On one end of the spectrum, clinicians are watching and waiting. On the other end, they are taking all their patients off rosiglitazone, sometimes switching them to pioglitazone, and sometimes taking them off all TZDs. Physicians taking a middle-of-the-road position are discontinuing rosiglitazone only in patients with the highest cardiovascular disease (CVD) risk and more closely monitoring those who stay on the drug.

Some physicians are asking patients to make the decision. But how well can patients parse the evidence? How many patients can appreciate the methodological and statistical issues surrounding the meta-analysis and evaluate them in light of other evidence about TZDs and alternative treatments?

Dr. Curt Furberg of Wake Forest University seems to go a step beyond his editorial opinion in NEJM by suggesting that all patients be switched from Avandia.

"If my wife were on a TZD, I'd switch her," Furberg says. "You don't gamble when treating patients. You play it safe."

The blogosphere’s reaction to the Google health Advisory Council

Is it a case of sour grapes? The Open Medicine Blog wonders.

U.S. versus Canada in treatment of survivors of cardiac arrest

Survival of cardiac arrest due to ventricular arrhythmia not due to a transient or reversible cause is a slam-dunk indication for an implantable defibrillator. However, almost twice as many eligible patients in the U.S. receive this treatment as do those in Canada according to this report from CMAJ:

In Canada, 3793 patients survived to discharge after a cardiac arrest; 628 (16.6%) of these were implanted with a cardioverter defibrillator before discharge. The implant rate rose steadily from 5.4% in 1994/95 to 26.7% in 2002/03. In the United States, 23 688 (30.2%) of 78 538 such survivors received an implantable cardioverter defibrillator before discharge.

Scrubs for Sicko

Some healthcare workers are campaigning to promote the film.

AMSA teams with Michael Moore, lauds Sicko

From an AMSA press release:

Members of the American Medical Student Association (AMSA) joined nurses, survivors of the private health insurance industry, Michael Moore, and members of Congress in a historic hearing on the negative health impacts of the for-profit private insurance industry.

Here’s the rest.

Tinea pedis

Med Rants has done some research on treatment. One important reason to treat is the fact that many cases of lower leg cellulitis derive from tinea pedis.

Tips for cost effective inpatient medicine

In response to a reader's request DB of Med Rants posted these suggestions.

SHM 2007 blog

Highlights of the Society of Hospital Medicine 2007 meeting in Dallas were featured in a blog for those who missed the meeting or just want to keep up on the latest buzz.

NSAIDS new and old

In this VA population traditional NSAIDs were at least as risky for cardiovascular health as COX-2s as reported in the American Journal of Medicine.

I believe I’ve cited similar evidence before, have I not?

This blog isn’t dead

Right now I’m blogging as time and energy allow. It’s hard work being a hospitalist! More soon.

Avandia hype illustrates our loss of drug safety perspective

In their NEJM editorial, Psaty and Furberg lament the lack of evidence for macrovascular benefit from rosiglitazone (Avandia). What is missing from the discussion is the fact that NO pharmacologic treatment for type 2 diabetes, with the possible exceptions of pioglitazone and metformin, are associated with macrovascular benefit. In fact, as I posted before, older drugs for diabetes, sulfonylureas and possibly insulin, are associated with macrovascular harm. In this post I tried to make the point that the evidence for macrovascular harm including death from first generation sulfonylureas is much more robust than the evidence concerning Avandia.

More recently a post from Retired Doc made the point better than I did:

Over thirty years ago another medical publication dealt with a purported increase in cardio vascular deaths from an oral diabetic medication. The University Group Diabetes Program (UGDP) was presented at the June 1970 meeting of the American Diabetes Association. Data presented indicated that tolbutamide increased cardiovascular deaths by over two and half times. (RR of 2.61, CI-1.29-5.27)…….

The UGDP study in many ways presented more robust evidence that the Nissen article. It was a randomized clinical trial (Yes Virginia, clinical trials were done before the folks from Canada descended from the mountain with the precepts of EBM carved into stone) and the R.R. was greater than 2, a number less than which many epidemiologists put little weight as small RR's can be pushed around by small biases. Putting too much emphasis on medical analyses which derive RR's less than 2 has been a issue of interest to me for some time and I have ranted on about that before.

It’s a shame about medical reporting in the popular media. Medical information, more often than not, is presented superficially, as a series of isolated sound bites without perspective, proportionality or regard for prior research.

Are anticoagulants beneficial for venous thromboembolism?

For most of us the answer is yes, but not if you’re an EBM purist. Dr. David Cundiff has been stirring the pot by asking some tough questions about VTE treatment in a couple of articles in MedGenMed. Dr. Roy Poses cites the two articles in a recent Health Care Renewal post. Although, as he points out, these papers received no attention in the press, the first article caught my eye and was the subject of a post of mine in October 2005.

At that time I pointed out that although anticoagulant treatment of VTE is not “evidence based” in a strict sense, the totality of evidence in favor of anticoagulant treatment is compelling. I also cited this paper which is a must read if one wants a balanced and thorough analysis of the literature on this subject.

Dr. Poses, discussing conflicts of interest surrounding the debate, focuses on money. I believe, though, he placed too little emphasis on Dr. Cundiff’s non-financial conflict which I mentioned in my 2005 post.

Woo invades the ICU

---and what I always thought was a reputable, science based, no nonsense journal, Chest. And the example, a trial of sublingual homeopathic potassium dichromate in patients undergoing mechanical ventilation, was from a good while back, March of ’05, in fact. I’m surprised I missed this paper, ever watchful that I am for examples of woo invading mainstream medicine. None other than Retired Doc points us to the article. He writes:

The Journal does a disservice to its readers when it presents a homeopathic jargon filled discussion as if a scientific discussion is taking place. There was no editorial explaining the reasoning behind publishing such an article. One of the characteristics of science is its coherence. The sciences of pharmacology, physiology and toxicology build upon and are consistent with the laws of chemistry and physics. To talk about diluting a substance to the point where it is undetectable and then explaining how it works to heal flies in the face of the principles of those disciplines. It is too late to write a letter to the editor but I hope someone did.

Well, eventually some people did: Treating Critically Ill Patients with Sugar Pills. Like Retired Doc, the letter writers are surprised Chest would accept such a paper.

The authors of the paper, in effect, admit that the study drug is mere water with this statement:

Since the potentiation (dilution and vigorously shaking) of the study drug beyond the Avogadro number imposes no interaction with the patient’s metabolism, and due to the low cost of the drug, its use in the ICU may be beneficial, minimizing morbidity and mortality.

The fact that this paper appeared in Chest impresses me with just how deep pseudoscience has penetrated the mainstream. I’d have expected something like this in BMJ, but not the revered Chest!

The hazards of diabulimia

Insulin deprivation in type I diabetes has, somewhat simplistically, been likened to starvation. It’s no surprise, then, that a few weight obsessed type I diabetic teens got the idea to reduce or occasionally skip their insulin injections as a means of weight control.

According to a CNN report the practice is known as diabulimia and has, with the help of Internet message boards, become increasingly popular, tried by as many as one third of type I diabetic women in the U.S. The report highlights the addictive nature of the problem and the risk of microvascular complications when the behavior is sustained over time.

Unfortunately the piece falls short in explaining diabulimia’s effects on the body with statements such as: “When sugars are high, the kidneys work overtime to filter the excess glucose from the blood.” Not exactly. Just the opposite, if anything. The kidneys work overtime NOT to excrete glucose by revving up the process of proximal tubular reabsorption, the capacity of which is exceeded in hyperglycemia due to increased concentration of glucose in the glomerular filtrate. Hyperfiltration does in fact occur in early diabetic nephropathy, though lacking in any teliologic explanation that I am aware of and involving mechanisms incompletely understood.

Added to the risk of microvascular disease is the threat of ketoacidosis. If weight loss, especially rapid weight loss is one’s goal then ketosis, the “smoke” of burning fat, might be considered desirable. But the ketosis of uncontrolled type I diabetes differs in at least one important respect from that of fasting in the normal individual due to inability of a self-regulating feedback mechanism in type I diabetes as will be explained below.

Insulin’s anti-ketotic mechanism involves two molecular sites, the first of which is the adipocyte and the second of which is the mitochondrial membranes in the hepatocyte. Insulin’s action on the adipocyte is the inhibition of hormone sensitive lipase (HSL). In insulin lack (or, in stress, a reduction in the ratio of insulin to counter-regulatory hormones) HSL is activated, leading to breakdown of stored triglyceride to glycerol and free fatty acid (FFA). Insulin lack at the level of hepatocytes creates a “ketogenic mode” in the liver which allows the beta oxidation of FFA to ketone bodies. This occurs via activation of carnitine palmitoyltransferase-1 (CPT-1), an enzyme which mediates attachment of a carnitine molecule to the fatty acid thus enabling entry into the mitochondria for beta oxidation.

Non type 1 diabetics have endogenous insulin. Fasting in such individuals causes ketosis. However, ketone bodies and FFAs feed back on the pancreas causing it to secrete a small amount of insulin, enough to partially inhibit HSL, thus limiting the supply of FFA to the liver and preventing ketoacidosis. (Exceptions are lactation, late pregnancy and some instances of acute alcoholism, states in which this system of checks and balances is defective). In type 1 diabetics this feedback mechanism is unavailable due to an absolute, or nearly absolute, lack of endogenous insulin.

Via Kevin M.D. and Clinical Cases and Images.

The medical thought police are watching out for us

Just in case you didn’t know, a JAMA commentary provides this warning about things you can no longer say in public about U.S. health care:

There are 3 phrases that should and can no longer be said about the US health care system without qualification, embarrassment, criticism, or even denunciation: "The United States has the best health care system in the world," "Health care is special," and "New is better."

A disruptive physician

…advocates for patients and tells his story in Medical Economics.

Throwing the baby out with the bathwater

An OP-ED writer in the New York Times wants to eliminate all pharmaceutical industry support for accredited CME. I guess he wants to criminalize it---he calls it money laundering. He writes:

The solution could hardly be simpler: any continuing medical education that is paid for by the drug industry should not be accredited. Drug companies could still pay for any educational event, article or pamphlet they choose, but their courses and materials would no longer bear the imprimatur and implied credibility of accreditation.

Doctors, in turn, would be encouraged to seek medical education from sources that are not financed by drug companies. A renewed commitment to unbiased education would allow doctors to learn about drug risks sooner.

So, we are to believe that drug company support for accredited CME keeps doctors from learning about the risks of drugs. I wish Daniel Carlat, the author of the piece and a professor at Tufts Medical School, would provide evidence to back that incredible claim. The adverse lipid effects of Avandia, for example, were well known for several years. (Some time ago I linked to this review which cited Avandia’s well known adverse effects).

Carlat seems to believe, as implied by the title of his OP-ED piece, that drug companies have a conflict of interest concerning information about adverse drug effects. But common sense and history suggest the opposite: that it’s very much in industry’s interest for doctors to be informed about the hazards of drugs. It would certainly have been in the interest of American Home Products for doctors to know the hazards of Fen-phen. Johnson and Johnson is still paying for doctors’ failures to heed their package information and repeated letters about the hazards of cisapride. Pharmaceutical companies know all too well that if the message about drug hazards could be communicated effectively and responsibly they would not have to pay, in money and reputation, for so many doctors’ mistakes.

There must be a reasonable middle ground. Drug companies should not become the primary educators of doctors. But with appropriate safeguards industry support for CME can be beneficial.

Avandia: two questions

Health Care Renewal discusses the Avandia Spin Cycle and concludes that the Avandia discussions boil down to two questions:

The first question is clinical: what are the benefits and harms of rosiglitazone as a treatment of Type 2 diabetes, and therefore for which patients under what circumstances should this drug be used?

The second question is about policy: what barriers, if any, have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?

My take is that the first question is complex, and must be answered in light of what we know about all the other available options for type 2 diabetes. The meta-analysis has its problems and must be considered hypothesis generating. As I posted here there seem to be disparate effects on macrovascular disease between the two available TZDs, pioglitazone (Actose) and rosiglitazone (Avandia) which have a plausible basis due to differing effects on lipids and differing molecular mechanisms.

So how can we summarize and compare macrovascular outcomes associated with various treatments for DM-2?

Pioglitazone, the only TZD available other than rosiglitazone appears to reduce macrovascular events.

In the UKPDS metformin decreased stroke and all cause mortality in obese patients, but the overall results for metformin were not internally consistent.

Insulin therapy has not been demonstrated to halt macrovascular disease. There is evidence that intensive insulin treatment may in fact be associated with increased macrovascular disease but this is controversial.

The first generation sulfonylurea tolbutamide is associated with a marked increase in cardiovascular mortality in the UGDP trial. Other sulfonylureas carry the cardiovascular warning although they have not been similarly studied.

The clinical bottom line of all these findings is that macrovascular disease is an elusive target in DM-2 and choices of agents at this time must be governed by limited information.

Concerning the second question, barriers on both sides have prevented physicians and patients from getting the best possible answer regarding Avandia. GSK may have suppressed information and its defenders appear to have engaged in personal attacks on the lead author of the NEJM meta-analysis. On the other hand, the timing and manner of the release of the NEJM meta-analysis suggest a case of orchestrated hype.

Both sides have explaining to do. Although Dr. Nissen’s testimony in the Waxman hearing seemed evasive, he was frequently interrupted and not given a chance to elaborate on his answers. He should have the opportunity to convince us that the meta-analysis was not agenda driven.

Rise in opiate use over the last decade is dogma based medicine

In one of my recent rants about methadone I said this:

1999 was about the time pain management became politicized and activists were beating up on doctors for under treating pain. They pummeled us with arguments based 90% on dogma and 10% on science. They told us that the patient’s numeric rating of pain was “the fifth vital sign.” They redefined the concept of addiction to suit their agenda and told us that most instances of drug seeking behavior were in fact “pseudo addiction”, supposedly an indication to give more narcotics. A stable patient verbalizing “eight out of ten” pain was a medical emergency and a mandate for narcotics. Respiratory hazards were downplayed.

At least one expert shares my view. In a recent point-counterpoint in Internal Medicine News William O. Witt, M.D. from the University of Kentucky Medical Center at Lexington opined that today’s widespread opiate use is not evidence based and poses an increasing public health risk. He notes: “Whereas no one is advocating the elimination of opioids as a tool for treating chronic nonmalignant pain, we should demand at least the same rigor that we demand for other treatments.”

Heparin-induced thrombocytopenia review

There have been many reviews of heparin-induced thrombocytopenia (HIT) in the last few years. The latest is Heparin Induced Thrombocytopenia in Intensive Care Patients published in Critical Care Medicine, the full text of which was posted in Medscape May 4. This is one of the more comprehensive reviews I’ve seen, and features several new points of interest.

In cardiac surgery patients a fall in the platelet count is expected in the first four postoperative days and is unlikely to be HIT, whereas HIT is much more likely the cause of thrombocytopenia on days 5-14, often manifested as a second fall during recovery from the initial thrombocytopenia.

Unusual presentations are highlighted (thrombosis before overt thrombocytopenia, systemic inflammatory reactions moments following heparin exposure in patients with pre-existing antibodies, adrenal crisis due to adrenal hemorrhage).

Disseminated intravascular coagulation has been reported in 10-20% of cases of HIT, potentially confounding both the diagnosis of HIT and the laboratory monitoring of patients treated with alternative anticoagulants.

Advantages and disadvantages of the various alternative anticoagulants are discussed.

The approach to patients with possible HIT but isolated thrombocytopenia (i.e. no thrombosis) is controversial. Use of the clinical probability score is helpful, and in some patients who merit treatment beyond merely stopping heparin, the authors favor lower dose regimens of alternative anticoagulants.

The duration of alternative anticoagulant therapy and the optimal timing to initiate warfarin are discussed.

Raw data speak louder than spin in tort reform debate

Just look at the numbers. Via Kevin M.D.

Calling off the dogs in the Avandia controversy

Two medical bloggers whom I deeply respect have lamented the deterioration of the public conversation on Avandia. Dr. Roy Poses of Health Care Renewal writes about intimidation by drug companies to suppress information and personal attacks on Dr. Steve Nissen (author of the controversial NEJM Avandia meta-analysis) by individuals with drug company ties.

DB of Med Rants writes:

This should remain a scientific debate. Unfortunately it has become a political debate. Guess what the culprit really is - $$$$$$$$.

Yes, this should have been a scientific debate. Unfortunately, the way the meta-analysis was presented, scientific debate never stood a chance. Politics and money have, to a degree, aligned on opposite sides of the controversy and both are culpable.

Dr. Poses wants to “call off the dogs”. But, unfortunately, once dogs on both sides of the issue have been released into the arena of public debate it may be too late too call them off.

What we need to be asking is how scientific discussion got stifled in the first place. Let’s go back to the beginning. We don’t have details about what transpired between Dr. Nissen and politicians on Capital Hill in the weeks leading up to the release of the meta-analysis. We do know that the meta-analysis and an accompanying editorial by drug safety crusaders with an agenda to reform the FDA were released on line for open access ahead of print without sufficient public health urgency. Worse, according to this Heartwire report the release was timed to precede by two days an anticipated FDA safety report on Avandia. (By Dr. Nissen’s own admission in his testimony before Waxman’s congressional hearing the FDA had all the data he had and more). Moreover, according to Dr. Scott Gottlieb’s Wall Street Journal article Waxman issued a press release immediately after the release of the meta-analysis, suggesting that the whole hyped up mess was orchestrated. (I was unable to find a press release from Waxman on line. However, this press release from the Senate Finance Committee, issued the same day as the meta-analysis, seems a little too detailed and lengthy not to have been planned. Also, this press release from Senator Kennedy appeared the day after the meta-analysis, and this one from Cleveland Clinic appeared the day of).

So I’ll reserve final judgment, as there are some unknowns here, but from where I sit this looks like a case of calculated hype. Among many potential players we don’t know which ones played major roles. And though there are many potential conflicts of interest we can only speculate on the actual ones. Dr. Nissen’s situation, for example, is complex. Were his conflicts political? I don’t know his political leanings. Was it a case of self promotion, or zeal to trump the FDA? (By his own admission the FDA was better equipped than he to analyze Avandia’s risk, so why didn’t he just wait and let the agency do its work?). Financial considerations could have been at play. Dr. Nissen has had ties to Takeda pharmaceuticals, makers of Avandia’s direct competitor Actose, the only other TZD approved in the U.S. (According to this Fox News piece new prescriptions for Actose jumped 50% following release of the meta-analysis).

Unfortunately this mess is self-reinforcing. Propaganda begets propaganda, and there’s been plenty on both sides. I have no pharmaceutical industry ties. Dr. Poses and others have done a commendable job of exposing the pharmaceutical industry’s dirty tricks. The focus of my blog has been non-industry related conflicts of interest. This is not out of any desire to defend the drug companies or minimize problems related to their influence. It is an attempt to balance the debate by addressing a selective outrage which seems to blame industry for virtually all the problems facing health care and under-recognizes other conflicts.

More here from Kevin M.D.

A glimpse of Giuliani’s health care proposal

Giuliani hasn’t announced the details yet but we can get an idea here.

Giuliani said he would give families a $15,000 tax credit to purchase private insurance policies and allow them to keep whatever credit remains as an incentive to purchase cost-effective plans. "If we can empower 30 million, 40 million, 50 million and eventually 100 million Americans to be able to go out and make these choices, you're going to have the free market accomplish the thing that only a free market can accomplish -- and that is, lower costs and better quality," Giuliani said in an interview on the Sean Hannity radio program.

Via Kaiser Network.

Internal medicine professor longs for the days of The House of God

He’s not particularly happy with house staff work hour restrictions. He concludes:

Thus, from its roots as a patient-centered, education-oriented year of learning, the medical internship has evolved into a laboratory-centered, algorithm-oriented, technology-driven, computer-dependent, Internet-based, “treat first, diagnose later” training program. Consequently, we are exchanging sleep-deprived healers for a cadre of wide-awake technicians who cannot take an adequate medical history, cannot perform a reliable physical examination, cannot critically assess information they gather, cannot create a sound management plan, have little reasoning power, and communicate poorly.

Read the rest.

Electrophysiology roundup

A recent review from the Journal of the American College of Cardiology on developments in the field of electrophysiology during the year 2006 was posted in Medscape May 21. I thought it was worth linking here, as it contains several items of general clinical interest. Some highlights follow.

Cardiac channel disorders continue to garner interest. Despite the discovery of new mutations leading to the long QT syndrome (LQTS) some 25% of patients with LQTS have no identifiable genetic abnormality. Brugada syndrome is increasingly well understood. The channelopathies of Brugada syndrome appear to cause a gradient between endocardium and epicardium caused by disparities in phase 1 of their respective action potentials. In contrast to the LQTS, relatively few patients with Brugada syndrome (20%-30%) have an identified genetic abnormality.

One study referenced in the review is interesting, to me anyway, not because of any immediate clinical relevance but because it’s an example herbal research done right. Investigators created a Brugada syndrome phenotype in isolated perfused canine right ventricular tissue. Drawing on prior research showing that dimethyl lithospermate B (dmLSB), a minor component of the root extract of the Danshen plant, is capable of decreasing inactivation of the sodium current INa, the researchers demonstrated reversal of the Brugada phenotype by adding dmLSB to the perfusate. Basic research such as this may pave the way for novel drug therapies for cardiac channelopathies

Recent research in Brugada syndrome has also made it increasingly evident that the electrocardiographic findings may fluctuate over time, often necessitating multiple tracings to diagnose, classify and risk stratify patients.

Genetic abnormalities, both germ line and somatic, also underlie non lethal conditions. Recent findings relating to genetic causes of sick sinus syndrome and somatic mutations in atrial fibrillation were presented.

Finally, nonantiarrhythmic drugs are increasingly being found to prevent arrhythmias. A meta-analysis cited in the review found that treatment with angiotensin converting enzyme inhibitors and angiotensin receptor blockers decreases the new onset of atrial fibrillation in patients with and without heart failure. The review cited prior studies indicating that statin drugs prevent atrial fibrillation and a recent study of patients with coronary artery disease and implanted defibrillators showing that administration of 80mg daily of atorvastatin decreases episodes of device intervention by 50%.

Scrupulosity in dealing with pharmaceutical companies may have unappreciated costs and unintended consequences

----which are largely ignored by the proponents. Richard Epstein provides a balanced view in his contribution to the conflict of interest symposium.

Observations on the Avandia hearings

I just got a chance to view a portion of the Avandia hearings. A video of the hearing along with transcripts of opening statements can be accessed here. I would urge anyone who’s interested in this debate to view the hearing and the transcripts in the original before accepting what I or any other blogger has to say about it.

One of the panel members mentioned that Dr. Scott Gottlieb’s Wall Street Journal piece is now on line (in full text) at the American Enterprise Institute web site. He writes:

NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's "handling" of the drug safety issues.

Under questioning from Congressman Waxman Dr. Nissen (author of the NEJM meta-analysis) confirmed that he had informed congress about the meta-analysis. Dr. Nissen was questioned extensively by multiple members of the committee. When asked repeatedly why he conferred with members of congress and did not notify the FDA he talked around the question with responses such as “I put people above politics”. The only reason he seemed able to give was that he wanted help in gathering data for his research.

Nissen indicated that he provided his preliminary analysis on Avandia to members of Congress in February. Why didn’t he go to the FDA? Because “that’s not how it’s done.” He also pointed out that they already had the data. True, but they didn’t have the results of the meta-analysis.

In his defense of not going to the FDA Nissen testified that the FDA already had much more data than he had access to. Well, if his purpose was to get missing data, again it begs the question, why didn’t he go to the FDA? Apparently because the FDA is not allowed to release that information. News to me, but perhaps so. But if the FDA had everything he had and more why not wait for them to release their analysis before submitting his meta-analysis to NEJM?

What bothers me more than anything is that a clinical investigator goes to politicians for help in researching for a scientific publication. I had to replay the video two or three times to be sure I heard correctly. Astounding. I’d say that fact should have been included in Dr. Nissen’s disclosure statement.

What are the active ingredients of homeopathy?

I always thought homeopathic medication was nothing but water, so this title from Biomed Central Complementary and Alternative Medicine naturally caught my eye: Homeopathy – what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions. Expecting the latest woo based explanation I was surprised at paper’s results (italics mine)---

Putative active ingredients included the patients' "openness to the mind-body connection", consultational empathy, in-depth enquiry into bodily complaints, disclosure, the remedy matching process and, potentially, the homeopathic remedies themselves.

This paper, largely promotional and uncritical, (the lead author practices homeopathy and the paper contains numerous homeopathy promoting statements) lends insight into the mind of homeopathic practitioners. There is, for example, this revealing statement:

The relative contributions of remedy and context cannot be distinguished either in real-world homeopathy or in this study. Most homeopaths behave as if the remedy is the main active ingredient.

So, the authors seem to acknowledge that any benefits of homeopathy likely derive as much from the empathy and engagement of the practitioner as from the medication (the “remedy”) itself.

So what’s the take home message here? How do these observations inform the debate on homeopathy? From the paper’s abstract:

These findings counsel against the use of placebo-controlled RCT designs in which both arms would potentially be receiving specific active ingredients. Future research in homeopathy should focus on pragmatic trials and seek to confirm or refute the therapeutic role of constructs such as patient "openness", disclosure and homeopathicity.

In other words, don’t study the efficacy of the homeopathic medication with other variables (e.g. practitioner engagement and empathy) controlled. This mindset is already pervasive in much of CAM “research”. Orac provided a good example recently, citing a study of the benefits of Tai Chi which failed to control for the effects of exercise.

I wouldn’t be all hot and bothered, merely amused, by this paper were it not for this statement from Biomed Central Complementary and Alternative Medicine’s masthead: BMC Complementary and Alternative Medicine (ISSN 1472-6882) is indexed/tracked/covered by PubMed, MEDLINE, CAS, Scopus, EMBASE and Google Scholar. Which means, of course, that innumerable woo based papers will be legitimized and, worse, find their way into systemic reviews and meta-analyses.

Res Ipsa Loquitur?

The West Virginia Record has this to day about a lawsuit over post surgical complications (italics mine):

According to the lawsuit, Christy was admitted to Thomas Memorial on May 24, 2006, and was treated for chronic diverticulitis. Kyer performed an elective sigmoid resection by laparoscopic means. Christy was released on May 28, 2006. However, on June 2, 2006, he went to the emergency room, complaining of severe abdominal pain. He was admitted and a CT scan revealed a free intraperitoneal error.

Post hoc ergo propter hoc and product liability

A man sues Novartis after drinking Boost Plus and developing priapism.

Radioactive iodine treatment for hyperthyroidism and the risk of cancer

In the May 15 issue of Cancer is a 10 year follow up report on patients treated with radioactive iodine (RAI) for hyperthyroidism, showing an excess in cancer incidence. There was a 5 year latent period after treatment before increasing cancer rates began to be seen. The absolute risk was low, with the number needed to harm being 418.

How does a medical journal manage to get sued for libel?

By not being evidence based in its reporting. It apparently happened to the British Medical Journal (BMJ). BMJ settled with Dr. Matthias Rath for £100,000 under the offer of amends procedure. The libel action was over a BMJ news story alleging that Dr. Rath improperly pressured parents to refuse treatment for a 9 year old boy, resulting in his death.

What’s ironic is that this is the second time BMJ, widely regarded as a scholarly journal and a champion of evidence based medicine, has been called out for faulty reporting. The other instance occurred in 2005 when a BMJ news story alleged that damaging drug company documents “went missing” in a product liability case. Following a complaint from the company BMJ, after investigating the matter, issued a correction and apology.

Via Kevin M.D.

This won’t help declining AMA membership

The president of the AMA applauds Michael Moore’s Sicko even though he hasn’t seen it.

But many others, including those in the medical community, are hoping Moore will help make a difference. "Anything—including a film—that can bring this issue into the public eye is good for the debate," says heart surgeon Dr. William Plested, president of the American Medical Assn. "So, I'm cheering on Michael Moore, even though I haven't seen the film."

Via Kevin M.D.

New details of Flea’s trial offer yet another lesson in smart blogging

Recent discussions of blogging hazards have focused on patient confidentiality, saying things you wouldn’t want your boss to read and, most recently, blogging about your malpractice trial. But new revelations about Flea’s trial raise another hazard that has received little attention up to now.

The New York Personal Injury Law Blog reports that the plaintiff’s attorney

…..scoured his blog for helpful information, much the way any attorney would review writings produced by a witness for the other side. She found a post where Flea referred to Nelson’s Pediatrics as the bible of pediatrics. (I have the 11th ed. from 1979 on my own bookshelf.) So she asked him on the witness stand if he considered Nelson's the bible for pediatrics. He said no. Lawyers call that a "prior inconsistent statement" that allows us to confront the witness with the other statement. That meant asking him if he was Flea and confronting him with the blog posting.

We tend to regard clinical topics as safe blogging material. Flea’s case tells us that’s not necessarily so. Clinical opinions, or opinions about text books and other clinical references, particularly strong declarative statements, could be used against you as a defendant when the clinical topic is relevant to the case you’re defending.

What’s a blogger to do? First and foremost, whether you’re anonymous or open don’t be dogmatic or absolute. Clinical medicine, after all, isn’t that way. It is subtle and nuanced, so be subtle and nuanced in your discussions. Be careful how you describe clinical references. Up to Date may be helpful at the point of care but it’s not “authoritative”. Harrison’s textbook may be a useful reference but it’s not “the bible”.

Kevin and his commenters have more.

How did plaintiff attorney find Flea’s blog?

The clue may have been an image of a rusty padlock. Read more from the New York Personal Injury Law Blog, then follow the link to Google’s cache of Flea’s blog, April 28 post.

The swinging pendulum of steroids in ARDS

Now I’m confused. Early high dose (30mg/kg/day) methylprednisolone for ARDS was popular until debunked in the early 1980s. More recently lower doses of methylprednisolone for late stage ARDS was popularized until the publication last year of negative results from an ARDSnet trial. But now, in the April issue of Chest, comes this study looking at even lower dose (1mg/kg/day infusion) methylprednisolone used early in ARDS:

In intention-to-treat analysis, the response of the two groups (63 treated and 28 control) clearly diverged by day 7, with twice the proportion of treated patients achieving a 1-point reduction in LIS (69.8% vs 35.7%; p = 0.002) and breathing without assistance (53.9% vs 25.0%; p = 0.01). Treated patients had significant reduction in C-reactive protein levels, and by day 7 had lower LIS and multiple organ dysfunction syndrome scores. Treatment was associated with a reduction in the duration of mechanical ventilation (p = 0.002), ICU stay (p = 0.007), and ICU mortality (20.6% vs 42.9%; p = 0.03). Treated patients had a lower rate of infections (p = 0.0002), and infection surveillance identified 56% of nosocomial infections in patients without fever.

A wide range of etiologies of ARDS was represented. 41% had pneumonia and 13% had extrapulmonary sepsis. Extrapulmonary and direct pulmonary etiologies of ARDS were equally represented.

A related editorial, Corticosteroids for ARDS: Just do it!, is strongly in favor of the protocol and cites other supporting literature. It stresses counter measures against the adverse effects of corticosteroids such as routine infection surveillance and glycemic control.

Web resources on mycology and fungal infections at Dr. Fungus

Dr. Fungus features images, web casts (some with CME credit), power point presentations and much more, including a scholarly debunking of “Candida hypersensitivity” woo.

The latest flap over Rate MDs

---comes from Australia. The Australian Medical Association wants the site closed.

Blog smart, blog safe

In the wake of Flea’s difficulties Clinical Cases and Images offers some timely advice on smart, safe blogging. Clinical Cases and Images is an examplar of smart blogging from design to content. The authors are open about who they are and their institutional affiliation. It’s one the blogs I trust so I thought I’d mention the post here, which advises us thusly:

I would encourage anybody to write a blog if they have something interesting to say and add value to the online conversation. Just be smart about it. Write to share and educate not to blow off steam. We live in a Google world. What you post online today can come back tomorrow to haunt you.

For me, not blowing off steam doesn’t mean we shouldn’t express strong opinions. My rule is to try and back up opinions with evidence, avoid personal attacks and avoid references to local health care issues.

Other tips:

- Write as if your boss and your patients are reading your blog every day
- Comply with HIPAA
- Do not blog anonymously. List your name and contact information
- If your blog is work-related, it is probably better to let your employer know
- Use a disclaimer, e.g. " All opinions expressed here are those of their authors and not of their employer. Information provided here is for medical education only. It is not intended as and does not substitute for medical advice."

Whether it’s best to blog anonymously is a point of controversy, but recent events have shown us that the veil of anonymity is thin.

Thrombotic microangiopathies

Do you know them from ADAM? (ADAM TS-13, that is). I stumbled on this review which, although a bit dated, provides an explanation of the pathophysiology, very helpful in understanding the distinctions between HUS and TTP as well as the rationale for treatment.

Emergency Medicine on the Web

A vast collection of links useful in emergency medicine, critical care and hospital medicine. Due to site redevelopment there may be some dead links for a while.

Deleting blog content safely

In a post yesterday about Flea’s legal difficulties I mentioned the fact that deletion of blog content is not entirely safe because it is preserved in Google’s cache and can easily be searched. Today I found this post from Cathy at I’m a Blogaholic which provides a workaround.

The workaround takes advantage of the fact that Google’s cache periodically updates its snapshot of your web page. Simply modify the post or posts in question in a way that removes content you consider risky or renders it harmless. Then wait a few days for Google to update the cache (you can search the cached content to verify that the update took place). Then delete. The same strategy works for blog lines.

The Internet Archive Wayback Machine is more problematic because it saves all the old copies of your site. If you’re lucky, the objectionable content will miss the archive, which updates at discrete points in time at variable intervals. Fortunately it’s fairly difficult to find specific content in the Wayback Machine. It’s not retrieved by Google, and the Wayback Machine itself can’t be searched by text or titles---the url must be entered.

Did NEJM and politically motivated whistleblowers conspire to upstage the FDA on Avandia?

The May 30 Heartwire report on fallout from the Avandia controversy (to which I linked earlier today) suggests so:

But new reports go one step further--suggesting that FDA whistleblowers coordinated with politicians critical of the agency and the study authors to get damaging data into the public arena before the FDA could issue a safety statement on rosiglitazone.

The Heartwire report is based on the Wall Street Journal editorial I linked here. That editorial was written by former FDA deputy commissioner Scott Gottlieb. In an earlier post I puzzled over NEJM’s decision for early open access release of the meta-analysis and related editorial. A timeline of events according to the Heartwire report, based on the WSJ editorial, suggests a reason for the decision: since the print release of the meta-analysis and editorial was not due until June 14 it was the only way to upstage the FDA safety evaluation, due out just two days later, May 23. The choice of Bruce Psaty and Curt Furberg to write the editorial would dovetail nicely with such a strategy, as these authors are well known critics of the FDA.

The question of the early open release nags. If not to discredit the FDA then why? According to the Heartwire report:

Gottlieb says the NEJM claims to have made the decision to publish quickly because of the medical importance of the research but, if that were the case, he wonders why it did not inform the FDA about its publication or the findings.

Indeed. Medically important research, maybe, but not a public health emergency. If the meta-analysis findings are to be believed the number needed to harm for rosiglitazone must be on the order of 1000, and that’s over months to years of treatment. If that’s the standard for early release it’s a new standard. Under such a standard virtually every paper in clinical epidemiology which shows a significant difference in event rates would merit early release.

Avandia and the drive-by media

As I experience the barrage of hype about the Avandia meta-analysis the term drive-by media comes to mind. According to the Urban Dictionary drive-by media means---

Rush Limbaugh's term for the sensational, scandal-seeking, and agenda-driven coverage that is typical of the national press corps in America. Limbaugh draws an analogy between the media who cover a story with a barrage of unfair cheap shots before moving on to the next flavor of the month and an inner city gang that drives by and sprays a target with gunfire and then moves on to their next target.

Media coverage of Avandia that’s fair, that has any depth at all, would have to include these little known facts:

1) The ADOPT and DREAM studies did not show increased macrovascular risk for rosiglitazone. The small increase in cardiac events was attributable to heart failure precipitated by renal and metabolic effects leading to fluid retention and not indicative of an adverse macrovascular effect. The risk of fluid retention was previously known and is adequately addressed in current product labeling.
2) According to a recent Heartwire piece an interim safety review of the ongoing RECORD study reveals no adverse safety signal for rosiglitazone.
3) The same Heartwire article also notes that the data safety monitoring boards of two other ongoing rosiglitazone studies (BARI 2D and ACCORD) have found no safety concerns.
4) The landmark UGDP study, a randomized prospective trial of cardiovascular outcomes associated with various treatments for type 2 diabetes, showed a highly statistically significant increase in cardiovascular death associated with the first generation sulfonylurea tolbutamide compared to placebo or insulin. This was (according to product labeling) a greater than two fold increase in cardiovascular death, mind you, a finding much more concerning than those of the Avandia meta-analysis which found no statistically significant increase in cardiovascular death. Whether the currently popular new generation sulfonylureas carry similar risk is controversial---head to head studies haven’t been done---but the newer sulfonylureas carry the boxed warning. Here is the one for glimepiride (Amaryl). (Why aren’t the media mentioning a possible two fold increase in risk of cardiovascular death? Shouldn’t they be advising patients taking sulfonylureas to ask their doctor?).

Not all newspaper reports were so distorted. One Wall Street Journal report apparently got some things right. And the drive-by label is not restricted to newspapers. It could apply to medical journals and blogs when the shoe fits.

Electrocardiographic findings in pulmonary embolism and acute coronary syndrome

Due to overlapping clinical presentations acute coronary syndrome (ACS) and pulmonary embolism (PE) can be confused. Moreover, both can be associated with electrocardiographic manifestations (T wave abnormality), elevated troponin levels (present in 42% of patients with PE in this study), and elevated d-dimer levels.

This case report (free full text after registration) illustrates disastrous consequences of massive PE mistaken for ACS. The electrocardiogram shown in the case report displayed findings which could be attributed to either ACS or PE. And while the tracing had a few previously described “red flags” for PE the elecrocardiographic distinction between ACS and PE had not been systematically studied as far as I am aware.

That’s why this paper from the March 15 issue of the American Journal of Cardiology is important. The authors studied patients with either ACS or PE who had T wave inversion on consecutive precordial leads. Among the findings: “In patients with APE, negative T waves were commonly present in leads II, III, aVF, V1, and V2, but were less frequent in leads I, aVL, and V3 to V6” and “Negative T waves in leads III and V1 were observed in only 1% of patients with ACS compared with 88% of patients with APE”. The sensitivity for PE in patients showing negative T waves in both III and V1 must be interpreted with caution, since the study population consisted only of patients with precordial lead T wave inversion. The sensitivity of the finding among PE patients in general is low. A normal electrocardiogram does not rule out PE. Nevertheless the findings of this paper should prove useful in distinguishing between ACS and PE in patients who have precordial T wave abnormality.

Viral glomerulopathy

Hepatitis B, Hepatitis C, HIV and the kidney. Via CCJM.

Central venous catheterization

Nice review in Critical Care Medicine.

Details unfold about Flea’s day in court

The New York Personal Injury Law Blog, to which I linked earlier today, wrote a follow up post in which he reported that the hard copy of the Boston Globe story is on the front page above the fold for all of Flea’s friends, family and patients to see. A big list of links can be found there.

He provided information on two other questions: What was the timing of the take down of Flea’s blog in relation to the events at trial? Who is the guy pictured at the upper left of Flea’s blog?

Finally, he provided a little reminder. Don’t think your risk is eliminated when you take down your blog. An update of his original post has this link to Google’s cache of Flea’s site.

Bacdground:

Kevin updated his post here.

The other Flea.

An attorney weighs in on Flea’s malpractice settlement

As Kevin reported earlier this morning, pediatrician blogger Flea settled his medical malpractice case the morning after his blog was revealed in trial. A New York attorney reflects on what it means:

The issues I raised, in the event plaintiffs' counsel discovered his blog, ran to the risks of losing his attorney-client privilege for all such communications. If this happened, he could be cross-examined on how he was coached by his defense team to act in front of the jury and the advice they gave him. He also ran the risk of his own insurance carrier trying to disclaim coverage if it thought he was hindering the defense.

Chilling indeed.

Colchicine for acute pericarditis

It’s old and off label, but is emerging as the best treatment.

CCJM review.

CCJM editorial outlining precautions against adverse effects.

The COPE trial.

What would you do if you encountered a patient with avian influenza?

I’ve referenced many reviews on this topic, but this one is the first to cover practical aspects of management and infection control.

A clinician needs to be a good observer

So test your powers of observation with this quiz.

Journalistic malpractice?

From the Wall Street Journal:

The behavior of the New England Journal of Medicine (NEJM) is a case in point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug ...

Via Kevin M.D.

Some ER docs are gonna be hopping mad

….about this New York Times article on tPA for stroke. It’s full of distortions and misstatements although it makes one interesting (and controversial) assertion, which is that defensive medicine is a significant reason for under treatment of patients:

Dr. Richard Burgess, a member of Dr. Warach’s stroke team, explained the situation: There is no particular penalty for not giving tPA. Doctors are unlikely to be sued if the patient dies or is left with brain damage that could have been avoided. But there is a penalty for giving tPA to someone who is not having a stroke. If that patient bleeds into the brain, the drug not only caused a tragic outcome but the doctor could also be sued. Few emergency room doctors want to take that chance.

Through several dramatic stroke anecdotes the piece, with little apparent regard for perspective or accuracy, paints tPA as some sort of miracle drug. Here are some of the distortions.

Doctors are therefore reluctant to give the only drug shown to make a real difference, tPA, or tissue plasminogen activator. The only drug shown to make a real difference? Wrong. Aspirin is associated with improved outcomes and reduced mortality in the first few weeks. This, in fact, is more than can be said for tPA, which does not reduce mortality.


Although tPA was shown in 1996 to save lives and prevent brain damage… Since the article contains no citations to back up its assertions I can only guess that this statement refers to the NINDS study, even though that study was published in 1995, not 1996. The study, the only large randomized trial to show benefit from tPA, showed no statistically significant reduction in mortality. The title of the NYT piece, Lost Chances for Survival, Before and After Stroke, also deceptively implies that tPA is life saving.

Concerning the evaluation of patients for tPA treatment, the article says Many hospitals say they cannot afford to have neurologists on call to diagnose strokes, and cannot afford to have M.R.I. scanners, the most accurate way to diagnose strokes, for the emergency room. Nonsense. The widely accepted guidelines for the use of tPA, which are based on clinical assessment and CT imaging, mention no role for MRI scans.

There’s more. Although the New York Times is widely regarded as a reputable source of medical news this particular NYT piece is yet another example of how scientific issues are distorted when discussed in popular media.

Grand Rounds 3.36

…is up at From Medskool.

Greedy Trial Lawyer distorts my comments on Avandia controversy

Today the Greedy Trial Lawyer referenced my discussion on the Avandia hype and built, then easily ridiculed, this straw man:

Dr. RW has a valid point. I am sick and tired of all this gibberish about medicine clogging up the media. What this country needs is a separation of scientific discourse (including medicine) from the public. What possible good comes from public awareness and discussion of scientific matters? We should ban any scientific thought and discourse by anyone without a Dr. before his name.

Heck, I don’t care whether you have Dr. before your name if you want to discuss science. The real points of my argument, which Greedy Trial Lawyer didn’t address, were these:

Scientific discussion was hijacked by CNN, the New York Times, activists and trial lawyers. (Do I really have to explain what’s so wrong with that?).

The “jury verdict” on Avandia was in within hours of the release of the scientifically flawed NEJM meta-analysis.

The irresponsible media hype surrounding Avandia jeopardized not only reasoned scientific discussion but also an important and much needed clinical trial whose future is now in question.

Public Citizen on Avandia: We told you so

The Public Citizen Health Research Group took advantage of the Avandia controversy for a little self congratulation, saying in effect “We told you so”. But that may be a little deceptive. What they actually told us about was stuff we already knew and had addressed, principally related to the problem of fluid retention which can exacerbate heart failure, and which in no way anticipated the concerns raised by the NEJM meta-analysis.

Worse, they come just short of advising patients to unilaterally discontinue Avandia with this statement: We strongly urge patients - as we have for almost two and a half years - not to use this drug. Wouldn't it suffice to say "ask your doctor"?

Tabloid based medicine trumps evidence based medicine

Mere moments following NEJM’s release of the Avandia meta-analysis and editorial there were millions of Google search queries for Avandia according to a recent post from Clinical Cases and Images. Malpractice attorney ads began appearing only hours later. Hype spreads more rapidly than nuanced critical analysis. So, long before defects in the paper had a chance to be exposed, the popular media, consumer activists and the trial lawyers had taken over the debate. Within hours Avandia was the new Vioxx. More recently we have learned that the ongoing prospective RECORD trial, designed to look at macrovascular outcomes in patients taking Avandia, is in jeopardy (hat tip to Kevin M.D.) due to patients dropping out as a result of the publicity. Something’s terribly wrong with this picture.

Some are accusing NEJM as being like a tabloid and PharmaGossip proposes a new cover style. Is NEJM deserving of the tabloid label? In my considered opinion, yes, for two reasons. First, the journal could have published a more critical, less inflammatory editorial. Even worse was the journal’s decision for early open access release of the paper and editorial. Such a tactic might be appropriate for a public health emergency such as the SARS outbreak. This is not SARS. This is not a public health emergency.

Clearly tabloid based medicine has trumped evidence based medicine and done much harm. I have repeatedly argued that discussions of science are corrupted when played out in the arena of public debate. The Avandia controversy is a case in point.

Is low molecular weight heparin better than unfractionated heparin for VTE prophylaxis?

The best regimen for VTE prophylaxis is controversial. Some recent research helps clarify but does not completely settle the controversy. This study in Thrombosis Journal evaluated outcomes in patients with a variety of medical conditions who received VTE prophylaxis with either the low molecular weight heparin (LMWH) enoxaparin versus unfractionated heparin (UH). There was a markedly reduced incidence of VTE in the enoxaparin group with no difference in adverse effects. The study received support from Aventis Pharmaceuticals, makers of enoxaparin. A potential weakness in this retrospective study is the lack of control over the doses of UH and LMWH. On the other hand it reflects real world use of the agents.

Then there was this prospective randomized open label study of enoxaparin versus UH for VTE prophylaxis in post-stroke patients presented at the American Stroke Association last February, showing a lower rate of VTE with enoxaparin and no difference in bleeding rates. This study, entitled Prevention of VTE After Acute Ischemic Stroke with Low-Molecular-Weight-Heparin Enoxaparin (PREVAIL), was also sponsored by Aventis. One weakness of this study, some might argue, is that it set up a straw man by testing enoxaparin against what some experts assume to be a less than optimal dose of UH (5000 units bid). However, this recent meta-analysis in Chest questions that assumption in that, in medical patients, the higher dose of UF, 5000 units tid, was no better than bid despite a higher bleeding rate.

Although the issue remains controversial, recent data suggest superiority of LMWH over UH for VTE prophylaxis in a variety of settings.

Anaphylaxis

Atypical presentations. Southern Medical Journal.